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Is This the Cure for Restless Legs?
I don’t rightly remember when I first learned of restless legs syndrome (RLS). It was many decades ago, and I recognized that once in a while, I would be restless during sleep, tossing and turning, seeking a favorable sleeping position. I felt like I just needed to move my legs around; my gastrocnemii and hamstrings might cramp; and my torso skin might strangely “crawl” a bit, but then normal sleep would return. I never sought medical care for it and used no treatment, except moving my legs when indicated.
My trusty LLM (large language model), Bard, tells me that there are about 53,000 articles about RLS in English, of which, some 20,000 are in the primary source, peer reviewed literature. Count this as one more article. Will it make a difference? Read on and see.
For many centuries (since Sir Thomas Willis in 1672), the symptoms now grouped and categorized as RLS have been recognized and reported but were often dismissed as bizarre and unexplained. The name was applied in 1948 by Dr Karl-Axel Ekborn.
In the 1960s, in sleep labs, RLS became better studied and characterized.
Mayo Clinic describes RLS as “… compelling, unpleasant sensations in the legs or feet ... both sides of the body ... within the limb rather than on the skin ... crawling, creeping, pulling, throbbing, aching, itching, electric ... difficult to explain …” Not numbness, but a consistent desire to move the legs.
When I read about it many decades ago, I realized that I may have RLS. But then many months would pass with no recurrence, so I dismissed it as just another of those “symptoms of unknown origin” that my late friend Clifton Meador has written about so eloquently.
I am sure that a lot of people experience this, don’t understand it, and don’t consider it important enough to do anything about. The cause is unknown, but it seems to run in families. It may be autosomal dominant, but no causative genes have been confirmed.
Treatment of RLS
Many pharmacologic and physical treatments have been tried with some success for some patients, but over time, these treatments have mostly failed.
We know how Big Pharma often operates. A company owns a drug, preferably under patent protection, but without an apparent profitable indication. They need to find a medical condition, ideally one with troublesome symptoms, that the drug might ameliorate to some degree. Armed with a plausible candidate symptom, the company embarks upon a campaign to find people who might want to take the drug. Mass communications, such as direct-to-consumer advertising, can identify large numbers of people who match to pretty much any symptoms, although many of these people never suspected they had a disease, much less a treatable one.
I figured long ago that RLS was just another of those nonspecific entities experienced by many people, making them good candidates for disease mongering.
In 2005, the marketing of GlaxoSmithKline’s (GSK’s) dopamine agonist drug Requip (ropinirole) was approved by the FDA. GSK had already undertaken an intensive promotional campaign for Requip, issuing press releases, advertising to doctors in medical journals, and advertising directly to consumers. To increase general awareness of RLS, GSK’s campaign told consumers that a “new survey reveals that a common yet underrecognized disorder-restless legs syndrome—is keeping Americans awake at night.” GSK was accused of “disease mongering,” trying to turn ordinary people into patients who needed specific drugs.
Within a year, sales of the drug had doubled, climbing from $165 million in 2005 to nearly $330 million in 2006. Soon, 4.4 million prescriptions were written annually for the drug, with sales reported to be nearly $491 million. However, the focus on RLS faded rapidly as the Requip television commercials were pulled from the airwaves following approval of generic ropinirole.
And Requip had competition. Boehringer Ingelheim manufactures pramipexole (brand name Mirapex) another dopamine agonist. Gabapentin enacarbil (marketed as Horizant by UCB Pharma) is also approved for RLS, and Pfizer’s pregabalin (brand name Lyrica) is used off-label to manage symptoms of RLS. Janssen Pharmaceuticals manufactures rotigotine, (brand name Neupro), a dopamine agonist delivered via a transdermal patch.
It is safe to say that RLS is a real clinical entity composed of clearly recognizable symptoms, with no cure and no ending, unless it is associated with iron-deficiency anemia. However, as a disease, it seems to lack etiology, pathology, pathogenesis, pathophysiology, diagnostic findings on physical examination, laboratory tests, or imaging, and any clear strategy for prevention.
Pharmacologic treatments include dopaminergic agents, benzodiazepines, opioids, anticonvulsants, alpha 2–adrenergic agonists and iron salts. Yes, you read that right; RLS is treated with a broad array of different drugs, which is usually a sign that nothing works very well. Some agents work for a while, but none seem to be the definitive solution.
Same for the physical interventions: sleep hygiene, exercise, hot or cold bathing, limb massage, vibratory or electrical stimulation of the feet, stopping caffeine before bedtime. Try everything and see if something works.
Taking the Sugar Challenge
Could the culprit be sugar?
Lacking clarity of scientific understanding of RLS or its treatment from an extensive clinical literature, after ascertaining that RLS is real, one might look for real-world evidence, including well-performed N-of-1 trials.
I am an antisugar guy. Read my prior Medscape columns. I practice what I preach, but sugar does taste good.
Early in November 2023, after a healthy, conservative dinner at home with some wine, I enjoyed a mini Dove bar for dessert. But I didn’t stop there.
Mini Dove bars contain 11 grams sugar. It was also just a few days after Halloween. Having had fewer trick-or-treaters than expected, we had leftovers. Snickers, Milky Ways, Twix mini bars, each with at least 20 grams of sugar.
I ate several of these not long before bedtime. Lo and behold, in the dark of that night, and continuing off and on for a few fitful hours, I had bad RLS. Shifting, tossing, turning, compulsively seeking a new sleeping position only to have to soon move again. Plus, I had repetitive leg cramps and that creepy-crawly skin sensation. An altogether unpleasant experience. Sound sleep eventually arrived, and there were no recurrences over subsequent weeks.
The classic way to determine whether a drug is causing a reaction, condition, or disease is to apply the challenge-dechallenge-rechallenge testing method.
Give the drug, the patient demonstrates the disease finding. Remove the drug, the problem disappears. Rinse and repeat three times. We pathologists first worked this out for drug-induced liver disease, such as steatosis, in the late 1960s. Blinding or double blinding in these N-of-1 situations would be nice but often not practical.
Siwert de Groot, in the Netherlands, published a very convincing use of this technique in 2023: Big-time sugar consumption for a week, then low intake of sugar for the following week, repeated three times on one patient.
Very elaborate RLS symptom reporting. I’m pretty convinced from my unintentional challenge and single dechallenge that my unusually high sugar intake resulted in RLS. I will not undergo a rechallenge, although it might be fun to binge on sucrose and see what happens.
If you are serious about identifying or treating RLS, I suggest that you incorporate the International Restless Legs Study Group Severity Rating Scale into your practice, and begin the systematic use of the dechallenge-rechallenge exclusion process for your patients with RLS. Start with sugar and see what happens. Keep records and let the world know what you discover. Be your own clinical investigator. Social media offers you abundant opportunity to share your results, whatever they may be.
How many millions of dollars would Big Pharma lose if patients with RLS just said no to sugar and it worked? Of course, humans being humans, many would probably prefer to continue to gorge on sugar, gain weight, develop diabetes, and then take medications to control their RLS symptoms. But patients ought to at least be given an informed choice.
I will be watching for your reports.
Dr. Lundberg had no disclosures.
A version of this article appeared on Medscape.com.
I don’t rightly remember when I first learned of restless legs syndrome (RLS). It was many decades ago, and I recognized that once in a while, I would be restless during sleep, tossing and turning, seeking a favorable sleeping position. I felt like I just needed to move my legs around; my gastrocnemii and hamstrings might cramp; and my torso skin might strangely “crawl” a bit, but then normal sleep would return. I never sought medical care for it and used no treatment, except moving my legs when indicated.
My trusty LLM (large language model), Bard, tells me that there are about 53,000 articles about RLS in English, of which, some 20,000 are in the primary source, peer reviewed literature. Count this as one more article. Will it make a difference? Read on and see.
For many centuries (since Sir Thomas Willis in 1672), the symptoms now grouped and categorized as RLS have been recognized and reported but were often dismissed as bizarre and unexplained. The name was applied in 1948 by Dr Karl-Axel Ekborn.
In the 1960s, in sleep labs, RLS became better studied and characterized.
Mayo Clinic describes RLS as “… compelling, unpleasant sensations in the legs or feet ... both sides of the body ... within the limb rather than on the skin ... crawling, creeping, pulling, throbbing, aching, itching, electric ... difficult to explain …” Not numbness, but a consistent desire to move the legs.
When I read about it many decades ago, I realized that I may have RLS. But then many months would pass with no recurrence, so I dismissed it as just another of those “symptoms of unknown origin” that my late friend Clifton Meador has written about so eloquently.
I am sure that a lot of people experience this, don’t understand it, and don’t consider it important enough to do anything about. The cause is unknown, but it seems to run in families. It may be autosomal dominant, but no causative genes have been confirmed.
Treatment of RLS
Many pharmacologic and physical treatments have been tried with some success for some patients, but over time, these treatments have mostly failed.
We know how Big Pharma often operates. A company owns a drug, preferably under patent protection, but without an apparent profitable indication. They need to find a medical condition, ideally one with troublesome symptoms, that the drug might ameliorate to some degree. Armed with a plausible candidate symptom, the company embarks upon a campaign to find people who might want to take the drug. Mass communications, such as direct-to-consumer advertising, can identify large numbers of people who match to pretty much any symptoms, although many of these people never suspected they had a disease, much less a treatable one.
I figured long ago that RLS was just another of those nonspecific entities experienced by many people, making them good candidates for disease mongering.
In 2005, the marketing of GlaxoSmithKline’s (GSK’s) dopamine agonist drug Requip (ropinirole) was approved by the FDA. GSK had already undertaken an intensive promotional campaign for Requip, issuing press releases, advertising to doctors in medical journals, and advertising directly to consumers. To increase general awareness of RLS, GSK’s campaign told consumers that a “new survey reveals that a common yet underrecognized disorder-restless legs syndrome—is keeping Americans awake at night.” GSK was accused of “disease mongering,” trying to turn ordinary people into patients who needed specific drugs.
Within a year, sales of the drug had doubled, climbing from $165 million in 2005 to nearly $330 million in 2006. Soon, 4.4 million prescriptions were written annually for the drug, with sales reported to be nearly $491 million. However, the focus on RLS faded rapidly as the Requip television commercials were pulled from the airwaves following approval of generic ropinirole.
And Requip had competition. Boehringer Ingelheim manufactures pramipexole (brand name Mirapex) another dopamine agonist. Gabapentin enacarbil (marketed as Horizant by UCB Pharma) is also approved for RLS, and Pfizer’s pregabalin (brand name Lyrica) is used off-label to manage symptoms of RLS. Janssen Pharmaceuticals manufactures rotigotine, (brand name Neupro), a dopamine agonist delivered via a transdermal patch.
It is safe to say that RLS is a real clinical entity composed of clearly recognizable symptoms, with no cure and no ending, unless it is associated with iron-deficiency anemia. However, as a disease, it seems to lack etiology, pathology, pathogenesis, pathophysiology, diagnostic findings on physical examination, laboratory tests, or imaging, and any clear strategy for prevention.
Pharmacologic treatments include dopaminergic agents, benzodiazepines, opioids, anticonvulsants, alpha 2–adrenergic agonists and iron salts. Yes, you read that right; RLS is treated with a broad array of different drugs, which is usually a sign that nothing works very well. Some agents work for a while, but none seem to be the definitive solution.
Same for the physical interventions: sleep hygiene, exercise, hot or cold bathing, limb massage, vibratory or electrical stimulation of the feet, stopping caffeine before bedtime. Try everything and see if something works.
Taking the Sugar Challenge
Could the culprit be sugar?
Lacking clarity of scientific understanding of RLS or its treatment from an extensive clinical literature, after ascertaining that RLS is real, one might look for real-world evidence, including well-performed N-of-1 trials.
I am an antisugar guy. Read my prior Medscape columns. I practice what I preach, but sugar does taste good.
Early in November 2023, after a healthy, conservative dinner at home with some wine, I enjoyed a mini Dove bar for dessert. But I didn’t stop there.
Mini Dove bars contain 11 grams sugar. It was also just a few days after Halloween. Having had fewer trick-or-treaters than expected, we had leftovers. Snickers, Milky Ways, Twix mini bars, each with at least 20 grams of sugar.
I ate several of these not long before bedtime. Lo and behold, in the dark of that night, and continuing off and on for a few fitful hours, I had bad RLS. Shifting, tossing, turning, compulsively seeking a new sleeping position only to have to soon move again. Plus, I had repetitive leg cramps and that creepy-crawly skin sensation. An altogether unpleasant experience. Sound sleep eventually arrived, and there were no recurrences over subsequent weeks.
The classic way to determine whether a drug is causing a reaction, condition, or disease is to apply the challenge-dechallenge-rechallenge testing method.
Give the drug, the patient demonstrates the disease finding. Remove the drug, the problem disappears. Rinse and repeat three times. We pathologists first worked this out for drug-induced liver disease, such as steatosis, in the late 1960s. Blinding or double blinding in these N-of-1 situations would be nice but often not practical.
Siwert de Groot, in the Netherlands, published a very convincing use of this technique in 2023: Big-time sugar consumption for a week, then low intake of sugar for the following week, repeated three times on one patient.
Very elaborate RLS symptom reporting. I’m pretty convinced from my unintentional challenge and single dechallenge that my unusually high sugar intake resulted in RLS. I will not undergo a rechallenge, although it might be fun to binge on sucrose and see what happens.
If you are serious about identifying or treating RLS, I suggest that you incorporate the International Restless Legs Study Group Severity Rating Scale into your practice, and begin the systematic use of the dechallenge-rechallenge exclusion process for your patients with RLS. Start with sugar and see what happens. Keep records and let the world know what you discover. Be your own clinical investigator. Social media offers you abundant opportunity to share your results, whatever they may be.
How many millions of dollars would Big Pharma lose if patients with RLS just said no to sugar and it worked? Of course, humans being humans, many would probably prefer to continue to gorge on sugar, gain weight, develop diabetes, and then take medications to control their RLS symptoms. But patients ought to at least be given an informed choice.
I will be watching for your reports.
Dr. Lundberg had no disclosures.
A version of this article appeared on Medscape.com.
I don’t rightly remember when I first learned of restless legs syndrome (RLS). It was many decades ago, and I recognized that once in a while, I would be restless during sleep, tossing and turning, seeking a favorable sleeping position. I felt like I just needed to move my legs around; my gastrocnemii and hamstrings might cramp; and my torso skin might strangely “crawl” a bit, but then normal sleep would return. I never sought medical care for it and used no treatment, except moving my legs when indicated.
My trusty LLM (large language model), Bard, tells me that there are about 53,000 articles about RLS in English, of which, some 20,000 are in the primary source, peer reviewed literature. Count this as one more article. Will it make a difference? Read on and see.
For many centuries (since Sir Thomas Willis in 1672), the symptoms now grouped and categorized as RLS have been recognized and reported but were often dismissed as bizarre and unexplained. The name was applied in 1948 by Dr Karl-Axel Ekborn.
In the 1960s, in sleep labs, RLS became better studied and characterized.
Mayo Clinic describes RLS as “… compelling, unpleasant sensations in the legs or feet ... both sides of the body ... within the limb rather than on the skin ... crawling, creeping, pulling, throbbing, aching, itching, electric ... difficult to explain …” Not numbness, but a consistent desire to move the legs.
When I read about it many decades ago, I realized that I may have RLS. But then many months would pass with no recurrence, so I dismissed it as just another of those “symptoms of unknown origin” that my late friend Clifton Meador has written about so eloquently.
I am sure that a lot of people experience this, don’t understand it, and don’t consider it important enough to do anything about. The cause is unknown, but it seems to run in families. It may be autosomal dominant, but no causative genes have been confirmed.
Treatment of RLS
Many pharmacologic and physical treatments have been tried with some success for some patients, but over time, these treatments have mostly failed.
We know how Big Pharma often operates. A company owns a drug, preferably under patent protection, but without an apparent profitable indication. They need to find a medical condition, ideally one with troublesome symptoms, that the drug might ameliorate to some degree. Armed with a plausible candidate symptom, the company embarks upon a campaign to find people who might want to take the drug. Mass communications, such as direct-to-consumer advertising, can identify large numbers of people who match to pretty much any symptoms, although many of these people never suspected they had a disease, much less a treatable one.
I figured long ago that RLS was just another of those nonspecific entities experienced by many people, making them good candidates for disease mongering.
