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Novel myasthenia gravis therapies bring opportunities, challenges
PHOENIX – , according to Pushpa Narayanaswami, MD, who discussed the topic at the 2023 annual meeting of the American Association for Neuromuscular & Electrodiagnostic Medicine (AANEM).
The first Food and Drug Administration–approved drug was pyridostigmine in 1955, and it was more than 60 years before the second drug, eculizumab, gained FDA approval in 2017. Activity in more recent years has been much more brisk with the approvals of efgartigimod in 2021; ravulizumab in 2022; and efgartigimod SQ, rozanolixizumab, and zilucoplan (Japan) in 2023. Eculizumab, efgartigimod, efgartigimod SQ, ravulizumab, and rozanolixizumab are approved for patients who are anti–acetylcholine receptor (AchR) positive. Rozanolixizumab is also approved for patients who are anti–muscle-specific tyrosine kinase (MuSK) antibody positive.
The new drugs have novel mechanisms of action, giving physicians more tools to treat the condition. The mechanisms fall into two general groups: C5-complement inhibitors and neonatal Fc receptor (FcRn) agonists. Dr. Narayanaswami sought to provide guidance in thinking about how to prescribe the new drugs. “How do we really use these drugs? It’s sort of confusing in terms of where they fit in in the algorithm. I don’t pretend to have the answers, but I’m going to sort of give you a general overview of how I look at these based on the trial data and based on what we’ve done in the past,” she said during her talk.
Assessing the risk/benefit ratio
Myasthenia gravis treatment strategies should take into account both disease control and minimization of the adverse effects of treatment, which can include both short- and long-term concerns such as hematologic issues, changes in mood and sleep, diarrhea, infection risk, detriments to bone health, hypertension, diabetes mellitus, glaucoma, and cancer.
Disease control can be subjective. “Each patient may have a different approach to what their disease control means, so we don’t quite understand what the definition of disease control is,” said Dr. Narayanaswami. For example, “[a physician] may think of a sleep disturbance as mild, but [the patient] may not. They may not be able to function, so a lot of conversations [are needed] there,” she added.
The international consensus guidance for myasthenia gravis, first published in 2016 and updated a few years later, which Dr. Narayanaswami coauthored, suggested that minimal manifestation of disease is achievable and is relevant to patients. “These are patients who are doing well, they come to your office and say, ‘I’m doing well, I really don’t have any problem [though they may have some weakness],’ ” said Dr. Narayanaswami. In such patients, mild, grade 1 side effects from medications are acceptable.
Dr. Narayanaswami discussed the efficacy of older drugs, including evidence from a 2022 study of 367 patients, that found that 72% of patients achieved MGFA-PIS (postintervention status) of minimal manifestations within 2 years of treatment. That rose to 76% within 3 years and 84% within 5 years. “The incremental benefit [after the first 2] years was not huge, and I think that’s something to pay attention to,” said Dr. Narayanaswami. The study also found that disease duration at first visit was shorter among patients who achieved minimal manifestation at 12 months versus at 16 months. That finding follows a trend in current thinking about treatment of myasthenia gravis. “Chip (James) Howard [of Duke University], who’s my sort of guru, says you’ve got to address this like MS. You’ve got to hit them early and hit them hard. And I think we’re seeing more and more of this. If you think about it even in your clinical practice, patients who did well tended to do well early on,” said Dr. Narayanaswami. She noted an important limitation in that the study did not adjust for confounders or covariates.
In addition, the PROMISE-MG study, which Dr. Narayanaswami coauthored, found that 57%-89% of patients treated with azathioprine or mycophenolate achieved clinically meaningful improvement in a variety of different outcome measures. “More than half to two-thirds of patients do well in clinical practice with the older drugs,” said Dr. Narayanaswami. In terms of time to outcomes, the study found that it took 2-6 months of azathioprine treatment and 2-3 months of mycophenolate mofetil (MMF) treatment for 25% of patients to experience clinically meaningful improvements. It took 14-22 months and 13-18 months, respectively, for 75% of patients to achieve this benchmark.
Regarding when to consider switching to newer therapies, Dr. Narayanaswami pointed out that there is no FDA requirement that patients fail previous therapies, but insurance companies often require it before reimbursement.
Dr. Narayanaswami said that the benefits of these drugs are well known, so she focused instead on their safety profiles in clinical practice. C-5 complement inhibitors carry a risk of meningococcal infection, which has been addressed in various postmarketing studies. “I will say that data is difficult to interpret for various reasons … but the point is that there is a risk for meningococcal infections. The risk appears to be low, but it’s not zero, even if you immunize patients, and I think that’s the conversation we need to have [with patients],” she said. Other issues with C5-complement inhibitors can include headache, nasopharyngitis, diarrhea, abdominal pain, back pain, nausea, and other infections.
FcRn antagonists have a range of potential side effects, but Dr. Narayanaswami emphasized timing of vaccinations, since the drugs antagonize recycling of IgG. She said vaccines should be given before the first dose of the cycle. There are no data on their use in pregnancy, but the agents could potentially reduce the passive transfer of IgG antibodies to the fetus.
Treatment strategies
In clinical practice, Dr. Narayanaswami employs the newer drugs in patients who have failed older drugs, or who experience intolerable side effects. An important consideration is how long to wait before determining a failure on previous therapies. Her current inclination is to treat earlier, which leads her to consider newer drugs at 2 years after disease onset, or after 1 year if the patient has had no improvement at all. She would consider the therapies as first-line therapies in patients for whom she doesn’t feel comfortable prescribing older medications, often older or more frail patients, or patients at any age when comorbidities might contraindicate glucocorticoids.
During the Q&A session after the talk, an attendee asked Dr. Narayanaswami what she does when payers balk at paying for new drugs. She noted that payers don’t necessarily have a specific number of months in mind for patients who are quite sick. “They just want somebody to try something. That has been my experience,” she said. She also goes peer-to-peer when disputing coverage. “Sometimes you can convince them on a peer-to-peer [basis] because they don’t really know myasthenia gravis.”
Another questioner wondered if clinical trials have been done or are in progress to demonstrate that earlier treatment can lead to better results. Dr. Narayanaswami responded that several observational trials are looking at the question. “It’s challenging because sometimes we don’t know the time from diagnosis. We know the first time they came in, which is not necessarily the same as the time from diagnosis, and sometimes that can be hard to get. And, again, it’s observational data, which can be dirty,” she said.
Dr. Narayanaswami disclosed ties with Alexion, Argenx, Dianthus, GSK, Janssen, Patient Centered Outcomes Research Institute, Sanofi, and UCB.
PHOENIX – , according to Pushpa Narayanaswami, MD, who discussed the topic at the 2023 annual meeting of the American Association for Neuromuscular & Electrodiagnostic Medicine (AANEM).
The first Food and Drug Administration–approved drug was pyridostigmine in 1955, and it was more than 60 years before the second drug, eculizumab, gained FDA approval in 2017. Activity in more recent years has been much more brisk with the approvals of efgartigimod in 2021; ravulizumab in 2022; and efgartigimod SQ, rozanolixizumab, and zilucoplan (Japan) in 2023. Eculizumab, efgartigimod, efgartigimod SQ, ravulizumab, and rozanolixizumab are approved for patients who are anti–acetylcholine receptor (AchR) positive. Rozanolixizumab is also approved for patients who are anti–muscle-specific tyrosine kinase (MuSK) antibody positive.
The new drugs have novel mechanisms of action, giving physicians more tools to treat the condition. The mechanisms fall into two general groups: C5-complement inhibitors and neonatal Fc receptor (FcRn) agonists. Dr. Narayanaswami sought to provide guidance in thinking about how to prescribe the new drugs. “How do we really use these drugs? It’s sort of confusing in terms of where they fit in in the algorithm. I don’t pretend to have the answers, but I’m going to sort of give you a general overview of how I look at these based on the trial data and based on what we’ve done in the past,” she said during her talk.
Assessing the risk/benefit ratio
Myasthenia gravis treatment strategies should take into account both disease control and minimization of the adverse effects of treatment, which can include both short- and long-term concerns such as hematologic issues, changes in mood and sleep, diarrhea, infection risk, detriments to bone health, hypertension, diabetes mellitus, glaucoma, and cancer.
Disease control can be subjective. “Each patient may have a different approach to what their disease control means, so we don’t quite understand what the definition of disease control is,” said Dr. Narayanaswami. For example, “[a physician] may think of a sleep disturbance as mild, but [the patient] may not. They may not be able to function, so a lot of conversations [are needed] there,” she added.
The international consensus guidance for myasthenia gravis, first published in 2016 and updated a few years later, which Dr. Narayanaswami coauthored, suggested that minimal manifestation of disease is achievable and is relevant to patients. “These are patients who are doing well, they come to your office and say, ‘I’m doing well, I really don’t have any problem [though they may have some weakness],’ ” said Dr. Narayanaswami. In such patients, mild, grade 1 side effects from medications are acceptable.
Dr. Narayanaswami discussed the efficacy of older drugs, including evidence from a 2022 study of 367 patients, that found that 72% of patients achieved MGFA-PIS (postintervention status) of minimal manifestations within 2 years of treatment. That rose to 76% within 3 years and 84% within 5 years. “The incremental benefit [after the first 2] years was not huge, and I think that’s something to pay attention to,” said Dr. Narayanaswami. The study also found that disease duration at first visit was shorter among patients who achieved minimal manifestation at 12 months versus at 16 months. That finding follows a trend in current thinking about treatment of myasthenia gravis. “Chip (James) Howard [of Duke University], who’s my sort of guru, says you’ve got to address this like MS. You’ve got to hit them early and hit them hard. And I think we’re seeing more and more of this. If you think about it even in your clinical practice, patients who did well tended to do well early on,” said Dr. Narayanaswami. She noted an important limitation in that the study did not adjust for confounders or covariates.
In addition, the PROMISE-MG study, which Dr. Narayanaswami coauthored, found that 57%-89% of patients treated with azathioprine or mycophenolate achieved clinically meaningful improvement in a variety of different outcome measures. “More than half to two-thirds of patients do well in clinical practice with the older drugs,” said Dr. Narayanaswami. In terms of time to outcomes, the study found that it took 2-6 months of azathioprine treatment and 2-3 months of mycophenolate mofetil (MMF) treatment for 25% of patients to experience clinically meaningful improvements. It took 14-22 months and 13-18 months, respectively, for 75% of patients to achieve this benchmark.
Regarding when to consider switching to newer therapies, Dr. Narayanaswami pointed out that there is no FDA requirement that patients fail previous therapies, but insurance companies often require it before reimbursement.
Dr. Narayanaswami said that the benefits of these drugs are well known, so she focused instead on their safety profiles in clinical practice. C-5 complement inhibitors carry a risk of meningococcal infection, which has been addressed in various postmarketing studies. “I will say that data is difficult to interpret for various reasons … but the point is that there is a risk for meningococcal infections. The risk appears to be low, but it’s not zero, even if you immunize patients, and I think that’s the conversation we need to have [with patients],” she said. Other issues with C5-complement inhibitors can include headache, nasopharyngitis, diarrhea, abdominal pain, back pain, nausea, and other infections.
FcRn antagonists have a range of potential side effects, but Dr. Narayanaswami emphasized timing of vaccinations, since the drugs antagonize recycling of IgG. She said vaccines should be given before the first dose of the cycle. There are no data on their use in pregnancy, but the agents could potentially reduce the passive transfer of IgG antibodies to the fetus.
Treatment strategies
In clinical practice, Dr. Narayanaswami employs the newer drugs in patients who have failed older drugs, or who experience intolerable side effects. An important consideration is how long to wait before determining a failure on previous therapies. Her current inclination is to treat earlier, which leads her to consider newer drugs at 2 years after disease onset, or after 1 year if the patient has had no improvement at all. She would consider the therapies as first-line therapies in patients for whom she doesn’t feel comfortable prescribing older medications, often older or more frail patients, or patients at any age when comorbidities might contraindicate glucocorticoids.
During the Q&A session after the talk, an attendee asked Dr. Narayanaswami what she does when payers balk at paying for new drugs. She noted that payers don’t necessarily have a specific number of months in mind for patients who are quite sick. “They just want somebody to try something. That has been my experience,” she said. She also goes peer-to-peer when disputing coverage. “Sometimes you can convince them on a peer-to-peer [basis] because they don’t really know myasthenia gravis.”
Another questioner wondered if clinical trials have been done or are in progress to demonstrate that earlier treatment can lead to better results. Dr. Narayanaswami responded that several observational trials are looking at the question. “It’s challenging because sometimes we don’t know the time from diagnosis. We know the first time they came in, which is not necessarily the same as the time from diagnosis, and sometimes that can be hard to get. And, again, it’s observational data, which can be dirty,” she said.
Dr. Narayanaswami disclosed ties with Alexion, Argenx, Dianthus, GSK, Janssen, Patient Centered Outcomes Research Institute, Sanofi, and UCB.
PHOENIX – , according to Pushpa Narayanaswami, MD, who discussed the topic at the 2023 annual meeting of the American Association for Neuromuscular & Electrodiagnostic Medicine (AANEM).
