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Rituximab more effective than other MS treatments?
, according to new research.
The risk for a first relapse was 6 times higher in patients receiving interferon beta or glatiramer acetate, compared with those receiving rituximab. But the level of disability at 3 years was only marginally different between the drugs studied.
The small differences in Expanded Disability Status Scale (EDSS) score are surprising, said investigator Peter Alping, a clinical assistant and doctoral student in the Department of Clinical Neuroscience at the Karolinska Institutet, Stockholm, as he presented the data. “It could be that we have too-short follow-up, so that EDSS doesn’t have time to diverge between therapies.”
He presented the findings at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
COMBAT-MS study
Direct comparisons of disease-modifying therapies (DMTs) for MS can help neurologists choose the most appropriate treatment for a given patient. To compare the effectiveness of the most common initial DMTs administered in Sweden, the researchers examined data from the COMBAT-MS study.
They identified all patients who initiated an injectable therapy (interferon beta or glatiramer acetate), dimethyl fumarate, natalizumab, or rituximab as a first treatment between Jan. 1, 2011, and Dec. 14, 2020. Eligible participants had prospectively recorded outcome data in the Swedish MS Register. Follow-up for a participant continued even if the participant stopped receiving therapy.
The investigators replaced missing data using multiple imputation. They adjusted for potential confounders using stabilized inverse probability of treatment weighting with baseline variables. These variables included age, sex, disease duration, geographical region, EDSS score, and relapses.
Rituximab reduced relapses
The researchers included 1,938 first-ever treatment episodes in their analysis. Of this group, 858 were associated with injectables, 339 with dimethyl fumarate, 269 with natalizumab, and 472 with rituximab.
Participants’ baseline characteristics differed by the DMT that they used. Patients who initiated natalizumab were the youngest, had the shortest disease duration, and had the most previous relapses.
For each outcome, the investigators compared all other therapies with rituximab. After they adjusted the data, they found that the hazard ratio for first relapse was 6.0 for injectables, 2.9 for dimethyl fumarate, and 1.8 for natalizumab.
In the adjusted model, the MRI lesion rate ratio for injectables, compared with rituximab, was 4.5. The rate ratio was 4.8 for dimethyl fumarate and 1.9 for natalizumab.
But differences in EDSS score at 3 years from treatment initiation were small. EDSS score in patients who received injectables was 0.24 points higher, compared with those receiving rituximab. EDSS score was 0.05 points higher in patients receiving dimethyl fumarate and 0.01 points lower in patients receiving natalizumab.
The risk for treatment discontinuation, however, differed significantly between therapies. The HR for treatment discontinuation was 32.7 for injectables, 20.3 for dimethyl fumarate, and 16.3 for natalizumab, compared with rituximab.
Among patients receiving dimethyl fumarate and injectables, the main reasons for discontinuing therapy were inadequate effect and adverse events. The main reason for discontinuation among patients receiving natalizumab was categorized as “other reason,” which mostly reflected John Cunningham virus positivity and concern for developing progressive multifocal leukoencephalopathy.
‘The uncertainty continues’
“These differences that we see in the effectiveness can be somewhat surprising, especially when it comes to natalizumab,” which is considered very effective, said Mr. Alping. The vulnerable period that occurs after switching from natalizumab may partly explain the difference. “This is something to keep in mind when starting patients on natalizumab treatment in the clinic,” Mr. Alping added.
Although rituximab is not indicated for MS, many clinics are using it in this population, said Robert Fox, MD, staff neurologist at the Mellen Center for MS and vice chair for research at the Neurological Institute of Cleveland Clinic, both in Cleveland, Ohio. Dr. Fox was not involved in the study.
“Assessing the generalizability of the study outside Sweden will be important,” he added, “but I would be surprised if their findings did not hold up to external validation.”
The way that the researchers addressed missing data could affect the interpretation of the findings. “Depending upon how much data was missing, their imputation methods may have a high level of uncertainty,” said Dr. Fox.
The researchers’ adjustments for baseline differences also raise questions. “Even though MRI was an outcome, it doesn’t appear they adjusted for baseline differences in MRI between the groups,” Dr. Fox observed.
Moreover, the study was conducted over a long period of time. “We know there are time effects in MS, with a very different disease activity expected from patients over time,” said Dr. Fox. For example, relapse rates in placebo groups of MS trials tend to decline over time. “This time effect likely impacted their results.”
But the disability findings may be the most important part of the study, according to Dr. Fox. The lack of significant difference in disability progression between therapies “highlights that a couple relapses or lesions on MRI may be too small to translate into long-term differences in disability progression,” he said.
“The long-term implications of small differences in relapse and MRI outcomes may be very small,” Dr. Fox went on. “Thus, the uncertainty continues around escalation treatment versus initial highly effective treatment paradigms.”
The Patient-Centered Outcomes Research Institute, the Swedish Research Council, and NEURO Sweden funded this study. Mr. Alping disclosed no relevant financial relationships. Dr. Fox receives consulting fees from the companies that manufacture all the therapies analyzed in the study.
A version of this article first appeared on Medscape.com.
, according to new research.
The risk for a first relapse was 6 times higher in patients receiving interferon beta or glatiramer acetate, compared with those receiving rituximab. But the level of disability at 3 years was only marginally different between the drugs studied.
The small differences in Expanded Disability Status Scale (EDSS) score are surprising, said investigator Peter Alping, a clinical assistant and doctoral student in the Department of Clinical Neuroscience at the Karolinska Institutet, Stockholm, as he presented the data. “It could be that we have too-short follow-up, so that EDSS doesn’t have time to diverge between therapies.”
He presented the findings at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
COMBAT-MS study
Direct comparisons of disease-modifying therapies (DMTs) for MS can help neurologists choose the most appropriate treatment for a given patient. To compare the effectiveness of the most common initial DMTs administered in Sweden, the researchers examined data from the COMBAT-MS study.
They identified all patients who initiated an injectable therapy (interferon beta or glatiramer acetate), dimethyl fumarate, natalizumab, or rituximab as a first treatment between Jan. 1, 2011, and Dec. 14, 2020. Eligible participants had prospectively recorded outcome data in the Swedish MS Register. Follow-up for a participant continued even if the participant stopped receiving therapy.
The investigators replaced missing data using multiple imputation. They adjusted for potential confounders using stabilized inverse probability of treatment weighting with baseline variables. These variables included age, sex, disease duration, geographical region, EDSS score, and relapses.
Rituximab reduced relapses
The researchers included 1,938 first-ever treatment episodes in their analysis. Of this group, 858 were associated with injectables, 339 with dimethyl fumarate, 269 with natalizumab, and 472 with rituximab.
Participants’ baseline characteristics differed by the DMT that they used. Patients who initiated natalizumab were the youngest, had the shortest disease duration, and had the most previous relapses.
For each outcome, the investigators compared all other therapies with rituximab. After they adjusted the data, they found that the hazard ratio for first relapse was 6.0 for injectables, 2.9 for dimethyl fumarate, and 1.8 for natalizumab.
In the adjusted model, the MRI lesion rate ratio for injectables, compared with rituximab, was 4.5. The rate ratio was 4.8 for dimethyl fumarate and 1.9 for natalizumab.
But differences in EDSS score at 3 years from treatment initiation were small. EDSS score in patients who received injectables was 0.24 points higher, compared with those receiving rituximab. EDSS score was 0.05 points higher in patients receiving dimethyl fumarate and 0.01 points lower in patients receiving natalizumab.
The risk for treatment discontinuation, however, differed significantly between therapies. The HR for treatment discontinuation was 32.7 for injectables, 20.3 for dimethyl fumarate, and 16.3 for natalizumab, compared with rituximab.
Among patients receiving dimethyl fumarate and injectables, the main reasons for discontinuing therapy were inadequate effect and adverse events. The main reason for discontinuation among patients receiving natalizumab was categorized as “other reason,” which mostly reflected John Cunningham virus positivity and concern for developing progressive multifocal leukoencephalopathy.
‘The uncertainty continues’
“These differences that we see in the effectiveness can be somewhat surprising, especially when it comes to natalizumab,” which is considered very effective, said Mr. Alping. The vulnerable period that occurs after switching from natalizumab may partly explain the difference. “This is something to keep in mind when starting patients on natalizumab treatment in the clinic,” Mr. Alping added.
Although rituximab is not indicated for MS, many clinics are using it in this population, said Robert Fox, MD, staff neurologist at the Mellen Center for MS and vice chair for research at the Neurological Institute of Cleveland Clinic, both in Cleveland, Ohio. Dr. Fox was not involved in the study.
“Assessing the generalizability of the study outside Sweden will be important,” he added, “but I would be surprised if their findings did not hold up to external validation.”
The way that the researchers addressed missing data could affect the interpretation of the findings. “Depending upon how much data was missing, their imputation methods may have a high level of uncertainty,” said Dr. Fox.
The researchers’ adjustments for baseline differences also raise questions. “Even though MRI was an outcome, it doesn’t appear they adjusted for baseline differences in MRI between the groups,” Dr. Fox observed.
Moreover, the study was conducted over a long period of time. “We know there are time effects in MS, with a very different disease activity expected from patients over time,” said Dr. Fox. For example, relapse rates in placebo groups of MS trials tend to decline over time. “This time effect likely impacted their results.”
But the disability findings may be the most important part of the study, according to Dr. Fox. The lack of significant difference in disability progression between therapies “highlights that a couple relapses or lesions on MRI may be too small to translate into long-term differences in disability progression,” he said.
“The long-term implications of small differences in relapse and MRI outcomes may be very small,” Dr. Fox went on. “Thus, the uncertainty continues around escalation treatment versus initial highly effective treatment paradigms.”
The Patient-Centered Outcomes Research Institute, the Swedish Research Council, and NEURO Sweden funded this study. Mr. Alping disclosed no relevant financial relationships. Dr. Fox receives consulting fees from the companies that manufacture all the therapies analyzed in the study.
A version of this article first appeared on Medscape.com.
, according to new research.
The risk for a first relapse was 6 times higher in patients receiving interferon beta or glatiramer acetate, compared with those receiving rituximab. But the level of disability at 3 years was only marginally different between the drugs studied.
The small differences in Expanded Disability Status Scale (EDSS) score are surprising, said investigator Peter Alping, a clinical assistant and doctoral student in the Department of Clinical Neuroscience at the Karolinska Institutet, Stockholm, as he presented the data. “It could be that we have too-short follow-up, so that EDSS doesn’t have time to diverge between therapies.”
He presented the findings at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
COMBAT-MS study
Direct comparisons of disease-modifying therapies (DMTs) for MS can help neurologists choose the most appropriate treatment for a given patient. To compare the effectiveness of the most common initial DMTs administered in Sweden, the researchers examined data from the COMBAT-MS study.
They identified all patients who initiated an injectable therapy (interferon beta or glatiramer acetate), dimethyl fumarate, natalizumab, or rituximab as a first treatment between Jan. 1, 2011, and Dec. 14, 2020. Eligible participants had prospectively recorded outcome data in the Swedish MS Register. Follow-up for a participant continued even if the participant stopped receiving therapy.
The investigators replaced missing data using multiple imputation. They adjusted for potential confounders using stabilized inverse probability of treatment weighting with baseline variables. These variables included age, sex, disease duration, geographical region, EDSS score, and relapses.
Rituximab reduced relapses
The researchers included 1,938 first-ever treatment episodes in their analysis. Of this group, 858 were associated with injectables, 339 with dimethyl fumarate, 269 with natalizumab, and 472 with rituximab.
Participants’ baseline characteristics differed by the DMT that they used. Patients who initiated natalizumab were the youngest, had the shortest disease duration, and had the most previous relapses.
For each outcome, the investigators compared all other therapies with rituximab. After they adjusted the data, they found that the hazard ratio for first relapse was 6.0 for injectables, 2.9 for dimethyl fumarate, and 1.8 for natalizumab.
In the adjusted model, the MRI lesion rate ratio for injectables, compared with rituximab, was 4.5. The rate ratio was 4.8 for dimethyl fumarate and 1.9 for natalizumab.
But differences in EDSS score at 3 years from treatment initiation were small. EDSS score in patients who received injectables was 0.24 points higher, compared with those receiving rituximab. EDSS score was 0.05 points higher in patients receiving dimethyl fumarate and 0.01 points lower in patients receiving natalizumab.
The risk for treatment discontinuation, however, differed significantly between therapies. The HR for treatment discontinuation was 32.7 for injectables, 20.3 for dimethyl fumarate, and 16.3 for natalizumab, compared with rituximab.
