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Brain Structure Differs in Youth With Conduct Disorder
Youth with conduct disorder (CD) have extensive brain structure differences, new research showed.
“We know very little about this disorder even though it can carry a high burden for families and societies,” co–lead author Yidian Gao, PhD, of the University of Birmingham, Birmingham, England, said in a press release.
“The sample included in our study is 10-20 times larger than previous studies and contains data on children from North America, Europe, and Asia. It provides the most compelling evidence to date that CD is associated with widespread structural brain differences,” he added.
The findings were published online in The Lancet Psychiatry.
An Understudied Disorder
In the largest study of its kind, researchers at the Universities of Bath and Birmingham, both in England, collaborated with research teams across Europe, North America, and Asia, as part of the Enhancing NeuroImaging Genetics through Meta-Analysis–Antisocial Behavior Working Group to learn more about one of the “least researched psychiatric disorders,” they wrote.
The investigators used MRI to examine the brain structure of 1185 children with a clinical diagnosis of CD and 1253 typically developing children from 17-21 across 15 international study cohorts.
After adjusting for total intracranial volume investigators found that youth with CD (29% women; mean age, 13.7 years) had lower total surface area and lower regional surface area in 26 of the 34 cortical regions, spanning all four lobes of the brain, compared with their typically developing counterparts (35.6% women; mean age, 13.5 years).
Youth with CD also showed greater cortical thickness in the caudal anterior cingulate cortex (P = .0001) and lower cortical thickness in the banks of the superior temporal sulcus vs those without CD (P = .0010).
In addition, the CD group also had lower volume in the thalamus (P = .0009), amygdala (P = .0014), hippocampus (P = .0031), and nucleus accumbens (P = .0052).
Most findings remained significant after adjusting for intelligence quotient, psychiatric comorbidities, and psychotropic medication use. Of note, group difference in cortical thickness, 22 of 27 differences in surface area. In addition, three of four subcortical differences remained robust after adjusting for co-occurring attention-deficit/hyperactivity disorder, the most frequent comorbidity.
When the investigators divided individuals with CD into two subgroups — those with high vs low levels of callous-unemotional traits — they found limited overall differences. However, those with high callous-unemotional traits had lower surface area in the superior temporal and superior frontal gyri vs those with low callous-unemotional traits and the typically developing group.
Investigators also found that individuals with childhood-onset CD had greater cortical thickness in the caudal anterior cingulate cortex compared with those with adolescent-onset CD.
Study limitations include comparison of different cohorts with differing protocols that could affect the validity of the findings. In addition, subgroup samples were small and had lower statistical power.
“Our finding of robust brain alterations in conduct disorder — similar to those in more widely recognized and widely treated disorders such as ADHD — emphasize the need for a greater focus on conduct disorder in research, treatment, and public policy,” the authors noted.
Seven study authors reported conflicts of interest with various pharmaceutical companies and other organizations.
A version of this article first appeared on Medscape.com.
Youth with conduct disorder (CD) have extensive brain structure differences, new research showed.
“We know very little about this disorder even though it can carry a high burden for families and societies,” co–lead author Yidian Gao, PhD, of the University of Birmingham, Birmingham, England, said in a press release.
“The sample included in our study is 10-20 times larger than previous studies and contains data on children from North America, Europe, and Asia. It provides the most compelling evidence to date that CD is associated with widespread structural brain differences,” he added.
The findings were published online in The Lancet Psychiatry.
An Understudied Disorder
In the largest study of its kind, researchers at the Universities of Bath and Birmingham, both in England, collaborated with research teams across Europe, North America, and Asia, as part of the Enhancing NeuroImaging Genetics through Meta-Analysis–Antisocial Behavior Working Group to learn more about one of the “least researched psychiatric disorders,” they wrote.
The investigators used MRI to examine the brain structure of 1185 children with a clinical diagnosis of CD and 1253 typically developing children from 17-21 across 15 international study cohorts.
After adjusting for total intracranial volume investigators found that youth with CD (29% women; mean age, 13.7 years) had lower total surface area and lower regional surface area in 26 of the 34 cortical regions, spanning all four lobes of the brain, compared with their typically developing counterparts (35.6% women; mean age, 13.5 years).
Youth with CD also showed greater cortical thickness in the caudal anterior cingulate cortex (P = .0001) and lower cortical thickness in the banks of the superior temporal sulcus vs those without CD (P = .0010).
In addition, the CD group also had lower volume in the thalamus (P = .0009), amygdala (P = .0014), hippocampus (P = .0031), and nucleus accumbens (P = .0052).
Most findings remained significant after adjusting for intelligence quotient, psychiatric comorbidities, and psychotropic medication use. Of note, group difference in cortical thickness, 22 of 27 differences in surface area. In addition, three of four subcortical differences remained robust after adjusting for co-occurring attention-deficit/hyperactivity disorder, the most frequent comorbidity.
When the investigators divided individuals with CD into two subgroups — those with high vs low levels of callous-unemotional traits — they found limited overall differences. However, those with high callous-unemotional traits had lower surface area in the superior temporal and superior frontal gyri vs those with low callous-unemotional traits and the typically developing group.
Investigators also found that individuals with childhood-onset CD had greater cortical thickness in the caudal anterior cingulate cortex compared with those with adolescent-onset CD.
Study limitations include comparison of different cohorts with differing protocols that could affect the validity of the findings. In addition, subgroup samples were small and had lower statistical power.
“Our finding of robust brain alterations in conduct disorder — similar to those in more widely recognized and widely treated disorders such as ADHD — emphasize the need for a greater focus on conduct disorder in research, treatment, and public policy,” the authors noted.
Seven study authors reported conflicts of interest with various pharmaceutical companies and other organizations.
A version of this article first appeared on Medscape.com.
Youth with conduct disorder (CD) have extensive brain structure differences, new research showed.
“We know very little about this disorder even though it can carry a high burden for families and societies,” co–lead author Yidian Gao, PhD, of the University of Birmingham, Birmingham, England, said in a press release.
“The sample included in our study is 10-20 times larger than previous studies and contains data on children from North America, Europe, and Asia. It provides the most compelling evidence to date that CD is associated with widespread structural brain differences,” he added.
The findings were published online in The Lancet Psychiatry.
An Understudied Disorder
In the largest study of its kind, researchers at the Universities of Bath and Birmingham, both in England, collaborated with research teams across Europe, North America, and Asia, as part of the Enhancing NeuroImaging Genetics through Meta-Analysis–Antisocial Behavior Working Group to learn more about one of the “least researched psychiatric disorders,” they wrote.
The investigators used MRI to examine the brain structure of 1185 children with a clinical diagnosis of CD and 1253 typically developing children from 17-21 across 15 international study cohorts.
After adjusting for total intracranial volume investigators found that youth with CD (29% women; mean age, 13.7 years) had lower total surface area and lower regional surface area in 26 of the 34 cortical regions, spanning all four lobes of the brain, compared with their typically developing counterparts (35.6% women; mean age, 13.5 years).
Youth with CD also showed greater cortical thickness in the caudal anterior cingulate cortex (P = .0001) and lower cortical thickness in the banks of the superior temporal sulcus vs those without CD (P = .0010).
In addition, the CD group also had lower volume in the thalamus (P = .0009), amygdala (P = .0014), hippocampus (P = .0031), and nucleus accumbens (P = .0052).
Most findings remained significant after adjusting for intelligence quotient, psychiatric comorbidities, and psychotropic medication use. Of note, group difference in cortical thickness, 22 of 27 differences in surface area. In addition, three of four subcortical differences remained robust after adjusting for co-occurring attention-deficit/hyperactivity disorder, the most frequent comorbidity.
When the investigators divided individuals with CD into two subgroups — those with high vs low levels of callous-unemotional traits — they found limited overall differences. However, those with high callous-unemotional traits had lower surface area in the superior temporal and superior frontal gyri vs those with low callous-unemotional traits and the typically developing group.
Investigators also found that individuals with childhood-onset CD had greater cortical thickness in the caudal anterior cingulate cortex compared with those with adolescent-onset CD.
Study limitations include comparison of different cohorts with differing protocols that could affect the validity of the findings. In addition, subgroup samples were small and had lower statistical power.
“Our finding of robust brain alterations in conduct disorder — similar to those in more widely recognized and widely treated disorders such as ADHD — emphasize the need for a greater focus on conduct disorder in research, treatment, and public policy,” the authors noted.
Seven study authors reported conflicts of interest with various pharmaceutical companies and other organizations.
A version of this article first appeared on Medscape.com.
FROM THE LANCET PSYCHIATRY
The Rise of the Scribes
“We really aren’t taking care of records — we’re taking care of people.” — Dr. Lawrence Weed
What is the purpose of a progress note? Anyone? Yes, you there. “Insurance billing?” Yes, that’s a good one. Anyone else? “To remember what you did?” Excellent. Another? Yes, that’s right, for others to follow along in your care. These are all good reasons for a progress note to exist. But they aren’t the whole story. Let’s start at the beginning.
Charts were once a collection of paper sheets with handwritten notes. Sometimes illegible, sometimes beautiful, always efficient. A progress note back then could be just 10 characters, AK, LN2, X,X,X,X,X (with X’s marking nitrogen sprays). Then came the healthcare K-Pg event: the conversion to EMRs. Those doctors who survived evolved into computer programmers, creating blocks of text from a few keystrokes. But like toddler-sized Legos, the blocks made it impossible to build a note that is nuanced or precise. Worse yet, many notes consisting of blocks from one note added awkwardly to a new note, creating grotesque structures unrecognizable as anything that should exist in nature. Words and numbers, but no information.
Thanks to the eternity of EMR, these creations live on, hideous and useless. They waste not only the server’s energy but also our time. Few things are more maddening than scrolling to reach the bottom of another physician’s note only to find there is nothing there.
Whose fault is this? Anyone? Yes, that’s right, insurers. As there are probably no payers in this audience, let’s blame them. I agree, the crushing burden of documentation-to-get-reimbursed has forced us to create “notes” that add no value to us but add up points for us to get paid for them. CMS, payers, prior authorizations, and now even patients, it seems we are documenting for lots of people except for us. There isn’t time to satisfy all and this significant burden for every encounter is a proximate cause for doctors despair. Until now.
A fully formed, comprehensive, sometimes pretty note that satisfies all audiences. Dr. Larry Weed must be dancing in heaven. It was Dr. Weed who led us from the nicotine-stained logs of the 1950s to the powerful problem-based notes we use today, an innovation that rivals the stethoscope in its impact.
Professor Weed also predicted that computers would be important to capture and make sense of patient data, helping us make accurate diagnoses and efficient plans. Again, he was right. He would surely be advocating to take advantage of AI scribes’ marvelous ability to capture salient data and present it in the form of a problem-oriented medical record.
AI scribes will be ubiquitous soon; I’m fast and even for me they save time. They also allow, for the first time in a decade, to turn from the glow of a screen to actually face the patient – we no longer have to scribe and care simultaneously. Hallelujah. And yet, lest I disappoint you without a twist, it seems with AI scribes, like EMRs we lose a little something too.
Like self-driving cars or ChatGPT-generated letters, they remove cognitive loads. They are lovely when you have to multitask or are trying to recall a visit from hours (days) ago. Using them, you’ll feel faster, lighter, freer, happier. But what’s missing is the thinking. At the end, you have an exquisite note, but you didn’t write it. It has the salient points, but none of the mental work to create it. AI scribes subvert the valuable work of synthesis. That was the critical part of Dr. Weed’s discovery: writing problem-oriented notes helped us think better.
Writing allows for the friction that helps us process what is going on with a patient. It allows for the discovery of diagnoses and prompts plans. When I was an intern, one of my attendings would hand write notes, succinctly showing what he had observed and was thinking. He’d sketch diagrams in the chart, for example, to help illustrate how we’d work though the toxic, metabolic, and infectious etiologies of acute liver failure. Sublime.
The act of writing also helps remind us there is a person attached to these words. Like a handwritten sympathy card, it is intimate, human. Even using our EMR, I’d still often type sentences that help tell the patient’s story. “Her sister just died. Utterly devastated. I’ll forward chart to Bob (her PCP) to check in on her.” Or: “Scratch golfer wants to know why he is getting so many SCCs now. ‘Like bankruptcy, gradually then suddenly,’ I explained. I think I broke through.”
Since we’ve concluded the purpose of a note is mostly to capture data, AI scribes are a godsend. They do so with remarkable quality and efficiency. We’ll just have to remember if the diagnosis is unclear, then it might help to write the note out yourself. And even when done by the AI machine, we might add human touches now and again lest there be no art left in what we do.
“For sale. Sun hat. Never worn.”
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].
“We really aren’t taking care of records — we’re taking care of people.” — Dr. Lawrence Weed
What is the purpose of a progress note? Anyone? Yes, you there. “Insurance billing?” Yes, that’s a good one. Anyone else? “To remember what you did?” Excellent. Another? Yes, that’s right, for others to follow along in your care. These are all good reasons for a progress note to exist. But they aren’t the whole story. Let’s start at the beginning.
Charts were once a collection of paper sheets with handwritten notes. Sometimes illegible, sometimes beautiful, always efficient. A progress note back then could be just 10 characters, AK, LN2, X,X,X,X,X (with X’s marking nitrogen sprays). Then came the healthcare K-Pg event: the conversion to EMRs. Those doctors who survived evolved into computer programmers, creating blocks of text from a few keystrokes. But like toddler-sized Legos, the blocks made it impossible to build a note that is nuanced or precise. Worse yet, many notes consisting of blocks from one note added awkwardly to a new note, creating grotesque structures unrecognizable as anything that should exist in nature. Words and numbers, but no information.
Thanks to the eternity of EMR, these creations live on, hideous and useless. They waste not only the server’s energy but also our time. Few things are more maddening than scrolling to reach the bottom of another physician’s note only to find there is nothing there.
Whose fault is this? Anyone? Yes, that’s right, insurers. As there are probably no payers in this audience, let’s blame them. I agree, the crushing burden of documentation-to-get-reimbursed has forced us to create “notes” that add no value to us but add up points for us to get paid for them. CMS, payers, prior authorizations, and now even patients, it seems we are documenting for lots of people except for us. There isn’t time to satisfy all and this significant burden for every encounter is a proximate cause for doctors despair. Until now.
A fully formed, comprehensive, sometimes pretty note that satisfies all audiences. Dr. Larry Weed must be dancing in heaven. It was Dr. Weed who led us from the nicotine-stained logs of the 1950s to the powerful problem-based notes we use today, an innovation that rivals the stethoscope in its impact.
Professor Weed also predicted that computers would be important to capture and make sense of patient data, helping us make accurate diagnoses and efficient plans. Again, he was right. He would surely be advocating to take advantage of AI scribes’ marvelous ability to capture salient data and present it in the form of a problem-oriented medical record.
AI scribes will be ubiquitous soon; I’m fast and even for me they save time. They also allow, for the first time in a decade, to turn from the glow of a screen to actually face the patient – we no longer have to scribe and care simultaneously. Hallelujah. And yet, lest I disappoint you without a twist, it seems with AI scribes, like EMRs we lose a little something too.
Like self-driving cars or ChatGPT-generated letters, they remove cognitive loads. They are lovely when you have to multitask or are trying to recall a visit from hours (days) ago. Using them, you’ll feel faster, lighter, freer, happier. But what’s missing is the thinking. At the end, you have an exquisite note, but you didn’t write it. It has the salient points, but none of the mental work to create it. AI scribes subvert the valuable work of synthesis. That was the critical part of Dr. Weed’s discovery: writing problem-oriented notes helped us think better.
Writing allows for the friction that helps us process what is going on with a patient. It allows for the discovery of diagnoses and prompts plans. When I was an intern, one of my attendings would hand write notes, succinctly showing what he had observed and was thinking. He’d sketch diagrams in the chart, for example, to help illustrate how we’d work though the toxic, metabolic, and infectious etiologies of acute liver failure. Sublime.
The act of writing also helps remind us there is a person attached to these words. Like a handwritten sympathy card, it is intimate, human. Even using our EMR, I’d still often type sentences that help tell the patient’s story. “Her sister just died. Utterly devastated. I’ll forward chart to Bob (her PCP) to check in on her.” Or: “Scratch golfer wants to know why he is getting so many SCCs now. ‘Like bankruptcy, gradually then suddenly,’ I explained. I think I broke through.”
Since we’ve concluded the purpose of a note is mostly to capture data, AI scribes are a godsend. They do so with remarkable quality and efficiency. We’ll just have to remember if the diagnosis is unclear, then it might help to write the note out yourself. And even when done by the AI machine, we might add human touches now and again lest there be no art left in what we do.
“For sale. Sun hat. Never worn.”
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].
“We really aren’t taking care of records — we’re taking care of people.” — Dr. Lawrence Weed
What is the purpose of a progress note? Anyone? Yes, you there. “Insurance billing?” Yes, that’s a good one. Anyone else? “To remember what you did?” Excellent. Another? Yes, that’s right, for others to follow along in your care. These are all good reasons for a progress note to exist. But they aren’t the whole story. Let’s start at the beginning.
Charts were once a collection of paper sheets with handwritten notes. Sometimes illegible, sometimes beautiful, always efficient. A progress note back then could be just 10 characters, AK, LN2, X,X,X,X,X (with X’s marking nitrogen sprays). Then came the healthcare K-Pg event: the conversion to EMRs. Those doctors who survived evolved into computer programmers, creating blocks of text from a few keystrokes. But like toddler-sized Legos, the blocks made it impossible to build a note that is nuanced or precise. Worse yet, many notes consisting of blocks from one note added awkwardly to a new note, creating grotesque structures unrecognizable as anything that should exist in nature. Words and numbers, but no information.
