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Record number of U.S. drug overdoses in 2020
More Americans died from drug overdoses in 2020 than in any other year, the CDC said July 14.
, according to the provisional data the National Center for Health Statistics reported.
The spikes are largely attributed to the rise in use of fentanyl and other synthetic opioids.
The Washington Post reported that more than 69,000 overdose deaths involved opioids, up from 50,963 in 2019.
Amid the crush of overdoses, the White House announced that President Joe Biden has nominated Rahul Gupta, MD, to lead the White House Office of National Drug Control Policy.
Dr. Gupta is a former health commissioner of West Virginia, and is chief medical and health officer for the March of Dimes.
“Dr. Gupta led efforts in West Virginia to address the opioid crisis, gaining national prominence as a leader in tackling this issue,” March of Dimes President and CEO Stacey Stewart said in a statement. “At March of Dimes, he has advocated for policies and programs to prevent and treat substance use, with a focus on the safety and care of pregnant women and infants.”
Healthday contributed to this report. A version of this article first appeared on WebMD.com.
More Americans died from drug overdoses in 2020 than in any other year, the CDC said July 14.
, according to the provisional data the National Center for Health Statistics reported.
The spikes are largely attributed to the rise in use of fentanyl and other synthetic opioids.
The Washington Post reported that more than 69,000 overdose deaths involved opioids, up from 50,963 in 2019.
Amid the crush of overdoses, the White House announced that President Joe Biden has nominated Rahul Gupta, MD, to lead the White House Office of National Drug Control Policy.
Dr. Gupta is a former health commissioner of West Virginia, and is chief medical and health officer for the March of Dimes.
“Dr. Gupta led efforts in West Virginia to address the opioid crisis, gaining national prominence as a leader in tackling this issue,” March of Dimes President and CEO Stacey Stewart said in a statement. “At March of Dimes, he has advocated for policies and programs to prevent and treat substance use, with a focus on the safety and care of pregnant women and infants.”
Healthday contributed to this report. A version of this article first appeared on WebMD.com.
More Americans died from drug overdoses in 2020 than in any other year, the CDC said July 14.
, according to the provisional data the National Center for Health Statistics reported.
The spikes are largely attributed to the rise in use of fentanyl and other synthetic opioids.
The Washington Post reported that more than 69,000 overdose deaths involved opioids, up from 50,963 in 2019.
Amid the crush of overdoses, the White House announced that President Joe Biden has nominated Rahul Gupta, MD, to lead the White House Office of National Drug Control Policy.
Dr. Gupta is a former health commissioner of West Virginia, and is chief medical and health officer for the March of Dimes.
“Dr. Gupta led efforts in West Virginia to address the opioid crisis, gaining national prominence as a leader in tackling this issue,” March of Dimes President and CEO Stacey Stewart said in a statement. “At March of Dimes, he has advocated for policies and programs to prevent and treat substance use, with a focus on the safety and care of pregnant women and infants.”
Healthday contributed to this report. A version of this article first appeared on WebMD.com.
State-of-the-art psych unit designed with recovery in mind
Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.
The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.
“We offer a really warm and welcoming environment that we think is going to promote health and healing,” the unit’s head, Sarah Edwards, DO, director of child and adolescent psychiatry at UMMC and assistant professor of psychiatry, University of Maryland School of Medicine (UMSOM), Baltimore, said in an interview.
Previous research shows that 1 in 4 children experience some kind of maltreatment, whether physical, sexual, or emotional, and that 1 in 5 develop a diagnosable mental health disorder.
, Dr. Edwards noted. Recent data show that the rate of suicidal ideation among youth has increased significantly during the COVID-19 crisis.
“Urban children have unfortunately suffered a lot of what we call traumatic stress, so they might be victims of physical or sexual abuse but also face layers of stressful situations – for example, living in unsafe neighborhoods and attending schools that might not be so welcoming and safe,” said Dr. Edwards.
Safety first
Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.
Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.
The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.
The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.
Safety is of the utmost importance in the unit, Jill RachBeisel, MD, chief of psychiatry at UMMC and professor and chair in the department of psychiatry at UMSOM, said in an interview.
“Health care workers must recognize and respond to the effects of trauma – and one very important way is to provide care in settings that emphasize physical and emotional safety, which helps instill a sense of control and empowerment,” Dr. RachBeisel said.
Providing youth with options is an important way to provide that sense of control, Dr. Edwards added. For example, residents can choose their own music in their bedroom, such as sounds of nature, running water, or birds chirping. They can also draw or write personal notes on a large whiteboard in their unit.
Circadian-rhythm lighting
Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.
These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.
A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.
The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.
Safe and empowering and adopt productive behaviors and coping skills, Dr. Edwards noted.
The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
Advice for other centers
“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.
School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.
Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.
“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.
It is also important to incorporate feedback from youth themselves, Dr. Edwards added.
A version of this article first appeared on Medscape.com.
Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.
The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.
“We offer a really warm and welcoming environment that we think is going to promote health and healing,” the unit’s head, Sarah Edwards, DO, director of child and adolescent psychiatry at UMMC and assistant professor of psychiatry, University of Maryland School of Medicine (UMSOM), Baltimore, said in an interview.
Previous research shows that 1 in 4 children experience some kind of maltreatment, whether physical, sexual, or emotional, and that 1 in 5 develop a diagnosable mental health disorder.
, Dr. Edwards noted. Recent data show that the rate of suicidal ideation among youth has increased significantly during the COVID-19 crisis.
“Urban children have unfortunately suffered a lot of what we call traumatic stress, so they might be victims of physical or sexual abuse but also face layers of stressful situations – for example, living in unsafe neighborhoods and attending schools that might not be so welcoming and safe,” said Dr. Edwards.
Safety first
Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.
Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.
The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.
The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.
Safety is of the utmost importance in the unit, Jill RachBeisel, MD, chief of psychiatry at UMMC and professor and chair in the department of psychiatry at UMSOM, said in an interview.
“Health care workers must recognize and respond to the effects of trauma – and one very important way is to provide care in settings that emphasize physical and emotional safety, which helps instill a sense of control and empowerment,” Dr. RachBeisel said.
Providing youth with options is an important way to provide that sense of control, Dr. Edwards added. For example, residents can choose their own music in their bedroom, such as sounds of nature, running water, or birds chirping. They can also draw or write personal notes on a large whiteboard in their unit.
Circadian-rhythm lighting
Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.
These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.
A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.
The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.
Safe and empowering and adopt productive behaviors and coping skills, Dr. Edwards noted.
The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
Advice for other centers
“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.
School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.
Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.
“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.
It is also important to incorporate feedback from youth themselves, Dr. Edwards added.
A version of this article first appeared on Medscape.com.
Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.
The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.
“We offer a really warm and welcoming environment that we think is going to promote health and healing,” the unit’s head, Sarah Edwards, DO, director of child and adolescent psychiatry at UMMC and assistant professor of psychiatry, University of Maryland School of Medicine (UMSOM), Baltimore, said in an interview.
Previous research shows that 1 in 4 children experience some kind of maltreatment, whether physical, sexual, or emotional, and that 1 in 5 develop a diagnosable mental health disorder.
, Dr. Edwards noted. Recent data show that the rate of suicidal ideation among youth has increased significantly during the COVID-19 crisis.
“Urban children have unfortunately suffered a lot of what we call traumatic stress, so they might be victims of physical or sexual abuse but also face layers of stressful situations – for example, living in unsafe neighborhoods and attending schools that might not be so welcoming and safe,” said Dr. Edwards.
Safety first
Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.
Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.
The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.
The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.
Safety is of the utmost importance in the unit, Jill RachBeisel, MD, chief of psychiatry at UMMC and professor and chair in the department of psychiatry at UMSOM, said in an interview.
“Health care workers must recognize and respond to the effects of trauma – and one very important way is to provide care in settings that emphasize physical and emotional safety, which helps instill a sense of control and empowerment,” Dr. RachBeisel said.
Providing youth with options is an important way to provide that sense of control, Dr. Edwards added. For example, residents can choose their own music in their bedroom, such as sounds of nature, running water, or birds chirping. They can also draw or write personal notes on a large whiteboard in their unit.
Circadian-rhythm lighting
Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.
These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.
A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.
The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.
Safe and empowering and adopt productive behaviors and coping skills, Dr. Edwards noted.
The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
Advice for other centers
“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.
School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.
Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.
“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.
It is also important to incorporate feedback from youth themselves, Dr. Edwards added.
A version of this article first appeared on Medscape.com.
Do patients with cancer need a third shot of COVID vaccine?
Patients with cancer have shown varying responses to COVID-19 vaccination, with good responses in patients with solid tumors (even while on systemic therapy) and poor responses in patients with blood cancers, particularly those on immunosuppressive therapies.
The data are evolving to show factors associated with a poor response but are not strong enough yet to recommend booster shots, say researchers.
The work is defining who will likely need a COVID vaccine booster when they become available. “It’s definitely not all cancer patients,” said Dimpy Shah, MD, PhD, a cancer epidemiologist at the Mays Cancer Center, University of Texas, San Antonio.
Public anxiously awaiting boosters
Boosters aren’t recommended in the United States at the moment, in large part because the Emergency Use Authorization under which the vaccines are being administered allows for only two shots of the Pfizer and Moderna vaccines and one shot of the Johnson & Johnson vaccine.
Even so, regulators and policymakers are “keenly aware that physicians and patients alike are anxious to get going and start doing boosters,” Dr. Shah said. There’s concern that antibody response might wane over time, perhaps even more quickly in patients with cancer.
Pfizer is already in talks with the U.S. Food and Drug Administration to authorize a third dose of its vaccine in the United States. Guidelines could very well change in coming months, said Ghady Haidar, MD, a specialist in infectious diseases and cancer at the University of Pittsburgh.
However, it’s still early in the game, and it’s not clear yet if boosters are necessary in cancer, Dr. Haidar said in an interview.
For one thing, it’s unknown if poor antibody response really means that patients aren’t protected, he explained. The vaccines elicit T-cell responses that could protect patients regardless of antibody levels. It’s also unclear if antibody titer levels are clinically relevant, and there hasn’t been much indication yet that less-than-robust vaccine responses translate to worse COVID outcomes in patients with cancer.
Those and other questions are areas of active investigation by Dr. Shah, Dr. Haidar, and others. Dozens of clinical trials are investigating vaccine response in patients with cancer, including the use of boosters.
Meanwhile, some cancer patients aren’t waiting around for more study results. “I get many, many emails a day” about booster shots, Dr. Haidar said. “We recommend against” them for now but some people bend the rules and get an extra shot anyway. “I get it. People are apprehensive.”
Three COVID deaths despite full vaccination
The vaccine clinical trials had fewer patients with cancer, so researchers are moving fast to backfill the data. Although there is some variation in what’s being reported, an overall picture is slowly emerging.
Dr. Shah and her team reported on responses to the mRNA COVID vaccines from Pfizer and Moderna and found a 94% seroconversion rate in 131 patients with cancer 3-4 weeks after their second dose of vaccine. They also found good responses among patients on cytotoxic chemotherapy within 6 months of their first vaccine dose, although their antibody titer levels were significantly lower than seen in other patients with cancer.
Investigators from Montefiore Medical Center in New York City also recently reported a 94% seroconversion rate among 200 patients with cancer, including 98% seroconversion in patients with solid tumors. Rates were lower in patients with blood cancers but were still 85% overall, with 70% conversion among patients on anti-CD20 therapies and 73% among stem cell transplant patients.
Dr. Haidar’s group reported a seroconversion rate of 82.4% among patients with solid tumors but only 54.7% among those with blood cancer. Risk factors for poor response included treatment with antimetabolites and anti-CD20 therapies, and, in the solid tumor group, radiation therapy, likely because of its overall toxicity and impact on lymphocyte function.
Israeli investigators reported in May a 90% seroconversion rate after two doses of the Pfizer vaccine among 102 patients with solid tumors on active treatment, which compared favorably to the 100% conversion rate in healthy controls, but they noted that antibody titers were considerably lower in patients with cancer.
The only variable associated with lower titer levels was combined use of chemotherapy and immunotherapy, they noted. There were also three women on dose-dense chemotherapy for breast cancer who did not produce any antibodies.
In a study limited to patients with blood cancers, a Lithuanian team recently reported that among 885 patients, those on Bruton tyrosine kinase inhibitors, ruxolitinib (Jakafi), venetoclax (Venclexta), or anti-CD20 therapies mounted almost no antibody response to the Pfizer vaccine.
The Lithuanian group also reported nine breakthrough COVID infections among their fully vaccinated blood cancer patients, including three deaths.
A team from the Icahn School of Medicine at Mount Sinai, New York reported that more than 15% of 260 patients with multiple myeloma also had no response to the Pfizer or Moderna vaccine; they were on BCMA-targeted therapy or anti-CD38 monoclonal antibody therapy at the time of vaccination, but a few had undergone CAR-T cell therapy more than 3 months beforehand.
Heated debate about antibody testing
Despite these reports of some patients with cancer having poorer responses, there’s some uncertainty over the benefit of giving a third (booster) shot.
There’s the question about the clinical relevance of antibody titer levels, and very little work has been done to date on cellular T-cell immunity from the vaccines.
“Right now, we are using titer levels like they actually mean something when they might not,” said Ravi Parikh, MD, a genitourinary and thoracic oncologist at the University of Pennsylvania, Philadelphia, who co-wrote an editorial that accompanies the Israeli report.
That’s one of the reasons why the FDA and others do not currently recommend antibody tests for COVID vaccine decisions outside of a clinical trial, but not everyone agrees with that position.
There’s been “a lot of heated debate in the medical community” over the issue, Dr. Haidar said.
The Icahn team, for instance, said that their results “underscore the need for routine serological monitoring of [multiple myeloma] patients following COVID-19 vaccination” to see if they might still need to mask-up and socially distance.
There is precedence, too, for vaccine boosters in cancer. As Dr. Parikh noted in his editorial, guidelines recommend revaccination after stem cell transplant for meningococcus, tetanus, and varicella, and other infections.
In France, COVID booster shots are already standard care for patients on dialysis and those on anti-CD20 agents, as well as for solid organ transplant recipients, for whom the literature supporting the benefit of COVID boosters is much more evolved than in cancer.
Israel has also authorized vaccine boosters for immunocompromised patients, including those with cancer, according to news reports.
It is also almost certain that the FDA will grant a formal approval for the COVID vaccines, at which point doctors will be free to administer boosters as they see fit.
“People are going to have to think really hard about what to do with them” if guidance hasn’t changed by then, Dr. Haidar said.
As the story unfolds, Dr. Haidar and others said in an interview that the take-home message for oncologists remains largely what it has been – namely to get patients vaccinated but also to consider masks and social distancing afterward for those at risk of a poor response.
Dr. Shah, Dr. Haidar, and Dr. Parikh have disclosed no relevant financial relationships. Dr. Parikh is a regular contributor to Medscape Oncology.
A version of this article first appeared on Medscape.com.
Patients with cancer have shown varying responses to COVID-19 vaccination, with good responses in patients with solid tumors (even while on systemic therapy) and poor responses in patients with blood cancers, particularly those on immunosuppressive therapies.
The data are evolving to show factors associated with a poor response but are not strong enough yet to recommend booster shots, say researchers.
The work is defining who will likely need a COVID vaccine booster when they become available. “It’s definitely not all cancer patients,” said Dimpy Shah, MD, PhD, a cancer epidemiologist at the Mays Cancer Center, University of Texas, San Antonio.
Public anxiously awaiting boosters
Boosters aren’t recommended in the United States at the moment, in large part because the Emergency Use Authorization under which the vaccines are being administered allows for only two shots of the Pfizer and Moderna vaccines and one shot of the Johnson & Johnson vaccine.
Even so, regulators and policymakers are “keenly aware that physicians and patients alike are anxious to get going and start doing boosters,” Dr. Shah said. There’s concern that antibody response might wane over time, perhaps even more quickly in patients with cancer.
Pfizer is already in talks with the U.S. Food and Drug Administration to authorize a third dose of its vaccine in the United States. Guidelines could very well change in coming months, said Ghady Haidar, MD, a specialist in infectious diseases and cancer at the University of Pittsburgh.
However, it’s still early in the game, and it’s not clear yet if boosters are necessary in cancer, Dr. Haidar said in an interview.
For one thing, it’s unknown if poor antibody response really means that patients aren’t protected, he explained. The vaccines elicit T-cell responses that could protect patients regardless of antibody levels. It’s also unclear if antibody titer levels are clinically relevant, and there hasn’t been much indication yet that less-than-robust vaccine responses translate to worse COVID outcomes in patients with cancer.
Those and other questions are areas of active investigation by Dr. Shah, Dr. Haidar, and others. Dozens of clinical trials are investigating vaccine response in patients with cancer, including the use of boosters.
Meanwhile, some cancer patients aren’t waiting around for more study results. “I get many, many emails a day” about booster shots, Dr. Haidar said. “We recommend against” them for now but some people bend the rules and get an extra shot anyway. “I get it. People are apprehensive.”
Three COVID deaths despite full vaccination
The vaccine clinical trials had fewer patients with cancer, so researchers are moving fast to backfill the data. Although there is some variation in what’s being reported, an overall picture is slowly emerging.
Dr. Shah and her team reported on responses to the mRNA COVID vaccines from Pfizer and Moderna and found a 94% seroconversion rate in 131 patients with cancer 3-4 weeks after their second dose of vaccine. They also found good responses among patients on cytotoxic chemotherapy within 6 months of their first vaccine dose, although their antibody titer levels were significantly lower than seen in other patients with cancer.
Investigators from Montefiore Medical Center in New York City also recently reported a 94% seroconversion rate among 200 patients with cancer, including 98% seroconversion in patients with solid tumors. Rates were lower in patients with blood cancers but were still 85% overall, with 70% conversion among patients on anti-CD20 therapies and 73% among stem cell transplant patients.
Dr. Haidar’s group reported a seroconversion rate of 82.4% among patients with solid tumors but only 54.7% among those with blood cancer. Risk factors for poor response included treatment with antimetabolites and anti-CD20 therapies, and, in the solid tumor group, radiation therapy, likely because of its overall toxicity and impact on lymphocyte function.
Israeli investigators reported in May a 90% seroconversion rate after two doses of the Pfizer vaccine among 102 patients with solid tumors on active treatment, which compared favorably to the 100% conversion rate in healthy controls, but they noted that antibody titers were considerably lower in patients with cancer.
The only variable associated with lower titer levels was combined use of chemotherapy and immunotherapy, they noted. There were also three women on dose-dense chemotherapy for breast cancer who did not produce any antibodies.
In a study limited to patients with blood cancers, a Lithuanian team recently reported that among 885 patients, those on Bruton tyrosine kinase inhibitors, ruxolitinib (Jakafi), venetoclax (Venclexta), or anti-CD20 therapies mounted almost no antibody response to the Pfizer vaccine.
The Lithuanian group also reported nine breakthrough COVID infections among their fully vaccinated blood cancer patients, including three deaths.
