MDedge Psychiatry

Patients with migraine experienced about a 60% reduction in pain intensity and number of headache days per month after exposure to green light therapy, according to results of a small study from the University of Arizona, Tucson.

“This is the first clinical study to evaluate green light exposure as a potential preventive therapy for patients with migraine, “ senior author Mohab M. Ibrahim, MD, PhD, said in a press release. “Now I have another tool in my toolbox to treat one of the most difficult neurologic conditions – migraine.”

“Given the safety, affordability, and efficacy of green light exposure, there is merit to conduct a larger study,” he and coauthors from the university wrote in their paper.

The study included 29 adult patients (average age 52.2 years), 22 with chronic migraine and the rest with episodic migraine who were recruited from the University of Arizona/Banner Medical Center chronic pain clinic. To be included, patients had to meet the International Headache Society diagnostic criteria for chronic or episodic migraine, have an average headache pain intensity of 5 out of 10 or greater on the numeric pain scale (NPS) over the 10 weeks prior to enrolling in the study, and be dissatisfied with their current migraine therapy.

The patients were free to start, continue, or discontinue any other migraine treatments as recommended by their physicians as long as this was reported to the study team.
 

White versus green

The one-way crossover design involved exposure to 10 weeks of white light emitting diodes, for 1-2 hours per day, followed by a 2-week washout period and then 10 weeks’ exposure to green light emitting diodes (GLED) for the same daily duration. The protocol involved use of a light strip emitting an intensity of between 4 and 100 lux measured at approximately 2 m and 1 m from a lux meter.

Patients were instructed to use the light in a dark room, without falling asleep, and to participate in activities that did not require external light sources, such as listening to music, reading books, doing exercises, or engaging in similar activities. The daily minimum exposure of 1 hour, up to a maximum of 2 hours, was to be completed in one sitting.

The primary outcome measure was the number of headache days per month, defined as days with moderate to severe headache pain for at least 4 hours. Secondary outcomes included perceived reduction in duration and intensity of the headache phase of the migraine episodes assessed every 2 weeks with the NPS, improved ability to fall and stay asleep, improved ability to perform work and daily activity, improved quality of life, and reduction of pain medications.

The researchers found that when the patients with chronic migraine and episodic migraine were examined as separate groups, white light exposure did not significantly reduce the number of headache days per month, but when the chronic migraine and episodic migraine groups were combined there was a significant reduction from 18.2 to 16.5 headache days per month.

On the other hand, green light did result in significantly reduced headache days both in the separate (from 7.9 to 2.4 days in the episodic migraine group and 22.3 to 9.4 days in the chronic migraine group) and combined groups (from 18.4 to 7.4 days).

“While some improvement in secondary outcomes was observed with white light emitting diodes, more secondary outcomes with significantly greater magnitude including assessments of quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version of the EuroQol five-dimensional survey without reported side effects were observed with green light emitting diodes,” the authors reported.

“The use of a nonpharmacological therapy such as green light can be of tremendous help to a variety of patients that either do not want to be on medications or do not respond to them,” coauthor Amol M. Patwardhan, MD, PhD, said in the press release. “The beauty of this approach is the lack of associated side effects. If at all, it appears to improve sleep and other quality of life measures,” said Dr. Patwardhan, associate professor and vice chair of research in the University of Arizona’s department of anesthesiology.
 

Better than white light

Asked to comment on the findings, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said research has shown for some time that exposure to green light has beneficial effects in migraine patients. This study, although small, does indicate that green light is more beneficial than is white light and reduces headache days and intensity. “I believe patients would be willing to spend 1-2 hours a day in green light to reduce and improve their migraine with few side effects. A larger randomized trial should be done,” he said.

The study was funded by support from the National Center for Complementary and Integrative Health (to Dr. Ibrahim), the Comprehensive Chronic Pain and Addiction Center–University of Arizona, and the University of Arizona CHiLLI initiative. Dr. Ibrahim and one coauthor have a patent pending through the University of Arizona for use of green light therapy for the management of chronic pain. Dr. Rapoport is a former president of the International Headache Society. He is an editor of Headache and CNS Drugs, and Editor-in-Chief of Neurology Reviews. He reviews for many peer-reviewed journals such as Cephalalgia, Neurology, New England Journal of Medicine, and Headache.

Patients with migraine experienced about a 60% reduction in pain intensity and number of headache days per month after exposure to green light therapy, according to results of a small study from the University of Arizona, Tucson.

“This is the first clinical study to evaluate green light exposure as a potential preventive therapy for patients with migraine, “ senior author Mohab M. Ibrahim, MD, PhD, said in a press release. “Now I have another tool in my toolbox to treat one of the most difficult neurologic conditions – migraine.”

“Given the safety, affordability, and efficacy of green light exposure, there is merit to conduct a larger study,” he and coauthors from the university wrote in their paper.

The study included 29 adult patients (average age 52.2 years), 22 with chronic migraine and the rest with episodic migraine who were recruited from the University of Arizona/Banner Medical Center chronic pain clinic. To be included, patients had to meet the International Headache Society diagnostic criteria for chronic or episodic migraine, have an average headache pain intensity of 5 out of 10 or greater on the numeric pain scale (NPS) over the 10 weeks prior to enrolling in the study, and be dissatisfied with their current migraine therapy.

The patients were free to start, continue, or discontinue any other migraine treatments as recommended by their physicians as long as this was reported to the study team.
 

White versus green

The one-way crossover design involved exposure to 10 weeks of white light emitting diodes, for 1-2 hours per day, followed by a 2-week washout period and then 10 weeks’ exposure to green light emitting diodes (GLED) for the same daily duration. The protocol involved use of a light strip emitting an intensity of between 4 and 100 lux measured at approximately 2 m and 1 m from a lux meter.

Patients were instructed to use the light in a dark room, without falling asleep, and to participate in activities that did not require external light sources, such as listening to music, reading books, doing exercises, or engaging in similar activities. The daily minimum exposure of 1 hour, up to a maximum of 2 hours, was to be completed in one sitting.

The primary outcome measure was the number of headache days per month, defined as days with moderate to severe headache pain for at least 4 hours. Secondary outcomes included perceived reduction in duration and intensity of the headache phase of the migraine episodes assessed every 2 weeks with the NPS, improved ability to fall and stay asleep, improved ability to perform work and daily activity, improved quality of life, and reduction of pain medications.

The researchers found that when the patients with chronic migraine and episodic migraine were examined as separate groups, white light exposure did not significantly reduce the number of headache days per month, but when the chronic migraine and episodic migraine groups were combined there was a significant reduction from 18.2 to 16.5 headache days per month.

On the other hand, green light did result in significantly reduced headache days both in the separate (from 7.9 to 2.4 days in the episodic migraine group and 22.3 to 9.4 days in the chronic migraine group) and combined groups (from 18.4 to 7.4 days).

“While some improvement in secondary outcomes was observed with white light emitting diodes, more secondary outcomes with significantly greater magnitude including assessments of quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version of the EuroQol five-dimensional survey without reported side effects were observed with green light emitting diodes,” the authors reported.

“The use of a nonpharmacological therapy such as green light can be of tremendous help to a variety of patients that either do not want to be on medications or do not respond to them,” coauthor Amol M. Patwardhan, MD, PhD, said in the press release. “The beauty of this approach is the lack of associated side effects. If at all, it appears to improve sleep and other quality of life measures,” said Dr. Patwardhan, associate professor and vice chair of research in the University of Arizona’s department of anesthesiology.
 

Better than white light

Asked to comment on the findings, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said research has shown for some time that exposure to green light has beneficial effects in migraine patients. This study, although small, does indicate that green light is more beneficial than is white light and reduces headache days and intensity. “I believe patients would be willing to spend 1-2 hours a day in green light to reduce and improve their migraine with few side effects. A larger randomized trial should be done,” he said.

The study was funded by support from the National Center for Complementary and Integrative Health (to Dr. Ibrahim), the Comprehensive Chronic Pain and Addiction Center–University of Arizona, and the University of Arizona CHiLLI initiative. Dr. Ibrahim and one coauthor have a patent pending through the University of Arizona for use of green light therapy for the management of chronic pain. Dr. Rapoport is a former president of the International Headache Society. He is an editor of Headache and CNS Drugs, and Editor-in-Chief of Neurology Reviews. He reviews for many peer-reviewed journals such as Cephalalgia, Neurology, New England Journal of Medicine, and Headache.

Patients with migraine experienced about a 60% reduction in pain intensity and number of headache days per month after exposure to green light therapy, according to results of a small study from the University of Arizona, Tucson.

“This is the first clinical study to evaluate green light exposure as a potential preventive therapy for patients with migraine, “ senior author Mohab M. Ibrahim, MD, PhD, said in a press release. “Now I have another tool in my toolbox to treat one of the most difficult neurologic conditions – migraine.”

“Given the safety, affordability, and efficacy of green light exposure, there is merit to conduct a larger study,” he and coauthors from the university wrote in their paper.

The study included 29 adult patients (average age 52.2 years), 22 with chronic migraine and the rest with episodic migraine who were recruited from the University of Arizona/Banner Medical Center chronic pain clinic. To be included, patients had to meet the International Headache Society diagnostic criteria for chronic or episodic migraine, have an average headache pain intensity of 5 out of 10 or greater on the numeric pain scale (NPS) over the 10 weeks prior to enrolling in the study, and be dissatisfied with their current migraine therapy.

The patients were free to start, continue, or discontinue any other migraine treatments as recommended by their physicians as long as this was reported to the study team.
 

White versus green

The one-way crossover design involved exposure to 10 weeks of white light emitting diodes, for 1-2 hours per day, followed by a 2-week washout period and then 10 weeks’ exposure to green light emitting diodes (GLED) for the same daily duration. The protocol involved use of a light strip emitting an intensity of between 4 and 100 lux measured at approximately 2 m and 1 m from a lux meter.

Patients were instructed to use the light in a dark room, without falling asleep, and to participate in activities that did not require external light sources, such as listening to music, reading books, doing exercises, or engaging in similar activities. The daily minimum exposure of 1 hour, up to a maximum of 2 hours, was to be completed in one sitting.

The primary outcome measure was the number of headache days per month, defined as days with moderate to severe headache pain for at least 4 hours. Secondary outcomes included perceived reduction in duration and intensity of the headache phase of the migraine episodes assessed every 2 weeks with the NPS, improved ability to fall and stay asleep, improved ability to perform work and daily activity, improved quality of life, and reduction of pain medications.

The researchers found that when the patients with chronic migraine and episodic migraine were examined as separate groups, white light exposure did not significantly reduce the number of headache days per month, but when the chronic migraine and episodic migraine groups were combined there was a significant reduction from 18.2 to 16.5 headache days per month.

On the other hand, green light did result in significantly reduced headache days both in the separate (from 7.9 to 2.4 days in the episodic migraine group and 22.3 to 9.4 days in the chronic migraine group) and combined groups (from 18.4 to 7.4 days).

“While some improvement in secondary outcomes was observed with white light emitting diodes, more secondary outcomes with significantly greater magnitude including assessments of quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version of the EuroQol five-dimensional survey without reported side effects were observed with green light emitting diodes,” the authors reported.

“The use of a nonpharmacological therapy such as green light can be of tremendous help to a variety of patients that either do not want to be on medications or do not respond to them,” coauthor Amol M. Patwardhan, MD, PhD, said in the press release. “The beauty of this approach is the lack of associated side effects. If at all, it appears to improve sleep and other quality of life measures,” said Dr. Patwardhan, associate professor and vice chair of research in the University of Arizona’s department of anesthesiology.
 

Better than white light

Asked to comment on the findings, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said research has shown for some time that exposure to green light has beneficial effects in migraine patients. This study, although small, does indicate that green light is more beneficial than is white light and reduces headache days and intensity. “I believe patients would be willing to spend 1-2 hours a day in green light to reduce and improve their migraine with few side effects. A larger randomized trial should be done,” he said.

The study was funded by support from the National Center for Complementary and Integrative Health (to Dr. Ibrahim), the Comprehensive Chronic Pain and Addiction Center–University of Arizona, and the University of Arizona CHiLLI initiative. Dr. Ibrahim and one coauthor have a patent pending through the University of Arizona for use of green light therapy for the management of chronic pain. Dr. Rapoport is a former president of the International Headache Society. He is an editor of Headache and CNS Drugs, and Editor-in-Chief of Neurology Reviews. He reviews for many peer-reviewed journals such as Cephalalgia, Neurology, New England Journal of Medicine, and Headache.

The Food and Drug Administration has approved the nonstimulant medication viloxazine extended-release capsules (Qelbree, Supernus Pharmaceuticals) for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6-17 years, the company has announced.

Viloxazine (formerly SPN-812) is a selective norepinephrine reuptake inhibitor. Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce, as needed.

The approval of viloxazine is supported by data from four phase 3 clinical trials involving more than 1,000 pediatric patients aged 6-17 years, the company said.

In one randomized, placebo-controlled phase 3 study that included more than 400 children, viloxazine reduced symptoms of ADHD as soon as 1 week after dosing and was well tolerated.

As reported by this news organization, the study was published last July in Clinical Therapeutics.

In addition to its fast onset of action, the fact that it was effective for both inattentive and hyperactive/impulsive clusters of symptoms is “impressive,” study investigator Andrew Cutler, MD, clinical associate professor of psychiatry, SUNY Upstate Medical University, Syracuse, N.Y., said in an interview.

Also noteworthy was the improvement in measures of quality of life and function, “especially function in the areas of school, home life, family relations, and peer relationships, which can be really disrupted with ADHD,” Dr. Cutler said.

The prescribing label for viloxazine includes a boxed warning regarding the potential for suicidal thoughts and behaviors in some children with ADHD treated with the drug, especially within the first few months of treatment or when the dose is changed. 

In clinical trials, higher rates of suicidal thoughts and behavior were reported in pediatric patients treated with viloxazine than in patients treated with placebo. Patients taking viloxazine should be closely monitored for any new or sudden changes in mood, behavior, thoughts, and feelings.

Viloxazine has shown promise in a phase 3 trial involving adults with ADHD.

The company plans to submit a supplemental new drug application to the FDA for viloxazine in adults later this year.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the nonstimulant medication viloxazine extended-release capsules (Qelbree, Supernus Pharmaceuticals) for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6-17 years, the company has announced.

Viloxazine (formerly SPN-812) is a selective norepinephrine reuptake inhibitor. Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce, as needed.

The approval of viloxazine is supported by data from four phase 3 clinical trials involving more than 1,000 pediatric patients aged 6-17 years, the company said.

In one randomized, placebo-controlled phase 3 study that included more than 400 children, viloxazine reduced symptoms of ADHD as soon as 1 week after dosing and was well tolerated.

As reported by this news organization, the study was published last July in Clinical Therapeutics.

In addition to its fast onset of action, the fact that it was effective for both inattentive and hyperactive/impulsive clusters of symptoms is “impressive,” study investigator Andrew Cutler, MD, clinical associate professor of psychiatry, SUNY Upstate Medical University, Syracuse, N.Y., said in an interview.

Also noteworthy was the improvement in measures of quality of life and function, “especially function in the areas of school, home life, family relations, and peer relationships, which can be really disrupted with ADHD,” Dr. Cutler said.

The prescribing label for viloxazine includes a boxed warning regarding the potential for suicidal thoughts and behaviors in some children with ADHD treated with the drug, especially within the first few months of treatment or when the dose is changed. 

In clinical trials, higher rates of suicidal thoughts and behavior were reported in pediatric patients treated with viloxazine than in patients treated with placebo. Patients taking viloxazine should be closely monitored for any new or sudden changes in mood, behavior, thoughts, and feelings.

Viloxazine has shown promise in a phase 3 trial involving adults with ADHD.

The company plans to submit a supplemental new drug application to the FDA for viloxazine in adults later this year.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the nonstimulant medication viloxazine extended-release capsules (Qelbree, Supernus Pharmaceuticals) for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6-17 years, the company has announced.

Viloxazine (formerly SPN-812) is a selective norepinephrine reuptake inhibitor. Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce, as needed.

The approval of viloxazine is supported by data from four phase 3 clinical trials involving more than 1,000 pediatric patients aged 6-17 years, the company said.

In one randomized, placebo-controlled phase 3 study that included more than 400 children, viloxazine reduced symptoms of ADHD as soon as 1 week after dosing and was well tolerated.

As reported by this news organization, the study was published last July in Clinical Therapeutics.

In addition to its fast onset of action, the fact that it was effective for both inattentive and hyperactive/impulsive clusters of symptoms is “impressive,” study investigator Andrew Cutler, MD, clinical associate professor of psychiatry, SUNY Upstate Medical University, Syracuse, N.Y., said in an interview.

Also noteworthy was the improvement in measures of quality of life and function, “especially function in the areas of school, home life, family relations, and peer relationships, which can be really disrupted with ADHD,” Dr. Cutler said.

The prescribing label for viloxazine includes a boxed warning regarding the potential for suicidal thoughts and behaviors in some children with ADHD treated with the drug, especially within the first few months of treatment or when the dose is changed. 

In clinical trials, higher rates of suicidal thoughts and behavior were reported in pediatric patients treated with viloxazine than in patients treated with placebo. Patients taking viloxazine should be closely monitored for any new or sudden changes in mood, behavior, thoughts, and feelings.

Viloxazine has shown promise in a phase 3 trial involving adults with ADHD.

The company plans to submit a supplemental new drug application to the FDA for viloxazine in adults later this year.

A version of this article first appeared on Medscape.com.

A minimally invasive blood test along with artificial intelligence (AI) may flag early-stage Alzheimer’s disease, raising the prospect of early intervention when effective treatments become available.

In a study, investigators used six AI methodologies, including Deep Learning, to assess blood leukocyte epigenomic biomarkers. They found more than 150 genetic differences among study participants with Alzheimer’s disease in comparison with participants who did not have Alzheimer’s disease.

