Pain

A psychotherapeutic intervention that unites mindfulness training, “third wave” cognitive behavioral therapy (CBT), and positive psychology significantly reduces chronic pain and opioid misuse, new research suggests.

In a randomized clinical trial, 250 adults with both opioid misuse and chronic pain received either the intervention, called mindfulness-oriented recovery enhancement (MORE), or supportive psychotherapy.

Results showed the first group was twice as likely to reduce opioid misuse after 9 months than the latter group.

University of Utah

The intervention was developed by Eric Garland, PhD, director of the Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah, Salt Lake City. “As the largest and longest-term clinical trial of MORE ever conducted, this study definitively establishes the efficacy of MORE as a treatment for chronic pain and opioid misuse,” he told this news organization.

The findings were published online Feb. 28 in JAMA Internal Medicine.
 

Self-regulation

Study participants included 250 adults (64% women; mean age, 51.8 years) with co-occurring opioid misuse and chronic pain who were randomly allocated to receive MORE or supportive psychotherapy, which served as a control group.

Both interventions were delivered by trained clinical social workers in six primary care clinics in Utah to groups of 6-12 participants across 8 weekly 2-hour sessions.

The MORE intervention, detailed on Dr. Garland’s website, provides sequenced training in mindfulness, reappraisal, and savoring skills.

Mindfulness consisted of meditation on breathing and body sensations to strengthen self-regulation of compulsive opioid use and to mitigate pain and opioid craving by reinterpreting these experiences as innocuous sensory information.

Reappraisal consisted of reframing maladaptive thoughts to decrease negative emotions and engender meaning in life.

Savoring consisted of training in focusing awareness on pleasurable events and sensations to amplify positive emotions and reward.
 

Fewer depressive symptoms

Through 9 months of follow-up, the MORE group had about a twofold greater likelihood than the supportive psychotherapy group for reduction in opioid misuse (odds ratio [OR], 2.06; 95% confidence interval, 1.17-3.61; P = .01)

“MORE reduced opioid misuse by 45% 9 months after the end of treatment, more than doubling the effect of standard supportive psychotherapy and exceeding the effect size of other therapies for opioid misuse among people with chronic pain,” Dr. Garland said.

Members of the MORE group experienced greater reduction in pain severity and pain-related functional interference compared with members of the control group.

“MORE’s effect size on chronic pain symptoms was greater than that observed for CBT, the current gold standard psychological treatment for chronic pain,” Dr. Garland noted.

Compared with supportive psychotherapy, MORE decreased emotional distress, depressive symptoms, and real-time reports of opioid craving in daily life.

“Although nearly 70% of participants met criteria for depression at the beginning of the trial, on average, patients in MORE no longer exhibited symptoms consistent with major depressive disorder by the end of the study,” Dr. Garland said.

The current study builds on prior studies of MORE showing similar results, as reported previously by this news organization.

MORE can be successfully delivered in routine primary care, Dr. Garland noted. “In this trial, we delivered MORE in conference rooms, break rooms, and lunch rooms at community primary care clinics,” he added.
 

‘Powerful program’

To date, Dr. Garland has trained more than 450 physicians, nurses, social workers, and psychologists in health care systems across the country to implement MORE as an insurance-reimbursable group visit for patients in need.

One of them is Nancy Sudak, MD, chief well-being officer and director of integrative health, Essentia Health, Duluth, Minn.

Essentia Health

“MORE is a very powerful program that teaches patients how to turn down the volume of their pain. I’ve been quite impressed by the power of MORE,” Dr. Sudak told this news organization

She noted that “buy-in” from patients is key – and the more a clinician knows a patient, the easier the buy-in.

“I recruited most of the patients in my groups from my own practice, so I already knew the patients quite well and there wasn’t really a need to sell it,” Dr. Sudak said.

“We have tried to operationalize it through our system and find that, as long as our recruitment techniques are robust enough, it’s not that hard to find patients to fill the groups, especially because chronic pain is just so common,” she added.

Dr. Sudak has found that patients who participate in MORE “bond and learn with each other and support each other. Patients love it, providers love it, and it’s a way to address isolation and loneliness” that can come with certain conditions.

“There are really only upsides to the group visit model and I think we’ll be seeing quite a bit more of it in the future,” she added.
 

Evidence-based data

Anna Parisi, PhD, is also delivering MORE to patients. She told this news organization, she was “really drawn” to the MORE program because oftentimes patients who require the most sophisticated therapies receive the ones with the least evidence.

This is often “what folks in the community are getting when they’re struggling with substance use,” added Dr. Parisi, a postdoctoral research associate working with Dr. Garland at the University of Utah. Dr. Parisi was not a coauthor on the current study.

“With MORE, all of the strategies and techniques are tied to mechanistic studies of their efficacy, so you know that what you’re delivering has a rationale behind it,” she said.

Like Dr. Sudak, Dr. Parisi said her patients, for the most part, have been receptive to the program. Although at first some were skeptical about mindfulness – with one patient using the term “tree-hugging” – they found immediate benefit even after the first session.

“That really helps them stay motivated to finish the program,” Dr. Parisi said.

This work was supported by a grant from the National Institute on Drug Abuse. Dr. Garland serves as director of the Center on Mindfulness and Integrative Health Intervention Development, which provides MORE, mindfulness-based therapy, and CBT in the context of research trials for no cost to research participants. He receives honoraria and payment for delivering seminars, lectures, and teaching engagements related to training clinicians in MORE and mindfulness and receives royalties from BehaVR and from the sales of books related to MORE outside the submitted work. Dr. Sudak and Dr. Parisi have disclosed no relevant financial relationships.

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

A psychotherapeutic intervention that unites mindfulness training, “third wave” cognitive behavioral therapy (CBT), and positive psychology significantly reduces chronic pain and opioid misuse, new research suggests.

In a randomized clinical trial, 250 adults with both opioid misuse and chronic pain received either the intervention, called mindfulness-oriented recovery enhancement (MORE), or supportive psychotherapy.

Results showed the first group was twice as likely to reduce opioid misuse after 9 months than the latter group.

University of Utah

The intervention was developed by Eric Garland, PhD, director of the Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah, Salt Lake City. “As the largest and longest-term clinical trial of MORE ever conducted, this study definitively establishes the efficacy of MORE as a treatment for chronic pain and opioid misuse,” he told this news organization.

The findings were published online Feb. 28 in JAMA Internal Medicine.
 

Self-regulation

Study participants included 250 adults (64% women; mean age, 51.8 years) with co-occurring opioid misuse and chronic pain who were randomly allocated to receive MORE or supportive psychotherapy, which served as a control group.

Both interventions were delivered by trained clinical social workers in six primary care clinics in Utah to groups of 6-12 participants across 8 weekly 2-hour sessions.

The MORE intervention, detailed on Dr. Garland’s website, provides sequenced training in mindfulness, reappraisal, and savoring skills.

Mindfulness consisted of meditation on breathing and body sensations to strengthen self-regulation of compulsive opioid use and to mitigate pain and opioid craving by reinterpreting these experiences as innocuous sensory information.

Reappraisal consisted of reframing maladaptive thoughts to decrease negative emotions and engender meaning in life.

Savoring consisted of training in focusing awareness on pleasurable events and sensations to amplify positive emotions and reward.
 

Fewer depressive symptoms

Through 9 months of follow-up, the MORE group had about a twofold greater likelihood than the supportive psychotherapy group for reduction in opioid misuse (odds ratio [OR], 2.06; 95% confidence interval, 1.17-3.61; P = .01)

“MORE reduced opioid misuse by 45% 9 months after the end of treatment, more than doubling the effect of standard supportive psychotherapy and exceeding the effect size of other therapies for opioid misuse among people with chronic pain,” Dr. Garland said.

Members of the MORE group experienced greater reduction in pain severity and pain-related functional interference compared with members of the control group.

“MORE’s effect size on chronic pain symptoms was greater than that observed for CBT, the current gold standard psychological treatment for chronic pain,” Dr. Garland noted.

Compared with supportive psychotherapy, MORE decreased emotional distress, depressive symptoms, and real-time reports of opioid craving in daily life.

“Although nearly 70% of participants met criteria for depression at the beginning of the trial, on average, patients in MORE no longer exhibited symptoms consistent with major depressive disorder by the end of the study,” Dr. Garland said.

The current study builds on prior studies of MORE showing similar results, as reported previously by this news organization.

MORE can be successfully delivered in routine primary care, Dr. Garland noted. “In this trial, we delivered MORE in conference rooms, break rooms, and lunch rooms at community primary care clinics,” he added.
 

‘Powerful program’

To date, Dr. Garland has trained more than 450 physicians, nurses, social workers, and psychologists in health care systems across the country to implement MORE as an insurance-reimbursable group visit for patients in need.

One of them is Nancy Sudak, MD, chief well-being officer and director of integrative health, Essentia Health, Duluth, Minn.

Essentia Health

“MORE is a very powerful program that teaches patients how to turn down the volume of their pain. I’ve been quite impressed by the power of MORE,” Dr. Sudak told this news organization

She noted that “buy-in” from patients is key – and the more a clinician knows a patient, the easier the buy-in.

“I recruited most of the patients in my groups from my own practice, so I already knew the patients quite well and there wasn’t really a need to sell it,” Dr. Sudak said.

“We have tried to operationalize it through our system and find that, as long as our recruitment techniques are robust enough, it’s not that hard to find patients to fill the groups, especially because chronic pain is just so common,” she added.

Dr. Sudak has found that patients who participate in MORE “bond and learn with each other and support each other. Patients love it, providers love it, and it’s a way to address isolation and loneliness” that can come with certain conditions.

“There are really only upsides to the group visit model and I think we’ll be seeing quite a bit more of it in the future,” she added.
 

Evidence-based data

Anna Parisi, PhD, is also delivering MORE to patients. She told this news organization, she was “really drawn” to the MORE program because oftentimes patients who require the most sophisticated therapies receive the ones with the least evidence.

This is often “what folks in the community are getting when they’re struggling with substance use,” added Dr. Parisi, a postdoctoral research associate working with Dr. Garland at the University of Utah. Dr. Parisi was not a coauthor on the current study.

“With MORE, all of the strategies and techniques are tied to mechanistic studies of their efficacy, so you know that what you’re delivering has a rationale behind it,” she said.

Like Dr. Sudak, Dr. Parisi said her patients, for the most part, have been receptive to the program. Although at first some were skeptical about mindfulness – with one patient using the term “tree-hugging” – they found immediate benefit even after the first session.

“That really helps them stay motivated to finish the program,” Dr. Parisi said.

This work was supported by a grant from the National Institute on Drug Abuse. Dr. Garland serves as director of the Center on Mindfulness and Integrative Health Intervention Development, which provides MORE, mindfulness-based therapy, and CBT in the context of research trials for no cost to research participants. He receives honoraria and payment for delivering seminars, lectures, and teaching engagements related to training clinicians in MORE and mindfulness and receives royalties from BehaVR and from the sales of books related to MORE outside the submitted work. Dr. Sudak and Dr. Parisi have disclosed no relevant financial relationships.

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

A psychotherapeutic intervention that unites mindfulness training, “third wave” cognitive behavioral therapy (CBT), and positive psychology significantly reduces chronic pain and opioid misuse, new research suggests.

In a randomized clinical trial, 250 adults with both opioid misuse and chronic pain received either the intervention, called mindfulness-oriented recovery enhancement (MORE), or supportive psychotherapy.

Results showed the first group was twice as likely to reduce opioid misuse after 9 months than the latter group.

University of Utah

The intervention was developed by Eric Garland, PhD, director of the Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah, Salt Lake City. “As the largest and longest-term clinical trial of MORE ever conducted, this study definitively establishes the efficacy of MORE as a treatment for chronic pain and opioid misuse,” he told this news organization.

The findings were published online Feb. 28 in JAMA Internal Medicine.
 

Self-regulation

Study participants included 250 adults (64% women; mean age, 51.8 years) with co-occurring opioid misuse and chronic pain who were randomly allocated to receive MORE or supportive psychotherapy, which served as a control group.

Both interventions were delivered by trained clinical social workers in six primary care clinics in Utah to groups of 6-12 participants across 8 weekly 2-hour sessions.

The MORE intervention, detailed on Dr. Garland’s website, provides sequenced training in mindfulness, reappraisal, and savoring skills.

Mindfulness consisted of meditation on breathing and body sensations to strengthen self-regulation of compulsive opioid use and to mitigate pain and opioid craving by reinterpreting these experiences as innocuous sensory information.

Reappraisal consisted of reframing maladaptive thoughts to decrease negative emotions and engender meaning in life.

Savoring consisted of training in focusing awareness on pleasurable events and sensations to amplify positive emotions and reward.
 

Fewer depressive symptoms

Through 9 months of follow-up, the MORE group had about a twofold greater likelihood than the supportive psychotherapy group for reduction in opioid misuse (odds ratio [OR], 2.06; 95% confidence interval, 1.17-3.61; P = .01)

“MORE reduced opioid misuse by 45% 9 months after the end of treatment, more than doubling the effect of standard supportive psychotherapy and exceeding the effect size of other therapies for opioid misuse among people with chronic pain,” Dr. Garland said.

Members of the MORE group experienced greater reduction in pain severity and pain-related functional interference compared with members of the control group.

“MORE’s effect size on chronic pain symptoms was greater than that observed for CBT, the current gold standard psychological treatment for chronic pain,” Dr. Garland noted.

Compared with supportive psychotherapy, MORE decreased emotional distress, depressive symptoms, and real-time reports of opioid craving in daily life.

“Although nearly 70% of participants met criteria for depression at the beginning of the trial, on average, patients in MORE no longer exhibited symptoms consistent with major depressive disorder by the end of the study,” Dr. Garland said.

The current study builds on prior studies of MORE showing similar results, as reported previously by this news organization.

MORE can be successfully delivered in routine primary care, Dr. Garland noted. “In this trial, we delivered MORE in conference rooms, break rooms, and lunch rooms at community primary care clinics,” he added.
 

‘Powerful program’

To date, Dr. Garland has trained more than 450 physicians, nurses, social workers, and psychologists in health care systems across the country to implement MORE as an insurance-reimbursable group visit for patients in need.

One of them is Nancy Sudak, MD, chief well-being officer and director of integrative health, Essentia Health, Duluth, Minn.

Essentia Health

“MORE is a very powerful program that teaches patients how to turn down the volume of their pain. I’ve been quite impressed by the power of MORE,” Dr. Sudak told this news organization

She noted that “buy-in” from patients is key – and the more a clinician knows a patient, the easier the buy-in.

“I recruited most of the patients in my groups from my own practice, so I already knew the patients quite well and there wasn’t really a need to sell it,” Dr. Sudak said.

“We have tried to operationalize it through our system and find that, as long as our recruitment techniques are robust enough, it’s not that hard to find patients to fill the groups, especially because chronic pain is just so common,” she added.

Dr. Sudak has found that patients who participate in MORE “bond and learn with each other and support each other. Patients love it, providers love it, and it’s a way to address isolation and loneliness” that can come with certain conditions.

“There are really only upsides to the group visit model and I think we’ll be seeing quite a bit more of it in the future,” she added.
 

Evidence-based data

Anna Parisi, PhD, is also delivering MORE to patients. She told this news organization, she was “really drawn” to the MORE program because oftentimes patients who require the most sophisticated therapies receive the ones with the least evidence.

This is often “what folks in the community are getting when they’re struggling with substance use,” added Dr. Parisi, a postdoctoral research associate working with Dr. Garland at the University of Utah. Dr. Parisi was not a coauthor on the current study.

“With MORE, all of the strategies and techniques are tied to mechanistic studies of their efficacy, so you know that what you’re delivering has a rationale behind it,” she said.

Like Dr. Sudak, Dr. Parisi said her patients, for the most part, have been receptive to the program. Although at first some were skeptical about mindfulness – with one patient using the term “tree-hugging” – they found immediate benefit even after the first session.

“That really helps them stay motivated to finish the program,” Dr. Parisi said.

