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If nuclear disaster strikes, U.S. hematologists stand ready
For many Americans – especially those too young to know much about the Cold War or Hiroshima – Russia’s invasion of Ukraine might mark the first time they’ve truly considered the dangers of nuclear weapons. But dozens of hematologists in the United States already know the drill and have placed themselves on the front lines. These physicians stand prepared to treat patients exposed to radiation caused by nuclear accidents or attacks on U.S. soil.
They work nationwide at 74 medical centers that make up the Radiation Injury Treatment Network, ready to manage cases of acute radiation syndrome (ARS) during disasters. While RITN keeps a low profile, it’s been in the news lately amid anxieties about the Ukraine conflict, nuclear plant accidents, and the potential launching of nuclear weapons by foreign adversaries.
“The Radiation Injury Treatment Network helps plan responses for disaster scenarios where a person’s cells would be damaged after having been exposed to ionizing radiation,” program director Cullen Case Jr., MPA, said in an interview.
A U.S. Army veteran who took part in hurricane response early in his career, Mr. Case now oversees preparedness activities among all RITN hospitals, blood donor centers, and cord blood banks, in readiness for a mass casualty radiological incident. He also serves as a senior manager of the National Marrow Donor Program/Be a Match Marrow Registry.
Intense preparation for nuclear attacks or accidents is necessary, Mr. Case said, despite the doomsday scenarios disseminated on television shows and movies.
“The most frequent misconception we hear is that a nuclear disaster will encompass the whole world and be so complete that preparedness isn’t useful. However, many planning scenarios include smaller-scale incidents where survivors will need prompt and expert care,” he said.
In the wake of 9/11, the National Marrow Donor Program and the American Society for Blood and Marrow Transplantation established the RITN in 2006, with a mission to prepare for nuclear disaster and help manage the response if one occurs.
“The widespread availability of radioactive material has made future exposure events, accidental or intentional, nearly inevitable,” RITN leaders warned in a 2008 report. “Hematologists, oncologists, and HSCT [hematopoietic stem cell transplantation] physicians are uniquely suited to care for victims of radiation exposure, creating a collective responsibility to prepare for a variety of contingencies.”
RITN doesn’t just train physicians, Mr. Case noted. All medical centers within the RITN are required to conduct an annual tabletop exercise where a radiation disaster scenario and a set of discussion questions are presented to the team.
Hematologists specially equipped to treat radiation injuries
Why are hematologists involved in treating people exposed to dangerously high levels of radiation? The answer has to do with how radiation harms the body, said Dr. Ann A. Jakubowski, a hematologist/oncologist and transplant physician at Memorial Sloan Kettering Cancer Center, New York, who serves as a medical director for RITN.
“One of the most common toxicities from radiation exposure and a major player in acute radiation syndrome is hematologic toxicity– damage to the bone marrow by the radiation, with a resultant decrease in peripheral blood counts,” she said in an interview. “This is similar to what is often seen in the treatment of cancers with radiation and/or chemotherapy.”
In cases of severe and nonreversible radiation damage to the bone marrow, Dr. Jakubowski noted, “patients can be considered for a stem cell transplant to provide new healthy cells to repopulate the bone marrow, which provides recovery of peripheral blood counts. Hematologist/oncologists are the physicians who manage stem cell transplants.”
The crucial role of hematologists in radiation injuries is not new. In fact, these physicians have been closely intertwined with nuclear research since the dawn of the atomic age. The work of developing atomic bombs also led investigators to an understanding of the structure and processes of hematopoiesis and helped them to identify hematopoietic stem cells and prove their existence in humans.
Disaster response poses multiple challenges
As noted in a recent article in ASH Clinical News, the challenges of treating radiation injuries would be intense, especially in the event of a nuclear accident or attack that affects a wide area. For starters, how quickly can medical professionals be mobilized, and will there be enough physicians comfortable treating patients? Fortunately, irradiated patients should not pose a direct risk to medical professionals who treat them.
“The expectation is that the patients will all be decontaminated,” said Nelson Chao, MD, MBA, one of the founders of RITN and a hematologist/oncologist and transplant physician at Duke University, Durham, N.C.
Dr. Jakubowski questions whether there will be adequate resources to handle the influx of patients who need more intensive treatment, as well as outpatients who “received lower doses of radiation and may experience a period of low blood counts but are expected to eventually recover blood counts.”
And if many people are injured, Dr. Chao asks, how will physicians “adopt altered standards of care to treat large numbers of patients?”
There will also be a need for physicians who aren’t hematologists, Dr. Jakubowski said. “There may be many victims who have both radiation exposure and traumatic or burn injuries, which need to be addressed first, before the hematologist can start addressing the consequences of ARS. Traumatic and burn injuries will require surgical resources.”
In addition, ARS affects the gastrointestinal track and central nervous system/cardiovascular, and it has multiple stages, she noted.
“Although we have methods of supporting the hematopoietic system – transfusions and growth factors – and even replacing it with a stem cell transplant, this will not necessarily fix the badly damaged other organs, Dr. Jakubowski said. “Also, not all radioactive isotopes are equal in their effects, nor are the various types of radiation exposure.”
Training goes beyond transplants and drugs
RITN offers individual hematologists specialized education about treating radiation injuries through annual exercises, modules, and “just-in-time” training.
For example, the RITN webpage devoted to triage includes guidelines for transferring radiation injury patients, triage guidelines for cytokine administration in cases of ARS, an exposure and symptom triage tool, and more. The treatment page includes details about subjects such as when human leukocyte antigen typing of casualties is appropriate and how to keep yourself safe while treating patients.
Another focus is teaching hematologists to react quickly in disasters, Mr. Case said. “The vast majority of hematologists have little to no experience in responding to disasters and making decisions with imperfect or incomplete information, as emergency medicine practitioners must do regularly.”
“Some of the RITN tabletop exercises present physicians and advanced practitioners with an incomplete set of patient information and ask physicians to then determine and prioritize their care,” Mr. Case said. “The resulting discussions help to lay the groundwork for being able to shift to the crisis standards of care mindset that would be necessary during a radiological disaster.”
Here’s how hematologists can get involved
If you want to help improve the nation’s response to radiation injuries, Mr. Case suggests checking RITN’s list of participating hospitals. If your facility is already part of this network, he said, contact its bone marrow transplant unit for more information.
In such cases, Dr. Jakubowski suggests that you “consider periodically giving a presentation to staff on the basics of radiation injury and the center’s role in RITN.” And if you’re not part of RITN, she said, consider contacting the network about becoming a member.
Hematologists, Mr. Case said, can also take advantage of RITN’s free short overview courses, review the RITN Treatment Guidelines, or watch short videos on the RITN’s YouTube channel.
He highlighted the Radiation Emergency Medical Management website administered by the Department of Health & Human Services, the Center for Disease Control’s radiation emergencies webpage, and the Department of Energy’s Radiation Emergency Assistance Center/Training Site.
For many Americans – especially those too young to know much about the Cold War or Hiroshima – Russia’s invasion of Ukraine might mark the first time they’ve truly considered the dangers of nuclear weapons. But dozens of hematologists in the United States already know the drill and have placed themselves on the front lines. These physicians stand prepared to treat patients exposed to radiation caused by nuclear accidents or attacks on U.S. soil.
They work nationwide at 74 medical centers that make up the Radiation Injury Treatment Network, ready to manage cases of acute radiation syndrome (ARS) during disasters. While RITN keeps a low profile, it’s been in the news lately amid anxieties about the Ukraine conflict, nuclear plant accidents, and the potential launching of nuclear weapons by foreign adversaries.
“The Radiation Injury Treatment Network helps plan responses for disaster scenarios where a person’s cells would be damaged after having been exposed to ionizing radiation,” program director Cullen Case Jr., MPA, said in an interview.
A U.S. Army veteran who took part in hurricane response early in his career, Mr. Case now oversees preparedness activities among all RITN hospitals, blood donor centers, and cord blood banks, in readiness for a mass casualty radiological incident. He also serves as a senior manager of the National Marrow Donor Program/Be a Match Marrow Registry.
Intense preparation for nuclear attacks or accidents is necessary, Mr. Case said, despite the doomsday scenarios disseminated on television shows and movies.
“The most frequent misconception we hear is that a nuclear disaster will encompass the whole world and be so complete that preparedness isn’t useful. However, many planning scenarios include smaller-scale incidents where survivors will need prompt and expert care,” he said.
In the wake of 9/11, the National Marrow Donor Program and the American Society for Blood and Marrow Transplantation established the RITN in 2006, with a mission to prepare for nuclear disaster and help manage the response if one occurs.
“The widespread availability of radioactive material has made future exposure events, accidental or intentional, nearly inevitable,” RITN leaders warned in a 2008 report. “Hematologists, oncologists, and HSCT [hematopoietic stem cell transplantation] physicians are uniquely suited to care for victims of radiation exposure, creating a collective responsibility to prepare for a variety of contingencies.”
RITN doesn’t just train physicians, Mr. Case noted. All medical centers within the RITN are required to conduct an annual tabletop exercise where a radiation disaster scenario and a set of discussion questions are presented to the team.
Hematologists specially equipped to treat radiation injuries
Why are hematologists involved in treating people exposed to dangerously high levels of radiation? The answer has to do with how radiation harms the body, said Dr. Ann A. Jakubowski, a hematologist/oncologist and transplant physician at Memorial Sloan Kettering Cancer Center, New York, who serves as a medical director for RITN.
“One of the most common toxicities from radiation exposure and a major player in acute radiation syndrome is hematologic toxicity– damage to the bone marrow by the radiation, with a resultant decrease in peripheral blood counts,” she said in an interview. “This is similar to what is often seen in the treatment of cancers with radiation and/or chemotherapy.”
In cases of severe and nonreversible radiation damage to the bone marrow, Dr. Jakubowski noted, “patients can be considered for a stem cell transplant to provide new healthy cells to repopulate the bone marrow, which provides recovery of peripheral blood counts. Hematologist/oncologists are the physicians who manage stem cell transplants.”
The crucial role of hematologists in radiation injuries is not new. In fact, these physicians have been closely intertwined with nuclear research since the dawn of the atomic age. The work of developing atomic bombs also led investigators to an understanding of the structure and processes of hematopoiesis and helped them to identify hematopoietic stem cells and prove their existence in humans.
Disaster response poses multiple challenges
As noted in a recent article in ASH Clinical News, the challenges of treating radiation injuries would be intense, especially in the event of a nuclear accident or attack that affects a wide area. For starters, how quickly can medical professionals be mobilized, and will there be enough physicians comfortable treating patients? Fortunately, irradiated patients should not pose a direct risk to medical professionals who treat them.
“The expectation is that the patients will all be decontaminated,” said Nelson Chao, MD, MBA, one of the founders of RITN and a hematologist/oncologist and transplant physician at Duke University, Durham, N.C.
Dr. Jakubowski questions whether there will be adequate resources to handle the influx of patients who need more intensive treatment, as well as outpatients who “received lower doses of radiation and may experience a period of low blood counts but are expected to eventually recover blood counts.”
And if many people are injured, Dr. Chao asks, how will physicians “adopt altered standards of care to treat large numbers of patients?”
There will also be a need for physicians who aren’t hematologists, Dr. Jakubowski said. “There may be many victims who have both radiation exposure and traumatic or burn injuries, which need to be addressed first, before the hematologist can start addressing the consequences of ARS. Traumatic and burn injuries will require surgical resources.”
In addition, ARS affects the gastrointestinal track and central nervous system/cardiovascular, and it has multiple stages, she noted.
“Although we have methods of supporting the hematopoietic system – transfusions and growth factors – and even replacing it with a stem cell transplant, this will not necessarily fix the badly damaged other organs, Dr. Jakubowski said. “Also, not all radioactive isotopes are equal in their effects, nor are the various types of radiation exposure.”
Training goes beyond transplants and drugs
RITN offers individual hematologists specialized education about treating radiation injuries through annual exercises, modules, and “just-in-time” training.
For example, the RITN webpage devoted to triage includes guidelines for transferring radiation injury patients, triage guidelines for cytokine administration in cases of ARS, an exposure and symptom triage tool, and more. The treatment page includes details about subjects such as when human leukocyte antigen typing of casualties is appropriate and how to keep yourself safe while treating patients.
Another focus is teaching hematologists to react quickly in disasters, Mr. Case said. “The vast majority of hematologists have little to no experience in responding to disasters and making decisions with imperfect or incomplete information, as emergency medicine practitioners must do regularly.”
“Some of the RITN tabletop exercises present physicians and advanced practitioners with an incomplete set of patient information and ask physicians to then determine and prioritize their care,” Mr. Case said. “The resulting discussions help to lay the groundwork for being able to shift to the crisis standards of care mindset that would be necessary during a radiological disaster.”
Here’s how hematologists can get involved
If you want to help improve the nation’s response to radiation injuries, Mr. Case suggests checking RITN’s list of participating hospitals. If your facility is already part of this network, he said, contact its bone marrow transplant unit for more information.
In such cases, Dr. Jakubowski suggests that you “consider periodically giving a presentation to staff on the basics of radiation injury and the center’s role in RITN.” And if you’re not part of RITN, she said, consider contacting the network about becoming a member.
Hematologists, Mr. Case said, can also take advantage of RITN’s free short overview courses, review the RITN Treatment Guidelines, or watch short videos on the RITN’s YouTube channel.