In 2005, the marketing of GlaxoSmithKline’s (GSK’s) dopamine agonist drug Requip (ropinirole) was approved by the FDA. GSK had already undertaken an intensive promotional campaign for Requip, issuing press releases, advertising to doctors in medical journals, and advertising directly to consumers. To increase general awareness of RLS, GSK’s campaign told consumers that a “new survey reveals that a common yet underrecognized disorder-restless legs syndrome—is keeping Americans awake at night.” GSK was accused of “disease mongering,” trying to turn ordinary people into patients who needed specific drugs.
Within a year, sales of the drug had doubled, climbing from $165 million in 2005 to nearly $330 million in 2006. Soon, 4.4 million prescriptions were written annually for the drug, with sales reported to be nearly $491 million. However, the focus on RLS faded rapidly as the Requip television commercials were pulled from the airwaves following approval of generic ropinirole.
And Requip had competition. Boehringer Ingelheim manufactures pramipexole (brand name Mirapex) another dopamine agonist. Gabapentin enacarbil (marketed as Horizant by UCB Pharma) is also approved for RLS, and Pfizer’s pregabalin (brand name Lyrica) is used off-label to manage symptoms of RLS. Janssen Pharmaceuticals manufactures rotigotine, (brand name Neupro), a dopamine agonist delivered via a transdermal patch.
It is safe to say that RLS is a real clinical entity composed of clearly recognizable symptoms, with no cure and no ending, unless it is associated with iron-deficiency anemia. However, as a disease, it seems to lack etiology, pathology, pathogenesis, pathophysiology, diagnostic findings on physical examination, laboratory tests, or imaging, and any clear strategy for prevention.
Pharmacologic treatments include dopaminergic agents, benzodiazepines, opioids, anticonvulsants, alpha 2–adrenergic agonists and iron salts. Yes, you read that right; RLS is treated with a broad array of different drugs, which is usually a sign that nothing works very well. Some agents work for a while, but none seem to be the definitive solution.
Same for the physical interventions: sleep hygiene, exercise, hot or cold bathing, limb massage, vibratory or electrical stimulation of the feet, stopping caffeine before bedtime. Try everything and see if something works.
Taking the Sugar Challenge
Could the culprit be sugar?
Lacking clarity of scientific understanding of RLS or its treatment from an extensive clinical literature, after ascertaining that RLS is real, one might look for real-world evidence, including well-performed N-of-1 trials.
I am an antisugar guy. Read my prior Medscape columns. I practice what I preach, but sugar does taste good.
Early in November 2023, after a healthy, conservative dinner at home with some wine, I enjoyed a mini Dove bar for dessert. But I didn’t stop there.
Mini Dove bars contain 11 grams sugar. It was also just a few days after Halloween. Having had fewer trick-or-treaters than expected, we had leftovers. Snickers, Milky Ways, Twix mini bars, each with at least 20 grams of sugar.
I ate several of these not long before bedtime. Lo and behold, in the dark of that night, and continuing off and on for a few fitful hours, I had bad RLS. Shifting, tossing, turning, compulsively seeking a new sleeping position only to have to soon move again. Plus, I had repetitive leg cramps and that creepy-crawly skin sensation. An altogether unpleasant experience. Sound sleep eventually arrived, and there were no recurrences over subsequent weeks.
The classic way to determine whether a drug is causing a reaction, condition, or disease is to apply the challenge-dechallenge-rechallenge testing method.
Give the drug, the patient demonstrates the disease finding. Remove the drug, the problem disappears. Rinse and repeat three times. We pathologists first worked this out for drug-induced liver disease, such as steatosis, in the late 1960s. Blinding or double blinding in these N-of-1 situations would be nice but often not practical.
Siwert de Groot, in the Netherlands, published a very convincing use of this technique in 2023: Big-time sugar consumption for a week, then low intake of sugar for the following week, repeated three times on one patient.
Very elaborate RLS symptom reporting. I’m pretty convinced from my unintentional challenge and single dechallenge that my unusually high sugar intake resulted in RLS. I will not undergo a rechallenge, although it might be fun to binge on sucrose and see what happens.
If you are serious about identifying or treating RLS, I suggest that you incorporate the International Restless Legs Study Group Severity Rating Scale into your practice, and begin the systematic use of the dechallenge-rechallenge exclusion process for your patients with RLS. Start with sugar and see what happens. Keep records and let the world know what you discover. Be your own clinical investigator. Social media offers you abundant opportunity to share your results, whatever they may be.
How many millions of dollars would Big Pharma lose if patients with RLS just said no to sugar and it worked? Of course, humans being humans, many would probably prefer to continue to gorge on sugar, gain weight, develop diabetes, and then take medications to control their RLS symptoms. But patients ought to at least be given an informed choice.
I will be watching for your reports.
Dr. Lundberg had no disclosures.
A version of this article appeared on Medscape.com.
Impact of Pregnancy on Rosacea Unpredictable, Study Suggests
TOPLINE:
Among women diagnosed with rosacea, the impact of pregnancy on the disease is unpredictable.
METHODOLOGY:
- Researchers conducted a telephone survey of 39 women with a diagnosis of rosacea in the electronic medical records prior to the onset of pregnancy who had been admitted to Oregon Health & Science University for labor and delivery from June 27, 2015, to June 27, 2020.
- Patient global assessment of clear (0), mild (1), moderate (2), or severe (3) rosacea was rated across five timepoints: 1-3 months preconception; first, second, and third trimesters; and 6 weeks postpartum.
TAKEAWAY:
- The mean age of the survey participants was 35.5 years, the mean gestational age at delivery was 39.4 weeks, and most had singleton pregnancies.
- All but one study participant (97.4%) reported symptoms of erythematotelangiectatic rosacea, while 26 (67%) reported symptoms of papulopustular rosacea.
- Nearly half of the participants (19, 48.7%) said their rosacea worsened during pregnancy, 13 (33.3%) reported no change in rosacea severity during pregnancy, and 7 (17.9%) reported that their rosacea improved during pregnancy.
- Before conceiving, the mean rosacea severity score among participants was mild (1.10; 95% CI, 0.92-1.29) and did not change significantly over time, a reflection of individual variations. In addition, 83.3% of participants did not use prescription rosacea treatments prior to pregnancy, and 89.6% did not use them during pregnancy.
IN PRACTICE:
“Rosacea, like acne, lacks a predictable group effect, and instead, each individual may have a different response to the physiologic changes of pregnancy,” the authors concluded.
SOURCE:
Genevieve Benedetti, MD, MPP, of the Department of Dermatology at Oregon Health & Science University, Portland, Oregon, led the research, published as a research letter in the International Journal of Women’s Dermatology.
LIMITATIONS:
The small sample size, single-center design, and overall prevalence of mild disease limit the ability to detect change.
DISCLOSURES:
The researchers reported having no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
Among women diagnosed with rosacea, the impact of pregnancy on the disease is unpredictable.
METHODOLOGY:
- Researchers conducted a telephone survey of 39 women with a diagnosis of rosacea in the electronic medical records prior to the onset of pregnancy who had been admitted to Oregon Health & Science University for labor and delivery from June 27, 2015, to June 27, 2020.
- Patient global assessment of clear (0), mild (1), moderate (2), or severe (3) rosacea was rated across five timepoints: 1-3 months preconception; first, second, and third trimesters; and 6 weeks postpartum.
TAKEAWAY:
- The mean age of the survey participants was 35.5 years, the mean gestational age at delivery was 39.4 weeks, and most had singleton pregnancies.
- All but one study participant (97.4%) reported symptoms of erythematotelangiectatic rosacea, while 26 (67%) reported symptoms of papulopustular rosacea.
- Nearly half of the participants (19, 48.7%) said their rosacea worsened during pregnancy, 13 (33.3%) reported no change in rosacea severity during pregnancy, and 7 (17.9%) reported that their rosacea improved during pregnancy.
- Before conceiving, the mean rosacea severity score among participants was mild (1.10; 95% CI, 0.92-1.29) and did not change significantly over time, a reflection of individual variations. In addition, 83.3% of participants did not use prescription rosacea treatments prior to pregnancy, and 89.6% did not use them during pregnancy.
IN PRACTICE:
“Rosacea, like acne, lacks a predictable group effect, and instead, each individual may have a different response to the physiologic changes of pregnancy,” the authors concluded.
SOURCE:
Genevieve Benedetti, MD, MPP, of the Department of Dermatology at Oregon Health & Science University, Portland, Oregon, led the research, published as a research letter in the International Journal of Women’s Dermatology.
LIMITATIONS:
The small sample size, single-center design, and overall prevalence of mild disease limit the ability to detect change.
DISCLOSURES:
The researchers reported having no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
Among women diagnosed with rosacea, the impact of pregnancy on the disease is unpredictable.
METHODOLOGY:
- Researchers conducted a telephone survey of 39 women with a diagnosis of rosacea in the electronic medical records prior to the onset of pregnancy who had been admitted to Oregon Health & Science University for labor and delivery from June 27, 2015, to June 27, 2020.
- Patient global assessment of clear (0), mild (1), moderate (2), or severe (3) rosacea was rated across five timepoints: 1-3 months preconception; first, second, and third trimesters; and 6 weeks postpartum.
TAKEAWAY:
- The mean age of the survey participants was 35.5 years, the mean gestational age at delivery was 39.4 weeks, and most had singleton pregnancies.
- All but one study participant (97.4%) reported symptoms of erythematotelangiectatic rosacea, while 26 (67%) reported symptoms of papulopustular rosacea.
- Nearly half of the participants (19, 48.7%) said their rosacea worsened during pregnancy, 13 (33.3%) reported no change in rosacea severity during pregnancy, and 7 (17.9%) reported that their rosacea improved during pregnancy.
- Before conceiving, the mean rosacea severity score among participants was mild (1.10; 95% CI, 0.92-1.29) and did not change significantly over time, a reflection of individual variations. In addition, 83.3% of participants did not use prescription rosacea treatments prior to pregnancy, and 89.6% did not use them during pregnancy.
IN PRACTICE:
“Rosacea, like acne, lacks a predictable group effect, and instead, each individual may have a different response to the physiologic changes of pregnancy,” the authors concluded.
SOURCE:
Genevieve Benedetti, MD, MPP, of the Department of Dermatology at Oregon Health & Science University, Portland, Oregon, led the research, published as a research letter in the International Journal of Women’s Dermatology.
LIMITATIONS:
The small sample size, single-center design, and overall prevalence of mild disease limit the ability to detect change.
DISCLOSURES:
The researchers reported having no disclosures.
A version of this article appeared on Medscape.com.
Study Identifies Cardiovascular Comorbidities Associated With Dermatomyositis
TOPLINE:
METHODOLOGY:
- DM is associated with cardiovascular disease (CVD), but US-based data studies on CVD comorbidities in patients with DM are lacking.
- In a cross-sectional analysis of participants in the All of Us research program aged 18 years and older with at least 1 year of electronic health record (EHR) data, researchers identified DM cases and controls with nearest neighbor propensity score matching by age, sex, race/ethnicity, EHR duration, and healthcare visit quantity.
- They used the Pearson’s chi-squared test, Fisher’s exact test, unpaired t-test, or Mann-Whitney U test to compare clinical characteristics and traditional CV comorbidities.
- Multivariable conditional logistic regression was used with backward elimination of comorbidities with P > .1 or evidence of collinearity.
TAKEAWAY:
- Among 235,161 All of Us participants, researchers identified 206 DM cases and 824 matched controls with largely similar demographic characteristics, including smoking status, obesity, and indicators of socioeconomic status.
- Participants with DM were more likely to have a history of atrial fibrillation (10.1% vs 16.0%, respectively), chronic kidney disease (15.2% vs 29.1%), congestive heart failure (9.6% vs 18.0%), coronary artery disease (CAD) (18.2% vs 34.0%), hypertension (52.5% vs 60.7%), myocardial infarction (7.4% vs 15.0), type 2 diabetes (27.3% vs 47.6%), and valvular heart disease (8.7% vs 16.5%) than matched controls.
- In a multivariable analysis that adjusted for potential confounders, three comorbidities remained associated with DM: CAD (odds ratio [OR], 2.0; P < .001), type 2 diabetes (OR, 2.2; P < .001), and chronic kidney disease (OR, 1.7; P = .015).
IN PRACTICE:
“Our findings are important both for prognosis and clinical care, suggesting DM patients should be screened for CVD risk factors to potentially reduce the increased risk for cardiovascular events and CVD-related mortality in DM,” the authors concluded.
SOURCE:
Corresponding author Alisa N. Femia, MD, of the department of dermatology at NYU Grossman School of Medicine, led the research. The study was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
How DM treatments might influence CVD development was not addressed. EHRs may have diagnostic inaccuracies and omissions and lack data on clinical features and severity.
DISCLOSURES:
The project was supported by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Femia reported consulting fees from Octagon Therapeutics, Timber Pharmaceuticals, and Guidepoint. Study author Michael S. Garshick, MD, reported consulting fees from AbbVie and Horizon Therapeutics. The remaining authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- DM is associated with cardiovascular disease (CVD), but US-based data studies on CVD comorbidities in patients with DM are lacking.
- In a cross-sectional analysis of participants in the All of Us research program aged 18 years and older with at least 1 year of electronic health record (EHR) data, researchers identified DM cases and controls with nearest neighbor propensity score matching by age, sex, race/ethnicity, EHR duration, and healthcare visit quantity.
- They used the Pearson’s chi-squared test, Fisher’s exact test, unpaired t-test, or Mann-Whitney U test to compare clinical characteristics and traditional CV comorbidities.
- Multivariable conditional logistic regression was used with backward elimination of comorbidities with P > .1 or evidence of collinearity.
TAKEAWAY:
- Among 235,161 All of Us participants, researchers identified 206 DM cases and 824 matched controls with largely similar demographic characteristics, including smoking status, obesity, and indicators of socioeconomic status.
- Participants with DM were more likely to have a history of atrial fibrillation (10.1% vs 16.0%, respectively), chronic kidney disease (15.2% vs 29.1%), congestive heart failure (9.6% vs 18.0%), coronary artery disease (CAD) (18.2% vs 34.0%), hypertension (52.5% vs 60.7%), myocardial infarction (7.4% vs 15.0), type 2 diabetes (27.3% vs 47.6%), and valvular heart disease (8.7% vs 16.5%) than matched controls.
- In a multivariable analysis that adjusted for potential confounders, three comorbidities remained associated with DM: CAD (odds ratio [OR], 2.0; P < .001), type 2 diabetes (OR, 2.2; P < .001), and chronic kidney disease (OR, 1.7; P = .015).
IN PRACTICE:
“Our findings are important both for prognosis and clinical care, suggesting DM patients should be screened for CVD risk factors to potentially reduce the increased risk for cardiovascular events and CVD-related mortality in DM,” the authors concluded.
SOURCE:
Corresponding author Alisa N. Femia, MD, of the department of dermatology at NYU Grossman School of Medicine, led the research. The study was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
How DM treatments might influence CVD development was not addressed. EHRs may have diagnostic inaccuracies and omissions and lack data on clinical features and severity.
DISCLOSURES:
The project was supported by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Femia reported consulting fees from Octagon Therapeutics, Timber Pharmaceuticals, and Guidepoint. Study author Michael S. Garshick, MD, reported consulting fees from AbbVie and Horizon Therapeutics. The remaining authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- DM is associated with cardiovascular disease (CVD), but US-based data studies on CVD comorbidities in patients with DM are lacking.
- In a cross-sectional analysis of participants in the All of Us research program aged 18 years and older with at least 1 year of electronic health record (EHR) data, researchers identified DM cases and controls with nearest neighbor propensity score matching by age, sex, race/ethnicity, EHR duration, and healthcare visit quantity.
- They used the Pearson’s chi-squared test, Fisher’s exact test, unpaired t-test, or Mann-Whitney U test to compare clinical characteristics and traditional CV comorbidities.
- Multivariable conditional logistic regression was used with backward elimination of comorbidities with P > .1 or evidence of collinearity.
TAKEAWAY:
- Among 235,161 All of Us participants, researchers identified 206 DM cases and 824 matched controls with largely similar demographic characteristics, including smoking status, obesity, and indicators of socioeconomic status.