All of the AI platforms were effective in predicting Alzheimer’s disease. Deep Learning’s assessment of intragenic cytosine-phosphate-guanines (CpGs) had sensitivity and specificity rates of 97%.

“It’s almost as if the leukocytes have become a newspaper to tell us, ‘This is what is going on in the brain,’ “ lead author Ray Bahado-Singh, MD, chair of the department of obstetrics and gynecology, Oakland University, Auburn Hills, Mich., said in a news release.

The researchers noted that the findings, if replicated in future studies, may help in providing Alzheimer’s disease diagnoses “much earlier” in the disease process. “The holy grail is to identify patients in the preclinical stage so effective early interventions, including new medications, can be studied and ultimately used,” Dr. Bahado-Singh said.

“This certainly isn’t the final step in Alzheimer’s research, but I think this represents a significant change in direction,” he told attendees at a press briefing.

The findings were published online March 31 in PLOS ONE.
 

Silver tsunami

The investigators noted that Alzheimer’s disease is often diagnosed when the disease is in its later stages, after irreversible brain damage has occurred. “There is currently no cure for the disease, and the treatment is limited to drugs that attempt to treat symptoms and have little effect on the disease’s progression,” they noted.

Coinvestigator Khaled Imam, MD, director of geriatric medicine for Beaumont Health in Michigan, pointed out that although MRI and lumbar puncture can identify Alzheimer’s disease early on, the processes are expensive and/or invasive.

“Having biomarkers in the blood ... and being able to identify [Alzheimer’s disease] years before symptoms start, hopefully we’d be able to intervene early on in the process of the disease,” Dr. Imam said.

It is estimated that the number of Americans aged 85 and older will triple by 2050. This impending “silver tsunami,” which will come with a commensurate increase in Alzheimer’s disease cases, makes it even more important to be able to diagnose the disease early on, he noted.

The study included 24 individuals with late-onset Alzheimer’s disease (70.8% women; mean age, 83 years); 24 were deemed to be “cognitively healthy” (66.7% women; mean age, 80 years). About 500 ng of genomic DNA was extracted from whole-blood samples from each participant.

The researchers used the Infinium MethylationEPIC BeadChip array, and the samples were then examined for markers of methylation that would “indicate the disease process has started,” they noted.

In addition to Deep Learning, the five other AI platforms were the Support Vector Machine, Generalized Linear Model, Prediction Analysis for Microarrays, Random Forest, and Linear Discriminant Analysis.

These platforms were used to assess leukocyte genome changes. To predict Alzheimer’s disease, the researchers also used Ingenuity Pathway Analysis.
 

Significant “chemical changes”

Results showed that the Alzheimer’s disease group had 152 significantly differentially methylated CpGs in 171 genes in comparison with the non-Alzheimer’s disease group (false discovery rate P value < .05).

As a whole, using intragenic and intergenic/extragenic CpGs, the AI platforms were effective in predicting who had Alzheimer’s disease (area under the curve [AUC], ≥ 0.93). Using intragenic markers, the AUC for Deep Learning was 0.99.

“We looked at close to a million different sites, and we saw some chemical changes that we know are associated with alteration or change in gene function,” Dr. Bahado-Singh said.

Altered genes that were found in the Alzheimer’s disease group included CR1L, CTSV, S1PR1, and LTB4R – all of which “have been previously linked with Alzheimer’s disease and dementia,” the researchers noted. They also found the methylated genes CTSV and PRMT5, both of which have been previously associated with cardiovascular disease.

“A significant strength of our study is the novelty, i.e. the use of blood leukocytes to accurately detect Alzheimer’s disease and also for interrogating the pathogenesis of Alzheimer’s disease,” the investigators wrote.

Dr. Bahado-Singh said that the test let them identify changes in cells in the blood, “giving us a comprehensive account not only of the fact that the brain is being affected by Alzheimer’s disease but it’s telling us what kinds of processes are going on in the brain.

“Normally you don’t have access to the brain. This gives us a simple blood test to get an ongoing reading of the course of events in the brain – and potentially tell us very early on before the onset of symptoms,” he added.
 

Cautiously optimistic

During the question-and-answer session following his presentation at the briefing, Dr. Bahado-Singh reiterated that they are at a very early stage in the research and were not able to make clinical recommendations at this point. However, he added, “There was evidence that DNA methylation change could likely precede the onset of abnormalities in the cells that give rise to the disease.”

Coinvestigator Stewart Graham, PhD, director of Alzheimer’s research at Beaumont Health, added that although the initial study findings led to some excitement for the team, “we have to be very conservative with what we say.”

He noted that the findings need to be replicated in a more diverse population. Still, “we’re excited at the moment and looking forward to seeing what the future results hold,” Dr. Graham said.

Dr. Bahado-Singh said that if larger studies confirm the findings and the test is viable, it would make sense to use it as a screen for individuals older than 65. He noted that because of the aging of the population, “this subset of individuals will constitute a larger and larger fraction of the population globally.”
 

Still early days

Commenting on the findings, Heather Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, noted that the investigators used an “interesting” diagnostic process.

“It was a unique approach to looking at and trying to understand what might be some of the biological underpinnings and using these tools and technologies to determine if they’re able to differentiate individuals with Alzheimer’s disease” from those without Alzheimer’s disease, said Dr. Snyder, who was not involved with the research.

“Ultimately, we want to know who is at greater risk, who may have some of the changing biology at the earliest time point so that we can intervene to stop the progression of the disease,” she said.

She pointed out that a number of types of biomarker tests are currently under investigation, many of which are measuring different outcomes. “And that’s what we want to see going forward. We want to have as many tools in our toolbox that allow us to accurately diagnose at that earliest time point,” Dr. Snyder said.

“At this point, [the current study] is still pretty early, so it needs to be replicated and then expanded to larger groups to really understand what they may be seeing,” she added.

Dr. Bahado-Singh, Dr. Imam, Dr. Graham, and Dr. Snyder have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A minimally invasive blood test along with artificial intelligence (AI) may flag early-stage Alzheimer’s disease, raising the prospect of early intervention when effective treatments become available.

In a study, investigators used six AI methodologies, including Deep Learning, to assess blood leukocyte epigenomic biomarkers. They found more than 150 genetic differences among study participants with Alzheimer’s disease in comparison with participants who did not have Alzheimer’s disease.

All of the AI platforms were effective in predicting Alzheimer’s disease. Deep Learning’s assessment of intragenic cytosine-phosphate-guanines (CpGs) had sensitivity and specificity rates of 97%.

“It’s almost as if the leukocytes have become a newspaper to tell us, ‘This is what is going on in the brain,’ “ lead author Ray Bahado-Singh, MD, chair of the department of obstetrics and gynecology, Oakland University, Auburn Hills, Mich., said in a news release.

The researchers noted that the findings, if replicated in future studies, may help in providing Alzheimer’s disease diagnoses “much earlier” in the disease process. “The holy grail is to identify patients in the preclinical stage so effective early interventions, including new medications, can be studied and ultimately used,” Dr. Bahado-Singh said.

“This certainly isn’t the final step in Alzheimer’s research, but I think this represents a significant change in direction,” he told attendees at a press briefing.

The findings were published online March 31 in PLOS ONE.
 

Silver tsunami

The investigators noted that Alzheimer’s disease is often diagnosed when the disease is in its later stages, after irreversible brain damage has occurred. “There is currently no cure for the disease, and the treatment is limited to drugs that attempt to treat symptoms and have little effect on the disease’s progression,” they noted.

Coinvestigator Khaled Imam, MD, director of geriatric medicine for Beaumont Health in Michigan, pointed out that although MRI and lumbar puncture can identify Alzheimer’s disease early on, the processes are expensive and/or invasive.

“Having biomarkers in the blood ... and being able to identify [Alzheimer’s disease] years before symptoms start, hopefully we’d be able to intervene early on in the process of the disease,” Dr. Imam said.

It is estimated that the number of Americans aged 85 and older will triple by 2050. This impending “silver tsunami,” which will come with a commensurate increase in Alzheimer’s disease cases, makes it even more important to be able to diagnose the disease early on, he noted.

The study included 24 individuals with late-onset Alzheimer’s disease (70.8% women; mean age, 83 years); 24 were deemed to be “cognitively healthy” (66.7% women; mean age, 80 years). About 500 ng of genomic DNA was extracted from whole-blood samples from each participant.

The researchers used the Infinium MethylationEPIC BeadChip array, and the samples were then examined for markers of methylation that would “indicate the disease process has started,” they noted.

In addition to Deep Learning, the five other AI platforms were the Support Vector Machine, Generalized Linear Model, Prediction Analysis for Microarrays, Random Forest, and Linear Discriminant Analysis.

These platforms were used to assess leukocyte genome changes. To predict Alzheimer’s disease, the researchers also used Ingenuity Pathway Analysis.
 

Significant “chemical changes”

Results showed that the Alzheimer’s disease group had 152 significantly differentially methylated CpGs in 171 genes in comparison with the non-Alzheimer’s disease group (false discovery rate P value < .05).

As a whole, using intragenic and intergenic/extragenic CpGs, the AI platforms were effective in predicting who had Alzheimer’s disease (area under the curve [AUC], ≥ 0.93). Using intragenic markers, the AUC for Deep Learning was 0.99.

“We looked at close to a million different sites, and we saw some chemical changes that we know are associated with alteration or change in gene function,” Dr. Bahado-Singh said.

Altered genes that were found in the Alzheimer’s disease group included CR1L, CTSV, S1PR1, and LTB4R – all of which “have been previously linked with Alzheimer’s disease and dementia,” the researchers noted. They also found the methylated genes CTSV and PRMT5, both of which have been previously associated with cardiovascular disease.

“A significant strength of our study is the novelty, i.e. the use of blood leukocytes to accurately detect Alzheimer’s disease and also for interrogating the pathogenesis of Alzheimer’s disease,” the investigators wrote.

Dr. Bahado-Singh said that the test let them identify changes in cells in the blood, “giving us a comprehensive account not only of the fact that the brain is being affected by Alzheimer’s disease but it’s telling us what kinds of processes are going on in the brain.

“Normally you don’t have access to the brain. This gives us a simple blood test to get an ongoing reading of the course of events in the brain – and potentially tell us very early on before the onset of symptoms,” he added.
 

Cautiously optimistic

During the question-and-answer session following his presentation at the briefing, Dr. Bahado-Singh reiterated that they are at a very early stage in the research and were not able to make clinical recommendations at this point. However, he added, “There was evidence that DNA methylation change could likely precede the onset of abnormalities in the cells that give rise to the disease.”

Coinvestigator Stewart Graham, PhD, director of Alzheimer’s research at Beaumont Health, added that although the initial study findings led to some excitement for the team, “we have to be very conservative with what we say.”

He noted that the findings need to be replicated in a more diverse population. Still, “we’re excited at the moment and looking forward to seeing what the future results hold,” Dr. Graham said.

Dr. Bahado-Singh said that if larger studies confirm the findings and the test is viable, it would make sense to use it as a screen for individuals older than 65. He noted that because of the aging of the population, “this subset of individuals will constitute a larger and larger fraction of the population globally.”
 

Still early days

Commenting on the findings, Heather Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, noted that the investigators used an “interesting” diagnostic process.

“It was a unique approach to looking at and trying to understand what might be some of the biological underpinnings and using these tools and technologies to determine if they’re able to differentiate individuals with Alzheimer’s disease” from those without Alzheimer’s disease, said Dr. Snyder, who was not involved with the research.

“Ultimately, we want to know who is at greater risk, who may have some of the changing biology at the earliest time point so that we can intervene to stop the progression of the disease,” she said.

She pointed out that a number of types of biomarker tests are currently under investigation, many of which are measuring different outcomes. “And that’s what we want to see going forward. We want to have as many tools in our toolbox that allow us to accurately diagnose at that earliest time point,” Dr. Snyder said.

“At this point, [the current study] is still pretty early, so it needs to be replicated and then expanded to larger groups to really understand what they may be seeing,” she added.

Dr. Bahado-Singh, Dr. Imam, Dr. Graham, and Dr. Snyder have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A minimally invasive blood test along with artificial intelligence (AI) may flag early-stage Alzheimer’s disease, raising the prospect of early intervention when effective treatments become available.

In a study, investigators used six AI methodologies, including Deep Learning, to assess blood leukocyte epigenomic biomarkers. They found more than 150 genetic differences among study participants with Alzheimer’s disease in comparison with participants who did not have Alzheimer’s disease.

All of the AI platforms were effective in predicting Alzheimer’s disease. Deep Learning’s assessment of intragenic cytosine-phosphate-guanines (CpGs) had sensitivity and specificity rates of 97%.

“It’s almost as if the leukocytes have become a newspaper to tell us, ‘This is what is going on in the brain,’ “ lead author Ray Bahado-Singh, MD, chair of the department of obstetrics and gynecology, Oakland University, Auburn Hills, Mich., said in a news release.

The researchers noted that the findings, if replicated in future studies, may help in providing Alzheimer’s disease diagnoses “much earlier” in the disease process. “The holy grail is to identify patients in the preclinical stage so effective early interventions, including new medications, can be studied and ultimately used,” Dr. Bahado-Singh said.

“This certainly isn’t the final step in Alzheimer’s research, but I think this represents a significant change in direction,” he told attendees at a press briefing.

The findings were published online March 31 in PLOS ONE.
 

Silver tsunami

The investigators noted that Alzheimer’s disease is often diagnosed when the disease is in its later stages, after irreversible brain damage has occurred. “There is currently no cure for the disease, and the treatment is limited to drugs that attempt to treat symptoms and have little effect on the disease’s progression,” they noted.

Coinvestigator Khaled Imam, MD, director of geriatric medicine for Beaumont Health in Michigan, pointed out that although MRI and lumbar puncture can identify Alzheimer’s disease early on, the processes are expensive and/or invasive.

“Having biomarkers in the blood ... and being able to identify [Alzheimer’s disease] years before symptoms start, hopefully we’d be able to intervene early on in the process of the disease,” Dr. Imam said.

It is estimated that the number of Americans aged 85 and older will triple by 2050. This impending “silver tsunami,” which will come with a commensurate increase in Alzheimer’s disease cases, makes it even more important to be able to diagnose the disease early on, he noted.

The study included 24 individuals with late-onset Alzheimer’s disease (70.8% women; mean age, 83 years); 24 were deemed to be “cognitively healthy” (66.7% women; mean age, 80 years). About 500 ng of genomic DNA was extracted from whole-blood samples from each participant.

The researchers used the Infinium MethylationEPIC BeadChip array, and the samples were then examined for markers of methylation that would “indicate the disease process has started,” they noted.

In addition to Deep Learning, the five other AI platforms were the Support Vector Machine, Generalized Linear Model, Prediction Analysis for Microarrays, Random Forest, and Linear Discriminant Analysis.

These platforms were used to assess leukocyte genome changes. To predict Alzheimer’s disease, the researchers also used Ingenuity Pathway Analysis.
 

Significant “chemical changes”

Results showed that the Alzheimer’s disease group had 152 significantly differentially methylated CpGs in 171 genes in comparison with the non-Alzheimer’s disease group (false discovery rate P value < .05).

As a whole, using intragenic and intergenic/extragenic CpGs, the AI platforms were effective in predicting who had Alzheimer’s disease (area under the curve [AUC], ≥ 0.93). Using intragenic markers, the AUC for Deep Learning was 0.99.

“We looked at close to a million different sites, and we saw some chemical changes that we know are associated with alteration or change in gene function,” Dr. Bahado-Singh said.

Altered genes that were found in the Alzheimer’s disease group included CR1L, CTSV, S1PR1, and LTB4R – all of which “have been previously linked with Alzheimer’s disease and dementia,” the researchers noted. They also found the methylated genes CTSV and PRMT5, both of which have been previously associated with cardiovascular disease.

“A significant strength of our study is the novelty, i.e. the use of blood leukocytes to accurately detect Alzheimer’s disease and also for interrogating the pathogenesis of Alzheimer’s disease,” the investigators wrote.

Dr. Bahado-Singh said that the test let them identify changes in cells in the blood, “giving us a comprehensive account not only of the fact that the brain is being affected by Alzheimer’s disease but it’s telling us what kinds of processes are going on in the brain.

“Normally you don’t have access to the brain. This gives us a simple blood test to get an ongoing reading of the course of events in the brain – and potentially tell us very early on before the onset of symptoms,” he added.
 

Cautiously optimistic

During the question-and-answer session following his presentation at the briefing, Dr. Bahado-Singh reiterated that they are at a very early stage in the research and were not able to make clinical recommendations at this point. However, he added, “There was evidence that DNA methylation change could likely precede the onset of abnormalities in the cells that give rise to the disease.”

Coinvestigator Stewart Graham, PhD, director of Alzheimer’s research at Beaumont Health, added that although the initial study findings led to some excitement for the team, “we have to be very conservative with what we say.”

He noted that the findings need to be replicated in a more diverse population. Still, “we’re excited at the moment and looking forward to seeing what the future results hold,” Dr. Graham said.

Dr. Bahado-Singh said that if larger studies confirm the findings and the test is viable, it would make sense to use it as a screen for individuals older than 65. He noted that because of the aging of the population, “this subset of individuals will constitute a larger and larger fraction of the population globally.”
 

Still early days

Commenting on the findings, Heather Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, noted that the investigators used an “interesting” diagnostic process.

“It was a unique approach to looking at and trying to understand what might be some of the biological underpinnings and using these tools and technologies to determine if they’re able to differentiate individuals with Alzheimer’s disease” from those without Alzheimer’s disease, said Dr. Snyder, who was not involved with the research.

“Ultimately, we want to know who is at greater risk, who may have some of the changing biology at the earliest time point so that we can intervene to stop the progression of the disease,” she said.

She pointed out that a number of types of biomarker tests are currently under investigation, many of which are measuring different outcomes. “And that’s what we want to see going forward. We want to have as many tools in our toolbox that allow us to accurately diagnose at that earliest time point,” Dr. Snyder said.

