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FDA, FTC uniting to promote biosimilars
The Food and Drug Administration is collaborating with the Federal Trade Commission (FTC) to expand the biosimilars market.
The two agencies signed a joint statement on Feb. 3, 2020, outlining four sets of goals aimed at creating meaningful competition from biosimilars against their reference biologic products.
“Competition is key for helping American patients have access to affordable medicines,” FDA Commissioner Stephen Hahn, MD, said in a statement. “Strengthening efforts to curtail and discourage anticompetitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”
“We appreciate and applaud the FDA and FTC in recognizing that biosimilar development and approval has not been as robust as many stakeholders had hoped,” said Colin Edgerton, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We continue to see anticompetitive activities that prevent manufacturers from developing biosimilar products. We hope that a greater focus on these practices will pave the way for more biosimilars to be developed.”
The statement highlighted four goals. First is that the agencies will coordinate to promote greater competition in the biologic market, including the development of materials to educate the market about biosimilars. The FDA and FTC also will be sponsoring a public workshop on March 9 to discuss competition for biologics.
“This workshop is the first step,” Dr. Edgerton said. “ACR will continue to work with other organizations and patient groups to help educate providers and patients on the scientific rigor that is required in developing and approving biosimilars. Additionally, we look forward to working with the FDA and FTC to continue this conversation on ways to encourage more development of biosimilar products and greater education for the providers and patients.”
The second goal has the FDA and FTC working together “to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars,” the joint statement notes.
Third, the agencies will crack down on “false or misleading communications about biologics, including biosimilars, within their respective authorities,” according to the joint statement.
“FDA and FTC, as authorized by their respective statutes, will work together to address false or misleading communications about biologics, including biosimilars,” the statement continues. “In particular, if a communication makes a false or misleading comparison between a reference product and a biosimilar in a manner that misrepresents the safety or efficacy of biosimilars, deceives consumers, or deters competition, FDA and FTC intend to take appropriate action within their respective authorities. FDA intends to take appropriate action to address such communications where those communications have the potential to impact public health.”
Finally, the FTC committed to review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.
Dr. Edgerton highlighted why this agreement between the two agencies is so important.
“Biologics are life-changing treatments for many of our patients,” he said. “Due to the high cost of discovery and development, the cost of biologics has resulted in delayed access and financial hardships for so many. It has always been our hope that biosimilars would offer the same life-changing treatment for patients at a lower price point. A robust biosimilars market is imperative to allow greater access to these treatments that can help patients to have a better quality of life.”
Separately, the FDA issued a draft guidance document for comment on manufacturers seeking licensure of biosimilar products that do not cover all the approved uses of the reference product, as well as how to add uses over time that were not part of the initial license of the biosimilar product. The draft guidance covers licensure of products, labeling of biosimilars with fewer indications than the reference product, supplemental applications for indications not on the initial biosimilar application but covered by the reference product, and the timing of applications.
The FDA notes in the draft guidance that this is needed to cover situations such as when some indications on the reference product are covered by exclusivity, although it does encourage a biosimilar manufacturer to seek licensure for all indications that the reference product does have.
The Food and Drug Administration is collaborating with the Federal Trade Commission (FTC) to expand the biosimilars market.
The two agencies signed a joint statement on Feb. 3, 2020, outlining four sets of goals aimed at creating meaningful competition from biosimilars against their reference biologic products.
“Competition is key for helping American patients have access to affordable medicines,” FDA Commissioner Stephen Hahn, MD, said in a statement. “Strengthening efforts to curtail and discourage anticompetitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”
“We appreciate and applaud the FDA and FTC in recognizing that biosimilar development and approval has not been as robust as many stakeholders had hoped,” said Colin Edgerton, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We continue to see anticompetitive activities that prevent manufacturers from developing biosimilar products. We hope that a greater focus on these practices will pave the way for more biosimilars to be developed.”
The statement highlighted four goals. First is that the agencies will coordinate to promote greater competition in the biologic market, including the development of materials to educate the market about biosimilars. The FDA and FTC also will be sponsoring a public workshop on March 9 to discuss competition for biologics.
“This workshop is the first step,” Dr. Edgerton said. “ACR will continue to work with other organizations and patient groups to help educate providers and patients on the scientific rigor that is required in developing and approving biosimilars. Additionally, we look forward to working with the FDA and FTC to continue this conversation on ways to encourage more development of biosimilar products and greater education for the providers and patients.”
The second goal has the FDA and FTC working together “to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars,” the joint statement notes.
Third, the agencies will crack down on “false or misleading communications about biologics, including biosimilars, within their respective authorities,” according to the joint statement.
“FDA and FTC, as authorized by their respective statutes, will work together to address false or misleading communications about biologics, including biosimilars,” the statement continues. “In particular, if a communication makes a false or misleading comparison between a reference product and a biosimilar in a manner that misrepresents the safety or efficacy of biosimilars, deceives consumers, or deters competition, FDA and FTC intend to take appropriate action within their respective authorities. FDA intends to take appropriate action to address such communications where those communications have the potential to impact public health.”
Finally, the FTC committed to review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.
Dr. Edgerton highlighted why this agreement between the two agencies is so important.
“Biologics are life-changing treatments for many of our patients,” he said. “Due to the high cost of discovery and development, the cost of biologics has resulted in delayed access and financial hardships for so many. It has always been our hope that biosimilars would offer the same life-changing treatment for patients at a lower price point. A robust biosimilars market is imperative to allow greater access to these treatments that can help patients to have a better quality of life.”
Separately, the FDA issued a draft guidance document for comment on manufacturers seeking licensure of biosimilar products that do not cover all the approved uses of the reference product, as well as how to add uses over time that were not part of the initial license of the biosimilar product. The draft guidance covers licensure of products, labeling of biosimilars with fewer indications than the reference product, supplemental applications for indications not on the initial biosimilar application but covered by the reference product, and the timing of applications.
The FDA notes in the draft guidance that this is needed to cover situations such as when some indications on the reference product are covered by exclusivity, although it does encourage a biosimilar manufacturer to seek licensure for all indications that the reference product does have.
The Food and Drug Administration is collaborating with the Federal Trade Commission (FTC) to expand the biosimilars market.
The two agencies signed a joint statement on Feb. 3, 2020, outlining four sets of goals aimed at creating meaningful competition from biosimilars against their reference biologic products.
“Competition is key for helping American patients have access to affordable medicines,” FDA Commissioner Stephen Hahn, MD, said in a statement. “Strengthening efforts to curtail and discourage anticompetitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”
“We appreciate and applaud the FDA and FTC in recognizing that biosimilar development and approval has not been as robust as many stakeholders had hoped,” said Colin Edgerton, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We continue to see anticompetitive activities that prevent manufacturers from developing biosimilar products. We hope that a greater focus on these practices will pave the way for more biosimilars to be developed.”
The statement highlighted four goals. First is that the agencies will coordinate to promote greater competition in the biologic market, including the development of materials to educate the market about biosimilars. The FDA and FTC also will be sponsoring a public workshop on March 9 to discuss competition for biologics.
“This workshop is the first step,” Dr. Edgerton said. “ACR will continue to work with other organizations and patient groups to help educate providers and patients on the scientific rigor that is required in developing and approving biosimilars. Additionally, we look forward to working with the FDA and FTC to continue this conversation on ways to encourage more development of biosimilar products and greater education for the providers and patients.”
The second goal has the FDA and FTC working together “to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars,” the joint statement notes.
Third, the agencies will crack down on “false or misleading communications about biologics, including biosimilars, within their respective authorities,” according to the joint statement.
“FDA and FTC, as authorized by their respective statutes, will work together to address false or misleading communications about biologics, including biosimilars,” the statement continues. “In particular, if a communication makes a false or misleading comparison between a reference product and a biosimilar in a manner that misrepresents the safety or efficacy of biosimilars, deceives consumers, or deters competition, FDA and FTC intend to take appropriate action within their respective authorities. FDA intends to take appropriate action to address such communications where those communications have the potential to impact public health.”
Finally, the FTC committed to review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.
Dr. Edgerton highlighted why this agreement between the two agencies is so important.
“Biologics are life-changing treatments for many of our patients,” he said. “Due to the high cost of discovery and development, the cost of biologics has resulted in delayed access and financial hardships for so many. It has always been our hope that biosimilars would offer the same life-changing treatment for patients at a lower price point. A robust biosimilars market is imperative to allow greater access to these treatments that can help patients to have a better quality of life.”
Separately, the FDA issued a draft guidance document for comment on manufacturers seeking licensure of biosimilar products that do not cover all the approved uses of the reference product, as well as how to add uses over time that were not part of the initial license of the biosimilar product. The draft guidance covers licensure of products, labeling of biosimilars with fewer indications than the reference product, supplemental applications for indications not on the initial biosimilar application but covered by the reference product, and the timing of applications.
The FDA notes in the draft guidance that this is needed to cover situations such as when some indications on the reference product are covered by exclusivity, although it does encourage a biosimilar manufacturer to seek licensure for all indications that the reference product does have.
Welcome Editorial
It’s an honor and a great pleasure to take on this new role as editor in chief for Hematology News. When I got the call from our outgoing editor Matt Kalaycio, MD, a year ago asking me to consider stepping into his shoes a few things flashed through my mind. Will I do this role justice? Do I have what it takes to be a great editor in chief?
Then I thought – will there be time to learn the ropes or will this be like most of my career positions where you jump into the water first and figure out how to swim later? I never once thought: “Oh no … I cannot do this and I’m going to say no!” So here I am today, reporting for duty as the editor in chief of Hematology News.
I was once accused of being “intellectually restless” which is a badge I wear with honor and is perhaps a trait I learned from my mom who was a public health nurse in Nigeria back in the seventies. She broke a lot of glass ceilings in her day – Cornell University–trained advanced practice nurse, mother of five girls, with a degree in textile and design and business accounting. She also got a certificate in baking and cake decorating and she used all her skills and certifications to raise her daughters to believe the sky was the limit.
Mom started one of the first licensed practical nursing (LPN) schools in Nigeria and I learned from her to never back down from a challenge – on a dare I got my LPN certification before I went to medical school.
You see I love a challenge and an adventure and serving as the editor in chief for Hematology News provides me with an amazing platform and opportunity to achieve a lot of firsts and satisfy that hunger to make a global difference that has always guided my career.
I’ve thought long and hard about what and how I envision this role shaping out. What do I want our readers to take away from this newspaper under my leadership? What common themes will be woven in every edition? I want our readers to be challenged and keep learning. Not just about hematologic disorders and the latest scientific breakthroughs that drive improved patient outcomes for blood disorders but also about the intersectionality between hematology and other life disciplines.
I remember taking an art class in high school learning about dimensions and proportions of buildings and I dreamt of becoming an architect. Fast forward 2 decades later, I attended a medical conference at Georgia Institute of Technology in Atlanta and was enthralled at how various sessions demonstrated how art, engineering and architecture played a role in the development and design of orthopedic prosthesis used in amputees. I learned how engineering shaped our understanding of microfluidics, something that is now being leveraged in drug delivery science and in the field of hematology.
I want our readers to keep learning not just from esteemed scientists and clinicians but from various stakeholders – the patient, the high school student, the spouse of the hematologist, not to mention our residents and fellows, who are the future of our discipline. Furthermore, I want our readers to see the human side of hematology – the face behind the scientist or clinician and the reality of what joys and tolls we experience in this field.
A Fall 2019 Medscape survey cited the prevalence of physician burnout among hematology oncology physicians: 32% of oncologists were burned out, 4% were depressed, and 9% were both burned out and depressed. These are statistics that cannot be ignored or minimized a they ultimately have a profound impact on patient outcomes. You see, I really believe that much of the success we have in healing our patients relies not just on the medications we prescribe or on the procedures we perform or the science we leverage. Much of healing in medicine and in hematology is based on the secret sauce of being humane – defined by Merriam-Webster dictionary as the character trait that is “marked by demonstrating compassion, sympathy, or consideration for humans or animals.”
So, to sum up what to expect in the coming year from your editor in chief? Look out for some thought-provoking, fun, and unusual perspectives that are aimed to keep us learning, growing, and remaining humane in our interactions with our patients, each other, but more importantly with ourselves. #bringit2020 #HematologyNews #NewEditorInChiefPerspectives.
Ifeyinwa (Ify) Osunkwo, MD, MPH, is a professor of medicine and the director of the Sickle Cell Disease Enterprise at the Levine Cancer Institute, Atrium Health, Charlotte, N.C. She is the editor in chief of Hematology News.
It’s an honor and a great pleasure to take on this new role as editor in chief for Hematology News. When I got the call from our outgoing editor Matt Kalaycio, MD, a year ago asking me to consider stepping into his shoes a few things flashed through my mind. Will I do this role justice? Do I have what it takes to be a great editor in chief?
Then I thought – will there be time to learn the ropes or will this be like most of my career positions where you jump into the water first and figure out how to swim later? I never once thought: “Oh no … I cannot do this and I’m going to say no!” So here I am today, reporting for duty as the editor in chief of Hematology News.
I was once accused of being “intellectually restless” which is a badge I wear with honor and is perhaps a trait I learned from my mom who was a public health nurse in Nigeria back in the seventies. She broke a lot of glass ceilings in her day – Cornell University–trained advanced practice nurse, mother of five girls, with a degree in textile and design and business accounting. She also got a certificate in baking and cake decorating and she used all her skills and certifications to raise her daughters to believe the sky was the limit.