A team from the Icahn School of Medicine at Mount Sinai, New York reported that more than 15% of 260 patients with multiple myeloma also had no response to the Pfizer or Moderna vaccine; they were on BCMA-targeted therapy or anti-CD38 monoclonal antibody therapy at the time of vaccination, but a few had undergone CAR-T cell therapy more than 3 months beforehand.
Heated debate about antibody testing
Despite these reports of some patients with cancer having poorer responses, there’s some uncertainty over the benefit of giving a third (booster) shot.
There’s the question about the clinical relevance of antibody titer levels, and very little work has been done to date on cellular T-cell immunity from the vaccines.
“Right now, we are using titer levels like they actually mean something when they might not,” said Ravi Parikh, MD, a genitourinary and thoracic oncologist at the University of Pennsylvania, Philadelphia, who co-wrote an editorial that accompanies the Israeli report.
That’s one of the reasons why the FDA and others do not currently recommend antibody tests for COVID vaccine decisions outside of a clinical trial, but not everyone agrees with that position.
There’s been “a lot of heated debate in the medical community” over the issue, Dr. Haidar said.
The Icahn team, for instance, said that their results “underscore the need for routine serological monitoring of [multiple myeloma] patients following COVID-19 vaccination” to see if they might still need to mask-up and socially distance.
There is precedence, too, for vaccine boosters in cancer. As Dr. Parikh noted in his editorial, guidelines recommend revaccination after stem cell transplant for meningococcus, tetanus, and varicella, and other infections.
In France, COVID booster shots are already standard care for patients on dialysis and those on anti-CD20 agents, as well as for solid organ transplant recipients, for whom the literature supporting the benefit of COVID boosters is much more evolved than in cancer.
Israel has also authorized vaccine boosters for immunocompromised patients, including those with cancer, according to news reports.
It is also almost certain that the FDA will grant a formal approval for the COVID vaccines, at which point doctors will be free to administer boosters as they see fit.
“People are going to have to think really hard about what to do with them” if guidance hasn’t changed by then, Dr. Haidar said.
As the story unfolds, Dr. Haidar and others said in an interview that the take-home message for oncologists remains largely what it has been – namely to get patients vaccinated but also to consider masks and social distancing afterward for those at risk of a poor response.
Dr. Shah, Dr. Haidar, and Dr. Parikh have disclosed no relevant financial relationships. Dr. Parikh is a regular contributor to Medscape Oncology.
A version of this article first appeared on Medscape.com.
Patients with cancer have shown varying responses to COVID-19 vaccination, with good responses in patients with solid tumors (even while on systemic therapy) and poor responses in patients with blood cancers, particularly those on immunosuppressive therapies.
The data are evolving to show factors associated with a poor response but are not strong enough yet to recommend booster shots, say researchers.
The work is defining who will likely need a COVID vaccine booster when they become available. “It’s definitely not all cancer patients,” said Dimpy Shah, MD, PhD, a cancer epidemiologist at the Mays Cancer Center, University of Texas, San Antonio.
Public anxiously awaiting boosters
Boosters aren’t recommended in the United States at the moment, in large part because the Emergency Use Authorization under which the vaccines are being administered allows for only two shots of the Pfizer and Moderna vaccines and one shot of the Johnson & Johnson vaccine.
Even so, regulators and policymakers are “keenly aware that physicians and patients alike are anxious to get going and start doing boosters,” Dr. Shah said. There’s concern that antibody response might wane over time, perhaps even more quickly in patients with cancer.
Pfizer is already in talks with the U.S. Food and Drug Administration to authorize a third dose of its vaccine in the United States. Guidelines could very well change in coming months, said Ghady Haidar, MD, a specialist in infectious diseases and cancer at the University of Pittsburgh.
However, it’s still early in the game, and it’s not clear yet if boosters are necessary in cancer, Dr. Haidar said in an interview.
For one thing, it’s unknown if poor antibody response really means that patients aren’t protected, he explained. The vaccines elicit T-cell responses that could protect patients regardless of antibody levels. It’s also unclear if antibody titer levels are clinically relevant, and there hasn’t been much indication yet that less-than-robust vaccine responses translate to worse COVID outcomes in patients with cancer.
Those and other questions are areas of active investigation by Dr. Shah, Dr. Haidar, and others. Dozens of clinical trials are investigating vaccine response in patients with cancer, including the use of boosters.
Meanwhile, some cancer patients aren’t waiting around for more study results. “I get many, many emails a day” about booster shots, Dr. Haidar said. “We recommend against” them for now but some people bend the rules and get an extra shot anyway. “I get it. People are apprehensive.”
Three COVID deaths despite full vaccination
The vaccine clinical trials had fewer patients with cancer, so researchers are moving fast to backfill the data. Although there is some variation in what’s being reported, an overall picture is slowly emerging.
Dr. Shah and her team reported on responses to the mRNA COVID vaccines from Pfizer and Moderna and found a 94% seroconversion rate in 131 patients with cancer 3-4 weeks after their second dose of vaccine. They also found good responses among patients on cytotoxic chemotherapy within 6 months of their first vaccine dose, although their antibody titer levels were significantly lower than seen in other patients with cancer.
Investigators from Montefiore Medical Center in New York City also recently reported a 94% seroconversion rate among 200 patients with cancer, including 98% seroconversion in patients with solid tumors. Rates were lower in patients with blood cancers but were still 85% overall, with 70% conversion among patients on anti-CD20 therapies and 73% among stem cell transplant patients.
Dr. Haidar’s group reported a seroconversion rate of 82.4% among patients with solid tumors but only 54.7% among those with blood cancer. Risk factors for poor response included treatment with antimetabolites and anti-CD20 therapies, and, in the solid tumor group, radiation therapy, likely because of its overall toxicity and impact on lymphocyte function.
Israeli investigators reported in May a 90% seroconversion rate after two doses of the Pfizer vaccine among 102 patients with solid tumors on active treatment, which compared favorably to the 100% conversion rate in healthy controls, but they noted that antibody titers were considerably lower in patients with cancer.
The only variable associated with lower titer levels was combined use of chemotherapy and immunotherapy, they noted. There were also three women on dose-dense chemotherapy for breast cancer who did not produce any antibodies.
In a study limited to patients with blood cancers, a Lithuanian team recently reported that among 885 patients, those on Bruton tyrosine kinase inhibitors, ruxolitinib (Jakafi), venetoclax (Venclexta), or anti-CD20 therapies mounted almost no antibody response to the Pfizer vaccine.
The Lithuanian group also reported nine breakthrough COVID infections among their fully vaccinated blood cancer patients, including three deaths.
A team from the Icahn School of Medicine at Mount Sinai, New York reported that more than 15% of 260 patients with multiple myeloma also had no response to the Pfizer or Moderna vaccine; they were on BCMA-targeted therapy or anti-CD38 monoclonal antibody therapy at the time of vaccination, but a few had undergone CAR-T cell therapy more than 3 months beforehand.
Heated debate about antibody testing
Despite these reports of some patients with cancer having poorer responses, there’s some uncertainty over the benefit of giving a third (booster) shot.
There’s the question about the clinical relevance of antibody titer levels, and very little work has been done to date on cellular T-cell immunity from the vaccines.
“Right now, we are using titer levels like they actually mean something when they might not,” said Ravi Parikh, MD, a genitourinary and thoracic oncologist at the University of Pennsylvania, Philadelphia, who co-wrote an editorial that accompanies the Israeli report.
That’s one of the reasons why the FDA and others do not currently recommend antibody tests for COVID vaccine decisions outside of a clinical trial, but not everyone agrees with that position.
There’s been “a lot of heated debate in the medical community” over the issue, Dr. Haidar said.
The Icahn team, for instance, said that their results “underscore the need for routine serological monitoring of [multiple myeloma] patients following COVID-19 vaccination” to see if they might still need to mask-up and socially distance.
There is precedence, too, for vaccine boosters in cancer. As Dr. Parikh noted in his editorial, guidelines recommend revaccination after stem cell transplant for meningococcus, tetanus, and varicella, and other infections.
In France, COVID booster shots are already standard care for patients on dialysis and those on anti-CD20 agents, as well as for solid organ transplant recipients, for whom the literature supporting the benefit of COVID boosters is much more evolved than in cancer.
Israel has also authorized vaccine boosters for immunocompromised patients, including those with cancer, according to news reports.
It is also almost certain that the FDA will grant a formal approval for the COVID vaccines, at which point doctors will be free to administer boosters as they see fit.
“People are going to have to think really hard about what to do with them” if guidance hasn’t changed by then, Dr. Haidar said.
As the story unfolds, Dr. Haidar and others said in an interview that the take-home message for oncologists remains largely what it has been – namely to get patients vaccinated but also to consider masks and social distancing afterward for those at risk of a poor response.
Dr. Shah, Dr. Haidar, and Dr. Parikh have disclosed no relevant financial relationships. Dr. Parikh is a regular contributor to Medscape Oncology.
A version of this article first appeared on Medscape.com.
Most U.S. adults age 50+ report good health: Survey
a nonprofit hospice/advanced illness care organization based in Virginia.
Among the respondents, 41% said their health was very good or excellent.
However, the ratings differed largely by race, employment status, and income.
Employment status was also associated with a significant difference in the way people viewed their health at the top tier and bottom tier.
The middle tier (“good” health) was reported similarly (from 33% to 37%) whether a person was employed, retired, or not employed. However, employed respondents were much more likely to report they had “excellent” or “very good” health (51% vs. 44% for retirees and 21% for the not employed).
Conversely, those who were not employed were far more likely to report “fair” or “poor” health (45%) than those who were employed (13%) or retired (20%).
Similarly, respondents with incomes of less than $50,000 were three times more likely to report their health as “fair” or “poor” than were those with incomes of more than $100,000 (36% vs. 12%).
WebMD/CCH surveyed 3,464 U.S. residents ages 50 and older between Aug. 13 and Nov. 9, 2020. WebMD.com readers were randomly invited to take a 10-minute online survey.
Aging at home a priority
The survey also highlighted a strong preference for aging in place, says Steve Cone, chief of communications and philanthropy at CCH.
“More now than ever before, thanks to the COVID experience, baby boomers and their children really believe that’s the holy grail,” he says.
Mr. Cone notes that the quick spread of COVID-19 through some nursing homes early in the pandemic likely has strengthened people’s resolve to live out their lives in their own homes.
The survey indicated that 85% of people aged 50+ who are living in their own home, a family member’s home, or a loved one’s home responded that it is “very important” or “important” to stay in their home as they age.
When asked what services they would need to continue their living situation, the most common responses were housekeeping, home repair services, and transportation (listed as needs by 35% to 45% of respondents). Regarding changes they would have to make to feel safe in their home as they age, installing grab bars and/or safety rails in the bath/shower was the most popular answer (50%).
Use of telemedicine
Respondents were also asked about their acceptance of telemedicine, and 62% said they would be likely or very likely to engage in virtual visits with a doctor it in the future.
However, the likelihood varied by income level. Specifically, respondents with incomes over $100,000 were significantly more likely to say they would use telemedicine in the future than were those with incomes below $50,000 (74% vs. 60%). They were also more likely to already have used telemedicine.
Although respondents generally embraced telemedicine, they are less confident about some types of monitoring, according to Mr. Cone.
Emergency response (64%) was the leading type of remote monitoring respondents ages 50 and older would allow. Only a minority of respondents would allow the other types of monitoring asked about in the survey.
Close to one-quarter of respondents would not allow any type of monitoring.
Fewer than one-third would allow tracking of medication compliance, refrigerator use, sleep habits, or bathroom use.
People see monitoring of some movements as “Orwellian,” Mr. Cone says.
Knowledge of hospice
The survey findings support the need for more widespread use of hospice so people can stay in their homes as they age, Mr. Cone says.
When illness gets severe, “There’s no reason you have to get rushed to the emergency room or wind up in a hospital,” Mr. Cone says.
He notes that hospice and palliative care can come to patients wherever they reside – in their home, an assisted living center, a nursing home, or even a hospital room.
“That doesn’t mean the physician isn’t involved,” he says. “But working as a team, we can keep them in their homes and their lifestyle intact.”
Patients whose doctors attest that they are likely to live a maximum 6 months are eligible for hospice. But most families wait too long to long to start hospice or palliative care for a patient, Mr. Cone says, and may not be aware of what these services typically cover, including meal preparation and pet care.
In the survey, nearly one-third of respondents said they did not know that palliative care is something that “can be given at any stage of a serious illness” or “provides non-medical services (e.g., patient/family communication, help with insurance issues, scheduling appointments, arranging transportation).”
He notes palliative care and hospice are covered by Medicare and Medicaid and also by most private insurance plans or by individual companies providing the service.
However, health care providers may have to overcome a general reluctance to discuss hospice when sharing options for those severely ill.
The survey showed that while 51% of those 50 and older are at least “slightly interested” in learning more about hospice, a nearly equal number say they are “not at all interested” (49%).
Most using hospice are White
More than 90% of those surveyed reported that aspects of hospice care, including “comfort and relief from pain at the end of patients’ lives,” providing a dedicated care team, and an alternative to other care settings, are “very important” or “important.”
However, national hospice use rates are extremely low for minorities and the LGBTQ community, according to Mr. Cone. Among Medicare hospice recipients, 82% were white, 8.2% Black, 6.7% Hispanic, and 1.8% Asian or Pacific Islander, according to the National Hospice and Palliative Care Organization.
Those numbers signal a need for outreach to those communities with information on what services are available and how to access them, he says.
Health costs top concern
The survey also asked about level of concern regarding matters including family, health, financials, and end-of-life directives and found adults aged 50 and older expressed the greatest amount of concern for health care costs that are not covered by insurance.
More than half (56%) said they were concerned or very concerned about those costs, which was higher than the percentage concerned about losing a spouse (49%).
Respondents were less concerned (“slightly concerned” or “not at all concerned”) about their children living far away, planning end-of life-directives, and falling or having reduced mobility.
A version of this article first appeared on WebMD.com.
a nonprofit hospice/advanced illness care organization based in Virginia.
Among the respondents, 41% said their health was very good or excellent.
However, the ratings differed largely by race, employment status, and income.
Employment status was also associated with a significant difference in the way people viewed their health at the top tier and bottom tier.
The middle tier (“good” health) was reported similarly (from 33% to 37%) whether a person was employed, retired, or not employed. However, employed respondents were much more likely to report they had “excellent” or “very good” health (51% vs. 44% for retirees and 21% for the not employed).
Conversely, those who were not employed were far more likely to report “fair” or “poor” health (45%) than those who were employed (13%) or retired (20%).
Similarly, respondents with incomes of less than $50,000 were three times more likely to report their health as “fair” or “poor” than were those with incomes of more than $100,000 (36% vs. 12%).
WebMD/CCH surveyed 3,464 U.S. residents ages 50 and older between Aug. 13 and Nov. 9, 2020. WebMD.com readers were randomly invited to take a 10-minute online survey.
Aging at home a priority
The survey also highlighted a strong preference for aging in place, says Steve Cone, chief of communications and philanthropy at CCH.
“More now than ever before, thanks to the COVID experience, baby boomers and their children really believe that’s the holy grail,” he says.
Mr. Cone notes that the quick spread of COVID-19 through some nursing homes early in the pandemic likely has strengthened people’s resolve to live out their lives in their own homes.
The survey indicated that 85% of people aged 50+ who are living in their own home, a family member’s home, or a loved one’s home responded that it is “very important” or “important” to stay in their home as they age.
When asked what services they would need to continue their living situation, the most common responses were housekeeping, home repair services, and transportation (listed as needs by 35% to 45% of respondents). Regarding changes they would have to make to feel safe in their home as they age, installing grab bars and/or safety rails in the bath/shower was the most popular answer (50%).
Use of telemedicine
Respondents were also asked about their acceptance of telemedicine, and 62% said they would be likely or very likely to engage in virtual visits with a doctor it in the future.
However, the likelihood varied by income level. Specifically, respondents with incomes over $100,000 were significantly more likely to say they would use telemedicine in the future than were those with incomes below $50,000 (74% vs. 60%). They were also more likely to already have used telemedicine.
Although respondents generally embraced telemedicine, they are less confident about some types of monitoring, according to Mr. Cone.
Emergency response (64%) was the leading type of remote monitoring respondents ages 50 and older would allow. Only a minority of respondents would allow the other types of monitoring asked about in the survey.
Close to one-quarter of respondents would not allow any type of monitoring.
Fewer than one-third would allow tracking of medication compliance, refrigerator use, sleep habits, or bathroom use.
People see monitoring of some movements as “Orwellian,” Mr. Cone says.
Knowledge of hospice
The survey findings support the need for more widespread use of hospice so people can stay in their homes as they age, Mr. Cone says.
When illness gets severe, “There’s no reason you have to get rushed to the emergency room or wind up in a hospital,” Mr. Cone says.
He notes that hospice and palliative care can come to patients wherever they reside – in their home, an assisted living center, a nursing home, or even a hospital room.
“That doesn’t mean the physician isn’t involved,” he says. “But working as a team, we can keep them in their homes and their lifestyle intact.”
Patients whose doctors attest that they are likely to live a maximum 6 months are eligible for hospice. But most families wait too long to long to start hospice or palliative care for a patient, Mr. Cone says, and may not be aware of what these services typically cover, including meal preparation and pet care.
In the survey, nearly one-third of respondents said they did not know that palliative care is something that “can be given at any stage of a serious illness” or “provides non-medical services (e.g., patient/family communication, help with insurance issues, scheduling appointments, arranging transportation).”
He notes palliative care and hospice are covered by Medicare and Medicaid and also by most private insurance plans or by individual companies providing the service.
However, health care providers may have to overcome a general reluctance to discuss hospice when sharing options for those severely ill.
The survey showed that while 51% of those 50 and older are at least “slightly interested” in learning more about hospice, a nearly equal number say they are “not at all interested” (49%).
Most using hospice are White
More than 90% of those surveyed reported that aspects of hospice care, including “comfort and relief from pain at the end of patients’ lives,” providing a dedicated care team, and an alternative to other care settings, are “very important” or “important.”
However, national hospice use rates are extremely low for minorities and the LGBTQ community, according to Mr. Cone. Among Medicare hospice recipients, 82% were white, 8.2% Black, 6.7% Hispanic, and 1.8% Asian or Pacific Islander, according to the National Hospice and Palliative Care Organization.
Those numbers signal a need for outreach to those communities with information on what services are available and how to access them, he says.
Health costs top concern
The survey also asked about level of concern regarding matters including family, health, financials, and end-of-life directives and found adults aged 50 and older expressed the greatest amount of concern for health care costs that are not covered by insurance.
More than half (56%) said they were concerned or very concerned about those costs, which was higher than the percentage concerned about losing a spouse (49%).
Respondents were less concerned (“slightly concerned” or “not at all concerned”) about their children living far away, planning end-of life-directives, and falling or having reduced mobility.