He highlighted the Radiation Emergency Medical Management website administered by the Department of Health & Human Services, the Center for Disease Control’s radiation emergencies webpage, and the Department of Energy’s Radiation Emergency Assistance Center/Training Site.
For many Americans – especially those too young to know much about the Cold War or Hiroshima – Russia’s invasion of Ukraine might mark the first time they’ve truly considered the dangers of nuclear weapons. But dozens of hematologists in the United States already know the drill and have placed themselves on the front lines. These physicians stand prepared to treat patients exposed to radiation caused by nuclear accidents or attacks on U.S. soil.
They work nationwide at 74 medical centers that make up the Radiation Injury Treatment Network, ready to manage cases of acute radiation syndrome (ARS) during disasters. While RITN keeps a low profile, it’s been in the news lately amid anxieties about the Ukraine conflict, nuclear plant accidents, and the potential launching of nuclear weapons by foreign adversaries.
“The Radiation Injury Treatment Network helps plan responses for disaster scenarios where a person’s cells would be damaged after having been exposed to ionizing radiation,” program director Cullen Case Jr., MPA, said in an interview.
A U.S. Army veteran who took part in hurricane response early in his career, Mr. Case now oversees preparedness activities among all RITN hospitals, blood donor centers, and cord blood banks, in readiness for a mass casualty radiological incident. He also serves as a senior manager of the National Marrow Donor Program/Be a Match Marrow Registry.
Intense preparation for nuclear attacks or accidents is necessary, Mr. Case said, despite the doomsday scenarios disseminated on television shows and movies.
“The most frequent misconception we hear is that a nuclear disaster will encompass the whole world and be so complete that preparedness isn’t useful. However, many planning scenarios include smaller-scale incidents where survivors will need prompt and expert care,” he said.
In the wake of 9/11, the National Marrow Donor Program and the American Society for Blood and Marrow Transplantation established the RITN in 2006, with a mission to prepare for nuclear disaster and help manage the response if one occurs.
“The widespread availability of radioactive material has made future exposure events, accidental or intentional, nearly inevitable,” RITN leaders warned in a 2008 report. “Hematologists, oncologists, and HSCT [hematopoietic stem cell transplantation] physicians are uniquely suited to care for victims of radiation exposure, creating a collective responsibility to prepare for a variety of contingencies.”
RITN doesn’t just train physicians, Mr. Case noted. All medical centers within the RITN are required to conduct an annual tabletop exercise where a radiation disaster scenario and a set of discussion questions are presented to the team.
Hematologists specially equipped to treat radiation injuries
Why are hematologists involved in treating people exposed to dangerously high levels of radiation? The answer has to do with how radiation harms the body, said Dr. Ann A. Jakubowski, a hematologist/oncologist and transplant physician at Memorial Sloan Kettering Cancer Center, New York, who serves as a medical director for RITN.
“One of the most common toxicities from radiation exposure and a major player in acute radiation syndrome is hematologic toxicity– damage to the bone marrow by the radiation, with a resultant decrease in peripheral blood counts,” she said in an interview. “This is similar to what is often seen in the treatment of cancers with radiation and/or chemotherapy.”
In cases of severe and nonreversible radiation damage to the bone marrow, Dr. Jakubowski noted, “patients can be considered for a stem cell transplant to provide new healthy cells to repopulate the bone marrow, which provides recovery of peripheral blood counts. Hematologist/oncologists are the physicians who manage stem cell transplants.”
The crucial role of hematologists in radiation injuries is not new. In fact, these physicians have been closely intertwined with nuclear research since the dawn of the atomic age. The work of developing atomic bombs also led investigators to an understanding of the structure and processes of hematopoiesis and helped them to identify hematopoietic stem cells and prove their existence in humans.
Disaster response poses multiple challenges
As noted in a recent article in ASH Clinical News, the challenges of treating radiation injuries would be intense, especially in the event of a nuclear accident or attack that affects a wide area. For starters, how quickly can medical professionals be mobilized, and will there be enough physicians comfortable treating patients? Fortunately, irradiated patients should not pose a direct risk to medical professionals who treat them.
“The expectation is that the patients will all be decontaminated,” said Nelson Chao, MD, MBA, one of the founders of RITN and a hematologist/oncologist and transplant physician at Duke University, Durham, N.C.
Dr. Jakubowski questions whether there will be adequate resources to handle the influx of patients who need more intensive treatment, as well as outpatients who “received lower doses of radiation and may experience a period of low blood counts but are expected to eventually recover blood counts.”
And if many people are injured, Dr. Chao asks, how will physicians “adopt altered standards of care to treat large numbers of patients?”
There will also be a need for physicians who aren’t hematologists, Dr. Jakubowski said. “There may be many victims who have both radiation exposure and traumatic or burn injuries, which need to be addressed first, before the hematologist can start addressing the consequences of ARS. Traumatic and burn injuries will require surgical resources.”
In addition, ARS affects the gastrointestinal track and central nervous system/cardiovascular, and it has multiple stages, she noted.
“Although we have methods of supporting the hematopoietic system – transfusions and growth factors – and even replacing it with a stem cell transplant, this will not necessarily fix the badly damaged other organs, Dr. Jakubowski said. “Also, not all radioactive isotopes are equal in their effects, nor are the various types of radiation exposure.”
Training goes beyond transplants and drugs
RITN offers individual hematologists specialized education about treating radiation injuries through annual exercises, modules, and “just-in-time” training.
For example, the RITN webpage devoted to triage includes guidelines for transferring radiation injury patients, triage guidelines for cytokine administration in cases of ARS, an exposure and symptom triage tool, and more. The treatment page includes details about subjects such as when human leukocyte antigen typing of casualties is appropriate and how to keep yourself safe while treating patients.
Another focus is teaching hematologists to react quickly in disasters, Mr. Case said. “The vast majority of hematologists have little to no experience in responding to disasters and making decisions with imperfect or incomplete information, as emergency medicine practitioners must do regularly.”
“Some of the RITN tabletop exercises present physicians and advanced practitioners with an incomplete set of patient information and ask physicians to then determine and prioritize their care,” Mr. Case said. “The resulting discussions help to lay the groundwork for being able to shift to the crisis standards of care mindset that would be necessary during a radiological disaster.”
Here’s how hematologists can get involved
If you want to help improve the nation’s response to radiation injuries, Mr. Case suggests checking RITN’s list of participating hospitals. If your facility is already part of this network, he said, contact its bone marrow transplant unit for more information.
In such cases, Dr. Jakubowski suggests that you “consider periodically giving a presentation to staff on the basics of radiation injury and the center’s role in RITN.” And if you’re not part of RITN, she said, consider contacting the network about becoming a member.
Hematologists, Mr. Case said, can also take advantage of RITN’s free short overview courses, review the RITN Treatment Guidelines, or watch short videos on the RITN’s YouTube channel.
He highlighted the Radiation Emergency Medical Management website administered by the Department of Health & Human Services, the Center for Disease Control’s radiation emergencies webpage, and the Department of Energy’s Radiation Emergency Assistance Center/Training Site.
Telemental health linked with improvements in key outcomes
, new research suggests.
In a nationwide study, researchers drew on Medicare data from nearly 3,000 counties covering the period from 2000 to 2018. Results show that counties in which there was greater use of telemental health services reported higher increases of clinical visits and better follow-up after hospitalization among patients with bipolar 1 disorder and schizophrenia or other psychotic disorders.
In the study, “clinical visits” referred to both in-person and telemental health visits.
“These findings really support the idea that telemental health can be safe and effective and beneficial for in-person care for people with severe mental illness,” coinvestigator Haiden Huskamp, PhD, professor of health care policy at Harvard Medical School, Boston, said in an interview.
The findings were published online in JAMA Network Open.
Continuing trend?
Past studies have pointed to a sharp increase in the use of telepsychiatry services for patients with SMI. As reported by this news organization, this is a trend some clinicians say is likely to continue after the pandemic.
Use of telemedicine during the pandemic received a boost by the temporary suspension of certain Medicare rules that restrict telehealth use. Debate continues at the federal and state levels on whether to make that suspension permanent. Dr. Huskamp said more information is needed about the efficacy and accessibility of telemental health.
To investigate, researchers used Medicare fee-for-service data from 118,170 patients in 2,916 counties. More than two-thirds of the patients were aged 65 years or younger.
During the study period, telemental health service increased from 0.03 visits per patient with SMI in 2010 to 0.19 visits per patient in 2018. This increase was broad, with the number of counties reporting high use of telemental health increasing from 2% in 2010 to 17% in 2018.
Compared with counties in which there was no telemental health services, those with high use were less densely populated and had fewer health care professionals and hospital beds.
The number of overall visits with a mental health professional increased slightly in high-use counties compared to no-use counties, from 4.65 visits in 2010 to 4.79 visits in 2018. The number of in-person visits during that period declined from 4.55 visits in 2010 to 3.73 visits in 2018, which suggests that the overall increase was due to higher use of telemental health.
In the high-use group, the number of patients who had at least four mental health care visits increased 8%, and the number of patients who had a follow-up visit within 30 days of a hospitalization increased 20.4%.
A ‘helpful option’
“Telemedicine doesn’t address the national shortage of providers, but it definitely helps in underserved areas [and] rural areas,” Dr. Huskamp said.
“We need more mental health providers and need to develop new models of care that can leverage the providers we have in the best way possible. This is at least a helpful option, especially when you’re thinking about the maldistribution of providers across the country,” she added.
The study results showed that there was no difference in medication adherence between low- and high-use counties.
There was greater contact with mental health care providers in counties with high use of telemental health, and patients in the high-use group were 7.6% more likely to be hospitalized within a year compared with their peers in counties that had no telemental health use.
“We did see modest increases in inpatient use in counties that shifted the most to telemental health services, but that’s not typically viewed as a measure of quality because it can mean so many different things,” Dr. Huskamp said.
For example, it could mean that counties with greater telemental health use did a better job of identifying and responding to patients’ need for acute care, she noted. It could also be a reflection of the loss of psychiatric inpatient care in low-use communities.
Another tool
Commenting on the findings, Robert Caudill, MD, director of Telemedicine and Information Technology Programs at the University of Louisville (Ky.), called the increase in hospitalization in high-use counties “surprising.” However, he noted it might be a reflection of the need to fine-tune telemental health for patients with SMI.
“I think that more time and experience with telehealth will further normalize the practice and help to narrow, if not close, the gap,” said Dr. Caudill, who was not involved with the research.
“There are so many side benefits to doing things via telehealth,” he added. “It is a simple matter of continuing to learn how to do those things better.”
A multidisciplinary approach that includes psychiatric care and case management is generally considered to be the gold standard in treating patients with the types of mental illness included in this study, Dr. Caudill said.
While some of that care can be delivered effectively via telemedicine, it is possible other aspects, such as case management, are better handled in person, he added.
“I don’t think it is the role of telehealth to make in-person care obsolete. It is simply a tool to be used when appropriate,” said Dr. Caudill, past chair of the American Telemedicine Association’s Telemental Health Special Interest Group.
“Surgeons did not abandon scalpels when laser surgery became possible,” he said.
The study was funded by the National Institutes of Mental Health. Dr. Huskamp and Dr. Caudill report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In a nationwide study, researchers drew on Medicare data from nearly 3,000 counties covering the period from 2000 to 2018. Results show that counties in which there was greater use of telemental health services reported higher increases of clinical visits and better follow-up after hospitalization among patients with bipolar 1 disorder and schizophrenia or other psychotic disorders.
In the study, “clinical visits” referred to both in-person and telemental health visits.
“These findings really support the idea that telemental health can be safe and effective and beneficial for in-person care for people with severe mental illness,” coinvestigator Haiden Huskamp, PhD, professor of health care policy at Harvard Medical School, Boston, said in an interview.
The findings were published online in JAMA Network Open.
Continuing trend?
Past studies have pointed to a sharp increase in the use of telepsychiatry services for patients with SMI. As reported by this news organization, this is a trend some clinicians say is likely to continue after the pandemic.
Use of telemedicine during the pandemic received a boost by the temporary suspension of certain Medicare rules that restrict telehealth use. Debate continues at the federal and state levels on whether to make that suspension permanent. Dr. Huskamp said more information is needed about the efficacy and accessibility of telemental health.
To investigate, researchers used Medicare fee-for-service data from 118,170 patients in 2,916 counties. More than two-thirds of the patients were aged 65 years or younger.
During the study period, telemental health service increased from 0.03 visits per patient with SMI in 2010 to 0.19 visits per patient in 2018. This increase was broad, with the number of counties reporting high use of telemental health increasing from 2% in 2010 to 17% in 2018.
Compared with counties in which there was no telemental health services, those with high use were less densely populated and had fewer health care professionals and hospital beds.
The number of overall visits with a mental health professional increased slightly in high-use counties compared to no-use counties, from 4.65 visits in 2010 to 4.79 visits in 2018. The number of in-person visits during that period declined from 4.55 visits in 2010 to 3.73 visits in 2018, which suggests that the overall increase was due to higher use of telemental health.
In the high-use group, the number of patients who had at least four mental health care visits increased 8%, and the number of patients who had a follow-up visit within 30 days of a hospitalization increased 20.4%.
