MDedge Psychiatry

Why are teenage boys obsessed with bulking up?

While the effects of Instagram on girls’ body image has long been documented – an article in The Wall Street Journal that was published this fall reported that Facebook knew Instagram was toxic for teen girls – teenage boys are under just as much pressure.

For adolescent boys, the goal is often to get superhero-size buff – and this is leading to anxiety, stress, excessive selfies, and, often, obsessive staring in the mirror to assess their “pec” progress.

So-called “bigorexia” – or extreme gym time, excessive focus on protein diets, and intense muscle-building goals – has hit new and concerning levels, according to a recent New York Times report.

Whether it’s the pandemic or TikTok that’s to blame, teen boys are pushing hard to achieve six-pack abs, with one-third of them in the U.S. trying to bulk up, according to a study published in the Journal of Adolescent Health. What’s more, 22% reported they’re engaging in muscle-enhancing behavior, including excess exercise, taking supplements or steroids, or eating more to bulk up, according to a study published in the International Journal of Eating Disorders.

“The pandemic and social media have been a perfect storm for eating disorders and body image issues for all teens, but this has been under-recognized in boys,” says Jason Nagata, MD, a pediatrician who specializes in adolescent medicine at the University of California, San Francisco. “Both are directly connected to an increase in muscle dysmorphia.”

While “bigorexia” is a newer term coined by mental health professionals, the concept of muscular dysmorphia isn’t, says Jennifer Bahrman, PhD, a licensed psychologist with McGovern Medical School at UTHealth Houston. This may be why about a third of boys ages 11-18 reported that they aren’t enamored with their bodies, according to a small survey published in 2019 in the Californian Journal of Health Promotion.

“When we think of dysmorphia, we think of girls having it, since we see it more in females,” says Dr. Bahrman, who works extensively with adolescents and athletes. “The interesting thing about muscular dysmorphia is that it’s the only body dysmorphic disorder that’s almost exclusively present in males.”
 

Social media’s role

Unlike other things in boys’ lives, like movies, TV, or even the uber-buff GI Joe doll, social media has created opportunities for young men to put their bodies on display – and become an influencer or get followers because of it.

“An everyday teen can become a celebrity,” Dr. Nagata says. “Then, thanks to social media algorithms, if a teenage boy likes or interacts with a post that features a muscular guy or is all about fitness, they’ll start getting all sorts of related content. They’ll get bombarded with tons of ads for protein shakes, for example, as well as bodybuilding equipment, and that will further distort reality.”

Before-and-after photos are also known to be quite misleading.

“Some of the most popular Instagram posts among teens feature people who have experienced a massive body transformation,” Dr. Nagata says. “It’s usually someone who lost a lot of weight or someone who was scrawny and then got muscular. The most drastic changes tend to get the most likes and are perpetuated the most and shared the most often with friends.”

But as many are aware, photos posted to social media are selected to tell the best story – with the best filters, lighting, and angles possible, however exaggerated.

“A guy will post his worst picture out of a thousand for his before shot and then post the best photo out of a thousand,” Dr. Nagata says. “This, in itself, can really confuse a teenager, because the story of this person’s changed body looks so realistic.”

Worse, these images tend to be damaging to your teenager’s self-esteem.

“When you see images of people you’re aspiring to look like, it can be very upsetting,” Dr. Bahrman says. “After all, it’s easy to think, ‘I’m doing all of these pushups, and I don’t look like this.’ From there, it’s easy to begin internalizing that something is wrong with you.”
 

Red flags to watch out for

If you’ve noticed that your son is obsessed with his appearance, weight, food, or exercise, take note. Also, notice if he’s asking you to buy protein powder or is spending more time at the gym than with his friends.

“Pay attention if he is withdrawing from friends and family because of his concerns about his appearance,” Dr. Nagata says. “For example, we often hear that a teenager will no longer eat family meals or at a restaurant because the protein content isn’t high enough or the food is too fatty.”

If you’re concerned, always make sure to discuss this with your son’s pediatrician.

“Ultimately, you want to make sure you share your concerns before your teen son becomes even more body-image obsessed,” Dr. Nagata says.

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

Why are teenage boys obsessed with bulking up?

While the effects of Instagram on girls’ body image has long been documented – an article in The Wall Street Journal that was published this fall reported that Facebook knew Instagram was toxic for teen girls – teenage boys are under just as much pressure.

For adolescent boys, the goal is often to get superhero-size buff – and this is leading to anxiety, stress, excessive selfies, and, often, obsessive staring in the mirror to assess their “pec” progress.

So-called “bigorexia” – or extreme gym time, excessive focus on protein diets, and intense muscle-building goals – has hit new and concerning levels, according to a recent New York Times report.

Whether it’s the pandemic or TikTok that’s to blame, teen boys are pushing hard to achieve six-pack abs, with one-third of them in the U.S. trying to bulk up, according to a study published in the Journal of Adolescent Health. What’s more, 22% reported they’re engaging in muscle-enhancing behavior, including excess exercise, taking supplements or steroids, or eating more to bulk up, according to a study published in the International Journal of Eating Disorders.

“The pandemic and social media have been a perfect storm for eating disorders and body image issues for all teens, but this has been under-recognized in boys,” says Jason Nagata, MD, a pediatrician who specializes in adolescent medicine at the University of California, San Francisco. “Both are directly connected to an increase in muscle dysmorphia.”

While “bigorexia” is a newer term coined by mental health professionals, the concept of muscular dysmorphia isn’t, says Jennifer Bahrman, PhD, a licensed psychologist with McGovern Medical School at UTHealth Houston. This may be why about a third of boys ages 11-18 reported that they aren’t enamored with their bodies, according to a small survey published in 2019 in the Californian Journal of Health Promotion.

“When we think of dysmorphia, we think of girls having it, since we see it more in females,” says Dr. Bahrman, who works extensively with adolescents and athletes. “The interesting thing about muscular dysmorphia is that it’s the only body dysmorphic disorder that’s almost exclusively present in males.”
 

Social media’s role

Unlike other things in boys’ lives, like movies, TV, or even the uber-buff GI Joe doll, social media has created opportunities for young men to put their bodies on display – and become an influencer or get followers because of it.

“An everyday teen can become a celebrity,” Dr. Nagata says. “Then, thanks to social media algorithms, if a teenage boy likes or interacts with a post that features a muscular guy or is all about fitness, they’ll start getting all sorts of related content. They’ll get bombarded with tons of ads for protein shakes, for example, as well as bodybuilding equipment, and that will further distort reality.”

Before-and-after photos are also known to be quite misleading.

“Some of the most popular Instagram posts among teens feature people who have experienced a massive body transformation,” Dr. Nagata says. “It’s usually someone who lost a lot of weight or someone who was scrawny and then got muscular. The most drastic changes tend to get the most likes and are perpetuated the most and shared the most often with friends.”

But as many are aware, photos posted to social media are selected to tell the best story – with the best filters, lighting, and angles possible, however exaggerated.

“A guy will post his worst picture out of a thousand for his before shot and then post the best photo out of a thousand,” Dr. Nagata says. “This, in itself, can really confuse a teenager, because the story of this person’s changed body looks so realistic.”

Worse, these images tend to be damaging to your teenager’s self-esteem.

“When you see images of people you’re aspiring to look like, it can be very upsetting,” Dr. Bahrman says. “After all, it’s easy to think, ‘I’m doing all of these pushups, and I don’t look like this.’ From there, it’s easy to begin internalizing that something is wrong with you.”
 

Red flags to watch out for

If you’ve noticed that your son is obsessed with his appearance, weight, food, or exercise, take note. Also, notice if he’s asking you to buy protein powder or is spending more time at the gym than with his friends.

“Pay attention if he is withdrawing from friends and family because of his concerns about his appearance,” Dr. Nagata says. “For example, we often hear that a teenager will no longer eat family meals or at a restaurant because the protein content isn’t high enough or the food is too fatty.”

If you’re concerned, always make sure to discuss this with your son’s pediatrician.

“Ultimately, you want to make sure you share your concerns before your teen son becomes even more body-image obsessed,” Dr. Nagata says.

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

Why are teenage boys obsessed with bulking up?

While the effects of Instagram on girls’ body image has long been documented – an article in The Wall Street Journal that was published this fall reported that Facebook knew Instagram was toxic for teen girls – teenage boys are under just as much pressure.

For adolescent boys, the goal is often to get superhero-size buff – and this is leading to anxiety, stress, excessive selfies, and, often, obsessive staring in the mirror to assess their “pec” progress.

So-called “bigorexia” – or extreme gym time, excessive focus on protein diets, and intense muscle-building goals – has hit new and concerning levels, according to a recent New York Times report.

Whether it’s the pandemic or TikTok that’s to blame, teen boys are pushing hard to achieve six-pack abs, with one-third of them in the U.S. trying to bulk up, according to a study published in the Journal of Adolescent Health. What’s more, 22% reported they’re engaging in muscle-enhancing behavior, including excess exercise, taking supplements or steroids, or eating more to bulk up, according to a study published in the International Journal of Eating Disorders.

“The pandemic and social media have been a perfect storm for eating disorders and body image issues for all teens, but this has been under-recognized in boys,” says Jason Nagata, MD, a pediatrician who specializes in adolescent medicine at the University of California, San Francisco. “Both are directly connected to an increase in muscle dysmorphia.”

While “bigorexia” is a newer term coined by mental health professionals, the concept of muscular dysmorphia isn’t, says Jennifer Bahrman, PhD, a licensed psychologist with McGovern Medical School at UTHealth Houston. This may be why about a third of boys ages 11-18 reported that they aren’t enamored with their bodies, according to a small survey published in 2019 in the Californian Journal of Health Promotion.

“When we think of dysmorphia, we think of girls having it, since we see it more in females,” says Dr. Bahrman, who works extensively with adolescents and athletes. “The interesting thing about muscular dysmorphia is that it’s the only body dysmorphic disorder that’s almost exclusively present in males.”
 

Social media’s role

Unlike other things in boys’ lives, like movies, TV, or even the uber-buff GI Joe doll, social media has created opportunities for young men to put their bodies on display – and become an influencer or get followers because of it.

“An everyday teen can become a celebrity,” Dr. Nagata says. “Then, thanks to social media algorithms, if a teenage boy likes or interacts with a post that features a muscular guy or is all about fitness, they’ll start getting all sorts of related content. They’ll get bombarded with tons of ads for protein shakes, for example, as well as bodybuilding equipment, and that will further distort reality.”

Before-and-after photos are also known to be quite misleading.

“Some of the most popular Instagram posts among teens feature people who have experienced a massive body transformation,” Dr. Nagata says. “It’s usually someone who lost a lot of weight or someone who was scrawny and then got muscular. The most drastic changes tend to get the most likes and are perpetuated the most and shared the most often with friends.”

But as many are aware, photos posted to social media are selected to tell the best story – with the best filters, lighting, and angles possible, however exaggerated.

“A guy will post his worst picture out of a thousand for his before shot and then post the best photo out of a thousand,” Dr. Nagata says. “This, in itself, can really confuse a teenager, because the story of this person’s changed body looks so realistic.”

Worse, these images tend to be damaging to your teenager’s self-esteem.

“When you see images of people you’re aspiring to look like, it can be very upsetting,” Dr. Bahrman says. “After all, it’s easy to think, ‘I’m doing all of these pushups, and I don’t look like this.’ From there, it’s easy to begin internalizing that something is wrong with you.”
 

Red flags to watch out for

If you’ve noticed that your son is obsessed with his appearance, weight, food, or exercise, take note. Also, notice if he’s asking you to buy protein powder or is spending more time at the gym than with his friends.

“Pay attention if he is withdrawing from friends and family because of his concerns about his appearance,” Dr. Nagata says. “For example, we often hear that a teenager will no longer eat family meals or at a restaurant because the protein content isn’t high enough or the food is too fatty.”

If you’re concerned, always make sure to discuss this with your son’s pediatrician.

“Ultimately, you want to make sure you share your concerns before your teen son becomes even more body-image obsessed,” Dr. Nagata says.

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

“People don’t think about schizophrenia when they think about HIV,” Christina Mangurian, MD, professor of clinical psychiatry and vice chair for diversity and health equity at the University of California, San Francisco (UCSF), told this news organization.

