Society of Hospital Medicine President Nasim Afsar, MD, SFHM, told a packed ballroom of hospitalists at HM19 on Monday that it’s not change to the health care industry that is most central to their future, but it’s how they assume a role within it and how they spark it themselves.

Lou Ferraro, Park South Photography

With a tone that was, at times, almost ebullient about change, Dr. Afsar characterized the flux of health care as a series of opportunities to improve patient care.

“Run toward change,” said Dr. Afsar, chief ambulatory officer and chief medical officer for accountable care organizations at University of California, Irvine. “And be a force of positive change.”

The push toward affordability and value has made for some “unlikely partners,” she noted, including the health care venture launched by Amazon, Berkshire Hathaway, and JPMorgan Chase, as well as some newer corporations stepping into the health care sphere, such as Uber with its UberHealth and the creation of giants like the CVS-Aetna merger.

She acknowledged it brings “uncertainty and risk” but suggested that hospitalists are equipped to cope, saying that “we’ve all experienced this in our personal and professional lives.”

Dr. Afsar described four major themes of change to the health care landscape that will affect how hospitalists do their jobs.

• A new setting of care. “The care of the patients is moving from the hospital to the ambulatory setting,” she said. “Some of the surgeries that we used to do in the ER are now being done in ambulatory surgery centers. Antibiotics are being infused via IVs at patients’ homes.”
• Focus on health and well-being. “There’s a transition as a society on focusing on the sick to prevention of disease,” she said. “How can we prevent chronic illness once it occurs? How can we limit its progression? This is a very new focus for us in health care.”
• An increasing role of patient care teams – including primary care doctors, pharmacists, and case managers – rather than hospital-based teams.
• A new focus on patient-centered care. “It’s a focus about how we can be everywhere the patient is, at anytime that the patient needs us,” she said.

A sense of the way forward, Dr. Afsar said, came out of recent strategic meetings of the SHM board of directors, in which they talked about the role and future of hospitalists in population health management and value-based care. They agreed hospitalists should define themselves by their values and competencies, not by the hospital building itself. Hospitalists should use the acute care episode to make sure patients are connected to a larger system of care with wellness and prevention in mind.

“It’s not the strongest of the species that survive, nor the most intelligent,” Dr. Afsar said. “But the ones who are most adaptable to change. While there’s debate on the Internet about who originally said this, there’s absolutely no debate that the theme in life and in health care is adaptability in the face of constant change.”

Lou Ferraro, Park South Photography

In his own address at the Annual Conference of the Society of Hospital Medicine, Christopher Frost, MD, SFHM, the president-elect of SHM and national medical director of hospital-based services for LifePoint Health in Brentwood, Tenn., echoed Dr. Afsar’s theme of action in the context of change.

A key word, he said, is “multifarious” – the health care industry changes and the ways hospitalists are tackling these changes come in many and various types.

“We will not just react to – but actually help author – aspects of this change,” he said, including the continued move from fee for service to value-based and risk-based models of payment, and how to put new insights into disease processes to use and how they’re linked to social factors.

Increasing the diversity of hospitalist teams, maximizing the use of technology, and improving LGBTQ care are all themes of change being addressed at the meeting, he noted.

“When we summit one mountain of our own professional Alps,” Dr. Frost said, “and we see another on the horizon, we say, ‘Let’s climb that one. Let’s go there.’ ”

Society of Hospital Medicine President Nasim Afsar, MD, SFHM, told a packed ballroom of hospitalists at HM19 on Monday that it’s not change to the health care industry that is most central to their future, but it’s how they assume a role within it and how they spark it themselves.

Lou Ferraro, Park South Photography

With a tone that was, at times, almost ebullient about change, Dr. Afsar characterized the flux of health care as a series of opportunities to improve patient care.

“Run toward change,” said Dr. Afsar, chief ambulatory officer and chief medical officer for accountable care organizations at University of California, Irvine. “And be a force of positive change.”

The push toward affordability and value has made for some “unlikely partners,” she noted, including the health care venture launched by Amazon, Berkshire Hathaway, and JPMorgan Chase, as well as some newer corporations stepping into the health care sphere, such as Uber with its UberHealth and the creation of giants like the CVS-Aetna merger.

She acknowledged it brings “uncertainty and risk” but suggested that hospitalists are equipped to cope, saying that “we’ve all experienced this in our personal and professional lives.”

Dr. Afsar described four major themes of change to the health care landscape that will affect how hospitalists do their jobs.

• A new setting of care. “The care of the patients is moving from the hospital to the ambulatory setting,” she said. “Some of the surgeries that we used to do in the ER are now being done in ambulatory surgery centers. Antibiotics are being infused via IVs at patients’ homes.”
• Focus on health and well-being. “There’s a transition as a society on focusing on the sick to prevention of disease,” she said. “How can we prevent chronic illness once it occurs? How can we limit its progression? This is a very new focus for us in health care.”
• An increasing role of patient care teams – including primary care doctors, pharmacists, and case managers – rather than hospital-based teams.
• A new focus on patient-centered care. “It’s a focus about how we can be everywhere the patient is, at anytime that the patient needs us,” she said.

A sense of the way forward, Dr. Afsar said, came out of recent strategic meetings of the SHM board of directors, in which they talked about the role and future of hospitalists in population health management and value-based care. They agreed hospitalists should define themselves by their values and competencies, not by the hospital building itself. Hospitalists should use the acute care episode to make sure patients are connected to a larger system of care with wellness and prevention in mind.

“It’s not the strongest of the species that survive, nor the most intelligent,” Dr. Afsar said. “But the ones who are most adaptable to change. While there’s debate on the Internet about who originally said this, there’s absolutely no debate that the theme in life and in health care is adaptability in the face of constant change.”

Lou Ferraro, Park South Photography

In his own address at the Annual Conference of the Society of Hospital Medicine, Christopher Frost, MD, SFHM, the president-elect of SHM and national medical director of hospital-based services for LifePoint Health in Brentwood, Tenn., echoed Dr. Afsar’s theme of action in the context of change.

A key word, he said, is “multifarious” – the health care industry changes and the ways hospitalists are tackling these changes come in many and various types.

“We will not just react to – but actually help author – aspects of this change,” he said, including the continued move from fee for service to value-based and risk-based models of payment, and how to put new insights into disease processes to use and how they’re linked to social factors.

Increasing the diversity of hospitalist teams, maximizing the use of technology, and improving LGBTQ care are all themes of change being addressed at the meeting, he noted.

“When we summit one mountain of our own professional Alps,” Dr. Frost said, “and we see another on the horizon, we say, ‘Let’s climb that one. Let’s go there.’ ”

Society of Hospital Medicine President Nasim Afsar, MD, SFHM, told a packed ballroom of hospitalists at HM19 on Monday that it’s not change to the health care industry that is most central to their future, but it’s how they assume a role within it and how they spark it themselves.

Lou Ferraro, Park South Photography

With a tone that was, at times, almost ebullient about change, Dr. Afsar characterized the flux of health care as a series of opportunities to improve patient care.

“Run toward change,” said Dr. Afsar, chief ambulatory officer and chief medical officer for accountable care organizations at University of California, Irvine. “And be a force of positive change.”

The push toward affordability and value has made for some “unlikely partners,” she noted, including the health care venture launched by Amazon, Berkshire Hathaway, and JPMorgan Chase, as well as some newer corporations stepping into the health care sphere, such as Uber with its UberHealth and the creation of giants like the CVS-Aetna merger.

She acknowledged it brings “uncertainty and risk” but suggested that hospitalists are equipped to cope, saying that “we’ve all experienced this in our personal and professional lives.”

Dr. Afsar described four major themes of change to the health care landscape that will affect how hospitalists do their jobs.

• A new setting of care. “The care of the patients is moving from the hospital to the ambulatory setting,” she said. “Some of the surgeries that we used to do in the ER are now being done in ambulatory surgery centers. Antibiotics are being infused via IVs at patients’ homes.”
• Focus on health and well-being. “There’s a transition as a society on focusing on the sick to prevention of disease,” she said. “How can we prevent chronic illness once it occurs? How can we limit its progression? This is a very new focus for us in health care.”
• An increasing role of patient care teams – including primary care doctors, pharmacists, and case managers – rather than hospital-based teams.
• A new focus on patient-centered care. “It’s a focus about how we can be everywhere the patient is, at anytime that the patient needs us,” she said.

A sense of the way forward, Dr. Afsar said, came out of recent strategic meetings of the SHM board of directors, in which they talked about the role and future of hospitalists in population health management and value-based care. They agreed hospitalists should define themselves by their values and competencies, not by the hospital building itself. Hospitalists should use the acute care episode to make sure patients are connected to a larger system of care with wellness and prevention in mind.

“It’s not the strongest of the species that survive, nor the most intelligent,” Dr. Afsar said. “But the ones who are most adaptable to change. While there’s debate on the Internet about who originally said this, there’s absolutely no debate that the theme in life and in health care is adaptability in the face of constant change.”

Lou Ferraro, Park South Photography

In his own address at the Annual Conference of the Society of Hospital Medicine, Christopher Frost, MD, SFHM, the president-elect of SHM and national medical director of hospital-based services for LifePoint Health in Brentwood, Tenn., echoed Dr. Afsar’s theme of action in the context of change.

A key word, he said, is “multifarious” – the health care industry changes and the ways hospitalists are tackling these changes come in many and various types.

“We will not just react to – but actually help author – aspects of this change,” he said, including the continued move from fee for service to value-based and risk-based models of payment, and how to put new insights into disease processes to use and how they’re linked to social factors.

Increasing the diversity of hospitalist teams, maximizing the use of technology, and improving LGBTQ care are all themes of change being addressed at the meeting, he noted.

“When we summit one mountain of our own professional Alps,” Dr. Frost said, “and we see another on the horizon, we say, ‘Let’s climb that one. Let’s go there.’ ”

SILVER SPRING, MD. – A mandatory, comprehensive approach to collecting adverse event data from breast implant recipients was favored during a March 25 hearing by a Food and Drug Administration advisory panel that oversees surgical devices.

This additional data could offer more complete information during the informed consent process for breast implants and potentially validate a new, autoimmune-like syndrome – breast implant illness (BII).

On the first day of a scheduled 2-day hearing, the advisory panel held no votes and took no formal actions. After a day of expert presentations and comments from more than 40 members of the public – mostly personal stories from affected patients and from plastic surgeons who place breast implants, panel members discussed a handful of questions from the FDA about relevant data to collect to better define the risks posed to breast implant recipients from breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) and BII.

The advisory panel meeting took place as reports recently appeared documenting the scope of BIA-ALCL (Plast Reconstr Surg. 2019 March;143[3S]:65S-73S) and how to diagnose and manage BIA-ALCL (Aesthetic Surg J. 2019 March;39[S1}:S3-S13), and the existence of BII (Plast Reconstr Surg. 2019 March;143[3S]:74S-81S).

During the day’s two public comment periods, the panel heard from several women who gave brief accounts of developing and dealing with BIA-ALCL or BII.

“We think it’s important that all breast implant patients be aware of the risk for BIA-ALCL,” said Binita Ashar, MD, director of the FDAs Division of Surgical Devices. The FDA “is asking the panel what further steps need to be taken to understand the BIA-ALCL risk,” said Dr. Ashar as she opened the meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee.

Mitchel L. Zoler/MDedge News

While the agency, as well as the plastic surgery community, have acknowledged the existence of BIA-ALCL since 2011, only recently have good data emerged on the scope of the complication. During the hearing, Mark W. Clemens, MD, a plastic surgeon at MD Anderson Cancer Center in Houston, reported on his analysis of 457 unique cases of BIA-ALCL reported to the FDA since 2011. He found that the vast majority of cases had occurred in women who had received textured implants while a relatively small minority were linked with the placement of smooth implants.

Further scrutiny of the reported details of each case showed that none of the lymphomas were linked with a confirmed instance of “pure” smooth implant exposure. He also estimated the U.S. incidence of BIA-ALCL as roughly one case for every 20,000 implants. Complete, en bloc removal of the implant seems to be the most effective way to treat the cancer; most explanted patients have a good prognosis, he said.

Despite the apparent link between textured implants specifically and onset of BIA-ALCL, some panel members did not see a ban on textured implants as the answer.

Mitchel L. Zoler/MDedge News

Texturing the implant helps to stabilize the implant in position. Without texturing “we would need to use something else to stabilize the implant, or there would be a tsunami of reoperations,” said panel member Mary H. McGrath, MD, professor of surgery at the University of California, San Francisco. The main alternative to texturing for stabilizing implants is to wrap them in place using surgical mesh, but that approach may also cause problems.

“Instead of just taking textured implants off the market, we need to also look at their advantages. A critical issue is informed consent,” said panel member Marc E. Lippman, MD, a professor of medicine at Georgetown University, Washington. Banning smooth implants based on what’s known so far “would be an extraordinary over reaction,” he said during the first day’s session.

Current U.S. anecdotal experience suggests that a ban may not even be necessary because “plastic surgeons are more and more walking away from textured implants” because of the apparent link to BIA-ALCL, Dr. McGrath said.

BII has been a more recent and more controversial complication of breast implants. As recently as September 2018, Dr. Ashar said in a written statement that “the agency continues to believe that the weight of the currently available scientific evidence does not conclusively demonstrate an association between breast implants and connective tissue diseases,” the types of symptoms that characterize BII.

While the panel heard no new, conclusive evidence of a causal link between breast implants and the range of symptoms that some implant recipients report and is now collectively known as BII, several participants seemed convinced that the syndrome was real and needed better surveillance and study.

“It’s in the same family as chronic fatigue syndrome and fibromyalgia. It’s not a diagnosis, but a set of symptoms.” said Benjamin O. Anderson, MD, a surgical oncologist and professor of surgery at the University of Washington in Seattle and a panel member. “It’s a giant challenge. BII is a constellation of difficult symptoms. We need to think about how we ask patients, what are your symptoms?”