Thanks to the eternity of EMR, these creations live on, hideous and useless. They waste not only the server’s energy but also our time. Few things are more maddening than scrolling to reach the bottom of another physician’s note only to find there is nothing there.
Whose fault is this? Anyone? Yes, that’s right, insurers. As there are probably no payers in this audience, let’s blame them. I agree, the crushing burden of documentation-to-get-reimbursed has forced us to create “notes” that add no value to us but add up points for us to get paid for them. CMS, payers, prior authorizations, and now even patients, it seems we are documenting for lots of people except for us. There isn’t time to satisfy all and this significant burden for every encounter is a proximate cause for doctors despair. Until now.
A fully formed, comprehensive, sometimes pretty note that satisfies all audiences. Dr. Larry Weed must be dancing in heaven. It was Dr. Weed who led us from the nicotine-stained logs of the 1950s to the powerful problem-based notes we use today, an innovation that rivals the stethoscope in its impact.
Professor Weed also predicted that computers would be important to capture and make sense of patient data, helping us make accurate diagnoses and efficient plans. Again, he was right. He would surely be advocating to take advantage of AI scribes’ marvelous ability to capture salient data and present it in the form of a problem-oriented medical record.
AI scribes will be ubiquitous soon; I’m fast and even for me they save time. They also allow, for the first time in a decade, to turn from the glow of a screen to actually face the patient – we no longer have to scribe and care simultaneously. Hallelujah. And yet, lest I disappoint you without a twist, it seems with AI scribes, like EMRs we lose a little something too.
Like self-driving cars or ChatGPT-generated letters, they remove cognitive loads. They are lovely when you have to multitask or are trying to recall a visit from hours (days) ago. Using them, you’ll feel faster, lighter, freer, happier. But what’s missing is the thinking. At the end, you have an exquisite note, but you didn’t write it. It has the salient points, but none of the mental work to create it. AI scribes subvert the valuable work of synthesis. That was the critical part of Dr. Weed’s discovery: writing problem-oriented notes helped us think better.
Writing allows for the friction that helps us process what is going on with a patient. It allows for the discovery of diagnoses and prompts plans. When I was an intern, one of my attendings would hand write notes, succinctly showing what he had observed and was thinking. He’d sketch diagrams in the chart, for example, to help illustrate how we’d work though the toxic, metabolic, and infectious etiologies of acute liver failure. Sublime.
The act of writing also helps remind us there is a person attached to these words. Like a handwritten sympathy card, it is intimate, human. Even using our EMR, I’d still often type sentences that help tell the patient’s story. “Her sister just died. Utterly devastated. I’ll forward chart to Bob (her PCP) to check in on her.” Or: “Scratch golfer wants to know why he is getting so many SCCs now. ‘Like bankruptcy, gradually then suddenly,’ I explained. I think I broke through.”
Since we’ve concluded the purpose of a note is mostly to capture data, AI scribes are a godsend. They do so with remarkable quality and efficiency. We’ll just have to remember if the diagnosis is unclear, then it might help to write the note out yourself. And even when done by the AI machine, we might add human touches now and again lest there be no art left in what we do.
“For sale. Sun hat. Never worn.”
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].
Emergency Contraception Recommended for Teens on Isotretinoin
TORONTO —
That was one of the main messages from Andrea L. Zaenglein, MD, professor of dermatology and pediatrics, Penn State University, Hershey, who discussed hormonal therapies for pediatric acne at the annual meeting of the Society for Pediatric Dermatology.
Many doctors are reluctant to prescribe EC, which refers to contraceptive methods used to prevent unintended pregnancy after unprotected sexual intercourse or contraceptive failure, whether that’s from discomfort with EC or lack of training, Dr. Zaenglein said in an interview.
Isotretinoin, a retinoid marketed as Accutane and other brand names, is an effective treatment for acne but carries serious teratogenicity risks; the iPLEDGE Risk Evaluation and Mitigation Strategy is designed to manage this risk and minimize fetal exposure. Yet from 2011 to 2017, 210-310 pregnancies per year were reported to the Food and Drug Administration, according to a 2019 study.
There is a knowledge gap regarding EC among dermatologists who prescribe isotretinoin, which “is perpetuated by the iPLEDGE program because it is inadequate in guiding clinicians or educating patients about the use of EC,” Dr. Zaenglein and colleagues wrote in a recently published viewpoint on EC prescribing in patients on isotretinoin.
Types of EC include oral levonorgestrel (plan B), available over the counter; oral ulipristal acetate (ella), which requires a prescription; and the copper/hormonal intrauterine device.
Not all teens taking isotretinoin can be trusted to be sexually abstinent. Dr. Zaenglein cited research showing 39% of female high school students have had sexual relations. “In my opinion, these patients should have emergency contraception prescribed to them as a backup,” she said.
Dr. Zaenglein believes there’s a fair amount of “misunderstanding” about EC, with many people thinking it’s an abortion pill. “It’s a totally different medicine. This is contraception; if you’re pregnant, it’s not going to affect your fetus.”
Outgoing SPD President Sheilagh Maguiness, MD, professor of dermatology and pediatrics, University of Minnesota, Minneapolis, agreed that Dr. Zaenglein raised an important issue. “She has identified a practice gap and a knowledge gap that we need to address,” she said in an interview.
When discussing contraception with female patients taking isotretinoin, assume they’re sexually active or could be, Dr. Zaenglein told meeting attendees. Be explicit about the risks to the fetus and consider their past compliance.
Complex Disorder
During her presentation, Dr. Zaenglein described acne as a “very complex, multifactorial inflammatory disorder” of the skin. It involves four steps: Increased sebum production, hyperkeratinization, Cutibacterium acnes, and inflammation. External factors such as diet, genes, and the environment play a role.
“But at the heart of all of it is androgens; if you didn’t have androgens, you wouldn’t have acne.” That’s why some acne treatments block androgen receptors.
Clinicians are increasingly using one such therapy, spironolactone, to treat acne in female adolescents. Dr. Zaenglein referred to a Mayo Clinic study of 80 patients (mean age, 19 years), who had moderate to severe acne treated with a mean dose of 100 mg/day, that found 80% had improvement with a favorable side effect profile. This included nearly 23% who had a complete response (90% or more) and 36% who had a partial response (more than 50%); 20% had no response.
However, response rates are higher in adults, said Dr. Zaenglein, noting that spironolactone works “much better” in adult women.
Side effects of spironolactone can include menstrual disturbances, breast enlargement and tenderness, and premenstrual syndrome–like symptoms.
Dermatologists should also consider combined oral contraceptives (COCs) in their adolescent patients with acne. These have an estrogen component as well as a progestin component.
They have proven effectiveness for acne in adolescents, yet a US survey of 170 dermatology residents found only 60% felt comfortable prescribing them to healthy adolescents. The survey also found only 62% of respondents felt adequately trained on the efficacy of COCs, and 42% felt adequately trained on their safety.
Contraindications for COCs include thrombosis, migraine with aura, lupus, seizures, and hypertension. Complex valvular heart disease and liver tumors also need to be ruled out, said Dr. Zaenglein. One of the “newer concerns” with COCs is depression. “There’s biological plausibility because, obviously, hormones impact the brain.”
Preventing Drug Interactions
Before prescribing hormonal therapy, clinicians should carry out an acne assessment, aimed in part at preventing drug interactions. “The one we mostly have to watch out for is rifampin,” an antibiotic that could interact with COCs, said Dr. Zaenglein.
The herbal supplement St John’s Wort can reduce the efficacy of COCs. “You also want to make sure that they’re not on any medicines that will increase potassium, such as ACE inhibitors,” said Dr. Zaenglein. But tetracyclines, ampicillin, or metronidazole are usually “all okay” when combined with COCs.
It’s important to get baseline blood pressure levels and to check these along with weight on a regular basis, she added.
Always Consider PCOS
Before starting hormonal therapy, she advises dermatologists to “always consider” polycystic ovary syndrome (PCOS), a condition that’s “probably much underdiagnosed.” Acne is common in adolescents with PCOS. She suggests using a PCOS checklist, a reminder to ask about irregular periods, hirsutism, signs of insulin resistance such as increased body mass index, a history of premature adrenarche, and a family history of PCOS, said Dr. Zaenglein, noting that a person with a sibling who has PCOS has about a 40% chance of developing the condition.
“We play an important role in getting kids diagnosed at an early age so that we can make interventions because the impact of the metabolic syndrome can have lifelong effects on their cardiovascular system, as well as infertility.”
Dr. Zaenglein is a member of the American Academy of Dermatology (AAD) Acne Guidelines work group, the immediate past president of the American Acne and Rosacea Society, a member of the AAD iPLEDGE work group, co–editor in chief of Pediatric Dermatology, an advisory board member of Ortho Dermatologics, and a consultant for Church & Dwight. Dr. Maguiness had no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TORONTO —
That was one of the main messages from Andrea L. Zaenglein, MD, professor of dermatology and pediatrics, Penn State University, Hershey, who discussed hormonal therapies for pediatric acne at the annual meeting of the Society for Pediatric Dermatology.
Many doctors are reluctant to prescribe EC, which refers to contraceptive methods used to prevent unintended pregnancy after unprotected sexual intercourse or contraceptive failure, whether that’s from discomfort with EC or lack of training, Dr. Zaenglein said in an interview.
Isotretinoin, a retinoid marketed as Accutane and other brand names, is an effective treatment for acne but carries serious teratogenicity risks; the iPLEDGE Risk Evaluation and Mitigation Strategy is designed to manage this risk and minimize fetal exposure. Yet from 2011 to 2017, 210-310 pregnancies per year were reported to the Food and Drug Administration, according to a 2019 study.
There is a knowledge gap regarding EC among dermatologists who prescribe isotretinoin, which “is perpetuated by the iPLEDGE program because it is inadequate in guiding clinicians or educating patients about the use of EC,” Dr. Zaenglein and colleagues wrote in a recently published viewpoint on EC prescribing in patients on isotretinoin.
Types of EC include oral levonorgestrel (plan B), available over the counter; oral ulipristal acetate (ella), which requires a prescription; and the copper/hormonal intrauterine device.
Not all teens taking isotretinoin can be trusted to be sexually abstinent. Dr. Zaenglein cited research showing 39% of female high school students have had sexual relations. “In my opinion, these patients should have emergency contraception prescribed to them as a backup,” she said.
Dr. Zaenglein believes there’s a fair amount of “misunderstanding” about EC, with many people thinking it’s an abortion pill. “It’s a totally different medicine. This is contraception; if you’re pregnant, it’s not going to affect your fetus.”
Outgoing SPD President Sheilagh Maguiness, MD, professor of dermatology and pediatrics, University of Minnesota, Minneapolis, agreed that Dr. Zaenglein raised an important issue. “She has identified a practice gap and a knowledge gap that we need to address,” she said in an interview.
When discussing contraception with female patients taking isotretinoin, assume they’re sexually active or could be, Dr. Zaenglein told meeting attendees. Be explicit about the risks to the fetus and consider their past compliance.
Complex Disorder
During her presentation, Dr. Zaenglein described acne as a “very complex, multifactorial inflammatory disorder” of the skin. It involves four steps: Increased sebum production, hyperkeratinization, Cutibacterium acnes, and inflammation. External factors such as diet, genes, and the environment play a role.
“But at the heart of all of it is androgens; if you didn’t have androgens, you wouldn’t have acne.” That’s why some acne treatments block androgen receptors.
Clinicians are increasingly using one such therapy, spironolactone, to treat acne in female adolescents. Dr. Zaenglein referred to a Mayo Clinic study of 80 patients (mean age, 19 years), who had moderate to severe acne treated with a mean dose of 100 mg/day, that found 80% had improvement with a favorable side effect profile. This included nearly 23% who had a complete response (90% or more) and 36% who had a partial response (more than 50%); 20% had no response.
However, response rates are higher in adults, said Dr. Zaenglein, noting that spironolactone works “much better” in adult women.
Side effects of spironolactone can include menstrual disturbances, breast enlargement and tenderness, and premenstrual syndrome–like symptoms.
Dermatologists should also consider combined oral contraceptives (COCs) in their adolescent patients with acne. These have an estrogen component as well as a progestin component.
They have proven effectiveness for acne in adolescents, yet a US survey of 170 dermatology residents found only 60% felt comfortable prescribing them to healthy adolescents. The survey also found only 62% of respondents felt adequately trained on the efficacy of COCs, and 42% felt adequately trained on their safety.
Contraindications for COCs include thrombosis, migraine with aura, lupus, seizures, and hypertension. Complex valvular heart disease and liver tumors also need to be ruled out, said Dr. Zaenglein. One of the “newer concerns” with COCs is depression. “There’s biological plausibility because, obviously, hormones impact the brain.”
Preventing Drug Interactions
Before prescribing hormonal therapy, clinicians should carry out an acne assessment, aimed in part at preventing drug interactions. “The one we mostly have to watch out for is rifampin,” an antibiotic that could interact with COCs, said Dr. Zaenglein.
The herbal supplement St John’s Wort can reduce the efficacy of COCs. “You also want to make sure that they’re not on any medicines that will increase potassium, such as ACE inhibitors,” said Dr. Zaenglein. But tetracyclines, ampicillin, or metronidazole are usually “all okay” when combined with COCs.
It’s important to get baseline blood pressure levels and to check these along with weight on a regular basis, she added.
Always Consider PCOS
Before starting hormonal therapy, she advises dermatologists to “always consider” polycystic ovary syndrome (PCOS), a condition that’s “probably much underdiagnosed.” Acne is common in adolescents with PCOS. She suggests using a PCOS checklist, a reminder to ask about irregular periods, hirsutism, signs of insulin resistance such as increased body mass index, a history of premature adrenarche, and a family history of PCOS, said Dr. Zaenglein, noting that a person with a sibling who has PCOS has about a 40% chance of developing the condition.
“We play an important role in getting kids diagnosed at an early age so that we can make interventions because the impact of the metabolic syndrome can have lifelong effects on their cardiovascular system, as well as infertility.”
Dr. Zaenglein is a member of the American Academy of Dermatology (AAD) Acne Guidelines work group, the immediate past president of the American Acne and Rosacea Society, a member of the AAD iPLEDGE work group, co–editor in chief of Pediatric Dermatology, an advisory board member of Ortho Dermatologics, and a consultant for Church & Dwight. Dr. Maguiness had no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TORONTO —
That was one of the main messages from Andrea L. Zaenglein, MD, professor of dermatology and pediatrics, Penn State University, Hershey, who discussed hormonal therapies for pediatric acne at the annual meeting of the Society for Pediatric Dermatology.
Many doctors are reluctant to prescribe EC, which refers to contraceptive methods used to prevent unintended pregnancy after unprotected sexual intercourse or contraceptive failure, whether that’s from discomfort with EC or lack of training, Dr. Zaenglein said in an interview.
Isotretinoin, a retinoid marketed as Accutane and other brand names, is an effective treatment for acne but carries serious teratogenicity risks; the iPLEDGE Risk Evaluation and Mitigation Strategy is designed to manage this risk and minimize fetal exposure. Yet from 2011 to 2017, 210-310 pregnancies per year were reported to the Food and Drug Administration, according to a 2019 study.
There is a knowledge gap regarding EC among dermatologists who prescribe isotretinoin, which “is perpetuated by the iPLEDGE program because it is inadequate in guiding clinicians or educating patients about the use of EC,” Dr. Zaenglein and colleagues wrote in a recently published viewpoint on EC prescribing in patients on isotretinoin.
Types of EC include oral levonorgestrel (plan B), available over the counter; oral ulipristal acetate (ella), which requires a prescription; and the copper/hormonal intrauterine device.
Not all teens taking isotretinoin can be trusted to be sexually abstinent. Dr. Zaenglein cited research showing 39% of female high school students have had sexual relations. “In my opinion, these patients should have emergency contraception prescribed to them as a backup,” she said.
Dr. Zaenglein believes there’s a fair amount of “misunderstanding” about EC, with many people thinking it’s an abortion pill. “It’s a totally different medicine. This is contraception; if you’re pregnant, it’s not going to affect your fetus.”
Outgoing SPD President Sheilagh Maguiness, MD, professor of dermatology and pediatrics, University of Minnesota, Minneapolis, agreed that Dr. Zaenglein raised an important issue. “She has identified a practice gap and a knowledge gap that we need to address,” she said in an interview.
When discussing contraception with female patients taking isotretinoin, assume they’re sexually active or could be, Dr. Zaenglein told meeting attendees. Be explicit about the risks to the fetus and consider their past compliance.
Complex Disorder
During her presentation, Dr. Zaenglein described acne as a “very complex, multifactorial inflammatory disorder” of the skin. It involves four steps: Increased sebum production, hyperkeratinization, Cutibacterium acnes, and inflammation. External factors such as diet, genes, and the environment play a role.
“But at the heart of all of it is androgens; if you didn’t have androgens, you wouldn’t have acne.” That’s why some acne treatments block androgen receptors.