The first Food and Drug Administration–approved drug was pyridostigmine in 1955, and it was more than 60 years before the second drug, eculizumab, gained FDA approval in 2017. Activity in more recent years has been much more brisk with the approvals of efgartigimod in 2021; ravulizumab in 2022; and efgartigimod SQ, rozanolixizumab, and zilucoplan (Japan) in 2023. Eculizumab, efgartigimod, efgartigimod SQ, ravulizumab, and rozanolixizumab are approved for patients who are anti–acetylcholine receptor (AchR) positive. Rozanolixizumab is also approved for patients who are anti–muscle-specific tyrosine kinase (MuSK) antibody positive.
The new drugs have novel mechanisms of action, giving physicians more tools to treat the condition. The mechanisms fall into two general groups: C5-complement inhibitors and neonatal Fc receptor (FcRn) agonists. Dr. Narayanaswami sought to provide guidance in thinking about how to prescribe the new drugs. “How do we really use these drugs? It’s sort of confusing in terms of where they fit in in the algorithm. I don’t pretend to have the answers, but I’m going to sort of give you a general overview of how I look at these based on the trial data and based on what we’ve done in the past,” she said during her talk.
Assessing the risk/benefit ratio
Myasthenia gravis treatment strategies should take into account both disease control and minimization of the adverse effects of treatment, which can include both short- and long-term concerns such as hematologic issues, changes in mood and sleep, diarrhea, infection risk, detriments to bone health, hypertension, diabetes mellitus, glaucoma, and cancer.
Disease control can be subjective. “Each patient may have a different approach to what their disease control means, so we don’t quite understand what the definition of disease control is,” said Dr. Narayanaswami. For example, “[a physician] may think of a sleep disturbance as mild, but [the patient] may not. They may not be able to function, so a lot of conversations [are needed] there,” she added.
The international consensus guidance for myasthenia gravis, first published in 2016 and updated a few years later, which Dr. Narayanaswami coauthored, suggested that minimal manifestation of disease is achievable and is relevant to patients. “These are patients who are doing well, they come to your office and say, ‘I’m doing well, I really don’t have any problem [though they may have some weakness],’ ” said Dr. Narayanaswami. In such patients, mild, grade 1 side effects from medications are acceptable.
Dr. Narayanaswami discussed the efficacy of older drugs, including evidence from a 2022 study of 367 patients, that found that 72% of patients achieved MGFA-PIS (postintervention status) of minimal manifestations within 2 years of treatment. That rose to 76% within 3 years and 84% within 5 years. “The incremental benefit [after the first 2] years was not huge, and I think that’s something to pay attention to,” said Dr. Narayanaswami. The study also found that disease duration at first visit was shorter among patients who achieved minimal manifestation at 12 months versus at 16 months. That finding follows a trend in current thinking about treatment of myasthenia gravis. “Chip (James) Howard [of Duke University], who’s my sort of guru, says you’ve got to address this like MS. You’ve got to hit them early and hit them hard. And I think we’re seeing more and more of this. If you think about it even in your clinical practice, patients who did well tended to do well early on,” said Dr. Narayanaswami. She noted an important limitation in that the study did not adjust for confounders or covariates.
In addition, the PROMISE-MG study, which Dr. Narayanaswami coauthored, found that 57%-89% of patients treated with azathioprine or mycophenolate achieved clinically meaningful improvement in a variety of different outcome measures. “More than half to two-thirds of patients do well in clinical practice with the older drugs,” said Dr. Narayanaswami. In terms of time to outcomes, the study found that it took 2-6 months of azathioprine treatment and 2-3 months of mycophenolate mofetil (MMF) treatment for 25% of patients to experience clinically meaningful improvements. It took 14-22 months and 13-18 months, respectively, for 75% of patients to achieve this benchmark.
Regarding when to consider switching to newer therapies, Dr. Narayanaswami pointed out that there is no FDA requirement that patients fail previous therapies, but insurance companies often require it before reimbursement.
Dr. Narayanaswami said that the benefits of these drugs are well known, so she focused instead on their safety profiles in clinical practice. C-5 complement inhibitors carry a risk of meningococcal infection, which has been addressed in various postmarketing studies. “I will say that data is difficult to interpret for various reasons … but the point is that there is a risk for meningococcal infections. The risk appears to be low, but it’s not zero, even if you immunize patients, and I think that’s the conversation we need to have [with patients],” she said. Other issues with C5-complement inhibitors can include headache, nasopharyngitis, diarrhea, abdominal pain, back pain, nausea, and other infections.
FcRn antagonists have a range of potential side effects, but Dr. Narayanaswami emphasized timing of vaccinations, since the drugs antagonize recycling of IgG. She said vaccines should be given before the first dose of the cycle. There are no data on their use in pregnancy, but the agents could potentially reduce the passive transfer of IgG antibodies to the fetus.
Treatment strategies
In clinical practice, Dr. Narayanaswami employs the newer drugs in patients who have failed older drugs, or who experience intolerable side effects. An important consideration is how long to wait before determining a failure on previous therapies. Her current inclination is to treat earlier, which leads her to consider newer drugs at 2 years after disease onset, or after 1 year if the patient has had no improvement at all. She would consider the therapies as first-line therapies in patients for whom she doesn’t feel comfortable prescribing older medications, often older or more frail patients, or patients at any age when comorbidities might contraindicate glucocorticoids.
During the Q&A session after the talk, an attendee asked Dr. Narayanaswami what she does when payers balk at paying for new drugs. She noted that payers don’t necessarily have a specific number of months in mind for patients who are quite sick. “They just want somebody to try something. That has been my experience,” she said. She also goes peer-to-peer when disputing coverage. “Sometimes you can convince them on a peer-to-peer [basis] because they don’t really know myasthenia gravis.”
Another questioner wondered if clinical trials have been done or are in progress to demonstrate that earlier treatment can lead to better results. Dr. Narayanaswami responded that several observational trials are looking at the question. “It’s challenging because sometimes we don’t know the time from diagnosis. We know the first time they came in, which is not necessarily the same as the time from diagnosis, and sometimes that can be hard to get. And, again, it’s observational data, which can be dirty,” she said.
Dr. Narayanaswami disclosed ties with Alexion, Argenx, Dianthus, GSK, Janssen, Patient Centered Outcomes Research Institute, Sanofi, and UCB.
AT AANEM 2023
Infographic: Careers that tempt doctors to leave medicine
In a recently published Medscape report, 26% of American physicians said they were considering a career away from practicing medicine, for various reasons. Becoming a teacher was one of the nonclinical careers that most enthused them. What were the others?
Medscape Physicians and Nonclinical Careers Report 2023.
For more details, check out theA version of this article first appeared on Medscape.com.
In a recently published Medscape report, 26% of American physicians said they were considering a career away from practicing medicine, for various reasons. Becoming a teacher was one of the nonclinical careers that most enthused them. What were the others?
Medscape Physicians and Nonclinical Careers Report 2023.
For more details, check out theA version of this article first appeared on Medscape.com.
In a recently published Medscape report, 26% of American physicians said they were considering a career away from practicing medicine, for various reasons. Becoming a teacher was one of the nonclinical careers that most enthused them. What were the others?
Medscape Physicians and Nonclinical Careers Report 2023.
For more details, check out theA version of this article first appeared on Medscape.com.
Memory-enhancing intervention may help boost confidence, not necessarily memory, in older adults, study suggests
A novel approach aimed at enhancing everyday memory may lead older adults to feel more confident that they can accurately recollect phone numbers, names, and other information, according to findings from a small randomized controlled trial that were presented at the annual meeting of the Gerontological Society of America.
The tool, called Everyday Memory and Metacognitive Intervention (EMMI), trains people to be more mindful of memories, like where they parked their car, by repeating information at increasing intervals and self-testing.
EMMI “is a very important approach, focused on everyday memory,” said George W. Rebok, PhD, professor emeritus in the department of mental health at Johns Hopkins University, Baltimore, who was not involved with the study. “Many times, when we do memory interventions, we only focus on improving objective memories,” such as recalling major life events or one-time occurrences.
Everyday memory was defined as recalling basic facts including names, phone numbers, and daily appointments. The research, led by Ann Pearman, MD, associate director of adult psychology at Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland, Ohio, expanded on previous work she conducted with colleagues. That study found that EMMI may help improve confidence in the ability to recollect information and functional independence among older adults.
The current study was of 62 of the same participants in the earlier research, with one group that received EMMI (n = 30) and another that underwent traditional memory strategy training ([MSC]; n = 32). Both groups underwent four 3-hour virtual training sessions in their designated intervention over 2 weeks.
“One of the most important parts of the study is the [training] period,” when participants build new habits to help recall their everyday memories, Dr. Pearman said.
For 7 weeks, participants reported errors in everyday memories on a smartphone and submitted diary entries for each. Dr. Rebok that said tracking can help identify patterns or circumstances under which a person is likely to experience a memory lapse.
The study found mixed results when comparing EMMI with MSC, with the latter group demonstrating greater improvements in associative memory, such as pairing of a name to a face, highlighting the effectiveness of traditional MCS.
However, participants who underwent EMMI reported an increase in self-confidence that they were able to remember things, compared with those in the MSC group (4.92, confidence interval 95%, P = .30).
The EMMI intervention also was not uniformly effective in reducing memory errors across all participants in the group, which is to be expected, experts note. “In memory training, as with any kind of cognitive training, one size doesn’t fit all,” Dr. Rebok said.
“The mixed findings may highlight the need for a holistic approach to memory improvement and brain health, especially in older adults,” said Krystal L. Culler, DBH, founder of the Virtual Brain Health Center in Cleveland, who was not involved with the study.
EMMI could potentially be part of a broader strategy that includes lifestyle factors like sleep hygiene, physical exercise, diet, and social engagement to support optimal memory care, Dr. Culler said.
Patients who noticed some change in their memory and who are interested in making some positive changes in their daily cognitive functioning may benefit most from EMMI, according to Dr. Pearman.
“Making proactive decisions about memory challenges [patients] in their thinking and doing in everyday life,” she said.
Dr. Pearman shared that she and her colleagues are now looking into a combined EMMI and traditional memory strategy training to maximize the benefits of both interventions.
The study was supported by the Retirement Research Foundation (2018-2019); and the National Institute of Diabetes and Digestive and Kidney Diseases (P30DK111024) from the Georgia Center for Diabetes Translation Research. The study authors report no relevant conflicts. Dr. Culler and Dr. Rebok report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A novel approach aimed at enhancing everyday memory may lead older adults to feel more confident that they can accurately recollect phone numbers, names, and other information, according to findings from a small randomized controlled trial that were presented at the annual meeting of the Gerontological Society of America.
The tool, called Everyday Memory and Metacognitive Intervention (EMMI), trains people to be more mindful of memories, like where they parked their car, by repeating information at increasing intervals and self-testing.
EMMI “is a very important approach, focused on everyday memory,” said George W. Rebok, PhD, professor emeritus in the department of mental health at Johns Hopkins University, Baltimore, who was not involved with the study. “Many times, when we do memory interventions, we only focus on improving objective memories,” such as recalling major life events or one-time occurrences.
Everyday memory was defined as recalling basic facts including names, phone numbers, and daily appointments. The research, led by Ann Pearman, MD, associate director of adult psychology at Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland, Ohio, expanded on previous work she conducted with colleagues. That study found that EMMI may help improve confidence in the ability to recollect information and functional independence among older adults.
The current study was of 62 of the same participants in the earlier research, with one group that received EMMI (n = 30) and another that underwent traditional memory strategy training ([MSC]; n = 32). Both groups underwent four 3-hour virtual training sessions in their designated intervention over 2 weeks.
“One of the most important parts of the study is the [training] period,” when participants build new habits to help recall their everyday memories, Dr. Pearman said.
For 7 weeks, participants reported errors in everyday memories on a smartphone and submitted diary entries for each. Dr. Rebok that said tracking can help identify patterns or circumstances under which a person is likely to experience a memory lapse.
The study found mixed results when comparing EMMI with MSC, with the latter group demonstrating greater improvements in associative memory, such as pairing of a name to a face, highlighting the effectiveness of traditional MCS.
However, participants who underwent EMMI reported an increase in self-confidence that they were able to remember things, compared with those in the MSC group (4.92, confidence interval 95%, P = .30).
The EMMI intervention also was not uniformly effective in reducing memory errors across all participants in the group, which is to be expected, experts note. “In memory training, as with any kind of cognitive training, one size doesn’t fit all,” Dr. Rebok said.
“The mixed findings may highlight the need for a holistic approach to memory improvement and brain health, especially in older adults,” said Krystal L. Culler, DBH, founder of the Virtual Brain Health Center in Cleveland, who was not involved with the study.
EMMI could potentially be part of a broader strategy that includes lifestyle factors like sleep hygiene, physical exercise, diet, and social engagement to support optimal memory care, Dr. Culler said.
Patients who noticed some change in their memory and who are interested in making some positive changes in their daily cognitive functioning may benefit most from EMMI, according to Dr. Pearman.
“Making proactive decisions about memory challenges [patients] in their thinking and doing in everyday life,” she said.
Dr. Pearman shared that she and her colleagues are now looking into a combined EMMI and traditional memory strategy training to maximize the benefits of both interventions.