“At this point, [the current study] is still pretty early, so it needs to be replicated and then expanded to larger groups to really understand what they may be seeing,” she added.

Dr. Bahado-Singh, Dr. Imam, Dr. Graham, and Dr. Snyder have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Exhaustion, numbness, dissociation, and most notably, anger are my emotional response when viewing the video of George Floyd’s death. The homicide trial of former Minneapolis police officer Derek Chauvin activates the shared stress of those who experienced intergenerational trauma and the legacy of racism in the United States of America.

On May 25, 2020, Mr. Floyd died after Derek Chauvin used a lethal maneuver and placed his knee on Mr. Floyd’s neck for 9 minutes and 29 seconds. Mr. Floyd has died physically, but his death is replayed through high-definition social media daily, if not hourly, as I write this article and think of the generational legacy of trauma that African Americans must cope with on an everyday basis. I struggle daily to explain this legacy to my daughters, students, residents, and colleagues. I hope to share with you some of my perspectives on the current trial and give you some insight as to how my training and personal life experience have affected my views on police brutality and the use of lethal force toward African American men.

My earliest recollection of public video-recorded images of police brutality occurred when Rodney King was beaten and assaulted by the Los Angeles Police Department on March 3, 1991. At that time, I was a senior in high school, and the world was different. My clear expectation was that any attempt to resist police arrest would be met with overwhelming and potentially lethal force. This was simply a matter of my daily reality, so, while witnessing the assault of Mr. King, the 17-year-old child didn’t expect much, if any, real change to come about in regard to police brutality. At that time, my mother kept me focused on one singular goal – becoming a physician – and protected me as best she could from the effects of intergenerational trauma woven into the African American experience.

The issue of police brutality and police-involved deaths has been recognized as a significant public health concern for some time. Over the 3 decades since the assault on Mr. King, several researchers have examined these issues. A review of all the research is beyond the scope of this opinion piece. Still, I will highlight a study that I believe illustrates some conclusions scholars have come to regarding police use of lethal force and subsequent mortality in African American men. A recent study by Frank Edwards, PhD, and colleagues, published in the Proceedings of the National Academy of Sciences, showed that Black men were 2.5 times more likely to be killed by police over their life course than White men.

The researchers also developed predictive models that about 1 in 1,000 Black men and boys will be killed by police over their life course, and that among all age groups Black men and boys face the highest lifetime risk. The authors concluded that “Our analysis shows that the risk of being killed by police is jointly patterned by one’s race, gender, and age. Police violence is a leading cause of death for young men, and young men of color face an exceptionally high risk of being killed by police. Inequalities in risk are pronounced throughout the life course. This study reinforces calls to treat police violence as a public health issue.”

Research such as this helps validate on a visceral level what I already was taught: “As a Black male, encounters with police can quickly become deadly, and you must remain calm, or you could die.” This thought process informed much of my thinking whenever I heard about a Black male being fatally shot by police. My first response was to ask, “Was he resisting arrest?” At this time, my naive impression was that “if you don’t resist or conflict, you’ll live.” It wasn’t until my training in psychiatry that I realized that the duty to calm, support, and most importantly, protect was the responsibility of the person who is given the trust of the public. As a psychiatrist, I am humbled by the trust the public places in physicians to restrain patients and take part in their involuntary hospitalizations. Over the years, I learned from my attending physicians, colleagues in security, social work, nursing, assertive community treatment (ACT) teams, and many other allied health professions that the responsibility to show restraint, calm, and compassion lies with those who have the power and trust of the public.

Mostly, I learned from my patients. They taught me to meet distress with compassion and humanity and not simply with force. With those lessons in mind, I now fast forward to July 17, 2014, and the death of Eric Garner. On July 17, New York Police Department officers approached Mr. Garner on the suspicion that he was selling loose cigarettes. Amid this encounter, Mr. Garner was subjected to a chokehold, and his face was pinned to the ground while he can be heard saying, “I can’t breathe.” At this time in my professional career, I had just become a dean of student affairs at the George Washington School of Medicine and Health Sciences. I can still remember the response of my minority students, and the sense of pain and anguish they felt watching the video of a chokehold being used on a man stating, “I can’t breathe.” At this point, my training would not allow me to see this as anything other than an unnecessary use of lethal force that would subsequently be ruled a homicide. I hoped that we as a nation had reached a “reckoning “ because of Mr. Garner’s death and Michael Brown Jr.’s subsequent death in Ferguson, Mo., in St. Louis County, on Aug. 9, 2014. I hoped we were ready to finally address police brutality and excessive use of force that had disproportionately affected Black men. I was utterly wrong. Black men such as Alton Sterling, Jamar Clark, and many others would die in fatal police encounters. So would Tamir Rice, who was 12 years old when he was shot and killed by a police officer.

This brings me back to the death of Mr. Floyd. As I listened to the witnesses’ testimony, it triggered an emotional response from sadness, fear, shock, but mostly anger. Some would consider it progress that the Minneapolis Police Department’s top homicide detective testified that kneeling on Mr. Floyd’s neck after he had been restrained was “unnecessary.” The officer stated, “If your knee is on someone’s neck, that could kill him.” While I acknowledge this is a form of progress, we must ultimately address the other “substantial causal factor of death” for Mr. Floyd. Namely, the systemic racism present in a criminal justice system in the form of policies and procedures that allow for continued racial disparities and inequities.

There will be coverage of the court proceedings and a detailed dissection of the legal arguments. Questions regarding Mr. Floyd’s physical health and struggle with opiate use disorder will be raised by the defense. The debate about the substantial causal factor will be played out in the court and the media. Ultimately, we, as health professionals, need to ask ourselves, “Who has the power and the duty to do no harm?”

Dr. Norris is associate dean of student affairs and administration at George Washington University, Washington. He has no disclosures.

Exhaustion, numbness, dissociation, and most notably, anger are my emotional response when viewing the video of George Floyd’s death. The homicide trial of former Minneapolis police officer Derek Chauvin activates the shared stress of those who experienced intergenerational trauma and the legacy of racism in the United States of America.

On May 25, 2020, Mr. Floyd died after Derek Chauvin used a lethal maneuver and placed his knee on Mr. Floyd’s neck for 9 minutes and 29 seconds. Mr. Floyd has died physically, but his death is replayed through high-definition social media daily, if not hourly, as I write this article and think of the generational legacy of trauma that African Americans must cope with on an everyday basis. I struggle daily to explain this legacy to my daughters, students, residents, and colleagues. I hope to share with you some of my perspectives on the current trial and give you some insight as to how my training and personal life experience have affected my views on police brutality and the use of lethal force toward African American men.

My earliest recollection of public video-recorded images of police brutality occurred when Rodney King was beaten and assaulted by the Los Angeles Police Department on March 3, 1991. At that time, I was a senior in high school, and the world was different. My clear expectation was that any attempt to resist police arrest would be met with overwhelming and potentially lethal force. This was simply a matter of my daily reality, so, while witnessing the assault of Mr. King, the 17-year-old child didn’t expect much, if any, real change to come about in regard to police brutality. At that time, my mother kept me focused on one singular goal – becoming a physician – and protected me as best she could from the effects of intergenerational trauma woven into the African American experience.

The issue of police brutality and police-involved deaths has been recognized as a significant public health concern for some time. Over the 3 decades since the assault on Mr. King, several researchers have examined these issues. A review of all the research is beyond the scope of this opinion piece. Still, I will highlight a study that I believe illustrates some conclusions scholars have come to regarding police use of lethal force and subsequent mortality in African American men. A recent study by Frank Edwards, PhD, and colleagues, published in the Proceedings of the National Academy of Sciences, showed that Black men were 2.5 times more likely to be killed by police over their life course than White men.

The researchers also developed predictive models that about 1 in 1,000 Black men and boys will be killed by police over their life course, and that among all age groups Black men and boys face the highest lifetime risk. The authors concluded that “Our analysis shows that the risk of being killed by police is jointly patterned by one’s race, gender, and age. Police violence is a leading cause of death for young men, and young men of color face an exceptionally high risk of being killed by police. Inequalities in risk are pronounced throughout the life course. This study reinforces calls to treat police violence as a public health issue.”

Research such as this helps validate on a visceral level what I already was taught: “As a Black male, encounters with police can quickly become deadly, and you must remain calm, or you could die.” This thought process informed much of my thinking whenever I heard about a Black male being fatally shot by police. My first response was to ask, “Was he resisting arrest?” At this time, my naive impression was that “if you don’t resist or conflict, you’ll live.” It wasn’t until my training in psychiatry that I realized that the duty to calm, support, and most importantly, protect was the responsibility of the person who is given the trust of the public. As a psychiatrist, I am humbled by the trust the public places in physicians to restrain patients and take part in their involuntary hospitalizations. Over the years, I learned from my attending physicians, colleagues in security, social work, nursing, assertive community treatment (ACT) teams, and many other allied health professions that the responsibility to show restraint, calm, and compassion lies with those who have the power and trust of the public.

Mostly, I learned from my patients. They taught me to meet distress with compassion and humanity and not simply with force. With those lessons in mind, I now fast forward to July 17, 2014, and the death of Eric Garner. On July 17, New York Police Department officers approached Mr. Garner on the suspicion that he was selling loose cigarettes. Amid this encounter, Mr. Garner was subjected to a chokehold, and his face was pinned to the ground while he can be heard saying, “I can’t breathe.” At this time in my professional career, I had just become a dean of student affairs at the George Washington School of Medicine and Health Sciences. I can still remember the response of my minority students, and the sense of pain and anguish they felt watching the video of a chokehold being used on a man stating, “I can’t breathe.” At this point, my training would not allow me to see this as anything other than an unnecessary use of lethal force that would subsequently be ruled a homicide. I hoped that we as a nation had reached a “reckoning “ because of Mr. Garner’s death and Michael Brown Jr.’s subsequent death in Ferguson, Mo., in St. Louis County, on Aug. 9, 2014. I hoped we were ready to finally address police brutality and excessive use of force that had disproportionately affected Black men. I was utterly wrong. Black men such as Alton Sterling, Jamar Clark, and many others would die in fatal police encounters. So would Tamir Rice, who was 12 years old when he was shot and killed by a police officer.

This brings me back to the death of Mr. Floyd. As I listened to the witnesses’ testimony, it triggered an emotional response from sadness, fear, shock, but mostly anger. Some would consider it progress that the Minneapolis Police Department’s top homicide detective testified that kneeling on Mr. Floyd’s neck after he had been restrained was “unnecessary.” The officer stated, “If your knee is on someone’s neck, that could kill him.” While I acknowledge this is a form of progress, we must ultimately address the other “substantial causal factor of death” for Mr. Floyd. Namely, the systemic racism present in a criminal justice system in the form of policies and procedures that allow for continued racial disparities and inequities.

There will be coverage of the court proceedings and a detailed dissection of the legal arguments. Questions regarding Mr. Floyd’s physical health and struggle with opiate use disorder will be raised by the defense. The debate about the substantial causal factor will be played out in the court and the media. Ultimately, we, as health professionals, need to ask ourselves, “Who has the power and the duty to do no harm?”

Dr. Norris is associate dean of student affairs and administration at George Washington University, Washington. He has no disclosures.

Exhaustion, numbness, dissociation, and most notably, anger are my emotional response when viewing the video of George Floyd’s death. The homicide trial of former Minneapolis police officer Derek Chauvin activates the shared stress of those who experienced intergenerational trauma and the legacy of racism in the United States of America.

On May 25, 2020, Mr. Floyd died after Derek Chauvin used a lethal maneuver and placed his knee on Mr. Floyd’s neck for 9 minutes and 29 seconds. Mr. Floyd has died physically, but his death is replayed through high-definition social media daily, if not hourly, as I write this article and think of the generational legacy of trauma that African Americans must cope with on an everyday basis. I struggle daily to explain this legacy to my daughters, students, residents, and colleagues. I hope to share with you some of my perspectives on the current trial and give you some insight as to how my training and personal life experience have affected my views on police brutality and the use of lethal force toward African American men.

My earliest recollection of public video-recorded images of police brutality occurred when Rodney King was beaten and assaulted by the Los Angeles Police Department on March 3, 1991. At that time, I was a senior in high school, and the world was different. My clear expectation was that any attempt to resist police arrest would be met with overwhelming and potentially lethal force. This was simply a matter of my daily reality, so, while witnessing the assault of Mr. King, the 17-year-old child didn’t expect much, if any, real change to come about in regard to police brutality. At that time, my mother kept me focused on one singular goal – becoming a physician – and protected me as best she could from the effects of intergenerational trauma woven into the African American experience.

The issue of police brutality and police-involved deaths has been recognized as a significant public health concern for some time. Over the 3 decades since the assault on Mr. King, several researchers have examined these issues. A review of all the research is beyond the scope of this opinion piece. Still, I will highlight a study that I believe illustrates some conclusions scholars have come to regarding police use of lethal force and subsequent mortality in African American men. A recent study by Frank Edwards, PhD, and colleagues, published in the Proceedings of the National Academy of Sciences, showed that Black men were 2.5 times more likely to be killed by police over their life course than White men.

The researchers also developed predictive models that about 1 in 1,000 Black men and boys will be killed by police over their life course, and that among all age groups Black men and boys face the highest lifetime risk. The authors concluded that “Our analysis shows that the risk of being killed by police is jointly patterned by one’s race, gender, and age. Police violence is a leading cause of death for young men, and young men of color face an exceptionally high risk of being killed by police. Inequalities in risk are pronounced throughout the life course. This study reinforces calls to treat police violence as a public health issue.”

Research such as this helps validate on a visceral level what I already was taught: “As a Black male, encounters with police can quickly become deadly, and you must remain calm, or you could die.” This thought process informed much of my thinking whenever I heard about a Black male being fatally shot by police. My first response was to ask, “Was he resisting arrest?” At this time, my naive impression was that “if you don’t resist or conflict, you’ll live.” It wasn’t until my training in psychiatry that I realized that the duty to calm, support, and most importantly, protect was the responsibility of the person who is given the trust of the public. As a psychiatrist, I am humbled by the trust the public places in physicians to restrain patients and take part in their involuntary hospitalizations. Over the years, I learned from my attending physicians, colleagues in security, social work, nursing, assertive community treatment (ACT) teams, and many other allied health professions that the responsibility to show restraint, calm, and compassion lies with those who have the power and trust of the public.

Mostly, I learned from my patients. They taught me to meet distress with compassion and humanity and not simply with force. With those lessons in mind, I now fast forward to July 17, 2014, and the death of Eric Garner. On July 17, New York Police Department officers approached Mr. Garner on the suspicion that he was selling loose cigarettes. Amid this encounter, Mr. Garner was subjected to a chokehold, and his face was pinned to the ground while he can be heard saying, “I can’t breathe.” At this time in my professional career, I had just become a dean of student affairs at the George Washington School of Medicine and Health Sciences. I can still remember the response of my minority students, and the sense of pain and anguish they felt watching the video of a chokehold being used on a man stating, “I can’t breathe.” At this point, my training would not allow me to see this as anything other than an unnecessary use of lethal force that would subsequently be ruled a homicide. I hoped that we as a nation had reached a “reckoning “ because of Mr. Garner’s death and Michael Brown Jr.’s subsequent death in Ferguson, Mo., in St. Louis County, on Aug. 9, 2014. I hoped we were ready to finally address police brutality and excessive use of force that had disproportionately affected Black men. I was utterly wrong. Black men such as Alton Sterling, Jamar Clark, and many others would die in fatal police encounters. So would Tamir Rice, who was 12 years old when he was shot and killed by a police officer.

This brings me back to the death of Mr. Floyd. As I listened to the witnesses’ testimony, it triggered an emotional response from sadness, fear, shock, but mostly anger. Some would consider it progress that the Minneapolis Police Department’s top homicide detective testified that kneeling on Mr. Floyd’s neck after he had been restrained was “unnecessary.” The officer stated, “If your knee is on someone’s neck, that could kill him.” While I acknowledge this is a form of progress, we must ultimately address the other “substantial causal factor of death” for Mr. Floyd. Namely, the systemic racism present in a criminal justice system in the form of policies and procedures that allow for continued racial disparities and inequities.

There will be coverage of the court proceedings and a detailed dissection of the legal arguments. Questions regarding Mr. Floyd’s physical health and struggle with opiate use disorder will be raised by the defense. The debate about the substantial causal factor will be played out in the court and the media. Ultimately, we, as health professionals, need to ask ourselves, “Who has the power and the duty to do no harm?”

Dr. Norris is associate dean of student affairs and administration at George Washington University, Washington. He has no disclosures.

The United States saw nearly 23% more deaths than expected during the first 9 months of the pandemic, and almost three-quarters of those deaths involved COVID-19.

For comparison, the death rate increased by 2.5% or less annually in recent years.

At the same time, rates of deaths from heart disease, Alzheimer’s disease or dementia, and diabetes also increased from March 1, 2020, to Jan. 2, 2021, especially during COVID-19 surges.

“Excess deaths surged in the east in April, followed by extended summer and early winter surges concentrated in Southern and Western states, respectively. Many of these states weakly embraced, or discouraged, pandemic control measures and lifted restrictions earlier than other states,” lead author Steven H. Woolf, MD, MPH, from the Virginia Commonwealth University, Richmond, and colleagues wrote in a research letter published online April 2, 2021, in JAMA.

COVID-19 mortality included all deaths for which it was cited as an underlying or contributing cause in records from the District of Columbia and 49 states. North Carolina was excluded for insufficient data.
 

More than half a million excess deaths

Between March 1, 2020, and Jan. 2, 2021, the United States experienced 2,801,439 deaths, or 522,368 excess deaths. A total 72.4% of these events were attributed to COVID-19.

Not all racial and ethnic groups were equally represented. For example, the rate of excess deaths was higher among non-Hispanic Black populations, at 208.4 deaths per 100,000. Non-Hispanic White populations experienced 157 deaths per 100,000, and Hispanic populations experienced 139.8 deaths per 100,000.