Mom started one of the first licensed practical nursing (LPN) schools in Nigeria and I learned from her to never back down from a challenge – on a dare I got my LPN certification before I went to medical school.
You see I love a challenge and an adventure and serving as the editor in chief for Hematology News provides me with an amazing platform and opportunity to achieve a lot of firsts and satisfy that hunger to make a global difference that has always guided my career.
I’ve thought long and hard about what and how I envision this role shaping out. What do I want our readers to take away from this newspaper under my leadership? What common themes will be woven in every edition? I want our readers to be challenged and keep learning. Not just about hematologic disorders and the latest scientific breakthroughs that drive improved patient outcomes for blood disorders but also about the intersectionality between hematology and other life disciplines.
I remember taking an art class in high school learning about dimensions and proportions of buildings and I dreamt of becoming an architect. Fast forward 2 decades later, I attended a medical conference at Georgia Institute of Technology in Atlanta and was enthralled at how various sessions demonstrated how art, engineering and architecture played a role in the development and design of orthopedic prosthesis used in amputees. I learned how engineering shaped our understanding of microfluidics, something that is now being leveraged in drug delivery science and in the field of hematology.
I want our readers to keep learning not just from esteemed scientists and clinicians but from various stakeholders – the patient, the high school student, the spouse of the hematologist, not to mention our residents and fellows, who are the future of our discipline. Furthermore, I want our readers to see the human side of hematology – the face behind the scientist or clinician and the reality of what joys and tolls we experience in this field.
A Fall 2019 Medscape survey cited the prevalence of physician burnout among hematology oncology physicians: 32% of oncologists were burned out, 4% were depressed, and 9% were both burned out and depressed. These are statistics that cannot be ignored or minimized a they ultimately have a profound impact on patient outcomes. You see, I really believe that much of the success we have in healing our patients relies not just on the medications we prescribe or on the procedures we perform or the science we leverage. Much of healing in medicine and in hematology is based on the secret sauce of being humane – defined by Merriam-Webster dictionary as the character trait that is “marked by demonstrating compassion, sympathy, or consideration for humans or animals.”
So, to sum up what to expect in the coming year from your editor in chief? Look out for some thought-provoking, fun, and unusual perspectives that are aimed to keep us learning, growing, and remaining humane in our interactions with our patients, each other, but more importantly with ourselves. #bringit2020 #HematologyNews #NewEditorInChiefPerspectives.
Ifeyinwa (Ify) Osunkwo, MD, MPH, is a professor of medicine and the director of the Sickle Cell Disease Enterprise at the Levine Cancer Institute, Atrium Health, Charlotte, N.C. She is the editor in chief of Hematology News.
It’s an honor and a great pleasure to take on this new role as editor in chief for Hematology News. When I got the call from our outgoing editor Matt Kalaycio, MD, a year ago asking me to consider stepping into his shoes a few things flashed through my mind. Will I do this role justice? Do I have what it takes to be a great editor in chief?
Then I thought – will there be time to learn the ropes or will this be like most of my career positions where you jump into the water first and figure out how to swim later? I never once thought: “Oh no … I cannot do this and I’m going to say no!” So here I am today, reporting for duty as the editor in chief of Hematology News.
I was once accused of being “intellectually restless” which is a badge I wear with honor and is perhaps a trait I learned from my mom who was a public health nurse in Nigeria back in the seventies. She broke a lot of glass ceilings in her day – Cornell University–trained advanced practice nurse, mother of five girls, with a degree in textile and design and business accounting. She also got a certificate in baking and cake decorating and she used all her skills and certifications to raise her daughters to believe the sky was the limit.
Mom started one of the first licensed practical nursing (LPN) schools in Nigeria and I learned from her to never back down from a challenge – on a dare I got my LPN certification before I went to medical school.
You see I love a challenge and an adventure and serving as the editor in chief for Hematology News provides me with an amazing platform and opportunity to achieve a lot of firsts and satisfy that hunger to make a global difference that has always guided my career.
I’ve thought long and hard about what and how I envision this role shaping out. What do I want our readers to take away from this newspaper under my leadership? What common themes will be woven in every edition? I want our readers to be challenged and keep learning. Not just about hematologic disorders and the latest scientific breakthroughs that drive improved patient outcomes for blood disorders but also about the intersectionality between hematology and other life disciplines.
I remember taking an art class in high school learning about dimensions and proportions of buildings and I dreamt of becoming an architect. Fast forward 2 decades later, I attended a medical conference at Georgia Institute of Technology in Atlanta and was enthralled at how various sessions demonstrated how art, engineering and architecture played a role in the development and design of orthopedic prosthesis used in amputees. I learned how engineering shaped our understanding of microfluidics, something that is now being leveraged in drug delivery science and in the field of hematology.
I want our readers to keep learning not just from esteemed scientists and clinicians but from various stakeholders – the patient, the high school student, the spouse of the hematologist, not to mention our residents and fellows, who are the future of our discipline. Furthermore, I want our readers to see the human side of hematology – the face behind the scientist or clinician and the reality of what joys and tolls we experience in this field.
A Fall 2019 Medscape survey cited the prevalence of physician burnout among hematology oncology physicians: 32% of oncologists were burned out, 4% were depressed, and 9% were both burned out and depressed. These are statistics that cannot be ignored or minimized a they ultimately have a profound impact on patient outcomes. You see, I really believe that much of the success we have in healing our patients relies not just on the medications we prescribe or on the procedures we perform or the science we leverage. Much of healing in medicine and in hematology is based on the secret sauce of being humane – defined by Merriam-Webster dictionary as the character trait that is “marked by demonstrating compassion, sympathy, or consideration for humans or animals.”
So, to sum up what to expect in the coming year from your editor in chief? Look out for some thought-provoking, fun, and unusual perspectives that are aimed to keep us learning, growing, and remaining humane in our interactions with our patients, each other, but more importantly with ourselves. #bringit2020 #HematologyNews #NewEditorInChiefPerspectives.
Ifeyinwa (Ify) Osunkwo, MD, MPH, is a professor of medicine and the director of the Sickle Cell Disease Enterprise at the Levine Cancer Institute, Atrium Health, Charlotte, N.C. She is the editor in chief of Hematology News.
Late effects in young cancer survivors underscore importance of high-risk screening
according to data from the Childhood Cancer Survivor Study.
At a median follow-up of 21 years, the SMR for all-cause mortality was 5.9 among survivors aged 15-20 years and 6.2 among diagnosis-matched children under 15 years, compared with expected rates at the same ages in the general population. For health-related causes – excluding primary cancer recurrence or progression but including late effects of cancer therapy – the SMRs were 4.8 in the older group and 6.8 in the younger group.
Eugene Suh, MD, of Loyola University Chicago Medical Center, Maywood, Ill., and colleagues reported these results in Lancet Oncology.
The difference between the older and younger survivors (n = 5,804 in each group) was most evident at least 20 years after cancer diagnosis, the authors noted.
For both groups, but more so for childhood cancer survivors, the risk of developing any chronic health condition and any grade 3-5 health condition was greater than for siblings of the same age who did not have cancer (hazard ratios, 4.2 for adolescents/young adults and 5.6 for childhood survivors). The same was true for grade 3-5 cardiac conditions (HRs, 4.3 and 5.6, respectively), endocrine conditions (HRs, 3.9 and 6.4, respectively), and musculoskeletal conditions (HRs, 6.5 and 8.0, respectively).
These findings, which confirm those of previous studies suggesting that younger children might be more vulnerable to the adverse effects of cancer treatment, “underscore that focused efforts are needed to ensure early-adolescent and young adult cancer survivors are receiving recommended risk-based care, with a focus on high-risk cancer screening, to reduce morbidity and premature mortality,” the researchers concluded, noting that “studies to date indicate that adherence to such high-risk screening is poor.”
In a related editorial, Päivi Lähteenmäki, MD, PhD, of University of Turku (Finland) and Turku University Hospital, wrote that these findings warrant long-term follow-up of adolescent and young adult cancer survivors. She also argued that the results “might not be fully generalizable to patients treated today who might be on different treatment regimens to those treated in previous decades” and that “[m]ore prospectively collected objective data focusing on survivors ... are needed.”
Accurate characterization of patients at high risk who would benefit from a tailored screening program is most important, and identifying underlying genetic or molecular factors that confer higher risk for late sequelae would be useful for “planning approaches to survivorship,” Dr. Lähteenmäki added.
This study was funded by the National Cancer Institute and American Lebanese-Syrian Associated Charities. Dr. Suh and Dr. Lähteenmäki reported having no competing interests.
SOURCES: Suh E et al. Lancet Oncology. 2020 Feb 14. doi: 10.1016/S1470-2045(19)30800-9;Lähteenmäki P. Lancet Oncol. 2020 Feb 14. doi: 10.106/S1470-2045(19)30858-7.
according to data from the Childhood Cancer Survivor Study.
At a median follow-up of 21 years, the SMR for all-cause mortality was 5.9 among survivors aged 15-20 years and 6.2 among diagnosis-matched children under 15 years, compared with expected rates at the same ages in the general population. For health-related causes – excluding primary cancer recurrence or progression but including late effects of cancer therapy – the SMRs were 4.8 in the older group and 6.8 in the younger group.
Eugene Suh, MD, of Loyola University Chicago Medical Center, Maywood, Ill., and colleagues reported these results in Lancet Oncology.
The difference between the older and younger survivors (n = 5,804 in each group) was most evident at least 20 years after cancer diagnosis, the authors noted.
For both groups, but more so for childhood cancer survivors, the risk of developing any chronic health condition and any grade 3-5 health condition was greater than for siblings of the same age who did not have cancer (hazard ratios, 4.2 for adolescents/young adults and 5.6 for childhood survivors). The same was true for grade 3-5 cardiac conditions (HRs, 4.3 and 5.6, respectively), endocrine conditions (HRs, 3.9 and 6.4, respectively), and musculoskeletal conditions (HRs, 6.5 and 8.0, respectively).
These findings, which confirm those of previous studies suggesting that younger children might be more vulnerable to the adverse effects of cancer treatment, “underscore that focused efforts are needed to ensure early-adolescent and young adult cancer survivors are receiving recommended risk-based care, with a focus on high-risk cancer screening, to reduce morbidity and premature mortality,” the researchers concluded, noting that “studies to date indicate that adherence to such high-risk screening is poor.”
In a related editorial, Päivi Lähteenmäki, MD, PhD, of University of Turku (Finland) and Turku University Hospital, wrote that these findings warrant long-term follow-up of adolescent and young adult cancer survivors. She also argued that the results “might not be fully generalizable to patients treated today who might be on different treatment regimens to those treated in previous decades” and that “[m]ore prospectively collected objective data focusing on survivors ... are needed.”
Accurate characterization of patients at high risk who would benefit from a tailored screening program is most important, and identifying underlying genetic or molecular factors that confer higher risk for late sequelae would be useful for “planning approaches to survivorship,” Dr. Lähteenmäki added.
This study was funded by the National Cancer Institute and American Lebanese-Syrian Associated Charities. Dr. Suh and Dr. Lähteenmäki reported having no competing interests.
SOURCES: Suh E et al. Lancet Oncology. 2020 Feb 14. doi: 10.1016/S1470-2045(19)30800-9;Lähteenmäki P. Lancet Oncol. 2020 Feb 14. doi: 10.106/S1470-2045(19)30858-7.
according to data from the Childhood Cancer Survivor Study.
At a median follow-up of 21 years, the SMR for all-cause mortality was 5.9 among survivors aged 15-20 years and 6.2 among diagnosis-matched children under 15 years, compared with expected rates at the same ages in the general population. For health-related causes – excluding primary cancer recurrence or progression but including late effects of cancer therapy – the SMRs were 4.8 in the older group and 6.8 in the younger group.
Eugene Suh, MD, of Loyola University Chicago Medical Center, Maywood, Ill., and colleagues reported these results in Lancet Oncology.
The difference between the older and younger survivors (n = 5,804 in each group) was most evident at least 20 years after cancer diagnosis, the authors noted.
For both groups, but more so for childhood cancer survivors, the risk of developing any chronic health condition and any grade 3-5 health condition was greater than for siblings of the same age who did not have cancer (hazard ratios, 4.2 for adolescents/young adults and 5.6 for childhood survivors). The same was true for grade 3-5 cardiac conditions (HRs, 4.3 and 5.6, respectively), endocrine conditions (HRs, 3.9 and 6.4, respectively), and musculoskeletal conditions (HRs, 6.5 and 8.0, respectively).
These findings, which confirm those of previous studies suggesting that younger children might be more vulnerable to the adverse effects of cancer treatment, “underscore that focused efforts are needed to ensure early-adolescent and young adult cancer survivors are receiving recommended risk-based care, with a focus on high-risk cancer screening, to reduce morbidity and premature mortality,” the researchers concluded, noting that “studies to date indicate that adherence to such high-risk screening is poor.”
In a related editorial, Päivi Lähteenmäki, MD, PhD, of University of Turku (Finland) and Turku University Hospital, wrote that these findings warrant long-term follow-up of adolescent and young adult cancer survivors. She also argued that the results “might not be fully generalizable to patients treated today who might be on different treatment regimens to those treated in previous decades” and that “[m]ore prospectively collected objective data focusing on survivors ... are needed.”