The study was supported by the Retirement Research Foundation (2018-2019); and the National Institute of Diabetes and Digestive and Kidney Diseases (P30DK111024) from the Georgia Center for Diabetes Translation Research. The study authors report no relevant conflicts. Dr. Culler and Dr. Rebok report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A novel approach aimed at enhancing everyday memory may lead older adults to feel more confident that they can accurately recollect phone numbers, names, and other information, according to findings from a small randomized controlled trial that were presented at the annual meeting of the Gerontological Society of America.
The tool, called Everyday Memory and Metacognitive Intervention (EMMI), trains people to be more mindful of memories, like where they parked their car, by repeating information at increasing intervals and self-testing.
EMMI “is a very important approach, focused on everyday memory,” said George W. Rebok, PhD, professor emeritus in the department of mental health at Johns Hopkins University, Baltimore, who was not involved with the study. “Many times, when we do memory interventions, we only focus on improving objective memories,” such as recalling major life events or one-time occurrences.
Everyday memory was defined as recalling basic facts including names, phone numbers, and daily appointments. The research, led by Ann Pearman, MD, associate director of adult psychology at Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland, Ohio, expanded on previous work she conducted with colleagues. That study found that EMMI may help improve confidence in the ability to recollect information and functional independence among older adults.
The current study was of 62 of the same participants in the earlier research, with one group that received EMMI (n = 30) and another that underwent traditional memory strategy training ([MSC]; n = 32). Both groups underwent four 3-hour virtual training sessions in their designated intervention over 2 weeks.
“One of the most important parts of the study is the [training] period,” when participants build new habits to help recall their everyday memories, Dr. Pearman said.
For 7 weeks, participants reported errors in everyday memories on a smartphone and submitted diary entries for each. Dr. Rebok that said tracking can help identify patterns or circumstances under which a person is likely to experience a memory lapse.
The study found mixed results when comparing EMMI with MSC, with the latter group demonstrating greater improvements in associative memory, such as pairing of a name to a face, highlighting the effectiveness of traditional MCS.
However, participants who underwent EMMI reported an increase in self-confidence that they were able to remember things, compared with those in the MSC group (4.92, confidence interval 95%, P = .30).
The EMMI intervention also was not uniformly effective in reducing memory errors across all participants in the group, which is to be expected, experts note. “In memory training, as with any kind of cognitive training, one size doesn’t fit all,” Dr. Rebok said.
“The mixed findings may highlight the need for a holistic approach to memory improvement and brain health, especially in older adults,” said Krystal L. Culler, DBH, founder of the Virtual Brain Health Center in Cleveland, who was not involved with the study.
EMMI could potentially be part of a broader strategy that includes lifestyle factors like sleep hygiene, physical exercise, diet, and social engagement to support optimal memory care, Dr. Culler said.
Patients who noticed some change in their memory and who are interested in making some positive changes in their daily cognitive functioning may benefit most from EMMI, according to Dr. Pearman.
“Making proactive decisions about memory challenges [patients] in their thinking and doing in everyday life,” she said.
Dr. Pearman shared that she and her colleagues are now looking into a combined EMMI and traditional memory strategy training to maximize the benefits of both interventions.
The study was supported by the Retirement Research Foundation (2018-2019); and the National Institute of Diabetes and Digestive and Kidney Diseases (P30DK111024) from the Georgia Center for Diabetes Translation Research. The study authors report no relevant conflicts. Dr. Culler and Dr. Rebok report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM GSA 2023
A mid-marathon cardiac arrest, an MD’s crisis of confidence
I was running my 25th New York City Marathon. It was 2018, and I almost pulled out of running that year. I wasn’t myself, and maybe that’s an understatement.
A month earlier, I had been involved in a malpractice case. I was found liable for $10 million. My colleagues didn’t think I had done anything wrong, but the jury did. And the local newspapers made me look like a villain.
I was devastated. But my priest, my friends, and my family all told me, “You can’t quit.” So, I decided to run for them.
I started on the Verrazzano-Narrows Bridge that morning with some friends from work. I usually listen to music as I’m running, but I didn’t that year. I was just in my zone, enjoying the crowds. They’re huge. Millions of people on the streets.
I was running well. I did half the race in an hour and 57 minutes. My family always meets me at mile 17, and I was almost there. I had reached 59th Street and was about to make the turn onto First Avenue.
That’s one of the noisiest places in the marathon. There’s a kind of tunnel, and with the crowd and the throng of runners, it’s incredibly loud. But somehow, I heard somebody yell, “Help!”
Now, how I heard that, I don’t know. And if I’d been listening to music like I always do, no way I would’ve heard it. I could swear it was an angel on my shoulder that said, “Turn around, dummy. You’ve got a person that needs your help to your left.”
I turned around and about 30 feet behind me, I saw a woman waving her hands and a runner on the ground. I thought, Somebody fainted. I pushed through the crowd to get to them. The woman was crying, saying, “My friend went down to tie her shoe and she fell back. I think she’s seizing or something.”
I got down and tried to wake the other woman up. I lifted her legs up. But I quickly realized there was more to the story.
Some volunteers and police started coming toward us. The police officers looked at me like, What’s this guy doing? I explained that I was a physician, and one of them began helping me with the CPR. As we did that, someone brought a defibrillator.
Meanwhile, runners were going past, almost over us. The police officers were trying to create a barrier.
The machine gave the woman a shock, but we didn’t get a response, so we resumed CPR. At that point, my legs began to cramp so badly I couldn’t go on. So the police officer took over, and I yelled, “I need an ambu bag!” Somebody brought one, and I started giving her oxygen.
At that point, a paramedic team arrived with a bigger defibrillator. We shocked her again. And again. That time we got results, but she quickly went out again. The fourth time, we got her heart back and she started breathing on her own.
We finally got her into an ambulance. I wanted to go with them, but the woman’s friend needed to get in, so there wasn’t enough room.
And then they were gone, and I was just standing there.
A police officer put his arm around me. He said, “Doc, you’re amazing. What do you need? Where can I take you?”
I said, “Take me? My wife is waiting for me at mile 17.”
I took off and ran. When I got to my wife and kids, they were so worried. We all wear tracking devices, and they could see that I had stopped for more than 20 minutes.
I fell into my wife’s arms and told her what had happened. I was crying. “I don’t know what to do. I need to get to the hospital.”
And she said, “No, you need to go finish the race.”
So, I did. It was painful because of the cramps, but I was numb at that point. I was thinking about the woman the whole way. My time was 5 hours and 20 minutes.
As soon as I finished, I went to every police officer I could find, but nobody knew anything. Suddenly, I remembered my cousin. He had previously been the head of EMS for New York City. I called him. “Abdo, it’s Ted, you’ve got to do me a favor.”
“What?” he said. “Are you delirious from running the marathon?”
I told him what I needed. He called me back 5 minutes later and said, “Ted, what’d you do? Everybody wants to know who you are and where you are! The woman just went out again at New York Cornell. But they got her back, and they’re bringing her up to the cath lab.”
After every marathon that I run, we host a big party at our house. My family and friends and neighbors all celebrate while I’m dying on the couch. That night, my daughter told everyone the story of what happened.
But I was still not right. Still thinking about the malpractice suit.
Yes, I just did something great. But I’d recently been called the worst physician in the world. The distraction of the marathon was gone, and I was back to thinking, What am I going to do with my life? Who’s ever going to want to see me again? I’m a pariah.
Everybody said, “Ted, what happened a month ago isn’t you. What happened today was you.”
I told them to leave it alone, but my daughter and my neighbor started calling people anyway. The next day I got a call from the local newspaper. It was the same journalist who had written about me from the trial. I told him I didn’t want to talk. I was actually pretty nasty.
But my wife said, “Ted, what are you doing? That guy was trying to help you.” So, I called back and apologized.
“Dr. Strange, we knew that story wasn’t right,” he said. “We have to write this story.”
After the article came out, I started getting more calls from the media. Channel 7 News and CBS News did segments. The New York Knicks invited us to a game and presented me with a watch. It was incredible. But I was also really embarrassed by it.
People started calling me a hero. I’m not a hero. I just did what I’m supposed to do, what I’m trained to do. Shame on me if I don’t do that. Good guy and hopefully good physician, sure, but not a hero.
I also give credit to the City of New York Police Department, the FDNY, and the volunteers. Without them, I couldn’t have done what I did. It was a true team effort.
A few weeks later, the woman went home to Minnesota. She’ll never run a marathon again, but she’s still alive to this day. It turned out she had a single lesion called the “widow-maker” lesion. She was in perfect health and had just completed an ultramarathon a few months before; but she had a genetic predisposition. She still calls me every December to thank me for another Christmas.
There’s more.
One year after this whole thing, almost to the date, I got a call from my attorney. “The court just threw out the malpractice verdict,” he said. “You didn’t do anything wrong.”
I’m a man of faith. And I believe all this happened for a reason. Maybe God was sending me a message, and that’s why I heard a call for help on 59th Street in my 25th marathon among millions of people in a crowd.
I ran the marathon the next year. And when I got to that spot, I stopped and reflected. Nobody knew why I was standing there, but I knew. To this day, I could take you to that spot.
I turn 65 next July, and I plan to keep on running the race.
Dr. Strange is chair of medicine at Staten Island University Hospital, associate ambulatory physician executive of the Staten Island Region, and an internal medicine and geriatric medicine physician with Northwell Health.
A version of this article first appeared on Medscape.com.
I was running my 25th New York City Marathon. It was 2018, and I almost pulled out of running that year. I wasn’t myself, and maybe that’s an understatement.
A month earlier, I had been involved in a malpractice case. I was found liable for $10 million. My colleagues didn’t think I had done anything wrong, but the jury did. And the local newspapers made me look like a villain.
I was devastated. But my priest, my friends, and my family all told me, “You can’t quit.” So, I decided to run for them.
I started on the Verrazzano-Narrows Bridge that morning with some friends from work. I usually listen to music as I’m running, but I didn’t that year. I was just in my zone, enjoying the crowds. They’re huge. Millions of people on the streets.
I was running well. I did half the race in an hour and 57 minutes. My family always meets me at mile 17, and I was almost there. I had reached 59th Street and was about to make the turn onto First Avenue.
That’s one of the noisiest places in the marathon. There’s a kind of tunnel, and with the crowd and the throng of runners, it’s incredibly loud. But somehow, I heard somebody yell, “Help!”
Now, how I heard that, I don’t know. And if I’d been listening to music like I always do, no way I would’ve heard it. I could swear it was an angel on my shoulder that said, “Turn around, dummy. You’ve got a person that needs your help to your left.”
I turned around and about 30 feet behind me, I saw a woman waving her hands and a runner on the ground. I thought, Somebody fainted. I pushed through the crowd to get to them. The woman was crying, saying, “My friend went down to tie her shoe and she fell back. I think she’s seizing or something.”
I got down and tried to wake the other woman up. I lifted her legs up. But I quickly realized there was more to the story.
Some volunteers and police started coming toward us. The police officers looked at me like, What’s this guy doing? I explained that I was a physician, and one of them began helping me with the CPR. As we did that, someone brought a defibrillator.
Meanwhile, runners were going past, almost over us. The police officers were trying to create a barrier.
The machine gave the woman a shock, but we didn’t get a response, so we resumed CPR. At that point, my legs began to cramp so badly I couldn’t go on. So the police officer took over, and I yelled, “I need an ambu bag!” Somebody brought one, and I started giving her oxygen.
At that point, a paramedic team arrived with a bigger defibrillator. We shocked her again. And again. That time we got results, but she quickly went out again. The fourth time, we got her heart back and she started breathing on her own.
We finally got her into an ambulance. I wanted to go with them, but the woman’s friend needed to get in, so there wasn’t enough room.
And then they were gone, and I was just standing there.
A police officer put his arm around me. He said, “Doc, you’re amazing. What do you need? Where can I take you?”
I said, “Take me? My wife is waiting for me at mile 17.”
I took off and ran. When I got to my wife and kids, they were so worried. We all wear tracking devices, and they could see that I had stopped for more than 20 minutes.
I fell into my wife’s arms and told her what had happened. I was crying. “I don’t know what to do. I need to get to the hospital.”
And she said, “No, you need to go finish the race.”
So, I did. It was painful because of the cramps, but I was numb at that point. I was thinking about the woman the whole way. My time was 5 hours and 20 minutes.
As soon as I finished, I went to every police officer I could find, but nobody knew anything. Suddenly, I remembered my cousin. He had previously been the head of EMS for New York City. I called him. “Abdo, it’s Ted, you’ve got to do me a favor.”
“What?” he said. “Are you delirious from running the marathon?”
I told him what I needed. He called me back 5 minutes later and said, “Ted, what’d you do? Everybody wants to know who you are and where you are! The woman just went out again at New York Cornell. But they got her back, and they’re bringing her up to the cath lab.”
After every marathon that I run, we host a big party at our house. My family and friends and neighbors all celebrate while I’m dying on the couch. That night, my daughter told everyone the story of what happened.
But I was still not right. Still thinking about the malpractice suit.
Yes, I just did something great. But I’d recently been called the worst physician in the world. The distraction of the marathon was gone, and I was back to thinking, What am I going to do with my life? Who’s ever going to want to see me again? I’m a pariah.
Everybody said, “Ted, what happened a month ago isn’t you. What happened today was you.”
I told them to leave it alone, but my daughter and my neighbor started calling people anyway. The next day I got a call from the local newspaper. It was the same journalist who had written about me from the trial. I told him I didn’t want to talk. I was actually pretty nasty.