Further, non-Hispanic Black individuals accounted for 16.9% of the excess deaths but only 12.5% of the U.S. population, which reflects “racial disparities in COVID-19 mortality,” the authors noted.

Not adjusting for population aging is a potential limitation, as was reliance on provisional data and the likelihood that some death certificates were inaccurate.

In February, Anthony S. Fauci, MD, chief medical adviser to President Joe Biden, stated that political divisions likely played a role in the 500,000-plus COVID-19–related deaths in the United States. 

Then a report came out on March 26 indicating that a different U.S. response to the pandemic could have avoided almost 400,000 COVID-19 deaths. In addition, an April 1 study in the CDC’s Morbidity and Mortality Weekly Report revealed that COVID-19 is now the third leading cause of death in the United States, after heart disease and cancer.
 

‘Massive’ excessive mortality

“There is no more visible or alarming manifestation of the toll of the COVID-19 pandemic than the deaths it has caused. In this issue of JAMA, Dr. Woolf and colleagues provide updated analyses that demonstrate that the excess mortality in the U.S. between March 1, 2020, and Jan. 2, 2021, has been massive,” Alan Garber, MD, PhD, wrote in an accompanying editorial.

“It seems likely that COVID-19 will have contributed to nearly as many deaths in the U.S. as the great influenza pandemic of 1918, and more than in any influenza outbreak in the U.S. since then,” added Dr. Garber, provost of Harvard University in Cambridge, Mass.

This study of excess mortality illustrates what is at stake, he added. “Despite the scientific, medical and public health progress of recent decades, the loss of life attributable to the COVID-19 pandemic exceeds the mortality of major wars. No nation should squander this opportunity to do what it takes to prepare for the next one.”

Dr. Woolf and Dr. Garber disclosed no relevant financial relationships. The National Institutes of Health supported the research through its National Center for Advancing Translational Sciences and the National Institute on Aging.

A version of this article first appeared on Medscape.com.

The United States saw nearly 23% more deaths than expected during the first 9 months of the pandemic, and almost three-quarters of those deaths involved COVID-19.

For comparison, the death rate increased by 2.5% or less annually in recent years.

At the same time, rates of deaths from heart disease, Alzheimer’s disease or dementia, and diabetes also increased from March 1, 2020, to Jan. 2, 2021, especially during COVID-19 surges.

“Excess deaths surged in the east in April, followed by extended summer and early winter surges concentrated in Southern and Western states, respectively. Many of these states weakly embraced, or discouraged, pandemic control measures and lifted restrictions earlier than other states,” lead author Steven H. Woolf, MD, MPH, from the Virginia Commonwealth University, Richmond, and colleagues wrote in a research letter published online April 2, 2021, in JAMA.

COVID-19 mortality included all deaths for which it was cited as an underlying or contributing cause in records from the District of Columbia and 49 states. North Carolina was excluded for insufficient data.
 

More than half a million excess deaths

Between March 1, 2020, and Jan. 2, 2021, the United States experienced 2,801,439 deaths, or 522,368 excess deaths. A total 72.4% of these events were attributed to COVID-19.

Not all racial and ethnic groups were equally represented. For example, the rate of excess deaths was higher among non-Hispanic Black populations, at 208.4 deaths per 100,000. Non-Hispanic White populations experienced 157 deaths per 100,000, and Hispanic populations experienced 139.8 deaths per 100,000.

Further, non-Hispanic Black individuals accounted for 16.9% of the excess deaths but only 12.5% of the U.S. population, which reflects “racial disparities in COVID-19 mortality,” the authors noted.

Not adjusting for population aging is a potential limitation, as was reliance on provisional data and the likelihood that some death certificates were inaccurate.

In February, Anthony S. Fauci, MD, chief medical adviser to President Joe Biden, stated that political divisions likely played a role in the 500,000-plus COVID-19–related deaths in the United States. 

Then a report came out on March 26 indicating that a different U.S. response to the pandemic could have avoided almost 400,000 COVID-19 deaths. In addition, an April 1 study in the CDC’s Morbidity and Mortality Weekly Report revealed that COVID-19 is now the third leading cause of death in the United States, after heart disease and cancer.
 

‘Massive’ excessive mortality

“There is no more visible or alarming manifestation of the toll of the COVID-19 pandemic than the deaths it has caused. In this issue of JAMA, Dr. Woolf and colleagues provide updated analyses that demonstrate that the excess mortality in the U.S. between March 1, 2020, and Jan. 2, 2021, has been massive,” Alan Garber, MD, PhD, wrote in an accompanying editorial.

“It seems likely that COVID-19 will have contributed to nearly as many deaths in the U.S. as the great influenza pandemic of 1918, and more than in any influenza outbreak in the U.S. since then,” added Dr. Garber, provost of Harvard University in Cambridge, Mass.

This study of excess mortality illustrates what is at stake, he added. “Despite the scientific, medical and public health progress of recent decades, the loss of life attributable to the COVID-19 pandemic exceeds the mortality of major wars. No nation should squander this opportunity to do what it takes to prepare for the next one.”

Dr. Woolf and Dr. Garber disclosed no relevant financial relationships. The National Institutes of Health supported the research through its National Center for Advancing Translational Sciences and the National Institute on Aging.

A version of this article first appeared on Medscape.com.

The United States saw nearly 23% more deaths than expected during the first 9 months of the pandemic, and almost three-quarters of those deaths involved COVID-19.

For comparison, the death rate increased by 2.5% or less annually in recent years.

At the same time, rates of deaths from heart disease, Alzheimer’s disease or dementia, and diabetes also increased from March 1, 2020, to Jan. 2, 2021, especially during COVID-19 surges.

“Excess deaths surged in the east in April, followed by extended summer and early winter surges concentrated in Southern and Western states, respectively. Many of these states weakly embraced, or discouraged, pandemic control measures and lifted restrictions earlier than other states,” lead author Steven H. Woolf, MD, MPH, from the Virginia Commonwealth University, Richmond, and colleagues wrote in a research letter published online April 2, 2021, in JAMA.

COVID-19 mortality included all deaths for which it was cited as an underlying or contributing cause in records from the District of Columbia and 49 states. North Carolina was excluded for insufficient data.
 

More than half a million excess deaths

Between March 1, 2020, and Jan. 2, 2021, the United States experienced 2,801,439 deaths, or 522,368 excess deaths. A total 72.4% of these events were attributed to COVID-19.

Not all racial and ethnic groups were equally represented. For example, the rate of excess deaths was higher among non-Hispanic Black populations, at 208.4 deaths per 100,000. Non-Hispanic White populations experienced 157 deaths per 100,000, and Hispanic populations experienced 139.8 deaths per 100,000.

Further, non-Hispanic Black individuals accounted for 16.9% of the excess deaths but only 12.5% of the U.S. population, which reflects “racial disparities in COVID-19 mortality,” the authors noted.

Not adjusting for population aging is a potential limitation, as was reliance on provisional data and the likelihood that some death certificates were inaccurate.

In February, Anthony S. Fauci, MD, chief medical adviser to President Joe Biden, stated that political divisions likely played a role in the 500,000-plus COVID-19–related deaths in the United States. 

Then a report came out on March 26 indicating that a different U.S. response to the pandemic could have avoided almost 400,000 COVID-19 deaths. In addition, an April 1 study in the CDC’s Morbidity and Mortality Weekly Report revealed that COVID-19 is now the third leading cause of death in the United States, after heart disease and cancer.
 

‘Massive’ excessive mortality

“There is no more visible or alarming manifestation of the toll of the COVID-19 pandemic than the deaths it has caused. In this issue of JAMA, Dr. Woolf and colleagues provide updated analyses that demonstrate that the excess mortality in the U.S. between March 1, 2020, and Jan. 2, 2021, has been massive,” Alan Garber, MD, PhD, wrote in an accompanying editorial.

“It seems likely that COVID-19 will have contributed to nearly as many deaths in the U.S. as the great influenza pandemic of 1918, and more than in any influenza outbreak in the U.S. since then,” added Dr. Garber, provost of Harvard University in Cambridge, Mass.

This study of excess mortality illustrates what is at stake, he added. “Despite the scientific, medical and public health progress of recent decades, the loss of life attributable to the COVID-19 pandemic exceeds the mortality of major wars. No nation should squander this opportunity to do what it takes to prepare for the next one.”

Dr. Woolf and Dr. Garber disclosed no relevant financial relationships. The National Institutes of Health supported the research through its National Center for Advancing Translational Sciences and the National Institute on Aging.

A version of this article first appeared on Medscape.com.

Screen time may be associated with a range of psychosocial symptoms at age 5 years, according to a study of Finnish children that was published online in BMJ Open

Janette Niiranen, a researcher in the department of public health solutions at the Finnish Institute for Health and Welfare in Helsinki, and colleagues examined the frequency of electronic media use by 699 preschool children.

They analyzed longitudinal associations between media use at age 18 months and psychosocial symptoms at age 5 years. They also looked at whether media use at age 5 years was associated with the presence of psychosocial symptoms at that time.

The study relied on data collected between 2011 and 2017 as part of the Finnish CHILD-SLEEP longitudinal birth cohort study. Parents reported child media use via questionnaires at age 18 months and age 5 years. Researchers measured psychosocial symptoms at age 5 years using two parent-reported questionnaires: Five-to-Fifteen (FTF) and the Strengths and Difficulties Questionnaire (SDQ).

At age 5 years, a high amount of total screen time – at least 135 minutes per day, representing the 75th percentile of use – was associated with increased likelihood of attention and concentration difficulties, hyperactivity and impulsivity, emotional internalizing and externalizing symptoms, and conduct problems, the researchers reported. Odds ratios ranged from 1.57 to 2.18. In a model that adjusted for confounding factors, internalizing symptoms was the only symptom significantly associated with screen time (OR, 2.01).

In a longitudinal analysis, increased media use at 18 months was associated with peer problems at age 5 years (OR, 1.59).

Compared with program viewing, electronic game playing at age 5 years appeared to be associated with fewer psychosocial risks, the researchers noted. In an unadjusted model, a high amount of game playing was associated with hyperactivity, whereas program viewing was associated with a broad range of symptoms.

Use of electronic media beyond recommended amounts was common.

“The results of our study show that 95% of preschool aged children exceed the recommended daily e-media use of 1 hour,” the authors wrote.
 

No causal link

Amy Orben, DPhil, a researcher at Emmanuel College and the MRC Cognition and Brain Sciences Unit, University of Cambridge (England) highlighted limitations of the research.

The study is “purely observational” and does not “establish a causal link between time spent on electronic media and developmental outcomes in small children,” Dr. Orben said. Factors that may influence how much time a child spends on electronic media – such as whether both parents work and where a child lives – may also influence psychosocial symptoms.

“This means that an association can exist even if no causal link is present,” Dr. Orben said. Furthermore, the statistically significant associations found in the study “could well be noise,” she added.

As the study authors note, associations between screen time and children’s psychosocial well-being “may be bidirectional,” commented Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn.

“There is no way to tell if the families who allow more screen time are doing that because the child already has some psychosocial issues like hyperactivity or dysregulation, and they are using media to calm them,” Dr. Kinsella said. “Or perhaps parents do not have the ability to interact as much with the child due to lack of time/work.” The lack of interaction, rather than electronic media use, may interfere with typical development.

“The end result is still pertinent, as we know children learn through play and social interaction,” Dr. Kinsella added. “I did find it interesting that electronic game playing when played with friends or family was less of a risk.”
 

Brainstorming alternatives

Libby Matile Milkovich, MD, a developmental pediatrician at Children’s Mercy Hospital, Kansas City, Mo., sees family electronic media use as an environmental factor that has significant variability for each patient.

“The need for electronic media to connect to others, to access entertainment, and to learn intensified with the pandemic,” Dr. Milkovich said. “In practice, after I identify concerning media habits, I try to help families create alternatives to their current habits as opposed to being prescriptive and saying to stop or limit media use. ... An alternative may not be limiting screen time but may be changing to more appropriate media content or sharing the media as a family activity.”

Seeing media use in the clinic can provide useful information and opportunities for discussion, Dr. Milkovich noted.

“When I see parents in the clinic room using media to calm a toddler or using their own media, these are great opportunities to open the door to brainstorming alternatives,” Dr. Milkovich said. “Commonly, family media use comes up when children have difficulty sleeping or disruptive behaviors related to media use, but I would challenge medical providers to think about problematic media use in all chief complaints where a behavioral component exists like toileting and feeding.”

The research was supported by the Academy of Finland, the Signe and Ane Gyllenberg Foundation, the Yrjö Jahnsson Foundation, the Foundation for Pediatric Research, the Finnish Cultural Foundation, and the Tampere University Hospital and Doctors’ Association in Tampere. The study authors, Dr. Milkovich, Dr. Orben, and Dr. Kinsella had no relevant financial disclosures. Dr. Kinsella serves on the Pediatric News editorial advisory board.

[email protected]

Screen time may be associated with a range of psychosocial symptoms at age 5 years, according to a study of Finnish children that was published online in BMJ Open

Janette Niiranen, a researcher in the department of public health solutions at the Finnish Institute for Health and Welfare in Helsinki, and colleagues examined the frequency of electronic media use by 699 preschool children.

They analyzed longitudinal associations between media use at age 18 months and psychosocial symptoms at age 5 years. They also looked at whether media use at age 5 years was associated with the presence of psychosocial symptoms at that time.

The study relied on data collected between 2011 and 2017 as part of the Finnish CHILD-SLEEP longitudinal birth cohort study. Parents reported child media use via questionnaires at age 18 months and age 5 years. Researchers measured psychosocial symptoms at age 5 years using two parent-reported questionnaires: Five-to-Fifteen (FTF) and the Strengths and Difficulties Questionnaire (SDQ).

At age 5 years, a high amount of total screen time – at least 135 minutes per day, representing the 75th percentile of use – was associated with increased likelihood of attention and concentration difficulties, hyperactivity and impulsivity, emotional internalizing and externalizing symptoms, and conduct problems, the researchers reported. Odds ratios ranged from 1.57 to 2.18. In a model that adjusted for confounding factors, internalizing symptoms was the only symptom significantly associated with screen time (OR, 2.01).

In a longitudinal analysis, increased media use at 18 months was associated with peer problems at age 5 years (OR, 1.59).

Compared with program viewing, electronic game playing at age 5 years appeared to be associated with fewer psychosocial risks, the researchers noted. In an unadjusted model, a high amount of game playing was associated with hyperactivity, whereas program viewing was associated with a broad range of symptoms.

Use of electronic media beyond recommended amounts was common.

“The results of our study show that 95% of preschool aged children exceed the recommended daily e-media use of 1 hour,” the authors wrote.
 

No causal link

Amy Orben, DPhil, a researcher at Emmanuel College and the MRC Cognition and Brain Sciences Unit, University of Cambridge (England) highlighted limitations of the research.

The study is “purely observational” and does not “establish a causal link between time spent on electronic media and developmental outcomes in small children,” Dr. Orben said. Factors that may influence how much time a child spends on electronic media – such as whether both parents work and where a child lives – may also influence psychosocial symptoms.

“This means that an association can exist even if no causal link is present,” Dr. Orben said. Furthermore, the statistically significant associations found in the study “could well be noise,” she added.

As the study authors note, associations between screen time and children’s psychosocial well-being “may be bidirectional,” commented Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn.

“There is no way to tell if the families who allow more screen time are doing that because the child already has some psychosocial issues like hyperactivity or dysregulation, and they are using media to calm them,” Dr. Kinsella said. “Or perhaps parents do not have the ability to interact as much with the child due to lack of time/work.” The lack of interaction, rather than electronic media use, may interfere with typical development.

“The end result is still pertinent, as we know children learn through play and social interaction,” Dr. Kinsella added. “I did find it interesting that electronic game playing when played with friends or family was less of a risk.”
 

Brainstorming alternatives

Libby Matile Milkovich, MD, a developmental pediatrician at Children’s Mercy Hospital, Kansas City, Mo., sees family electronic media use as an environmental factor that has significant variability for each patient.

“The need for electronic media to connect to others, to access entertainment, and to learn intensified with the pandemic,” Dr. Milkovich said. “In practice, after I identify concerning media habits, I try to help families create alternatives to their current habits as opposed to being prescriptive and saying to stop or limit media use. ... An alternative may not be limiting screen time but may be changing to more appropriate media content or sharing the media as a family activity.”

Seeing media use in the clinic can provide useful information and opportunities for discussion, Dr. Milkovich noted.

“When I see parents in the clinic room using media to calm a toddler or using their own media, these are great opportunities to open the door to brainstorming alternatives,” Dr. Milkovich said. “Commonly, family media use comes up when children have difficulty sleeping or disruptive behaviors related to media use, but I would challenge medical providers to think about problematic media use in all chief complaints where a behavioral component exists like toileting and feeding.”

The research was supported by the Academy of Finland, the Signe and Ane Gyllenberg Foundation, the Yrjö Jahnsson Foundation, the Foundation for Pediatric Research, the Finnish Cultural Foundation, and the Tampere University Hospital and Doctors’ Association in Tampere. The study authors, Dr. Milkovich, Dr. Orben, and Dr. Kinsella had no relevant financial disclosures. Dr. Kinsella serves on the Pediatric News editorial advisory board.

[email protected]

Screen time may be associated with a range of psychosocial symptoms at age 5 years, according to a study of Finnish children that was published online in BMJ Open

Janette Niiranen, a researcher in the department of public health solutions at the Finnish Institute for Health and Welfare in Helsinki, and colleagues examined the frequency of electronic media use by 699 preschool children.

They analyzed longitudinal associations between media use at age 18 months and psychosocial symptoms at age 5 years. They also looked at whether media use at age 5 years was associated with the presence of psychosocial symptoms at that time.