A ‘helpful option’
“Telemedicine doesn’t address the national shortage of providers, but it definitely helps in underserved areas [and] rural areas,” Dr. Huskamp said.
“We need more mental health providers and need to develop new models of care that can leverage the providers we have in the best way possible. This is at least a helpful option, especially when you’re thinking about the maldistribution of providers across the country,” she added.
The study results showed that there was no difference in medication adherence between low- and high-use counties.
There was greater contact with mental health care providers in counties with high use of telemental health, and patients in the high-use group were 7.6% more likely to be hospitalized within a year compared with their peers in counties that had no telemental health use.
“We did see modest increases in inpatient use in counties that shifted the most to telemental health services, but that’s not typically viewed as a measure of quality because it can mean so many different things,” Dr. Huskamp said.
For example, it could mean that counties with greater telemental health use did a better job of identifying and responding to patients’ need for acute care, she noted. It could also be a reflection of the loss of psychiatric inpatient care in low-use communities.
Another tool
Commenting on the findings, Robert Caudill, MD, director of Telemedicine and Information Technology Programs at the University of Louisville (Ky.), called the increase in hospitalization in high-use counties “surprising.” However, he noted it might be a reflection of the need to fine-tune telemental health for patients with SMI.
“I think that more time and experience with telehealth will further normalize the practice and help to narrow, if not close, the gap,” said Dr. Caudill, who was not involved with the research.
“There are so many side benefits to doing things via telehealth,” he added. “It is a simple matter of continuing to learn how to do those things better.”
A multidisciplinary approach that includes psychiatric care and case management is generally considered to be the gold standard in treating patients with the types of mental illness included in this study, Dr. Caudill said.
While some of that care can be delivered effectively via telemedicine, it is possible other aspects, such as case management, are better handled in person, he added.
“I don’t think it is the role of telehealth to make in-person care obsolete. It is simply a tool to be used when appropriate,” said Dr. Caudill, past chair of the American Telemedicine Association’s Telemental Health Special Interest Group.
“Surgeons did not abandon scalpels when laser surgery became possible,” he said.
The study was funded by the National Institutes of Mental Health. Dr. Huskamp and Dr. Caudill report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In a nationwide study, researchers drew on Medicare data from nearly 3,000 counties covering the period from 2000 to 2018. Results show that counties in which there was greater use of telemental health services reported higher increases of clinical visits and better follow-up after hospitalization among patients with bipolar 1 disorder and schizophrenia or other psychotic disorders.
In the study, “clinical visits” referred to both in-person and telemental health visits.
“These findings really support the idea that telemental health can be safe and effective and beneficial for in-person care for people with severe mental illness,” coinvestigator Haiden Huskamp, PhD, professor of health care policy at Harvard Medical School, Boston, said in an interview.
The findings were published online in JAMA Network Open.
Continuing trend?
Past studies have pointed to a sharp increase in the use of telepsychiatry services for patients with SMI. As reported by this news organization, this is a trend some clinicians say is likely to continue after the pandemic.
Use of telemedicine during the pandemic received a boost by the temporary suspension of certain Medicare rules that restrict telehealth use. Debate continues at the federal and state levels on whether to make that suspension permanent. Dr. Huskamp said more information is needed about the efficacy and accessibility of telemental health.
To investigate, researchers used Medicare fee-for-service data from 118,170 patients in 2,916 counties. More than two-thirds of the patients were aged 65 years or younger.
During the study period, telemental health service increased from 0.03 visits per patient with SMI in 2010 to 0.19 visits per patient in 2018. This increase was broad, with the number of counties reporting high use of telemental health increasing from 2% in 2010 to 17% in 2018.
Compared with counties in which there was no telemental health services, those with high use were less densely populated and had fewer health care professionals and hospital beds.
The number of overall visits with a mental health professional increased slightly in high-use counties compared to no-use counties, from 4.65 visits in 2010 to 4.79 visits in 2018. The number of in-person visits during that period declined from 4.55 visits in 2010 to 3.73 visits in 2018, which suggests that the overall increase was due to higher use of telemental health.
In the high-use group, the number of patients who had at least four mental health care visits increased 8%, and the number of patients who had a follow-up visit within 30 days of a hospitalization increased 20.4%.
A ‘helpful option’
“Telemedicine doesn’t address the national shortage of providers, but it definitely helps in underserved areas [and] rural areas,” Dr. Huskamp said.
“We need more mental health providers and need to develop new models of care that can leverage the providers we have in the best way possible. This is at least a helpful option, especially when you’re thinking about the maldistribution of providers across the country,” she added.
The study results showed that there was no difference in medication adherence between low- and high-use counties.
There was greater contact with mental health care providers in counties with high use of telemental health, and patients in the high-use group were 7.6% more likely to be hospitalized within a year compared with their peers in counties that had no telemental health use.
“We did see modest increases in inpatient use in counties that shifted the most to telemental health services, but that’s not typically viewed as a measure of quality because it can mean so many different things,” Dr. Huskamp said.
For example, it could mean that counties with greater telemental health use did a better job of identifying and responding to patients’ need for acute care, she noted. It could also be a reflection of the loss of psychiatric inpatient care in low-use communities.
Another tool
Commenting on the findings, Robert Caudill, MD, director of Telemedicine and Information Technology Programs at the University of Louisville (Ky.), called the increase in hospitalization in high-use counties “surprising.” However, he noted it might be a reflection of the need to fine-tune telemental health for patients with SMI.
“I think that more time and experience with telehealth will further normalize the practice and help to narrow, if not close, the gap,” said Dr. Caudill, who was not involved with the research.
“There are so many side benefits to doing things via telehealth,” he added. “It is a simple matter of continuing to learn how to do those things better.”
A multidisciplinary approach that includes psychiatric care and case management is generally considered to be the gold standard in treating patients with the types of mental illness included in this study, Dr. Caudill said.
While some of that care can be delivered effectively via telemedicine, it is possible other aspects, such as case management, are better handled in person, he added.
“I don’t think it is the role of telehealth to make in-person care obsolete. It is simply a tool to be used when appropriate,” said Dr. Caudill, past chair of the American Telemedicine Association’s Telemental Health Special Interest Group.
“Surgeons did not abandon scalpels when laser surgery became possible,” he said.
The study was funded by the National Institutes of Mental Health. Dr. Huskamp and Dr. Caudill report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Sociogenomics may explain race disparities in breast cancer mortality
Racial differences in cancer outcomes are widespread. Studies indicate that Black people face higher rates of mortality for most cancers than their White counterparts. To bridge this racial gap, researchers need to investigate the biological effects of structural racism and discrimination on cancer outcomes, experts say.
“As a physician, I always like to think that I can influence care in that if I just find the right drugs, help patients understand what their options are, it will help them,” said Ruth Carlos, MD, a radiologist with the University of Michigan Hospital, Ann Arbor. But these things alone are often not enough, because a large proportion of the variation in cancer outcomes is attributable to neighborhood social conditions and the physical environment. “It is incredibly important for us to start to understand just how the neighborhood exerts this effect.”
In a commentary published in the Journal of Clinical Oncology, Dr. Carlos and colleagues highlighted the limitations of previous studies aimed at identifying the causes of racial differences in cancer outcomes. They call upon researchers to turn instead to the long-underexamined biological effects of structural racism and discrimination that contribute to these differences.
In the past, studies on the role of race in health outcomes largely looked at race as a proxy for genetic predisposition. But such an interpretation is flawed, because no genes are specific for a racial or ethnic group, Dr. Carlos and coauthors wrote. Researchers have shown that the vast majority of genetic variation occurs within, rather than between groups.
In an analysis published in Science, researchers reported that within-group differences account for more than 90% of genetic variation.
“Using race in these analyses was not necessarily wrong, but the inferences may have been flawed or incomplete,” Dr. Carlos said. On one hand, looking at genetic predisposition has led to important insights, such as the link between mutations in the BRCA gene and increased risk for breast and ovarian cancer.
However, genetic variation alone is not enough to explain the disparities in cancer outcomes between racial and ethnic groups. The fact that breast cancer can be more aggressive in Black women raises several questions, Dr. Carlos said. Is the cancer worse because Black women have a specific genetic predisposition? Is it worse because Black women exist in a society that marginalizes them and exposes them to increased stress, which in turn produces bad outcomes? Or, could it be both?
Despite progress in the screening, diagnosis and treatment of breast cancer, Black women are 40% more likely to die from the disease than White women. At the time of diagnosis, Black women are more likely to have high-grade, more aggressive breast cancer molecular subtypes, and to have had their cancer spread to the lymph nodes. They also tend to be diagnosed at more advanced stages of breast cancer while at the same time, experience higher rates of false-positive screening results.
Although researchers have hypothesized that genetic differences related to African or European ancestry might contribute, studies have not turned up any differences in cancer susceptibility genes by race. Other factors, such as racial differences in the stage of presentation, molecular subtypes, and disparities in treatment, have also emerged as potential culprits.
In her commentary, Dr. Carlos and colleagues wrote that disparities in breast cancer outcomes previously attributed to race need to be examined from multiple angles. This means looking at both the complex interactions between social conditions and policies, which encompass racism both at the individual and structural level, and stressors such as the experience of discrimination in addition to potential biological and genetic contributions.
Many studies now provide evidence for the harmful effects of racism on health. For breast cancer, specifically, studies also suggest that factors such as racial segregation can influence the stage at which Black women get diagnosed and their likelihood of dying from the disease.
However, an important question that remains is what biological changes occur in women exposed to the kind of persistent low-level stress that is associated with structural racism and discrimination, Dr. Carlos said. “We don’t know what stress pathways actually manifest in the body and how they eventually produce the disease.” Studies to address this issue are important, “especially if you would like to develop interventions to prevent or mitigate disease.”
To address this issue, Dr. Carlos and colleagues called upon the research community to conduct both studies that delineate the underlying biology as well as those that test potential interventions – particularly those associated with breast cancer screening outcomes – to try to shed light on why Black women receive more false positives and diagnoses of more aggressive cancer.
Interventions that can target these specific biological pathways could potentially reduce the negative effects of structural racism and discrimination as well as the effects of other social factors that contribute to breast cancer outcomes, “to ultimately help enhance clinical outcomes and close persistent disparities gaps,” the authors wrote.
Racial differences in cancer outcomes are widespread. Studies indicate that Black people face higher rates of mortality for most cancers than their White counterparts. To bridge this racial gap, researchers need to investigate the biological effects of structural racism and discrimination on cancer outcomes, experts say.
“As a physician, I always like to think that I can influence care in that if I just find the right drugs, help patients understand what their options are, it will help them,” said Ruth Carlos, MD, a radiologist with the University of Michigan Hospital, Ann Arbor. But these things alone are often not enough, because a large proportion of the variation in cancer outcomes is attributable to neighborhood social conditions and the physical environment. “It is incredibly important for us to start to understand just how the neighborhood exerts this effect.”
In a commentary published in the Journal of Clinical Oncology, Dr. Carlos and colleagues highlighted the limitations of previous studies aimed at identifying the causes of racial differences in cancer outcomes. They call upon researchers to turn instead to the long-underexamined biological effects of structural racism and discrimination that contribute to these differences.
In the past, studies on the role of race in health outcomes largely looked at race as a proxy for genetic predisposition. But such an interpretation is flawed, because no genes are specific for a racial or ethnic group, Dr. Carlos and coauthors wrote. Researchers have shown that the vast majority of genetic variation occurs within, rather than between groups.
In an analysis published in Science, researchers reported that within-group differences account for more than 90% of genetic variation.
“Using race in these analyses was not necessarily wrong, but the inferences may have been flawed or incomplete,” Dr. Carlos said. On one hand, looking at genetic predisposition has led to important insights, such as the link between mutations in the BRCA gene and increased risk for breast and ovarian cancer.
However, genetic variation alone is not enough to explain the disparities in cancer outcomes between racial and ethnic groups. The fact that breast cancer can be more aggressive in Black women raises several questions, Dr. Carlos said. Is the cancer worse because Black women have a specific genetic predisposition? Is it worse because Black women exist in a society that marginalizes them and exposes them to increased stress, which in turn produces bad outcomes? Or, could it be both?
Despite progress in the screening, diagnosis and treatment of breast cancer, Black women are 40% more likely to die from the disease than White women. At the time of diagnosis, Black women are more likely to have high-grade, more aggressive breast cancer molecular subtypes, and to have had their cancer spread to the lymph nodes. They also tend to be diagnosed at more advanced stages of breast cancer while at the same time, experience higher rates of false-positive screening results.
Although researchers have hypothesized that genetic differences related to African or European ancestry might contribute, studies have not turned up any differences in cancer susceptibility genes by race. Other factors, such as racial differences in the stage of presentation, molecular subtypes, and disparities in treatment, have also emerged as potential culprits.
In her commentary, Dr. Carlos and colleagues wrote that disparities in breast cancer outcomes previously attributed to race need to be examined from multiple angles. This means looking at both the complex interactions between social conditions and policies, which encompass racism both at the individual and structural level, and stressors such as the experience of discrimination in addition to potential biological and genetic contributions.
Many studies now provide evidence for the harmful effects of racism on health. For breast cancer, specifically, studies also suggest that factors such as racial segregation can influence the stage at which Black women get diagnosed and their likelihood of dying from the disease.