Mitchel L. Zoler/MDedge News

Frank R. Lewis Jr., MD, committee chair, said a more standardized measure of the most common BII symptoms is needed. “That may be exceedingly difficult, with as many as a hundred reported symptoms,” said Dr. Lewis, executive director, emeritus, of the American Board of Surgery in Philadelphia.

The hearing featured results from some of the most research projects aimed at fleshing out an understanding of BII.
 

Diana Zuckerman, PhD, president of the National Center for Health Research, reported data she and her associates collected in an online survey completed in late 2018 and early 2019 by 449 women who had approached the Center for help in getting health insurance coverage for medically-necessary explantation of their breast implants.

Mitchel L. Zoler/MDedge News

Their most common symptoms included joint, muscle or back pain, weakness or stiffness; fatigue; “brain fog;” and anxiety and depression. More than two-thirds of the respondents had a family history and 3% had a personal history of an autoimmune disease, and 61% said their symptoms improved after their implants were removed, Dr. Zuckerman reported during her presentation to the panel.

During the discussion, panel members seemed intent on expanding mandatory, routine surveillance to all breast implants placed in U.S. practice.

Andrea L. Pusic, MD, president of the Plastic Surgery Foundation, summarized the recent launch of the National Breast Implant Registry by the Foundation and its parent organization, the American Society of Plastic Surgeons. These organizations, and plastic surgeons in general, would be amenable to collecting the data the FDA deemed necessary to better track BIA-ALCL and BII, said Dr. Pusic, professor of surgery at Harvard Medical School and chief of plastic and reconstructive surgery at Brigham and Women’s Hospital in Boston.

“Plastic surgeons are willing to enter these data because we know they are important,” she told the FDA panel.

Dr. Ashar, Dr. Clemens, Dr. McGrath, Dr. Lippman, Dr. Anderson, Dr. Lewis, Dr. Zuckerman, and Dr. Pusic reported having no relevant commercial disclosures.

[email protected]

SILVER SPRING, MD. – A mandatory, comprehensive approach to collecting adverse event data from breast implant recipients was favored during a March 25 hearing by a Food and Drug Administration advisory panel that oversees surgical devices.

This additional data could offer more complete information during the informed consent process for breast implants and potentially validate a new, autoimmune-like syndrome – breast implant illness (BII).

On the first day of a scheduled 2-day hearing, the advisory panel held no votes and took no formal actions. After a day of expert presentations and comments from more than 40 members of the public – mostly personal stories from affected patients and from plastic surgeons who place breast implants, panel members discussed a handful of questions from the FDA about relevant data to collect to better define the risks posed to breast implant recipients from breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) and BII.

The advisory panel meeting took place as reports recently appeared documenting the scope of BIA-ALCL (Plast Reconstr Surg. 2019 March;143[3S]:65S-73S) and how to diagnose and manage BIA-ALCL (Aesthetic Surg J. 2019 March;39[S1}:S3-S13), and the existence of BII (Plast Reconstr Surg. 2019 March;143[3S]:74S-81S).

During the day’s two public comment periods, the panel heard from several women who gave brief accounts of developing and dealing with BIA-ALCL or BII.

“We think it’s important that all breast implant patients be aware of the risk for BIA-ALCL,” said Binita Ashar, MD, director of the FDAs Division of Surgical Devices. The FDA “is asking the panel what further steps need to be taken to understand the BIA-ALCL risk,” said Dr. Ashar as she opened the meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee.

Mitchel L. Zoler/MDedge News

While the agency, as well as the plastic surgery community, have acknowledged the existence of BIA-ALCL since 2011, only recently have good data emerged on the scope of the complication. During the hearing, Mark W. Clemens, MD, a plastic surgeon at MD Anderson Cancer Center in Houston, reported on his analysis of 457 unique cases of BIA-ALCL reported to the FDA since 2011. He found that the vast majority of cases had occurred in women who had received textured implants while a relatively small minority were linked with the placement of smooth implants.

Further scrutiny of the reported details of each case showed that none of the lymphomas were linked with a confirmed instance of “pure” smooth implant exposure. He also estimated the U.S. incidence of BIA-ALCL as roughly one case for every 20,000 implants. Complete, en bloc removal of the implant seems to be the most effective way to treat the cancer; most explanted patients have a good prognosis, he said.

Despite the apparent link between textured implants specifically and onset of BIA-ALCL, some panel members did not see a ban on textured implants as the answer.

Mitchel L. Zoler/MDedge News

Texturing the implant helps to stabilize the implant in position. Without texturing “we would need to use something else to stabilize the implant, or there would be a tsunami of reoperations,” said panel member Mary H. McGrath, MD, professor of surgery at the University of California, San Francisco. The main alternative to texturing for stabilizing implants is to wrap them in place using surgical mesh, but that approach may also cause problems.

“Instead of just taking textured implants off the market, we need to also look at their advantages. A critical issue is informed consent,” said panel member Marc E. Lippman, MD, a professor of medicine at Georgetown University, Washington. Banning smooth implants based on what’s known so far “would be an extraordinary over reaction,” he said during the first day’s session.

Current U.S. anecdotal experience suggests that a ban may not even be necessary because “plastic surgeons are more and more walking away from textured implants” because of the apparent link to BIA-ALCL, Dr. McGrath said.

BII has been a more recent and more controversial complication of breast implants. As recently as September 2018, Dr. Ashar said in a written statement that “the agency continues to believe that the weight of the currently available scientific evidence does not conclusively demonstrate an association between breast implants and connective tissue diseases,” the types of symptoms that characterize BII.

While the panel heard no new, conclusive evidence of a causal link between breast implants and the range of symptoms that some implant recipients report and is now collectively known as BII, several participants seemed convinced that the syndrome was real and needed better surveillance and study.

“It’s in the same family as chronic fatigue syndrome and fibromyalgia. It’s not a diagnosis, but a set of symptoms.” said Benjamin O. Anderson, MD, a surgical oncologist and professor of surgery at the University of Washington in Seattle and a panel member. “It’s a giant challenge. BII is a constellation of difficult symptoms. We need to think about how we ask patients, what are your symptoms?”

Mitchel L. Zoler/MDedge News

Frank R. Lewis Jr., MD, committee chair, said a more standardized measure of the most common BII symptoms is needed. “That may be exceedingly difficult, with as many as a hundred reported symptoms,” said Dr. Lewis, executive director, emeritus, of the American Board of Surgery in Philadelphia.

The hearing featured results from some of the most research projects aimed at fleshing out an understanding of BII.
 

Diana Zuckerman, PhD, president of the National Center for Health Research, reported data she and her associates collected in an online survey completed in late 2018 and early 2019 by 449 women who had approached the Center for help in getting health insurance coverage for medically-necessary explantation of their breast implants.

Mitchel L. Zoler/MDedge News

Their most common symptoms included joint, muscle or back pain, weakness or stiffness; fatigue; “brain fog;” and anxiety and depression. More than two-thirds of the respondents had a family history and 3% had a personal history of an autoimmune disease, and 61% said their symptoms improved after their implants were removed, Dr. Zuckerman reported during her presentation to the panel.

During the discussion, panel members seemed intent on expanding mandatory, routine surveillance to all breast implants placed in U.S. practice.

Andrea L. Pusic, MD, president of the Plastic Surgery Foundation, summarized the recent launch of the National Breast Implant Registry by the Foundation and its parent organization, the American Society of Plastic Surgeons. These organizations, and plastic surgeons in general, would be amenable to collecting the data the FDA deemed necessary to better track BIA-ALCL and BII, said Dr. Pusic, professor of surgery at Harvard Medical School and chief of plastic and reconstructive surgery at Brigham and Women’s Hospital in Boston.

“Plastic surgeons are willing to enter these data because we know they are important,” she told the FDA panel.

Dr. Ashar, Dr. Clemens, Dr. McGrath, Dr. Lippman, Dr. Anderson, Dr. Lewis, Dr. Zuckerman, and Dr. Pusic reported having no relevant commercial disclosures.

[email protected]

SILVER SPRING, MD. – A mandatory, comprehensive approach to collecting adverse event data from breast implant recipients was favored during a March 25 hearing by a Food and Drug Administration advisory panel that oversees surgical devices.

This additional data could offer more complete information during the informed consent process for breast implants and potentially validate a new, autoimmune-like syndrome – breast implant illness (BII).

On the first day of a scheduled 2-day hearing, the advisory panel held no votes and took no formal actions. After a day of expert presentations and comments from more than 40 members of the public – mostly personal stories from affected patients and from plastic surgeons who place breast implants, panel members discussed a handful of questions from the FDA about relevant data to collect to better define the risks posed to breast implant recipients from breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) and BII.

The advisory panel meeting took place as reports recently appeared documenting the scope of BIA-ALCL (Plast Reconstr Surg. 2019 March;143[3S]:65S-73S) and how to diagnose and manage BIA-ALCL (Aesthetic Surg J. 2019 March;39[S1}:S3-S13), and the existence of BII (Plast Reconstr Surg. 2019 March;143[3S]:74S-81S).

During the day’s two public comment periods, the panel heard from several women who gave brief accounts of developing and dealing with BIA-ALCL or BII.

“We think it’s important that all breast implant patients be aware of the risk for BIA-ALCL,” said Binita Ashar, MD, director of the FDAs Division of Surgical Devices. The FDA “is asking the panel what further steps need to be taken to understand the BIA-ALCL risk,” said Dr. Ashar as she opened the meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee.

Mitchel L. Zoler/MDedge News

While the agency, as well as the plastic surgery community, have acknowledged the existence of BIA-ALCL since 2011, only recently have good data emerged on the scope of the complication. During the hearing, Mark W. Clemens, MD, a plastic surgeon at MD Anderson Cancer Center in Houston, reported on his analysis of 457 unique cases of BIA-ALCL reported to the FDA since 2011. He found that the vast majority of cases had occurred in women who had received textured implants while a relatively small minority were linked with the placement of smooth implants.

Further scrutiny of the reported details of each case showed that none of the lymphomas were linked with a confirmed instance of “pure” smooth implant exposure. He also estimated the U.S. incidence of BIA-ALCL as roughly one case for every 20,000 implants. Complete, en bloc removal of the implant seems to be the most effective way to treat the cancer; most explanted patients have a good prognosis, he said.

Despite the apparent link between textured implants specifically and onset of BIA-ALCL, some panel members did not see a ban on textured implants as the answer.

Mitchel L. Zoler/MDedge News

Texturing the implant helps to stabilize the implant in position. Without texturing “we would need to use something else to stabilize the implant, or there would be a tsunami of reoperations,” said panel member Mary H. McGrath, MD, professor of surgery at the University of California, San Francisco. The main alternative to texturing for stabilizing implants is to wrap them in place using surgical mesh, but that approach may also cause problems.

“Instead of just taking textured implants off the market, we need to also look at their advantages. A critical issue is informed consent,” said panel member Marc E. Lippman, MD, a professor of medicine at Georgetown University, Washington. Banning smooth implants based on what’s known so far “would be an extraordinary over reaction,” he said during the first day’s session.

Current U.S. anecdotal experience suggests that a ban may not even be necessary because “plastic surgeons are more and more walking away from textured implants” because of the apparent link to BIA-ALCL, Dr. McGrath said.

BII has been a more recent and more controversial complication of breast implants. As recently as September 2018, Dr. Ashar said in a written statement that “the agency continues to believe that the weight of the currently available scientific evidence does not conclusively demonstrate an association between breast implants and connective tissue diseases,” the types of symptoms that characterize BII.

While the panel heard no new, conclusive evidence of a causal link between breast implants and the range of symptoms that some implant recipients report and is now collectively known as BII, several participants seemed convinced that the syndrome was real and needed better surveillance and study.

“It’s in the same family as chronic fatigue syndrome and fibromyalgia. It’s not a diagnosis, but a set of symptoms.” said Benjamin O. Anderson, MD, a surgical oncologist and professor of surgery at the University of Washington in Seattle and a panel member. “It’s a giant challenge. BII is a constellation of difficult symptoms. We need to think about how we ask patients, what are your symptoms?”

Mitchel L. Zoler/MDedge News

Frank R. Lewis Jr., MD, committee chair, said a more standardized measure of the most common BII symptoms is needed. “That may be exceedingly difficult, with as many as a hundred reported symptoms,” said Dr. Lewis, executive director, emeritus, of the American Board of Surgery in Philadelphia.

The hearing featured results from some of the most research projects aimed at fleshing out an understanding of BII.
 

Diana Zuckerman, PhD, president of the National Center for Health Research, reported data she and her associates collected in an online survey completed in late 2018 and early 2019 by 449 women who had approached the Center for help in getting health insurance coverage for medically-necessary explantation of their breast implants.

Mitchel L. Zoler/MDedge News

Their most common symptoms included joint, muscle or back pain, weakness or stiffness; fatigue; “brain fog;” and anxiety and depression. More than two-thirds of the respondents had a family history and 3% had a personal history of an autoimmune disease, and 61% said their symptoms improved after their implants were removed, Dr. Zuckerman reported during her presentation to the panel.

During the discussion, panel members seemed intent on expanding mandatory, routine surveillance to all breast implants placed in U.S. practice.

Andrea L. Pusic, MD, president of the Plastic Surgery Foundation, summarized the recent launch of the National Breast Implant Registry by the Foundation and its parent organization, the American Society of Plastic Surgeons. These organizations, and plastic surgeons in general, would be amenable to collecting the data the FDA deemed necessary to better track BIA-ALCL and BII, said Dr. Pusic, professor of surgery at Harvard Medical School and chief of plastic and reconstructive surgery at Brigham and Women’s Hospital in Boston.