- Participants with DM were more likely to have a history of atrial fibrillation (10.1% vs 16.0%, respectively), chronic kidney disease (15.2% vs 29.1%), congestive heart failure (9.6% vs 18.0%), coronary artery disease (CAD) (18.2% vs 34.0%), hypertension (52.5% vs 60.7%), myocardial infarction (7.4% vs 15.0), type 2 diabetes (27.3% vs 47.6%), and valvular heart disease (8.7% vs 16.5%) than matched controls.
- In a multivariable analysis that adjusted for potential confounders, three comorbidities remained associated with DM: CAD (odds ratio [OR], 2.0; P < .001), type 2 diabetes (OR, 2.2; P < .001), and chronic kidney disease (OR, 1.7; P = .015).
IN PRACTICE:
“Our findings are important both for prognosis and clinical care, suggesting DM patients should be screened for CVD risk factors to potentially reduce the increased risk for cardiovascular events and CVD-related mortality in DM,” the authors concluded.
SOURCE:
Corresponding author Alisa N. Femia, MD, of the department of dermatology at NYU Grossman School of Medicine, led the research. The study was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
How DM treatments might influence CVD development was not addressed. EHRs may have diagnostic inaccuracies and omissions and lack data on clinical features and severity.
DISCLOSURES:
The project was supported by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Femia reported consulting fees from Octagon Therapeutics, Timber Pharmaceuticals, and Guidepoint. Study author Michael S. Garshick, MD, reported consulting fees from AbbVie and Horizon Therapeutics. The remaining authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
Cannabis for Psychiatric Disorders? ‘Not Today,’ Experts Say
This transcript has been edited for clarity.
Stephen M. Strakowski, MD: Hello. Thank you all for joining us today. I’m very excited to have some great guests to talk about what I consider an active controversy. I’m Stephen M. Strakowski. I’m a professor and vice chair of psychiatry at Indiana University, and professor and associate vice president at University of Texas in Austin.
Today we’re going to talk about cannabis. As all of you are aware, everyone’s talking about cannabis. We hear constantly on social media and in interviews, particularly with relevance to psychiatric disorders, that everyone should be thinking about using cannabis. That seems to be the common conversation.
Last week, I had a patient who said, “All my friends tell me I need to be on cannabis.” That was their solution to her problems. With that in mind, let me introduce our guests, who are both experts on this, to talk about the role of cannabis in psychiatric disorders today.
First, I want to welcome Dr. Leslie Hulvershorn. Dr. Hulvershorn is an associate professor and chair at Indiana University in Indianapolis. Dr. Christopher Hammond is an assistant professor and the director of the co-occurring disorders program at Johns Hopkins. Welcome!
Leslie A. Hulvershorn, MD, MSc: Thank you.
Christopher J. Hammond, MD, PhD: Thank you.
Dr. Strakowski: Leslie, as I mentioned, many people are talking about how cannabis could be a good treatment for psychiatric disorders. Is that true?
Dr. Hulvershorn: If you look at what defines a good treatment, what you’re looking for is clinical trials, ideally randomized, placebo-controlled clinical trials.
When we look at research related to cannabis, we see very few of those trials, and we see that the cannabis plant is actually quite complicated and there are many different compounds that come from it. So we need to look at all the different compounds.
If you think about THC, delta 9 or delta 8, depending on the version, that’s the active ingredient that we most often think about when we say “cannabis.” If you look at THC studies, there really is no evidence that I could find that it helps psychiatric disorders.
What we do find is an enormous literature, many hunDr.eds of studies, actually, that show that THC actually worsens or even brings on psychiatric disorders. There’s a separate conversation about other compounds within the cannabis plant, like CBD, cannabidiol, where there’s maybe a signal that certain anxiety disorders might be improved by a compound like that.
Certainly, rare forms of epilepsy have been found to be improved with that compound. It really depends on what you’re looking at within the cannabis plant, but if we’re thinking about THC, the answer really is no, this is not a helpful thing. In fact, it’s probably a harmful thing to be ingesting in terms of psychiatric disorders.
Dr. Strakowski: Thank you, Leslie. Chris, what would you add to that? Do we know anything about the use of cannabis in any psychiatric condition?
Dr. Hammond: I definitely would echo what Leslie said. The popular opinion, that the media and the state legislatures have really, in many ways, put the cart before the horse — they speak about cannabis as a medication for the treatment of psychiatric conditions before we have sufficient evidence to say that it’s safe or effective for these conditions. Most of the evidence that we have, particularly in regard to the cannabinoid compound, delta 9, tetrahyDr.ocannabinol, or THC, suggests that that cannabinoid is associated with adverse mental health outcomes across different categories.
Dr. Strakowski: Our group, a long time ago, conducted a study looking at first episode of mania, and found that regular cannabis use increases the risk for subsequent manic episodes. I’m not aware of many other studies like that.
You referred, Chris, to the safety aspect. This is something anybody can use. There are no negative consequences. Is that true? I mean, is it really risk free?
Dr. Hammond: Research shows that that’s an inaccurate framing of the safety profile of cannabis. Again, as Leslie put it very well, cannabis is many different compounds. Using this catchall phrase of «cannabis» is not very helpful.
In regard to the main bioactive compounds of the cannabis plant, THC and cannabidiol, or CBD, what we know from studies of THC administration and from medications that have been designed to mimic THC and act on receptors that THC acts on is that those medications have clear side effects and adverse events in a percentage of patients who take them, particularly in regard to precipitating panic attacks, dysphoric episodes, and psychosis in some individuals.
Dr. Hulvershorn: I would add that it really depends on the age of the person that you’re talking about and when they’re first exposed to cannabis. If you’re talking about a person, say, under the age of 14 who uses cannabis, there’s a large amount of concern about the worsening of psychosis and mental health symptoms, but also cognitive features like memory.
There’s a very good study that was conducted in New Zealand that followed a large number of kids over time and showed significant decreases in working memory capacity for kids who used quite heavily.
Then you think about pregnant women. That’s very interesting literature, where people are finding that cannabis not only affects brain development but also a host of other systems in the body. For example, I think the risk for asthma is increased. If you look at the genes in the placenta that are affected, it has much to do with the immune system.
Women who are using cannabis during pregnancy are really exposing their fetus to a range of potential risks that we certainly don’t understand well enough, but there’s enough science that suggests this is really concerning.
If you take a step back and look at animal models, even with things like CBD products, which, again, everybody seems to be buying and they’re viewed as very safe — it’s almost hard to find things without CBD these days.
There we find, for example, in developing rats that testicular development seems to be affected with high doses of CBD. There’s just a huge array of effects, even outside of the psychiatric world, that make me very nervous about anyone using, especially a pregnant woman or a young person.
Then there’s a whole separate literature on adults. It’s hard to find studies that suggest this is a great idea. You’re going to find on the mental health side of things, and the cognitive side of things, many effects as well.
I, personally, am agnostic one way or the other. If cannabis turns out to be helpful, great. We love things that are helpful in medicine. We don’t really care where they come from. I’m not biased politically one way or the other. It’s just when you look at the totality of the literature, it’s hard to feel excited about people using cannabis at any age.
Dr. Hammond: It’s difficult to interpret the literature because of some biases there. It speaks to the importance of thoughtful research being done in this space that takes a neutral approach to assessing cannabis and looking for evidence of both potential benefit and potential harm.
The other piece that I think is of value that builds off what Leslie mentioned is the effects of cannabis and THC. The risk for harm appears to be greater in pregnant women and in young people. For adults, I think, we’re also still trying to understand what the effects are.
The other way of parsing out effects and thinking about them is in terms of the acute effects and the acute response in the moment right after one ingests cannabis vs the long-term effects.
After acute ingestion of cannabis, it can precipitate a psychotic episode, dysphoria or severe depressive symptoms, or severe anxiety, and can cause one to be disoriented, have delayed response time, and affect the ability to Dr.ive. In that capacity, it is related to a higher risk for motor vehicle crashes.
Dr. Strakowski: That’s very interesting. In my practice, and maybe it’s atypical, but half to two thirds of my patients, particularly the younger ones, are using cannabis in some form or another. In my experience, if they’re under 21, they’re more likely to use cannabis than alcohol.
What do we tell our patients? Is there a safe level of use? Do we say to never touch it? How do we manage the social pressure and environment that our patients have to live in?
Dr. Hulvershorn: I think about what we call motivational interviewing and the substance use disorder field, which is a style of interacting with someone that’s very neutral to discuss the pros and the cons. In my practice, people are usually coming to us because of problems related to their substance use.
Not everyone is experiencing those, but for those people, it’s a pretty easy discussion. It sounds like you’re getting into trouble. Your athletic performance is suffering. Your scholastic performance is suffering.
You walk them toward understanding that, wait a minute, if I smoked less weed or no weed, I would probably be doing better in this or that domain of my life. That seems to be the most helpful thing, by allowing them to come to that conclusion.
I think it is a more difficult conversation for people who don’t identify any problems related to their use. What is the right answer? Again, I just go back to saying, “Is this good for you? It’s hard to find the literature that suggests that. Is it neutral for you? Maybe, for some people. Is it harmful for some people? Absolutely.”
I think, for me, the most impactful studies have been those that showed for certain people with certain genetic makeup, cannabis is an absolutely terrible idea. Their risk for psychosis development and things like that are so high. For other people, they could smoke weed all day and never have a problem, based on their genetics — maybe. We don’t know. It’s not like we’re doing blood tests to figure out who you are.
The safest advice, I think, is no use. That’s never going to be bad advice.
Dr. Hammond: I mostly agree with Leslie on this point but feel very, very strongly that — in this era, where in the context of popular media, celebrities and other people are stating that cannabis is good and should be put in everything — clinical providers, especially pediatric providers, need to be extremely grounded in the science, and not let popular media sway our approach and strategy for working with these young people.
There’s two decades worth of data from longitudinal studies that have followed individuals from birth or from preadolescence into their thirties and forties, that show us that, for this association between cannabis use and later adverse mental health outcomes, there is a dose effect there.
The earlier an individual starts using, the more frequent they use, and more persistent their use is over time, those individuals have poorer mental health outcomes compared with individuals who choose to abstain or individuals who use just a few times and stop.
There’s also a signal for higher-THC-potency products being associated with poorer mental health outcomes, particularly when used during adolescence.
I apply a motivational interviewing approach as well to disseminate this information to both the young people and their parents about the risks, and to communicate what the data clearly show in regard to using THC-based cannabinoid products, which is that we don’t have evidence that shows that any use is healthy to the developing brain.
There’s a large amount of evidence that suggests it’s harmful to the developing brain, so the recommendation is not to use, to delay the onset of use, if you want to use, until adulthood. Many youth choose to use. For those young people, we meet them where they’re at and try to work with them on cutting down.
Dr. Strakowski: Thank you both. There’s an interesting effort in different states, with lobbying by celebrities and legislators pushing insurance companies to fund cannabis use broadly, including in a number of psychiatric indications, with no FDA approval at this point. Do you support that? Is that a good idea?
Dr. Hammond: Absolutely not.
Dr. Strakowski: Thank you.
Dr. Hammond: I think that’s a very important statement to make. For the medical and healthcare profession to stand strong related to states requiring insurance companies to cover medical cannabis really opens the door to lawsuits that would force insurance companies to cover other undertested bioactive chemicals and health supplements.
There are insufficient safety data for medical cannabis for FDA approval for any condition right now. The FDA has approved cannabinoid-based medications. Those cannabinoid-based medications have really undergone rigorous safety and efficacy testing, and have been approved for very narrow indications, none of which are psychiatric conditions.
They’ve been approved for chemotherapy-associated nausea and vomiting, treatment-resistant seizures related to two rare seizure disorders that emerge during childhood, and related to tuberous sclerosis, and one related to treating multiple sclerosis–associated spasticity and central neuropathic pain.
Dr. Hulvershorn: Steve, I think it’s important for listeners to be aware that there is a process in place for any therapeutic to become tested and reviewed. We see an industry that stands to make an enormous amount of money, and that is really the motivation for this industry.
These are not folks who are, out of the kindness of their heart, just hoping for better treatments for people. There are many ways you could channel that desire that does not include cannabis making money.
It’s really a profit-motivated industry. They’re very effective at lobbying. The public, unfortunately, has been sort of manipulated by this industry to believe that these are healthy, safe, and natural just because they grow in the ground.
Unfortunately, that’s really the issue. I think people just need to keep that in mind. Someone stands to make a large amount of money off of this. This is a very calculated, strategic approach that goes state by state but is nationally organized, and is potentially, like Chris says, for many reasons, really harmful.
I see it as sort of a bullying approach. Like if your Dr.ug works, Medicaid will pay for it. Medicaid in each state will review the studies. The FDA obviously leads the way. To cut the line without the research is really not helpful — circumventing the process that’s been in place for a long time and works well.
Dr. Hammond: Yes, it sets a dangerous precedent.
Dr. Strakowski: I was going to add the same, that it’s potentially dangerous. Thank you both, Dr.s Hulvershorn and Hammond, for a really good, lively discussion. I know we could talk for a very long time about this situation.
I do think it’s clear for listeners, most of whom are practitioners, that at this point in time, there just really does not seem to be strong evidence for the use of cannabis-based products for any psychiatric condition.
I do think we have to approach the people we’re working with around their psychiatric conditions to manage use and abuse wisely, like we would with any other substance. I appreciate everyone who’s tuned in today to watch us. I hope this is useful for your practice. Thank you.
Stephen M. Strakowski, MD, has disclosed the following relevant financial relationships:
- Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Roche; Procter & Gamble; Novartis; Sunovion
- Received income in an amount equal to or greater than $250 from: Roche; Procter & Gamble; Novartis; Sunovion; Oxford University Press
Leslie A. Hulvershorn, MD, MSc, has disclosed the following relevant financial relationships:
- Received income in an amount equal to or greater than $250 from: Greenwich Biosciences, educational grant for Summit
Christopher J. Hammond, MD, PhD, has disclosed the following relevant financial relationships:
- Received research grant from National Institutes of Health Grants; Bench to Bench Award; Substance Abuse and Mental Health Services Administration; Doris Duke.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Stephen M. Strakowski, MD: Hello. Thank you all for joining us today. I’m very excited to have some great guests to talk about what I consider an active controversy. I’m Stephen M. Strakowski. I’m a professor and vice chair of psychiatry at Indiana University, and professor and associate vice president at University of Texas in Austin.
Today we’re going to talk about cannabis. As all of you are aware, everyone’s talking about cannabis. We hear constantly on social media and in interviews, particularly with relevance to psychiatric disorders, that everyone should be thinking about using cannabis. That seems to be the common conversation.
Last week, I had a patient who said, “All my friends tell me I need to be on cannabis.” That was their solution to her problems. With that in mind, let me introduce our guests, who are both experts on this, to talk about the role of cannabis in psychiatric disorders today.
First, I want to welcome Dr. Leslie Hulvershorn. Dr. Hulvershorn is an associate professor and chair at Indiana University in Indianapolis. Dr. Christopher Hammond is an assistant professor and the director of the co-occurring disorders program at Johns Hopkins. Welcome!
Leslie A. Hulvershorn, MD, MSc: Thank you.
Christopher J. Hammond, MD, PhD: Thank you.
Dr. Strakowski: Leslie, as I mentioned, many people are talking about how cannabis could be a good treatment for psychiatric disorders. Is that true?
Dr. Hulvershorn: If you look at what defines a good treatment, what you’re looking for is clinical trials, ideally randomized, placebo-controlled clinical trials.
When we look at research related to cannabis, we see very few of those trials, and we see that the cannabis plant is actually quite complicated and there are many different compounds that come from it. So we need to look at all the different compounds.
If you think about THC, delta 9 or delta 8, depending on the version, that’s the active ingredient that we most often think about when we say “cannabis.” If you look at THC studies, there really is no evidence that I could find that it helps psychiatric disorders.
What we do find is an enormous literature, many hunDr.eds of studies, actually, that show that THC actually worsens or even brings on psychiatric disorders. There’s a separate conversation about other compounds within the cannabis plant, like CBD, cannabidiol, where there’s maybe a signal that certain anxiety disorders might be improved by a compound like that.
Certainly, rare forms of epilepsy have been found to be improved with that compound. It really depends on what you’re looking at within the cannabis plant, but if we’re thinking about THC, the answer really is no, this is not a helpful thing. In fact, it’s probably a harmful thing to be ingesting in terms of psychiatric disorders.