However, an important question that remains is what biological changes occur in women exposed to the kind of persistent low-level stress that is associated with structural racism and discrimination, Dr. Carlos said. “We don’t know what stress pathways actually manifest in the body and how they eventually produce the disease.” Studies to address this issue are important, “especially if you would like to develop interventions to prevent or mitigate disease.”
To address this issue, Dr. Carlos and colleagues called upon the research community to conduct both studies that delineate the underlying biology as well as those that test potential interventions – particularly those associated with breast cancer screening outcomes – to try to shed light on why Black women receive more false positives and diagnoses of more aggressive cancer.
Interventions that can target these specific biological pathways could potentially reduce the negative effects of structural racism and discrimination as well as the effects of other social factors that contribute to breast cancer outcomes, “to ultimately help enhance clinical outcomes and close persistent disparities gaps,” the authors wrote.
Racial differences in cancer outcomes are widespread. Studies indicate that Black people face higher rates of mortality for most cancers than their White counterparts. To bridge this racial gap, researchers need to investigate the biological effects of structural racism and discrimination on cancer outcomes, experts say.
“As a physician, I always like to think that I can influence care in that if I just find the right drugs, help patients understand what their options are, it will help them,” said Ruth Carlos, MD, a radiologist with the University of Michigan Hospital, Ann Arbor. But these things alone are often not enough, because a large proportion of the variation in cancer outcomes is attributable to neighborhood social conditions and the physical environment. “It is incredibly important for us to start to understand just how the neighborhood exerts this effect.”
In a commentary published in the Journal of Clinical Oncology, Dr. Carlos and colleagues highlighted the limitations of previous studies aimed at identifying the causes of racial differences in cancer outcomes. They call upon researchers to turn instead to the long-underexamined biological effects of structural racism and discrimination that contribute to these differences.
In the past, studies on the role of race in health outcomes largely looked at race as a proxy for genetic predisposition. But such an interpretation is flawed, because no genes are specific for a racial or ethnic group, Dr. Carlos and coauthors wrote. Researchers have shown that the vast majority of genetic variation occurs within, rather than between groups.
In an analysis published in Science, researchers reported that within-group differences account for more than 90% of genetic variation.
“Using race in these analyses was not necessarily wrong, but the inferences may have been flawed or incomplete,” Dr. Carlos said. On one hand, looking at genetic predisposition has led to important insights, such as the link between mutations in the BRCA gene and increased risk for breast and ovarian cancer.
However, genetic variation alone is not enough to explain the disparities in cancer outcomes between racial and ethnic groups. The fact that breast cancer can be more aggressive in Black women raises several questions, Dr. Carlos said. Is the cancer worse because Black women have a specific genetic predisposition? Is it worse because Black women exist in a society that marginalizes them and exposes them to increased stress, which in turn produces bad outcomes? Or, could it be both?
Despite progress in the screening, diagnosis and treatment of breast cancer, Black women are 40% more likely to die from the disease than White women. At the time of diagnosis, Black women are more likely to have high-grade, more aggressive breast cancer molecular subtypes, and to have had their cancer spread to the lymph nodes. They also tend to be diagnosed at more advanced stages of breast cancer while at the same time, experience higher rates of false-positive screening results.
Although researchers have hypothesized that genetic differences related to African or European ancestry might contribute, studies have not turned up any differences in cancer susceptibility genes by race. Other factors, such as racial differences in the stage of presentation, molecular subtypes, and disparities in treatment, have also emerged as potential culprits.
In her commentary, Dr. Carlos and colleagues wrote that disparities in breast cancer outcomes previously attributed to race need to be examined from multiple angles. This means looking at both the complex interactions between social conditions and policies, which encompass racism both at the individual and structural level, and stressors such as the experience of discrimination in addition to potential biological and genetic contributions.
Many studies now provide evidence for the harmful effects of racism on health. For breast cancer, specifically, studies also suggest that factors such as racial segregation can influence the stage at which Black women get diagnosed and their likelihood of dying from the disease.
However, an important question that remains is what biological changes occur in women exposed to the kind of persistent low-level stress that is associated with structural racism and discrimination, Dr. Carlos said. “We don’t know what stress pathways actually manifest in the body and how they eventually produce the disease.” Studies to address this issue are important, “especially if you would like to develop interventions to prevent or mitigate disease.”
To address this issue, Dr. Carlos and colleagues called upon the research community to conduct both studies that delineate the underlying biology as well as those that test potential interventions – particularly those associated with breast cancer screening outcomes – to try to shed light on why Black women receive more false positives and diagnoses of more aggressive cancer.
Interventions that can target these specific biological pathways could potentially reduce the negative effects of structural racism and discrimination as well as the effects of other social factors that contribute to breast cancer outcomes, “to ultimately help enhance clinical outcomes and close persistent disparities gaps,” the authors wrote.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Doctor who lied about his age sentenced to 3 years for killing woman with botched marrow procedure
A mother-of-three was killed at her hospital appointment in the United Kingdom by a doctor who botched a routine procedure, a court has heard. On July 5, Dr. Isyaka Mamman was sentenced at Manchester Crown Court to 3 years imprisonment after pleading guilty to the manslaughter by gross negligence of his patient.
Dr. Mamman, 85, had already been suspended once by medical watchdogs for lying about his age and was sacked but then re-employed by the Royal Oldham Hospital, where he was responsible for a series of critical incidents before the fatal appointment, Manchester Crown Court heard.
The Nigerian-born doctor had also used various dates of birth and left his previous job through “poor performance.”
‘Highly dangerous’ procedure
Shahida Parveen, 48, had gone to the hospital with her husband, Khizar Mahmood, for investigations into possible myeloproliferative disorder.
A bone marrow biopsy had been advised and the routine procedure was allocated to Dr. Mamman, who was working as a specialty doctor in hematology, Andrew Thomas QC, prosecuting, told the hearing.
Normally, bone marrow samples are taken from the hip bone but Dr. Mamman failed to obtain a sample at the first attempt.
Instead, he attempted a rare and “highly dangerous” procedure of getting a sample from Ms. Parveen’s sternum – despite objections from the patient and her husband.
Dr. Mamman, using the wrong biopsy needle, missed the bone and pierced her pericardium, the sac containing the heart, causing massive internal bleeding.
Ms. Parveen lost consciousness as soon as the needle was inserted, with her husband running from the room shouting: “He killed her. I told him to stop three times and he did not listen. He killed her.”
A crash team arrived but Ms. Parveen was confirmed dead later the same day, September 3, 2018.
Controversy over his ‘true age’
Dr. Mamman qualified as a doctor in Nigeria in 1965 and had worked in the United Kingdom since 1991. From 2004 until the time of the fatal incident he was employed by the Pennine Acute Hospitals NHS Trust.
But his “true age” is a matter of “controversy,” the court heard, as his birthplace in rural Nigeria had no system of birth registration.
During his medical training he gave a date of birth of September 16, 1936, which meant that he was 21 years old when he began his medical training and 81 at the time of the fatal hospital incident.
But he knocked years off his age by adopting a birth date in 1941, provided to the NHS, suggesting he began his medical degree at the age of 16.
However, in about 2001 and approaching what was then the compulsory retirement age of 65, Dr. Mamman adopted an even later birth date – October 1947 – which he relied upon in an application for naturalisation as a British citizen – suggesting he started his degree course at the age of 10.
In 2004 he was found guilty of serious professional misconduct by the General Medical Council and suspended for 12 months for lying about his age.
The Pennine Trust sacked him but then re-employed him in 2006, after he had been restored to the register by the GMC, who accepted his date of birth to be 1943 – which meant he was 14 or 15 when he began his medical degree.
Dr. Mamman had left his previous employment with the Medway Trust because of “poor performance,” and in 2015 a formal complaint was made to the Oldham hospital when a patient complained he used “excessive force” during a bone marrow biopsy.
The patient was told that Dr. Mamman was in his 70s and his colleagues thought he should retire but they could not dismiss him purely because of his age. She was assured he would be put on light duties in future.
However, the same year there was another clinical incident, which resulted in serious injury to another patient, again during a bone marrow biopsy, and again involving a needle being inserted in the wrong place. The patient survived but has been left permanently disabled.
Michael Hayton, mitigating, said it was clear Dr. Mamman was a “failing” doctor and he should not have been allowed to continue treating patients.
He added: “He is not the only person at fault. He should not have been allowed to be in the position he was.
“There’s a grotesque catalogue of failings by the trust from 2015.”
This article contains information from PA Media.
A version of this article first appeared on Medscape.co.uk.
A mother-of-three was killed at her hospital appointment in the United Kingdom by a doctor who botched a routine procedure, a court has heard. On July 5, Dr. Isyaka Mamman was sentenced at Manchester Crown Court to 3 years imprisonment after pleading guilty to the manslaughter by gross negligence of his patient.
Dr. Mamman, 85, had already been suspended once by medical watchdogs for lying about his age and was sacked but then re-employed by the Royal Oldham Hospital, where he was responsible for a series of critical incidents before the fatal appointment, Manchester Crown Court heard.
The Nigerian-born doctor had also used various dates of birth and left his previous job through “poor performance.”
‘Highly dangerous’ procedure
Shahida Parveen, 48, had gone to the hospital with her husband, Khizar Mahmood, for investigations into possible myeloproliferative disorder.
A bone marrow biopsy had been advised and the routine procedure was allocated to Dr. Mamman, who was working as a specialty doctor in hematology, Andrew Thomas QC, prosecuting, told the hearing.
Normally, bone marrow samples are taken from the hip bone but Dr. Mamman failed to obtain a sample at the first attempt.
Instead, he attempted a rare and “highly dangerous” procedure of getting a sample from Ms. Parveen’s sternum – despite objections from the patient and her husband.
Dr. Mamman, using the wrong biopsy needle, missed the bone and pierced her pericardium, the sac containing the heart, causing massive internal bleeding.
Ms. Parveen lost consciousness as soon as the needle was inserted, with her husband running from the room shouting: “He killed her. I told him to stop three times and he did not listen. He killed her.”
A crash team arrived but Ms. Parveen was confirmed dead later the same day, September 3, 2018.
Controversy over his ‘true age’
Dr. Mamman qualified as a doctor in Nigeria in 1965 and had worked in the United Kingdom since 1991. From 2004 until the time of the fatal incident he was employed by the Pennine Acute Hospitals NHS Trust.
But his “true age” is a matter of “controversy,” the court heard, as his birthplace in rural Nigeria had no system of birth registration.
During his medical training he gave a date of birth of September 16, 1936, which meant that he was 21 years old when he began his medical training and 81 at the time of the fatal hospital incident.
But he knocked years off his age by adopting a birth date in 1941, provided to the NHS, suggesting he began his medical degree at the age of 16.
However, in about 2001 and approaching what was then the compulsory retirement age of 65, Dr. Mamman adopted an even later birth date – October 1947 – which he relied upon in an application for naturalisation as a British citizen – suggesting he started his degree course at the age of 10.
In 2004 he was found guilty of serious professional misconduct by the General Medical Council and suspended for 12 months for lying about his age.
The Pennine Trust sacked him but then re-employed him in 2006, after he had been restored to the register by the GMC, who accepted his date of birth to be 1943 – which meant he was 14 or 15 when he began his medical degree.
Dr. Mamman had left his previous employment with the Medway Trust because of “poor performance,” and in 2015 a formal complaint was made to the Oldham hospital when a patient complained he used “excessive force” during a bone marrow biopsy.
The patient was told that Dr. Mamman was in his 70s and his colleagues thought he should retire but they could not dismiss him purely because of his age. She was assured he would be put on light duties in future.
However, the same year there was another clinical incident, which resulted in serious injury to another patient, again during a bone marrow biopsy, and again involving a needle being inserted in the wrong place. The patient survived but has been left permanently disabled.
Michael Hayton, mitigating, said it was clear Dr. Mamman was a “failing” doctor and he should not have been allowed to continue treating patients.
He added: “He is not the only person at fault. He should not have been allowed to be in the position he was.
“There’s a grotesque catalogue of failings by the trust from 2015.”
This article contains information from PA Media.
A version of this article first appeared on Medscape.co.uk.
A mother-of-three was killed at her hospital appointment in the United Kingdom by a doctor who botched a routine procedure, a court has heard. On July 5, Dr. Isyaka Mamman was sentenced at Manchester Crown Court to 3 years imprisonment after pleading guilty to the manslaughter by gross negligence of his patient.
Dr. Mamman, 85, had already been suspended once by medical watchdogs for lying about his age and was sacked but then re-employed by the Royal Oldham Hospital, where he was responsible for a series of critical incidents before the fatal appointment, Manchester Crown Court heard.
The Nigerian-born doctor had also used various dates of birth and left his previous job through “poor performance.”
‘Highly dangerous’ procedure
Shahida Parveen, 48, had gone to the hospital with her husband, Khizar Mahmood, for investigations into possible myeloproliferative disorder.
A bone marrow biopsy had been advised and the routine procedure was allocated to Dr. Mamman, who was working as a specialty doctor in hematology, Andrew Thomas QC, prosecuting, told the hearing.
Normally, bone marrow samples are taken from the hip bone but Dr. Mamman failed to obtain a sample at the first attempt.
Instead, he attempted a rare and “highly dangerous” procedure of getting a sample from Ms. Parveen’s sternum – despite objections from the patient and her husband.