Clinicians are increasingly using one such therapy, spironolactone, to treat acne in female adolescents. Dr. Zaenglein referred to a Mayo Clinic study of 80 patients (mean age, 19 years), who had moderate to severe acne treated with a mean dose of 100 mg/day, that found 80% had improvement with a favorable side effect profile. This included nearly 23% who had a complete response (90% or more) and 36% who had a partial response (more than 50%); 20% had no response.
However, response rates are higher in adults, said Dr. Zaenglein, noting that spironolactone works “much better” in adult women.
Side effects of spironolactone can include menstrual disturbances, breast enlargement and tenderness, and premenstrual syndrome–like symptoms.
Dermatologists should also consider combined oral contraceptives (COCs) in their adolescent patients with acne. These have an estrogen component as well as a progestin component.
They have proven effectiveness for acne in adolescents, yet a US survey of 170 dermatology residents found only 60% felt comfortable prescribing them to healthy adolescents. The survey also found only 62% of respondents felt adequately trained on the efficacy of COCs, and 42% felt adequately trained on their safety.
Contraindications for COCs include thrombosis, migraine with aura, lupus, seizures, and hypertension. Complex valvular heart disease and liver tumors also need to be ruled out, said Dr. Zaenglein. One of the “newer concerns” with COCs is depression. “There’s biological plausibility because, obviously, hormones impact the brain.”
Preventing Drug Interactions
Before prescribing hormonal therapy, clinicians should carry out an acne assessment, aimed in part at preventing drug interactions. “The one we mostly have to watch out for is rifampin,” an antibiotic that could interact with COCs, said Dr. Zaenglein.
The herbal supplement St John’s Wort can reduce the efficacy of COCs. “You also want to make sure that they’re not on any medicines that will increase potassium, such as ACE inhibitors,” said Dr. Zaenglein. But tetracyclines, ampicillin, or metronidazole are usually “all okay” when combined with COCs.
It’s important to get baseline blood pressure levels and to check these along with weight on a regular basis, she added.
Always Consider PCOS
Before starting hormonal therapy, she advises dermatologists to “always consider” polycystic ovary syndrome (PCOS), a condition that’s “probably much underdiagnosed.” Acne is common in adolescents with PCOS. She suggests using a PCOS checklist, a reminder to ask about irregular periods, hirsutism, signs of insulin resistance such as increased body mass index, a history of premature adrenarche, and a family history of PCOS, said Dr. Zaenglein, noting that a person with a sibling who has PCOS has about a 40% chance of developing the condition.
“We play an important role in getting kids diagnosed at an early age so that we can make interventions because the impact of the metabolic syndrome can have lifelong effects on their cardiovascular system, as well as infertility.”
Dr. Zaenglein is a member of the American Academy of Dermatology (AAD) Acne Guidelines work group, the immediate past president of the American Acne and Rosacea Society, a member of the AAD iPLEDGE work group, co–editor in chief of Pediatric Dermatology, an advisory board member of Ortho Dermatologics, and a consultant for Church & Dwight. Dr. Maguiness had no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM SPD 2024
Several Skin Conditions More Likely in Children With Obesity
TORONTO — results of new research show.
The retrospective cohort study found markedly higher rates of skin infections, atopic dermatitis (AD), and acanthosis nigricans among children with overweight, compared with children with average weight.
“Many conditions associated with obesity are strong predictors of cardiovascular mortality as these children age, so doctors can play a key role in advocating for weight loss strategies in this population,” lead study author Samantha Epstein, third-year medical student at Case Western Reserve University, Cleveland, Ohio, said in an interview. The findings were presented at the annual meeting of the Society for Pediatric Dermatology.
Previous research has linked obesity, a chronic inflammatory condition, to psoriasis, AD, hidradenitis suppurativa (HS), acne vulgaris, infections, and rosacea in adults. However, there’s scant research exploring the connection between obesity and cutaneous conditions in children.
According to the Cleveland Clinic, childhood obesity is defined as a body mass index, which is weight in kg divided by the square of height in m2, at or above the 95th percentile for age and sex in children aged 2 years or older.
For the study, Ms. Epstein and coauthor Sonal D. Shah, MD, associate professor, Department of Dermatology, Case Western Reserve University, and a board-certified pediatric dermatologist accessed a large national research database and used diagnostic codes to identify over 1 million children (mean age, 8.5 years). Most (about 44%) were White; about one-quarter were Black. The groups were propensity matched, so there were about equal numbers of youngsters with and without obesity and of boys and girls.
They collected data on AD, HS, rosacea, psoriasis, and acanthosis nigricans (a thickened purplish discoloration typically found in body folds around the armpits, groin, and neck). They also gathered information on comorbidities.
Acanthosis nigricans, which is linked to metabolic syndrome, type 2 diabetes, and insulin resistance , was more prevalent among children with obesity (20,885 cases in the with-obesity group and 336 in the without-obesity group, for a relative risk [RR] of 62.16 and an odds ratio [OR] of 64.38).
Skin and subcutaneous tissue infections were also more common among those with obesity (14,795 cases) vs 4720 cases among those without obesity (RR, 3.14; OR, 3.2). As for AD, there were 11,892 cases in the with-obesity group and 2983 in the without-obesity group (RR, 3.99; OR, 4.06). There were 1166 cases of psoriasis among those with obesity and 408 among those without obesity (RR, 2.86; OR, 2.88).
HS (587 cases in the with-obesity group and 70 in the without-obesity group; RR, 8.39; OR, 8.39) and rosacea (351 in the with-obesity group and 138 in the without-obesity group; RR, 2.54; OR, 2.55) were the least common skin conditions.
Higher Comorbidity Rates
Compared with their average-weight counterparts, the children with obesity had higher rates of comorbidities, including type 2 diabetes. Ms. Epstein noted that children with diabetes and obesity had increased risks for every skin condition except for infections of the skin and subcutaneous tissue when compared with children without obesity.
Such infections were the most common skin conditions among children without obesity. “This was expected just due to the fact that children are outside, they’re playing in the grass and the dirt, and they get infected,” said Ms. Epstein. Still, these infections were three times more common in youngsters with obesity.
Although acanthosis nigricans is “highly correlated” with type 2 diabetes, “not as many children as we would expect in this population have developed type 2 diabetes,” said Ms. Epstein. This might make some sense, though, because these children are still quite young. “When dermatologists recognize this skin condition, they can advocate for weight loss management to try to prevent it.”
Other conditions seen more often in the overweight children with overweight included: hypertension, hyperlipidemia, obstructive sleep apnea, polycystic ovarian syndrome, attention-deficit/hyperactivity disorder, major depressive disorder, depressive episodes, and anxiety (all P < .001).
Commenting on the results, Sonia Havele, MD, a pediatrician and dermatology resident at Children’s Mercy Hospital, Kansas City, Missouri, said in an interview that the study reflects trends that she and her colleagues see in clinic: There are more common skin conditions in their patients with obesity.
She agreed that it offers an opening for education. “The results of this study highlight the opportunity we have as pediatric dermatologists to provide additional counseling on obesity and offer referrals to our colleagues in endocrinology, gastroenterology, and nutrition if needed.”
No conflicts of interest were reported.
TORONTO — results of new research show.
The retrospective cohort study found markedly higher rates of skin infections, atopic dermatitis (AD), and acanthosis nigricans among children with overweight, compared with children with average weight.
“Many conditions associated with obesity are strong predictors of cardiovascular mortality as these children age, so doctors can play a key role in advocating for weight loss strategies in this population,” lead study author Samantha Epstein, third-year medical student at Case Western Reserve University, Cleveland, Ohio, said in an interview. The findings were presented at the annual meeting of the Society for Pediatric Dermatology.
Previous research has linked obesity, a chronic inflammatory condition, to psoriasis, AD, hidradenitis suppurativa (HS), acne vulgaris, infections, and rosacea in adults. However, there’s scant research exploring the connection between obesity and cutaneous conditions in children.
According to the Cleveland Clinic, childhood obesity is defined as a body mass index, which is weight in kg divided by the square of height in m2, at or above the 95th percentile for age and sex in children aged 2 years or older.
For the study, Ms. Epstein and coauthor Sonal D. Shah, MD, associate professor, Department of Dermatology, Case Western Reserve University, and a board-certified pediatric dermatologist accessed a large national research database and used diagnostic codes to identify over 1 million children (mean age, 8.5 years). Most (about 44%) were White; about one-quarter were Black. The groups were propensity matched, so there were about equal numbers of youngsters with and without obesity and of boys and girls.
They collected data on AD, HS, rosacea, psoriasis, and acanthosis nigricans (a thickened purplish discoloration typically found in body folds around the armpits, groin, and neck). They also gathered information on comorbidities.
Acanthosis nigricans, which is linked to metabolic syndrome, type 2 diabetes, and insulin resistance , was more prevalent among children with obesity (20,885 cases in the with-obesity group and 336 in the without-obesity group, for a relative risk [RR] of 62.16 and an odds ratio [OR] of 64.38).
Skin and subcutaneous tissue infections were also more common among those with obesity (14,795 cases) vs 4720 cases among those without obesity (RR, 3.14; OR, 3.2). As for AD, there were 11,892 cases in the with-obesity group and 2983 in the without-obesity group (RR, 3.99; OR, 4.06). There were 1166 cases of psoriasis among those with obesity and 408 among those without obesity (RR, 2.86; OR, 2.88).
HS (587 cases in the with-obesity group and 70 in the without-obesity group; RR, 8.39; OR, 8.39) and rosacea (351 in the with-obesity group and 138 in the without-obesity group; RR, 2.54; OR, 2.55) were the least common skin conditions.
Higher Comorbidity Rates
Compared with their average-weight counterparts, the children with obesity had higher rates of comorbidities, including type 2 diabetes. Ms. Epstein noted that children with diabetes and obesity had increased risks for every skin condition except for infections of the skin and subcutaneous tissue when compared with children without obesity.
Such infections were the most common skin conditions among children without obesity. “This was expected just due to the fact that children are outside, they’re playing in the grass and the dirt, and they get infected,” said Ms. Epstein. Still, these infections were three times more common in youngsters with obesity.
Although acanthosis nigricans is “highly correlated” with type 2 diabetes, “not as many children as we would expect in this population have developed type 2 diabetes,” said Ms. Epstein. This might make some sense, though, because these children are still quite young. “When dermatologists recognize this skin condition, they can advocate for weight loss management to try to prevent it.”
Other conditions seen more often in the overweight children with overweight included: hypertension, hyperlipidemia, obstructive sleep apnea, polycystic ovarian syndrome, attention-deficit/hyperactivity disorder, major depressive disorder, depressive episodes, and anxiety (all P < .001).
Commenting on the results, Sonia Havele, MD, a pediatrician and dermatology resident at Children’s Mercy Hospital, Kansas City, Missouri, said in an interview that the study reflects trends that she and her colleagues see in clinic: There are more common skin conditions in their patients with obesity.
She agreed that it offers an opening for education. “The results of this study highlight the opportunity we have as pediatric dermatologists to provide additional counseling on obesity and offer referrals to our colleagues in endocrinology, gastroenterology, and nutrition if needed.”
No conflicts of interest were reported.
TORONTO — results of new research show.
The retrospective cohort study found markedly higher rates of skin infections, atopic dermatitis (AD), and acanthosis nigricans among children with overweight, compared with children with average weight.
“Many conditions associated with obesity are strong predictors of cardiovascular mortality as these children age, so doctors can play a key role in advocating for weight loss strategies in this population,” lead study author Samantha Epstein, third-year medical student at Case Western Reserve University, Cleveland, Ohio, said in an interview. The findings were presented at the annual meeting of the Society for Pediatric Dermatology.
Previous research has linked obesity, a chronic inflammatory condition, to psoriasis, AD, hidradenitis suppurativa (HS), acne vulgaris, infections, and rosacea in adults. However, there’s scant research exploring the connection between obesity and cutaneous conditions in children.
According to the Cleveland Clinic, childhood obesity is defined as a body mass index, which is weight in kg divided by the square of height in m2, at or above the 95th percentile for age and sex in children aged 2 years or older.
For the study, Ms. Epstein and coauthor Sonal D. Shah, MD, associate professor, Department of Dermatology, Case Western Reserve University, and a board-certified pediatric dermatologist accessed a large national research database and used diagnostic codes to identify over 1 million children (mean age, 8.5 years). Most (about 44%) were White; about one-quarter were Black. The groups were propensity matched, so there were about equal numbers of youngsters with and without obesity and of boys and girls.
They collected data on AD, HS, rosacea, psoriasis, and acanthosis nigricans (a thickened purplish discoloration typically found in body folds around the armpits, groin, and neck). They also gathered information on comorbidities.
Acanthosis nigricans, which is linked to metabolic syndrome, type 2 diabetes, and insulin resistance , was more prevalent among children with obesity (20,885 cases in the with-obesity group and 336 in the without-obesity group, for a relative risk [RR] of 62.16 and an odds ratio [OR] of 64.38).
Skin and subcutaneous tissue infections were also more common among those with obesity (14,795 cases) vs 4720 cases among those without obesity (RR, 3.14; OR, 3.2). As for AD, there were 11,892 cases in the with-obesity group and 2983 in the without-obesity group (RR, 3.99; OR, 4.06). There were 1166 cases of psoriasis among those with obesity and 408 among those without obesity (RR, 2.86; OR, 2.88).
HS (587 cases in the with-obesity group and 70 in the without-obesity group; RR, 8.39; OR, 8.39) and rosacea (351 in the with-obesity group and 138 in the without-obesity group; RR, 2.54; OR, 2.55) were the least common skin conditions.
Higher Comorbidity Rates
Compared with their average-weight counterparts, the children with obesity had higher rates of comorbidities, including type 2 diabetes. Ms. Epstein noted that children with diabetes and obesity had increased risks for every skin condition except for infections of the skin and subcutaneous tissue when compared with children without obesity.
Such infections were the most common skin conditions among children without obesity. “This was expected just due to the fact that children are outside, they’re playing in the grass and the dirt, and they get infected,” said Ms. Epstein. Still, these infections were three times more common in youngsters with obesity.
Although acanthosis nigricans is “highly correlated” with type 2 diabetes, “not as many children as we would expect in this population have developed type 2 diabetes,” said Ms. Epstein. This might make some sense, though, because these children are still quite young. “When dermatologists recognize this skin condition, they can advocate for weight loss management to try to prevent it.”
Other conditions seen more often in the overweight children with overweight included: hypertension, hyperlipidemia, obstructive sleep apnea, polycystic ovarian syndrome, attention-deficit/hyperactivity disorder, major depressive disorder, depressive episodes, and anxiety (all P < .001).
Commenting on the results, Sonia Havele, MD, a pediatrician and dermatology resident at Children’s Mercy Hospital, Kansas City, Missouri, said in an interview that the study reflects trends that she and her colleagues see in clinic: There are more common skin conditions in their patients with obesity.
She agreed that it offers an opening for education. “The results of this study highlight the opportunity we have as pediatric dermatologists to provide additional counseling on obesity and offer referrals to our colleagues in endocrinology, gastroenterology, and nutrition if needed.”
No conflicts of interest were reported.
FROM SPD 2024
Topical Ruxolitinib: Analysis Finds Repigmentation Rates in Adolescents with Vitiligo
data showed.
“We consider repigmenting vitiligo a two-step process, where the overactive immune system needs to be calmed down and then the melanocytes need to repopulate to the white areas,” one of the study investigators, David Rosmarin, MD, chair of the Department of Dermatology at Indiana University School of Medicine, Indianapolis, said in an interview in advance of the annual meeting of the Society for Pediatric Dermatology, where the study results were presented during a poster session. “In younger patients, it may be that the melanocytes are more rapidly repigmenting the patches, which is why we see this effect.”
Ruxolitinib, 1.5% cream (Opzelura) is a Janus kinase inhibitor approved for the treatment of nonsegmental vitiligo in patients 12 years of age and older. Dr. Rosmarin and colleagues sought to evaluate differences in rates of complete or near-complete repigmentation and repigmentation by body region between adolescents 12-17 years of age and adults 18 years of age and older who applied ruxolitinib cream twice daily. The researchers evaluated patients who were initially randomized to ruxolitinib cream, 1.5% in the pivotal TRuE-V1 and TRuE-V2 studies and applied it for up to 104 weeks. Complete facial improvement was defined as 100% improvement on the Facial Vitiligo Area Scoring Index (F-VASI 100) from baseline, and near-total improvement was categorized as a ≥ 75% or ≥ 90% improvement from baseline on the Total body VASI (T-VASI). Responses for each of six body regions, excluding the face, were assessed by the proportion of patients who achieved at least a 50% improvement from baseline on the T-VASI.
Compared with adults, a greater proportion of adolescents achieved F-VASI 100 at week 24 (5.7% [3/53] vs 2.9% [10/341], respectively), but there were no differences between the two groups at week 52 (8.0% [4/50] vs 8.0% [24/300]). Response rates were greater among adolescents vs adults for T-VASI 75 at weeks 24 (13.2% [7/53] vs 5.6% [19/341]) and 52 (22.0% [11/50] vs 20.3% [61/300]), as well as T-VASI 90 at weeks 24 (3.8% [2/53] vs 0.3% [1/341]) and 52 (12.0% [6/50] vs 4.0% [12/300]).
The researchers observed that VASI 50 responses by body region were generally similar between adolescents and adults, but a greater proportion of adolescents achieved a VASI 50 in lower extremities (67.3% [33/49] vs 51.8% [118/228]) and feet (37.5% [12/32] vs 27.9% [51/183]) at week 52.