“Plastic surgeons are willing to enter these data because we know they are important,” she told the FDA panel.

Dr. Ashar, Dr. Clemens, Dr. McGrath, Dr. Lippman, Dr. Anderson, Dr. Lewis, Dr. Zuckerman, and Dr. Pusic reported having no relevant commercial disclosures.

[email protected]

Discontinuing

How would you characterize the prevalence of MS in the elderly?

DR. CORBOY:  A recent large demographic study put together by the National MS Society found that there’s almost a million individuals diagnosed with MS over the course of the last 40 to 50 years. The largest population segment was those aged 55 to 64 years. People with MS aged 55 or older constituted 46% of all those with MS.

What disease-modifying therapies (DMTs) are approved by the FDA for the elderly?

DR. CORBOY: Of the drugs that have received FDA approval, most are for individuals over the age of 18 and there’s no specific age cutoff. However, there’s no data supporting DMT use in people over the age of 55 because they were excluded from the studies.

There’s one DMT, fingolimod, that was approved for use in patients under the age of 18; all others are approved for 18 and above. However, none of them are explicitly approved for people over the age of 55, because there is no data to support it.

What is the goal of your study, the DISCO MS trial?

DR. CORBOY: The DISCO MS trial will be the first randomized, controlled, blinded discontinuation trial in the MS space. The objective is to assess the benefit of DMTs in patients over the age of 55.

Part of the rationale for the trial is that prior subgroup analyses have shown that the vast majority of the benefit that we’ve been able to measure with all of these DMTs is seen in those who are under age 45.

A number of studies have examined existing databases and individuals who were either randomly or deliberately taken off of their medication as they age, including people who were felt to be stable with no recent relapses and no recent changes on their MRI brain. These studies reinforced that when discontinuing medications, the individuals who were much more likely to have recurrence of disease activity were younger patients.

Pathological studies clearly show the number of acutely inflamed plaques in the white matter is dramatically lower in autopsies of older vs younger patients. There are different changes in older patients, with lymphocytic nodules in the meninges, gray matter plaques related to these meningeal nodules, microglial activation, and smaller numbers of active, or mostly, inactive, white matter plaques. It’s been difficult to show any substantial benefit in slowing disability progression, much of which is felt to not be associated with acute inflammatory disease in the aging patient. All of these medicines, which can be thought of as anti-inflammatory medicines, are very beneficial when patients are young but less so as they age.

Would you describe the DISCO MS study design?

DR. CORBOY: Our study looks at individuals who are 55 and older who have not had a relapse for at least 5 years, and who’ve not had a change on their brain scan for at least 3 years.

Individuals will be randomized to either stay on the medication that they’re currently taking or discontinue that medicine. They will be followed then for 2 years. The primary outcome will be either a new relapse or a new scan change. The examining investigators are blinded to whether the patient is currently taking a MS disease modifying therapy.

Secondary outcomes include progression of disability as measured by confirmed change on the Extended Disability Status Scale (EDSS).

The enrollment goal is about 300 patients. There are presently 15 sites. The goal is to have the study completed in about 3 years. We’re presently over halfway through enrollment.

We also have a number of patient-reported outcomes because we’re particularly interested in the patient’s view of what’s going on in terms of how they feel. Understanding that dynamic will be extremely important.

We are including both patients with relapsing MS and progressive forms of MS, noting that they should have no relapse and no scan change at study entry.

What are the challenges with this study?

DR. CORBOY: One challenge is interpreting the information with the assumption that the hypothesis is validated. The hypothesis is that in a stable population of older patients that we can safely discontinue DMTs.

If that is found to be true, the question is how many people will be affected? We know that about 46% of people with MS are 55 and older, but there are not really good estimates of the number of individuals 55 and older who remain on a DMT and who are stable by the definition I just described.

It can be safely said, I think, that a substantial number of the individuals 55 and older are still on DMTs. If there’s almost a million people with MS and 46% are 55 and older, that means around 400,000 people with MS in the United States are aged 55 and older. If only half of those are on a DMT, that leaves 200,000. If only half of those are stable and could go off therapy, that would mean perhaps 100,000 people could discontinue DMTs in the United States. If all those assumptions are true, that would be a substantial savings in the health care burden of the United States from a relatively small population of individuals.

Beyond the cost, there are adverse events associated with using these medications. Older patients are more likely to be at risk of complications of MS DMTs. There also are doctor visits, blood monitoring, and other things that are done over time, and the inconvenience of taking a medicine on a routine basis if, indeed, it’s really not necessary because there is no benefit. Moreover, older individuals have other conditions (eg diabetes, hypertension, arrhythmias, cancer, etc) that may limit their ability to use medications due to risk. We’re very interested to see the outcome.

Discontinuing

How would you characterize the prevalence of MS in the elderly?

DR. CORBOY:  A recent large demographic study put together by the National MS Society found that there’s almost a million individuals diagnosed with MS over the course of the last 40 to 50 years. The largest population segment was those aged 55 to 64 years. People with MS aged 55 or older constituted 46% of all those with MS.

What disease-modifying therapies (DMTs) are approved by the FDA for the elderly?

DR. CORBOY: Of the drugs that have received FDA approval, most are for individuals over the age of 18 and there’s no specific age cutoff. However, there’s no data supporting DMT use in people over the age of 55 because they were excluded from the studies.

There’s one DMT, fingolimod, that was approved for use in patients under the age of 18; all others are approved for 18 and above. However, none of them are explicitly approved for people over the age of 55, because there is no data to support it.

What is the goal of your study, the DISCO MS trial?

DR. CORBOY: The DISCO MS trial will be the first randomized, controlled, blinded discontinuation trial in the MS space. The objective is to assess the benefit of DMTs in patients over the age of 55.

Part of the rationale for the trial is that prior subgroup analyses have shown that the vast majority of the benefit that we’ve been able to measure with all of these DMTs is seen in those who are under age 45.

A number of studies have examined existing databases and individuals who were either randomly or deliberately taken off of their medication as they age, including people who were felt to be stable with no recent relapses and no recent changes on their MRI brain. These studies reinforced that when discontinuing medications, the individuals who were much more likely to have recurrence of disease activity were younger patients.

Pathological studies clearly show the number of acutely inflamed plaques in the white matter is dramatically lower in autopsies of older vs younger patients. There are different changes in older patients, with lymphocytic nodules in the meninges, gray matter plaques related to these meningeal nodules, microglial activation, and smaller numbers of active, or mostly, inactive, white matter plaques. It’s been difficult to show any substantial benefit in slowing disability progression, much of which is felt to not be associated with acute inflammatory disease in the aging patient. All of these medicines, which can be thought of as anti-inflammatory medicines, are very beneficial when patients are young but less so as they age.

Would you describe the DISCO MS study design?

DR. CORBOY: Our study looks at individuals who are 55 and older who have not had a relapse for at least 5 years, and who’ve not had a change on their brain scan for at least 3 years.

Individuals will be randomized to either stay on the medication that they’re currently taking or discontinue that medicine. They will be followed then for 2 years. The primary outcome will be either a new relapse or a new scan change. The examining investigators are blinded to whether the patient is currently taking a MS disease modifying therapy.

Secondary outcomes include progression of disability as measured by confirmed change on the Extended Disability Status Scale (EDSS).

The enrollment goal is about 300 patients. There are presently 15 sites. The goal is to have the study completed in about 3 years. We’re presently over halfway through enrollment.

We also have a number of patient-reported outcomes because we’re particularly interested in the patient’s view of what’s going on in terms of how they feel. Understanding that dynamic will be extremely important.

We are including both patients with relapsing MS and progressive forms of MS, noting that they should have no relapse and no scan change at study entry.

What are the challenges with this study?

DR. CORBOY: One challenge is interpreting the information with the assumption that the hypothesis is validated. The hypothesis is that in a stable population of older patients that we can safely discontinue DMTs.

If that is found to be true, the question is how many people will be affected? We know that about 46% of people with MS are 55 and older, but there are not really good estimates of the number of individuals 55 and older who remain on a DMT and who are stable by the definition I just described.

It can be safely said, I think, that a substantial number of the individuals 55 and older are still on DMTs. If there’s almost a million people with MS and 46% are 55 and older, that means around 400,000 people with MS in the United States are aged 55 and older. If only half of those are on a DMT, that leaves 200,000. If only half of those are stable and could go off therapy, that would mean perhaps 100,000 people could discontinue DMTs in the United States. If all those assumptions are true, that would be a substantial savings in the health care burden of the United States from a relatively small population of individuals.

Beyond the cost, there are adverse events associated with using these medications. Older patients are more likely to be at risk of complications of MS DMTs. There also are doctor visits, blood monitoring, and other things that are done over time, and the inconvenience of taking a medicine on a routine basis if, indeed, it’s really not necessary because there is no benefit. Moreover, older individuals have other conditions (eg diabetes, hypertension, arrhythmias, cancer, etc) that may limit their ability to use medications due to risk. We’re very interested to see the outcome.

Discontinuing

How would you characterize the prevalence of MS in the elderly?

DR. CORBOY:  A recent large demographic study put together by the National MS Society found that there’s almost a million individuals diagnosed with MS over the course of the last 40 to 50 years. The largest population segment was those aged 55 to 64 years. People with MS aged 55 or older constituted 46% of all those with MS.

What disease-modifying therapies (DMTs) are approved by the FDA for the elderly?

DR. CORBOY: Of the drugs that have received FDA approval, most are for individuals over the age of 18 and there’s no specific age cutoff. However, there’s no data supporting DMT use in people over the age of 55 because they were excluded from the studies.

There’s one DMT, fingolimod, that was approved for use in patients under the age of 18; all others are approved for 18 and above. However, none of them are explicitly approved for people over the age of 55, because there is no data to support it.

What is the goal of your study, the DISCO MS trial?

DR. CORBOY: The DISCO MS trial will be the first randomized, controlled, blinded discontinuation trial in the MS space. The objective is to assess the benefit of DMTs in patients over the age of 55.

Part of the rationale for the trial is that prior subgroup analyses have shown that the vast majority of the benefit that we’ve been able to measure with all of these DMTs is seen in those who are under age 45.

A number of studies have examined existing databases and individuals who were either randomly or deliberately taken off of their medication as they age, including people who were felt to be stable with no recent relapses and no recent changes on their MRI brain. These studies reinforced that when discontinuing medications, the individuals who were much more likely to have recurrence of disease activity were younger patients.

Pathological studies clearly show the number of acutely inflamed plaques in the white matter is dramatically lower in autopsies of older vs younger patients. There are different changes in older patients, with lymphocytic nodules in the meninges, gray matter plaques related to these meningeal nodules, microglial activation, and smaller numbers of active, or mostly, inactive, white matter plaques. It’s been difficult to show any substantial benefit in slowing disability progression, much of which is felt to not be associated with acute inflammatory disease in the aging patient. All of these medicines, which can be thought of as anti-inflammatory medicines, are very beneficial when patients are young but less so as they age.

Would you describe the DISCO MS study design?

DR. CORBOY: Our study looks at individuals who are 55 and older who have not had a relapse for at least 5 years, and who’ve not had a change on their brain scan for at least 3 years.

Individuals will be randomized to either stay on the medication that they’re currently taking or discontinue that medicine. They will be followed then for 2 years. The primary outcome will be either a new relapse or a new scan change. The examining investigators are blinded to whether the patient is currently taking a MS disease modifying therapy.

Secondary outcomes include progression of disability as measured by confirmed change on the Extended Disability Status Scale (EDSS).

The enrollment goal is about 300 patients. There are presently 15 sites. The goal is to have the study completed in about 3 years. We’re presently over halfway through enrollment.

We also have a number of patient-reported outcomes because we’re particularly interested in the patient’s view of what’s going on in terms of how they feel. Understanding that dynamic will be extremely important.

We are including both patients with relapsing MS and progressive forms of MS, noting that they should have no relapse and no scan change at study entry.

What are the challenges with this study?

DR. CORBOY: One challenge is interpreting the information with the assumption that the hypothesis is validated. The hypothesis is that in a stable population of older patients that we can safely discontinue DMTs.

If that is found to be true, the question is how many people will be affected? We know that about 46% of people with MS are 55 and older, but there are not really good estimates of the number of individuals 55 and older who remain on a DMT and who are stable by the definition I just described.

It can be safely said, I think, that a substantial number of the individuals 55 and older are still on DMTs. If there’s almost a million people with MS and 46% are 55 and older, that means around 400,000 people with MS in the United States are aged 55 and older. If only half of those are on a DMT, that leaves 200,000. If only half of those are stable and could go off therapy, that would mean perhaps 100,000 people could discontinue DMTs in the United States. If all those assumptions are true, that would be a substantial savings in the health care burden of the United States from a relatively small population of individuals.

Beyond the cost, there are adverse events associated with using these medications. Older patients are more likely to be at risk of complications of MS DMTs. There also are doctor visits, blood monitoring, and other things that are done over time, and the inconvenience of taking a medicine on a routine basis if, indeed, it’s really not necessary because there is no benefit. Moreover, older individuals have other conditions (eg diabetes, hypertension, arrhythmias, cancer, etc) that may limit their ability to use medications due to risk. We’re very interested to see the outcome.

When fire is eating entire neighborhoods, or a hurricane is smashing towns like toys, the hospitalist will invariably run right toward the disaster.

Lou Ferraro, Park South Photography

It sounds completely crazy, unless you’re a hospitalist, Mark Shapiro, MD, said during a Monday session. Or a hospitalist’s spouse.

As the Tubbs Fire raged across Northern California in October 2017, Dr. Shapiro fled with his 5-month-old son, his dog, and his wife. And then they had that conversation.