But my wife said, “Ted, what are you doing? That guy was trying to help you.” So, I called back and apologized.
“Dr. Strange, we knew that story wasn’t right,” he said. “We have to write this story.”
After the article came out, I started getting more calls from the media. Channel 7 News and CBS News did segments. The New York Knicks invited us to a game and presented me with a watch. It was incredible. But I was also really embarrassed by it.
People started calling me a hero. I’m not a hero. I just did what I’m supposed to do, what I’m trained to do. Shame on me if I don’t do that. Good guy and hopefully good physician, sure, but not a hero.
I also give credit to the City of New York Police Department, the FDNY, and the volunteers. Without them, I couldn’t have done what I did. It was a true team effort.
A few weeks later, the woman went home to Minnesota. She’ll never run a marathon again, but she’s still alive to this day. It turned out she had a single lesion called the “widow-maker” lesion. She was in perfect health and had just completed an ultramarathon a few months before; but she had a genetic predisposition. She still calls me every December to thank me for another Christmas.
There’s more.
One year after this whole thing, almost to the date, I got a call from my attorney. “The court just threw out the malpractice verdict,” he said. “You didn’t do anything wrong.”
I’m a man of faith. And I believe all this happened for a reason. Maybe God was sending me a message, and that’s why I heard a call for help on 59th Street in my 25th marathon among millions of people in a crowd.
I ran the marathon the next year. And when I got to that spot, I stopped and reflected. Nobody knew why I was standing there, but I knew. To this day, I could take you to that spot.
I turn 65 next July, and I plan to keep on running the race.
Dr. Strange is chair of medicine at Staten Island University Hospital, associate ambulatory physician executive of the Staten Island Region, and an internal medicine and geriatric medicine physician with Northwell Health.
A version of this article first appeared on Medscape.com.
I was running my 25th New York City Marathon. It was 2018, and I almost pulled out of running that year. I wasn’t myself, and maybe that’s an understatement.
A month earlier, I had been involved in a malpractice case. I was found liable for $10 million. My colleagues didn’t think I had done anything wrong, but the jury did. And the local newspapers made me look like a villain.
I was devastated. But my priest, my friends, and my family all told me, “You can’t quit.” So, I decided to run for them.
I started on the Verrazzano-Narrows Bridge that morning with some friends from work. I usually listen to music as I’m running, but I didn’t that year. I was just in my zone, enjoying the crowds. They’re huge. Millions of people on the streets.
I was running well. I did half the race in an hour and 57 minutes. My family always meets me at mile 17, and I was almost there. I had reached 59th Street and was about to make the turn onto First Avenue.
That’s one of the noisiest places in the marathon. There’s a kind of tunnel, and with the crowd and the throng of runners, it’s incredibly loud. But somehow, I heard somebody yell, “Help!”
Now, how I heard that, I don’t know. And if I’d been listening to music like I always do, no way I would’ve heard it. I could swear it was an angel on my shoulder that said, “Turn around, dummy. You’ve got a person that needs your help to your left.”
I turned around and about 30 feet behind me, I saw a woman waving her hands and a runner on the ground. I thought, Somebody fainted. I pushed through the crowd to get to them. The woman was crying, saying, “My friend went down to tie her shoe and she fell back. I think she’s seizing or something.”
I got down and tried to wake the other woman up. I lifted her legs up. But I quickly realized there was more to the story.
Some volunteers and police started coming toward us. The police officers looked at me like, What’s this guy doing? I explained that I was a physician, and one of them began helping me with the CPR. As we did that, someone brought a defibrillator.
Meanwhile, runners were going past, almost over us. The police officers were trying to create a barrier.
The machine gave the woman a shock, but we didn’t get a response, so we resumed CPR. At that point, my legs began to cramp so badly I couldn’t go on. So the police officer took over, and I yelled, “I need an ambu bag!” Somebody brought one, and I started giving her oxygen.
At that point, a paramedic team arrived with a bigger defibrillator. We shocked her again. And again. That time we got results, but she quickly went out again. The fourth time, we got her heart back and she started breathing on her own.
We finally got her into an ambulance. I wanted to go with them, but the woman’s friend needed to get in, so there wasn’t enough room.
And then they were gone, and I was just standing there.
A police officer put his arm around me. He said, “Doc, you’re amazing. What do you need? Where can I take you?”
I said, “Take me? My wife is waiting for me at mile 17.”
I took off and ran. When I got to my wife and kids, they were so worried. We all wear tracking devices, and they could see that I had stopped for more than 20 minutes.
I fell into my wife’s arms and told her what had happened. I was crying. “I don’t know what to do. I need to get to the hospital.”
And she said, “No, you need to go finish the race.”
So, I did. It was painful because of the cramps, but I was numb at that point. I was thinking about the woman the whole way. My time was 5 hours and 20 minutes.
As soon as I finished, I went to every police officer I could find, but nobody knew anything. Suddenly, I remembered my cousin. He had previously been the head of EMS for New York City. I called him. “Abdo, it’s Ted, you’ve got to do me a favor.”
“What?” he said. “Are you delirious from running the marathon?”
I told him what I needed. He called me back 5 minutes later and said, “Ted, what’d you do? Everybody wants to know who you are and where you are! The woman just went out again at New York Cornell. But they got her back, and they’re bringing her up to the cath lab.”
After every marathon that I run, we host a big party at our house. My family and friends and neighbors all celebrate while I’m dying on the couch. That night, my daughter told everyone the story of what happened.
But I was still not right. Still thinking about the malpractice suit.
Yes, I just did something great. But I’d recently been called the worst physician in the world. The distraction of the marathon was gone, and I was back to thinking, What am I going to do with my life? Who’s ever going to want to see me again? I’m a pariah.
Everybody said, “Ted, what happened a month ago isn’t you. What happened today was you.”
I told them to leave it alone, but my daughter and my neighbor started calling people anyway. The next day I got a call from the local newspaper. It was the same journalist who had written about me from the trial. I told him I didn’t want to talk. I was actually pretty nasty.
But my wife said, “Ted, what are you doing? That guy was trying to help you.” So, I called back and apologized.
“Dr. Strange, we knew that story wasn’t right,” he said. “We have to write this story.”
After the article came out, I started getting more calls from the media. Channel 7 News and CBS News did segments. The New York Knicks invited us to a game and presented me with a watch. It was incredible. But I was also really embarrassed by it.
People started calling me a hero. I’m not a hero. I just did what I’m supposed to do, what I’m trained to do. Shame on me if I don’t do that. Good guy and hopefully good physician, sure, but not a hero.
I also give credit to the City of New York Police Department, the FDNY, and the volunteers. Without them, I couldn’t have done what I did. It was a true team effort.
A few weeks later, the woman went home to Minnesota. She’ll never run a marathon again, but she’s still alive to this day. It turned out she had a single lesion called the “widow-maker” lesion. She was in perfect health and had just completed an ultramarathon a few months before; but she had a genetic predisposition. She still calls me every December to thank me for another Christmas.
There’s more.
One year after this whole thing, almost to the date, I got a call from my attorney. “The court just threw out the malpractice verdict,” he said. “You didn’t do anything wrong.”
I’m a man of faith. And I believe all this happened for a reason. Maybe God was sending me a message, and that’s why I heard a call for help on 59th Street in my 25th marathon among millions of people in a crowd.
I ran the marathon the next year. And when I got to that spot, I stopped and reflected. Nobody knew why I was standing there, but I knew. To this day, I could take you to that spot.
I turn 65 next July, and I plan to keep on running the race.
Dr. Strange is chair of medicine at Staten Island University Hospital, associate ambulatory physician executive of the Staten Island Region, and an internal medicine and geriatric medicine physician with Northwell Health.
A version of this article first appeared on Medscape.com.
Avoid adding to minority stress when treating headache in LGBTQIA+ patients
It is “important not to assume that just because someone is a member of the LGBTQ+ community they will need psychiatric or behavioral health support,” said Maya A. Marzouk, PhD, division of behavioral medicine and clinical psychology, Cincinnati Children’s Hospital Medical Center.
Instead, it is useful not to make any assumptions. There is a potential association between minority status and headache susceptibility, but it is more reasonable initially to address the diagnosis and treatment of headache in LGBTQIA+ patients the same way it is addressed in any other patient, Dr. Marzouk said at the 2023 Scottsdale Headache Symposium.
The acronym to describe individuals with gender identities different from male and female and sexual orientations not limited to heterosexuality has been in almost constant evolution over several decades. An addition sign that accompanies LGBTQIA refers to those who do not identify with any letters in the acronym (lesbian, gay, bisexual, transsexual, queer/questioning, intersex, and asexual).
Take steps to normalize the interaction
Although many clinicians have been acclimated to these diverse identifies, not all have risen above preconceptions that become obstacles to effective care, according to Dr. Marzouk. In the context of headache management, Dr. Marzouk emphasized the need to be respectful of the range of gender identities and sexual orientations and to take steps to normalize the interaction.
For example, Dr. Marzouk advised using gender-neutral language at the start of each patient encounter and ask open-ended questions about gender, sexual identify, and pronouns to avoid patient discomfort from misidentification. In turn, the clinicians can establish their own gender identification and preferred pronouns to reinforce the idea that doing so is normal behavior.
This change in approach should be made “for all patients. Do not try to guess who needs them,” she said.
Intake forms and office atmosphere, such as signs and images, should also be welcoming to all patients, she added. Rather than trying to make adjustments for a LGBTQIA+ visit, Dr. Marzouk said a uniform approach helps normalize the experience of LGBTQIA+ patients without singling them out.
Despite the effort to provide an open and welcoming environment, Dr. Marzouk acknowledged that mistakes are difficult to avoid for those with limited experience serving the LGBTQIA+ community. When mistakes are made, she advised clinicians to immediately acknowledge the mistake and ask for guidance from the patient.
The potential offense is making the patient feel “other” or abnormal.
A higher rate of migraine
The interactions that LBGTQIA+ patients have with others outside their community is a possible explanation for the substantial rate of headache as well as headache with comorbid psychiatric disorders in this population.
In a survey published in 2020, the rate of migraine was 19.7% in heterosexual women, 26.7% in lesbians, and 36.8% in bisexual women. Among men, it rose from 9.8% in heterosexuals to 14.8% in gays and then to 22.8% in bisexuals.
Migraine relative to headache is also associated with more mood disorders among LGBTQIA+ individuals. In a study published in 2022, LGBTQIA+ patients with migraine relative to those with headache were more likely to have depression (46.4% vs. 22.3%; P < .001), anxiety (72.1% vs. 51.6%; P < .001), and posttraumatic stress disorder (37.5% vs. 21.4%; P < .001).
A vicious cycle of underdiagnosis and undertreatment
These associations are consistent with minority stress theory, according to Dr. Marzouk. This theory postulates that the associated stress of discrimination, rejection, and microaggressions, such as explicit efforts to make LGBTQIA+ individuals to feel “other,” produces epigenetic changes and dysregulation of the hypothalamic-pituitary-adrenal axis. In turn, this plays a role in the pathogenesis of migraine.
The inconsistency with which minority stress affects LGBTQIA+ patients might be due to relative differences in social support, coping skills, an innate resilience to these effects, Dr. Marzouk explained.
Dr. Marzouk characterized the LGBTQIA+ community as “underserved” for treatment of headache. She suggested that medical mistrust and self-blame among LGBTQIA+ individuals might be factors contributing to a vicious cycle of underdiagnosis and undertreatment. Efforts by the medical community to reach out to the LGBTQIA+ community are appropriate to address an unmet need.
“Individuals with psychiatric comorbidities may experience even more benefit from migraine care,” she said.
Clinical studies should be more inclusive
While agreeing in principle with these remarks, Eric A. Kaiser, MD, PhD, department of neurology, University of Pennsylvania, Philadelphia, said that this area would be better advanced if studies routinely included patients with diverse-gender identities and sexual orientations. Speaking about how to organize these studies, Dr. Kaiser suggested that enrollment criteria should explicitly seek these individuals and that these differences should be captured in the baseline characteristics.
“For example, gender options could include man, woman, non-binary, gender diverse, gender nonconforming, or gender nonspecified,” he said.
To close “the significant knowledge gap that exists in managing headache disorders in sexually- and gender- diverse people,” Dr. Kaiser said that clinical research studies, like patient treatment of diverse populations, “should be conducted with welcoming and affirming practices.”
Dr. Marzouk reported no potential conflicts of interest. Dr. Kaiser reported financial relationships with Amgen and Lundbeck.
It is “important not to assume that just because someone is a member of the LGBTQ+ community they will need psychiatric or behavioral health support,” said Maya A. Marzouk, PhD, division of behavioral medicine and clinical psychology, Cincinnati Children’s Hospital Medical Center.
Instead, it is useful not to make any assumptions. There is a potential association between minority status and headache susceptibility, but it is more reasonable initially to address the diagnosis and treatment of headache in LGBTQIA+ patients the same way it is addressed in any other patient, Dr. Marzouk said at the 2023 Scottsdale Headache Symposium.
The acronym to describe individuals with gender identities different from male and female and sexual orientations not limited to heterosexuality has been in almost constant evolution over several decades. An addition sign that accompanies LGBTQIA refers to those who do not identify with any letters in the acronym (lesbian, gay, bisexual, transsexual, queer/questioning, intersex, and asexual).