University of California, San Francisco

The problem is complicated. According to the Centers for Disease Control and Prevention and National Institutes of Health, roughly 6% of people with serious mental illness are living with HIV, a rate that is about 10 times higher than the general U.S. population (0.4%). However, findings from a study by Dr. Mangurian and her team, published online in the journal AIDS, demonstrated that half of Medicaid patients with schizophrenia and HIV admitted to inpatient units in New York State were not coded as such upon discharge.

These data raise the question: How many people living with comorbid HIV and serious mental illness are diagnosed, virally suppressed, and/or lost to treatment as a result of the stigma associated with both conditions, lack of social support, and under-recognition by practitioners that a problem even exists?
 

Lost in the care continuum

Dr. Mangurian and her research team examined documentation of pre-existing HIV/AIDS diagnoses and absence of ICD-9-CM HIV/AIDS coding at psychiatric discharge among 14,602 adults (aged 18-64 years) admitted to hospital inpatient units in New York State between Jan. 1, 2012, and Dec. 31, 2013. HIV diagnoses were defined as recent (within 30 days of admission) or distant (within 30-366 days of admission), and first admission was used as the index in people with multiple hospitalizations.

People living with HIV comprised 5.1% (741) of the overall dataset; 34% were diagnosed with schizophrenia and 27.9% with bipolar disorders. Overall, 54.5% were male and 50.7% were non-Hispanic Black. Furthermore, 58.3% were discharged without HIV/AIDS ICD-9 coding, reinforcing the likelihood that they were lost in the care continuum.

Dr. Mangurian explained that this break in the chain of care upon discharge can have an important impact on efforts to break the cycle of HIV transmission.

“There’s data that people with serious mental illnesses like schizophrenia are less likely to have sex, but when they do they’re more likely to engage in risky sexual behaviors, including sex for money [and] unprotected sex with partners who use injection drugs or who have HIV,” she said.

Although the majority of patients – both with and without prior HIV diagnoses – were older, adjusted models demonstrated that people aged 18-24 years had more than twice the odds of having their HIV/AIDS undocumented at discharge, compared with older adults aged 55-64 years (adjusted odds ratio, 2.37; P = .038), as were those aged 25-34 years (aOR, 2.17; P = .003). Individuals with more distant HIV diagnoses had three times the odds for an undocumented HIV/AIDS discharge, compared with more recent diagnoses (aOR, 3.25; P < .001). 

Additional factors contributing to the lack of ICD-9 discharge coding included shorter lengths of stay (0-3 days vs. 15-30 days; aOR, 0.03; P = .01) and fewer HIV claims for HIV/AIDS services before hospitalization (1-2 vs. 3-9; aOR, 0.34; P < .01). Hospitals serving medium or high levels of Medicaid patients were also less likely to document HIV/AIDS before discharge (medium aOR, 1.69, P = .01; high aOR, 1.71, P = .03).

The study is not without limitations. For example, the 10-year-old dataset might not entirely reflect more recent structural or systemic changes for improving HIV detection on inpatient psychiatric units. Moreover, there was no comparator group without psychiatric inpatient admission.

Still, “[if these patients] didn’t have a discharge diagnosis, then it’s possible that they were not managed for their HIV, or their HIV was not addressed while they were in the hospital,” Sarah Andrews, MD, assistant professor of psychiatry and behavioral sciences and AIDS psychiatrist at Johns Hopkins School of Medicine, Baltimore, explained.

Johns Hopkins School of Medicine

Severe mental health an HIV disparity

Despite the burden of HIV among patient populations with serious mental health issues and data suggesting that these populations are over-represented among new HIV infections, the study findings point to an important missed opportunity for meeting several key outcomes on the HIV/AIDS care continuum, especially linkage to and retention in care.

The challenge is multifactorial.

In an earlier publication appearing in April 2021 in The Lancet HIV, Dr. Mangurian and colleagues explore a concept known as the “purview paradox,” which refers to a practitioner’s belief about who should be responsible for offering patients a particular intervention.

Structural and systemic issues also abound, as psychiatry records are often kept separate from the rest of the medical system due to insurer billing issues. “The true integration of all psychiatric and medical care has to happen to make sure that all of our patients receive the care that they deserve,” explained Dr. Mangurian.

Dr. Andrews agrees. “HIV care, as well as psychiatry, case management, pharmacy ... putting them together really helps decrease the risk of falling through the cracks and being able to refer appropriately for mental health,” she said.

Aside from changing practitioner attitudes and awareness and changing systems to include the wrap-around care model, current guidelines also need to reflect the role that patients with HIV and psychiatric comorbidities play in HIV transmission. Dr. Andrews and Dr. Mangurian agree: Routine screening in psychiatric inpatient units might be a good start.

The study was independently supported. Dr. Mangurian has reported grant funding from Genentech Charitable Foundation. Dr. Andrews has reported no relevant financial relationships.

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

“People don’t think about schizophrenia when they think about HIV,” Christina Mangurian, MD, professor of clinical psychiatry and vice chair for diversity and health equity at the University of California, San Francisco (UCSF), told this news organization.

University of California, San Francisco

The problem is complicated. According to the Centers for Disease Control and Prevention and National Institutes of Health, roughly 6% of people with serious mental illness are living with HIV, a rate that is about 10 times higher than the general U.S. population (0.4%). However, findings from a study by Dr. Mangurian and her team, published online in the journal AIDS, demonstrated that half of Medicaid patients with schizophrenia and HIV admitted to inpatient units in New York State were not coded as such upon discharge.

These data raise the question: How many people living with comorbid HIV and serious mental illness are diagnosed, virally suppressed, and/or lost to treatment as a result of the stigma associated with both conditions, lack of social support, and under-recognition by practitioners that a problem even exists?
 

Lost in the care continuum

Dr. Mangurian and her research team examined documentation of pre-existing HIV/AIDS diagnoses and absence of ICD-9-CM HIV/AIDS coding at psychiatric discharge among 14,602 adults (aged 18-64 years) admitted to hospital inpatient units in New York State between Jan. 1, 2012, and Dec. 31, 2013. HIV diagnoses were defined as recent (within 30 days of admission) or distant (within 30-366 days of admission), and first admission was used as the index in people with multiple hospitalizations.

People living with HIV comprised 5.1% (741) of the overall dataset; 34% were diagnosed with schizophrenia and 27.9% with bipolar disorders. Overall, 54.5% were male and 50.7% were non-Hispanic Black. Furthermore, 58.3% were discharged without HIV/AIDS ICD-9 coding, reinforcing the likelihood that they were lost in the care continuum.

Dr. Mangurian explained that this break in the chain of care upon discharge can have an important impact on efforts to break the cycle of HIV transmission.

“There’s data that people with serious mental illnesses like schizophrenia are less likely to have sex, but when they do they’re more likely to engage in risky sexual behaviors, including sex for money [and] unprotected sex with partners who use injection drugs or who have HIV,” she said.

Although the majority of patients – both with and without prior HIV diagnoses – were older, adjusted models demonstrated that people aged 18-24 years had more than twice the odds of having their HIV/AIDS undocumented at discharge, compared with older adults aged 55-64 years (adjusted odds ratio, 2.37; P = .038), as were those aged 25-34 years (aOR, 2.17; P = .003). Individuals with more distant HIV diagnoses had three times the odds for an undocumented HIV/AIDS discharge, compared with more recent diagnoses (aOR, 3.25; P < .001). 

Additional factors contributing to the lack of ICD-9 discharge coding included shorter lengths of stay (0-3 days vs. 15-30 days; aOR, 0.03; P = .01) and fewer HIV claims for HIV/AIDS services before hospitalization (1-2 vs. 3-9; aOR, 0.34; P < .01). Hospitals serving medium or high levels of Medicaid patients were also less likely to document HIV/AIDS before discharge (medium aOR, 1.69, P = .01; high aOR, 1.71, P = .03).

The study is not without limitations. For example, the 10-year-old dataset might not entirely reflect more recent structural or systemic changes for improving HIV detection on inpatient psychiatric units. Moreover, there was no comparator group without psychiatric inpatient admission.

Still, “[if these patients] didn’t have a discharge diagnosis, then it’s possible that they were not managed for their HIV, or their HIV was not addressed while they were in the hospital,” Sarah Andrews, MD, assistant professor of psychiatry and behavioral sciences and AIDS psychiatrist at Johns Hopkins School of Medicine, Baltimore, explained.

Johns Hopkins School of Medicine

Severe mental health an HIV disparity

Despite the burden of HIV among patient populations with serious mental health issues and data suggesting that these populations are over-represented among new HIV infections, the study findings point to an important missed opportunity for meeting several key outcomes on the HIV/AIDS care continuum, especially linkage to and retention in care.

The challenge is multifactorial.

In an earlier publication appearing in April 2021 in The Lancet HIV, Dr. Mangurian and colleagues explore a concept known as the “purview paradox,” which refers to a practitioner’s belief about who should be responsible for offering patients a particular intervention.

Structural and systemic issues also abound, as psychiatry records are often kept separate from the rest of the medical system due to insurer billing issues. “The true integration of all psychiatric and medical care has to happen to make sure that all of our patients receive the care that they deserve,” explained Dr. Mangurian.

Dr. Andrews agrees. “HIV care, as well as psychiatry, case management, pharmacy ... putting them together really helps decrease the risk of falling through the cracks and being able to refer appropriately for mental health,” she said.

Aside from changing practitioner attitudes and awareness and changing systems to include the wrap-around care model, current guidelines also need to reflect the role that patients with HIV and psychiatric comorbidities play in HIV transmission. Dr. Andrews and Dr. Mangurian agree: Routine screening in psychiatric inpatient units might be a good start.

The study was independently supported. Dr. Mangurian has reported grant funding from Genentech Charitable Foundation. Dr. Andrews has reported no relevant financial relationships.

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

“People don’t think about schizophrenia when they think about HIV,” Christina Mangurian, MD, professor of clinical psychiatry and vice chair for diversity and health equity at the University of California, San Francisco (UCSF), told this news organization.

University of California, San Francisco

The problem is complicated. According to the Centers for Disease Control and Prevention and National Institutes of Health, roughly 6% of people with serious mental illness are living with HIV, a rate that is about 10 times higher than the general U.S. population (0.4%). However, findings from a study by Dr. Mangurian and her team, published online in the journal AIDS, demonstrated that half of Medicaid patients with schizophrenia and HIV admitted to inpatient units in New York State were not coded as such upon discharge.

These data raise the question: How many people living with comorbid HIV and serious mental illness are diagnosed, virally suppressed, and/or lost to treatment as a result of the stigma associated with both conditions, lack of social support, and under-recognition by practitioners that a problem even exists?
 

Lost in the care continuum

Dr. Mangurian and her research team examined documentation of pre-existing HIV/AIDS diagnoses and absence of ICD-9-CM HIV/AIDS coding at psychiatric discharge among 14,602 adults (aged 18-64 years) admitted to hospital inpatient units in New York State between Jan. 1, 2012, and Dec. 31, 2013. HIV diagnoses were defined as recent (within 30 days of admission) or distant (within 30-366 days of admission), and first admission was used as the index in people with multiple hospitalizations.

People living with HIV comprised 5.1% (741) of the overall dataset; 34% were diagnosed with schizophrenia and 27.9% with bipolar disorders. Overall, 54.5% were male and 50.7% were non-Hispanic Black. Furthermore, 58.3% were discharged without HIV/AIDS ICD-9 coding, reinforcing the likelihood that they were lost in the care continuum.

Dr. Mangurian explained that this break in the chain of care upon discharge can have an important impact on efforts to break the cycle of HIV transmission.

“There’s data that people with serious mental illnesses like schizophrenia are less likely to have sex, but when they do they’re more likely to engage in risky sexual behaviors, including sex for money [and] unprotected sex with partners who use injection drugs or who have HIV,” she said.

Although the majority of patients – both with and without prior HIV diagnoses – were older, adjusted models demonstrated that people aged 18-24 years had more than twice the odds of having their HIV/AIDS undocumented at discharge, compared with older adults aged 55-64 years (adjusted odds ratio, 2.37; P = .038), as were those aged 25-34 years (aOR, 2.17; P = .003). Individuals with more distant HIV diagnoses had three times the odds for an undocumented HIV/AIDS discharge, compared with more recent diagnoses (aOR, 3.25; P < .001). 

Additional factors contributing to the lack of ICD-9 discharge coding included shorter lengths of stay (0-3 days vs. 15-30 days; aOR, 0.03; P = .01) and fewer HIV claims for HIV/AIDS services before hospitalization (1-2 vs. 3-9; aOR, 0.34; P < .01). Hospitals serving medium or high levels of Medicaid patients were also less likely to document HIV/AIDS before discharge (medium aOR, 1.69, P = .01; high aOR, 1.71, P = .03).