A version of this article first appeared on WebMD.com.
a nonprofit hospice/advanced illness care organization based in Virginia.
Among the respondents, 41% said their health was very good or excellent.
However, the ratings differed largely by race, employment status, and income.
Employment status was also associated with a significant difference in the way people viewed their health at the top tier and bottom tier.
The middle tier (“good” health) was reported similarly (from 33% to 37%) whether a person was employed, retired, or not employed. However, employed respondents were much more likely to report they had “excellent” or “very good” health (51% vs. 44% for retirees and 21% for the not employed).
Conversely, those who were not employed were far more likely to report “fair” or “poor” health (45%) than those who were employed (13%) or retired (20%).
Similarly, respondents with incomes of less than $50,000 were three times more likely to report their health as “fair” or “poor” than were those with incomes of more than $100,000 (36% vs. 12%).
WebMD/CCH surveyed 3,464 U.S. residents ages 50 and older between Aug. 13 and Nov. 9, 2020. WebMD.com readers were randomly invited to take a 10-minute online survey.
Aging at home a priority
The survey also highlighted a strong preference for aging in place, says Steve Cone, chief of communications and philanthropy at CCH.
“More now than ever before, thanks to the COVID experience, baby boomers and their children really believe that’s the holy grail,” he says.
Mr. Cone notes that the quick spread of COVID-19 through some nursing homes early in the pandemic likely has strengthened people’s resolve to live out their lives in their own homes.
The survey indicated that 85% of people aged 50+ who are living in their own home, a family member’s home, or a loved one’s home responded that it is “very important” or “important” to stay in their home as they age.
When asked what services they would need to continue their living situation, the most common responses were housekeeping, home repair services, and transportation (listed as needs by 35% to 45% of respondents). Regarding changes they would have to make to feel safe in their home as they age, installing grab bars and/or safety rails in the bath/shower was the most popular answer (50%).
Use of telemedicine
Respondents were also asked about their acceptance of telemedicine, and 62% said they would be likely or very likely to engage in virtual visits with a doctor it in the future.
However, the likelihood varied by income level. Specifically, respondents with incomes over $100,000 were significantly more likely to say they would use telemedicine in the future than were those with incomes below $50,000 (74% vs. 60%). They were also more likely to already have used telemedicine.
Although respondents generally embraced telemedicine, they are less confident about some types of monitoring, according to Mr. Cone.
Emergency response (64%) was the leading type of remote monitoring respondents ages 50 and older would allow. Only a minority of respondents would allow the other types of monitoring asked about in the survey.
Close to one-quarter of respondents would not allow any type of monitoring.
Fewer than one-third would allow tracking of medication compliance, refrigerator use, sleep habits, or bathroom use.
People see monitoring of some movements as “Orwellian,” Mr. Cone says.
Knowledge of hospice
The survey findings support the need for more widespread use of hospice so people can stay in their homes as they age, Mr. Cone says.
When illness gets severe, “There’s no reason you have to get rushed to the emergency room or wind up in a hospital,” Mr. Cone says.
He notes that hospice and palliative care can come to patients wherever they reside – in their home, an assisted living center, a nursing home, or even a hospital room.
“That doesn’t mean the physician isn’t involved,” he says. “But working as a team, we can keep them in their homes and their lifestyle intact.”
Patients whose doctors attest that they are likely to live a maximum 6 months are eligible for hospice. But most families wait too long to long to start hospice or palliative care for a patient, Mr. Cone says, and may not be aware of what these services typically cover, including meal preparation and pet care.
In the survey, nearly one-third of respondents said they did not know that palliative care is something that “can be given at any stage of a serious illness” or “provides non-medical services (e.g., patient/family communication, help with insurance issues, scheduling appointments, arranging transportation).”
He notes palliative care and hospice are covered by Medicare and Medicaid and also by most private insurance plans or by individual companies providing the service.
However, health care providers may have to overcome a general reluctance to discuss hospice when sharing options for those severely ill.
The survey showed that while 51% of those 50 and older are at least “slightly interested” in learning more about hospice, a nearly equal number say they are “not at all interested” (49%).
Most using hospice are White
More than 90% of those surveyed reported that aspects of hospice care, including “comfort and relief from pain at the end of patients’ lives,” providing a dedicated care team, and an alternative to other care settings, are “very important” or “important.”
However, national hospice use rates are extremely low for minorities and the LGBTQ community, according to Mr. Cone. Among Medicare hospice recipients, 82% were white, 8.2% Black, 6.7% Hispanic, and 1.8% Asian or Pacific Islander, according to the National Hospice and Palliative Care Organization.
Those numbers signal a need for outreach to those communities with information on what services are available and how to access them, he says.
Health costs top concern
The survey also asked about level of concern regarding matters including family, health, financials, and end-of-life directives and found adults aged 50 and older expressed the greatest amount of concern for health care costs that are not covered by insurance.
More than half (56%) said they were concerned or very concerned about those costs, which was higher than the percentage concerned about losing a spouse (49%).
Respondents were less concerned (“slightly concerned” or “not at all concerned”) about their children living far away, planning end-of life-directives, and falling or having reduced mobility.
A version of this article first appeared on WebMD.com.
St. Jude to pay $27 million to end DOJ suit over faulty ICDs
St. Jude Medical, now part of Abbott Laboratories, will pay the American government $27 million to settle allegations that it knowingly sold defective implantable cardiac defibrillators to health care facilities, which were implanted into patients, causing injuries and two deaths, the U.S. Department of Justice (DOJ) has announced.
“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration, and the U.S. government will not pay for devices that are unsafe and risk injury or death,” Jonathan F. Lenzner, Acting U.S. Attorney for the District of Maryland, said in a July 8 statement.
“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall,” Mr. Lenzner added.
Those claims were submitted to the Medicare, TRICARE, and Federal Employees Health Benefits programs, according to the settlement agreement.
“The U.S. Attorney’s Office is committed to protecting Medicare and other federal health care programs from fraud, and in doing so, strengthen[ing] patient safety,” Mr. Lenzner said.
Premature battery depletion
The government alleges that St. Jude failed to disclose “serious adverse health events” related to premature battery depletion of certain models of its Fortify, Fortify Assura, Quadra, and Unify implantable defibrillators.
The government further alleges that, by 2013, St. Jude knew that lithium clusters could form on the batteries, causing them to short and run out of power. But it took until late 2014 for St. Jude to ask the FDA to approve a change to prevent lithium clusters from draining the battery.
And at this point, St. Jude told the FDA that “no serious injury, permanent harm, or deaths have been reported associated with this” issue, the government alleges.
However, according to the government’s allegations, St. Jude was aware at that time of two reported serious injuries and one death associated with the faulty batteries and continued to distribute devices that had been manufactured without the new design.
Not until August 2016 did St. Jude inform the FDA that the number of premature battery depletion events had increased to 729, including two deaths and 29 events associated with loss of pacing, the government alleges.
In October 2016, St. Jude issued a medical advisory regarding the battery problem, which the FDA classified as a Class I recall, the most serious type.
After the recall, St. Jude no longer sold the older devices, but thousands of them had been implanted into patients between November 2014 and October 2016.
In September 2017, as reported by this news organization, a nationwide class-action lawsuit was filed against St. Jude Medical and parent company Abbott Laboratories alleging that, despite knowing about a battery-depletion defect in some of its cardiac defibrillators as early as 2011, St. Jude failed to adequately report the risk and waited nearly 5 years before issuing a recall.
“To ensure the health and safety of patients, manufacturers of implantable cardiac devices must be transparent when communicating with the government about safety issues and incidents,” Acting Assistant Attorney General Brian Boynton, from the DOJ’s Civil Division, said in the DOJ statement announcing the settlement.
“We will hold accountable those companies whose conduct violates the law and puts patients’ health at risk,” Mr. Boynton said.
The civil settlement includes the resolution of claims brought under the qui tam, or whistleblower, provisions of the False Claims Act by Debbie Burke, a patient who received one of the devices that was subject to recall.
The claims resolved by the settlement are allegations only; there has been no determination of liability, the DOJ noted. St. Jude denies the allegations raised in the lawsuit.
A version of this article first appeared on Medscape.com.
St. Jude Medical, now part of Abbott Laboratories, will pay the American government $27 million to settle allegations that it knowingly sold defective implantable cardiac defibrillators to health care facilities, which were implanted into patients, causing injuries and two deaths, the U.S. Department of Justice (DOJ) has announced.
“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration, and the U.S. government will not pay for devices that are unsafe and risk injury or death,” Jonathan F. Lenzner, Acting U.S. Attorney for the District of Maryland, said in a July 8 statement.
“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall,” Mr. Lenzner added.
Those claims were submitted to the Medicare, TRICARE, and Federal Employees Health Benefits programs, according to the settlement agreement.
“The U.S. Attorney’s Office is committed to protecting Medicare and other federal health care programs from fraud, and in doing so, strengthen[ing] patient safety,” Mr. Lenzner said.
Premature battery depletion
The government alleges that St. Jude failed to disclose “serious adverse health events” related to premature battery depletion of certain models of its Fortify, Fortify Assura, Quadra, and Unify implantable defibrillators.
The government further alleges that, by 2013, St. Jude knew that lithium clusters could form on the batteries, causing them to short and run out of power. But it took until late 2014 for St. Jude to ask the FDA to approve a change to prevent lithium clusters from draining the battery.
And at this point, St. Jude told the FDA that “no serious injury, permanent harm, or deaths have been reported associated with this” issue, the government alleges.
However, according to the government’s allegations, St. Jude was aware at that time of two reported serious injuries and one death associated with the faulty batteries and continued to distribute devices that had been manufactured without the new design.
Not until August 2016 did St. Jude inform the FDA that the number of premature battery depletion events had increased to 729, including two deaths and 29 events associated with loss of pacing, the government alleges.
In October 2016, St. Jude issued a medical advisory regarding the battery problem, which the FDA classified as a Class I recall, the most serious type.
After the recall, St. Jude no longer sold the older devices, but thousands of them had been implanted into patients between November 2014 and October 2016.
In September 2017, as reported by this news organization, a nationwide class-action lawsuit was filed against St. Jude Medical and parent company Abbott Laboratories alleging that, despite knowing about a battery-depletion defect in some of its cardiac defibrillators as early as 2011, St. Jude failed to adequately report the risk and waited nearly 5 years before issuing a recall.
“To ensure the health and safety of patients, manufacturers of implantable cardiac devices must be transparent when communicating with the government about safety issues and incidents,” Acting Assistant Attorney General Brian Boynton, from the DOJ’s Civil Division, said in the DOJ statement announcing the settlement.
“We will hold accountable those companies whose conduct violates the law and puts patients’ health at risk,” Mr. Boynton said.
The civil settlement includes the resolution of claims brought under the qui tam, or whistleblower, provisions of the False Claims Act by Debbie Burke, a patient who received one of the devices that was subject to recall.
The claims resolved by the settlement are allegations only; there has been no determination of liability, the DOJ noted. St. Jude denies the allegations raised in the lawsuit.
A version of this article first appeared on Medscape.com.
St. Jude Medical, now part of Abbott Laboratories, will pay the American government $27 million to settle allegations that it knowingly sold defective implantable cardiac defibrillators to health care facilities, which were implanted into patients, causing injuries and two deaths, the U.S. Department of Justice (DOJ) has announced.
“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration, and the U.S. government will not pay for devices that are unsafe and risk injury or death,” Jonathan F. Lenzner, Acting U.S. Attorney for the District of Maryland, said in a July 8 statement.
“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall,” Mr. Lenzner added.
Those claims were submitted to the Medicare, TRICARE, and Federal Employees Health Benefits programs, according to the settlement agreement.
“The U.S. Attorney’s Office is committed to protecting Medicare and other federal health care programs from fraud, and in doing so, strengthen[ing] patient safety,” Mr. Lenzner said.
Premature battery depletion
The government alleges that St. Jude failed to disclose “serious adverse health events” related to premature battery depletion of certain models of its Fortify, Fortify Assura, Quadra, and Unify implantable defibrillators.
The government further alleges that, by 2013, St. Jude knew that lithium clusters could form on the batteries, causing them to short and run out of power. But it took until late 2014 for St. Jude to ask the FDA to approve a change to prevent lithium clusters from draining the battery.
And at this point, St. Jude told the FDA that “no serious injury, permanent harm, or deaths have been reported associated with this” issue, the government alleges.
However, according to the government’s allegations, St. Jude was aware at that time of two reported serious injuries and one death associated with the faulty batteries and continued to distribute devices that had been manufactured without the new design.
Not until August 2016 did St. Jude inform the FDA that the number of premature battery depletion events had increased to 729, including two deaths and 29 events associated with loss of pacing, the government alleges.
In October 2016, St. Jude issued a medical advisory regarding the battery problem, which the FDA classified as a Class I recall, the most serious type.
After the recall, St. Jude no longer sold the older devices, but thousands of them had been implanted into patients between November 2014 and October 2016.
In September 2017, as reported by this news organization, a nationwide class-action lawsuit was filed against St. Jude Medical and parent company Abbott Laboratories alleging that, despite knowing about a battery-depletion defect in some of its cardiac defibrillators as early as 2011, St. Jude failed to adequately report the risk and waited nearly 5 years before issuing a recall.
“To ensure the health and safety of patients, manufacturers of implantable cardiac devices must be transparent when communicating with the government about safety issues and incidents,” Acting Assistant Attorney General Brian Boynton, from the DOJ’s Civil Division, said in the DOJ statement announcing the settlement.
“We will hold accountable those companies whose conduct violates the law and puts patients’ health at risk,” Mr. Boynton said.
The civil settlement includes the resolution of claims brought under the qui tam, or whistleblower, provisions of the False Claims Act by Debbie Burke, a patient who received one of the devices that was subject to recall.
The claims resolved by the settlement are allegations only; there has been no determination of liability, the DOJ noted. St. Jude denies the allegations raised in the lawsuit.
A version of this article first appeared on Medscape.com.
Can overweight docs really give credible weight loss advice?
Kevin Gendreau, MD, a weight loss doctor at Southcoast Health in Fall River, Maine, lets patients know that he was once obese. He says this knowledge inspires and motivates them to lose weight.
After dropping 125 pounds over 18 months, “I can relate to their binges, hardships, and plateaus on a very personal level,” he says.
Peminda Cabandugama, MD, an endocrinologist and obesity medicine specialist at Truman Medical Center at the University of Missouri-Kansas City, has weighed between 180 and 240 pounds in the past decade. He now weighs 225 pounds and has a healthy lifestyle.
“I have had patients come to me saying, ‘I used to see a different weight loss doctor who was not heavy. But how can he understand what I’m going through?’” he says.
Dr. Cabandugama shares his weight loss struggles with patients “to dispel this myth that weight management is as simple as just eating too much and not exercising. It involves a smorgasbord of emotions and hormones, some within and outside of our control. I hope that sharing this allows me to connect more with my patients so that they know that even their health care professional goes through the same challenges that they do.”
“Patients are more likely to make behavior changes when doctors are supportive and have had similar experiences and talk about their stories,” says Wendy Bennett, MD, an obesity researcher and associate professor of medicine at Johns Hopkins University in Baltimore.
Do patients respect overweight doctors?
While Dr. Gendreau and Dr. Cabandugama have lost weight,
Doctors sometimes have biased attitudes toward overweight patients, but few studies have looked at whether patients have biases towards overweight doctors. The results vary and may depend on whether or not the patients are overweight.
A random online survey of 358 participants suggested that regardless of their own weight, people had biases about doctor weight gain. They viewed the overweight or obese doctors as less trustworthy and credible, which could lead the participants to reject their medical advice and change doctors.
“Patients expect doctors who are providing health care to be doing everything they can to take care of their own health and well-being,” says Pamela Peeke, MD, an assistant clinical professor of medicine at the University of Maryland in Baltimore.
“I am a physician who believes you have to walk the talk — that the best teachers are those who live it,” she says.
Still, “I don’t think based on this one experimental study that we can conclude that overweight physicians are harming patients’ efforts to change their behavior,” notes Dr. Bennett, who was not involved in the study.
“I think that patients do often want to connect with their physicians on more personal levels, but without the story behind where the advice is coming from, patients may struggle to trust a provider who seems to be contradicting the messages,” she says.
A study that Dr. Bennett helped lead suggests that patients are not biased against overweight doctors if they themselves need to lose weight. A national survey of 600 overweight patients showed that 87% trusted diet advice from overweight primary care doctors, compared to 77% who trusted diet advice from doctors who had a healthy weight.
“This shows that patients were more trusting of physicians who are more like them, which can lead to better relationships. We know from the studies on race that patients are often more trusting of physicians from the same race as them,” says Dr. Bennett.
Dr. Gendreau says that when he was severely obese, some patients questioned whether to trust his weight loss advice.
“It was very awkward when they turned to me and said, ‘What about you?’ I would respond that it’s my job to inform them about the risks to their health,” he says.
Nearly half (48%) of doctors said they are trying to lose weight, according to the 2021 Medscape Physician Lifestyle and Happiness Report. As a result, many doctors may end up in the position of seemingly advising to “do what I say, not what I do.”
Nearly three in five Americans are trying to lose weight, according to Gelesis poll results released in December 2020.
Should doctors pay more attention to wellness?
Doctors have an ethical duty to maintain their own health and wellness so they can provide safe and effective medical care. If they don’t have a healthy lifestyle, they need to make adjustments, the American Medical Association Code of Ethics advises.
Dr. Peeke agrees with the AMA. “We signed on to do this — we have to go out of our way to carve out time, even if it’s just 15 minutes where we hide away and eat that healthy lunch that we brought with us,” she says.
Dr. Gendreau suggests busy doctors do what he did.
“I started by bringing healthy snacks — small Ziploc bags filled with mixed nuts and berries — and expanded from there. This way, if I got hungry or stressed between patients, I would have easy access to something nutritious,” he says.
He and Dr. Peeke also suggest making protein shakes or berry smoothies that are low in sugar.
“These can keep you full for hours as you sip them between patients,” says Dr. Gendreau.
Convincing busy doctors to make lifestyle changes may be challenging. Sixty-five percent of those who responded to the Physician Lifestyle and Happiness Report say that they sometimes, rarely, or never focus on their health and wellness. Only 45% said they are eating healthy, and 65% said they exercise.
“Self-care isn’t a priority for most physicians because we are taught to take care of others and to put them first,” says Dr. Gendreau. “Like many doctors, I had so many other priorities — family, friends, career. Also, my last year of medical school was so difficult that my priority was finishing. I pushed my health to the side and told myself that I could fix this later.”
Only about one in five medical schools require students to take a nutrition course, according to David Eisenberg, MD, an adjunct associate professor of nutrition at the Harvard T.H. Chan School of Public Health, Boston.
“I didn’t get one ounce of nutrition training, which is the reason I became a Pew Foundation scholar in nutrition and metabolism. I had to go outside of my traditional training,” says Dr. Peeke.