Among patients receiving dimethyl fumarate and injectables, the main reasons for discontinuing therapy were inadequate effect and adverse events. The main reason for discontinuation among patients receiving natalizumab was categorized as “other reason,” which mostly reflected John Cunningham virus positivity and concern for developing progressive multifocal leukoencephalopathy.
‘The uncertainty continues’
“These differences that we see in the effectiveness can be somewhat surprising, especially when it comes to natalizumab,” which is considered very effective, said Mr. Alping. The vulnerable period that occurs after switching from natalizumab may partly explain the difference. “This is something to keep in mind when starting patients on natalizumab treatment in the clinic,” Mr. Alping added.
Although rituximab is not indicated for MS, many clinics are using it in this population, said Robert Fox, MD, staff neurologist at the Mellen Center for MS and vice chair for research at the Neurological Institute of Cleveland Clinic, both in Cleveland, Ohio. Dr. Fox was not involved in the study.
“Assessing the generalizability of the study outside Sweden will be important,” he added, “but I would be surprised if their findings did not hold up to external validation.”
The way that the researchers addressed missing data could affect the interpretation of the findings. “Depending upon how much data was missing, their imputation methods may have a high level of uncertainty,” said Dr. Fox.
The researchers’ adjustments for baseline differences also raise questions. “Even though MRI was an outcome, it doesn’t appear they adjusted for baseline differences in MRI between the groups,” Dr. Fox observed.
Moreover, the study was conducted over a long period of time. “We know there are time effects in MS, with a very different disease activity expected from patients over time,” said Dr. Fox. For example, relapse rates in placebo groups of MS trials tend to decline over time. “This time effect likely impacted their results.”
But the disability findings may be the most important part of the study, according to Dr. Fox. The lack of significant difference in disability progression between therapies “highlights that a couple relapses or lesions on MRI may be too small to translate into long-term differences in disability progression,” he said.
“The long-term implications of small differences in relapse and MRI outcomes may be very small,” Dr. Fox went on. “Thus, the uncertainty continues around escalation treatment versus initial highly effective treatment paradigms.”
The Patient-Centered Outcomes Research Institute, the Swedish Research Council, and NEURO Sweden funded this study. Mr. Alping disclosed no relevant financial relationships. Dr. Fox receives consulting fees from the companies that manufacture all the therapies analyzed in the study.
A version of this article first appeared on Medscape.com.
From ECTRIMS 2021
States can reserve COVID shots for kids 5-11 this week
States can preorder COVID-19 vaccine doses for younger children this week as they begin to set up vaccination campaigns for ages 5-11.
Vaccine advisory groups for the FDA and CDC are scheduled to discuss and approve the Pfizer shot for kids in the next three weeks. To help states and cities prepare for the rollout, the CDC issued guidance on how to set up expanded vaccination programs.
Immunization program managers can begin ordering doses on Wednesday, according to the guidance. The vials won’t be delivered until the FDA and CDC authorize the shot, but registering now will help federal officials ship doses quickly once they’re available.
Pharmacies in every state will be able to give COVID-19 shots to children, but they can only use doses that are prepared specifically for children. Ages 5-11 will need a 10-microgram dose, which is one-third of the dose administered to ages 12 and older. The guidance warns that doctors should not try to split up or fraction the adult doses.
The CDC guidance also recommends that pediatricians and family practice doctors should serve as primary places to give shots to kids. The document mentions other options, such as vaccination clinics at schools, but doesn’t endorse them as the first choice for vaccinating kids.
The CDC hasn’t yet addressed questions around whether kids should be required to get vaccinated to attend school. The decision will likely be left to state and city officials.
Federal health officials aren’t yet sure how many parents and guardians will seek shots for their younger kids right away, the AP reported. Demand may be high at first for some families, but it may not be as high as when shots first became available for adults, Marcus Plescia, MD, chief medical officer of the Association of State and Territorial Health Officials, told The Associated Press.
“We’re going to have potentially a very busy, and perhaps modestly chaotic time,” he said.
When vaccines were first authorized for adults, hospitals and pharmacies received priority for ordering shots. Some doctors felt left out. This time, however, the CDC has said that pediatricians will receive higher priority and be able to receive shipments quickly.
As the vaccine rollout begins, health officials should consider logistical concerns to address racial and economic disparities for younger kids, Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation and a former acting director of the CDC, told the AP.
If parents or guardians can’t leave work to take their kids to a pharmacy or doctor’s office, for instance, their kids may not receive a shot quickly – or at all.
“It’s really important that we recognize the barriers to vaccinations,” he said.
A version of this article first appeared on WebMD.com.
States can preorder COVID-19 vaccine doses for younger children this week as they begin to set up vaccination campaigns for ages 5-11.
Vaccine advisory groups for the FDA and CDC are scheduled to discuss and approve the Pfizer shot for kids in the next three weeks. To help states and cities prepare for the rollout, the CDC issued guidance on how to set up expanded vaccination programs.
Immunization program managers can begin ordering doses on Wednesday, according to the guidance. The vials won’t be delivered until the FDA and CDC authorize the shot, but registering now will help federal officials ship doses quickly once they’re available.
Pharmacies in every state will be able to give COVID-19 shots to children, but they can only use doses that are prepared specifically for children. Ages 5-11 will need a 10-microgram dose, which is one-third of the dose administered to ages 12 and older. The guidance warns that doctors should not try to split up or fraction the adult doses.
The CDC guidance also recommends that pediatricians and family practice doctors should serve as primary places to give shots to kids. The document mentions other options, such as vaccination clinics at schools, but doesn’t endorse them as the first choice for vaccinating kids.
The CDC hasn’t yet addressed questions around whether kids should be required to get vaccinated to attend school. The decision will likely be left to state and city officials.
Federal health officials aren’t yet sure how many parents and guardians will seek shots for their younger kids right away, the AP reported. Demand may be high at first for some families, but it may not be as high as when shots first became available for adults, Marcus Plescia, MD, chief medical officer of the Association of State and Territorial Health Officials, told The Associated Press.
“We’re going to have potentially a very busy, and perhaps modestly chaotic time,” he said.
When vaccines were first authorized for adults, hospitals and pharmacies received priority for ordering shots. Some doctors felt left out. This time, however, the CDC has said that pediatricians will receive higher priority and be able to receive shipments quickly.
As the vaccine rollout begins, health officials should consider logistical concerns to address racial and economic disparities for younger kids, Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation and a former acting director of the CDC, told the AP.
If parents or guardians can’t leave work to take their kids to a pharmacy or doctor’s office, for instance, their kids may not receive a shot quickly – or at all.
“It’s really important that we recognize the barriers to vaccinations,” he said.
A version of this article first appeared on WebMD.com.
States can preorder COVID-19 vaccine doses for younger children this week as they begin to set up vaccination campaigns for ages 5-11.
Vaccine advisory groups for the FDA and CDC are scheduled to discuss and approve the Pfizer shot for kids in the next three weeks. To help states and cities prepare for the rollout, the CDC issued guidance on how to set up expanded vaccination programs.
Immunization program managers can begin ordering doses on Wednesday, according to the guidance. The vials won’t be delivered until the FDA and CDC authorize the shot, but registering now will help federal officials ship doses quickly once they’re available.
Pharmacies in every state will be able to give COVID-19 shots to children, but they can only use doses that are prepared specifically for children. Ages 5-11 will need a 10-microgram dose, which is one-third of the dose administered to ages 12 and older. The guidance warns that doctors should not try to split up or fraction the adult doses.
The CDC guidance also recommends that pediatricians and family practice doctors should serve as primary places to give shots to kids. The document mentions other options, such as vaccination clinics at schools, but doesn’t endorse them as the first choice for vaccinating kids.
The CDC hasn’t yet addressed questions around whether kids should be required to get vaccinated to attend school. The decision will likely be left to state and city officials.
Federal health officials aren’t yet sure how many parents and guardians will seek shots for their younger kids right away, the AP reported. Demand may be high at first for some families, but it may not be as high as when shots first became available for adults, Marcus Plescia, MD, chief medical officer of the Association of State and Territorial Health Officials, told The Associated Press.
“We’re going to have potentially a very busy, and perhaps modestly chaotic time,” he said.
When vaccines were first authorized for adults, hospitals and pharmacies received priority for ordering shots. Some doctors felt left out. This time, however, the CDC has said that pediatricians will receive higher priority and be able to receive shipments quickly.
As the vaccine rollout begins, health officials should consider logistical concerns to address racial and economic disparities for younger kids, Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation and a former acting director of the CDC, told the AP.
If parents or guardians can’t leave work to take their kids to a pharmacy or doctor’s office, for instance, their kids may not receive a shot quickly – or at all.
“It’s really important that we recognize the barriers to vaccinations,” he said.
A version of this article first appeared on WebMD.com.
Sleep problems in mental illness highly pervasive
An inpatient psychiatric diagnosis at some point over a lifetime is significantly associated with a range of sleep problems, results from the largest study of its kind show.
A prior diagnosis of major depression, schizophrenia, anxiety, or bipolar disorder was associated with a later bedtime, earlier waking time, and significantly poorer sleep quality that included frequent awakenings during the night and shorter sleep bouts.
“We were struck by the pervasiveness of sleep problems across all the diagnoses of mental illness and sleep parameters we looked at,” study investigator Michael Wainberg, PhD, a postdoctoral fellow at the Krembil Centre for Neuroinformatics at the Center for Addiction and Mental Health (CAMH), Toronto, told this news organization. “This suggests there may need to be even more of an emphasis on sleep in these patients than there already is.”
The study, which includes data from nearly 90,000 adults in the United Kingdom, was published online October 12 in PLoS Medicine.
Trove of data
Data for the analysis comes from the UK Biobank, a large-scale biomedical database launched in 2006 that has collected biological and medical data on more than 500,000 individuals who consented to provide blood, urine, and saliva samples and detailed lifestyle information that is matched to their medical records.
Between 2013 and 2015, more than 103,000 of these participants agreed to wear accelerometers on their wrists for 24 hours a day for 7 days, collecting a trove of data for researchers to mine.
“This allows us to get at objectively derived sleep measures and to measure them in greater numbers of people who have experienced mental illness,” said senior author Shreejoy Tripathy, PhD, assistant professor at the University of Toronto and independent scientist for CAMH. “You can study multiple disorders at once and the influence of other variables that might not be possible in the context of other studies.”
The research is the first known large-scale transdiagnostic study of objectively measured sleep and mental health. Insomnia and other sleep disorders are common among people with mental illness, as shown in prior research, including at least one study that used the same dataset the team employed for this project.
The new findings add to that body of work, Dr. Wainberg said, and look beyond just how long a person sleeps to the quality of the sleep they get.
“We found that the metrics of sleep quality seem to be affected more than mere sleep duration,” he said.
Unexpected finding
After excluding participants with faulty accelerometers and those who didn’t wear them for the entire 7-day study period, data from 89,205 participants (aged 43-79, 56% female, 97% self-reported White) was included. Lifetime inpatient psychiatric diagnoses were reported in 2.5% of the entire cohort.
Researchers looked at 10 sleep measures: bedtime, wake-up time, sleep duration, wake after sleep onset, sleep efficiency, number of awakenings, duration of longest sleep bout, number of naps, and variability in bedtime and sleep duration.
Although the effect sizes were small, having any psychiatric diagnosis was associated with significantly lower scores on every sleep measure except sleep duration.
Compared with those with no inpatient psychiatric diagnosis, those with any psychiatric diagnosis were significantly more likely to:
- have a later bedtime (beta = 0.07; 95% confidence interval, 0.06-0.09)
- have later wake-up time (beta = 0.10; 95% CI, 0.09-0.11)
- wake after sleep onset (beta = 0.10; 95% CI, 0.09-0.12)
- have poorer sleep efficiency (beta = –0.12; 95% CI, −0.14 to −0.11)
- have more awakenings (beta = 0.10; 95% CI, 0.09-0.11)
- have shorter duration of their longest sleep bout (beta = –0.09; 95% CI, −0.11 to −0.08)
- take more naps (beta = 0.11; 95% CI, 0.09-0.12)
- have greater variability in their bedtime (beta = 0.08; 95% CI, 0.06-0.09)
- have greater variability in their sleep duration (beta = 0.10; 95% CI, 0.09-0.12)
The only significant differences in sleep duration were found in those with lifetime major depressive disorder, who slept significantly less (beta = −0.02; P = .003), and in those with lifetime schizophrenia, who slept significantly longer (beta = 0.02; P = .0008).
Researchers found similar results when they examined patient-reported sleep measures collected when participants enrolled in the biobank, long before they agreed to wear an accelerometer.
