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Case report describes pediatric RIME triggered by norovirus
, according to a newly published case report.
Lead author Anna Yasmine Kirkorian, MD, chief of dermatology at Children’s National Hospital in Washington, said she wanted to get the word out in part because it seems like RIME is occurring more frequently. “I do feel like we’re seeing more cases and from a more diverse number of pathogens,” Dr. Kirkorian told this news organization.
There was a decrease in RIME during the early stages of the COVID-19 pandemic when people were isolating more, Dr. Kirkorian said. SARS-CoV-2 has been a trigger for some cases, but she did not find that remarkable, given that respiratory viruses are known RIME precursors. The question is why RIME is being triggered more frequently now that people have essentially gone back to their normal lives, she said.
Dr. Kirkorian and colleagues at Children’s National Hospital and George Washington University, Washington, wrote about a 5-year-old boy with norovirus-triggered RIME in a case report published in Pediatric Dermatology.
RIME – previously known as Mycoplasma pneumoniae–induced rash and mucositis (MIRM) – tends to arise after a viral infection, with upper respiratory viruses such as mycoplasma and Chlamydophila pneumoniae, influenza, and enterovirus among the common triggers. “We think this is actually your own immune system overreacting to a pathogen,” Dr. Kirkorian said in an interview, adding that the mechanism of RIME is still not understood.
While the norovirus discovery was a surprise, it shows that much is still unknown about this rare condition. “I don’t think we know what is usual and what is unusual,” Dr. Kirkorian said.
In this case, the boy swiftly declined, with progressive conjunctivitis, high fever, and rapidly developing mucositis. By the time the 5-year-old got to Children’s National Hospital, he had a spreading, painful rash, including tense vesicles and bullae involving more than 30% of his total body surface area, and areas of denuded skin on both cheeks and the back of his neck.
He had hemorrhagic mucositis of the lips, a large erosion at the urethral meatus, and hemorrhagic conjunctivitis of both eyes with thick yellow crusting on the eyelids.
The clinicians intubated the boy and admitted him to the intensive care unit. He was given a one-time injection of etanercept (25 mg) followed by 8 days of intravenous cyclosporine at a dose of 5 mg per kilogram, divided twice daily, which helped calm the mucositis and stopped the rash from progressing. There is not an accepted protocol or list of evidence-based therapeutics for RIME, Dr. Kirkorian noted.
The severe eye damage required amniotic membrane grafts. The patient was extubated after 9 days but remained in the hospital for a total of 26 days because he needed to receive nutritional support (the mucositis kept him from eating), and for pain control and weaning of sedation.
As the clinicians searched for a potential triggering virus, they came up empty. Results were negative for adenovirus, Epstein Barr virus, cytomegalovirus, herpes simplex, and varicella zoster. But they noted that the child’s household contacts had all been sick a week before with presumed viral gastroenteritis. They decided to run a stool screen and the polymerase chain reaction for norovirus was positive. The boy never had GI symptoms.
Dr. Kirkorian said in the interview that she has seen other RIME cases where a child did not have symptoms associated with the original virus but did have a sudden onset of mucositis.
Although the definition of RIME is evolving, it is defined in part by mucositis in at least two of three areas: the mouth, eyes, and genitals. “Once you have the inflammation of the mucous membranes you should be on alert to think about more serious conditions,” like RIME, said Dr. Kirkorian. “Why does it manifest with the mucositis? I don’t think we know that,” she added.
RIME recurrence has also been vexing for patients, families and clinicians. In May, at the annual Atlantic Dermatology Conference, held in Baltimore, Dr. Kirkorian also discussed an 11-year-old patient who had RIME after SARS-CoV-2 infection early in the pandemic, resulting in a 22-day hospitalization and placement of a peripherally inserted central catheter and a feeding tube. He improved with cyclosporine and was discharged on systemic tacrolimus.
He was fine for several years, until another COVID infection. He again responded to medication. But not long after, an undetermined viral infection triggered another episode of RIME.
Dr. Kirkorian said there is no way to predict recurrence – making a devastating condition all the more worrisome. “Knowing that it might come back and it’s totally haphazard as to what might make it come back – that is very stressful for families,” she said in the interview.
“Some of the most perplexing patients with RIME are those with recurrent disease,” wrote Warren R. Heymann, MD, professor of dermatology and pediatrics at Rowan University, Camden, N.J., wrote in an online column on RIME in the American Academy of Dermatology’s “Dermatology World Insights and Inquiries”.
“Recurrent RIME is of particular interest, given that we could potentially intervene and prevent additional disease,” wrote Camille Introcaso, MD, associate professor of medicine at Rowan University, in response to Dr. Heymann’s remarks. “Although multiple possible mechanisms for the clinical findings of RIME have been proposed, including molecular mimicry between infectious agent proteins and keratinocyte antigens, immune complex deposition, and combinations of medication and infection, the pathophysiology is unknown,” she added.
In the interview, Dr. Kirkorian said that she and colleagues in the Pediatric Dermatology Research Alliance (PeDRA) are trying to assemble more multicenter trials to assess the underlying pathology of RIME, effectiveness of various treatments, and to “find some predictive factors.” Given that RIME is an acute-onset emergency, it is not easy to conduct randomized controlled trials, she added.
Dr. Kirkorian, Dr. Heymann, and Dr. Introcaso report no relevant financial relationships.
, according to a newly published case report.
Lead author Anna Yasmine Kirkorian, MD, chief of dermatology at Children’s National Hospital in Washington, said she wanted to get the word out in part because it seems like RIME is occurring more frequently. “I do feel like we’re seeing more cases and from a more diverse number of pathogens,” Dr. Kirkorian told this news organization.
There was a decrease in RIME during the early stages of the COVID-19 pandemic when people were isolating more, Dr. Kirkorian said. SARS-CoV-2 has been a trigger for some cases, but she did not find that remarkable, given that respiratory viruses are known RIME precursors. The question is why RIME is being triggered more frequently now that people have essentially gone back to their normal lives, she said.
Dr. Kirkorian and colleagues at Children’s National Hospital and George Washington University, Washington, wrote about a 5-year-old boy with norovirus-triggered RIME in a case report published in Pediatric Dermatology.
RIME – previously known as Mycoplasma pneumoniae–induced rash and mucositis (MIRM) – tends to arise after a viral infection, with upper respiratory viruses such as mycoplasma and Chlamydophila pneumoniae, influenza, and enterovirus among the common triggers. “We think this is actually your own immune system overreacting to a pathogen,” Dr. Kirkorian said in an interview, adding that the mechanism of RIME is still not understood.
While the norovirus discovery was a surprise, it shows that much is still unknown about this rare condition. “I don’t think we know what is usual and what is unusual,” Dr. Kirkorian said.
In this case, the boy swiftly declined, with progressive conjunctivitis, high fever, and rapidly developing mucositis. By the time the 5-year-old got to Children’s National Hospital, he had a spreading, painful rash, including tense vesicles and bullae involving more than 30% of his total body surface area, and areas of denuded skin on both cheeks and the back of his neck.
He had hemorrhagic mucositis of the lips, a large erosion at the urethral meatus, and hemorrhagic conjunctivitis of both eyes with thick yellow crusting on the eyelids.
The clinicians intubated the boy and admitted him to the intensive care unit. He was given a one-time injection of etanercept (25 mg) followed by 8 days of intravenous cyclosporine at a dose of 5 mg per kilogram, divided twice daily, which helped calm the mucositis and stopped the rash from progressing. There is not an accepted protocol or list of evidence-based therapeutics for RIME, Dr. Kirkorian noted.
The severe eye damage required amniotic membrane grafts. The patient was extubated after 9 days but remained in the hospital for a total of 26 days because he needed to receive nutritional support (the mucositis kept him from eating), and for pain control and weaning of sedation.
As the clinicians searched for a potential triggering virus, they came up empty. Results were negative for adenovirus, Epstein Barr virus, cytomegalovirus, herpes simplex, and varicella zoster. But they noted that the child’s household contacts had all been sick a week before with presumed viral gastroenteritis. They decided to run a stool screen and the polymerase chain reaction for norovirus was positive. The boy never had GI symptoms.
Dr. Kirkorian said in the interview that she has seen other RIME cases where a child did not have symptoms associated with the original virus but did have a sudden onset of mucositis.
Although the definition of RIME is evolving, it is defined in part by mucositis in at least two of three areas: the mouth, eyes, and genitals. “Once you have the inflammation of the mucous membranes you should be on alert to think about more serious conditions,” like RIME, said Dr. Kirkorian. “Why does it manifest with the mucositis? I don’t think we know that,” she added.
RIME recurrence has also been vexing for patients, families and clinicians. In May, at the annual Atlantic Dermatology Conference, held in Baltimore, Dr. Kirkorian also discussed an 11-year-old patient who had RIME after SARS-CoV-2 infection early in the pandemic, resulting in a 22-day hospitalization and placement of a peripherally inserted central catheter and a feeding tube. He improved with cyclosporine and was discharged on systemic tacrolimus.
He was fine for several years, until another COVID infection. He again responded to medication. But not long after, an undetermined viral infection triggered another episode of RIME.
Dr. Kirkorian said there is no way to predict recurrence – making a devastating condition all the more worrisome. “Knowing that it might come back and it’s totally haphazard as to what might make it come back – that is very stressful for families,” she said in the interview.
“Some of the most perplexing patients with RIME are those with recurrent disease,” wrote Warren R. Heymann, MD, professor of dermatology and pediatrics at Rowan University, Camden, N.J., wrote in an online column on RIME in the American Academy of Dermatology’s “Dermatology World Insights and Inquiries”.
“Recurrent RIME is of particular interest, given that we could potentially intervene and prevent additional disease,” wrote Camille Introcaso, MD, associate professor of medicine at Rowan University, in response to Dr. Heymann’s remarks. “Although multiple possible mechanisms for the clinical findings of RIME have been proposed, including molecular mimicry between infectious agent proteins and keratinocyte antigens, immune complex deposition, and combinations of medication and infection, the pathophysiology is unknown,” she added.
In the interview, Dr. Kirkorian said that she and colleagues in the Pediatric Dermatology Research Alliance (PeDRA) are trying to assemble more multicenter trials to assess the underlying pathology of RIME, effectiveness of various treatments, and to “find some predictive factors.” Given that RIME is an acute-onset emergency, it is not easy to conduct randomized controlled trials, she added.
Dr. Kirkorian, Dr. Heymann, and Dr. Introcaso report no relevant financial relationships.
, according to a newly published case report.
Lead author Anna Yasmine Kirkorian, MD, chief of dermatology at Children’s National Hospital in Washington, said she wanted to get the word out in part because it seems like RIME is occurring more frequently. “I do feel like we’re seeing more cases and from a more diverse number of pathogens,” Dr. Kirkorian told this news organization.
There was a decrease in RIME during the early stages of the COVID-19 pandemic when people were isolating more, Dr. Kirkorian said. SARS-CoV-2 has been a trigger for some cases, but she did not find that remarkable, given that respiratory viruses are known RIME precursors. The question is why RIME is being triggered more frequently now that people have essentially gone back to their normal lives, she said.
Dr. Kirkorian and colleagues at Children’s National Hospital and George Washington University, Washington, wrote about a 5-year-old boy with norovirus-triggered RIME in a case report published in Pediatric Dermatology.
RIME – previously known as Mycoplasma pneumoniae–induced rash and mucositis (MIRM) – tends to arise after a viral infection, with upper respiratory viruses such as mycoplasma and Chlamydophila pneumoniae, influenza, and enterovirus among the common triggers. “We think this is actually your own immune system overreacting to a pathogen,” Dr. Kirkorian said in an interview, adding that the mechanism of RIME is still not understood.
While the norovirus discovery was a surprise, it shows that much is still unknown about this rare condition. “I don’t think we know what is usual and what is unusual,” Dr. Kirkorian said.
In this case, the boy swiftly declined, with progressive conjunctivitis, high fever, and rapidly developing mucositis. By the time the 5-year-old got to Children’s National Hospital, he had a spreading, painful rash, including tense vesicles and bullae involving more than 30% of his total body surface area, and areas of denuded skin on both cheeks and the back of his neck.
He had hemorrhagic mucositis of the lips, a large erosion at the urethral meatus, and hemorrhagic conjunctivitis of both eyes with thick yellow crusting on the eyelids.
The clinicians intubated the boy and admitted him to the intensive care unit. He was given a one-time injection of etanercept (25 mg) followed by 8 days of intravenous cyclosporine at a dose of 5 mg per kilogram, divided twice daily, which helped calm the mucositis and stopped the rash from progressing. There is not an accepted protocol or list of evidence-based therapeutics for RIME, Dr. Kirkorian noted.
The severe eye damage required amniotic membrane grafts. The patient was extubated after 9 days but remained in the hospital for a total of 26 days because he needed to receive nutritional support (the mucositis kept him from eating), and for pain control and weaning of sedation.