“Adolescents repigmented more rapidly than adults, so that at 24 weeks, more teens had complete facial repigmentation and T-VASI 75 and T-VASI 90 results,” Dr. Rosmarin said. “With continued use of ruxolitinib cream, both more adults and adolescents achieved greater repigmentation.” He acknowledged certain limitations of the study, including the fact that it was only vehicle controlled up through 24 weeks and that, after week 52, there were fewer patients who completed the long-term extension.
“The take-home message is that ruxolitinib cream can effectively and safely help many patients repigment, including adolescents,” he said.
The study was funded by topical ruxolitinib manufacturer Incyte. Dr. Rosmarin disclosed that he has consulted, spoken for, or conducted trials for AbbVie, Abcuro, Almirall, AltruBio, Amgen, Arena, Astria, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant Sciences, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Nektar, Novartis, Pfizer, RAPT, Regeneron, Recludix Pharma, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, Viela Bio, and Zura.
A version of this article first appeared on Medscape.com.
data showed.
“We consider repigmenting vitiligo a two-step process, where the overactive immune system needs to be calmed down and then the melanocytes need to repopulate to the white areas,” one of the study investigators, David Rosmarin, MD, chair of the Department of Dermatology at Indiana University School of Medicine, Indianapolis, said in an interview in advance of the annual meeting of the Society for Pediatric Dermatology, where the study results were presented during a poster session. “In younger patients, it may be that the melanocytes are more rapidly repigmenting the patches, which is why we see this effect.”
Ruxolitinib, 1.5% cream (Opzelura) is a Janus kinase inhibitor approved for the treatment of nonsegmental vitiligo in patients 12 years of age and older. Dr. Rosmarin and colleagues sought to evaluate differences in rates of complete or near-complete repigmentation and repigmentation by body region between adolescents 12-17 years of age and adults 18 years of age and older who applied ruxolitinib cream twice daily. The researchers evaluated patients who were initially randomized to ruxolitinib cream, 1.5% in the pivotal TRuE-V1 and TRuE-V2 studies and applied it for up to 104 weeks. Complete facial improvement was defined as 100% improvement on the Facial Vitiligo Area Scoring Index (F-VASI 100) from baseline, and near-total improvement was categorized as a ≥ 75% or ≥ 90% improvement from baseline on the Total body VASI (T-VASI). Responses for each of six body regions, excluding the face, were assessed by the proportion of patients who achieved at least a 50% improvement from baseline on the T-VASI.
Compared with adults, a greater proportion of adolescents achieved F-VASI 100 at week 24 (5.7% [3/53] vs 2.9% [10/341], respectively), but there were no differences between the two groups at week 52 (8.0% [4/50] vs 8.0% [24/300]). Response rates were greater among adolescents vs adults for T-VASI 75 at weeks 24 (13.2% [7/53] vs 5.6% [19/341]) and 52 (22.0% [11/50] vs 20.3% [61/300]), as well as T-VASI 90 at weeks 24 (3.8% [2/53] vs 0.3% [1/341]) and 52 (12.0% [6/50] vs 4.0% [12/300]).
The researchers observed that VASI 50 responses by body region were generally similar between adolescents and adults, but a greater proportion of adolescents achieved a VASI 50 in lower extremities (67.3% [33/49] vs 51.8% [118/228]) and feet (37.5% [12/32] vs 27.9% [51/183]) at week 52.
“Adolescents repigmented more rapidly than adults, so that at 24 weeks, more teens had complete facial repigmentation and T-VASI 75 and T-VASI 90 results,” Dr. Rosmarin said. “With continued use of ruxolitinib cream, both more adults and adolescents achieved greater repigmentation.” He acknowledged certain limitations of the study, including the fact that it was only vehicle controlled up through 24 weeks and that, after week 52, there were fewer patients who completed the long-term extension.
“The take-home message is that ruxolitinib cream can effectively and safely help many patients repigment, including adolescents,” he said.
The study was funded by topical ruxolitinib manufacturer Incyte. Dr. Rosmarin disclosed that he has consulted, spoken for, or conducted trials for AbbVie, Abcuro, Almirall, AltruBio, Amgen, Arena, Astria, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant Sciences, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Nektar, Novartis, Pfizer, RAPT, Regeneron, Recludix Pharma, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, Viela Bio, and Zura.
A version of this article first appeared on Medscape.com.
data showed.
“We consider repigmenting vitiligo a two-step process, where the overactive immune system needs to be calmed down and then the melanocytes need to repopulate to the white areas,” one of the study investigators, David Rosmarin, MD, chair of the Department of Dermatology at Indiana University School of Medicine, Indianapolis, said in an interview in advance of the annual meeting of the Society for Pediatric Dermatology, where the study results were presented during a poster session. “In younger patients, it may be that the melanocytes are more rapidly repigmenting the patches, which is why we see this effect.”
Ruxolitinib, 1.5% cream (Opzelura) is a Janus kinase inhibitor approved for the treatment of nonsegmental vitiligo in patients 12 years of age and older. Dr. Rosmarin and colleagues sought to evaluate differences in rates of complete or near-complete repigmentation and repigmentation by body region between adolescents 12-17 years of age and adults 18 years of age and older who applied ruxolitinib cream twice daily. The researchers evaluated patients who were initially randomized to ruxolitinib cream, 1.5% in the pivotal TRuE-V1 and TRuE-V2 studies and applied it for up to 104 weeks. Complete facial improvement was defined as 100% improvement on the Facial Vitiligo Area Scoring Index (F-VASI 100) from baseline, and near-total improvement was categorized as a ≥ 75% or ≥ 90% improvement from baseline on the Total body VASI (T-VASI). Responses for each of six body regions, excluding the face, were assessed by the proportion of patients who achieved at least a 50% improvement from baseline on the T-VASI.
Compared with adults, a greater proportion of adolescents achieved F-VASI 100 at week 24 (5.7% [3/53] vs 2.9% [10/341], respectively), but there were no differences between the two groups at week 52 (8.0% [4/50] vs 8.0% [24/300]). Response rates were greater among adolescents vs adults for T-VASI 75 at weeks 24 (13.2% [7/53] vs 5.6% [19/341]) and 52 (22.0% [11/50] vs 20.3% [61/300]), as well as T-VASI 90 at weeks 24 (3.8% [2/53] vs 0.3% [1/341]) and 52 (12.0% [6/50] vs 4.0% [12/300]).
The researchers observed that VASI 50 responses by body region were generally similar between adolescents and adults, but a greater proportion of adolescents achieved a VASI 50 in lower extremities (67.3% [33/49] vs 51.8% [118/228]) and feet (37.5% [12/32] vs 27.9% [51/183]) at week 52.
“Adolescents repigmented more rapidly than adults, so that at 24 weeks, more teens had complete facial repigmentation and T-VASI 75 and T-VASI 90 results,” Dr. Rosmarin said. “With continued use of ruxolitinib cream, both more adults and adolescents achieved greater repigmentation.” He acknowledged certain limitations of the study, including the fact that it was only vehicle controlled up through 24 weeks and that, after week 52, there were fewer patients who completed the long-term extension.
“The take-home message is that ruxolitinib cream can effectively and safely help many patients repigment, including adolescents,” he said.
The study was funded by topical ruxolitinib manufacturer Incyte. Dr. Rosmarin disclosed that he has consulted, spoken for, or conducted trials for AbbVie, Abcuro, Almirall, AltruBio, Amgen, Arena, Astria, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant Sciences, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Nektar, Novartis, Pfizer, RAPT, Regeneron, Recludix Pharma, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, Viela Bio, and Zura.
A version of this article first appeared on Medscape.com.
FROM SPD 2024
It’s the Television, Stupid
As more and more of us begin to feel (or believe we are feeling) the symptoms of aging, our language has begun to incorporate new words and phrases such as “aging in place” or “healthy aging.” In fact, some scientists have created a diagnostic criteria to define “healthy aging.” If you have reached your 70th birthday without mental health issues, memory issues, physical impairments, or chronic disease, according to some researchers at T.H. Chan School of Public Health and Brigham and Women’s Hospital, you should receive a gold star for healthy aging.
I am now nearly a decade past that milestone and can’t remember where I’ve put my gold star, or even if I had ever received one. But, I get up each morning looking forward to another day of activity and feeling “pretty good.”
Healthy aging is not something you start doing when you turn 65. Aging is something that goes on from the moment you are born. For the first couple decades we call it “maturing.” If you have lived well, the odds are you will age well. And, for that reason we should take note of some recent work by Boston-based researchers.
Looking at recent data from 45,000 participants in the well-known Nurses Health Study, the investigators found that for every 2-hour increase in daily sedentary behavior, the participants cut their chances of healthy aging by 12%. On the other hand, for every 2 hours of light physical activity, they increased their odds of healthy aging by 6 %.
There are two important messages sitting just below the surface of these two observations. First, we continue to overemphasize the importance of “exercise” in our attempt to help our patients achieve wellness. The word “exercise” carries with it whole carousel full of baggage including “fitness programs,” gym memberships, pulse rate monitors, pain, sweat, and spandex, to name just a few. Exercise can conjure up bad memories of suiting up for phys ed class, group showers, and being picked last when teams were being chosen.
It turns out the we should simply be promoting activity, and light activity at that — vacuuming the living room, walking around the block, rearranging the books on your bedroom book shelf, making a pot of soup, doing the laundry. Just getting up off one’s behind and doing something instead of being a passive spectator.
This somewhat counterintuitive notion of the benefit of light activity is beginning to get more attention. Earlier this year, I reported on a study by Andre O. Abaje MD, MPH, in which he showed that light physical activity in children was superior to more vigorous activity in lowering lipids.
The more important message embedded in this paper based on the Nurses Health Study is that the researchers used television watching time as their proxy for sedentary behavior. The investigators chose TV viewing because it is ubiquitous and includes prolonged sitting. Being semi-reclined on the couch or in a lounger requires very little muscle activity, which is in turn linked to disruption of glucose metabolism, increased inflammation, and altered blood flow to the brain, to name just a few of its collateral damages. I would add that TV viewing often prompts viewers to stay up well beyond their healthy bedtime. And, we know sleep deprivation is not compatible with health aging.
A traditional warning issued to new retirees was once “Don’t let the old rocking chair get ya.” In fact, I wonder how many folks watching television even have or use wood rocking chairs anymore, which, if rocked, might qualify as a light exercise if the viewer made the effort to rock. Instead I suspect most television viewing is done cocooned in soft recliners or curled up on a couch.
I will admit that this recent paper merely supports a suspicion I have harbored for decades. Like many of you, I have wondered how our society got to the point where obesity is frequent enough to be labeled a disease, attention deficit diagnoses are becoming increasingly prevalent, and our life expectancy is shrinking. There are dozens of factors, but if I had to pick one, I would paraphrase James Carville’s advice to Bill Clinton: “It’s the television, stupid.”
At least a couple of notches above “Are you wearing your seatbelt?” It can start with a nonjudgmental question such as “What are your favorite television shows?” And then deftly move toward compiling a tally of how many hours the patient watches each day.
How you manage the situation from there is up to you and can be based on the patient’s complaints and problem list. You might suggest he or she start by eliminating 2 hours of viewing a day. Then ask if he or she thinks that new schedule is achievable. If they ask for alternatives, be ready with a list of light activities that they might be surprised are healthier than their current behavior. Follow up with another visit or a call to see how they are doing. It’s that important, and your call will underscore your concern.
Sedentism is a serious health problem in this country and our emphasis on encouraging vigorous exercise isn’t working. Selling a television diet will be a tough sell, but it needs to be done.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
As more and more of us begin to feel (or believe we are feeling) the symptoms of aging, our language has begun to incorporate new words and phrases such as “aging in place” or “healthy aging.” In fact, some scientists have created a diagnostic criteria to define “healthy aging.” If you have reached your 70th birthday without mental health issues, memory issues, physical impairments, or chronic disease, according to some researchers at T.H. Chan School of Public Health and Brigham and Women’s Hospital, you should receive a gold star for healthy aging.
I am now nearly a decade past that milestone and can’t remember where I’ve put my gold star, or even if I had ever received one. But, I get up each morning looking forward to another day of activity and feeling “pretty good.”
Healthy aging is not something you start doing when you turn 65. Aging is something that goes on from the moment you are born. For the first couple decades we call it “maturing.” If you have lived well, the odds are you will age well. And, for that reason we should take note of some recent work by Boston-based researchers.
Looking at recent data from 45,000 participants in the well-known Nurses Health Study, the investigators found that for every 2-hour increase in daily sedentary behavior, the participants cut their chances of healthy aging by 12%. On the other hand, for every 2 hours of light physical activity, they increased their odds of healthy aging by 6 %.
There are two important messages sitting just below the surface of these two observations. First, we continue to overemphasize the importance of “exercise” in our attempt to help our patients achieve wellness. The word “exercise” carries with it whole carousel full of baggage including “fitness programs,” gym memberships, pulse rate monitors, pain, sweat, and spandex, to name just a few. Exercise can conjure up bad memories of suiting up for phys ed class, group showers, and being picked last when teams were being chosen.
It turns out the we should simply be promoting activity, and light activity at that — vacuuming the living room, walking around the block, rearranging the books on your bedroom book shelf, making a pot of soup, doing the laundry. Just getting up off one’s behind and doing something instead of being a passive spectator.
This somewhat counterintuitive notion of the benefit of light activity is beginning to get more attention. Earlier this year, I reported on a study by Andre O. Abaje MD, MPH, in which he showed that light physical activity in children was superior to more vigorous activity in lowering lipids.
The more important message embedded in this paper based on the Nurses Health Study is that the researchers used television watching time as their proxy for sedentary behavior. The investigators chose TV viewing because it is ubiquitous and includes prolonged sitting. Being semi-reclined on the couch or in a lounger requires very little muscle activity, which is in turn linked to disruption of glucose metabolism, increased inflammation, and altered blood flow to the brain, to name just a few of its collateral damages. I would add that TV viewing often prompts viewers to stay up well beyond their healthy bedtime. And, we know sleep deprivation is not compatible with health aging.
A traditional warning issued to new retirees was once “Don’t let the old rocking chair get ya.” In fact, I wonder how many folks watching television even have or use wood rocking chairs anymore, which, if rocked, might qualify as a light exercise if the viewer made the effort to rock. Instead I suspect most television viewing is done cocooned in soft recliners or curled up on a couch.
I will admit that this recent paper merely supports a suspicion I have harbored for decades. Like many of you, I have wondered how our society got to the point where obesity is frequent enough to be labeled a disease, attention deficit diagnoses are becoming increasingly prevalent, and our life expectancy is shrinking. There are dozens of factors, but if I had to pick one, I would paraphrase James Carville’s advice to Bill Clinton: “It’s the television, stupid.”
At least a couple of notches above “Are you wearing your seatbelt?” It can start with a nonjudgmental question such as “What are your favorite television shows?” And then deftly move toward compiling a tally of how many hours the patient watches each day.
How you manage the situation from there is up to you and can be based on the patient’s complaints and problem list. You might suggest he or she start by eliminating 2 hours of viewing a day. Then ask if he or she thinks that new schedule is achievable. If they ask for alternatives, be ready with a list of light activities that they might be surprised are healthier than their current behavior. Follow up with another visit or a call to see how they are doing. It’s that important, and your call will underscore your concern.
Sedentism is a serious health problem in this country and our emphasis on encouraging vigorous exercise isn’t working. Selling a television diet will be a tough sell, but it needs to be done.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
As more and more of us begin to feel (or believe we are feeling) the symptoms of aging, our language has begun to incorporate new words and phrases such as “aging in place” or “healthy aging.” In fact, some scientists have created a diagnostic criteria to define “healthy aging.” If you have reached your 70th birthday without mental health issues, memory issues, physical impairments, or chronic disease, according to some researchers at T.H. Chan School of Public Health and Brigham and Women’s Hospital, you should receive a gold star for healthy aging.
I am now nearly a decade past that milestone and can’t remember where I’ve put my gold star, or even if I had ever received one. But, I get up each morning looking forward to another day of activity and feeling “pretty good.”
Healthy aging is not something you start doing when you turn 65. Aging is something that goes on from the moment you are born. For the first couple decades we call it “maturing.” If you have lived well, the odds are you will age well. And, for that reason we should take note of some recent work by Boston-based researchers.
Looking at recent data from 45,000 participants in the well-known Nurses Health Study, the investigators found that for every 2-hour increase in daily sedentary behavior, the participants cut their chances of healthy aging by 12%. On the other hand, for every 2 hours of light physical activity, they increased their odds of healthy aging by 6 %.
There are two important messages sitting just below the surface of these two observations. First, we continue to overemphasize the importance of “exercise” in our attempt to help our patients achieve wellness. The word “exercise” carries with it whole carousel full of baggage including “fitness programs,” gym memberships, pulse rate monitors, pain, sweat, and spandex, to name just a few. Exercise can conjure up bad memories of suiting up for phys ed class, group showers, and being picked last when teams were being chosen.
It turns out the we should simply be promoting activity, and light activity at that — vacuuming the living room, walking around the block, rearranging the books on your bedroom book shelf, making a pot of soup, doing the laundry. Just getting up off one’s behind and doing something instead of being a passive spectator.
This somewhat counterintuitive notion of the benefit of light activity is beginning to get more attention. Earlier this year, I reported on a study by Andre O. Abaje MD, MPH, in which he showed that light physical activity in children was superior to more vigorous activity in lowering lipids.