Dr. Strakowski: Thank you, Leslie. Chris, what would you add to that? Do we know anything about the use of cannabis in any psychiatric condition?
Dr. Hammond: I definitely would echo what Leslie said. The popular opinion, that the media and the state legislatures have really, in many ways, put the cart before the horse — they speak about cannabis as a medication for the treatment of psychiatric conditions before we have sufficient evidence to say that it’s safe or effective for these conditions. Most of the evidence that we have, particularly in regard to the cannabinoid compound, delta 9, tetrahyDr.ocannabinol, or THC, suggests that that cannabinoid is associated with adverse mental health outcomes across different categories.
Dr. Strakowski: Our group, a long time ago, conducted a study looking at first episode of mania, and found that regular cannabis use increases the risk for subsequent manic episodes. I’m not aware of many other studies like that.
You referred, Chris, to the safety aspect. This is something anybody can use. There are no negative consequences. Is that true? I mean, is it really risk free?
Dr. Hammond: Research shows that that’s an inaccurate framing of the safety profile of cannabis. Again, as Leslie put it very well, cannabis is many different compounds. Using this catchall phrase of «cannabis» is not very helpful.
In regard to the main bioactive compounds of the cannabis plant, THC and cannabidiol, or CBD, what we know from studies of THC administration and from medications that have been designed to mimic THC and act on receptors that THC acts on is that those medications have clear side effects and adverse events in a percentage of patients who take them, particularly in regard to precipitating panic attacks, dysphoric episodes, and psychosis in some individuals.
Dr. Hulvershorn: I would add that it really depends on the age of the person that you’re talking about and when they’re first exposed to cannabis. If you’re talking about a person, say, under the age of 14 who uses cannabis, there’s a large amount of concern about the worsening of psychosis and mental health symptoms, but also cognitive features like memory.
There’s a very good study that was conducted in New Zealand that followed a large number of kids over time and showed significant decreases in working memory capacity for kids who used quite heavily.
Then you think about pregnant women. That’s very interesting literature, where people are finding that cannabis not only affects brain development but also a host of other systems in the body. For example, I think the risk for asthma is increased. If you look at the genes in the placenta that are affected, it has much to do with the immune system.
Women who are using cannabis during pregnancy are really exposing their fetus to a range of potential risks that we certainly don’t understand well enough, but there’s enough science that suggests this is really concerning.
If you take a step back and look at animal models, even with things like CBD products, which, again, everybody seems to be buying and they’re viewed as very safe — it’s almost hard to find things without CBD these days.
There we find, for example, in developing rats that testicular development seems to be affected with high doses of CBD. There’s just a huge array of effects, even outside of the psychiatric world, that make me very nervous about anyone using, especially a pregnant woman or a young person.
Then there’s a whole separate literature on adults. It’s hard to find studies that suggest this is a great idea. You’re going to find on the mental health side of things, and the cognitive side of things, many effects as well.
I, personally, am agnostic one way or the other. If cannabis turns out to be helpful, great. We love things that are helpful in medicine. We don’t really care where they come from. I’m not biased politically one way or the other. It’s just when you look at the totality of the literature, it’s hard to feel excited about people using cannabis at any age.
Dr. Hammond: It’s difficult to interpret the literature because of some biases there. It speaks to the importance of thoughtful research being done in this space that takes a neutral approach to assessing cannabis and looking for evidence of both potential benefit and potential harm.
The other piece that I think is of value that builds off what Leslie mentioned is the effects of cannabis and THC. The risk for harm appears to be greater in pregnant women and in young people. For adults, I think, we’re also still trying to understand what the effects are.
The other way of parsing out effects and thinking about them is in terms of the acute effects and the acute response in the moment right after one ingests cannabis vs the long-term effects.
After acute ingestion of cannabis, it can precipitate a psychotic episode, dysphoria or severe depressive symptoms, or severe anxiety, and can cause one to be disoriented, have delayed response time, and affect the ability to Dr.ive. In that capacity, it is related to a higher risk for motor vehicle crashes.
Dr. Strakowski: That’s very interesting. In my practice, and maybe it’s atypical, but half to two thirds of my patients, particularly the younger ones, are using cannabis in some form or another. In my experience, if they’re under 21, they’re more likely to use cannabis than alcohol.
What do we tell our patients? Is there a safe level of use? Do we say to never touch it? How do we manage the social pressure and environment that our patients have to live in?
Dr. Hulvershorn: I think about what we call motivational interviewing and the substance use disorder field, which is a style of interacting with someone that’s very neutral to discuss the pros and the cons. In my practice, people are usually coming to us because of problems related to their substance use.
Not everyone is experiencing those, but for those people, it’s a pretty easy discussion. It sounds like you’re getting into trouble. Your athletic performance is suffering. Your scholastic performance is suffering.
You walk them toward understanding that, wait a minute, if I smoked less weed or no weed, I would probably be doing better in this or that domain of my life. That seems to be the most helpful thing, by allowing them to come to that conclusion.
I think it is a more difficult conversation for people who don’t identify any problems related to their use. What is the right answer? Again, I just go back to saying, “Is this good for you? It’s hard to find the literature that suggests that. Is it neutral for you? Maybe, for some people. Is it harmful for some people? Absolutely.”
I think, for me, the most impactful studies have been those that showed for certain people with certain genetic makeup, cannabis is an absolutely terrible idea. Their risk for psychosis development and things like that are so high. For other people, they could smoke weed all day and never have a problem, based on their genetics — maybe. We don’t know. It’s not like we’re doing blood tests to figure out who you are.
The safest advice, I think, is no use. That’s never going to be bad advice.
Dr. Hammond: I mostly agree with Leslie on this point but feel very, very strongly that — in this era, where in the context of popular media, celebrities and other people are stating that cannabis is good and should be put in everything — clinical providers, especially pediatric providers, need to be extremely grounded in the science, and not let popular media sway our approach and strategy for working with these young people.
There’s two decades worth of data from longitudinal studies that have followed individuals from birth or from preadolescence into their thirties and forties, that show us that, for this association between cannabis use and later adverse mental health outcomes, there is a dose effect there.
The earlier an individual starts using, the more frequent they use, and more persistent their use is over time, those individuals have poorer mental health outcomes compared with individuals who choose to abstain or individuals who use just a few times and stop.
There’s also a signal for higher-THC-potency products being associated with poorer mental health outcomes, particularly when used during adolescence.
I apply a motivational interviewing approach as well to disseminate this information to both the young people and their parents about the risks, and to communicate what the data clearly show in regard to using THC-based cannabinoid products, which is that we don’t have evidence that shows that any use is healthy to the developing brain.
There’s a large amount of evidence that suggests it’s harmful to the developing brain, so the recommendation is not to use, to delay the onset of use, if you want to use, until adulthood. Many youth choose to use. For those young people, we meet them where they’re at and try to work with them on cutting down.
Dr. Strakowski: Thank you both. There’s an interesting effort in different states, with lobbying by celebrities and legislators pushing insurance companies to fund cannabis use broadly, including in a number of psychiatric indications, with no FDA approval at this point. Do you support that? Is that a good idea?
Dr. Hammond: Absolutely not.
Dr. Strakowski: Thank you.
Dr. Hammond: I think that’s a very important statement to make. For the medical and healthcare profession to stand strong related to states requiring insurance companies to cover medical cannabis really opens the door to lawsuits that would force insurance companies to cover other undertested bioactive chemicals and health supplements.
There are insufficient safety data for medical cannabis for FDA approval for any condition right now. The FDA has approved cannabinoid-based medications. Those cannabinoid-based medications have really undergone rigorous safety and efficacy testing, and have been approved for very narrow indications, none of which are psychiatric conditions.
They’ve been approved for chemotherapy-associated nausea and vomiting, treatment-resistant seizures related to two rare seizure disorders that emerge during childhood, and related to tuberous sclerosis, and one related to treating multiple sclerosis–associated spasticity and central neuropathic pain.
Dr. Hulvershorn: Steve, I think it’s important for listeners to be aware that there is a process in place for any therapeutic to become tested and reviewed. We see an industry that stands to make an enormous amount of money, and that is really the motivation for this industry.
These are not folks who are, out of the kindness of their heart, just hoping for better treatments for people. There are many ways you could channel that desire that does not include cannabis making money.
It’s really a profit-motivated industry. They’re very effective at lobbying. The public, unfortunately, has been sort of manipulated by this industry to believe that these are healthy, safe, and natural just because they grow in the ground.
Unfortunately, that’s really the issue. I think people just need to keep that in mind. Someone stands to make a large amount of money off of this. This is a very calculated, strategic approach that goes state by state but is nationally organized, and is potentially, like Chris says, for many reasons, really harmful.
I see it as sort of a bullying approach. Like if your Dr.ug works, Medicaid will pay for it. Medicaid in each state will review the studies. The FDA obviously leads the way. To cut the line without the research is really not helpful — circumventing the process that’s been in place for a long time and works well.
Dr. Hammond: Yes, it sets a dangerous precedent.
Dr. Strakowski: I was going to add the same, that it’s potentially dangerous. Thank you both, Dr.s Hulvershorn and Hammond, for a really good, lively discussion. I know we could talk for a very long time about this situation.
I do think it’s clear for listeners, most of whom are practitioners, that at this point in time, there just really does not seem to be strong evidence for the use of cannabis-based products for any psychiatric condition.
I do think we have to approach the people we’re working with around their psychiatric conditions to manage use and abuse wisely, like we would with any other substance. I appreciate everyone who’s tuned in today to watch us. I hope this is useful for your practice. Thank you.
Stephen M. Strakowski, MD, has disclosed the following relevant financial relationships:
- Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Roche; Procter & Gamble; Novartis; Sunovion
- Received income in an amount equal to or greater than $250 from: Roche; Procter & Gamble; Novartis; Sunovion; Oxford University Press
Leslie A. Hulvershorn, MD, MSc, has disclosed the following relevant financial relationships:
- Received income in an amount equal to or greater than $250 from: Greenwich Biosciences, educational grant for Summit
Christopher J. Hammond, MD, PhD, has disclosed the following relevant financial relationships:
- Received research grant from National Institutes of Health Grants; Bench to Bench Award; Substance Abuse and Mental Health Services Administration; Doris Duke.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Stephen M. Strakowski, MD: Hello. Thank you all for joining us today. I’m very excited to have some great guests to talk about what I consider an active controversy. I’m Stephen M. Strakowski. I’m a professor and vice chair of psychiatry at Indiana University, and professor and associate vice president at University of Texas in Austin.
Today we’re going to talk about cannabis. As all of you are aware, everyone’s talking about cannabis. We hear constantly on social media and in interviews, particularly with relevance to psychiatric disorders, that everyone should be thinking about using cannabis. That seems to be the common conversation.
Last week, I had a patient who said, “All my friends tell me I need to be on cannabis.” That was their solution to her problems. With that in mind, let me introduce our guests, who are both experts on this, to talk about the role of cannabis in psychiatric disorders today.
First, I want to welcome Dr. Leslie Hulvershorn. Dr. Hulvershorn is an associate professor and chair at Indiana University in Indianapolis. Dr. Christopher Hammond is an assistant professor and the director of the co-occurring disorders program at Johns Hopkins. Welcome!
Leslie A. Hulvershorn, MD, MSc: Thank you.
Christopher J. Hammond, MD, PhD: Thank you.
Dr. Strakowski: Leslie, as I mentioned, many people are talking about how cannabis could be a good treatment for psychiatric disorders. Is that true?
Dr. Hulvershorn: If you look at what defines a good treatment, what you’re looking for is clinical trials, ideally randomized, placebo-controlled clinical trials.
When we look at research related to cannabis, we see very few of those trials, and we see that the cannabis plant is actually quite complicated and there are many different compounds that come from it. So we need to look at all the different compounds.
If you think about THC, delta 9 or delta 8, depending on the version, that’s the active ingredient that we most often think about when we say “cannabis.” If you look at THC studies, there really is no evidence that I could find that it helps psychiatric disorders.
What we do find is an enormous literature, many hunDr.eds of studies, actually, that show that THC actually worsens or even brings on psychiatric disorders. There’s a separate conversation about other compounds within the cannabis plant, like CBD, cannabidiol, where there’s maybe a signal that certain anxiety disorders might be improved by a compound like that.
Certainly, rare forms of epilepsy have been found to be improved with that compound. It really depends on what you’re looking at within the cannabis plant, but if we’re thinking about THC, the answer really is no, this is not a helpful thing. In fact, it’s probably a harmful thing to be ingesting in terms of psychiatric disorders.
Dr. Strakowski: Thank you, Leslie. Chris, what would you add to that? Do we know anything about the use of cannabis in any psychiatric condition?
Dr. Hammond: I definitely would echo what Leslie said. The popular opinion, that the media and the state legislatures have really, in many ways, put the cart before the horse — they speak about cannabis as a medication for the treatment of psychiatric conditions before we have sufficient evidence to say that it’s safe or effective for these conditions. Most of the evidence that we have, particularly in regard to the cannabinoid compound, delta 9, tetrahyDr.ocannabinol, or THC, suggests that that cannabinoid is associated with adverse mental health outcomes across different categories.
Dr. Strakowski: Our group, a long time ago, conducted a study looking at first episode of mania, and found that regular cannabis use increases the risk for subsequent manic episodes. I’m not aware of many other studies like that.
You referred, Chris, to the safety aspect. This is something anybody can use. There are no negative consequences. Is that true? I mean, is it really risk free?
Dr. Hammond: Research shows that that’s an inaccurate framing of the safety profile of cannabis. Again, as Leslie put it very well, cannabis is many different compounds. Using this catchall phrase of «cannabis» is not very helpful.
In regard to the main bioactive compounds of the cannabis plant, THC and cannabidiol, or CBD, what we know from studies of THC administration and from medications that have been designed to mimic THC and act on receptors that THC acts on is that those medications have clear side effects and adverse events in a percentage of patients who take them, particularly in regard to precipitating panic attacks, dysphoric episodes, and psychosis in some individuals.
Dr. Hulvershorn: I would add that it really depends on the age of the person that you’re talking about and when they’re first exposed to cannabis. If you’re talking about a person, say, under the age of 14 who uses cannabis, there’s a large amount of concern about the worsening of psychosis and mental health symptoms, but also cognitive features like memory.
There’s a very good study that was conducted in New Zealand that followed a large number of kids over time and showed significant decreases in working memory capacity for kids who used quite heavily.
Then you think about pregnant women. That’s very interesting literature, where people are finding that cannabis not only affects brain development but also a host of other systems in the body. For example, I think the risk for asthma is increased. If you look at the genes in the placenta that are affected, it has much to do with the immune system.
Women who are using cannabis during pregnancy are really exposing their fetus to a range of potential risks that we certainly don’t understand well enough, but there’s enough science that suggests this is really concerning.
If you take a step back and look at animal models, even with things like CBD products, which, again, everybody seems to be buying and they’re viewed as very safe — it’s almost hard to find things without CBD these days.
There we find, for example, in developing rats that testicular development seems to be affected with high doses of CBD. There’s just a huge array of effects, even outside of the psychiatric world, that make me very nervous about anyone using, especially a pregnant woman or a young person.
Then there’s a whole separate literature on adults. It’s hard to find studies that suggest this is a great idea. You’re going to find on the mental health side of things, and the cognitive side of things, many effects as well.
I, personally, am agnostic one way or the other. If cannabis turns out to be helpful, great. We love things that are helpful in medicine. We don’t really care where they come from. I’m not biased politically one way or the other. It’s just when you look at the totality of the literature, it’s hard to feel excited about people using cannabis at any age.
Dr. Hammond: It’s difficult to interpret the literature because of some biases there. It speaks to the importance of thoughtful research being done in this space that takes a neutral approach to assessing cannabis and looking for evidence of both potential benefit and potential harm.
The other piece that I think is of value that builds off what Leslie mentioned is the effects of cannabis and THC. The risk for harm appears to be greater in pregnant women and in young people. For adults, I think, we’re also still trying to understand what the effects are.
The other way of parsing out effects and thinking about them is in terms of the acute effects and the acute response in the moment right after one ingests cannabis vs the long-term effects.
After acute ingestion of cannabis, it can precipitate a psychotic episode, dysphoria or severe depressive symptoms, or severe anxiety, and can cause one to be disoriented, have delayed response time, and affect the ability to Dr.ive. In that capacity, it is related to a higher risk for motor vehicle crashes.