This work was supported by a grant from the National Institute on Drug Abuse. Dr. Garland serves as director of the Center on Mindfulness and Integrative Health Intervention Development, which provides MORE, mindfulness-based therapy, and CBT in the context of research trials for no cost to research participants. He receives honoraria and payment for delivering seminars, lectures, and teaching engagements related to training clinicians in MORE and mindfulness and receives royalties from BehaVR and from the sales of books related to MORE outside the submitted work. Dr. Sudak and Dr. Parisi have disclosed no relevant financial relationships.

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

A 64-year-old woman is evaluated for fever, diarrhea, and abdominal pain. She was diagnosed with Clostridioides difficile 2 months ago and completed a 10-day course of vancomycin. Her stool toxin test is positive for Clostridioides difficile (C. diff). Based on the most recent Infectious Diseases Society of America (IDSA) guidelines, what would be the preferred therapy?

A) Metronidazole

B) Fidaxomicin + bezlotoxumab

C) Vancomycin

D) Fecal microbiota transplant

The recommendations from the 2021 guidelines would be to treat with fidaxomicin and add bezlotoxumab.¹ The guidelines highlight the following changes:

• In patients with an initial Clostridioides difficile infections (CDI) fidaxomicin is preferred over vancomycin.
• In patients with a recurrent CDI episode, fidaxomicin is favored over vancomycin. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.
• Addition of bezlotoxumab to standard of care antibiotics is recommended for recurrence of CDI within the first 6 months over standard of care antibiotics alone

The feasibility of these recommendations is up for debate. The cost of a course of fidaxomicin is $2,800, and the cost of bezlotoxumab is about $4,500. Cost effectiveness studies that helped drive the recommendations show a savings by reducing future hospitalizations for C. diff.² Unfortunately, this enthusiasm is not shared by many insurance companies for outpatient treatment.

Knee osteoarthritis

I will save you the excitement of the new acromegaly guidelines and focus on something we see all the time: knee osteoarthritis. The American Academy of Orthopedic Surgeons has released guidelines for this condition.³ The useful points I found were as follows:

• Topical application of nonsteroidal anti-inflammatory drugs (e.g., diclofenac) should be used to improve function and quality of life in patients with knee osteoarthritis.
• Exercise routines (i.e, supervised, unsupervised, and/or aquatic) are recommended versus no exercise for improving pain and function in patients with knee osteoarthritis.
• Not recommended is the use of oral narcotics (including tramadol), as they are not effective at improving pain or function, and their use results in a significant increased risk of adverse events.
• Not recommended for routine use in symptomatic knee osteoarthritis is intra-articular injection of hyaluronic acid.

I was happy to see topical NSAIDS recommended, as they are a much safer option in older patients than oral NSAIDS (which were also recommended). The recommendation against narcotics, including tramadol, is a shift from the recommendation of tramadol in the 2013 guidelines.⁴ Acetaminophen was enthusiastically recommended, and is still worth a try.

Sexually transmitted infections

• The dosing for the treatment of gonorrhea has increased to 500 mg of ceftriaxone (was 250 mg in 2015 guidelines), with a dose of 1 gram for patients who weigh more than 150 kg.
• Chlamydia infections should be treated with a 7-day course of doxycycline as the preferred antibiotic, except in pregnant women (where azithromycin is recommended).
• Herpes simplex virus 2 recurrences can be treated with twice-daily dosing of 800 mg of acyclovir for 5 days, or acyclovir 800 mg three times a day for 2 days. The shortest course for recurrence is famciclovir 1 gram twice a day for 1 day.
• The Centers for Disease Control and Prevention has removed the recommendation for avoidance of alcohol when taking metronidazole.

I hope these highlights of guidelines for common issues we see are helpful!

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Johnson S et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile Infection in adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044.

2. Pabhu VS et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018 Feb 1;66(3):355-62.

3. American Academy of Orthopaedic Surgeons: Management of osteoarthritis of the knee (non-arthroplasty) – Evidence-based clinical practice guideline (2021 Aug 31. https://www.aaos.org/oak3cpg).

4. Jevsevar DS. Treatment of osteoarthritis of the knee: Evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013: Sep;21(9):571-6.

5. Sexually transmitted infections treatment guidelines, 2021 recommendations and reports. MMWR 2021 Jul 23;70(4):1-187.

A 64-year-old woman is evaluated for fever, diarrhea, and abdominal pain. She was diagnosed with Clostridioides difficile 2 months ago and completed a 10-day course of vancomycin. Her stool toxin test is positive for Clostridioides difficile (C. diff). Based on the most recent Infectious Diseases Society of America (IDSA) guidelines, what would be the preferred therapy?

A) Metronidazole

B) Fidaxomicin + bezlotoxumab

C) Vancomycin

D) Fecal microbiota transplant

The recommendations from the 2021 guidelines would be to treat with fidaxomicin and add bezlotoxumab.¹ The guidelines highlight the following changes:

• In patients with an initial Clostridioides difficile infections (CDI) fidaxomicin is preferred over vancomycin.
• In patients with a recurrent CDI episode, fidaxomicin is favored over vancomycin. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.
• Addition of bezlotoxumab to standard of care antibiotics is recommended for recurrence of CDI within the first 6 months over standard of care antibiotics alone

The feasibility of these recommendations is up for debate. The cost of a course of fidaxomicin is $2,800, and the cost of bezlotoxumab is about $4,500. Cost effectiveness studies that helped drive the recommendations show a savings by reducing future hospitalizations for C. diff.² Unfortunately, this enthusiasm is not shared by many insurance companies for outpatient treatment.

Knee osteoarthritis

I will save you the excitement of the new acromegaly guidelines and focus on something we see all the time: knee osteoarthritis. The American Academy of Orthopedic Surgeons has released guidelines for this condition.³ The useful points I found were as follows:

• Topical application of nonsteroidal anti-inflammatory drugs (e.g., diclofenac) should be used to improve function and quality of life in patients with knee osteoarthritis.
• Exercise routines (i.e, supervised, unsupervised, and/or aquatic) are recommended versus no exercise for improving pain and function in patients with knee osteoarthritis.
• Not recommended is the use of oral narcotics (including tramadol), as they are not effective at improving pain or function, and their use results in a significant increased risk of adverse events.
• Not recommended for routine use in symptomatic knee osteoarthritis is intra-articular injection of hyaluronic acid.

I was happy to see topical NSAIDS recommended, as they are a much safer option in older patients than oral NSAIDS (which were also recommended). The recommendation against narcotics, including tramadol, is a shift from the recommendation of tramadol in the 2013 guidelines.⁴ Acetaminophen was enthusiastically recommended, and is still worth a try.

Sexually transmitted infections

• The dosing for the treatment of gonorrhea has increased to 500 mg of ceftriaxone (was 250 mg in 2015 guidelines), with a dose of 1 gram for patients who weigh more than 150 kg.
• Chlamydia infections should be treated with a 7-day course of doxycycline as the preferred antibiotic, except in pregnant women (where azithromycin is recommended).
• Herpes simplex virus 2 recurrences can be treated with twice-daily dosing of 800 mg of acyclovir for 5 days, or acyclovir 800 mg three times a day for 2 days. The shortest course for recurrence is famciclovir 1 gram twice a day for 1 day.
• The Centers for Disease Control and Prevention has removed the recommendation for avoidance of alcohol when taking metronidazole.

I hope these highlights of guidelines for common issues we see are helpful!

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Johnson S et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile Infection in adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044.

2. Pabhu VS et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018 Feb 1;66(3):355-62.

3. American Academy of Orthopaedic Surgeons: Management of osteoarthritis of the knee (non-arthroplasty) – Evidence-based clinical practice guideline (2021 Aug 31. https://www.aaos.org/oak3cpg).

4. Jevsevar DS. Treatment of osteoarthritis of the knee: Evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013: Sep;21(9):571-6.

5. Sexually transmitted infections treatment guidelines, 2021 recommendations and reports. MMWR 2021 Jul 23;70(4):1-187.

A 64-year-old woman is evaluated for fever, diarrhea, and abdominal pain. She was diagnosed with Clostridioides difficile 2 months ago and completed a 10-day course of vancomycin. Her stool toxin test is positive for Clostridioides difficile (C. diff). Based on the most recent Infectious Diseases Society of America (IDSA) guidelines, what would be the preferred therapy?

A) Metronidazole

B) Fidaxomicin + bezlotoxumab

C) Vancomycin

D) Fecal microbiota transplant

The recommendations from the 2021 guidelines would be to treat with fidaxomicin and add bezlotoxumab.¹ The guidelines highlight the following changes:

• In patients with an initial Clostridioides difficile infections (CDI) fidaxomicin is preferred over vancomycin.
• In patients with a recurrent CDI episode, fidaxomicin is favored over vancomycin. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.
• Addition of bezlotoxumab to standard of care antibiotics is recommended for recurrence of CDI within the first 6 months over standard of care antibiotics alone

The feasibility of these recommendations is up for debate. The cost of a course of fidaxomicin is $2,800, and the cost of bezlotoxumab is about $4,500. Cost effectiveness studies that helped drive the recommendations show a savings by reducing future hospitalizations for C. diff.² Unfortunately, this enthusiasm is not shared by many insurance companies for outpatient treatment.

Knee osteoarthritis

I will save you the excitement of the new acromegaly guidelines and focus on something we see all the time: knee osteoarthritis. The American Academy of Orthopedic Surgeons has released guidelines for this condition.³ The useful points I found were as follows:

• Topical application of nonsteroidal anti-inflammatory drugs (e.g., diclofenac) should be used to improve function and quality of life in patients with knee osteoarthritis.
• Exercise routines (i.e, supervised, unsupervised, and/or aquatic) are recommended versus no exercise for improving pain and function in patients with knee osteoarthritis.
• Not recommended is the use of oral narcotics (including tramadol), as they are not effective at improving pain or function, and their use results in a significant increased risk of adverse events.
• Not recommended for routine use in symptomatic knee osteoarthritis is intra-articular injection of hyaluronic acid.

I was happy to see topical NSAIDS recommended, as they are a much safer option in older patients than oral NSAIDS (which were also recommended). The recommendation against narcotics, including tramadol, is a shift from the recommendation of tramadol in the 2013 guidelines.⁴ Acetaminophen was enthusiastically recommended, and is still worth a try.

Sexually transmitted infections

• The dosing for the treatment of gonorrhea has increased to 500 mg of ceftriaxone (was 250 mg in 2015 guidelines), with a dose of 1 gram for patients who weigh more than 150 kg.
• Chlamydia infections should be treated with a 7-day course of doxycycline as the preferred antibiotic, except in pregnant women (where azithromycin is recommended).
• Herpes simplex virus 2 recurrences can be treated with twice-daily dosing of 800 mg of acyclovir for 5 days, or acyclovir 800 mg three times a day for 2 days. The shortest course for recurrence is famciclovir 1 gram twice a day for 1 day.
• The Centers for Disease Control and Prevention has removed the recommendation for avoidance of alcohol when taking metronidazole.

I hope these highlights of guidelines for common issues we see are helpful!

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Johnson S et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile Infection in adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044.

2. Pabhu VS et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018 Feb 1;66(3):355-62.

3. American Academy of Orthopaedic Surgeons: Management of osteoarthritis of the knee (non-arthroplasty) – Evidence-based clinical practice guideline (2021 Aug 31. https://www.aaos.org/oak3cpg).

4. Jevsevar DS. Treatment of osteoarthritis of the knee: Evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013: Sep;21(9):571-6.

5. Sexually transmitted infections treatment guidelines, 2021 recommendations and reports. MMWR 2021 Jul 23;70(4):1-187.

Use of neuraxial analgesia for vaginal delivery is associated with a 14% decreased risk for severe maternal morbidity, in part from a reduction in postpartum hemorrhage, new research shows.

The findings indicate that increasing the use of epidural or combined spinal-epidural analgesia may improve maternal health outcomes, especially for Hispanic, Black, and uninsured women who are less likely than White women to receive these interventions, according to the researchers, who published their findings online in JAMA Network Open.

About 80% of non-Hispanic White women receive neuraxial analgesia during labor in the United States, compared with 70% of non-Hispanic Black women and 65% of Hispanic women, according to birth certificate data. Among women without health insurance, half receive epidurals.  

Programs that inform pregnant women about epidural use, expand Medicaid, and provide in-house obstetric anesthesia teams “may improve patient participation in clinical decision making and access to care,” study author Guohua Li, MD, DrPH, of Columbia University, New York, said in a statement about the research.

Earlier data from France showed that neuraxial analgesia is associated with reduced risk for severe postpartum hemorrhage. To examine the association between labor neuraxial analgesia and severe maternal morbidity in the United States, Dr. Li and colleagues analyzed more than 575,000 vaginal deliveries in New York hospitals between 2010 and 2017; about half (47.4%) of the women received epidurals during labor.

The researchers focused on severe maternal morbidity, including 16 complications, such as heart failure and sepsis, and five procedures, including hysterectomy and ventilation.

They also considered patient characteristics and comorbidities and hospital-related factors to identify patients who were at higher risk for injury or death.

Severe maternal morbidity occurred in 1.3% of the women. Of the 7,712 women with severe morbidity, more than one in three (35.6%) experienced postpartum hemorrhage.

The overall incidence of severe maternal morbidity was 1.3% among women who received an epidural injection and 1.4% among those who did not. In a weighted analysis, the adjusted odds ratio of severe maternal morbidity associated with epidurals was 0.86 (95% confidence interval, 0.82-0.90).

The study is limited by its observational design and does not prove causation, the authors acknowledged.

“Labor neuraxial analgesia may facilitate early evaluation and management of the third stage of labor to avoid escalation of postpartum hemorrhaging into grave complications and death,” study author Jean Guglielminotti, MD, PhD, an anesthesiologist at Columbia University, said in a statement.
 

Concerning trends

The Department of Health & Human Services has labeled severe maternal morbidity a public health priority. Recent data from the Centers for Disease Control and Prevention show an increase in maternal mortality rates and worsening disparities by race and ethnicity.

According to the CDC, 861 women died of maternal causes in 2020, up from 754 in 2019. The rate of maternal mortality increased from 20.1 to 23.8 deaths per 100,000 live births.

For Black women, however, the maternal mortality rate was far higher: 55.3 deaths per 100,000 live births – nearly triple the figure of 19.1 per 100,000 for White women. Between 2019 and 2020, the mortality rate increased significantly for Black and Hispanic women, but not White mothers.

Researchers affiliated with University of Toronto and the Hospital for Sick Children agreed in an accompanying editorial that more access to neuraxial labor analgesia for vaginal delivery might improve maternal health outcomes and “may be a strategy well worth pursuing in public health policy.”

The intervention is relatively safe and can “alleviate discomfort and distress,” they wrote.

Neuraxial anesthesia in surgical procedures has been shown to decrease the risk for complications like deep vein thrombosis, pulmonary embolus, transfusion requirements, and kidney failure, said editorialists Evelina Pankiv, MD; Alan Yang, MSc; and Kazuyoshi Aoyama, MD, PhD.

Benefits potentially could stem from improving blood flow, mitigating hypercoagulation, or reducing surgical stress response. But there are rare risks to consider as well, including hemorrhage, infection, and neurologic injury, they added.

Guglielminotti disclosed grants from the National Institute on Minority Health and Health Disparities. Dr. Aoyama reported receiving grants from the Perioperative Services Facilitator Grant Program and Hospital for Sick Children. The other authors disclosed no relevant financial relationships.

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

Use of neuraxial analgesia for vaginal delivery is associated with a 14% decreased risk for severe maternal morbidity, in part from a reduction in postpartum hemorrhage, new research shows.

The findings indicate that increasing the use of epidural or combined spinal-epidural analgesia may improve maternal health outcomes, especially for Hispanic, Black, and uninsured women who are less likely than White women to receive these interventions, according to the researchers, who published their findings online in JAMA Network Open.