As the clinicians searched for a potential triggering virus, they came up empty. Results were negative for adenovirus, Epstein Barr virus, cytomegalovirus, herpes simplex, and varicella zoster. But they noted that the child’s household contacts had all been sick a week before with presumed viral gastroenteritis. They decided to run a stool screen and the polymerase chain reaction for norovirus was positive. The boy never had GI symptoms.
Dr. Kirkorian said in the interview that she has seen other RIME cases where a child did not have symptoms associated with the original virus but did have a sudden onset of mucositis.
Although the definition of RIME is evolving, it is defined in part by mucositis in at least two of three areas: the mouth, eyes, and genitals. “Once you have the inflammation of the mucous membranes you should be on alert to think about more serious conditions,” like RIME, said Dr. Kirkorian. “Why does it manifest with the mucositis? I don’t think we know that,” she added.
RIME recurrence has also been vexing for patients, families and clinicians. In May, at the annual Atlantic Dermatology Conference, held in Baltimore, Dr. Kirkorian also discussed an 11-year-old patient who had RIME after SARS-CoV-2 infection early in the pandemic, resulting in a 22-day hospitalization and placement of a peripherally inserted central catheter and a feeding tube. He improved with cyclosporine and was discharged on systemic tacrolimus.
He was fine for several years, until another COVID infection. He again responded to medication. But not long after, an undetermined viral infection triggered another episode of RIME.
Dr. Kirkorian said there is no way to predict recurrence – making a devastating condition all the more worrisome. “Knowing that it might come back and it’s totally haphazard as to what might make it come back – that is very stressful for families,” she said in the interview.
“Some of the most perplexing patients with RIME are those with recurrent disease,” wrote Warren R. Heymann, MD, professor of dermatology and pediatrics at Rowan University, Camden, N.J., wrote in an online column on RIME in the American Academy of Dermatology’s “Dermatology World Insights and Inquiries”.
“Recurrent RIME is of particular interest, given that we could potentially intervene and prevent additional disease,” wrote Camille Introcaso, MD, associate professor of medicine at Rowan University, in response to Dr. Heymann’s remarks. “Although multiple possible mechanisms for the clinical findings of RIME have been proposed, including molecular mimicry between infectious agent proteins and keratinocyte antigens, immune complex deposition, and combinations of medication and infection, the pathophysiology is unknown,” she added.
In the interview, Dr. Kirkorian said that she and colleagues in the Pediatric Dermatology Research Alliance (PeDRA) are trying to assemble more multicenter trials to assess the underlying pathology of RIME, effectiveness of various treatments, and to “find some predictive factors.” Given that RIME is an acute-onset emergency, it is not easy to conduct randomized controlled trials, she added.
Dr. Kirkorian, Dr. Heymann, and Dr. Introcaso report no relevant financial relationships.
Study finds big growth in advanced-practice clinicians in Medicare dermatology
A .
Researchers from the University of Texas MD Anderson Cancer Center, Houston, and the University of Pennsylvania, Philadelphia, reported in JAMA Dermatology that in 2013 APCs made up 28% of the dermatology clinician workforce. By 2020, they made up 37% of the dermatology clinicians giving care to Medicare beneficiaries.
Retrospective cohort study
APCs provided care in 15.5% of dermatology office visits in 2013 and 27.4% in 2020 (P =.02), the authors reported. “By 2020, more than one in four dermatology visits for patients with Medicare were delivered by APCs,” wrote the authors, led by Mackenzie R. Wehner, MD, MPhil, assistant professor of dermatology and health services research at MD Anderson.
“Everyone in dermatology is aware of the increasing adoption of advanced practice clinicians in the field,” Justin D. Arnold, MD, MMSc, a 3rd-year dermatology resident at the University of California, Irvine, said in an interview. “However, seeing how quickly this happening and the absolute number of these clinicians is still startling,” said Dr. Arnold, who in 2022 published a research letter in JAMA Dermatology on the impact of physician assistants in dermatology.
In that study, he and his coauthors reported that the PA workforce in dermatology was growing faster than in other specialties.
In the current study, Dr. Wehner and her colleagues identified 8,444 dermatology APCs and 14,402 physician dermatologists who provided 109.3 million Medicare office visits from 2013 to 2020. More than 80% of the procedures were performed by physicians, but APCs appeared to increasingly be taking on more of the procedural load.
Over the study period, APCs had an average annual increase of 12.6% in the number of premalignant lesion destructions performed; physicians saw an average 1.4% decline. For skin biopsies, APCs performed 11.7% more per year on average, compared with a 1.4% drop for physicians.
“This data is not surprising given most agree that skin biopsies and destruction of premalignant lesions are well within the scope of practice of APCs,” Dr. Arnold told this news organization.
The authors also reported that, while most APCs – similar to physician dermatologists – practice in metropolitan areas, they are working in other locations also. Slightly more than half of dermatology clinicians in micropolitan areas are APCs, and in rural areas, 88% of clinicians are APCs, Dr. Wehner and colleagues found.
APCs may be filling a gap in rural areas for Medicare patients, said Dr. Arnold, but, he added, “it is unclear if dermatology APCs are growing as quickly in practices that predominantly accept Medicaid and if dermatology APCs are expanding access to these populations.”
Dr. Arnold said he expected the number of APCs in dermatology to continue growing, serving commercially insured patients, as well. “There are a multitude of potential reasons for more APCs in dermatology, including difficulty recruiting dermatologists in rural communities, financial motivators, and the expansion of private equity, and the increasing acceptance of these clinicians within medicine and by patients.”
APCs can provide good-quality care if they are properly trained and supervised, said Dr. Arnold, adding that he is concerned, however, that the training and supervision is not being provided. “This study provides further evidence that dermatologists, and national dermatology organizations such as the AAD [American Academy of Dermatology], need to take a more active role in the leadership of APC training,” he said.
Dermatology, he noted, “would benefit from consensus guidelines on clinical competencies for dermatology APCs,” similar to an effort by the American College of Cardiology.
A review* published online in July noted that, compared with dermatologists, some data suggest that non-physician operators (NPOs) may have a higher rate of adverse events when performing aesthetic procedures, according to the authors of the review, led by Shelby L. Kubicki, MD, of the department of dermatology at the UTHealth Science Center in Houston. There is no mandatory reporting of complications for nonphysician providers, so the authors relied on data from cosmetic-focused practices, medical spas, and a survey by the American Society of Dermatologic Surgery of consumers and its members. More than half of the responding physicians “reported treating complications of a cosmetic procedure performed by an NPO,” the authors wrote.
They also found higher rates of burns and discoloration among patients who were treated by NPOs. The injuries occurred primarily at medical spas.
“Although NPOs may help to meet the rising demand for dermatologic procedures, care should still be taken to prioritize patient safety and outcomes above all else, including financial profits and revenues,” the authors wrote.
Dr. Wehner and her colleagues report no relevant financial relationships. Their study research was supported, in part, by a Cancer Center Support Grant and by the Cancer Prevention and Research Institute of Texas. Dr. Arnold also reports no relevant financial relationships. No author disclosures or funding information were available for the Clinics in Dermatology paper.
*Correction, 12/8/23: An earlier version of this story misstated the study design.
A .
Researchers from the University of Texas MD Anderson Cancer Center, Houston, and the University of Pennsylvania, Philadelphia, reported in JAMA Dermatology that in 2013 APCs made up 28% of the dermatology clinician workforce. By 2020, they made up 37% of the dermatology clinicians giving care to Medicare beneficiaries.
Retrospective cohort study
APCs provided care in 15.5% of dermatology office visits in 2013 and 27.4% in 2020 (P =.02), the authors reported. “By 2020, more than one in four dermatology visits for patients with Medicare were delivered by APCs,” wrote the authors, led by Mackenzie R. Wehner, MD, MPhil, assistant professor of dermatology and health services research at MD Anderson.
“Everyone in dermatology is aware of the increasing adoption of advanced practice clinicians in the field,” Justin D. Arnold, MD, MMSc, a 3rd-year dermatology resident at the University of California, Irvine, said in an interview. “However, seeing how quickly this happening and the absolute number of these clinicians is still startling,” said Dr. Arnold, who in 2022 published a research letter in JAMA Dermatology on the impact of physician assistants in dermatology.
In that study, he and his coauthors reported that the PA workforce in dermatology was growing faster than in other specialties.
In the current study, Dr. Wehner and her colleagues identified 8,444 dermatology APCs and 14,402 physician dermatologists who provided 109.3 million Medicare office visits from 2013 to 2020. More than 80% of the procedures were performed by physicians, but APCs appeared to increasingly be taking on more of the procedural load.
Over the study period, APCs had an average annual increase of 12.6% in the number of premalignant lesion destructions performed; physicians saw an average 1.4% decline. For skin biopsies, APCs performed 11.7% more per year on average, compared with a 1.4% drop for physicians.
“This data is not surprising given most agree that skin biopsies and destruction of premalignant lesions are well within the scope of practice of APCs,” Dr. Arnold told this news organization.
The authors also reported that, while most APCs – similar to physician dermatologists – practice in metropolitan areas, they are working in other locations also. Slightly more than half of dermatology clinicians in micropolitan areas are APCs, and in rural areas, 88% of clinicians are APCs, Dr. Wehner and colleagues found.
APCs may be filling a gap in rural areas for Medicare patients, said Dr. Arnold, but, he added, “it is unclear if dermatology APCs are growing as quickly in practices that predominantly accept Medicaid and if dermatology APCs are expanding access to these populations.”
Dr. Arnold said he expected the number of APCs in dermatology to continue growing, serving commercially insured patients, as well. “There are a multitude of potential reasons for more APCs in dermatology, including difficulty recruiting dermatologists in rural communities, financial motivators, and the expansion of private equity, and the increasing acceptance of these clinicians within medicine and by patients.”
APCs can provide good-quality care if they are properly trained and supervised, said Dr. Arnold, adding that he is concerned, however, that the training and supervision is not being provided. “This study provides further evidence that dermatologists, and national dermatology organizations such as the AAD [American Academy of Dermatology], need to take a more active role in the leadership of APC training,” he said.
Dermatology, he noted, “would benefit from consensus guidelines on clinical competencies for dermatology APCs,” similar to an effort by the American College of Cardiology.
A review* published online in July noted that, compared with dermatologists, some data suggest that non-physician operators (NPOs) may have a higher rate of adverse events when performing aesthetic procedures, according to the authors of the review, led by Shelby L. Kubicki, MD, of the department of dermatology at the UTHealth Science Center in Houston. There is no mandatory reporting of complications for nonphysician providers, so the authors relied on data from cosmetic-focused practices, medical spas, and a survey by the American Society of Dermatologic Surgery of consumers and its members. More than half of the responding physicians “reported treating complications of a cosmetic procedure performed by an NPO,” the authors wrote.
They also found higher rates of burns and discoloration among patients who were treated by NPOs. The injuries occurred primarily at medical spas.
“Although NPOs may help to meet the rising demand for dermatologic procedures, care should still be taken to prioritize patient safety and outcomes above all else, including financial profits and revenues,” the authors wrote.
Dr. Wehner and her colleagues report no relevant financial relationships. Their study research was supported, in part, by a Cancer Center Support Grant and by the Cancer Prevention and Research Institute of Texas. Dr. Arnold also reports no relevant financial relationships. No author disclosures or funding information were available for the Clinics in Dermatology paper.
*Correction, 12/8/23: An earlier version of this story misstated the study design.
A .
Researchers from the University of Texas MD Anderson Cancer Center, Houston, and the University of Pennsylvania, Philadelphia, reported in JAMA Dermatology that in 2013 APCs made up 28% of the dermatology clinician workforce. By 2020, they made up 37% of the dermatology clinicians giving care to Medicare beneficiaries.
Retrospective cohort study
APCs provided care in 15.5% of dermatology office visits in 2013 and 27.4% in 2020 (P =.02), the authors reported. “By 2020, more than one in four dermatology visits for patients with Medicare were delivered by APCs,” wrote the authors, led by Mackenzie R. Wehner, MD, MPhil, assistant professor of dermatology and health services research at MD Anderson.
“Everyone in dermatology is aware of the increasing adoption of advanced practice clinicians in the field,” Justin D. Arnold, MD, MMSc, a 3rd-year dermatology resident at the University of California, Irvine, said in an interview. “However, seeing how quickly this happening and the absolute number of these clinicians is still startling,” said Dr. Arnold, who in 2022 published a research letter in JAMA Dermatology on the impact of physician assistants in dermatology.
In that study, he and his coauthors reported that the PA workforce in dermatology was growing faster than in other specialties.
In the current study, Dr. Wehner and her colleagues identified 8,444 dermatology APCs and 14,402 physician dermatologists who provided 109.3 million Medicare office visits from 2013 to 2020. More than 80% of the procedures were performed by physicians, but APCs appeared to increasingly be taking on more of the procedural load.