“Physicians are not adequately trained to do the behavioral counseling and motivational interviewing that is needed,” says Dr. Bennett. “We do a good job of diagnosing obesity based on body mass index and understanding the relationship with future health conditions. But most doctors struggle with both a lack of time and the skill set to make significant behavior changes.”
“Medical school curriculum is focused so heavily on the pathology and pathophysiology of obesity, rather than how to prevent it with the appropriate diet and exercise regimen,” Dr. Gendreau says. “My physician patients often tell me that their own education in the field of nutrition is lacking, which can affect their weight loss journey and what they teach their patients.”
Dr. Gendreau, crediting his own weight loss journey as well as his obesity medicine fellowship, says his confidence in discussing weight loss with patients has soared.
Reframing obesity as a chronic disease
Rather than criticizing overweight people, including doctors, for their personal health choices, a better approach is to think of weight or obesity as a chronic illness, says Dr. Bennett.
“If we understand that obesity is a chronic health condition that people are struggling with, we can empathize with them,” she says, recommending that more providers share their weight loss journeys with patients they give lifestyle advice to, which may help address and repair potential biases.
A version of this article first appeared on WebMD.com.
Kevin Gendreau, MD, a weight loss doctor at Southcoast Health in Fall River, Maine, lets patients know that he was once obese. He says this knowledge inspires and motivates them to lose weight.
After dropping 125 pounds over 18 months, “I can relate to their binges, hardships, and plateaus on a very personal level,” he says.
Peminda Cabandugama, MD, an endocrinologist and obesity medicine specialist at Truman Medical Center at the University of Missouri-Kansas City, has weighed between 180 and 240 pounds in the past decade. He now weighs 225 pounds and has a healthy lifestyle.
“I have had patients come to me saying, ‘I used to see a different weight loss doctor who was not heavy. But how can he understand what I’m going through?’” he says.
Dr. Cabandugama shares his weight loss struggles with patients “to dispel this myth that weight management is as simple as just eating too much and not exercising. It involves a smorgasbord of emotions and hormones, some within and outside of our control. I hope that sharing this allows me to connect more with my patients so that they know that even their health care professional goes through the same challenges that they do.”
“Patients are more likely to make behavior changes when doctors are supportive and have had similar experiences and talk about their stories,” says Wendy Bennett, MD, an obesity researcher and associate professor of medicine at Johns Hopkins University in Baltimore.
Do patients respect overweight doctors?
While Dr. Gendreau and Dr. Cabandugama have lost weight,
Doctors sometimes have biased attitudes toward overweight patients, but few studies have looked at whether patients have biases towards overweight doctors. The results vary and may depend on whether or not the patients are overweight.
A random online survey of 358 participants suggested that regardless of their own weight, people had biases about doctor weight gain. They viewed the overweight or obese doctors as less trustworthy and credible, which could lead the participants to reject their medical advice and change doctors.
“Patients expect doctors who are providing health care to be doing everything they can to take care of their own health and well-being,” says Pamela Peeke, MD, an assistant clinical professor of medicine at the University of Maryland in Baltimore.
“I am a physician who believes you have to walk the talk — that the best teachers are those who live it,” she says.
Still, “I don’t think based on this one experimental study that we can conclude that overweight physicians are harming patients’ efforts to change their behavior,” notes Dr. Bennett, who was not involved in the study.
“I think that patients do often want to connect with their physicians on more personal levels, but without the story behind where the advice is coming from, patients may struggle to trust a provider who seems to be contradicting the messages,” she says.
A study that Dr. Bennett helped lead suggests that patients are not biased against overweight doctors if they themselves need to lose weight. A national survey of 600 overweight patients showed that 87% trusted diet advice from overweight primary care doctors, compared to 77% who trusted diet advice from doctors who had a healthy weight.
“This shows that patients were more trusting of physicians who are more like them, which can lead to better relationships. We know from the studies on race that patients are often more trusting of physicians from the same race as them,” says Dr. Bennett.
Dr. Gendreau says that when he was severely obese, some patients questioned whether to trust his weight loss advice.
“It was very awkward when they turned to me and said, ‘What about you?’ I would respond that it’s my job to inform them about the risks to their health,” he says.
Nearly half (48%) of doctors said they are trying to lose weight, according to the 2021 Medscape Physician Lifestyle and Happiness Report. As a result, many doctors may end up in the position of seemingly advising to “do what I say, not what I do.”
Nearly three in five Americans are trying to lose weight, according to Gelesis poll results released in December 2020.
Should doctors pay more attention to wellness?
Doctors have an ethical duty to maintain their own health and wellness so they can provide safe and effective medical care. If they don’t have a healthy lifestyle, they need to make adjustments, the American Medical Association Code of Ethics advises.
Dr. Peeke agrees with the AMA. “We signed on to do this — we have to go out of our way to carve out time, even if it’s just 15 minutes where we hide away and eat that healthy lunch that we brought with us,” she says.
Dr. Gendreau suggests busy doctors do what he did.
“I started by bringing healthy snacks — small Ziploc bags filled with mixed nuts and berries — and expanded from there. This way, if I got hungry or stressed between patients, I would have easy access to something nutritious,” he says.
He and Dr. Peeke also suggest making protein shakes or berry smoothies that are low in sugar.
“These can keep you full for hours as you sip them between patients,” says Dr. Gendreau.
Convincing busy doctors to make lifestyle changes may be challenging. Sixty-five percent of those who responded to the Physician Lifestyle and Happiness Report say that they sometimes, rarely, or never focus on their health and wellness. Only 45% said they are eating healthy, and 65% said they exercise.
“Self-care isn’t a priority for most physicians because we are taught to take care of others and to put them first,” says Dr. Gendreau. “Like many doctors, I had so many other priorities — family, friends, career. Also, my last year of medical school was so difficult that my priority was finishing. I pushed my health to the side and told myself that I could fix this later.”
Only about one in five medical schools require students to take a nutrition course, according to David Eisenberg, MD, an adjunct associate professor of nutrition at the Harvard T.H. Chan School of Public Health, Boston.
“I didn’t get one ounce of nutrition training, which is the reason I became a Pew Foundation scholar in nutrition and metabolism. I had to go outside of my traditional training,” says Dr. Peeke.
“Physicians are not adequately trained to do the behavioral counseling and motivational interviewing that is needed,” says Dr. Bennett. “We do a good job of diagnosing obesity based on body mass index and understanding the relationship with future health conditions. But most doctors struggle with both a lack of time and the skill set to make significant behavior changes.”
“Medical school curriculum is focused so heavily on the pathology and pathophysiology of obesity, rather than how to prevent it with the appropriate diet and exercise regimen,” Dr. Gendreau says. “My physician patients often tell me that their own education in the field of nutrition is lacking, which can affect their weight loss journey and what they teach their patients.”
Dr. Gendreau, crediting his own weight loss journey as well as his obesity medicine fellowship, says his confidence in discussing weight loss with patients has soared.
Reframing obesity as a chronic disease
Rather than criticizing overweight people, including doctors, for their personal health choices, a better approach is to think of weight or obesity as a chronic illness, says Dr. Bennett.
“If we understand that obesity is a chronic health condition that people are struggling with, we can empathize with them,” she says, recommending that more providers share their weight loss journeys with patients they give lifestyle advice to, which may help address and repair potential biases.
A version of this article first appeared on WebMD.com.
Kevin Gendreau, MD, a weight loss doctor at Southcoast Health in Fall River, Maine, lets patients know that he was once obese. He says this knowledge inspires and motivates them to lose weight.
After dropping 125 pounds over 18 months, “I can relate to their binges, hardships, and plateaus on a very personal level,” he says.
Peminda Cabandugama, MD, an endocrinologist and obesity medicine specialist at Truman Medical Center at the University of Missouri-Kansas City, has weighed between 180 and 240 pounds in the past decade. He now weighs 225 pounds and has a healthy lifestyle.
“I have had patients come to me saying, ‘I used to see a different weight loss doctor who was not heavy. But how can he understand what I’m going through?’” he says.
Dr. Cabandugama shares his weight loss struggles with patients “to dispel this myth that weight management is as simple as just eating too much and not exercising. It involves a smorgasbord of emotions and hormones, some within and outside of our control. I hope that sharing this allows me to connect more with my patients so that they know that even their health care professional goes through the same challenges that they do.”
“Patients are more likely to make behavior changes when doctors are supportive and have had similar experiences and talk about their stories,” says Wendy Bennett, MD, an obesity researcher and associate professor of medicine at Johns Hopkins University in Baltimore.
Do patients respect overweight doctors?
While Dr. Gendreau and Dr. Cabandugama have lost weight,
Doctors sometimes have biased attitudes toward overweight patients, but few studies have looked at whether patients have biases towards overweight doctors. The results vary and may depend on whether or not the patients are overweight.
A random online survey of 358 participants suggested that regardless of their own weight, people had biases about doctor weight gain. They viewed the overweight or obese doctors as less trustworthy and credible, which could lead the participants to reject their medical advice and change doctors.
“Patients expect doctors who are providing health care to be doing everything they can to take care of their own health and well-being,” says Pamela Peeke, MD, an assistant clinical professor of medicine at the University of Maryland in Baltimore.
“I am a physician who believes you have to walk the talk — that the best teachers are those who live it,” she says.
Still, “I don’t think based on this one experimental study that we can conclude that overweight physicians are harming patients’ efforts to change their behavior,” notes Dr. Bennett, who was not involved in the study.
“I think that patients do often want to connect with their physicians on more personal levels, but without the story behind where the advice is coming from, patients may struggle to trust a provider who seems to be contradicting the messages,” she says.
A study that Dr. Bennett helped lead suggests that patients are not biased against overweight doctors if they themselves need to lose weight. A national survey of 600 overweight patients showed that 87% trusted diet advice from overweight primary care doctors, compared to 77% who trusted diet advice from doctors who had a healthy weight.
“This shows that patients were more trusting of physicians who are more like them, which can lead to better relationships. We know from the studies on race that patients are often more trusting of physicians from the same race as them,” says Dr. Bennett.
Dr. Gendreau says that when he was severely obese, some patients questioned whether to trust his weight loss advice.
“It was very awkward when they turned to me and said, ‘What about you?’ I would respond that it’s my job to inform them about the risks to their health,” he says.
Nearly half (48%) of doctors said they are trying to lose weight, according to the 2021 Medscape Physician Lifestyle and Happiness Report. As a result, many doctors may end up in the position of seemingly advising to “do what I say, not what I do.”
Nearly three in five Americans are trying to lose weight, according to Gelesis poll results released in December 2020.
Should doctors pay more attention to wellness?
Doctors have an ethical duty to maintain their own health and wellness so they can provide safe and effective medical care. If they don’t have a healthy lifestyle, they need to make adjustments, the American Medical Association Code of Ethics advises.
Dr. Peeke agrees with the AMA. “We signed on to do this — we have to go out of our way to carve out time, even if it’s just 15 minutes where we hide away and eat that healthy lunch that we brought with us,” she says.
Dr. Gendreau suggests busy doctors do what he did.
“I started by bringing healthy snacks — small Ziploc bags filled with mixed nuts and berries — and expanded from there. This way, if I got hungry or stressed between patients, I would have easy access to something nutritious,” he says.
He and Dr. Peeke also suggest making protein shakes or berry smoothies that are low in sugar.
“These can keep you full for hours as you sip them between patients,” says Dr. Gendreau.
Convincing busy doctors to make lifestyle changes may be challenging. Sixty-five percent of those who responded to the Physician Lifestyle and Happiness Report say that they sometimes, rarely, or never focus on their health and wellness. Only 45% said they are eating healthy, and 65% said they exercise.
“Self-care isn’t a priority for most physicians because we are taught to take care of others and to put them first,” says Dr. Gendreau. “Like many doctors, I had so many other priorities — family, friends, career. Also, my last year of medical school was so difficult that my priority was finishing. I pushed my health to the side and told myself that I could fix this later.”
Only about one in five medical schools require students to take a nutrition course, according to David Eisenberg, MD, an adjunct associate professor of nutrition at the Harvard T.H. Chan School of Public Health, Boston.
“I didn’t get one ounce of nutrition training, which is the reason I became a Pew Foundation scholar in nutrition and metabolism. I had to go outside of my traditional training,” says Dr. Peeke.
“Physicians are not adequately trained to do the behavioral counseling and motivational interviewing that is needed,” says Dr. Bennett. “We do a good job of diagnosing obesity based on body mass index and understanding the relationship with future health conditions. But most doctors struggle with both a lack of time and the skill set to make significant behavior changes.”
“Medical school curriculum is focused so heavily on the pathology and pathophysiology of obesity, rather than how to prevent it with the appropriate diet and exercise regimen,” Dr. Gendreau says. “My physician patients often tell me that their own education in the field of nutrition is lacking, which can affect their weight loss journey and what they teach their patients.”
Dr. Gendreau, crediting his own weight loss journey as well as his obesity medicine fellowship, says his confidence in discussing weight loss with patients has soared.
Reframing obesity as a chronic disease
Rather than criticizing overweight people, including doctors, for their personal health choices, a better approach is to think of weight or obesity as a chronic illness, says Dr. Bennett.
“If we understand that obesity is a chronic health condition that people are struggling with, we can empathize with them,” she says, recommending that more providers share their weight loss journeys with patients they give lifestyle advice to, which may help address and repair potential biases.
A version of this article first appeared on WebMD.com.
South Asian ancestry associated with twice the risk of heart disease
according to the results of a new study.
These findings confirm previous reports and practice guidelines that identify South Asian ancestry as a risk enhancer for atherosclerotic cardiovascular disease (ASCVD), suggesting that earlier heart disease screening and prevention is warranted in this patient population, lead author Aniruddh P. Patel, MD, research fellow at the Center for Genomic Medicine, Massachusetts General Hospital, Boston, and colleagues said.
“Previous studies in multiple countries have estimated a 1.7- to 4-fold higher risk of ASCVD among South Asian individuals, compared with other ancestries, but have important potential limitations,” Dr. Patel and colleagues wrote in the paper on their prospective cohort study, published in Circulation.
The INTERHEART case-control study, for example, which assessed risk factors for acute myocardial infarction among more than 15,000 cases from 52 countries, is now 2 decades old, and “may not reflect recent advances in cardiovascular disease prevention,” the investigators wrote.
Most studies in the area have been small and retrospective, they added, and have not adequately assessed emerging risk factors, such as prediabetes, which appear to play a relatively greater role in the development of heart disease among South Asians.
Methods and results
To address this knowledge gap, Dr. Patel and colleagues analyzed data from the UK Biobank prospective cohort study, including 449,349 middle-aged participants of European ancestry and 8,124 similarly aged participants of South Asian descent who did not have heart disease upon enrollment. Respective rates of incident ASCVD (i.e., MI, ischemic stroke, or coronary revascularization) were analyzed in the context of a variety of lifestyle, anthropometric, and clinical factors.
After a median follow-up of 11.1 years, individuals of South Asian descent had an incident ASCVD rate of 6.8%, compared with 4.4% for individuals of European descent, representing twice the relative risk (adjusted hazard ratio, 2.03; 95% CI, 1.86-2.22; P < .001). Even after accounting for all covariates, risk of ASCVD remained 45% higher for South Asian individuals (aHR, 1.45; 95% CI, 1.28-1.65; P < .001). This elevation in risk was not captured by existing risk calculators, including the American College of Cardiology/American Heart Association Pooled Cohort Equations, or the QRISK3 equations.
The findings were “largely consistent across a range of age, sex, and clinical subgroups,” and “confirm and extend previous reports that hypertension, diabetes, and central adiposity are the leading associations in this observed disparity,” the investigators wrote.
Two diabetes subtypes are more prevalent in South Asians
Hypertension, diabetes, and central adiposity do not fully explain South Asians’ higher risk for ASCVD, wrote Namratha R. Kandula, MD, of Northwestern University Medical Center, Chicago, and Alka M. Kanaya, MD, of the University of California, San Francisco, in an accompanying editorial published in Circulation.
Some of the undetected risk may stem from unique diabetes disease factors, Dr. Kandula and Dr. Kanaya added.
“Newer data have demonstrated distinct subtypes of type 2 diabetes, with South Asians having a higher prevalence of both a severe insulin resistant with obesity subtype and a less recognized severe insulin deficient subtype,” they wrote. “Importantly, both of these more prevalent diabetes subtypes in South Asians were associated with a higher incidence of coronary artery calcium, a marker of subclinical atherosclerosis and strong predictor of future ASCVD, compared to other diabetes subtypes.”
Diabetes rate is higher for South Asians in the U.S.
Although the present study was conducted in the United Kingdom, the findings likely apply to individuals of South Asian ancestry living in the United States, according to principal author Amit V. Khera, MD, associate director of the precision medicine unit at the Center for Genomic Medicine, Massachusetts General Hospital.
“There are already more than 5 million individuals of South Asian ancestry in the U.S. and this represents one of the fastest-growing ethnic subgroups,” Dr. Khera said in an interview. “As in our study of individuals in the U.K., South Asians in the U.S. suffer from diabetes at much higher rates – 23% versus 12% – and this often occurs even in the absence of obesity.”
Dr. Khera noted that the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease identify South Asian ancestry as a risk-enhancing factor, calling this a “stopgap measure.” More work is needed, he said, in the research arena and in the clinic.
Zero South Asians included in studies used to develop risk estimator
“I think the first step is to simply acknowledge that the risk estimators we use in clinical practice have important limitations when it comes to diverse patient populations,” Dr. Khera said in an interview. “We saw this in our study, where – despite a more than doubling of risk – the predicted risk based on the equations used in primary care showed no difference. This risk estimator was developed based on legacy cohort studies, in [which] zero South Asians were included. Despite important differences across race/ethnicity, the current state-of-the-art in the U.S. is to use one equation for Black individuals and another for all other ethnicities.”
Experts suggest steps for reducing heart disease risk
While risk modeling remains suboptimal, Dr. Khera suggested that clinicians can take immediate steps to reduce the risk of heart disease among individuals with South Asian ancestry.
“Despite all of the uncertainty – we still don’t have a complete understanding of why the risk is so high – there are still several things primary care doctors can do for their patients,” Dr. Khera said.
Foremost, he recommended lifestyle and dietary counseling.
“Dietary counseling is particularly effective if put in the context of cultural norms,” Dr. Khera said. “Many South Asians consider fruit juices or white rice to be healthy, when they lead to rapid spikes in blood sugar.”
Dr. Khera also advised earlier heart disease screening, such as coronary calcium scanning “sometime between age 40-50 years,” noting that positive test results may motivate patients to start or adhere to medications, such as cholesterol-lowering therapies. If necessary, clinicians can also refer to heart centers for South Asian patients, which are becoming increasingly common.
According to Cheryl A.M. Anderson, PhD, chair of the AHA’s Council on Epidemiology and Prevention, and professor and dean of the Herbert Wertheim School of Public Health and Human Longevity Science at the University of California, San Diego, the current study suggests that heart disease management strategies for South Asian patients may be lacking.