Dr. Strakowski: That’s very interesting. In my practice, and maybe it’s atypical, but half to two thirds of my patients, particularly the younger ones, are using cannabis in some form or another. In my experience, if they’re under 21, they’re more likely to use cannabis than alcohol.
What do we tell our patients? Is there a safe level of use? Do we say to never touch it? How do we manage the social pressure and environment that our patients have to live in?
Dr. Hulvershorn: I think about what we call motivational interviewing and the substance use disorder field, which is a style of interacting with someone that’s very neutral to discuss the pros and the cons. In my practice, people are usually coming to us because of problems related to their substance use.
Not everyone is experiencing those, but for those people, it’s a pretty easy discussion. It sounds like you’re getting into trouble. Your athletic performance is suffering. Your scholastic performance is suffering.
You walk them toward understanding that, wait a minute, if I smoked less weed or no weed, I would probably be doing better in this or that domain of my life. That seems to be the most helpful thing, by allowing them to come to that conclusion.
I think it is a more difficult conversation for people who don’t identify any problems related to their use. What is the right answer? Again, I just go back to saying, “Is this good for you? It’s hard to find the literature that suggests that. Is it neutral for you? Maybe, for some people. Is it harmful for some people? Absolutely.”
I think, for me, the most impactful studies have been those that showed for certain people with certain genetic makeup, cannabis is an absolutely terrible idea. Their risk for psychosis development and things like that are so high. For other people, they could smoke weed all day and never have a problem, based on their genetics — maybe. We don’t know. It’s not like we’re doing blood tests to figure out who you are.
The safest advice, I think, is no use. That’s never going to be bad advice.
Dr. Hammond: I mostly agree with Leslie on this point but feel very, very strongly that — in this era, where in the context of popular media, celebrities and other people are stating that cannabis is good and should be put in everything — clinical providers, especially pediatric providers, need to be extremely grounded in the science, and not let popular media sway our approach and strategy for working with these young people.
There’s two decades worth of data from longitudinal studies that have followed individuals from birth or from preadolescence into their thirties and forties, that show us that, for this association between cannabis use and later adverse mental health outcomes, there is a dose effect there.
The earlier an individual starts using, the more frequent they use, and more persistent their use is over time, those individuals have poorer mental health outcomes compared with individuals who choose to abstain or individuals who use just a few times and stop.
There’s also a signal for higher-THC-potency products being associated with poorer mental health outcomes, particularly when used during adolescence.
I apply a motivational interviewing approach as well to disseminate this information to both the young people and their parents about the risks, and to communicate what the data clearly show in regard to using THC-based cannabinoid products, which is that we don’t have evidence that shows that any use is healthy to the developing brain.
There’s a large amount of evidence that suggests it’s harmful to the developing brain, so the recommendation is not to use, to delay the onset of use, if you want to use, until adulthood. Many youth choose to use. For those young people, we meet them where they’re at and try to work with them on cutting down.
Dr. Strakowski: Thank you both. There’s an interesting effort in different states, with lobbying by celebrities and legislators pushing insurance companies to fund cannabis use broadly, including in a number of psychiatric indications, with no FDA approval at this point. Do you support that? Is that a good idea?
Dr. Hammond: Absolutely not.
Dr. Strakowski: Thank you.
Dr. Hammond: I think that’s a very important statement to make. For the medical and healthcare profession to stand strong related to states requiring insurance companies to cover medical cannabis really opens the door to lawsuits that would force insurance companies to cover other undertested bioactive chemicals and health supplements.
There are insufficient safety data for medical cannabis for FDA approval for any condition right now. The FDA has approved cannabinoid-based medications. Those cannabinoid-based medications have really undergone rigorous safety and efficacy testing, and have been approved for very narrow indications, none of which are psychiatric conditions.
They’ve been approved for chemotherapy-associated nausea and vomiting, treatment-resistant seizures related to two rare seizure disorders that emerge during childhood, and related to tuberous sclerosis, and one related to treating multiple sclerosis–associated spasticity and central neuropathic pain.
Dr. Hulvershorn: Steve, I think it’s important for listeners to be aware that there is a process in place for any therapeutic to become tested and reviewed. We see an industry that stands to make an enormous amount of money, and that is really the motivation for this industry.
These are not folks who are, out of the kindness of their heart, just hoping for better treatments for people. There are many ways you could channel that desire that does not include cannabis making money.
It’s really a profit-motivated industry. They’re very effective at lobbying. The public, unfortunately, has been sort of manipulated by this industry to believe that these are healthy, safe, and natural just because they grow in the ground.
Unfortunately, that’s really the issue. I think people just need to keep that in mind. Someone stands to make a large amount of money off of this. This is a very calculated, strategic approach that goes state by state but is nationally organized, and is potentially, like Chris says, for many reasons, really harmful.
I see it as sort of a bullying approach. Like if your Dr.ug works, Medicaid will pay for it. Medicaid in each state will review the studies. The FDA obviously leads the way. To cut the line without the research is really not helpful — circumventing the process that’s been in place for a long time and works well.
Dr. Hammond: Yes, it sets a dangerous precedent.
Dr. Strakowski: I was going to add the same, that it’s potentially dangerous. Thank you both, Dr.s Hulvershorn and Hammond, for a really good, lively discussion. I know we could talk for a very long time about this situation.
I do think it’s clear for listeners, most of whom are practitioners, that at this point in time, there just really does not seem to be strong evidence for the use of cannabis-based products for any psychiatric condition.
I do think we have to approach the people we’re working with around their psychiatric conditions to manage use and abuse wisely, like we would with any other substance. I appreciate everyone who’s tuned in today to watch us. I hope this is useful for your practice. Thank you.
Stephen M. Strakowski, MD, has disclosed the following relevant financial relationships:
- Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Roche; Procter & Gamble; Novartis; Sunovion
- Received income in an amount equal to or greater than $250 from: Roche; Procter & Gamble; Novartis; Sunovion; Oxford University Press
Leslie A. Hulvershorn, MD, MSc, has disclosed the following relevant financial relationships:
- Received income in an amount equal to or greater than $250 from: Greenwich Biosciences, educational grant for Summit
Christopher J. Hammond, MD, PhD, has disclosed the following relevant financial relationships:
- Received research grant from National Institutes of Health Grants; Bench to Bench Award; Substance Abuse and Mental Health Services Administration; Doris Duke.
A version of this article appeared on Medscape.com.
Yes, Patients Are Getting More Complicated
This transcript has been edited for clarity.
The first time I saw a patient in the hospital was in 2004, twenty years ago, when I was a third-year med student. I mean, look at that guy. The things I could tell him.
Since that time, I have spent countless hours in the hospital as a resident, a renal fellow, and finally as an attending. And I’m sure many of you in the medical community feel the same thing I do, which is that patients are much more complicated now than they used to be. I’ll listen to an intern present a new case on rounds and she’ll have an assessment and plan that encompasses a dozen individual medical problems. Sometimes I have to literally be like, “Wait, why is this patient here again?”
But until now, I had no data to convince myself that this feeling was real — that hospitalized patients are getting more and more complicated, or that they only seem more complicated because I’m getting older. Maybe I was better able to keep track of things when I was an intern rather than now as an attending, spending just a couple months of the year in the hospital. I mean, after all, if patients were getting more complicated, surely hospitals would know this and allocate more resources to patient care, right?
Right?
It’s not an illusion. At least not according to this paper, Population-Based Trends in Complexity of Hospital Inpatients, appearing in JAMA Internal Medicine, which examines about 15 years of inpatient hospital admissions in British Columbia.
I like Canada for this study for two reasons: First, their electronic health record system is province-wide, so they don’t have issues of getting data from hospital A vs hospital B. All the data are there — in this case, more than 3 million nonelective hospital admissions from British Columbia. Second, there is universal healthcare. We don’t have to worry about insurance companies changing, or the start of a new program like the Affordable Care Act. It’s just a cleaner set-up.
Of course, complexity is hard to define, and the authors here decide to look at a variety of metrics I think we can agree are tied into complexity. These include things like patient age, comorbidities, medications, frequency of hospitalization, and so on. They also looked at outcomes associated with hospitalization: Did the patient require the ICU? Did they survive? Were they readmitted?
And the tale of the tape is as clear as that British Columbian air: Over the past 15 years, your average hospitalized patient is about 3 years older, is twice as likely to have kidney disease, 70% more likely to have diabetes, is on more medications (particularly anticoagulants), and is much more likely to be admitted through the emergency room. They’ve also spent more time in the hospital in the past year.
Given the increased complexity, you might expect that the outcomes for these patients are worse than years ago, but the data do not bear that out. In fact, inpatient mortality is lower now than it was 15 years ago, although 30-day postdischarge mortality is higher. Put those together and it turns out that death rates are pretty stable: 9% of people admitted for nonelective reasons to the hospital will die within 30 days. It’s just that nowadays, we tend to discharge them before that happens.
Why are our patients getting more complex? Some of it is demographics; the population is aging, after all. Some of it relates to the increasing burden of comorbidities like diabetes and kidney disease, which are associated with the obesity epidemic. But in some ways, we’re a victim of our own success.
Given all that, does it make any sense that many of our hospitals are at skeleton-crew staffing levels? That hospitalists report taking care of more patients than they ever have before?
There’s been so much talk about burnout in the health professions lately. Maybe something people need to start acknowledging — particularly those who haven’t practiced on the front lines for a decade or two — is that the job is, quite simply, harder now. As patients become more complex, we need more resources, human and otherwise, to care for them.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and public health and director of Yale’s Clinical and Translational Research Accelerator. His science communication work can be found in the Huffington Post, on NPR, and here on Medscape. He tweets @fperrywilson and his book, How Medicine Works and When It Doesn’t, is available now. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
The first time I saw a patient in the hospital was in 2004, twenty years ago, when I was a third-year med student. I mean, look at that guy. The things I could tell him.
Since that time, I have spent countless hours in the hospital as a resident, a renal fellow, and finally as an attending. And I’m sure many of you in the medical community feel the same thing I do, which is that patients are much more complicated now than they used to be. I’ll listen to an intern present a new case on rounds and she’ll have an assessment and plan that encompasses a dozen individual medical problems. Sometimes I have to literally be like, “Wait, why is this patient here again?”
But until now, I had no data to convince myself that this feeling was real — that hospitalized patients are getting more and more complicated, or that they only seem more complicated because I’m getting older. Maybe I was better able to keep track of things when I was an intern rather than now as an attending, spending just a couple months of the year in the hospital. I mean, after all, if patients were getting more complicated, surely hospitals would know this and allocate more resources to patient care, right?
Right?
It’s not an illusion. At least not according to this paper, Population-Based Trends in Complexity of Hospital Inpatients, appearing in JAMA Internal Medicine, which examines about 15 years of inpatient hospital admissions in British Columbia.
I like Canada for this study for two reasons: First, their electronic health record system is province-wide, so they don’t have issues of getting data from hospital A vs hospital B. All the data are there — in this case, more than 3 million nonelective hospital admissions from British Columbia. Second, there is universal healthcare. We don’t have to worry about insurance companies changing, or the start of a new program like the Affordable Care Act. It’s just a cleaner set-up.
Of course, complexity is hard to define, and the authors here decide to look at a variety of metrics I think we can agree are tied into complexity. These include things like patient age, comorbidities, medications, frequency of hospitalization, and so on. They also looked at outcomes associated with hospitalization: Did the patient require the ICU? Did they survive? Were they readmitted?
And the tale of the tape is as clear as that British Columbian air: Over the past 15 years, your average hospitalized patient is about 3 years older, is twice as likely to have kidney disease, 70% more likely to have diabetes, is on more medications (particularly anticoagulants), and is much more likely to be admitted through the emergency room. They’ve also spent more time in the hospital in the past year.
Given the increased complexity, you might expect that the outcomes for these patients are worse than years ago, but the data do not bear that out. In fact, inpatient mortality is lower now than it was 15 years ago, although 30-day postdischarge mortality is higher. Put those together and it turns out that death rates are pretty stable: 9% of people admitted for nonelective reasons to the hospital will die within 30 days. It’s just that nowadays, we tend to discharge them before that happens.
Why are our patients getting more complex? Some of it is demographics; the population is aging, after all. Some of it relates to the increasing burden of comorbidities like diabetes and kidney disease, which are associated with the obesity epidemic. But in some ways, we’re a victim of our own success.
Given all that, does it make any sense that many of our hospitals are at skeleton-crew staffing levels? That hospitalists report taking care of more patients than they ever have before?
There’s been so much talk about burnout in the health professions lately. Maybe something people need to start acknowledging — particularly those who haven’t practiced on the front lines for a decade or two — is that the job is, quite simply, harder now. As patients become more complex, we need more resources, human and otherwise, to care for them.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and public health and director of Yale’s Clinical and Translational Research Accelerator. His science communication work can be found in the Huffington Post, on NPR, and here on Medscape. He tweets @fperrywilson and his book, How Medicine Works and When It Doesn’t, is available now. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
The first time I saw a patient in the hospital was in 2004, twenty years ago, when I was a third-year med student. I mean, look at that guy. The things I could tell him.
Since that time, I have spent countless hours in the hospital as a resident, a renal fellow, and finally as an attending. And I’m sure many of you in the medical community feel the same thing I do, which is that patients are much more complicated now than they used to be. I’ll listen to an intern present a new case on rounds and she’ll have an assessment and plan that encompasses a dozen individual medical problems. Sometimes I have to literally be like, “Wait, why is this patient here again?”
But until now, I had no data to convince myself that this feeling was real — that hospitalized patients are getting more and more complicated, or that they only seem more complicated because I’m getting older. Maybe I was better able to keep track of things when I was an intern rather than now as an attending, spending just a couple months of the year in the hospital. I mean, after all, if patients were getting more complicated, surely hospitals would know this and allocate more resources to patient care, right?
Right?
It’s not an illusion. At least not according to this paper, Population-Based Trends in Complexity of Hospital Inpatients, appearing in JAMA Internal Medicine, which examines about 15 years of inpatient hospital admissions in British Columbia.
I like Canada for this study for two reasons: First, their electronic health record system is province-wide, so they don’t have issues of getting data from hospital A vs hospital B. All the data are there — in this case, more than 3 million nonelective hospital admissions from British Columbia. Second, there is universal healthcare. We don’t have to worry about insurance companies changing, or the start of a new program like the Affordable Care Act. It’s just a cleaner set-up.
Of course, complexity is hard to define, and the authors here decide to look at a variety of metrics I think we can agree are tied into complexity. These include things like patient age, comorbidities, medications, frequency of hospitalization, and so on. They also looked at outcomes associated with hospitalization: Did the patient require the ICU? Did they survive? Were they readmitted?
And the tale of the tape is as clear as that British Columbian air: Over the past 15 years, your average hospitalized patient is about 3 years older, is twice as likely to have kidney disease, 70% more likely to have diabetes, is on more medications (particularly anticoagulants), and is much more likely to be admitted through the emergency room. They’ve also spent more time in the hospital in the past year.
Given the increased complexity, you might expect that the outcomes for these patients are worse than years ago, but the data do not bear that out. In fact, inpatient mortality is lower now than it was 15 years ago, although 30-day postdischarge mortality is higher. Put those together and it turns out that death rates are pretty stable: 9% of people admitted for nonelective reasons to the hospital will die within 30 days. It’s just that nowadays, we tend to discharge them before that happens.
Why are our patients getting more complex? Some of it is demographics; the population is aging, after all. Some of it relates to the increasing burden of comorbidities like diabetes and kidney disease, which are associated with the obesity epidemic. But in some ways, we’re a victim of our own success.
Given all that, does it make any sense that many of our hospitals are at skeleton-crew staffing levels? That hospitalists report taking care of more patients than they ever have before?
There’s been so much talk about burnout in the health professions lately. Maybe something people need to start acknowledging — particularly those who haven’t practiced on the front lines for a decade or two — is that the job is, quite simply, harder now. As patients become more complex, we need more resources, human and otherwise, to care for them.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and public health and director of Yale’s Clinical and Translational Research Accelerator. His science communication work can be found in the Huffington Post, on NPR, and here on Medscape. He tweets @fperrywilson and his book, How Medicine Works and When It Doesn’t, is available now. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Noninvasive Brain Stimulation a Breakthrough for Hypnotherapy?