“Everyone with a lifetime mental illness diagnosis trended toward worse sleep quality, regardless of their diagnosis,” Dr. Tripathy said. “We didn’t expect to see that.”
Limitations of the biobank data prohibited analysis by age and past or current use of psychiatric medications. In addition, investigators were unable to determine whether mental illness was active or controlled at the time of the study. Information on these, and other factors, is needed to truly begin to understand the real-world status of sleep patterns in people with mental illness, the researchers note.
However, the biobank data demonstrates how this type of information can be collected, helping Dr. Tripathy and others to design a new study that will launch next year with patients at CAMH. This effort is part of the BrainHealth Databank, a project that aims to develop a patient data bank similar to the one in the UK that was used for this study.
“We’ve shown that you can use wearable devices to measure correlates of sleep and derive insights about the objective measurements of sleep and associate them with mental illness diagnosis,” Dr. Tripathy said.
The study received no outside funding. Dr. Wainberg and Dr. Tripathy report receiving funding from Kavli Foundation, Krembil Foundation, CAMH Discovery Fund, the McLaughlin Foundation, NSERC, and CIHR. Disclosures for other authors are fully listed in the original article.
A version of this article first appeared on Medscape.com.
An inpatient psychiatric diagnosis at some point over a lifetime is significantly associated with a range of sleep problems, results from the largest study of its kind show.
A prior diagnosis of major depression, schizophrenia, anxiety, or bipolar disorder was associated with a later bedtime, earlier waking time, and significantly poorer sleep quality that included frequent awakenings during the night and shorter sleep bouts.
“We were struck by the pervasiveness of sleep problems across all the diagnoses of mental illness and sleep parameters we looked at,” study investigator Michael Wainberg, PhD, a postdoctoral fellow at the Krembil Centre for Neuroinformatics at the Center for Addiction and Mental Health (CAMH), Toronto, told this news organization. “This suggests there may need to be even more of an emphasis on sleep in these patients than there already is.”
The study, which includes data from nearly 90,000 adults in the United Kingdom, was published online October 12 in PLoS Medicine.
Trove of data
Data for the analysis comes from the UK Biobank, a large-scale biomedical database launched in 2006 that has collected biological and medical data on more than 500,000 individuals who consented to provide blood, urine, and saliva samples and detailed lifestyle information that is matched to their medical records.
Between 2013 and 2015, more than 103,000 of these participants agreed to wear accelerometers on their wrists for 24 hours a day for 7 days, collecting a trove of data for researchers to mine.
“This allows us to get at objectively derived sleep measures and to measure them in greater numbers of people who have experienced mental illness,” said senior author Shreejoy Tripathy, PhD, assistant professor at the University of Toronto and independent scientist for CAMH. “You can study multiple disorders at once and the influence of other variables that might not be possible in the context of other studies.”
The research is the first known large-scale transdiagnostic study of objectively measured sleep and mental health. Insomnia and other sleep disorders are common among people with mental illness, as shown in prior research, including at least one study that used the same dataset the team employed for this project.
The new findings add to that body of work, Dr. Wainberg said, and look beyond just how long a person sleeps to the quality of the sleep they get.
“We found that the metrics of sleep quality seem to be affected more than mere sleep duration,” he said.
Unexpected finding
After excluding participants with faulty accelerometers and those who didn’t wear them for the entire 7-day study period, data from 89,205 participants (aged 43-79, 56% female, 97% self-reported White) was included. Lifetime inpatient psychiatric diagnoses were reported in 2.5% of the entire cohort.
Researchers looked at 10 sleep measures: bedtime, wake-up time, sleep duration, wake after sleep onset, sleep efficiency, number of awakenings, duration of longest sleep bout, number of naps, and variability in bedtime and sleep duration.
Although the effect sizes were small, having any psychiatric diagnosis was associated with significantly lower scores on every sleep measure except sleep duration.
Compared with those with no inpatient psychiatric diagnosis, those with any psychiatric diagnosis were significantly more likely to:
- have a later bedtime (beta = 0.07; 95% confidence interval, 0.06-0.09)
- have later wake-up time (beta = 0.10; 95% CI, 0.09-0.11)
- wake after sleep onset (beta = 0.10; 95% CI, 0.09-0.12)
- have poorer sleep efficiency (beta = –0.12; 95% CI, −0.14 to −0.11)
- have more awakenings (beta = 0.10; 95% CI, 0.09-0.11)
- have shorter duration of their longest sleep bout (beta = –0.09; 95% CI, −0.11 to −0.08)
- take more naps (beta = 0.11; 95% CI, 0.09-0.12)
- have greater variability in their bedtime (beta = 0.08; 95% CI, 0.06-0.09)
- have greater variability in their sleep duration (beta = 0.10; 95% CI, 0.09-0.12)
The only significant differences in sleep duration were found in those with lifetime major depressive disorder, who slept significantly less (beta = −0.02; P = .003), and in those with lifetime schizophrenia, who slept significantly longer (beta = 0.02; P = .0008).
Researchers found similar results when they examined patient-reported sleep measures collected when participants enrolled in the biobank, long before they agreed to wear an accelerometer.
“Everyone with a lifetime mental illness diagnosis trended toward worse sleep quality, regardless of their diagnosis,” Dr. Tripathy said. “We didn’t expect to see that.”
Limitations of the biobank data prohibited analysis by age and past or current use of psychiatric medications. In addition, investigators were unable to determine whether mental illness was active or controlled at the time of the study. Information on these, and other factors, is needed to truly begin to understand the real-world status of sleep patterns in people with mental illness, the researchers note.
However, the biobank data demonstrates how this type of information can be collected, helping Dr. Tripathy and others to design a new study that will launch next year with patients at CAMH. This effort is part of the BrainHealth Databank, a project that aims to develop a patient data bank similar to the one in the UK that was used for this study.
“We’ve shown that you can use wearable devices to measure correlates of sleep and derive insights about the objective measurements of sleep and associate them with mental illness diagnosis,” Dr. Tripathy said.
The study received no outside funding. Dr. Wainberg and Dr. Tripathy report receiving funding from Kavli Foundation, Krembil Foundation, CAMH Discovery Fund, the McLaughlin Foundation, NSERC, and CIHR. Disclosures for other authors are fully listed in the original article.
A version of this article first appeared on Medscape.com.
An inpatient psychiatric diagnosis at some point over a lifetime is significantly associated with a range of sleep problems, results from the largest study of its kind show.
A prior diagnosis of major depression, schizophrenia, anxiety, or bipolar disorder was associated with a later bedtime, earlier waking time, and significantly poorer sleep quality that included frequent awakenings during the night and shorter sleep bouts.
“We were struck by the pervasiveness of sleep problems across all the diagnoses of mental illness and sleep parameters we looked at,” study investigator Michael Wainberg, PhD, a postdoctoral fellow at the Krembil Centre for Neuroinformatics at the Center for Addiction and Mental Health (CAMH), Toronto, told this news organization. “This suggests there may need to be even more of an emphasis on sleep in these patients than there already is.”
The study, which includes data from nearly 90,000 adults in the United Kingdom, was published online October 12 in PLoS Medicine.
Trove of data
Data for the analysis comes from the UK Biobank, a large-scale biomedical database launched in 2006 that has collected biological and medical data on more than 500,000 individuals who consented to provide blood, urine, and saliva samples and detailed lifestyle information that is matched to their medical records.
Between 2013 and 2015, more than 103,000 of these participants agreed to wear accelerometers on their wrists for 24 hours a day for 7 days, collecting a trove of data for researchers to mine.
“This allows us to get at objectively derived sleep measures and to measure them in greater numbers of people who have experienced mental illness,” said senior author Shreejoy Tripathy, PhD, assistant professor at the University of Toronto and independent scientist for CAMH. “You can study multiple disorders at once and the influence of other variables that might not be possible in the context of other studies.”
The research is the first known large-scale transdiagnostic study of objectively measured sleep and mental health. Insomnia and other sleep disorders are common among people with mental illness, as shown in prior research, including at least one study that used the same dataset the team employed for this project.
The new findings add to that body of work, Dr. Wainberg said, and look beyond just how long a person sleeps to the quality of the sleep they get.
“We found that the metrics of sleep quality seem to be affected more than mere sleep duration,” he said.
Unexpected finding
After excluding participants with faulty accelerometers and those who didn’t wear them for the entire 7-day study period, data from 89,205 participants (aged 43-79, 56% female, 97% self-reported White) was included. Lifetime inpatient psychiatric diagnoses were reported in 2.5% of the entire cohort.
Researchers looked at 10 sleep measures: bedtime, wake-up time, sleep duration, wake after sleep onset, sleep efficiency, number of awakenings, duration of longest sleep bout, number of naps, and variability in bedtime and sleep duration.
Although the effect sizes were small, having any psychiatric diagnosis was associated with significantly lower scores on every sleep measure except sleep duration.
Compared with those with no inpatient psychiatric diagnosis, those with any psychiatric diagnosis were significantly more likely to:
- have a later bedtime (beta = 0.07; 95% confidence interval, 0.06-0.09)
- have later wake-up time (beta = 0.10; 95% CI, 0.09-0.11)
- wake after sleep onset (beta = 0.10; 95% CI, 0.09-0.12)
- have poorer sleep efficiency (beta = –0.12; 95% CI, −0.14 to −0.11)
- have more awakenings (beta = 0.10; 95% CI, 0.09-0.11)
- have shorter duration of their longest sleep bout (beta = –0.09; 95% CI, −0.11 to −0.08)
- take more naps (beta = 0.11; 95% CI, 0.09-0.12)
- have greater variability in their bedtime (beta = 0.08; 95% CI, 0.06-0.09)
- have greater variability in their sleep duration (beta = 0.10; 95% CI, 0.09-0.12)
The only significant differences in sleep duration were found in those with lifetime major depressive disorder, who slept significantly less (beta = −0.02; P = .003), and in those with lifetime schizophrenia, who slept significantly longer (beta = 0.02; P = .0008).
Researchers found similar results when they examined patient-reported sleep measures collected when participants enrolled in the biobank, long before they agreed to wear an accelerometer.
“Everyone with a lifetime mental illness diagnosis trended toward worse sleep quality, regardless of their diagnosis,” Dr. Tripathy said. “We didn’t expect to see that.”
Limitations of the biobank data prohibited analysis by age and past or current use of psychiatric medications. In addition, investigators were unable to determine whether mental illness was active or controlled at the time of the study. Information on these, and other factors, is needed to truly begin to understand the real-world status of sleep patterns in people with mental illness, the researchers note.
However, the biobank data demonstrates how this type of information can be collected, helping Dr. Tripathy and others to design a new study that will launch next year with patients at CAMH. This effort is part of the BrainHealth Databank, a project that aims to develop a patient data bank similar to the one in the UK that was used for this study.
“We’ve shown that you can use wearable devices to measure correlates of sleep and derive insights about the objective measurements of sleep and associate them with mental illness diagnosis,” Dr. Tripathy said.
The study received no outside funding. Dr. Wainberg and Dr. Tripathy report receiving funding from Kavli Foundation, Krembil Foundation, CAMH Discovery Fund, the McLaughlin Foundation, NSERC, and CIHR. Disclosures for other authors are fully listed in the original article.
A version of this article first appeared on Medscape.com.
Art therapy linked to slowed Parkinson’s progression
Adding art therapy to standard drug treatment in Parkinson’s disease (PD) not only improves severity of both motor and nonmotor symptoms, but also slows rates of disease progression, new research suggests.
Fifty PD patients were randomly assigned to receive either art therapy, including sculpting and drawing, plus drug therapy or drug therapy alone, and followed up over 12 months.
Patients receiving combined therapy experienced improvements in symptoms, depression, and cognitive scores, and had reduced tremor and daytime sleepiness. They were also substantially less likely to experience disease progression.
“The use of art therapy can reduce the severity of motor and nonmotor manifestations of Parkinson’s disease,” said study investigator Iryna Khubetova, MD, PhD, head of the neurology department, Odessa (Ukraine) Regional Clinical Hospital.
she added.
The findings were presented at the virtual congress of the European College of Neuropsychopharmacology.
A promising approach
Dr. Khubetova told this news organization that offering art therapy to PD patients was “very affordable,” especially as professional artists “provided materials for painting and other art supplies free of charge.”
“We hope this approach is very promising and would be widely adopted.”
She suggested the positive effect of art therapy could be related to “activating the brain’s reward neural network.”
This may be via improved visual attention acting on visuospatial mechanisms and emotional drive, with “activation of the medial orbitofrontal cortex, ventral striatum, and other structures.”