The study relied on data collected between 2011 and 2017 as part of the Finnish CHILD-SLEEP longitudinal birth cohort study. Parents reported child media use via questionnaires at age 18 months and age 5 years. Researchers measured psychosocial symptoms at age 5 years using two parent-reported questionnaires: Five-to-Fifteen (FTF) and the Strengths and Difficulties Questionnaire (SDQ).

At age 5 years, a high amount of total screen time – at least 135 minutes per day, representing the 75th percentile of use – was associated with increased likelihood of attention and concentration difficulties, hyperactivity and impulsivity, emotional internalizing and externalizing symptoms, and conduct problems, the researchers reported. Odds ratios ranged from 1.57 to 2.18. In a model that adjusted for confounding factors, internalizing symptoms was the only symptom significantly associated with screen time (OR, 2.01).

In a longitudinal analysis, increased media use at 18 months was associated with peer problems at age 5 years (OR, 1.59).

Compared with program viewing, electronic game playing at age 5 years appeared to be associated with fewer psychosocial risks, the researchers noted. In an unadjusted model, a high amount of game playing was associated with hyperactivity, whereas program viewing was associated with a broad range of symptoms.

Use of electronic media beyond recommended amounts was common.

“The results of our study show that 95% of preschool aged children exceed the recommended daily e-media use of 1 hour,” the authors wrote.
 

No causal link

Amy Orben, DPhil, a researcher at Emmanuel College and the MRC Cognition and Brain Sciences Unit, University of Cambridge (England) highlighted limitations of the research.

The study is “purely observational” and does not “establish a causal link between time spent on electronic media and developmental outcomes in small children,” Dr. Orben said. Factors that may influence how much time a child spends on electronic media – such as whether both parents work and where a child lives – may also influence psychosocial symptoms.

“This means that an association can exist even if no causal link is present,” Dr. Orben said. Furthermore, the statistically significant associations found in the study “could well be noise,” she added.

As the study authors note, associations between screen time and children’s psychosocial well-being “may be bidirectional,” commented Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn.

“There is no way to tell if the families who allow more screen time are doing that because the child already has some psychosocial issues like hyperactivity or dysregulation, and they are using media to calm them,” Dr. Kinsella said. “Or perhaps parents do not have the ability to interact as much with the child due to lack of time/work.” The lack of interaction, rather than electronic media use, may interfere with typical development.

“The end result is still pertinent, as we know children learn through play and social interaction,” Dr. Kinsella added. “I did find it interesting that electronic game playing when played with friends or family was less of a risk.”
 

Brainstorming alternatives

Libby Matile Milkovich, MD, a developmental pediatrician at Children’s Mercy Hospital, Kansas City, Mo., sees family electronic media use as an environmental factor that has significant variability for each patient.

“The need for electronic media to connect to others, to access entertainment, and to learn intensified with the pandemic,” Dr. Milkovich said. “In practice, after I identify concerning media habits, I try to help families create alternatives to their current habits as opposed to being prescriptive and saying to stop or limit media use. ... An alternative may not be limiting screen time but may be changing to more appropriate media content or sharing the media as a family activity.”

Seeing media use in the clinic can provide useful information and opportunities for discussion, Dr. Milkovich noted.

“When I see parents in the clinic room using media to calm a toddler or using their own media, these are great opportunities to open the door to brainstorming alternatives,” Dr. Milkovich said. “Commonly, family media use comes up when children have difficulty sleeping or disruptive behaviors related to media use, but I would challenge medical providers to think about problematic media use in all chief complaints where a behavioral component exists like toileting and feeding.”

The research was supported by the Academy of Finland, the Signe and Ane Gyllenberg Foundation, the Yrjö Jahnsson Foundation, the Foundation for Pediatric Research, the Finnish Cultural Foundation, and the Tampere University Hospital and Doctors’ Association in Tampere. The study authors, Dr. Milkovich, Dr. Orben, and Dr. Kinsella had no relevant financial disclosures. Dr. Kinsella serves on the Pediatric News editorial advisory board.

[email protected]

In 1967, when the United Nations Convention on Drugs classified psychedelics as schedule I substances, it effectively ended research into these agents as potential therapeutics for psychiatric disorders.

eskymaks/iStock/Getty Images

Psychedelics induce altered states of perception. They bind to the 5-hydroxytryptamine 2A (5-HT2A) receptor and include psilocybin, which is derived from “magic mushrooms”; N,N-dimethyltryptamine (DMT), a component of ayahuasca and mescaline (peyote cactus); and the synthesized compound D-lysergic acid diethylamide (LSD). Other agents, such as ketamine and 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy, are sometimes considered psychedelics as well.

Before they were classified as schedule I agents, psychedelics had been shown to be particularly beneficial for patients with treatment-resistant conditions, including depression and posttraumatic stress disorder (PTSD), especially when administered in a supportive, therapeutic setting.

Now, after a hiatus of almost 50 years, there is renewed global interest in the scientific investigation of psychedelics. The attention was spurred in part by several exploratory studies of DMT in humans conducted in the 1990s by Rick Strassman, MD, and colleagues at the University of New Mexico, Albuquerque.

Around the same time, Franz X. Vollenweider, MD, and colleagues at the University of Zürich began researching psilocybin and its effects on human behavior. However, it was a 2006 study of psilocybin by a team of researchers at Johns Hopkins University, Baltimore, that is widely cited as a catalyst for the current renaissance in psychedelic research.

To provide a broad-based, international perspective on these agents, including their current legal status and indications, treatment regimens, safety, efficacy, and future considerations, this news organization interviewed nine expert researchers from around the globe.
 

Global legal status

In most, if not all, countries, it is still illegal to prescribe psychedelics in other than a research setting.

In the United States, classic psychedelics remain schedule I substances and therefore are unavailable for clinical use. They can be used in research, but only with approval from the Food and Drug Administration under licensure from the Drug Enforcement Administration.

France lists all synthetic hallucinogens and hallucinogenic mushrooms as narcotic. As a result, possession, use, transportation, and collection are subject to criminal sanctions.

In France, NMDA antagonists such as ketamine and nitrous oxide are regarded as psychedelic molecules and can be used off label for various conditions or as part of research protocols authorized by the French public health code.

Although psychedelics are illegal under Mexican law, they are commonly used in indigenous communities as part of traditional rituals.

“The line between traditional consumption and psychedelic tourism is very thin,” José J. Mendoza Velásquez, MD, professor in the department of mental health, National Autonomous University of Mexico, Mexico City, said in an interview.

Psychedelics also are illegal in the United Kingdom, although government agencies have recently allowed research groups to investigate them. Psychedelics cannot be prescribed in Germany, Spain, or Italy. However, investigators in these countries can request permission from regulatory agencies to conduct research.

Brazil allows psychedelic substances to be researched, particularly ayahuasca, which has long traditional and religious roots in the country.

However, as in other countries, none of the classic psychedelics is regulated for therapeutic use in Brazil. It is widely expected that the Brazilian government will approve MDMA sometime in 2024 for use in the treatment of PTSD.
 

Potential indications

Psychedelics are currently under investigation as potential treatments for major depression, treatment-resistant depression, PTSD, pain management, and anorexia, among other conditions.

In France, Florian Ferreri, MD, PhD, at Hospital Saint-Antoine, Paris, is researching ketamine for treatment of patients with suicidal crisis/ideation and treatment-resistant depression.

In the United Kingdom, David Nutt, FMedSci, Edmond J. Safra Professor of Neuropsychopharmacology at Imperial College London, and his team have conducted studies of the use of psychedelics in conjunction with psychological support for patients with treatment-resistant depression, and they are currently exploring their use in the treatment of anorexia and various pain syndromes.

In Germany, Gerhard Gründer, MD, professor of psychiatry at the Central Institute of Mental Health, in Mannheim, noted that a study of psilocybin for treatment-resistant depression will launch sometime in 2021. In Italy, current research is focusing on MDMA and ketamine in the laboratory environment and in animal models for treating depression and drug abuse.

Researcher Helen Dolengevich-Segal, MD, a psychiatrist at Hospital Universitario del Henares, Madrid, noted that although research on esketamine for the treatment of severe depressive disorder with suicidal thoughts is underway, there is very limited published research from that country into the use of classic psychedelics for various psychiatric disorders, given their current illegal status.

Mexico’s Dr. Velásquez noted that although he is prohibited from prescribing psychedelics, he does have patients who take the drugs to augment medical treatment. For instance, he said, his patients frequently use psilocybin to help with severe depression, pain, and insomnia.
 

Environment is key

Most researchers agree that for psychedelics to be safe and effective, patient education and administration in a controlled environment by experienced clinicians are key to successful treatment.

Roland R. Griffiths, PhD, director of the Center for Psychedelic and Consciousness Research at Johns Hopkins, said that ongoing U.S. psilocybin research – primarily in major depressive disorder and psychological distress associated with life-threatening illness, drug addiction, anorexia nervosa, obsessive-compulsive disorder, and headache – generally includes one or two treatment sessions, each of which lasts 6-8 hours.

Such sessions typically involve oral administration of a moderately high dose of a psychedelic under what he characterizes as “psychologically supported conditions.”

For Dr. Griffiths, there are serious potential risks associated with the use of psilocybin and other psychedelics outside such environments.

“When taken in uncontrolled conditions, classic psychedelics can produce confusion and disorientation resulting in behavior dangerous to the participant and others, including life-threatening risk,” he said.

Dr. Gründer agreed.

“At the moment, I cannot imagine that you would go to the pharmacy with a prescription for psilocybin and get yourself a pill and then take it in a quiet little room,” he said. Dr. Dolengevich-Segal and Dr. Velásquez echoed these sentiments, noting the optimal location for administration is one that is quiet and secure and where patients feel safe.

Luís Fernando Tófoli, MD, PhD, professor of medical psychology and psychiatry at the University of Campinas, and Eduardo Schenberg, PhD, founder and CEO of Instituto Phaneros in São Paulo, Brazil, said more research is needed to determine the optimal therapeutic environment for individual agents.

“Most studies have a low number of participants (around 20 or 30), especially in neuroimaging, with high unblinding rates,” Dr. Schenberg said. “Therefore, novel methodological approaches are also necessary, as these substances do not easily fit into the traditional pharmacology epistemic model.”
 

Risks, abuse potential

The abuse potential of psychedelics is an ongoing concern for the public, researchers, and regulators, but the consensus among nearly all of these experts is that when administered by medical professionals in controlled settings, these drugs are associated with extremely low risk.

It is recreational use that presents an abuse concern, said Dr. Ferreri, but with the low doses used in psychiatry, the risk is “very limited or even nonexistent.”

Dr. Nutt said the abuse potential of psychedelics is so low that they can be used to treat addiction.

“Functionally, psychedelics are antiaddictive,” Dr. Nutt said. “The fact is, if you take them repeatedly, you develop tolerance, and the effect disappears. You can’t overcome it. But everyone believes they’re addictive because they’re scheduled drugs.”

Dr. Velásquez is something of an outlier. He believes the abuse potential with psychedelics is poorly understood and that some patients may develop tolerance, which is a potential gateway to dependence.

“Such is the case with LSD,” he said, “where this substance also favors tolerance to other psychedelic drugs such as psilocybin.”

Dosing also seems to play a key role in mitigating potential abuse, said Luca Pani, MD, professor of pharmacology and psychiatry at the University of Modena, Italy. Dr. Pani explained that with low doses and microdoses of psychedelics, the potential for abuse is eliminated.

Dr. Nutt, Dr. Pani, and Dr. Ferreri also noted the importance of medical supervision. For instance, said Dr. Ferreri, when administering ketamine, his team closely monitors both mental and physical parameters – heart rate and blood pressure, in particular – because the drug can have hypertensive effects.

Dr. Schenberg noted that ibogaine, a naturally occurring psychedelic frequently used by traditional communities in Africa in rituals and for healing purposes, could cause potentially fatal arrhythmias, so it’s critical that the treatment is administered in a hospital setting that has a cardiac unit.

Dr. Pani said there is a need for more research, especially regarding the molecular mechanisms behind the behavioral effects of low-dose psychedelic therapy and the potential risks of multiple treatments with the drugs.

“Although extensive toxicology has been conducted on a single active dose of psilocybin, which has been proven to be safe, further research is required to understand better the possible health risks, especially in relation to cardiac and lung tissue,” he said.
 

Psychologically challenging

The experts note that given the relative lack of experience with psychedelic therapy, preparing patients for potential adverse effects is paramount. This is particularly relevant in the research setting and highlights the need for adequate patient screening and aftercare.

Dr. Gründer and Dr. Dolengevich-Segal emphasized the importance of having qualified personnel available in the event that patients experience adverse psychological events during treatment.

For Dr. Gründer, the potential for psilocybin to cause patients to lose control, experience psychotic symptoms, or become paranoid warrants considerable preparation by treating physicians.

Patients occasionally experience fear and anxiety during treatment, though it’s usually short-lived, said Dr. Griffiths. Nevertheless, these experiences may open the door to greater insight. “A number of people report that these psychologically challenging states are a valuable part of the overall experience,” he said.

The situation is similar in Spain, where Dr. Dolengevich-Segal noted that typical treatment regimens have a strong focus on the patient’s experience as a therapeutic tool. As in the United Kingdom and the United States, her team guides patients to what they call a “peak experience,” which allows them to gain a better understanding of the trauma underlying their mental health problems.

Dr. Nutt said that in the United Kingdom, they haven’t seen adverse reactions in patients receiving psychedelic therapy, although sedatives such as benzodiazepines could be used to manage them. He added that at his center, two therapists are present at every treatment session, and all personnel are “trained medics or psychologists.”
 

Patient education

Preparing and educating patients about the therapy are critical, said Dr. Gründer, especially given the intense response psychedelic treatment often invokes.

Echoing Dr. Gründer, Dr. Tófoli said explaining the nature of psychedelic treatment to potential patients helps ease anxiety.

Dr. Griffiths noted that in the United States, study participants are not only educated about the potential effects of psychedelic agents but also undergo several hours of psychological preparation in advance of their first treatment session and are provided with psychological support after treatment.

There is also a strong emphasis on patient preparation and education in the United Kingdom, where patients meet with therapists before and after treatment. During these posttreatment debriefings, clinicians use the patients’ experience with psychedelics to help them gain insight into the underlying cause of their depression.

Dr. Schenberg noted that at his institution in São Paulo, there are online courses to teach clinicians about psychedelic therapy for psychiatric disorders. Next year, he added, a new training program in MDMA-assisted psychotherapy will begin.
 

Working out treatment protocols

Treatment protocols for psychedelics vary by agent and indication from country to country. For instance, Dr. Pani noted that current psychedelic research in Italy predominantly focuses more on microdosing, which involves administering 1% of the pharmacologically active dose to a maximum of 100 mcg, in contrast to low dosing or full dosing.

Therapeutic regimens in Brazil, said Dr. Schenberg, also differ by agent but share common elements. For instance, psychedelics are always administered in a research setting, and sessions include concomitant psychotherapy.

In Germany, investigators are working to determine optimal treatment regimen for psilocybin for resistant depression in a randomized three-arm study planned for 2021.

For Mexico’s Dr. Velásquez, treatment regimens are complex and varied. Either way, he said, patients always require long-term follow-up.

With ketamine therapy, Dr. Ferreri said his team administers the drug in 45- to 60-minute intravenous infusion sessions in a hospital room without light or sound stimulation. Regardless of the drug’s immediate effect, he said, the protocol is repeated within a 6-month period.

The question of the duration of treatment effect is important. Dr. Griffiths said research suggests that the positive effects of psilocybin are long lasting and that most individuals report positive changes in mood, attitude, and behavior that endure for months or even years after the session.

“Our research has shown that the benefits of these experiences can last as long as 14 months, often longer, and that many participants characterize their psilocybin experience as among the most profound and personally meaningful experiences of their lives,” said Dr. Griffiths.

Dr. Nutt agreed, noting that a single intense “trip” can improve mood for weeks, months, or even years. Nevertheless, he said, in his experience, approximately three-quarters of patients treated with psychedelics for major depression relapse within 3-9 months.

“Most get better,” he said, “but the majority of depression comes back over a period of months.”

Given the current illegal status of the drugs, he said it’s nearly impossible to provide patients with regular, subsequent treatment with psychedelics over time.

“My suspicion is that you might well have to dose four or five times over a couple of years to get people to escape from very severe depression,” said Dr. Nutt. “The longer they’ve been depressed, the harder it is for them to make a full recovery, because it’s more entrenched in the brain.”

All experts agree that exciting times are ahead for psychedelics as therapeutics for a wide range of psychiatric disorders.

“We can look forward to continued growth and expansion of this research,” said Dr. Griffiths, “including the refinement of protocols for a variety of therapeutic indications and to the development of a variety of new classic psychedelic compounds.”

A version of this article first appeared on Medscape.com.

In 1967, when the United Nations Convention on Drugs classified psychedelics as schedule I substances, it effectively ended research into these agents as potential therapeutics for psychiatric disorders.

eskymaks/iStock/Getty Images

Psychedelics induce altered states of perception. They bind to the 5-hydroxytryptamine 2A (5-HT2A) receptor and include psilocybin, which is derived from “magic mushrooms”; N,N-dimethyltryptamine (DMT), a component of ayahuasca and mescaline (peyote cactus); and the synthesized compound D-lysergic acid diethylamide (LSD). Other agents, such as ketamine and 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy, are sometimes considered psychedelics as well.

Before they were classified as schedule I agents, psychedelics had been shown to be particularly beneficial for patients with treatment-resistant conditions, including depression and posttraumatic stress disorder (PTSD), especially when administered in a supportive, therapeutic setting.

Now, after a hiatus of almost 50 years, there is renewed global interest in the scientific investigation of psychedelics. The attention was spurred in part by several exploratory studies of DMT in humans conducted in the 1990s by Rick Strassman, MD, and colleagues at the University of New Mexico, Albuquerque.