Less than 2 minutes of transcranial magnetic stimulation (TMS) targeting specific areas of the brain can boost an individual’s ability to be hypnotized, in new findings that could increase the efficacy of therapeutic hypnosis and expand the pool of patients who can benefit from it.
“We were able to increase hypnotizability, a neuropsychological trait previously shown to be as stable as IQ in adulthood,” said co-senior author David Spiegel, MD, professor of psychiatry and behavioral sciences, Stanford University, Palo Alto, California.
“Our findings would allow us to combine neurostimulation with hypnosis to expand the number of people able to benefit from hypnosis and enhance their responsiveness to treatment,” Dr. Spiegel added.
The study was published online on January 4, 2024, in Nature Mental Health.
A Breakthrough for Hypnotherapy?
About two thirds of the general adult population are estimated to be at least somewhat hypnotizable, and 15% are highly hypnotizable.
Through brain imaging, the Stanford team found that high hypnotizability is associated with greater functional connectivity between the left dorsolateral prefrontal cortex (DLPFC) and the dorsal anterior cingulate cortex.
In the double-blind study, they randomly assigned 80 patients (mean age, 48 years; 94% women) with fibromyalgia syndrome to active, or sham, continuous theta-burst stimulation over a personalized neuroimaging-derived left DLPFC target — a technique known as Stanford Hypnosis Integrated with Functional Connectivity-targeted Transcranial Stimulation (SHIFT). Individuals who were naturally highly hypnotizable were excluded.
“A novel aspect of this trial is that we used the person’s own brain networks, based on brain imaging, to target the right spot,” Co-senior author Nolan Williams, MD, with Stanford University, California, said in a news release.
The team chose patients with chronic pain because hypnosis has been shown to be a “highly effective analgesic that has a far better risk/benefit ratio than widely overutilized opioids that have serious fatal overdose potential,” Spiegel told this news organization.
The pre-to-post SHIFT change in hypnotic induction profile scores, a standardized measure of hypnotizability, was significantly greater in the active vs sham group after just 92 seconds of stimulation (P = .046).
Only the active SHIFT group showed a significant increase in hypnotizability following stimulation, an effect that lasted for about 1 hour.
“Increasing hypnotizability in people who are low-to-medium hypnotizable individuals could improve both the efficacy and effectiveness of therapeutic hypnosis as a clinical intervention,” the researchers wrote.
They note that because this was a “mechanistic study,” it did not explore the impact of increased hypnotizability on disease symptoms. They also note that further studies are needed to assess the dose-response relationships of SHIFT.
Transformative Research
“This line of research is fascinating,” Shaheen Lakhan, MD, PhD, neurologist, and researcher in Boston, told this news organization.
“We are nearing an era of personalized, noninvasive brain modulation. The ability to individually modulate the DLPFC opens new possibilities for brain health beyond hypnotizability for fibromyalgia,” said Dr. Lakhan, who wasn’t involved in the study.
“The DLPFC is involved in executive functions (and disorders) like attention (ADHD), emotional regulation (depression), motivation (schizophrenia), and impulse control (addiction),” he noted.
“Soon we may no longer need large expensive devices like transcranial magnetic stimulators as in this research study. Smartphones could deliver tailored digital therapeutics by engaging specific brain circuits,” Dr. Lakhan predicted.
“Imagine using an app to receive treatment customized to your unique brain and needs — all without anything implanted and delivered anywhere. The potential to precisely modulate the brain’s wiring to enhance cognition and mental health, without surgery or physical constraints, is incredibly promising. The possibilities are intriguing and could truly transform how we address brain diseases,” he added.
The study was supported by a grant from the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH). Dr. Williams is a named inventor on Stanford-owned intellectual property relating to accelerated TMS pulse pattern sequences and neuroimaging-based TMS targeting; has served on scientific advisory boards for Otsuka, NeuraWell, Magnus Medical, and Nooma as a paid advisor; and holds equity/stock options in Magnus Medical, NeuraWell, and Nooma. Dr. Spiegel is a cofounder of Reveri Health, Inc., an interactive hypnosis app (not utilized in the current study).
A version of this article appeared on Medscape.com.
Less than 2 minutes of transcranial magnetic stimulation (TMS) targeting specific areas of the brain can boost an individual’s ability to be hypnotized, in new findings that could increase the efficacy of therapeutic hypnosis and expand the pool of patients who can benefit from it.
“We were able to increase hypnotizability, a neuropsychological trait previously shown to be as stable as IQ in adulthood,” said co-senior author David Spiegel, MD, professor of psychiatry and behavioral sciences, Stanford University, Palo Alto, California.
“Our findings would allow us to combine neurostimulation with hypnosis to expand the number of people able to benefit from hypnosis and enhance their responsiveness to treatment,” Dr. Spiegel added.
The study was published online on January 4, 2024, in Nature Mental Health.
A Breakthrough for Hypnotherapy?
About two thirds of the general adult population are estimated to be at least somewhat hypnotizable, and 15% are highly hypnotizable.
Through brain imaging, the Stanford team found that high hypnotizability is associated with greater functional connectivity between the left dorsolateral prefrontal cortex (DLPFC) and the dorsal anterior cingulate cortex.
In the double-blind study, they randomly assigned 80 patients (mean age, 48 years; 94% women) with fibromyalgia syndrome to active, or sham, continuous theta-burst stimulation over a personalized neuroimaging-derived left DLPFC target — a technique known as Stanford Hypnosis Integrated with Functional Connectivity-targeted Transcranial Stimulation (SHIFT). Individuals who were naturally highly hypnotizable were excluded.
“A novel aspect of this trial is that we used the person’s own brain networks, based on brain imaging, to target the right spot,” Co-senior author Nolan Williams, MD, with Stanford University, California, said in a news release.
The team chose patients with chronic pain because hypnosis has been shown to be a “highly effective analgesic that has a far better risk/benefit ratio than widely overutilized opioids that have serious fatal overdose potential,” Spiegel told this news organization.
The pre-to-post SHIFT change in hypnotic induction profile scores, a standardized measure of hypnotizability, was significantly greater in the active vs sham group after just 92 seconds of stimulation (P = .046).
Only the active SHIFT group showed a significant increase in hypnotizability following stimulation, an effect that lasted for about 1 hour.
“Increasing hypnotizability in people who are low-to-medium hypnotizable individuals could improve both the efficacy and effectiveness of therapeutic hypnosis as a clinical intervention,” the researchers wrote.
They note that because this was a “mechanistic study,” it did not explore the impact of increased hypnotizability on disease symptoms. They also note that further studies are needed to assess the dose-response relationships of SHIFT.
Transformative Research
“This line of research is fascinating,” Shaheen Lakhan, MD, PhD, neurologist, and researcher in Boston, told this news organization.
“We are nearing an era of personalized, noninvasive brain modulation. The ability to individually modulate the DLPFC opens new possibilities for brain health beyond hypnotizability for fibromyalgia,” said Dr. Lakhan, who wasn’t involved in the study.
“The DLPFC is involved in executive functions (and disorders) like attention (ADHD), emotional regulation (depression), motivation (schizophrenia), and impulse control (addiction),” he noted.
“Soon we may no longer need large expensive devices like transcranial magnetic stimulators as in this research study. Smartphones could deliver tailored digital therapeutics by engaging specific brain circuits,” Dr. Lakhan predicted.
“Imagine using an app to receive treatment customized to your unique brain and needs — all without anything implanted and delivered anywhere. The potential to precisely modulate the brain’s wiring to enhance cognition and mental health, without surgery or physical constraints, is incredibly promising. The possibilities are intriguing and could truly transform how we address brain diseases,” he added.
The study was supported by a grant from the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH). Dr. Williams is a named inventor on Stanford-owned intellectual property relating to accelerated TMS pulse pattern sequences and neuroimaging-based TMS targeting; has served on scientific advisory boards for Otsuka, NeuraWell, Magnus Medical, and Nooma as a paid advisor; and holds equity/stock options in Magnus Medical, NeuraWell, and Nooma. Dr. Spiegel is a cofounder of Reveri Health, Inc., an interactive hypnosis app (not utilized in the current study).
A version of this article appeared on Medscape.com.
Less than 2 minutes of transcranial magnetic stimulation (TMS) targeting specific areas of the brain can boost an individual’s ability to be hypnotized, in new findings that could increase the efficacy of therapeutic hypnosis and expand the pool of patients who can benefit from it.
“We were able to increase hypnotizability, a neuropsychological trait previously shown to be as stable as IQ in adulthood,” said co-senior author David Spiegel, MD, professor of psychiatry and behavioral sciences, Stanford University, Palo Alto, California.
“Our findings would allow us to combine neurostimulation with hypnosis to expand the number of people able to benefit from hypnosis and enhance their responsiveness to treatment,” Dr. Spiegel added.
The study was published online on January 4, 2024, in Nature Mental Health.
A Breakthrough for Hypnotherapy?
About two thirds of the general adult population are estimated to be at least somewhat hypnotizable, and 15% are highly hypnotizable.
Through brain imaging, the Stanford team found that high hypnotizability is associated with greater functional connectivity between the left dorsolateral prefrontal cortex (DLPFC) and the dorsal anterior cingulate cortex.
In the double-blind study, they randomly assigned 80 patients (mean age, 48 years; 94% women) with fibromyalgia syndrome to active, or sham, continuous theta-burst stimulation over a personalized neuroimaging-derived left DLPFC target — a technique known as Stanford Hypnosis Integrated with Functional Connectivity-targeted Transcranial Stimulation (SHIFT). Individuals who were naturally highly hypnotizable were excluded.
“A novel aspect of this trial is that we used the person’s own brain networks, based on brain imaging, to target the right spot,” Co-senior author Nolan Williams, MD, with Stanford University, California, said in a news release.
The team chose patients with chronic pain because hypnosis has been shown to be a “highly effective analgesic that has a far better risk/benefit ratio than widely overutilized opioids that have serious fatal overdose potential,” Spiegel told this news organization.
The pre-to-post SHIFT change in hypnotic induction profile scores, a standardized measure of hypnotizability, was significantly greater in the active vs sham group after just 92 seconds of stimulation (P = .046).
Only the active SHIFT group showed a significant increase in hypnotizability following stimulation, an effect that lasted for about 1 hour.
“Increasing hypnotizability in people who are low-to-medium hypnotizable individuals could improve both the efficacy and effectiveness of therapeutic hypnosis as a clinical intervention,” the researchers wrote.
They note that because this was a “mechanistic study,” it did not explore the impact of increased hypnotizability on disease symptoms. They also note that further studies are needed to assess the dose-response relationships of SHIFT.
Transformative Research
“This line of research is fascinating,” Shaheen Lakhan, MD, PhD, neurologist, and researcher in Boston, told this news organization.
“We are nearing an era of personalized, noninvasive brain modulation. The ability to individually modulate the DLPFC opens new possibilities for brain health beyond hypnotizability for fibromyalgia,” said Dr. Lakhan, who wasn’t involved in the study.
“The DLPFC is involved in executive functions (and disorders) like attention (ADHD), emotional regulation (depression), motivation (schizophrenia), and impulse control (addiction),” he noted.
“Soon we may no longer need large expensive devices like transcranial magnetic stimulators as in this research study. Smartphones could deliver tailored digital therapeutics by engaging specific brain circuits,” Dr. Lakhan predicted.
“Imagine using an app to receive treatment customized to your unique brain and needs — all without anything implanted and delivered anywhere. The potential to precisely modulate the brain’s wiring to enhance cognition and mental health, without surgery or physical constraints, is incredibly promising. The possibilities are intriguing and could truly transform how we address brain diseases,” he added.
The study was supported by a grant from the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH). Dr. Williams is a named inventor on Stanford-owned intellectual property relating to accelerated TMS pulse pattern sequences and neuroimaging-based TMS targeting; has served on scientific advisory boards for Otsuka, NeuraWell, Magnus Medical, and Nooma as a paid advisor; and holds equity/stock options in Magnus Medical, NeuraWell, and Nooma. Dr. Spiegel is a cofounder of Reveri Health, Inc., an interactive hypnosis app (not utilized in the current study).
A version of this article appeared on Medscape.com.
FDA Investigates Three Side Effects Reported With Weight Loss Drugs
or two other health problems.
A new FDA report listed potential links between the medications and alopecia, aspiration, or suicidal ideation, CBS News reported. The investigation centers on reports of the health problems among people taking GLP-1 receptor agonists, some of which are Ozempic, Wegovy, Mounjaro, and Zepbound. The drugs are used to treat diabetes and overweight or obesity.
An investigation by the FDA doesn’t mean that the FDA has concluded a risk exists, the FDA’s webpage for risk evaluation cautions.
“It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk,” the FDA site states.
Possible next steps after an investigation could include updating drug labels with new information, putting a risk management plan in place to prevent or manage the health risks, or gathering more information.
“The FDA monitors the safety of drugs throughout their life cycle,” even after the drugs are approved. In addition, the FDA uses “surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process,” FDA spokesperson Chanapa Tantibanchachai said in an email published by multiple news outlets.
Although an investigation may lead to no changes in how a drug is regulated by the FDA, this isn’t the first time that the popular medicines have landed on the FDA’s radar for safety reevaluation. Last year, the label for the drug Ozempic was updated to acknowledge reports of intestinal obstructions, CBS News reported.
European regulators are also looking into reports of suicidal thoughts among people taking GLP-1 receptor agonists, although no link has been established.
Concerns about aspiration during surgery resulted in the American Society of Anesthesiologists advising in June that people should stop taking GLP-1 receptor agonists before they have elective surgeries.
“While there is currently a lack of scientific data on how GLP-1 receptor agonists affect patients having surgery and interact with anesthesia, we’ve received anecdotal reports that the delay in stomach emptying could be associated with an increased risk of regurgitation and aspiration of food into the airways and lungs during general anesthesia and deep sedation,” the society’s president, Michael W. Champeau, MD, said in a statement at the time.
According to CBS News, the FDA’s drug reporting system links the medications to 201 reports of suicide or suicidal ideation, 18 reports that mention aspiration, and 422 reports that mention alopecia.
Novo Nordisk, whose portfolio includes Wegovy and Ozempic, told CNN that it works with the FDA to monitor safety and is aware of the reports of side effects.
“Novo Nordisk stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional,” the company said in a statement to CNN.
A spokesperson for Eli Lilly, which makes Mounjaro and Zepbound, told CBS News in a statement, “Currently, the FDA is reviewing data on certain potential risks for GLP-1 receptor agonist medicines. Patient safety is our priority, and we are collaborating with the FDA on these potential signals.”
A version of this article appeared on WebMD.com .
or two other health problems.
A new FDA report listed potential links between the medications and alopecia, aspiration, or suicidal ideation, CBS News reported. The investigation centers on reports of the health problems among people taking GLP-1 receptor agonists, some of which are Ozempic, Wegovy, Mounjaro, and Zepbound. The drugs are used to treat diabetes and overweight or obesity.
An investigation by the FDA doesn’t mean that the FDA has concluded a risk exists, the FDA’s webpage for risk evaluation cautions.
“It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk,” the FDA site states.
Possible next steps after an investigation could include updating drug labels with new information, putting a risk management plan in place to prevent or manage the health risks, or gathering more information.
“The FDA monitors the safety of drugs throughout their life cycle,” even after the drugs are approved. In addition, the FDA uses “surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process,” FDA spokesperson Chanapa Tantibanchachai said in an email published by multiple news outlets.
Although an investigation may lead to no changes in how a drug is regulated by the FDA, this isn’t the first time that the popular medicines have landed on the FDA’s radar for safety reevaluation. Last year, the label for the drug Ozempic was updated to acknowledge reports of intestinal obstructions, CBS News reported.
European regulators are also looking into reports of suicidal thoughts among people taking GLP-1 receptor agonists, although no link has been established.
Concerns about aspiration during surgery resulted in the American Society of Anesthesiologists advising in June that people should stop taking GLP-1 receptor agonists before they have elective surgeries.
“While there is currently a lack of scientific data on how GLP-1 receptor agonists affect patients having surgery and interact with anesthesia, we’ve received anecdotal reports that the delay in stomach emptying could be associated with an increased risk of regurgitation and aspiration of food into the airways and lungs during general anesthesia and deep sedation,” the society’s president, Michael W. Champeau, MD, said in a statement at the time.