The more important message embedded in this paper based on the Nurses Health Study is that the researchers used television watching time as their proxy for sedentary behavior. The investigators chose TV viewing because it is ubiquitous and includes prolonged sitting. Being semi-reclined on the couch or in a lounger requires very little muscle activity, which is in turn linked to disruption of glucose metabolism, increased inflammation, and altered blood flow to the brain, to name just a few of its collateral damages. I would add that TV viewing often prompts viewers to stay up well beyond their healthy bedtime. And, we know sleep deprivation is not compatible with health aging.
A traditional warning issued to new retirees was once “Don’t let the old rocking chair get ya.” In fact, I wonder how many folks watching television even have or use wood rocking chairs anymore, which, if rocked, might qualify as a light exercise if the viewer made the effort to rock. Instead I suspect most television viewing is done cocooned in soft recliners or curled up on a couch.
I will admit that this recent paper merely supports a suspicion I have harbored for decades. Like many of you, I have wondered how our society got to the point where obesity is frequent enough to be labeled a disease, attention deficit diagnoses are becoming increasingly prevalent, and our life expectancy is shrinking. There are dozens of factors, but if I had to pick one, I would paraphrase James Carville’s advice to Bill Clinton: “It’s the television, stupid.”
At least a couple of notches above “Are you wearing your seatbelt?” It can start with a nonjudgmental question such as “What are your favorite television shows?” And then deftly move toward compiling a tally of how many hours the patient watches each day.
How you manage the situation from there is up to you and can be based on the patient’s complaints and problem list. You might suggest he or she start by eliminating 2 hours of viewing a day. Then ask if he or she thinks that new schedule is achievable. If they ask for alternatives, be ready with a list of light activities that they might be surprised are healthier than their current behavior. Follow up with another visit or a call to see how they are doing. It’s that important, and your call will underscore your concern.
Sedentism is a serious health problem in this country and our emphasis on encouraging vigorous exercise isn’t working. Selling a television diet will be a tough sell, but it needs to be done.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Debate: Should Dermatologists or Rheumatologists Manage Musculoskeletal Symptoms in Patients With Psoriasis?
SEATTLE — That was the subject of a debate between a dermatologist and a rheumatologist at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
Fabian Proft, MD, the rheumatologist, spoke first and emphasized the potential that MSK symptoms are a sign of psoriatic arthritis (PsA) and therefore should be managed by a rheumatologist.
“Obviously, the rheumatologist perspective [is that] I should be in the driver’s seat when taking care of patient with psoriasis and MSK symptoms, but I will still need to have a copilot there: [The dermatologist] will have a slot,” said Dr. Proft, who is a rheumatologist at Charité — Universitätsmedizin Berlin.
“It’s so important that we make the correct and early diagnosis of [psoriatic arthritis and psoriasis] symptoms,” said Dr. Proft. He specifically called out cases where patients have symptoms that are difficult to determine, whether the cause is inflammatory, and when experience with imaging can be a key factor in the diagnosis.
It’s important not to overdiagnose or overtreat patients, he said, providing an example of a patient with psoriasis who had been training for a marathon. The MRI image suggested that his Achilles tendonitis pain was related to his athletic training, not PsA-associated inflammation. “So I think this is very important that you have the knowledge to read MRIs, and especially also carefully assessing them so as not to overdiagnose patients,” said Dr. Proft.
Dermatologist Rebuttal
In her rebuttal, Laura Savage, MD, PhD, emphasized the need for more of a coequal partnership between the two specialties because of the ability of dermatologists to intervene early in the treatment and prevention of PsA.
“Traditionally, I agree rheumatologists would solely be responsible for the assessment and the management of psoriatic arthritis, but I think that paradigm has shifted in part due to the increased recognition of the need for earlier intervention to limit disease progression and to reduce or even prevent functional limitation,” said Dr. Savage, who is a consultant dermatologist at Leeds Teaching Hospitals NHS Trust and a senior lecturer at the University of Leeds, Leeds, England.
Ideally, molecular biomarkers would be available to predict the development of PsA, but there aren’t any. Still, “we have a huge biomarker in the form of the skin, and it’s recognized that the majority of patients who will develop psoriatic arthritis will have antecedent psoriasis in about 70% of cases,” Dr. Savage said. “There’s a typical time delay of around 7-12 years between the onset of the skin [disease] and the patients developing psoriatic arthritis, and so many of them are going to be into the care of other healthcare practitioners, and particularly the care of dermatologists.”
Dermatologists may also be able to play a role in the prevention of PsA, according to Dr. Savage. In one retrospective study, treatment of skin lesions with biologics was associated with a reduced frequency of progression to PsA (11.1% vs 16.4%) over 10 years (P = .0006). Studies with tumor necrosis factor inhibitors and other interventions have shown similar results.
Such findings have led to the treat intercept strategy, which targets patients with psoriasis who have risk factors for transition to PsA — such as nail pitting, gluteal cleft disease, scalp disease, type 2 diabetes, obesity, and a first-degree relative with PsA — as well as symptoms of prodromal PSA, such as arthralgia and fatigue.
“I think dermatologists are aware of the need to not leave our patients languishing on these therapies and actually escalating them onto effective treatments that may also be able to treat early psoriatic arthritis. We could be more mindful about our choice of treatments for these patients, going on to thinking about their increased risk of PSA and trying to intercept,” Dr. Savage said. “What we don’t want is our patients to be developing these musculoskeletal symptoms of pain and stiffness and functional limitation and disability. We want to be treating the patients with musculoskeletal symptoms of that earlier prodromal phase when they’re developing arthralgia and fatigue.”
She conceded that more complicated patients are good candidates for care by the rheumatologist. “You can do your fancy imaging, and we’ll leave that to you, and the difficult-to-treat patients to [the rheumatologist], but actually we need to just get on and treat them,” she said. “One could argue as well that as a dermatologist, I’m likely to broaden my horizons in terms of choice of therapy and treat all of the domains of the patient. So I would argue that actually it should be the dermatologist who is in that driving seat, particularly when it comes to the management of early psoriatic arthritis, and actually what we should be doing is driving our patients and steering them to earlier intervention and better control for all domains of disease.”
Collaborative Care
During the follow-up discussion, both Dr. Proft and Dr. Savage agreed that dermatologists and rheumatologists should be working together in managing patients. “What we need to do is steer our patients toward collaborative care with our rheumatologists by trying to minimize delays to treatment, by working together in parallel clinics, combined clinics, and on virtual [multidisciplinary teams],” said Dr. Savage.
Dr. Proft agreed. “We should join forces and make decisions together.”
Dr. Savage and Dr. Proft did not provide any financial disclosures.
A version of this article appeared on Medscape.com.
SEATTLE — That was the subject of a debate between a dermatologist and a rheumatologist at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
Fabian Proft, MD, the rheumatologist, spoke first and emphasized the potential that MSK symptoms are a sign of psoriatic arthritis (PsA) and therefore should be managed by a rheumatologist.
“Obviously, the rheumatologist perspective [is that] I should be in the driver’s seat when taking care of patient with psoriasis and MSK symptoms, but I will still need to have a copilot there: [The dermatologist] will have a slot,” said Dr. Proft, who is a rheumatologist at Charité — Universitätsmedizin Berlin.
“It’s so important that we make the correct and early diagnosis of [psoriatic arthritis and psoriasis] symptoms,” said Dr. Proft. He specifically called out cases where patients have symptoms that are difficult to determine, whether the cause is inflammatory, and when experience with imaging can be a key factor in the diagnosis.
It’s important not to overdiagnose or overtreat patients, he said, providing an example of a patient with psoriasis who had been training for a marathon. The MRI image suggested that his Achilles tendonitis pain was related to his athletic training, not PsA-associated inflammation. “So I think this is very important that you have the knowledge to read MRIs, and especially also carefully assessing them so as not to overdiagnose patients,” said Dr. Proft.
Dermatologist Rebuttal
In her rebuttal, Laura Savage, MD, PhD, emphasized the need for more of a coequal partnership between the two specialties because of the ability of dermatologists to intervene early in the treatment and prevention of PsA.
“Traditionally, I agree rheumatologists would solely be responsible for the assessment and the management of psoriatic arthritis, but I think that paradigm has shifted in part due to the increased recognition of the need for earlier intervention to limit disease progression and to reduce or even prevent functional limitation,” said Dr. Savage, who is a consultant dermatologist at Leeds Teaching Hospitals NHS Trust and a senior lecturer at the University of Leeds, Leeds, England.
Ideally, molecular biomarkers would be available to predict the development of PsA, but there aren’t any. Still, “we have a huge biomarker in the form of the skin, and it’s recognized that the majority of patients who will develop psoriatic arthritis will have antecedent psoriasis in about 70% of cases,” Dr. Savage said. “There’s a typical time delay of around 7-12 years between the onset of the skin [disease] and the patients developing psoriatic arthritis, and so many of them are going to be into the care of other healthcare practitioners, and particularly the care of dermatologists.”
Dermatologists may also be able to play a role in the prevention of PsA, according to Dr. Savage. In one retrospective study, treatment of skin lesions with biologics was associated with a reduced frequency of progression to PsA (11.1% vs 16.4%) over 10 years (P = .0006). Studies with tumor necrosis factor inhibitors and other interventions have shown similar results.
Such findings have led to the treat intercept strategy, which targets patients with psoriasis who have risk factors for transition to PsA — such as nail pitting, gluteal cleft disease, scalp disease, type 2 diabetes, obesity, and a first-degree relative with PsA — as well as symptoms of prodromal PSA, such as arthralgia and fatigue.
“I think dermatologists are aware of the need to not leave our patients languishing on these therapies and actually escalating them onto effective treatments that may also be able to treat early psoriatic arthritis. We could be more mindful about our choice of treatments for these patients, going on to thinking about their increased risk of PSA and trying to intercept,” Dr. Savage said. “What we don’t want is our patients to be developing these musculoskeletal symptoms of pain and stiffness and functional limitation and disability. We want to be treating the patients with musculoskeletal symptoms of that earlier prodromal phase when they’re developing arthralgia and fatigue.”
She conceded that more complicated patients are good candidates for care by the rheumatologist. “You can do your fancy imaging, and we’ll leave that to you, and the difficult-to-treat patients to [the rheumatologist], but actually we need to just get on and treat them,” she said. “One could argue as well that as a dermatologist, I’m likely to broaden my horizons in terms of choice of therapy and treat all of the domains of the patient. So I would argue that actually it should be the dermatologist who is in that driving seat, particularly when it comes to the management of early psoriatic arthritis, and actually what we should be doing is driving our patients and steering them to earlier intervention and better control for all domains of disease.”
Collaborative Care
During the follow-up discussion, both Dr. Proft and Dr. Savage agreed that dermatologists and rheumatologists should be working together in managing patients. “What we need to do is steer our patients toward collaborative care with our rheumatologists by trying to minimize delays to treatment, by working together in parallel clinics, combined clinics, and on virtual [multidisciplinary teams],” said Dr. Savage.
Dr. Proft agreed. “We should join forces and make decisions together.”
Dr. Savage and Dr. Proft did not provide any financial disclosures.
A version of this article appeared on Medscape.com.
SEATTLE — That was the subject of a debate between a dermatologist and a rheumatologist at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
Fabian Proft, MD, the rheumatologist, spoke first and emphasized the potential that MSK symptoms are a sign of psoriatic arthritis (PsA) and therefore should be managed by a rheumatologist.
“Obviously, the rheumatologist perspective [is that] I should be in the driver’s seat when taking care of patient with psoriasis and MSK symptoms, but I will still need to have a copilot there: [The dermatologist] will have a slot,” said Dr. Proft, who is a rheumatologist at Charité — Universitätsmedizin Berlin.
“It’s so important that we make the correct and early diagnosis of [psoriatic arthritis and psoriasis] symptoms,” said Dr. Proft. He specifically called out cases where patients have symptoms that are difficult to determine, whether the cause is inflammatory, and when experience with imaging can be a key factor in the diagnosis.
It’s important not to overdiagnose or overtreat patients, he said, providing an example of a patient with psoriasis who had been training for a marathon. The MRI image suggested that his Achilles tendonitis pain was related to his athletic training, not PsA-associated inflammation. “So I think this is very important that you have the knowledge to read MRIs, and especially also carefully assessing them so as not to overdiagnose patients,” said Dr. Proft.
Dermatologist Rebuttal
In her rebuttal, Laura Savage, MD, PhD, emphasized the need for more of a coequal partnership between the two specialties because of the ability of dermatologists to intervene early in the treatment and prevention of PsA.
“Traditionally, I agree rheumatologists would solely be responsible for the assessment and the management of psoriatic arthritis, but I think that paradigm has shifted in part due to the increased recognition of the need for earlier intervention to limit disease progression and to reduce or even prevent functional limitation,” said Dr. Savage, who is a consultant dermatologist at Leeds Teaching Hospitals NHS Trust and a senior lecturer at the University of Leeds, Leeds, England.
Ideally, molecular biomarkers would be available to predict the development of PsA, but there aren’t any. Still, “we have a huge biomarker in the form of the skin, and it’s recognized that the majority of patients who will develop psoriatic arthritis will have antecedent psoriasis in about 70% of cases,” Dr. Savage said. “There’s a typical time delay of around 7-12 years between the onset of the skin [disease] and the patients developing psoriatic arthritis, and so many of them are going to be into the care of other healthcare practitioners, and particularly the care of dermatologists.”
Dermatologists may also be able to play a role in the prevention of PsA, according to Dr. Savage. In one retrospective study, treatment of skin lesions with biologics was associated with a reduced frequency of progression to PsA (11.1% vs 16.4%) over 10 years (P = .0006). Studies with tumor necrosis factor inhibitors and other interventions have shown similar results.
Such findings have led to the treat intercept strategy, which targets patients with psoriasis who have risk factors for transition to PsA — such as nail pitting, gluteal cleft disease, scalp disease, type 2 diabetes, obesity, and a first-degree relative with PsA — as well as symptoms of prodromal PSA, such as arthralgia and fatigue.
“I think dermatologists are aware of the need to not leave our patients languishing on these therapies and actually escalating them onto effective treatments that may also be able to treat early psoriatic arthritis. We could be more mindful about our choice of treatments for these patients, going on to thinking about their increased risk of PSA and trying to intercept,” Dr. Savage said. “What we don’t want is our patients to be developing these musculoskeletal symptoms of pain and stiffness and functional limitation and disability. We want to be treating the patients with musculoskeletal symptoms of that earlier prodromal phase when they’re developing arthralgia and fatigue.”
She conceded that more complicated patients are good candidates for care by the rheumatologist. “You can do your fancy imaging, and we’ll leave that to you, and the difficult-to-treat patients to [the rheumatologist], but actually we need to just get on and treat them,” she said. “One could argue as well that as a dermatologist, I’m likely to broaden my horizons in terms of choice of therapy and treat all of the domains of the patient. So I would argue that actually it should be the dermatologist who is in that driving seat, particularly when it comes to the management of early psoriatic arthritis, and actually what we should be doing is driving our patients and steering them to earlier intervention and better control for all domains of disease.”
Collaborative Care
During the follow-up discussion, both Dr. Proft and Dr. Savage agreed that dermatologists and rheumatologists should be working together in managing patients. “What we need to do is steer our patients toward collaborative care with our rheumatologists by trying to minimize delays to treatment, by working together in parallel clinics, combined clinics, and on virtual [multidisciplinary teams],” said Dr. Savage.
Dr. Proft agreed. “We should join forces and make decisions together.”
Dr. Savage and Dr. Proft did not provide any financial disclosures.
A version of this article appeared on Medscape.com.
FROM GRAPPA 2024
Two New Studies on Benzoyl Peroxide Provide Reassuring Data on Safety
Two
.Earlier this year, controversy erupted after an independent lab Valisure petitioned the US Food and Drug Administration (FDA) to recall acne products with BP because it found extremely high levels of the carcinogen benzene. In the research, the lab directors contended that the products can form over 800 times the “conditionally restricted” FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter (OTC) products affected. The issue, according to the lab’s report, is one of degradation, not contamination; BP can decompose into benzene. Exposures to benzene have been linked with a higher risk for leukemia and other blood cancers.
(“Conditionally restricted” means that the maximum of 2 ppm only applies to a drug product in which the use of benzene is unavoidable in order to produce a drug product with a significant therapeutic advance, according to FDA guidance.)
Critics of the report questioned the method used to test the products, calling for more “real-world” use data, and said the temperature used may not be what is expected with everyday use.
Now, both new studies are reassuring about the safety of the products, John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a telephone interview. He was a coauthor of both studies. A leading dermatologist not involved in the new research reviewed the findings and agreed.
One study using data from the National Health and Nutrition Examination Survey compared blood levels of benzene between 14 people who had used BP products and 65 people without a history of BP product use, finding no difference between the groups .
The other, much larger study analyzed electronic health records of more than 27,000 patients with acne using BP products, comparing them with more than 27,000 controls who did not use the products. The patients were followed for 10 years after the use of BP products began, and no increased risk for cancer, either blood cancers or solid tumors, was found.
The studies were recently published in the Journal of the American Academy of Dermatology.
“Both studies are well done,” said Henry W. Lim, MD, former chair of the Department of Dermatology and senior vice president for academic affairs at Henry Ford Health, Detroit. Dr. Lim, a former president of the American Academy of Dermatology, reviewed the results of both studies.