Over the study period, APCs had an average annual increase of 12.6% in the number of premalignant lesion destructions performed; physicians saw an average 1.4% decline. For skin biopsies, APCs performed 11.7% more per year on average, compared with a 1.4% drop for physicians.
“This data is not surprising given most agree that skin biopsies and destruction of premalignant lesions are well within the scope of practice of APCs,” Dr. Arnold told this news organization.
The authors also reported that, while most APCs – similar to physician dermatologists – practice in metropolitan areas, they are working in other locations also. Slightly more than half of dermatology clinicians in micropolitan areas are APCs, and in rural areas, 88% of clinicians are APCs, Dr. Wehner and colleagues found.
APCs may be filling a gap in rural areas for Medicare patients, said Dr. Arnold, but, he added, “it is unclear if dermatology APCs are growing as quickly in practices that predominantly accept Medicaid and if dermatology APCs are expanding access to these populations.”
Dr. Arnold said he expected the number of APCs in dermatology to continue growing, serving commercially insured patients, as well. “There are a multitude of potential reasons for more APCs in dermatology, including difficulty recruiting dermatologists in rural communities, financial motivators, and the expansion of private equity, and the increasing acceptance of these clinicians within medicine and by patients.”
APCs can provide good-quality care if they are properly trained and supervised, said Dr. Arnold, adding that he is concerned, however, that the training and supervision is not being provided. “This study provides further evidence that dermatologists, and national dermatology organizations such as the AAD [American Academy of Dermatology], need to take a more active role in the leadership of APC training,” he said.
Dermatology, he noted, “would benefit from consensus guidelines on clinical competencies for dermatology APCs,” similar to an effort by the American College of Cardiology.
A review* published online in July noted that, compared with dermatologists, some data suggest that non-physician operators (NPOs) may have a higher rate of adverse events when performing aesthetic procedures, according to the authors of the review, led by Shelby L. Kubicki, MD, of the department of dermatology at the UTHealth Science Center in Houston. There is no mandatory reporting of complications for nonphysician providers, so the authors relied on data from cosmetic-focused practices, medical spas, and a survey by the American Society of Dermatologic Surgery of consumers and its members. More than half of the responding physicians “reported treating complications of a cosmetic procedure performed by an NPO,” the authors wrote.
They also found higher rates of burns and discoloration among patients who were treated by NPOs. The injuries occurred primarily at medical spas.
“Although NPOs may help to meet the rising demand for dermatologic procedures, care should still be taken to prioritize patient safety and outcomes above all else, including financial profits and revenues,” the authors wrote.
Dr. Wehner and her colleagues report no relevant financial relationships. Their study research was supported, in part, by a Cancer Center Support Grant and by the Cancer Prevention and Research Institute of Texas. Dr. Arnold also reports no relevant financial relationships. No author disclosures or funding information were available for the Clinics in Dermatology paper.
*Correction, 12/8/23: An earlier version of this story misstated the study design.
FROM JAMA DERMATOLOGY
Harvard medical school sued over stolen body part scandal
Plaintiffs include relatives of people whose remains were allegedly stolen and sold. The lawsuit alleges that as many as 400 cadavers may have been trafficked in a multi-year scheme. Details were revealed in a June 13 indictment by the U.S. attorney for the Middle District of Pennsylvania.
“Medical schools like Harvard have a duty to ensure [donated remains] are handled properly and with decency and to ensure they are used for their intended purpose of scientific study,” attorney Jeff Catalano said in a statement.
“I do think Harvard has that duty,” said Arthur Caplan, PhD, director, Division of Medical Ethics, New York University. But, he added, “I will say there’s not much they can do when employees set out to systematically undermine them.”
The indictment alleges that from 2018 through August 2022, Harvard morgue manager Cedric Lodge stole dissected portions of donated cadavers, including heads, brains, skin, and bones, which were then sold by him and his wife, Denise Lodge, to Katrina Maclean, owner of Kat’s Creepy Creations, Peabody, Mass. Ms. Maclean allegedly sold human remains to Joshua Taylor and Jeremy Pauley, both Pennsylvania residents.
On occasion, Mr. Lodge allowed Ms. Maclean, Mr. Taylor, and others into the morgue to choose which parts they wanted, according to the indictment. Mr. Taylor, Ms. Maclean, and Denise Lodge are all named in the indictment. Mr. Pauley was charged separately.
They each face a maximum of 15 years in prison.
Ms. Maclean allegedly bought two dissected faces for $600 and shipped human skin to Mr. Pauley to be made into leather; Mr. Pauley then eventually shipped the “tanned human skin” back to Ms. Maclean, according to the indictment. Over a 3-year period, Mr. Taylor paid the Lodges some $37,000 for stolen human remains, the indictment charges.
Mr. Pauley also purchased human remains from Candace Chapman Scott, who stole them from her employer, a mortuary in Little Rock, Ark. The mortuary received remains for cremation from an area medical school, according to the indictment.
After being notified of the investigation in March, Harvard cooperated fully, the school said in a statement from George Q. Daley, MD, PhD, dean of the Faculty of Medicine.
“We are appalled to learn that something so disturbing could happen on our campus – a community dedicated to healing and serving others,” the statement said. “The reported incidents are a betrayal of HMS and, most importantly, each of the individuals who altruistically chose to will their bodies to HMS through the Anatomical Gift Program to advance medical education and research.”
The U.S. attorney thanked Harvard for its cooperation, saying that it “is also a victim here.”
Dr. Caplan, who also writes an ethics column for this news organization, agrees. The school was betrayed, he said.
“You expect professionalism, integrity on the part of your doctors, on the part of your technicians, on the part of your workforce,” he said. He noted that those expectations are explained in institutions’ codes of ethics and policies.
Harvard said Mr. Lodge had worked in the morgue since 1995 and that he took several leaves: from September 2021 to February 2022, and again starting February 14. The school terminated his employment on May 6.
His duties included intake of anatomic donors’ bodies. He coordinated embalming and oversaw the storage and movement of cadavers to and from teaching labs. When studies were complete, he prepared remains to be transported to and from the external crematorium and, when appropriate, for burial, according to a Harvard fact sheet for families.
The medical school has convened an outside expert panel to evaluate the Anatomical Gift Program and morgue policies and practices. The panel is expected to make its findings public at the end of the summer.
Dr. Caplan said he hoped the committee recommends unannounced audits of cadaver donation programs and medical tissue and bone suppliers, which could help expose illicit diversions. “You need to keep an eye, which no one seems to do because it’s a state issue and it’s not a priority, on that trade in body parts,” he said.
He believes other medical schools will reexamine their donation programs, especially given Harvard’s status.
“With a prominent place like that having this kind of problem, I can’t imagine there’s not a little bit of a scramble at a lot of the body programs to make sure that they know that things are as they should be,” Dr. Caplan said.
A version of this article first appeared on Medscape.com.
Plaintiffs include relatives of people whose remains were allegedly stolen and sold. The lawsuit alleges that as many as 400 cadavers may have been trafficked in a multi-year scheme. Details were revealed in a June 13 indictment by the U.S. attorney for the Middle District of Pennsylvania.
“Medical schools like Harvard have a duty to ensure [donated remains] are handled properly and with decency and to ensure they are used for their intended purpose of scientific study,” attorney Jeff Catalano said in a statement.
“I do think Harvard has that duty,” said Arthur Caplan, PhD, director, Division of Medical Ethics, New York University. But, he added, “I will say there’s not much they can do when employees set out to systematically undermine them.”
The indictment alleges that from 2018 through August 2022, Harvard morgue manager Cedric Lodge stole dissected portions of donated cadavers, including heads, brains, skin, and bones, which were then sold by him and his wife, Denise Lodge, to Katrina Maclean, owner of Kat’s Creepy Creations, Peabody, Mass. Ms. Maclean allegedly sold human remains to Joshua Taylor and Jeremy Pauley, both Pennsylvania residents.
On occasion, Mr. Lodge allowed Ms. Maclean, Mr. Taylor, and others into the morgue to choose which parts they wanted, according to the indictment. Mr. Taylor, Ms. Maclean, and Denise Lodge are all named in the indictment. Mr. Pauley was charged separately.
They each face a maximum of 15 years in prison.
Ms. Maclean allegedly bought two dissected faces for $600 and shipped human skin to Mr. Pauley to be made into leather; Mr. Pauley then eventually shipped the “tanned human skin” back to Ms. Maclean, according to the indictment. Over a 3-year period, Mr. Taylor paid the Lodges some $37,000 for stolen human remains, the indictment charges.
Mr. Pauley also purchased human remains from Candace Chapman Scott, who stole them from her employer, a mortuary in Little Rock, Ark. The mortuary received remains for cremation from an area medical school, according to the indictment.
After being notified of the investigation in March, Harvard cooperated fully, the school said in a statement from George Q. Daley, MD, PhD, dean of the Faculty of Medicine.
“We are appalled to learn that something so disturbing could happen on our campus – a community dedicated to healing and serving others,” the statement said. “The reported incidents are a betrayal of HMS and, most importantly, each of the individuals who altruistically chose to will their bodies to HMS through the Anatomical Gift Program to advance medical education and research.”
The U.S. attorney thanked Harvard for its cooperation, saying that it “is also a victim here.”
Dr. Caplan, who also writes an ethics column for this news organization, agrees. The school was betrayed, he said.
“You expect professionalism, integrity on the part of your doctors, on the part of your technicians, on the part of your workforce,” he said. He noted that those expectations are explained in institutions’ codes of ethics and policies.
Harvard said Mr. Lodge had worked in the morgue since 1995 and that he took several leaves: from September 2021 to February 2022, and again starting February 14. The school terminated his employment on May 6.
His duties included intake of anatomic donors’ bodies. He coordinated embalming and oversaw the storage and movement of cadavers to and from teaching labs. When studies were complete, he prepared remains to be transported to and from the external crematorium and, when appropriate, for burial, according to a Harvard fact sheet for families.
The medical school has convened an outside expert panel to evaluate the Anatomical Gift Program and morgue policies and practices. The panel is expected to make its findings public at the end of the summer.
Dr. Caplan said he hoped the committee recommends unannounced audits of cadaver donation programs and medical tissue and bone suppliers, which could help expose illicit diversions. “You need to keep an eye, which no one seems to do because it’s a state issue and it’s not a priority, on that trade in body parts,” he said.
He believes other medical schools will reexamine their donation programs, especially given Harvard’s status.
“With a prominent place like that having this kind of problem, I can’t imagine there’s not a little bit of a scramble at a lot of the body programs to make sure that they know that things are as they should be,” Dr. Caplan said.
A version of this article first appeared on Medscape.com.
Plaintiffs include relatives of people whose remains were allegedly stolen and sold. The lawsuit alleges that as many as 400 cadavers may have been trafficked in a multi-year scheme. Details were revealed in a June 13 indictment by the U.S. attorney for the Middle District of Pennsylvania.
“Medical schools like Harvard have a duty to ensure [donated remains] are handled properly and with decency and to ensure they are used for their intended purpose of scientific study,” attorney Jeff Catalano said in a statement.
“I do think Harvard has that duty,” said Arthur Caplan, PhD, director, Division of Medical Ethics, New York University. But, he added, “I will say there’s not much they can do when employees set out to systematically undermine them.”
The indictment alleges that from 2018 through August 2022, Harvard morgue manager Cedric Lodge stole dissected portions of donated cadavers, including heads, brains, skin, and bones, which were then sold by him and his wife, Denise Lodge, to Katrina Maclean, owner of Kat’s Creepy Creations, Peabody, Mass. Ms. Maclean allegedly sold human remains to Joshua Taylor and Jeremy Pauley, both Pennsylvania residents.
On occasion, Mr. Lodge allowed Ms. Maclean, Mr. Taylor, and others into the morgue to choose which parts they wanted, according to the indictment. Mr. Taylor, Ms. Maclean, and Denise Lodge are all named in the indictment. Mr. Pauley was charged separately.
They each face a maximum of 15 years in prison.
Ms. Maclean allegedly bought two dissected faces for $600 and shipped human skin to Mr. Pauley to be made into leather; Mr. Pauley then eventually shipped the “tanned human skin” back to Ms. Maclean, according to the indictment. Over a 3-year period, Mr. Taylor paid the Lodges some $37,000 for stolen human remains, the indictment charges.
Mr. Pauley also purchased human remains from Candace Chapman Scott, who stole them from her employer, a mortuary in Little Rock, Ark. The mortuary received remains for cremation from an area medical school, according to the indictment.
After being notified of the investigation in March, Harvard cooperated fully, the school said in a statement from George Q. Daley, MD, PhD, dean of the Faculty of Medicine.