Dr. Mamman, using the wrong biopsy needle, missed the bone and pierced her pericardium, the sac containing the heart, causing massive internal bleeding.
Ms. Parveen lost consciousness as soon as the needle was inserted, with her husband running from the room shouting: “He killed her. I told him to stop three times and he did not listen. He killed her.”
A crash team arrived but Ms. Parveen was confirmed dead later the same day, September 3, 2018.
Controversy over his ‘true age’
Dr. Mamman qualified as a doctor in Nigeria in 1965 and had worked in the United Kingdom since 1991. From 2004 until the time of the fatal incident he was employed by the Pennine Acute Hospitals NHS Trust.
But his “true age” is a matter of “controversy,” the court heard, as his birthplace in rural Nigeria had no system of birth registration.
During his medical training he gave a date of birth of September 16, 1936, which meant that he was 21 years old when he began his medical training and 81 at the time of the fatal hospital incident.
But he knocked years off his age by adopting a birth date in 1941, provided to the NHS, suggesting he began his medical degree at the age of 16.
However, in about 2001 and approaching what was then the compulsory retirement age of 65, Dr. Mamman adopted an even later birth date – October 1947 – which he relied upon in an application for naturalisation as a British citizen – suggesting he started his degree course at the age of 10.
In 2004 he was found guilty of serious professional misconduct by the General Medical Council and suspended for 12 months for lying about his age.
The Pennine Trust sacked him but then re-employed him in 2006, after he had been restored to the register by the GMC, who accepted his date of birth to be 1943 – which meant he was 14 or 15 when he began his medical degree.
Dr. Mamman had left his previous employment with the Medway Trust because of “poor performance,” and in 2015 a formal complaint was made to the Oldham hospital when a patient complained he used “excessive force” during a bone marrow biopsy.
The patient was told that Dr. Mamman was in his 70s and his colleagues thought he should retire but they could not dismiss him purely because of his age. She was assured he would be put on light duties in future.
However, the same year there was another clinical incident, which resulted in serious injury to another patient, again during a bone marrow biopsy, and again involving a needle being inserted in the wrong place. The patient survived but has been left permanently disabled.
Michael Hayton, mitigating, said it was clear Dr. Mamman was a “failing” doctor and he should not have been allowed to continue treating patients.
He added: “He is not the only person at fault. He should not have been allowed to be in the position he was.
“There’s a grotesque catalogue of failings by the trust from 2015.”
This article contains information from PA Media.
A version of this article first appeared on Medscape.co.uk.
U.S. allows pharmacists to prescribe Paxlovid directly
The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.
Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.
“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.
Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”
“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.
But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”
“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.
After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.
Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.
If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.
In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.
Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.
Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.
Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.
“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.
Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”
“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.
But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”
“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.
After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.
Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.
If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.
In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.
Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.
Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.
Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.
“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.
Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”
“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.
But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”
“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.
After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.
Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.
If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.
In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.
Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.
Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.
A version of this article first appeared on WebMD.com.
WHO tracking new Omicron subvariant in India
The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.
“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.
The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.
“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.
The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.
Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.
BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.
Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.
The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.
BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.
“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.
“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.
Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.
A version of this article first appeared on WebMD.com.
The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.
“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.
The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.
“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.
The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.
Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.
BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.
Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.
The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.
BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.
“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.
“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.
Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.
A version of this article first appeared on WebMD.com.
The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.
“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.
The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.
“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.
The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.
Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.
BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.
Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.
The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.
BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.
“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.
“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.
Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.
A version of this article first appeared on WebMD.com.
Will the headache field embrace rofecoxib?
In June, the Concord, Mass.–based company Tremeau Pharmaceuticals announced that the Food and Drug Administration was letting it proceed with a phase 3 clinical trial to test rofecoxib, the once-bestselling painkiller known as Vioxx, in patients with migraine.
The anti-inflammatory drug, a cyclooxygenase-2 (COX-2) inhibitor, received its first FDA approval in 1999 and became widely prescribed for arthritis and acute pain. In 2004 it was withdrawn by its manufacturer, Merck, after being shown to raise the risk of cardiovascular events.
In clinical trials and in real-world epidemiological studies, rofecoxib was associated with elevated heart attack, stroke, and related deaths; one 2005 study estimated that it had been responsible for some 38,000 excess deaths in the United States before being withdrawn. In 2007 Merck, beset with allegations that it had suppressed and mischaracterized rofecoxib’s safety data, paid out nearly $5 billion to settle thousands of lawsuits filed by patients and their families.
, an indication for which it received an orphan drug designation in 2017 and the agency’s green light for trials in 2020.
Brad Sippy, Tremeau’s chief executive officer, said that his company chose the two indications in part because both patient populations have low cardiovascular risk. Migraine patients are generally younger than the arthritis populations formerly treated with rofecoxib and are unlikely to take the drug for more than a day or 2 at time, avoiding the risks associated with extended exposure.
A crowded market
The past several years have seen the emergence of a cornucopia of new migraine treatments, including monoclonal antibodies such as erenumab (Aimovig, Amgen), which help prevent attacks by blocking the vasodilator calcitonin gene-related peptide, or CGRP. In addition to the standard arsenal of triptans and nonsteroidal anti-inflammatory drugs for acute pain relief, migraine patients can now choose among serotonin-blocking agents such as lasmiditan (Reyvow, Eli Lilly), known as “ditans,” and small-molecule CGRP antagonists such as ubrogepant (Ubrelvy, Abbie), known as “gepants.” Some NSAIDs, including one COX inhibitor, have been formulated into rapidly absorbed powders or liquids for migraine.
Mr. Sippy said he sees a role for rofecoxib even in this crowded space. “Migraine as you know is a multimodal situation – few people say that only one drug works for them,” he said. “We think this is an option that would basically be like a high dose of ibuprofen,” but with less frequent dosing and lower gastrointestinal and platelet effects compared with ibuprofen and other NSAIDs.
An improved formulation
Rofecoxib “crosses the blood brain barrier very readily – better than other COX inhibitors on the market,” Mr. Sippy added. “It was well absorbed in its original formulation, and our product is even better absorbed than the original – we estimate it’s probably an hour quicker to [peak concentration].” In addition, he said, “our formulation is more efficient at delivering the drug so we don’t need as much active ingredient – our 17.5 milligrams gets you the same systemic exposure as 25 milligrams of the old product.”
A different mechanism of action
Neurologist Alan M. Rapoport, MD, editor-in-chief of Neurology Reviews and professor of neurology at the University of California, Los Angeles, said that he was “cautiously optimistic” that “if used correctly and not too frequently, [rofecoxib] will find its niche in migraine treatment.”
“Patients liked Vioxx,” said Dr. Rapoport, past president of the International Headache Society. Even people currently on prevention “need to have an acute care drug handy.” While some patients on monoclonal antibodies have had success with gepants for acute care, “these both target the same pathway. It’s always nice to have options with a different mechanism of action.”
One of the arguments Tremeau has cited for reintroducing rofecoxib has been an urgent need for alternatives to opioid painkillers. Indeed some analysts have linked the demise of Vioxx with a subsequent increase in opioid prescribing.
Dr. Rapoport noted that he never prescribes opioids or butalbital, a barbiturate, for migraine, and that most headache specialists avoid them in clinical practice. But in the emergency setting, he said, patients receive them all too frequently.
Mr. Sippy said that opioid prescribing, while not unknown in migraine, was a bigger problem in hemophilic arthropathy, the first indication his company has pursued for rofecoxib. People with hemophilia “have a kind of arthritis that would respond well to an anti-inflammatory drug but they can’t take NSAIDs due to bleeding risk. This is why so many end up on opioids. Rofecoxib, as a COX-2 inhibitor, doesn’t have any effect on platelet aggregation, which would make it another option.”
No unique risks at prescribed doses
The migraine indication originally started out narrower: Patients with both migraine and bleeding disorders. “But in talking with the FDA, they encouraged us to develop it for migraine,” Mr. Sippy said. The company is considering pursuing a third indication: menstrual pain co-occurring with migraine. Tremeau has not ruled out seeking an indication in patients with arthritis who cannot take other painkillers, whether opioids or NSAIDs.
Five years ago, when Tremeau first announced its plans to bring rofecoxib back – indeed the company was set up for that purpose and has only this and another COX-2 inhibitor in development – some experts warned that there is little to prevent the drug from being used off-label, whether in higher doses or for other diseases.
“That’s something else we’re seeking to solve in addition to going for younger populations,” said Mr. Sippy, who worked at Merck during the Vioxx crisis and later headed neurology at Sunovion before starting his own company.
“We’re going for the former middle dose as our high dose and now we know that you don’t want to take more than the prescribed amount. If it doesn’t work you get off it; you don’t want to dose-creep on it. That’s been a key insight: At the appropriate dose, this product has no unique risk relative to the drug class and potentially some unique benefits,” he said.
Risk versus benefit
Joseph Ross, MD, a health policy researcher at Yale University in New Haven, Conn., who in a 2018 editorial expressed concerns about rofecoxib’s revival, said in an email that he felt its use in migraine could be justified, with caveats.
During Vioxx’s original approval and time on the market, “there was a cardiovascular risk associated with use that was not being transparently and clearly reported to patients and clinicians,” Dr. Ross said.
“In terms of testing the product for use in patients with migraine – a population of generally younger patients at lower risk of cardiovascular disease – my only concern is that the risk is clearly communicated and that there is adequate postmarket safety surveillance,” he said. “If patients are making fully informed decisions, the potential benefit of the drug with respect to pain control may be worth the risks.”
Dr. Rapoport serves as an adviser for AbbVie, Amgen, Biohaven, Cala Health, Collegium Pharmaceutical, Satsuma, Teva, Theranica and Xoc; he is on the speakers bureau of AbbVie, Amgen, Biohaven, Impel, Lundbeck, and Teva. Dr. Ross disclosed research support from Johnson and Johnson, the Medical Device Innovation Consortium, and the Laura and John Arnold Foundation, along with government grants; he is also an expert witness in a lawsuit against Biogen.
In June, the Concord, Mass.–based company Tremeau Pharmaceuticals announced that the Food and Drug Administration was letting it proceed with a phase 3 clinical trial to test rofecoxib, the once-bestselling painkiller known as Vioxx, in patients with migraine.
The anti-inflammatory drug, a cyclooxygenase-2 (COX-2) inhibitor, received its first FDA approval in 1999 and became widely prescribed for arthritis and acute pain. In 2004 it was withdrawn by its manufacturer, Merck, after being shown to raise the risk of cardiovascular events.
In clinical trials and in real-world epidemiological studies, rofecoxib was associated with elevated heart attack, stroke, and related deaths; one 2005 study estimated that it had been responsible for some 38,000 excess deaths in the United States before being withdrawn. In 2007 Merck, beset with allegations that it had suppressed and mischaracterized rofecoxib’s safety data, paid out nearly $5 billion to settle thousands of lawsuits filed by patients and their families.
, an indication for which it received an orphan drug designation in 2017 and the agency’s green light for trials in 2020.
Brad Sippy, Tremeau’s chief executive officer, said that his company chose the two indications in part because both patient populations have low cardiovascular risk. Migraine patients are generally younger than the arthritis populations formerly treated with rofecoxib and are unlikely to take the drug for more than a day or 2 at time, avoiding the risks associated with extended exposure.
A crowded market
The past several years have seen the emergence of a cornucopia of new migraine treatments, including monoclonal antibodies such as erenumab (Aimovig, Amgen), which help prevent attacks by blocking the vasodilator calcitonin gene-related peptide, or CGRP. In addition to the standard arsenal of triptans and nonsteroidal anti-inflammatory drugs for acute pain relief, migraine patients can now choose among serotonin-blocking agents such as lasmiditan (Reyvow, Eli Lilly), known as “ditans,” and small-molecule CGRP antagonists such as ubrogepant (Ubrelvy, Abbie), known as “gepants.” Some NSAIDs, including one COX inhibitor, have been formulated into rapidly absorbed powders or liquids for migraine.
Mr. Sippy said he sees a role for rofecoxib even in this crowded space. “Migraine as you know is a multimodal situation – few people say that only one drug works for them,” he said. “We think this is an option that would basically be like a high dose of ibuprofen,” but with less frequent dosing and lower gastrointestinal and platelet effects compared with ibuprofen and other NSAIDs.
An improved formulation
Rofecoxib “crosses the blood brain barrier very readily – better than other COX inhibitors on the market,” Mr. Sippy added. “It was well absorbed in its original formulation, and our product is even better absorbed than the original – we estimate it’s probably an hour quicker to [peak concentration].” In addition, he said, “our formulation is more efficient at delivering the drug so we don’t need as much active ingredient – our 17.5 milligrams gets you the same systemic exposure as 25 milligrams of the old product.”
A different mechanism of action
Neurologist Alan M. Rapoport, MD, editor-in-chief of Neurology Reviews and professor of neurology at the University of California, Los Angeles, said that he was “cautiously optimistic” that “if used correctly and not too frequently, [rofecoxib] will find its niche in migraine treatment.”
“Patients liked Vioxx,” said Dr. Rapoport, past president of the International Headache Society. Even people currently on prevention “need to have an acute care drug handy.” While some patients on monoclonal antibodies have had success with gepants for acute care, “these both target the same pathway. It’s always nice to have options with a different mechanism of action.”