“These studies indicate that [a] report of detection of benzene in [BP] products exposed to high temperature does not have any relevant clinical significance, both in terms of blood levels and in terms of internal cancer,” Dr. Lim said. “This is consistent with the clinical experience of practicing dermatologists; no internal side effects have been observed in patients using [BP products].”
Further Details
Under high temperatures, or over a long period, BP can decompose to benzene, a colorless, flammable liquid with a sweet odor. Benzene is formed from natural processes such as forest fires and volcanoes, according to the American Cancer Society, and is found in the air, cigarette smoke, some foods (at low levels), and contaminated drinking water. It’s one of the 20 widely used chemicals involved in making plastics, resins, detergents, and pesticides, among other products.
In the study evaluating blood levels, the researchers matched 14 people who used BP products currently with 65 controls who did not. Five (36%) of those using the products had detectable blood levels; 21 (32%) of those who did not use them did. There was no association between BP exposure and detectable blood benzene levels (odds ratio, 1.12; P = .80).
In the larger study, the researchers used the TriNetX US Collaborative Network database, comparing more than 27,000 patients treated with BP products for acne with more than 27,000 patients aged 12-40 years who had a diagnosis of nevus or seborrheic keratosis with no exposure to prescribed BP or any diagnosis of acne, hidradenitis suppurativa, or rosacea. The researchers looked at the database over the subsequent 10 years to determine the risk for either blood cancers or internal malignancies.
Compared with patients diagnosed with nevus or seborrheic keratosis, those with acne treated with BP had no significant difference in the risk for lymphoma (hazard ratio [HR], 1.00), leukemia (HR, 0.91), any lymphoma or leukemia (HR, 1.04), and internal malignancies (HR, 0.93).
The findings suggest no increased risk for malignancy, the researchers said, although they acknowledged study limitations, such as possible misclassification of BP exposure due to OTC availability and other issues.
Value of BP Treatments
BP is the “go-to” acne treatment, as Dr. Barbieri pointed out. “It’s probably the number one treatment for acne,” and there’s no substitute for it and it’s one of the most effective topical acne treatments, he noted.
Despite the reassuring findings, Dr. Barbieri repeated advice he gave soon after the Valisure report was released. Use common sense and don’t store BP-containing products in hot cars or other hot environments. In warmer climates, refrigeration could be considered, he said. Discard old products. Manufacturers should use cold-chain storage from the manufacturing site to retail or pharmacy sale sites, he added.
FDA and Citizen Petition Status
Asked about the status of the petition from Valisure, an FDA spokesperson said: “The FDA does not comment on the status of pending petitions.”
Dr. Barbieri and Dr. Lim had no relevant disclosures. There were no funding sources for either of the two studies.
A version of this article first appeared on Medscape.com.
Two
.Earlier this year, controversy erupted after an independent lab Valisure petitioned the US Food and Drug Administration (FDA) to recall acne products with BP because it found extremely high levels of the carcinogen benzene. In the research, the lab directors contended that the products can form over 800 times the “conditionally restricted” FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter (OTC) products affected. The issue, according to the lab’s report, is one of degradation, not contamination; BP can decompose into benzene. Exposures to benzene have been linked with a higher risk for leukemia and other blood cancers.
(“Conditionally restricted” means that the maximum of 2 ppm only applies to a drug product in which the use of benzene is unavoidable in order to produce a drug product with a significant therapeutic advance, according to FDA guidance.)
Critics of the report questioned the method used to test the products, calling for more “real-world” use data, and said the temperature used may not be what is expected with everyday use.
Now, both new studies are reassuring about the safety of the products, John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a telephone interview. He was a coauthor of both studies. A leading dermatologist not involved in the new research reviewed the findings and agreed.
One study using data from the National Health and Nutrition Examination Survey compared blood levels of benzene between 14 people who had used BP products and 65 people without a history of BP product use, finding no difference between the groups .
The other, much larger study analyzed electronic health records of more than 27,000 patients with acne using BP products, comparing them with more than 27,000 controls who did not use the products. The patients were followed for 10 years after the use of BP products began, and no increased risk for cancer, either blood cancers or solid tumors, was found.
The studies were recently published in the Journal of the American Academy of Dermatology.
“Both studies are well done,” said Henry W. Lim, MD, former chair of the Department of Dermatology and senior vice president for academic affairs at Henry Ford Health, Detroit. Dr. Lim, a former president of the American Academy of Dermatology, reviewed the results of both studies.
“These studies indicate that [a] report of detection of benzene in [BP] products exposed to high temperature does not have any relevant clinical significance, both in terms of blood levels and in terms of internal cancer,” Dr. Lim said. “This is consistent with the clinical experience of practicing dermatologists; no internal side effects have been observed in patients using [BP products].”
Further Details
Under high temperatures, or over a long period, BP can decompose to benzene, a colorless, flammable liquid with a sweet odor. Benzene is formed from natural processes such as forest fires and volcanoes, according to the American Cancer Society, and is found in the air, cigarette smoke, some foods (at low levels), and contaminated drinking water. It’s one of the 20 widely used chemicals involved in making plastics, resins, detergents, and pesticides, among other products.
In the study evaluating blood levels, the researchers matched 14 people who used BP products currently with 65 controls who did not. Five (36%) of those using the products had detectable blood levels; 21 (32%) of those who did not use them did. There was no association between BP exposure and detectable blood benzene levels (odds ratio, 1.12; P = .80).
In the larger study, the researchers used the TriNetX US Collaborative Network database, comparing more than 27,000 patients treated with BP products for acne with more than 27,000 patients aged 12-40 years who had a diagnosis of nevus or seborrheic keratosis with no exposure to prescribed BP or any diagnosis of acne, hidradenitis suppurativa, or rosacea. The researchers looked at the database over the subsequent 10 years to determine the risk for either blood cancers or internal malignancies.
Compared with patients diagnosed with nevus or seborrheic keratosis, those with acne treated with BP had no significant difference in the risk for lymphoma (hazard ratio [HR], 1.00), leukemia (HR, 0.91), any lymphoma or leukemia (HR, 1.04), and internal malignancies (HR, 0.93).
The findings suggest no increased risk for malignancy, the researchers said, although they acknowledged study limitations, such as possible misclassification of BP exposure due to OTC availability and other issues.
Value of BP Treatments
BP is the “go-to” acne treatment, as Dr. Barbieri pointed out. “It’s probably the number one treatment for acne,” and there’s no substitute for it and it’s one of the most effective topical acne treatments, he noted.
Despite the reassuring findings, Dr. Barbieri repeated advice he gave soon after the Valisure report was released. Use common sense and don’t store BP-containing products in hot cars or other hot environments. In warmer climates, refrigeration could be considered, he said. Discard old products. Manufacturers should use cold-chain storage from the manufacturing site to retail or pharmacy sale sites, he added.
FDA and Citizen Petition Status
Asked about the status of the petition from Valisure, an FDA spokesperson said: “The FDA does not comment on the status of pending petitions.”
Dr. Barbieri and Dr. Lim had no relevant disclosures. There were no funding sources for either of the two studies.
A version of this article first appeared on Medscape.com.
Two
.Earlier this year, controversy erupted after an independent lab Valisure petitioned the US Food and Drug Administration (FDA) to recall acne products with BP because it found extremely high levels of the carcinogen benzene. In the research, the lab directors contended that the products can form over 800 times the “conditionally restricted” FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter (OTC) products affected. The issue, according to the lab’s report, is one of degradation, not contamination; BP can decompose into benzene. Exposures to benzene have been linked with a higher risk for leukemia and other blood cancers.
(“Conditionally restricted” means that the maximum of 2 ppm only applies to a drug product in which the use of benzene is unavoidable in order to produce a drug product with a significant therapeutic advance, according to FDA guidance.)
Critics of the report questioned the method used to test the products, calling for more “real-world” use data, and said the temperature used may not be what is expected with everyday use.
Now, both new studies are reassuring about the safety of the products, John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a telephone interview. He was a coauthor of both studies. A leading dermatologist not involved in the new research reviewed the findings and agreed.
One study using data from the National Health and Nutrition Examination Survey compared blood levels of benzene between 14 people who had used BP products and 65 people without a history of BP product use, finding no difference between the groups .
The other, much larger study analyzed electronic health records of more than 27,000 patients with acne using BP products, comparing them with more than 27,000 controls who did not use the products. The patients were followed for 10 years after the use of BP products began, and no increased risk for cancer, either blood cancers or solid tumors, was found.
The studies were recently published in the Journal of the American Academy of Dermatology.
“Both studies are well done,” said Henry W. Lim, MD, former chair of the Department of Dermatology and senior vice president for academic affairs at Henry Ford Health, Detroit. Dr. Lim, a former president of the American Academy of Dermatology, reviewed the results of both studies.
“These studies indicate that [a] report of detection of benzene in [BP] products exposed to high temperature does not have any relevant clinical significance, both in terms of blood levels and in terms of internal cancer,” Dr. Lim said. “This is consistent with the clinical experience of practicing dermatologists; no internal side effects have been observed in patients using [BP products].”
Further Details
Under high temperatures, or over a long period, BP can decompose to benzene, a colorless, flammable liquid with a sweet odor. Benzene is formed from natural processes such as forest fires and volcanoes, according to the American Cancer Society, and is found in the air, cigarette smoke, some foods (at low levels), and contaminated drinking water. It’s one of the 20 widely used chemicals involved in making plastics, resins, detergents, and pesticides, among other products.
In the study evaluating blood levels, the researchers matched 14 people who used BP products currently with 65 controls who did not. Five (36%) of those using the products had detectable blood levels; 21 (32%) of those who did not use them did. There was no association between BP exposure and detectable blood benzene levels (odds ratio, 1.12; P = .80).
In the larger study, the researchers used the TriNetX US Collaborative Network database, comparing more than 27,000 patients treated with BP products for acne with more than 27,000 patients aged 12-40 years who had a diagnosis of nevus or seborrheic keratosis with no exposure to prescribed BP or any diagnosis of acne, hidradenitis suppurativa, or rosacea. The researchers looked at the database over the subsequent 10 years to determine the risk for either blood cancers or internal malignancies.
Compared with patients diagnosed with nevus or seborrheic keratosis, those with acne treated with BP had no significant difference in the risk for lymphoma (hazard ratio [HR], 1.00), leukemia (HR, 0.91), any lymphoma or leukemia (HR, 1.04), and internal malignancies (HR, 0.93).
The findings suggest no increased risk for malignancy, the researchers said, although they acknowledged study limitations, such as possible misclassification of BP exposure due to OTC availability and other issues.
Value of BP Treatments
BP is the “go-to” acne treatment, as Dr. Barbieri pointed out. “It’s probably the number one treatment for acne,” and there’s no substitute for it and it’s one of the most effective topical acne treatments, he noted.
Despite the reassuring findings, Dr. Barbieri repeated advice he gave soon after the Valisure report was released. Use common sense and don’t store BP-containing products in hot cars or other hot environments. In warmer climates, refrigeration could be considered, he said. Discard old products. Manufacturers should use cold-chain storage from the manufacturing site to retail or pharmacy sale sites, he added.
FDA and Citizen Petition Status
Asked about the status of the petition from Valisure, an FDA spokesperson said: “The FDA does not comment on the status of pending petitions.”
Dr. Barbieri and Dr. Lim had no relevant disclosures. There were no funding sources for either of the two studies.
A version of this article first appeared on Medscape.com.
Ask Teenage Boys If They Use Muscle-Building Supplements
new commentary in the Journal of Adolescent Health.
such as protein or creatine, according to aMuscle-building supplements are not tested before going to market, as are pharmaceutical drugs, and they are associated with greater rates of death and disability in adolescents than are vitamin supplements such as A, C, and folate. Even if protein shakes or creatine gummies do not seem to negatively affect a teen, in many cases the needed nutrients are obtained from food intake, and supplements are not necessary.
“For many young people, particularly boys, use of these supplements is pretty ubiquitous,” said Kyle T. Ganson, PhD, MSW, assistant professor of social work at the University of Toronto, and author of the commentary.
Other research has shown that males are more likely to have eating disorders linked to muscle-building, in addition to being the largest number of consumers of muscle-building supplements.
Dr. Ganson’s research has shown that more than 80% of adolescent boys and young men take a protein supplement, and 50% or less take a creatine boost. But health clinicians may not know about use because they do not ask, Dr. Ganson added.
After clinicians ask about use and learn that a teenager or young adult is taking a dietary supplement, they should use a harm reduction approach that encourages curtailing or modifying supplement use rather than insisting on total abstinence, Dr. Ganson and coauthors wrote.
For example, a clinician can assess the patient’s dietary intake of carbohydrates, proteins, fats, calories, vitamins, and minerals, and, if appropriate, advise the teen that he or she can get all the necessary nutrients at mealtime. Michele LaBotz, MD, medical director of the Master of Science in Athletic Training program at the University of New England in Biddeford, Maine, said most teen boys and young adults will not listen to a clinician telling them about the potential harms from supplements.
However, counseling these patients that the supplements are probably a waste of money — muscles will develop just fine with a healthy diet and regular exercise — is more effective at reducing use, according to Dr. LaBotz, who was a sports medicine physician for nearly 20 years.
Keeping open lines of communication about supplements may open the door for teens to share that they are also using muscle-building steroids. Dr. Ganson said the step to a more dangerous product sometimes occurs after teens no longer perceive they are benefiting from supplements.
“It’s not one conversation and you’re done: It’s about providing support and medical monitoring,” Dr. Ganson said.
Dr. Ganson said his colleagues hope professional societies develop formal clinical practice guidelines about muscle-building supplements in teens and young adults.
Contaminated and Dangerous Supplements
Although any teenage boy may want to build muscles, athletes are of particular concern. Dr. LaBotz authored an American Academy of Pediatrics recommendation that young athletes adhere to appropriate nutrition and training programs rather than turning to supplements.
Adverse outcomes from muscle-building supplements can occur when the products are labeled deceptively. For example, what is sold as creatine sometimes contains other ingredients that may be harmful, such as deterenol or oxilofrine, which are not approved for use in the United States.
Words like “proprietary,” “blend,” or “complex” on a supplement label should raise red flags, according to Pieter Cohen, MD, associate professor at Harvard Medical School, Boston, and an internist at the Cambridge Health Alliance who advises clinicians and patients about the safe use of dietary supplements.
Unlike for pharmaceuticals, the US Food and Drug Administration (FDA) is not authorized to assess the safety of dietary supplements before they are sold to consumers. Supplement manufacturers are not required to disclose the quantity of each ingredient in a proprietary blend on product labels. By one estimate, 23,000 emergency department visits annually in the United States are due to adverse effects from dietary supplements, ranging from cardiac trouble to swallowing difficulties.
In general, Dr. Cohen said, supplements with fewer than six ingredients that have been certified by a third party are more likely than others to be safe. The Department of Defense provides a scorecard for consumers to help decipher which supplements are safer to use.
“American consumers are the lab rats for these products,” said Bryn Austin, ScD, SM, professor of social sciences at the Harvard T.H. Chan School of Public Health, Boston, and director of a program that trains health professionals how to intervene to prevent eating disorders. “This industry invests a lot of money to invent a health halo for themselves. Muscle-building supplements can be downright dangerous and will not turn anyone into the elite athlete of their dreams.”
The commentary authors reported no financial disclosures.
A version of this article first appeared on Medscape.com.
new commentary in the Journal of Adolescent Health.
such as protein or creatine, according to aMuscle-building supplements are not tested before going to market, as are pharmaceutical drugs, and they are associated with greater rates of death and disability in adolescents than are vitamin supplements such as A, C, and folate. Even if protein shakes or creatine gummies do not seem to negatively affect a teen, in many cases the needed nutrients are obtained from food intake, and supplements are not necessary.
“For many young people, particularly boys, use of these supplements is pretty ubiquitous,” said Kyle T. Ganson, PhD, MSW, assistant professor of social work at the University of Toronto, and author of the commentary.
Other research has shown that males are more likely to have eating disorders linked to muscle-building, in addition to being the largest number of consumers of muscle-building supplements.
Dr. Ganson’s research has shown that more than 80% of adolescent boys and young men take a protein supplement, and 50% or less take a creatine boost. But health clinicians may not know about use because they do not ask, Dr. Ganson added.
After clinicians ask about use and learn that a teenager or young adult is taking a dietary supplement, they should use a harm reduction approach that encourages curtailing or modifying supplement use rather than insisting on total abstinence, Dr. Ganson and coauthors wrote.
For example, a clinician can assess the patient’s dietary intake of carbohydrates, proteins, fats, calories, vitamins, and minerals, and, if appropriate, advise the teen that he or she can get all the necessary nutrients at mealtime. Michele LaBotz, MD, medical director of the Master of Science in Athletic Training program at the University of New England in Biddeford, Maine, said most teen boys and young adults will not listen to a clinician telling them about the potential harms from supplements.
However, counseling these patients that the supplements are probably a waste of money — muscles will develop just fine with a healthy diet and regular exercise — is more effective at reducing use, according to Dr. LaBotz, who was a sports medicine physician for nearly 20 years.
Keeping open lines of communication about supplements may open the door for teens to share that they are also using muscle-building steroids. Dr. Ganson said the step to a more dangerous product sometimes occurs after teens no longer perceive they are benefiting from supplements.
“It’s not one conversation and you’re done: It’s about providing support and medical monitoring,” Dr. Ganson said.