About 80% of non-Hispanic White women receive neuraxial analgesia during labor in the United States, compared with 70% of non-Hispanic Black women and 65% of Hispanic women, according to birth certificate data. Among women without health insurance, half receive epidurals.  

Programs that inform pregnant women about epidural use, expand Medicaid, and provide in-house obstetric anesthesia teams “may improve patient participation in clinical decision making and access to care,” study author Guohua Li, MD, DrPH, of Columbia University, New York, said in a statement about the research.

Earlier data from France showed that neuraxial analgesia is associated with reduced risk for severe postpartum hemorrhage. To examine the association between labor neuraxial analgesia and severe maternal morbidity in the United States, Dr. Li and colleagues analyzed more than 575,000 vaginal deliveries in New York hospitals between 2010 and 2017; about half (47.4%) of the women received epidurals during labor.

The researchers focused on severe maternal morbidity, including 16 complications, such as heart failure and sepsis, and five procedures, including hysterectomy and ventilation.

They also considered patient characteristics and comorbidities and hospital-related factors to identify patients who were at higher risk for injury or death.

Severe maternal morbidity occurred in 1.3% of the women. Of the 7,712 women with severe morbidity, more than one in three (35.6%) experienced postpartum hemorrhage.

The overall incidence of severe maternal morbidity was 1.3% among women who received an epidural injection and 1.4% among those who did not. In a weighted analysis, the adjusted odds ratio of severe maternal morbidity associated with epidurals was 0.86 (95% confidence interval, 0.82-0.90).

The study is limited by its observational design and does not prove causation, the authors acknowledged.

“Labor neuraxial analgesia may facilitate early evaluation and management of the third stage of labor to avoid escalation of postpartum hemorrhaging into grave complications and death,” study author Jean Guglielminotti, MD, PhD, an anesthesiologist at Columbia University, said in a statement.
 

Concerning trends

The Department of Health & Human Services has labeled severe maternal morbidity a public health priority. Recent data from the Centers for Disease Control and Prevention show an increase in maternal mortality rates and worsening disparities by race and ethnicity.

According to the CDC, 861 women died of maternal causes in 2020, up from 754 in 2019. The rate of maternal mortality increased from 20.1 to 23.8 deaths per 100,000 live births.

For Black women, however, the maternal mortality rate was far higher: 55.3 deaths per 100,000 live births – nearly triple the figure of 19.1 per 100,000 for White women. Between 2019 and 2020, the mortality rate increased significantly for Black and Hispanic women, but not White mothers.

Researchers affiliated with University of Toronto and the Hospital for Sick Children agreed in an accompanying editorial that more access to neuraxial labor analgesia for vaginal delivery might improve maternal health outcomes and “may be a strategy well worth pursuing in public health policy.”

The intervention is relatively safe and can “alleviate discomfort and distress,” they wrote.

Neuraxial anesthesia in surgical procedures has been shown to decrease the risk for complications like deep vein thrombosis, pulmonary embolus, transfusion requirements, and kidney failure, said editorialists Evelina Pankiv, MD; Alan Yang, MSc; and Kazuyoshi Aoyama, MD, PhD.

Benefits potentially could stem from improving blood flow, mitigating hypercoagulation, or reducing surgical stress response. But there are rare risks to consider as well, including hemorrhage, infection, and neurologic injury, they added.

Guglielminotti disclosed grants from the National Institute on Minority Health and Health Disparities. Dr. Aoyama reported receiving grants from the Perioperative Services Facilitator Grant Program and Hospital for Sick Children. The other authors disclosed no relevant financial relationships.

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

Use of neuraxial analgesia for vaginal delivery is associated with a 14% decreased risk for severe maternal morbidity, in part from a reduction in postpartum hemorrhage, new research shows.

The findings indicate that increasing the use of epidural or combined spinal-epidural analgesia may improve maternal health outcomes, especially for Hispanic, Black, and uninsured women who are less likely than White women to receive these interventions, according to the researchers, who published their findings online in JAMA Network Open.

About 80% of non-Hispanic White women receive neuraxial analgesia during labor in the United States, compared with 70% of non-Hispanic Black women and 65% of Hispanic women, according to birth certificate data. Among women without health insurance, half receive epidurals.  

Programs that inform pregnant women about epidural use, expand Medicaid, and provide in-house obstetric anesthesia teams “may improve patient participation in clinical decision making and access to care,” study author Guohua Li, MD, DrPH, of Columbia University, New York, said in a statement about the research.

Earlier data from France showed that neuraxial analgesia is associated with reduced risk for severe postpartum hemorrhage. To examine the association between labor neuraxial analgesia and severe maternal morbidity in the United States, Dr. Li and colleagues analyzed more than 575,000 vaginal deliveries in New York hospitals between 2010 and 2017; about half (47.4%) of the women received epidurals during labor.

The researchers focused on severe maternal morbidity, including 16 complications, such as heart failure and sepsis, and five procedures, including hysterectomy and ventilation.

They also considered patient characteristics and comorbidities and hospital-related factors to identify patients who were at higher risk for injury or death.

Severe maternal morbidity occurred in 1.3% of the women. Of the 7,712 women with severe morbidity, more than one in three (35.6%) experienced postpartum hemorrhage.

The overall incidence of severe maternal morbidity was 1.3% among women who received an epidural injection and 1.4% among those who did not. In a weighted analysis, the adjusted odds ratio of severe maternal morbidity associated with epidurals was 0.86 (95% confidence interval, 0.82-0.90).

The study is limited by its observational design and does not prove causation, the authors acknowledged.

“Labor neuraxial analgesia may facilitate early evaluation and management of the third stage of labor to avoid escalation of postpartum hemorrhaging into grave complications and death,” study author Jean Guglielminotti, MD, PhD, an anesthesiologist at Columbia University, said in a statement.
 

Concerning trends

The Department of Health & Human Services has labeled severe maternal morbidity a public health priority. Recent data from the Centers for Disease Control and Prevention show an increase in maternal mortality rates and worsening disparities by race and ethnicity.

According to the CDC, 861 women died of maternal causes in 2020, up from 754 in 2019. The rate of maternal mortality increased from 20.1 to 23.8 deaths per 100,000 live births.

For Black women, however, the maternal mortality rate was far higher: 55.3 deaths per 100,000 live births – nearly triple the figure of 19.1 per 100,000 for White women. Between 2019 and 2020, the mortality rate increased significantly for Black and Hispanic women, but not White mothers.

Researchers affiliated with University of Toronto and the Hospital for Sick Children agreed in an accompanying editorial that more access to neuraxial labor analgesia for vaginal delivery might improve maternal health outcomes and “may be a strategy well worth pursuing in public health policy.”

The intervention is relatively safe and can “alleviate discomfort and distress,” they wrote.

Neuraxial anesthesia in surgical procedures has been shown to decrease the risk for complications like deep vein thrombosis, pulmonary embolus, transfusion requirements, and kidney failure, said editorialists Evelina Pankiv, MD; Alan Yang, MSc; and Kazuyoshi Aoyama, MD, PhD.

Benefits potentially could stem from improving blood flow, mitigating hypercoagulation, or reducing surgical stress response. But there are rare risks to consider as well, including hemorrhage, infection, and neurologic injury, they added.

Guglielminotti disclosed grants from the National Institute on Minority Health and Health Disparities. Dr. Aoyama reported receiving grants from the Perioperative Services Facilitator Grant Program and Hospital for Sick Children. The other authors disclosed no relevant financial relationships.

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

Although there is a lack of evidence for use of cannabidiol (CBD) products and cannabis in rheumatology, many patients are using them anyway and want to discuss the use of these products with their rheumatologists, according to a speaker at the 2022 Rheumatology Winter Clinical Symposium.

While cannabis is still regulated as a Schedule I drug in the United States, CBD products are “all over the place,” Orrin Troum, MD, a rheumatologist at the University of Southern California, Los Angeles, said in his presentation. “You can get it at the pharmacy; you can get it at the dispensaries.”

Patients in rheumatology are also increasingly using cannabis across the United States, Dr. Troum said. In an abstract from the 2019 American College of Rheumatology annual meeting, researchers examined data from FORWARD, the National Databank for Rheumatic Diseases, and found 17.6% of 11,006 respondents reported using cannabis in 2017, an increase from 6.3% of respondents in 2014.

“Putting your personal biases aside, you have to be able to discuss this, and I try to do that openly with my patients,” he said.

According to a 2018 report from the World Health Organization, CBD is “generally well tolerated with a good safety profile.” While CBD itself is safe, CBD products offered over the counter as pills, lotions, foods, drinks, shampoos, cosmetics, oils, and other products carry the risk of being manufactured with “unverified contents” because they are not subject to regulatory oversight.

“There may be heavy metals, pesticides, microbes, [and] mycotoxins that are in these substances that you’re recommending to patients,” Dr. Troum said. There may also be tetrahydrocannabinol (THC) in certain CBD products, he added. Other concerns about CBD products include potential drug-drug interactions with medications used in rheumatology, and potential inhibition of drug metabolism through the CYP450 pathway.

Rheumatologists should be careful when recommending CBD products for this reason, Dr. Troum cautioned. In the absence of products approved by the Food and Drug Administration, “try to get at least products that have a good manufacturing practices certification.”

RWCS 2022 screenshot

Dr. Troum highlighted the additional problem of dispensaries recommending specific products, and emphasized that treatment shouldn’t be managed by dispensary personnel without a medical background. “Our patients are being promoted this, either from the dispensaries or even in some clinicians’ offices, without the real true knowledge as to what we’re dealing with,” he said.
 

Evidence of health effects of CBD, cannabis

When it comes to actual evidence of clinical benefit, “I can tell you there’s lacking data for the majority of what we’re being asked every day in our practices,” Dr. Troum said.

The greatest evidence for the health benefits of cannabinoids appears to be for chronic pain, according to a 2017 report from the National Academies of Sciences, Engineering, and Medicine. Within rheumatology, a position statement released by the Canadian Rheumatology Association in 2019 found insufficient evidence to recommend cannabinoids for use in fibromyalgia, osteoarthritis, RA, or back pain, but acknowledged medical cannabis may relieve symptoms based on evidence from other conditions.

There is some preliminary evidence that cannabis can be used as a substitute for opioids when treating chronic pain, to improve symptoms of fibromyalgia and inflammatory bowel disease, and although a trial of patients with Crohn’s disease failed its primary outcome of disease remission, 10 of 11 patients who smoked cigarettes with THC saw significant improvements in clinical outcomes (P = .028).

In RA, “clinical research focusing on the cannabinoids’ disease-modifying qualities is still lacking,” Dr. Troum said, although an active randomized, controlled trial led by researchers at the University of California, Los Angeles, is testing patients for clinical response to CBD. A separate randomized, double-blind, placebo-controlled trial in Denmark is evaluating whether CBD, followed by open-label add-on of THC, improves chronic pain for patients with RA or ankylosing spondylitis.

The lack of data in this area largely has to do with how cannabis is regulated at the federal level and the differing regulations between U.S. states. “There’s a lot of hurdles you have to go through, and therefore, I think, really has decreased the availability of good studies,” he said.

Overarching principles for medical cannabis in rheumatology

For the rheumatologist counseling a patient who either is self-medicating or wants to start using medical cannabis, the Canadian Rheumatology Association created overarching principles as part of their position statement to guide decision-making for clinicians.

First, clinicians should know that cannabis shouldn’t be used as an alternative treatment for standard of care in rheumatology, and the CRA noted that patients aged under 25 years should not use cannabis. CRA also recommended that clinicians try currently available treatment strategies for common reasons patients seek to use medical cannabis, such as pain relief or a sleep aid, before attempting to use medical cannabis. The CRA noted long-term effects of medical cannabis are not known for patients with rheumatic diseases.

In an interview, Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, and director of RWCS, said that CBD and cannabis “come up quite frequently” at his clinic. “Many patients have already tried CBD, especially the topical formulation, prior to discussing it with me. In general, I do not dissuade patients from trying CBD, especially topical.”

Typically, he said his practice situation gives him access to a counselor from the anesthesia department with “significant expertise” in dosing and formulations. “It would be great if there were proper controlled trials of specific formulations to allow us to have real scientific data that may help the patients make optimal choices.”

One issue that is brought up by patients is cost. “These preparations can be relatively expensive,” Dr. Kavanaugh said, but noted that this is also a consideration when patients decide to use any therapy.

Dr. Troum reported having financial relationships with eight pharmaceutical companies.

Although there is a lack of evidence for use of cannabidiol (CBD) products and cannabis in rheumatology, many patients are using them anyway and want to discuss the use of these products with their rheumatologists, according to a speaker at the 2022 Rheumatology Winter Clinical Symposium.

While cannabis is still regulated as a Schedule I drug in the United States, CBD products are “all over the place,” Orrin Troum, MD, a rheumatologist at the University of Southern California, Los Angeles, said in his presentation. “You can get it at the pharmacy; you can get it at the dispensaries.”

Patients in rheumatology are also increasingly using cannabis across the United States, Dr. Troum said. In an abstract from the 2019 American College of Rheumatology annual meeting, researchers examined data from FORWARD, the National Databank for Rheumatic Diseases, and found 17.6% of 11,006 respondents reported using cannabis in 2017, an increase from 6.3% of respondents in 2014.

“Putting your personal biases aside, you have to be able to discuss this, and I try to do that openly with my patients,” he said.

According to a 2018 report from the World Health Organization, CBD is “generally well tolerated with a good safety profile.” While CBD itself is safe, CBD products offered over the counter as pills, lotions, foods, drinks, shampoos, cosmetics, oils, and other products carry the risk of being manufactured with “unverified contents” because they are not subject to regulatory oversight.

“There may be heavy metals, pesticides, microbes, [and] mycotoxins that are in these substances that you’re recommending to patients,” Dr. Troum said. There may also be tetrahydrocannabinol (THC) in certain CBD products, he added. Other concerns about CBD products include potential drug-drug interactions with medications used in rheumatology, and potential inhibition of drug metabolism through the CYP450 pathway.

Rheumatologists should be careful when recommending CBD products for this reason, Dr. Troum cautioned. In the absence of products approved by the Food and Drug Administration, “try to get at least products that have a good manufacturing practices certification.”

RWCS 2022 screenshot

Dr. Troum highlighted the additional problem of dispensaries recommending specific products, and emphasized that treatment shouldn’t be managed by dispensary personnel without a medical background. “Our patients are being promoted this, either from the dispensaries or even in some clinicians’ offices, without the real true knowledge as to what we’re dealing with,” he said.
 

Evidence of health effects of CBD, cannabis

When it comes to actual evidence of clinical benefit, “I can tell you there’s lacking data for the majority of what we’re being asked every day in our practices,” Dr. Troum said.

The greatest evidence for the health benefits of cannabinoids appears to be for chronic pain, according to a 2017 report from the National Academies of Sciences, Engineering, and Medicine. Within rheumatology, a position statement released by the Canadian Rheumatology Association in 2019 found insufficient evidence to recommend cannabinoids for use in fibromyalgia, osteoarthritis, RA, or back pain, but acknowledged medical cannabis may relieve symptoms based on evidence from other conditions.

There is some preliminary evidence that cannabis can be used as a substitute for opioids when treating chronic pain, to improve symptoms of fibromyalgia and inflammatory bowel disease, and although a trial of patients with Crohn’s disease failed its primary outcome of disease remission, 10 of 11 patients who smoked cigarettes with THC saw significant improvements in clinical outcomes (P = .028).

In RA, “clinical research focusing on the cannabinoids’ disease-modifying qualities is still lacking,” Dr. Troum said, although an active randomized, controlled trial led by researchers at the University of California, Los Angeles, is testing patients for clinical response to CBD. A separate randomized, double-blind, placebo-controlled trial in Denmark is evaluating whether CBD, followed by open-label add-on of THC, improves chronic pain for patients with RA or ankylosing spondylitis.

The lack of data in this area largely has to do with how cannabis is regulated at the federal level and the differing regulations between U.S. states. “There’s a lot of hurdles you have to go through, and therefore, I think, really has decreased the availability of good studies,” he said.