Around the same time, Franz X. Vollenweider, MD, and colleagues at the University of Zürich began researching psilocybin and its effects on human behavior. However, it was a 2006 study of psilocybin by a team of researchers at Johns Hopkins University, Baltimore, that is widely cited as a catalyst for the current renaissance in psychedelic research.

To provide a broad-based, international perspective on these agents, including their current legal status and indications, treatment regimens, safety, efficacy, and future considerations, this news organization interviewed nine expert researchers from around the globe.
 

Global legal status

In most, if not all, countries, it is still illegal to prescribe psychedelics in other than a research setting.

In the United States, classic psychedelics remain schedule I substances and therefore are unavailable for clinical use. They can be used in research, but only with approval from the Food and Drug Administration under licensure from the Drug Enforcement Administration.

France lists all synthetic hallucinogens and hallucinogenic mushrooms as narcotic. As a result, possession, use, transportation, and collection are subject to criminal sanctions.

In France, NMDA antagonists such as ketamine and nitrous oxide are regarded as psychedelic molecules and can be used off label for various conditions or as part of research protocols authorized by the French public health code.

Although psychedelics are illegal under Mexican law, they are commonly used in indigenous communities as part of traditional rituals.

“The line between traditional consumption and psychedelic tourism is very thin,” José J. Mendoza Velásquez, MD, professor in the department of mental health, National Autonomous University of Mexico, Mexico City, said in an interview.

Psychedelics also are illegal in the United Kingdom, although government agencies have recently allowed research groups to investigate them. Psychedelics cannot be prescribed in Germany, Spain, or Italy. However, investigators in these countries can request permission from regulatory agencies to conduct research.

Brazil allows psychedelic substances to be researched, particularly ayahuasca, which has long traditional and religious roots in the country.

However, as in other countries, none of the classic psychedelics is regulated for therapeutic use in Brazil. It is widely expected that the Brazilian government will approve MDMA sometime in 2024 for use in the treatment of PTSD.
 

Potential indications

Psychedelics are currently under investigation as potential treatments for major depression, treatment-resistant depression, PTSD, pain management, and anorexia, among other conditions.

In France, Florian Ferreri, MD, PhD, at Hospital Saint-Antoine, Paris, is researching ketamine for treatment of patients with suicidal crisis/ideation and treatment-resistant depression.

In the United Kingdom, David Nutt, FMedSci, Edmond J. Safra Professor of Neuropsychopharmacology at Imperial College London, and his team have conducted studies of the use of psychedelics in conjunction with psychological support for patients with treatment-resistant depression, and they are currently exploring their use in the treatment of anorexia and various pain syndromes.

In Germany, Gerhard Gründer, MD, professor of psychiatry at the Central Institute of Mental Health, in Mannheim, noted that a study of psilocybin for treatment-resistant depression will launch sometime in 2021. In Italy, current research is focusing on MDMA and ketamine in the laboratory environment and in animal models for treating depression and drug abuse.

Researcher Helen Dolengevich-Segal, MD, a psychiatrist at Hospital Universitario del Henares, Madrid, noted that although research on esketamine for the treatment of severe depressive disorder with suicidal thoughts is underway, there is very limited published research from that country into the use of classic psychedelics for various psychiatric disorders, given their current illegal status.

Mexico’s Dr. Velásquez noted that although he is prohibited from prescribing psychedelics, he does have patients who take the drugs to augment medical treatment. For instance, he said, his patients frequently use psilocybin to help with severe depression, pain, and insomnia.
 

Environment is key

Most researchers agree that for psychedelics to be safe and effective, patient education and administration in a controlled environment by experienced clinicians are key to successful treatment.

Roland R. Griffiths, PhD, director of the Center for Psychedelic and Consciousness Research at Johns Hopkins, said that ongoing U.S. psilocybin research – primarily in major depressive disorder and psychological distress associated with life-threatening illness, drug addiction, anorexia nervosa, obsessive-compulsive disorder, and headache – generally includes one or two treatment sessions, each of which lasts 6-8 hours.

Such sessions typically involve oral administration of a moderately high dose of a psychedelic under what he characterizes as “psychologically supported conditions.”

For Dr. Griffiths, there are serious potential risks associated with the use of psilocybin and other psychedelics outside such environments.

“When taken in uncontrolled conditions, classic psychedelics can produce confusion and disorientation resulting in behavior dangerous to the participant and others, including life-threatening risk,” he said.

Dr. Gründer agreed.

“At the moment, I cannot imagine that you would go to the pharmacy with a prescription for psilocybin and get yourself a pill and then take it in a quiet little room,” he said. Dr. Dolengevich-Segal and Dr. Velásquez echoed these sentiments, noting the optimal location for administration is one that is quiet and secure and where patients feel safe.

Luís Fernando Tófoli, MD, PhD, professor of medical psychology and psychiatry at the University of Campinas, and Eduardo Schenberg, PhD, founder and CEO of Instituto Phaneros in São Paulo, Brazil, said more research is needed to determine the optimal therapeutic environment for individual agents.

“Most studies have a low number of participants (around 20 or 30), especially in neuroimaging, with high unblinding rates,” Dr. Schenberg said. “Therefore, novel methodological approaches are also necessary, as these substances do not easily fit into the traditional pharmacology epistemic model.”
 

Risks, abuse potential

The abuse potential of psychedelics is an ongoing concern for the public, researchers, and regulators, but the consensus among nearly all of these experts is that when administered by medical professionals in controlled settings, these drugs are associated with extremely low risk.

It is recreational use that presents an abuse concern, said Dr. Ferreri, but with the low doses used in psychiatry, the risk is “very limited or even nonexistent.”

Dr. Nutt said the abuse potential of psychedelics is so low that they can be used to treat addiction.

“Functionally, psychedelics are antiaddictive,” Dr. Nutt said. “The fact is, if you take them repeatedly, you develop tolerance, and the effect disappears. You can’t overcome it. But everyone believes they’re addictive because they’re scheduled drugs.”

Dr. Velásquez is something of an outlier. He believes the abuse potential with psychedelics is poorly understood and that some patients may develop tolerance, which is a potential gateway to dependence.

“Such is the case with LSD,” he said, “where this substance also favors tolerance to other psychedelic drugs such as psilocybin.”

Dosing also seems to play a key role in mitigating potential abuse, said Luca Pani, MD, professor of pharmacology and psychiatry at the University of Modena, Italy. Dr. Pani explained that with low doses and microdoses of psychedelics, the potential for abuse is eliminated.

Dr. Nutt, Dr. Pani, and Dr. Ferreri also noted the importance of medical supervision. For instance, said Dr. Ferreri, when administering ketamine, his team closely monitors both mental and physical parameters – heart rate and blood pressure, in particular – because the drug can have hypertensive effects.

Dr. Schenberg noted that ibogaine, a naturally occurring psychedelic frequently used by traditional communities in Africa in rituals and for healing purposes, could cause potentially fatal arrhythmias, so it’s critical that the treatment is administered in a hospital setting that has a cardiac unit.

Dr. Pani said there is a need for more research, especially regarding the molecular mechanisms behind the behavioral effects of low-dose psychedelic therapy and the potential risks of multiple treatments with the drugs.

“Although extensive toxicology has been conducted on a single active dose of psilocybin, which has been proven to be safe, further research is required to understand better the possible health risks, especially in relation to cardiac and lung tissue,” he said.
 

Psychologically challenging

The experts note that given the relative lack of experience with psychedelic therapy, preparing patients for potential adverse effects is paramount. This is particularly relevant in the research setting and highlights the need for adequate patient screening and aftercare.

Dr. Gründer and Dr. Dolengevich-Segal emphasized the importance of having qualified personnel available in the event that patients experience adverse psychological events during treatment.

For Dr. Gründer, the potential for psilocybin to cause patients to lose control, experience psychotic symptoms, or become paranoid warrants considerable preparation by treating physicians.

Patients occasionally experience fear and anxiety during treatment, though it’s usually short-lived, said Dr. Griffiths. Nevertheless, these experiences may open the door to greater insight. “A number of people report that these psychologically challenging states are a valuable part of the overall experience,” he said.

The situation is similar in Spain, where Dr. Dolengevich-Segal noted that typical treatment regimens have a strong focus on the patient’s experience as a therapeutic tool. As in the United Kingdom and the United States, her team guides patients to what they call a “peak experience,” which allows them to gain a better understanding of the trauma underlying their mental health problems.

Dr. Nutt said that in the United Kingdom, they haven’t seen adverse reactions in patients receiving psychedelic therapy, although sedatives such as benzodiazepines could be used to manage them. He added that at his center, two therapists are present at every treatment session, and all personnel are “trained medics or psychologists.”
 

Patient education

Preparing and educating patients about the therapy are critical, said Dr. Gründer, especially given the intense response psychedelic treatment often invokes.

Echoing Dr. Gründer, Dr. Tófoli said explaining the nature of psychedelic treatment to potential patients helps ease anxiety.

Dr. Griffiths noted that in the United States, study participants are not only educated about the potential effects of psychedelic agents but also undergo several hours of psychological preparation in advance of their first treatment session and are provided with psychological support after treatment.

There is also a strong emphasis on patient preparation and education in the United Kingdom, where patients meet with therapists before and after treatment. During these posttreatment debriefings, clinicians use the patients’ experience with psychedelics to help them gain insight into the underlying cause of their depression.

Dr. Schenberg noted that at his institution in São Paulo, there are online courses to teach clinicians about psychedelic therapy for psychiatric disorders. Next year, he added, a new training program in MDMA-assisted psychotherapy will begin.
 

Working out treatment protocols

Treatment protocols for psychedelics vary by agent and indication from country to country. For instance, Dr. Pani noted that current psychedelic research in Italy predominantly focuses more on microdosing, which involves administering 1% of the pharmacologically active dose to a maximum of 100 mcg, in contrast to low dosing or full dosing.

Therapeutic regimens in Brazil, said Dr. Schenberg, also differ by agent but share common elements. For instance, psychedelics are always administered in a research setting, and sessions include concomitant psychotherapy.

In Germany, investigators are working to determine optimal treatment regimen for psilocybin for resistant depression in a randomized three-arm study planned for 2021.

For Mexico’s Dr. Velásquez, treatment regimens are complex and varied. Either way, he said, patients always require long-term follow-up.

With ketamine therapy, Dr. Ferreri said his team administers the drug in 45- to 60-minute intravenous infusion sessions in a hospital room without light or sound stimulation. Regardless of the drug’s immediate effect, he said, the protocol is repeated within a 6-month period.

The question of the duration of treatment effect is important. Dr. Griffiths said research suggests that the positive effects of psilocybin are long lasting and that most individuals report positive changes in mood, attitude, and behavior that endure for months or even years after the session.

“Our research has shown that the benefits of these experiences can last as long as 14 months, often longer, and that many participants characterize their psilocybin experience as among the most profound and personally meaningful experiences of their lives,” said Dr. Griffiths.

Dr. Nutt agreed, noting that a single intense “trip” can improve mood for weeks, months, or even years. Nevertheless, he said, in his experience, approximately three-quarters of patients treated with psychedelics for major depression relapse within 3-9 months.

“Most get better,” he said, “but the majority of depression comes back over a period of months.”

Given the current illegal status of the drugs, he said it’s nearly impossible to provide patients with regular, subsequent treatment with psychedelics over time.

“My suspicion is that you might well have to dose four or five times over a couple of years to get people to escape from very severe depression,” said Dr. Nutt. “The longer they’ve been depressed, the harder it is for them to make a full recovery, because it’s more entrenched in the brain.”

All experts agree that exciting times are ahead for psychedelics as therapeutics for a wide range of psychiatric disorders.

“We can look forward to continued growth and expansion of this research,” said Dr. Griffiths, “including the refinement of protocols for a variety of therapeutic indications and to the development of a variety of new classic psychedelic compounds.”

A version of this article first appeared on Medscape.com.

In 1967, when the United Nations Convention on Drugs classified psychedelics as schedule I substances, it effectively ended research into these agents as potential therapeutics for psychiatric disorders.

eskymaks/iStock/Getty Images

Psychedelics induce altered states of perception. They bind to the 5-hydroxytryptamine 2A (5-HT2A) receptor and include psilocybin, which is derived from “magic mushrooms”; N,N-dimethyltryptamine (DMT), a component of ayahuasca and mescaline (peyote cactus); and the synthesized compound D-lysergic acid diethylamide (LSD). Other agents, such as ketamine and 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy, are sometimes considered psychedelics as well.

Before they were classified as schedule I agents, psychedelics had been shown to be particularly beneficial for patients with treatment-resistant conditions, including depression and posttraumatic stress disorder (PTSD), especially when administered in a supportive, therapeutic setting.

Now, after a hiatus of almost 50 years, there is renewed global interest in the scientific investigation of psychedelics. The attention was spurred in part by several exploratory studies of DMT in humans conducted in the 1990s by Rick Strassman, MD, and colleagues at the University of New Mexico, Albuquerque.

Around the same time, Franz X. Vollenweider, MD, and colleagues at the University of Zürich began researching psilocybin and its effects on human behavior. However, it was a 2006 study of psilocybin by a team of researchers at Johns Hopkins University, Baltimore, that is widely cited as a catalyst for the current renaissance in psychedelic research.

To provide a broad-based, international perspective on these agents, including their current legal status and indications, treatment regimens, safety, efficacy, and future considerations, this news organization interviewed nine expert researchers from around the globe.
 

Global legal status

In most, if not all, countries, it is still illegal to prescribe psychedelics in other than a research setting.

In the United States, classic psychedelics remain schedule I substances and therefore are unavailable for clinical use. They can be used in research, but only with approval from the Food and Drug Administration under licensure from the Drug Enforcement Administration.

France lists all synthetic hallucinogens and hallucinogenic mushrooms as narcotic. As a result, possession, use, transportation, and collection are subject to criminal sanctions.

In France, NMDA antagonists such as ketamine and nitrous oxide are regarded as psychedelic molecules and can be used off label for various conditions or as part of research protocols authorized by the French public health code.

Although psychedelics are illegal under Mexican law, they are commonly used in indigenous communities as part of traditional rituals.

“The line between traditional consumption and psychedelic tourism is very thin,” José J. Mendoza Velásquez, MD, professor in the department of mental health, National Autonomous University of Mexico, Mexico City, said in an interview.

Psychedelics also are illegal in the United Kingdom, although government agencies have recently allowed research groups to investigate them. Psychedelics cannot be prescribed in Germany, Spain, or Italy. However, investigators in these countries can request permission from regulatory agencies to conduct research.

Brazil allows psychedelic substances to be researched, particularly ayahuasca, which has long traditional and religious roots in the country.

However, as in other countries, none of the classic psychedelics is regulated for therapeutic use in Brazil. It is widely expected that the Brazilian government will approve MDMA sometime in 2024 for use in the treatment of PTSD.
 

Potential indications

Psychedelics are currently under investigation as potential treatments for major depression, treatment-resistant depression, PTSD, pain management, and anorexia, among other conditions.

In France, Florian Ferreri, MD, PhD, at Hospital Saint-Antoine, Paris, is researching ketamine for treatment of patients with suicidal crisis/ideation and treatment-resistant depression.

In the United Kingdom, David Nutt, FMedSci, Edmond J. Safra Professor of Neuropsychopharmacology at Imperial College London, and his team have conducted studies of the use of psychedelics in conjunction with psychological support for patients with treatment-resistant depression, and they are currently exploring their use in the treatment of anorexia and various pain syndromes.

In Germany, Gerhard Gründer, MD, professor of psychiatry at the Central Institute of Mental Health, in Mannheim, noted that a study of psilocybin for treatment-resistant depression will launch sometime in 2021. In Italy, current research is focusing on MDMA and ketamine in the laboratory environment and in animal models for treating depression and drug abuse.

Researcher Helen Dolengevich-Segal, MD, a psychiatrist at Hospital Universitario del Henares, Madrid, noted that although research on esketamine for the treatment of severe depressive disorder with suicidal thoughts is underway, there is very limited published research from that country into the use of classic psychedelics for various psychiatric disorders, given their current illegal status.

Mexico’s Dr. Velásquez noted that although he is prohibited from prescribing psychedelics, he does have patients who take the drugs to augment medical treatment. For instance, he said, his patients frequently use psilocybin to help with severe depression, pain, and insomnia.
 

Environment is key

Most researchers agree that for psychedelics to be safe and effective, patient education and administration in a controlled environment by experienced clinicians are key to successful treatment.

Roland R. Griffiths, PhD, director of the Center for Psychedelic and Consciousness Research at Johns Hopkins, said that ongoing U.S. psilocybin research – primarily in major depressive disorder and psychological distress associated with life-threatening illness, drug addiction, anorexia nervosa, obsessive-compulsive disorder, and headache – generally includes one or two treatment sessions, each of which lasts 6-8 hours.

Such sessions typically involve oral administration of a moderately high dose of a psychedelic under what he characterizes as “psychologically supported conditions.”

For Dr. Griffiths, there are serious potential risks associated with the use of psilocybin and other psychedelics outside such environments.

“When taken in uncontrolled conditions, classic psychedelics can produce confusion and disorientation resulting in behavior dangerous to the participant and others, including life-threatening risk,” he said.

Dr. Gründer agreed.

“At the moment, I cannot imagine that you would go to the pharmacy with a prescription for psilocybin and get yourself a pill and then take it in a quiet little room,” he said. Dr. Dolengevich-Segal and Dr. Velásquez echoed these sentiments, noting the optimal location for administration is one that is quiet and secure and where patients feel safe.

Luís Fernando Tófoli, MD, PhD, professor of medical psychology and psychiatry at the University of Campinas, and Eduardo Schenberg, PhD, founder and CEO of Instituto Phaneros in São Paulo, Brazil, said more research is needed to determine the optimal therapeutic environment for individual agents.

“Most studies have a low number of participants (around 20 or 30), especially in neuroimaging, with high unblinding rates,” Dr. Schenberg said. “Therefore, novel methodological approaches are also necessary, as these substances do not easily fit into the traditional pharmacology epistemic model.”
 