Dr. Ganson said his colleagues hope professional societies develop formal clinical practice guidelines about muscle-building supplements in teens and young adults.
Contaminated and Dangerous Supplements
Although any teenage boy may want to build muscles, athletes are of particular concern. Dr. LaBotz authored an American Academy of Pediatrics recommendation that young athletes adhere to appropriate nutrition and training programs rather than turning to supplements.
Adverse outcomes from muscle-building supplements can occur when the products are labeled deceptively. For example, what is sold as creatine sometimes contains other ingredients that may be harmful, such as deterenol or oxilofrine, which are not approved for use in the United States.
Words like “proprietary,” “blend,” or “complex” on a supplement label should raise red flags, according to Pieter Cohen, MD, associate professor at Harvard Medical School, Boston, and an internist at the Cambridge Health Alliance who advises clinicians and patients about the safe use of dietary supplements.
Unlike for pharmaceuticals, the US Food and Drug Administration (FDA) is not authorized to assess the safety of dietary supplements before they are sold to consumers. Supplement manufacturers are not required to disclose the quantity of each ingredient in a proprietary blend on product labels. By one estimate, 23,000 emergency department visits annually in the United States are due to adverse effects from dietary supplements, ranging from cardiac trouble to swallowing difficulties.
In general, Dr. Cohen said, supplements with fewer than six ingredients that have been certified by a third party are more likely than others to be safe. The Department of Defense provides a scorecard for consumers to help decipher which supplements are safer to use.
“American consumers are the lab rats for these products,” said Bryn Austin, ScD, SM, professor of social sciences at the Harvard T.H. Chan School of Public Health, Boston, and director of a program that trains health professionals how to intervene to prevent eating disorders. “This industry invests a lot of money to invent a health halo for themselves. Muscle-building supplements can be downright dangerous and will not turn anyone into the elite athlete of their dreams.”
The commentary authors reported no financial disclosures.
A version of this article first appeared on Medscape.com.
new commentary in the Journal of Adolescent Health.
such as protein or creatine, according to aMuscle-building supplements are not tested before going to market, as are pharmaceutical drugs, and they are associated with greater rates of death and disability in adolescents than are vitamin supplements such as A, C, and folate. Even if protein shakes or creatine gummies do not seem to negatively affect a teen, in many cases the needed nutrients are obtained from food intake, and supplements are not necessary.
“For many young people, particularly boys, use of these supplements is pretty ubiquitous,” said Kyle T. Ganson, PhD, MSW, assistant professor of social work at the University of Toronto, and author of the commentary.
Other research has shown that males are more likely to have eating disorders linked to muscle-building, in addition to being the largest number of consumers of muscle-building supplements.
Dr. Ganson’s research has shown that more than 80% of adolescent boys and young men take a protein supplement, and 50% or less take a creatine boost. But health clinicians may not know about use because they do not ask, Dr. Ganson added.
After clinicians ask about use and learn that a teenager or young adult is taking a dietary supplement, they should use a harm reduction approach that encourages curtailing or modifying supplement use rather than insisting on total abstinence, Dr. Ganson and coauthors wrote.
For example, a clinician can assess the patient’s dietary intake of carbohydrates, proteins, fats, calories, vitamins, and minerals, and, if appropriate, advise the teen that he or she can get all the necessary nutrients at mealtime. Michele LaBotz, MD, medical director of the Master of Science in Athletic Training program at the University of New England in Biddeford, Maine, said most teen boys and young adults will not listen to a clinician telling them about the potential harms from supplements.
However, counseling these patients that the supplements are probably a waste of money — muscles will develop just fine with a healthy diet and regular exercise — is more effective at reducing use, according to Dr. LaBotz, who was a sports medicine physician for nearly 20 years.
Keeping open lines of communication about supplements may open the door for teens to share that they are also using muscle-building steroids. Dr. Ganson said the step to a more dangerous product sometimes occurs after teens no longer perceive they are benefiting from supplements.
“It’s not one conversation and you’re done: It’s about providing support and medical monitoring,” Dr. Ganson said.
Dr. Ganson said his colleagues hope professional societies develop formal clinical practice guidelines about muscle-building supplements in teens and young adults.
Contaminated and Dangerous Supplements
Although any teenage boy may want to build muscles, athletes are of particular concern. Dr. LaBotz authored an American Academy of Pediatrics recommendation that young athletes adhere to appropriate nutrition and training programs rather than turning to supplements.
Adverse outcomes from muscle-building supplements can occur when the products are labeled deceptively. For example, what is sold as creatine sometimes contains other ingredients that may be harmful, such as deterenol or oxilofrine, which are not approved for use in the United States.
Words like “proprietary,” “blend,” or “complex” on a supplement label should raise red flags, according to Pieter Cohen, MD, associate professor at Harvard Medical School, Boston, and an internist at the Cambridge Health Alliance who advises clinicians and patients about the safe use of dietary supplements.
Unlike for pharmaceuticals, the US Food and Drug Administration (FDA) is not authorized to assess the safety of dietary supplements before they are sold to consumers. Supplement manufacturers are not required to disclose the quantity of each ingredient in a proprietary blend on product labels. By one estimate, 23,000 emergency department visits annually in the United States are due to adverse effects from dietary supplements, ranging from cardiac trouble to swallowing difficulties.
In general, Dr. Cohen said, supplements with fewer than six ingredients that have been certified by a third party are more likely than others to be safe. The Department of Defense provides a scorecard for consumers to help decipher which supplements are safer to use.
“American consumers are the lab rats for these products,” said Bryn Austin, ScD, SM, professor of social sciences at the Harvard T.H. Chan School of Public Health, Boston, and director of a program that trains health professionals how to intervene to prevent eating disorders. “This industry invests a lot of money to invent a health halo for themselves. Muscle-building supplements can be downright dangerous and will not turn anyone into the elite athlete of their dreams.”
The commentary authors reported no financial disclosures.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF ADOLESCENT HEALTH
Greater Transparency of Oncologists’ Pharma Relationships Needed
The findings reflect limited awareness in low-income countries about what scenarios constitute a conflict of interest, first author, Khalid El Bairi, MD, said during an interview. “There is a lack of training in ethics and integrity in medical schools [in countries in Africa], so people are not informed about conflicts of interest,” continued Dr. El Bairi, who presented the new research at the annual meeting of the American Society of Clinical Oncology. “There is also a lack of policies in universities and hospitals to guide clinicians about conflict of interest reporting.”
Overall, 58.5% of survey participants categorized honoraria as a conflict of interest that required disclosure, while 50% said the same of gifts from pharmaceutical representatives, and 44.5% identified travel grants for attending conferences as conflicts of interests. The report was published in JCO Global Oncology. Less often considered conflicts of interest were personal and institutional research funding, trips to conferences, consulting or advisory roles, food and beverages, expert testimony, and sample drugs provided by the pharmaceutical industry.
Just 24% of participants indicated that all of the listed items were deemed conflicts of interest. The survey — called Oncology Transparency Under Scrutiny and Tracking, or ONCOTRUST-1 — considered the perceptions of 200 oncologists, about 70% of whom practice in low- and middle-income countries.
What’s more, 37.5% of respondents identified fear of losing financial support as a reason not to report a conflict of interest. Still, 75% indicated that industry-sponsored speaking does not affect treatment decisions, and 60% said conflicts of interest do not impair objective appraisal of clinical trials.
Dr. El Bairi, a research associate in the department of medical oncology at Mohammed VI University Hospital, Oujda, Morocco, and his colleagues undertook the study in part because of an editorial published in The Lancet Oncology last year. First author Fidel Rubagumya, MD, a consultant oncologist and director of research at Rwanda Military Hospital, Kigali, and colleagues called for more research on the ties between oncologists and industry in Africa. The ONCOTRUST-1 findings set the stage for a planned follow-up study, which aims to compare views surrounding conflicts of interests between oncologists in different economic settings.
Open Payments Houses US Physicians’ Conflicts of Interest
To be sure, many authors of research published in major US journals are based outside of the United States. According to JAMA Network Open, 69% of submissions to the journal are from international authors. However, Dr. El Bairi also raised other potential signs of industry influence that he said need global discussion, such as the role of pharmaceutical companies in presentations of clinical trial findings at large cancer societies’ conferences, a shift toward progression-free survival as the endpoint in clinical cancer trials, and the rise of third-party writing assistance.
“There are two sides of the story,” Dr. El Bairi said. “The good side is that unfortunately, sometimes [industry money is] the only way for African oncologists to go abroad for training, to conferences for their continuous medical education. The bad is now we may harm patients, we might harm science by having conflicts of interest not reported.”
Unlike other countries, the United States has plentiful data on the scale of physicians’ financial conflicts of interest in the form of the Open Payments platform. Championed by Sen. Chuck Grassley (R-Iowa), the federal repository of payments to doctors and teaching hospitals by drug and medical device companies was established as part of the Affordable Care Act (ACA).
The health care reform law, which passed in 2010, requires pharmaceutical companies and medical device makers to report this information.
From 2013 to 2021, the pharmaceutical and medical device industry paid physicians $12.1 billion, according to a research letter published in JAMA in March of 2024 that reviewed Open Payments data.
Ranked by specialty, hematologists and oncologists received the fourth-largest amount of money in aggregate, the study shows. Their total of $825.8 million trailed only physicians in orthopedics ($1.36 billion), neurology and psychiatry ($1.32 billion) and cardiology ($1.29 billion). What’s more, this specialty had the biggest share of physicians taking industry money, with 74.2% of hematologists and oncologists receiving payments.
The payments from industry include fees for consulting services and speaking, as well as food and beverages, travel and lodging, education, gifts, grants, and honoraria.
Joseph S. Ross, MD, MHS, one of the JAMA study’s coauthors, said in an interview that the continued prevalence of such funding runs counter to the expectation behind the measure, which was that transparency would lead to physicians’ becoming less likely to accept a payment.
“We as a profession need to take a cold hard look in the mirror,” he said, referring to physicians in general.
Dr. Ross, professor of medicine at Yale University School of Medicine, New Haven, Connecticut, said he hopes that the profession will self-police, and that patients will make a bigger deal of the issue. Still, he acknowledged that “the vast majority” of patient advocacy groups, too, are funded by the pharmaceutical industry.
Exposing Industry Payments May Have Perverse Effect
A growing body of research explores the effect that physicians’ financial relationships with pharmaceutical companies can have on their prescribing practices. Indeed, oncologists taking industry payments seem to be more likely to prescribe nonrecommended and low-value drugs in some clinical settings, according to a study published in The BMJ last year.
That study’s first author, Aaron P. Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, New York City, suggested in an interview that exposing industry payments to the sunlight may have had a perverse effect on physicians.
“There’s this idea of having license to do something,” Dr. Mitchell said, speaking broadly about human psychology rather than drawing on empirical data. “You might feel a little less bad about then prescribing more of that company’s drug, because the disclosure has already been done.”
The influence of pharmaceutical industry money on oncologists goes beyond what’s prescribed to which treatments get studied, approved, and recommended by guidelines, Dr. Mitchell said. He was also first author of a 2016 paper published in JAMA Oncology that found 86% of authors of the National Comprehensive Cancer Network guidelines had at least one conflict of interest reported on Open Systems in 2014.
Meanwhile, the fact that physicians’ payments from industry are a matter of public record on Open Systems has not guaranteed that doctors will disclose their conflicts of interest in other forums. A study published in JAMA earlier this year, for which Dr. Mitchell served as first author, found that almost one in three physicians endorsing drugs and devices on the social media platform X failed to disclose that the manufacturer paid them.
The lack of disclosure seems to extend beyond social media. A 2018 study published in JAMA Oncology found that 32% of oncologist authors of clinical drug trials for drugs approved over a 20-month period from 2016 to 2017 did not fully disclose payments from the trial sponsor when checked against the Open Payments database.
A lion’s share of industry payments within oncology appears to be going to a small group of high-profile physicians, suggested a 2022 study published in JCO Oncology Practice. It found that just 1% of all US oncologists accounted for 37% of industry payments, with each receiving more than $100,000 a year.
Experts: Professional Societies Should Further Limit Industry Payments
While partnerships between drug companies and physicians are necessary and have often been positive, more than disclosure is needed to minimize the risk of patient harm, according to an editorial published in March in JCO Oncology Practice. In it, Nina Niu Sanford, MD, a radiation oncologist UT Southwestern Medical Center, Dallas, and Bishal Gyawali, MD, PhD, a medical oncologist at Queen’s University, Kingston, Ontario, Canada, argue that following a specific blueprint could help mitigate financial conflicts of interest.
For starters, Dr. Sanford and Dr. Gyawali contend in the editorial that the maximum general payment NCCN members are allowed to receive from industry should be $0, compared with a current bar of $20,000 from a single entity or $50,000 from all external entities combined. They also urge professional societies to follow the current policy of the American Society of Clinical Oncology and ban members serving in their leadership from receiving any general payments from the industry.
The authors further suggest that investigators of clinical trials should be barred from holding stock for the drug or product while it is under study and that editorialists should not have conflicts of interest with the company whose drug or product they are discussing.
Pharmaceutical money can harm patients in ways that are not always obvious, Dr. Gyawali said in an interview.
“It can dominate the conversation by removing critical viewpoints from these top people about certain drugs,” he said. “It’s not always about saying good things about the drug.”
For instance, he suggested, a doctor receiving payments from Pfizer might openly criticize perceived flaws in drugs from other companies but refrain from weighing in negatively on a Pfizer drug.
From 2016 to 2018, industry made general payments to more than 52,000 physicians for 137 unique cancer drugs, according to a separate 2021 study published in the Journal of Cancer Policy, for which Dr. Gyawali served as one of the coauthors.
The results suggest that pharmaceutical money affects the entire cancer system, not relatively few oncology leaders. The amounts and dollar values grew each year covered by the study, to nearly 466,000 payments totaling $98.5 million in 2018.
Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, Washington, DC, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, has called for a ban on industry gifts to physicians.
When a publication asks physicians to disclose relevant conflicts of interest, physicians may choose not to disclose, because they don’t feel that their conflicts are relevant, Dr. Fugh-Berman said. Drug and device makers have also grown sophisticated about how they work with physicians, she suggested. “It’s illegal to market a drug before it comes on the market, but it’s not illegal to market the disease,” said Dr. Fugh-Berman, noting that drugmakers often work on long timelines.
“The doctor is going around saying we don’t have good therapies. They’re not pushing a drug. And so they feel totally fine about it.”
Anecdotally, Dr. Fugh-Berman noted that, if anything, speaking fees and similar payments only improve doctors’ reputations. She said that’s especially true if the physicians are paid by multiple companies, on the supposed theory that their conflicts of interest cancel each other out.
“I’m not defending this,” added Dr. Fugh-Berman, observing that, at the end of the day, such conflicts may go against the interests of patients.
“Sometimes the best drugs are older, generic, cheap drugs, and if oncologists or other specialists are only choosing among the most promoted drugs, they’re not necessarily choosing the best drugs.”
Beyond any prestige, doctors have other possible nonfinancial incentives for receiving industry payments. “It’s the relationships,” Dr. Fugh-Berman said. “Companies are very good at offering friendship.”
Dr. El Bairi reported NCODA leadership and honoraria along with expert testimony through techspert.io. Dr. Ross reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of or the review of the manuscript he authored and discussed in this article. Dr. Ross also reported receiving grants from the Food and Drug Administration, Johnson & Johnson, the Medical Device Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Mitchell reported no relevant financial relationships. Dr. Gyawali reported a consulting or advisory role with Vivio Health. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.
The findings reflect limited awareness in low-income countries about what scenarios constitute a conflict of interest, first author, Khalid El Bairi, MD, said during an interview. “There is a lack of training in ethics and integrity in medical schools [in countries in Africa], so people are not informed about conflicts of interest,” continued Dr. El Bairi, who presented the new research at the annual meeting of the American Society of Clinical Oncology. “There is also a lack of policies in universities and hospitals to guide clinicians about conflict of interest reporting.”
Overall, 58.5% of survey participants categorized honoraria as a conflict of interest that required disclosure, while 50% said the same of gifts from pharmaceutical representatives, and 44.5% identified travel grants for attending conferences as conflicts of interests. The report was published in JCO Global Oncology. Less often considered conflicts of interest were personal and institutional research funding, trips to conferences, consulting or advisory roles, food and beverages, expert testimony, and sample drugs provided by the pharmaceutical industry.
Just 24% of participants indicated that all of the listed items were deemed conflicts of interest. The survey — called Oncology Transparency Under Scrutiny and Tracking, or ONCOTRUST-1 — considered the perceptions of 200 oncologists, about 70% of whom practice in low- and middle-income countries.
What’s more, 37.5% of respondents identified fear of losing financial support as a reason not to report a conflict of interest. Still, 75% indicated that industry-sponsored speaking does not affect treatment decisions, and 60% said conflicts of interest do not impair objective appraisal of clinical trials.
Dr. El Bairi, a research associate in the department of medical oncology at Mohammed VI University Hospital, Oujda, Morocco, and his colleagues undertook the study in part because of an editorial published in The Lancet Oncology last year. First author Fidel Rubagumya, MD, a consultant oncologist and director of research at Rwanda Military Hospital, Kigali, and colleagues called for more research on the ties between oncologists and industry in Africa. The ONCOTRUST-1 findings set the stage for a planned follow-up study, which aims to compare views surrounding conflicts of interests between oncologists in different economic settings.