Accurate characterization of patients at high risk who would benefit from a tailored screening program is most important, and identifying underlying genetic or molecular factors that confer higher risk for late sequelae would be useful for “planning approaches to survivorship,” Dr. Lähteenmäki added.
This study was funded by the National Cancer Institute and American Lebanese-Syrian Associated Charities. Dr. Suh and Dr. Lähteenmäki reported having no competing interests.
SOURCES: Suh E et al. Lancet Oncology. 2020 Feb 14. doi: 10.1016/S1470-2045(19)30800-9;Lähteenmäki P. Lancet Oncol. 2020 Feb 14. doi: 10.106/S1470-2045(19)30858-7.
FROM LANCET ONCOLOGY
As costs for neurologic drugs rise, adherence to therapy drops
For their study, published online Feb. 19 in Neurology, Brian C. Callaghan, MD, of the University of Michigan, Ann Arbor, and colleagues looked at claims records from a large national private insurer to identify new cases of dementia, Parkinson’s disease, and neuropathy between 2001 and 2016, along with pharmacy records following diagnoses.
The researchers identified more than 52,000 patients with neuropathy on gabapentinoids and another 5,000 treated with serotonin-norepinephrine reuptake inhibitors for the same. They also identified some 20,000 patients with dementia taking cholinesterase inhibitors, and 3,000 with Parkinson’s disease taking dopamine agonists. Dr. Callaghan and colleagues compared patient adherence over 6 months for pairs of drugs in the same class with similar or equal efficacy, but with different costs to the patient.
Such cost differences can be stark: The researchers noted that the average 2016 out-of-pocket cost for 30 days of pregabalin, a drug used in the treatment of peripheral neuropathy, was $65.70, compared with $8.40 for gabapentin. With two common dementia drugs the difference was even more pronounced: $79.30 for rivastigmine compared with $3.10 for donepezil, both cholinesterase inhibitors with similar efficacy and tolerability.
Dr. Callaghan and colleagues found that such cost differences bore significantly on patient adherence. An increase of $50 in patient costs was seen decreasing adherence by 9% for neuropathy patients on gabapentinoids (adjusted incidence rate ratio [IRR] 0.91, 0.89-0.93) and by 12% for dementia patients on cholinesterase inhibitors (adjusted IRR 0.88, 0.86-0.91, P less than .05 for both). Similar price-linked decreases were seen for neuropathy patients on SNRIs and Parkinson’s patients on dopamine agonists, but the differences did not reach statistical significance.
Black, Asian, and Hispanic patients saw greater drops in adherence than did white patients associated with the same out-of-pocket cost differences, leading the researchers to note that special care should be taken in prescribing decisions for these populations.
“When choosing among medications with differential [out-of-pocket] costs, prescribing the medication with lower [out-of-pocket] expense will likely improve medication adherence while reducing overall costs,” Dr. Callaghan and colleagues wrote in their analysis. “For example, prescribing gabapentin or venlafaxine to patients with newly diagnosed neuropathy is likely to lead to higher adherence compared with pregabalin or duloxetine, and therefore, there is a higher likelihood of relief from neuropathic pain.” The researchers noted that while combination pills and extended-release formulations may be marketed as a way to increase adherence, the higher out-of-pocket costs of such medicines could offset any adherence benefit.
Dr. Callaghan and his colleagues described as strengths of their study its large sample and statistical approach that “allowed us to best estimate the causal relationship between [out-of-pocket] costs and medication adherence by limiting selection bias, residual confounding, and the confounding inherent to medication choice.” Nonadherence – patients who never filled a prescription after diagnosis – was not captured in the study.
The American Academy of Neurology funded the study. Two of its authors reported financial conflicts of interest in the form of compensation from pharmaceutical or device companies. Its lead author, Dr. Callaghan, reported funding for a device maker and performing medical legal consultations.
SOURCE: Reynolds EL et al. Neurology. 2020 Feb 19. doi/10.1212/WNL.0000000000009039.
For their study, published online Feb. 19 in Neurology, Brian C. Callaghan, MD, of the University of Michigan, Ann Arbor, and colleagues looked at claims records from a large national private insurer to identify new cases of dementia, Parkinson’s disease, and neuropathy between 2001 and 2016, along with pharmacy records following diagnoses.
The researchers identified more than 52,000 patients with neuropathy on gabapentinoids and another 5,000 treated with serotonin-norepinephrine reuptake inhibitors for the same. They also identified some 20,000 patients with dementia taking cholinesterase inhibitors, and 3,000 with Parkinson’s disease taking dopamine agonists. Dr. Callaghan and colleagues compared patient adherence over 6 months for pairs of drugs in the same class with similar or equal efficacy, but with different costs to the patient.
Such cost differences can be stark: The researchers noted that the average 2016 out-of-pocket cost for 30 days of pregabalin, a drug used in the treatment of peripheral neuropathy, was $65.70, compared with $8.40 for gabapentin. With two common dementia drugs the difference was even more pronounced: $79.30 for rivastigmine compared with $3.10 for donepezil, both cholinesterase inhibitors with similar efficacy and tolerability.
Dr. Callaghan and colleagues found that such cost differences bore significantly on patient adherence. An increase of $50 in patient costs was seen decreasing adherence by 9% for neuropathy patients on gabapentinoids (adjusted incidence rate ratio [IRR] 0.91, 0.89-0.93) and by 12% for dementia patients on cholinesterase inhibitors (adjusted IRR 0.88, 0.86-0.91, P less than .05 for both). Similar price-linked decreases were seen for neuropathy patients on SNRIs and Parkinson’s patients on dopamine agonists, but the differences did not reach statistical significance.
Black, Asian, and Hispanic patients saw greater drops in adherence than did white patients associated with the same out-of-pocket cost differences, leading the researchers to note that special care should be taken in prescribing decisions for these populations.
“When choosing among medications with differential [out-of-pocket] costs, prescribing the medication with lower [out-of-pocket] expense will likely improve medication adherence while reducing overall costs,” Dr. Callaghan and colleagues wrote in their analysis. “For example, prescribing gabapentin or venlafaxine to patients with newly diagnosed neuropathy is likely to lead to higher adherence compared with pregabalin or duloxetine, and therefore, there is a higher likelihood of relief from neuropathic pain.” The researchers noted that while combination pills and extended-release formulations may be marketed as a way to increase adherence, the higher out-of-pocket costs of such medicines could offset any adherence benefit.
Dr. Callaghan and his colleagues described as strengths of their study its large sample and statistical approach that “allowed us to best estimate the causal relationship between [out-of-pocket] costs and medication adherence by limiting selection bias, residual confounding, and the confounding inherent to medication choice.” Nonadherence – patients who never filled a prescription after diagnosis – was not captured in the study.
The American Academy of Neurology funded the study. Two of its authors reported financial conflicts of interest in the form of compensation from pharmaceutical or device companies. Its lead author, Dr. Callaghan, reported funding for a device maker and performing medical legal consultations.
SOURCE: Reynolds EL et al. Neurology. 2020 Feb 19. doi/10.1212/WNL.0000000000009039.
For their study, published online Feb. 19 in Neurology, Brian C. Callaghan, MD, of the University of Michigan, Ann Arbor, and colleagues looked at claims records from a large national private insurer to identify new cases of dementia, Parkinson’s disease, and neuropathy between 2001 and 2016, along with pharmacy records following diagnoses.
The researchers identified more than 52,000 patients with neuropathy on gabapentinoids and another 5,000 treated with serotonin-norepinephrine reuptake inhibitors for the same. They also identified some 20,000 patients with dementia taking cholinesterase inhibitors, and 3,000 with Parkinson’s disease taking dopamine agonists. Dr. Callaghan and colleagues compared patient adherence over 6 months for pairs of drugs in the same class with similar or equal efficacy, but with different costs to the patient.
Such cost differences can be stark: The researchers noted that the average 2016 out-of-pocket cost for 30 days of pregabalin, a drug used in the treatment of peripheral neuropathy, was $65.70, compared with $8.40 for gabapentin. With two common dementia drugs the difference was even more pronounced: $79.30 for rivastigmine compared with $3.10 for donepezil, both cholinesterase inhibitors with similar efficacy and tolerability.
Dr. Callaghan and colleagues found that such cost differences bore significantly on patient adherence. An increase of $50 in patient costs was seen decreasing adherence by 9% for neuropathy patients on gabapentinoids (adjusted incidence rate ratio [IRR] 0.91, 0.89-0.93) and by 12% for dementia patients on cholinesterase inhibitors (adjusted IRR 0.88, 0.86-0.91, P less than .05 for both). Similar price-linked decreases were seen for neuropathy patients on SNRIs and Parkinson’s patients on dopamine agonists, but the differences did not reach statistical significance.
Black, Asian, and Hispanic patients saw greater drops in adherence than did white patients associated with the same out-of-pocket cost differences, leading the researchers to note that special care should be taken in prescribing decisions for these populations.
“When choosing among medications with differential [out-of-pocket] costs, prescribing the medication with lower [out-of-pocket] expense will likely improve medication adherence while reducing overall costs,” Dr. Callaghan and colleagues wrote in their analysis. “For example, prescribing gabapentin or venlafaxine to patients with newly diagnosed neuropathy is likely to lead to higher adherence compared with pregabalin or duloxetine, and therefore, there is a higher likelihood of relief from neuropathic pain.” The researchers noted that while combination pills and extended-release formulations may be marketed as a way to increase adherence, the higher out-of-pocket costs of such medicines could offset any adherence benefit.
Dr. Callaghan and his colleagues described as strengths of their study its large sample and statistical approach that “allowed us to best estimate the causal relationship between [out-of-pocket] costs and medication adherence by limiting selection bias, residual confounding, and the confounding inherent to medication choice.” Nonadherence – patients who never filled a prescription after diagnosis – was not captured in the study.
The American Academy of Neurology funded the study. Two of its authors reported financial conflicts of interest in the form of compensation from pharmaceutical or device companies. Its lead author, Dr. Callaghan, reported funding for a device maker and performing medical legal consultations.
SOURCE: Reynolds EL et al. Neurology. 2020 Feb 19. doi/10.1212/WNL.0000000000009039.
FROM NEUROLOGY
The evolution of social media and visual abstracts in hospital medicine
In recent years, social media platforms like Twitter, Facebook, and Instagram have become popular gathering spots for clinicians to connect, engage, and share medical content. Medical journals, which often act as purveyors of this content, have recognized social media’s growing power and influence and have begun looking for ways to better engage their audiences.
In 2016, the Annals of Surgery was looking to better disseminate the work being published in its pages and looked to Twitter as one way of accomplishing this. At the time, most journals were only posting the title or a brief description of the published manuscript and hoping their Twitter followers would click on the article link. As journal editors were finding, if the audience was not immediately familiar with the topic or able to quickly capture the nuances of the study, there was a good chance the reader would continue to scroll past the post and never view the article.
Recognizing that social media heavily relies on visual material to garner attention, Annals turned to Andrew Ibrahim, MD, an architect turned surgeon, to help them rethink their social media strategy. Using the design training he had previously received in his career as an architect, Dr. Ibrahim created a simple visual tool that could be used to capture the often complicated and nuanced aspects of a research study. He called his creation a “visual abstract.”
But what is a visual abstract? Simply, they are visual representations of the key findings of a published manuscript; or put another way, a “movie trailer” to the full manuscript. While they can take many different forms and designs, they often consist of three key components: (1) a simple, easy to understand title, (2) a primary focus on outcomes, and (3) the use of visual cues or images to help the reader absorb and remember the take home message. This simplified delivery of complex information allows the producer to efficiently share complex findings in a format that allows for rapid visualization and interpretation.
Since its inception, several studies have examined the influence visual abstracts have on disseminating research. One study conducted by Dr. Ibrahim and his colleagues found that articles tweeted with a visual abstract had an almost eightfold increase in the number of Twitter impressions (a measure of social media dissemination) and a threefold increase in article visits, compared with those manuscripts tweeted with the article title only.1 These results reflect what behavioral scientists have long understood: Humans process visual data better than any other type of data.2 For instance, according to research compiled by 3M, the company behind popular sticky notes, visual data is processed 60,000 times faster than text and has been shown to improve learning by 400%.3 Likewise, digital marketers have found that pages with videos and images draw on average 94% more views than their text-only counterparts.4
This knowledge, along with the substantial difference in engagement and dissemination characteristics from Dr. Ibrahim’s study, was far beyond what anyone might have expected and started a trend in medicine that continues to grow today. Medical journals across all practices and disciplines, including several leading journals, such as the New England Journal of Medicine, the Journal of the American Medical Association, and the Journal of Hospital Medicine (JHM), are utilizing this new tool to help disseminate their work in social media.
Visual abstracts have expanded beyond the social media sphere and are now frequently used in Grand Rounds presentations and as teaching tools among medical educators. JHM was one of the first journals to adopt the use of visual abstracts and has since published more than 150 in total. Given the growing popularity and expanded use of visual abstracts, JHM recently began archiving them on the journal’s website to allow clinicians to use the material in their own creative ways.