“We have had a tradition of preventing or trying to treat heart disease in a fashion that doesn’t yet account for the increased risk that might be prevalent in those of South Asian ancestry,” Dr. Anderson said in an interview.
She suggested that improving associated risk-analysis tools could be beneficial, although the tools themselves, in the context of race or ethnicity, may present their own risks.
“We want to be mindful of potential adverse implications from having everything linked to one’s ancestry, which I think this tool doesn’t do,” Dr. Anderson said, referring to the AHA/ACC Pooled Cohort Equations. “But in sort of the bigger picture of things, we always want to expand and refine our toolkit.”
According to Rajesh Dash, MD, PhD, associate professor, cardiologist, and director of the South Asian Translational Heart Initiative (SSATHI) Prevention Clinic and CardioClick Telemedicine Clinic at Stanford (Calif.) HealthCare, the science supports more active risk mitigation strategies for South Asian patients, and the AHA and the ACC “are the two entities that need to lead the way.”
“Certainly the American Heart Association and the American College of Cardiology should be taking a more active leadership role in this,” Dr. Dash said in an interview.
In 2018, the AHA issued a scientific statement about the elevated risk of ASCVD among South Asian individuals, “but it did not rise to the level of specific recommendations, and did not necessarily go as far as to incorporate new screening parameters for that population,” Dr. Dash said. He also noted that the most recent AHA/ACC guideline identifies South Asian ancestry as a risk-enhancing feature, a statement similarly lacking in actionable value.
“That does not definitively lead someone like a primary care physician to a decision to start a statin, or to be more aggressive with a diagnostic workup, like a stress test, for instance, for a patient who they otherwise would not have done one in had they not been South Asian,” Dr. Dash said.
The steps taken by the AHA and the ACC are “a healthy step forward,” he noted, “but not nearly the degree of attention or vigilance that is required, as well as the level of action that is required to change the narrative for the population.”
At the SSATHI Prevention Clinic, Dr. Dash and colleagues aren’t waiting for the narrative to change, and are already taking a more aggressive approach.
The clinic has an average patient age of 41 years, “easily 15 years younger than the average age in most cardiology clinics,” Dr. Dash said, based on the fact that approximately two-thirds of heart attacks in South Asian individuals occur under the age of 55. “We have to look earlier.”
The SSATHI Prevention Clinic screens for both traditional and emerging risk factors, and Dr. Dash suggested that primary care doctors should do the same.
“If you have a South Asian patient as a primary care physician, you should be aggressively looking for risk factors, traditional ones to start, like elevated cholesterol, hypertension, diabetes, or – and I would argue strongly – prediabetes or insulin resistance.”
Dr. Dash also recommended looking into family history, and considering screening for inflammatory biomarkers, the latter of which are commonly elevated at an earlier age among South Asian individuals, and may have a relatively greater prognostic impact.
To encourage broader implementation of this kind of approach, Dr. Dash called for more large-scale studies. Ideally, these would be randomized clinical trials, but, realistically, real-world datasets may be the answer.
The study was supported by the National Heart, Lung, and Blood Institute; the Broad Institute at MIT and Harvard; the National Human Genome Research Institute; and others. The investigators disclosed relationships with IBM Research, Sanofi, Amgen, and others. Dr. Dash disclosed relationships with HealthPals and AstraZeneca. Dr. Anderson reported no relevant conflicts of interest.
according to the results of a new study.
These findings confirm previous reports and practice guidelines that identify South Asian ancestry as a risk enhancer for atherosclerotic cardiovascular disease (ASCVD), suggesting that earlier heart disease screening and prevention is warranted in this patient population, lead author Aniruddh P. Patel, MD, research fellow at the Center for Genomic Medicine, Massachusetts General Hospital, Boston, and colleagues said.
“Previous studies in multiple countries have estimated a 1.7- to 4-fold higher risk of ASCVD among South Asian individuals, compared with other ancestries, but have important potential limitations,” Dr. Patel and colleagues wrote in the paper on their prospective cohort study, published in Circulation.
The INTERHEART case-control study, for example, which assessed risk factors for acute myocardial infarction among more than 15,000 cases from 52 countries, is now 2 decades old, and “may not reflect recent advances in cardiovascular disease prevention,” the investigators wrote.
Most studies in the area have been small and retrospective, they added, and have not adequately assessed emerging risk factors, such as prediabetes, which appear to play a relatively greater role in the development of heart disease among South Asians.
Methods and results
To address this knowledge gap, Dr. Patel and colleagues analyzed data from the UK Biobank prospective cohort study, including 449,349 middle-aged participants of European ancestry and 8,124 similarly aged participants of South Asian descent who did not have heart disease upon enrollment. Respective rates of incident ASCVD (i.e., MI, ischemic stroke, or coronary revascularization) were analyzed in the context of a variety of lifestyle, anthropometric, and clinical factors.
After a median follow-up of 11.1 years, individuals of South Asian descent had an incident ASCVD rate of 6.8%, compared with 4.4% for individuals of European descent, representing twice the relative risk (adjusted hazard ratio, 2.03; 95% CI, 1.86-2.22; P < .001). Even after accounting for all covariates, risk of ASCVD remained 45% higher for South Asian individuals (aHR, 1.45; 95% CI, 1.28-1.65; P < .001). This elevation in risk was not captured by existing risk calculators, including the American College of Cardiology/American Heart Association Pooled Cohort Equations, or the QRISK3 equations.
The findings were “largely consistent across a range of age, sex, and clinical subgroups,” and “confirm and extend previous reports that hypertension, diabetes, and central adiposity are the leading associations in this observed disparity,” the investigators wrote.
Two diabetes subtypes are more prevalent in South Asians
Hypertension, diabetes, and central adiposity do not fully explain South Asians’ higher risk for ASCVD, wrote Namratha R. Kandula, MD, of Northwestern University Medical Center, Chicago, and Alka M. Kanaya, MD, of the University of California, San Francisco, in an accompanying editorial published in Circulation.
Some of the undetected risk may stem from unique diabetes disease factors, Dr. Kandula and Dr. Kanaya added.
“Newer data have demonstrated distinct subtypes of type 2 diabetes, with South Asians having a higher prevalence of both a severe insulin resistant with obesity subtype and a less recognized severe insulin deficient subtype,” they wrote. “Importantly, both of these more prevalent diabetes subtypes in South Asians were associated with a higher incidence of coronary artery calcium, a marker of subclinical atherosclerosis and strong predictor of future ASCVD, compared to other diabetes subtypes.”
Diabetes rate is higher for South Asians in the U.S.
Although the present study was conducted in the United Kingdom, the findings likely apply to individuals of South Asian ancestry living in the United States, according to principal author Amit V. Khera, MD, associate director of the precision medicine unit at the Center for Genomic Medicine, Massachusetts General Hospital.
“There are already more than 5 million individuals of South Asian ancestry in the U.S. and this represents one of the fastest-growing ethnic subgroups,” Dr. Khera said in an interview. “As in our study of individuals in the U.K., South Asians in the U.S. suffer from diabetes at much higher rates – 23% versus 12% – and this often occurs even in the absence of obesity.”
Dr. Khera noted that the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease identify South Asian ancestry as a risk-enhancing factor, calling this a “stopgap measure.” More work is needed, he said, in the research arena and in the clinic.
Zero South Asians included in studies used to develop risk estimator
“I think the first step is to simply acknowledge that the risk estimators we use in clinical practice have important limitations when it comes to diverse patient populations,” Dr. Khera said in an interview. “We saw this in our study, where – despite a more than doubling of risk – the predicted risk based on the equations used in primary care showed no difference. This risk estimator was developed based on legacy cohort studies, in [which] zero South Asians were included. Despite important differences across race/ethnicity, the current state-of-the-art in the U.S. is to use one equation for Black individuals and another for all other ethnicities.”
Experts suggest steps for reducing heart disease risk
While risk modeling remains suboptimal, Dr. Khera suggested that clinicians can take immediate steps to reduce the risk of heart disease among individuals with South Asian ancestry.
“Despite all of the uncertainty – we still don’t have a complete understanding of why the risk is so high – there are still several things primary care doctors can do for their patients,” Dr. Khera said.
Foremost, he recommended lifestyle and dietary counseling.
“Dietary counseling is particularly effective if put in the context of cultural norms,” Dr. Khera said. “Many South Asians consider fruit juices or white rice to be healthy, when they lead to rapid spikes in blood sugar.”
Dr. Khera also advised earlier heart disease screening, such as coronary calcium scanning “sometime between age 40-50 years,” noting that positive test results may motivate patients to start or adhere to medications, such as cholesterol-lowering therapies. If necessary, clinicians can also refer to heart centers for South Asian patients, which are becoming increasingly common.
According to Cheryl A.M. Anderson, PhD, chair of the AHA’s Council on Epidemiology and Prevention, and professor and dean of the Herbert Wertheim School of Public Health and Human Longevity Science at the University of California, San Diego, the current study suggests that heart disease management strategies for South Asian patients may be lacking.
“We have had a tradition of preventing or trying to treat heart disease in a fashion that doesn’t yet account for the increased risk that might be prevalent in those of South Asian ancestry,” Dr. Anderson said in an interview.
She suggested that improving associated risk-analysis tools could be beneficial, although the tools themselves, in the context of race or ethnicity, may present their own risks.
“We want to be mindful of potential adverse implications from having everything linked to one’s ancestry, which I think this tool doesn’t do,” Dr. Anderson said, referring to the AHA/ACC Pooled Cohort Equations. “But in sort of the bigger picture of things, we always want to expand and refine our toolkit.”
According to Rajesh Dash, MD, PhD, associate professor, cardiologist, and director of the South Asian Translational Heart Initiative (SSATHI) Prevention Clinic and CardioClick Telemedicine Clinic at Stanford (Calif.) HealthCare, the science supports more active risk mitigation strategies for South Asian patients, and the AHA and the ACC “are the two entities that need to lead the way.”
“Certainly the American Heart Association and the American College of Cardiology should be taking a more active leadership role in this,” Dr. Dash said in an interview.
In 2018, the AHA issued a scientific statement about the elevated risk of ASCVD among South Asian individuals, “but it did not rise to the level of specific recommendations, and did not necessarily go as far as to incorporate new screening parameters for that population,” Dr. Dash said. He also noted that the most recent AHA/ACC guideline identifies South Asian ancestry as a risk-enhancing feature, a statement similarly lacking in actionable value.
“That does not definitively lead someone like a primary care physician to a decision to start a statin, or to be more aggressive with a diagnostic workup, like a stress test, for instance, for a patient who they otherwise would not have done one in had they not been South Asian,” Dr. Dash said.
The steps taken by the AHA and the ACC are “a healthy step forward,” he noted, “but not nearly the degree of attention or vigilance that is required, as well as the level of action that is required to change the narrative for the population.”
At the SSATHI Prevention Clinic, Dr. Dash and colleagues aren’t waiting for the narrative to change, and are already taking a more aggressive approach.
The clinic has an average patient age of 41 years, “easily 15 years younger than the average age in most cardiology clinics,” Dr. Dash said, based on the fact that approximately two-thirds of heart attacks in South Asian individuals occur under the age of 55. “We have to look earlier.”
The SSATHI Prevention Clinic screens for both traditional and emerging risk factors, and Dr. Dash suggested that primary care doctors should do the same.
“If you have a South Asian patient as a primary care physician, you should be aggressively looking for risk factors, traditional ones to start, like elevated cholesterol, hypertension, diabetes, or – and I would argue strongly – prediabetes or insulin resistance.”
Dr. Dash also recommended looking into family history, and considering screening for inflammatory biomarkers, the latter of which are commonly elevated at an earlier age among South Asian individuals, and may have a relatively greater prognostic impact.
To encourage broader implementation of this kind of approach, Dr. Dash called for more large-scale studies. Ideally, these would be randomized clinical trials, but, realistically, real-world datasets may be the answer.
The study was supported by the National Heart, Lung, and Blood Institute; the Broad Institute at MIT and Harvard; the National Human Genome Research Institute; and others. The investigators disclosed relationships with IBM Research, Sanofi, Amgen, and others. Dr. Dash disclosed relationships with HealthPals and AstraZeneca. Dr. Anderson reported no relevant conflicts of interest.
according to the results of a new study.
These findings confirm previous reports and practice guidelines that identify South Asian ancestry as a risk enhancer for atherosclerotic cardiovascular disease (ASCVD), suggesting that earlier heart disease screening and prevention is warranted in this patient population, lead author Aniruddh P. Patel, MD, research fellow at the Center for Genomic Medicine, Massachusetts General Hospital, Boston, and colleagues said.
“Previous studies in multiple countries have estimated a 1.7- to 4-fold higher risk of ASCVD among South Asian individuals, compared with other ancestries, but have important potential limitations,” Dr. Patel and colleagues wrote in the paper on their prospective cohort study, published in Circulation.
The INTERHEART case-control study, for example, which assessed risk factors for acute myocardial infarction among more than 15,000 cases from 52 countries, is now 2 decades old, and “may not reflect recent advances in cardiovascular disease prevention,” the investigators wrote.
Most studies in the area have been small and retrospective, they added, and have not adequately assessed emerging risk factors, such as prediabetes, which appear to play a relatively greater role in the development of heart disease among South Asians.
Methods and results
To address this knowledge gap, Dr. Patel and colleagues analyzed data from the UK Biobank prospective cohort study, including 449,349 middle-aged participants of European ancestry and 8,124 similarly aged participants of South Asian descent who did not have heart disease upon enrollment. Respective rates of incident ASCVD (i.e., MI, ischemic stroke, or coronary revascularization) were analyzed in the context of a variety of lifestyle, anthropometric, and clinical factors.
After a median follow-up of 11.1 years, individuals of South Asian descent had an incident ASCVD rate of 6.8%, compared with 4.4% for individuals of European descent, representing twice the relative risk (adjusted hazard ratio, 2.03; 95% CI, 1.86-2.22; P < .001). Even after accounting for all covariates, risk of ASCVD remained 45% higher for South Asian individuals (aHR, 1.45; 95% CI, 1.28-1.65; P < .001). This elevation in risk was not captured by existing risk calculators, including the American College of Cardiology/American Heart Association Pooled Cohort Equations, or the QRISK3 equations.
The findings were “largely consistent across a range of age, sex, and clinical subgroups,” and “confirm and extend previous reports that hypertension, diabetes, and central adiposity are the leading associations in this observed disparity,” the investigators wrote.
Two diabetes subtypes are more prevalent in South Asians
Hypertension, diabetes, and central adiposity do not fully explain South Asians’ higher risk for ASCVD, wrote Namratha R. Kandula, MD, of Northwestern University Medical Center, Chicago, and Alka M. Kanaya, MD, of the University of California, San Francisco, in an accompanying editorial published in Circulation.
Some of the undetected risk may stem from unique diabetes disease factors, Dr. Kandula and Dr. Kanaya added.
“Newer data have demonstrated distinct subtypes of type 2 diabetes, with South Asians having a higher prevalence of both a severe insulin resistant with obesity subtype and a less recognized severe insulin deficient subtype,” they wrote. “Importantly, both of these more prevalent diabetes subtypes in South Asians were associated with a higher incidence of coronary artery calcium, a marker of subclinical atherosclerosis and strong predictor of future ASCVD, compared to other diabetes subtypes.”
Diabetes rate is higher for South Asians in the U.S.
Although the present study was conducted in the United Kingdom, the findings likely apply to individuals of South Asian ancestry living in the United States, according to principal author Amit V. Khera, MD, associate director of the precision medicine unit at the Center for Genomic Medicine, Massachusetts General Hospital.
“There are already more than 5 million individuals of South Asian ancestry in the U.S. and this represents one of the fastest-growing ethnic subgroups,” Dr. Khera said in an interview. “As in our study of individuals in the U.K., South Asians in the U.S. suffer from diabetes at much higher rates – 23% versus 12% – and this often occurs even in the absence of obesity.”
Dr. Khera noted that the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease identify South Asian ancestry as a risk-enhancing factor, calling this a “stopgap measure.” More work is needed, he said, in the research arena and in the clinic.
Zero South Asians included in studies used to develop risk estimator
“I think the first step is to simply acknowledge that the risk estimators we use in clinical practice have important limitations when it comes to diverse patient populations,” Dr. Khera said in an interview. “We saw this in our study, where – despite a more than doubling of risk – the predicted risk based on the equations used in primary care showed no difference. This risk estimator was developed based on legacy cohort studies, in [which] zero South Asians were included. Despite important differences across race/ethnicity, the current state-of-the-art in the U.S. is to use one equation for Black individuals and another for all other ethnicities.”
Experts suggest steps for reducing heart disease risk
While risk modeling remains suboptimal, Dr. Khera suggested that clinicians can take immediate steps to reduce the risk of heart disease among individuals with South Asian ancestry.
“Despite all of the uncertainty – we still don’t have a complete understanding of why the risk is so high – there are still several things primary care doctors can do for their patients,” Dr. Khera said.
Foremost, he recommended lifestyle and dietary counseling.
“Dietary counseling is particularly effective if put in the context of cultural norms,” Dr. Khera said. “Many South Asians consider fruit juices or white rice to be healthy, when they lead to rapid spikes in blood sugar.”
Dr. Khera also advised earlier heart disease screening, such as coronary calcium scanning “sometime between age 40-50 years,” noting that positive test results may motivate patients to start or adhere to medications, such as cholesterol-lowering therapies. If necessary, clinicians can also refer to heart centers for South Asian patients, which are becoming increasingly common.
According to Cheryl A.M. Anderson, PhD, chair of the AHA’s Council on Epidemiology and Prevention, and professor and dean of the Herbert Wertheim School of Public Health and Human Longevity Science at the University of California, San Diego, the current study suggests that heart disease management strategies for South Asian patients may be lacking.
“We have had a tradition of preventing or trying to treat heart disease in a fashion that doesn’t yet account for the increased risk that might be prevalent in those of South Asian ancestry,” Dr. Anderson said in an interview.
She suggested that improving associated risk-analysis tools could be beneficial, although the tools themselves, in the context of race or ethnicity, may present their own risks.
“We want to be mindful of potential adverse implications from having everything linked to one’s ancestry, which I think this tool doesn’t do,” Dr. Anderson said, referring to the AHA/ACC Pooled Cohort Equations. “But in sort of the bigger picture of things, we always want to expand and refine our toolkit.”
According to Rajesh Dash, MD, PhD, associate professor, cardiologist, and director of the South Asian Translational Heart Initiative (SSATHI) Prevention Clinic and CardioClick Telemedicine Clinic at Stanford (Calif.) HealthCare, the science supports more active risk mitigation strategies for South Asian patients, and the AHA and the ACC “are the two entities that need to lead the way.”
“Certainly the American Heart Association and the American College of Cardiology should be taking a more active leadership role in this,” Dr. Dash said in an interview.