One of the arguments Tremeau has cited for reintroducing rofecoxib has been an urgent need for alternatives to opioid painkillers. Indeed some analysts have linked the demise of Vioxx with a subsequent increase in opioid prescribing.
Dr. Rapoport noted that he never prescribes opioids or butalbital, a barbiturate, for migraine, and that most headache specialists avoid them in clinical practice. But in the emergency setting, he said, patients receive them all too frequently.
Mr. Sippy said that opioid prescribing, while not unknown in migraine, was a bigger problem in hemophilic arthropathy, the first indication his company has pursued for rofecoxib. People with hemophilia “have a kind of arthritis that would respond well to an anti-inflammatory drug but they can’t take NSAIDs due to bleeding risk. This is why so many end up on opioids. Rofecoxib, as a COX-2 inhibitor, doesn’t have any effect on platelet aggregation, which would make it another option.”
No unique risks at prescribed doses
The migraine indication originally started out narrower: Patients with both migraine and bleeding disorders. “But in talking with the FDA, they encouraged us to develop it for migraine,” Mr. Sippy said. The company is considering pursuing a third indication: menstrual pain co-occurring with migraine. Tremeau has not ruled out seeking an indication in patients with arthritis who cannot take other painkillers, whether opioids or NSAIDs.
Five years ago, when Tremeau first announced its plans to bring rofecoxib back – indeed the company was set up for that purpose and has only this and another COX-2 inhibitor in development – some experts warned that there is little to prevent the drug from being used off-label, whether in higher doses or for other diseases.
“That’s something else we’re seeking to solve in addition to going for younger populations,” said Mr. Sippy, who worked at Merck during the Vioxx crisis and later headed neurology at Sunovion before starting his own company.
“We’re going for the former middle dose as our high dose and now we know that you don’t want to take more than the prescribed amount. If it doesn’t work you get off it; you don’t want to dose-creep on it. That’s been a key insight: At the appropriate dose, this product has no unique risk relative to the drug class and potentially some unique benefits,” he said.
Risk versus benefit
Joseph Ross, MD, a health policy researcher at Yale University in New Haven, Conn., who in a 2018 editorial expressed concerns about rofecoxib’s revival, said in an email that he felt its use in migraine could be justified, with caveats.
During Vioxx’s original approval and time on the market, “there was a cardiovascular risk associated with use that was not being transparently and clearly reported to patients and clinicians,” Dr. Ross said.
“In terms of testing the product for use in patients with migraine – a population of generally younger patients at lower risk of cardiovascular disease – my only concern is that the risk is clearly communicated and that there is adequate postmarket safety surveillance,” he said. “If patients are making fully informed decisions, the potential benefit of the drug with respect to pain control may be worth the risks.”
Dr. Rapoport serves as an adviser for AbbVie, Amgen, Biohaven, Cala Health, Collegium Pharmaceutical, Satsuma, Teva, Theranica and Xoc; he is on the speakers bureau of AbbVie, Amgen, Biohaven, Impel, Lundbeck, and Teva. Dr. Ross disclosed research support from Johnson and Johnson, the Medical Device Innovation Consortium, and the Laura and John Arnold Foundation, along with government grants; he is also an expert witness in a lawsuit against Biogen.
In June, the Concord, Mass.–based company Tremeau Pharmaceuticals announced that the Food and Drug Administration was letting it proceed with a phase 3 clinical trial to test rofecoxib, the once-bestselling painkiller known as Vioxx, in patients with migraine.
The anti-inflammatory drug, a cyclooxygenase-2 (COX-2) inhibitor, received its first FDA approval in 1999 and became widely prescribed for arthritis and acute pain. In 2004 it was withdrawn by its manufacturer, Merck, after being shown to raise the risk of cardiovascular events.
In clinical trials and in real-world epidemiological studies, rofecoxib was associated with elevated heart attack, stroke, and related deaths; one 2005 study estimated that it had been responsible for some 38,000 excess deaths in the United States before being withdrawn. In 2007 Merck, beset with allegations that it had suppressed and mischaracterized rofecoxib’s safety data, paid out nearly $5 billion to settle thousands of lawsuits filed by patients and their families.
, an indication for which it received an orphan drug designation in 2017 and the agency’s green light for trials in 2020.
Brad Sippy, Tremeau’s chief executive officer, said that his company chose the two indications in part because both patient populations have low cardiovascular risk. Migraine patients are generally younger than the arthritis populations formerly treated with rofecoxib and are unlikely to take the drug for more than a day or 2 at time, avoiding the risks associated with extended exposure.
A crowded market
The past several years have seen the emergence of a cornucopia of new migraine treatments, including monoclonal antibodies such as erenumab (Aimovig, Amgen), which help prevent attacks by blocking the vasodilator calcitonin gene-related peptide, or CGRP. In addition to the standard arsenal of triptans and nonsteroidal anti-inflammatory drugs for acute pain relief, migraine patients can now choose among serotonin-blocking agents such as lasmiditan (Reyvow, Eli Lilly), known as “ditans,” and small-molecule CGRP antagonists such as ubrogepant (Ubrelvy, Abbie), known as “gepants.” Some NSAIDs, including one COX inhibitor, have been formulated into rapidly absorbed powders or liquids for migraine.
Mr. Sippy said he sees a role for rofecoxib even in this crowded space. “Migraine as you know is a multimodal situation – few people say that only one drug works for them,” he said. “We think this is an option that would basically be like a high dose of ibuprofen,” but with less frequent dosing and lower gastrointestinal and platelet effects compared with ibuprofen and other NSAIDs.
An improved formulation
Rofecoxib “crosses the blood brain barrier very readily – better than other COX inhibitors on the market,” Mr. Sippy added. “It was well absorbed in its original formulation, and our product is even better absorbed than the original – we estimate it’s probably an hour quicker to [peak concentration].” In addition, he said, “our formulation is more efficient at delivering the drug so we don’t need as much active ingredient – our 17.5 milligrams gets you the same systemic exposure as 25 milligrams of the old product.”
A different mechanism of action
Neurologist Alan M. Rapoport, MD, editor-in-chief of Neurology Reviews and professor of neurology at the University of California, Los Angeles, said that he was “cautiously optimistic” that “if used correctly and not too frequently, [rofecoxib] will find its niche in migraine treatment.”
“Patients liked Vioxx,” said Dr. Rapoport, past president of the International Headache Society. Even people currently on prevention “need to have an acute care drug handy.” While some patients on monoclonal antibodies have had success with gepants for acute care, “these both target the same pathway. It’s always nice to have options with a different mechanism of action.”
One of the arguments Tremeau has cited for reintroducing rofecoxib has been an urgent need for alternatives to opioid painkillers. Indeed some analysts have linked the demise of Vioxx with a subsequent increase in opioid prescribing.
Dr. Rapoport noted that he never prescribes opioids or butalbital, a barbiturate, for migraine, and that most headache specialists avoid them in clinical practice. But in the emergency setting, he said, patients receive them all too frequently.
Mr. Sippy said that opioid prescribing, while not unknown in migraine, was a bigger problem in hemophilic arthropathy, the first indication his company has pursued for rofecoxib. People with hemophilia “have a kind of arthritis that would respond well to an anti-inflammatory drug but they can’t take NSAIDs due to bleeding risk. This is why so many end up on opioids. Rofecoxib, as a COX-2 inhibitor, doesn’t have any effect on platelet aggregation, which would make it another option.”
No unique risks at prescribed doses
The migraine indication originally started out narrower: Patients with both migraine and bleeding disorders. “But in talking with the FDA, they encouraged us to develop it for migraine,” Mr. Sippy said. The company is considering pursuing a third indication: menstrual pain co-occurring with migraine. Tremeau has not ruled out seeking an indication in patients with arthritis who cannot take other painkillers, whether opioids or NSAIDs.
Five years ago, when Tremeau first announced its plans to bring rofecoxib back – indeed the company was set up for that purpose and has only this and another COX-2 inhibitor in development – some experts warned that there is little to prevent the drug from being used off-label, whether in higher doses or for other diseases.
“That’s something else we’re seeking to solve in addition to going for younger populations,” said Mr. Sippy, who worked at Merck during the Vioxx crisis and later headed neurology at Sunovion before starting his own company.
“We’re going for the former middle dose as our high dose and now we know that you don’t want to take more than the prescribed amount. If it doesn’t work you get off it; you don’t want to dose-creep on it. That’s been a key insight: At the appropriate dose, this product has no unique risk relative to the drug class and potentially some unique benefits,” he said.
Risk versus benefit
Joseph Ross, MD, a health policy researcher at Yale University in New Haven, Conn., who in a 2018 editorial expressed concerns about rofecoxib’s revival, said in an email that he felt its use in migraine could be justified, with caveats.
During Vioxx’s original approval and time on the market, “there was a cardiovascular risk associated with use that was not being transparently and clearly reported to patients and clinicians,” Dr. Ross said.
“In terms of testing the product for use in patients with migraine – a population of generally younger patients at lower risk of cardiovascular disease – my only concern is that the risk is clearly communicated and that there is adequate postmarket safety surveillance,” he said. “If patients are making fully informed decisions, the potential benefit of the drug with respect to pain control may be worth the risks.”
Dr. Rapoport serves as an adviser for AbbVie, Amgen, Biohaven, Cala Health, Collegium Pharmaceutical, Satsuma, Teva, Theranica and Xoc; he is on the speakers bureau of AbbVie, Amgen, Biohaven, Impel, Lundbeck, and Teva. Dr. Ross disclosed research support from Johnson and Johnson, the Medical Device Innovation Consortium, and the Laura and John Arnold Foundation, along with government grants; he is also an expert witness in a lawsuit against Biogen.
What is palliative care and what’s new in practicing this type of medicine?
The World Health Organization defines palliative care as “an approach that improves the quality of life of patients (adults and children) and their families who are facing problems associated with life-threatening illness. It prevents and relieves suffering through the early identification, correct assessment, and treatment of pain and other problems, whether physical, psychosocial or spiritual.”1
The common misperception is that palliative care is only for those at end of life or only in the advanced stages of their illness. However, palliative care is ideally most helpful following individuals from diagnosis through their illness trajectory. Another misperception is that palliative care and hospice are the same thing. Though all hospice is palliative care, all palliative care is not hospice. Both palliative care and hospice provide care for individuals facing a serious illness and focus on the same philosophy of care, but palliative care can be initiated at any stage of illness, even if the goal is to pursue curative and life-prolonging therapies/interventions.
In contrast, hospice is considered for those who are at the end of life and are usually not pursuing life-prolonging therapies or interventions, instead focusing on comfort, symptom management, and optimization of quality of life.
Though there is a growing need for palliative care, there is a shortage of specialist palliative care providers. Much of the palliative care needs can be met by all providers who can offer basic symptom management, identification surrounding goals of care and discussions of advance care planning, and understanding of illness/prognosis and treatment options, which is called primary palliative care.2 In fact, two-thirds of patients with a serious illness other than cancer prefer discussion of end-of-life care or advance care planning with their primary care providers.3
Referral to specialty palliative care should be considered when there are more complexities to symptom/pain management and goals of care/end of life, transition to hospice, or complex communication dynamics.4
Though specialty palliative care was shown to be more comprehensive, both primary palliative care and specialty palliative care have led to improvements in the quality of life in individuals living with serious illness.5 Early integration of palliative care into routine care has been shown to improve symptom burden, mood, quality of life, survival, and health care costs.6
Updates in alternative and complementary therapies to palliative care
There are several alternative and complementary therapies to palliative care, including cannabis and psychedelics. These therapies are becoming or may become a familiar part of medical therapies that are listed in a patient’s history as part of their medical regimen, especially as more states continue to legalize and/or decriminalize the use of these alternative therapies for recreational or medicinal use.
Both cannabis and psychedelics have a longstanding history of therapeutic and holistic use. Cannabis has been used to manage symptoms such as pain since the 16th and 17th century.7 In palliative care, more patients may turn to various forms of cannabis as a source of relief from symptoms and suffering as their focus shifts more to quality of life.
Even with the increasing popularity of the use of cannabis among seriously ill patients, there is still a lack of evidence of the benefits of medical cannabis use in palliative care, and there is a lack of standardization of type of cannabis used and state regulations regarding their use.7
A recent systematic review found that despite the reported positive treatment effects of cannabis in palliative care, the results of the studies were conflicting. This highlights the need for further high-quality research to determine whether cannabis products are an effective treatment in palliative care patients.8
One limitation to note is that the majority of the included studies focused on cannabis use in patients with cancer for cancer-related symptoms. Few studies included patients with other serious conditions.
Psychedelics
There is evidence that psychedelic assisted therapy (PAT) is a safe and effective treatment for individuals with refractory depression, posttraumatic stress disorder, and substance use disorder.9 Plus, there have been ample studies providing support that PAT improves symptoms such as refractory anxiety/depression, demoralization, and existential distress in seriously ill patients, thus improving their quality of life and overall well-being.9
Nine U.S. cities and the State of Oregon have decriminalized or legalized the psychedelic psilocybin, based on the medical benefits patients have experienced evidenced from using it.10
In light of the increasing interest in PAT, Dr. Ira Byock provided the following points on what “all clinicians should know as they enter this uncharted territory”:
- Psychedelics have been around for a long time.
- Psychedelic-assisted therapies’ therapeutic effects are experiential.
- There are a variety of terms for specific categories of psychedelic compounds.