“After we got everyone settled, I said to my wife, ‘Honey, I need to go back.’ And she said, ‘Yes, of course you do.’ Having that clarity and support behind me was so important. I was able to return to the hospital and focus on my job.”

“Trust me,” said Dr. Shapiro, director of hospital medicine at Providence-St. Joseph Health Medical Group in Santa Rosa, Calif. “You will want to do your work.”

The Tubbs Fire opened a week of “extraordinary challenges” said Dr. Shapiro. His lecture, “A Survival Guide for Hospitalists: Emergency Preparedness for Hurricanes, Fires, Mass Casualties, and Other Emergencies,” drew on his personal experiences from that fire, his leadership during the emergency response, and the debriefings that inspired his colleagues and him to plan how to handle future emergencies.

“Over 1 week we struggled and suffered and learned a great deal about hospital operations and how to keep safe in an emergency situation,” he said in an interview.

The prime directive during any emergency situation is communication, on both a microcosmic and a macrocosmic scale.

“It pays to have these conversations with family and friends before a disaster happens, so that they understand you will have to go to work and that – importantly – you will want to go to work. Lay the groundwork so that when you say, ‘I love you,’ and leave, it’s not a surprise. It’s extremely important. You need to be able to do your work knowing that not only are they safe, but they’re also behind you on this.”

On a system-wide scale, emergency communications at work must be “redundant, flexible, and sustainable,” he added.

“You have to be able to communicate as a team, and that means knowing if your team is OK. Are they able to work? Are they hurt? Are they dead? We had to ask those questions at 3 a.m.”

Flexibility gives teams the option to switch communications modes on the fly – extremely important when standard modes may be endangered by natural disasters of all types.

“You don’t know how long one method will last, so your communication tools have to change. In our case, we lost cell communication but texting was intact. And we were lucky – we might not even have had that. What would you do if you lost that? Go to landlines? Pagers? It’s all very contextual.”

Another emergency preparedness must-do that Dr. Shapiro addressed in his presentation? It’s “Drill, drill, drill.”

“You have to understand what this is going to look like,” he said. Who’s going to go where, and when? What is the chain of command, and what happens when something disrupts those things, as will inevitably happen?

Cross-training is a big part of the picture, too. Not only do team members need to do their own job, they should be able to step in and at least competently do someone else’s job, as well.

“People need to be flexible, because ‘job X’ still needs to get done, no matter what.”

Dr. Shapiro’s interest in hospitalists responding to disaster extends even to his podcast, “Explore the Space,” which examines the interface between health care and society, with thought leaders from across the spectrum. Several podcasts in his series touch on disaster response and preparedness, including two from the fall of 2017, focusing specifically on the wildfire. [They can be downloaded for free at Stitcher or Apple Podcasts.]

Dr. Shapiro had no financial disclosures.

When fire is eating entire neighborhoods, or a hurricane is smashing towns like toys, the hospitalist will invariably run right toward the disaster.

Lou Ferraro, Park South Photography

It sounds completely crazy, unless you’re a hospitalist, Mark Shapiro, MD, said during a Monday session. Or a hospitalist’s spouse.

As the Tubbs Fire raged across Northern California in October 2017, Dr. Shapiro fled with his 5-month-old son, his dog, and his wife. And then they had that conversation.

“After we got everyone settled, I said to my wife, ‘Honey, I need to go back.’ And she said, ‘Yes, of course you do.’ Having that clarity and support behind me was so important. I was able to return to the hospital and focus on my job.”

“Trust me,” said Dr. Shapiro, director of hospital medicine at Providence-St. Joseph Health Medical Group in Santa Rosa, Calif. “You will want to do your work.”

The Tubbs Fire opened a week of “extraordinary challenges” said Dr. Shapiro. His lecture, “A Survival Guide for Hospitalists: Emergency Preparedness for Hurricanes, Fires, Mass Casualties, and Other Emergencies,” drew on his personal experiences from that fire, his leadership during the emergency response, and the debriefings that inspired his colleagues and him to plan how to handle future emergencies.

“Over 1 week we struggled and suffered and learned a great deal about hospital operations and how to keep safe in an emergency situation,” he said in an interview.

The prime directive during any emergency situation is communication, on both a microcosmic and a macrocosmic scale.

“It pays to have these conversations with family and friends before a disaster happens, so that they understand you will have to go to work and that – importantly – you will want to go to work. Lay the groundwork so that when you say, ‘I love you,’ and leave, it’s not a surprise. It’s extremely important. You need to be able to do your work knowing that not only are they safe, but they’re also behind you on this.”

On a system-wide scale, emergency communications at work must be “redundant, flexible, and sustainable,” he added.

“You have to be able to communicate as a team, and that means knowing if your team is OK. Are they able to work? Are they hurt? Are they dead? We had to ask those questions at 3 a.m.”

Flexibility gives teams the option to switch communications modes on the fly – extremely important when standard modes may be endangered by natural disasters of all types.

“You don’t know how long one method will last, so your communication tools have to change. In our case, we lost cell communication but texting was intact. And we were lucky – we might not even have had that. What would you do if you lost that? Go to landlines? Pagers? It’s all very contextual.”

Another emergency preparedness must-do that Dr. Shapiro addressed in his presentation? It’s “Drill, drill, drill.”

“You have to understand what this is going to look like,” he said. Who’s going to go where, and when? What is the chain of command, and what happens when something disrupts those things, as will inevitably happen?

Cross-training is a big part of the picture, too. Not only do team members need to do their own job, they should be able to step in and at least competently do someone else’s job, as well.

“People need to be flexible, because ‘job X’ still needs to get done, no matter what.”

Dr. Shapiro’s interest in hospitalists responding to disaster extends even to his podcast, “Explore the Space,” which examines the interface between health care and society, with thought leaders from across the spectrum. Several podcasts in his series touch on disaster response and preparedness, including two from the fall of 2017, focusing specifically on the wildfire. [They can be downloaded for free at Stitcher or Apple Podcasts.]

Dr. Shapiro had no financial disclosures.

When fire is eating entire neighborhoods, or a hurricane is smashing towns like toys, the hospitalist will invariably run right toward the disaster.

Lou Ferraro, Park South Photography

It sounds completely crazy, unless you’re a hospitalist, Mark Shapiro, MD, said during a Monday session. Or a hospitalist’s spouse.

As the Tubbs Fire raged across Northern California in October 2017, Dr. Shapiro fled with his 5-month-old son, his dog, and his wife. And then they had that conversation.

“After we got everyone settled, I said to my wife, ‘Honey, I need to go back.’ And she said, ‘Yes, of course you do.’ Having that clarity and support behind me was so important. I was able to return to the hospital and focus on my job.”

“Trust me,” said Dr. Shapiro, director of hospital medicine at Providence-St. Joseph Health Medical Group in Santa Rosa, Calif. “You will want to do your work.”

The Tubbs Fire opened a week of “extraordinary challenges” said Dr. Shapiro. His lecture, “A Survival Guide for Hospitalists: Emergency Preparedness for Hurricanes, Fires, Mass Casualties, and Other Emergencies,” drew on his personal experiences from that fire, his leadership during the emergency response, and the debriefings that inspired his colleagues and him to plan how to handle future emergencies.

“Over 1 week we struggled and suffered and learned a great deal about hospital operations and how to keep safe in an emergency situation,” he said in an interview.

The prime directive during any emergency situation is communication, on both a microcosmic and a macrocosmic scale.

“It pays to have these conversations with family and friends before a disaster happens, so that they understand you will have to go to work and that – importantly – you will want to go to work. Lay the groundwork so that when you say, ‘I love you,’ and leave, it’s not a surprise. It’s extremely important. You need to be able to do your work knowing that not only are they safe, but they’re also behind you on this.”

On a system-wide scale, emergency communications at work must be “redundant, flexible, and sustainable,” he added.

“You have to be able to communicate as a team, and that means knowing if your team is OK. Are they able to work? Are they hurt? Are they dead? We had to ask those questions at 3 a.m.”

Flexibility gives teams the option to switch communications modes on the fly – extremely important when standard modes may be endangered by natural disasters of all types.

“You don’t know how long one method will last, so your communication tools have to change. In our case, we lost cell communication but texting was intact. And we were lucky – we might not even have had that. What would you do if you lost that? Go to landlines? Pagers? It’s all very contextual.”

Another emergency preparedness must-do that Dr. Shapiro addressed in his presentation? It’s “Drill, drill, drill.”

“You have to understand what this is going to look like,” he said. Who’s going to go where, and when? What is the chain of command, and what happens when something disrupts those things, as will inevitably happen?

Cross-training is a big part of the picture, too. Not only do team members need to do their own job, they should be able to step in and at least competently do someone else’s job, as well.

“People need to be flexible, because ‘job X’ still needs to get done, no matter what.”

Dr. Shapiro’s interest in hospitalists responding to disaster extends even to his podcast, “Explore the Space,” which examines the interface between health care and society, with thought leaders from across the spectrum. Several podcasts in his series touch on disaster response and preparedness, including two from the fall of 2017, focusing specifically on the wildfire. [They can be downloaded for free at Stitcher or Apple Podcasts.]

Dr. Shapiro had no financial disclosures.

WASHINGTON – Psoriasis induced by tumor necrosis factor (TNF) therapy is among the treatment-associated effects that involve the skin in patients with inflammatory bowel disease (IBD), Sophia Delano, MD, said during a session on the cutaneous effects of IBD at the annual meeting of the American Academy of Dermatology.

Jeff Craven/MDedge News

This is a paradoxical reaction, which can happen “weeks to years after starting a TNF blocker,” with about 70% of cases occurring during the first year of therapy, said Dr. Delano, an attending physician in the dermatology program at Boston Children’s Hospital.

Those receiving infliximab are more likely to develop TNF inhibitor–induced psoriasis, compared with those on adalimumab or etanercept. TNF inhibitor–induced psoriasis may not track with gastrointestinal activity, and some patients whose gastrointestinal disease is responding to treatment can begin to develop psoriasis, she noted.

The clinical presentation of TNF inhibitor–induced psoriasis can also vary. In one study of 216 cases, 26.9% of patients had a mixed morphology, with the most common presentations including plaque psoriasis (44.8%) and palmoplantar pustular psoriasis (36.3%). Other presentations were psoriasiform dermatitis (19.9%), scalp involvement with alopecia (7.5%), and generalized pustular psoriasis (10.9%). Locations affected were the soles of the feet (45.8%), extremities (45.4%), palms (44.9%), scalp (36.1%), and trunk (32.4%), Dr. Delano said.


TNF inhibitor–induced psoriasis is likely a class effect, she said, noting that, in the same review, symptoms resolved in 47.7% of patients who discontinued TNF inhibitors, in 36.7% of patients who switched to another TNF inhibitor, and in 32.9% of patients who continued their original therapy (J Am Acad Dermatol. 2017 Feb;76[2]:334-41). In the study, Crohn’s disease and RA were the most common diseases, in 40.7% and 37.0% of the patients, respectively.

There have been case reports of TNF antagonist–induced lupus-like syndrome (TAILS), which is more common in patients with RA and ulcerative colitis. TAILS occurs more often in women than in men; can present similarly to systemic lupus erythematosus, subacute cutaneous lupus erythematosus, and chronic cutaneous lupus; and resolves by stopping TNF inhibitor treatment, Dr. Delano said.

Skin cancer risk, infections, and injection site reactions

Both adult and pediatric patients treated with TNF inhibitors for IBD may be at increased risk for lymphoma, visceral tumors, melanoma, and nonmelanoma skin cancers. Dr. Delano referred to a study published in 2014, which identified 972 reports of melanoma in the Food and Drug Administration’s Adverse Event Reporting System database associated with TNF inhibitor use; of these, 69 cases involved patients using more than one TNF inhibitor. Infliximab, golimumab, etanercept, and adalimumab were associated with a safety signal for melanoma, but not certolizumab (Br J Dermatol. 2014 May;170[5]:1170-2).

Dr. Delano observed that thiopurines such as azathioprine are also associated with an increased cancer risk, as noted in one retrospective study that found that the risk of nonmelanoma skin cancer was 2.1 times higher in a mostly white male cohort with ulcerative colitis during treatment with thiopurines, compared with patients not treated with thiopurines (Am J Gastroenterol. 2014 Nov;109[11]:1781-93). A greater duration of treatment (more than 6 months) and higher doses were associated with higher risks.

Adalimumab, golimumab, and certolizumab can also cause injection site reactions, typically within 1- 2 days of injection, said Dr. Delano. In these cases, symptoms of erythema, warmth, burning, or pruritus are worse at the beginning of treatment and can be relieved by rotating the injection site as well as providing cool compresses, topical steroids, antihistamines, and supportive care.

“If you have a patient with a worsening reaction, consider it may represent the type 1 IgE-related hypersensitivity requiring desensitization to continue that systemic,” she noted.

Cutaneous bacterial, fungal, and viral infections such as molluscum contagiosum, verruca vulgaris, herpes simplex, and varicella zoster can occur as a result of TNF inhibition as well, and can be difficult to clear because of immunosuppression, she added.

Dr. Delano reported no relevant conflicts of interest.

WASHINGTON – Psoriasis induced by tumor necrosis factor (TNF) therapy is among the treatment-associated effects that involve the skin in patients with inflammatory bowel disease (IBD), Sophia Delano, MD, said during a session on the cutaneous effects of IBD at the annual meeting of the American Academy of Dermatology.

Jeff Craven/MDedge News

This is a paradoxical reaction, which can happen “weeks to years after starting a TNF blocker,” with about 70% of cases occurring during the first year of therapy, said Dr. Delano, an attending physician in the dermatology program at Boston Children’s Hospital.

Those receiving infliximab are more likely to develop TNF inhibitor–induced psoriasis, compared with those on adalimumab or etanercept. TNF inhibitor–induced psoriasis may not track with gastrointestinal activity, and some patients whose gastrointestinal disease is responding to treatment can begin to develop psoriasis, she noted.