In 2018, the AHA issued a scientific statement about the elevated risk of ASCVD among South Asian individuals, “but it did not rise to the level of specific recommendations, and did not necessarily go as far as to incorporate new screening parameters for that population,” Dr. Dash said. He also noted that the most recent AHA/ACC guideline identifies South Asian ancestry as a risk-enhancing feature, a statement similarly lacking in actionable value.
“That does not definitively lead someone like a primary care physician to a decision to start a statin, or to be more aggressive with a diagnostic workup, like a stress test, for instance, for a patient who they otherwise would not have done one in had they not been South Asian,” Dr. Dash said.
The steps taken by the AHA and the ACC are “a healthy step forward,” he noted, “but not nearly the degree of attention or vigilance that is required, as well as the level of action that is required to change the narrative for the population.”
At the SSATHI Prevention Clinic, Dr. Dash and colleagues aren’t waiting for the narrative to change, and are already taking a more aggressive approach.
The clinic has an average patient age of 41 years, “easily 15 years younger than the average age in most cardiology clinics,” Dr. Dash said, based on the fact that approximately two-thirds of heart attacks in South Asian individuals occur under the age of 55. “We have to look earlier.”
The SSATHI Prevention Clinic screens for both traditional and emerging risk factors, and Dr. Dash suggested that primary care doctors should do the same.
“If you have a South Asian patient as a primary care physician, you should be aggressively looking for risk factors, traditional ones to start, like elevated cholesterol, hypertension, diabetes, or – and I would argue strongly – prediabetes or insulin resistance.”
Dr. Dash also recommended looking into family history, and considering screening for inflammatory biomarkers, the latter of which are commonly elevated at an earlier age among South Asian individuals, and may have a relatively greater prognostic impact.
To encourage broader implementation of this kind of approach, Dr. Dash called for more large-scale studies. Ideally, these would be randomized clinical trials, but, realistically, real-world datasets may be the answer.
The study was supported by the National Heart, Lung, and Blood Institute; the Broad Institute at MIT and Harvard; the National Human Genome Research Institute; and others. The investigators disclosed relationships with IBM Research, Sanofi, Amgen, and others. Dr. Dash disclosed relationships with HealthPals and AstraZeneca. Dr. Anderson reported no relevant conflicts of interest.
FROM CIRCULATION
Are oncologists liable for pandemic-related treatment delays?
Albuquerque oncologist Barbara McAneny, MD, has a patient in his 30s who experienced rectal bleeding for 6 months in 2020 but didn’t see a physician because he was afraid of catching COVID-19. He hoped it was just hemorrhoids.
When he finally came in to see her recently, Dr. McAneny diagnosed a large colon cancer. She fears the delay could prove fatal. “We’ll do our best to cure him, but I don’t know if he’ll be treatable,” she said. “Six months absolutely can make a difference.”
She and other oncologists around the country are seeing many patients in the past few months with advanced breast, colon, lung, and other cancers who were not diagnosed and treated during the COVID-19 pandemic because the patients didn’t want to come in, or because medical facilities weren’t taking nonemergency or non-COVID patients.
Given that failure to diagnose cancer is among the most common medical malpractice allegations, should oncologists be worried that they are at legal risk?
Pandemic provides ‘safe harbor’
In a March survey done by medical malpractice insurer The Doctors Company, one-third of physicians said they were very concerned or somewhat concerned that malpractice claims related to care during the pandemic will rise.
But in most of these cases, physicians and hospitals have little to worry about in terms of medical malpractice liability, according to veteran plaintiff and defense attorneys and the head of a large medical liability insurer.
“You had people with diseases like cancer not getting care because health care systems were overwhelmed,” said Sean Domnick, JD, a malpractice plaintiff attorney in Boca Raton, Fla. “Will those lead to successful malpractice lawsuits? Most likely not.”
“The risks will be low because it’s hard to pin it on the doctor if the patient didn’t want to come in or facilities weren’t scheduling appointments because of the public health emergency,” said Richard Roberts, MD, JD, a professor of family medicine at the University of Wisconsin–Madison who is also a malpractice defense attorney.
In addition, liability protections enacted in more than 30 states because of the COVID-19 pandemic will help shield clinicians from lawsuits. Those laws generally require allegations of gross negligence or reckless conduct far beyond ordinary negligence, which are hard to prove. But the immunity provisions remain largely untested in the courts, and it’s unclear how they will affect cases involving care for conditions other than COVID-19.
Another helpful factor is the widespread public appreciation of the valiant work by health care professionals throughout the pandemic, though that halo effect could fade over the next several years as malpractice claims from the pandemic period are filed and tried.
“In many circumstances, the pandemic will prove to be a safe harbor for providers,” said Steven Wigrizer, JD, a malpractice plaintiff attorney in Philadelphia. “Jurors will be reluctant to impose liability on providers who were doing their best in a global pandemic the world hadn’t seen in 100 years.”
Risky situations
These predictions from liability experts should reassure physicians who are anxious over reports that many cancer diagnoses were missed as a result of the COVID-19 pandemic.
Still, there are situations where physicians and hospitals could be vulnerable to malpractice claims despite the pandemic conditions. The highest-risk cases are those where patients recognized a potential cancer symptom like a breast lump or rectal bleeding, and tried to visit a doctor’s office or hospital, but were told they couldn’t be seen.
“Those kinds of cases lend themselves to delayed diagnosis claims,” said Richard Anderson, MD, an oncologist who is chairman and CEO of The Doctors Company. “My guess is we will see claims,” though he expects a reduced number arising from 2020 care scenarios, compared with previous years.
So far, his company has seen 20% fewer claims in 2020, which he said isn’t surprising given that the volume of physician and hospital visits plummeted.
Another risky situation is where physicians – particularly primary care physicians but also specialists like gynecologists and urologists – did not inform patients about concerning test results and order a follow-up test or visit. That is dangerous even if the physician did try to schedule a visit but the patient canceled the appointment.
“The jury will ask, ‘What did you do to get the patient back?’ ” said Sean Byrne, JD, a malpractice defense attorney in Richmond, Va. “The provider will say: ‘I’m sure we called.’ But it’s a difficult defense to say the patient didn’t return the call. I need written proof.”
Mr. Domnick said failures to follow up on suspicious test results could produce viable malpractice claims, pandemic or not. “The question becomes to what extent doctors will try to hide behind COVID to explain otherwise run-of-the-mill negligence,” he said. “We’ll have to see how that plays out.”
There are also worries about missed cancer diagnoses during telemedicine visits. “On telemedicine, I can’t feel a lymph node, I can’t palpate a breast mass, and I can’t see if someone’s liver is enlarged,” Dr. McAneny fretted. “I think you’ll get suits because you’ll miss stuff.”
One other area of exposure cited by the experts: Radiologists and pathologists could be sued for missing tumors in reading imaging tests. “The COVID-19 demand on resources has been immense,” Mr. Byrne said. “If that production pressure resulted in any quality loss in testing services, we could see claims.”
Patient protocols provide protection
There’s no question that cancer screenings dropped sharply during the pandemic. In June 2020, the National Cancer Institute estimated there was a 75% decrease in mammograms and colonoscopies during the first few months of the pandemic. It projected that delays in screenings, diagnoses, and treatment likely would result in 10,000 more breast and colorectal cancer deaths than otherwise expected over the next decade.
Delays of even 1 month in treatment for seven common forms of cancer can increase mortality risk by 6%-13%, according to a BMJ study.
While many medical facilities stopped doing preventive screening tests during the height of the pandemic last year, health care professionals still found ways to bring in patients with diagnosed cancers or who were at heightened cancer risk for tests and treatment.
Most facilities convened multidisciplinary tumor boards to decide which patients could wait for treatment, which patients could be maintained on drug therapy, and which ones needed immediate surgery, said Carla Fisher, MD, director of breast surgery at Indiana University, Indianapolis. For breast cancer, they used guidelines from her professional group, the American Society of Breast Surgeons.
Following such protocols for prioritizing patients for treatment during the pandemic should help protect against liability, experts said.
Even if it can be shown that a clinician’s negligence led to delayed diagnosis or treatment of a patient’s cancer, plaintiff attorneys will be wary about filing such claims. That is because it is difficult in most cases to prove that the delay significantly worsened the course of the patient’s disease or the odds of survival. Showing harm may be more possible with certain cancers known to be particularly aggressive.
“The plaintiff attorney will have to get an expert to say that the 3-month delay in getting the patient a mammogram caused her great harm,” said Dr. Roberts. “But it’s hard to calculate that scientifically, and it’s really hard to lay that all on the doctor or health system, because they were supposed to lock down during the pandemic.”
Playing catch-up
With patients now feeling more comfortable about coming in for physician visits, Mr. Byrne urges clinicians to make a special effort to mitigate potential liability arising from the past year. Physicians should carefully review patients’ charts and make sure to catch them up on preventive screenings. Some health systems, like Kaiser Permanente, have been doing proactive patient outreach for cancer screening throughout the pandemic.
“Providers may need to be extra diligent, and consider expanding the exam into a wellness visit and remind patients about cancer surveillance,” he said.
Overall, however, the expert consensus is that physicians should focus on providing the best quality care going forward, and not worry excessively about the care they wish they could have delivered over the past year during the extraordinary pandemic conditions.
“Liability risks will be decreased, because state laws have changed and doctors will be cut some slack, not just by judges and juries but by patients themselves,” Dr. Roberts said. “As you are running down the hall to take care of the next person, don’t be looking over your shoulder or you’ll run into the wall.”
A version of this article first appeared on Medscape.com.
Albuquerque oncologist Barbara McAneny, MD, has a patient in his 30s who experienced rectal bleeding for 6 months in 2020 but didn’t see a physician because he was afraid of catching COVID-19. He hoped it was just hemorrhoids.
When he finally came in to see her recently, Dr. McAneny diagnosed a large colon cancer. She fears the delay could prove fatal. “We’ll do our best to cure him, but I don’t know if he’ll be treatable,” she said. “Six months absolutely can make a difference.”
She and other oncologists around the country are seeing many patients in the past few months with advanced breast, colon, lung, and other cancers who were not diagnosed and treated during the COVID-19 pandemic because the patients didn’t want to come in, or because medical facilities weren’t taking nonemergency or non-COVID patients.
Given that failure to diagnose cancer is among the most common medical malpractice allegations, should oncologists be worried that they are at legal risk?
Pandemic provides ‘safe harbor’
In a March survey done by medical malpractice insurer The Doctors Company, one-third of physicians said they were very concerned or somewhat concerned that malpractice claims related to care during the pandemic will rise.
But in most of these cases, physicians and hospitals have little to worry about in terms of medical malpractice liability, according to veteran plaintiff and defense attorneys and the head of a large medical liability insurer.
“You had people with diseases like cancer not getting care because health care systems were overwhelmed,” said Sean Domnick, JD, a malpractice plaintiff attorney in Boca Raton, Fla. “Will those lead to successful malpractice lawsuits? Most likely not.”
“The risks will be low because it’s hard to pin it on the doctor if the patient didn’t want to come in or facilities weren’t scheduling appointments because of the public health emergency,” said Richard Roberts, MD, JD, a professor of family medicine at the University of Wisconsin–Madison who is also a malpractice defense attorney.
In addition, liability protections enacted in more than 30 states because of the COVID-19 pandemic will help shield clinicians from lawsuits. Those laws generally require allegations of gross negligence or reckless conduct far beyond ordinary negligence, which are hard to prove. But the immunity provisions remain largely untested in the courts, and it’s unclear how they will affect cases involving care for conditions other than COVID-19.
Another helpful factor is the widespread public appreciation of the valiant work by health care professionals throughout the pandemic, though that halo effect could fade over the next several years as malpractice claims from the pandemic period are filed and tried.
“In many circumstances, the pandemic will prove to be a safe harbor for providers,” said Steven Wigrizer, JD, a malpractice plaintiff attorney in Philadelphia. “Jurors will be reluctant to impose liability on providers who were doing their best in a global pandemic the world hadn’t seen in 100 years.”
Risky situations
These predictions from liability experts should reassure physicians who are anxious over reports that many cancer diagnoses were missed as a result of the COVID-19 pandemic.
Still, there are situations where physicians and hospitals could be vulnerable to malpractice claims despite the pandemic conditions. The highest-risk cases are those where patients recognized a potential cancer symptom like a breast lump or rectal bleeding, and tried to visit a doctor’s office or hospital, but were told they couldn’t be seen.
“Those kinds of cases lend themselves to delayed diagnosis claims,” said Richard Anderson, MD, an oncologist who is chairman and CEO of The Doctors Company. “My guess is we will see claims,” though he expects a reduced number arising from 2020 care scenarios, compared with previous years.
So far, his company has seen 20% fewer claims in 2020, which he said isn’t surprising given that the volume of physician and hospital visits plummeted.
Another risky situation is where physicians – particularly primary care physicians but also specialists like gynecologists and urologists – did not inform patients about concerning test results and order a follow-up test or visit. That is dangerous even if the physician did try to schedule a visit but the patient canceled the appointment.
“The jury will ask, ‘What did you do to get the patient back?’ ” said Sean Byrne, JD, a malpractice defense attorney in Richmond, Va. “The provider will say: ‘I’m sure we called.’ But it’s a difficult defense to say the patient didn’t return the call. I need written proof.”
Mr. Domnick said failures to follow up on suspicious test results could produce viable malpractice claims, pandemic or not. “The question becomes to what extent doctors will try to hide behind COVID to explain otherwise run-of-the-mill negligence,” he said. “We’ll have to see how that plays out.”
There are also worries about missed cancer diagnoses during telemedicine visits. “On telemedicine, I can’t feel a lymph node, I can’t palpate a breast mass, and I can’t see if someone’s liver is enlarged,” Dr. McAneny fretted. “I think you’ll get suits because you’ll miss stuff.”
One other area of exposure cited by the experts: Radiologists and pathologists could be sued for missing tumors in reading imaging tests. “The COVID-19 demand on resources has been immense,” Mr. Byrne said. “If that production pressure resulted in any quality loss in testing services, we could see claims.”
Patient protocols provide protection
There’s no question that cancer screenings dropped sharply during the pandemic. In June 2020, the National Cancer Institute estimated there was a 75% decrease in mammograms and colonoscopies during the first few months of the pandemic. It projected that delays in screenings, diagnoses, and treatment likely would result in 10,000 more breast and colorectal cancer deaths than otherwise expected over the next decade.
Delays of even 1 month in treatment for seven common forms of cancer can increase mortality risk by 6%-13%, according to a BMJ study.
While many medical facilities stopped doing preventive screening tests during the height of the pandemic last year, health care professionals still found ways to bring in patients with diagnosed cancers or who were at heightened cancer risk for tests and treatment.
Most facilities convened multidisciplinary tumor boards to decide which patients could wait for treatment, which patients could be maintained on drug therapy, and which ones needed immediate surgery, said Carla Fisher, MD, director of breast surgery at Indiana University, Indianapolis. For breast cancer, they used guidelines from her professional group, the American Society of Breast Surgeons.
Following such protocols for prioritizing patients for treatment during the pandemic should help protect against liability, experts said.
Even if it can be shown that a clinician’s negligence led to delayed diagnosis or treatment of a patient’s cancer, plaintiff attorneys will be wary about filing such claims. That is because it is difficult in most cases to prove that the delay significantly worsened the course of the patient’s disease or the odds of survival. Showing harm may be more possible with certain cancers known to be particularly aggressive.
“The plaintiff attorney will have to get an expert to say that the 3-month delay in getting the patient a mammogram caused her great harm,” said Dr. Roberts. “But it’s hard to calculate that scientifically, and it’s really hard to lay that all on the doctor or health system, because they were supposed to lock down during the pandemic.”
Playing catch-up
With patients now feeling more comfortable about coming in for physician visits, Mr. Byrne urges clinicians to make a special effort to mitigate potential liability arising from the past year. Physicians should carefully review patients’ charts and make sure to catch them up on preventive screenings. Some health systems, like Kaiser Permanente, have been doing proactive patient outreach for cancer screening throughout the pandemic.
“Providers may need to be extra diligent, and consider expanding the exam into a wellness visit and remind patients about cancer surveillance,” he said.
Overall, however, the expert consensus is that physicians should focus on providing the best quality care going forward, and not worry excessively about the care they wish they could have delivered over the past year during the extraordinary pandemic conditions.
“Liability risks will be decreased, because state laws have changed and doctors will be cut some slack, not just by judges and juries but by patients themselves,” Dr. Roberts said. “As you are running down the hall to take care of the next person, don’t be looking over your shoulder or you’ll run into the wall.”
A version of this article first appeared on Medscape.com.
Albuquerque oncologist Barbara McAneny, MD, has a patient in his 30s who experienced rectal bleeding for 6 months in 2020 but didn’t see a physician because he was afraid of catching COVID-19. He hoped it was just hemorrhoids.
When he finally came in to see her recently, Dr. McAneny diagnosed a large colon cancer. She fears the delay could prove fatal. “We’ll do our best to cure him, but I don’t know if he’ll be treatable,” she said. “Six months absolutely can make a difference.”
She and other oncologists around the country are seeing many patients in the past few months with advanced breast, colon, lung, and other cancers who were not diagnosed and treated during the COVID-19 pandemic because the patients didn’t want to come in, or because medical facilities weren’t taking nonemergency or non-COVID patients.
Given that failure to diagnose cancer is among the most common medical malpractice allegations, should oncologists be worried that they are at legal risk?
Pandemic provides ‘safe harbor’
In a March survey done by medical malpractice insurer The Doctors Company, one-third of physicians said they were very concerned or somewhat concerned that malpractice claims related to care during the pandemic will rise.
But in most of these cases, physicians and hospitals have little to worry about in terms of medical malpractice liability, according to veteran plaintiff and defense attorneys and the head of a large medical liability insurer.
“You had people with diseases like cancer not getting care because health care systems were overwhelmed,” said Sean Domnick, JD, a malpractice plaintiff attorney in Boca Raton, Fla. “Will those lead to successful malpractice lawsuits? Most likely not.”
“The risks will be low because it’s hard to pin it on the doctor if the patient didn’t want to come in or facilities weren’t scheduling appointments because of the public health emergency,” said Richard Roberts, MD, JD, a professor of family medicine at the University of Wisconsin–Madison who is also a malpractice defense attorney.
In addition, liability protections enacted in more than 30 states because of the COVID-19 pandemic will help shield clinicians from lawsuits. Those laws generally require allegations of gross negligence or reckless conduct far beyond ordinary negligence, which are hard to prove. But the immunity provisions remain largely untested in the courts, and it’s unclear how they will affect cases involving care for conditions other than COVID-19.
Another helpful factor is the widespread public appreciation of the valiant work by health care professionals throughout the pandemic, though that halo effect could fade over the next several years as malpractice claims from the pandemic period are filed and tried.