The researchers note PD, a “multisystem progressive neurodegenerative disease,” is among the three most common neurological disorders, with an incidence of 100-150 cases per 100,000 people.
They also note that nonpharmacologic approaches are “widely used” as an adjunct to drug therapy and as part of an “integrated approach” to disease management.
To examine the clinical efficacy of art therapy, the team recruited patients with PD who had preserved facility for independent movement, defined as stages 1-2.5 on the Hoehn and Yahr scale.
Patients were randomly assigned to art therapy sessions alongside standard drug therapy or to standard drug therapy alone. The art therapy included sculpting, free drawing, and coloring patterns.
Multiple benefits
Participants were assessed at baseline and at 6 and 12 months with the Unified Parkinson Disease Rating Scale (UPDRS), the Beck Depression Inventory, the Montreal Cognitive Assessment, and the Pegboard Test of finger dexterity.
Fifty patients were included in the study, with 30 assigned to standard drug therapy alone and 20 to the combined intervention. Participants had a mean age of 57.8 years, and 46% were women.
Over the study period, investigators found patients assigned to art therapy plus drug treatment had improved mood, as well as decreased daytime sleeping, reduced tremor, and a decrease in anxiety and fear intensity.
Between baseline and the 6- and 12-month assessments, patients in the combined therapy group showed improvements in scores on all of the questionnaires, and on the Pegboard Test. In contrast, scores were either stable or worsened in the standard drug therapy–alone group.
The team notes that there was also a marked difference in rates of disease progression, defined as a change on the Hoehn and Yahr scale of at least 0.5 points, between the two groups.
Only two (10%) patients in the combined drug and art therapy progressed over the study period, compared with 10 (33%) in the control group (P = .05).
The findings complement those of a recent study conducted by Alberto Cucca, MD, of the Fresco Institute for Parkinson’s and Movement Disorders, New York University, and colleagues.
Eighteen patients took part in the prospective, open-label trial. They were assessed before and after 20 sessions of art therapy on a range of measures.
Results revealed that following the art therapy, patients had improvements in the Navon Test (which assesses visual neglect, eye tracking, and UPDRS scores), as well as significantly increased functional connectivity levels in the visual cortex on resting-state functional MRI.
Many benefits, no side effects
Rebecca Gilbert, MD, PhD, vice president and chief scientific officer of the American Parkinson Disease Association, who was not involved in either study, told this news organization that the idea of art therapy for patients with Parkinson’s is “very reasonable.”
She highlighted that “people with Parkinson’s have many issues with their visuospatial abilities,” as well as their depth and distance perception, and so “enhancing that aspect could potentially be very beneficial.”
“So I’m hopeful that it’s a really good avenue to explore, and the preliminary data are very exciting.”
Dr. Gilbert also highlighted that the “wonderful” aspect of art therapy is that there are “so many benefits and not really any side effects.” Patients can “take the meds … and then enhance that with various therapies, and this would be an additional option.”
Another notable aspect of art therapy is the “social element” and the sense of “camaraderie,” although that has “to be teased out from the benefits you would get from the actual art therapy.”
Finally, Dr. Gilbert pointed out that the difference between the current trial and Dr. Cucca’s trial is the presence of a control group.
“Of course, it’s not blinded, because you know whether you got therapy or not … but that extra element of being able to compare with a group that didn’t get the treatment gives it a little more weight in terms of the field.”
No funding was declared. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adding art therapy to standard drug treatment in Parkinson’s disease (PD) not only improves severity of both motor and nonmotor symptoms, but also slows rates of disease progression, new research suggests.
Fifty PD patients were randomly assigned to receive either art therapy, including sculpting and drawing, plus drug therapy or drug therapy alone, and followed up over 12 months.
Patients receiving combined therapy experienced improvements in symptoms, depression, and cognitive scores, and had reduced tremor and daytime sleepiness. They were also substantially less likely to experience disease progression.
“The use of art therapy can reduce the severity of motor and nonmotor manifestations of Parkinson’s disease,” said study investigator Iryna Khubetova, MD, PhD, head of the neurology department, Odessa (Ukraine) Regional Clinical Hospital.
she added.
The findings were presented at the virtual congress of the European College of Neuropsychopharmacology.
A promising approach
Dr. Khubetova told this news organization that offering art therapy to PD patients was “very affordable,” especially as professional artists “provided materials for painting and other art supplies free of charge.”
“We hope this approach is very promising and would be widely adopted.”
She suggested the positive effect of art therapy could be related to “activating the brain’s reward neural network.”
This may be via improved visual attention acting on visuospatial mechanisms and emotional drive, with “activation of the medial orbitofrontal cortex, ventral striatum, and other structures.”
The researchers note PD, a “multisystem progressive neurodegenerative disease,” is among the three most common neurological disorders, with an incidence of 100-150 cases per 100,000 people.
They also note that nonpharmacologic approaches are “widely used” as an adjunct to drug therapy and as part of an “integrated approach” to disease management.
To examine the clinical efficacy of art therapy, the team recruited patients with PD who had preserved facility for independent movement, defined as stages 1-2.5 on the Hoehn and Yahr scale.
Patients were randomly assigned to art therapy sessions alongside standard drug therapy or to standard drug therapy alone. The art therapy included sculpting, free drawing, and coloring patterns.
Multiple benefits
Participants were assessed at baseline and at 6 and 12 months with the Unified Parkinson Disease Rating Scale (UPDRS), the Beck Depression Inventory, the Montreal Cognitive Assessment, and the Pegboard Test of finger dexterity.
Fifty patients were included in the study, with 30 assigned to standard drug therapy alone and 20 to the combined intervention. Participants had a mean age of 57.8 years, and 46% were women.
Over the study period, investigators found patients assigned to art therapy plus drug treatment had improved mood, as well as decreased daytime sleeping, reduced tremor, and a decrease in anxiety and fear intensity.
Between baseline and the 6- and 12-month assessments, patients in the combined therapy group showed improvements in scores on all of the questionnaires, and on the Pegboard Test. In contrast, scores were either stable or worsened in the standard drug therapy–alone group.
The team notes that there was also a marked difference in rates of disease progression, defined as a change on the Hoehn and Yahr scale of at least 0.5 points, between the two groups.
Only two (10%) patients in the combined drug and art therapy progressed over the study period, compared with 10 (33%) in the control group (P = .05).
The findings complement those of a recent study conducted by Alberto Cucca, MD, of the Fresco Institute for Parkinson’s and Movement Disorders, New York University, and colleagues.
Eighteen patients took part in the prospective, open-label trial. They were assessed before and after 20 sessions of art therapy on a range of measures.
Results revealed that following the art therapy, patients had improvements in the Navon Test (which assesses visual neglect, eye tracking, and UPDRS scores), as well as significantly increased functional connectivity levels in the visual cortex on resting-state functional MRI.
Many benefits, no side effects
Rebecca Gilbert, MD, PhD, vice president and chief scientific officer of the American Parkinson Disease Association, who was not involved in either study, told this news organization that the idea of art therapy for patients with Parkinson’s is “very reasonable.”
She highlighted that “people with Parkinson’s have many issues with their visuospatial abilities,” as well as their depth and distance perception, and so “enhancing that aspect could potentially be very beneficial.”
“So I’m hopeful that it’s a really good avenue to explore, and the preliminary data are very exciting.”
Dr. Gilbert also highlighted that the “wonderful” aspect of art therapy is that there are “so many benefits and not really any side effects.” Patients can “take the meds … and then enhance that with various therapies, and this would be an additional option.”
Another notable aspect of art therapy is the “social element” and the sense of “camaraderie,” although that has “to be teased out from the benefits you would get from the actual art therapy.”
Finally, Dr. Gilbert pointed out that the difference between the current trial and Dr. Cucca’s trial is the presence of a control group.
“Of course, it’s not blinded, because you know whether you got therapy or not … but that extra element of being able to compare with a group that didn’t get the treatment gives it a little more weight in terms of the field.”
No funding was declared. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adding art therapy to standard drug treatment in Parkinson’s disease (PD) not only improves severity of both motor and nonmotor symptoms, but also slows rates of disease progression, new research suggests.
Fifty PD patients were randomly assigned to receive either art therapy, including sculpting and drawing, plus drug therapy or drug therapy alone, and followed up over 12 months.
Patients receiving combined therapy experienced improvements in symptoms, depression, and cognitive scores, and had reduced tremor and daytime sleepiness. They were also substantially less likely to experience disease progression.
“The use of art therapy can reduce the severity of motor and nonmotor manifestations of Parkinson’s disease,” said study investigator Iryna Khubetova, MD, PhD, head of the neurology department, Odessa (Ukraine) Regional Clinical Hospital.
she added.
The findings were presented at the virtual congress of the European College of Neuropsychopharmacology.
A promising approach
Dr. Khubetova told this news organization that offering art therapy to PD patients was “very affordable,” especially as professional artists “provided materials for painting and other art supplies free of charge.”
“We hope this approach is very promising and would be widely adopted.”
She suggested the positive effect of art therapy could be related to “activating the brain’s reward neural network.”
This may be via improved visual attention acting on visuospatial mechanisms and emotional drive, with “activation of the medial orbitofrontal cortex, ventral striatum, and other structures.”
The researchers note PD, a “multisystem progressive neurodegenerative disease,” is among the three most common neurological disorders, with an incidence of 100-150 cases per 100,000 people.
They also note that nonpharmacologic approaches are “widely used” as an adjunct to drug therapy and as part of an “integrated approach” to disease management.
To examine the clinical efficacy of art therapy, the team recruited patients with PD who had preserved facility for independent movement, defined as stages 1-2.5 on the Hoehn and Yahr scale.
Patients were randomly assigned to art therapy sessions alongside standard drug therapy or to standard drug therapy alone. The art therapy included sculpting, free drawing, and coloring patterns.
Multiple benefits
Participants were assessed at baseline and at 6 and 12 months with the Unified Parkinson Disease Rating Scale (UPDRS), the Beck Depression Inventory, the Montreal Cognitive Assessment, and the Pegboard Test of finger dexterity.
Fifty patients were included in the study, with 30 assigned to standard drug therapy alone and 20 to the combined intervention. Participants had a mean age of 57.8 years, and 46% were women.
Over the study period, investigators found patients assigned to art therapy plus drug treatment had improved mood, as well as decreased daytime sleeping, reduced tremor, and a decrease in anxiety and fear intensity.
Between baseline and the 6- and 12-month assessments, patients in the combined therapy group showed improvements in scores on all of the questionnaires, and on the Pegboard Test. In contrast, scores were either stable or worsened in the standard drug therapy–alone group.
The team notes that there was also a marked difference in rates of disease progression, defined as a change on the Hoehn and Yahr scale of at least 0.5 points, between the two groups.
Only two (10%) patients in the combined drug and art therapy progressed over the study period, compared with 10 (33%) in the control group (P = .05).
The findings complement those of a recent study conducted by Alberto Cucca, MD, of the Fresco Institute for Parkinson’s and Movement Disorders, New York University, and colleagues.
Eighteen patients took part in the prospective, open-label trial. They were assessed before and after 20 sessions of art therapy on a range of measures.
Results revealed that following the art therapy, patients had improvements in the Navon Test (which assesses visual neglect, eye tracking, and UPDRS scores), as well as significantly increased functional connectivity levels in the visual cortex on resting-state functional MRI.
Many benefits, no side effects
Rebecca Gilbert, MD, PhD, vice president and chief scientific officer of the American Parkinson Disease Association, who was not involved in either study, told this news organization that the idea of art therapy for patients with Parkinson’s is “very reasonable.”
She highlighted that “people with Parkinson’s have many issues with their visuospatial abilities,” as well as their depth and distance perception, and so “enhancing that aspect could potentially be very beneficial.”
“So I’m hopeful that it’s a really good avenue to explore, and the preliminary data are very exciting.”
Dr. Gilbert also highlighted that the “wonderful” aspect of art therapy is that there are “so many benefits and not really any side effects.” Patients can “take the meds … and then enhance that with various therapies, and this would be an additional option.”
Another notable aspect of art therapy is the “social element” and the sense of “camaraderie,” although that has “to be teased out from the benefits you would get from the actual art therapy.”
Finally, Dr. Gilbert pointed out that the difference between the current trial and Dr. Cucca’s trial is the presence of a control group.
“Of course, it’s not blinded, because you know whether you got therapy or not … but that extra element of being able to compare with a group that didn’t get the treatment gives it a little more weight in terms of the field.”
No funding was declared. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ECNP 2021
Substance use or substance use disorder: A question of judgment
Substance use disorders can be a thorny topic in residency because of our role as gatekeepers of mental hospitals during our training. Intoxicated patients often get dismissed as a burden and distraction, malingering their way into a comfortable place to regain sobriety. This is extremely prevalent, often constituting the majority of patients seen during an emergency department call.