Risks, abuse potential

The abuse potential of psychedelics is an ongoing concern for the public, researchers, and regulators, but the consensus among nearly all of these experts is that when administered by medical professionals in controlled settings, these drugs are associated with extremely low risk.

It is recreational use that presents an abuse concern, said Dr. Ferreri, but with the low doses used in psychiatry, the risk is “very limited or even nonexistent.”

Dr. Nutt said the abuse potential of psychedelics is so low that they can be used to treat addiction.

“Functionally, psychedelics are antiaddictive,” Dr. Nutt said. “The fact is, if you take them repeatedly, you develop tolerance, and the effect disappears. You can’t overcome it. But everyone believes they’re addictive because they’re scheduled drugs.”

Dr. Velásquez is something of an outlier. He believes the abuse potential with psychedelics is poorly understood and that some patients may develop tolerance, which is a potential gateway to dependence.

“Such is the case with LSD,” he said, “where this substance also favors tolerance to other psychedelic drugs such as psilocybin.”

Dosing also seems to play a key role in mitigating potential abuse, said Luca Pani, MD, professor of pharmacology and psychiatry at the University of Modena, Italy. Dr. Pani explained that with low doses and microdoses of psychedelics, the potential for abuse is eliminated.

Dr. Nutt, Dr. Pani, and Dr. Ferreri also noted the importance of medical supervision. For instance, said Dr. Ferreri, when administering ketamine, his team closely monitors both mental and physical parameters – heart rate and blood pressure, in particular – because the drug can have hypertensive effects.

Dr. Schenberg noted that ibogaine, a naturally occurring psychedelic frequently used by traditional communities in Africa in rituals and for healing purposes, could cause potentially fatal arrhythmias, so it’s critical that the treatment is administered in a hospital setting that has a cardiac unit.

Dr. Pani said there is a need for more research, especially regarding the molecular mechanisms behind the behavioral effects of low-dose psychedelic therapy and the potential risks of multiple treatments with the drugs.

“Although extensive toxicology has been conducted on a single active dose of psilocybin, which has been proven to be safe, further research is required to understand better the possible health risks, especially in relation to cardiac and lung tissue,” he said.
 

Psychologically challenging

The experts note that given the relative lack of experience with psychedelic therapy, preparing patients for potential adverse effects is paramount. This is particularly relevant in the research setting and highlights the need for adequate patient screening and aftercare.

Dr. Gründer and Dr. Dolengevich-Segal emphasized the importance of having qualified personnel available in the event that patients experience adverse psychological events during treatment.

For Dr. Gründer, the potential for psilocybin to cause patients to lose control, experience psychotic symptoms, or become paranoid warrants considerable preparation by treating physicians.

Patients occasionally experience fear and anxiety during treatment, though it’s usually short-lived, said Dr. Griffiths. Nevertheless, these experiences may open the door to greater insight. “A number of people report that these psychologically challenging states are a valuable part of the overall experience,” he said.

The situation is similar in Spain, where Dr. Dolengevich-Segal noted that typical treatment regimens have a strong focus on the patient’s experience as a therapeutic tool. As in the United Kingdom and the United States, her team guides patients to what they call a “peak experience,” which allows them to gain a better understanding of the trauma underlying their mental health problems.

Dr. Nutt said that in the United Kingdom, they haven’t seen adverse reactions in patients receiving psychedelic therapy, although sedatives such as benzodiazepines could be used to manage them. He added that at his center, two therapists are present at every treatment session, and all personnel are “trained medics or psychologists.”
 

Patient education

Preparing and educating patients about the therapy are critical, said Dr. Gründer, especially given the intense response psychedelic treatment often invokes.

Echoing Dr. Gründer, Dr. Tófoli said explaining the nature of psychedelic treatment to potential patients helps ease anxiety.

Dr. Griffiths noted that in the United States, study participants are not only educated about the potential effects of psychedelic agents but also undergo several hours of psychological preparation in advance of their first treatment session and are provided with psychological support after treatment.

There is also a strong emphasis on patient preparation and education in the United Kingdom, where patients meet with therapists before and after treatment. During these posttreatment debriefings, clinicians use the patients’ experience with psychedelics to help them gain insight into the underlying cause of their depression.

Dr. Schenberg noted that at his institution in São Paulo, there are online courses to teach clinicians about psychedelic therapy for psychiatric disorders. Next year, he added, a new training program in MDMA-assisted psychotherapy will begin.
 

Working out treatment protocols

Treatment protocols for psychedelics vary by agent and indication from country to country. For instance, Dr. Pani noted that current psychedelic research in Italy predominantly focuses more on microdosing, which involves administering 1% of the pharmacologically active dose to a maximum of 100 mcg, in contrast to low dosing or full dosing.

Therapeutic regimens in Brazil, said Dr. Schenberg, also differ by agent but share common elements. For instance, psychedelics are always administered in a research setting, and sessions include concomitant psychotherapy.

In Germany, investigators are working to determine optimal treatment regimen for psilocybin for resistant depression in a randomized three-arm study planned for 2021.

For Mexico’s Dr. Velásquez, treatment regimens are complex and varied. Either way, he said, patients always require long-term follow-up.

With ketamine therapy, Dr. Ferreri said his team administers the drug in 45- to 60-minute intravenous infusion sessions in a hospital room without light or sound stimulation. Regardless of the drug’s immediate effect, he said, the protocol is repeated within a 6-month period.

The question of the duration of treatment effect is important. Dr. Griffiths said research suggests that the positive effects of psilocybin are long lasting and that most individuals report positive changes in mood, attitude, and behavior that endure for months or even years after the session.

“Our research has shown that the benefits of these experiences can last as long as 14 months, often longer, and that many participants characterize their psilocybin experience as among the most profound and personally meaningful experiences of their lives,” said Dr. Griffiths.

Dr. Nutt agreed, noting that a single intense “trip” can improve mood for weeks, months, or even years. Nevertheless, he said, in his experience, approximately three-quarters of patients treated with psychedelics for major depression relapse within 3-9 months.

“Most get better,” he said, “but the majority of depression comes back over a period of months.”

Given the current illegal status of the drugs, he said it’s nearly impossible to provide patients with regular, subsequent treatment with psychedelics over time.

“My suspicion is that you might well have to dose four or five times over a couple of years to get people to escape from very severe depression,” said Dr. Nutt. “The longer they’ve been depressed, the harder it is for them to make a full recovery, because it’s more entrenched in the brain.”

All experts agree that exciting times are ahead for psychedelics as therapeutics for a wide range of psychiatric disorders.

“We can look forward to continued growth and expansion of this research,” said Dr. Griffiths, “including the refinement of protocols for a variety of therapeutic indications and to the development of a variety of new classic psychedelic compounds.”

A version of this article first appeared on Medscape.com.

News of actor/comedian Pete Davidson expressing relief after finally receiving a diagnosis of borderline personality disorder (BPD) prompted a recent Twitter discussion among physicians regarding the ongoing debate on whether or not to tell a patient he or she has this diagnosis.

“I’ve heard from [many] trainees that they were told never to tell a patient they had BPD, but I can hardly think of anything more paternalistic and stigmatizing,” Amy Barnhorst, MD, vice chair of community psychiatry at University of California, Davis, tweeted.

“Most patients, when I explain it to them, have this kind of reaction – they feel relieved and understood,” she added.

“I was told that as well [not to tell] in one of my practicum placements,” one respondent who identified herself as a clinical/forensic psychologist tweeted back. “I said it anyway and the person was relieved there was a name for what they were living with.”

However, others disagreed with Dr. Barnhorst, noting that BPD is a very serious, stigmatizing, and challenging disorder to treat and, because of this, may cause patients to lose hope.

Still, Dr. Barnhorst stands by her position. Although “there is a negative stigma against a diagnosis of BPD,” that idea more often comes from the clinician instead of the patient, she said.

“I’ve never had a patient say, ‘how dare you call me that!’ like it was an insult,” she said in an interview. Not disclosing a diagnosis “is like you’re not trusting a patient to be a reasonable adult human about this.”
 

‘Hard diagnosis’

Although BPD is a “hard diagnosis, we would never withhold a diagnosis of cancer or liver disease or something else we knew patients didn’t want but that we were going to try and treat them for,” said Dr. Barnhorst.

BPD is linked to significant morbidity because of its common association with comorbid conditions, such as major depressive disorder, substance use disorders, and dysthymia. A history of self-harm is present in 70%-75% of these patients and some estimates suggest up to 9% of individuals with BPD die by suicide.

In an article published in Innovations in Clinical Neuroscience investigators discussed “ethical and clinical questions psychiatrists should consider” when treating BPD, including whether a diagnosis should be shared with a patient.

After such a diagnosis a patient may “react intensely in negative ways and these responses may be easily triggered,” the researchers wrote.

“A propensity that will likely cause psychiatrists anguish, however, is BPD patients’ increased likelihood of attempting suicide,” they added. Part of the problem has been that, in the past, it was thought that a BPD prognosis was untreatable. However, the researchers note that is no longer the case.

Still, Kaz Nelson, MD, associate professor of psychiatry and behavioral sciences at the University of Minnesota, Minneapolis, has labeled BPD a so-called “asterisk” disorder.  

As she wrote in a recent blog, “We tell patients when they meet criteria for a medical diagnosis.* We show compassion and nonjudgmentalism to patients.* We do not discriminate against patients.*” However, the asterisk for each of these statements is: *Except for those with BPD.
 

Ongoing debate

Starting around the 1980s, the DSM listed personality disorders under the No. 2 Axis, which is for conditions with symptoms that are “not mitigatable,” said Dr. Nelson.

“It really started as well-meaning therapists who care about their patients who wanted to develop some precision in understanding people, and them starting to notice some patterns that can get in the way of optimal function,” she said in an interview.

The thought was not to disclose these diagnoses “because that was for you to understand, and for the patient to discover these patterns over time in the course of your work together,” Dr. Nelson added.

Although treatment for BPD used to be virtually nonexistent, there is now hope – especially with dialectic-behavior therapy (DBT), which uses mindfulness to teach patients how to control emotions and improve relationships.

According to the National Education Alliance for BPD, other useful treatments include mentalization-based therapy, transference-focused therapy, and “good psychiatric management.” Although there are currently no approved medications for BPD, some drugs are used to treat comorbid conditions such as depression or anxiety.

“We now know that people recover, and the whole paradigm has been turned on its head,” Dr. Nelson said. For example, “we no longer categorize these things as treatable or untreatable, which was a very positive move.”

So why is the field still debating the issue of diagnosis disclosure?

“To this day there are different psychiatrists and some medical school curricula that continue to teach that personality disorders are long-term, fixed, and nontreatable – and that it’s kind of disparaging to give this kind of diagnosis to a patient,” Dr. Nelson said.

Dr. Nelson, also the vice chair for education at the University of Minnesota, Minneapolis, medical school, reported that there “we acknowledge BPD’s painful history and that there are these misconceptions. They’re going to be on the front line of combating discrimination and the idea that if you see a patient with possible BPD coming you should run. That’s just unacceptable.”

Dr. Nelson noted that the idea of disclosing a BPD diagnosis is less controversial now than in the past, but “the whole thing is still under debate, and treatment guidelines [on BPD] are old and expired.”

Criteria for BPD were not updated when the DSM-5 was published in 2013, and that needs to be fixed, Dr. Nelson added. “In the meantime, we’re trying to get the word out that it’s okay to interact with people about the diagnosis, discuss treatment plans, and manage it as one would with any other psychiatric or medical illness.”
 

An evolution, not a debate

Paul Appelbaum, MD, past president of the American Psychiatric Association and current chair of the organization’s DSM steering committee, said in an interview that he hasn’t been involved in any recent debate on this issue.

“I think practice has changed to the point where the general practice is to discuss patient diagnoses with [patients] openly. Patients appreciate that and psychiatrists have come to see the advantages of it,” said Dr. Appelbaum, a professor of psychiatry, medicine, and law at Columbia University, New York.

Dr. Appelbaum noted that patients also increasingly have access to their medical records, “so the reality is that it’s no longer possible in many cases to withhold a diagnosis.”

“I don’t think it’s a debate; I think it’s been an evolution,” he said. “Maybe not everyone is entirely on board yet but there has been a sea change in psychiatric practices.”

Asked whether there needs to be some type of guideline update or statement released by the APA regarding BPD, Dr. Appelbaum said he doesn’t think the overall issue is BPD specific but applies to all psychiatric diagnoses.

“To the extent that there are still practitioners today that are telling students or residents [not to disclose], I would guess that they were trained a very long time ago and have not adapted to the new world,” he said.

“I don’t want to speak for the APA, but speaking for myself: I certainly encourage residents that I teach to be open about a diagnosis. It’s not just clinically helpful in some cases, it’s also ethically required from the perspective of allowing patients to make appropriate decisions about their treatment. And arguably it’s legally required as well, as part of the informed consent requirement,” Dr. Appelbaum said.

Regarding DSM updates, he noted that the committee “looks to the field to propose to us additions or changes to the DSM that are warranted by data that have been gathered since the DSM-5 came out.” There is a process set up on the DSM’s website to review such proposals.

In addition, Dr. Appelbaum said that there have been discussions about using a new model “that focuses on dimensions rather than on discreet categories” in order to classify personality disorders.

“There’s a group out there that is formulating a proposal that they will submit to us” on this, he added. “That’s the major discussion that is going on right now and it would clearly have implications for borderline as well as all the other personality disorders.”

In a statement, the APA said practice guidelines for BPD are currently under review and that the organization does not have a “position statement” on BPD for clinicians. The last update to its guideline was in the early 2000s.

A version of this article first appeared on Medscape.com.

News of actor/comedian Pete Davidson expressing relief after finally receiving a diagnosis of borderline personality disorder (BPD) prompted a recent Twitter discussion among physicians regarding the ongoing debate on whether or not to tell a patient he or she has this diagnosis.

“I’ve heard from [many] trainees that they were told never to tell a patient they had BPD, but I can hardly think of anything more paternalistic and stigmatizing,” Amy Barnhorst, MD, vice chair of community psychiatry at University of California, Davis, tweeted.

“Most patients, when I explain it to them, have this kind of reaction – they feel relieved and understood,” she added.

“I was told that as well [not to tell] in one of my practicum placements,” one respondent who identified herself as a clinical/forensic psychologist tweeted back. “I said it anyway and the person was relieved there was a name for what they were living with.”

However, others disagreed with Dr. Barnhorst, noting that BPD is a very serious, stigmatizing, and challenging disorder to treat and, because of this, may cause patients to lose hope.

Still, Dr. Barnhorst stands by her position. Although “there is a negative stigma against a diagnosis of BPD,” that idea more often comes from the clinician instead of the patient, she said.

“I’ve never had a patient say, ‘how dare you call me that!’ like it was an insult,” she said in an interview. Not disclosing a diagnosis “is like you’re not trusting a patient to be a reasonable adult human about this.”
 

‘Hard diagnosis’

Although BPD is a “hard diagnosis, we would never withhold a diagnosis of cancer or liver disease or something else we knew patients didn’t want but that we were going to try and treat them for,” said Dr. Barnhorst.

BPD is linked to significant morbidity because of its common association with comorbid conditions, such as major depressive disorder, substance use disorders, and dysthymia. A history of self-harm is present in 70%-75% of these patients and some estimates suggest up to 9% of individuals with BPD die by suicide.

In an article published in Innovations in Clinical Neuroscience investigators discussed “ethical and clinical questions psychiatrists should consider” when treating BPD, including whether a diagnosis should be shared with a patient.

After such a diagnosis a patient may “react intensely in negative ways and these responses may be easily triggered,” the researchers wrote.

“A propensity that will likely cause psychiatrists anguish, however, is BPD patients’ increased likelihood of attempting suicide,” they added. Part of the problem has been that, in the past, it was thought that a BPD prognosis was untreatable. However, the researchers note that is no longer the case.

Still, Kaz Nelson, MD, associate professor of psychiatry and behavioral sciences at the University of Minnesota, Minneapolis, has labeled BPD a so-called “asterisk” disorder.  

As she wrote in a recent blog, “We tell patients when they meet criteria for a medical diagnosis.* We show compassion and nonjudgmentalism to patients.* We do not discriminate against patients.*” However, the asterisk for each of these statements is: *Except for those with BPD.
 

Ongoing debate

Starting around the 1980s, the DSM listed personality disorders under the No. 2 Axis, which is for conditions with symptoms that are “not mitigatable,” said Dr. Nelson.

“It really started as well-meaning therapists who care about their patients who wanted to develop some precision in understanding people, and them starting to notice some patterns that can get in the way of optimal function,” she said in an interview.

The thought was not to disclose these diagnoses “because that was for you to understand, and for the patient to discover these patterns over time in the course of your work together,” Dr. Nelson added.

Although treatment for BPD used to be virtually nonexistent, there is now hope – especially with dialectic-behavior therapy (DBT), which uses mindfulness to teach patients how to control emotions and improve relationships.

According to the National Education Alliance for BPD, other useful treatments include mentalization-based therapy, transference-focused therapy, and “good psychiatric management.” Although there are currently no approved medications for BPD, some drugs are used to treat comorbid conditions such as depression or anxiety.

“We now know that people recover, and the whole paradigm has been turned on its head,” Dr. Nelson said. For example, “we no longer categorize these things as treatable or untreatable, which was a very positive move.”

So why is the field still debating the issue of diagnosis disclosure?

“To this day there are different psychiatrists and some medical school curricula that continue to teach that personality disorders are long-term, fixed, and nontreatable – and that it’s kind of disparaging to give this kind of diagnosis to a patient,” Dr. Nelson said.

Dr. Nelson, also the vice chair for education at the University of Minnesota, Minneapolis, medical school, reported that there “we acknowledge BPD’s painful history and that there are these misconceptions. They’re going to be on the front line of combating discrimination and the idea that if you see a patient with possible BPD coming you should run. That’s just unacceptable.”