“In many circumstances, the pandemic will prove to be a safe harbor for providers,” said Steven Wigrizer, JD, a malpractice plaintiff attorney in Philadelphia. “Jurors will be reluctant to impose liability on providers who were doing their best in a global pandemic the world hadn’t seen in 100 years.”
Risky situations
These predictions from liability experts should reassure physicians who are anxious over reports that many cancer diagnoses were missed as a result of the COVID-19 pandemic.
Still, there are situations where physicians and hospitals could be vulnerable to malpractice claims despite the pandemic conditions. The highest-risk cases are those where patients recognized a potential cancer symptom like a breast lump or rectal bleeding, and tried to visit a doctor’s office or hospital, but were told they couldn’t be seen.
“Those kinds of cases lend themselves to delayed diagnosis claims,” said Richard Anderson, MD, an oncologist who is chairman and CEO of The Doctors Company. “My guess is we will see claims,” though he expects a reduced number arising from 2020 care scenarios, compared with previous years.
So far, his company has seen 20% fewer claims in 2020, which he said isn’t surprising given that the volume of physician and hospital visits plummeted.
Another risky situation is where physicians – particularly primary care physicians but also specialists like gynecologists and urologists – did not inform patients about concerning test results and order a follow-up test or visit. That is dangerous even if the physician did try to schedule a visit but the patient canceled the appointment.
“The jury will ask, ‘What did you do to get the patient back?’ ” said Sean Byrne, JD, a malpractice defense attorney in Richmond, Va. “The provider will say: ‘I’m sure we called.’ But it’s a difficult defense to say the patient didn’t return the call. I need written proof.”
Mr. Domnick said failures to follow up on suspicious test results could produce viable malpractice claims, pandemic or not. “The question becomes to what extent doctors will try to hide behind COVID to explain otherwise run-of-the-mill negligence,” he said. “We’ll have to see how that plays out.”
There are also worries about missed cancer diagnoses during telemedicine visits. “On telemedicine, I can’t feel a lymph node, I can’t palpate a breast mass, and I can’t see if someone’s liver is enlarged,” Dr. McAneny fretted. “I think you’ll get suits because you’ll miss stuff.”
One other area of exposure cited by the experts: Radiologists and pathologists could be sued for missing tumors in reading imaging tests. “The COVID-19 demand on resources has been immense,” Mr. Byrne said. “If that production pressure resulted in any quality loss in testing services, we could see claims.”
Patient protocols provide protection
There’s no question that cancer screenings dropped sharply during the pandemic. In June 2020, the National Cancer Institute estimated there was a 75% decrease in mammograms and colonoscopies during the first few months of the pandemic. It projected that delays in screenings, diagnoses, and treatment likely would result in 10,000 more breast and colorectal cancer deaths than otherwise expected over the next decade.
Delays of even 1 month in treatment for seven common forms of cancer can increase mortality risk by 6%-13%, according to a BMJ study.
While many medical facilities stopped doing preventive screening tests during the height of the pandemic last year, health care professionals still found ways to bring in patients with diagnosed cancers or who were at heightened cancer risk for tests and treatment.
Most facilities convened multidisciplinary tumor boards to decide which patients could wait for treatment, which patients could be maintained on drug therapy, and which ones needed immediate surgery, said Carla Fisher, MD, director of breast surgery at Indiana University, Indianapolis. For breast cancer, they used guidelines from her professional group, the American Society of Breast Surgeons.
Following such protocols for prioritizing patients for treatment during the pandemic should help protect against liability, experts said.
Even if it can be shown that a clinician’s negligence led to delayed diagnosis or treatment of a patient’s cancer, plaintiff attorneys will be wary about filing such claims. That is because it is difficult in most cases to prove that the delay significantly worsened the course of the patient’s disease or the odds of survival. Showing harm may be more possible with certain cancers known to be particularly aggressive.
“The plaintiff attorney will have to get an expert to say that the 3-month delay in getting the patient a mammogram caused her great harm,” said Dr. Roberts. “But it’s hard to calculate that scientifically, and it’s really hard to lay that all on the doctor or health system, because they were supposed to lock down during the pandemic.”
Playing catch-up
With patients now feeling more comfortable about coming in for physician visits, Mr. Byrne urges clinicians to make a special effort to mitigate potential liability arising from the past year. Physicians should carefully review patients’ charts and make sure to catch them up on preventive screenings. Some health systems, like Kaiser Permanente, have been doing proactive patient outreach for cancer screening throughout the pandemic.
“Providers may need to be extra diligent, and consider expanding the exam into a wellness visit and remind patients about cancer surveillance,” he said.
Overall, however, the expert consensus is that physicians should focus on providing the best quality care going forward, and not worry excessively about the care they wish they could have delivered over the past year during the extraordinary pandemic conditions.
“Liability risks will be decreased, because state laws have changed and doctors will be cut some slack, not just by judges and juries but by patients themselves,” Dr. Roberts said. “As you are running down the hall to take care of the next person, don’t be looking over your shoulder or you’ll run into the wall.”
A version of this article first appeared on Medscape.com.
Limited English proficiency linked with less health care in U.S.
Jessica Himmelstein, MD, a Harvard research fellow and primary care physician at Cambridge Health Alliance in Cambridge, Mass., led a study of more than 120,000 adults published July 6, 2021. The study population included 17,776 Hispanic adults with limited English proficiency, 14,936 Hispanic adults proficient in English and 87,834 non-Hispanic, English-proficient adults.
Researchers compared several measures of care usage from information in the Agency for Healthcare Research and Quality’s Medical Expenditure Panel Survey from 1998 to 2018.
They found that, in adjusted analyses, total use of care per capita from 2014-2018, measured by health care expenditures, was $1,463 lower (98% confidence interval, $1,030-$1,897), or 35% lower for primary-Spanish speakers than for Hispanic adults who were English proficient and $2,802 lower (98% CI, $2,356-$3,247), or 42% lower versus non-Hispanic adults who were English proficient.
Spanish speakers also had 36% fewer outpatient visits and 48% fewer prescription medications than non-Hispanic adults, and 35% fewer outpatient visits and 37% fewer prescription medications than English-proficient Hispanic adults.
Even when accounting for differences in health, age, sex, income and insurance, adults with language barriers fared worse.
Gaps span all types of care
The services that those with limited English skills are missing are “the types of care people need to lead a healthy life,” from routine visits and medications to urgent or emergency care, Dr. Himmelstein said in an interview.
She said the gaps were greater in outpatient care and in medication use, compared with emergency department visits and inpatient care, but the inequities were present in all the categories she and her coinvestigators studied.
Underlying causes for having less care may include that people who struggle with English may not feel comfortable accessing the health system or may feel unwelcome or discriminated against.
“An undercurrent of biases, including racism, could also be contributing,” she said.
The data show that, despite several federal policy changes aimed at promoting language services in hospitals and clinics, several language-based disparities have not improved over 2 decades.
Some of the changes have included an executive order in 2000 requiring interpreters to be available in federally funded health facilities. In 2010, the Affordable Care Act enhanced the definition of meaningful access to language services and setting standards for qualified interpreters.
Gap widened over 2 decades
The adjusted gap in annual health care expenditures per capita between adults with limited English skills and non-Hispanic, English-proficient adults widened by $1,596 (98% CI, $837-$2,356) between 1999-2000 and 2017-2018, after accounting for inflation.
Dr. Himmelstein said that though this study period predated COVID-19, its findings may help explain the disproportionate burden the pandemic placed on the Hispanic population.
“This is a community that traditionally wasn’t getting access to care and then suddenly something like COVID-19 comes and they were even more devastated,” she noted.
Telehealth, which proved an important way to access care during the pandemic, also added a degree of communication difficulty for those with fewer English skills, she said.
Many of the telehealth changes are here to stay, and it will be important to ask: “Are we ensuring equity in telehealth use for individuals who face language barriers?” Dr. Himmelstein said.
Olga Garcia-Bedoya, MD, an associate professor at University of Illinois at Chicago’s department of medicine and medical director of UIC’s Institute for Minority Health Research, said having access to interpreters with high accuracy is key to narrowing the gaps.
“The literature is very clear that access to professional medical interpreters is associated with decreased health disparities for patients with limited English proficiency,” she said.
More cultural training for clinicians is needed surrounding beliefs about illness and that some care may be declined not because of a person’s limited English proficiency, but because their beliefs may keep them from getting care, Dr. Garcia-Bedoya added. When it comes to getting a flu shot, for example, sometimes belief systems, rather than English proficiency, keep people from accessing care.
What can be done?
Addressing barriers caused by lack of English proficiency will likely take change in policies, including one related reimbursement for medical interpreters, Dr. Himmelstein said.
Currently, only 15 states’ Medicaid programs or Children’s Health Insurance Programs reimburse providers for language services, the paper notes, and neither Medicare nor private insurers routinely pay for those services.
Recruiting bilingual providers and staff at health care facilities and in medical and nursing schools will also be important to narrow the gaps, Dr. Himmelstein said.
Strengthening standards for interpreters also will help. “Currently such standards vary by state or by institution and are not necessarily enforced,” she explained.
It will also be important to make sure patients know that they are entitled by law to care, free of discriminatory practices and to have certain language services including qualified interpreters, Dr. Himmelstein said.
Dr. Garcia-Bedoya said changes need to come from health systems working in combination with clinicians, providing resources so that quality interpreters can be accessed and making sure that equipment supports clear communication in telehealth. Patients’ language preferences should also be noted as soon as they make the appointment.
The findings of the study may have large significance as one in seven people in the United States speak Spanish at home, and 25 million people in the United States have limited English proficiency, the authors noted.
Dr. Himmelstein receives funding support from an Institutional National Research Service Award. Dr. Garcia-Bedoya reports no relevant financial relationships.
Jessica Himmelstein, MD, a Harvard research fellow and primary care physician at Cambridge Health Alliance in Cambridge, Mass., led a study of more than 120,000 adults published July 6, 2021. The study population included 17,776 Hispanic adults with limited English proficiency, 14,936 Hispanic adults proficient in English and 87,834 non-Hispanic, English-proficient adults.
Researchers compared several measures of care usage from information in the Agency for Healthcare Research and Quality’s Medical Expenditure Panel Survey from 1998 to 2018.
They found that, in adjusted analyses, total use of care per capita from 2014-2018, measured by health care expenditures, was $1,463 lower (98% confidence interval, $1,030-$1,897), or 35% lower for primary-Spanish speakers than for Hispanic adults who were English proficient and $2,802 lower (98% CI, $2,356-$3,247), or 42% lower versus non-Hispanic adults who were English proficient.
Spanish speakers also had 36% fewer outpatient visits and 48% fewer prescription medications than non-Hispanic adults, and 35% fewer outpatient visits and 37% fewer prescription medications than English-proficient Hispanic adults.
Even when accounting for differences in health, age, sex, income and insurance, adults with language barriers fared worse.
Gaps span all types of care
The services that those with limited English skills are missing are “the types of care people need to lead a healthy life,” from routine visits and medications to urgent or emergency care, Dr. Himmelstein said in an interview.
She said the gaps were greater in outpatient care and in medication use, compared with emergency department visits and inpatient care, but the inequities were present in all the categories she and her coinvestigators studied.
Underlying causes for having less care may include that people who struggle with English may not feel comfortable accessing the health system or may feel unwelcome or discriminated against.
“An undercurrent of biases, including racism, could also be contributing,” she said.
The data show that, despite several federal policy changes aimed at promoting language services in hospitals and clinics, several language-based disparities have not improved over 2 decades.
Some of the changes have included an executive order in 2000 requiring interpreters to be available in federally funded health facilities. In 2010, the Affordable Care Act enhanced the definition of meaningful access to language services and setting standards for qualified interpreters.
Gap widened over 2 decades
The adjusted gap in annual health care expenditures per capita between adults with limited English skills and non-Hispanic, English-proficient adults widened by $1,596 (98% CI, $837-$2,356) between 1999-2000 and 2017-2018, after accounting for inflation.
Dr. Himmelstein said that though this study period predated COVID-19, its findings may help explain the disproportionate burden the pandemic placed on the Hispanic population.
“This is a community that traditionally wasn’t getting access to care and then suddenly something like COVID-19 comes and they were even more devastated,” she noted.
Telehealth, which proved an important way to access care during the pandemic, also added a degree of communication difficulty for those with fewer English skills, she said.
Many of the telehealth changes are here to stay, and it will be important to ask: “Are we ensuring equity in telehealth use for individuals who face language barriers?” Dr. Himmelstein said.
Olga Garcia-Bedoya, MD, an associate professor at University of Illinois at Chicago’s department of medicine and medical director of UIC’s Institute for Minority Health Research, said having access to interpreters with high accuracy is key to narrowing the gaps.
“The literature is very clear that access to professional medical interpreters is associated with decreased health disparities for patients with limited English proficiency,” she said.
More cultural training for clinicians is needed surrounding beliefs about illness and that some care may be declined not because of a person’s limited English proficiency, but because their beliefs may keep them from getting care, Dr. Garcia-Bedoya added. When it comes to getting a flu shot, for example, sometimes belief systems, rather than English proficiency, keep people from accessing care.
What can be done?
Addressing barriers caused by lack of English proficiency will likely take change in policies, including one related reimbursement for medical interpreters, Dr. Himmelstein said.
Currently, only 15 states’ Medicaid programs or Children’s Health Insurance Programs reimburse providers for language services, the paper notes, and neither Medicare nor private insurers routinely pay for those services.
Recruiting bilingual providers and staff at health care facilities and in medical and nursing schools will also be important to narrow the gaps, Dr. Himmelstein said.
Strengthening standards for interpreters also will help. “Currently such standards vary by state or by institution and are not necessarily enforced,” she explained.
It will also be important to make sure patients know that they are entitled by law to care, free of discriminatory practices and to have certain language services including qualified interpreters, Dr. Himmelstein said.
Dr. Garcia-Bedoya said changes need to come from health systems working in combination with clinicians, providing resources so that quality interpreters can be accessed and making sure that equipment supports clear communication in telehealth. Patients’ language preferences should also be noted as soon as they make the appointment.
The findings of the study may have large significance as one in seven people in the United States speak Spanish at home, and 25 million people in the United States have limited English proficiency, the authors noted.
Dr. Himmelstein receives funding support from an Institutional National Research Service Award. Dr. Garcia-Bedoya reports no relevant financial relationships.
Jessica Himmelstein, MD, a Harvard research fellow and primary care physician at Cambridge Health Alliance in Cambridge, Mass., led a study of more than 120,000 adults published July 6, 2021. The study population included 17,776 Hispanic adults with limited English proficiency, 14,936 Hispanic adults proficient in English and 87,834 non-Hispanic, English-proficient adults.
Researchers compared several measures of care usage from information in the Agency for Healthcare Research and Quality’s Medical Expenditure Panel Survey from 1998 to 2018.
They found that, in adjusted analyses, total use of care per capita from 2014-2018, measured by health care expenditures, was $1,463 lower (98% confidence interval, $1,030-$1,897), or 35% lower for primary-Spanish speakers than for Hispanic adults who were English proficient and $2,802 lower (98% CI, $2,356-$3,247), or 42% lower versus non-Hispanic adults who were English proficient.
Spanish speakers also had 36% fewer outpatient visits and 48% fewer prescription medications than non-Hispanic adults, and 35% fewer outpatient visits and 37% fewer prescription medications than English-proficient Hispanic adults.
Even when accounting for differences in health, age, sex, income and insurance, adults with language barriers fared worse.
Gaps span all types of care
The services that those with limited English skills are missing are “the types of care people need to lead a healthy life,” from routine visits and medications to urgent or emergency care, Dr. Himmelstein said in an interview.
She said the gaps were greater in outpatient care and in medication use, compared with emergency department visits and inpatient care, but the inequities were present in all the categories she and her coinvestigators studied.
Underlying causes for having less care may include that people who struggle with English may not feel comfortable accessing the health system or may feel unwelcome or discriminated against.
“An undercurrent of biases, including racism, could also be contributing,” she said.
The data show that, despite several federal policy changes aimed at promoting language services in hospitals and clinics, several language-based disparities have not improved over 2 decades.
Some of the changes have included an executive order in 2000 requiring interpreters to be available in federally funded health facilities. In 2010, the Affordable Care Act enhanced the definition of meaningful access to language services and setting standards for qualified interpreters.
Gap widened over 2 decades
The adjusted gap in annual health care expenditures per capita between adults with limited English skills and non-Hispanic, English-proficient adults widened by $1,596 (98% CI, $837-$2,356) between 1999-2000 and 2017-2018, after accounting for inflation.
Dr. Himmelstein said that though this study period predated COVID-19, its findings may help explain the disproportionate burden the pandemic placed on the Hispanic population.
“This is a community that traditionally wasn’t getting access to care and then suddenly something like COVID-19 comes and they were even more devastated,” she noted.
Telehealth, which proved an important way to access care during the pandemic, also added a degree of communication difficulty for those with fewer English skills, she said.
Many of the telehealth changes are here to stay, and it will be important to ask: “Are we ensuring equity in telehealth use for individuals who face language barriers?” Dr. Himmelstein said.
Olga Garcia-Bedoya, MD, an associate professor at University of Illinois at Chicago’s department of medicine and medical director of UIC’s Institute for Minority Health Research, said having access to interpreters with high accuracy is key to narrowing the gaps.
“The literature is very clear that access to professional medical interpreters is associated with decreased health disparities for patients with limited English proficiency,” she said.
More cultural training for clinicians is needed surrounding beliefs about illness and that some care may be declined not because of a person’s limited English proficiency, but because their beliefs may keep them from getting care, Dr. Garcia-Bedoya added. When it comes to getting a flu shot, for example, sometimes belief systems, rather than English proficiency, keep people from accessing care.
What can be done?
Addressing barriers caused by lack of English proficiency will likely take change in policies, including one related reimbursement for medical interpreters, Dr. Himmelstein said.
Currently, only 15 states’ Medicaid programs or Children’s Health Insurance Programs reimburse providers for language services, the paper notes, and neither Medicare nor private insurers routinely pay for those services.
Recruiting bilingual providers and staff at health care facilities and in medical and nursing schools will also be important to narrow the gaps, Dr. Himmelstein said.
Strengthening standards for interpreters also will help. “Currently such standards vary by state or by institution and are not necessarily enforced,” she explained.
It will also be important to make sure patients know that they are entitled by law to care, free of discriminatory practices and to have certain language services including qualified interpreters, Dr. Himmelstein said.
Dr. Garcia-Bedoya said changes need to come from health systems working in combination with clinicians, providing resources so that quality interpreters can be accessed and making sure that equipment supports clear communication in telehealth. Patients’ language preferences should also be noted as soon as they make the appointment.
The findings of the study may have large significance as one in seven people in the United States speak Spanish at home, and 25 million people in the United States have limited English proficiency, the authors noted.
Dr. Himmelstein receives funding support from an Institutional National Research Service Award. Dr. Garcia-Bedoya reports no relevant financial relationships.