The study is not without limitations. For example, the 10-year-old dataset might not entirely reflect more recent structural or systemic changes for improving HIV detection on inpatient psychiatric units. Moreover, there was no comparator group without psychiatric inpatient admission.

Still, “[if these patients] didn’t have a discharge diagnosis, then it’s possible that they were not managed for their HIV, or their HIV was not addressed while they were in the hospital,” Sarah Andrews, MD, assistant professor of psychiatry and behavioral sciences and AIDS psychiatrist at Johns Hopkins School of Medicine, Baltimore, explained.

Johns Hopkins School of Medicine

Severe mental health an HIV disparity

Despite the burden of HIV among patient populations with serious mental health issues and data suggesting that these populations are over-represented among new HIV infections, the study findings point to an important missed opportunity for meeting several key outcomes on the HIV/AIDS care continuum, especially linkage to and retention in care.

The challenge is multifactorial.

In an earlier publication appearing in April 2021 in The Lancet HIV, Dr. Mangurian and colleagues explore a concept known as the “purview paradox,” which refers to a practitioner’s belief about who should be responsible for offering patients a particular intervention.

Structural and systemic issues also abound, as psychiatry records are often kept separate from the rest of the medical system due to insurer billing issues. “The true integration of all psychiatric and medical care has to happen to make sure that all of our patients receive the care that they deserve,” explained Dr. Mangurian.

Dr. Andrews agrees. “HIV care, as well as psychiatry, case management, pharmacy ... putting them together really helps decrease the risk of falling through the cracks and being able to refer appropriately for mental health,” she said.

Aside from changing practitioner attitudes and awareness and changing systems to include the wrap-around care model, current guidelines also need to reflect the role that patients with HIV and psychiatric comorbidities play in HIV transmission. Dr. Andrews and Dr. Mangurian agree: Routine screening in psychiatric inpatient units might be a good start.

The study was independently supported. Dr. Mangurian has reported grant funding from Genentech Charitable Foundation. Dr. Andrews has reported no relevant financial relationships.

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

The American Academy of Neurology (AAN) has released new expert guidance on palliative care for patients with stroke, dementia, Parkinson’s disease, and other neurologic disorders.

Palliative care includes much more than hospice services, lead author of the new position statement Lynne P. Taylor, MD, University of Washington, Seattle, and a fellow of the AAN, said in a press release.

“Neurologists provide palliative care to people living with life-altering neurologic illnesses not just at the end of life but throughout the course of a disease, improving their lives with symptom control,” Dr. Taylor added.

The position paper, developed by a joint committee of the AAN, American Neurological Association, and Child Neurology Society, was published online March 8 in Neurology.
 

Guidance across the lifespan

The new paper, an update of previous position statements, includes palliative care guidance for different neurologic disorders across the lifespan. For example, neuropalliative care for neonates deserves “extra consideration,” because one-third of pediatric deaths occur during the neonatal period, most often in the neonatal intensive care unit, and after withdrawal of life-sustaining interventions, the authors note.

For older children, neuropalliative care consultation benefits families trying to maximize the quality of the remainder of their child’s life. Decisionmaking must consider the child’s cognitive abilities, the diagnosis, the perceived level of suffering, parental values, and the family’s understanding of the prognosis, the authors note.

They note that discussions about prognosis are often difficult but critical. Previous research “supports that patients desire prognostic information even when prognosis is uncertain and appreciate when their physicians disclose the presence of that uncertainty,” the authors note.

Also important is engaging in shared decisionmaking with patients and families. “This approach requires the physician to elicit a patient’s goals, make recommendations based on whether medical treatments are likely to achieve those goals, and work with patients and families to finalize a treatment plan,” according to the new guidance.
 

Ethical considerations

When treatments are physiologically futile, clinicians need to explain why interventions that may cause harm and have no benefit are not offered.

The authors cite cardiopulmonary resuscitation in the setting of cardiac arrest from irreversible herniation as an example of futility in the context of neurologic disease.

When life-prolonging care is no longer an option, clinicians have an obligation to shift the focus of care to preserving quality of life and comfort as much as possible, they add.

Hospices, which provide comfort-focused medical care as well as psychosocial and spiritual support, are reserved for patients believed to be in the last 6 months of their life if their disease follows the expected course.

The investigators also broached ethical considerations for individual neurologic conditions. Concerns for disorders of consciousness include misdiagnosis or inaccurate prognostication, and serial examinations are needed to re-evaluate levels of cognition, psychological state, decisionmaking capacity, and disease trajectory.

In patients with locked-in syndrome, a state of irreversible paralysis, often with respiratory and vocal paralysis, consciousness may range from a chronic minimally conscious state to intact cognition.

Without careful examination, patients with preserved consciousness may be mistaken as having a disorder of consciousness and risk their decisional capacity being ignored, the researchers note.

These patients may need assistance from speech pathologists to identify techniques to enhance communication, such as careful “yes/no” questioning, communication boards, or advanced eye-gaze technology, they add.
 

Stroke, dementia, Parkinson’s guidance

For stroke, the guidance suggests neurologists encourage patients with retained decisionmaking capacity to complete advance care planning given the risk of recurrent stroke and loss of capacity in the future.

For dementia, a proper and timely diagnosis can help patients and their families prepare for the consequences of cognitive dysfunction and loss of autonomy while respecting their identified values, the authors write.

They note that for Parkinson’s disease, which is marked by slow functional and cognitive decline, neurologists must aim to anticipate and treat symptoms, address psychosocial and spiritual distress and caregiver burden, and engage patients and families in advance care planning before onset of cognitive impairment.

For patients with amyotrophic lateral sclerosis (ALS) and related disorders, clinicians should aim to document goals and treatment preferences prior to extreme weakness and aphonia.

It is also important to anticipate patient preferences for future disability-specific decisions, such as those related to feeding tubes and mechanical ventilation, and to identify the patient’s minimal acceptable outcome from these life-sustaining interventions.

On the topic of withdrawal of treatment, the paper notes that competent patients have the right to refuse life-prolonging therapies, including artificial nutrition, hydration, mechanical ventilation, and antibiotics. If physicians have a moral objection to removing life-support systems, they are obligated to transfer the care of the patient to another physician, the authors add.

Once a decision is made to forgo life-sustaining treatment, physicians should minimize subsequent suffering. The investigators note most symptoms at the end of life can be managed without sedation.

In broaching the “gap” in neurology training programs, the statement referred to a survey of 49 neurology residency programs. Results showed that 42% of respondents reported being dissatisfied with their palliative care education.
 

Well-timed update

Kate T. Brizzi, MD, a Boston neurologist with experience in hospice and palliative care, said the updated position statement is “well-timed” as neuropalliative care has evolved dramatically over the last decade.

“In the last several years, I’ve witnessed a significant increase in trainee interest in the field, and there is growing recognition of how a palliative care approach can improve patient care and hopefully outcomes,” said Dr. Brizzi.

She praised the authors for doing “an excellent job” in highlighting the ethical challenges facing the neurology provider, particularly as it relates to prognostication in an uncertain setting.

Dr. Brizzi noted communication tools that help facilitate discussions around shared decisionmaking “have enhanced our ability to meet the palliative care needs of our patients and can be incorporated by any provider.”

However, she added that the paper only briefly comments on the role of the neurologist in “lawful physician-hastened death.”

“I anticipate that this will be an area of further discussion in the neurology and palliative care community in the future, as requests for hastened death are frequently encountered from patients with serious neurologic illness,” she said.

Dr. Brizzi also noted the importance of understanding the reasons behind the request – and addressing patient worries related to end-of-life care, which can frequently help alleviate distress.

There was no targeted funding for this paper. Coauthor Salvador Cruz-Flores, MD, department of neurology, Texas Tech University Center, El Paso, reported participation on member adjudication committees for clinical trials for Novo Nordisk, Sunovion, and Galapagos. The remaining authors have disclosed no relevant financial relationships.

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

The American Academy of Neurology (AAN) has released new expert guidance on palliative care for patients with stroke, dementia, Parkinson’s disease, and other neurologic disorders.

Palliative care includes much more than hospice services, lead author of the new position statement Lynne P. Taylor, MD, University of Washington, Seattle, and a fellow of the AAN, said in a press release.

“Neurologists provide palliative care to people living with life-altering neurologic illnesses not just at the end of life but throughout the course of a disease, improving their lives with symptom control,” Dr. Taylor added.

The position paper, developed by a joint committee of the AAN, American Neurological Association, and Child Neurology Society, was published online March 8 in Neurology.
 

Guidance across the lifespan

The new paper, an update of previous position statements, includes palliative care guidance for different neurologic disorders across the lifespan. For example, neuropalliative care for neonates deserves “extra consideration,” because one-third of pediatric deaths occur during the neonatal period, most often in the neonatal intensive care unit, and after withdrawal of life-sustaining interventions, the authors note.

For older children, neuropalliative care consultation benefits families trying to maximize the quality of the remainder of their child’s life. Decisionmaking must consider the child’s cognitive abilities, the diagnosis, the perceived level of suffering, parental values, and the family’s understanding of the prognosis, the authors note.

They note that discussions about prognosis are often difficult but critical. Previous research “supports that patients desire prognostic information even when prognosis is uncertain and appreciate when their physicians disclose the presence of that uncertainty,” the authors note.

Also important is engaging in shared decisionmaking with patients and families. “This approach requires the physician to elicit a patient’s goals, make recommendations based on whether medical treatments are likely to achieve those goals, and work with patients and families to finalize a treatment plan,” according to the new guidance.
 

Ethical considerations

When treatments are physiologically futile, clinicians need to explain why interventions that may cause harm and have no benefit are not offered.

The authors cite cardiopulmonary resuscitation in the setting of cardiac arrest from irreversible herniation as an example of futility in the context of neurologic disease.

When life-prolonging care is no longer an option, clinicians have an obligation to shift the focus of care to preserving quality of life and comfort as much as possible, they add.

Hospices, which provide comfort-focused medical care as well as psychosocial and spiritual support, are reserved for patients believed to be in the last 6 months of their life if their disease follows the expected course.

The investigators also broached ethical considerations for individual neurologic conditions. Concerns for disorders of consciousness include misdiagnosis or inaccurate prognostication, and serial examinations are needed to re-evaluate levels of cognition, psychological state, decisionmaking capacity, and disease trajectory.

In patients with locked-in syndrome, a state of irreversible paralysis, often with respiratory and vocal paralysis, consciousness may range from a chronic minimally conscious state to intact cognition.

Without careful examination, patients with preserved consciousness may be mistaken as having a disorder of consciousness and risk their decisional capacity being ignored, the researchers note.

These patients may need assistance from speech pathologists to identify techniques to enhance communication, such as careful “yes/no” questioning, communication boards, or advanced eye-gaze technology, they add.
 

Stroke, dementia, Parkinson’s guidance

For stroke, the guidance suggests neurologists encourage patients with retained decisionmaking capacity to complete advance care planning given the risk of recurrent stroke and loss of capacity in the future.

For dementia, a proper and timely diagnosis can help patients and their families prepare for the consequences of cognitive dysfunction and loss of autonomy while respecting their identified values, the authors write.

They note that for Parkinson’s disease, which is marked by slow functional and cognitive decline, neurologists must aim to anticipate and treat symptoms, address psychosocial and spiritual distress and caregiver burden, and engage patients and families in advance care planning before onset of cognitive impairment.

For patients with amyotrophic lateral sclerosis (ALS) and related disorders, clinicians should aim to document goals and treatment preferences prior to extreme weakness and aphonia.

It is also important to anticipate patient preferences for future disability-specific decisions, such as those related to feeding tubes and mechanical ventilation, and to identify the patient’s minimal acceptable outcome from these life-sustaining interventions.

On the topic of withdrawal of treatment, the paper notes that competent patients have the right to refuse life-prolonging therapies, including artificial nutrition, hydration, mechanical ventilation, and antibiotics. If physicians have a moral objection to removing life-support systems, they are obligated to transfer the care of the patient to another physician, the authors add.

Once a decision is made to forgo life-sustaining treatment, physicians should minimize subsequent suffering. The investigators note most symptoms at the end of life can be managed without sedation.

In broaching the “gap” in neurology training programs, the statement referred to a survey of 49 neurology residency programs. Results showed that 42% of respondents reported being dissatisfied with their palliative care education.
 