A typical interview may elicit any or all symptoms in the DSM yet be best explained by substance use intoxication or withdrawal. Alcohol and other CNS depressants commonly cause feelings of sadness and/or suicidality. Methamphetamine and other CNS stimulants commonly cause symptoms of psychosis or mania, followed by feelings of sadness and/or suicidality.
Different EDs have different degrees of patience for individuals in the process of becoming sober. Some departments will pressure clinicians into quickly discarding those patients and often frown upon any attempt at providing solace by raising the concern of reinforcing maladaptive behavior. A mystery-meat sandwich of admirable blandness may be the extent of help offered. Some more fortunate patients also receive a juice box or even a taxi voucher in an especially generous ED. This is always against our better judgment, of course, as we are told those gestures encourage abuse.
Other EDs will permit patients to remain until sober, allowing for another evaluation without the influence of controlled substances. We are reminded of many conversations with patients with substance use disorders, where topics discussed included: 1. Recommendation to seek substance use services, which are often nonexistent or with wait lists spanning months; 2. Education on the role of mental health hospitals and how patients’ despair in the context of intoxication does not meet some scriptural criteria; 3. Pep talks aided by such previously described sandwiches and juice boxes to encourage a sobering patient to leave the facility of their own will.
Methamphetamine, heroin, and alcohol are rarely one-and-done endeavors. We sparingly see our patients for their very first ED visit while intoxicated or crashing. They know how the system runs and which ED will more readily allow them an overnight stay. The number of times they have been recommended for substance use treatment is beyond counting – they may have been on a wait list a handful of times. They are aware of our reluctance to provide inpatient psychiatric treatment for substance use, but it is worth a shot trying, anyway – sometimes they get lucky. Usually it is the pep talk, relief from hunger pangs, and daylight that get them out the doors – until next time.
It is under this context that many trainees become psychiatrists, a process that solidifies the separation between drug use and mental illness. Many graduate from residency practically equating substance use disorder with malingering or futility. This can take on a surreal quality as many localities have recently adopted particular forms or requirements like the dispensation of naloxone syringes to all patients with substance use disorders. While the desire and effort are noble, it may suggest to a patient presenting for help that society’s main interest is to avoid seeing them die rather than help with available resources for maintaining sobriety.
Therein lies the conundrum, a conundrum that spans psychiatry to society. The conundrum is our ambivalence between punishing the choice of drug use or healing the substance use disorder. Should we discharge the intoxicated patient as soon as they are safe to walk out, or should we make every effort possible to find long-term solutions?
The calculation becomes more complex
A defining moment appears to have been society’s reconsideration of its stance on substance use disorders when affluent White teenagers started dying in the suburbs from pain pills overdoses. Suddenly, those children needed and deserved treatment, not punishment. We find ourselves far away from a time when the loudest societal commentary on substance use entailed mothers advocating for harsher sentences against drunk drivers.
More recently, as psychiatry and large contingents of society have decided to take up the mantle of equity and social justice, we have begun to make progress in decriminalizing substance use in an effort to reverse systemic discrimination toward minority groups. This has taken many shapes, including drug legalization, criminal justice reform, and even the provision of clean substance use paraphernalia for safer use of IV drugs. Police reform has led to reluctance to arrest or press charges for nonviolent crimes and reduced police presence in minority neighborhoods. The “rich White teenager” approach is now recommended in all neighborhoods.
Society’s attempt at decriminalizing drug use has run parallel with psychiatry’s recent attempts at reduced pathologizing of behaviors more prevalent in underprivileged groups and cultures. This runs the gamut, from avoiding the use of the term “agitated” because of its racial connotations, to advocating for reduced rates of schizophrenia diagnoses in Black males.1 A diagnosis of substance use disorder carries with it similar troublesome societal implications. Decriminalization, legalization, provision of substances to the population, normalization, and other societal reforms will likely have an impact on the prevalence of substance use disorder diagnoses, which involve many criteria dependent on societal context.
It would be expected that criteria such as hazardous use, social problems, and attempts to quit will decrease as social acceptance increases. How might this affect access to substance use treatment, an already extremely limited resource?
Now, as forensic psychiatrists, we find ourselves adjudicating on the role of drugs at a time when society is wrestling with its attitude on the breadth of responsibility possessed by people who use drugs. In California, as in many other states, insanity laws exclude those who were insane as a result of drug use, as a testament to or possibly a remnant of how society feels about the role of choice and responsibility in the use of drugs. Yet another defendant who admits to drug use may on the contrary receive a much more lenient plea deal if willing to commit to sobriety. But in a never-ending maze of differing judgments and opinions, a less understanding district attorney may argue that the additional risk posed by the use of drugs and resulting impulsivity may actually warrant a heavier sentence.
In a recent attempt at atonement for our past punitive stance on drug users, we have found a desire to protect those who use drugs by punishing those who sell, at times forgetting that these populations are deeply intertwined. A recent law permits the federal charge of distribution of fentanyl resulting in death, which carries the mandatory minimum of 20 years in prison. Yet, if the user whom we are trying to protect by this law is also the one selling, what are we left with?
Fentanyl has been a particularly tragic development in the history of mankind and drug use. Substance use has rarely been so easily linked to accidental death. While many physicians can easily explain the safety of fentanyl when used as prescribed and in controlled settings, this is certainly not the case in the community. Measuring micrograms of fentanyl is outside the knowledge and capabilities of most drug dealers, who are not equipped with pharmacy-grade scales. Yet, as a result, they sell and customers buy quantities of fentanyl that range from homeopathically low to lethally high because of a mixture of negligence and deliberate indifference.
Another effort at atonement has been attempts at decriminalizing drug use and releasing many nonviolent offenders. This can, however, encourage bystanders to report more acts as crime rather than public intoxication, to ensure a police response when confronted by intoxicated people. Whereas previously an inebriated person who is homeless may have been called for and asked to seek shelter, they now get called on, and subsequently charged for, allegedly mumbling a threat by a frustrated bystander.
The release of offenders has its limits. Many placements on probation require sobriety and result in longer sentences for the use of substances that are otherwise decriminalized. The decriminalization and reexamination of substance use by society should widen the scope from simply considering crime to examining the use of drugs throughout the legal system and even beyond.
The DSM and psychiatry are not intended or equipped to adjudicate disputes on where the lines should be drawn between determinism and free will. We are knowledgeable of patients with substance use disorders, the effect of intoxicating substances, and the capacity of patients with substance use disorders to act in law-abiding ways. Our field can inform without simply advocating whether our patients should be punished. While society is currently struggling with how to apportion blame, psychiatry should resist the urge to impose medical solutions to social problems. Our solutions would almost certainly be grossly limited as we are still struggling to repent for lobotomizing “uppity” young women2 and using electroshock therapy to disrupt perverse impulses in homosexual males.3 Social norms and political zeitgeists change over time while the psychological and physiological principles underlying our understanding of mental illness should, in theory, stay relatively constant. Psychiatry’s answers for societal ills do not usually improve with time but rather have a tendency to be humbling.
Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com.
Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research.
References
1.Medlock MM et al., eds. “Racism and Psychiatry: Contemporary Issues and Interventions” (New York: Springer, 2018).
2. Tone A and Koziol M. CMAJ. 2018:190(20):e624-5.
3. McGuire RJ and Vallance M. BMJ. 1964;1(5376):151-3.
Substance use disorders can be a thorny topic in residency because of our role as gatekeepers of mental hospitals during our training. Intoxicated patients often get dismissed as a burden and distraction, malingering their way into a comfortable place to regain sobriety. This is extremely prevalent, often constituting the majority of patients seen during an emergency department call.
A typical interview may elicit any or all symptoms in the DSM yet be best explained by substance use intoxication or withdrawal. Alcohol and other CNS depressants commonly cause feelings of sadness and/or suicidality. Methamphetamine and other CNS stimulants commonly cause symptoms of psychosis or mania, followed by feelings of sadness and/or suicidality.
Different EDs have different degrees of patience for individuals in the process of becoming sober. Some departments will pressure clinicians into quickly discarding those patients and often frown upon any attempt at providing solace by raising the concern of reinforcing maladaptive behavior. A mystery-meat sandwich of admirable blandness may be the extent of help offered. Some more fortunate patients also receive a juice box or even a taxi voucher in an especially generous ED. This is always against our better judgment, of course, as we are told those gestures encourage abuse.
Other EDs will permit patients to remain until sober, allowing for another evaluation without the influence of controlled substances. We are reminded of many conversations with patients with substance use disorders, where topics discussed included: 1. Recommendation to seek substance use services, which are often nonexistent or with wait lists spanning months; 2. Education on the role of mental health hospitals and how patients’ despair in the context of intoxication does not meet some scriptural criteria; 3. Pep talks aided by such previously described sandwiches and juice boxes to encourage a sobering patient to leave the facility of their own will.
Methamphetamine, heroin, and alcohol are rarely one-and-done endeavors. We sparingly see our patients for their very first ED visit while intoxicated or crashing. They know how the system runs and which ED will more readily allow them an overnight stay. The number of times they have been recommended for substance use treatment is beyond counting – they may have been on a wait list a handful of times. They are aware of our reluctance to provide inpatient psychiatric treatment for substance use, but it is worth a shot trying, anyway – sometimes they get lucky. Usually it is the pep talk, relief from hunger pangs, and daylight that get them out the doors – until next time.
It is under this context that many trainees become psychiatrists, a process that solidifies the separation between drug use and mental illness. Many graduate from residency practically equating substance use disorder with malingering or futility. This can take on a surreal quality as many localities have recently adopted particular forms or requirements like the dispensation of naloxone syringes to all patients with substance use disorders. While the desire and effort are noble, it may suggest to a patient presenting for help that society’s main interest is to avoid seeing them die rather than help with available resources for maintaining sobriety.
Therein lies the conundrum, a conundrum that spans psychiatry to society. The conundrum is our ambivalence between punishing the choice of drug use or healing the substance use disorder. Should we discharge the intoxicated patient as soon as they are safe to walk out, or should we make every effort possible to find long-term solutions?
The calculation becomes more complex
A defining moment appears to have been society’s reconsideration of its stance on substance use disorders when affluent White teenagers started dying in the suburbs from pain pills overdoses. Suddenly, those children needed and deserved treatment, not punishment. We find ourselves far away from a time when the loudest societal commentary on substance use entailed mothers advocating for harsher sentences against drunk drivers.
More recently, as psychiatry and large contingents of society have decided to take up the mantle of equity and social justice, we have begun to make progress in decriminalizing substance use in an effort to reverse systemic discrimination toward minority groups. This has taken many shapes, including drug legalization, criminal justice reform, and even the provision of clean substance use paraphernalia for safer use of IV drugs. Police reform has led to reluctance to arrest or press charges for nonviolent crimes and reduced police presence in minority neighborhoods. The “rich White teenager” approach is now recommended in all neighborhoods.
Society’s attempt at decriminalizing drug use has run parallel with psychiatry’s recent attempts at reduced pathologizing of behaviors more prevalent in underprivileged groups and cultures. This runs the gamut, from avoiding the use of the term “agitated” because of its racial connotations, to advocating for reduced rates of schizophrenia diagnoses in Black males.1 A diagnosis of substance use disorder carries with it similar troublesome societal implications. Decriminalization, legalization, provision of substances to the population, normalization, and other societal reforms will likely have an impact on the prevalence of substance use disorder diagnoses, which involve many criteria dependent on societal context.
It would be expected that criteria such as hazardous use, social problems, and attempts to quit will decrease as social acceptance increases. How might this affect access to substance use treatment, an already extremely limited resource?
Now, as forensic psychiatrists, we find ourselves adjudicating on the role of drugs at a time when society is wrestling with its attitude on the breadth of responsibility possessed by people who use drugs. In California, as in many other states, insanity laws exclude those who were insane as a result of drug use, as a testament to or possibly a remnant of how society feels about the role of choice and responsibility in the use of drugs. Yet another defendant who admits to drug use may on the contrary receive a much more lenient plea deal if willing to commit to sobriety. But in a never-ending maze of differing judgments and opinions, a less understanding district attorney may argue that the additional risk posed by the use of drugs and resulting impulsivity may actually warrant a heavier sentence.
In a recent attempt at atonement for our past punitive stance on drug users, we have found a desire to protect those who use drugs by punishing those who sell, at times forgetting that these populations are deeply intertwined. A recent law permits the federal charge of distribution of fentanyl resulting in death, which carries the mandatory minimum of 20 years in prison. Yet, if the user whom we are trying to protect by this law is also the one selling, what are we left with?