According to CBS News, the FDA’s drug reporting system links the medications to 201 reports of suicide or suicidal ideation, 18 reports that mention aspiration, and 422 reports that mention alopecia.
Novo Nordisk, whose portfolio includes Wegovy and Ozempic, told CNN that it works with the FDA to monitor safety and is aware of the reports of side effects.
“Novo Nordisk stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional,” the company said in a statement to CNN.
A spokesperson for Eli Lilly, which makes Mounjaro and Zepbound, told CBS News in a statement, “Currently, the FDA is reviewing data on certain potential risks for GLP-1 receptor agonist medicines. Patient safety is our priority, and we are collaborating with the FDA on these potential signals.”
A version of this article appeared on WebMD.com .
or two other health problems.
A new FDA report listed potential links between the medications and alopecia, aspiration, or suicidal ideation, CBS News reported. The investigation centers on reports of the health problems among people taking GLP-1 receptor agonists, some of which are Ozempic, Wegovy, Mounjaro, and Zepbound. The drugs are used to treat diabetes and overweight or obesity.
An investigation by the FDA doesn’t mean that the FDA has concluded a risk exists, the FDA’s webpage for risk evaluation cautions.
“It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk,” the FDA site states.
Possible next steps after an investigation could include updating drug labels with new information, putting a risk management plan in place to prevent or manage the health risks, or gathering more information.
“The FDA monitors the safety of drugs throughout their life cycle,” even after the drugs are approved. In addition, the FDA uses “surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process,” FDA spokesperson Chanapa Tantibanchachai said in an email published by multiple news outlets.
Although an investigation may lead to no changes in how a drug is regulated by the FDA, this isn’t the first time that the popular medicines have landed on the FDA’s radar for safety reevaluation. Last year, the label for the drug Ozempic was updated to acknowledge reports of intestinal obstructions, CBS News reported.
European regulators are also looking into reports of suicidal thoughts among people taking GLP-1 receptor agonists, although no link has been established.
Concerns about aspiration during surgery resulted in the American Society of Anesthesiologists advising in June that people should stop taking GLP-1 receptor agonists before they have elective surgeries.
“While there is currently a lack of scientific data on how GLP-1 receptor agonists affect patients having surgery and interact with anesthesia, we’ve received anecdotal reports that the delay in stomach emptying could be associated with an increased risk of regurgitation and aspiration of food into the airways and lungs during general anesthesia and deep sedation,” the society’s president, Michael W. Champeau, MD, said in a statement at the time.
According to CBS News, the FDA’s drug reporting system links the medications to 201 reports of suicide or suicidal ideation, 18 reports that mention aspiration, and 422 reports that mention alopecia.
Novo Nordisk, whose portfolio includes Wegovy and Ozempic, told CNN that it works with the FDA to monitor safety and is aware of the reports of side effects.
“Novo Nordisk stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional,” the company said in a statement to CNN.
A spokesperson for Eli Lilly, which makes Mounjaro and Zepbound, told CBS News in a statement, “Currently, the FDA is reviewing data on certain potential risks for GLP-1 receptor agonist medicines. Patient safety is our priority, and we are collaborating with the FDA on these potential signals.”
A version of this article appeared on WebMD.com .
Chronicling Health Care Transformation: Federal Practitioner Looks Back 40 Years
When VA Practitioner published its first issue in January 1984, federal health care was at the cusp of a dramatic transformation. VA Practitioner stepped in to serve “as a forum, as a bulletin, as an easy means of communication with colleagues who share your unique concerns,” founding editor James McCloskey noted in the first issue.
The need for this forum was most acute at the US Department of Veterans Affairs (VA). The agency of about 200,000 employees was decentralizing its management, developing the first electronic health record system, and caring for an aging population of World War II and Vietnam War era veterans with high comorbidity burdens. In the 1980s, the VA was at a nadir and under increasing pressure to change. At that moment of challenge, VA Practitioner offered columns suggesting a way forward and focused on clinical improvements with articles like, “The ghosts of budgets past,” “Psychoenvironment: a therapeutic redesign plan,” and “The VA’s geriatric goals.” Within a few years, the journal had enlisted an editorial advisory board to help guide the journal and provide the first peer review process for articles.
Peer Review and Expanded Focus
Ten years later, tremendous changes were underway for both VA Practitioner and the VA. Ken Kizer, MD, MPH, was named Under Secretary of Health in 1994 and almost immediately started the massive process of reforming and reorganizing the VA’s health care arm: Veterans Health Administration (VHA). The VHA would expand from 2.7 million enrolled veteran patients in 1993 to 8.9 million in 2014. In the process, the VA transformed from an oft derided institution to a major source of research and care that hosted most US physician residents while delivering the “best care anywhere.”
In 1994, VA Practitioner changed its name, becoming Federal Practitioner with an expanded mandate to address the needs of US Department of Defense (DoD) and US Public Health Service (PHS) clinicians working at the Indian Health Service (IHS), Bureau of Prisons, and US Coast Guard. In addition, the journal instituted a double-blind peer review process. Health care reform was clearly on the agenda for the new journal.
A new vision for VHA sought to redistribute resources, decentralize decision making, and make care more patient centered. The VHA began development of the Computerized Patient Record System (CPRS), which was fully implemented by 1999 as one of the earliest electronic health record systems and shared it with the IHS.
The DoD, on the other hand, was in a long-term period of reduction and consolidation. The active-duty service member population dropped from 2.1 million to 1.6 million between 1984 and 1994 and would continue to drop to 1.4 million in 2001, even with the onset of the first Gulf War. The DoD rolled out the Civilian Health and Medical Program of the United States (CHAMPUS), which would later become TRICARE, that reshaped the way the DoD delivered health care for active-duty service members, their families, and retirees.
From the outset, Federal Practitioner sought to play a role in those transformations. For PHS officers stationed across the Centers for Disease Control and Prevention, US Food and Drug Administration, IHS, and Bureau of Prisons, the journal provided a new way to share findings and best practices. With a growing group of dedicated peer reviewers, Federal Practitioner articles became more clinical and more patient centered. Frequent columns gave way to clinical reviews, continuing medical education, and best practice articles.
Addressing Post-9/11 Veteran Needs
All of these changes were well under way on the eve of September 11, 2001. After years of reductions, the size of the military stabilized, but the demographics were shifting in important ways. Women made up a larger proportion of the active-duty population, growing from 5% in 1975 to 10% in 1985 and 14% in 2005. The military was also becoming more diverse, with a growing number of service members indicating Hispanic, Asian, Pacific Islander, and other identities. More importantly, a new set of health care concerns emerged to challenge DoD and VHA clinicians. A growing number of service members and veterans of the Gulf Wars were seeking care for respiratory diseases, cancers, blast injuries, and prosthetics.
Federal Practitioner articles primarily focused on quality improvement but increasingly the journal published original research and case studies. Columns like Common Errors in Internal Medicine and Advances in Geriatrics focused on quality improvement and innovative therapies, respectively. To supplement its 12 regular issues, in 2011 Federal Practitioner began publishing special issues to provide even more depth of coverage in specific disease states, including hematology/oncology (in cooperation with the Association of VA Hematology/Oncology), mental health, neurology, infectious diseases, diabetes, among other topics.
The Last 10 Years and the Next 40
In 2013, the DoD formally reorganized its health care operations under the Defense Health Agency, starting an entirely new process that would dramatically reshape health care delivery for 8 million beneficiaries and 140,000 employees. This started a long process of consolidating separate systems and priorities for each branch into a single approach. Meanwhile, controversies around long wait times for VHA appointments (and veterans who died while waiting) put it under intense scrutiny. Legislation to privatize some or all of health care for veterans were discussed and considered, which finally resulted in the creation of the Veterans Choice Program, which greatly expanded the use of private health care services for covered conditions.
In 2018, Federal Practitioner was accepted by the national Library of Medicine’s PubMed Central, ensuring the widest possible access to journal articles. The journal saw a steady growth in submissions and published a combined 21 regular and special issues that year driven by increased submissions and more original research studies.
More and more through the work of its authors, Federal Practitioner has been in the middle of critical and ongoing federal health care concerns. Federal Practitioner authors have turned to the journal to address issues ranging from the deprescribing of opioid medications to measures taken to decrease the incidence of veteran suicide and the challenges presented by artificial intelligence and telehealth delivery. Whether it was the federal responses to Ebola outbreaks in Africa or the myriad ways that the PHS and VA responded to the COVID-19 pandemic in the US, Federal Practitioner has been at the center of federal health care.
Further reading
To learn more about the past 40 years of federal health care visit mdedge.com/fedprac or doi:10.12788/fp.0453.
When VA Practitioner published its first issue in January 1984, federal health care was at the cusp of a dramatic transformation. VA Practitioner stepped in to serve “as a forum, as a bulletin, as an easy means of communication with colleagues who share your unique concerns,” founding editor James McCloskey noted in the first issue.
The need for this forum was most acute at the US Department of Veterans Affairs (VA). The agency of about 200,000 employees was decentralizing its management, developing the first electronic health record system, and caring for an aging population of World War II and Vietnam War era veterans with high comorbidity burdens. In the 1980s, the VA was at a nadir and under increasing pressure to change. At that moment of challenge, VA Practitioner offered columns suggesting a way forward and focused on clinical improvements with articles like, “The ghosts of budgets past,” “Psychoenvironment: a therapeutic redesign plan,” and “The VA’s geriatric goals.” Within a few years, the journal had enlisted an editorial advisory board to help guide the journal and provide the first peer review process for articles.
Peer Review and Expanded Focus
Ten years later, tremendous changes were underway for both VA Practitioner and the VA. Ken Kizer, MD, MPH, was named Under Secretary of Health in 1994 and almost immediately started the massive process of reforming and reorganizing the VA’s health care arm: Veterans Health Administration (VHA). The VHA would expand from 2.7 million enrolled veteran patients in 1993 to 8.9 million in 2014. In the process, the VA transformed from an oft derided institution to a major source of research and care that hosted most US physician residents while delivering the “best care anywhere.”
In 1994, VA Practitioner changed its name, becoming Federal Practitioner with an expanded mandate to address the needs of US Department of Defense (DoD) and US Public Health Service (PHS) clinicians working at the Indian Health Service (IHS), Bureau of Prisons, and US Coast Guard. In addition, the journal instituted a double-blind peer review process. Health care reform was clearly on the agenda for the new journal.
A new vision for VHA sought to redistribute resources, decentralize decision making, and make care more patient centered. The VHA began development of the Computerized Patient Record System (CPRS), which was fully implemented by 1999 as one of the earliest electronic health record systems and shared it with the IHS.
The DoD, on the other hand, was in a long-term period of reduction and consolidation. The active-duty service member population dropped from 2.1 million to 1.6 million between 1984 and 1994 and would continue to drop to 1.4 million in 2001, even with the onset of the first Gulf War. The DoD rolled out the Civilian Health and Medical Program of the United States (CHAMPUS), which would later become TRICARE, that reshaped the way the DoD delivered health care for active-duty service members, their families, and retirees.
From the outset, Federal Practitioner sought to play a role in those transformations. For PHS officers stationed across the Centers for Disease Control and Prevention, US Food and Drug Administration, IHS, and Bureau of Prisons, the journal provided a new way to share findings and best practices. With a growing group of dedicated peer reviewers, Federal Practitioner articles became more clinical and more patient centered. Frequent columns gave way to clinical reviews, continuing medical education, and best practice articles.
Addressing Post-9/11 Veteran Needs
All of these changes were well under way on the eve of September 11, 2001. After years of reductions, the size of the military stabilized, but the demographics were shifting in important ways. Women made up a larger proportion of the active-duty population, growing from 5% in 1975 to 10% in 1985 and 14% in 2005. The military was also becoming more diverse, with a growing number of service members indicating Hispanic, Asian, Pacific Islander, and other identities. More importantly, a new set of health care concerns emerged to challenge DoD and VHA clinicians. A growing number of service members and veterans of the Gulf Wars were seeking care for respiratory diseases, cancers, blast injuries, and prosthetics.
Federal Practitioner articles primarily focused on quality improvement but increasingly the journal published original research and case studies. Columns like Common Errors in Internal Medicine and Advances in Geriatrics focused on quality improvement and innovative therapies, respectively. To supplement its 12 regular issues, in 2011 Federal Practitioner began publishing special issues to provide even more depth of coverage in specific disease states, including hematology/oncology (in cooperation with the Association of VA Hematology/Oncology), mental health, neurology, infectious diseases, diabetes, among other topics.
The Last 10 Years and the Next 40
In 2013, the DoD formally reorganized its health care operations under the Defense Health Agency, starting an entirely new process that would dramatically reshape health care delivery for 8 million beneficiaries and 140,000 employees. This started a long process of consolidating separate systems and priorities for each branch into a single approach. Meanwhile, controversies around long wait times for VHA appointments (and veterans who died while waiting) put it under intense scrutiny. Legislation to privatize some or all of health care for veterans were discussed and considered, which finally resulted in the creation of the Veterans Choice Program, which greatly expanded the use of private health care services for covered conditions.
In 2018, Federal Practitioner was accepted by the national Library of Medicine’s PubMed Central, ensuring the widest possible access to journal articles. The journal saw a steady growth in submissions and published a combined 21 regular and special issues that year driven by increased submissions and more original research studies.
More and more through the work of its authors, Federal Practitioner has been in the middle of critical and ongoing federal health care concerns. Federal Practitioner authors have turned to the journal to address issues ranging from the deprescribing of opioid medications to measures taken to decrease the incidence of veteran suicide and the challenges presented by artificial intelligence and telehealth delivery. Whether it was the federal responses to Ebola outbreaks in Africa or the myriad ways that the PHS and VA responded to the COVID-19 pandemic in the US, Federal Practitioner has been at the center of federal health care.
Further reading
To learn more about the past 40 years of federal health care visit mdedge.com/fedprac or doi:10.12788/fp.0453.
When VA Practitioner published its first issue in January 1984, federal health care was at the cusp of a dramatic transformation. VA Practitioner stepped in to serve “as a forum, as a bulletin, as an easy means of communication with colleagues who share your unique concerns,” founding editor James McCloskey noted in the first issue.
The need for this forum was most acute at the US Department of Veterans Affairs (VA). The agency of about 200,000 employees was decentralizing its management, developing the first electronic health record system, and caring for an aging population of World War II and Vietnam War era veterans with high comorbidity burdens. In the 1980s, the VA was at a nadir and under increasing pressure to change. At that moment of challenge, VA Practitioner offered columns suggesting a way forward and focused on clinical improvements with articles like, “The ghosts of budgets past,” “Psychoenvironment: a therapeutic redesign plan,” and “The VA’s geriatric goals.” Within a few years, the journal had enlisted an editorial advisory board to help guide the journal and provide the first peer review process for articles.
Peer Review and Expanded Focus
Ten years later, tremendous changes were underway for both VA Practitioner and the VA. Ken Kizer, MD, MPH, was named Under Secretary of Health in 1994 and almost immediately started the massive process of reforming and reorganizing the VA’s health care arm: Veterans Health Administration (VHA). The VHA would expand from 2.7 million enrolled veteran patients in 1993 to 8.9 million in 2014. In the process, the VA transformed from an oft derided institution to a major source of research and care that hosted most US physician residents while delivering the “best care anywhere.”
In 1994, VA Practitioner changed its name, becoming Federal Practitioner with an expanded mandate to address the needs of US Department of Defense (DoD) and US Public Health Service (PHS) clinicians working at the Indian Health Service (IHS), Bureau of Prisons, and US Coast Guard. In addition, the journal instituted a double-blind peer review process. Health care reform was clearly on the agenda for the new journal.
A new vision for VHA sought to redistribute resources, decentralize decision making, and make care more patient centered. The VHA began development of the Computerized Patient Record System (CPRS), which was fully implemented by 1999 as one of the earliest electronic health record systems and shared it with the IHS.
The DoD, on the other hand, was in a long-term period of reduction and consolidation. The active-duty service member population dropped from 2.1 million to 1.6 million between 1984 and 1994 and would continue to drop to 1.4 million in 2001, even with the onset of the first Gulf War. The DoD rolled out the Civilian Health and Medical Program of the United States (CHAMPUS), which would later become TRICARE, that reshaped the way the DoD delivered health care for active-duty service members, their families, and retirees.