Visual abstracts are just one piece of the growing enterprise in social media for JHM. Recognizing the growing utilization of social media among physicians, JHM has taken a leading role in the use of online journal clubs. Since 2014, JHM has run a monthly Twitter-based journal club that discusses recently published articles and hospital medicine–based topics, called #JHMChat.5 This forum has allowed hospitalists from across the country, and around the world, to connect, network, and engage around topics important to the field of hospital medicine. The journal frequently reaches beyond hospital medicine borders and partners with other specialties and interest groups to gain perspective and insights into shared topic areas. To date, #JHMChat has one of the most robust online communities and continues to attract new followers each month.
As social media use continues to expand among clinicians, engagement tools like visual abstracts and Twitter chats will certainly continue to grow. Given that more clinicians are scrolling through websites than flipping through journal pages, medical journals like JHM will continually look for novel ways to engage their audiences and create communities among their followers. While a former architect who now practices as a surgeon led the way with visual abstracts, it remains to be seen who will create the next tool used to capture our attention on the ever-evolving sphere of social media.
Dr. Wray is a hospitalist at the University of California, San Francisco, and the San Francisco Veterans Affairs Medical Center. He also serves as a digital media and associate editor for the Journal of Hospital Medicine.
References
1. Ibrahim AM et al. Visual abstracts to disseminate research on social media: A prospective, case-control crossover study. Ann Surg. 2017;266(6):e46.
2. Tufte ER. The Visual Display of Quantitative Information. Second edition. Cheshire, Conn. Graphics Press, 2001. https://search.library.wisc.edu/catalog/999913808702121.
3. Polishing Your Presentation. http://web.archive.org/web/20001014041642/http://www.3m.com:80/meetingnetwork/files/meetingguide_pres.pdf. Accessed May 28, 2017.
4. 7 reasons you need visual content in your marketing strategy. https://medium.com/@nikos_iliopoulos/7-reasons-you-need-visual-content-in-your-marketing-strategy-bc77ca5521ac. Accessed May 28, 2017.
5. Wray CM et al. The adoption of an online journal club to improve research dissemination and social media engagement among hospitalists. J Hosp Med. 2018. doi: 10.12788/jhm.2987.
In recent years, social media platforms like Twitter, Facebook, and Instagram have become popular gathering spots for clinicians to connect, engage, and share medical content. Medical journals, which often act as purveyors of this content, have recognized social media’s growing power and influence and have begun looking for ways to better engage their audiences.
In 2016, the Annals of Surgery was looking to better disseminate the work being published in its pages and looked to Twitter as one way of accomplishing this. At the time, most journals were only posting the title or a brief description of the published manuscript and hoping their Twitter followers would click on the article link. As journal editors were finding, if the audience was not immediately familiar with the topic or able to quickly capture the nuances of the study, there was a good chance the reader would continue to scroll past the post and never view the article.
Recognizing that social media heavily relies on visual material to garner attention, Annals turned to Andrew Ibrahim, MD, an architect turned surgeon, to help them rethink their social media strategy. Using the design training he had previously received in his career as an architect, Dr. Ibrahim created a simple visual tool that could be used to capture the often complicated and nuanced aspects of a research study. He called his creation a “visual abstract.”
But what is a visual abstract? Simply, they are visual representations of the key findings of a published manuscript; or put another way, a “movie trailer” to the full manuscript. While they can take many different forms and designs, they often consist of three key components: (1) a simple, easy to understand title, (2) a primary focus on outcomes, and (3) the use of visual cues or images to help the reader absorb and remember the take home message. This simplified delivery of complex information allows the producer to efficiently share complex findings in a format that allows for rapid visualization and interpretation.
Since its inception, several studies have examined the influence visual abstracts have on disseminating research. One study conducted by Dr. Ibrahim and his colleagues found that articles tweeted with a visual abstract had an almost eightfold increase in the number of Twitter impressions (a measure of social media dissemination) and a threefold increase in article visits, compared with those manuscripts tweeted with the article title only.1 These results reflect what behavioral scientists have long understood: Humans process visual data better than any other type of data.2 For instance, according to research compiled by 3M, the company behind popular sticky notes, visual data is processed 60,000 times faster than text and has been shown to improve learning by 400%.3 Likewise, digital marketers have found that pages with videos and images draw on average 94% more views than their text-only counterparts.4
This knowledge, along with the substantial difference in engagement and dissemination characteristics from Dr. Ibrahim’s study, was far beyond what anyone might have expected and started a trend in medicine that continues to grow today. Medical journals across all practices and disciplines, including several leading journals, such as the New England Journal of Medicine, the Journal of the American Medical Association, and the Journal of Hospital Medicine (JHM), are utilizing this new tool to help disseminate their work in social media.
Visual abstracts have expanded beyond the social media sphere and are now frequently used in Grand Rounds presentations and as teaching tools among medical educators. JHM was one of the first journals to adopt the use of visual abstracts and has since published more than 150 in total. Given the growing popularity and expanded use of visual abstracts, JHM recently began archiving them on the journal’s website to allow clinicians to use the material in their own creative ways.
Visual abstracts are just one piece of the growing enterprise in social media for JHM. Recognizing the growing utilization of social media among physicians, JHM has taken a leading role in the use of online journal clubs. Since 2014, JHM has run a monthly Twitter-based journal club that discusses recently published articles and hospital medicine–based topics, called #JHMChat.5 This forum has allowed hospitalists from across the country, and around the world, to connect, network, and engage around topics important to the field of hospital medicine. The journal frequently reaches beyond hospital medicine borders and partners with other specialties and interest groups to gain perspective and insights into shared topic areas. To date, #JHMChat has one of the most robust online communities and continues to attract new followers each month.
As social media use continues to expand among clinicians, engagement tools like visual abstracts and Twitter chats will certainly continue to grow. Given that more clinicians are scrolling through websites than flipping through journal pages, medical journals like JHM will continually look for novel ways to engage their audiences and create communities among their followers. While a former architect who now practices as a surgeon led the way with visual abstracts, it remains to be seen who will create the next tool used to capture our attention on the ever-evolving sphere of social media.
Dr. Wray is a hospitalist at the University of California, San Francisco, and the San Francisco Veterans Affairs Medical Center. He also serves as a digital media and associate editor for the Journal of Hospital Medicine.
References
1. Ibrahim AM et al. Visual abstracts to disseminate research on social media: A prospective, case-control crossover study. Ann Surg. 2017;266(6):e46.
2. Tufte ER. The Visual Display of Quantitative Information. Second edition. Cheshire, Conn. Graphics Press, 2001. https://search.library.wisc.edu/catalog/999913808702121.
3. Polishing Your Presentation. http://web.archive.org/web/20001014041642/http://www.3m.com:80/meetingnetwork/files/meetingguide_pres.pdf. Accessed May 28, 2017.
4. 7 reasons you need visual content in your marketing strategy. https://medium.com/@nikos_iliopoulos/7-reasons-you-need-visual-content-in-your-marketing-strategy-bc77ca5521ac. Accessed May 28, 2017.
5. Wray CM et al. The adoption of an online journal club to improve research dissemination and social media engagement among hospitalists. J Hosp Med. 2018. doi: 10.12788/jhm.2987.
In recent years, social media platforms like Twitter, Facebook, and Instagram have become popular gathering spots for clinicians to connect, engage, and share medical content. Medical journals, which often act as purveyors of this content, have recognized social media’s growing power and influence and have begun looking for ways to better engage their audiences.
In 2016, the Annals of Surgery was looking to better disseminate the work being published in its pages and looked to Twitter as one way of accomplishing this. At the time, most journals were only posting the title or a brief description of the published manuscript and hoping their Twitter followers would click on the article link. As journal editors were finding, if the audience was not immediately familiar with the topic or able to quickly capture the nuances of the study, there was a good chance the reader would continue to scroll past the post and never view the article.
Recognizing that social media heavily relies on visual material to garner attention, Annals turned to Andrew Ibrahim, MD, an architect turned surgeon, to help them rethink their social media strategy. Using the design training he had previously received in his career as an architect, Dr. Ibrahim created a simple visual tool that could be used to capture the often complicated and nuanced aspects of a research study. He called his creation a “visual abstract.”
But what is a visual abstract? Simply, they are visual representations of the key findings of a published manuscript; or put another way, a “movie trailer” to the full manuscript. While they can take many different forms and designs, they often consist of three key components: (1) a simple, easy to understand title, (2) a primary focus on outcomes, and (3) the use of visual cues or images to help the reader absorb and remember the take home message. This simplified delivery of complex information allows the producer to efficiently share complex findings in a format that allows for rapid visualization and interpretation.
Since its inception, several studies have examined the influence visual abstracts have on disseminating research. One study conducted by Dr. Ibrahim and his colleagues found that articles tweeted with a visual abstract had an almost eightfold increase in the number of Twitter impressions (a measure of social media dissemination) and a threefold increase in article visits, compared with those manuscripts tweeted with the article title only.1 These results reflect what behavioral scientists have long understood: Humans process visual data better than any other type of data.2 For instance, according to research compiled by 3M, the company behind popular sticky notes, visual data is processed 60,000 times faster than text and has been shown to improve learning by 400%.3 Likewise, digital marketers have found that pages with videos and images draw on average 94% more views than their text-only counterparts.4
This knowledge, along with the substantial difference in engagement and dissemination characteristics from Dr. Ibrahim’s study, was far beyond what anyone might have expected and started a trend in medicine that continues to grow today. Medical journals across all practices and disciplines, including several leading journals, such as the New England Journal of Medicine, the Journal of the American Medical Association, and the Journal of Hospital Medicine (JHM), are utilizing this new tool to help disseminate their work in social media.
Visual abstracts have expanded beyond the social media sphere and are now frequently used in Grand Rounds presentations and as teaching tools among medical educators. JHM was one of the first journals to adopt the use of visual abstracts and has since published more than 150 in total. Given the growing popularity and expanded use of visual abstracts, JHM recently began archiving them on the journal’s website to allow clinicians to use the material in their own creative ways.
Visual abstracts are just one piece of the growing enterprise in social media for JHM. Recognizing the growing utilization of social media among physicians, JHM has taken a leading role in the use of online journal clubs. Since 2014, JHM has run a monthly Twitter-based journal club that discusses recently published articles and hospital medicine–based topics, called #JHMChat.5 This forum has allowed hospitalists from across the country, and around the world, to connect, network, and engage around topics important to the field of hospital medicine. The journal frequently reaches beyond hospital medicine borders and partners with other specialties and interest groups to gain perspective and insights into shared topic areas. To date, #JHMChat has one of the most robust online communities and continues to attract new followers each month.
As social media use continues to expand among clinicians, engagement tools like visual abstracts and Twitter chats will certainly continue to grow. Given that more clinicians are scrolling through websites than flipping through journal pages, medical journals like JHM will continually look for novel ways to engage their audiences and create communities among their followers. While a former architect who now practices as a surgeon led the way with visual abstracts, it remains to be seen who will create the next tool used to capture our attention on the ever-evolving sphere of social media.
Dr. Wray is a hospitalist at the University of California, San Francisco, and the San Francisco Veterans Affairs Medical Center. He also serves as a digital media and associate editor for the Journal of Hospital Medicine.
References
1. Ibrahim AM et al. Visual abstracts to disseminate research on social media: A prospective, case-control crossover study. Ann Surg. 2017;266(6):e46.
2. Tufte ER. The Visual Display of Quantitative Information. Second edition. Cheshire, Conn. Graphics Press, 2001. https://search.library.wisc.edu/catalog/999913808702121.
3. Polishing Your Presentation. http://web.archive.org/web/20001014041642/http://www.3m.com:80/meetingnetwork/files/meetingguide_pres.pdf. Accessed May 28, 2017.
4. 7 reasons you need visual content in your marketing strategy. https://medium.com/@nikos_iliopoulos/7-reasons-you-need-visual-content-in-your-marketing-strategy-bc77ca5521ac. Accessed May 28, 2017.
5. Wray CM et al. The adoption of an online journal club to improve research dissemination and social media engagement among hospitalists. J Hosp Med. 2018. doi: 10.12788/jhm.2987.
Number of sexual partners linked to cancer risk
A higher lifetime number of sexual partners was associated with a greater risk of being diagnosed with cancer in older adults, according to a recent study.
Additionally, among women, having had more lifetime partners was linked to higher odds of reporting a limiting long-standing condition.
Igor Grabovac, MD, of the Medical University of Vienna, and colleagues reported these results in BMJ Sexual & Reproductive Health.
The exploratory analysis included 2,537 men and 3,185 women, aged 50 years and older, who were a part of the English Longitudinal Study of Ageing. The mean age of study subjects was 64 years in men and 65 years in women, and most were either married or cohabitating.
Researchers collected data on sexual history using a self-administered questionnaire, which privately recorded the lifetime number of sexual partners among study participants. Data on other health outcomes, such as limiting long-standing illness and cancer diagnoses, were also self-reported.
Among male participants, 28.5% reported a history of 0-1 lifetime sexual partners, 29.0% had 2-4 partners, 20.2% had 5-9 partners, and 22.2% had 10 or more partners. The respective measures in women were 40.8%, 35.5%, 15.8%, and 7.8%.
Among all participants, a greater number of sexual partners was associated with being single, younger age, and being in the least or greatest brackets of household income.