Well-timed update

Kate T. Brizzi, MD, a Boston neurologist with experience in hospice and palliative care, said the updated position statement is “well-timed” as neuropalliative care has evolved dramatically over the last decade.

“In the last several years, I’ve witnessed a significant increase in trainee interest in the field, and there is growing recognition of how a palliative care approach can improve patient care and hopefully outcomes,” said Dr. Brizzi.

She praised the authors for doing “an excellent job” in highlighting the ethical challenges facing the neurology provider, particularly as it relates to prognostication in an uncertain setting.

Dr. Brizzi noted communication tools that help facilitate discussions around shared decisionmaking “have enhanced our ability to meet the palliative care needs of our patients and can be incorporated by any provider.”

However, she added that the paper only briefly comments on the role of the neurologist in “lawful physician-hastened death.”

“I anticipate that this will be an area of further discussion in the neurology and palliative care community in the future, as requests for hastened death are frequently encountered from patients with serious neurologic illness,” she said.

Dr. Brizzi also noted the importance of understanding the reasons behind the request – and addressing patient worries related to end-of-life care, which can frequently help alleviate distress.

There was no targeted funding for this paper. Coauthor Salvador Cruz-Flores, MD, department of neurology, Texas Tech University Center, El Paso, reported participation on member adjudication committees for clinical trials for Novo Nordisk, Sunovion, and Galapagos. The remaining authors have disclosed no relevant financial relationships.

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

The American Academy of Neurology (AAN) has released new expert guidance on palliative care for patients with stroke, dementia, Parkinson’s disease, and other neurologic disorders.

Palliative care includes much more than hospice services, lead author of the new position statement Lynne P. Taylor, MD, University of Washington, Seattle, and a fellow of the AAN, said in a press release.

“Neurologists provide palliative care to people living with life-altering neurologic illnesses not just at the end of life but throughout the course of a disease, improving their lives with symptom control,” Dr. Taylor added.

The position paper, developed by a joint committee of the AAN, American Neurological Association, and Child Neurology Society, was published online March 8 in Neurology.
 

Guidance across the lifespan

The new paper, an update of previous position statements, includes palliative care guidance for different neurologic disorders across the lifespan. For example, neuropalliative care for neonates deserves “extra consideration,” because one-third of pediatric deaths occur during the neonatal period, most often in the neonatal intensive care unit, and after withdrawal of life-sustaining interventions, the authors note.

For older children, neuropalliative care consultation benefits families trying to maximize the quality of the remainder of their child’s life. Decisionmaking must consider the child’s cognitive abilities, the diagnosis, the perceived level of suffering, parental values, and the family’s understanding of the prognosis, the authors note.

They note that discussions about prognosis are often difficult but critical. Previous research “supports that patients desire prognostic information even when prognosis is uncertain and appreciate when their physicians disclose the presence of that uncertainty,” the authors note.

Also important is engaging in shared decisionmaking with patients and families. “This approach requires the physician to elicit a patient’s goals, make recommendations based on whether medical treatments are likely to achieve those goals, and work with patients and families to finalize a treatment plan,” according to the new guidance.
 

Ethical considerations

When treatments are physiologically futile, clinicians need to explain why interventions that may cause harm and have no benefit are not offered.

The authors cite cardiopulmonary resuscitation in the setting of cardiac arrest from irreversible herniation as an example of futility in the context of neurologic disease.

When life-prolonging care is no longer an option, clinicians have an obligation to shift the focus of care to preserving quality of life and comfort as much as possible, they add.

Hospices, which provide comfort-focused medical care as well as psychosocial and spiritual support, are reserved for patients believed to be in the last 6 months of their life if their disease follows the expected course.

The investigators also broached ethical considerations for individual neurologic conditions. Concerns for disorders of consciousness include misdiagnosis or inaccurate prognostication, and serial examinations are needed to re-evaluate levels of cognition, psychological state, decisionmaking capacity, and disease trajectory.

In patients with locked-in syndrome, a state of irreversible paralysis, often with respiratory and vocal paralysis, consciousness may range from a chronic minimally conscious state to intact cognition.

Without careful examination, patients with preserved consciousness may be mistaken as having a disorder of consciousness and risk their decisional capacity being ignored, the researchers note.

These patients may need assistance from speech pathologists to identify techniques to enhance communication, such as careful “yes/no” questioning, communication boards, or advanced eye-gaze technology, they add.
 

Stroke, dementia, Parkinson’s guidance

For stroke, the guidance suggests neurologists encourage patients with retained decisionmaking capacity to complete advance care planning given the risk of recurrent stroke and loss of capacity in the future.

For dementia, a proper and timely diagnosis can help patients and their families prepare for the consequences of cognitive dysfunction and loss of autonomy while respecting their identified values, the authors write.

They note that for Parkinson’s disease, which is marked by slow functional and cognitive decline, neurologists must aim to anticipate and treat symptoms, address psychosocial and spiritual distress and caregiver burden, and engage patients and families in advance care planning before onset of cognitive impairment.

For patients with amyotrophic lateral sclerosis (ALS) and related disorders, clinicians should aim to document goals and treatment preferences prior to extreme weakness and aphonia.

It is also important to anticipate patient preferences for future disability-specific decisions, such as those related to feeding tubes and mechanical ventilation, and to identify the patient’s minimal acceptable outcome from these life-sustaining interventions.

On the topic of withdrawal of treatment, the paper notes that competent patients have the right to refuse life-prolonging therapies, including artificial nutrition, hydration, mechanical ventilation, and antibiotics. If physicians have a moral objection to removing life-support systems, they are obligated to transfer the care of the patient to another physician, the authors add.

Once a decision is made to forgo life-sustaining treatment, physicians should minimize subsequent suffering. The investigators note most symptoms at the end of life can be managed without sedation.

In broaching the “gap” in neurology training programs, the statement referred to a survey of 49 neurology residency programs. Results showed that 42% of respondents reported being dissatisfied with their palliative care education.
 

Well-timed update

Kate T. Brizzi, MD, a Boston neurologist with experience in hospice and palliative care, said the updated position statement is “well-timed” as neuropalliative care has evolved dramatically over the last decade.

“In the last several years, I’ve witnessed a significant increase in trainee interest in the field, and there is growing recognition of how a palliative care approach can improve patient care and hopefully outcomes,” said Dr. Brizzi.

She praised the authors for doing “an excellent job” in highlighting the ethical challenges facing the neurology provider, particularly as it relates to prognostication in an uncertain setting.

Dr. Brizzi noted communication tools that help facilitate discussions around shared decisionmaking “have enhanced our ability to meet the palliative care needs of our patients and can be incorporated by any provider.”

However, she added that the paper only briefly comments on the role of the neurologist in “lawful physician-hastened death.”

“I anticipate that this will be an area of further discussion in the neurology and palliative care community in the future, as requests for hastened death are frequently encountered from patients with serious neurologic illness,” she said.

Dr. Brizzi also noted the importance of understanding the reasons behind the request – and addressing patient worries related to end-of-life care, which can frequently help alleviate distress.

There was no targeted funding for this paper. Coauthor Salvador Cruz-Flores, MD, department of neurology, Texas Tech University Center, El Paso, reported participation on member adjudication committees for clinical trials for Novo Nordisk, Sunovion, and Galapagos. The remaining authors have disclosed no relevant financial relationships.

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

The endocannabinoid system is a promising therapeutic target for the treatment of migraine, according to Italian researchers at the University of Pavia, and the C. Mondino National Institute of Neurology Foundation. “The complexity of the endocannabinoid system calls for accurate biochemical and pharmacological characterization of any new compounds undergoing testing and development,” noted Rosaria Greco, PhD. She and her colleagues authored a review on the topic that was published online Feb. 18, 2022, in Headache.

Although cannabis has been investigated for both the treatment and prevention of migraine, evidence for its benefit is weak because of lack of controlled studies, they explained. Archival data from a large database “showed greater improvements in men than in women and suggested that concentrated preparations were more effective than flower consumption.” In addition, a small single-center study linked nabilone, a synthetic cannabinoid, to reductions in pain duration, intensity, and daily intake of analgesics among patients with medication overuse headache. Finally, a pilot study reported a reduction in pain intensity among patients with chronic migraine treated with a combination of tested a combination of delta-9-tetrahydrocannabinol and cannabidiol. “Methodologically sound studies are now needed to investigate the possible effects of cannabis in migraine treatment and to define strains, formulations, and dosage,” they noted.
 

Not just cannabis

In addition to exogenous cannabis, there are now preclinical studies suggesting other compounds that interact with the endocannabinoid system “are also able to modulate the pathways involved in migraine-related pain,” the study authors wrote. “But the road ahead is still long. Multiple molecules linked to the endocannabinoid system have emerged as potential therapeutic targets.

The complexity of the system demands caution and precise biochemical and pharmacological characterization of the new compounds to be tested and developed.”

Among these compounds are endogenous ligands such as N-arachidonoylethanolamine (anandamide) and 2-arachidonoylglycerol that specifically target CB1 and CB2 receptors. Additionally, there are endocannabinoid-based drugs that also target the CB1/CB2 receptors, as well as other substances, such as lipids (palmitoylethanolamide [PEA]) and enzymes, that do not bind to the CB1/CB2 receptors but are responsible for endocannabinoid biosynthesis.

There is some evidence that the endocannabinoid system may be dysfunctional in patients with migraine, and the authors noted their work has shown that PEA plasma levels are increased during experimentally triggered migraine-like attacks. Thus, some preclinical and preliminary evidence suggests that administration of PEA or anandamide may have analgesic and anti-inflammatory effects in migraine.

Another approach is the inhibition of endocannabinoid catabolic enzymes, which could circumvent the adverse effects associated with direct activation of CB receptors. “Endocannabinoid tone enhancement has been proposed as an alternative modality of activation of CB receptors and is possibly devoid of the psychotropic effects reported with CB receptor agonists,” noted the authors, who have shown in animal and preclinical studies that inhibition of fatty acid amide hydrolase (FAAH) and monoacylglycerol lipase can modulate migraine pain.

Yet another way of indirectly impacting CB receptors is through their allosteric ligands, an approach that “deserves further investigation”, and “might provide interesting leads for clinical development, given that it may have a favorable side-effect profile with limited psychomimetic and depressant effects,” wrote the authors. And finally, inhibition of N-acylethanolamine acid amide hydrolase, the enzyme that preferentially hydrolyzes PEA, might be a promising approach.

“The multiplicity of options and the wealth of data already obtained in animal models underscore the importance of further advancing research in this area,” the authors concluded.
 

Patients are taking cannabinoids; physicians should learn about them

Commenting on the paper, Alan Rapaport, MD, clinical professor of neurology at the University of California, Los Angeles, said “this well-done paper points out the complexity of the endocannabinoid system and the multiple ways of getting it to work for certain patients. It details some of the studies that show beneficial results in migraine, medication overuse headache, chronic migraine, and pain. Patients with headache, other types of pain, anxiety, nausea, sleep issues, and other symptoms are already taking cannabinoids, usually derived from the marijuana plant, that are not well regulated. A few are prescribed drugs which target CB1 and CB2 receptors. Patients often get relief of some of their symptoms, sometimes getting high and many times not.

“The paper makes the point that previous studies are often small, not carefully controlled, or well documented. We do need to start doing larger, properly designed studies and getting them into the literature. Doctors need to learn more about these treatments. The next step will be to get [Food and Drug Administration]–approved treatments, so physicians and nurses will know exactly what we are giving, the beneficial effects to expect in a certain percentage of patients, and the adverse events to warn our patients about. Cannabinoids have been tried by a large percentage of patients with headache and pain. Now we need to standardize the various treatments that are sure to be suggested in the future.”

The study was funded by the Migraine Research Foundation, and the Italian Ministry of Health. The study authors declared no conflicts of interest.

The endocannabinoid system is a promising therapeutic target for the treatment of migraine, according to Italian researchers at the University of Pavia, and the C. Mondino National Institute of Neurology Foundation. “The complexity of the endocannabinoid system calls for accurate biochemical and pharmacological characterization of any new compounds undergoing testing and development,” noted Rosaria Greco, PhD. She and her colleagues authored a review on the topic that was published online Feb. 18, 2022, in Headache.