The clinical presentation of TNF inhibitor–induced psoriasis can also vary. In one study of 216 cases, 26.9% of patients had a mixed morphology, with the most common presentations including plaque psoriasis (44.8%) and palmoplantar pustular psoriasis (36.3%). Other presentations were psoriasiform dermatitis (19.9%), scalp involvement with alopecia (7.5%), and generalized pustular psoriasis (10.9%). Locations affected were the soles of the feet (45.8%), extremities (45.4%), palms (44.9%), scalp (36.1%), and trunk (32.4%), Dr. Delano said.


TNF inhibitor–induced psoriasis is likely a class effect, she said, noting that, in the same review, symptoms resolved in 47.7% of patients who discontinued TNF inhibitors, in 36.7% of patients who switched to another TNF inhibitor, and in 32.9% of patients who continued their original therapy (J Am Acad Dermatol. 2017 Feb;76[2]:334-41). In the study, Crohn’s disease and RA were the most common diseases, in 40.7% and 37.0% of the patients, respectively.

There have been case reports of TNF antagonist–induced lupus-like syndrome (TAILS), which is more common in patients with RA and ulcerative colitis. TAILS occurs more often in women than in men; can present similarly to systemic lupus erythematosus, subacute cutaneous lupus erythematosus, and chronic cutaneous lupus; and resolves by stopping TNF inhibitor treatment, Dr. Delano said.

Skin cancer risk, infections, and injection site reactions

Both adult and pediatric patients treated with TNF inhibitors for IBD may be at increased risk for lymphoma, visceral tumors, melanoma, and nonmelanoma skin cancers. Dr. Delano referred to a study published in 2014, which identified 972 reports of melanoma in the Food and Drug Administration’s Adverse Event Reporting System database associated with TNF inhibitor use; of these, 69 cases involved patients using more than one TNF inhibitor. Infliximab, golimumab, etanercept, and adalimumab were associated with a safety signal for melanoma, but not certolizumab (Br J Dermatol. 2014 May;170[5]:1170-2).

Dr. Delano observed that thiopurines such as azathioprine are also associated with an increased cancer risk, as noted in one retrospective study that found that the risk of nonmelanoma skin cancer was 2.1 times higher in a mostly white male cohort with ulcerative colitis during treatment with thiopurines, compared with patients not treated with thiopurines (Am J Gastroenterol. 2014 Nov;109[11]:1781-93). A greater duration of treatment (more than 6 months) and higher doses were associated with higher risks.

Adalimumab, golimumab, and certolizumab can also cause injection site reactions, typically within 1- 2 days of injection, said Dr. Delano. In these cases, symptoms of erythema, warmth, burning, or pruritus are worse at the beginning of treatment and can be relieved by rotating the injection site as well as providing cool compresses, topical steroids, antihistamines, and supportive care.

“If you have a patient with a worsening reaction, consider it may represent the type 1 IgE-related hypersensitivity requiring desensitization to continue that systemic,” she noted.

Cutaneous bacterial, fungal, and viral infections such as molluscum contagiosum, verruca vulgaris, herpes simplex, and varicella zoster can occur as a result of TNF inhibition as well, and can be difficult to clear because of immunosuppression, she added.

Dr. Delano reported no relevant conflicts of interest.

WASHINGTON – Psoriasis induced by tumor necrosis factor (TNF) therapy is among the treatment-associated effects that involve the skin in patients with inflammatory bowel disease (IBD), Sophia Delano, MD, said during a session on the cutaneous effects of IBD at the annual meeting of the American Academy of Dermatology.

Jeff Craven/MDedge News

This is a paradoxical reaction, which can happen “weeks to years after starting a TNF blocker,” with about 70% of cases occurring during the first year of therapy, said Dr. Delano, an attending physician in the dermatology program at Boston Children’s Hospital.

Those receiving infliximab are more likely to develop TNF inhibitor–induced psoriasis, compared with those on adalimumab or etanercept. TNF inhibitor–induced psoriasis may not track with gastrointestinal activity, and some patients whose gastrointestinal disease is responding to treatment can begin to develop psoriasis, she noted.

The clinical presentation of TNF inhibitor–induced psoriasis can also vary. In one study of 216 cases, 26.9% of patients had a mixed morphology, with the most common presentations including plaque psoriasis (44.8%) and palmoplantar pustular psoriasis (36.3%). Other presentations were psoriasiform dermatitis (19.9%), scalp involvement with alopecia (7.5%), and generalized pustular psoriasis (10.9%). Locations affected were the soles of the feet (45.8%), extremities (45.4%), palms (44.9%), scalp (36.1%), and trunk (32.4%), Dr. Delano said.


TNF inhibitor–induced psoriasis is likely a class effect, she said, noting that, in the same review, symptoms resolved in 47.7% of patients who discontinued TNF inhibitors, in 36.7% of patients who switched to another TNF inhibitor, and in 32.9% of patients who continued their original therapy (J Am Acad Dermatol. 2017 Feb;76[2]:334-41). In the study, Crohn’s disease and RA were the most common diseases, in 40.7% and 37.0% of the patients, respectively.

There have been case reports of TNF antagonist–induced lupus-like syndrome (TAILS), which is more common in patients with RA and ulcerative colitis. TAILS occurs more often in women than in men; can present similarly to systemic lupus erythematosus, subacute cutaneous lupus erythematosus, and chronic cutaneous lupus; and resolves by stopping TNF inhibitor treatment, Dr. Delano said.

Skin cancer risk, infections, and injection site reactions

Both adult and pediatric patients treated with TNF inhibitors for IBD may be at increased risk for lymphoma, visceral tumors, melanoma, and nonmelanoma skin cancers. Dr. Delano referred to a study published in 2014, which identified 972 reports of melanoma in the Food and Drug Administration’s Adverse Event Reporting System database associated with TNF inhibitor use; of these, 69 cases involved patients using more than one TNF inhibitor. Infliximab, golimumab, etanercept, and adalimumab were associated with a safety signal for melanoma, but not certolizumab (Br J Dermatol. 2014 May;170[5]:1170-2).

Dr. Delano observed that thiopurines such as azathioprine are also associated with an increased cancer risk, as noted in one retrospective study that found that the risk of nonmelanoma skin cancer was 2.1 times higher in a mostly white male cohort with ulcerative colitis during treatment with thiopurines, compared with patients not treated with thiopurines (Am J Gastroenterol. 2014 Nov;109[11]:1781-93). A greater duration of treatment (more than 6 months) and higher doses were associated with higher risks.

Adalimumab, golimumab, and certolizumab can also cause injection site reactions, typically within 1- 2 days of injection, said Dr. Delano. In these cases, symptoms of erythema, warmth, burning, or pruritus are worse at the beginning of treatment and can be relieved by rotating the injection site as well as providing cool compresses, topical steroids, antihistamines, and supportive care.

“If you have a patient with a worsening reaction, consider it may represent the type 1 IgE-related hypersensitivity requiring desensitization to continue that systemic,” she noted.

Cutaneous bacterial, fungal, and viral infections such as molluscum contagiosum, verruca vulgaris, herpes simplex, and varicella zoster can occur as a result of TNF inhibition as well, and can be difficult to clear because of immunosuppression, she added.

Dr. Delano reported no relevant conflicts of interest.

HONOLULU – The novel antibody-drug conjugate tisotumab vedotin (TV) shows encouraging activity and tolerability in heavily pretreated recurrent or metastatic cervical cancer, according to findings from the phase 1/2a innovaTV 201 trial.

Sharon Worcester/MDedge News

The investigator-assessed overall response rate (ORR) among 55 patients enrolled in the cervical cancer expansion portion of the study was 35%, and the confirmed response rate was 22%, including one complete response lasting 46 weeks, David S. Hong, MD, reported at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.

The median duration of response in confirmed responders was 6 months, median progression-free survival (PFS) was 4.1 months, and 6-month PFS was 40%, said Dr. Hong, deputy chair, department of investigational cancer therapeutics, division of cancer medicine, the University of Texas MD Anderson Cancer Center, Houston.

“Overall, the independent review and investigator review were highly correlated,” he noted.

Study participants had recurrent or metastatic cervical cancer that progressed on standard therapy, and Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1. Most had received at least two prior therapies.

As established in the phase 1 dose-escalation portion of the study, TV in the expansion phase was given at a dose of 2 mg/kg every 3 weeks until disease progression, toxicity, or withdrawal.

Median follow-up was 3.5 months and the median number of doses received was four; the treatment had acceptable tolerability, Dr. Hong said, noting that no treatment-related deaths occurred, and only 13% of patients had a dose reduction caused by an adverse event (AE).

The most common AE occurring in more than 20% of patients was epistaxis; most cases were grade 1. AEs of special interest and possibly related to the TV mechanism of action included neuropathy, bleeding-related events, and ocular events.

While there were a few cases of vaginal bleeding, they were believed to be caused by underlying disease, he noted.

The ocular events noted early in phase 1 of the study included mainly dry eyes and conjunctivitis, but a plan to mitigate these events, which involved the use of steroid eye drops, cooling eye masks, and dose reductions, reduced their incidence.

There were no grade 4 or 5 adverse events related to the agent, he said, noting that most patients came off study because of disease progression.

The prognosis for recurrent or metastatic cervical cancer is very poor, with a 5-year survival rate of only about 17%, Dr. Hong said, adding that data on the overall response and survival after the first line of therapy are somewhat limited.

Pembrolizumab (Keytruda) received Food and Drug Administration approval based on second-line setting data from the Keynote-158 trial showing a median ORR of just 14% and median PFS of just 2.1 months in programmed death-ligand 1–positive cervical cancer, he noted.

“Tissue factor (TF) is a protein expressed in cervical cancer, as well as ... a broad range of solid tumors. It is associated with high tumor stage, metastasis, and poor prognosis,” he explained. “TV is a first-in-class antibody-drug conjugate that’s a fully human monoclonal antibody targeting tissue factor.”

The drug, which has multiple mechanisms of action, is conjugated to the microtubule disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable linker. Findings regarding its safety and tolerability in cervical cancer and a number of other tumors were published recently in The Lancet.

Dr. Hong’s presentation focused on the cervical cancer cohort.

The median PFS in innovaTV 201 compares favorably with that for pembrolizumab and supports continued investigation of TV, he said, noting that phase 2 studies of TV alone and in combination with other agents for recurrent or metastatic cervical cancer, as well as for platinum-resistant ovarian cancer, are ongoing.

The innovaTV 201 trial is sponsored by Genmab A/S. Dr. Hong reported having no disclosures.

[email protected]

SOURCE: Hong DS et al. SGO 2019, Abstract 19.

HONOLULU – The novel antibody-drug conjugate tisotumab vedotin (TV) shows encouraging activity and tolerability in heavily pretreated recurrent or metastatic cervical cancer, according to findings from the phase 1/2a innovaTV 201 trial.

Sharon Worcester/MDedge News

The investigator-assessed overall response rate (ORR) among 55 patients enrolled in the cervical cancer expansion portion of the study was 35%, and the confirmed response rate was 22%, including one complete response lasting 46 weeks, David S. Hong, MD, reported at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.

The median duration of response in confirmed responders was 6 months, median progression-free survival (PFS) was 4.1 months, and 6-month PFS was 40%, said Dr. Hong, deputy chair, department of investigational cancer therapeutics, division of cancer medicine, the University of Texas MD Anderson Cancer Center, Houston.

“Overall, the independent review and investigator review were highly correlated,” he noted.

Study participants had recurrent or metastatic cervical cancer that progressed on standard therapy, and Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1. Most had received at least two prior therapies.

As established in the phase 1 dose-escalation portion of the study, TV in the expansion phase was given at a dose of 2 mg/kg every 3 weeks until disease progression, toxicity, or withdrawal.

Median follow-up was 3.5 months and the median number of doses received was four; the treatment had acceptable tolerability, Dr. Hong said, noting that no treatment-related deaths occurred, and only 13% of patients had a dose reduction caused by an adverse event (AE).

The most common AE occurring in more than 20% of patients was epistaxis; most cases were grade 1. AEs of special interest and possibly related to the TV mechanism of action included neuropathy, bleeding-related events, and ocular events.

While there were a few cases of vaginal bleeding, they were believed to be caused by underlying disease, he noted.

The ocular events noted early in phase 1 of the study included mainly dry eyes and conjunctivitis, but a plan to mitigate these events, which involved the use of steroid eye drops, cooling eye masks, and dose reductions, reduced their incidence.

There were no grade 4 or 5 adverse events related to the agent, he said, noting that most patients came off study because of disease progression.

The prognosis for recurrent or metastatic cervical cancer is very poor, with a 5-year survival rate of only about 17%, Dr. Hong said, adding that data on the overall response and survival after the first line of therapy are somewhat limited.

Pembrolizumab (Keytruda) received Food and Drug Administration approval based on second-line setting data from the Keynote-158 trial showing a median ORR of just 14% and median PFS of just 2.1 months in programmed death-ligand 1–positive cervical cancer, he noted.

“Tissue factor (TF) is a protein expressed in cervical cancer, as well as ... a broad range of solid tumors. It is associated with high tumor stage, metastasis, and poor prognosis,” he explained. “TV is a first-in-class antibody-drug conjugate that’s a fully human monoclonal antibody targeting tissue factor.”

The drug, which has multiple mechanisms of action, is conjugated to the microtubule disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable linker. Findings regarding its safety and tolerability in cervical cancer and a number of other tumors were published recently in The Lancet.

Dr. Hong’s presentation focused on the cervical cancer cohort.