Overarching principles for medical cannabis in rheumatology

For the rheumatologist counseling a patient who either is self-medicating or wants to start using medical cannabis, the Canadian Rheumatology Association created overarching principles as part of their position statement to guide decision-making for clinicians.

First, clinicians should know that cannabis shouldn’t be used as an alternative treatment for standard of care in rheumatology, and the CRA noted that patients aged under 25 years should not use cannabis. CRA also recommended that clinicians try currently available treatment strategies for common reasons patients seek to use medical cannabis, such as pain relief or a sleep aid, before attempting to use medical cannabis. The CRA noted long-term effects of medical cannabis are not known for patients with rheumatic diseases.

In an interview, Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, and director of RWCS, said that CBD and cannabis “come up quite frequently” at his clinic. “Many patients have already tried CBD, especially the topical formulation, prior to discussing it with me. In general, I do not dissuade patients from trying CBD, especially topical.”

Typically, he said his practice situation gives him access to a counselor from the anesthesia department with “significant expertise” in dosing and formulations. “It would be great if there were proper controlled trials of specific formulations to allow us to have real scientific data that may help the patients make optimal choices.”

One issue that is brought up by patients is cost. “These preparations can be relatively expensive,” Dr. Kavanaugh said, but noted that this is also a consideration when patients decide to use any therapy.

Dr. Troum reported having financial relationships with eight pharmaceutical companies.

Although there is a lack of evidence for use of cannabidiol (CBD) products and cannabis in rheumatology, many patients are using them anyway and want to discuss the use of these products with their rheumatologists, according to a speaker at the 2022 Rheumatology Winter Clinical Symposium.

While cannabis is still regulated as a Schedule I drug in the United States, CBD products are “all over the place,” Orrin Troum, MD, a rheumatologist at the University of Southern California, Los Angeles, said in his presentation. “You can get it at the pharmacy; you can get it at the dispensaries.”

Patients in rheumatology are also increasingly using cannabis across the United States, Dr. Troum said. In an abstract from the 2019 American College of Rheumatology annual meeting, researchers examined data from FORWARD, the National Databank for Rheumatic Diseases, and found 17.6% of 11,006 respondents reported using cannabis in 2017, an increase from 6.3% of respondents in 2014.

“Putting your personal biases aside, you have to be able to discuss this, and I try to do that openly with my patients,” he said.

According to a 2018 report from the World Health Organization, CBD is “generally well tolerated with a good safety profile.” While CBD itself is safe, CBD products offered over the counter as pills, lotions, foods, drinks, shampoos, cosmetics, oils, and other products carry the risk of being manufactured with “unverified contents” because they are not subject to regulatory oversight.

“There may be heavy metals, pesticides, microbes, [and] mycotoxins that are in these substances that you’re recommending to patients,” Dr. Troum said. There may also be tetrahydrocannabinol (THC) in certain CBD products, he added. Other concerns about CBD products include potential drug-drug interactions with medications used in rheumatology, and potential inhibition of drug metabolism through the CYP450 pathway.

Rheumatologists should be careful when recommending CBD products for this reason, Dr. Troum cautioned. In the absence of products approved by the Food and Drug Administration, “try to get at least products that have a good manufacturing practices certification.”

RWCS 2022 screenshot

Dr. Troum highlighted the additional problem of dispensaries recommending specific products, and emphasized that treatment shouldn’t be managed by dispensary personnel without a medical background. “Our patients are being promoted this, either from the dispensaries or even in some clinicians’ offices, without the real true knowledge as to what we’re dealing with,” he said.
 

Evidence of health effects of CBD, cannabis

When it comes to actual evidence of clinical benefit, “I can tell you there’s lacking data for the majority of what we’re being asked every day in our practices,” Dr. Troum said.

The greatest evidence for the health benefits of cannabinoids appears to be for chronic pain, according to a 2017 report from the National Academies of Sciences, Engineering, and Medicine. Within rheumatology, a position statement released by the Canadian Rheumatology Association in 2019 found insufficient evidence to recommend cannabinoids for use in fibromyalgia, osteoarthritis, RA, or back pain, but acknowledged medical cannabis may relieve symptoms based on evidence from other conditions.

There is some preliminary evidence that cannabis can be used as a substitute for opioids when treating chronic pain, to improve symptoms of fibromyalgia and inflammatory bowel disease, and although a trial of patients with Crohn’s disease failed its primary outcome of disease remission, 10 of 11 patients who smoked cigarettes with THC saw significant improvements in clinical outcomes (P = .028).

In RA, “clinical research focusing on the cannabinoids’ disease-modifying qualities is still lacking,” Dr. Troum said, although an active randomized, controlled trial led by researchers at the University of California, Los Angeles, is testing patients for clinical response to CBD. A separate randomized, double-blind, placebo-controlled trial in Denmark is evaluating whether CBD, followed by open-label add-on of THC, improves chronic pain for patients with RA or ankylosing spondylitis.

The lack of data in this area largely has to do with how cannabis is regulated at the federal level and the differing regulations between U.S. states. “There’s a lot of hurdles you have to go through, and therefore, I think, really has decreased the availability of good studies,” he said.

Overarching principles for medical cannabis in rheumatology

For the rheumatologist counseling a patient who either is self-medicating or wants to start using medical cannabis, the Canadian Rheumatology Association created overarching principles as part of their position statement to guide decision-making for clinicians.

First, clinicians should know that cannabis shouldn’t be used as an alternative treatment for standard of care in rheumatology, and the CRA noted that patients aged under 25 years should not use cannabis. CRA also recommended that clinicians try currently available treatment strategies for common reasons patients seek to use medical cannabis, such as pain relief or a sleep aid, before attempting to use medical cannabis. The CRA noted long-term effects of medical cannabis are not known for patients with rheumatic diseases.

In an interview, Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, and director of RWCS, said that CBD and cannabis “come up quite frequently” at his clinic. “Many patients have already tried CBD, especially the topical formulation, prior to discussing it with me. In general, I do not dissuade patients from trying CBD, especially topical.”

Typically, he said his practice situation gives him access to a counselor from the anesthesia department with “significant expertise” in dosing and formulations. “It would be great if there were proper controlled trials of specific formulations to allow us to have real scientific data that may help the patients make optimal choices.”

One issue that is brought up by patients is cost. “These preparations can be relatively expensive,” Dr. Kavanaugh said, but noted that this is also a consideration when patients decide to use any therapy.

Dr. Troum reported having financial relationships with eight pharmaceutical companies.

The Centers for Disease Controls and Prevention has released a draft update of its current Clinical Practice Guidelines for Prescribing Opioids for pain management and is asking for public comment before moving forward.

The last guidance on this topic was released in 2016 and, among other things, noted that clinicians should be cautious when considering increasing dosage of opioids to 50 or more morphine milligram equivalents (MME)/day and should avoid increasing to a dose of 90 or more MME/day. It also noted that 3 days or less “will often be sufficient” regarding the quantity of lowest effective dose of immediate-release opioids to be prescribed for acute pain – and that more than 7 days “will rarely be needed.”

In the new report from the CDC’s National Center for Injury Prevention and Control (NCIPC), those dose limits have been replaced with the suggestion that clinicians use their best judgement – albeit still urging conservative use and even the possibility of nonopioid treatments.

The updated recommendations are now open for public comment via the Federal Register’s website through April 11.

“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, acting director for the NCIPC, said in a release.

“We want to hear many voices from the public, including people living with pain and health care providers who help their patients manage pain,” Dr. Jones added.

Outpatient recommendations

The CDC noted that the updated guidance provides “evidence-based recommendations” for treatment of adults with acute, subacute, or chronic pain. It does not include guidance for managing pain related to sickle cell disease, cancer, or palliative care.

It is aimed at primary care clinicians and others who manage pain in an outpatient setting, including in dental and postsurgical practices and for those discharging patients from emergency departments. It does not apply to inpatient care.

The draft guidance includes 12 recommendations focused on four key areas:

• Helping clinicians determine whether or not to initiate opioid treatment for pain
• Opioid selection and dosage
• Duration of use and follow-up
• Assessing risk and addressing potential harms from use

The overall aim “is to ensure people have access to safe, accessible, and effective pain management that improves their function and quality of life while illuminating and reducing risks associated with prescription opioids and ultimately reducing the consequences of prescription opioid misuse and overdose,” the CDC notes.

In addition, the guidance itself “is intended to be a clinical tool to improve communication between providers and patients and empower them to make informed, patient-centered decisions,” the agency said in a press release.

It added that the new recommendations “are not intended to be applied as inflexible standards of care.” Rather, it is intended as a guide to support health care providers in their clinical decisionmaking as they provide individualized patient care.

Patients, caregivers, and providers are invited to submit comments over the next 60 days through the Federal Register docket.

“It is vitally important to CDC that we receive, process, and understand public feedback during the guideline update process,” the agency noted.

“The ultimate goal of this clinical practice guideline is to help people set and achieve personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal,” Dr. Jones said.

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

The Centers for Disease Controls and Prevention has released a draft update of its current Clinical Practice Guidelines for Prescribing Opioids for pain management and is asking for public comment before moving forward.

The last guidance on this topic was released in 2016 and, among other things, noted that clinicians should be cautious when considering increasing dosage of opioids to 50 or more morphine milligram equivalents (MME)/day and should avoid increasing to a dose of 90 or more MME/day. It also noted that 3 days or less “will often be sufficient” regarding the quantity of lowest effective dose of immediate-release opioids to be prescribed for acute pain – and that more than 7 days “will rarely be needed.”

In the new report from the CDC’s National Center for Injury Prevention and Control (NCIPC), those dose limits have been replaced with the suggestion that clinicians use their best judgement – albeit still urging conservative use and even the possibility of nonopioid treatments.

The updated recommendations are now open for public comment via the Federal Register’s website through April 11.

“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, acting director for the NCIPC, said in a release.

“We want to hear many voices from the public, including people living with pain and health care providers who help their patients manage pain,” Dr. Jones added.

Outpatient recommendations

The CDC noted that the updated guidance provides “evidence-based recommendations” for treatment of adults with acute, subacute, or chronic pain. It does not include guidance for managing pain related to sickle cell disease, cancer, or palliative care.

It is aimed at primary care clinicians and others who manage pain in an outpatient setting, including in dental and postsurgical practices and for those discharging patients from emergency departments. It does not apply to inpatient care.

The draft guidance includes 12 recommendations focused on four key areas:

• Helping clinicians determine whether or not to initiate opioid treatment for pain
• Opioid selection and dosage
• Duration of use and follow-up
• Assessing risk and addressing potential harms from use

The overall aim “is to ensure people have access to safe, accessible, and effective pain management that improves their function and quality of life while illuminating and reducing risks associated with prescription opioids and ultimately reducing the consequences of prescription opioid misuse and overdose,” the CDC notes.

In addition, the guidance itself “is intended to be a clinical tool to improve communication between providers and patients and empower them to make informed, patient-centered decisions,” the agency said in a press release.

It added that the new recommendations “are not intended to be applied as inflexible standards of care.” Rather, it is intended as a guide to support health care providers in their clinical decisionmaking as they provide individualized patient care.

Patients, caregivers, and providers are invited to submit comments over the next 60 days through the Federal Register docket.

“It is vitally important to CDC that we receive, process, and understand public feedback during the guideline update process,” the agency noted.

“The ultimate goal of this clinical practice guideline is to help people set and achieve personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal,” Dr. Jones said.

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

The Centers for Disease Controls and Prevention has released a draft update of its current Clinical Practice Guidelines for Prescribing Opioids for pain management and is asking for public comment before moving forward.

The last guidance on this topic was released in 2016 and, among other things, noted that clinicians should be cautious when considering increasing dosage of opioids to 50 or more morphine milligram equivalents (MME)/day and should avoid increasing to a dose of 90 or more MME/day. It also noted that 3 days or less “will often be sufficient” regarding the quantity of lowest effective dose of immediate-release opioids to be prescribed for acute pain – and that more than 7 days “will rarely be needed.”

In the new report from the CDC’s National Center for Injury Prevention and Control (NCIPC), those dose limits have been replaced with the suggestion that clinicians use their best judgement – albeit still urging conservative use and even the possibility of nonopioid treatments.

The updated recommendations are now open for public comment via the Federal Register’s website through April 11.

“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, acting director for the NCIPC, said in a release.

“We want to hear many voices from the public, including people living with pain and health care providers who help their patients manage pain,” Dr. Jones added.

Outpatient recommendations

The CDC noted that the updated guidance provides “evidence-based recommendations” for treatment of adults with acute, subacute, or chronic pain. It does not include guidance for managing pain related to sickle cell disease, cancer, or palliative care.

It is aimed at primary care clinicians and others who manage pain in an outpatient setting, including in dental and postsurgical practices and for those discharging patients from emergency departments. It does not apply to inpatient care.

The draft guidance includes 12 recommendations focused on four key areas:

• Helping clinicians determine whether or not to initiate opioid treatment for pain
• Opioid selection and dosage
• Duration of use and follow-up
• Assessing risk and addressing potential harms from use

The overall aim “is to ensure people have access to safe, accessible, and effective pain management that improves their function and quality of life while illuminating and reducing risks associated with prescription opioids and ultimately reducing the consequences of prescription opioid misuse and overdose,” the CDC notes.

In addition, the guidance itself “is intended to be a clinical tool to improve communication between providers and patients and empower them to make informed, patient-centered decisions,” the agency said in a press release.

It added that the new recommendations “are not intended to be applied as inflexible standards of care.” Rather, it is intended as a guide to support health care providers in their clinical decisionmaking as they provide individualized patient care.

Patients, caregivers, and providers are invited to submit comments over the next 60 days through the Federal Register docket.

“It is vitally important to CDC that we receive, process, and understand public feedback during the guideline update process,” the agency noted.

“The ultimate goal of this clinical practice guideline is to help people set and achieve personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal,” Dr. Jones said.

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

Most adults in the United States who have chronic pain favor a combination of nondrug and nonopioid approaches to control their pain, which is “encouraging,” new research shows.

A national survey reveals 55% of adults with chronic pain used pain management techniques that did not involve any opioids at all during the prior 3-month period.

However, few participants took advantage of cognitive-behavioral therapy (CBT), which is effective for easing chronic pain, Cornelius Groenewald, MB ChB, department of anesthesiology and pain medicine, University of Seattle, and colleagues write.

The results were published online in a research letter Feb. 7 in JAMA Network Open.

First time for pain questions

An estimated 50.2 million U.S. adults experience chronic pain, according to the 2019 National Health Interview Survey.

The 2019 version of the survey included questions on pain management techniques for the first time. Adults with chronic pain were asked to report on their use of 11 pain management techniques during the previous 3 months.

Among the 31,916 survey respondents, 64% were women; 69% were non-Hispanic White, 13% were Hispanic, and 11% were non-Hispanic Black; 71% were between 18 and 64 years of age, and 29% were 65 and older.

Among the key findings, an estimated 55% of adults with chronic pain used only nonopioid pain management techniques, 11% used both opioids and nonopioid techniques, and 4% used only opioids for chronic pain management; 30% did not report any pain management techniques during the previous 3 months.

Complementary therapies were the most commonly used nonopioid pain management technique (by 35% of adults with chronic pain), followed by physical, occupational, or rehabilitative therapies (19%).

Only about 4% of adults with chronic pain used CBT.

Other techniques used included self-management programs (5%) and chronic pain peer support groups (2%). In addition, 39% of adults with chronic pain reported using other pain approaches not specifically captured in the data set.

Benchmark data

Participants using complementary and psychological or psychotherapeutic interventions were more likely to be younger women with more education, the investigators report.

Adults using physical, occupational, or rehabilitative therapy were more likely to be highly educated older women with medical insurance.

Prescription opioid use for chronic pain was more common among older adults aged 45-64 years vs. those aged 18-44 years (19% vs. 8%).

It was also more common in women than men (17% vs. 13%), in adults with vs. without health insurance (16% vs. 6%), and in those with a high school education or lower, compared with those had more than a high school education (17% vs. 14%).