Open Payments Houses US Physicians’ Conflicts of Interest
To be sure, many authors of research published in major US journals are based outside of the United States. According to JAMA Network Open, 69% of submissions to the journal are from international authors. However, Dr. El Bairi also raised other potential signs of industry influence that he said need global discussion, such as the role of pharmaceutical companies in presentations of clinical trial findings at large cancer societies’ conferences, a shift toward progression-free survival as the endpoint in clinical cancer trials, and the rise of third-party writing assistance.
“There are two sides of the story,” Dr. El Bairi said. “The good side is that unfortunately, sometimes [industry money is] the only way for African oncologists to go abroad for training, to conferences for their continuous medical education. The bad is now we may harm patients, we might harm science by having conflicts of interest not reported.”
Unlike other countries, the United States has plentiful data on the scale of physicians’ financial conflicts of interest in the form of the Open Payments platform. Championed by Sen. Chuck Grassley (R-Iowa), the federal repository of payments to doctors and teaching hospitals by drug and medical device companies was established as part of the Affordable Care Act (ACA).
The health care reform law, which passed in 2010, requires pharmaceutical companies and medical device makers to report this information.
From 2013 to 2021, the pharmaceutical and medical device industry paid physicians $12.1 billion, according to a research letter published in JAMA in March of 2024 that reviewed Open Payments data.
Ranked by specialty, hematologists and oncologists received the fourth-largest amount of money in aggregate, the study shows. Their total of $825.8 million trailed only physicians in orthopedics ($1.36 billion), neurology and psychiatry ($1.32 billion) and cardiology ($1.29 billion). What’s more, this specialty had the biggest share of physicians taking industry money, with 74.2% of hematologists and oncologists receiving payments.
The payments from industry include fees for consulting services and speaking, as well as food and beverages, travel and lodging, education, gifts, grants, and honoraria.
Joseph S. Ross, MD, MHS, one of the JAMA study’s coauthors, said in an interview that the continued prevalence of such funding runs counter to the expectation behind the measure, which was that transparency would lead to physicians’ becoming less likely to accept a payment.
“We as a profession need to take a cold hard look in the mirror,” he said, referring to physicians in general.
Dr. Ross, professor of medicine at Yale University School of Medicine, New Haven, Connecticut, said he hopes that the profession will self-police, and that patients will make a bigger deal of the issue. Still, he acknowledged that “the vast majority” of patient advocacy groups, too, are funded by the pharmaceutical industry.
Exposing Industry Payments May Have Perverse Effect
A growing body of research explores the effect that physicians’ financial relationships with pharmaceutical companies can have on their prescribing practices. Indeed, oncologists taking industry payments seem to be more likely to prescribe nonrecommended and low-value drugs in some clinical settings, according to a study published in The BMJ last year.
That study’s first author, Aaron P. Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, New York City, suggested in an interview that exposing industry payments to the sunlight may have had a perverse effect on physicians.
“There’s this idea of having license to do something,” Dr. Mitchell said, speaking broadly about human psychology rather than drawing on empirical data. “You might feel a little less bad about then prescribing more of that company’s drug, because the disclosure has already been done.”
The influence of pharmaceutical industry money on oncologists goes beyond what’s prescribed to which treatments get studied, approved, and recommended by guidelines, Dr. Mitchell said. He was also first author of a 2016 paper published in JAMA Oncology that found 86% of authors of the National Comprehensive Cancer Network guidelines had at least one conflict of interest reported on Open Systems in 2014.
Meanwhile, the fact that physicians’ payments from industry are a matter of public record on Open Systems has not guaranteed that doctors will disclose their conflicts of interest in other forums. A study published in JAMA earlier this year, for which Dr. Mitchell served as first author, found that almost one in three physicians endorsing drugs and devices on the social media platform X failed to disclose that the manufacturer paid them.
The lack of disclosure seems to extend beyond social media. A 2018 study published in JAMA Oncology found that 32% of oncologist authors of clinical drug trials for drugs approved over a 20-month period from 2016 to 2017 did not fully disclose payments from the trial sponsor when checked against the Open Payments database.
A lion’s share of industry payments within oncology appears to be going to a small group of high-profile physicians, suggested a 2022 study published in JCO Oncology Practice. It found that just 1% of all US oncologists accounted for 37% of industry payments, with each receiving more than $100,000 a year.
Experts: Professional Societies Should Further Limit Industry Payments
While partnerships between drug companies and physicians are necessary and have often been positive, more than disclosure is needed to minimize the risk of patient harm, according to an editorial published in March in JCO Oncology Practice. In it, Nina Niu Sanford, MD, a radiation oncologist UT Southwestern Medical Center, Dallas, and Bishal Gyawali, MD, PhD, a medical oncologist at Queen’s University, Kingston, Ontario, Canada, argue that following a specific blueprint could help mitigate financial conflicts of interest.
For starters, Dr. Sanford and Dr. Gyawali contend in the editorial that the maximum general payment NCCN members are allowed to receive from industry should be $0, compared with a current bar of $20,000 from a single entity or $50,000 from all external entities combined. They also urge professional societies to follow the current policy of the American Society of Clinical Oncology and ban members serving in their leadership from receiving any general payments from the industry.
The authors further suggest that investigators of clinical trials should be barred from holding stock for the drug or product while it is under study and that editorialists should not have conflicts of interest with the company whose drug or product they are discussing.
Pharmaceutical money can harm patients in ways that are not always obvious, Dr. Gyawali said in an interview.
“It can dominate the conversation by removing critical viewpoints from these top people about certain drugs,” he said. “It’s not always about saying good things about the drug.”
For instance, he suggested, a doctor receiving payments from Pfizer might openly criticize perceived flaws in drugs from other companies but refrain from weighing in negatively on a Pfizer drug.
From 2016 to 2018, industry made general payments to more than 52,000 physicians for 137 unique cancer drugs, according to a separate 2021 study published in the Journal of Cancer Policy, for which Dr. Gyawali served as one of the coauthors.
The results suggest that pharmaceutical money affects the entire cancer system, not relatively few oncology leaders. The amounts and dollar values grew each year covered by the study, to nearly 466,000 payments totaling $98.5 million in 2018.
Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, Washington, DC, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, has called for a ban on industry gifts to physicians.
When a publication asks physicians to disclose relevant conflicts of interest, physicians may choose not to disclose, because they don’t feel that their conflicts are relevant, Dr. Fugh-Berman said. Drug and device makers have also grown sophisticated about how they work with physicians, she suggested. “It’s illegal to market a drug before it comes on the market, but it’s not illegal to market the disease,” said Dr. Fugh-Berman, noting that drugmakers often work on long timelines.
“The doctor is going around saying we don’t have good therapies. They’re not pushing a drug. And so they feel totally fine about it.”
Anecdotally, Dr. Fugh-Berman noted that, if anything, speaking fees and similar payments only improve doctors’ reputations. She said that’s especially true if the physicians are paid by multiple companies, on the supposed theory that their conflicts of interest cancel each other out.
“I’m not defending this,” added Dr. Fugh-Berman, observing that, at the end of the day, such conflicts may go against the interests of patients.
“Sometimes the best drugs are older, generic, cheap drugs, and if oncologists or other specialists are only choosing among the most promoted drugs, they’re not necessarily choosing the best drugs.”
Beyond any prestige, doctors have other possible nonfinancial incentives for receiving industry payments. “It’s the relationships,” Dr. Fugh-Berman said. “Companies are very good at offering friendship.”
Dr. El Bairi reported NCODA leadership and honoraria along with expert testimony through techspert.io. Dr. Ross reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of or the review of the manuscript he authored and discussed in this article. Dr. Ross also reported receiving grants from the Food and Drug Administration, Johnson & Johnson, the Medical Device Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Mitchell reported no relevant financial relationships. Dr. Gyawali reported a consulting or advisory role with Vivio Health. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.
The findings reflect limited awareness in low-income countries about what scenarios constitute a conflict of interest, first author, Khalid El Bairi, MD, said during an interview. “There is a lack of training in ethics and integrity in medical schools [in countries in Africa], so people are not informed about conflicts of interest,” continued Dr. El Bairi, who presented the new research at the annual meeting of the American Society of Clinical Oncology. “There is also a lack of policies in universities and hospitals to guide clinicians about conflict of interest reporting.”
Overall, 58.5% of survey participants categorized honoraria as a conflict of interest that required disclosure, while 50% said the same of gifts from pharmaceutical representatives, and 44.5% identified travel grants for attending conferences as conflicts of interests. The report was published in JCO Global Oncology. Less often considered conflicts of interest were personal and institutional research funding, trips to conferences, consulting or advisory roles, food and beverages, expert testimony, and sample drugs provided by the pharmaceutical industry.
Just 24% of participants indicated that all of the listed items were deemed conflicts of interest. The survey — called Oncology Transparency Under Scrutiny and Tracking, or ONCOTRUST-1 — considered the perceptions of 200 oncologists, about 70% of whom practice in low- and middle-income countries.
What’s more, 37.5% of respondents identified fear of losing financial support as a reason not to report a conflict of interest. Still, 75% indicated that industry-sponsored speaking does not affect treatment decisions, and 60% said conflicts of interest do not impair objective appraisal of clinical trials.
Dr. El Bairi, a research associate in the department of medical oncology at Mohammed VI University Hospital, Oujda, Morocco, and his colleagues undertook the study in part because of an editorial published in The Lancet Oncology last year. First author Fidel Rubagumya, MD, a consultant oncologist and director of research at Rwanda Military Hospital, Kigali, and colleagues called for more research on the ties between oncologists and industry in Africa. The ONCOTRUST-1 findings set the stage for a planned follow-up study, which aims to compare views surrounding conflicts of interests between oncologists in different economic settings.
Open Payments Houses US Physicians’ Conflicts of Interest
To be sure, many authors of research published in major US journals are based outside of the United States. According to JAMA Network Open, 69% of submissions to the journal are from international authors. However, Dr. El Bairi also raised other potential signs of industry influence that he said need global discussion, such as the role of pharmaceutical companies in presentations of clinical trial findings at large cancer societies’ conferences, a shift toward progression-free survival as the endpoint in clinical cancer trials, and the rise of third-party writing assistance.
“There are two sides of the story,” Dr. El Bairi said. “The good side is that unfortunately, sometimes [industry money is] the only way for African oncologists to go abroad for training, to conferences for their continuous medical education. The bad is now we may harm patients, we might harm science by having conflicts of interest not reported.”
Unlike other countries, the United States has plentiful data on the scale of physicians’ financial conflicts of interest in the form of the Open Payments platform. Championed by Sen. Chuck Grassley (R-Iowa), the federal repository of payments to doctors and teaching hospitals by drug and medical device companies was established as part of the Affordable Care Act (ACA).
The health care reform law, which passed in 2010, requires pharmaceutical companies and medical device makers to report this information.
From 2013 to 2021, the pharmaceutical and medical device industry paid physicians $12.1 billion, according to a research letter published in JAMA in March of 2024 that reviewed Open Payments data.
Ranked by specialty, hematologists and oncologists received the fourth-largest amount of money in aggregate, the study shows. Their total of $825.8 million trailed only physicians in orthopedics ($1.36 billion), neurology and psychiatry ($1.32 billion) and cardiology ($1.29 billion). What’s more, this specialty had the biggest share of physicians taking industry money, with 74.2% of hematologists and oncologists receiving payments.
The payments from industry include fees for consulting services and speaking, as well as food and beverages, travel and lodging, education, gifts, grants, and honoraria.
Joseph S. Ross, MD, MHS, one of the JAMA study’s coauthors, said in an interview that the continued prevalence of such funding runs counter to the expectation behind the measure, which was that transparency would lead to physicians’ becoming less likely to accept a payment.
“We as a profession need to take a cold hard look in the mirror,” he said, referring to physicians in general.
Dr. Ross, professor of medicine at Yale University School of Medicine, New Haven, Connecticut, said he hopes that the profession will self-police, and that patients will make a bigger deal of the issue. Still, he acknowledged that “the vast majority” of patient advocacy groups, too, are funded by the pharmaceutical industry.
Exposing Industry Payments May Have Perverse Effect
A growing body of research explores the effect that physicians’ financial relationships with pharmaceutical companies can have on their prescribing practices. Indeed, oncologists taking industry payments seem to be more likely to prescribe nonrecommended and low-value drugs in some clinical settings, according to a study published in The BMJ last year.
That study’s first author, Aaron P. Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, New York City, suggested in an interview that exposing industry payments to the sunlight may have had a perverse effect on physicians.
“There’s this idea of having license to do something,” Dr. Mitchell said, speaking broadly about human psychology rather than drawing on empirical data. “You might feel a little less bad about then prescribing more of that company’s drug, because the disclosure has already been done.”
The influence of pharmaceutical industry money on oncologists goes beyond what’s prescribed to which treatments get studied, approved, and recommended by guidelines, Dr. Mitchell said. He was also first author of a 2016 paper published in JAMA Oncology that found 86% of authors of the National Comprehensive Cancer Network guidelines had at least one conflict of interest reported on Open Systems in 2014.
Meanwhile, the fact that physicians’ payments from industry are a matter of public record on Open Systems has not guaranteed that doctors will disclose their conflicts of interest in other forums. A study published in JAMA earlier this year, for which Dr. Mitchell served as first author, found that almost one in three physicians endorsing drugs and devices on the social media platform X failed to disclose that the manufacturer paid them.
The lack of disclosure seems to extend beyond social media. A 2018 study published in JAMA Oncology found that 32% of oncologist authors of clinical drug trials for drugs approved over a 20-month period from 2016 to 2017 did not fully disclose payments from the trial sponsor when checked against the Open Payments database.
A lion’s share of industry payments within oncology appears to be going to a small group of high-profile physicians, suggested a 2022 study published in JCO Oncology Practice. It found that just 1% of all US oncologists accounted for 37% of industry payments, with each receiving more than $100,000 a year.
Experts: Professional Societies Should Further Limit Industry Payments
While partnerships between drug companies and physicians are necessary and have often been positive, more than disclosure is needed to minimize the risk of patient harm, according to an editorial published in March in JCO Oncology Practice. In it, Nina Niu Sanford, MD, a radiation oncologist UT Southwestern Medical Center, Dallas, and Bishal Gyawali, MD, PhD, a medical oncologist at Queen’s University, Kingston, Ontario, Canada, argue that following a specific blueprint could help mitigate financial conflicts of interest.
For starters, Dr. Sanford and Dr. Gyawali contend in the editorial that the maximum general payment NCCN members are allowed to receive from industry should be $0, compared with a current bar of $20,000 from a single entity or $50,000 from all external entities combined. They also urge professional societies to follow the current policy of the American Society of Clinical Oncology and ban members serving in their leadership from receiving any general payments from the industry.
The authors further suggest that investigators of clinical trials should be barred from holding stock for the drug or product while it is under study and that editorialists should not have conflicts of interest with the company whose drug or product they are discussing.
Pharmaceutical money can harm patients in ways that are not always obvious, Dr. Gyawali said in an interview.
“It can dominate the conversation by removing critical viewpoints from these top people about certain drugs,” he said. “It’s not always about saying good things about the drug.”
For instance, he suggested, a doctor receiving payments from Pfizer might openly criticize perceived flaws in drugs from other companies but refrain from weighing in negatively on a Pfizer drug.
From 2016 to 2018, industry made general payments to more than 52,000 physicians for 137 unique cancer drugs, according to a separate 2021 study published in the Journal of Cancer Policy, for which Dr. Gyawali served as one of the coauthors.
The results suggest that pharmaceutical money affects the entire cancer system, not relatively few oncology leaders. The amounts and dollar values grew each year covered by the study, to nearly 466,000 payments totaling $98.5 million in 2018.
Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, Washington, DC, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, has called for a ban on industry gifts to physicians.
When a publication asks physicians to disclose relevant conflicts of interest, physicians may choose not to disclose, because they don’t feel that their conflicts are relevant, Dr. Fugh-Berman said. Drug and device makers have also grown sophisticated about how they work with physicians, she suggested. “It’s illegal to market a drug before it comes on the market, but it’s not illegal to market the disease,” said Dr. Fugh-Berman, noting that drugmakers often work on long timelines.
“The doctor is going around saying we don’t have good therapies. They’re not pushing a drug. And so they feel totally fine about it.”
Anecdotally, Dr. Fugh-Berman noted that, if anything, speaking fees and similar payments only improve doctors’ reputations. She said that’s especially true if the physicians are paid by multiple companies, on the supposed theory that their conflicts of interest cancel each other out.
“I’m not defending this,” added Dr. Fugh-Berman, observing that, at the end of the day, such conflicts may go against the interests of patients.
“Sometimes the best drugs are older, generic, cheap drugs, and if oncologists or other specialists are only choosing among the most promoted drugs, they’re not necessarily choosing the best drugs.”
Beyond any prestige, doctors have other possible nonfinancial incentives for receiving industry payments. “It’s the relationships,” Dr. Fugh-Berman said. “Companies are very good at offering friendship.”
Dr. El Bairi reported NCODA leadership and honoraria along with expert testimony through techspert.io. Dr. Ross reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of or the review of the manuscript he authored and discussed in this article. Dr. Ross also reported receiving grants from the Food and Drug Administration, Johnson & Johnson, the Medical Device Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Mitchell reported no relevant financial relationships. Dr. Gyawali reported a consulting or advisory role with Vivio Health. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.
FROM ASCO 2024