Fentanyl has been a particularly tragic development in the history of mankind and drug use. Substance use has rarely been so easily linked to accidental death. While many physicians can easily explain the safety of fentanyl when used as prescribed and in controlled settings, this is certainly not the case in the community. Measuring micrograms of fentanyl is outside the knowledge and capabilities of most drug dealers, who are not equipped with pharmacy-grade scales. Yet, as a result, they sell and customers buy quantities of fentanyl that range from homeopathically low to lethally high because of a mixture of negligence and deliberate indifference.
Another effort at atonement has been attempts at decriminalizing drug use and releasing many nonviolent offenders. This can, however, encourage bystanders to report more acts as crime rather than public intoxication, to ensure a police response when confronted by intoxicated people. Whereas previously an inebriated person who is homeless may have been called for and asked to seek shelter, they now get called on, and subsequently charged for, allegedly mumbling a threat by a frustrated bystander.
The release of offenders has its limits. Many placements on probation require sobriety and result in longer sentences for the use of substances that are otherwise decriminalized. The decriminalization and reexamination of substance use by society should widen the scope from simply considering crime to examining the use of drugs throughout the legal system and even beyond.
The DSM and psychiatry are not intended or equipped to adjudicate disputes on where the lines should be drawn between determinism and free will. We are knowledgeable of patients with substance use disorders, the effect of intoxicating substances, and the capacity of patients with substance use disorders to act in law-abiding ways. Our field can inform without simply advocating whether our patients should be punished. While society is currently struggling with how to apportion blame, psychiatry should resist the urge to impose medical solutions to social problems. Our solutions would almost certainly be grossly limited as we are still struggling to repent for lobotomizing “uppity” young women2 and using electroshock therapy to disrupt perverse impulses in homosexual males.3 Social norms and political zeitgeists change over time while the psychological and physiological principles underlying our understanding of mental illness should, in theory, stay relatively constant. Psychiatry’s answers for societal ills do not usually improve with time but rather have a tendency to be humbling.
Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com.
Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research.
References
1.Medlock MM et al., eds. “Racism and Psychiatry: Contemporary Issues and Interventions” (New York: Springer, 2018).
2. Tone A and Koziol M. CMAJ. 2018:190(20):e624-5.
3. McGuire RJ and Vallance M. BMJ. 1964;1(5376):151-3.
Substance use disorders can be a thorny topic in residency because of our role as gatekeepers of mental hospitals during our training. Intoxicated patients often get dismissed as a burden and distraction, malingering their way into a comfortable place to regain sobriety. This is extremely prevalent, often constituting the majority of patients seen during an emergency department call.
A typical interview may elicit any or all symptoms in the DSM yet be best explained by substance use intoxication or withdrawal. Alcohol and other CNS depressants commonly cause feelings of sadness and/or suicidality. Methamphetamine and other CNS stimulants commonly cause symptoms of psychosis or mania, followed by feelings of sadness and/or suicidality.
Different EDs have different degrees of patience for individuals in the process of becoming sober. Some departments will pressure clinicians into quickly discarding those patients and often frown upon any attempt at providing solace by raising the concern of reinforcing maladaptive behavior. A mystery-meat sandwich of admirable blandness may be the extent of help offered. Some more fortunate patients also receive a juice box or even a taxi voucher in an especially generous ED. This is always against our better judgment, of course, as we are told those gestures encourage abuse.
Other EDs will permit patients to remain until sober, allowing for another evaluation without the influence of controlled substances. We are reminded of many conversations with patients with substance use disorders, where topics discussed included: 1. Recommendation to seek substance use services, which are often nonexistent or with wait lists spanning months; 2. Education on the role of mental health hospitals and how patients’ despair in the context of intoxication does not meet some scriptural criteria; 3. Pep talks aided by such previously described sandwiches and juice boxes to encourage a sobering patient to leave the facility of their own will.
Methamphetamine, heroin, and alcohol are rarely one-and-done endeavors. We sparingly see our patients for their very first ED visit while intoxicated or crashing. They know how the system runs and which ED will more readily allow them an overnight stay. The number of times they have been recommended for substance use treatment is beyond counting – they may have been on a wait list a handful of times. They are aware of our reluctance to provide inpatient psychiatric treatment for substance use, but it is worth a shot trying, anyway – sometimes they get lucky. Usually it is the pep talk, relief from hunger pangs, and daylight that get them out the doors – until next time.
It is under this context that many trainees become psychiatrists, a process that solidifies the separation between drug use and mental illness. Many graduate from residency practically equating substance use disorder with malingering or futility. This can take on a surreal quality as many localities have recently adopted particular forms or requirements like the dispensation of naloxone syringes to all patients with substance use disorders. While the desire and effort are noble, it may suggest to a patient presenting for help that society’s main interest is to avoid seeing them die rather than help with available resources for maintaining sobriety.
Therein lies the conundrum, a conundrum that spans psychiatry to society. The conundrum is our ambivalence between punishing the choice of drug use or healing the substance use disorder. Should we discharge the intoxicated patient as soon as they are safe to walk out, or should we make every effort possible to find long-term solutions?
The calculation becomes more complex
A defining moment appears to have been society’s reconsideration of its stance on substance use disorders when affluent White teenagers started dying in the suburbs from pain pills overdoses. Suddenly, those children needed and deserved treatment, not punishment. We find ourselves far away from a time when the loudest societal commentary on substance use entailed mothers advocating for harsher sentences against drunk drivers.
More recently, as psychiatry and large contingents of society have decided to take up the mantle of equity and social justice, we have begun to make progress in decriminalizing substance use in an effort to reverse systemic discrimination toward minority groups. This has taken many shapes, including drug legalization, criminal justice reform, and even the provision of clean substance use paraphernalia for safer use of IV drugs. Police reform has led to reluctance to arrest or press charges for nonviolent crimes and reduced police presence in minority neighborhoods. The “rich White teenager” approach is now recommended in all neighborhoods.
Society’s attempt at decriminalizing drug use has run parallel with psychiatry’s recent attempts at reduced pathologizing of behaviors more prevalent in underprivileged groups and cultures. This runs the gamut, from avoiding the use of the term “agitated” because of its racial connotations, to advocating for reduced rates of schizophrenia diagnoses in Black males.1 A diagnosis of substance use disorder carries with it similar troublesome societal implications. Decriminalization, legalization, provision of substances to the population, normalization, and other societal reforms will likely have an impact on the prevalence of substance use disorder diagnoses, which involve many criteria dependent on societal context.
It would be expected that criteria such as hazardous use, social problems, and attempts to quit will decrease as social acceptance increases. How might this affect access to substance use treatment, an already extremely limited resource?
Now, as forensic psychiatrists, we find ourselves adjudicating on the role of drugs at a time when society is wrestling with its attitude on the breadth of responsibility possessed by people who use drugs. In California, as in many other states, insanity laws exclude those who were insane as a result of drug use, as a testament to or possibly a remnant of how society feels about the role of choice and responsibility in the use of drugs. Yet another defendant who admits to drug use may on the contrary receive a much more lenient plea deal if willing to commit to sobriety. But in a never-ending maze of differing judgments and opinions, a less understanding district attorney may argue that the additional risk posed by the use of drugs and resulting impulsivity may actually warrant a heavier sentence.
In a recent attempt at atonement for our past punitive stance on drug users, we have found a desire to protect those who use drugs by punishing those who sell, at times forgetting that these populations are deeply intertwined. A recent law permits the federal charge of distribution of fentanyl resulting in death, which carries the mandatory minimum of 20 years in prison. Yet, if the user whom we are trying to protect by this law is also the one selling, what are we left with?
Fentanyl has been a particularly tragic development in the history of mankind and drug use. Substance use has rarely been so easily linked to accidental death. While many physicians can easily explain the safety of fentanyl when used as prescribed and in controlled settings, this is certainly not the case in the community. Measuring micrograms of fentanyl is outside the knowledge and capabilities of most drug dealers, who are not equipped with pharmacy-grade scales. Yet, as a result, they sell and customers buy quantities of fentanyl that range from homeopathically low to lethally high because of a mixture of negligence and deliberate indifference.
Another effort at atonement has been attempts at decriminalizing drug use and releasing many nonviolent offenders. This can, however, encourage bystanders to report more acts as crime rather than public intoxication, to ensure a police response when confronted by intoxicated people. Whereas previously an inebriated person who is homeless may have been called for and asked to seek shelter, they now get called on, and subsequently charged for, allegedly mumbling a threat by a frustrated bystander.
The release of offenders has its limits. Many placements on probation require sobriety and result in longer sentences for the use of substances that are otherwise decriminalized. The decriminalization and reexamination of substance use by society should widen the scope from simply considering crime to examining the use of drugs throughout the legal system and even beyond.
The DSM and psychiatry are not intended or equipped to adjudicate disputes on where the lines should be drawn between determinism and free will. We are knowledgeable of patients with substance use disorders, the effect of intoxicating substances, and the capacity of patients with substance use disorders to act in law-abiding ways. Our field can inform without simply advocating whether our patients should be punished. While society is currently struggling with how to apportion blame, psychiatry should resist the urge to impose medical solutions to social problems. Our solutions would almost certainly be grossly limited as we are still struggling to repent for lobotomizing “uppity” young women2 and using electroshock therapy to disrupt perverse impulses in homosexual males.3 Social norms and political zeitgeists change over time while the psychological and physiological principles underlying our understanding of mental illness should, in theory, stay relatively constant. Psychiatry’s answers for societal ills do not usually improve with time but rather have a tendency to be humbling.
Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com.
Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research.
References
1.Medlock MM et al., eds. “Racism and Psychiatry: Contemporary Issues and Interventions” (New York: Springer, 2018).
2. Tone A and Koziol M. CMAJ. 2018:190(20):e624-5.
3. McGuire RJ and Vallance M. BMJ. 1964;1(5376):151-3.
White House unveils plan to combat endocrine-disrupting PFAS pollution
The federal government is stepping up actions to protect Americans from per- and polyfluoroalkyl substances that continue to threaten health through pollution in the air, water, and foods, according to a statement from the White House on Oct. 18.
The comprehensive plan includes efforts to prevent per- and polyfluoroalkyl substances (PFAS) from being released into the air, drinking and ground water, and the food supply chain, according to the statement. Other efforts will expand cleanup and remediation of the impact of PFAS already present in the environment.
PFAS are a category of endocrine-disrupting chemicals (EDCs) that have been used for decades in a range of consumer products including cookware, stain-resistant clothes, fast food wrappers, treatments for carpets and furniture, and firefighting foams. PFAS can be released into the air, and also into surface water, drinking water, and ground water, because of how they are disposed, according to a 2020 report from the Endocrine Society and the International Pollutants Elimination Network. The report suggested that creation of more plastic products will likely increase exposure to PFAS and other EDCs.
The Environmental Protection Agency will take the lead on the Biden administration’s PFAS reduction efforts. The agency announced a PFAS Roadmap, which outlines actions to control PFAS over the next 3 years. The Roadmap’s goals include keeping PFAS out of the environment, holding polluters accountable for their actions, investing in scientific research to learn more about the impact of PFAS on human health, and prioritizing protection for disadvantaged communities. The EPA described its approach to PFAS as three pronged (Research, Restrict, Remediate). Planned actions noted on the EPA website include publication of a national PFAS testing strategy, establishing an improved review process for new PFAS, reviewing existing PFAS, and enhancing reporting to track sources and quantities of PFAS.
White House statement noted that other agencies committed to controlling PFAS include the Department of Defense, which will conduct cleanups and assessments at DOD and National Guard locations; the Food and Drug Administration, which will to expand its food supply testing to estimate dietary exposure to PFAS; and the Department of Agriculture, which is investigating causes and impacts of PFAS in the food system, and supporting research on environmental contaminants including PFAS.
The Department of Homeland Security has conducted an inventory of PFAS use, notably the use of PFAS in firefighting foams, and established an Emerging Contaminants Working Group to remediate PFAS and other contaminants. In addition, the Department of Health & Human Services monitors the evolving science on human health and PFAS and anticipates a report by the Centers for Disease Control and Prevention on the health effects of PFAS exposure, with data from eight states.
The American Chemistry Council (ACC), a trade association for American chemistry companies, issued a statement in response to the EPA’s PFAS Strategic Roadmap in which they supported the value of science-based regulation, but emphasized that PFAS are distinct from one another, and should not be grouped together for regulation purposes.