Prescription opioid use was less common among adults making $100,000 or more annually than in those making less than $35,000 a year (9% vs. 20%).

“While effective for some, opioids prescribed for chronic pain management remain an important determinant of the national opioid crisis,” the investigators write.

The study “provides baseline information on opioid and nonopioid pain management techniques used for chronic pain and serves as a benchmark for evaluating the outcome of health care policies aimed at reducing prescription opioid use,” they add.

The study had no specific funding. The investigators have disclosed no relevant financial relationships.

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

Most adults in the United States who have chronic pain favor a combination of nondrug and nonopioid approaches to control their pain, which is “encouraging,” new research shows.

A national survey reveals 55% of adults with chronic pain used pain management techniques that did not involve any opioids at all during the prior 3-month period.

However, few participants took advantage of cognitive-behavioral therapy (CBT), which is effective for easing chronic pain, Cornelius Groenewald, MB ChB, department of anesthesiology and pain medicine, University of Seattle, and colleagues write.

The results were published online in a research letter Feb. 7 in JAMA Network Open.

First time for pain questions

An estimated 50.2 million U.S. adults experience chronic pain, according to the 2019 National Health Interview Survey.

The 2019 version of the survey included questions on pain management techniques for the first time. Adults with chronic pain were asked to report on their use of 11 pain management techniques during the previous 3 months.

Among the 31,916 survey respondents, 64% were women; 69% were non-Hispanic White, 13% were Hispanic, and 11% were non-Hispanic Black; 71% were between 18 and 64 years of age, and 29% were 65 and older.

Among the key findings, an estimated 55% of adults with chronic pain used only nonopioid pain management techniques, 11% used both opioids and nonopioid techniques, and 4% used only opioids for chronic pain management; 30% did not report any pain management techniques during the previous 3 months.

Complementary therapies were the most commonly used nonopioid pain management technique (by 35% of adults with chronic pain), followed by physical, occupational, or rehabilitative therapies (19%).

Only about 4% of adults with chronic pain used CBT.

Other techniques used included self-management programs (5%) and chronic pain peer support groups (2%). In addition, 39% of adults with chronic pain reported using other pain approaches not specifically captured in the data set.

Benchmark data

Participants using complementary and psychological or psychotherapeutic interventions were more likely to be younger women with more education, the investigators report.

Adults using physical, occupational, or rehabilitative therapy were more likely to be highly educated older women with medical insurance.

Prescription opioid use for chronic pain was more common among older adults aged 45-64 years vs. those aged 18-44 years (19% vs. 8%).

It was also more common in women than men (17% vs. 13%), in adults with vs. without health insurance (16% vs. 6%), and in those with a high school education or lower, compared with those had more than a high school education (17% vs. 14%).

Prescription opioid use was less common among adults making $100,000 or more annually than in those making less than $35,000 a year (9% vs. 20%).

“While effective for some, opioids prescribed for chronic pain management remain an important determinant of the national opioid crisis,” the investigators write.

The study “provides baseline information on opioid and nonopioid pain management techniques used for chronic pain and serves as a benchmark for evaluating the outcome of health care policies aimed at reducing prescription opioid use,” they add.

The study had no specific funding. The investigators have disclosed no relevant financial relationships.

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

Most adults in the United States who have chronic pain favor a combination of nondrug and nonopioid approaches to control their pain, which is “encouraging,” new research shows.

A national survey reveals 55% of adults with chronic pain used pain management techniques that did not involve any opioids at all during the prior 3-month period.

However, few participants took advantage of cognitive-behavioral therapy (CBT), which is effective for easing chronic pain, Cornelius Groenewald, MB ChB, department of anesthesiology and pain medicine, University of Seattle, and colleagues write.

The results were published online in a research letter Feb. 7 in JAMA Network Open.

First time for pain questions

An estimated 50.2 million U.S. adults experience chronic pain, according to the 2019 National Health Interview Survey.

The 2019 version of the survey included questions on pain management techniques for the first time. Adults with chronic pain were asked to report on their use of 11 pain management techniques during the previous 3 months.

Among the 31,916 survey respondents, 64% were women; 69% were non-Hispanic White, 13% were Hispanic, and 11% were non-Hispanic Black; 71% were between 18 and 64 years of age, and 29% were 65 and older.

Among the key findings, an estimated 55% of adults with chronic pain used only nonopioid pain management techniques, 11% used both opioids and nonopioid techniques, and 4% used only opioids for chronic pain management; 30% did not report any pain management techniques during the previous 3 months.

Complementary therapies were the most commonly used nonopioid pain management technique (by 35% of adults with chronic pain), followed by physical, occupational, or rehabilitative therapies (19%).

Only about 4% of adults with chronic pain used CBT.

Other techniques used included self-management programs (5%) and chronic pain peer support groups (2%). In addition, 39% of adults with chronic pain reported using other pain approaches not specifically captured in the data set.

Benchmark data

Participants using complementary and psychological or psychotherapeutic interventions were more likely to be younger women with more education, the investigators report.

Adults using physical, occupational, or rehabilitative therapy were more likely to be highly educated older women with medical insurance.

Prescription opioid use for chronic pain was more common among older adults aged 45-64 years vs. those aged 18-44 years (19% vs. 8%).

It was also more common in women than men (17% vs. 13%), in adults with vs. without health insurance (16% vs. 6%), and in those with a high school education or lower, compared with those had more than a high school education (17% vs. 14%).

Prescription opioid use was less common among adults making $100,000 or more annually than in those making less than $35,000 a year (9% vs. 20%).

“While effective for some, opioids prescribed for chronic pain management remain an important determinant of the national opioid crisis,” the investigators write.

The study “provides baseline information on opioid and nonopioid pain management techniques used for chronic pain and serves as a benchmark for evaluating the outcome of health care policies aimed at reducing prescription opioid use,” they add.

The study had no specific funding. The investigators have disclosed no relevant financial relationships.

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

Without bold and urgent action, including public health policy reform and stricter corporate regulations, an additional 1.2 million people in North America will die of an opioid overdose by 2029, according to an analysis by the Stanford-Lancet Commission.

“Over the past quarter-century, the opioid epidemic has taken nearly 600,000 lives and triggered a cascade of public health catastrophes such as disability, family breakdown, unemployment, and child neglect in North America,” commission chair Keith Humphreys, PhD, said in a news release.

“If no action is taken, by the end of this decade, we are predicting the number of deaths to be twice as high as it has been over the last 20 years,” said Dr. Humphreys, professor of psychiatry and behavioral sciences at Stanford (Calif.) University.

The report was published online Feb. 2, 2022, in The Lancet.
 

Blame it on COVID-19?

The COVID-19 pandemic has both overshadowed and exacerbated the opioid crisis in North America, the commission pointed out in their report.

Their analysis suggests that 2020 was the worst year on record for overdose deaths in the United States and Canada in terms of both the total number of deaths and percentage annual increase.

In the United States, opioid overdose deaths increased by 37%, from 51,133 in 2019 to 70,168 in 2020, bringing the total number of deaths since 1999 to 583,000.

In Canada, opioid overdose deaths jumped by 72%, from 3,668 in 2019 to 6,306 in 2020, with a further 3,515 deaths reported in the first 6 months of 2021.

Although the 2020 spikes might be partly caused by the effects of the COVID-19 pandemic, a rising trajectory of deaths was evident in both the United States and Canada before the pandemic hit, the Stanford-Lancet Commission said.
 

Profit motives, lack of regulation

The commission blames the opioid epidemic on a lack of adequate regulation and oversight coupled with profit motives of the pharmaceutical and health care industry.

Harvard T. H. Chan School of Public Health

“To ensure safeguards are in place to curb the opioid addiction epidemic and prevent future ones involving other addictive drugs, we must end the pharmaceutical and health care industry’s undue influence on the government and its unregulated push for opioid use,” commission member Howard Koh, MD, MPH, said in the news release.

“This includes insulating the medical community from pharmaceutical company influence and closing the constantly revolving door between regulators and industry,” said Dr. Koh, with the Harvard School of Public Health, Boston.

In addition to regulation and policy reform, the commission said prevention efforts that focus on treating addiction as a chronic condition are key.

The United States in particular lacks accessible, high-quality, nonstigmatizing, and integrated health and social care services for people experiencing opioid use disorder, the Commission notes.

Addiction-related services must become a permanent feature of health and social care systems in the United States and Canada, in line with established chronic disease management models that are financed and organized as a core public health commitment, the commission said.

“Addiction is an enduring part of population health and should not be treated as a moral failing that needs punishment but as a chronic health condition that requires ongoing treatment and long-term support,” commission member Yasmin Hurd, PhD, director of the Addiction Institute at Icahn School of Medicine at Mount Sinai, New York, said in the release.

Investing in young people to reduce the risk of addiction will also be important going forward.

“Preventing drug addiction should be part of a comprehensive public health strategy that starts in childhood and lays the foundation for long-term declines in addiction,” said commission member Chelsea Shover, PhD, with the University of California, Los Angeles.
 

‘Audacious but achievable goal’

The commission calls for a nuanced approach to pain management that prioritizes innovation both in society’s response to drug addiction through policy reform and by supporting the development of new, nonaddictive pain management options.

“Opioids should not be viewed as good or bad, but instead as a class of medications essential to the management of pain. However, opioids also come with serious risks, some of which can be difficult to recognize,” commission member David Juurlink, MD, PhD, said in the release.

“Clinicians should begin learning about responsible pain management prescribing in medical school and continue to learn about it as part of their commitment to continued medical education throughout their careers,” said Dr. Juurlink, with Sunnybrook Health Sciences Centre in Toronto.

Humphreys said ending the opioid epidemic in North America and preventing its global spread is “an audacious but achievable goal” that will require a “dramatic shift in policy and culture where innovation, collaboration, and regulation are encouraged.

“We can save and improve lives by summoning the resources and political will necessary to eliminate the sources of addiction and boldly implement policies that will maximize efforts to treat it,” Dr. Humphreys added.

The study was funded by Stanford University.

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

Without bold and urgent action, including public health policy reform and stricter corporate regulations, an additional 1.2 million people in North America will die of an opioid overdose by 2029, according to an analysis by the Stanford-Lancet Commission.

“Over the past quarter-century, the opioid epidemic has taken nearly 600,000 lives and triggered a cascade of public health catastrophes such as disability, family breakdown, unemployment, and child neglect in North America,” commission chair Keith Humphreys, PhD, said in a news release.

“If no action is taken, by the end of this decade, we are predicting the number of deaths to be twice as high as it has been over the last 20 years,” said Dr. Humphreys, professor of psychiatry and behavioral sciences at Stanford (Calif.) University.

The report was published online Feb. 2, 2022, in The Lancet.
 

Blame it on COVID-19?

The COVID-19 pandemic has both overshadowed and exacerbated the opioid crisis in North America, the commission pointed out in their report.

Their analysis suggests that 2020 was the worst year on record for overdose deaths in the United States and Canada in terms of both the total number of deaths and percentage annual increase.

In the United States, opioid overdose deaths increased by 37%, from 51,133 in 2019 to 70,168 in 2020, bringing the total number of deaths since 1999 to 583,000.

In Canada, opioid overdose deaths jumped by 72%, from 3,668 in 2019 to 6,306 in 2020, with a further 3,515 deaths reported in the first 6 months of 2021.

Although the 2020 spikes might be partly caused by the effects of the COVID-19 pandemic, a rising trajectory of deaths was evident in both the United States and Canada before the pandemic hit, the Stanford-Lancet Commission said.
 

Profit motives, lack of regulation

The commission blames the opioid epidemic on a lack of adequate regulation and oversight coupled with profit motives of the pharmaceutical and health care industry.

Harvard T. H. Chan School of Public Health

“To ensure safeguards are in place to curb the opioid addiction epidemic and prevent future ones involving other addictive drugs, we must end the pharmaceutical and health care industry’s undue influence on the government and its unregulated push for opioid use,” commission member Howard Koh, MD, MPH, said in the news release.

“This includes insulating the medical community from pharmaceutical company influence and closing the constantly revolving door between regulators and industry,” said Dr. Koh, with the Harvard School of Public Health, Boston.

In addition to regulation and policy reform, the commission said prevention efforts that focus on treating addiction as a chronic condition are key.

The United States in particular lacks accessible, high-quality, nonstigmatizing, and integrated health and social care services for people experiencing opioid use disorder, the Commission notes.

Addiction-related services must become a permanent feature of health and social care systems in the United States and Canada, in line with established chronic disease management models that are financed and organized as a core public health commitment, the commission said.

“Addiction is an enduring part of population health and should not be treated as a moral failing that needs punishment but as a chronic health condition that requires ongoing treatment and long-term support,” commission member Yasmin Hurd, PhD, director of the Addiction Institute at Icahn School of Medicine at Mount Sinai, New York, said in the release.

Investing in young people to reduce the risk of addiction will also be important going forward.

“Preventing drug addiction should be part of a comprehensive public health strategy that starts in childhood and lays the foundation for long-term declines in addiction,” said commission member Chelsea Shover, PhD, with the University of California, Los Angeles.
 

‘Audacious but achievable goal’

The commission calls for a nuanced approach to pain management that prioritizes innovation both in society’s response to drug addiction through policy reform and by supporting the development of new, nonaddictive pain management options.

“Opioids should not be viewed as good or bad, but instead as a class of medications essential to the management of pain. However, opioids also come with serious risks, some of which can be difficult to recognize,” commission member David Juurlink, MD, PhD, said in the release.

“Clinicians should begin learning about responsible pain management prescribing in medical school and continue to learn about it as part of their commitment to continued medical education throughout their careers,” said Dr. Juurlink, with Sunnybrook Health Sciences Centre in Toronto.

Humphreys said ending the opioid epidemic in North America and preventing its global spread is “an audacious but achievable goal” that will require a “dramatic shift in policy and culture where innovation, collaboration, and regulation are encouraged.

“We can save and improve lives by summoning the resources and political will necessary to eliminate the sources of addiction and boldly implement policies that will maximize efforts to treat it,” Dr. Humphreys added.

The study was funded by Stanford University.

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

Without bold and urgent action, including public health policy reform and stricter corporate regulations, an additional 1.2 million people in North America will die of an opioid overdose by 2029, according to an analysis by the Stanford-Lancet Commission.

“Over the past quarter-century, the opioid epidemic has taken nearly 600,000 lives and triggered a cascade of public health catastrophes such as disability, family breakdown, unemployment, and child neglect in North America,” commission chair Keith Humphreys, PhD, said in a news release.

“If no action is taken, by the end of this decade, we are predicting the number of deaths to be twice as high as it has been over the last 20 years,” said Dr. Humphreys, professor of psychiatry and behavioral sciences at Stanford (Calif.) University.

The report was published online Feb. 2, 2022, in The Lancet.
 

Blame it on COVID-19?

The COVID-19 pandemic has both overshadowed and exacerbated the opioid crisis in North America, the commission pointed out in their report.

Their analysis suggests that 2020 was the worst year on record for overdose deaths in the United States and Canada in terms of both the total number of deaths and percentage annual increase.

In the United States, opioid overdose deaths increased by 37%, from 51,133 in 2019 to 70,168 in 2020, bringing the total number of deaths since 1999 to 583,000.

In Canada, opioid overdose deaths jumped by 72%, from 3,668 in 2019 to 6,306 in 2020, with a further 3,515 deaths reported in the first 6 months of 2021.

Although the 2020 spikes might be partly caused by the effects of the COVID-19 pandemic, a rising trajectory of deaths was evident in both the United States and Canada before the pandemic hit, the Stanford-Lancet Commission said.
 

Profit motives, lack of regulation

The commission blames the opioid epidemic on a lack of adequate regulation and oversight coupled with profit motives of the pharmaceutical and health care industry.

Harvard T. H. Chan School of Public Health

“To ensure safeguards are in place to curb the opioid addiction epidemic and prevent future ones involving other addictive drugs, we must end the pharmaceutical and health care industry’s undue influence on the government and its unregulated push for opioid use,” commission member Howard Koh, MD, MPH, said in the news release.