“We are appalled to learn that something so disturbing could happen on our campus – a community dedicated to healing and serving others,” the statement said. “The reported incidents are a betrayal of HMS and, most importantly, each of the individuals who altruistically chose to will their bodies to HMS through the Anatomical Gift Program to advance medical education and research.”
The U.S. attorney thanked Harvard for its cooperation, saying that it “is also a victim here.”
Dr. Caplan, who also writes an ethics column for this news organization, agrees. The school was betrayed, he said.
“You expect professionalism, integrity on the part of your doctors, on the part of your technicians, on the part of your workforce,” he said. He noted that those expectations are explained in institutions’ codes of ethics and policies.
Harvard said Mr. Lodge had worked in the morgue since 1995 and that he took several leaves: from September 2021 to February 2022, and again starting February 14. The school terminated his employment on May 6.
His duties included intake of anatomic donors’ bodies. He coordinated embalming and oversaw the storage and movement of cadavers to and from teaching labs. When studies were complete, he prepared remains to be transported to and from the external crematorium and, when appropriate, for burial, according to a Harvard fact sheet for families.
The medical school has convened an outside expert panel to evaluate the Anatomical Gift Program and morgue policies and practices. The panel is expected to make its findings public at the end of the summer.
Dr. Caplan said he hoped the committee recommends unannounced audits of cadaver donation programs and medical tissue and bone suppliers, which could help expose illicit diversions. “You need to keep an eye, which no one seems to do because it’s a state issue and it’s not a priority, on that trade in body parts,” he said.
He believes other medical schools will reexamine their donation programs, especially given Harvard’s status.
“With a prominent place like that having this kind of problem, I can’t imagine there’s not a little bit of a scramble at a lot of the body programs to make sure that they know that things are as they should be,” Dr. Caplan said.
A version of this article first appeared on Medscape.com.
Did ob.gyn. residencies take a hit from abortion bans?
Emilee Gibson, MD, recently graduated from Southern Illinois University, Springfield, and starts her ob.gyn. residency at Vanderbilt University Medical Center in Nashville, Tenn., later this month. Abortion is permitted in Illinois but banned in Tennessee, a factor she weighed cautiously when she applied for residencies.
Dr. Gibson told this news organization that medical students, not just those interested in ob.gyn., are starting to think more about what it means to move to a state where it might be difficult to access abortion care. “Just from a personal standpoint, that’s a little scary.”
The Supreme Court’s decision to overturn Roe v. Wade abortion rights last June threatened to derail ob.gyns. in training from pursuing the specialty or locating in states that have banned or limited abortion.
, but some industry leaders, residents, and medical students say it may be too early to judge the full impact of the ruling because most students were already far along in their decision and application for a 2023 residency position.
At this point, some ob.gyn. students are planning careers on the basis of whether they have family ties in a particular state, whether limiting their search might hurt their potential to match in a competitive specialty, and whether their faith in the family planning and abortion training being offered by a program outweighs the drawbacks of being in a state with abortion bans or restrictions.
Lucy Brown, MD, a recent graduate of Indiana University, Indianapolis, said in an interview that she’d be “very nervous” about living and practicing in abortion-restricted Indiana if she were ready to start a family.
Dr. Brown said that she mostly limited applications in the recent Match to ob.gyn. residencies in states that protected abortion rights. Though she applied to a program in her home state of Kentucky, she noted that it – along with a program in Missouri – was very low on her rank list because of their abortion restrictions.
Ultimately, Dr. Brown matched at Johns Hopkins University, Baltimore, where she will receive abortion training and assist with abortions throughout her residency. Maryland’s abortion rights status was a big attraction, she said. “Abortion is integrated into every aspect of the education.”
By the numbers
For students applying to residencies this summer, evaluating the state legislative landscape is a little clearer than it was 1 year ago but is still evolving. As of June 1, 56 ob.gyn. residency programs and more than 1,100 medical residents are in states with the most restrictive bans in the country (19% of all programs), according to the Bixby Center for Reproductive Health at the University of California, San Francisco.
In terms of the latest abortion laws: 14 states banned abortion, 2 states banned abortion between 6 and 12 weeks, and 9 states banned abortion between 15 and 22 weeks, whereas abortion is legal in 25 states and Washington, according to a recent analysis by the Kaiser Family Foundation.
The impact on residencies? The Association of American Medical Colleges recently reported a 2% drop in the number of U.S. MD seniors who applied to residencies and a 5% decline in the number of seniors who applied to ob.gyn. residencies. In states where abortion was banned, the number of senior applicants to ob.gyn. programs dropped by more than 10%, according to AAMC’s Research and Action Institute.
“U.S. MD seniors appear, in general, more likely to avoid states where abortions are banned,” said Atul Grover, MD, PhD, executive director of the Research and Action Institute. “That’s a big difference between states where there are abortion bans and gestational limits and states with no bans or limits; it’s almost twice as large,” Dr. Grover said in an interview. “The question is: Was it a 1-year blip or something that will be the beginning of a trend?”
In a statement to this news organization, officials from the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said that they were aware of the AAMC data but needed to further evaluate the impact of the Dobbs ruling.
A survey released at ACOG’s annual meeting in May found that 58% of third- and fourth-year medical students were unlikely to apply to a residency program in a state with abortion restrictions. Conducted after the Dobbs ruling last year, the survey found that future physicians are choosing where to attend residency according to state abortion policies, indicating that access to abortion care is changing the landscape of medical practice.
“For personal as well as professional reasons, reproductive health care access is now a key factor in residency match decisions as a result of Dobbs,” lead author Ariana Traub, MPH, said. She studies at Emory University, Atlanta, where abortion is restricted.
“Many students, including myself, struggle when trying to decide whether to stay in restricted states where the need is greatest (highest maternal mortality, infant mortality, lower number of physicians), versus going to an unrestricted state” for more comprehensive training and care, Ms. Traub said. “Regardless of this decision, Dobbs and subsequent abortion laws are making students question what matters most and how they can provide the best care.”
In another recently published survey, University of Miami fourth-year student Morgan Levy, MD, MPH, and colleagues found that 77% of students would prefer to apply to a residency program in a state that preserves access to abortion. Ensuring access to those services for themselves or a family member was a key factor, according to the paper published in the Journal of General Internal Medicine.
For Dr. Levy, who recently graduated from a school in abortion-restricted Florida and will soon apply to ob.gyn. residencies, the Dobbs decision made her more committed to becoming an ob.gyn., an interest she’s had since college, she said.
“I do not intend to limit my search,” Dr. Levy said in an interview. “In the states where there are restrictions in place, it’s really important to make sure that people are getting good care,” she said.
Differing perspective
Though survey and anecdotal data show that students and residents expressing hesitation about states with bans or restrictive laws, it appears that most who applied to residency programs during the 2023 Match did not shy away from those states. Almost all the open ob.gyn. residency positions were filled, according to the National Resident Matching Program.
There was no change in how U.S. MD seniors applying for 2023 residency ranked programs on the basis of whether abortion was legal, limited, or banned in the state where a program was based, Donna Lamb, DHSc, MBA, BSN, president and CEO of the NRMP, said.
“We’re seeing what we’ve seen over the past 5 years, and that is a very high fill rate, a very high rate of preference for ob.gyn., and not a heck of a lot of change,” Dr. Lamb said, noting that ob.gyn. programs continue to be very competitive. “We have more applicants than we have positions available,” she said.
In the most recent Match, there were 2,100 applicants (more than half U.S. MD seniors) for about 1,500 slots, with 1,499 initial matches, according to NRMP data. The overall fill rate was 99.7% after the Supplemental Offer and Assistance Program and Electronic Residency Applications process, NRMP reported. The results are similar to what NRMP reported as its previous all-time high year for ob.gyn. placements.
There was a dip in applicants from 2022 to 2023, even though the slots available stayed the same, but it was not markedly different from the previous 5 years, Dr. Lamb said.
“While the Dobbs decision may, indeed, have impacted applicant and application numbers to residency programs, interventions such as signaling may also contribute to the decrease in numbers of applications submitted as well,” AnnaMarie Connolly, MD, ACOG chief of education and academic affairs, and Arthur Ollendorff, MD, APOG president, said in a statement to this news organization.
For the first time in 2022, Match Day applicants were required to “signal” interest in a particular program in an effort to reduce the number of applications and cost to medical students, they noted.
Personal view
When it was time for Dr. Gibson to apply for ob.gyn. residencies, she wondered: Where do you apply in this landscape? But she did not limit her applications: “If I don’t apply to Indiana, Missouri, Tennessee, Wisconsin, Iowa, I’m taking a lot of really great programs off the table.” She did not want to hurt her chances for a match in a competitive specialty, she said.
“Being in Tennessee is going to give me a very different, unique opportunity to hopefully do a lot of advocacy and lobbying and hopefully have my voice heard in maybe a different way than [in Illinois],” Dr. Gibson added.
Cassie Crifase, MPH, a fourth-year student at the University of Wisconsin–Madison applying to ob.gyn. residencies in next year’s Match, said in an interview that she’s concerned about the health risk of living in a state with abortion restrictions. Wisconsin is one of those.
“My list skews toward programs that are in abortion-protected states, but I also am applying to some programs that are in restricted states.” Those states would have to help her meet the Accreditation Council for Graduate Medical Education training requirements. And, she said, she’d want to know if she could still advocate for abortion access in the state.
Sereena Jivraj, a third-year medical student at Texas Christian University in Fort Worth, said that she won’t apply to programs in Alabama, Mississippi, Arkansas, and other nearby states with abortion restrictions. However, Texas is still on her list. “I’m from Texas, my family lives in Texas, and I go to school in Fort Worth, so I have made those connections,” Ms. Jivraj said.
Student advisers generally encourage ob.gyn. hopefuls to apply to 60-100 programs to ensure that they will match, Ms. Jivraj said. “How are you supposed to apply to 100 programs if many of them fall within states with high restrictions?”
What the future holds
Ms. Jivraj said that she’s concerned about what the future holds, especially if the law does not change in Texas. “I don’t want to go to work every day wondering if I’m going to go to jail for something that I say,” she said.
Dr. Crifase has similar fears. “I want to be able to provide the best care for my patients and that would require being able to do those procedures without having to have my first thought be: Is this legal?”
“Things feel very volatile and uncertain,” Pamela Merritt, executive director of the nonprofit Medical Students for Choice in Philadelphia, where abortion is permitted, said. “What we’re asking medical students to do right now is to envision a future in a profession, a lifetime of providing care, where the policies and procedures and standards of the profession are under attack by 26 state legislatures and the federal court system,” she said.
“I don’t think you’re going to see people as willing to take risk.” She added that if someone matches to a program and then has regrets, “You can’t easily jump from residency program to residency program.”
Dr. Levy believes that the impact of the Dobbs decision is “definitely going to be a more common question of applicants to their potential programs.”
Applicants undoubtedly are thinking about how abortion restrictions or bans might affect their own health or that of their partners or families, she said. In a 2022 survey, Dr. Levy and colleagues reported that abortion is not uncommon among physicians, with 11.5% of the 1,566 respondents who had been pregnant saying they had at least one therapeutic abortion.
Students are also considering the potential ramification of a ban on emergency contraception and laws that criminalize physicians’ provision of abortion care, Dr. Levy said. Another complicating factor is individuals’ family ties or roots in specific geographic areas, she said.
Prospective residents will also have a lot of questions about how they will receive family planning training, Dr. Levy commented. “If you’re somewhere that you can’t really provide full-spectrum reproductive health care, then the question will become: How is the program going to provide that training?”
A version of this article first appeared on Medscape.com.
Emilee Gibson, MD, recently graduated from Southern Illinois University, Springfield, and starts her ob.gyn. residency at Vanderbilt University Medical Center in Nashville, Tenn., later this month. Abortion is permitted in Illinois but banned in Tennessee, a factor she weighed cautiously when she applied for residencies.
Dr. Gibson told this news organization that medical students, not just those interested in ob.gyn., are starting to think more about what it means to move to a state where it might be difficult to access abortion care. “Just from a personal standpoint, that’s a little scary.”
The Supreme Court’s decision to overturn Roe v. Wade abortion rights last June threatened to derail ob.gyns. in training from pursuing the specialty or locating in states that have banned or limited abortion.
, but some industry leaders, residents, and medical students say it may be too early to judge the full impact of the ruling because most students were already far along in their decision and application for a 2023 residency position.
At this point, some ob.gyn. students are planning careers on the basis of whether they have family ties in a particular state, whether limiting their search might hurt their potential to match in a competitive specialty, and whether their faith in the family planning and abortion training being offered by a program outweighs the drawbacks of being in a state with abortion bans or restrictions.
Lucy Brown, MD, a recent graduate of Indiana University, Indianapolis, said in an interview that she’d be “very nervous” about living and practicing in abortion-restricted Indiana if she were ready to start a family.