Although cannabis has been investigated for both the treatment and prevention of migraine, evidence for its benefit is weak because of lack of controlled studies, they explained. Archival data from a large database “showed greater improvements in men than in women and suggested that concentrated preparations were more effective than flower consumption.” In addition, a small single-center study linked nabilone, a synthetic cannabinoid, to reductions in pain duration, intensity, and daily intake of analgesics among patients with medication overuse headache. Finally, a pilot study reported a reduction in pain intensity among patients with chronic migraine treated with a combination of tested a combination of delta-9-tetrahydrocannabinol and cannabidiol. “Methodologically sound studies are now needed to investigate the possible effects of cannabis in migraine treatment and to define strains, formulations, and dosage,” they noted.
 

Not just cannabis

In addition to exogenous cannabis, there are now preclinical studies suggesting other compounds that interact with the endocannabinoid system “are also able to modulate the pathways involved in migraine-related pain,” the study authors wrote. “But the road ahead is still long. Multiple molecules linked to the endocannabinoid system have emerged as potential therapeutic targets.

The complexity of the system demands caution and precise biochemical and pharmacological characterization of the new compounds to be tested and developed.”

Among these compounds are endogenous ligands such as N-arachidonoylethanolamine (anandamide) and 2-arachidonoylglycerol that specifically target CB1 and CB2 receptors. Additionally, there are endocannabinoid-based drugs that also target the CB1/CB2 receptors, as well as other substances, such as lipids (palmitoylethanolamide [PEA]) and enzymes, that do not bind to the CB1/CB2 receptors but are responsible for endocannabinoid biosynthesis.

There is some evidence that the endocannabinoid system may be dysfunctional in patients with migraine, and the authors noted their work has shown that PEA plasma levels are increased during experimentally triggered migraine-like attacks. Thus, some preclinical and preliminary evidence suggests that administration of PEA or anandamide may have analgesic and anti-inflammatory effects in migraine.

Another approach is the inhibition of endocannabinoid catabolic enzymes, which could circumvent the adverse effects associated with direct activation of CB receptors. “Endocannabinoid tone enhancement has been proposed as an alternative modality of activation of CB receptors and is possibly devoid of the psychotropic effects reported with CB receptor agonists,” noted the authors, who have shown in animal and preclinical studies that inhibition of fatty acid amide hydrolase (FAAH) and monoacylglycerol lipase can modulate migraine pain.

Yet another way of indirectly impacting CB receptors is through their allosteric ligands, an approach that “deserves further investigation”, and “might provide interesting leads for clinical development, given that it may have a favorable side-effect profile with limited psychomimetic and depressant effects,” wrote the authors. And finally, inhibition of N-acylethanolamine acid amide hydrolase, the enzyme that preferentially hydrolyzes PEA, might be a promising approach.

“The multiplicity of options and the wealth of data already obtained in animal models underscore the importance of further advancing research in this area,” the authors concluded.
 

Patients are taking cannabinoids; physicians should learn about them

Commenting on the paper, Alan Rapaport, MD, clinical professor of neurology at the University of California, Los Angeles, said “this well-done paper points out the complexity of the endocannabinoid system and the multiple ways of getting it to work for certain patients. It details some of the studies that show beneficial results in migraine, medication overuse headache, chronic migraine, and pain. Patients with headache, other types of pain, anxiety, nausea, sleep issues, and other symptoms are already taking cannabinoids, usually derived from the marijuana plant, that are not well regulated. A few are prescribed drugs which target CB1 and CB2 receptors. Patients often get relief of some of their symptoms, sometimes getting high and many times not.

“The paper makes the point that previous studies are often small, not carefully controlled, or well documented. We do need to start doing larger, properly designed studies and getting them into the literature. Doctors need to learn more about these treatments. The next step will be to get [Food and Drug Administration]–approved treatments, so physicians and nurses will know exactly what we are giving, the beneficial effects to expect in a certain percentage of patients, and the adverse events to warn our patients about. Cannabinoids have been tried by a large percentage of patients with headache and pain. Now we need to standardize the various treatments that are sure to be suggested in the future.”

The study was funded by the Migraine Research Foundation, and the Italian Ministry of Health. The study authors declared no conflicts of interest.

The endocannabinoid system is a promising therapeutic target for the treatment of migraine, according to Italian researchers at the University of Pavia, and the C. Mondino National Institute of Neurology Foundation. “The complexity of the endocannabinoid system calls for accurate biochemical and pharmacological characterization of any new compounds undergoing testing and development,” noted Rosaria Greco, PhD. She and her colleagues authored a review on the topic that was published online Feb. 18, 2022, in Headache.

Although cannabis has been investigated for both the treatment and prevention of migraine, evidence for its benefit is weak because of lack of controlled studies, they explained. Archival data from a large database “showed greater improvements in men than in women and suggested that concentrated preparations were more effective than flower consumption.” In addition, a small single-center study linked nabilone, a synthetic cannabinoid, to reductions in pain duration, intensity, and daily intake of analgesics among patients with medication overuse headache. Finally, a pilot study reported a reduction in pain intensity among patients with chronic migraine treated with a combination of tested a combination of delta-9-tetrahydrocannabinol and cannabidiol. “Methodologically sound studies are now needed to investigate the possible effects of cannabis in migraine treatment and to define strains, formulations, and dosage,” they noted.
 

Not just cannabis

In addition to exogenous cannabis, there are now preclinical studies suggesting other compounds that interact with the endocannabinoid system “are also able to modulate the pathways involved in migraine-related pain,” the study authors wrote. “But the road ahead is still long. Multiple molecules linked to the endocannabinoid system have emerged as potential therapeutic targets.

The complexity of the system demands caution and precise biochemical and pharmacological characterization of the new compounds to be tested and developed.”

Among these compounds are endogenous ligands such as N-arachidonoylethanolamine (anandamide) and 2-arachidonoylglycerol that specifically target CB1 and CB2 receptors. Additionally, there are endocannabinoid-based drugs that also target the CB1/CB2 receptors, as well as other substances, such as lipids (palmitoylethanolamide [PEA]) and enzymes, that do not bind to the CB1/CB2 receptors but are responsible for endocannabinoid biosynthesis.

There is some evidence that the endocannabinoid system may be dysfunctional in patients with migraine, and the authors noted their work has shown that PEA plasma levels are increased during experimentally triggered migraine-like attacks. Thus, some preclinical and preliminary evidence suggests that administration of PEA or anandamide may have analgesic and anti-inflammatory effects in migraine.

Another approach is the inhibition of endocannabinoid catabolic enzymes, which could circumvent the adverse effects associated with direct activation of CB receptors. “Endocannabinoid tone enhancement has been proposed as an alternative modality of activation of CB receptors and is possibly devoid of the psychotropic effects reported with CB receptor agonists,” noted the authors, who have shown in animal and preclinical studies that inhibition of fatty acid amide hydrolase (FAAH) and monoacylglycerol lipase can modulate migraine pain.

Yet another way of indirectly impacting CB receptors is through their allosteric ligands, an approach that “deserves further investigation”, and “might provide interesting leads for clinical development, given that it may have a favorable side-effect profile with limited psychomimetic and depressant effects,” wrote the authors. And finally, inhibition of N-acylethanolamine acid amide hydrolase, the enzyme that preferentially hydrolyzes PEA, might be a promising approach.

“The multiplicity of options and the wealth of data already obtained in animal models underscore the importance of further advancing research in this area,” the authors concluded.
 

Patients are taking cannabinoids; physicians should learn about them

Commenting on the paper, Alan Rapaport, MD, clinical professor of neurology at the University of California, Los Angeles, said “this well-done paper points out the complexity of the endocannabinoid system and the multiple ways of getting it to work for certain patients. It details some of the studies that show beneficial results in migraine, medication overuse headache, chronic migraine, and pain. Patients with headache, other types of pain, anxiety, nausea, sleep issues, and other symptoms are already taking cannabinoids, usually derived from the marijuana plant, that are not well regulated. A few are prescribed drugs which target CB1 and CB2 receptors. Patients often get relief of some of their symptoms, sometimes getting high and many times not.

“The paper makes the point that previous studies are often small, not carefully controlled, or well documented. We do need to start doing larger, properly designed studies and getting them into the literature. Doctors need to learn more about these treatments. The next step will be to get [Food and Drug Administration]–approved treatments, so physicians and nurses will know exactly what we are giving, the beneficial effects to expect in a certain percentage of patients, and the adverse events to warn our patients about. Cannabinoids have been tried by a large percentage of patients with headache and pain. Now we need to standardize the various treatments that are sure to be suggested in the future.”

The study was funded by the Migraine Research Foundation, and the Italian Ministry of Health. The study authors declared no conflicts of interest.

Lack of contact with the outside world and an active lifestyle could play a role in why indigenous groups in the remote Amazon of Bolivia have some of the lowest rates of dementia in the world.   

What to know

• Only about 1% of members of the Tsimane and Moseten peoples of the Bolivian Amazon suffer from dementia, compared with 11% of people aged 65 and older in the United States.
• Underscoring the profound relationship between lifestyle and cognitive health, something about the preindustrial subsistence lifestyle of the groups appears to protect older tribe members from dementia.
• The rate of  generally accepted as typical in aging is comparable between the tribes and rates in developed countries such as the United States.
• The Tsimane and Moseten people remain very physically active throughout their lives by fishing, hunting, and farming and experience less brain atrophy than their American and European peers.
• Indigenous populations elsewhere in the world have been found to have high rates of dementia, which are attributed to more contact with their nonindigenous neighbors and adoption of their lifestyles.

--From staff reports

This is a summary of the article, “Study: Some of the world’s lowest rates of dementia found in Amazonian indigenous groups,” published by Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, on March 9, 2022. The full article can be found on news.ucsb.edu.



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

Lack of contact with the outside world and an active lifestyle could play a role in why indigenous groups in the remote Amazon of Bolivia have some of the lowest rates of dementia in the world.   

What to know

• Only about 1% of members of the Tsimane and Moseten peoples of the Bolivian Amazon suffer from dementia, compared with 11% of people aged 65 and older in the United States.
• Underscoring the profound relationship between lifestyle and cognitive health, something about the preindustrial subsistence lifestyle of the groups appears to protect older tribe members from dementia.
• The rate of  generally accepted as typical in aging is comparable between the tribes and rates in developed countries such as the United States.
• The Tsimane and Moseten people remain very physically active throughout their lives by fishing, hunting, and farming and experience less brain atrophy than their American and European peers.
• Indigenous populations elsewhere in the world have been found to have high rates of dementia, which are attributed to more contact with their nonindigenous neighbors and adoption of their lifestyles.

--From staff reports

This is a summary of the article, “Study: Some of the world’s lowest rates of dementia found in Amazonian indigenous groups,” published by Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, on March 9, 2022. The full article can be found on news.ucsb.edu.



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

Lack of contact with the outside world and an active lifestyle could play a role in why indigenous groups in the remote Amazon of Bolivia have some of the lowest rates of dementia in the world.   

What to know

• Only about 1% of members of the Tsimane and Moseten peoples of the Bolivian Amazon suffer from dementia, compared with 11% of people aged 65 and older in the United States.
• Underscoring the profound relationship between lifestyle and cognitive health, something about the preindustrial subsistence lifestyle of the groups appears to protect older tribe members from dementia.
• The rate of  generally accepted as typical in aging is comparable between the tribes and rates in developed countries such as the United States.
• The Tsimane and Moseten people remain very physically active throughout their lives by fishing, hunting, and farming and experience less brain atrophy than their American and European peers.
• Indigenous populations elsewhere in the world have been found to have high rates of dementia, which are attributed to more contact with their nonindigenous neighbors and adoption of their lifestyles.

--From staff reports

This is a summary of the article, “Study: Some of the world’s lowest rates of dementia found in Amazonian indigenous groups,” published by Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, on March 9, 2022. The full article can be found on news.ucsb.edu.



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

The Biden administration’s new test-to-treat program is simple on the surface: if you feel like you may have COVID-19, go to a pharmacy, get tested, and, if positive, get treated with an antiviral medication on the spot.

But the program is not that simple to groups representing physicians and pharmacists.

One large physicians’ group is concerned that the program leaves doctors on the margins, and may put patients at risk if there are adverse effects from the medications. Pharmacists groups, on the other hand, say the program is too restrictive, according to an article by the research group Advisory Board.

Recently, the White House announced that more than 1,000 pharmacy clinics across the United States had registered to participate in the initiative, according to CNN. Ordering of the drugs is underway in many of these clinics, a White House official told the network.