From the outset, Federal Practitioner sought to play a role in those transformations. For PHS officers stationed across the Centers for Disease Control and Prevention, US Food and Drug Administration, IHS, and Bureau of Prisons, the journal provided a new way to share findings and best practices. With a growing group of dedicated peer reviewers, Federal Practitioner articles became more clinical and more patient centered. Frequent columns gave way to clinical reviews, continuing medical education, and best practice articles.
Addressing Post-9/11 Veteran Needs
All of these changes were well under way on the eve of September 11, 2001. After years of reductions, the size of the military stabilized, but the demographics were shifting in important ways. Women made up a larger proportion of the active-duty population, growing from 5% in 1975 to 10% in 1985 and 14% in 2005. The military was also becoming more diverse, with a growing number of service members indicating Hispanic, Asian, Pacific Islander, and other identities. More importantly, a new set of health care concerns emerged to challenge DoD and VHA clinicians. A growing number of service members and veterans of the Gulf Wars were seeking care for respiratory diseases, cancers, blast injuries, and prosthetics.
Federal Practitioner articles primarily focused on quality improvement but increasingly the journal published original research and case studies. Columns like Common Errors in Internal Medicine and Advances in Geriatrics focused on quality improvement and innovative therapies, respectively. To supplement its 12 regular issues, in 2011 Federal Practitioner began publishing special issues to provide even more depth of coverage in specific disease states, including hematology/oncology (in cooperation with the Association of VA Hematology/Oncology), mental health, neurology, infectious diseases, diabetes, among other topics.
The Last 10 Years and the Next 40
In 2013, the DoD formally reorganized its health care operations under the Defense Health Agency, starting an entirely new process that would dramatically reshape health care delivery for 8 million beneficiaries and 140,000 employees. This started a long process of consolidating separate systems and priorities for each branch into a single approach. Meanwhile, controversies around long wait times for VHA appointments (and veterans who died while waiting) put it under intense scrutiny. Legislation to privatize some or all of health care for veterans were discussed and considered, which finally resulted in the creation of the Veterans Choice Program, which greatly expanded the use of private health care services for covered conditions.
In 2018, Federal Practitioner was accepted by the national Library of Medicine’s PubMed Central, ensuring the widest possible access to journal articles. The journal saw a steady growth in submissions and published a combined 21 regular and special issues that year driven by increased submissions and more original research studies.
More and more through the work of its authors, Federal Practitioner has been in the middle of critical and ongoing federal health care concerns. Federal Practitioner authors have turned to the journal to address issues ranging from the deprescribing of opioid medications to measures taken to decrease the incidence of veteran suicide and the challenges presented by artificial intelligence and telehealth delivery. Whether it was the federal responses to Ebola outbreaks in Africa or the myriad ways that the PHS and VA responded to the COVID-19 pandemic in the US, Federal Practitioner has been at the center of federal health care.
Further reading
To learn more about the past 40 years of federal health care visit mdedge.com/fedprac or doi:10.12788/fp.0453.
Public Citizen seeks stronger warning for Botox, related products
.
The nonprofit watchdog group successfully petitioned the FDA in 2008 to require a warning for Botox and related products regarding the risk of distant spread of the toxin. In its latest petition to the agency, it says that the injectables need additional warnings about the possibility of iatrogenic botulism with initial and repeated doses and that individuals who contract the condition may need botulinum antitoxin to avert temporary muscle paralysis, hospitalization, and death.
The current warning does not contain any information about the potential need for antitoxin and downplays the need for giving antitoxin in the settings of excessive dosing, accidental injection, and oral ingestion, said Public Citizen.
“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” Azza AbuDagga, PhD, health services researcher at Public Citizen’s Health Research Group, said in a statement.
Public Citizen said that using data from the FDA’s Adverse Event Reporting System (FAERS), it found 5414 reports of serious outcomes from botulinum toxin products from January 1989 through March 2021. Almost 22% involved cosmetic indications and about 78% involved therapeutic indications.
Of the 5414 reports, 121 (2%) specified botulism as an adverse reaction; 89 involved therapeutic uses of a botulinum toxin products, and 32 involved cosmetic uses. Many of those 121 reports involved doses within the recommended range for the indication, according to Public Citizen.
The group is also asking the FDA to remove what it calls misleading promotional statements in the labeling of Botox and Botox Cosmetic and from the medication guides for those products. The labels state that there have been “no definitive serious adverse event reports of distant spread of toxin effect” with either the cosmetic use or for use in treating chronic migraine, severe underarm sweating, blepharospasm, or strabismus. These statements do not appear in similar labeling in other countries, such as Canada and the United Kingdom, said Public Citizen.
“The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs,” Dr. AbuDagga said in the Public Citizen statement. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”
The Public Citizen petition would apply to all seven approved botulinum toxin biological products: abobotulinumtoxinA (Dysport), daxibotulinumtoxinA-lanm (Daxxify), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox, Botox Cosmetic), prabotulinumtoxinA-xvfs (Jeuveau) and rimabotulinumtoxinB (Myobloc).
An FDA spokesperson said the agency is reviewing the citizen petition, and that generally the agency does not comment on pending petitions. “When we respond to the petition, we will respond directly to the petitioner and post the response in the designated agency docket,” the spokesperson told this news organization. At press time, Botox manufacturer AbbVie had not responded to a request for a comment.
Botulinum toxin is the most-used product for nonsurgical cosmetic procedures, according to the International Society of Aesthetic Plastic Surgery (ISAPS). The ISAPS reported that there were more than 7 million botulinum toxin procedures performed by plastic surgeons worldwide in 2021.
The American Society of Plastic Surgery reported that its members performed 4.4 million Botox procedures in 2020, while the American Society of Dermatologic Surgery (ASDS) said its members performed 2.3 million wrinkle-relaxing procedures in 2019, a 60% increase since 2012.
.
The nonprofit watchdog group successfully petitioned the FDA in 2008 to require a warning for Botox and related products regarding the risk of distant spread of the toxin. In its latest petition to the agency, it says that the injectables need additional warnings about the possibility of iatrogenic botulism with initial and repeated doses and that individuals who contract the condition may need botulinum antitoxin to avert temporary muscle paralysis, hospitalization, and death.
The current warning does not contain any information about the potential need for antitoxin and downplays the need for giving antitoxin in the settings of excessive dosing, accidental injection, and oral ingestion, said Public Citizen.
“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” Azza AbuDagga, PhD, health services researcher at Public Citizen’s Health Research Group, said in a statement.
Public Citizen said that using data from the FDA’s Adverse Event Reporting System (FAERS), it found 5414 reports of serious outcomes from botulinum toxin products from January 1989 through March 2021. Almost 22% involved cosmetic indications and about 78% involved therapeutic indications.
Of the 5414 reports, 121 (2%) specified botulism as an adverse reaction; 89 involved therapeutic uses of a botulinum toxin products, and 32 involved cosmetic uses. Many of those 121 reports involved doses within the recommended range for the indication, according to Public Citizen.
The group is also asking the FDA to remove what it calls misleading promotional statements in the labeling of Botox and Botox Cosmetic and from the medication guides for those products. The labels state that there have been “no definitive serious adverse event reports of distant spread of toxin effect” with either the cosmetic use or for use in treating chronic migraine, severe underarm sweating, blepharospasm, or strabismus. These statements do not appear in similar labeling in other countries, such as Canada and the United Kingdom, said Public Citizen.
“The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs,” Dr. AbuDagga said in the Public Citizen statement. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”
The Public Citizen petition would apply to all seven approved botulinum toxin biological products: abobotulinumtoxinA (Dysport), daxibotulinumtoxinA-lanm (Daxxify), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox, Botox Cosmetic), prabotulinumtoxinA-xvfs (Jeuveau) and rimabotulinumtoxinB (Myobloc).
An FDA spokesperson said the agency is reviewing the citizen petition, and that generally the agency does not comment on pending petitions. “When we respond to the petition, we will respond directly to the petitioner and post the response in the designated agency docket,” the spokesperson told this news organization. At press time, Botox manufacturer AbbVie had not responded to a request for a comment.
Botulinum toxin is the most-used product for nonsurgical cosmetic procedures, according to the International Society of Aesthetic Plastic Surgery (ISAPS). The ISAPS reported that there were more than 7 million botulinum toxin procedures performed by plastic surgeons worldwide in 2021.
The American Society of Plastic Surgery reported that its members performed 4.4 million Botox procedures in 2020, while the American Society of Dermatologic Surgery (ASDS) said its members performed 2.3 million wrinkle-relaxing procedures in 2019, a 60% increase since 2012.
.
The nonprofit watchdog group successfully petitioned the FDA in 2008 to require a warning for Botox and related products regarding the risk of distant spread of the toxin. In its latest petition to the agency, it says that the injectables need additional warnings about the possibility of iatrogenic botulism with initial and repeated doses and that individuals who contract the condition may need botulinum antitoxin to avert temporary muscle paralysis, hospitalization, and death.
The current warning does not contain any information about the potential need for antitoxin and downplays the need for giving antitoxin in the settings of excessive dosing, accidental injection, and oral ingestion, said Public Citizen.
“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” Azza AbuDagga, PhD, health services researcher at Public Citizen’s Health Research Group, said in a statement.
Public Citizen said that using data from the FDA’s Adverse Event Reporting System (FAERS), it found 5414 reports of serious outcomes from botulinum toxin products from January 1989 through March 2021. Almost 22% involved cosmetic indications and about 78% involved therapeutic indications.
Of the 5414 reports, 121 (2%) specified botulism as an adverse reaction; 89 involved therapeutic uses of a botulinum toxin products, and 32 involved cosmetic uses. Many of those 121 reports involved doses within the recommended range for the indication, according to Public Citizen.
The group is also asking the FDA to remove what it calls misleading promotional statements in the labeling of Botox and Botox Cosmetic and from the medication guides for those products. The labels state that there have been “no definitive serious adverse event reports of distant spread of toxin effect” with either the cosmetic use or for use in treating chronic migraine, severe underarm sweating, blepharospasm, or strabismus. These statements do not appear in similar labeling in other countries, such as Canada and the United Kingdom, said Public Citizen.
“The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs,” Dr. AbuDagga said in the Public Citizen statement. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”
The Public Citizen petition would apply to all seven approved botulinum toxin biological products: abobotulinumtoxinA (Dysport), daxibotulinumtoxinA-lanm (Daxxify), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox, Botox Cosmetic), prabotulinumtoxinA-xvfs (Jeuveau) and rimabotulinumtoxinB (Myobloc).
An FDA spokesperson said the agency is reviewing the citizen petition, and that generally the agency does not comment on pending petitions. “When we respond to the petition, we will respond directly to the petitioner and post the response in the designated agency docket,” the spokesperson told this news organization. At press time, Botox manufacturer AbbVie had not responded to a request for a comment.
Botulinum toxin is the most-used product for nonsurgical cosmetic procedures, according to the International Society of Aesthetic Plastic Surgery (ISAPS). The ISAPS reported that there were more than 7 million botulinum toxin procedures performed by plastic surgeons worldwide in 2021.
The American Society of Plastic Surgery reported that its members performed 4.4 million Botox procedures in 2020, while the American Society of Dermatologic Surgery (ASDS) said its members performed 2.3 million wrinkle-relaxing procedures in 2019, a 60% increase since 2012.
We Want to Hear From You, Our Readers
Happy New Year, everyone. It’s hard to believe, but we are nearing the mid-point of our five-year term on the GI & Hepatology News (GIHN) board of editors. Our central goal over the past two-and-a-half years has been to curate thought-provoking content for GIHN that helps to inform clinical practice and keeps you up-to-date on emerging scientific innovations and policy changes impacting patients with digestive and liver diseases.
Your feedback is critical to ensuring the continued success of the newspaper as your go-to source for cutting edge news relevant to our field.
To start, we welcome your thoughts on the following questions:
- What do you want to see more of in the newspaper (e.g., a particular column, topic)?
- How can we continue to serve you best as a reader?
Please email your feedback to us at [email protected]. Your input is greatly appreciated by both the board and our larger editorial team and will help inform future coverage.
In this month’s issue of GIHN, we update you on the proceedings of AGA’s 2023 Innovation Conference, highlight a new Clinical Practice Guideline focused on the role of biomarkers in Crohn’s disease management, and summarize key AGA journal content.
The AGA Government Affairs Committee also details 2024 updates to Medicare payment rules, including a new add-on code for complex care, increased facility payment for POEM procedures, and continuation of expanded telehealth coverage through the end of 2024.
GIHN associate editor Dr. Avi Ketwaroo introduces this month’s Perspectives column focused on the impact of substance use (specifically alcohol and marijuana) on liver transplant candidacy.
In our January Member Spotlight, we feature Dr. Sonali Paul, a hepatologist and co-founder of Rainbows in Gastro. She shares her passion for promoting health equity in sexual and gender minority populations.
We hope you enjoy this, and all the exciting content included in our January issue.
Megan A. Adams, MD, JD, MSc
Editor-in-Chief
Happy New Year, everyone. It’s hard to believe, but we are nearing the mid-point of our five-year term on the GI & Hepatology News (GIHN) board of editors. Our central goal over the past two-and-a-half years has been to curate thought-provoking content for GIHN that helps to inform clinical practice and keeps you up-to-date on emerging scientific innovations and policy changes impacting patients with digestive and liver diseases.
Your feedback is critical to ensuring the continued success of the newspaper as your go-to source for cutting edge news relevant to our field.
To start, we welcome your thoughts on the following questions:
- What do you want to see more of in the newspaper (e.g., a particular column, topic)?
- How can we continue to serve you best as a reader?
Please email your feedback to us at [email protected]. Your input is greatly appreciated by both the board and our larger editorial team and will help inform future coverage.
In this month’s issue of GIHN, we update you on the proceedings of AGA’s 2023 Innovation Conference, highlight a new Clinical Practice Guideline focused on the role of biomarkers in Crohn’s disease management, and summarize key AGA journal content.
The AGA Government Affairs Committee also details 2024 updates to Medicare payment rules, including a new add-on code for complex care, increased facility payment for POEM procedures, and continuation of expanded telehealth coverage through the end of 2024.
GIHN associate editor Dr. Avi Ketwaroo introduces this month’s Perspectives column focused on the impact of substance use (specifically alcohol and marijuana) on liver transplant candidacy.
In our January Member Spotlight, we feature Dr. Sonali Paul, a hepatologist and co-founder of Rainbows in Gastro. She shares her passion for promoting health equity in sexual and gender minority populations.
We hope you enjoy this, and all the exciting content included in our January issue.
Megan A. Adams, MD, JD, MSc
Editor-in-Chief
Happy New Year, everyone. It’s hard to believe, but we are nearing the mid-point of our five-year term on the GI & Hepatology News (GIHN) board of editors. Our central goal over the past two-and-a-half years has been to curate thought-provoking content for GIHN that helps to inform clinical practice and keeps you up-to-date on emerging scientific innovations and policy changes impacting patients with digestive and liver diseases.
Your feedback is critical to ensuring the continued success of the newspaper as your go-to source for cutting edge news relevant to our field.
To start, we welcome your thoughts on the following questions:
- What do you want to see more of in the newspaper (e.g., a particular column, topic)?
- How can we continue to serve you best as a reader?
Please email your feedback to us at [email protected]. Your input is greatly appreciated by both the board and our larger editorial team and will help inform future coverage.
In this month’s issue of GIHN, we update you on the proceedings of AGA’s 2023 Innovation Conference, highlight a new Clinical Practice Guideline focused on the role of biomarkers in Crohn’s disease management, and summarize key AGA journal content.
The AGA Government Affairs Committee also details 2024 updates to Medicare payment rules, including a new add-on code for complex care, increased facility payment for POEM procedures, and continuation of expanded telehealth coverage through the end of 2024.
GIHN associate editor Dr. Avi Ketwaroo introduces this month’s Perspectives column focused on the impact of substance use (specifically alcohol and marijuana) on liver transplant candidacy.
In our January Member Spotlight, we feature Dr. Sonali Paul, a hepatologist and co-founder of Rainbows in Gastro. She shares her passion for promoting health equity in sexual and gender minority populations.
We hope you enjoy this, and all the exciting content included in our January issue.
Megan A. Adams, MD, JD, MSc
Editor-in-Chief