The researchers found that, compared with having 0-1 sexual partners, a lifetime history of 10 or more sexual partners was associated with a greater risk of reported cancer in both men (odds ratio, 1.69; P = .047) and women (OR, 1.91; P = .038).
In addition, women with a lifetime history of 10 or more sexual partners had greater odds of reporting a limiting long-standing condition (OR, 1.64; P = .007).
“We observed no statistically significant association between number of lifetime sexual partners and self-rated health, CHD [coronary heart disease], or stroke in either sex, or with limiting long-standing illness in men,” the researchers explained.
They acknowledged that a key limitation of the study was the self-reported nature of the data. As a result, further studies are required to establish causality.
“Sexual history may be a relevant clinical indicator for cancer risk in older patients,” they concluded.
No funding sources were reported. The authors reported having no conflicts of interest.
SOURCE: Grabovac I et al. BMJ Sex Reprod Health. 2020 Feb 13. doi: 10.1136/bmjsrh-2019-200352.
A higher lifetime number of sexual partners was associated with a greater risk of being diagnosed with cancer in older adults, according to a recent study.
Additionally, among women, having had more lifetime partners was linked to higher odds of reporting a limiting long-standing condition.
Igor Grabovac, MD, of the Medical University of Vienna, and colleagues reported these results in BMJ Sexual & Reproductive Health.
The exploratory analysis included 2,537 men and 3,185 women, aged 50 years and older, who were a part of the English Longitudinal Study of Ageing. The mean age of study subjects was 64 years in men and 65 years in women, and most were either married or cohabitating.
Researchers collected data on sexual history using a self-administered questionnaire, which privately recorded the lifetime number of sexual partners among study participants. Data on other health outcomes, such as limiting long-standing illness and cancer diagnoses, were also self-reported.
Among male participants, 28.5% reported a history of 0-1 lifetime sexual partners, 29.0% had 2-4 partners, 20.2% had 5-9 partners, and 22.2% had 10 or more partners. The respective measures in women were 40.8%, 35.5%, 15.8%, and 7.8%.
Among all participants, a greater number of sexual partners was associated with being single, younger age, and being in the least or greatest brackets of household income.
The researchers found that, compared with having 0-1 sexual partners, a lifetime history of 10 or more sexual partners was associated with a greater risk of reported cancer in both men (odds ratio, 1.69; P = .047) and women (OR, 1.91; P = .038).
In addition, women with a lifetime history of 10 or more sexual partners had greater odds of reporting a limiting long-standing condition (OR, 1.64; P = .007).
“We observed no statistically significant association between number of lifetime sexual partners and self-rated health, CHD [coronary heart disease], or stroke in either sex, or with limiting long-standing illness in men,” the researchers explained.
They acknowledged that a key limitation of the study was the self-reported nature of the data. As a result, further studies are required to establish causality.
“Sexual history may be a relevant clinical indicator for cancer risk in older patients,” they concluded.
No funding sources were reported. The authors reported having no conflicts of interest.
SOURCE: Grabovac I et al. BMJ Sex Reprod Health. 2020 Feb 13. doi: 10.1136/bmjsrh-2019-200352.
A higher lifetime number of sexual partners was associated with a greater risk of being diagnosed with cancer in older adults, according to a recent study.
Additionally, among women, having had more lifetime partners was linked to higher odds of reporting a limiting long-standing condition.
Igor Grabovac, MD, of the Medical University of Vienna, and colleagues reported these results in BMJ Sexual & Reproductive Health.
The exploratory analysis included 2,537 men and 3,185 women, aged 50 years and older, who were a part of the English Longitudinal Study of Ageing. The mean age of study subjects was 64 years in men and 65 years in women, and most were either married or cohabitating.
Researchers collected data on sexual history using a self-administered questionnaire, which privately recorded the lifetime number of sexual partners among study participants. Data on other health outcomes, such as limiting long-standing illness and cancer diagnoses, were also self-reported.
Among male participants, 28.5% reported a history of 0-1 lifetime sexual partners, 29.0% had 2-4 partners, 20.2% had 5-9 partners, and 22.2% had 10 or more partners. The respective measures in women were 40.8%, 35.5%, 15.8%, and 7.8%.
Among all participants, a greater number of sexual partners was associated with being single, younger age, and being in the least or greatest brackets of household income.
The researchers found that, compared with having 0-1 sexual partners, a lifetime history of 10 or more sexual partners was associated with a greater risk of reported cancer in both men (odds ratio, 1.69; P = .047) and women (OR, 1.91; P = .038).
In addition, women with a lifetime history of 10 or more sexual partners had greater odds of reporting a limiting long-standing condition (OR, 1.64; P = .007).
“We observed no statistically significant association between number of lifetime sexual partners and self-rated health, CHD [coronary heart disease], or stroke in either sex, or with limiting long-standing illness in men,” the researchers explained.
They acknowledged that a key limitation of the study was the self-reported nature of the data. As a result, further studies are required to establish causality.
“Sexual history may be a relevant clinical indicator for cancer risk in older patients,” they concluded.
No funding sources were reported. The authors reported having no conflicts of interest.
SOURCE: Grabovac I et al. BMJ Sex Reprod Health. 2020 Feb 13. doi: 10.1136/bmjsrh-2019-200352.
FROM BMJ SEXUAL AND REPRODUCTIVE HEALTH
Hyperhidrosis treatment options include glycopyrrolate
LAHAINA, HAWAII – Hyperhidrosis affects nearly 5% of the U.S. population, and in a survey of U.S. teenagers, about 17% reported excessive sweating, Jashin Wu, MD, said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
In an interview with MDedge reporter Bruce Jancin, Dr. Wu, founder of the Dermatology Research and Education Foundation, Irvine, Calif., discussed the off-label use of oral agents to treat hyperhidrosis. Dr. Wu said he is a fan of oral glycopyrrolate in particular, which he tends to use even earlier than suggested in the International Hyperhidrosis Society guidelines.
Glycopyrrolate is available in 1 mg and 2 mg tablets; Dr. Wu starts patients at a dose of 1 mg twice a day, escalating by 1 mg per week until the “desired effects occur” or the patient has problems tolerating treatment because of side effects.
Other oral options include oxybutynin and propranolol. Sofpironium bromide, an analog of glycopyrrolate, is in the pipeline, he said.
During the interview, Dr. Wu discussed mydriasis, an adverse effect associated with both topical and systemic anticholinergic treatment. In the two pivotal phase 3 randomized trials of prescription glycopyrronium cloth (Qbrexza) for axillary hyperhidrosis, the incidence of mydriasis was 6.8% in 463 patients on active treatment for 4 weeks. Three-quarters of cases were unilateral. The mydriasis resolved without permanent treatment discontinuation in 27 of the 31 patients (J Am Acad Dermatol. 2019 Jan;80[1]:128-138.e2).
“The most important point is that patients need to be educated that they need to wash their hands very well after they apply it to the affected areas” to prevent accidental medication contact with the eyes, he advised.
Alarm bells can go off when a patient with anticholinergic therapy–induced mydriasis presents to an ED without mentioning their treatment status, Dr. Wu observed.
Dr. Wu had no relevant disclosures. SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
To listen to the interview, click the play button below.
LAHAINA, HAWAII – Hyperhidrosis affects nearly 5% of the U.S. population, and in a survey of U.S. teenagers, about 17% reported excessive sweating, Jashin Wu, MD, said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
In an interview with MDedge reporter Bruce Jancin, Dr. Wu, founder of the Dermatology Research and Education Foundation, Irvine, Calif., discussed the off-label use of oral agents to treat hyperhidrosis. Dr. Wu said he is a fan of oral glycopyrrolate in particular, which he tends to use even earlier than suggested in the International Hyperhidrosis Society guidelines.
Glycopyrrolate is available in 1 mg and 2 mg tablets; Dr. Wu starts patients at a dose of 1 mg twice a day, escalating by 1 mg per week until the “desired effects occur” or the patient has problems tolerating treatment because of side effects.
Other oral options include oxybutynin and propranolol. Sofpironium bromide, an analog of glycopyrrolate, is in the pipeline, he said.
During the interview, Dr. Wu discussed mydriasis, an adverse effect associated with both topical and systemic anticholinergic treatment. In the two pivotal phase 3 randomized trials of prescription glycopyrronium cloth (Qbrexza) for axillary hyperhidrosis, the incidence of mydriasis was 6.8% in 463 patients on active treatment for 4 weeks. Three-quarters of cases were unilateral. The mydriasis resolved without permanent treatment discontinuation in 27 of the 31 patients (J Am Acad Dermatol. 2019 Jan;80[1]:128-138.e2).
“The most important point is that patients need to be educated that they need to wash their hands very well after they apply it to the affected areas” to prevent accidental medication contact with the eyes, he advised.
Alarm bells can go off when a patient with anticholinergic therapy–induced mydriasis presents to an ED without mentioning their treatment status, Dr. Wu observed.
Dr. Wu had no relevant disclosures. SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
To listen to the interview, click the play button below.
LAHAINA, HAWAII – Hyperhidrosis affects nearly 5% of the U.S. population, and in a survey of U.S. teenagers, about 17% reported excessive sweating, Jashin Wu, MD, said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
In an interview with MDedge reporter Bruce Jancin, Dr. Wu, founder of the Dermatology Research and Education Foundation, Irvine, Calif., discussed the off-label use of oral agents to treat hyperhidrosis. Dr. Wu said he is a fan of oral glycopyrrolate in particular, which he tends to use even earlier than suggested in the International Hyperhidrosis Society guidelines.
Glycopyrrolate is available in 1 mg and 2 mg tablets; Dr. Wu starts patients at a dose of 1 mg twice a day, escalating by 1 mg per week until the “desired effects occur” or the patient has problems tolerating treatment because of side effects.
Other oral options include oxybutynin and propranolol. Sofpironium bromide, an analog of glycopyrrolate, is in the pipeline, he said.
During the interview, Dr. Wu discussed mydriasis, an adverse effect associated with both topical and systemic anticholinergic treatment. In the two pivotal phase 3 randomized trials of prescription glycopyrronium cloth (Qbrexza) for axillary hyperhidrosis, the incidence of mydriasis was 6.8% in 463 patients on active treatment for 4 weeks. Three-quarters of cases were unilateral. The mydriasis resolved without permanent treatment discontinuation in 27 of the 31 patients (J Am Acad Dermatol. 2019 Jan;80[1]:128-138.e2).
“The most important point is that patients need to be educated that they need to wash their hands very well after they apply it to the affected areas” to prevent accidental medication contact with the eyes, he advised.
Alarm bells can go off when a patient with anticholinergic therapy–induced mydriasis presents to an ED without mentioning their treatment status, Dr. Wu observed.
Dr. Wu had no relevant disclosures. SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
To listen to the interview, click the play button below.
REPORTING FROM THE HAWAII DERMATOLOGY SEMINAR
Resetting your compensation
Using the State of Hospital Medicine Report to bolster your proposal
In the ever-changing world of health care, one thing is for sure: If you’re not paying attention, you’re falling behind. In this column, I will discuss how you may utilize the Society of Hospital Medicine (SHM) State of Hospital Medicine Report (SoHM) to evaluate your current compensation structure and strengthen your business plan for change. For purposes of this exercise, I will focus on data referenced as Internal Medicine only, hospital-owned Hospital Medicine Groups (HMG).
Issues with retention, recruitment, or burnout may be among the first factors that lead you to reevaluate your compensation plan. The SoHM Report can help you to take a dive into feedback for these areas. Look for any indications that compensation may be affecting your turnover, inability to hire, or leaving your current team frustrated with their current pay structure. Feedback surrounding each of these factors may drive you to evaluate your comp plan but remain mindful that money is not always the answer.
You may complete your evaluation and find the data could suggest you are in fact well paid for the work you do. Even though this may be the case, the evaluation and transparency to your provider team may help flush out the real reason you are struggling with recruitment, retention, or burnout. However, if you do find you have an opportunity to improve your compensation structure, remember that you will need a compelling, data-driven case, to present to your C-suite.
Let us start by understanding how the market has changed over time using data from the 2014, 2016, and 2018 SoHM Reports. Of note, each report is based on data from the prior year. Since 2013, hospital owned HMGs have seen a 16% increase in total compensation while experiencing only a 9% increase in collections. Meanwhile RVU productivity has remained relatively stable over time. From this, we see hospitalists are earning more for similar productivity. The hospital reimbursement for professional fees has not grown at the same rate as compensation. Also, the collection per RVU has remained relatively flat over time.
It’s simple: Hospitalists are earning more and professional revenues are not making up the difference. This market change is driving hospitals to invest more money to maintain their HMGs. If your hospital hasn’t been responding to these data, you will need a strong business plan to get buy in from your hospital administration.
Now that you have evaluated the market change, it is time to put some optics on where your compensation falls in the current market. When you combine your total compensation with your total RVU productivity, you can use the SoHM Report to evaluate the current reported benchmarks for Compensation per RVU. Plotting these benchmarks against your own compensation and any proposed changes can help your administration really begin to see whether a change should be considered. Providing that clear picture in relevance to the SoHM benchmark is important, as a chart or graph can simplify your C-suite’s understanding of your proposal.