“This includes insulating the medical community from pharmaceutical company influence and closing the constantly revolving door between regulators and industry,” said Dr. Koh, with the Harvard School of Public Health, Boston.

In addition to regulation and policy reform, the commission said prevention efforts that focus on treating addiction as a chronic condition are key.

The United States in particular lacks accessible, high-quality, nonstigmatizing, and integrated health and social care services for people experiencing opioid use disorder, the Commission notes.

Addiction-related services must become a permanent feature of health and social care systems in the United States and Canada, in line with established chronic disease management models that are financed and organized as a core public health commitment, the commission said.

“Addiction is an enduring part of population health and should not be treated as a moral failing that needs punishment but as a chronic health condition that requires ongoing treatment and long-term support,” commission member Yasmin Hurd, PhD, director of the Addiction Institute at Icahn School of Medicine at Mount Sinai, New York, said in the release.

Investing in young people to reduce the risk of addiction will also be important going forward.

“Preventing drug addiction should be part of a comprehensive public health strategy that starts in childhood and lays the foundation for long-term declines in addiction,” said commission member Chelsea Shover, PhD, with the University of California, Los Angeles.
 

‘Audacious but achievable goal’

The commission calls for a nuanced approach to pain management that prioritizes innovation both in society’s response to drug addiction through policy reform and by supporting the development of new, nonaddictive pain management options.

“Opioids should not be viewed as good or bad, but instead as a class of medications essential to the management of pain. However, opioids also come with serious risks, some of which can be difficult to recognize,” commission member David Juurlink, MD, PhD, said in the release.

“Clinicians should begin learning about responsible pain management prescribing in medical school and continue to learn about it as part of their commitment to continued medical education throughout their careers,” said Dr. Juurlink, with Sunnybrook Health Sciences Centre in Toronto.

Humphreys said ending the opioid epidemic in North America and preventing its global spread is “an audacious but achievable goal” that will require a “dramatic shift in policy and culture where innovation, collaboration, and regulation are encouraged.

“We can save and improve lives by summoning the resources and political will necessary to eliminate the sources of addiction and boldly implement policies that will maximize efforts to treat it,” Dr. Humphreys added.

The study was funded by Stanford University.

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

Most people avoid smartphones when they have a migraine headache, but a noninvasive treatment for episodic migraines may change that.

A smartphone-enabled device, cleared by the Food and Drug Administration in early 2021, uses technology to trick the brain into releasing the neurotransmitters serotonin and noradrenaline that can help ease migraine pain.

Tina Montgomery, 58, has suffered from migraines since childhood and spent years looking for something to help manage them. Doctors consider her a “chronic” sufferer in that she has more than 14 migraines a month (fewer than 14 is considered “episodic”). Prescription antidepressants, anticonvulsants, and botulinum toxin shots as preventive treatments helped a little but not enough.

A few years ago, she found some relief using a new preventive injectable medication that targets a peptide known as CGRP, combined with an oral CGRP rescue medication, ubrogepant (Ubrelvy). However, by early 2021, Ms. Montgomery’s chronic migraines were back as she faced stress from the pandemic and her role as a caregiver for her aging parents.

“I was going through so much medication. I just didn’t feel good taking so much,” she said.

Looking for relief, she read about Nerivio, a wearable migraine treatment device that uses remote electrical neuromodulation (REN). She mentioned the device to her neurologist, and he agreed she might benefit from trying it out. Today, she uses the device whenever she feels a migraine may be imminent, she said.

“It really helps me stave off migraines I feel coming on and the milder ones where I would normally hesitate to use prescription medication because [insurance] limits the number of pills they give you in a month,” she said. “I follow through with the Nerivio treatment and usually find that my migraine doesn’t fully develop or is completely gone, and I don’t get a migraine at all.”
 

Taking it on the arm

The device works by stimulating nerves at the back of the arm right around the triceps. “Those nerve fibers relay information to the brain stem [so it can] work its magic and use the brain’s own natural mechanisms for reducing pain,” said Brian M. Grosberg, MD, director of the Hartford Healthcare Ayer Neuroscience Institute Headache Center, West Hartford, Conn.  

These mechanisms are like a bait-and-switch for the brain, said Britany Klenofsky, MD, assistant professor of neurology, Icahn School of Medicine at Mount Sinai, New York. “You’re trying to stimulate pain somewhere else [on the body] to tell the brain to protect itself and release [the neurotransmitter] serotonin,” she said. “You do this by putting the device on your arm, an area that’s away from the head where the pain is actively occurring, turning the device on, and increasing the stimulation to a nearly painful stimulus.”

This pseudo pain prompts the brain to release serotonin, the feel-good hormone along with norepinephrine and noradrenaline. The device works best when it’s used as soon as a migraine starts, so patients should hook up Nerivio within the first 20-30 minutes of onset of pain, said Dr. Grosberg, who was an investigator on the double-blind treatment study that led to FDA clearance. If patients wait too long, the device may not work.

This is why as soon as Ms. Montgomery feels a migraine aura (there are six types of migraine auras, including visual changes and muscle weakness) that occurs right before a migraine strikes, she puts the device armband on her upper arm and launches its smartphone app. Then she turns on the device for a 45-minute treatment, which begins with what she characterizes as tingling and vibration sensations on her arm. She turns up the intensity of the sensations, which are mild electric currents, until they are well-felt but not painful.

Ms. Montgomery said she can use the device and multitask since there’s no need for her to lie down or sit in a darkened room. And since it is worn on the arm, she can wear it under a shirtsleeve while working or out in public without anyone noticing. She also uses the app’s migraine diary and guided meditation to help reduce the anxiety that often accompanies her migraines.

The device is approved for adolescents and adults and can be used for both episodic and chronic migraines. From an efficacy standpoint, the device provides relief about as well as a commonly used pharmaceutical class of drugs, triptans. About 37% of people with episodic migraine achieved complete freedom from pain 2 hours after their treatment. In addition, about two-thirds of people reported pain relief after 2 hours, which is better success than people find with many prescription and nonprescription drugs.

A separate study looked at acute treatment for chronic migraine sufferers and found nearly 60% of people using the device found relief and 21% said they were pain-free after 2 hours. Almost two-thirds of those who experienced pain relief were pain-free 24 hours after the treatment.
 

Finding the perfect patient

There are other FDA-cleared noninvasive devices to treat migraines. One device, CEFALY, is an external trigeminal nerve stimulation device that sits on the forehead. Another device, SpringTMS, uses transcranial magnetic stimulation on the back of the head. A third option, the gammaCore Sapphire, is placed on the neck to stimulate the vagus nerve. All three have been cleared by the FDA to work as preventive and acute treatments for migraine.

Theranica, the company that developed Nerivio, is trying to boost use of the device by allowing patients to get a prescription via telehealth visits with a physician.

The company, as well as the companies behind the other neuromodulation devices, are marketing their treatments to children ages 12 and up since nonpharmacologic options are often preferable for parents, said Thomas Berk, MD, a clinical associate professor in the division of headache at NYU Langone Health in New York.

Dr. Berk said the devices could be appealing for those people who don’t want or can’t take medication, such as pregnant women or those who don’t respond well to drugs. “[They] could also be used by somebody who needs something in addition to a medication,” he said.

For now, people like Ms. Montgomery say they are happy to have another tool in their migraine arsenal. “Overall, I’m taking less medication because I haven’t had to have my Ubrelvy refilled as often as I used to,” she said. “It’s really helped me manage changes and stresses in my life.”

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

Most people avoid smartphones when they have a migraine headache, but a noninvasive treatment for episodic migraines may change that.

A smartphone-enabled device, cleared by the Food and Drug Administration in early 2021, uses technology to trick the brain into releasing the neurotransmitters serotonin and noradrenaline that can help ease migraine pain.

Tina Montgomery, 58, has suffered from migraines since childhood and spent years looking for something to help manage them. Doctors consider her a “chronic” sufferer in that she has more than 14 migraines a month (fewer than 14 is considered “episodic”). Prescription antidepressants, anticonvulsants, and botulinum toxin shots as preventive treatments helped a little but not enough.

A few years ago, she found some relief using a new preventive injectable medication that targets a peptide known as CGRP, combined with an oral CGRP rescue medication, ubrogepant (Ubrelvy). However, by early 2021, Ms. Montgomery’s chronic migraines were back as she faced stress from the pandemic and her role as a caregiver for her aging parents.

“I was going through so much medication. I just didn’t feel good taking so much,” she said.

Looking for relief, she read about Nerivio, a wearable migraine treatment device that uses remote electrical neuromodulation (REN). She mentioned the device to her neurologist, and he agreed she might benefit from trying it out. Today, she uses the device whenever she feels a migraine may be imminent, she said.

“It really helps me stave off migraines I feel coming on and the milder ones where I would normally hesitate to use prescription medication because [insurance] limits the number of pills they give you in a month,” she said. “I follow through with the Nerivio treatment and usually find that my migraine doesn’t fully develop or is completely gone, and I don’t get a migraine at all.”
 

Taking it on the arm

The device works by stimulating nerves at the back of the arm right around the triceps. “Those nerve fibers relay information to the brain stem [so it can] work its magic and use the brain’s own natural mechanisms for reducing pain,” said Brian M. Grosberg, MD, director of the Hartford Healthcare Ayer Neuroscience Institute Headache Center, West Hartford, Conn.  

These mechanisms are like a bait-and-switch for the brain, said Britany Klenofsky, MD, assistant professor of neurology, Icahn School of Medicine at Mount Sinai, New York. “You’re trying to stimulate pain somewhere else [on the body] to tell the brain to protect itself and release [the neurotransmitter] serotonin,” she said. “You do this by putting the device on your arm, an area that’s away from the head where the pain is actively occurring, turning the device on, and increasing the stimulation to a nearly painful stimulus.”

This pseudo pain prompts the brain to release serotonin, the feel-good hormone along with norepinephrine and noradrenaline. The device works best when it’s used as soon as a migraine starts, so patients should hook up Nerivio within the first 20-30 minutes of onset of pain, said Dr. Grosberg, who was an investigator on the double-blind treatment study that led to FDA clearance. If patients wait too long, the device may not work.

This is why as soon as Ms. Montgomery feels a migraine aura (there are six types of migraine auras, including visual changes and muscle weakness) that occurs right before a migraine strikes, she puts the device armband on her upper arm and launches its smartphone app. Then she turns on the device for a 45-minute treatment, which begins with what she characterizes as tingling and vibration sensations on her arm. She turns up the intensity of the sensations, which are mild electric currents, until they are well-felt but not painful.

Ms. Montgomery said she can use the device and multitask since there’s no need for her to lie down or sit in a darkened room. And since it is worn on the arm, she can wear it under a shirtsleeve while working or out in public without anyone noticing. She also uses the app’s migraine diary and guided meditation to help reduce the anxiety that often accompanies her migraines.

The device is approved for adolescents and adults and can be used for both episodic and chronic migraines. From an efficacy standpoint, the device provides relief about as well as a commonly used pharmaceutical class of drugs, triptans. About 37% of people with episodic migraine achieved complete freedom from pain 2 hours after their treatment. In addition, about two-thirds of people reported pain relief after 2 hours, which is better success than people find with many prescription and nonprescription drugs.

A separate study looked at acute treatment for chronic migraine sufferers and found nearly 60% of people using the device found relief and 21% said they were pain-free after 2 hours. Almost two-thirds of those who experienced pain relief were pain-free 24 hours after the treatment.
 

Finding the perfect patient

There are other FDA-cleared noninvasive devices to treat migraines. One device, CEFALY, is an external trigeminal nerve stimulation device that sits on the forehead. Another device, SpringTMS, uses transcranial magnetic stimulation on the back of the head. A third option, the gammaCore Sapphire, is placed on the neck to stimulate the vagus nerve. All three have been cleared by the FDA to work as preventive and acute treatments for migraine.

Theranica, the company that developed Nerivio, is trying to boost use of the device by allowing patients to get a prescription via telehealth visits with a physician.

The company, as well as the companies behind the other neuromodulation devices, are marketing their treatments to children ages 12 and up since nonpharmacologic options are often preferable for parents, said Thomas Berk, MD, a clinical associate professor in the division of headache at NYU Langone Health in New York.

Dr. Berk said the devices could be appealing for those people who don’t want or can’t take medication, such as pregnant women or those who don’t respond well to drugs. “[They] could also be used by somebody who needs something in addition to a medication,” he said.

For now, people like Ms. Montgomery say they are happy to have another tool in their migraine arsenal. “Overall, I’m taking less medication because I haven’t had to have my Ubrelvy refilled as often as I used to,” she said. “It’s really helped me manage changes and stresses in my life.”

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

Most people avoid smartphones when they have a migraine headache, but a noninvasive treatment for episodic migraines may change that.

A smartphone-enabled device, cleared by the Food and Drug Administration in early 2021, uses technology to trick the brain into releasing the neurotransmitters serotonin and noradrenaline that can help ease migraine pain.

Tina Montgomery, 58, has suffered from migraines since childhood and spent years looking for something to help manage them. Doctors consider her a “chronic” sufferer in that she has more than 14 migraines a month (fewer than 14 is considered “episodic”). Prescription antidepressants, anticonvulsants, and botulinum toxin shots as preventive treatments helped a little but not enough.

A few years ago, she found some relief using a new preventive injectable medication that targets a peptide known as CGRP, combined with an oral CGRP rescue medication, ubrogepant (Ubrelvy). However, by early 2021, Ms. Montgomery’s chronic migraines were back as she faced stress from the pandemic and her role as a caregiver for her aging parents.

“I was going through so much medication. I just didn’t feel good taking so much,” she said.

Looking for relief, she read about Nerivio, a wearable migraine treatment device that uses remote electrical neuromodulation (REN). She mentioned the device to her neurologist, and he agreed she might benefit from trying it out. Today, she uses the device whenever she feels a migraine may be imminent, she said.

“It really helps me stave off migraines I feel coming on and the milder ones where I would normally hesitate to use prescription medication because [insurance] limits the number of pills they give you in a month,” she said. “I follow through with the Nerivio treatment and usually find that my migraine doesn’t fully develop or is completely gone, and I don’t get a migraine at all.”
 

Taking it on the arm

The device works by stimulating nerves at the back of the arm right around the triceps. “Those nerve fibers relay information to the brain stem [so it can] work its magic and use the brain’s own natural mechanisms for reducing pain,” said Brian M. Grosberg, MD, director of the Hartford Healthcare Ayer Neuroscience Institute Headache Center, West Hartford, Conn.  

These mechanisms are like a bait-and-switch for the brain, said Britany Klenofsky, MD, assistant professor of neurology, Icahn School of Medicine at Mount Sinai, New York. “You’re trying to stimulate pain somewhere else [on the body] to tell the brain to protect itself and release [the neurotransmitter] serotonin,” she said. “You do this by putting the device on your arm, an area that’s away from the head where the pain is actively occurring, turning the device on, and increasing the stimulation to a nearly painful stimulus.”

This pseudo pain prompts the brain to release serotonin, the feel-good hormone along with norepinephrine and noradrenaline. The device works best when it’s used as soon as a migraine starts, so patients should hook up Nerivio within the first 20-30 minutes of onset of pain, said Dr. Grosberg, who was an investigator on the double-blind treatment study that led to FDA clearance. If patients wait too long, the device may not work.

This is why as soon as Ms. Montgomery feels a migraine aura (there are six types of migraine auras, including visual changes and muscle weakness) that occurs right before a migraine strikes, she puts the device armband on her upper arm and launches its smartphone app. Then she turns on the device for a 45-minute treatment, which begins with what she characterizes as tingling and vibration sensations on her arm. She turns up the intensity of the sensations, which are mild electric currents, until they are well-felt but not painful.