The median PFS in innovaTV 201 compares favorably with that for pembrolizumab and supports continued investigation of TV, he said, noting that phase 2 studies of TV alone and in combination with other agents for recurrent or metastatic cervical cancer, as well as for platinum-resistant ovarian cancer, are ongoing.

The innovaTV 201 trial is sponsored by Genmab A/S. Dr. Hong reported having no disclosures.

[email protected]

SOURCE: Hong DS et al. SGO 2019, Abstract 19.

HONOLULU – The novel antibody-drug conjugate tisotumab vedotin (TV) shows encouraging activity and tolerability in heavily pretreated recurrent or metastatic cervical cancer, according to findings from the phase 1/2a innovaTV 201 trial.

Sharon Worcester/MDedge News

The investigator-assessed overall response rate (ORR) among 55 patients enrolled in the cervical cancer expansion portion of the study was 35%, and the confirmed response rate was 22%, including one complete response lasting 46 weeks, David S. Hong, MD, reported at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.

The median duration of response in confirmed responders was 6 months, median progression-free survival (PFS) was 4.1 months, and 6-month PFS was 40%, said Dr. Hong, deputy chair, department of investigational cancer therapeutics, division of cancer medicine, the University of Texas MD Anderson Cancer Center, Houston.

“Overall, the independent review and investigator review were highly correlated,” he noted.

Study participants had recurrent or metastatic cervical cancer that progressed on standard therapy, and Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1. Most had received at least two prior therapies.

As established in the phase 1 dose-escalation portion of the study, TV in the expansion phase was given at a dose of 2 mg/kg every 3 weeks until disease progression, toxicity, or withdrawal.

Median follow-up was 3.5 months and the median number of doses received was four; the treatment had acceptable tolerability, Dr. Hong said, noting that no treatment-related deaths occurred, and only 13% of patients had a dose reduction caused by an adverse event (AE).

The most common AE occurring in more than 20% of patients was epistaxis; most cases were grade 1. AEs of special interest and possibly related to the TV mechanism of action included neuropathy, bleeding-related events, and ocular events.

While there were a few cases of vaginal bleeding, they were believed to be caused by underlying disease, he noted.

The ocular events noted early in phase 1 of the study included mainly dry eyes and conjunctivitis, but a plan to mitigate these events, which involved the use of steroid eye drops, cooling eye masks, and dose reductions, reduced their incidence.

There were no grade 4 or 5 adverse events related to the agent, he said, noting that most patients came off study because of disease progression.

The prognosis for recurrent or metastatic cervical cancer is very poor, with a 5-year survival rate of only about 17%, Dr. Hong said, adding that data on the overall response and survival after the first line of therapy are somewhat limited.

Pembrolizumab (Keytruda) received Food and Drug Administration approval based on second-line setting data from the Keynote-158 trial showing a median ORR of just 14% and median PFS of just 2.1 months in programmed death-ligand 1–positive cervical cancer, he noted.

“Tissue factor (TF) is a protein expressed in cervical cancer, as well as ... a broad range of solid tumors. It is associated with high tumor stage, metastasis, and poor prognosis,” he explained. “TV is a first-in-class antibody-drug conjugate that’s a fully human monoclonal antibody targeting tissue factor.”

The drug, which has multiple mechanisms of action, is conjugated to the microtubule disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable linker. Findings regarding its safety and tolerability in cervical cancer and a number of other tumors were published recently in The Lancet.

Dr. Hong’s presentation focused on the cervical cancer cohort.

The median PFS in innovaTV 201 compares favorably with that for pembrolizumab and supports continued investigation of TV, he said, noting that phase 2 studies of TV alone and in combination with other agents for recurrent or metastatic cervical cancer, as well as for platinum-resistant ovarian cancer, are ongoing.

The innovaTV 201 trial is sponsored by Genmab A/S. Dr. Hong reported having no disclosures.

[email protected]

SOURCE: Hong DS et al. SGO 2019, Abstract 19.

NEW ORLEANS – Transgender adolescents who take hormones and gonadotropin-releasing hormone analogs have body composition measures that vary between those seen in control females and males, according to results of a pilot study presented during a poster session at the annual meeting of the Endocrine Society.

“Between 0.7% and 1.6% of adolescents in the United States identify as transgender,” Natalie Nokoff, MD, of the University of Colorado Anschutz, so there will be a large population of teens who may be taking gender-affirming medications over the course of their lives. At the transgender care clinic at the university, the population of these patients has recently climbed to nearly 1,000 patients.

“There have been a few studies that have come out about the health of transgender female adults” – individuals born with a male sex but a female gender identity – for whom standard of care includes blocking puberty with a gonadotropin-releasing hormone (GnRH) analog to prevent development of male secondary sex characteristics at puberty, said Dr. Nokoff. Estradiol is used later, as well.

The impact of these regimens on overall health was examined in a cross-sectional pilot study of 14 adolescent transgender females, average age 16 years. The patients had been on estradiol for an average of about a year. Control groups were adolescent males and females who were matched by age and body mass index.

“Really, my main question of interest as a pediatric endocrinologist is what is the impact of not only hormones on short- and long-term heart health, and diabetes risk, and long-term health, but also, what [is] the impact of the puberty blockers, or GnRH analogs, with subsequent hormones on health as well,” said Dr. Nokoff. “That’s really the understudied area – what people don’t understand.

“We found that there were several differences in terms of markers of metabolic health between transgender females on estradiol” and the controls, Dr. Nokoff said. “Most notably ... they had a higher (level of) body fat than males, and lower (level) than females” in the control group.

The difference between transgender females and control females and control males for percent body fat was statistically significant (P = .03 and .003, respectively). Differences in lean body mass were also significant when comparing the transgender females and the control males and females (P = .001 and .001, respectively).

“In terms of insulin sensitivity, our other outcome of interest, there was no difference in insulin sensitivity between transgender females and control females, but they were more insulin resistant – or less insulin sensitive – than control males.” This latter difference was statistically significant (P = .01).

Dr. Nokoff reported that she had no relevant conflicts of interest.

[email protected]

NEW ORLEANS – Transgender adolescents who take hormones and gonadotropin-releasing hormone analogs have body composition measures that vary between those seen in control females and males, according to results of a pilot study presented during a poster session at the annual meeting of the Endocrine Society.

“Between 0.7% and 1.6% of adolescents in the United States identify as transgender,” Natalie Nokoff, MD, of the University of Colorado Anschutz, so there will be a large population of teens who may be taking gender-affirming medications over the course of their lives. At the transgender care clinic at the university, the population of these patients has recently climbed to nearly 1,000 patients.

“There have been a few studies that have come out about the health of transgender female adults” – individuals born with a male sex but a female gender identity – for whom standard of care includes blocking puberty with a gonadotropin-releasing hormone (GnRH) analog to prevent development of male secondary sex characteristics at puberty, said Dr. Nokoff. Estradiol is used later, as well.

The impact of these regimens on overall health was examined in a cross-sectional pilot study of 14 adolescent transgender females, average age 16 years. The patients had been on estradiol for an average of about a year. Control groups were adolescent males and females who were matched by age and body mass index.

“Really, my main question of interest as a pediatric endocrinologist is what is the impact of not only hormones on short- and long-term heart health, and diabetes risk, and long-term health, but also, what [is] the impact of the puberty blockers, or GnRH analogs, with subsequent hormones on health as well,” said Dr. Nokoff. “That’s really the understudied area – what people don’t understand.

“We found that there were several differences in terms of markers of metabolic health between transgender females on estradiol” and the controls, Dr. Nokoff said. “Most notably ... they had a higher (level of) body fat than males, and lower (level) than females” in the control group.

The difference between transgender females and control females and control males for percent body fat was statistically significant (P = .03 and .003, respectively). Differences in lean body mass were also significant when comparing the transgender females and the control males and females (P = .001 and .001, respectively).

“In terms of insulin sensitivity, our other outcome of interest, there was no difference in insulin sensitivity between transgender females and control females, but they were more insulin resistant – or less insulin sensitive – than control males.” This latter difference was statistically significant (P = .01).

Dr. Nokoff reported that she had no relevant conflicts of interest.

[email protected]

NEW ORLEANS – Transgender adolescents who take hormones and gonadotropin-releasing hormone analogs have body composition measures that vary between those seen in control females and males, according to results of a pilot study presented during a poster session at the annual meeting of the Endocrine Society.

“Between 0.7% and 1.6% of adolescents in the United States identify as transgender,” Natalie Nokoff, MD, of the University of Colorado Anschutz, so there will be a large population of teens who may be taking gender-affirming medications over the course of their lives. At the transgender care clinic at the university, the population of these patients has recently climbed to nearly 1,000 patients.

“There have been a few studies that have come out about the health of transgender female adults” – individuals born with a male sex but a female gender identity – for whom standard of care includes blocking puberty with a gonadotropin-releasing hormone (GnRH) analog to prevent development of male secondary sex characteristics at puberty, said Dr. Nokoff. Estradiol is used later, as well.

The impact of these regimens on overall health was examined in a cross-sectional pilot study of 14 adolescent transgender females, average age 16 years. The patients had been on estradiol for an average of about a year. Control groups were adolescent males and females who were matched by age and body mass index.

“Really, my main question of interest as a pediatric endocrinologist is what is the impact of not only hormones on short- and long-term heart health, and diabetes risk, and long-term health, but also, what [is] the impact of the puberty blockers, or GnRH analogs, with subsequent hormones on health as well,” said Dr. Nokoff. “That’s really the understudied area – what people don’t understand.

“We found that there were several differences in terms of markers of metabolic health between transgender females on estradiol” and the controls, Dr. Nokoff said. “Most notably ... they had a higher (level of) body fat than males, and lower (level) than females” in the control group.

The difference between transgender females and control females and control males for percent body fat was statistically significant (P = .03 and .003, respectively). Differences in lean body mass were also significant when comparing the transgender females and the control males and females (P = .001 and .001, respectively).

“In terms of insulin sensitivity, our other outcome of interest, there was no difference in insulin sensitivity between transgender females and control females, but they were more insulin resistant – or less insulin sensitive – than control males.” This latter difference was statistically significant (P = .01).

Dr. Nokoff reported that she had no relevant conflicts of interest.

[email protected]

Pimavanserin (Nuplazid), an atypical antipsychotic approved to treat hallucinations and delusions in Parkinson’s disease, shows promise as a treatment for patients with refractory schizophrenia who fail to respond to clozapine, a retrospective study suggests.

“Within a month, sometimes 2 months, hallucinations and delusions that have persisted for years were completely gone,” said lead author Henry A. Nasrallah, MD, in an interview. The study was published in Schizophrenia Research.

Dr. Nasrallah and his colleagues launched the study in a bid to help “the most desperate group of patients” with schizophrenia – the 60% of those with refractory psychosis who do not respond to clozapine.

“This group of patients is so desperate that psychiatrists have used everything in our pharmacopeia,” said Dr. Nasrallah, the Sydney W. Souers Endowed Chair and professor and chairman of the department of psychiatry and behavioral neuroscience at Saint Louis University. “Nothing has been shown to work. We decided to give them this medication [pimavanserin], which was approved by the FDA [Food and Drug Administration] 2 years ago for hallucinations and delusions for Parkinson’s disease.”

For the new study, Dr. Nasrallah and his coauthors gave 34 mg/day of pimavanserin to 10 patients, aged 21-77 years, with schizophrenia or schizoaffective disorder and refractory hallucinations and delusions. The subjects, all of whom live in a residential group home, had either failed clozapine (n = 6) or failed several antipsychotics but had not yet received clozapine (n = 4).


The results, Dr. Nasrallah said, were remarkable. “Not only did they get relief from their delusions and hallucinations, but nursing staff reported they were much more sociable and affable, getting out of their rooms, and mixing and mingling. It seems to help them beyond suppressing delusions and hallucinations. It made them more sociable and pleasant.”

Patients were able to avoid blood tests and the “sometimes life-threatening side effects of clozapine,” he said. According to the study, no patients needed to discontinue treatment because of safety or tolerability.

However, pimavanserin is expensive. According to GoodRx.com, monthly prices for 60 tablets of 17 mg pimavanserin – equal to the daily dose in this study – run from $2,759 to $2,907 with a free coupon.

Should psychiatrists prescribe the drug now for treatment-resistant schizophrenia? “We use drugs off label all the time for patients who do not have any FDA-approved medication,” Dr. Nasrallah said. “Sometimes, off-label use in psychiatry is a necessity, because around 80% of DSM-5 disorders do not have any approved drugs at this time.”

Moving forward, “double-blind, placebo-controlled trials of pimavanserin in refractory schizophrenia are certainly warranted, given these findings,” Dr. Nasrallah and his coauthors wrote. “It would also be interesting to test pimavanserin in first-episode psychosis to identify a ‘serotonergic subtype’ of the schizophrenia syndrome but also to completely avoid the extrapyramidal side effects of dopamine antagonists, to which first-episode psychosis patients are especially susceptible.”

No outside funding was reported. Dr. Nasrallah reported advisory board and consultant and speaker’s bureau relationships with Acadia, Alkermes, Allergan, Janssen, Lundbeck, Neurocrine Biosciences, Otsuka Pharmaceutical, Sunovion, and Teva. Another author reported no disclosures, and a third author reported numerous disclosures.

SOURCE: Nasrallah HA et al. Schizophr Res. 2019 Mar 2. doi: 10/1016/j.schres.2019.02.018.

Pimavanserin (Nuplazid), an atypical antipsychotic approved to treat hallucinations and delusions in Parkinson’s disease, shows promise as a treatment for patients with refractory schizophrenia who fail to respond to clozapine, a retrospective study suggests.

“Within a month, sometimes 2 months, hallucinations and delusions that have persisted for years were completely gone,” said lead author Henry A. Nasrallah, MD, in an interview. The study was published in Schizophrenia Research.