Besides retail clinics in chain pharmacies, the antivirals will also be available in community health centers, long-term-care facilities, and Veterans Health Administration clinics, according to a statement from the U.S. Department of Health and Human Services.

The two antiviral pills authorized by the U.S. Food and Drug Administration include Pfizer’s Paxlovid, for people 12 and older, and Merck’s molnupiravir, for adults. Either drug has to be taken within 5 days after symptoms appear to be effective in preventing serious illness.

The need for speed is a major reason why the government chose to work with retail clinics that are more accessible than most primary care offices. However, the American Medical Association (AMA), the National Community Pharmacists Association (NCPA), and the American Pharmacists Association (APhA) have publicly criticized the administration’s approach.

The pharmacists’ groups are concerned that the program is limited only to pharmacies with clinics on site, thus restricting the number of pharmacies qualified to participate. Fourteen pharmacy groups, including the NCPA and the APhA, have also sent a letter to the Biden administration urging it to remove barriers to pharmacies ordering the medications.

The groups also want permission as “clinically trained medication experts” to prescribe the drugs and ensure their safe use.

The AMA on March 4 took issue with the prescribing component, saying that “the pharmacy-based clinic component of the test-to-treat plan flouts patient safety and risks significant negative health outcomes.”

In the AMA’s view, prescribing Paxlovid without a patient’s physician being present poses a risk for adverse drug interactions, as neither the nurse practitioners in retail clinics nor the pharmacists who dispense the drug have full knowledge of a patient›s medical history.

The next day, the AMA released another statement, saying it was reassured by comments from administration officials “that patients who have access to a regular source of care should contact their physician shortly after testing positive for COVID-19 to assess their treatment options.”
 

“Traditional doctor-only approach”

Having patients call their doctors after testing positive for COVID in a pharmacy “strikes me as unnecessary in the vast majority of cases, and it will delay treatment,” Robert Wachter, MD, professor and chair of the department of medicine at the University of California San Francisco, said in an interview. “In this case, it seems like the AMA is taking a very traditional doctor-only approach. And the world has changed. It’s much more of a team sport than an individual sport, the way it was years ago.”

Dr. Wachter said he has the utmost respect for pharmacists’ ability to screen prescriptions for adverse drug interactions. “We’re required to do medication reconciliation when patients see us,” he says. “And in many hospitals, we delegate that to pharmacists. They’re at least as good at it if not better than physicians are.”

While it’s essential to know what other medications a patient is taking, he noted, pharmacies have computer records of all the prescriptions they’ve filled for patients. In addition, pharmacies have access to complete medication histories through Surescripts, the company that enables electronic prescribing transactions between prescribers and pharmacies.
 

Drug interactions “not trivial”

Preeti Malani, MD, the chief health officer and a professor of medicine in the division of infectious diseases at the University of Michigan in Ann Arbor, told this news organization that the potential interactions between Paxlovid and some other medications are “not trivial.”

However, she said, “The really dangerous drugs are the ones for people who have had organ transplants and the like. Those aren’t individuals who are going to shop at a pharmacy.”

Besides the antirejection drugs, Dr. Wachter said, there can be serious interactions with cholesterol-lowering medications. If a person is taking Lipitor, for instance, “Someone would have to make the decision on whether it’s ok for me to stop it for a while, or to lower the dose. But I trust the pharmacist to do that as well as anybody.”

Except for these potential drug interactions with Paxlovid, the antiviral medications are “quite safe,” he said, adding that being able to treat people who test positive for COVID-19 right away is a big advantage of the test-to-treat program, considering how difficult it is for many people to get access to a doctor. That delay could mean that the antivirals are not prescribed and taken until they are no longer effective.

Both Dr. Wachter and Dr. Malani said that the widespread distribution of pharmacies and their extended hours are other big pluses, especially for people who can’t easily leave work or travel far to visit a physician.

Dr. Malani cautioned that there are still kinks to work out in the test-to-treat program. It will be a while before the retail clinics all have the antiviral drugs, and many pharmacies don’t have clinics on site.

Still, she said people can still go to their physicians to be tested, and presumably those doctors can also write antiviral prescriptions. But it’s not clear where the antivirals will be available in the near term.

“Right now, we’re playing catch-up,” Dr. Malani said. “But pharmacies are an important piece of the puzzle.”

Looking at the big picture, she said, “We know that neither vaccination nor natural infection provides long lasting immunity, and so there will be a role for antivirals in order to make this a manageable illness. And when you’re talking about millions of cases, as we were having a few months ago, the health system can’t field all those patients. So we do need a system where I can go to a pharmacy and get a test and treatment.”

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

The Biden administration’s new test-to-treat program is simple on the surface: if you feel like you may have COVID-19, go to a pharmacy, get tested, and, if positive, get treated with an antiviral medication on the spot.

But the program is not that simple to groups representing physicians and pharmacists.

One large physicians’ group is concerned that the program leaves doctors on the margins, and may put patients at risk if there are adverse effects from the medications. Pharmacists groups, on the other hand, say the program is too restrictive, according to an article by the research group Advisory Board.

Recently, the White House announced that more than 1,000 pharmacy clinics across the United States had registered to participate in the initiative, according to CNN. Ordering of the drugs is underway in many of these clinics, a White House official told the network.

Besides retail clinics in chain pharmacies, the antivirals will also be available in community health centers, long-term-care facilities, and Veterans Health Administration clinics, according to a statement from the U.S. Department of Health and Human Services.

The two antiviral pills authorized by the U.S. Food and Drug Administration include Pfizer’s Paxlovid, for people 12 and older, and Merck’s molnupiravir, for adults. Either drug has to be taken within 5 days after symptoms appear to be effective in preventing serious illness.

The need for speed is a major reason why the government chose to work with retail clinics that are more accessible than most primary care offices. However, the American Medical Association (AMA), the National Community Pharmacists Association (NCPA), and the American Pharmacists Association (APhA) have publicly criticized the administration’s approach.

The pharmacists’ groups are concerned that the program is limited only to pharmacies with clinics on site, thus restricting the number of pharmacies qualified to participate. Fourteen pharmacy groups, including the NCPA and the APhA, have also sent a letter to the Biden administration urging it to remove barriers to pharmacies ordering the medications.

The groups also want permission as “clinically trained medication experts” to prescribe the drugs and ensure their safe use.

The AMA on March 4 took issue with the prescribing component, saying that “the pharmacy-based clinic component of the test-to-treat plan flouts patient safety and risks significant negative health outcomes.”

In the AMA’s view, prescribing Paxlovid without a patient’s physician being present poses a risk for adverse drug interactions, as neither the nurse practitioners in retail clinics nor the pharmacists who dispense the drug have full knowledge of a patient›s medical history.

The next day, the AMA released another statement, saying it was reassured by comments from administration officials “that patients who have access to a regular source of care should contact their physician shortly after testing positive for COVID-19 to assess their treatment options.”
 

“Traditional doctor-only approach”

Having patients call their doctors after testing positive for COVID in a pharmacy “strikes me as unnecessary in the vast majority of cases, and it will delay treatment,” Robert Wachter, MD, professor and chair of the department of medicine at the University of California San Francisco, said in an interview. “In this case, it seems like the AMA is taking a very traditional doctor-only approach. And the world has changed. It’s much more of a team sport than an individual sport, the way it was years ago.”

Dr. Wachter said he has the utmost respect for pharmacists’ ability to screen prescriptions for adverse drug interactions. “We’re required to do medication reconciliation when patients see us,” he says. “And in many hospitals, we delegate that to pharmacists. They’re at least as good at it if not better than physicians are.”

While it’s essential to know what other medications a patient is taking, he noted, pharmacies have computer records of all the prescriptions they’ve filled for patients. In addition, pharmacies have access to complete medication histories through Surescripts, the company that enables electronic prescribing transactions between prescribers and pharmacies.
 

Drug interactions “not trivial”

Preeti Malani, MD, the chief health officer and a professor of medicine in the division of infectious diseases at the University of Michigan in Ann Arbor, told this news organization that the potential interactions between Paxlovid and some other medications are “not trivial.”

However, she said, “The really dangerous drugs are the ones for people who have had organ transplants and the like. Those aren’t individuals who are going to shop at a pharmacy.”

Besides the antirejection drugs, Dr. Wachter said, there can be serious interactions with cholesterol-lowering medications. If a person is taking Lipitor, for instance, “Someone would have to make the decision on whether it’s ok for me to stop it for a while, or to lower the dose. But I trust the pharmacist to do that as well as anybody.”

Except for these potential drug interactions with Paxlovid, the antiviral medications are “quite safe,” he said, adding that being able to treat people who test positive for COVID-19 right away is a big advantage of the test-to-treat program, considering how difficult it is for many people to get access to a doctor. That delay could mean that the antivirals are not prescribed and taken until they are no longer effective.

Both Dr. Wachter and Dr. Malani said that the widespread distribution of pharmacies and their extended hours are other big pluses, especially for people who can’t easily leave work or travel far to visit a physician.

Dr. Malani cautioned that there are still kinks to work out in the test-to-treat program. It will be a while before the retail clinics all have the antiviral drugs, and many pharmacies don’t have clinics on site.

Still, she said people can still go to their physicians to be tested, and presumably those doctors can also write antiviral prescriptions. But it’s not clear where the antivirals will be available in the near term.

“Right now, we’re playing catch-up,” Dr. Malani said. “But pharmacies are an important piece of the puzzle.”

Looking at the big picture, she said, “We know that neither vaccination nor natural infection provides long lasting immunity, and so there will be a role for antivirals in order to make this a manageable illness. And when you’re talking about millions of cases, as we were having a few months ago, the health system can’t field all those patients. So we do need a system where I can go to a pharmacy and get a test and treatment.”

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

The Biden administration’s new test-to-treat program is simple on the surface: if you feel like you may have COVID-19, go to a pharmacy, get tested, and, if positive, get treated with an antiviral medication on the spot.

But the program is not that simple to groups representing physicians and pharmacists.

One large physicians’ group is concerned that the program leaves doctors on the margins, and may put patients at risk if there are adverse effects from the medications. Pharmacists groups, on the other hand, say the program is too restrictive, according to an article by the research group Advisory Board.

Recently, the White House announced that more than 1,000 pharmacy clinics across the United States had registered to participate in the initiative, according to CNN. Ordering of the drugs is underway in many of these clinics, a White House official told the network.

Besides retail clinics in chain pharmacies, the antivirals will also be available in community health centers, long-term-care facilities, and Veterans Health Administration clinics, according to a statement from the U.S. Department of Health and Human Services.

The two antiviral pills authorized by the U.S. Food and Drug Administration include Pfizer’s Paxlovid, for people 12 and older, and Merck’s molnupiravir, for adults. Either drug has to be taken within 5 days after symptoms appear to be effective in preventing serious illness.

The need for speed is a major reason why the government chose to work with retail clinics that are more accessible than most primary care offices. However, the American Medical Association (AMA), the National Community Pharmacists Association (NCPA), and the American Pharmacists Association (APhA) have publicly criticized the administration’s approach.

The pharmacists’ groups are concerned that the program is limited only to pharmacies with clinics on site, thus restricting the number of pharmacies qualified to participate. Fourteen pharmacy groups, including the NCPA and the APhA, have also sent a letter to the Biden administration urging it to remove barriers to pharmacies ordering the medications.

The groups also want permission as “clinically trained medication experts” to prescribe the drugs and ensure their safe use.

The AMA on March 4 took issue with the prescribing component, saying that “the pharmacy-based clinic component of the test-to-treat plan flouts patient safety and risks significant negative health outcomes.”

In the AMA’s view, prescribing Paxlovid without a patient’s physician being present poses a risk for adverse drug interactions, as neither the nurse practitioners in retail clinics nor the pharmacists who dispense the drug have full knowledge of a patient›s medical history.

The next day, the AMA released another statement, saying it was reassured by comments from administration officials “that patients who have access to a regular source of care should contact their physician shortly after testing positive for COVID-19 to assess their treatment options.”
 

“Traditional doctor-only approach”

Having patients call their doctors after testing positive for COVID in a pharmacy “strikes me as unnecessary in the vast majority of cases, and it will delay treatment,” Robert Wachter, MD, professor and chair of the department of medicine at the University of California San Francisco, said in an interview. “In this case, it seems like the AMA is taking a very traditional doctor-only approach. And the world has changed. It’s much more of a team sport than an individual sport, the way it was years ago.”