Ms. Montgomery said she can use the device and multitask since there’s no need for her to lie down or sit in a darkened room. And since it is worn on the arm, she can wear it under a shirtsleeve while working or out in public without anyone noticing. She also uses the app’s migraine diary and guided meditation to help reduce the anxiety that often accompanies her migraines.

The device is approved for adolescents and adults and can be used for both episodic and chronic migraines. From an efficacy standpoint, the device provides relief about as well as a commonly used pharmaceutical class of drugs, triptans. About 37% of people with episodic migraine achieved complete freedom from pain 2 hours after their treatment. In addition, about two-thirds of people reported pain relief after 2 hours, which is better success than people find with many prescription and nonprescription drugs.

A separate study looked at acute treatment for chronic migraine sufferers and found nearly 60% of people using the device found relief and 21% said they were pain-free after 2 hours. Almost two-thirds of those who experienced pain relief were pain-free 24 hours after the treatment.
 

Finding the perfect patient

There are other FDA-cleared noninvasive devices to treat migraines. One device, CEFALY, is an external trigeminal nerve stimulation device that sits on the forehead. Another device, SpringTMS, uses transcranial magnetic stimulation on the back of the head. A third option, the gammaCore Sapphire, is placed on the neck to stimulate the vagus nerve. All three have been cleared by the FDA to work as preventive and acute treatments for migraine.

Theranica, the company that developed Nerivio, is trying to boost use of the device by allowing patients to get a prescription via telehealth visits with a physician.

The company, as well as the companies behind the other neuromodulation devices, are marketing their treatments to children ages 12 and up since nonpharmacologic options are often preferable for parents, said Thomas Berk, MD, a clinical associate professor in the division of headache at NYU Langone Health in New York.

Dr. Berk said the devices could be appealing for those people who don’t want or can’t take medication, such as pregnant women or those who don’t respond well to drugs. “[They] could also be used by somebody who needs something in addition to a medication,” he said.

For now, people like Ms. Montgomery say they are happy to have another tool in their migraine arsenal. “Overall, I’m taking less medication because I haven’t had to have my Ubrelvy refilled as often as I used to,” she said. “It’s really helped me manage changes and stresses in my life.”

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

Updated guidelines for the management and treatment of endometriosis reflect changes in clinical practice to guide clinician and patient decision-making, according to a statement from the European Society of Human Reproduction and Embryology, which issued the guidelines in February 2022.

Although the exact prevalence of endometriosis remains unclear, estimates suggest that approximately 190 million women and adolescent girls are affected by endometriosis during their reproductive years, and women continue to suffer beyond menopause, according to the authors. Endometriosis has a significant impact on society through both direct and indirect health care costs comparable to those of type 2 diabetes, rheumatoid arthritis, and Crohn’s disease, they noted.

The guidelines are the first update on the topic of endometriosis since 2014, and include more than 100 recommendations, according to the European Society of Human Reproduction and Embryology (ESHRE). The target audience, according to the authors, is secondary and tertiary health care providers who treat women with endometriosis. The recommendations were based on research papers published up to Dec. 1, 2020.

Although most of the recent studies confirm previous ESHRE recommendations, several topics reflect significant changes in clinical practice.

Notably, laparoscopy is no longer recommended as the diagnostic gold standard, and should be used only in patients with negative imaging for whom empirical treatment was unsuccessful.

For pain management, studies support the use of GnRH antagonists as a second-line treatment, while laparoscopic uterosacral nerve ablation and presacral neurectomy are no longer included in the recommendations.

The guidelines include new information on pregnancy and fertility preservation for women with endometriosis. The Endometriosis Fertility Index (EFI) was added to support joint decision-making for women seeking pregnancy after surgery. However, the extended use of GnRH antagonist prior to assisted reproductive technology treatments to improve live birth rate is not recommended.

Endometriosis in adolescent patients is included in the guidelines for the first time, and strong recommendations include taking a careful history and using ultrasound if appropriate, but the use of serum biomarkers is not recommended for diagnosis. Strong recommendations for treatment strategies for adolescents include hormonal contraceptives or progestins as a first-line therapy.

Recommendations for managing endometriosis in menopause are more extensive than in previous guidelines and the strongest update is against the use of estrogen-only treatment in these patients. However, the guidelines continue to recommend treating women with a history of endometriosis after surgical menopause with combined estrogen-progestogen therapy “at least up to the age of natural menopause.”

Expanded recommendations related to endometriosis and cancer begin with a strong recommendation for clinicians to advise women that endometriosis is not associated with a significantly higher risk of cancer overall. “Although endometriosis is associated with a higher risk of ovarian, breast, and thyroid cancers in particular, the increase in absolute risk compared with women in the general population is low,” the authors wrote. Other strong recommendations include reassuring women with endometriosis of the low risk of malignancy associated with hormonal contraceptive use, and performing cancer screening according to the existing population-based guidelines without additional screening. Epidemiologic data show that complete excision of visible endometriosis may reduce the risk of ovarian cancer, but the potential benefits must be weighed against the risks of surgery, including morbidity, pain, and ovarian reserve, the authors said.

The guidelines include recommendations related to asymptomatic endometriosis, extrapelvic endometriosis, and primary prevention of endometriosis, but without major changes to the 2014 guidelines.
 

Guidelines expand strategies, but research gaps remain

In 2021, an international working group of the American Association of Gynecologic Laparoscopists, the European Society for Gynecologic Endoscopy, ESHRE, and the World Endometriosis Society defined endometriosis as “a disease characterized by the presence of endometrium-like epithelium and/or stroma outside the endometrium and myometrium, usually with an associated inflammatory process,” Mark P. Trolice, MD, director of The IVF Center, Orlando, Fla., and professor of obstetrics and gynecology at the University of Central Florida, said in an interview.

Although the current guidelines represent the second update since 2005, many unanswered questions remain, Dr. Trolice said. “There is a large diagnostic void between the onset of symptoms and the time to a reliable diagnosis averaging between 8 and 12 years,” he emphasized.

Dr. Trolice noted the change of the addition of an oral GnRH antagonist, “now FDA approved for the treatment of pain associated with endometriosis,” he said. However, “Extended GnRH agonist prior to ART is not recommended due to the lack of any clear benefit,” he noted.

Dr. Trolice noted the inclusion of the Endometriosis Fertility Index (EFI), published in 2010, “as a useful scoring system to predict postoperative non-IVF pregnancy rates (both by natural means and IUI [intrauterine insemination]) based on patient characteristics, revised ASRM staging, and ‘least function score of the adnexa.’ ” He agreed with the need for expanded information on the topics of endometriosis and adolescence and endometriosis and cancer.

The most important changes for clinical practice include reducing unnecessary laparoscopy and procedures without benefit, such as laparoscopic uterosacral nerve ablation and presacral neurectomy, and GnRH suppression using an oral antagonist, said Dr. Trolice. Other especially practical guidance includes the recommendation to discontinue advising patients that pregnancy will reduce symptoms of endometriosis, and to avoid prescribing estrogen-only treatment in menopause given the risk of malignant transformation of endometriosis, he said.

Another clinically useful recommendation, though not a significant update, is the need to identify extrapelvic endometriosis symptoms, such as cyclical shoulder pain, cyclical spontaneous pneumothorax, cyclical cough, or nodules that enlarge during menses, Dr. Trolice added.

Barriers to implementing the updated guidelines include lack of education of clinicians, including primary care providers, and the lack of definitive evidence for many areas, he noted.

As for additional research, more data are needed to explore the genetic, mutational, and epigenetic profile of endometriosis, and to identify biomarkers to noninvasively detect and provide a prognosis for endometriosis, and optimal methods for prevention and management, said Dr. Trolice. Other research gaps include “definitive medical and surgical treatment of endometriosis for improvement of fertility, quality of life, and reduction of pain,” he noted. From a fertility standpoint, more studies are needed on “the use of ovarian tissue or oocytes cryopreservation in adolescents and adults who undergo ovarian surgery for endometriomas, and the role of the EFI as a presurgical triage tool and to predict IUI outcomes,” said Dr. Trolice.

Overall, society recommendations such as these from ESHRE “serve as guides for physicians by providing evidence-based medicine and dispelling prior unproven practices so patients may receive the most effective care of endometriosis, throughout a woman’s life,” Dr. Trolice emphasized.

The current guideline will be considered for revision in 2025, and the full version is available on the ESHRE website.

Members of the ESHRE guideline development group received no payment for participating in the development process, although they were reimbursed for travel expenses related to guideline meetings.

Dr. Trolice had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn News.

Updated guidelines for the management and treatment of endometriosis reflect changes in clinical practice to guide clinician and patient decision-making, according to a statement from the European Society of Human Reproduction and Embryology, which issued the guidelines in February 2022.

Although the exact prevalence of endometriosis remains unclear, estimates suggest that approximately 190 million women and adolescent girls are affected by endometriosis during their reproductive years, and women continue to suffer beyond menopause, according to the authors. Endometriosis has a significant impact on society through both direct and indirect health care costs comparable to those of type 2 diabetes, rheumatoid arthritis, and Crohn’s disease, they noted.

The guidelines are the first update on the topic of endometriosis since 2014, and include more than 100 recommendations, according to the European Society of Human Reproduction and Embryology (ESHRE). The target audience, according to the authors, is secondary and tertiary health care providers who treat women with endometriosis. The recommendations were based on research papers published up to Dec. 1, 2020.

Although most of the recent studies confirm previous ESHRE recommendations, several topics reflect significant changes in clinical practice.

Notably, laparoscopy is no longer recommended as the diagnostic gold standard, and should be used only in patients with negative imaging for whom empirical treatment was unsuccessful.

For pain management, studies support the use of GnRH antagonists as a second-line treatment, while laparoscopic uterosacral nerve ablation and presacral neurectomy are no longer included in the recommendations.

The guidelines include new information on pregnancy and fertility preservation for women with endometriosis. The Endometriosis Fertility Index (EFI) was added to support joint decision-making for women seeking pregnancy after surgery. However, the extended use of GnRH antagonist prior to assisted reproductive technology treatments to improve live birth rate is not recommended.

Endometriosis in adolescent patients is included in the guidelines for the first time, and strong recommendations include taking a careful history and using ultrasound if appropriate, but the use of serum biomarkers is not recommended for diagnosis. Strong recommendations for treatment strategies for adolescents include hormonal contraceptives or progestins as a first-line therapy.

Recommendations for managing endometriosis in menopause are more extensive than in previous guidelines and the strongest update is against the use of estrogen-only treatment in these patients. However, the guidelines continue to recommend treating women with a history of endometriosis after surgical menopause with combined estrogen-progestogen therapy “at least up to the age of natural menopause.”

Expanded recommendations related to endometriosis and cancer begin with a strong recommendation for clinicians to advise women that endometriosis is not associated with a significantly higher risk of cancer overall. “Although endometriosis is associated with a higher risk of ovarian, breast, and thyroid cancers in particular, the increase in absolute risk compared with women in the general population is low,” the authors wrote. Other strong recommendations include reassuring women with endometriosis of the low risk of malignancy associated with hormonal contraceptive use, and performing cancer screening according to the existing population-based guidelines without additional screening. Epidemiologic data show that complete excision of visible endometriosis may reduce the risk of ovarian cancer, but the potential benefits must be weighed against the risks of surgery, including morbidity, pain, and ovarian reserve, the authors said.

The guidelines include recommendations related to asymptomatic endometriosis, extrapelvic endometriosis, and primary prevention of endometriosis, but without major changes to the 2014 guidelines.
 

Guidelines expand strategies, but research gaps remain

In 2021, an international working group of the American Association of Gynecologic Laparoscopists, the European Society for Gynecologic Endoscopy, ESHRE, and the World Endometriosis Society defined endometriosis as “a disease characterized by the presence of endometrium-like epithelium and/or stroma outside the endometrium and myometrium, usually with an associated inflammatory process,” Mark P. Trolice, MD, director of The IVF Center, Orlando, Fla., and professor of obstetrics and gynecology at the University of Central Florida, said in an interview.

Although the current guidelines represent the second update since 2005, many unanswered questions remain, Dr. Trolice said. “There is a large diagnostic void between the onset of symptoms and the time to a reliable diagnosis averaging between 8 and 12 years,” he emphasized.

Dr. Trolice noted the change of the addition of an oral GnRH antagonist, “now FDA approved for the treatment of pain associated with endometriosis,” he said. However, “Extended GnRH agonist prior to ART is not recommended due to the lack of any clear benefit,” he noted.

Dr. Trolice noted the inclusion of the Endometriosis Fertility Index (EFI), published in 2010, “as a useful scoring system to predict postoperative non-IVF pregnancy rates (both by natural means and IUI [intrauterine insemination]) based on patient characteristics, revised ASRM staging, and ‘least function score of the adnexa.’ ” He agreed with the need for expanded information on the topics of endometriosis and adolescence and endometriosis and cancer.

The most important changes for clinical practice include reducing unnecessary laparoscopy and procedures without benefit, such as laparoscopic uterosacral nerve ablation and presacral neurectomy, and GnRH suppression using an oral antagonist, said Dr. Trolice. Other especially practical guidance includes the recommendation to discontinue advising patients that pregnancy will reduce symptoms of endometriosis, and to avoid prescribing estrogen-only treatment in menopause given the risk of malignant transformation of endometriosis, he said.

Another clinically useful recommendation, though not a significant update, is the need to identify extrapelvic endometriosis symptoms, such as cyclical shoulder pain, cyclical spontaneous pneumothorax, cyclical cough, or nodules that enlarge during menses, Dr. Trolice added.

Barriers to implementing the updated guidelines include lack of education of clinicians, including primary care providers, and the lack of definitive evidence for many areas, he noted.

As for additional research, more data are needed to explore the genetic, mutational, and epigenetic profile of endometriosis, and to identify biomarkers to noninvasively detect and provide a prognosis for endometriosis, and optimal methods for prevention and management, said Dr. Trolice. Other research gaps include “definitive medical and surgical treatment of endometriosis for improvement of fertility, quality of life, and reduction of pain,” he noted. From a fertility standpoint, more studies are needed on “the use of ovarian tissue or oocytes cryopreservation in adolescents and adults who undergo ovarian surgery for endometriomas, and the role of the EFI as a presurgical triage tool and to predict IUI outcomes,” said Dr. Trolice.

Overall, society recommendations such as these from ESHRE “serve as guides for physicians by providing evidence-based medicine and dispelling prior unproven practices so patients may receive the most effective care of endometriosis, throughout a woman’s life,” Dr. Trolice emphasized.

The current guideline will be considered for revision in 2025, and the full version is available on the ESHRE website.

Members of the ESHRE guideline development group received no payment for participating in the development process, although they were reimbursed for travel expenses related to guideline meetings.

Dr. Trolice had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn News.

Updated guidelines for the management and treatment of endometriosis reflect changes in clinical practice to guide clinician and patient decision-making, according to a statement from the European Society of Human Reproduction and Embryology, which issued the guidelines in February 2022.

Although the exact prevalence of endometriosis remains unclear, estimates suggest that approximately 190 million women and adolescent girls are affected by endometriosis during their reproductive years, and women continue to suffer beyond menopause, according to the authors. Endometriosis has a significant impact on society through both direct and indirect health care costs comparable to those of type 2 diabetes, rheumatoid arthritis, and Crohn’s disease, they noted.

The guidelines are the first update on the topic of endometriosis since 2014, and include more than 100 recommendations, according to the European Society of Human Reproduction and Embryology (ESHRE). The target audience, according to the authors, is secondary and tertiary health care providers who treat women with endometriosis. The recommendations were based on research papers published up to Dec. 1, 2020.

Although most of the recent studies confirm previous ESHRE recommendations, several topics reflect significant changes in clinical practice.

Notably, laparoscopy is no longer recommended as the diagnostic gold standard, and should be used only in patients with negative imaging for whom empirical treatment was unsuccessful.

For pain management, studies support the use of GnRH antagonists as a second-line treatment, while laparoscopic uterosacral nerve ablation and presacral neurectomy are no longer included in the recommendations.