By simplifying your example using Compensation per RVU, you are making the conversation easier to follow. Your hospital leaders can clearly see the cost for every RVU generated and understand the impact. This is not to say that you should base your compensation around productivity. It is merely a way to roll in all compensation factors, whether quality related, performance based, or productivity driven, and tie them to a metric that is clear and easy for administration to understand.
Remember, when designing your new compensation plan, you can reference the SoHM Report to see how HMGs around the country are providing incentive and what percentage of compensation is based on incentive. There are sections within the report directly outlining these data points.
Now that we have reviewed market change and how to visualize change between your current and proposed future state, I will leave you with some final thoughts regarding other considerations when building your business plan:
- Focus on only physician-generated RVUs.
- Consider Length of Stay impact on productivity.
- Decide if Case Mix Index changes have impacted your staffing needs.
- Understand your E and M coding practices in reference to industry benchmarks. The SoHM Report provides benchmarks for billing practices across the country.
- Lastly, clearly identify the issues you want to address and set goals with measurable outcomes.
There is still time for your group to be part of the 2020 State of Hospital Medicine Report data by participating in the 2020 Survey. Data are being accepted through Feb. 28, 2020. Submit your data at www.hospitalmedicine.org/2020survey.
Mr. Sandroni is director of operations, hospitalists, at Rochester (N.Y.) Regional Health.
Using the State of Hospital Medicine Report to bolster your proposal
Using the State of Hospital Medicine Report to bolster your proposal
In the ever-changing world of health care, one thing is for sure: If you’re not paying attention, you’re falling behind. In this column, I will discuss how you may utilize the Society of Hospital Medicine (SHM) State of Hospital Medicine Report (SoHM) to evaluate your current compensation structure and strengthen your business plan for change. For purposes of this exercise, I will focus on data referenced as Internal Medicine only, hospital-owned Hospital Medicine Groups (HMG).
Issues with retention, recruitment, or burnout may be among the first factors that lead you to reevaluate your compensation plan. The SoHM Report can help you to take a dive into feedback for these areas. Look for any indications that compensation may be affecting your turnover, inability to hire, or leaving your current team frustrated with their current pay structure. Feedback surrounding each of these factors may drive you to evaluate your comp plan but remain mindful that money is not always the answer.
You may complete your evaluation and find the data could suggest you are in fact well paid for the work you do. Even though this may be the case, the evaluation and transparency to your provider team may help flush out the real reason you are struggling with recruitment, retention, or burnout. However, if you do find you have an opportunity to improve your compensation structure, remember that you will need a compelling, data-driven case, to present to your C-suite.
Let us start by understanding how the market has changed over time using data from the 2014, 2016, and 2018 SoHM Reports. Of note, each report is based on data from the prior year. Since 2013, hospital owned HMGs have seen a 16% increase in total compensation while experiencing only a 9% increase in collections. Meanwhile RVU productivity has remained relatively stable over time. From this, we see hospitalists are earning more for similar productivity. The hospital reimbursement for professional fees has not grown at the same rate as compensation. Also, the collection per RVU has remained relatively flat over time.
It’s simple: Hospitalists are earning more and professional revenues are not making up the difference. This market change is driving hospitals to invest more money to maintain their HMGs. If your hospital hasn’t been responding to these data, you will need a strong business plan to get buy in from your hospital administration.
Now that you have evaluated the market change, it is time to put some optics on where your compensation falls in the current market. When you combine your total compensation with your total RVU productivity, you can use the SoHM Report to evaluate the current reported benchmarks for Compensation per RVU. Plotting these benchmarks against your own compensation and any proposed changes can help your administration really begin to see whether a change should be considered. Providing that clear picture in relevance to the SoHM benchmark is important, as a chart or graph can simplify your C-suite’s understanding of your proposal.
By simplifying your example using Compensation per RVU, you are making the conversation easier to follow. Your hospital leaders can clearly see the cost for every RVU generated and understand the impact. This is not to say that you should base your compensation around productivity. It is merely a way to roll in all compensation factors, whether quality related, performance based, or productivity driven, and tie them to a metric that is clear and easy for administration to understand.
Remember, when designing your new compensation plan, you can reference the SoHM Report to see how HMGs around the country are providing incentive and what percentage of compensation is based on incentive. There are sections within the report directly outlining these data points.
Now that we have reviewed market change and how to visualize change between your current and proposed future state, I will leave you with some final thoughts regarding other considerations when building your business plan:
- Focus on only physician-generated RVUs.
- Consider Length of Stay impact on productivity.
- Decide if Case Mix Index changes have impacted your staffing needs.
- Understand your E and M coding practices in reference to industry benchmarks. The SoHM Report provides benchmarks for billing practices across the country.
- Lastly, clearly identify the issues you want to address and set goals with measurable outcomes.
There is still time for your group to be part of the 2020 State of Hospital Medicine Report data by participating in the 2020 Survey. Data are being accepted through Feb. 28, 2020. Submit your data at www.hospitalmedicine.org/2020survey.
Mr. Sandroni is director of operations, hospitalists, at Rochester (N.Y.) Regional Health.
In the ever-changing world of health care, one thing is for sure: If you’re not paying attention, you’re falling behind. In this column, I will discuss how you may utilize the Society of Hospital Medicine (SHM) State of Hospital Medicine Report (SoHM) to evaluate your current compensation structure and strengthen your business plan for change. For purposes of this exercise, I will focus on data referenced as Internal Medicine only, hospital-owned Hospital Medicine Groups (HMG).
Issues with retention, recruitment, or burnout may be among the first factors that lead you to reevaluate your compensation plan. The SoHM Report can help you to take a dive into feedback for these areas. Look for any indications that compensation may be affecting your turnover, inability to hire, or leaving your current team frustrated with their current pay structure. Feedback surrounding each of these factors may drive you to evaluate your comp plan but remain mindful that money is not always the answer.
You may complete your evaluation and find the data could suggest you are in fact well paid for the work you do. Even though this may be the case, the evaluation and transparency to your provider team may help flush out the real reason you are struggling with recruitment, retention, or burnout. However, if you do find you have an opportunity to improve your compensation structure, remember that you will need a compelling, data-driven case, to present to your C-suite.
Let us start by understanding how the market has changed over time using data from the 2014, 2016, and 2018 SoHM Reports. Of note, each report is based on data from the prior year. Since 2013, hospital owned HMGs have seen a 16% increase in total compensation while experiencing only a 9% increase in collections. Meanwhile RVU productivity has remained relatively stable over time. From this, we see hospitalists are earning more for similar productivity. The hospital reimbursement for professional fees has not grown at the same rate as compensation. Also, the collection per RVU has remained relatively flat over time.
It’s simple: Hospitalists are earning more and professional revenues are not making up the difference. This market change is driving hospitals to invest more money to maintain their HMGs. If your hospital hasn’t been responding to these data, you will need a strong business plan to get buy in from your hospital administration.
Now that you have evaluated the market change, it is time to put some optics on where your compensation falls in the current market. When you combine your total compensation with your total RVU productivity, you can use the SoHM Report to evaluate the current reported benchmarks for Compensation per RVU. Plotting these benchmarks against your own compensation and any proposed changes can help your administration really begin to see whether a change should be considered. Providing that clear picture in relevance to the SoHM benchmark is important, as a chart or graph can simplify your C-suite’s understanding of your proposal.
By simplifying your example using Compensation per RVU, you are making the conversation easier to follow. Your hospital leaders can clearly see the cost for every RVU generated and understand the impact. This is not to say that you should base your compensation around productivity. It is merely a way to roll in all compensation factors, whether quality related, performance based, or productivity driven, and tie them to a metric that is clear and easy for administration to understand.
Remember, when designing your new compensation plan, you can reference the SoHM Report to see how HMGs around the country are providing incentive and what percentage of compensation is based on incentive. There are sections within the report directly outlining these data points.
Now that we have reviewed market change and how to visualize change between your current and proposed future state, I will leave you with some final thoughts regarding other considerations when building your business plan:
- Focus on only physician-generated RVUs.
- Consider Length of Stay impact on productivity.
- Decide if Case Mix Index changes have impacted your staffing needs.
- Understand your E and M coding practices in reference to industry benchmarks. The SoHM Report provides benchmarks for billing practices across the country.
- Lastly, clearly identify the issues you want to address and set goals with measurable outcomes.
There is still time for your group to be part of the 2020 State of Hospital Medicine Report data by participating in the 2020 Survey. Data are being accepted through Feb. 28, 2020. Submit your data at www.hospitalmedicine.org/2020survey.
Mr. Sandroni is director of operations, hospitalists, at Rochester (N.Y.) Regional Health.
Make the Diagnosis - March 2020
The patient’s biopsy showed sparse and grouped and slightly enlarged atypical stained mononuclear cells in mostly perifollicular areas with focal epidermotropism. CD30 staining was positive. She responded to potent topical steroids.
The etiology of LyP is unknown. It is unclear whether the proliferation of T-cells is a benign and chronic disorder, or an indolent T-cell malignancy.
In addition, 10% of LyP cases are associated with anaplastic large-cell lymphoma, cutaneous T-cell lymphoma (mycosis fungoides), or Hodgkin lymphoma. Borderline cases are those that overlap LyP and lymphoma.
Patients typically present with crops of asymptomatic erythematous to brown papules that may become pustular, vesicular, or necrotic. Lesions tend to resolve within 2-8 weeks with or without scarring. The trunk and extremities are commonly affected. The condition tends to be chronic over months to years. The waxing and waning course is characteristic of LyP. Constitutional symptoms are generally absent in cases not associated with systemic disease.
Histopathologic examination reveals a dense wedge-shaped dermal infiltrate of atypical lymphocytes along with numerous eosinophils and neutrophils. Epidermotropism may be present and lymphocytes stain positive for CD30+. Vessels in the dermis may exhibit fibrin deposition and red blood cell extravasation. Histologically, LyP can be classified as Type A to E. These subtypes are determined by the size and type of atypical cells, location and amount of infiltrate, and staining of CD30 and CD8.
The differential diagnosis of LyP includes pityriasis lichenoides, anaplastic large cell lymphoma, cutaneous T-cell lymphoma, folliculitis, arthropod assault, Langerhans cell histiocytosis, and leukemia cutis. Treatment is symptomatic. Mild forms of LyP can many times be managed with superpotent topical corticosteroids. Bexarotene gel has been used for early lesions. For more widespread or persistent disease, intralesional corticosteroids, phototherapy (UVB or PUVA), tetracycline antibiotics, and methotrexate have been reported to be effective. Refractory cases may respond to interferon alpha or oral bexarotene. Routine evaluations are recommended as patients may be at increased risk for the development of lymphoma.
This case and photo were submitted by Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
The patient’s biopsy showed sparse and grouped and slightly enlarged atypical stained mononuclear cells in mostly perifollicular areas with focal epidermotropism. CD30 staining was positive. She responded to potent topical steroids.
The etiology of LyP is unknown. It is unclear whether the proliferation of T-cells is a benign and chronic disorder, or an indolent T-cell malignancy.
In addition, 10% of LyP cases are associated with anaplastic large-cell lymphoma, cutaneous T-cell lymphoma (mycosis fungoides), or Hodgkin lymphoma. Borderline cases are those that overlap LyP and lymphoma.
Patients typically present with crops of asymptomatic erythematous to brown papules that may become pustular, vesicular, or necrotic. Lesions tend to resolve within 2-8 weeks with or without scarring. The trunk and extremities are commonly affected. The condition tends to be chronic over months to years. The waxing and waning course is characteristic of LyP. Constitutional symptoms are generally absent in cases not associated with systemic disease.
Histopathologic examination reveals a dense wedge-shaped dermal infiltrate of atypical lymphocytes along with numerous eosinophils and neutrophils. Epidermotropism may be present and lymphocytes stain positive for CD30+. Vessels in the dermis may exhibit fibrin deposition and red blood cell extravasation. Histologically, LyP can be classified as Type A to E. These subtypes are determined by the size and type of atypical cells, location and amount of infiltrate, and staining of CD30 and CD8.
The differential diagnosis of LyP includes pityriasis lichenoides, anaplastic large cell lymphoma, cutaneous T-cell lymphoma, folliculitis, arthropod assault, Langerhans cell histiocytosis, and leukemia cutis. Treatment is symptomatic. Mild forms of LyP can many times be managed with superpotent topical corticosteroids. Bexarotene gel has been used for early lesions. For more widespread or persistent disease, intralesional corticosteroids, phototherapy (UVB or PUVA), tetracycline antibiotics, and methotrexate have been reported to be effective. Refractory cases may respond to interferon alpha or oral bexarotene. Routine evaluations are recommended as patients may be at increased risk for the development of lymphoma.
This case and photo were submitted by Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
The patient’s biopsy showed sparse and grouped and slightly enlarged atypical stained mononuclear cells in mostly perifollicular areas with focal epidermotropism. CD30 staining was positive. She responded to potent topical steroids.
The etiology of LyP is unknown. It is unclear whether the proliferation of T-cells is a benign and chronic disorder, or an indolent T-cell malignancy.
In addition, 10% of LyP cases are associated with anaplastic large-cell lymphoma, cutaneous T-cell lymphoma (mycosis fungoides), or Hodgkin lymphoma. Borderline cases are those that overlap LyP and lymphoma.