Dr. Wachter said he has the utmost respect for pharmacists’ ability to screen prescriptions for adverse drug interactions. “We’re required to do medication reconciliation when patients see us,” he says. “And in many hospitals, we delegate that to pharmacists. They’re at least as good at it if not better than physicians are.”

While it’s essential to know what other medications a patient is taking, he noted, pharmacies have computer records of all the prescriptions they’ve filled for patients. In addition, pharmacies have access to complete medication histories through Surescripts, the company that enables electronic prescribing transactions between prescribers and pharmacies.
 

Drug interactions “not trivial”

Preeti Malani, MD, the chief health officer and a professor of medicine in the division of infectious diseases at the University of Michigan in Ann Arbor, told this news organization that the potential interactions between Paxlovid and some other medications are “not trivial.”

However, she said, “The really dangerous drugs are the ones for people who have had organ transplants and the like. Those aren’t individuals who are going to shop at a pharmacy.”

Besides the antirejection drugs, Dr. Wachter said, there can be serious interactions with cholesterol-lowering medications. If a person is taking Lipitor, for instance, “Someone would have to make the decision on whether it’s ok for me to stop it for a while, or to lower the dose. But I trust the pharmacist to do that as well as anybody.”

Except for these potential drug interactions with Paxlovid, the antiviral medications are “quite safe,” he said, adding that being able to treat people who test positive for COVID-19 right away is a big advantage of the test-to-treat program, considering how difficult it is for many people to get access to a doctor. That delay could mean that the antivirals are not prescribed and taken until they are no longer effective.

Both Dr. Wachter and Dr. Malani said that the widespread distribution of pharmacies and their extended hours are other big pluses, especially for people who can’t easily leave work or travel far to visit a physician.

Dr. Malani cautioned that there are still kinks to work out in the test-to-treat program. It will be a while before the retail clinics all have the antiviral drugs, and many pharmacies don’t have clinics on site.

Still, she said people can still go to their physicians to be tested, and presumably those doctors can also write antiviral prescriptions. But it’s not clear where the antivirals will be available in the near term.

“Right now, we’re playing catch-up,” Dr. Malani said. “But pharmacies are an important piece of the puzzle.”

Looking at the big picture, she said, “We know that neither vaccination nor natural infection provides long lasting immunity, and so there will be a role for antivirals in order to make this a manageable illness. And when you’re talking about millions of cases, as we were having a few months ago, the health system can’t field all those patients. So we do need a system where I can go to a pharmacy and get a test and treatment.”

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

Should pharmaceutical companies continue to do business in Russia, running ongoing clinical trials, starting new ones, or continuing to sell their products there?

Some argue that medicine and science must not get enmeshed in politics, staying above the fray to protect their independence and credibility. Other defenders of business-as-usual say the pharmaceutical industry deals in health and aids the vulnerable. Humanitarianism requires continued interaction with Russia.

I think both arguments fail. Pharma should follow the lead of other Western companies and suspend their involvement with Putin’s Russia.

We are fighting a war with Russia. It is a war of economic strangulation, social isolation, and pushing Russia as hard as we can to become a pariah state so that internal pressure on Putin will cause him to rethink his cruel, unjustified invasion or the Russian people to replace him. This pressure must be harsh and it must happen quickly. Why?

Having failed to rapidly defeat the Ukrainian army in the war’s first weeks, Russian commanders are now resorting to the horrible barbarism they used in previous wars in Chechnya and Syria: flattening cities, attacking civilians, killing children with massive and indiscriminate firepower.

To mention one recent horror among many, Russian shelling destroyed a maternity hospital in Mariupol. Ukraine’s president, Volodymyr Zelensky, in bemoaning the Russians for their continuing series of war crimes called on the world to act.

“Mariupol. Direct Strike of Russian troops at the maternity hospital,” he wrote in a Twitter post. “People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror?”

The Russian government’s response: “It is not the first time we have seen pathetic outcries concerning the so-called atrocities,” said Minister of Foreign Affairs Sergei Lavrov, claiming the hospital was being used as a base by an “ultra-radical” Ukrainian battalion.

Health and its preservation are key parts of the aim of medicine and science. There is no way that medicine and science can ignore what war does to health, what attacks on hospitals do to the sick and those who serve them there, the psychological toll that intentional terrorism takes on civilians and their defenders, and what the destruction of infrastructure means for the long-term well-being of Ukrainians.

There can be no collusion with war criminals. There can be no denial of the inextricable link between medicine, science, and politics. Medicine and science are controlled by political forces; their use for good or evil is driven by political considerations, and each doctor, scientist, and scientific society must take a stand when politics corrodes the underlying aims of research and healing.

How far does noncooperation with Russia go? Very, very far. All research, both ongoing and new, must cease immediately. Whatever can be done to minimize harm to existing subjects in a short period of time ought to be done, but that is it.

Similarly, no sale of medicines or therapies ought to be occurring, be they life-saving or consumer products. Putin will see to it that such shipments go to the military or are sold on the black market for revenue, and there is nothing pharma companies can do to stop that.

The Russian people need to be pinched not only by the loss of cheeseburgers and boutique coffee but by products they use to maintain their well-being. War is cruel that way, but if you tolerate a government that is bombing and shelling a peaceful neighbor to oblivion, then pharma must ensure that efforts to make Putin and his kleptocratic goons feel the wrath of their fellow citizens.

Given the realities of nuclear Armageddon, the civilized world must fight obvious barbarity as best it can with sanctions, financial assaults, property seizures, and forgoing commerce, including important raw materials and health products. War, even in a fiscal form, is not without terrible costs; but achieving a rapid, just resolution against tyranny permits no exceptions for pharma or any other business if it is a war that must be fought.

Dr. Caplan is director of the division of medical ethics at New York University. He has consulted with Johnson & Johnson’s Panel for Compassionate Drug Use.



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

Should pharmaceutical companies continue to do business in Russia, running ongoing clinical trials, starting new ones, or continuing to sell their products there?

Some argue that medicine and science must not get enmeshed in politics, staying above the fray to protect their independence and credibility. Other defenders of business-as-usual say the pharmaceutical industry deals in health and aids the vulnerable. Humanitarianism requires continued interaction with Russia.

I think both arguments fail. Pharma should follow the lead of other Western companies and suspend their involvement with Putin’s Russia.

We are fighting a war with Russia. It is a war of economic strangulation, social isolation, and pushing Russia as hard as we can to become a pariah state so that internal pressure on Putin will cause him to rethink his cruel, unjustified invasion or the Russian people to replace him. This pressure must be harsh and it must happen quickly. Why?

Having failed to rapidly defeat the Ukrainian army in the war’s first weeks, Russian commanders are now resorting to the horrible barbarism they used in previous wars in Chechnya and Syria: flattening cities, attacking civilians, killing children with massive and indiscriminate firepower.

To mention one recent horror among many, Russian shelling destroyed a maternity hospital in Mariupol. Ukraine’s president, Volodymyr Zelensky, in bemoaning the Russians for their continuing series of war crimes called on the world to act.

“Mariupol. Direct Strike of Russian troops at the maternity hospital,” he wrote in a Twitter post. “People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror?”

The Russian government’s response: “It is not the first time we have seen pathetic outcries concerning the so-called atrocities,” said Minister of Foreign Affairs Sergei Lavrov, claiming the hospital was being used as a base by an “ultra-radical” Ukrainian battalion.

Health and its preservation are key parts of the aim of medicine and science. There is no way that medicine and science can ignore what war does to health, what attacks on hospitals do to the sick and those who serve them there, the psychological toll that intentional terrorism takes on civilians and their defenders, and what the destruction of infrastructure means for the long-term well-being of Ukrainians.

There can be no collusion with war criminals. There can be no denial of the inextricable link between medicine, science, and politics. Medicine and science are controlled by political forces; their use for good or evil is driven by political considerations, and each doctor, scientist, and scientific society must take a stand when politics corrodes the underlying aims of research and healing.

How far does noncooperation with Russia go? Very, very far. All research, both ongoing and new, must cease immediately. Whatever can be done to minimize harm to existing subjects in a short period of time ought to be done, but that is it.

Similarly, no sale of medicines or therapies ought to be occurring, be they life-saving or consumer products. Putin will see to it that such shipments go to the military or are sold on the black market for revenue, and there is nothing pharma companies can do to stop that.

The Russian people need to be pinched not only by the loss of cheeseburgers and boutique coffee but by products they use to maintain their well-being. War is cruel that way, but if you tolerate a government that is bombing and shelling a peaceful neighbor to oblivion, then pharma must ensure that efforts to make Putin and his kleptocratic goons feel the wrath of their fellow citizens.

Given the realities of nuclear Armageddon, the civilized world must fight obvious barbarity as best it can with sanctions, financial assaults, property seizures, and forgoing commerce, including important raw materials and health products. War, even in a fiscal form, is not without terrible costs; but achieving a rapid, just resolution against tyranny permits no exceptions for pharma or any other business if it is a war that must be fought.

Dr. Caplan is director of the division of medical ethics at New York University. He has consulted with Johnson & Johnson’s Panel for Compassionate Drug Use.



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

Should pharmaceutical companies continue to do business in Russia, running ongoing clinical trials, starting new ones, or continuing to sell their products there?

Some argue that medicine and science must not get enmeshed in politics, staying above the fray to protect their independence and credibility. Other defenders of business-as-usual say the pharmaceutical industry deals in health and aids the vulnerable. Humanitarianism requires continued interaction with Russia.

I think both arguments fail. Pharma should follow the lead of other Western companies and suspend their involvement with Putin’s Russia.

We are fighting a war with Russia. It is a war of economic strangulation, social isolation, and pushing Russia as hard as we can to become a pariah state so that internal pressure on Putin will cause him to rethink his cruel, unjustified invasion or the Russian people to replace him. This pressure must be harsh and it must happen quickly. Why?

Having failed to rapidly defeat the Ukrainian army in the war’s first weeks, Russian commanders are now resorting to the horrible barbarism they used in previous wars in Chechnya and Syria: flattening cities, attacking civilians, killing children with massive and indiscriminate firepower.

To mention one recent horror among many, Russian shelling destroyed a maternity hospital in Mariupol. Ukraine’s president, Volodymyr Zelensky, in bemoaning the Russians for their continuing series of war crimes called on the world to act.

“Mariupol. Direct Strike of Russian troops at the maternity hospital,” he wrote in a Twitter post. “People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror?”

The Russian government’s response: “It is not the first time we have seen pathetic outcries concerning the so-called atrocities,” said Minister of Foreign Affairs Sergei Lavrov, claiming the hospital was being used as a base by an “ultra-radical” Ukrainian battalion.

Health and its preservation are key parts of the aim of medicine and science. There is no way that medicine and science can ignore what war does to health, what attacks on hospitals do to the sick and those who serve them there, the psychological toll that intentional terrorism takes on civilians and their defenders, and what the destruction of infrastructure means for the long-term well-being of Ukrainians.

There can be no collusion with war criminals. There can be no denial of the inextricable link between medicine, science, and politics. Medicine and science are controlled by political forces; their use for good or evil is driven by political considerations, and each doctor, scientist, and scientific society must take a stand when politics corrodes the underlying aims of research and healing.

How far does noncooperation with Russia go? Very, very far. All research, both ongoing and new, must cease immediately. Whatever can be done to minimize harm to existing subjects in a short period of time ought to be done, but that is it.

Similarly, no sale of medicines or therapies ought to be occurring, be they life-saving or consumer products. Putin will see to it that such shipments go to the military or are sold on the black market for revenue, and there is nothing pharma companies can do to stop that.

The Russian people need to be pinched not only by the loss of cheeseburgers and boutique coffee but by products they use to maintain their well-being. War is cruel that way, but if you tolerate a government that is bombing and shelling a peaceful neighbor to oblivion, then pharma must ensure that efforts to make Putin and his kleptocratic goons feel the wrath of their fellow citizens.

Given the realities of nuclear Armageddon, the civilized world must fight obvious barbarity as best it can with sanctions, financial assaults, property seizures, and forgoing commerce, including important raw materials and health products. War, even in a fiscal form, is not without terrible costs; but achieving a rapid, just resolution against tyranny permits no exceptions for pharma or any other business if it is a war that must be fought.

Dr. Caplan is director of the division of medical ethics at New York University. He has consulted with Johnson & Johnson’s Panel for Compassionate Drug Use.



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

Twelve physicians in Michigan and Ohio were sentenced to prison because of their involvement in distributing 6.6 million opioid pills, according to the U.S. Department of Justice (DOJ). The defendants’s activities also resulted in more than $250 million in false billings.