“According to EPA, approximately 600 PFAS substances are manufactured or in use today, each with its own unique properties and uses, from cellphones to solar panels, for which alternatives are not always available,” according to the ACC statement. “EPA’s Roadmap reinforces the differences between these chemistries and that they should not all be grouped together.” The newly formed Interagency Policy Committee on PFAS will coordinate PFAS response efforts across agencies and “help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country,” according to the White House statement.
The federal government is stepping up actions to protect Americans from per- and polyfluoroalkyl substances that continue to threaten health through pollution in the air, water, and foods, according to a statement from the White House on Oct. 18.
The comprehensive plan includes efforts to prevent per- and polyfluoroalkyl substances (PFAS) from being released into the air, drinking and ground water, and the food supply chain, according to the statement. Other efforts will expand cleanup and remediation of the impact of PFAS already present in the environment.
PFAS are a category of endocrine-disrupting chemicals (EDCs) that have been used for decades in a range of consumer products including cookware, stain-resistant clothes, fast food wrappers, treatments for carpets and furniture, and firefighting foams. PFAS can be released into the air, and also into surface water, drinking water, and ground water, because of how they are disposed, according to a 2020 report from the Endocrine Society and the International Pollutants Elimination Network. The report suggested that creation of more plastic products will likely increase exposure to PFAS and other EDCs.
The Environmental Protection Agency will take the lead on the Biden administration’s PFAS reduction efforts. The agency announced a PFAS Roadmap, which outlines actions to control PFAS over the next 3 years. The Roadmap’s goals include keeping PFAS out of the environment, holding polluters accountable for their actions, investing in scientific research to learn more about the impact of PFAS on human health, and prioritizing protection for disadvantaged communities. The EPA described its approach to PFAS as three pronged (Research, Restrict, Remediate). Planned actions noted on the EPA website include publication of a national PFAS testing strategy, establishing an improved review process for new PFAS, reviewing existing PFAS, and enhancing reporting to track sources and quantities of PFAS.
White House statement noted that other agencies committed to controlling PFAS include the Department of Defense, which will conduct cleanups and assessments at DOD and National Guard locations; the Food and Drug Administration, which will to expand its food supply testing to estimate dietary exposure to PFAS; and the Department of Agriculture, which is investigating causes and impacts of PFAS in the food system, and supporting research on environmental contaminants including PFAS.
The Department of Homeland Security has conducted an inventory of PFAS use, notably the use of PFAS in firefighting foams, and established an Emerging Contaminants Working Group to remediate PFAS and other contaminants. In addition, the Department of Health & Human Services monitors the evolving science on human health and PFAS and anticipates a report by the Centers for Disease Control and Prevention on the health effects of PFAS exposure, with data from eight states.
The American Chemistry Council (ACC), a trade association for American chemistry companies, issued a statement in response to the EPA’s PFAS Strategic Roadmap in which they supported the value of science-based regulation, but emphasized that PFAS are distinct from one another, and should not be grouped together for regulation purposes.
“According to EPA, approximately 600 PFAS substances are manufactured or in use today, each with its own unique properties and uses, from cellphones to solar panels, for which alternatives are not always available,” according to the ACC statement. “EPA’s Roadmap reinforces the differences between these chemistries and that they should not all be grouped together.” The newly formed Interagency Policy Committee on PFAS will coordinate PFAS response efforts across agencies and “help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country,” according to the White House statement.
The federal government is stepping up actions to protect Americans from per- and polyfluoroalkyl substances that continue to threaten health through pollution in the air, water, and foods, according to a statement from the White House on Oct. 18.
The comprehensive plan includes efforts to prevent per- and polyfluoroalkyl substances (PFAS) from being released into the air, drinking and ground water, and the food supply chain, according to the statement. Other efforts will expand cleanup and remediation of the impact of PFAS already present in the environment.
PFAS are a category of endocrine-disrupting chemicals (EDCs) that have been used for decades in a range of consumer products including cookware, stain-resistant clothes, fast food wrappers, treatments for carpets and furniture, and firefighting foams. PFAS can be released into the air, and also into surface water, drinking water, and ground water, because of how they are disposed, according to a 2020 report from the Endocrine Society and the International Pollutants Elimination Network. The report suggested that creation of more plastic products will likely increase exposure to PFAS and other EDCs.
The Environmental Protection Agency will take the lead on the Biden administration’s PFAS reduction efforts. The agency announced a PFAS Roadmap, which outlines actions to control PFAS over the next 3 years. The Roadmap’s goals include keeping PFAS out of the environment, holding polluters accountable for their actions, investing in scientific research to learn more about the impact of PFAS on human health, and prioritizing protection for disadvantaged communities. The EPA described its approach to PFAS as three pronged (Research, Restrict, Remediate). Planned actions noted on the EPA website include publication of a national PFAS testing strategy, establishing an improved review process for new PFAS, reviewing existing PFAS, and enhancing reporting to track sources and quantities of PFAS.
White House statement noted that other agencies committed to controlling PFAS include the Department of Defense, which will conduct cleanups and assessments at DOD and National Guard locations; the Food and Drug Administration, which will to expand its food supply testing to estimate dietary exposure to PFAS; and the Department of Agriculture, which is investigating causes and impacts of PFAS in the food system, and supporting research on environmental contaminants including PFAS.
The Department of Homeland Security has conducted an inventory of PFAS use, notably the use of PFAS in firefighting foams, and established an Emerging Contaminants Working Group to remediate PFAS and other contaminants. In addition, the Department of Health & Human Services monitors the evolving science on human health and PFAS and anticipates a report by the Centers for Disease Control and Prevention on the health effects of PFAS exposure, with data from eight states.
The American Chemistry Council (ACC), a trade association for American chemistry companies, issued a statement in response to the EPA’s PFAS Strategic Roadmap in which they supported the value of science-based regulation, but emphasized that PFAS are distinct from one another, and should not be grouped together for regulation purposes.
“According to EPA, approximately 600 PFAS substances are manufactured or in use today, each with its own unique properties and uses, from cellphones to solar panels, for which alternatives are not always available,” according to the ACC statement. “EPA’s Roadmap reinforces the differences between these chemistries and that they should not all be grouped together.” The newly formed Interagency Policy Committee on PFAS will coordinate PFAS response efforts across agencies and “help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country,” according to the White House statement.
AHA: Quality of STEMI care has stalled, needs improvement
Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.
The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.
The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.
“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.
“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”
The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).
However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.
Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”
Other key recommendations of the statement include:
- Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
- Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
- Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
- Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.
The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”
The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.
Dr. Jacobs has no relevant relationships to disclose.
Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.
The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.
The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.
“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.
“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”
The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).
However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.
Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”
Other key recommendations of the statement include:
- Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
- Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
- Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
- Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.
The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”
The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.
Dr. Jacobs has no relevant relationships to disclose.
Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.
The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.
The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.
“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.
“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”
The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).
However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.
Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”
Other key recommendations of the statement include:
- Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
- Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
- Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
- Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.
The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”
The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.
Dr. Jacobs has no relevant relationships to disclose.
FROM CIRCULATION
FDA OKs new high-dose naloxone product for opioid overdose
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
Use live donors for liver transplants for HCC patients, say experts
A new study shows that outcomes with liver transplants from live donors are better than outcomes with transplants from deceased donors, leading to calls for increasing the availability of live donation.
“Transplant programs worldwide should be encouraged to expand their live donor programs to manage patients with HCC,” suggest authors of the new study, published in September in JAMA Surgery.
The findings are important in light of the fact that among patients with HCC, liver transplants are restricted to those patients who have the highest chances of survival, owing to long donor organ waiting lists, say the authors. Use of transplants from living donors could increase the availability of organs for patients on the deceased donor waiting list.
“One could even argue that a living donor gives two organs back to the organ pool,” the authors comment.
“Efforts to expand the donor pool through living donor liver transplant for patients with HCC will ultimately increase the number of available deceased donor liver transplants to help all patients in need of liver transplant,” David A. Gerber, MD, of the University of North Carolina at Chapel Hill, and colleagues write in an accompanying commentary.
“It is very important that donors aren’t recruited or solicited, but with the growth of transplant programs, more potential donors will become aware of this opportunity and will step forward seeking to help someone else,” Dr. Gerber commented.
Live liver donor = lower death risk
The new study was conducted by first author Quirino Laid, MD, PhD, of the Department of General Surgery and Organ Transplantation, Sapienza University, Rome, and colleagues. They explain that the need to better understand the potential benefits of living donor organs is pressing. Liver cancer rates continue to rise, and the demand for organs outpaces the supply. Although various smaller studies have shown survival benefits of live donor liver transplant for people with HCC, debate continues. Previous evidence has suggested higher cancer recurrence rates and unfavorable outcomes.
The multicenter study is thought to be the largest to date on this issue. The investigators evaluated data from patients who were on liver donation waiting lists for a first transplant between January 2000 and December 2017. The study included two cohorts of patients on waiting lists: an international cohort, consisting of 3,052 patients at 12 collaborative transplant centers in Europe, Asia, and the United States; and a Canadian cohort, consisting of 906 patients.
The majority of patients were men (80.2%). The median age at the time of first referral was 58 years.
About a third of patients (33.1%) in the international cohort and slightly fewer than a third (27%) in the Canadian cohort received live donor liver transplants; the reminder received liver transplants from deceased donors.
The median follow-up period was 3.3 years. Receiving a live donor liver transplant was independently associated with a 49% reduction in the overall risk for death (hazard ratio, 0.51) in the international cohort and a 43% reduction in the Canadian cohort (HR, 0.57; both P < .001).
After adjustment for potential confounders, living donor liver transplantation remained independently associated with a reduced the risk for overall death. There was a reduction of 33% in the international cohort (P = .001) and a reduction of 48% in the Canadian cohort (P < .001).
“Divergent experiences all converged to a similar 40% to 50% reduction in intention-to-treat death risk,” the authors write.
Importantly, there were no increases in post-transplant cancer recurrence rates in the live donor groups in either cohort. Rates ranged from 13% to 16% over 5 years and from 17% to 22% after 10 years in both groups.
The median amount of time on the waiting list was significantly shorter for patients in the live donor group than for those in the deceased donor group (1 month vs. 6 months in the international cohort [P < .001]; 5 months vs. 6 months in the Canadian cohort [P = .006]).
Notably, in the deceased donor groups, there were 295 dropouts, compared with no dropouts among the live donor patients in the international cohort (P < .001). In the Canadian cohort, the corresponding rates were 32.2% and 13.9% (P < .001).
Diverse transplant centers, larger cohorts set study apart
Although these latest results are consistent with those of recent studies conducted in France, Hong Kong, and elsewhere, in the current study, the cohorts were larger, say the authors.
“Compared with previous studies, all of which were based on relatively small case series, the present study examined the data of almost 4,000 patients who were on a waiting list for a transplant; therefore, this study may be the largest cohort study on this topic,” they point out.
In addition to improved timing of a transplant, other factors, such as patient selection, help explain the better survival, editorialist Dr. Gerber commented.
“Survival improvement [with live donor liver transplants] is a combination of [surgeon] experience in this transplant procedure and an appropriate selection bias, meaning taking patients who aren’t too sick while waiting on the transplant but who would benefit from the operation,” he said.
Gaining that experience may be particularly challenging in the United States, owing to regulatory barriers to expanding the programs, but efforts to overcome that are moving ahead, Dr. Gerber added.
“This issue of where an individual gains the experience or expertise is being discussed as transplantation has grown worldwide,” he notes.
As programs expand, the availability of live liver donors should improve, he suggested.
In a related story, this news organization recently reported on the controversial issue of liver transplant as an option for the treatment of liver metastases resulting from colorectal cancer.
Study coauthor Gonzalo Sapisochin, MD, has received grants from Bayer and Roche outside the submitted work as well as personal fees from Integra, Novartis, and AstraZeneca. No other relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
A new study shows that outcomes with liver transplants from live donors are better than outcomes with transplants from deceased donors, leading to calls for increasing the availability of live donation.
“Transplant programs worldwide should be encouraged to expand their live donor programs to manage patients with HCC,” suggest authors of the new study, published in September in JAMA Surgery.
The findings are important in light of the fact that among patients with HCC, liver transplants are restricted to those patients who have the highest chances of survival, owing to long donor organ waiting lists, say the authors. Use of transplants from living donors could increase the availability of organs for patients on the deceased donor waiting list.
“One could even argue that a living donor gives two organs back to the organ pool,” the authors comment.
“Efforts to expand the donor pool through living donor liver transplant for patients with HCC will ultimately increase the number of available deceased donor liver transplants to help all patients in need of liver transplant,” David A. Gerber, MD, of the University of North Carolina at Chapel Hill, and colleagues write in an accompanying commentary.