Take steps to normalize the interaction
Although many clinicians have been acclimated to these diverse identifies, not all have risen above preconceptions that become obstacles to effective care, according to Dr. Marzouk. In the context of headache management, Dr. Marzouk emphasized the need to be respectful of the range of gender identities and sexual orientations and to take steps to normalize the interaction.
For example, Dr. Marzouk advised using gender-neutral language at the start of each patient encounter and ask open-ended questions about gender, sexual identify, and pronouns to avoid patient discomfort from misidentification. In turn, the clinicians can establish their own gender identification and preferred pronouns to reinforce the idea that doing so is normal behavior.
This change in approach should be made “for all patients. Do not try to guess who needs them,” she said.
Intake forms and office atmosphere, such as signs and images, should also be welcoming to all patients, she added. Rather than trying to make adjustments for a LGBTQIA+ visit, Dr. Marzouk said a uniform approach helps normalize the experience of LGBTQIA+ patients without singling them out.
Despite the effort to provide an open and welcoming environment, Dr. Marzouk acknowledged that mistakes are difficult to avoid for those with limited experience serving the LGBTQIA+ community. When mistakes are made, she advised clinicians to immediately acknowledge the mistake and ask for guidance from the patient.
The potential offense is making the patient feel “other” or abnormal.
A higher rate of migraine
The interactions that LBGTQIA+ patients have with others outside their community is a possible explanation for the substantial rate of headache as well as headache with comorbid psychiatric disorders in this population.
In a survey published in 2020, the rate of migraine was 19.7% in heterosexual women, 26.7% in lesbians, and 36.8% in bisexual women. Among men, it rose from 9.8% in heterosexuals to 14.8% in gays and then to 22.8% in bisexuals.
Migraine relative to headache is also associated with more mood disorders among LGBTQIA+ individuals. In a study published in 2022, LGBTQIA+ patients with migraine relative to those with headache were more likely to have depression (46.4% vs. 22.3%; P < .001), anxiety (72.1% vs. 51.6%; P < .001), and posttraumatic stress disorder (37.5% vs. 21.4%; P < .001).
A vicious cycle of underdiagnosis and undertreatment
These associations are consistent with minority stress theory, according to Dr. Marzouk. This theory postulates that the associated stress of discrimination, rejection, and microaggressions, such as explicit efforts to make LGBTQIA+ individuals to feel “other,” produces epigenetic changes and dysregulation of the hypothalamic-pituitary-adrenal axis. In turn, this plays a role in the pathogenesis of migraine.
The inconsistency with which minority stress affects LGBTQIA+ patients might be due to relative differences in social support, coping skills, an innate resilience to these effects, Dr. Marzouk explained.
Dr. Marzouk characterized the LGBTQIA+ community as “underserved” for treatment of headache. She suggested that medical mistrust and self-blame among LGBTQIA+ individuals might be factors contributing to a vicious cycle of underdiagnosis and undertreatment. Efforts by the medical community to reach out to the LGBTQIA+ community are appropriate to address an unmet need.
“Individuals with psychiatric comorbidities may experience even more benefit from migraine care,” she said.
Clinical studies should be more inclusive
While agreeing in principle with these remarks, Eric A. Kaiser, MD, PhD, department of neurology, University of Pennsylvania, Philadelphia, said that this area would be better advanced if studies routinely included patients with diverse-gender identities and sexual orientations. Speaking about how to organize these studies, Dr. Kaiser suggested that enrollment criteria should explicitly seek these individuals and that these differences should be captured in the baseline characteristics.
“For example, gender options could include man, woman, non-binary, gender diverse, gender nonconforming, or gender nonspecified,” he said.
To close “the significant knowledge gap that exists in managing headache disorders in sexually- and gender- diverse people,” Dr. Kaiser said that clinical research studies, like patient treatment of diverse populations, “should be conducted with welcoming and affirming practices.”
Dr. Marzouk reported no potential conflicts of interest. Dr. Kaiser reported financial relationships with Amgen and Lundbeck.
It is “important not to assume that just because someone is a member of the LGBTQ+ community they will need psychiatric or behavioral health support,” said Maya A. Marzouk, PhD, division of behavioral medicine and clinical psychology, Cincinnati Children’s Hospital Medical Center.
Instead, it is useful not to make any assumptions. There is a potential association between minority status and headache susceptibility, but it is more reasonable initially to address the diagnosis and treatment of headache in LGBTQIA+ patients the same way it is addressed in any other patient, Dr. Marzouk said at the 2023 Scottsdale Headache Symposium.
The acronym to describe individuals with gender identities different from male and female and sexual orientations not limited to heterosexuality has been in almost constant evolution over several decades. An addition sign that accompanies LGBTQIA refers to those who do not identify with any letters in the acronym (lesbian, gay, bisexual, transsexual, queer/questioning, intersex, and asexual).
Take steps to normalize the interaction
Although many clinicians have been acclimated to these diverse identifies, not all have risen above preconceptions that become obstacles to effective care, according to Dr. Marzouk. In the context of headache management, Dr. Marzouk emphasized the need to be respectful of the range of gender identities and sexual orientations and to take steps to normalize the interaction.
For example, Dr. Marzouk advised using gender-neutral language at the start of each patient encounter and ask open-ended questions about gender, sexual identify, and pronouns to avoid patient discomfort from misidentification. In turn, the clinicians can establish their own gender identification and preferred pronouns to reinforce the idea that doing so is normal behavior.
This change in approach should be made “for all patients. Do not try to guess who needs them,” she said.
Intake forms and office atmosphere, such as signs and images, should also be welcoming to all patients, she added. Rather than trying to make adjustments for a LGBTQIA+ visit, Dr. Marzouk said a uniform approach helps normalize the experience of LGBTQIA+ patients without singling them out.
Despite the effort to provide an open and welcoming environment, Dr. Marzouk acknowledged that mistakes are difficult to avoid for those with limited experience serving the LGBTQIA+ community. When mistakes are made, she advised clinicians to immediately acknowledge the mistake and ask for guidance from the patient.
The potential offense is making the patient feel “other” or abnormal.
A higher rate of migraine
The interactions that LBGTQIA+ patients have with others outside their community is a possible explanation for the substantial rate of headache as well as headache with comorbid psychiatric disorders in this population.
In a survey published in 2020, the rate of migraine was 19.7% in heterosexual women, 26.7% in lesbians, and 36.8% in bisexual women. Among men, it rose from 9.8% in heterosexuals to 14.8% in gays and then to 22.8% in bisexuals.
Migraine relative to headache is also associated with more mood disorders among LGBTQIA+ individuals. In a study published in 2022, LGBTQIA+ patients with migraine relative to those with headache were more likely to have depression (46.4% vs. 22.3%; P < .001), anxiety (72.1% vs. 51.6%; P < .001), and posttraumatic stress disorder (37.5% vs. 21.4%; P < .001).
A vicious cycle of underdiagnosis and undertreatment
These associations are consistent with minority stress theory, according to Dr. Marzouk. This theory postulates that the associated stress of discrimination, rejection, and microaggressions, such as explicit efforts to make LGBTQIA+ individuals to feel “other,” produces epigenetic changes and dysregulation of the hypothalamic-pituitary-adrenal axis. In turn, this plays a role in the pathogenesis of migraine.
The inconsistency with which minority stress affects LGBTQIA+ patients might be due to relative differences in social support, coping skills, an innate resilience to these effects, Dr. Marzouk explained.
Dr. Marzouk characterized the LGBTQIA+ community as “underserved” for treatment of headache. She suggested that medical mistrust and self-blame among LGBTQIA+ individuals might be factors contributing to a vicious cycle of underdiagnosis and undertreatment. Efforts by the medical community to reach out to the LGBTQIA+ community are appropriate to address an unmet need.
“Individuals with psychiatric comorbidities may experience even more benefit from migraine care,” she said.
Clinical studies should be more inclusive
While agreeing in principle with these remarks, Eric A. Kaiser, MD, PhD, department of neurology, University of Pennsylvania, Philadelphia, said that this area would be better advanced if studies routinely included patients with diverse-gender identities and sexual orientations. Speaking about how to organize these studies, Dr. Kaiser suggested that enrollment criteria should explicitly seek these individuals and that these differences should be captured in the baseline characteristics.
“For example, gender options could include man, woman, non-binary, gender diverse, gender nonconforming, or gender nonspecified,” he said.
To close “the significant knowledge gap that exists in managing headache disorders in sexually- and gender- diverse people,” Dr. Kaiser said that clinical research studies, like patient treatment of diverse populations, “should be conducted with welcoming and affirming practices.”
Dr. Marzouk reported no potential conflicts of interest. Dr. Kaiser reported financial relationships with Amgen and Lundbeck.
FROM THE 2023 SCOTTSDALE HEADACHE SYMPOSIUM
Hourly air pollution exposure: A risk factor for stroke
TOPLINE:
METHODOLOGY:
- Limited studies have investigated the association between hourly exposure to air pollutants and specific stroke subtypes, especially in regions with moderate to high levels of air pollution.
- The multicenter case-crossover study evaluated the association between hourly exposure to air pollution and stroke among 86,635 emergency admissions for stroke across 10 hospitals in 3 cities.
- Of 86,635 admissions, 79,478 were admitted for ischemic stroke, 3,122 for hemorrhagic stroke, and 4,035 for undetermined type of stroke.
- Hourly levels of fine particulate matter (PM2.5), respirable PM (PM10), nitrogen dioxide (NO2), and sulfur dioxide (SO2) were collected from the China National Environmental Monitoring Center.
TAKEAWAY:
- Exposure to NO2 and SO2 increased the risk for emergency admission for stroke shortly after exposure by 3.34% (95% confidence interval, 1.41%-5.31%) and 2.81% (95% CI, 1.15%-4.51%), respectively.
- Among men, exposure to PM2.5 and PM10 increased the risk for emergency admission for stroke by 3.40% (95% CI, 1.21%-5.64%) and 4.33% (95% CI, 2.18%-6.53%), respectively.
- Among patients aged less than 65 years, exposure to PM10 and NO2 increased the risk for emergency admissions for stroke shortly after exposure by 4.88% (95% CI, 2.29%-7.54%) and 5.59% (95% CI, 2.34%-8.93%), respectively.
IN PRACTICE:
“These variations in susceptibility highlight the importance of implementing effective health protection measures to reduce exposure to air pollution and mitigate the risk of stroke in younger and male populations,” wrote the authors.
SOURCE:
The study was led by Xin Lv, MD, department of epidemiology and biostatistics, School of Public Health, Capital Medical University, Beijing. It was published online in the journal Stroke.
LIMITATIONS:
- Using data from the nearest monitoring site to the hospital address may lead to localized variations in pollution concentrations when assessing exposure.
- There may be a possibility of residual confounding resulting from time-varying lifestyle-related factors.
DISCLOSURES:
This study was supported by the Zhejiang Provincial Project for Medical Research and Health Sciences. No disclosures were reported.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Limited studies have investigated the association between hourly exposure to air pollutants and specific stroke subtypes, especially in regions with moderate to high levels of air pollution.
- The multicenter case-crossover study evaluated the association between hourly exposure to air pollution and stroke among 86,635 emergency admissions for stroke across 10 hospitals in 3 cities.
- Of 86,635 admissions, 79,478 were admitted for ischemic stroke, 3,122 for hemorrhagic stroke, and 4,035 for undetermined type of stroke.
- Hourly levels of fine particulate matter (PM2.5), respirable PM (PM10), nitrogen dioxide (NO2), and sulfur dioxide (SO2) were collected from the China National Environmental Monitoring Center.
TAKEAWAY:
- Exposure to NO2 and SO2 increased the risk for emergency admission for stroke shortly after exposure by 3.34% (95% confidence interval, 1.41%-5.31%) and 2.81% (95% CI, 1.15%-4.51%), respectively.
- Among men, exposure to PM2.5 and PM10 increased the risk for emergency admission for stroke by 3.40% (95% CI, 1.21%-5.64%) and 4.33% (95% CI, 2.18%-6.53%), respectively.
- Among patients aged less than 65 years, exposure to PM10 and NO2 increased the risk for emergency admissions for stroke shortly after exposure by 4.88% (95% CI, 2.29%-7.54%) and 5.59% (95% CI, 2.34%-8.93%), respectively.
IN PRACTICE:
“These variations in susceptibility highlight the importance of implementing effective health protection measures to reduce exposure to air pollution and mitigate the risk of stroke in younger and male populations,” wrote the authors.
SOURCE:
The study was led by Xin Lv, MD, department of epidemiology and biostatistics, School of Public Health, Capital Medical University, Beijing. It was published online in the journal Stroke.
LIMITATIONS:
- Using data from the nearest monitoring site to the hospital address may lead to localized variations in pollution concentrations when assessing exposure.
- There may be a possibility of residual confounding resulting from time-varying lifestyle-related factors.
DISCLOSURES:
This study was supported by the Zhejiang Provincial Project for Medical Research and Health Sciences. No disclosures were reported.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Limited studies have investigated the association between hourly exposure to air pollutants and specific stroke subtypes, especially in regions with moderate to high levels of air pollution.