- Some palliative care teams are already caring for patients who undergo psychedelic experiences.
- Use of psychedelics should be well-observed by a skilled clinician with expertise.
I am hoping this provides a general refresher on palliative care and an overview of updates to alternative and complementary therapies for patients living with serious illness.9
Dr. Kang is a geriatrician and palliative care provider at the University of Washington, Seattle in the division of geriatrics and gerontology. She has no conflicts related to the content of this piece.
References
1. World Health Organization. Palliative care. 2020 Aug 5..
2. Weissman DE and Meier DE. Identifying patients in need of a palliative care assessment in the hospital setting a consensus report from the center to advance palliative care. J Palliat Med. 2011;14(1):17-23.
3. Sherry D et al. Is primary care physician involvement associated with earlier advance care planning? A study of patients in an academic primary care setting. J Palliat Med. 2022;25(1):75-80.
4. Quill TE and Abernethy AP. Generalist plus specialist palliative care-creating a more sustainable model. N Engl J Med. 2013;368:1173-75.
5. Ernecoff NC et al. Comparing specialty and primary palliative care interventions: Analysis of a systematic review. J Palliat Med. 2020;23(3):389-96.
6. Temmel JS et al. Early palliative care for patients with metastatic non–small-cell lung cancer. N Engl J Med. 2011;363:733-42.
7. Kogan M and Sexton M. Medical cannabis: A new old tool for palliative care. J Altern Complement Med . 2020 Sep;26(9):776-8.
8. Doppen M et al. Cannabis in palliative care: A systematic review of the current evidence. J Pain Symptom Manage. 2022 Jun 12;S0885-3924(22)00760-6.
9. Byock I. Psychedelics for serious illness: Five things clinicians need to know. The Center to Advance Palliative Care. Psychedelics for Serious Illness, Palliative in Practice, Center to Advance Palliative Care (capc.org). June 13, 2022.
10. Marks M. A strategy for rescheduling psilocybin. Scientific American. Oct. 11, 2021.
The World Health Organization defines palliative care as “an approach that improves the quality of life of patients (adults and children) and their families who are facing problems associated with life-threatening illness. It prevents and relieves suffering through the early identification, correct assessment, and treatment of pain and other problems, whether physical, psychosocial or spiritual.”1
The common misperception is that palliative care is only for those at end of life or only in the advanced stages of their illness. However, palliative care is ideally most helpful following individuals from diagnosis through their illness trajectory. Another misperception is that palliative care and hospice are the same thing. Though all hospice is palliative care, all palliative care is not hospice. Both palliative care and hospice provide care for individuals facing a serious illness and focus on the same philosophy of care, but palliative care can be initiated at any stage of illness, even if the goal is to pursue curative and life-prolonging therapies/interventions.
In contrast, hospice is considered for those who are at the end of life and are usually not pursuing life-prolonging therapies or interventions, instead focusing on comfort, symptom management, and optimization of quality of life.
Though there is a growing need for palliative care, there is a shortage of specialist palliative care providers. Much of the palliative care needs can be met by all providers who can offer basic symptom management, identification surrounding goals of care and discussions of advance care planning, and understanding of illness/prognosis and treatment options, which is called primary palliative care.2 In fact, two-thirds of patients with a serious illness other than cancer prefer discussion of end-of-life care or advance care planning with their primary care providers.3
Referral to specialty palliative care should be considered when there are more complexities to symptom/pain management and goals of care/end of life, transition to hospice, or complex communication dynamics.4
Though specialty palliative care was shown to be more comprehensive, both primary palliative care and specialty palliative care have led to improvements in the quality of life in individuals living with serious illness.5 Early integration of palliative care into routine care has been shown to improve symptom burden, mood, quality of life, survival, and health care costs.6
Updates in alternative and complementary therapies to palliative care
There are several alternative and complementary therapies to palliative care, including cannabis and psychedelics. These therapies are becoming or may become a familiar part of medical therapies that are listed in a patient’s history as part of their medical regimen, especially as more states continue to legalize and/or decriminalize the use of these alternative therapies for recreational or medicinal use.
Both cannabis and psychedelics have a longstanding history of therapeutic and holistic use. Cannabis has been used to manage symptoms such as pain since the 16th and 17th century.7 In palliative care, more patients may turn to various forms of cannabis as a source of relief from symptoms and suffering as their focus shifts more to quality of life.
Even with the increasing popularity of the use of cannabis among seriously ill patients, there is still a lack of evidence of the benefits of medical cannabis use in palliative care, and there is a lack of standardization of type of cannabis used and state regulations regarding their use.7
A recent systematic review found that despite the reported positive treatment effects of cannabis in palliative care, the results of the studies were conflicting. This highlights the need for further high-quality research to determine whether cannabis products are an effective treatment in palliative care patients.8
One limitation to note is that the majority of the included studies focused on cannabis use in patients with cancer for cancer-related symptoms. Few studies included patients with other serious conditions.
Psychedelics
There is evidence that psychedelic assisted therapy (PAT) is a safe and effective treatment for individuals with refractory depression, posttraumatic stress disorder, and substance use disorder.9 Plus, there have been ample studies providing support that PAT improves symptoms such as refractory anxiety/depression, demoralization, and existential distress in seriously ill patients, thus improving their quality of life and overall well-being.9
Nine U.S. cities and the State of Oregon have decriminalized or legalized the psychedelic psilocybin, based on the medical benefits patients have experienced evidenced from using it.10
In light of the increasing interest in PAT, Dr. Ira Byock provided the following points on what “all clinicians should know as they enter this uncharted territory”:
- Psychedelics have been around for a long time.
- Psychedelic-assisted therapies’ therapeutic effects are experiential.
- There are a variety of terms for specific categories of psychedelic compounds.
- Some palliative care teams are already caring for patients who undergo psychedelic experiences.
- Use of psychedelics should be well-observed by a skilled clinician with expertise.
I am hoping this provides a general refresher on palliative care and an overview of updates to alternative and complementary therapies for patients living with serious illness.9
Dr. Kang is a geriatrician and palliative care provider at the University of Washington, Seattle in the division of geriatrics and gerontology. She has no conflicts related to the content of this piece.
References
1. World Health Organization. Palliative care. 2020 Aug 5..
2. Weissman DE and Meier DE. Identifying patients in need of a palliative care assessment in the hospital setting a consensus report from the center to advance palliative care. J Palliat Med. 2011;14(1):17-23.
3. Sherry D et al. Is primary care physician involvement associated with earlier advance care planning? A study of patients in an academic primary care setting. J Palliat Med. 2022;25(1):75-80.
4. Quill TE and Abernethy AP. Generalist plus specialist palliative care-creating a more sustainable model. N Engl J Med. 2013;368:1173-75.
5. Ernecoff NC et al. Comparing specialty and primary palliative care interventions: Analysis of a systematic review. J Palliat Med. 2020;23(3):389-96.
6. Temmel JS et al. Early palliative care for patients with metastatic non–small-cell lung cancer. N Engl J Med. 2011;363:733-42.
7. Kogan M and Sexton M. Medical cannabis: A new old tool for palliative care. J Altern Complement Med . 2020 Sep;26(9):776-8.
8. Doppen M et al. Cannabis in palliative care: A systematic review of the current evidence. J Pain Symptom Manage. 2022 Jun 12;S0885-3924(22)00760-6.
9. Byock I. Psychedelics for serious illness: Five things clinicians need to know. The Center to Advance Palliative Care. Psychedelics for Serious Illness, Palliative in Practice, Center to Advance Palliative Care (capc.org). June 13, 2022.
10. Marks M. A strategy for rescheduling psilocybin. Scientific American. Oct. 11, 2021.
The World Health Organization defines palliative care as “an approach that improves the quality of life of patients (adults and children) and their families who are facing problems associated with life-threatening illness. It prevents and relieves suffering through the early identification, correct assessment, and treatment of pain and other problems, whether physical, psychosocial or spiritual.”1
The common misperception is that palliative care is only for those at end of life or only in the advanced stages of their illness. However, palliative care is ideally most helpful following individuals from diagnosis through their illness trajectory. Another misperception is that palliative care and hospice are the same thing. Though all hospice is palliative care, all palliative care is not hospice. Both palliative care and hospice provide care for individuals facing a serious illness and focus on the same philosophy of care, but palliative care can be initiated at any stage of illness, even if the goal is to pursue curative and life-prolonging therapies/interventions.
In contrast, hospice is considered for those who are at the end of life and are usually not pursuing life-prolonging therapies or interventions, instead focusing on comfort, symptom management, and optimization of quality of life.
Though there is a growing need for palliative care, there is a shortage of specialist palliative care providers. Much of the palliative care needs can be met by all providers who can offer basic symptom management, identification surrounding goals of care and discussions of advance care planning, and understanding of illness/prognosis and treatment options, which is called primary palliative care.2 In fact, two-thirds of patients with a serious illness other than cancer prefer discussion of end-of-life care or advance care planning with their primary care providers.3
Referral to specialty palliative care should be considered when there are more complexities to symptom/pain management and goals of care/end of life, transition to hospice, or complex communication dynamics.4
Though specialty palliative care was shown to be more comprehensive, both primary palliative care and specialty palliative care have led to improvements in the quality of life in individuals living with serious illness.5 Early integration of palliative care into routine care has been shown to improve symptom burden, mood, quality of life, survival, and health care costs.6
Updates in alternative and complementary therapies to palliative care
There are several alternative and complementary therapies to palliative care, including cannabis and psychedelics. These therapies are becoming or may become a familiar part of medical therapies that are listed in a patient’s history as part of their medical regimen, especially as more states continue to legalize and/or decriminalize the use of these alternative therapies for recreational or medicinal use.
Both cannabis and psychedelics have a longstanding history of therapeutic and holistic use. Cannabis has been used to manage symptoms such as pain since the 16th and 17th century.7 In palliative care, more patients may turn to various forms of cannabis as a source of relief from symptoms and suffering as their focus shifts more to quality of life.
Even with the increasing popularity of the use of cannabis among seriously ill patients, there is still a lack of evidence of the benefits of medical cannabis use in palliative care, and there is a lack of standardization of type of cannabis used and state regulations regarding their use.7
A recent systematic review found that despite the reported positive treatment effects of cannabis in palliative care, the results of the studies were conflicting. This highlights the need for further high-quality research to determine whether cannabis products are an effective treatment in palliative care patients.8
One limitation to note is that the majority of the included studies focused on cannabis use in patients with cancer for cancer-related symptoms. Few studies included patients with other serious conditions.
Psychedelics
There is evidence that psychedelic assisted therapy (PAT) is a safe and effective treatment for individuals with refractory depression, posttraumatic stress disorder, and substance use disorder.9 Plus, there have been ample studies providing support that PAT improves symptoms such as refractory anxiety/depression, demoralization, and existential distress in seriously ill patients, thus improving their quality of life and overall well-being.9
Nine U.S. cities and the State of Oregon have decriminalized or legalized the psychedelic psilocybin, based on the medical benefits patients have experienced evidenced from using it.10
In light of the increasing interest in PAT, Dr. Ira Byock provided the following points on what “all clinicians should know as they enter this uncharted territory”:
- Psychedelics have been around for a long time.
- Psychedelic-assisted therapies’ therapeutic effects are experiential.
- There are a variety of terms for specific categories of psychedelic compounds.
- Some palliative care teams are already caring for patients who undergo psychedelic experiences.
- Use of psychedelics should be well-observed by a skilled clinician with expertise.
I am hoping this provides a general refresher on palliative care and an overview of updates to alternative and complementary therapies for patients living with serious illness.9
Dr. Kang is a geriatrician and palliative care provider at the University of Washington, Seattle in the division of geriatrics and gerontology. She has no conflicts related to the content of this piece.
References
1. World Health Organization. Palliative care. 2020 Aug 5..
2. Weissman DE and Meier DE. Identifying patients in need of a palliative care assessment in the hospital setting a consensus report from the center to advance palliative care. J Palliat Med. 2011;14(1):17-23.
3. Sherry D et al. Is primary care physician involvement associated with earlier advance care planning? A study of patients in an academic primary care setting. J Palliat Med. 2022;25(1):75-80.
4. Quill TE and Abernethy AP. Generalist plus specialist palliative care-creating a more sustainable model. N Engl J Med. 2013;368:1173-75.
5. Ernecoff NC et al. Comparing specialty and primary palliative care interventions: Analysis of a systematic review. J Palliat Med. 2020;23(3):389-96.
6. Temmel JS et al. Early palliative care for patients with metastatic non–small-cell lung cancer. N Engl J Med. 2011;363:733-42.
7. Kogan M and Sexton M. Medical cannabis: A new old tool for palliative care. J Altern Complement Med . 2020 Sep;26(9):776-8.
8. Doppen M et al. Cannabis in palliative care: A systematic review of the current evidence. J Pain Symptom Manage. 2022 Jun 12;S0885-3924(22)00760-6.
9. Byock I. Psychedelics for serious illness: Five things clinicians need to know. The Center to Advance Palliative Care. Psychedelics for Serious Illness, Palliative in Practice, Center to Advance Palliative Care (capc.org). June 13, 2022.