“It is very important that donors aren’t recruited or solicited, but with the growth of transplant programs, more potential donors will become aware of this opportunity and will step forward seeking to help someone else,” Dr. Gerber commented.
Live liver donor = lower death risk
The new study was conducted by first author Quirino Laid, MD, PhD, of the Department of General Surgery and Organ Transplantation, Sapienza University, Rome, and colleagues. They explain that the need to better understand the potential benefits of living donor organs is pressing. Liver cancer rates continue to rise, and the demand for organs outpaces the supply. Although various smaller studies have shown survival benefits of live donor liver transplant for people with HCC, debate continues. Previous evidence has suggested higher cancer recurrence rates and unfavorable outcomes.
The multicenter study is thought to be the largest to date on this issue. The investigators evaluated data from patients who were on liver donation waiting lists for a first transplant between January 2000 and December 2017. The study included two cohorts of patients on waiting lists: an international cohort, consisting of 3,052 patients at 12 collaborative transplant centers in Europe, Asia, and the United States; and a Canadian cohort, consisting of 906 patients.
The majority of patients were men (80.2%). The median age at the time of first referral was 58 years.
About a third of patients (33.1%) in the international cohort and slightly fewer than a third (27%) in the Canadian cohort received live donor liver transplants; the reminder received liver transplants from deceased donors.
The median follow-up period was 3.3 years. Receiving a live donor liver transplant was independently associated with a 49% reduction in the overall risk for death (hazard ratio, 0.51) in the international cohort and a 43% reduction in the Canadian cohort (HR, 0.57; both P < .001).
After adjustment for potential confounders, living donor liver transplantation remained independently associated with a reduced the risk for overall death. There was a reduction of 33% in the international cohort (P = .001) and a reduction of 48% in the Canadian cohort (P < .001).
“Divergent experiences all converged to a similar 40% to 50% reduction in intention-to-treat death risk,” the authors write.
Importantly, there were no increases in post-transplant cancer recurrence rates in the live donor groups in either cohort. Rates ranged from 13% to 16% over 5 years and from 17% to 22% after 10 years in both groups.
The median amount of time on the waiting list was significantly shorter for patients in the live donor group than for those in the deceased donor group (1 month vs. 6 months in the international cohort [P < .001]; 5 months vs. 6 months in the Canadian cohort [P = .006]).
Notably, in the deceased donor groups, there were 295 dropouts, compared with no dropouts among the live donor patients in the international cohort (P < .001). In the Canadian cohort, the corresponding rates were 32.2% and 13.9% (P < .001).
Diverse transplant centers, larger cohorts set study apart
Although these latest results are consistent with those of recent studies conducted in France, Hong Kong, and elsewhere, in the current study, the cohorts were larger, say the authors.
“Compared with previous studies, all of which were based on relatively small case series, the present study examined the data of almost 4,000 patients who were on a waiting list for a transplant; therefore, this study may be the largest cohort study on this topic,” they point out.
In addition to improved timing of a transplant, other factors, such as patient selection, help explain the better survival, editorialist Dr. Gerber commented.
“Survival improvement [with live donor liver transplants] is a combination of [surgeon] experience in this transplant procedure and an appropriate selection bias, meaning taking patients who aren’t too sick while waiting on the transplant but who would benefit from the operation,” he said.
Gaining that experience may be particularly challenging in the United States, owing to regulatory barriers to expanding the programs, but efforts to overcome that are moving ahead, Dr. Gerber added.
“This issue of where an individual gains the experience or expertise is being discussed as transplantation has grown worldwide,” he notes.
As programs expand, the availability of live liver donors should improve, he suggested.
In a related story, this news organization recently reported on the controversial issue of liver transplant as an option for the treatment of liver metastases resulting from colorectal cancer.
Study coauthor Gonzalo Sapisochin, MD, has received grants from Bayer and Roche outside the submitted work as well as personal fees from Integra, Novartis, and AstraZeneca. No other relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
A new study shows that outcomes with liver transplants from live donors are better than outcomes with transplants from deceased donors, leading to calls for increasing the availability of live donation.
“Transplant programs worldwide should be encouraged to expand their live donor programs to manage patients with HCC,” suggest authors of the new study, published in September in JAMA Surgery.
The findings are important in light of the fact that among patients with HCC, liver transplants are restricted to those patients who have the highest chances of survival, owing to long donor organ waiting lists, say the authors. Use of transplants from living donors could increase the availability of organs for patients on the deceased donor waiting list.
“One could even argue that a living donor gives two organs back to the organ pool,” the authors comment.
“Efforts to expand the donor pool through living donor liver transplant for patients with HCC will ultimately increase the number of available deceased donor liver transplants to help all patients in need of liver transplant,” David A. Gerber, MD, of the University of North Carolina at Chapel Hill, and colleagues write in an accompanying commentary.
“It is very important that donors aren’t recruited or solicited, but with the growth of transplant programs, more potential donors will become aware of this opportunity and will step forward seeking to help someone else,” Dr. Gerber commented.
Live liver donor = lower death risk
The new study was conducted by first author Quirino Laid, MD, PhD, of the Department of General Surgery and Organ Transplantation, Sapienza University, Rome, and colleagues. They explain that the need to better understand the potential benefits of living donor organs is pressing. Liver cancer rates continue to rise, and the demand for organs outpaces the supply. Although various smaller studies have shown survival benefits of live donor liver transplant for people with HCC, debate continues. Previous evidence has suggested higher cancer recurrence rates and unfavorable outcomes.
The multicenter study is thought to be the largest to date on this issue. The investigators evaluated data from patients who were on liver donation waiting lists for a first transplant between January 2000 and December 2017. The study included two cohorts of patients on waiting lists: an international cohort, consisting of 3,052 patients at 12 collaborative transplant centers in Europe, Asia, and the United States; and a Canadian cohort, consisting of 906 patients.
The majority of patients were men (80.2%). The median age at the time of first referral was 58 years.
About a third of patients (33.1%) in the international cohort and slightly fewer than a third (27%) in the Canadian cohort received live donor liver transplants; the reminder received liver transplants from deceased donors.
The median follow-up period was 3.3 years. Receiving a live donor liver transplant was independently associated with a 49% reduction in the overall risk for death (hazard ratio, 0.51) in the international cohort and a 43% reduction in the Canadian cohort (HR, 0.57; both P < .001).
After adjustment for potential confounders, living donor liver transplantation remained independently associated with a reduced the risk for overall death. There was a reduction of 33% in the international cohort (P = .001) and a reduction of 48% in the Canadian cohort (P < .001).
“Divergent experiences all converged to a similar 40% to 50% reduction in intention-to-treat death risk,” the authors write.
Importantly, there were no increases in post-transplant cancer recurrence rates in the live donor groups in either cohort. Rates ranged from 13% to 16% over 5 years and from 17% to 22% after 10 years in both groups.
The median amount of time on the waiting list was significantly shorter for patients in the live donor group than for those in the deceased donor group (1 month vs. 6 months in the international cohort [P < .001]; 5 months vs. 6 months in the Canadian cohort [P = .006]).
Notably, in the deceased donor groups, there were 295 dropouts, compared with no dropouts among the live donor patients in the international cohort (P < .001). In the Canadian cohort, the corresponding rates were 32.2% and 13.9% (P < .001).
Diverse transplant centers, larger cohorts set study apart
Although these latest results are consistent with those of recent studies conducted in France, Hong Kong, and elsewhere, in the current study, the cohorts were larger, say the authors.
“Compared with previous studies, all of which were based on relatively small case series, the present study examined the data of almost 4,000 patients who were on a waiting list for a transplant; therefore, this study may be the largest cohort study on this topic,” they point out.
In addition to improved timing of a transplant, other factors, such as patient selection, help explain the better survival, editorialist Dr. Gerber commented.
“Survival improvement [with live donor liver transplants] is a combination of [surgeon] experience in this transplant procedure and an appropriate selection bias, meaning taking patients who aren’t too sick while waiting on the transplant but who would benefit from the operation,” he said.
Gaining that experience may be particularly challenging in the United States, owing to regulatory barriers to expanding the programs, but efforts to overcome that are moving ahead, Dr. Gerber added.
“This issue of where an individual gains the experience or expertise is being discussed as transplantation has grown worldwide,” he notes.
As programs expand, the availability of live liver donors should improve, he suggested.
In a related story, this news organization recently reported on the controversial issue of liver transplant as an option for the treatment of liver metastases resulting from colorectal cancer.
Study coauthor Gonzalo Sapisochin, MD, has received grants from Bayer and Roche outside the submitted work as well as personal fees from Integra, Novartis, and AstraZeneca. No other relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
AGA News
New patient care resource: NASH Clinical Care Pathway
The American Gastroenterological Association – in collaboration with seven professional associations – assembled a multidisciplinary taskforce of 15 experts to develop an action plan to develop a nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) Clinical Care Pathway providing practical guidance across multiple disciplines of care. The guidance ranges from screening and diagnosis to management of individuals with NAFLD and NASH, as well as facilitating value-based, efficient, and safe care that is consistent with evidence-based guidelines.
This clinical care pathway is intended to be applicable in any setting in which care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices.
Read the special report: Clinical Care Pathway for the Risk Stratification and Management of Patients with Nonalcoholic Fatty Liver Disease.
To learn more about the development of this publication, visit NASH.gastro.org.
GI societies push CMS for payment rules favorable for practices
As part of our longstanding collaboration and ongoing efforts on critical policy and payment issues impacting GI clinicians, AGA, the American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy submitted comments on proposed 2022 Medicare payments to physicians, ambulatory surgery centers (ASCs), and hospital outpatient departments to the CMS. We advocated for the following:
Increased and more accurate valuation for peroral endoscopic myotomy (POEM) and capsule endoscopy services.
Continued flexibility and payment parity for telehealth and telephone services.
Elimination of the secondary scalar for ASCs, which contributes to the widening differential in payments to ASCs compared to the hospital outpatient department.
You can access our letter here.
New patient care resource: NASH Clinical Care Pathway
The American Gastroenterological Association – in collaboration with seven professional associations – assembled a multidisciplinary taskforce of 15 experts to develop an action plan to develop a nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) Clinical Care Pathway providing practical guidance across multiple disciplines of care. The guidance ranges from screening and diagnosis to management of individuals with NAFLD and NASH, as well as facilitating value-based, efficient, and safe care that is consistent with evidence-based guidelines.
This clinical care pathway is intended to be applicable in any setting in which care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices.
Read the special report: Clinical Care Pathway for the Risk Stratification and Management of Patients with Nonalcoholic Fatty Liver Disease.
To learn more about the development of this publication, visit NASH.gastro.org.
GI societies push CMS for payment rules favorable for practices
As part of our longstanding collaboration and ongoing efforts on critical policy and payment issues impacting GI clinicians, AGA, the American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy submitted comments on proposed 2022 Medicare payments to physicians, ambulatory surgery centers (ASCs), and hospital outpatient departments to the CMS. We advocated for the following:
Increased and more accurate valuation for peroral endoscopic myotomy (POEM) and capsule endoscopy services.
Continued flexibility and payment parity for telehealth and telephone services.
Elimination of the secondary scalar for ASCs, which contributes to the widening differential in payments to ASCs compared to the hospital outpatient department.
You can access our letter here.
New patient care resource: NASH Clinical Care Pathway
The American Gastroenterological Association – in collaboration with seven professional associations – assembled a multidisciplinary taskforce of 15 experts to develop an action plan to develop a nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) Clinical Care Pathway providing practical guidance across multiple disciplines of care. The guidance ranges from screening and diagnosis to management of individuals with NAFLD and NASH, as well as facilitating value-based, efficient, and safe care that is consistent with evidence-based guidelines.
This clinical care pathway is intended to be applicable in any setting in which care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices.
Read the special report: Clinical Care Pathway for the Risk Stratification and Management of Patients with Nonalcoholic Fatty Liver Disease.
To learn more about the development of this publication, visit NASH.gastro.org.
GI societies push CMS for payment rules favorable for practices
As part of our longstanding collaboration and ongoing efforts on critical policy and payment issues impacting GI clinicians, AGA, the American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy submitted comments on proposed 2022 Medicare payments to physicians, ambulatory surgery centers (ASCs), and hospital outpatient departments to the CMS. We advocated for the following:
Increased and more accurate valuation for peroral endoscopic myotomy (POEM) and capsule endoscopy services.
Continued flexibility and payment parity for telehealth and telephone services.
Elimination of the secondary scalar for ASCs, which contributes to the widening differential in payments to ASCs compared to the hospital outpatient department.
You can access our letter here.