The guidelines include new information on pregnancy and fertility preservation for women with endometriosis. The Endometriosis Fertility Index (EFI) was added to support joint decision-making for women seeking pregnancy after surgery. However, the extended use of GnRH antagonist prior to assisted reproductive technology treatments to improve live birth rate is not recommended.

Endometriosis in adolescent patients is included in the guidelines for the first time, and strong recommendations include taking a careful history and using ultrasound if appropriate, but the use of serum biomarkers is not recommended for diagnosis. Strong recommendations for treatment strategies for adolescents include hormonal contraceptives or progestins as a first-line therapy.

Recommendations for managing endometriosis in menopause are more extensive than in previous guidelines and the strongest update is against the use of estrogen-only treatment in these patients. However, the guidelines continue to recommend treating women with a history of endometriosis after surgical menopause with combined estrogen-progestogen therapy “at least up to the age of natural menopause.”

Expanded recommendations related to endometriosis and cancer begin with a strong recommendation for clinicians to advise women that endometriosis is not associated with a significantly higher risk of cancer overall. “Although endometriosis is associated with a higher risk of ovarian, breast, and thyroid cancers in particular, the increase in absolute risk compared with women in the general population is low,” the authors wrote. Other strong recommendations include reassuring women with endometriosis of the low risk of malignancy associated with hormonal contraceptive use, and performing cancer screening according to the existing population-based guidelines without additional screening. Epidemiologic data show that complete excision of visible endometriosis may reduce the risk of ovarian cancer, but the potential benefits must be weighed against the risks of surgery, including morbidity, pain, and ovarian reserve, the authors said.

The guidelines include recommendations related to asymptomatic endometriosis, extrapelvic endometriosis, and primary prevention of endometriosis, but without major changes to the 2014 guidelines.
 

Guidelines expand strategies, but research gaps remain

In 2021, an international working group of the American Association of Gynecologic Laparoscopists, the European Society for Gynecologic Endoscopy, ESHRE, and the World Endometriosis Society defined endometriosis as “a disease characterized by the presence of endometrium-like epithelium and/or stroma outside the endometrium and myometrium, usually with an associated inflammatory process,” Mark P. Trolice, MD, director of The IVF Center, Orlando, Fla., and professor of obstetrics and gynecology at the University of Central Florida, said in an interview.

Although the current guidelines represent the second update since 2005, many unanswered questions remain, Dr. Trolice said. “There is a large diagnostic void between the onset of symptoms and the time to a reliable diagnosis averaging between 8 and 12 years,” he emphasized.

Dr. Trolice noted the change of the addition of an oral GnRH antagonist, “now FDA approved for the treatment of pain associated with endometriosis,” he said. However, “Extended GnRH agonist prior to ART is not recommended due to the lack of any clear benefit,” he noted.

Dr. Trolice noted the inclusion of the Endometriosis Fertility Index (EFI), published in 2010, “as a useful scoring system to predict postoperative non-IVF pregnancy rates (both by natural means and IUI [intrauterine insemination]) based on patient characteristics, revised ASRM staging, and ‘least function score of the adnexa.’ ” He agreed with the need for expanded information on the topics of endometriosis and adolescence and endometriosis and cancer.

The most important changes for clinical practice include reducing unnecessary laparoscopy and procedures without benefit, such as laparoscopic uterosacral nerve ablation and presacral neurectomy, and GnRH suppression using an oral antagonist, said Dr. Trolice. Other especially practical guidance includes the recommendation to discontinue advising patients that pregnancy will reduce symptoms of endometriosis, and to avoid prescribing estrogen-only treatment in menopause given the risk of malignant transformation of endometriosis, he said.

Another clinically useful recommendation, though not a significant update, is the need to identify extrapelvic endometriosis symptoms, such as cyclical shoulder pain, cyclical spontaneous pneumothorax, cyclical cough, or nodules that enlarge during menses, Dr. Trolice added.

Barriers to implementing the updated guidelines include lack of education of clinicians, including primary care providers, and the lack of definitive evidence for many areas, he noted.

As for additional research, more data are needed to explore the genetic, mutational, and epigenetic profile of endometriosis, and to identify biomarkers to noninvasively detect and provide a prognosis for endometriosis, and optimal methods for prevention and management, said Dr. Trolice. Other research gaps include “definitive medical and surgical treatment of endometriosis for improvement of fertility, quality of life, and reduction of pain,” he noted. From a fertility standpoint, more studies are needed on “the use of ovarian tissue or oocytes cryopreservation in adolescents and adults who undergo ovarian surgery for endometriomas, and the role of the EFI as a presurgical triage tool and to predict IUI outcomes,” said Dr. Trolice.

Overall, society recommendations such as these from ESHRE “serve as guides for physicians by providing evidence-based medicine and dispelling prior unproven practices so patients may receive the most effective care of endometriosis, throughout a woman’s life,” Dr. Trolice emphasized.

The current guideline will be considered for revision in 2025, and the full version is available on the ESHRE website.

Members of the ESHRE guideline development group received no payment for participating in the development process, although they were reimbursed for travel expenses related to guideline meetings.

Dr. Trolice had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn News.

Hundreds of Native American tribes have tentatively settled in what one of the lead attorneys describes as “an epic deal”: The top 3 pharmaceutical distributors in the US and Johnson & Johnson have agreed to pay $665 million for deceptive marketing practices and overdistribution of opioids. Native Americans were among those hardest hit by the opioid epidemic. Between 2006 and 2014, Native Americans were nearly 50% more likely than non-Natives to die of an opioid overdose. In 2014, they ranked number 1 for death by opioid overdose.

Overprescribing was rampant. In some areas, such as southwestern Virginia, eastern Kentucky, and Alabama, prescriptions were 5 to 6 times higher than the national average. The overprescribing was largely due to massive and aggressive billion-dollar marketing campaigns, which misrepresented the safety of opioid medications. Purdue Pharma, for instance, trained sales representatives to claim that the risk of addiction was “less than 1 percent.” In an interview with Smithsonian Magazine, Caleb Alexander, MD, codirector of Johns Hopkins’ Center for Drug Safety and Effectiveness, said, “When I was in residency training, we were taught that one needn’t worry about the addictive potential of opioids if a patient had true pain.” He said it was no accident that physicians were cultivated to overestimate the effectiveness for chronic, noncancer pain while underestimating the risks.

Native Americans were not only in the target group for prescriptions, but also apparently singularly targeted. “We were preyed upon,” said Chickasaw Nation Governor Bill Anoatubby in the Washington Post. “It was unconscionable.” A Washington Post analysis found that, between 2006 and 2014, opioid distributors shipped an average of 36 pills per person in the US. States in the so-called opioid belt (mostly Southern states), received an average of 60 to 66 pills per person. The distributors shipped 57 pills per person to Oklahoma, home to nearly 322,000 Native Americans. (The opioid death rate for Native Americans in Oklahoma from 2006 to 2014 was more than triple the nationwide rate for non-Natives.) In South Dakota as recently as 2015, enough opioids were prescribed to medicate every adult around-the-clock for 19 consecutive days. Native Americans comprise 9% of South Dakota’s population; however, almost 30% of the patients are being treated for opioid use disorder.

In the settlement, which is a first for tribes, McKesson, Cardinal Health, and AmerisourceBergen would pay $515 million over 7 years. Johnson & Johnson would contribute $150 million in 2 years to the federally recognized tribes. “This settlement is a real turning point in history,” said Lloyd Miller, one of the attorneys representing one-third of the litigating tribes.

But the money is still small compensation for ravaging millions of lives. “Flooding the Native community with Western medicine—sedating a population rather than seeking to understand its needs and challenges—is not an acceptable means of handling its trauma,” the Lakota People’s Law Project says in an article on its website. Thus, the money dispersal will be overseen by a panel of tribal health experts, to go toward programs that aid drug users and their communities.

The funds will be managed in a way that will consider the long-term damage, Native American leaders vow. Children, for instance, have not been exempt from the sequelae of the overprescribing. Foster care systems are “overrun” with children of addicted parents, the Law Project says, and the children are placed in homes outside the tribe. “In the long run, this has the potential to curtail tribal membership, break down familial lines, and degrade cultural values.”

Dealing with the problem has drained tribal resources—doubly strained by the COVID-19 epidemic. Chairman Douglas Yankton, of the Spirit Lake Nation in North Dakota, said in a statement, “The dollars that will flow to Tribes under this initial settlement will help fund crucial, on-reservation, culturally appropriate opioid treatment services.”

However, Chairman Kristopher Peters, of the Squaxin Island Tribe in Washington State, told the Washington Post, “There is no amount of money that’s going to solve the generational issues that have been created from this. Our hope is that we can use these funds to help revitalize our culture and help heal our people.”

Johnson & Johnson says it no longer sells prescription opioids in the US

Hundreds of Native American tribes have tentatively settled in what one of the lead attorneys describes as “an epic deal”: The top 3 pharmaceutical distributors in the US and Johnson & Johnson have agreed to pay $665 million for deceptive marketing practices and overdistribution of opioids. Native Americans were among those hardest hit by the opioid epidemic. Between 2006 and 2014, Native Americans were nearly 50% more likely than non-Natives to die of an opioid overdose. In 2014, they ranked number 1 for death by opioid overdose.

Overprescribing was rampant. In some areas, such as southwestern Virginia, eastern Kentucky, and Alabama, prescriptions were 5 to 6 times higher than the national average. The overprescribing was largely due to massive and aggressive billion-dollar marketing campaigns, which misrepresented the safety of opioid medications. Purdue Pharma, for instance, trained sales representatives to claim that the risk of addiction was “less than 1 percent.” In an interview with Smithsonian Magazine, Caleb Alexander, MD, codirector of Johns Hopkins’ Center for Drug Safety and Effectiveness, said, “When I was in residency training, we were taught that one needn’t worry about the addictive potential of opioids if a patient had true pain.” He said it was no accident that physicians were cultivated to overestimate the effectiveness for chronic, noncancer pain while underestimating the risks.

Native Americans were not only in the target group for prescriptions, but also apparently singularly targeted. “We were preyed upon,” said Chickasaw Nation Governor Bill Anoatubby in the Washington Post. “It was unconscionable.” A Washington Post analysis found that, between 2006 and 2014, opioid distributors shipped an average of 36 pills per person in the US. States in the so-called opioid belt (mostly Southern states), received an average of 60 to 66 pills per person. The distributors shipped 57 pills per person to Oklahoma, home to nearly 322,000 Native Americans. (The opioid death rate for Native Americans in Oklahoma from 2006 to 2014 was more than triple the nationwide rate for non-Natives.) In South Dakota as recently as 2015, enough opioids were prescribed to medicate every adult around-the-clock for 19 consecutive days. Native Americans comprise 9% of South Dakota’s population; however, almost 30% of the patients are being treated for opioid use disorder.

In the settlement, which is a first for tribes, McKesson, Cardinal Health, and AmerisourceBergen would pay $515 million over 7 years. Johnson & Johnson would contribute $150 million in 2 years to the federally recognized tribes. “This settlement is a real turning point in history,” said Lloyd Miller, one of the attorneys representing one-third of the litigating tribes.

But the money is still small compensation for ravaging millions of lives. “Flooding the Native community with Western medicine—sedating a population rather than seeking to understand its needs and challenges—is not an acceptable means of handling its trauma,” the Lakota People’s Law Project says in an article on its website. Thus, the money dispersal will be overseen by a panel of tribal health experts, to go toward programs that aid drug users and their communities.

The funds will be managed in a way that will consider the long-term damage, Native American leaders vow. Children, for instance, have not been exempt from the sequelae of the overprescribing. Foster care systems are “overrun” with children of addicted parents, the Law Project says, and the children are placed in homes outside the tribe. “In the long run, this has the potential to curtail tribal membership, break down familial lines, and degrade cultural values.”

Dealing with the problem has drained tribal resources—doubly strained by the COVID-19 epidemic. Chairman Douglas Yankton, of the Spirit Lake Nation in North Dakota, said in a statement, “The dollars that will flow to Tribes under this initial settlement will help fund crucial, on-reservation, culturally appropriate opioid treatment services.”

However, Chairman Kristopher Peters, of the Squaxin Island Tribe in Washington State, told the Washington Post, “There is no amount of money that’s going to solve the generational issues that have been created from this. Our hope is that we can use these funds to help revitalize our culture and help heal our people.”

Johnson & Johnson says it no longer sells prescription opioids in the US

Hundreds of Native American tribes have tentatively settled in what one of the lead attorneys describes as “an epic deal”: The top 3 pharmaceutical distributors in the US and Johnson & Johnson have agreed to pay $665 million for deceptive marketing practices and overdistribution of opioids. Native Americans were among those hardest hit by the opioid epidemic. Between 2006 and 2014, Native Americans were nearly 50% more likely than non-Natives to die of an opioid overdose. In 2014, they ranked number 1 for death by opioid overdose.

Overprescribing was rampant. In some areas, such as southwestern Virginia, eastern Kentucky, and Alabama, prescriptions were 5 to 6 times higher than the national average. The overprescribing was largely due to massive and aggressive billion-dollar marketing campaigns, which misrepresented the safety of opioid medications. Purdue Pharma, for instance, trained sales representatives to claim that the risk of addiction was “less than 1 percent.” In an interview with Smithsonian Magazine, Caleb Alexander, MD, codirector of Johns Hopkins’ Center for Drug Safety and Effectiveness, said, “When I was in residency training, we were taught that one needn’t worry about the addictive potential of opioids if a patient had true pain.” He said it was no accident that physicians were cultivated to overestimate the effectiveness for chronic, noncancer pain while underestimating the risks.

Native Americans were not only in the target group for prescriptions, but also apparently singularly targeted. “We were preyed upon,” said Chickasaw Nation Governor Bill Anoatubby in the Washington Post. “It was unconscionable.” A Washington Post analysis found that, between 2006 and 2014, opioid distributors shipped an average of 36 pills per person in the US. States in the so-called opioid belt (mostly Southern states), received an average of 60 to 66 pills per person. The distributors shipped 57 pills per person to Oklahoma, home to nearly 322,000 Native Americans. (The opioid death rate for Native Americans in Oklahoma from 2006 to 2014 was more than triple the nationwide rate for non-Natives.) In South Dakota as recently as 2015, enough opioids were prescribed to medicate every adult around-the-clock for 19 consecutive days. Native Americans comprise 9% of South Dakota’s population; however, almost 30% of the patients are being treated for opioid use disorder.

In the settlement, which is a first for tribes, McKesson, Cardinal Health, and AmerisourceBergen would pay $515 million over 7 years. Johnson & Johnson would contribute $150 million in 2 years to the federally recognized tribes. “This settlement is a real turning point in history,” said Lloyd Miller, one of the attorneys representing one-third of the litigating tribes.

But the money is still small compensation for ravaging millions of lives. “Flooding the Native community with Western medicine—sedating a population rather than seeking to understand its needs and challenges—is not an acceptable means of handling its trauma,” the Lakota People’s Law Project says in an article on its website. Thus, the money dispersal will be overseen by a panel of tribal health experts, to go toward programs that aid drug users and their communities.

The funds will be managed in a way that will consider the long-term damage, Native American leaders vow. Children, for instance, have not been exempt from the sequelae of the overprescribing. Foster care systems are “overrun” with children of addicted parents, the Law Project says, and the children are placed in homes outside the tribe. “In the long run, this has the potential to curtail tribal membership, break down familial lines, and degrade cultural values.”

Dealing with the problem has drained tribal resources—doubly strained by the COVID-19 epidemic. Chairman Douglas Yankton, of the Spirit Lake Nation in North Dakota, said in a statement, “The dollars that will flow to Tribes under this initial settlement will help fund crucial, on-reservation, culturally appropriate opioid treatment services.”

However, Chairman Kristopher Peters, of the Squaxin Island Tribe in Washington State, told the Washington Post, “There is no amount of money that’s going to solve the generational issues that have been created from this. Our hope is that we can use these funds to help revitalize our culture and help heal our people.”

Johnson & Johnson says it no longer sells prescription opioids in the US