FROM HEALTH AFFAIRS
Married docs remove girl’s lethal facial tumor in ‘excruciatingly difficult’ procedure
In 2019, doctors in London saw a 5-year old girl from rural Ethiopia with an enormous tumor extending from her cheek to her lower jaw. Her name was Negalem and the tumor was a vascular malformation, a life-threatening web of tangled blood vessels.
Surgery to remove it was impossible, the doctors told the foundation advocating for the girl. The child would never make it off the operating table. After a closer examination, the London group still declined to do the procedure, but told the child’s parents and advocates that if anyone was going to attempt this, they’d need to get the little girl to New York.
In New York City, on 64th St. in Manhattan, is the Vascular Birthmark Institute, founded by Milton Waner, MD, who has exclusively treated hemangiomas and vascular malformations for the last 30 years. “I’m the only person in the [United] States whose practice is exclusively [treating] vascular anomalies,” Dr. Waner said in an interview.
Dr. Waner has assembled a multidisciplinary team of experts at the institute’s offices in Lenox Hill – including his wife Teresa O, MD, a facial plastic and reconstructive surgeon and neurospecialist. “People often ask how the hell do you spend so much time with your spouse?” Dr. Waner says. “We work extremely well together. We complement each other.”
Dr. O and Dr. Waner each manage half of the cases at VBI. And in January they received an email about Negalem. After corresponding with the child’s advocate and reviewing images,
The challenge with vascular malformations in children, Dr. Waner said, is that they have a fraction of the blood an adult has. Where adults have an average of 5 L of blood, a child this age has only 1 L. To lose 200 or 300 mL of blood, “that’s 20% or 30% of their blood volume,” Dr. Waner said. So the removal of such a mass, which requires a meticulous dissection around many blood vessels, carries a high risk of the child bleeding out.
There were some logistical hurdles, but the patient arrived in Manhattan in mid-June, at no cost to her family. The medical visa was organized by a volunteer who also work for USAID. Healing the Children Northeast paid for her travel and the Waner Kids Foundation paid for her hotel stay. Lenox Hill Hospital and Northwell Health covered all hospital costs and postsurgery care. And Dr. O and Dr. Waner did the planning, consult visits, and procedure pro bono.
The surgery was possible because of the generosity of several organizations, but the two surgeons still had a limited time to remove the mass. Under different circumstances, and with the luxury of more time, the patient would have undergone several rounds of sclerotherapy. This procedure, done by interventional radiologists, involves injecting a toxin into the blood vessels, which causes them to clot. Done prior to surgery it can help limit bleeding risk.
On June 23, the morning of the surgery, the patient underwent one round of sclerotherapy. However, it didn’t have the intended effect, Dr. Waner said, “because the lesion was just so massive.”
The team had planned several of their moves ahead of time. But this isn’t the sort of surgery you’d find in a textbook. Because it’s such a unique field, Dr. Waner and Dr. O have developed many of their own techniques along the way. This patient was much like the cases they treat every day, only “several orders of magnitudes greater,” Dr. Waner said. “On a scale of 1 to 10 she was a 12.”
The morning of the surgery, “I was very apprehensive,” Dr. Waner recalled. He vividly remembers the girl’s father repeatedly kissing her to say goodbye as she lay on the operating table, fully aware that this procedure was a life-threatening one. And from the beginning there were challenges, like getting her under anesthesia when the anatomy of her mouth, deformed by the tumor, didn’t allow the anesthesiologists to use their typical tubing. Then, once the skin was removed, it became clear how dilated and tangled the involved blood vessels were. There were many vital structures tangled in the anomaly. “The jugular vein was right there. The carotid artery was right there,” Dr. Waner said. It was extremely difficult to delineate and preserve them, he said.
“That’s why we really took our time. We just went very slowly and deliberately,” Dr. O said. The blood vessels were so dilated that their only option was to move painstakingly slow – otherwise a small nick could be devastating.
But even with the slow pace the surgery was “excruciatingly difficult,” Dr. Waner said. And early on in the dissection he wasn’t quite sure they’d make it out. The sclerotherapy hadn’t done much to prevent bleeding. “At one point every millimeter or 2 that we advanced we got into some bleeding,” Dr. Waner said. “Brisk bleeding.”
Once they got into the surgery they also realized that the growth had adhered to the jaw bone. “There were vessels traversing into the bone, which were hard to control,” Dr. O said.
But finally, both doctors realized they’d be able to remove it. With the lesion removed they began the work of reconstruction and reanimation.
The child’s jaw and cheek bone had grown beyond their normal size to support the growth. They had to shave them down to achieve facial symmetry. The tumor had also inhibited much of the child’s facial nerve control. With it gone, Dr. O began the work of finding all the facial nerve branches and assembling them to reanimate the child’s face.
Before medicine, Dr. O trained as an architect, which, according to Dr. Waner, has equipped her with very good spatial awareness – a valuable skill in the surgical reconstruction phase. After seeing a lecture by Dr. Waner, she immediately saw a fit for her unique interest and skill set. She did fellowship training with Dr. Waner in vascular anomalies, and then went on to specialize in facial nerve reanimation. The proof of Dr. O’s expertise is Negalem’s new, beautiful smile, Dr. Waner said.
The surgery drew out over 8 hours, as long as a day of surgeries for the two doctors. When Dr. O finally walked into the waiting room to inform the family of the success, the first words out of the father’s mouth were: “Is my daughter alive?”
A growth like Negalem had is not compatible with a normal life. Dr. Waner’s mantra is that every child has the right to look normal. But this case went beyond aesthetics. If the growth hadn’t been removed, the child was expected to live only 4-6 more years, Dr. Waner said. Without the surgery, she could have suffocated, starved without the ability to swallow, or suffered a fatal bleed.
Dr. O and Dr. Waner are uniquely equipped to do this kind of work, but both are adamant that treating vascular anomalies is a multidisciplinary, multimodal approach. Specialties in anesthesiology, radiology, lasers, facial nerves – they are all critical to these procedures. And often patients with these kinds of lesions require medical and radiologic interventions in addition to surgery. In this particular case, from logistics to post op, “it was a lot of teamwork,” Dr. O said, “a lot of international teams coming together.”
Though extremely difficult, “in the end the result was exactly what we wanted,” Dr. Waner said. Negalem can live a normal life. And as for the surgical duo, both feel very fortunate to do this work. Dr. O said, “I’m honored to have found this specialty and to be able to train with and work with Milton. I’m so happy to do what I do every day.”
A version of this article first appeared on Medscape.com.
In 2019, doctors in London saw a 5-year old girl from rural Ethiopia with an enormous tumor extending from her cheek to her lower jaw. Her name was Negalem and the tumor was a vascular malformation, a life-threatening web of tangled blood vessels.
Surgery to remove it was impossible, the doctors told the foundation advocating for the girl. The child would never make it off the operating table. After a closer examination, the London group still declined to do the procedure, but told the child’s parents and advocates that if anyone was going to attempt this, they’d need to get the little girl to New York.
In New York City, on 64th St. in Manhattan, is the Vascular Birthmark Institute, founded by Milton Waner, MD, who has exclusively treated hemangiomas and vascular malformations for the last 30 years. “I’m the only person in the [United] States whose practice is exclusively [treating] vascular anomalies,” Dr. Waner said in an interview.
Dr. Waner has assembled a multidisciplinary team of experts at the institute’s offices in Lenox Hill – including his wife Teresa O, MD, a facial plastic and reconstructive surgeon and neurospecialist. “People often ask how the hell do you spend so much time with your spouse?” Dr. Waner says. “We work extremely well together. We complement each other.”
Dr. O and Dr. Waner each manage half of the cases at VBI. And in January they received an email about Negalem. After corresponding with the child’s advocate and reviewing images,
The challenge with vascular malformations in children, Dr. Waner said, is that they have a fraction of the blood an adult has. Where adults have an average of 5 L of blood, a child this age has only 1 L. To lose 200 or 300 mL of blood, “that’s 20% or 30% of their blood volume,” Dr. Waner said. So the removal of such a mass, which requires a meticulous dissection around many blood vessels, carries a high risk of the child bleeding out.
There were some logistical hurdles, but the patient arrived in Manhattan in mid-June, at no cost to her family. The medical visa was organized by a volunteer who also work for USAID. Healing the Children Northeast paid for her travel and the Waner Kids Foundation paid for her hotel stay. Lenox Hill Hospital and Northwell Health covered all hospital costs and postsurgery care. And Dr. O and Dr. Waner did the planning, consult visits, and procedure pro bono.
The surgery was possible because of the generosity of several organizations, but the two surgeons still had a limited time to remove the mass. Under different circumstances, and with the luxury of more time, the patient would have undergone several rounds of sclerotherapy. This procedure, done by interventional radiologists, involves injecting a toxin into the blood vessels, which causes them to clot. Done prior to surgery it can help limit bleeding risk.
On June 23, the morning of the surgery, the patient underwent one round of sclerotherapy. However, it didn’t have the intended effect, Dr. Waner said, “because the lesion was just so massive.”
The team had planned several of their moves ahead of time. But this isn’t the sort of surgery you’d find in a textbook. Because it’s such a unique field, Dr. Waner and Dr. O have developed many of their own techniques along the way. This patient was much like the cases they treat every day, only “several orders of magnitudes greater,” Dr. Waner said. “On a scale of 1 to 10 she was a 12.”
The morning of the surgery, “I was very apprehensive,” Dr. Waner recalled. He vividly remembers the girl’s father repeatedly kissing her to say goodbye as she lay on the operating table, fully aware that this procedure was a life-threatening one. And from the beginning there were challenges, like getting her under anesthesia when the anatomy of her mouth, deformed by the tumor, didn’t allow the anesthesiologists to use their typical tubing. Then, once the skin was removed, it became clear how dilated and tangled the involved blood vessels were. There were many vital structures tangled in the anomaly. “The jugular vein was right there. The carotid artery was right there,” Dr. Waner said. It was extremely difficult to delineate and preserve them, he said.
“That’s why we really took our time. We just went very slowly and deliberately,” Dr. O said. The blood vessels were so dilated that their only option was to move painstakingly slow – otherwise a small nick could be devastating.
But even with the slow pace the surgery was “excruciatingly difficult,” Dr. Waner said. And early on in the dissection he wasn’t quite sure they’d make it out. The sclerotherapy hadn’t done much to prevent bleeding. “At one point every millimeter or 2 that we advanced we got into some bleeding,” Dr. Waner said. “Brisk bleeding.”
Once they got into the surgery they also realized that the growth had adhered to the jaw bone. “There were vessels traversing into the bone, which were hard to control,” Dr. O said.
But finally, both doctors realized they’d be able to remove it. With the lesion removed they began the work of reconstruction and reanimation.
The child’s jaw and cheek bone had grown beyond their normal size to support the growth. They had to shave them down to achieve facial symmetry. The tumor had also inhibited much of the child’s facial nerve control. With it gone, Dr. O began the work of finding all the facial nerve branches and assembling them to reanimate the child’s face.
Before medicine, Dr. O trained as an architect, which, according to Dr. Waner, has equipped her with very good spatial awareness – a valuable skill in the surgical reconstruction phase. After seeing a lecture by Dr. Waner, she immediately saw a fit for her unique interest and skill set. She did fellowship training with Dr. Waner in vascular anomalies, and then went on to specialize in facial nerve reanimation. The proof of Dr. O’s expertise is Negalem’s new, beautiful smile, Dr. Waner said.
The surgery drew out over 8 hours, as long as a day of surgeries for the two doctors. When Dr. O finally walked into the waiting room to inform the family of the success, the first words out of the father’s mouth were: “Is my daughter alive?”
A growth like Negalem had is not compatible with a normal life. Dr. Waner’s mantra is that every child has the right to look normal. But this case went beyond aesthetics. If the growth hadn’t been removed, the child was expected to live only 4-6 more years, Dr. Waner said. Without the surgery, she could have suffocated, starved without the ability to swallow, or suffered a fatal bleed.
Dr. O and Dr. Waner are uniquely equipped to do this kind of work, but both are adamant that treating vascular anomalies is a multidisciplinary, multimodal approach. Specialties in anesthesiology, radiology, lasers, facial nerves – they are all critical to these procedures. And often patients with these kinds of lesions require medical and radiologic interventions in addition to surgery. In this particular case, from logistics to post op, “it was a lot of teamwork,” Dr. O said, “a lot of international teams coming together.”
Though extremely difficult, “in the end the result was exactly what we wanted,” Dr. Waner said. Negalem can live a normal life. And as for the surgical duo, both feel very fortunate to do this work. Dr. O said, “I’m honored to have found this specialty and to be able to train with and work with Milton. I’m so happy to do what I do every day.”
A version of this article first appeared on Medscape.com.
In 2019, doctors in London saw a 5-year old girl from rural Ethiopia with an enormous tumor extending from her cheek to her lower jaw. Her name was Negalem and the tumor was a vascular malformation, a life-threatening web of tangled blood vessels.
Surgery to remove it was impossible, the doctors told the foundation advocating for the girl. The child would never make it off the operating table. After a closer examination, the London group still declined to do the procedure, but told the child’s parents and advocates that if anyone was going to attempt this, they’d need to get the little girl to New York.
In New York City, on 64th St. in Manhattan, is the Vascular Birthmark Institute, founded by Milton Waner, MD, who has exclusively treated hemangiomas and vascular malformations for the last 30 years. “I’m the only person in the [United] States whose practice is exclusively [treating] vascular anomalies,” Dr. Waner said in an interview.
Dr. Waner has assembled a multidisciplinary team of experts at the institute’s offices in Lenox Hill – including his wife Teresa O, MD, a facial plastic and reconstructive surgeon and neurospecialist. “People often ask how the hell do you spend so much time with your spouse?” Dr. Waner says. “We work extremely well together. We complement each other.”
Dr. O and Dr. Waner each manage half of the cases at VBI. And in January they received an email about Negalem. After corresponding with the child’s advocate and reviewing images,
The challenge with vascular malformations in children, Dr. Waner said, is that they have a fraction of the blood an adult has. Where adults have an average of 5 L of blood, a child this age has only 1 L. To lose 200 or 300 mL of blood, “that’s 20% or 30% of their blood volume,” Dr. Waner said. So the removal of such a mass, which requires a meticulous dissection around many blood vessels, carries a high risk of the child bleeding out.
There were some logistical hurdles, but the patient arrived in Manhattan in mid-June, at no cost to her family. The medical visa was organized by a volunteer who also work for USAID. Healing the Children Northeast paid for her travel and the Waner Kids Foundation paid for her hotel stay. Lenox Hill Hospital and Northwell Health covered all hospital costs and postsurgery care. And Dr. O and Dr. Waner did the planning, consult visits, and procedure pro bono.
The surgery was possible because of the generosity of several organizations, but the two surgeons still had a limited time to remove the mass. Under different circumstances, and with the luxury of more time, the patient would have undergone several rounds of sclerotherapy. This procedure, done by interventional radiologists, involves injecting a toxin into the blood vessels, which causes them to clot. Done prior to surgery it can help limit bleeding risk.
On June 23, the morning of the surgery, the patient underwent one round of sclerotherapy. However, it didn’t have the intended effect, Dr. Waner said, “because the lesion was just so massive.”
The team had planned several of their moves ahead of time. But this isn’t the sort of surgery you’d find in a textbook. Because it’s such a unique field, Dr. Waner and Dr. O have developed many of their own techniques along the way. This patient was much like the cases they treat every day, only “several orders of magnitudes greater,” Dr. Waner said. “On a scale of 1 to 10 she was a 12.”
The morning of the surgery, “I was very apprehensive,” Dr. Waner recalled. He vividly remembers the girl’s father repeatedly kissing her to say goodbye as she lay on the operating table, fully aware that this procedure was a life-threatening one. And from the beginning there were challenges, like getting her under anesthesia when the anatomy of her mouth, deformed by the tumor, didn’t allow the anesthesiologists to use their typical tubing. Then, once the skin was removed, it became clear how dilated and tangled the involved blood vessels were. There were many vital structures tangled in the anomaly. “The jugular vein was right there. The carotid artery was right there,” Dr. Waner said. It was extremely difficult to delineate and preserve them, he said.
“That’s why we really took our time. We just went very slowly and deliberately,” Dr. O said. The blood vessels were so dilated that their only option was to move painstakingly slow – otherwise a small nick could be devastating.
But even with the slow pace the surgery was “excruciatingly difficult,” Dr. Waner said. And early on in the dissection he wasn’t quite sure they’d make it out. The sclerotherapy hadn’t done much to prevent bleeding. “At one point every millimeter or 2 that we advanced we got into some bleeding,” Dr. Waner said. “Brisk bleeding.”
Once they got into the surgery they also realized that the growth had adhered to the jaw bone. “There were vessels traversing into the bone, which were hard to control,” Dr. O said.
But finally, both doctors realized they’d be able to remove it. With the lesion removed they began the work of reconstruction and reanimation.
The child’s jaw and cheek bone had grown beyond their normal size to support the growth. They had to shave them down to achieve facial symmetry. The tumor had also inhibited much of the child’s facial nerve control. With it gone, Dr. O began the work of finding all the facial nerve branches and assembling them to reanimate the child’s face.
Before medicine, Dr. O trained as an architect, which, according to Dr. Waner, has equipped her with very good spatial awareness – a valuable skill in the surgical reconstruction phase. After seeing a lecture by Dr. Waner, she immediately saw a fit for her unique interest and skill set. She did fellowship training with Dr. Waner in vascular anomalies, and then went on to specialize in facial nerve reanimation. The proof of Dr. O’s expertise is Negalem’s new, beautiful smile, Dr. Waner said.
The surgery drew out over 8 hours, as long as a day of surgeries for the two doctors. When Dr. O finally walked into the waiting room to inform the family of the success, the first words out of the father’s mouth were: “Is my daughter alive?”
A growth like Negalem had is not compatible with a normal life. Dr. Waner’s mantra is that every child has the right to look normal. But this case went beyond aesthetics. If the growth hadn’t been removed, the child was expected to live only 4-6 more years, Dr. Waner said. Without the surgery, she could have suffocated, starved without the ability to swallow, or suffered a fatal bleed.
Dr. O and Dr. Waner are uniquely equipped to do this kind of work, but both are adamant that treating vascular anomalies is a multidisciplinary, multimodal approach. Specialties in anesthesiology, radiology, lasers, facial nerves – they are all critical to these procedures. And often patients with these kinds of lesions require medical and radiologic interventions in addition to surgery. In this particular case, from logistics to post op, “it was a lot of teamwork,” Dr. O said, “a lot of international teams coming together.”
Though extremely difficult, “in the end the result was exactly what we wanted,” Dr. Waner said. Negalem can live a normal life. And as for the surgical duo, both feel very fortunate to do this work. Dr. O said, “I’m honored to have found this specialty and to be able to train with and work with Milton. I’m so happy to do what I do every day.”
A version of this article first appeared on Medscape.com.