Dr. Nelson noted that the idea of disclosing a BPD diagnosis is less controversial now than in the past, but “the whole thing is still under debate, and treatment guidelines [on BPD] are old and expired.”

Criteria for BPD were not updated when the DSM-5 was published in 2013, and that needs to be fixed, Dr. Nelson added. “In the meantime, we’re trying to get the word out that it’s okay to interact with people about the diagnosis, discuss treatment plans, and manage it as one would with any other psychiatric or medical illness.”
 

An evolution, not a debate

Paul Appelbaum, MD, past president of the American Psychiatric Association and current chair of the organization’s DSM steering committee, said in an interview that he hasn’t been involved in any recent debate on this issue.

“I think practice has changed to the point where the general practice is to discuss patient diagnoses with [patients] openly. Patients appreciate that and psychiatrists have come to see the advantages of it,” said Dr. Appelbaum, a professor of psychiatry, medicine, and law at Columbia University, New York.

Dr. Appelbaum noted that patients also increasingly have access to their medical records, “so the reality is that it’s no longer possible in many cases to withhold a diagnosis.”

“I don’t think it’s a debate; I think it’s been an evolution,” he said. “Maybe not everyone is entirely on board yet but there has been a sea change in psychiatric practices.”

Asked whether there needs to be some type of guideline update or statement released by the APA regarding BPD, Dr. Appelbaum said he doesn’t think the overall issue is BPD specific but applies to all psychiatric diagnoses.

“To the extent that there are still practitioners today that are telling students or residents [not to disclose], I would guess that they were trained a very long time ago and have not adapted to the new world,” he said.

“I don’t want to speak for the APA, but speaking for myself: I certainly encourage residents that I teach to be open about a diagnosis. It’s not just clinically helpful in some cases, it’s also ethically required from the perspective of allowing patients to make appropriate decisions about their treatment. And arguably it’s legally required as well, as part of the informed consent requirement,” Dr. Appelbaum said.

Regarding DSM updates, he noted that the committee “looks to the field to propose to us additions or changes to the DSM that are warranted by data that have been gathered since the DSM-5 came out.” There is a process set up on the DSM’s website to review such proposals.

In addition, Dr. Appelbaum said that there have been discussions about using a new model “that focuses on dimensions rather than on discreet categories” in order to classify personality disorders.

“There’s a group out there that is formulating a proposal that they will submit to us” on this, he added. “That’s the major discussion that is going on right now and it would clearly have implications for borderline as well as all the other personality disorders.”

In a statement, the APA said practice guidelines for BPD are currently under review and that the organization does not have a “position statement” on BPD for clinicians. The last update to its guideline was in the early 2000s.

A version of this article first appeared on Medscape.com.

News of actor/comedian Pete Davidson expressing relief after finally receiving a diagnosis of borderline personality disorder (BPD) prompted a recent Twitter discussion among physicians regarding the ongoing debate on whether or not to tell a patient he or she has this diagnosis.

“I’ve heard from [many] trainees that they were told never to tell a patient they had BPD, but I can hardly think of anything more paternalistic and stigmatizing,” Amy Barnhorst, MD, vice chair of community psychiatry at University of California, Davis, tweeted.

“Most patients, when I explain it to them, have this kind of reaction – they feel relieved and understood,” she added.

“I was told that as well [not to tell] in one of my practicum placements,” one respondent who identified herself as a clinical/forensic psychologist tweeted back. “I said it anyway and the person was relieved there was a name for what they were living with.”

However, others disagreed with Dr. Barnhorst, noting that BPD is a very serious, stigmatizing, and challenging disorder to treat and, because of this, may cause patients to lose hope.

Still, Dr. Barnhorst stands by her position. Although “there is a negative stigma against a diagnosis of BPD,” that idea more often comes from the clinician instead of the patient, she said.

“I’ve never had a patient say, ‘how dare you call me that!’ like it was an insult,” she said in an interview. Not disclosing a diagnosis “is like you’re not trusting a patient to be a reasonable adult human about this.”
 

‘Hard diagnosis’

Although BPD is a “hard diagnosis, we would never withhold a diagnosis of cancer or liver disease or something else we knew patients didn’t want but that we were going to try and treat them for,” said Dr. Barnhorst.

BPD is linked to significant morbidity because of its common association with comorbid conditions, such as major depressive disorder, substance use disorders, and dysthymia. A history of self-harm is present in 70%-75% of these patients and some estimates suggest up to 9% of individuals with BPD die by suicide.

In an article published in Innovations in Clinical Neuroscience investigators discussed “ethical and clinical questions psychiatrists should consider” when treating BPD, including whether a diagnosis should be shared with a patient.

After such a diagnosis a patient may “react intensely in negative ways and these responses may be easily triggered,” the researchers wrote.

“A propensity that will likely cause psychiatrists anguish, however, is BPD patients’ increased likelihood of attempting suicide,” they added. Part of the problem has been that, in the past, it was thought that a BPD prognosis was untreatable. However, the researchers note that is no longer the case.

Still, Kaz Nelson, MD, associate professor of psychiatry and behavioral sciences at the University of Minnesota, Minneapolis, has labeled BPD a so-called “asterisk” disorder.  

As she wrote in a recent blog, “We tell patients when they meet criteria for a medical diagnosis.* We show compassion and nonjudgmentalism to patients.* We do not discriminate against patients.*” However, the asterisk for each of these statements is: *Except for those with BPD.
 

Ongoing debate

Starting around the 1980s, the DSM listed personality disorders under the No. 2 Axis, which is for conditions with symptoms that are “not mitigatable,” said Dr. Nelson.

“It really started as well-meaning therapists who care about their patients who wanted to develop some precision in understanding people, and them starting to notice some patterns that can get in the way of optimal function,” she said in an interview.

The thought was not to disclose these diagnoses “because that was for you to understand, and for the patient to discover these patterns over time in the course of your work together,” Dr. Nelson added.

Although treatment for BPD used to be virtually nonexistent, there is now hope – especially with dialectic-behavior therapy (DBT), which uses mindfulness to teach patients how to control emotions and improve relationships.

According to the National Education Alliance for BPD, other useful treatments include mentalization-based therapy, transference-focused therapy, and “good psychiatric management.” Although there are currently no approved medications for BPD, some drugs are used to treat comorbid conditions such as depression or anxiety.

“We now know that people recover, and the whole paradigm has been turned on its head,” Dr. Nelson said. For example, “we no longer categorize these things as treatable or untreatable, which was a very positive move.”

So why is the field still debating the issue of diagnosis disclosure?

“To this day there are different psychiatrists and some medical school curricula that continue to teach that personality disorders are long-term, fixed, and nontreatable – and that it’s kind of disparaging to give this kind of diagnosis to a patient,” Dr. Nelson said.

Dr. Nelson, also the vice chair for education at the University of Minnesota, Minneapolis, medical school, reported that there “we acknowledge BPD’s painful history and that there are these misconceptions. They’re going to be on the front line of combating discrimination and the idea that if you see a patient with possible BPD coming you should run. That’s just unacceptable.”

Dr. Nelson noted that the idea of disclosing a BPD diagnosis is less controversial now than in the past, but “the whole thing is still under debate, and treatment guidelines [on BPD] are old and expired.”

Criteria for BPD were not updated when the DSM-5 was published in 2013, and that needs to be fixed, Dr. Nelson added. “In the meantime, we’re trying to get the word out that it’s okay to interact with people about the diagnosis, discuss treatment plans, and manage it as one would with any other psychiatric or medical illness.”
 

An evolution, not a debate

Paul Appelbaum, MD, past president of the American Psychiatric Association and current chair of the organization’s DSM steering committee, said in an interview that he hasn’t been involved in any recent debate on this issue.

“I think practice has changed to the point where the general practice is to discuss patient diagnoses with [patients] openly. Patients appreciate that and psychiatrists have come to see the advantages of it,” said Dr. Appelbaum, a professor of psychiatry, medicine, and law at Columbia University, New York.

Dr. Appelbaum noted that patients also increasingly have access to their medical records, “so the reality is that it’s no longer possible in many cases to withhold a diagnosis.”

“I don’t think it’s a debate; I think it’s been an evolution,” he said. “Maybe not everyone is entirely on board yet but there has been a sea change in psychiatric practices.”

Asked whether there needs to be some type of guideline update or statement released by the APA regarding BPD, Dr. Appelbaum said he doesn’t think the overall issue is BPD specific but applies to all psychiatric diagnoses.

“To the extent that there are still practitioners today that are telling students or residents [not to disclose], I would guess that they were trained a very long time ago and have not adapted to the new world,” he said.

“I don’t want to speak for the APA, but speaking for myself: I certainly encourage residents that I teach to be open about a diagnosis. It’s not just clinically helpful in some cases, it’s also ethically required from the perspective of allowing patients to make appropriate decisions about their treatment. And arguably it’s legally required as well, as part of the informed consent requirement,” Dr. Appelbaum said.

Regarding DSM updates, he noted that the committee “looks to the field to propose to us additions or changes to the DSM that are warranted by data that have been gathered since the DSM-5 came out.” There is a process set up on the DSM’s website to review such proposals.

In addition, Dr. Appelbaum said that there have been discussions about using a new model “that focuses on dimensions rather than on discreet categories” in order to classify personality disorders.

“There’s a group out there that is formulating a proposal that they will submit to us” on this, he added. “That’s the major discussion that is going on right now and it would clearly have implications for borderline as well as all the other personality disorders.”

In a statement, the APA said practice guidelines for BPD are currently under review and that the organization does not have a “position statement” on BPD for clinicians. The last update to its guideline was in the early 2000s.

A version of this article first appeared on Medscape.com.

April 5 is the official start date of a U.S. law requiring health care organizations to provide patients with free, full, and immediate electronic access to their doctor’s clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal health care legislation. The previous deadline of Nov. 2, 2020, for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.

Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the Department of Health & Human Services for “information blocking.”

This news organization reported on the mandate in 2020, and some readers said it was an unwelcome intrusion into practice. Since then, this news organization has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.

Now, as the legislation turns into a practical clinical matter, there are five key points clinicians should consider.
 

Clinicians don’t have to change writing style.

The new law mandates timely patient access to notes and test results, but it doesn’t require that clinicians alter their writing, said Scott MacDonald, MD, an internist and electronic health record medical director at University of California Davis Health in Sacramento.

“You don’t have to change your notes,” he said. However, patients are now part of the note audience and some health care systems are directing clinicians to make patient-friendly style changes.

Everyday experience should guide clinicians when writing notes, said one expert.

“When you’re not sure [of how to write a note], just mirror the way you would speak in the office – that’s going to get you right, including for mental health issues,” advised Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, in her “take-away” comments in the online video, How to Write an Open Note.

According to a 2020 Medscape poll of 1,050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two-thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1,000 physicians in Boston, Seattle, and rural Pennsylvania, who already work in open notes settings. Only about one-third (37%) reported “spending more time on documentation.”

Note writing is going to change because of the addition of the patient reader, and something will be lost, argued Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” commented Dr. Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.

However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved health care disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple people last year.
 

Some clinical notes can be withheld. 

The new rules from the federal government permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties, Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston wrote in a commentary in February 2021.

There are also state-level laws that can supersede the new U.S. law and block access to notes, points out MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.

The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”
 

Some patients are more likely readers. 

Some patients are more likely to peer into their files than others, said Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient.

“Those patients who have more serious or chronic conditions ... are more likely to read their notes,” she said in an interview.

A new study of nearly 6,000 medical oncology patients at the University of Wisconsin confirmed that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.

Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, N.C., where all patients already have access to clinicians’ notes, told this news organization in 2018.
 

You are part of the avant garde. 

The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, Dr. Blease said in an interview.

“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Dr. Blease’s home country, or most of Europe.

In the United States, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.

It may be hard for the United States to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Uppsala (Sweden) MedTech Science Innovation Center during a webinar last year.
 

The start day will come, and you may not notice. 

“When April 5 happens, something brand new is going to happen symbolically,” Ms. Salmi said. Its importance is hard to measure.

“Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that,” she said.

Dr. MacDonald suggested that open notes are both new and not new. In the fall of 2020, he predicted that the launch day would come, and few clinicians would notice, in part because many patients already access truncated information via patient portals.

However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control.”

Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be okay than what’s actually going to happen [as the law takes effect],” Dr. MacDonald said.

The OpenNotes organization is grant funded, and staff disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

April 5 is the official start date of a U.S. law requiring health care organizations to provide patients with free, full, and immediate electronic access to their doctor’s clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal health care legislation. The previous deadline of Nov. 2, 2020, for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.

Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the Department of Health & Human Services for “information blocking.”

This news organization reported on the mandate in 2020, and some readers said it was an unwelcome intrusion into practice. Since then, this news organization has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.

Now, as the legislation turns into a practical clinical matter, there are five key points clinicians should consider.
 

Clinicians don’t have to change writing style.

The new law mandates timely patient access to notes and test results, but it doesn’t require that clinicians alter their writing, said Scott MacDonald, MD, an internist and electronic health record medical director at University of California Davis Health in Sacramento.

“You don’t have to change your notes,” he said. However, patients are now part of the note audience and some health care systems are directing clinicians to make patient-friendly style changes.

Everyday experience should guide clinicians when writing notes, said one expert.

“When you’re not sure [of how to write a note], just mirror the way you would speak in the office – that’s going to get you right, including for mental health issues,” advised Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, in her “take-away” comments in the online video, How to Write an Open Note.

According to a 2020 Medscape poll of 1,050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two-thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1,000 physicians in Boston, Seattle, and rural Pennsylvania, who already work in open notes settings. Only about one-third (37%) reported “spending more time on documentation.”

Note writing is going to change because of the addition of the patient reader, and something will be lost, argued Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” commented Dr. Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.

However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved health care disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple people last year.
 

Some clinical notes can be withheld. 

The new rules from the federal government permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties, Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston wrote in a commentary in February 2021.

There are also state-level laws that can supersede the new U.S. law and block access to notes, points out MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.

The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”
 

Some patients are more likely readers. 

Some patients are more likely to peer into their files than others, said Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient.

“Those patients who have more serious or chronic conditions ... are more likely to read their notes,” she said in an interview.

A new study of nearly 6,000 medical oncology patients at the University of Wisconsin confirmed that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.

Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, N.C., where all patients already have access to clinicians’ notes, told this news organization in 2018.
 

You are part of the avant garde. 

The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, Dr. Blease said in an interview.

“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Dr. Blease’s home country, or most of Europe.

In the United States, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.

It may be hard for the United States to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Uppsala (Sweden) MedTech Science Innovation Center during a webinar last year.
 

The start day will come, and you may not notice. 

“When April 5 happens, something brand new is going to happen symbolically,” Ms. Salmi said. Its importance is hard to measure.

“Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that,” she said.

Dr. MacDonald suggested that open notes are both new and not new. In the fall of 2020, he predicted that the launch day would come, and few clinicians would notice, in part because many patients already access truncated information via patient portals.

However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control.”

Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be okay than what’s actually going to happen [as the law takes effect],” Dr. MacDonald said.

The OpenNotes organization is grant funded, and staff disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

April 5 is the official start date of a U.S. law requiring health care organizations to provide patients with free, full, and immediate electronic access to their doctor’s clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal health care legislation. The previous deadline of Nov. 2, 2020, for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.

Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the Department of Health & Human Services for “information blocking.”

This news organization reported on the mandate in 2020, and some readers said it was an unwelcome intrusion into practice. Since then, this news organization has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.

Now, as the legislation turns into a practical clinical matter, there are five key points clinicians should consider.
 

Clinicians don’t have to change writing style.

The new law mandates timely patient access to notes and test results, but it doesn’t require that clinicians alter their writing, said Scott MacDonald, MD, an internist and electronic health record medical director at University of California Davis Health in Sacramento.

“You don’t have to change your notes,” he said. However, patients are now part of the note audience and some health care systems are directing clinicians to make patient-friendly style changes.

Everyday experience should guide clinicians when writing notes, said one expert.

“When you’re not sure [of how to write a note], just mirror the way you would speak in the office – that’s going to get you right, including for mental health issues,” advised Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, in her “take-away” comments in the online video, How to Write an Open Note.

According to a 2020 Medscape poll of 1,050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two-thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1,000 physicians in Boston, Seattle, and rural Pennsylvania, who already work in open notes settings. Only about one-third (37%) reported “spending more time on documentation.”

Note writing is going to change because of the addition of the patient reader, and something will be lost, argued Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” commented Dr. Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.

However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved health care disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple people last year.
 

Some clinical notes can be withheld. 

The new rules from the federal government permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties, Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston wrote in a commentary in February 2021.

There are also state-level laws that can supersede the new U.S. law and block access to notes, points out MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.

The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”
 

Some patients are more likely readers. 

Some patients are more likely to peer into their files than others, said Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient.

“Those patients who have more serious or chronic conditions ... are more likely to read their notes,” she said in an interview.

A new study of nearly 6,000 medical oncology patients at the University of Wisconsin confirmed that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.

Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, N.C., where all patients already have access to clinicians’ notes, told this news organization in 2018.
 

You are part of the avant garde. 

The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, Dr. Blease said in an interview.

“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Dr. Blease’s home country, or most of Europe.

In the United States, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.

It may be hard for the United States to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Uppsala (Sweden) MedTech Science Innovation Center during a webinar last year.
 

The start day will come, and you may not notice. 

“When April 5 happens, something brand new is going to happen symbolically,” Ms. Salmi said. Its importance is hard to measure.

“Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that,” she said.

Dr. MacDonald suggested that open notes are both new and not new. In the fall of 2020, he predicted that the launch day would come, and few clinicians would notice, in part because many patients already access truncated information via patient portals.

However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control.”

Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be okay than what’s actually going to happen [as the law takes effect],” Dr. MacDonald said.

The OpenNotes organization is grant funded, and staff disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.