Dr. Brown said that she mostly limited applications in the recent Match to ob.gyn. residencies in states that protected abortion rights. Though she applied to a program in her home state of Kentucky, she noted that it – along with a program in Missouri – was very low on her rank list because of their abortion restrictions.
Ultimately, Dr. Brown matched at Johns Hopkins University, Baltimore, where she will receive abortion training and assist with abortions throughout her residency. Maryland’s abortion rights status was a big attraction, she said. “Abortion is integrated into every aspect of the education.”
By the numbers
For students applying to residencies this summer, evaluating the state legislative landscape is a little clearer than it was 1 year ago but is still evolving. As of June 1, 56 ob.gyn. residency programs and more than 1,100 medical residents are in states with the most restrictive bans in the country (19% of all programs), according to the Bixby Center for Reproductive Health at the University of California, San Francisco.
In terms of the latest abortion laws: 14 states banned abortion, 2 states banned abortion between 6 and 12 weeks, and 9 states banned abortion between 15 and 22 weeks, whereas abortion is legal in 25 states and Washington, according to a recent analysis by the Kaiser Family Foundation.
The impact on residencies? The Association of American Medical Colleges recently reported a 2% drop in the number of U.S. MD seniors who applied to residencies and a 5% decline in the number of seniors who applied to ob.gyn. residencies. In states where abortion was banned, the number of senior applicants to ob.gyn. programs dropped by more than 10%, according to AAMC’s Research and Action Institute.
“U.S. MD seniors appear, in general, more likely to avoid states where abortions are banned,” said Atul Grover, MD, PhD, executive director of the Research and Action Institute. “That’s a big difference between states where there are abortion bans and gestational limits and states with no bans or limits; it’s almost twice as large,” Dr. Grover said in an interview. “The question is: Was it a 1-year blip or something that will be the beginning of a trend?”
In a statement to this news organization, officials from the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said that they were aware of the AAMC data but needed to further evaluate the impact of the Dobbs ruling.
A survey released at ACOG’s annual meeting in May found that 58% of third- and fourth-year medical students were unlikely to apply to a residency program in a state with abortion restrictions. Conducted after the Dobbs ruling last year, the survey found that future physicians are choosing where to attend residency according to state abortion policies, indicating that access to abortion care is changing the landscape of medical practice.
“For personal as well as professional reasons, reproductive health care access is now a key factor in residency match decisions as a result of Dobbs,” lead author Ariana Traub, MPH, said. She studies at Emory University, Atlanta, where abortion is restricted.
“Many students, including myself, struggle when trying to decide whether to stay in restricted states where the need is greatest (highest maternal mortality, infant mortality, lower number of physicians), versus going to an unrestricted state” for more comprehensive training and care, Ms. Traub said. “Regardless of this decision, Dobbs and subsequent abortion laws are making students question what matters most and how they can provide the best care.”
In another recently published survey, University of Miami fourth-year student Morgan Levy, MD, MPH, and colleagues found that 77% of students would prefer to apply to a residency program in a state that preserves access to abortion. Ensuring access to those services for themselves or a family member was a key factor, according to the paper published in the Journal of General Internal Medicine.
For Dr. Levy, who recently graduated from a school in abortion-restricted Florida and will soon apply to ob.gyn. residencies, the Dobbs decision made her more committed to becoming an ob.gyn., an interest she’s had since college, she said.
“I do not intend to limit my search,” Dr. Levy said in an interview. “In the states where there are restrictions in place, it’s really important to make sure that people are getting good care,” she said.
Differing perspective
Though survey and anecdotal data show that students and residents expressing hesitation about states with bans or restrictive laws, it appears that most who applied to residency programs during the 2023 Match did not shy away from those states. Almost all the open ob.gyn. residency positions were filled, according to the National Resident Matching Program.
There was no change in how U.S. MD seniors applying for 2023 residency ranked programs on the basis of whether abortion was legal, limited, or banned in the state where a program was based, Donna Lamb, DHSc, MBA, BSN, president and CEO of the NRMP, said.
“We’re seeing what we’ve seen over the past 5 years, and that is a very high fill rate, a very high rate of preference for ob.gyn., and not a heck of a lot of change,” Dr. Lamb said, noting that ob.gyn. programs continue to be very competitive. “We have more applicants than we have positions available,” she said.
In the most recent Match, there were 2,100 applicants (more than half U.S. MD seniors) for about 1,500 slots, with 1,499 initial matches, according to NRMP data. The overall fill rate was 99.7% after the Supplemental Offer and Assistance Program and Electronic Residency Applications process, NRMP reported. The results are similar to what NRMP reported as its previous all-time high year for ob.gyn. placements.
There was a dip in applicants from 2022 to 2023, even though the slots available stayed the same, but it was not markedly different from the previous 5 years, Dr. Lamb said.
“While the Dobbs decision may, indeed, have impacted applicant and application numbers to residency programs, interventions such as signaling may also contribute to the decrease in numbers of applications submitted as well,” AnnaMarie Connolly, MD, ACOG chief of education and academic affairs, and Arthur Ollendorff, MD, APOG president, said in a statement to this news organization.
For the first time in 2022, Match Day applicants were required to “signal” interest in a particular program in an effort to reduce the number of applications and cost to medical students, they noted.
Personal view
When it was time for Dr. Gibson to apply for ob.gyn. residencies, she wondered: Where do you apply in this landscape? But she did not limit her applications: “If I don’t apply to Indiana, Missouri, Tennessee, Wisconsin, Iowa, I’m taking a lot of really great programs off the table.” She did not want to hurt her chances for a match in a competitive specialty, she said.
“Being in Tennessee is going to give me a very different, unique opportunity to hopefully do a lot of advocacy and lobbying and hopefully have my voice heard in maybe a different way than [in Illinois],” Dr. Gibson added.
Cassie Crifase, MPH, a fourth-year student at the University of Wisconsin–Madison applying to ob.gyn. residencies in next year’s Match, said in an interview that she’s concerned about the health risk of living in a state with abortion restrictions. Wisconsin is one of those.
“My list skews toward programs that are in abortion-protected states, but I also am applying to some programs that are in restricted states.” Those states would have to help her meet the Accreditation Council for Graduate Medical Education training requirements. And, she said, she’d want to know if she could still advocate for abortion access in the state.
Sereena Jivraj, a third-year medical student at Texas Christian University in Fort Worth, said that she won’t apply to programs in Alabama, Mississippi, Arkansas, and other nearby states with abortion restrictions. However, Texas is still on her list. “I’m from Texas, my family lives in Texas, and I go to school in Fort Worth, so I have made those connections,” Ms. Jivraj said.
Student advisers generally encourage ob.gyn. hopefuls to apply to 60-100 programs to ensure that they will match, Ms. Jivraj said. “How are you supposed to apply to 100 programs if many of them fall within states with high restrictions?”
What the future holds
Ms. Jivraj said that she’s concerned about what the future holds, especially if the law does not change in Texas. “I don’t want to go to work every day wondering if I’m going to go to jail for something that I say,” she said.
Dr. Crifase has similar fears. “I want to be able to provide the best care for my patients and that would require being able to do those procedures without having to have my first thought be: Is this legal?”
“Things feel very volatile and uncertain,” Pamela Merritt, executive director of the nonprofit Medical Students for Choice in Philadelphia, where abortion is permitted, said. “What we’re asking medical students to do right now is to envision a future in a profession, a lifetime of providing care, where the policies and procedures and standards of the profession are under attack by 26 state legislatures and the federal court system,” she said.
“I don’t think you’re going to see people as willing to take risk.” She added that if someone matches to a program and then has regrets, “You can’t easily jump from residency program to residency program.”
Dr. Levy believes that the impact of the Dobbs decision is “definitely going to be a more common question of applicants to their potential programs.”
Applicants undoubtedly are thinking about how abortion restrictions or bans might affect their own health or that of their partners or families, she said. In a 2022 survey, Dr. Levy and colleagues reported that abortion is not uncommon among physicians, with 11.5% of the 1,566 respondents who had been pregnant saying they had at least one therapeutic abortion.
Students are also considering the potential ramification of a ban on emergency contraception and laws that criminalize physicians’ provision of abortion care, Dr. Levy said. Another complicating factor is individuals’ family ties or roots in specific geographic areas, she said.
Prospective residents will also have a lot of questions about how they will receive family planning training, Dr. Levy commented. “If you’re somewhere that you can’t really provide full-spectrum reproductive health care, then the question will become: How is the program going to provide that training?”
A version of this article first appeared on Medscape.com.
Emilee Gibson, MD, recently graduated from Southern Illinois University, Springfield, and starts her ob.gyn. residency at Vanderbilt University Medical Center in Nashville, Tenn., later this month. Abortion is permitted in Illinois but banned in Tennessee, a factor she weighed cautiously when she applied for residencies.
Dr. Gibson told this news organization that medical students, not just those interested in ob.gyn., are starting to think more about what it means to move to a state where it might be difficult to access abortion care. “Just from a personal standpoint, that’s a little scary.”
The Supreme Court’s decision to overturn Roe v. Wade abortion rights last June threatened to derail ob.gyns. in training from pursuing the specialty or locating in states that have banned or limited abortion.
, but some industry leaders, residents, and medical students say it may be too early to judge the full impact of the ruling because most students were already far along in their decision and application for a 2023 residency position.
At this point, some ob.gyn. students are planning careers on the basis of whether they have family ties in a particular state, whether limiting their search might hurt their potential to match in a competitive specialty, and whether their faith in the family planning and abortion training being offered by a program outweighs the drawbacks of being in a state with abortion bans or restrictions.
Lucy Brown, MD, a recent graduate of Indiana University, Indianapolis, said in an interview that she’d be “very nervous” about living and practicing in abortion-restricted Indiana if she were ready to start a family.
Dr. Brown said that she mostly limited applications in the recent Match to ob.gyn. residencies in states that protected abortion rights. Though she applied to a program in her home state of Kentucky, she noted that it – along with a program in Missouri – was very low on her rank list because of their abortion restrictions.
Ultimately, Dr. Brown matched at Johns Hopkins University, Baltimore, where she will receive abortion training and assist with abortions throughout her residency. Maryland’s abortion rights status was a big attraction, she said. “Abortion is integrated into every aspect of the education.”
By the numbers
For students applying to residencies this summer, evaluating the state legislative landscape is a little clearer than it was 1 year ago but is still evolving. As of June 1, 56 ob.gyn. residency programs and more than 1,100 medical residents are in states with the most restrictive bans in the country (19% of all programs), according to the Bixby Center for Reproductive Health at the University of California, San Francisco.
In terms of the latest abortion laws: 14 states banned abortion, 2 states banned abortion between 6 and 12 weeks, and 9 states banned abortion between 15 and 22 weeks, whereas abortion is legal in 25 states and Washington, according to a recent analysis by the Kaiser Family Foundation.
The impact on residencies? The Association of American Medical Colleges recently reported a 2% drop in the number of U.S. MD seniors who applied to residencies and a 5% decline in the number of seniors who applied to ob.gyn. residencies. In states where abortion was banned, the number of senior applicants to ob.gyn. programs dropped by more than 10%, according to AAMC’s Research and Action Institute.
“U.S. MD seniors appear, in general, more likely to avoid states where abortions are banned,” said Atul Grover, MD, PhD, executive director of the Research and Action Institute. “That’s a big difference between states where there are abortion bans and gestational limits and states with no bans or limits; it’s almost twice as large,” Dr. Grover said in an interview. “The question is: Was it a 1-year blip or something that will be the beginning of a trend?”
In a statement to this news organization, officials from the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said that they were aware of the AAMC data but needed to further evaluate the impact of the Dobbs ruling.
A survey released at ACOG’s annual meeting in May found that 58% of third- and fourth-year medical students were unlikely to apply to a residency program in a state with abortion restrictions. Conducted after the Dobbs ruling last year, the survey found that future physicians are choosing where to attend residency according to state abortion policies, indicating that access to abortion care is changing the landscape of medical practice.
“For personal as well as professional reasons, reproductive health care access is now a key factor in residency match decisions as a result of Dobbs,” lead author Ariana Traub, MPH, said. She studies at Emory University, Atlanta, where abortion is restricted.
“Many students, including myself, struggle when trying to decide whether to stay in restricted states where the need is greatest (highest maternal mortality, infant mortality, lower number of physicians), versus going to an unrestricted state” for more comprehensive training and care, Ms. Traub said. “Regardless of this decision, Dobbs and subsequent abortion laws are making students question what matters most and how they can provide the best care.”
In another recently published survey, University of Miami fourth-year student Morgan Levy, MD, MPH, and colleagues found that 77% of students would prefer to apply to a residency program in a state that preserves access to abortion. Ensuring access to those services for themselves or a family member was a key factor, according to the paper published in the Journal of General Internal Medicine.
For Dr. Levy, who recently graduated from a school in abortion-restricted Florida and will soon apply to ob.gyn. residencies, the Dobbs decision made her more committed to becoming an ob.gyn., an interest she’s had since college, she said.