“It is unconscionable that doctors and health care professionals would violate their oath to do no harm and exploit vulnerable patients struggling with addiction,” said Assistant Attorney General Kenneth Polite Jr., of the Justice Department’s Criminal Division, in the announcement. “These are not just crimes of greed, these are crimes that make this country’s opioid crisis even worse – and that is why the department will continue to relentlessly pursue these cases.”

Francisco Patino, MD, 66, a Wayne County, Michigan-based emergency medicine physician and part owner of one of the clinics involved, purchased cars, jewelry, and vacations as a result of the fraudulent activity, according to federal officials. He will face sentencing at a later date on a variety of counts related to defrauding the United States, health care fraud, money laundering, and wire fraud after his conviction in a 2021 trial.

Prosecutors also allege that he laundered money through a diet program and spent funds on sponsoring mixed martial arts fighters, the Detroit News reported.

Mashiyat Rashid, Dr. Patino’s business partner and part owner of the Tri-County Wellness Group, was sentenced to 15 years in prison and ordered to pay more than $51 million in restitution in connection with his guilty plea to one count of conspiracy to commit health care fraud and wire fraud, in addition to one count of money laundering. As a result of the scheme, Mr. Rashid bought courtside tickets to the NBA Finals, expensive real estate, and private jet flights, according to the DOJ.

Gold bars, indoor basketball courts, luxury cars, and swimming pools were purchases secured by other defendants who were involved in the fraudulent scheme.

Court documents and evidence show that the physicians required that patients receive unnecessary and costly back injections in return for opioids, per the agency charged with enforcing federal law. The scheme, which took place from 2007 to 2018, involved a network of pain clinics across multiple states. Referred to as “pill mills” by the DOJ, the pain clinics dispensed the high-dosage prescriptions, such as oxycodone, to drug dealers and patients with opioid use disorder.

The procedures, billed to insurance, were for facet joint injections. According to the DOJ, the injections were chosen because they generated high reimbursements rather than being medically necessary.

The Detroit News reported in September that some of the medically unnecessary drugs prescribed by Dr. Patino, which included fentanyl, oxycodone, and oxymorphone, per an indictment, were resold “on the street.” Dr. Patino wrote prescriptions for more than 2.2 million pills between 2016 and 2017.

Dr. Patino and Mr. Rashid join physicians and others in the health care field, who are charged or sentenced for their involvement in the scheme. In total, five physicians were convicted in two separate trials and 18 defendants pleaded guilty, per the DOJ. Meanwhile, seven defendants await sentencing.

Included in this group were:

• Spilios Pappas, MD, 63, an emergency medicine specialist in Lucas County, Ohio, sentenced to nine years in prison and ordered to pay $32.2 million in restitution
• Joseph Betro, DO, 60, an emergency medicine physician from Oakland County, Mich., sentenced to nine years in prison and ordered to pay $27.4 million in restitution
• Tariq Omar, MD, 63, a pulmonologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $24.2 million in restitution
• Mohammed Zahoor, MD, 53, a neurologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $36.6 million in restitution

The four physicians worked at various clinics under the Tri-County Wellness Group, operated by Mr. Rashid, according to federal officials. During their employment with the clinics, they defrauded Medicare of more than $150 million through the scheme that involved opioids for medically unnecessary services, the DOJ noted.

Shortly after being indicted, Dr. Pappas posted a fundraising page for his legal services, claiming he and the other doctors had no idea what was going on and that he was “sickened and nauseous” when learning of the details of the case.

More than $16 million was forfeited by the defendants to the United States, according to the DOJ.

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

Twelve physicians in Michigan and Ohio were sentenced to prison because of their involvement in distributing 6.6 million opioid pills, according to the U.S. Department of Justice (DOJ). The defendants’s activities also resulted in more than $250 million in false billings.

“It is unconscionable that doctors and health care professionals would violate their oath to do no harm and exploit vulnerable patients struggling with addiction,” said Assistant Attorney General Kenneth Polite Jr., of the Justice Department’s Criminal Division, in the announcement. “These are not just crimes of greed, these are crimes that make this country’s opioid crisis even worse – and that is why the department will continue to relentlessly pursue these cases.”

Francisco Patino, MD, 66, a Wayne County, Michigan-based emergency medicine physician and part owner of one of the clinics involved, purchased cars, jewelry, and vacations as a result of the fraudulent activity, according to federal officials. He will face sentencing at a later date on a variety of counts related to defrauding the United States, health care fraud, money laundering, and wire fraud after his conviction in a 2021 trial.

Prosecutors also allege that he laundered money through a diet program and spent funds on sponsoring mixed martial arts fighters, the Detroit News reported.

Mashiyat Rashid, Dr. Patino’s business partner and part owner of the Tri-County Wellness Group, was sentenced to 15 years in prison and ordered to pay more than $51 million in restitution in connection with his guilty plea to one count of conspiracy to commit health care fraud and wire fraud, in addition to one count of money laundering. As a result of the scheme, Mr. Rashid bought courtside tickets to the NBA Finals, expensive real estate, and private jet flights, according to the DOJ.

Gold bars, indoor basketball courts, luxury cars, and swimming pools were purchases secured by other defendants who were involved in the fraudulent scheme.

Court documents and evidence show that the physicians required that patients receive unnecessary and costly back injections in return for opioids, per the agency charged with enforcing federal law. The scheme, which took place from 2007 to 2018, involved a network of pain clinics across multiple states. Referred to as “pill mills” by the DOJ, the pain clinics dispensed the high-dosage prescriptions, such as oxycodone, to drug dealers and patients with opioid use disorder.

The procedures, billed to insurance, were for facet joint injections. According to the DOJ, the injections were chosen because they generated high reimbursements rather than being medically necessary.

The Detroit News reported in September that some of the medically unnecessary drugs prescribed by Dr. Patino, which included fentanyl, oxycodone, and oxymorphone, per an indictment, were resold “on the street.” Dr. Patino wrote prescriptions for more than 2.2 million pills between 2016 and 2017.

Dr. Patino and Mr. Rashid join physicians and others in the health care field, who are charged or sentenced for their involvement in the scheme. In total, five physicians were convicted in two separate trials and 18 defendants pleaded guilty, per the DOJ. Meanwhile, seven defendants await sentencing.

Included in this group were:

• Spilios Pappas, MD, 63, an emergency medicine specialist in Lucas County, Ohio, sentenced to nine years in prison and ordered to pay $32.2 million in restitution
• Joseph Betro, DO, 60, an emergency medicine physician from Oakland County, Mich., sentenced to nine years in prison and ordered to pay $27.4 million in restitution
• Tariq Omar, MD, 63, a pulmonologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $24.2 million in restitution
• Mohammed Zahoor, MD, 53, a neurologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $36.6 million in restitution

The four physicians worked at various clinics under the Tri-County Wellness Group, operated by Mr. Rashid, according to federal officials. During their employment with the clinics, they defrauded Medicare of more than $150 million through the scheme that involved opioids for medically unnecessary services, the DOJ noted.

Shortly after being indicted, Dr. Pappas posted a fundraising page for his legal services, claiming he and the other doctors had no idea what was going on and that he was “sickened and nauseous” when learning of the details of the case.

More than $16 million was forfeited by the defendants to the United States, according to the DOJ.

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

Twelve physicians in Michigan and Ohio were sentenced to prison because of their involvement in distributing 6.6 million opioid pills, according to the U.S. Department of Justice (DOJ). The defendants’s activities also resulted in more than $250 million in false billings.

“It is unconscionable that doctors and health care professionals would violate their oath to do no harm and exploit vulnerable patients struggling with addiction,” said Assistant Attorney General Kenneth Polite Jr., of the Justice Department’s Criminal Division, in the announcement. “These are not just crimes of greed, these are crimes that make this country’s opioid crisis even worse – and that is why the department will continue to relentlessly pursue these cases.”

Francisco Patino, MD, 66, a Wayne County, Michigan-based emergency medicine physician and part owner of one of the clinics involved, purchased cars, jewelry, and vacations as a result of the fraudulent activity, according to federal officials. He will face sentencing at a later date on a variety of counts related to defrauding the United States, health care fraud, money laundering, and wire fraud after his conviction in a 2021 trial.

Prosecutors also allege that he laundered money through a diet program and spent funds on sponsoring mixed martial arts fighters, the Detroit News reported.

Mashiyat Rashid, Dr. Patino’s business partner and part owner of the Tri-County Wellness Group, was sentenced to 15 years in prison and ordered to pay more than $51 million in restitution in connection with his guilty plea to one count of conspiracy to commit health care fraud and wire fraud, in addition to one count of money laundering. As a result of the scheme, Mr. Rashid bought courtside tickets to the NBA Finals, expensive real estate, and private jet flights, according to the DOJ.

Gold bars, indoor basketball courts, luxury cars, and swimming pools were purchases secured by other defendants who were involved in the fraudulent scheme.

Court documents and evidence show that the physicians required that patients receive unnecessary and costly back injections in return for opioids, per the agency charged with enforcing federal law. The scheme, which took place from 2007 to 2018, involved a network of pain clinics across multiple states. Referred to as “pill mills” by the DOJ, the pain clinics dispensed the high-dosage prescriptions, such as oxycodone, to drug dealers and patients with opioid use disorder.

The procedures, billed to insurance, were for facet joint injections. According to the DOJ, the injections were chosen because they generated high reimbursements rather than being medically necessary.

The Detroit News reported in September that some of the medically unnecessary drugs prescribed by Dr. Patino, which included fentanyl, oxycodone, and oxymorphone, per an indictment, were resold “on the street.” Dr. Patino wrote prescriptions for more than 2.2 million pills between 2016 and 2017.

Dr. Patino and Mr. Rashid join physicians and others in the health care field, who are charged or sentenced for their involvement in the scheme. In total, five physicians were convicted in two separate trials and 18 defendants pleaded guilty, per the DOJ. Meanwhile, seven defendants await sentencing.

Included in this group were:

• Spilios Pappas, MD, 63, an emergency medicine specialist in Lucas County, Ohio, sentenced to nine years in prison and ordered to pay $32.2 million in restitution
• Joseph Betro, DO, 60, an emergency medicine physician from Oakland County, Mich., sentenced to nine years in prison and ordered to pay $27.4 million in restitution
• Tariq Omar, MD, 63, a pulmonologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $24.2 million in restitution
• Mohammed Zahoor, MD, 53, a neurologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $36.6 million in restitution

The four physicians worked at various clinics under the Tri-County Wellness Group, operated by Mr. Rashid, according to federal officials. During their employment with the clinics, they defrauded Medicare of more than $150 million through the scheme that involved opioids for medically unnecessary services, the DOJ noted.

Shortly after being indicted, Dr. Pappas posted a fundraising page for his legal services, claiming he and the other doctors had no idea what was going on and that he was “sickened and nauseous” when learning of the details of the case.

More than $16 million was forfeited by the defendants to the United States, according to the DOJ.

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

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.

PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.

Scott Harms/iStockphoto

The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.

In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.

Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.

The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.

The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.

What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.

What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?

Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.

The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.

Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.

You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?

Dr. Velea: Some of my patients have been quite successful in cutting down on their cannabis use by switching to CBD. Knowing the risk and harm associated with the absorption of THC, they prefer to smoke CBD instead. Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.

Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.

Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?

Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.

What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.

Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.

Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.

So, what position can a doctor take toward patients who express their desire to use CBD-derived products?

Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.

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

PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.

Scott Harms/iStockphoto

The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.

In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.

Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.

The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.

The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.

What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.

What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?

Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.

The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.

Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.

You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?

Dr. Velea: Some of my patients have been quite successful in cutting down on their cannabis use by switching to CBD. Knowing the risk and harm associated with the absorption of THC, they prefer to smoke CBD instead. Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.

Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.

Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?

Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.

What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.

Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.

Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.

So, what position can a doctor take toward patients who express their desire to use CBD-derived products?

Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.

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

PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.

Scott Harms/iStockphoto

The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.

In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.

Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.

The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.

The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.

What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.

What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?

Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.

The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.

Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.

You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?

Dr. Velea: Some of my patients have been quite successful in cutting down on their cannabis use by switching to CBD. Knowing the risk and harm associated with the absorption of THC, they prefer to smoke CBD instead. Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.

Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.

Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?

Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.

What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.

Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.

Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.

So, what position can a doctor take toward patients who express their desire to use CBD-derived products?

Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.

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