Dr. Nasrallah and his colleagues launched the study in a bid to help “the most desperate group of patients” with schizophrenia – the 60% of those with refractory psychosis who do not respond to clozapine.

“This group of patients is so desperate that psychiatrists have used everything in our pharmacopeia,” said Dr. Nasrallah, the Sydney W. Souers Endowed Chair and professor and chairman of the department of psychiatry and behavioral neuroscience at Saint Louis University. “Nothing has been shown to work. We decided to give them this medication [pimavanserin], which was approved by the FDA [Food and Drug Administration] 2 years ago for hallucinations and delusions for Parkinson’s disease.”

For the new study, Dr. Nasrallah and his coauthors gave 34 mg/day of pimavanserin to 10 patients, aged 21-77 years, with schizophrenia or schizoaffective disorder and refractory hallucinations and delusions. The subjects, all of whom live in a residential group home, had either failed clozapine (n = 6) or failed several antipsychotics but had not yet received clozapine (n = 4).


The results, Dr. Nasrallah said, were remarkable. “Not only did they get relief from their delusions and hallucinations, but nursing staff reported they were much more sociable and affable, getting out of their rooms, and mixing and mingling. It seems to help them beyond suppressing delusions and hallucinations. It made them more sociable and pleasant.”

Patients were able to avoid blood tests and the “sometimes life-threatening side effects of clozapine,” he said. According to the study, no patients needed to discontinue treatment because of safety or tolerability.

However, pimavanserin is expensive. According to GoodRx.com, monthly prices for 60 tablets of 17 mg pimavanserin – equal to the daily dose in this study – run from $2,759 to $2,907 with a free coupon.

Should psychiatrists prescribe the drug now for treatment-resistant schizophrenia? “We use drugs off label all the time for patients who do not have any FDA-approved medication,” Dr. Nasrallah said. “Sometimes, off-label use in psychiatry is a necessity, because around 80% of DSM-5 disorders do not have any approved drugs at this time.”

Moving forward, “double-blind, placebo-controlled trials of pimavanserin in refractory schizophrenia are certainly warranted, given these findings,” Dr. Nasrallah and his coauthors wrote. “It would also be interesting to test pimavanserin in first-episode psychosis to identify a ‘serotonergic subtype’ of the schizophrenia syndrome but also to completely avoid the extrapyramidal side effects of dopamine antagonists, to which first-episode psychosis patients are especially susceptible.”

No outside funding was reported. Dr. Nasrallah reported advisory board and consultant and speaker’s bureau relationships with Acadia, Alkermes, Allergan, Janssen, Lundbeck, Neurocrine Biosciences, Otsuka Pharmaceutical, Sunovion, and Teva. Another author reported no disclosures, and a third author reported numerous disclosures.

SOURCE: Nasrallah HA et al. Schizophr Res. 2019 Mar 2. doi: 10/1016/j.schres.2019.02.018.

Pimavanserin (Nuplazid), an atypical antipsychotic approved to treat hallucinations and delusions in Parkinson’s disease, shows promise as a treatment for patients with refractory schizophrenia who fail to respond to clozapine, a retrospective study suggests.

“Within a month, sometimes 2 months, hallucinations and delusions that have persisted for years were completely gone,” said lead author Henry A. Nasrallah, MD, in an interview. The study was published in Schizophrenia Research.

Dr. Nasrallah and his colleagues launched the study in a bid to help “the most desperate group of patients” with schizophrenia – the 60% of those with refractory psychosis who do not respond to clozapine.

“This group of patients is so desperate that psychiatrists have used everything in our pharmacopeia,” said Dr. Nasrallah, the Sydney W. Souers Endowed Chair and professor and chairman of the department of psychiatry and behavioral neuroscience at Saint Louis University. “Nothing has been shown to work. We decided to give them this medication [pimavanserin], which was approved by the FDA [Food and Drug Administration] 2 years ago for hallucinations and delusions for Parkinson’s disease.”

For the new study, Dr. Nasrallah and his coauthors gave 34 mg/day of pimavanserin to 10 patients, aged 21-77 years, with schizophrenia or schizoaffective disorder and refractory hallucinations and delusions. The subjects, all of whom live in a residential group home, had either failed clozapine (n = 6) or failed several antipsychotics but had not yet received clozapine (n = 4).


The results, Dr. Nasrallah said, were remarkable. “Not only did they get relief from their delusions and hallucinations, but nursing staff reported they were much more sociable and affable, getting out of their rooms, and mixing and mingling. It seems to help them beyond suppressing delusions and hallucinations. It made them more sociable and pleasant.”

Patients were able to avoid blood tests and the “sometimes life-threatening side effects of clozapine,” he said. According to the study, no patients needed to discontinue treatment because of safety or tolerability.

However, pimavanserin is expensive. According to GoodRx.com, monthly prices for 60 tablets of 17 mg pimavanserin – equal to the daily dose in this study – run from $2,759 to $2,907 with a free coupon.

Should psychiatrists prescribe the drug now for treatment-resistant schizophrenia? “We use drugs off label all the time for patients who do not have any FDA-approved medication,” Dr. Nasrallah said. “Sometimes, off-label use in psychiatry is a necessity, because around 80% of DSM-5 disorders do not have any approved drugs at this time.”

Moving forward, “double-blind, placebo-controlled trials of pimavanserin in refractory schizophrenia are certainly warranted, given these findings,” Dr. Nasrallah and his coauthors wrote. “It would also be interesting to test pimavanserin in first-episode psychosis to identify a ‘serotonergic subtype’ of the schizophrenia syndrome but also to completely avoid the extrapyramidal side effects of dopamine antagonists, to which first-episode psychosis patients are especially susceptible.”

No outside funding was reported. Dr. Nasrallah reported advisory board and consultant and speaker’s bureau relationships with Acadia, Alkermes, Allergan, Janssen, Lundbeck, Neurocrine Biosciences, Otsuka Pharmaceutical, Sunovion, and Teva. Another author reported no disclosures, and a third author reported numerous disclosures.

SOURCE: Nasrallah HA et al. Schizophr Res. 2019 Mar 2. doi: 10/1016/j.schres.2019.02.018.

Depression, suicidal thoughts, and mental distress appear to be on the rise among American teenagers and young adults, and a new study points to their use of social media as a cause. According to the study’s lead author, Jean M. Twenge, PhD, the findings might be evident of a generational shift in mental illness. The study looked at data from more than 200,000 adolescents aged 12-17 and nearly 400,000 young adults aged 18 and over from 2005 to 2017. During that time, reported symptoms consistent with major depression increased by 52% among the teens and 63% among the young adults. Girls were especially at risk, with one in five teenage girls having experienced major depression in 2017. In addition, by 2017, nearly three-quarters of young adults had experienced feelings of hopelessness about their lives. Meanwhile, the rate of suicide rose during that study period. Dr. Twenge said a major factor contributing to those trends is the plugged-in lifestyle of many teens and young adults. “Spending time on social media tends not to be in real time,” said Dr. Twenge, a psychologist at San Diego State University. “You’re not having a real-time conversation with someone – usually you’re not seeing their face, and you can’t give them a hug; it’s just not as emotionally fulfilling as seeing someone in person,” she said in an interview with National Public Radio. The uncertain times are likely another influence, according to Robert Crosnoe, PhD, a sociologist and adolescent health researcher from the University of Texas at Austin. “I think we are living in a time of great uncertainty, where people are unsure about the future of the country but also their own futures,” he said. “And that is anxiety provoking for anybody, but it’s especially true for young people whose whole future is ahead of them.” NPR.

Peerayot/Thinkstock.com

Alexandra Valoras was a high school student who earned straight As and participated in extracurricular school activities like robotics and pastimes like snowboarding. On the outside, her future looked bright. But inside, Alexandra lived in a world of despair. Her journals revealed profound self-loathing and sadness. She repeatedly expressed a desire to end her own life, reported Jim Axelrod of CBS News. Alexandra is far from alone. The suicide rate for American teens her age is at a 40-year high. One reason is the pressure for perfection, with failure being viewed as catastrophic. “I don’t want this notebook to end, I love it more than myself (?) I need a place where there is no need for me to be perfect,” Alexandra wrote in one entry. “We have a culture that makes kids think that if they’re not perfect, they’re less than good,” said Scott White, a counselor at Alexandra’s high school. Not every person can reach them.” On March 18, 2018, Alexandra wrote her last entry. “What I will miss by dying tonight. The possibility of anything getting better.” She then tidied up her room, walked to an overpass, and jumped. She was 17 years old. Her parents, Dean and Alysia Valoras, shared their daughter’s journals with the hope of helping others. “The hurt, the sadness is evolving,” Mr. Valoras said in the report. “And now there is this thing called living, so that I am a good father, a good husband, a good person.” CBS Sunday Morning.

For college students, accessing mental health services can be a challenge – especially when cost is an issue. In an effort to address that problem Loyola University in New Orleans recently opened a clinic for low-income students in need of psychiatric services. The clinic, opened in February, hopes to serve about 50 patients each week and is open to students and community members. “I’m really stoked about working with this demographic. It’s a population that doesn’t make a lot of money. So you can go to this clinic, pay a small co-pay, and not have to rely on having health insurance,” said Sarah Zoghbi of the New Orleans Musicians’ Clinic & Assistance Foundation, one of the organizations providing support to the clinic. The clinic aims to address the gap in mental health services for the underinsured and uninsured in the area. And it’s sorely needed. Louisiana ranks 38th among the states for lower rates of access to care and higher prevalence of mental illness, according to the 2019 Mental Health America report. About 599,000 adults in Louisiana, about 17% of the population, have a mental illness. “It is our sincere hope to fill a gap in the community by providing high-quality services for those in need,” said the clinic’s director John Dewell, PhD. “No one will be turned away for lack of funds.” The Times-Picayune.

More and more video games are “tackling mental health issues,” Laura Parker wrote in the New York Times. “Mental health is becoming a more central narrative in our culture with efforts to normalize mental health challenges,” according to Eve Crevoshay, of Take This, a group that seeks to destigmatize mental illness within the video game industry. “With that trend comes response from creative industries, including games.” One of the games that Ms. Parker mentioned, called Sea of Solitude, is expected to publish this year. Another, called Celeste, examines depression and anxiety through a protagonist who tries to avoid obstacles. And yet another, called Hellblade, focuses on a warrior who deals with psychosis. Raffael Boccamazzo, PsyD, a psychotherapist who works as clinical director for Take This, said video games can be more effective at helping people bounce back “from negative moods than passive forms of media like TV or movies.” Take This provides resources, guidelines, and training about mental health on its website. The New York Times.

General offers of help to families in crisis are fine but might not get acted upon. It is better to offer something specific, and “the more specific, the better,” wrote Andrea Paterson in the Washington Post. “Not ‘Can I bring dinner sometime?’ Instead, something like, ‘I’d like to come over on Thursday and bring turkey chili.’ Ms. Paterson wrote that she came to that conclusion after her husband was diagnosed with stage 4 metastatic lung cancer in 2013. His death 4½ years later plunged Ms. Paterson and her sons “into crisis,” she wrote. Her tight network of friends and neighbors helped her cope, she said, and their concrete offers of help kept the family going. Such offers need not be earth shattering or monumental, she said. One of her “all-time favorites” was delightfully simple: “ ‘I’m having a cup of tea, watching Audrey learn to roller skate in the driveway. Come join me.’ Needless to say, I joined her.” Ms. Paterson shared several other specifics that might help families in crisis, such as getting a friend to set up a support network of helpers who can pick up prescriptions, meet repairmen, and so on. “Remember that what you offer doesn’t need to be expensive or extravagant,” Ms. Paterson wrote. “ ‘Tomorrow night we are watching the Super Bowl: Join us for tacos and ice cream.’ After all, no one can be in a crisis 24/7.” The Washington Post.

Depression, suicidal thoughts, and mental distress appear to be on the rise among American teenagers and young adults, and a new study points to their use of social media as a cause. According to the study’s lead author, Jean M. Twenge, PhD, the findings might be evident of a generational shift in mental illness. The study looked at data from more than 200,000 adolescents aged 12-17 and nearly 400,000 young adults aged 18 and over from 2005 to 2017. During that time, reported symptoms consistent with major depression increased by 52% among the teens and 63% among the young adults. Girls were especially at risk, with one in five teenage girls having experienced major depression in 2017. In addition, by 2017, nearly three-quarters of young adults had experienced feelings of hopelessness about their lives. Meanwhile, the rate of suicide rose during that study period. Dr. Twenge said a major factor contributing to those trends is the plugged-in lifestyle of many teens and young adults. “Spending time on social media tends not to be in real time,” said Dr. Twenge, a psychologist at San Diego State University. “You’re not having a real-time conversation with someone – usually you’re not seeing their face, and you can’t give them a hug; it’s just not as emotionally fulfilling as seeing someone in person,” she said in an interview with National Public Radio. The uncertain times are likely another influence, according to Robert Crosnoe, PhD, a sociologist and adolescent health researcher from the University of Texas at Austin. “I think we are living in a time of great uncertainty, where people are unsure about the future of the country but also their own futures,” he said. “And that is anxiety provoking for anybody, but it’s especially true for young people whose whole future is ahead of them.” NPR.