“I do not intend to limit my search,” Dr. Levy said in an interview. “In the states where there are restrictions in place, it’s really important to make sure that people are getting good care,” she said.
Differing perspective
Though survey and anecdotal data show that students and residents expressing hesitation about states with bans or restrictive laws, it appears that most who applied to residency programs during the 2023 Match did not shy away from those states. Almost all the open ob.gyn. residency positions were filled, according to the National Resident Matching Program.
There was no change in how U.S. MD seniors applying for 2023 residency ranked programs on the basis of whether abortion was legal, limited, or banned in the state where a program was based, Donna Lamb, DHSc, MBA, BSN, president and CEO of the NRMP, said.
“We’re seeing what we’ve seen over the past 5 years, and that is a very high fill rate, a very high rate of preference for ob.gyn., and not a heck of a lot of change,” Dr. Lamb said, noting that ob.gyn. programs continue to be very competitive. “We have more applicants than we have positions available,” she said.
In the most recent Match, there were 2,100 applicants (more than half U.S. MD seniors) for about 1,500 slots, with 1,499 initial matches, according to NRMP data. The overall fill rate was 99.7% after the Supplemental Offer and Assistance Program and Electronic Residency Applications process, NRMP reported. The results are similar to what NRMP reported as its previous all-time high year for ob.gyn. placements.
There was a dip in applicants from 2022 to 2023, even though the slots available stayed the same, but it was not markedly different from the previous 5 years, Dr. Lamb said.
“While the Dobbs decision may, indeed, have impacted applicant and application numbers to residency programs, interventions such as signaling may also contribute to the decrease in numbers of applications submitted as well,” AnnaMarie Connolly, MD, ACOG chief of education and academic affairs, and Arthur Ollendorff, MD, APOG president, said in a statement to this news organization.
For the first time in 2022, Match Day applicants were required to “signal” interest in a particular program in an effort to reduce the number of applications and cost to medical students, they noted.
Personal view
When it was time for Dr. Gibson to apply for ob.gyn. residencies, she wondered: Where do you apply in this landscape? But she did not limit her applications: “If I don’t apply to Indiana, Missouri, Tennessee, Wisconsin, Iowa, I’m taking a lot of really great programs off the table.” She did not want to hurt her chances for a match in a competitive specialty, she said.
“Being in Tennessee is going to give me a very different, unique opportunity to hopefully do a lot of advocacy and lobbying and hopefully have my voice heard in maybe a different way than [in Illinois],” Dr. Gibson added.
Cassie Crifase, MPH, a fourth-year student at the University of Wisconsin–Madison applying to ob.gyn. residencies in next year’s Match, said in an interview that she’s concerned about the health risk of living in a state with abortion restrictions. Wisconsin is one of those.
“My list skews toward programs that are in abortion-protected states, but I also am applying to some programs that are in restricted states.” Those states would have to help her meet the Accreditation Council for Graduate Medical Education training requirements. And, she said, she’d want to know if she could still advocate for abortion access in the state.
Sereena Jivraj, a third-year medical student at Texas Christian University in Fort Worth, said that she won’t apply to programs in Alabama, Mississippi, Arkansas, and other nearby states with abortion restrictions. However, Texas is still on her list. “I’m from Texas, my family lives in Texas, and I go to school in Fort Worth, so I have made those connections,” Ms. Jivraj said.
Student advisers generally encourage ob.gyn. hopefuls to apply to 60-100 programs to ensure that they will match, Ms. Jivraj said. “How are you supposed to apply to 100 programs if many of them fall within states with high restrictions?”
What the future holds
Ms. Jivraj said that she’s concerned about what the future holds, especially if the law does not change in Texas. “I don’t want to go to work every day wondering if I’m going to go to jail for something that I say,” she said.
Dr. Crifase has similar fears. “I want to be able to provide the best care for my patients and that would require being able to do those procedures without having to have my first thought be: Is this legal?”
“Things feel very volatile and uncertain,” Pamela Merritt, executive director of the nonprofit Medical Students for Choice in Philadelphia, where abortion is permitted, said. “What we’re asking medical students to do right now is to envision a future in a profession, a lifetime of providing care, where the policies and procedures and standards of the profession are under attack by 26 state legislatures and the federal court system,” she said.
“I don’t think you’re going to see people as willing to take risk.” She added that if someone matches to a program and then has regrets, “You can’t easily jump from residency program to residency program.”
Dr. Levy believes that the impact of the Dobbs decision is “definitely going to be a more common question of applicants to their potential programs.”
Applicants undoubtedly are thinking about how abortion restrictions or bans might affect their own health or that of their partners or families, she said. In a 2022 survey, Dr. Levy and colleagues reported that abortion is not uncommon among physicians, with 11.5% of the 1,566 respondents who had been pregnant saying they had at least one therapeutic abortion.
Students are also considering the potential ramification of a ban on emergency contraception and laws that criminalize physicians’ provision of abortion care, Dr. Levy said. Another complicating factor is individuals’ family ties or roots in specific geographic areas, she said.
Prospective residents will also have a lot of questions about how they will receive family planning training, Dr. Levy commented. “If you’re somewhere that you can’t really provide full-spectrum reproductive health care, then the question will become: How is the program going to provide that training?”
A version of this article first appeared on Medscape.com.
Low-dose oral minoxidil for hair loss soars after NYT article
.
The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication,” at 0.9 prescriptions, compared with 0.5 per 10,000, wrote the authors of the research letter, published in JAMA Network Open. There was no similar bump for first-time finasteride or hypertension prescriptions, wrote the authors, from Harvard Medical School and Massachusetts General Hospital, Boston, and Truveta, a company that provides EHR data from U.S. health care systems.
The New York Times article noted that LDOM was relatively unknown to patients and doctors – and not approved by the Food and Drug Administration for treating hair loss – but that it was inexpensive, safe, and very effective for many individuals. “The article did not report new research findings or large-scale randomized evidence,” wrote the authors of the JAMA study.
Rodney Sinclair, MD, professor of dermatology at the University of Melbourne, who conducted the original research on LDOM and hair loss and was quoted in the Times story, told this news organization that “the sharp uplift after the New York Times article was on the back of a gradual increase.” He added that “the momentum for minoxidil prescriptions is increasing,” so much so that it has led to a global shortage of LDOM. The drug appears to still be widely available in the United States, however. It is not on the ASHP shortages list.
“There has been growing momentum for minoxidil use since I first presented our data about 6 years ago,” Dr. Sinclair said. He noted that 2022 International Society of Hair Restoration Surgery survey data found that 26% of treating physicians always or often prescribed off-label oral minoxidil, up from 10% in 2019 and 0% in 2017, while another 20% said they prescribed it sometimes.
The authors of the new study looked at prescriptions for patients at eight health care systems before and after the Times article was published in August 2022. They calculated the rate of first-time oral minoxidil prescriptions for 2.5 mg and 5 mg tablets, excluding 10 mg tablets, which are prescribed for hypertension.
Among those receiving first-time prescriptions, 2,846 received them in the 7 months before the article and 3,695 in the 5 months after publication. Men (43.6% after vs. 37.7% before publication) and White individuals (68.6% after vs. 60.8% before publication) accounted for a higher proportion of prescriptions after the article was published. There was a 2.4-fold increase in first-time prescriptions among men, and a 1.7-fold increase among females, while people with comorbidities accounted for a smaller proportion after the publication.
“Socioeconomic factors, such as access to health care and education and income levels, may be associated with individuals seeking low-dose oral minoxidil after article publication,” wrote the authors.
In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said that he was not surprised to see an uptick in prescriptions after the Times article.
He and his colleagues were curious as to whether the article might have prompted newfound interest in LDOM. They experienced an uptick at George Washington, which Dr. Friedman thought could have been because he was quoted in the Times story. He and colleagues conducted a national survey of dermatologists asking if more patients had called, emailed, or come in to the office asking about LDOM after the article’s publication. “Over 85% said yes,” Dr. Friedman said in the interview. He and his coauthors also found a huge increase in Google searches for terms such as hair loss, alopecia, and minoxidil in the weeks after the article, he said.
The results are expected to published soon in the Journal of Drugs in Dermatology.
“I think a lot of people know about [LDOM] and it’s certainly has gained a lot more attention and acceptance in recent years,” said Dr. Friedman, but he added that “there’s no question” that the Times article increased interest.
That is not necessarily a bad thing, he said. “With one article, education on a common disease was disseminated worldwide in a way that no one doctor can do,” he said. The article was truthful, evidence-based, and included expert dermatologists, he noted.
“It probably got people who never thought twice about their hair thinning to actually think that there’s hope,” he said, adding that it also likely prompted them to seek care, and, more importantly, “to seek care from the person who should be taking care of this, which is the dermatologist.”
However, the article might also inspire some people to think LDOM can help when it can’t, or they might insist on a prescription when another medication is more appropriate, said Dr. Friedman.
Both he and Dr. Sinclair expect demand for LDOM to continue increasing.
“Word of mouth will drive the next wave of prescriptions,” said Dr. Sinclair. “We are continuing to do work to improve safety, to understand its mechanism of action, and identify ways to improve equity of access to treatment for men and women who are concerned about their hair loss and motivated to treat it,” he said.
Dr. Sinclair and Dr. Friedman report no relevant financial relationships.
.
The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication,” at 0.9 prescriptions, compared with 0.5 per 10,000, wrote the authors of the research letter, published in JAMA Network Open. There was no similar bump for first-time finasteride or hypertension prescriptions, wrote the authors, from Harvard Medical School and Massachusetts General Hospital, Boston, and Truveta, a company that provides EHR data from U.S. health care systems.
The New York Times article noted that LDOM was relatively unknown to patients and doctors – and not approved by the Food and Drug Administration for treating hair loss – but that it was inexpensive, safe, and very effective for many individuals. “The article did not report new research findings or large-scale randomized evidence,” wrote the authors of the JAMA study.
Rodney Sinclair, MD, professor of dermatology at the University of Melbourne, who conducted the original research on LDOM and hair loss and was quoted in the Times story, told this news organization that “the sharp uplift after the New York Times article was on the back of a gradual increase.” He added that “the momentum for minoxidil prescriptions is increasing,” so much so that it has led to a global shortage of LDOM. The drug appears to still be widely available in the United States, however. It is not on the ASHP shortages list.
“There has been growing momentum for minoxidil use since I first presented our data about 6 years ago,” Dr. Sinclair said. He noted that 2022 International Society of Hair Restoration Surgery survey data found that 26% of treating physicians always or often prescribed off-label oral minoxidil, up from 10% in 2019 and 0% in 2017, while another 20% said they prescribed it sometimes.
The authors of the new study looked at prescriptions for patients at eight health care systems before and after the Times article was published in August 2022. They calculated the rate of first-time oral minoxidil prescriptions for 2.5 mg and 5 mg tablets, excluding 10 mg tablets, which are prescribed for hypertension.
Among those receiving first-time prescriptions, 2,846 received them in the 7 months before the article and 3,695 in the 5 months after publication. Men (43.6% after vs. 37.7% before publication) and White individuals (68.6% after vs. 60.8% before publication) accounted for a higher proportion of prescriptions after the article was published. There was a 2.4-fold increase in first-time prescriptions among men, and a 1.7-fold increase among females, while people with comorbidities accounted for a smaller proportion after the publication.
“Socioeconomic factors, such as access to health care and education and income levels, may be associated with individuals seeking low-dose oral minoxidil after article publication,” wrote the authors.
In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said that he was not surprised to see an uptick in prescriptions after the Times article.
He and his colleagues were curious as to whether the article might have prompted newfound interest in LDOM. They experienced an uptick at George Washington, which Dr. Friedman thought could have been because he was quoted in the Times story. He and colleagues conducted a national survey of dermatologists asking if more patients had called, emailed, or come in to the office asking about LDOM after the article’s publication. “Over 85% said yes,” Dr. Friedman said in the interview. He and his coauthors also found a huge increase in Google searches for terms such as hair loss, alopecia, and minoxidil in the weeks after the article, he said.
The results are expected to published soon in the Journal of Drugs in Dermatology.
“I think a lot of people know about [LDOM] and it’s certainly has gained a lot more attention and acceptance in recent years,” said Dr. Friedman, but he added that “there’s no question” that the Times article increased interest.
That is not necessarily a bad thing, he said. “With one article, education on a common disease was disseminated worldwide in a way that no one doctor can do,” he said. The article was truthful, evidence-based, and included expert dermatologists, he noted.
“It probably got people who never thought twice about their hair thinning to actually think that there’s hope,” he said, adding that it also likely prompted them to seek care, and, more importantly, “to seek care from the person who should be taking care of this, which is the dermatologist.”
However, the article might also inspire some people to think LDOM can help when it can’t, or they might insist on a prescription when another medication is more appropriate, said Dr. Friedman.