Patients typically present with crops of asymptomatic erythematous to brown papules that may become pustular, vesicular, or necrotic. Lesions tend to resolve within 2-8 weeks with or without scarring. The trunk and extremities are commonly affected. The condition tends to be chronic over months to years. The waxing and waning course is characteristic of LyP. Constitutional symptoms are generally absent in cases not associated with systemic disease.
Histopathologic examination reveals a dense wedge-shaped dermal infiltrate of atypical lymphocytes along with numerous eosinophils and neutrophils. Epidermotropism may be present and lymphocytes stain positive for CD30+. Vessels in the dermis may exhibit fibrin deposition and red blood cell extravasation. Histologically, LyP can be classified as Type A to E. These subtypes are determined by the size and type of atypical cells, location and amount of infiltrate, and staining of CD30 and CD8.
The differential diagnosis of LyP includes pityriasis lichenoides, anaplastic large cell lymphoma, cutaneous T-cell lymphoma, folliculitis, arthropod assault, Langerhans cell histiocytosis, and leukemia cutis. Treatment is symptomatic. Mild forms of LyP can many times be managed with superpotent topical corticosteroids. Bexarotene gel has been used for early lesions. For more widespread or persistent disease, intralesional corticosteroids, phototherapy (UVB or PUVA), tetracycline antibiotics, and methotrexate have been reported to be effective. Refractory cases may respond to interferon alpha or oral bexarotene. Routine evaluations are recommended as patients may be at increased risk for the development of lymphoma.
This case and photo were submitted by Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
Glaring gap in CV event reporting in pivotal cancer trials
Clinical trials supporting Food and Drug Adminstration approval of contemporary cancer therapies frequently failed to capture major adverse cardiovascular events (MACE) and, when they did, reported rates 2.6-fold lower than noncancer trials, new research shows.
Overall, 51.3% of trials did not report MACE, with that number reaching 57.6% in trials enrolling patients with baseline cardiovascular disease (CVD).
Nearly 40% of trials did not report any CVD events in follow-up, the authors reported online Feb. 10, 2020, in the Journal of the American College of Cardiology (2020;75:620-8).
“Even in drug classes where there were established or emerging associations with cardiotoxic events, often there were no reported heart events or cardiovascular events across years of follow-up in trials that examined hundreds or even thousands of patients. That was actually pretty surprising,” senior author Daniel Addison, MD, codirector of the cardio-oncology program at the Ohio State University Medical Center, Columbus, said in an interview.
The study was prompted by a series of events that crescendoed when his team was called to the ICU to determine whether a novel targeted agent played a role in the heart decline of a patient with acute myeloid leukemia. “I had a resident ask me a very important question: ‘How do we really know for sure that the trial actually reflects the true risk of heart events?’ to which I told him, ‘it’s difficult to know,’ ” he said.
“I think many of us rely heavily on what we see in the trials, particularly when they make it to the top journals, and quite frankly, we generally take it at face value,” Dr. Addison observed.
Lower Rate of Reported Events
The investigators reviewed CV events reported in 97,365 patients (median age, 61 years; 46% female) enrolled in 189 phase 2 and 3 trials supporting FDA approval of 123 anticancer drugs from 1998 to 2018. Biologic, targeted, or immune-based therapies accounted for 72.5% of drug approvals.
Over 148,138 person-years of follow-up (median trial duration, 30 months), there were 1,148 incidents of MACE (375 heart failure, 253 MIs, 180 strokes, 65 atrial fibrillation, 29 coronary revascularizations, and 246 CVD deaths). MACE rates were higher in the intervention group than in the control group (792 vs. 356; P less than .01). Among the 64 trials that excluded patients with baseline CVD, there were 269 incidents of MACE.
To put this finding in context, the researchers examined the reported incidence of MACE among some 6,000 similarly aged participants in the Multi-Ethnic Study of Atherosclerosis (MESA). The overall weighted-average incidence rate was 1,408 per 100,000 person-years among MESA participants, compared with 542 events per 100,000 person-years among oncology trial participants (716 per 100,000 in the intervention arm). This represents a reported-to-expected ratio of 0.38 – a 2.6-fold lower rate of reported events (P less than .001) – and a risk difference of 866.
Further, MACE reporting was lower by a factor of 1.7 among all cancer trial participants irrespective of baseline CVD status (reported-to-expected ratio, 0.56; risk difference, 613; P less than .001).
There was no significant difference in MACE reporting between independent or industry-sponsored trials, the authors report.
No malicious intent
“There are likely some that might lean toward not wanting to attribute blame to a new drug when the drug is in a study, but I really think that the leading factor is lack of awareness,” Dr. Addison said. “I’ve talked with several cancer collaborators around the country who run large clinical trials, and I think often, when an event may be brought to someone’s attention, there is a tendency to just write it off as kind of a generic expected event due to age, or just something that’s not really pertinent to the study. So they don’t really focus on it as much.”
“Closer collaboration between cardiologists and cancer physicians is needed to better determine true cardiac risks among patients treated with these drugs.”
Breast cancer oncologist Marc E. Lippman, MD, of Georgetown University Medical Center and Georgetown Lombardi Comprehensive Cancer Center, Washington, D.C., isn’t convinced a lack of awareness is the culprit.
“I don’t agree with that at all,” he said in an interview. “I think there are very, very clear rules and guidelines these days for adverse-event reporting. I think that’s not a very likely explanation – that it’s not on the radar.”
Part of the problem may be that some of the toxicities, particularly cardiovascular, may not emerge for years, he said. Participant screening for the trials also likely removed patients with high cardiovascular risk. “It’s very understandable to me – I’m not saying it’s good particularly – but I think it’s very understandable that, if you’re trying to develop a drug, the last thing you’d want to have is a lot of toxicity that you might have avoided by just being restrictive in who you let into the study,” Dr. Lippman said.
The underreported CVD events may also reflect the rapidly changing profile of cardiovascular toxicities associated with novel anticancer therapies.
“Providers, both cancer and noncancer, generally put cardiotoxicity in the box of anthracyclines and radiation, but particularly over the last decade, we’ve begun to understand it’s well beyond any one class of drugs,” Dr. Addison said.
“I agree completely,” Dr. Lippman said. For example, “the checkpoint inhibitors are so unbelievably different in terms of their toxicities that many people simply didn’t even know what they were getting into at first.”
One size does not fit all
Javid Moslehi, MD, director of the cardio-oncology program at Vanderbilt University, Nashville, Tenn., said echocardiography – recommended to detect changes in left ventricular function in patients exposed to anthracyclines or targeted agents like trastuzumab (Herceptin) – isn’t enough to address today’s cancer therapy–related CVD events.
“Initial drugs like anthracyclines or Herceptin in cardio-oncology were associated with systolic cardiac dysfunction, whereas the majority of issues we see in the cardio-oncology clinics today are vascular, metabolic, arrhythmogenic, and inflammatory,” he said in an interview. “Echocardiography misses the big and increasingly complex picture.”
His group, for example, has been studying myocarditis associated with immunotherapies, but none of the clinical trials require screening or surveillance for myocarditis with a cardiac biomarker like troponin.
The group also recently identified 303 deaths in patients exposed to ibrutinib, a drug that revolutionized the treatment of several B-cell malignancies but is associated with higher rates of atrial fibrillation, which is also associated with increased bleeding risk. “So there’s a little bit of a double whammy there, given that we often treat atrial fibrillation with anticoagulation and where we can cause complications in patients,” Dr. Moslehi noted.
Although there needs to be closer collaboration between cardiologists and oncologists on individual trials, cardiologists also have to realize that oncology care has become very personalized, he suggested.
“What’s probably relevant for the breast cancer patient may not be relevant for the prostate cancer patient and their respective treatments,” Dr. Moslehi said. “So if we were to say, ‘every person should get an echo,’ that may be less relevant to the prostate cancer patient where treatments can cause vascular and metabolic perturbations or to the patient treated with immunotherapy who may have myocarditis, where many of the echos can be normal. There’s no one-size-fits-all for these things.”
Wearable technologies like smartwatches could play a role in improving the reporting of CVD events with novel therapies but a lot more research needs to be done to validate these tools, Dr. Addison said. “But as we continue on into the 21st century, this is going to expand and may potentially help us,” he added.
In the interim, better standardization is needed of the cardiovascular events reported in oncology trials, particularly the Common Terminology Criteria for Adverse Events (CTCAE), said Dr. Moslehi, who also serves as chair of the American Heart Association’s subcommittee on cardio-oncology.
“Cardiovascular definitions are not exactly uniform and are not consistent with what we in cardiology consider to be important or relevant,” he said. “So I think there needs to be better standardization of these definitions, specifically within the CTCAE, which is what the oncologists use to identify adverse events.”
In a linked editorial (J Am Coll Cardiol. 2020;75:629-31), Dr. Lippman and cardiologist Nanette Bishopric, MD, of the Medstar Heart and Vascular Institute in Washington, D.C., suggested it may also be time to organize a consortium that can carry out “rigorous multicenter clinical investigations to evaluate the cardiotoxicity of emerging cancer treatments,” similar to the Thrombosis in Myocardial Infarction Study Group.
“The success of this consortium in pioneering and targeting multiple generations of drugs for the treatment of MI, involving tens of thousands of patients and thousands of collaborations across multiple national borders, is a model for how to move forward in providing the new hope of cancer cure without the trade-off of years lost to heart disease,” the editorialists concluded.
The study was supported in part by National Institutes of Health grants, including a K12-CA133250 grant to Dr. Addison. Dr. Bishopric reported being on the scientific board of C&C Biopharma. Dr. Lippman reports being on the board of directors of and holding stock in Seattle Genetics. Dr. Moslehi reported having served on advisory boards for Pfizer, Novartis, Bristol-Myers Squibb, Deciphera, Audentes Pharmaceuticals, Nektar, Takeda, Ipsen, Myokardia, AstraZeneca, GlaxoSmithKline, Intrexon, and Regeneron.
This article first appeared on Medscape.com.
Clinical trials supporting Food and Drug Adminstration approval of contemporary cancer therapies frequently failed to capture major adverse cardiovascular events (MACE) and, when they did, reported rates 2.6-fold lower than noncancer trials, new research shows.
Overall, 51.3% of trials did not report MACE, with that number reaching 57.6% in trials enrolling patients with baseline cardiovascular disease (CVD).
Nearly 40% of trials did not report any CVD events in follow-up, the authors reported online Feb. 10, 2020, in the Journal of the American College of Cardiology (2020;75:620-8).
“Even in drug classes where there were established or emerging associations with cardiotoxic events, often there were no reported heart events or cardiovascular events across years of follow-up in trials that examined hundreds or even thousands of patients. That was actually pretty surprising,” senior author Daniel Addison, MD, codirector of the cardio-oncology program at the Ohio State University Medical Center, Columbus, said in an interview.
The study was prompted by a series of events that crescendoed when his team was called to the ICU to determine whether a novel targeted agent played a role in the heart decline of a patient with acute myeloid leukemia. “I had a resident ask me a very important question: ‘How do we really know for sure that the trial actually reflects the true risk of heart events?’ to which I told him, ‘it’s difficult to know,’ ” he said.
“I think many of us rely heavily on what we see in the trials, particularly when they make it to the top journals, and quite frankly, we generally take it at face value,” Dr. Addison observed.
Lower Rate of Reported Events
The investigators reviewed CV events reported in 97,365 patients (median age, 61 years; 46% female) enrolled in 189 phase 2 and 3 trials supporting FDA approval of 123 anticancer drugs from 1998 to 2018. Biologic, targeted, or immune-based therapies accounted for 72.5% of drug approvals.
Over 148,138 person-years of follow-up (median trial duration, 30 months), there were 1,148 incidents of MACE (375 heart failure, 253 MIs, 180 strokes, 65 atrial fibrillation, 29 coronary revascularizations, and 246 CVD deaths). MACE rates were higher in the intervention group than in the control group (792 vs. 356; P less than .01). Among the 64 trials that excluded patients with baseline CVD, there were 269 incidents of MACE.
To put this finding in context, the researchers examined the reported incidence of MACE among some 6,000 similarly aged participants in the Multi-Ethnic Study of Atherosclerosis (MESA). The overall weighted-average incidence rate was 1,408 per 100,000 person-years among MESA participants, compared with 542 events per 100,000 person-years among oncology trial participants (716 per 100,000 in the intervention arm). This represents a reported-to-expected ratio of 0.38 – a 2.6-fold lower rate of reported events (P less than .001) – and a risk difference of 866.
Further, MACE reporting was lower by a factor of 1.7 among all cancer trial participants irrespective of baseline CVD status (reported-to-expected ratio, 0.56; risk difference, 613; P less than .001).
There was no significant difference in MACE reporting between independent or industry-sponsored trials, the authors report.
No malicious intent
“There are likely some that might lean toward not wanting to attribute blame to a new drug when the drug is in a study, but I really think that the leading factor is lack of awareness,” Dr. Addison said. “I’ve talked with several cancer collaborators around the country who run large clinical trials, and I think often, when an event may be brought to someone’s attention, there is a tendency to just write it off as kind of a generic expected event due to age, or just something that’s not really pertinent to the study. So they don’t really focus on it as much.”
“Closer collaboration between cardiologists and cancer physicians is needed to better determine true cardiac risks among patients treated with these drugs.”
Breast cancer oncologist Marc E. Lippman, MD, of Georgetown University Medical Center and Georgetown Lombardi Comprehensive Cancer Center, Washington, D.C., isn’t convinced a lack of awareness is the culprit.