- The multicenter case-crossover study evaluated the association between hourly exposure to air pollution and stroke among 86,635 emergency admissions for stroke across 10 hospitals in 3 cities.
- Of 86,635 admissions, 79,478 were admitted for ischemic stroke, 3,122 for hemorrhagic stroke, and 4,035 for undetermined type of stroke.
- Hourly levels of fine particulate matter (PM2.5), respirable PM (PM10), nitrogen dioxide (NO2), and sulfur dioxide (SO2) were collected from the China National Environmental Monitoring Center.
TAKEAWAY:
- Exposure to NO2 and SO2 increased the risk for emergency admission for stroke shortly after exposure by 3.34% (95% confidence interval, 1.41%-5.31%) and 2.81% (95% CI, 1.15%-4.51%), respectively.
- Among men, exposure to PM2.5 and PM10 increased the risk for emergency admission for stroke by 3.40% (95% CI, 1.21%-5.64%) and 4.33% (95% CI, 2.18%-6.53%), respectively.
- Among patients aged less than 65 years, exposure to PM10 and NO2 increased the risk for emergency admissions for stroke shortly after exposure by 4.88% (95% CI, 2.29%-7.54%) and 5.59% (95% CI, 2.34%-8.93%), respectively.
IN PRACTICE:
“These variations in susceptibility highlight the importance of implementing effective health protection measures to reduce exposure to air pollution and mitigate the risk of stroke in younger and male populations,” wrote the authors.
SOURCE:
The study was led by Xin Lv, MD, department of epidemiology and biostatistics, School of Public Health, Capital Medical University, Beijing. It was published online in the journal Stroke.
LIMITATIONS:
- Using data from the nearest monitoring site to the hospital address may lead to localized variations in pollution concentrations when assessing exposure.
- There may be a possibility of residual confounding resulting from time-varying lifestyle-related factors.
DISCLOSURES:
This study was supported by the Zhejiang Provincial Project for Medical Research and Health Sciences. No disclosures were reported.
A version of this article first appeared on Medscape.com.
Abstracts from the Neurology Exchange 2023, a virtual event held September 19-21, 2023
Spinal cord stimulator restores Parkinson patient’s gait
The neuroprosthesis involves targeted epidural electrical stimulation of areas of the lumbosacral spinal cord that produce walking.
This new therapeutic tool offers hope to patients with PD and, combined with existing approaches, may alleviate a motor sign in PD for which there is currently “no real solution,” study investigator Eduardo Martin Moraud, PhD, who leads PD research at the Defitech Center for Interventional Neurotherapies (NeuroRestore), Lausanne, Switzerland, said in an interview.
“This is exciting for the many patients that develop gait deficits and experience frequent falls, who can only rely on physical therapy to try and minimize the consequences,” he added.
The findings were published online in Nature Medicine.
Personalized stimulation
About 90% of people with advanced PD experience gait and balance problems or freezing-of-gait episodes. These locomotor deficits typically don’t respond well to dopamine replacement therapy or deep brain stimulation (DBS) of the subthalamic nucleus, possibly because the neural origins of these motor problems involve brain circuits not related to dopamine, said Dr. Moraud.
Continuous electrical stimulation over the cervical or thoracic segments of the spinal cord reduces locomotor deficits in some people with PD, but the broader application of this strategy has led to variable and unsatisfying outcomes.
The new approach focuses on correcting abnormal activation of circuits in the lumbar spinal cord, a region that hosts all the neurons that control activation of the leg muscles used for walking.
The stimulating device is placed on the lumbar region of the spinal cord, which sends messages to leg muscles. It is wired to a small impulse generator implanted under the skin of the abdomen. Sensors placed in shoes align the stimulation to the patient’s movement.
The system can detect the beginning of a movement, immediately activate the appropriate electrode, and so facilitate the necessary movement, be that leg flexion, extension, or propulsion, said Dr. Moraud. “This allows for increased walking symmetry, reinforced balance, and increased length of steps.”
The concept of this neuroprosthesis is similar to that used to allow patients with a spinal cord injury (SCI) to walk. But unlike patients with SCI, those with PD can move their legs, indicating that there is a descending command from the brain that needs to interact with the stimulation of the spinal cord, and patients with PD can feel the stimulation.
“Both these elements imply that amplitudes of stimulation need to be much lower in PD than SCI, and that stimulation needs to be fully personalized in PD to synergistically interact with the descending commands from the brain.”
After fine-tuning this new neuroprosthesis in animal models, researchers implanted the device in a 62-year-old man with a 30-year history of PD who presented with severe gait impairments, including marked gait asymmetry, reduced stride length, and balance problems.
Gait restored to near normal
The patient had frequent freezing-of-gait episodes when turning and passing through narrow paths, which led to multiple falls a day. This was despite being treated with DBS and dopaminergic replacement therapies.
But after getting used to the neuroprosthesis, the patient now walks with a gait akin to that of people without PD.
“Our experience in the preclinical animal models and this first patient is that gait can be restored to an almost healthy level, but this, of course, may vary across patients, depending on the severity of their disease progression, and their other motor deficits,” said Dr. Moraud.
When the neuroprosthesis is turned on, freezing of gait nearly vanishes, both with and without DBS.
In addition, the neuroprosthesis augmented the impact of the patient’s rehabilitation program, which involved a variety of regular exercises, including walking on basic and complex terrains, navigating outdoors in community settings, balance training, and basic physical therapy.
Frequent use of the neuroprosthesis during gait rehabilitation also translated into “highly improved” quality of life as reported by the patient (and his wife), said Dr. Moraud.
The patient has now been using the neuroprosthesis about 8 hours a day for nearly 2 years, only switching it off when sitting for long periods of time or while sleeping.
“He regained the capacity to walk in complex or crowded environments such as shops, airports, or his own home, without falling,” said Dr. Moraud. “He went from falling five to six times per day to one or two [falls] every couple of weeks. He’s also much more confident. He can walk for many miles, run, and go on holidays, without the constant fear of falling and having related injuries.”
Dr. Moraud stressed that the device does not replace DBS, which is a “key therapy” that addresses other deficits in PD, such as rigidity or slowness of movement. “What we propose here is a fully complementary approach for the gait problems that are not well addressed by DBS.”
One of the next steps will be to evaluate the efficacy of this approach across a wider spectrum of patient profiles to fully define the best responders, said Dr. Moraud.
A ‘tour de force’
In a comment, Michael S. Okun, MD, director of the Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, and medical director of the Parkinson’s Foundation, noted that the researchers used “a smarter device” than past approaches that failed to adequately address progressive walking challenges of patients with PD.
Although it’s “tempting to get excited” about the findings, it’s important to consider that the study included only one human subject and did not target circuits for both walking and balance, said Dr. Okun. “It’s possible that even if future studies revealed a benefit for walking, the device may or may not address falling.”
In an accompanying editorial, Aviv Mizrahi-Kliger, MD, PhD, department of neurology, University of California, San Francisco, and Karunesh Ganguly, MD, PhD, Neurology and Rehabilitation Service, San Francisco Veterans Affairs Health Care System, called the study an “impressive tour de force,” with data from the nonhuman primate model and the individual with PD “jointly” indicating that epidural electrical stimulation (EES) “is a very promising treatment for several aspects of gait, posture and balance impairments in PD.”
But although the effect in the single patient “is quite impressive,” the “next crucial step” is to test this approach in a larger cohort of patients, they said.
They noted the nonhuman model does not exhibit freezing of gait, “which precluded the ability to corroborate or further study the role of EES in alleviating this symptom of PD in an animal model.”
In addition, stimulation parameters in the patient with PD “had to rely on estimated normal activity patterns, owing to the inability to measure pre-disease patterns at the individual level,” they wrote.
The study received funding from the Defitech Foundation, ONWARD Medical, CAMS Innovation Fund for Medical Sciences, National Natural Science Foundation of China, Parkinson Schweiz Foundation, European Community’s Seventh Framework Program (NeuWalk), European Research Council, Wyss Center for Bio and Neuroengineering, Bertarelli Foundation, and Swiss National Science Foundation. Dr. Moraud and other study authors hold various patents or applications in relation to the present work. Dr. Mizrahi-Kliger has no relevant conflicts of interest; Dr. Ganguly has a patent for modulation of sensory inputs to improve motor recovery from stroke and has been a consultant to Cala Health.
A version of this article first appeared on Medscape.com.
The neuroprosthesis involves targeted epidural electrical stimulation of areas of the lumbosacral spinal cord that produce walking.
This new therapeutic tool offers hope to patients with PD and, combined with existing approaches, may alleviate a motor sign in PD for which there is currently “no real solution,” study investigator Eduardo Martin Moraud, PhD, who leads PD research at the Defitech Center for Interventional Neurotherapies (NeuroRestore), Lausanne, Switzerland, said in an interview.
“This is exciting for the many patients that develop gait deficits and experience frequent falls, who can only rely on physical therapy to try and minimize the consequences,” he added.
The findings were published online in Nature Medicine.
Personalized stimulation
About 90% of people with advanced PD experience gait and balance problems or freezing-of-gait episodes. These locomotor deficits typically don’t respond well to dopamine replacement therapy or deep brain stimulation (DBS) of the subthalamic nucleus, possibly because the neural origins of these motor problems involve brain circuits not related to dopamine, said Dr. Moraud.
Continuous electrical stimulation over the cervical or thoracic segments of the spinal cord reduces locomotor deficits in some people with PD, but the broader application of this strategy has led to variable and unsatisfying outcomes.
The new approach focuses on correcting abnormal activation of circuits in the lumbar spinal cord, a region that hosts all the neurons that control activation of the leg muscles used for walking.
The stimulating device is placed on the lumbar region of the spinal cord, which sends messages to leg muscles. It is wired to a small impulse generator implanted under the skin of the abdomen. Sensors placed in shoes align the stimulation to the patient’s movement.
The system can detect the beginning of a movement, immediately activate the appropriate electrode, and so facilitate the necessary movement, be that leg flexion, extension, or propulsion, said Dr. Moraud. “This allows for increased walking symmetry, reinforced balance, and increased length of steps.”
The concept of this neuroprosthesis is similar to that used to allow patients with a spinal cord injury (SCI) to walk. But unlike patients with SCI, those with PD can move their legs, indicating that there is a descending command from the brain that needs to interact with the stimulation of the spinal cord, and patients with PD can feel the stimulation.
“Both these elements imply that amplitudes of stimulation need to be much lower in PD than SCI, and that stimulation needs to be fully personalized in PD to synergistically interact with the descending commands from the brain.”
After fine-tuning this new neuroprosthesis in animal models, researchers implanted the device in a 62-year-old man with a 30-year history of PD who presented with severe gait impairments, including marked gait asymmetry, reduced stride length, and balance problems.
Gait restored to near normal
The patient had frequent freezing-of-gait episodes when turning and passing through narrow paths, which led to multiple falls a day. This was despite being treated with DBS and dopaminergic replacement therapies.
But after getting used to the neuroprosthesis, the patient now walks with a gait akin to that of people without PD.
“Our experience in the preclinical animal models and this first patient is that gait can be restored to an almost healthy level, but this, of course, may vary across patients, depending on the severity of their disease progression, and their other motor deficits,” said Dr. Moraud.
When the neuroprosthesis is turned on, freezing of gait nearly vanishes, both with and without DBS.
In addition, the neuroprosthesis augmented the impact of the patient’s rehabilitation program, which involved a variety of regular exercises, including walking on basic and complex terrains, navigating outdoors in community settings, balance training, and basic physical therapy.
Frequent use of the neuroprosthesis during gait rehabilitation also translated into “highly improved” quality of life as reported by the patient (and his wife), said Dr. Moraud.
The patient has now been using the neuroprosthesis about 8 hours a day for nearly 2 years, only switching it off when sitting for long periods of time or while sleeping.
“He regained the capacity to walk in complex or crowded environments such as shops, airports, or his own home, without falling,” said Dr. Moraud. “He went from falling five to six times per day to one or two [falls] every couple of weeks. He’s also much more confident. He can walk for many miles, run, and go on holidays, without the constant fear of falling and having related injuries.”
Dr. Moraud stressed that the device does not replace DBS, which is a “key therapy” that addresses other deficits in PD, such as rigidity or slowness of movement. “What we propose here is a fully complementary approach for the gait problems that are not well addressed by DBS.”
One of the next steps will be to evaluate the efficacy of this approach across a wider spectrum of patient profiles to fully define the best responders, said Dr. Moraud.
A ‘tour de force’
In a comment, Michael S. Okun, MD, director of the Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, and medical director of the Parkinson’s Foundation, noted that the researchers used “a smarter device” than past approaches that failed to adequately address progressive walking challenges of patients with PD.
Although it’s “tempting to get excited” about the findings, it’s important to consider that the study included only one human subject and did not target circuits for both walking and balance, said Dr. Okun. “It’s possible that even if future studies revealed a benefit for walking, the device may or may not address falling.”
In an accompanying editorial, Aviv Mizrahi-Kliger, MD, PhD, department of neurology, University of California, San Francisco, and Karunesh Ganguly, MD, PhD, Neurology and Rehabilitation Service, San Francisco Veterans Affairs Health Care System, called the study an “impressive tour de force,” with data from the nonhuman primate model and the individual with PD “jointly” indicating that epidural electrical stimulation (EES) “is a very promising treatment for several aspects of gait, posture and balance impairments in PD.”