10. Marks M. A strategy for rescheduling psilocybin. Scientific American. Oct. 11, 2021.
CBT may improve comorbid posttraumatic headache, PTSD
Results from a randomized clinical trial of almost 200 military veterans showed that, compared with usual care, CBT for headache led to significant improvement in both headache disability and PTSD symptoms. Cognitive-processing therapy (CPT) also led to significant improvement in PTSD symptoms, but it did not improve headache disability.
Lead author Donald McGeary, PhD, department of rehabilitation medicine, the University of Texas Health Science Center,San Antonio, noted the improvements shown in headache disability after CBT were likely caused by its building of patients’ confidence that they could control or manage their headaches themselves.
That sense of control was key to helping patients “get their lives back. If you can improve a person’s belief that they can control their headache, they function better,” Dr. McGeary said in a news release.
The findings were published online in JAMA Neurology.
Signature wounds
Both mild traumatic brain injury (TBI) and PTSD are signature wounds of post-9/11 military conflicts. The two conditions commonly occur together and can harm quality of life and functioning, the investigators noted. Following mild TBI, many veterans experience persistent posttraumatic headache, which often co-occurs with PTSD.
To gauge the impact of CBTs for this patient population, researchers recruited 193 post-9/11 combat veterans (mean age, 39.7 years) with clinically significant PTSD symptoms and posttraumatic headache that had persisted more than 3 months after TBI. Of these, 167 were men.
All participants were receiving care at the Polytrauma Rehabilitation Center of the South Texas Veterans Health Care System in Houston.
They were randomly allocated to undergo 8 sessions of manualized CBT for headache, 12 sessions of manualized CPT for PTSD, or usual headache treatment.
CBT for headache uses CBT concepts to reduce headache disability and improve mood – and includes key components, such as relaxation, setting goals for activities patients want to resume, and planning for those situations.
CPT is a leading psychotherapy for PTSD. It teaches patients how to evaluate and change upsetting and maladaptive thoughts related to their trauma. The idea is that, by changing thoughts, patients can change the way they feel.
Treatment as usual was consistent with multidisciplinary treatment in a large Veterans Affairs multiple-trauma center and could include pharmacotherapies, physical and occupational therapies, pain medications, acupuncture, and massage.
The coprimary outcomes were headache-related disability on the six-item Headache Impact Test (HIT-6) and PTSD symptom severity on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5), assessed from end of treatment to 6 months post treatment.
At baseline, all participants reported severe headache-related disability (mean HIT-6 score, 65.8 points) and severe PTSD symptoms (mean PCL-5 score, 48.4 points).
Significant improvement
Compared with usual care, CBT for headache led to significant improvement in headache disability (posttreatment mean change in HIT-6 score, –3.4 points; P < .01) and PTSD symptoms (posttreatment change in PCL-5, –6.5 points; P = .04).
CPT also led to significant improvement in PTSD symptoms (8.9 points lower on the PCL-5 after treatment; P = .01), but it had only a modest effect on headache disability (1.4 points lower after treatment; P = .21).
“This was a surprise,” Dr. McGeary said. “If theories about PTSD driving posttraumatic headache are correct, you’d expect CPT to help both PTSD and headache. Our findings call that into question.”
Despite improvements in headache disability, CBT for headache did not significantly reduce headache frequency or intensity.
The researchers are now hoping to replicate their findings in a larger trial at multiple military and VA sites around the United States.
“We need more women, more racial and ethnic diversity, veterans as well as active military of different branches with varying comorbidities in different geographic regions attached to different hospitals and medical systems, because we’re comparing to usual care,” Dr. McGeary said.
A step forward
Commenting on the study, retired Col. Elspeth Cameron Ritchie, MD, chair of psychiatry, MedStar Washington Hospital Center, Washington, said she was “pleased” to see that this study was conducted and that she was pleased with the results.
“It’s been 20 years since 9/11, and wars are pretty much forgotten, but people are still suffering from the effects of traumatic brain injury and posttraumatic stress disorder. These are not conditions that go away quickly or lightly. They do take work,” said Dr. Ritchie, who was not involved with the research.
Finding therapies besides medication that are helpful is “good and is a step forward. The more alternatives we have, the better,” she concluded.
The study was supported in part by the Department of Defense and the Department of Veterans Affairs. Dr. McGeary and Dr. Ritchie have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from a randomized clinical trial of almost 200 military veterans showed that, compared with usual care, CBT for headache led to significant improvement in both headache disability and PTSD symptoms. Cognitive-processing therapy (CPT) also led to significant improvement in PTSD symptoms, but it did not improve headache disability.
Lead author Donald McGeary, PhD, department of rehabilitation medicine, the University of Texas Health Science Center,San Antonio, noted the improvements shown in headache disability after CBT were likely caused by its building of patients’ confidence that they could control or manage their headaches themselves.
That sense of control was key to helping patients “get their lives back. If you can improve a person’s belief that they can control their headache, they function better,” Dr. McGeary said in a news release.
The findings were published online in JAMA Neurology.
Signature wounds
Both mild traumatic brain injury (TBI) and PTSD are signature wounds of post-9/11 military conflicts. The two conditions commonly occur together and can harm quality of life and functioning, the investigators noted. Following mild TBI, many veterans experience persistent posttraumatic headache, which often co-occurs with PTSD.
To gauge the impact of CBTs for this patient population, researchers recruited 193 post-9/11 combat veterans (mean age, 39.7 years) with clinically significant PTSD symptoms and posttraumatic headache that had persisted more than 3 months after TBI. Of these, 167 were men.
All participants were receiving care at the Polytrauma Rehabilitation Center of the South Texas Veterans Health Care System in Houston.
They were randomly allocated to undergo 8 sessions of manualized CBT for headache, 12 sessions of manualized CPT for PTSD, or usual headache treatment.
CBT for headache uses CBT concepts to reduce headache disability and improve mood – and includes key components, such as relaxation, setting goals for activities patients want to resume, and planning for those situations.
CPT is a leading psychotherapy for PTSD. It teaches patients how to evaluate and change upsetting and maladaptive thoughts related to their trauma. The idea is that, by changing thoughts, patients can change the way they feel.
Treatment as usual was consistent with multidisciplinary treatment in a large Veterans Affairs multiple-trauma center and could include pharmacotherapies, physical and occupational therapies, pain medications, acupuncture, and massage.
The coprimary outcomes were headache-related disability on the six-item Headache Impact Test (HIT-6) and PTSD symptom severity on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5), assessed from end of treatment to 6 months post treatment.
At baseline, all participants reported severe headache-related disability (mean HIT-6 score, 65.8 points) and severe PTSD symptoms (mean PCL-5 score, 48.4 points).
Significant improvement
Compared with usual care, CBT for headache led to significant improvement in headache disability (posttreatment mean change in HIT-6 score, –3.4 points; P < .01) and PTSD symptoms (posttreatment change in PCL-5, –6.5 points; P = .04).
CPT also led to significant improvement in PTSD symptoms (8.9 points lower on the PCL-5 after treatment; P = .01), but it had only a modest effect on headache disability (1.4 points lower after treatment; P = .21).
“This was a surprise,” Dr. McGeary said. “If theories about PTSD driving posttraumatic headache are correct, you’d expect CPT to help both PTSD and headache. Our findings call that into question.”
Despite improvements in headache disability, CBT for headache did not significantly reduce headache frequency or intensity.
The researchers are now hoping to replicate their findings in a larger trial at multiple military and VA sites around the United States.
“We need more women, more racial and ethnic diversity, veterans as well as active military of different branches with varying comorbidities in different geographic regions attached to different hospitals and medical systems, because we’re comparing to usual care,” Dr. McGeary said.
A step forward
Commenting on the study, retired Col. Elspeth Cameron Ritchie, MD, chair of psychiatry, MedStar Washington Hospital Center, Washington, said she was “pleased” to see that this study was conducted and that she was pleased with the results.
“It’s been 20 years since 9/11, and wars are pretty much forgotten, but people are still suffering from the effects of traumatic brain injury and posttraumatic stress disorder. These are not conditions that go away quickly or lightly. They do take work,” said Dr. Ritchie, who was not involved with the research.
Finding therapies besides medication that are helpful is “good and is a step forward. The more alternatives we have, the better,” she concluded.
The study was supported in part by the Department of Defense and the Department of Veterans Affairs. Dr. McGeary and Dr. Ritchie have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from a randomized clinical trial of almost 200 military veterans showed that, compared with usual care, CBT for headache led to significant improvement in both headache disability and PTSD symptoms. Cognitive-processing therapy (CPT) also led to significant improvement in PTSD symptoms, but it did not improve headache disability.
Lead author Donald McGeary, PhD, department of rehabilitation medicine, the University of Texas Health Science Center,San Antonio, noted the improvements shown in headache disability after CBT were likely caused by its building of patients’ confidence that they could control or manage their headaches themselves.
That sense of control was key to helping patients “get their lives back. If you can improve a person’s belief that they can control their headache, they function better,” Dr. McGeary said in a news release.
The findings were published online in JAMA Neurology.
Signature wounds
Both mild traumatic brain injury (TBI) and PTSD are signature wounds of post-9/11 military conflicts. The two conditions commonly occur together and can harm quality of life and functioning, the investigators noted. Following mild TBI, many veterans experience persistent posttraumatic headache, which often co-occurs with PTSD.
To gauge the impact of CBTs for this patient population, researchers recruited 193 post-9/11 combat veterans (mean age, 39.7 years) with clinically significant PTSD symptoms and posttraumatic headache that had persisted more than 3 months after TBI. Of these, 167 were men.
All participants were receiving care at the Polytrauma Rehabilitation Center of the South Texas Veterans Health Care System in Houston.
They were randomly allocated to undergo 8 sessions of manualized CBT for headache, 12 sessions of manualized CPT for PTSD, or usual headache treatment.
CBT for headache uses CBT concepts to reduce headache disability and improve mood – and includes key components, such as relaxation, setting goals for activities patients want to resume, and planning for those situations.
CPT is a leading psychotherapy for PTSD. It teaches patients how to evaluate and change upsetting and maladaptive thoughts related to their trauma. The idea is that, by changing thoughts, patients can change the way they feel.
Treatment as usual was consistent with multidisciplinary treatment in a large Veterans Affairs multiple-trauma center and could include pharmacotherapies, physical and occupational therapies, pain medications, acupuncture, and massage.
The coprimary outcomes were headache-related disability on the six-item Headache Impact Test (HIT-6) and PTSD symptom severity on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5), assessed from end of treatment to 6 months post treatment.
At baseline, all participants reported severe headache-related disability (mean HIT-6 score, 65.8 points) and severe PTSD symptoms (mean PCL-5 score, 48.4 points).
Significant improvement
Compared with usual care, CBT for headache led to significant improvement in headache disability (posttreatment mean change in HIT-6 score, –3.4 points; P < .01) and PTSD symptoms (posttreatment change in PCL-5, –6.5 points; P = .04).
CPT also led to significant improvement in PTSD symptoms (8.9 points lower on the PCL-5 after treatment; P = .01), but it had only a modest effect on headache disability (1.4 points lower after treatment; P = .21).
“This was a surprise,” Dr. McGeary said. “If theories about PTSD driving posttraumatic headache are correct, you’d expect CPT to help both PTSD and headache. Our findings call that into question.”
Despite improvements in headache disability, CBT for headache did not significantly reduce headache frequency or intensity.
The researchers are now hoping to replicate their findings in a larger trial at multiple military and VA sites around the United States.
“We need more women, more racial and ethnic diversity, veterans as well as active military of different branches with varying comorbidities in different geographic regions attached to different hospitals and medical systems, because we’re comparing to usual care,” Dr. McGeary said.
A step forward
Commenting on the study, retired Col. Elspeth Cameron Ritchie, MD, chair of psychiatry, MedStar Washington Hospital Center, Washington, said she was “pleased” to see that this study was conducted and that she was pleased with the results.
“It’s been 20 years since 9/11, and wars are pretty much forgotten, but people are still suffering from the effects of traumatic brain injury and posttraumatic stress disorder. These are not conditions that go away quickly or lightly. They do take work,” said Dr. Ritchie, who was not involved with the research.
Finding therapies besides medication that are helpful is “good and is a step forward. The more alternatives we have, the better,” she concluded.
The study was supported in part by the Department of Defense and the Department of Veterans Affairs. Dr. McGeary and Dr. Ritchie have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NEUROLOGY
Nordic walking bests other workouts on functional outcome in CVD
Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.
Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).
From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.
Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.
“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.
“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.
Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”
The results were published online in the Canadian Journal of Cardiology.
“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.
“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.
Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.
“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.
Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
Cardiac rehabilitation
The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.
Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.
The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.
Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.
From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).
Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).
Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.
Other data indicated the following:
- From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
- During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
- After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
- Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.
Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.
“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.
Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.
Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).
From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.
Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.
“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.
“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.
Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”
The results were published online in the Canadian Journal of Cardiology.
“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.
“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.
Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.
“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.
Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
Cardiac rehabilitation
The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.
Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.
The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.
Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.
From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).
Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).
Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.
Other data indicated the following:
- From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
- During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
- After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
- Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.
Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.
“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.
Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.
Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).
From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.
Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.
“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.
“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.
Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”
The results were published online in the Canadian Journal of Cardiology.
“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.
“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.
Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.
“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.
Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
Cardiac rehabilitation
The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.
Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.
The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.
Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.
From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).
Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).
Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.
Other data indicated the following:
- From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
- During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
- After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
- Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.
Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.
“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.
Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE CANADIAN JOURNAL OF CARDIOLOGY