“I don’t agree with that at all,” he said in an interview. “I think there are very, very clear rules and guidelines these days for adverse-event reporting. I think that’s not a very likely explanation – that it’s not on the radar.”
Part of the problem may be that some of the toxicities, particularly cardiovascular, may not emerge for years, he said. Participant screening for the trials also likely removed patients with high cardiovascular risk. “It’s very understandable to me – I’m not saying it’s good particularly – but I think it’s very understandable that, if you’re trying to develop a drug, the last thing you’d want to have is a lot of toxicity that you might have avoided by just being restrictive in who you let into the study,” Dr. Lippman said.
The underreported CVD events may also reflect the rapidly changing profile of cardiovascular toxicities associated with novel anticancer therapies.
“Providers, both cancer and noncancer, generally put cardiotoxicity in the box of anthracyclines and radiation, but particularly over the last decade, we’ve begun to understand it’s well beyond any one class of drugs,” Dr. Addison said.
“I agree completely,” Dr. Lippman said. For example, “the checkpoint inhibitors are so unbelievably different in terms of their toxicities that many people simply didn’t even know what they were getting into at first.”
One size does not fit all
Javid Moslehi, MD, director of the cardio-oncology program at Vanderbilt University, Nashville, Tenn., said echocardiography – recommended to detect changes in left ventricular function in patients exposed to anthracyclines or targeted agents like trastuzumab (Herceptin) – isn’t enough to address today’s cancer therapy–related CVD events.
“Initial drugs like anthracyclines or Herceptin in cardio-oncology were associated with systolic cardiac dysfunction, whereas the majority of issues we see in the cardio-oncology clinics today are vascular, metabolic, arrhythmogenic, and inflammatory,” he said in an interview. “Echocardiography misses the big and increasingly complex picture.”
His group, for example, has been studying myocarditis associated with immunotherapies, but none of the clinical trials require screening or surveillance for myocarditis with a cardiac biomarker like troponin.
The group also recently identified 303 deaths in patients exposed to ibrutinib, a drug that revolutionized the treatment of several B-cell malignancies but is associated with higher rates of atrial fibrillation, which is also associated with increased bleeding risk. “So there’s a little bit of a double whammy there, given that we often treat atrial fibrillation with anticoagulation and where we can cause complications in patients,” Dr. Moslehi noted.
Although there needs to be closer collaboration between cardiologists and oncologists on individual trials, cardiologists also have to realize that oncology care has become very personalized, he suggested.
“What’s probably relevant for the breast cancer patient may not be relevant for the prostate cancer patient and their respective treatments,” Dr. Moslehi said. “So if we were to say, ‘every person should get an echo,’ that may be less relevant to the prostate cancer patient where treatments can cause vascular and metabolic perturbations or to the patient treated with immunotherapy who may have myocarditis, where many of the echos can be normal. There’s no one-size-fits-all for these things.”
Wearable technologies like smartwatches could play a role in improving the reporting of CVD events with novel therapies but a lot more research needs to be done to validate these tools, Dr. Addison said. “But as we continue on into the 21st century, this is going to expand and may potentially help us,” he added.
In the interim, better standardization is needed of the cardiovascular events reported in oncology trials, particularly the Common Terminology Criteria for Adverse Events (CTCAE), said Dr. Moslehi, who also serves as chair of the American Heart Association’s subcommittee on cardio-oncology.
“Cardiovascular definitions are not exactly uniform and are not consistent with what we in cardiology consider to be important or relevant,” he said. “So I think there needs to be better standardization of these definitions, specifically within the CTCAE, which is what the oncologists use to identify adverse events.”
In a linked editorial (J Am Coll Cardiol. 2020;75:629-31), Dr. Lippman and cardiologist Nanette Bishopric, MD, of the Medstar Heart and Vascular Institute in Washington, D.C., suggested it may also be time to organize a consortium that can carry out “rigorous multicenter clinical investigations to evaluate the cardiotoxicity of emerging cancer treatments,” similar to the Thrombosis in Myocardial Infarction Study Group.
“The success of this consortium in pioneering and targeting multiple generations of drugs for the treatment of MI, involving tens of thousands of patients and thousands of collaborations across multiple national borders, is a model for how to move forward in providing the new hope of cancer cure without the trade-off of years lost to heart disease,” the editorialists concluded.
The study was supported in part by National Institutes of Health grants, including a K12-CA133250 grant to Dr. Addison. Dr. Bishopric reported being on the scientific board of C&C Biopharma. Dr. Lippman reports being on the board of directors of and holding stock in Seattle Genetics. Dr. Moslehi reported having served on advisory boards for Pfizer, Novartis, Bristol-Myers Squibb, Deciphera, Audentes Pharmaceuticals, Nektar, Takeda, Ipsen, Myokardia, AstraZeneca, GlaxoSmithKline, Intrexon, and Regeneron.
This article first appeared on Medscape.com.
Clinical trials supporting Food and Drug Adminstration approval of contemporary cancer therapies frequently failed to capture major adverse cardiovascular events (MACE) and, when they did, reported rates 2.6-fold lower than noncancer trials, new research shows.
Overall, 51.3% of trials did not report MACE, with that number reaching 57.6% in trials enrolling patients with baseline cardiovascular disease (CVD).
Nearly 40% of trials did not report any CVD events in follow-up, the authors reported online Feb. 10, 2020, in the Journal of the American College of Cardiology (2020;75:620-8).
“Even in drug classes where there were established or emerging associations with cardiotoxic events, often there were no reported heart events or cardiovascular events across years of follow-up in trials that examined hundreds or even thousands of patients. That was actually pretty surprising,” senior author Daniel Addison, MD, codirector of the cardio-oncology program at the Ohio State University Medical Center, Columbus, said in an interview.
The study was prompted by a series of events that crescendoed when his team was called to the ICU to determine whether a novel targeted agent played a role in the heart decline of a patient with acute myeloid leukemia. “I had a resident ask me a very important question: ‘How do we really know for sure that the trial actually reflects the true risk of heart events?’ to which I told him, ‘it’s difficult to know,’ ” he said.
“I think many of us rely heavily on what we see in the trials, particularly when they make it to the top journals, and quite frankly, we generally take it at face value,” Dr. Addison observed.
Lower Rate of Reported Events
The investigators reviewed CV events reported in 97,365 patients (median age, 61 years; 46% female) enrolled in 189 phase 2 and 3 trials supporting FDA approval of 123 anticancer drugs from 1998 to 2018. Biologic, targeted, or immune-based therapies accounted for 72.5% of drug approvals.
Over 148,138 person-years of follow-up (median trial duration, 30 months), there were 1,148 incidents of MACE (375 heart failure, 253 MIs, 180 strokes, 65 atrial fibrillation, 29 coronary revascularizations, and 246 CVD deaths). MACE rates were higher in the intervention group than in the control group (792 vs. 356; P less than .01). Among the 64 trials that excluded patients with baseline CVD, there were 269 incidents of MACE.
To put this finding in context, the researchers examined the reported incidence of MACE among some 6,000 similarly aged participants in the Multi-Ethnic Study of Atherosclerosis (MESA). The overall weighted-average incidence rate was 1,408 per 100,000 person-years among MESA participants, compared with 542 events per 100,000 person-years among oncology trial participants (716 per 100,000 in the intervention arm). This represents a reported-to-expected ratio of 0.38 – a 2.6-fold lower rate of reported events (P less than .001) – and a risk difference of 866.
Further, MACE reporting was lower by a factor of 1.7 among all cancer trial participants irrespective of baseline CVD status (reported-to-expected ratio, 0.56; risk difference, 613; P less than .001).
There was no significant difference in MACE reporting between independent or industry-sponsored trials, the authors report.
No malicious intent
“There are likely some that might lean toward not wanting to attribute blame to a new drug when the drug is in a study, but I really think that the leading factor is lack of awareness,” Dr. Addison said. “I’ve talked with several cancer collaborators around the country who run large clinical trials, and I think often, when an event may be brought to someone’s attention, there is a tendency to just write it off as kind of a generic expected event due to age, or just something that’s not really pertinent to the study. So they don’t really focus on it as much.”
“Closer collaboration between cardiologists and cancer physicians is needed to better determine true cardiac risks among patients treated with these drugs.”
Breast cancer oncologist Marc E. Lippman, MD, of Georgetown University Medical Center and Georgetown Lombardi Comprehensive Cancer Center, Washington, D.C., isn’t convinced a lack of awareness is the culprit.
“I don’t agree with that at all,” he said in an interview. “I think there are very, very clear rules and guidelines these days for adverse-event reporting. I think that’s not a very likely explanation – that it’s not on the radar.”
Part of the problem may be that some of the toxicities, particularly cardiovascular, may not emerge for years, he said. Participant screening for the trials also likely removed patients with high cardiovascular risk. “It’s very understandable to me – I’m not saying it’s good particularly – but I think it’s very understandable that, if you’re trying to develop a drug, the last thing you’d want to have is a lot of toxicity that you might have avoided by just being restrictive in who you let into the study,” Dr. Lippman said.
The underreported CVD events may also reflect the rapidly changing profile of cardiovascular toxicities associated with novel anticancer therapies.
“Providers, both cancer and noncancer, generally put cardiotoxicity in the box of anthracyclines and radiation, but particularly over the last decade, we’ve begun to understand it’s well beyond any one class of drugs,” Dr. Addison said.
“I agree completely,” Dr. Lippman said. For example, “the checkpoint inhibitors are so unbelievably different in terms of their toxicities that many people simply didn’t even know what they were getting into at first.”
One size does not fit all
Javid Moslehi, MD, director of the cardio-oncology program at Vanderbilt University, Nashville, Tenn., said echocardiography – recommended to detect changes in left ventricular function in patients exposed to anthracyclines or targeted agents like trastuzumab (Herceptin) – isn’t enough to address today’s cancer therapy–related CVD events.
“Initial drugs like anthracyclines or Herceptin in cardio-oncology were associated with systolic cardiac dysfunction, whereas the majority of issues we see in the cardio-oncology clinics today are vascular, metabolic, arrhythmogenic, and inflammatory,” he said in an interview. “Echocardiography misses the big and increasingly complex picture.”
His group, for example, has been studying myocarditis associated with immunotherapies, but none of the clinical trials require screening or surveillance for myocarditis with a cardiac biomarker like troponin.
The group also recently identified 303 deaths in patients exposed to ibrutinib, a drug that revolutionized the treatment of several B-cell malignancies but is associated with higher rates of atrial fibrillation, which is also associated with increased bleeding risk. “So there’s a little bit of a double whammy there, given that we often treat atrial fibrillation with anticoagulation and where we can cause complications in patients,” Dr. Moslehi noted.
Although there needs to be closer collaboration between cardiologists and oncologists on individual trials, cardiologists also have to realize that oncology care has become very personalized, he suggested.
“What’s probably relevant for the breast cancer patient may not be relevant for the prostate cancer patient and their respective treatments,” Dr. Moslehi said. “So if we were to say, ‘every person should get an echo,’ that may be less relevant to the prostate cancer patient where treatments can cause vascular and metabolic perturbations or to the patient treated with immunotherapy who may have myocarditis, where many of the echos can be normal. There’s no one-size-fits-all for these things.”
Wearable technologies like smartwatches could play a role in improving the reporting of CVD events with novel therapies but a lot more research needs to be done to validate these tools, Dr. Addison said. “But as we continue on into the 21st century, this is going to expand and may potentially help us,” he added.
In the interim, better standardization is needed of the cardiovascular events reported in oncology trials, particularly the Common Terminology Criteria for Adverse Events (CTCAE), said Dr. Moslehi, who also serves as chair of the American Heart Association’s subcommittee on cardio-oncology.
“Cardiovascular definitions are not exactly uniform and are not consistent with what we in cardiology consider to be important or relevant,” he said. “So I think there needs to be better standardization of these definitions, specifically within the CTCAE, which is what the oncologists use to identify adverse events.”
In a linked editorial (J Am Coll Cardiol. 2020;75:629-31), Dr. Lippman and cardiologist Nanette Bishopric, MD, of the Medstar Heart and Vascular Institute in Washington, D.C., suggested it may also be time to organize a consortium that can carry out “rigorous multicenter clinical investigations to evaluate the cardiotoxicity of emerging cancer treatments,” similar to the Thrombosis in Myocardial Infarction Study Group.
“The success of this consortium in pioneering and targeting multiple generations of drugs for the treatment of MI, involving tens of thousands of patients and thousands of collaborations across multiple national borders, is a model for how to move forward in providing the new hope of cancer cure without the trade-off of years lost to heart disease,” the editorialists concluded.
The study was supported in part by National Institutes of Health grants, including a K12-CA133250 grant to Dr. Addison. Dr. Bishopric reported being on the scientific board of C&C Biopharma. Dr. Lippman reports being on the board of directors of and holding stock in Seattle Genetics. Dr. Moslehi reported having served on advisory boards for Pfizer, Novartis, Bristol-Myers Squibb, Deciphera, Audentes Pharmaceuticals, Nektar, Takeda, Ipsen, Myokardia, AstraZeneca, GlaxoSmithKline, Intrexon, and Regeneron.
This article first appeared on Medscape.com.