Peerayot/Thinkstock.com

Alexandra Valoras was a high school student who earned straight As and participated in extracurricular school activities like robotics and pastimes like snowboarding. On the outside, her future looked bright. But inside, Alexandra lived in a world of despair. Her journals revealed profound self-loathing and sadness. She repeatedly expressed a desire to end her own life, reported Jim Axelrod of CBS News. Alexandra is far from alone. The suicide rate for American teens her age is at a 40-year high. One reason is the pressure for perfection, with failure being viewed as catastrophic. “I don’t want this notebook to end, I love it more than myself (?) I need a place where there is no need for me to be perfect,” Alexandra wrote in one entry. “We have a culture that makes kids think that if they’re not perfect, they’re less than good,” said Scott White, a counselor at Alexandra’s high school. Not every person can reach them.” On March 18, 2018, Alexandra wrote her last entry. “What I will miss by dying tonight. The possibility of anything getting better.” She then tidied up her room, walked to an overpass, and jumped. She was 17 years old. Her parents, Dean and Alysia Valoras, shared their daughter’s journals with the hope of helping others. “The hurt, the sadness is evolving,” Mr. Valoras said in the report. “And now there is this thing called living, so that I am a good father, a good husband, a good person.” CBS Sunday Morning.

For college students, accessing mental health services can be a challenge – especially when cost is an issue. In an effort to address that problem Loyola University in New Orleans recently opened a clinic for low-income students in need of psychiatric services. The clinic, opened in February, hopes to serve about 50 patients each week and is open to students and community members. “I’m really stoked about working with this demographic. It’s a population that doesn’t make a lot of money. So you can go to this clinic, pay a small co-pay, and not have to rely on having health insurance,” said Sarah Zoghbi of the New Orleans Musicians’ Clinic & Assistance Foundation, one of the organizations providing support to the clinic. The clinic aims to address the gap in mental health services for the underinsured and uninsured in the area. And it’s sorely needed. Louisiana ranks 38th among the states for lower rates of access to care and higher prevalence of mental illness, according to the 2019 Mental Health America report. About 599,000 adults in Louisiana, about 17% of the population, have a mental illness. “It is our sincere hope to fill a gap in the community by providing high-quality services for those in need,” said the clinic’s director John Dewell, PhD. “No one will be turned away for lack of funds.” The Times-Picayune.

More and more video games are “tackling mental health issues,” Laura Parker wrote in the New York Times. “Mental health is becoming a more central narrative in our culture with efforts to normalize mental health challenges,” according to Eve Crevoshay, of Take This, a group that seeks to destigmatize mental illness within the video game industry. “With that trend comes response from creative industries, including games.” One of the games that Ms. Parker mentioned, called Sea of Solitude, is expected to publish this year. Another, called Celeste, examines depression and anxiety through a protagonist who tries to avoid obstacles. And yet another, called Hellblade, focuses on a warrior who deals with psychosis. Raffael Boccamazzo, PsyD, a psychotherapist who works as clinical director for Take This, said video games can be more effective at helping people bounce back “from negative moods than passive forms of media like TV or movies.” Take This provides resources, guidelines, and training about mental health on its website. The New York Times.

General offers of help to families in crisis are fine but might not get acted upon. It is better to offer something specific, and “the more specific, the better,” wrote Andrea Paterson in the Washington Post. “Not ‘Can I bring dinner sometime?’ Instead, something like, ‘I’d like to come over on Thursday and bring turkey chili.’ Ms. Paterson wrote that she came to that conclusion after her husband was diagnosed with stage 4 metastatic lung cancer in 2013. His death 4½ years later plunged Ms. Paterson and her sons “into crisis,” she wrote. Her tight network of friends and neighbors helped her cope, she said, and their concrete offers of help kept the family going. Such offers need not be earth shattering or monumental, she said. One of her “all-time favorites” was delightfully simple: “ ‘I’m having a cup of tea, watching Audrey learn to roller skate in the driveway. Come join me.’ Needless to say, I joined her.” Ms. Paterson shared several other specifics that might help families in crisis, such as getting a friend to set up a support network of helpers who can pick up prescriptions, meet repairmen, and so on. “Remember that what you offer doesn’t need to be expensive or extravagant,” Ms. Paterson wrote. “ ‘Tomorrow night we are watching the Super Bowl: Join us for tacos and ice cream.’ After all, no one can be in a crisis 24/7.” The Washington Post.

Depression, suicidal thoughts, and mental distress appear to be on the rise among American teenagers and young adults, and a new study points to their use of social media as a cause. According to the study’s lead author, Jean M. Twenge, PhD, the findings might be evident of a generational shift in mental illness. The study looked at data from more than 200,000 adolescents aged 12-17 and nearly 400,000 young adults aged 18 and over from 2005 to 2017. During that time, reported symptoms consistent with major depression increased by 52% among the teens and 63% among the young adults. Girls were especially at risk, with one in five teenage girls having experienced major depression in 2017. In addition, by 2017, nearly three-quarters of young adults had experienced feelings of hopelessness about their lives. Meanwhile, the rate of suicide rose during that study period. Dr. Twenge said a major factor contributing to those trends is the plugged-in lifestyle of many teens and young adults. “Spending time on social media tends not to be in real time,” said Dr. Twenge, a psychologist at San Diego State University. “You’re not having a real-time conversation with someone – usually you’re not seeing their face, and you can’t give them a hug; it’s just not as emotionally fulfilling as seeing someone in person,” she said in an interview with National Public Radio. The uncertain times are likely another influence, according to Robert Crosnoe, PhD, a sociologist and adolescent health researcher from the University of Texas at Austin. “I think we are living in a time of great uncertainty, where people are unsure about the future of the country but also their own futures,” he said. “And that is anxiety provoking for anybody, but it’s especially true for young people whose whole future is ahead of them.” NPR.

Peerayot/Thinkstock.com

Alexandra Valoras was a high school student who earned straight As and participated in extracurricular school activities like robotics and pastimes like snowboarding. On the outside, her future looked bright. But inside, Alexandra lived in a world of despair. Her journals revealed profound self-loathing and sadness. She repeatedly expressed a desire to end her own life, reported Jim Axelrod of CBS News. Alexandra is far from alone. The suicide rate for American teens her age is at a 40-year high. One reason is the pressure for perfection, with failure being viewed as catastrophic. “I don’t want this notebook to end, I love it more than myself (?) I need a place where there is no need for me to be perfect,” Alexandra wrote in one entry. “We have a culture that makes kids think that if they’re not perfect, they’re less than good,” said Scott White, a counselor at Alexandra’s high school. Not every person can reach them.” On March 18, 2018, Alexandra wrote her last entry. “What I will miss by dying tonight. The possibility of anything getting better.” She then tidied up her room, walked to an overpass, and jumped. She was 17 years old. Her parents, Dean and Alysia Valoras, shared their daughter’s journals with the hope of helping others. “The hurt, the sadness is evolving,” Mr. Valoras said in the report. “And now there is this thing called living, so that I am a good father, a good husband, a good person.” CBS Sunday Morning.

For college students, accessing mental health services can be a challenge – especially when cost is an issue. In an effort to address that problem Loyola University in New Orleans recently opened a clinic for low-income students in need of psychiatric services. The clinic, opened in February, hopes to serve about 50 patients each week and is open to students and community members. “I’m really stoked about working with this demographic. It’s a population that doesn’t make a lot of money. So you can go to this clinic, pay a small co-pay, and not have to rely on having health insurance,” said Sarah Zoghbi of the New Orleans Musicians’ Clinic & Assistance Foundation, one of the organizations providing support to the clinic. The clinic aims to address the gap in mental health services for the underinsured and uninsured in the area. And it’s sorely needed. Louisiana ranks 38th among the states for lower rates of access to care and higher prevalence of mental illness, according to the 2019 Mental Health America report. About 599,000 adults in Louisiana, about 17% of the population, have a mental illness. “It is our sincere hope to fill a gap in the community by providing high-quality services for those in need,” said the clinic’s director John Dewell, PhD. “No one will be turned away for lack of funds.” The Times-Picayune.

More and more video games are “tackling mental health issues,” Laura Parker wrote in the New York Times. “Mental health is becoming a more central narrative in our culture with efforts to normalize mental health challenges,” according to Eve Crevoshay, of Take This, a group that seeks to destigmatize mental illness within the video game industry. “With that trend comes response from creative industries, including games.” One of the games that Ms. Parker mentioned, called Sea of Solitude, is expected to publish this year. Another, called Celeste, examines depression and anxiety through a protagonist who tries to avoid obstacles. And yet another, called Hellblade, focuses on a warrior who deals with psychosis. Raffael Boccamazzo, PsyD, a psychotherapist who works as clinical director for Take This, said video games can be more effective at helping people bounce back “from negative moods than passive forms of media like TV or movies.” Take This provides resources, guidelines, and training about mental health on its website. The New York Times.

General offers of help to families in crisis are fine but might not get acted upon. It is better to offer something specific, and “the more specific, the better,” wrote Andrea Paterson in the Washington Post. “Not ‘Can I bring dinner sometime?’ Instead, something like, ‘I’d like to come over on Thursday and bring turkey chili.’ Ms. Paterson wrote that she came to that conclusion after her husband was diagnosed with stage 4 metastatic lung cancer in 2013. His death 4½ years later plunged Ms. Paterson and her sons “into crisis,” she wrote. Her tight network of friends and neighbors helped her cope, she said, and their concrete offers of help kept the family going. Such offers need not be earth shattering or monumental, she said. One of her “all-time favorites” was delightfully simple: “ ‘I’m having a cup of tea, watching Audrey learn to roller skate in the driveway. Come join me.’ Needless to say, I joined her.” Ms. Paterson shared several other specifics that might help families in crisis, such as getting a friend to set up a support network of helpers who can pick up prescriptions, meet repairmen, and so on. “Remember that what you offer doesn’t need to be expensive or extravagant,” Ms. Paterson wrote. “ ‘Tomorrow night we are watching the Super Bowl: Join us for tacos and ice cream.’ After all, no one can be in a crisis 24/7.” The Washington Post.

There is no specialty in which women physicians make as much as men, but hematology came the closest in 2018, according to a new survey by the medical social network Doximity.

Female hematologists averaged $309,000 in earnings in 2018, just 4% less than their male counterparts, who brought in an average of $323,000. Rheumatology had the next-smallest gap, 8%, between women and men, followed by radiation oncology at 9% and thoracic surgery and plastic surgery at 11% each, Doximity reported March 26. All of the 90,000 physicians involved in the survey worked at least 40 hours per week.

At the other end of the scale is pediatric pulmonology, home of the largest gender wage gap. Average compensation for women in the specialty was $195,000, or 23% less than the $253,000 that men received. Women in otolaryngology and urology were next, earning 22% less than men in those specialties, while women in radiology and pediatrics averaged 21% and 20% less, respectively, than men, Doximity said in its report.

The gender wage gap has been persistent, but the latest data show that it is starting to close as the earnings curve for male physicians flattened in 2018 while pay increased for female physicians.


“Compensation transparency is a powerful force. As more data becomes available to us, exposing the pay gap between men and women, we see more movements to rectify this issue,” said Christopher Whaley, PhD, of the University of California, Berkeley, School of Public Health, who was lead author of the study.

To account for differences in specialty, geography, and physician-specific factors, the Doximity researchers used “a multivariate regression with fixed effects for provider specialty and [metropolitan statistical area].” They also controlled for how long each physician has been in practice and their self-reported average hours worked.

[email protected]

There is no specialty in which women physicians make as much as men, but hematology came the closest in 2018, according to a new survey by the medical social network Doximity.

Female hematologists averaged $309,000 in earnings in 2018, just 4% less than their male counterparts, who brought in an average of $323,000. Rheumatology had the next-smallest gap, 8%, between women and men, followed by radiation oncology at 9% and thoracic surgery and plastic surgery at 11% each, Doximity reported March 26. All of the 90,000 physicians involved in the survey worked at least 40 hours per week.

At the other end of the scale is pediatric pulmonology, home of the largest gender wage gap. Average compensation for women in the specialty was $195,000, or 23% less than the $253,000 that men received. Women in otolaryngology and urology were next, earning 22% less than men in those specialties, while women in radiology and pediatrics averaged 21% and 20% less, respectively, than men, Doximity said in its report.

The gender wage gap has been persistent, but the latest data show that it is starting to close as the earnings curve for male physicians flattened in 2018 while pay increased for female physicians.


“Compensation transparency is a powerful force. As more data becomes available to us, exposing the pay gap between men and women, we see more movements to rectify this issue,” said Christopher Whaley, PhD, of the University of California, Berkeley, School of Public Health, who was lead author of the study.

To account for differences in specialty, geography, and physician-specific factors, the Doximity researchers used “a multivariate regression with fixed effects for provider specialty and [metropolitan statistical area].” They also controlled for how long each physician has been in practice and their self-reported average hours worked.

[email protected]

There is no specialty in which women physicians make as much as men, but hematology came the closest in 2018, according to a new survey by the medical social network Doximity.

Female hematologists averaged $309,000 in earnings in 2018, just 4% less than their male counterparts, who brought in an average of $323,000. Rheumatology had the next-smallest gap, 8%, between women and men, followed by radiation oncology at 9% and thoracic surgery and plastic surgery at 11% each, Doximity reported March 26. All of the 90,000 physicians involved in the survey worked at least 40 hours per week.

At the other end of the scale is pediatric pulmonology, home of the largest gender wage gap. Average compensation for women in the specialty was $195,000, or 23% less than the $253,000 that men received. Women in otolaryngology and urology were next, earning 22% less than men in those specialties, while women in radiology and pediatrics averaged 21% and 20% less, respectively, than men, Doximity said in its report.

The gender wage gap has been persistent, but the latest data show that it is starting to close as the earnings curve for male physicians flattened in 2018 while pay increased for female physicians.


“Compensation transparency is a powerful force. As more data becomes available to us, exposing the pay gap between men and women, we see more movements to rectify this issue,” said Christopher Whaley, PhD, of the University of California, Berkeley, School of Public Health, who was lead author of the study.

To account for differences in specialty, geography, and physician-specific factors, the Doximity researchers used “a multivariate regression with fixed effects for provider specialty and [metropolitan statistical area].” They also controlled for how long each physician has been in practice and their self-reported average hours worked.

[email protected]