But although the effect in the single patient “is quite impressive,” the “next crucial step” is to test this approach in a larger cohort of patients, they said.
They noted the nonhuman model does not exhibit freezing of gait, “which precluded the ability to corroborate or further study the role of EES in alleviating this symptom of PD in an animal model.”
In addition, stimulation parameters in the patient with PD “had to rely on estimated normal activity patterns, owing to the inability to measure pre-disease patterns at the individual level,” they wrote.
The study received funding from the Defitech Foundation, ONWARD Medical, CAMS Innovation Fund for Medical Sciences, National Natural Science Foundation of China, Parkinson Schweiz Foundation, European Community’s Seventh Framework Program (NeuWalk), European Research Council, Wyss Center for Bio and Neuroengineering, Bertarelli Foundation, and Swiss National Science Foundation. Dr. Moraud and other study authors hold various patents or applications in relation to the present work. Dr. Mizrahi-Kliger has no relevant conflicts of interest; Dr. Ganguly has a patent for modulation of sensory inputs to improve motor recovery from stroke and has been a consultant to Cala Health.
A version of this article first appeared on Medscape.com.
The neuroprosthesis involves targeted epidural electrical stimulation of areas of the lumbosacral spinal cord that produce walking.
This new therapeutic tool offers hope to patients with PD and, combined with existing approaches, may alleviate a motor sign in PD for which there is currently “no real solution,” study investigator Eduardo Martin Moraud, PhD, who leads PD research at the Defitech Center for Interventional Neurotherapies (NeuroRestore), Lausanne, Switzerland, said in an interview.
“This is exciting for the many patients that develop gait deficits and experience frequent falls, who can only rely on physical therapy to try and minimize the consequences,” he added.
The findings were published online in Nature Medicine.
Personalized stimulation
About 90% of people with advanced PD experience gait and balance problems or freezing-of-gait episodes. These locomotor deficits typically don’t respond well to dopamine replacement therapy or deep brain stimulation (DBS) of the subthalamic nucleus, possibly because the neural origins of these motor problems involve brain circuits not related to dopamine, said Dr. Moraud.
Continuous electrical stimulation over the cervical or thoracic segments of the spinal cord reduces locomotor deficits in some people with PD, but the broader application of this strategy has led to variable and unsatisfying outcomes.
The new approach focuses on correcting abnormal activation of circuits in the lumbar spinal cord, a region that hosts all the neurons that control activation of the leg muscles used for walking.
The stimulating device is placed on the lumbar region of the spinal cord, which sends messages to leg muscles. It is wired to a small impulse generator implanted under the skin of the abdomen. Sensors placed in shoes align the stimulation to the patient’s movement.
The system can detect the beginning of a movement, immediately activate the appropriate electrode, and so facilitate the necessary movement, be that leg flexion, extension, or propulsion, said Dr. Moraud. “This allows for increased walking symmetry, reinforced balance, and increased length of steps.”
The concept of this neuroprosthesis is similar to that used to allow patients with a spinal cord injury (SCI) to walk. But unlike patients with SCI, those with PD can move their legs, indicating that there is a descending command from the brain that needs to interact with the stimulation of the spinal cord, and patients with PD can feel the stimulation.
“Both these elements imply that amplitudes of stimulation need to be much lower in PD than SCI, and that stimulation needs to be fully personalized in PD to synergistically interact with the descending commands from the brain.”
After fine-tuning this new neuroprosthesis in animal models, researchers implanted the device in a 62-year-old man with a 30-year history of PD who presented with severe gait impairments, including marked gait asymmetry, reduced stride length, and balance problems.
Gait restored to near normal
The patient had frequent freezing-of-gait episodes when turning and passing through narrow paths, which led to multiple falls a day. This was despite being treated with DBS and dopaminergic replacement therapies.
But after getting used to the neuroprosthesis, the patient now walks with a gait akin to that of people without PD.
“Our experience in the preclinical animal models and this first patient is that gait can be restored to an almost healthy level, but this, of course, may vary across patients, depending on the severity of their disease progression, and their other motor deficits,” said Dr. Moraud.
When the neuroprosthesis is turned on, freezing of gait nearly vanishes, both with and without DBS.
In addition, the neuroprosthesis augmented the impact of the patient’s rehabilitation program, which involved a variety of regular exercises, including walking on basic and complex terrains, navigating outdoors in community settings, balance training, and basic physical therapy.
Frequent use of the neuroprosthesis during gait rehabilitation also translated into “highly improved” quality of life as reported by the patient (and his wife), said Dr. Moraud.
The patient has now been using the neuroprosthesis about 8 hours a day for nearly 2 years, only switching it off when sitting for long periods of time or while sleeping.
“He regained the capacity to walk in complex or crowded environments such as shops, airports, or his own home, without falling,” said Dr. Moraud. “He went from falling five to six times per day to one or two [falls] every couple of weeks. He’s also much more confident. He can walk for many miles, run, and go on holidays, without the constant fear of falling and having related injuries.”
Dr. Moraud stressed that the device does not replace DBS, which is a “key therapy” that addresses other deficits in PD, such as rigidity or slowness of movement. “What we propose here is a fully complementary approach for the gait problems that are not well addressed by DBS.”
One of the next steps will be to evaluate the efficacy of this approach across a wider spectrum of patient profiles to fully define the best responders, said Dr. Moraud.
A ‘tour de force’
In a comment, Michael S. Okun, MD, director of the Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, and medical director of the Parkinson’s Foundation, noted that the researchers used “a smarter device” than past approaches that failed to adequately address progressive walking challenges of patients with PD.
Although it’s “tempting to get excited” about the findings, it’s important to consider that the study included only one human subject and did not target circuits for both walking and balance, said Dr. Okun. “It’s possible that even if future studies revealed a benefit for walking, the device may or may not address falling.”
In an accompanying editorial, Aviv Mizrahi-Kliger, MD, PhD, department of neurology, University of California, San Francisco, and Karunesh Ganguly, MD, PhD, Neurology and Rehabilitation Service, San Francisco Veterans Affairs Health Care System, called the study an “impressive tour de force,” with data from the nonhuman primate model and the individual with PD “jointly” indicating that epidural electrical stimulation (EES) “is a very promising treatment for several aspects of gait, posture and balance impairments in PD.”
But although the effect in the single patient “is quite impressive,” the “next crucial step” is to test this approach in a larger cohort of patients, they said.
They noted the nonhuman model does not exhibit freezing of gait, “which precluded the ability to corroborate or further study the role of EES in alleviating this symptom of PD in an animal model.”
In addition, stimulation parameters in the patient with PD “had to rely on estimated normal activity patterns, owing to the inability to measure pre-disease patterns at the individual level,” they wrote.
The study received funding from the Defitech Foundation, ONWARD Medical, CAMS Innovation Fund for Medical Sciences, National Natural Science Foundation of China, Parkinson Schweiz Foundation, European Community’s Seventh Framework Program (NeuWalk), European Research Council, Wyss Center for Bio and Neuroengineering, Bertarelli Foundation, and Swiss National Science Foundation. Dr. Moraud and other study authors hold various patents or applications in relation to the present work. Dr. Mizrahi-Kliger has no relevant conflicts of interest; Dr. Ganguly has a patent for modulation of sensory inputs to improve motor recovery from stroke and has been a consultant to Cala Health.
A version of this article first appeared on Medscape.com.
FROM NATURE MEDICINE
Life in the woods
“I went to the woods because I wished to live deliberately, to front only the essential facts of life, and see if I could not learn what it had to teach.” – Henry David Thoreau
I have many patients like Maxine. Tall, with a shock of white hair. Old, but still in charge. When you try to make eye contact, she looks right through you. First with her left eye. Then her right. Her face is inscrutable. What’s she thinking? Unlike many of my patients, however, this Maxine was a llama. Every morning my daughter and I tried to coax her into moving as we leaned on the cold steel gate that kept her in her pasture. We were visiting family in October and chose to stay on a working New England farm. The kids will love the animals, we thought, and we’ll appreciate the extra bedrooms.
Airbnb helped us find this charming fiber-farm in Rhode Island where they raise Leicester Longwool sheep, a historic breed that once roamed George Washington’s pastures, along with a few goats, ducks, chickens, and Maxine. It’s situated deep in the woods, which were yellow, orange, and red that week. As it happens, we were just a short drive due south of Walden Pond where Henry David Thoreau spent 2 years, 2 months and 2 days escaping “overcivilization” nearly 175 years ago. Hoisting our overweight bags over the uneven granite stone steps when we arrived, I realized this was going to be more like the Thoreau experiment than I intended. The farmhouse dated to the 1790s. There were wide, creaky floorboards, low ceilings, one staircase to the bedrooms (which could have aptly been called a ladder) and loads of book-laden shelves. Instructions posted in the kitchen warned that the heat is tricky to regulate – a redundant admonition as we watched our 3-year-old putting on her socks and shoes as she got into bed.
Now, if you’ve ever been on vacation with little kids, you know that it’s basically just childcare in a novel location. After barricading the staircase with luggage and unplugging lamps from their dicey outlets we set out to feed the chickens and try to pet a sheep. Walking the perimeter of the farm we saw stone walls that needed mending and stumbled across two ancient cemeteries, one had been for family, the other for slaves. I wondered how many farmers and weavers and menders had walked this trail with their kids over the generations.
The next morning, we learned that roosters do not in fact crow at dawn, they crow before dawn (which could also aptly be called nighttime). There were no commutes or late patients here. But there was work to be done. Chickens don’t care that it’s Sunday. It downpoured. Watching the sheep from the kitchen as I sipped my coffee, they didn’t seem to mind. Nor did our farmer hosts who trudged past them in tall boots, just as they had every other day of their farmer lives.
By the fifth day, we had fallen into the rhythms of the homestead. We cracked the blue, green, and brown eggs that our hosts placed outside our door in the early hours and made omelets that were as orange as the foliage. We finally learned to adjust the heat so we neither got chilblains nor had to open the windows and strip naked to cool down. The sky was a brilliant blue that last morning and Sloan ran around trying to catch leaves as they blew off the trees. She had no objective. No counting. No contest. Just chasing leaves as they fell. It was the ultimate atelic activity, done just for doing it. I joined her and found I was no better at this than a 3-year-old.
We might all benefit from a little time in the woods.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
“I went to the woods because I wished to live deliberately, to front only the essential facts of life, and see if I could not learn what it had to teach.” – Henry David Thoreau
I have many patients like Maxine. Tall, with a shock of white hair. Old, but still in charge. When you try to make eye contact, she looks right through you. First with her left eye. Then her right. Her face is inscrutable. What’s she thinking? Unlike many of my patients, however, this Maxine was a llama. Every morning my daughter and I tried to coax her into moving as we leaned on the cold steel gate that kept her in her pasture. We were visiting family in October and chose to stay on a working New England farm. The kids will love the animals, we thought, and we’ll appreciate the extra bedrooms.
Airbnb helped us find this charming fiber-farm in Rhode Island where they raise Leicester Longwool sheep, a historic breed that once roamed George Washington’s pastures, along with a few goats, ducks, chickens, and Maxine. It’s situated deep in the woods, which were yellow, orange, and red that week. As it happens, we were just a short drive due south of Walden Pond where Henry David Thoreau spent 2 years, 2 months and 2 days escaping “overcivilization” nearly 175 years ago. Hoisting our overweight bags over the uneven granite stone steps when we arrived, I realized this was going to be more like the Thoreau experiment than I intended. The farmhouse dated to the 1790s. There were wide, creaky floorboards, low ceilings, one staircase to the bedrooms (which could have aptly been called a ladder) and loads of book-laden shelves. Instructions posted in the kitchen warned that the heat is tricky to regulate – a redundant admonition as we watched our 3-year-old putting on her socks and shoes as she got into bed.
Now, if you’ve ever been on vacation with little kids, you know that it’s basically just childcare in a novel location. After barricading the staircase with luggage and unplugging lamps from their dicey outlets we set out to feed the chickens and try to pet a sheep. Walking the perimeter of the farm we saw stone walls that needed mending and stumbled across two ancient cemeteries, one had been for family, the other for slaves. I wondered how many farmers and weavers and menders had walked this trail with their kids over the generations.
The next morning, we learned that roosters do not in fact crow at dawn, they crow before dawn (which could also aptly be called nighttime). There were no commutes or late patients here. But there was work to be done. Chickens don’t care that it’s Sunday. It downpoured. Watching the sheep from the kitchen as I sipped my coffee, they didn’t seem to mind. Nor did our farmer hosts who trudged past them in tall boots, just as they had every other day of their farmer lives.
By the fifth day, we had fallen into the rhythms of the homestead. We cracked the blue, green, and brown eggs that our hosts placed outside our door in the early hours and made omelets that were as orange as the foliage. We finally learned to adjust the heat so we neither got chilblains nor had to open the windows and strip naked to cool down. The sky was a brilliant blue that last morning and Sloan ran around trying to catch leaves as they blew off the trees. She had no objective. No counting. No contest. Just chasing leaves as they fell. It was the ultimate atelic activity, done just for doing it. I joined her and found I was no better at this than a 3-year-old.