Both he and Dr. Sinclair expect demand for LDOM to continue increasing.
“Word of mouth will drive the next wave of prescriptions,” said Dr. Sinclair. “We are continuing to do work to improve safety, to understand its mechanism of action, and identify ways to improve equity of access to treatment for men and women who are concerned about their hair loss and motivated to treat it,” he said.
Dr. Sinclair and Dr. Friedman report no relevant financial relationships.
.
The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication,” at 0.9 prescriptions, compared with 0.5 per 10,000, wrote the authors of the research letter, published in JAMA Network Open. There was no similar bump for first-time finasteride or hypertension prescriptions, wrote the authors, from Harvard Medical School and Massachusetts General Hospital, Boston, and Truveta, a company that provides EHR data from U.S. health care systems.
The New York Times article noted that LDOM was relatively unknown to patients and doctors – and not approved by the Food and Drug Administration for treating hair loss – but that it was inexpensive, safe, and very effective for many individuals. “The article did not report new research findings or large-scale randomized evidence,” wrote the authors of the JAMA study.
Rodney Sinclair, MD, professor of dermatology at the University of Melbourne, who conducted the original research on LDOM and hair loss and was quoted in the Times story, told this news organization that “the sharp uplift after the New York Times article was on the back of a gradual increase.” He added that “the momentum for minoxidil prescriptions is increasing,” so much so that it has led to a global shortage of LDOM. The drug appears to still be widely available in the United States, however. It is not on the ASHP shortages list.
“There has been growing momentum for minoxidil use since I first presented our data about 6 years ago,” Dr. Sinclair said. He noted that 2022 International Society of Hair Restoration Surgery survey data found that 26% of treating physicians always or often prescribed off-label oral minoxidil, up from 10% in 2019 and 0% in 2017, while another 20% said they prescribed it sometimes.
The authors of the new study looked at prescriptions for patients at eight health care systems before and after the Times article was published in August 2022. They calculated the rate of first-time oral minoxidil prescriptions for 2.5 mg and 5 mg tablets, excluding 10 mg tablets, which are prescribed for hypertension.
Among those receiving first-time prescriptions, 2,846 received them in the 7 months before the article and 3,695 in the 5 months after publication. Men (43.6% after vs. 37.7% before publication) and White individuals (68.6% after vs. 60.8% before publication) accounted for a higher proportion of prescriptions after the article was published. There was a 2.4-fold increase in first-time prescriptions among men, and a 1.7-fold increase among females, while people with comorbidities accounted for a smaller proportion after the publication.
“Socioeconomic factors, such as access to health care and education and income levels, may be associated with individuals seeking low-dose oral minoxidil after article publication,” wrote the authors.
In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said that he was not surprised to see an uptick in prescriptions after the Times article.
He and his colleagues were curious as to whether the article might have prompted newfound interest in LDOM. They experienced an uptick at George Washington, which Dr. Friedman thought could have been because he was quoted in the Times story. He and colleagues conducted a national survey of dermatologists asking if more patients had called, emailed, or come in to the office asking about LDOM after the article’s publication. “Over 85% said yes,” Dr. Friedman said in the interview. He and his coauthors also found a huge increase in Google searches for terms such as hair loss, alopecia, and minoxidil in the weeks after the article, he said.
The results are expected to published soon in the Journal of Drugs in Dermatology.
“I think a lot of people know about [LDOM] and it’s certainly has gained a lot more attention and acceptance in recent years,” said Dr. Friedman, but he added that “there’s no question” that the Times article increased interest.
That is not necessarily a bad thing, he said. “With one article, education on a common disease was disseminated worldwide in a way that no one doctor can do,” he said. The article was truthful, evidence-based, and included expert dermatologists, he noted.
“It probably got people who never thought twice about their hair thinning to actually think that there’s hope,” he said, adding that it also likely prompted them to seek care, and, more importantly, “to seek care from the person who should be taking care of this, which is the dermatologist.”
However, the article might also inspire some people to think LDOM can help when it can’t, or they might insist on a prescription when another medication is more appropriate, said Dr. Friedman.
Both he and Dr. Sinclair expect demand for LDOM to continue increasing.
“Word of mouth will drive the next wave of prescriptions,” said Dr. Sinclair. “We are continuing to do work to improve safety, to understand its mechanism of action, and identify ways to improve equity of access to treatment for men and women who are concerned about their hair loss and motivated to treat it,” he said.
Dr. Sinclair and Dr. Friedman report no relevant financial relationships.
FROM JAMA NETWORK OPEN
Scientists discover variants, therapy for disabling pansclerotic morphea
A team of especially in patients who have not responded to other interventions.
DPM was first reported in 1923, and while a genetic cause has been suspected, it had not been identified until now. The disease is the most severe form of deep morphea, which affects individuals with juvenile localized scleroderma. Patients, generally children under age 14, experience rapid sclerosis of all layers of the skin, fascia, muscle, and bone. DPM is also deadly: Most patients do not live more than 10 years after diagnosis, as they contract squamous cell carcinoma, restrictive pulmonary disease, sepsis, and gangrene.
In the study, published in the New England Journal of Medicine, the researchers discovered that people with DPM have an overactive version of the protein STAT4, which regulates inflammation and wound healing. The scientists studied four patients from three unrelated families with an autosomal dominant pattern of inheritance of DPM.
“Researchers previously thought that this disorder was caused by the immune system attacking the skin,” Sarah Blackstone, a predoctoral fellow in the inflammatory disease section at the National Human Genome Research Institute and co–first author of the study, said in a statement from the National Institutes of Health describing the results. “However, we found that this is an oversimplification, and that both skin and the immune system play an active role in disabling pansclerotic morphea,” added Ms. Blackstone, also a medical student at the University of South Dakota, Sioux Falls.
The overactive STAT4 protein creates a positive feedback loop of inflammation and impaired wound-healing. By targeting JAK, the researchers were able to stop the feedback and patients’ wounds dramatically improved. After 18 months of treatment with oral ruxolitinib, one patient had discontinued all other medications, and had complete resolution of a chest rash, substantial clearing on the arms and legs, and global clinical improvement.
The authors said that oral systemic JAK inhibitor therapy is preferred over topical therapy. Their research also suggested that anti–interleukin-6 monoclonal antibodies – such as tocilizumab, approved for indications that include rheumatoid arthritis and systemic sclerosis–associated interstitial lung disease, “may be an alternative therapy or may be useful in combination with JAK inhibitors in patients with DPM,” the authors wrote.
Most current DPM therapies – including methotrexate, mycophenolate mofetil, and ultraviolet A light therapy – have been ineffective, and some have severe side effects.
“The findings of this study open doors for JAK inhibitors to be a potential treatment for other inflammatory skin disorders or disorders related to tissue scarring, whether it is scarring of the lungs, liver or bone marrow,” Dan Kastner, MD, PhD, an NIH distinguished investigator, head of the NHGRI’s inflammatory disease section, and a senior author of the paper, said in the NIH statement.
“We hope to continue studying other molecules in this pathway and how they are altered in patients with disabling pansclerotic morphea and related conditions to find clues to understanding a broader array of more common diseases,” Lori Broderick, MD, PhD, a senior author of the paper and an associate professor at University of California, San Diego, said in the statement.
The study was led by researchers at NHGRI in collaboration with researchers from UCSD and the University of Pittsburgh. Researchers from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Allergy and Infectious Diseases also participated.
The study was supported by grants from the American Academy of Allergy, Asthma, and Immunology Foundation; the Ludwig Institute for Cancer Research; the University of California, San Diego, department of pediatrics; and the Novo Nordisk Foundation. Additional support and grants were given by the Deutsche Forschungsgemeinschaft, various institutes at the NIH, the California Institute for Regenerative Medicine, the Hydrocephalus Association, the Scleroderma Research Foundation, the Biowulf High-Performance Computing Cluster of the Center for Information Technology, the Undiagnosed Diseases Program of the Common Fund of the Office of the Director of the NIH, and the NIH Clinical Center.
A team of especially in patients who have not responded to other interventions.
DPM was first reported in 1923, and while a genetic cause has been suspected, it had not been identified until now. The disease is the most severe form of deep morphea, which affects individuals with juvenile localized scleroderma. Patients, generally children under age 14, experience rapid sclerosis of all layers of the skin, fascia, muscle, and bone. DPM is also deadly: Most patients do not live more than 10 years after diagnosis, as they contract squamous cell carcinoma, restrictive pulmonary disease, sepsis, and gangrene.
In the study, published in the New England Journal of Medicine, the researchers discovered that people with DPM have an overactive version of the protein STAT4, which regulates inflammation and wound healing. The scientists studied four patients from three unrelated families with an autosomal dominant pattern of inheritance of DPM.
“Researchers previously thought that this disorder was caused by the immune system attacking the skin,” Sarah Blackstone, a predoctoral fellow in the inflammatory disease section at the National Human Genome Research Institute and co–first author of the study, said in a statement from the National Institutes of Health describing the results. “However, we found that this is an oversimplification, and that both skin and the immune system play an active role in disabling pansclerotic morphea,” added Ms. Blackstone, also a medical student at the University of South Dakota, Sioux Falls.
The overactive STAT4 protein creates a positive feedback loop of inflammation and impaired wound-healing. By targeting JAK, the researchers were able to stop the feedback and patients’ wounds dramatically improved. After 18 months of treatment with oral ruxolitinib, one patient had discontinued all other medications, and had complete resolution of a chest rash, substantial clearing on the arms and legs, and global clinical improvement.
The authors said that oral systemic JAK inhibitor therapy is preferred over topical therapy. Their research also suggested that anti–interleukin-6 monoclonal antibodies – such as tocilizumab, approved for indications that include rheumatoid arthritis and systemic sclerosis–associated interstitial lung disease, “may be an alternative therapy or may be useful in combination with JAK inhibitors in patients with DPM,” the authors wrote.
Most current DPM therapies – including methotrexate, mycophenolate mofetil, and ultraviolet A light therapy – have been ineffective, and some have severe side effects.
“The findings of this study open doors for JAK inhibitors to be a potential treatment for other inflammatory skin disorders or disorders related to tissue scarring, whether it is scarring of the lungs, liver or bone marrow,” Dan Kastner, MD, PhD, an NIH distinguished investigator, head of the NHGRI’s inflammatory disease section, and a senior author of the paper, said in the NIH statement.
“We hope to continue studying other molecules in this pathway and how they are altered in patients with disabling pansclerotic morphea and related conditions to find clues to understanding a broader array of more common diseases,” Lori Broderick, MD, PhD, a senior author of the paper and an associate professor at University of California, San Diego, said in the statement.
The study was led by researchers at NHGRI in collaboration with researchers from UCSD and the University of Pittsburgh. Researchers from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Allergy and Infectious Diseases also participated.
The study was supported by grants from the American Academy of Allergy, Asthma, and Immunology Foundation; the Ludwig Institute for Cancer Research; the University of California, San Diego, department of pediatrics; and the Novo Nordisk Foundation. Additional support and grants were given by the Deutsche Forschungsgemeinschaft, various institutes at the NIH, the California Institute for Regenerative Medicine, the Hydrocephalus Association, the Scleroderma Research Foundation, the Biowulf High-Performance Computing Cluster of the Center for Information Technology, the Undiagnosed Diseases Program of the Common Fund of the Office of the Director of the NIH, and the NIH Clinical Center.
A team of especially in patients who have not responded to other interventions.
DPM was first reported in 1923, and while a genetic cause has been suspected, it had not been identified until now. The disease is the most severe form of deep morphea, which affects individuals with juvenile localized scleroderma. Patients, generally children under age 14, experience rapid sclerosis of all layers of the skin, fascia, muscle, and bone. DPM is also deadly: Most patients do not live more than 10 years after diagnosis, as they contract squamous cell carcinoma, restrictive pulmonary disease, sepsis, and gangrene.
In the study, published in the New England Journal of Medicine, the researchers discovered that people with DPM have an overactive version of the protein STAT4, which regulates inflammation and wound healing. The scientists studied four patients from three unrelated families with an autosomal dominant pattern of inheritance of DPM.
“Researchers previously thought that this disorder was caused by the immune system attacking the skin,” Sarah Blackstone, a predoctoral fellow in the inflammatory disease section at the National Human Genome Research Institute and co–first author of the study, said in a statement from the National Institutes of Health describing the results. “However, we found that this is an oversimplification, and that both skin and the immune system play an active role in disabling pansclerotic morphea,” added Ms. Blackstone, also a medical student at the University of South Dakota, Sioux Falls.
The overactive STAT4 protein creates a positive feedback loop of inflammation and impaired wound-healing. By targeting JAK, the researchers were able to stop the feedback and patients’ wounds dramatically improved. After 18 months of treatment with oral ruxolitinib, one patient had discontinued all other medications, and had complete resolution of a chest rash, substantial clearing on the arms and legs, and global clinical improvement.