We might all benefit from a little time in the woods.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
“I went to the woods because I wished to live deliberately, to front only the essential facts of life, and see if I could not learn what it had to teach.” – Henry David Thoreau
I have many patients like Maxine. Tall, with a shock of white hair. Old, but still in charge. When you try to make eye contact, she looks right through you. First with her left eye. Then her right. Her face is inscrutable. What’s she thinking? Unlike many of my patients, however, this Maxine was a llama. Every morning my daughter and I tried to coax her into moving as we leaned on the cold steel gate that kept her in her pasture. We were visiting family in October and chose to stay on a working New England farm. The kids will love the animals, we thought, and we’ll appreciate the extra bedrooms.
Airbnb helped us find this charming fiber-farm in Rhode Island where they raise Leicester Longwool sheep, a historic breed that once roamed George Washington’s pastures, along with a few goats, ducks, chickens, and Maxine. It’s situated deep in the woods, which were yellow, orange, and red that week. As it happens, we were just a short drive due south of Walden Pond where Henry David Thoreau spent 2 years, 2 months and 2 days escaping “overcivilization” nearly 175 years ago. Hoisting our overweight bags over the uneven granite stone steps when we arrived, I realized this was going to be more like the Thoreau experiment than I intended. The farmhouse dated to the 1790s. There were wide, creaky floorboards, low ceilings, one staircase to the bedrooms (which could have aptly been called a ladder) and loads of book-laden shelves. Instructions posted in the kitchen warned that the heat is tricky to regulate – a redundant admonition as we watched our 3-year-old putting on her socks and shoes as she got into bed.
Now, if you’ve ever been on vacation with little kids, you know that it’s basically just childcare in a novel location. After barricading the staircase with luggage and unplugging lamps from their dicey outlets we set out to feed the chickens and try to pet a sheep. Walking the perimeter of the farm we saw stone walls that needed mending and stumbled across two ancient cemeteries, one had been for family, the other for slaves. I wondered how many farmers and weavers and menders had walked this trail with their kids over the generations.
The next morning, we learned that roosters do not in fact crow at dawn, they crow before dawn (which could also aptly be called nighttime). There were no commutes or late patients here. But there was work to be done. Chickens don’t care that it’s Sunday. It downpoured. Watching the sheep from the kitchen as I sipped my coffee, they didn’t seem to mind. Nor did our farmer hosts who trudged past them in tall boots, just as they had every other day of their farmer lives.
By the fifth day, we had fallen into the rhythms of the homestead. We cracked the blue, green, and brown eggs that our hosts placed outside our door in the early hours and made omelets that were as orange as the foliage. We finally learned to adjust the heat so we neither got chilblains nor had to open the windows and strip naked to cool down. The sky was a brilliant blue that last morning and Sloan ran around trying to catch leaves as they blew off the trees. She had no objective. No counting. No contest. Just chasing leaves as they fell. It was the ultimate atelic activity, done just for doing it. I joined her and found I was no better at this than a 3-year-old.
We might all benefit from a little time in the woods.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
FTC considers proposals on mergers and noncompete clauses
Changes may be in store for how physicians do business based on pending proposals from the Federal Trade Commission to ban noncompete clauses and monitor potential merger monopolies.
In January 2023, the FTC announced a rule that would ban noncompete clauses, stating that such clauses reduce workers’ wages and stifle new businesses. Simply put, the rule would ban employers from entering into noncompete clauses with workers, including independent contractors.
Aspects of the rule include whether it should pertain to franchisees, whether senior executives should be exempted, and whether low-wage and high-wage workers should be treated differently.
According to the FTC, banning noncompete clauses would increase workers’ earnings by approximately $300 billion per year, save consumers as much as $148 billion in health care costs, and double the number of companies founded by former workers in the same field.
In June 2023, the FTC and the Department of Justice proposed changes to rules governing mergers, including changes to prenotification forms that would promote more efficient screening of potential mergers. According to a press release from the FTC, the proposed changes include provision of details about investments or corporate relationships, product and services, projected revenue streams, and previous acquisitions.
The proposal also includes a waiting period during which agencies would assess the risk that a merger would lessen competition or tend to create a monopoly.
What the FTC proposals mean for physicians
FTC Chair Lina M. Khan addressed attendees at the American College of Physicians at their annual meeting in October.
In March 2023, ACEP wrote to Ms. Khan in support of the banning of noncompete clauses. The ACEP also stated that the FTC should monitor the effect of a ban on the ability to recruit and maintain a stable physician workforce in rural and underserved areas “and should examine the potential impacts should nonprofit health systems be exempt from a ban.”
However, the American Medical Group Association, a nonprofit trade organization that supports multispecialty medical groups, opposes the ban. In a press release issued in March 2023, AMGA noted that, “As employers, AMGA members rely in part on noncompete agreements to build strong, sustainable care teams that work together to coordinate care for their patients. These care teams emphasize the importance of the doctor-patient relationship, which reasonable noncompete agreements help support.”
The American Medical Association supports the ban on noncompete clauses, detailed in an official AMA policy statement as, “support[ing] policies, regulations, and legislation that prohibits covenants not-to-compete for all physicians in clinical practice who hold employment contracts with for-profit or nonprofit hospital, hospital system, or staffing company employers.”
In regard to the merger guidelines, ACEP wrote a separate letter to Ms. Khan identifying some of the unique aspects of emergency medicine practice. The ACEP stressed the need for caution as the consolidation of medical practices continues, many under the umbrella of private equity investment companies.
“Unchecked mergers that substantially lessen competition in the labor market for emergency physicians, in which the employer is the buyer and the physician is the seller, can impact physicians directly by lowering wages or slowing wage growth, worsening benefits or working conditions, or contributing to other degradations in workplace quality,” according to ACEP.
The AMA also supports the FTC’s draft merger guidelines as protective of physicians and their working environments.
In September 2023, the AMA sent a letter to the FTC commending the agency on the proposed guidelines: “It is our strong contention that the agencies must have merger guidelines that protect physicians against health insurer mergers that may substantially lessen competition for the purchase of physician services and that degrade physician working conditions,” according to the AMA letter.
According the FTC, the proposed changes represent an expansion and reorganization of information along with the addition of new document requirements and represents the first comprehensive review of the Hart-Scott-Rodino Antitrust Improvements Act since 1978.
After soliciting public comments, the FTC is reviewing the proposals, and no specific date for a final vote has been announced.
More specifics on the potential changes to premerger notification, reporting, and waiting period requirements are available on the FTC website.
A version of this article appeared on Medscape.com.
Changes may be in store for how physicians do business based on pending proposals from the Federal Trade Commission to ban noncompete clauses and monitor potential merger monopolies.
In January 2023, the FTC announced a rule that would ban noncompete clauses, stating that such clauses reduce workers’ wages and stifle new businesses. Simply put, the rule would ban employers from entering into noncompete clauses with workers, including independent contractors.
Aspects of the rule include whether it should pertain to franchisees, whether senior executives should be exempted, and whether low-wage and high-wage workers should be treated differently.
According to the FTC, banning noncompete clauses would increase workers’ earnings by approximately $300 billion per year, save consumers as much as $148 billion in health care costs, and double the number of companies founded by former workers in the same field.
In June 2023, the FTC and the Department of Justice proposed changes to rules governing mergers, including changes to prenotification forms that would promote more efficient screening of potential mergers. According to a press release from the FTC, the proposed changes include provision of details about investments or corporate relationships, product and services, projected revenue streams, and previous acquisitions.
The proposal also includes a waiting period during which agencies would assess the risk that a merger would lessen competition or tend to create a monopoly.
What the FTC proposals mean for physicians
FTC Chair Lina M. Khan addressed attendees at the American College of Physicians at their annual meeting in October.
In March 2023, ACEP wrote to Ms. Khan in support of the banning of noncompete clauses. The ACEP also stated that the FTC should monitor the effect of a ban on the ability to recruit and maintain a stable physician workforce in rural and underserved areas “and should examine the potential impacts should nonprofit health systems be exempt from a ban.”
However, the American Medical Group Association, a nonprofit trade organization that supports multispecialty medical groups, opposes the ban. In a press release issued in March 2023, AMGA noted that, “As employers, AMGA members rely in part on noncompete agreements to build strong, sustainable care teams that work together to coordinate care for their patients. These care teams emphasize the importance of the doctor-patient relationship, which reasonable noncompete agreements help support.”
The American Medical Association supports the ban on noncompete clauses, detailed in an official AMA policy statement as, “support[ing] policies, regulations, and legislation that prohibits covenants not-to-compete for all physicians in clinical practice who hold employment contracts with for-profit or nonprofit hospital, hospital system, or staffing company employers.”
In regard to the merger guidelines, ACEP wrote a separate letter to Ms. Khan identifying some of the unique aspects of emergency medicine practice. The ACEP stressed the need for caution as the consolidation of medical practices continues, many under the umbrella of private equity investment companies.
“Unchecked mergers that substantially lessen competition in the labor market for emergency physicians, in which the employer is the buyer and the physician is the seller, can impact physicians directly by lowering wages or slowing wage growth, worsening benefits or working conditions, or contributing to other degradations in workplace quality,” according to ACEP.
The AMA also supports the FTC’s draft merger guidelines as protective of physicians and their working environments.
In September 2023, the AMA sent a letter to the FTC commending the agency on the proposed guidelines: “It is our strong contention that the agencies must have merger guidelines that protect physicians against health insurer mergers that may substantially lessen competition for the purchase of physician services and that degrade physician working conditions,” according to the AMA letter.
According the FTC, the proposed changes represent an expansion and reorganization of information along with the addition of new document requirements and represents the first comprehensive review of the Hart-Scott-Rodino Antitrust Improvements Act since 1978.
After soliciting public comments, the FTC is reviewing the proposals, and no specific date for a final vote has been announced.
More specifics on the potential changes to premerger notification, reporting, and waiting period requirements are available on the FTC website.
A version of this article appeared on Medscape.com.
Changes may be in store for how physicians do business based on pending proposals from the Federal Trade Commission to ban noncompete clauses and monitor potential merger monopolies.
In January 2023, the FTC announced a rule that would ban noncompete clauses, stating that such clauses reduce workers’ wages and stifle new businesses. Simply put, the rule would ban employers from entering into noncompete clauses with workers, including independent contractors.
Aspects of the rule include whether it should pertain to franchisees, whether senior executives should be exempted, and whether low-wage and high-wage workers should be treated differently.
According to the FTC, banning noncompete clauses would increase workers’ earnings by approximately $300 billion per year, save consumers as much as $148 billion in health care costs, and double the number of companies founded by former workers in the same field.
In June 2023, the FTC and the Department of Justice proposed changes to rules governing mergers, including changes to prenotification forms that would promote more efficient screening of potential mergers. According to a press release from the FTC, the proposed changes include provision of details about investments or corporate relationships, product and services, projected revenue streams, and previous acquisitions.
The proposal also includes a waiting period during which agencies would assess the risk that a merger would lessen competition or tend to create a monopoly.
What the FTC proposals mean for physicians
FTC Chair Lina M. Khan addressed attendees at the American College of Physicians at their annual meeting in October.
In March 2023, ACEP wrote to Ms. Khan in support of the banning of noncompete clauses. The ACEP also stated that the FTC should monitor the effect of a ban on the ability to recruit and maintain a stable physician workforce in rural and underserved areas “and should examine the potential impacts should nonprofit health systems be exempt from a ban.”
However, the American Medical Group Association, a nonprofit trade organization that supports multispecialty medical groups, opposes the ban. In a press release issued in March 2023, AMGA noted that, “As employers, AMGA members rely in part on noncompete agreements to build strong, sustainable care teams that work together to coordinate care for their patients. These care teams emphasize the importance of the doctor-patient relationship, which reasonable noncompete agreements help support.”
The American Medical Association supports the ban on noncompete clauses, detailed in an official AMA policy statement as, “support[ing] policies, regulations, and legislation that prohibits covenants not-to-compete for all physicians in clinical practice who hold employment contracts with for-profit or nonprofit hospital, hospital system, or staffing company employers.”
In regard to the merger guidelines, ACEP wrote a separate letter to Ms. Khan identifying some of the unique aspects of emergency medicine practice. The ACEP stressed the need for caution as the consolidation of medical practices continues, many under the umbrella of private equity investment companies.
“Unchecked mergers that substantially lessen competition in the labor market for emergency physicians, in which the employer is the buyer and the physician is the seller, can impact physicians directly by lowering wages or slowing wage growth, worsening benefits or working conditions, or contributing to other degradations in workplace quality,” according to ACEP.
The AMA also supports the FTC’s draft merger guidelines as protective of physicians and their working environments.
In September 2023, the AMA sent a letter to the FTC commending the agency on the proposed guidelines: “It is our strong contention that the agencies must have merger guidelines that protect physicians against health insurer mergers that may substantially lessen competition for the purchase of physician services and that degrade physician working conditions,” according to the AMA letter.
According the FTC, the proposed changes represent an expansion and reorganization of information along with the addition of new document requirements and represents the first comprehensive review of the Hart-Scott-Rodino Antitrust Improvements Act since 1978.
After soliciting public comments, the FTC is reviewing the proposals, and no specific date for a final vote has been announced.
More specifics on the potential changes to premerger notification, reporting, and waiting period requirements are available on the FTC website.
A version of this article appeared on Medscape.com.