The authors said that oral systemic JAK inhibitor therapy is preferred over topical therapy. Their research also suggested that anti–interleukin-6 monoclonal antibodies – such as tocilizumab, approved for indications that include rheumatoid arthritis and systemic sclerosis–associated interstitial lung disease, “may be an alternative therapy or may be useful in combination with JAK inhibitors in patients with DPM,” the authors wrote.
Most current DPM therapies – including methotrexate, mycophenolate mofetil, and ultraviolet A light therapy – have been ineffective, and some have severe side effects.
“The findings of this study open doors for JAK inhibitors to be a potential treatment for other inflammatory skin disorders or disorders related to tissue scarring, whether it is scarring of the lungs, liver or bone marrow,” Dan Kastner, MD, PhD, an NIH distinguished investigator, head of the NHGRI’s inflammatory disease section, and a senior author of the paper, said in the NIH statement.
“We hope to continue studying other molecules in this pathway and how they are altered in patients with disabling pansclerotic morphea and related conditions to find clues to understanding a broader array of more common diseases,” Lori Broderick, MD, PhD, a senior author of the paper and an associate professor at University of California, San Diego, said in the statement.
The study was led by researchers at NHGRI in collaboration with researchers from UCSD and the University of Pittsburgh. Researchers from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Allergy and Infectious Diseases also participated.
The study was supported by grants from the American Academy of Allergy, Asthma, and Immunology Foundation; the Ludwig Institute for Cancer Research; the University of California, San Diego, department of pediatrics; and the Novo Nordisk Foundation. Additional support and grants were given by the Deutsche Forschungsgemeinschaft, various institutes at the NIH, the California Institute for Regenerative Medicine, the Hydrocephalus Association, the Scleroderma Research Foundation, the Biowulf High-Performance Computing Cluster of the Center for Information Technology, the Undiagnosed Diseases Program of the Common Fund of the Office of the Director of the NIH, and the NIH Clinical Center.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
FDA OKs first-ever topical gene therapy, for rare skin disease
(DEB), a rare skin disease.
The therapy, Vyjuvek (beremagene geperpavec, formerly known as B-VEC), uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure.
Vyjuvek, developed by Krystal Biotech, is designed to be used repetitively to heal a single wound or on more than one wound. In the pivotal study, the gene therapy, delivered in a topical gel, was administered once a week for 6 months.
The FDA gave Vyjuvek priority review, approving the therapy just 9 months after Krystal filed its application for approval. Vyjuvek is also an orphan drug, giving it potentially 7 years of marketing exclusivity.
“Vyjuvek is the first FDA-approved gene therapy treatment for DEB, a rare and serious genetic skin disorder,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA’s statement announcing the approval.
“With the FDA approval of Vyjuvek, the DEB population has reached a monumental milestone in the treatment of this horrible disorder,” said Brett Kopelan, executive director of debra of America, a national advocacy group for people with DEB, in a statement issued by Krystal Biotech. “Our hopes have now been realized for a safe and effective treatment for one of the most devastating symptoms of the disorder,” said Mr. Kopelan.
“This is a devastating disease,” said M. Peter Marinkovich, MD, primary investigator of Krystal’s pivotal GEM-3 trial and director of the Blistering Disease Clinic at Stanford Health Care, in the statement issued by Krystal. “Until now, doctors and nurses had no way to stop blisters and wounds from developing on dystrophic EB patient skin, and all we could do was to give them bandages and helplessly watch as new blisters formed,” said Dr. Marinkovich, who is also associate professor of dermatology at Stanford (Calif.) University School of Medicine.
“Because it’s safe and easy to apply directly to wounds, it doesn’t require a lot of supporting technology or specialized expertise, making Vyjuvek highly accessible even to patients who live far away from specialized centers,” he said.
Paras P. Vakharia, MD, PharmD, assistant professor of dermatology at Northwestern University, Chicago, said that Vyjuvek is an important advance for DEB. “This to me would be a treatment that I would consider for almost all patients,” Dr. Vakharia said in an interview.
Dr. Vakharia, who was not involved with trials of Vyjuvek, said he had concerns about whether patients might develop antibodies to either HSV or C7 but that the greater initial worry is if Vyjuvek will be affordable and accessible. “I envision that it will be a costly medication,” he said.
Mr. Kopelan, the patient advocate, said that his organization “will continue to work closely with Krystal to assure patients have ready access to Vyjuvek.”
Krystal did not respond before press time to a request for comment on pricing.
Dystrophic epidermolysis bullosa affects 1 to 3 people per million in the United States. It is caused by mutations in the COL7A1 gene, which encodes the alpha-1 chain of collagen type VII (C7) protein. C7 forms the anchoring fibrils that attach the epidermis to the underlying dermal connective tissue. COL71A mutations that lead to defective, decreased, or absent C7 can make the skin so fragile that it tears with the slightest touch.
DEB usually presents at birth and is divided into two major types depending on the inheritance pattern: recessive dystrophic epidermolysis bullosa and dominant dystrophic epidermolysis bullosa.
People with the dominant form typically have mild cases with blistering primarily on the hands, feet, knees, and elbows. The recessive form can be painful and debilitating, causing widespread blistering. Depending on the severity, it can lead to nonhealing wounds, fusing of fingers and toes, anemia, weak bones, and esophageal and genitourinary strictures. Squamous cell cancers are a frequent cause of death.
Vyjuvek is mixed into an inactive gel and is evenly applied to a wound once a week by a health care professional, according to the FDA.
The agency recommends the following precautions for patients and caregivers:
- Avoid direct contact with treated wounds and dressings of treated wounds for 24 hours following application. Clean any area that is accidentally exposed.
- Wash hands and wear protective gloves when changing wound dressings.
- Disinfect the bandages used for the first dressing with a viricidal agent, such as 70% isopropyl alcohol, 6% hydrogen peroxide, or less than 0.4% ammonium chloride, and dispose of them in a separate, sealed plastic bag in household waste. Subsequent used dressings and cleaning materials should be disposed of in sealed plastic bags in household waste.
FDA approval of Vyjuvek was based on a randomized, double-blinded, placebo-controlled, 31-patient, phase 3 trial published in the New England Journal of Medicine, which showed that 71% of wounds treated with the gene therapy had complete healing at 3 months, compared with 20% of those treated with placebo (95% confidence interval, 29-73; P < .001). At 6 months, 67% of wounds treated with the gene therapy had complete healing, compared with 22% of wounds treated with placebo (95% CI, 24-68; P = .002).
Almost two-thirds of the patients had at least one adverse event. Most were mild or moderate. The most common events were pruritus, chills, and squamous cell carcinoma, reported in three patients each. SCC cases occurred at wound sites that had not been exposed to Vyjuvek or placebo. Serious adverse events, which were unrelated to the treatment, occurred in three patients and included diarrhea, anemia, and cellulitis.
Krystal will also be seeking marketing approval for Vyjuvek in the European Union, likely in 2024, said the company. In September, the European Medicines Agency’s Pediatric Committee issued a positive opinion on the gene therapy and Krystal’s plan to test B-VEC in children.
Dr. Marinkovich and Dr. Vakharia have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
(DEB), a rare skin disease.
The therapy, Vyjuvek (beremagene geperpavec, formerly known as B-VEC), uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure.
Vyjuvek, developed by Krystal Biotech, is designed to be used repetitively to heal a single wound or on more than one wound. In the pivotal study, the gene therapy, delivered in a topical gel, was administered once a week for 6 months.
The FDA gave Vyjuvek priority review, approving the therapy just 9 months after Krystal filed its application for approval. Vyjuvek is also an orphan drug, giving it potentially 7 years of marketing exclusivity.
“Vyjuvek is the first FDA-approved gene therapy treatment for DEB, a rare and serious genetic skin disorder,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA’s statement announcing the approval.
“With the FDA approval of Vyjuvek, the DEB population has reached a monumental milestone in the treatment of this horrible disorder,” said Brett Kopelan, executive director of debra of America, a national advocacy group for people with DEB, in a statement issued by Krystal Biotech. “Our hopes have now been realized for a safe and effective treatment for one of the most devastating symptoms of the disorder,” said Mr. Kopelan.
“This is a devastating disease,” said M. Peter Marinkovich, MD, primary investigator of Krystal’s pivotal GEM-3 trial and director of the Blistering Disease Clinic at Stanford Health Care, in the statement issued by Krystal. “Until now, doctors and nurses had no way to stop blisters and wounds from developing on dystrophic EB patient skin, and all we could do was to give them bandages and helplessly watch as new blisters formed,” said Dr. Marinkovich, who is also associate professor of dermatology at Stanford (Calif.) University School of Medicine.
“Because it’s safe and easy to apply directly to wounds, it doesn’t require a lot of supporting technology or specialized expertise, making Vyjuvek highly accessible even to patients who live far away from specialized centers,” he said.
Paras P. Vakharia, MD, PharmD, assistant professor of dermatology at Northwestern University, Chicago, said that Vyjuvek is an important advance for DEB. “This to me would be a treatment that I would consider for almost all patients,” Dr. Vakharia said in an interview.
Dr. Vakharia, who was not involved with trials of Vyjuvek, said he had concerns about whether patients might develop antibodies to either HSV or C7 but that the greater initial worry is if Vyjuvek will be affordable and accessible. “I envision that it will be a costly medication,” he said.
Mr. Kopelan, the patient advocate, said that his organization “will continue to work closely with Krystal to assure patients have ready access to Vyjuvek.”
Krystal did not respond before press time to a request for comment on pricing.
Dystrophic epidermolysis bullosa affects 1 to 3 people per million in the United States. It is caused by mutations in the COL7A1 gene, which encodes the alpha-1 chain of collagen type VII (C7) protein. C7 forms the anchoring fibrils that attach the epidermis to the underlying dermal connective tissue. COL71A mutations that lead to defective, decreased, or absent C7 can make the skin so fragile that it tears with the slightest touch.
DEB usually presents at birth and is divided into two major types depending on the inheritance pattern: recessive dystrophic epidermolysis bullosa and dominant dystrophic epidermolysis bullosa.
People with the dominant form typically have mild cases with blistering primarily on the hands, feet, knees, and elbows. The recessive form can be painful and debilitating, causing widespread blistering. Depending on the severity, it can lead to nonhealing wounds, fusing of fingers and toes, anemia, weak bones, and esophageal and genitourinary strictures. Squamous cell cancers are a frequent cause of death.
Vyjuvek is mixed into an inactive gel and is evenly applied to a wound once a week by a health care professional, according to the FDA.
The agency recommends the following precautions for patients and caregivers:
- Avoid direct contact with treated wounds and dressings of treated wounds for 24 hours following application. Clean any area that is accidentally exposed.
- Wash hands and wear protective gloves when changing wound dressings.
- Disinfect the bandages used for the first dressing with a viricidal agent, such as 70% isopropyl alcohol, 6% hydrogen peroxide, or less than 0.4% ammonium chloride, and dispose of them in a separate, sealed plastic bag in household waste. Subsequent used dressings and cleaning materials should be disposed of in sealed plastic bags in household waste.
FDA approval of Vyjuvek was based on a randomized, double-blinded, placebo-controlled, 31-patient, phase 3 trial published in the New England Journal of Medicine, which showed that 71% of wounds treated with the gene therapy had complete healing at 3 months, compared with 20% of those treated with placebo (95% confidence interval, 29-73; P < .001). At 6 months, 67% of wounds treated with the gene therapy had complete healing, compared with 22% of wounds treated with placebo (95% CI, 24-68; P = .002).
Almost two-thirds of the patients had at least one adverse event. Most were mild or moderate. The most common events were pruritus, chills, and squamous cell carcinoma, reported in three patients each. SCC cases occurred at wound sites that had not been exposed to Vyjuvek or placebo. Serious adverse events, which were unrelated to the treatment, occurred in three patients and included diarrhea, anemia, and cellulitis.
Krystal will also be seeking marketing approval for Vyjuvek in the European Union, likely in 2024, said the company. In September, the European Medicines Agency’s Pediatric Committee issued a positive opinion on the gene therapy and Krystal’s plan to test B-VEC in children.
Dr. Marinkovich and Dr. Vakharia have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
(DEB), a rare skin disease.
The therapy, Vyjuvek (beremagene geperpavec, formerly known as B-VEC), uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure.
Vyjuvek, developed by Krystal Biotech, is designed to be used repetitively to heal a single wound or on more than one wound. In the pivotal study, the gene therapy, delivered in a topical gel, was administered once a week for 6 months.
The FDA gave Vyjuvek priority review, approving the therapy just 9 months after Krystal filed its application for approval. Vyjuvek is also an orphan drug, giving it potentially 7 years of marketing exclusivity.
“Vyjuvek is the first FDA-approved gene therapy treatment for DEB, a rare and serious genetic skin disorder,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA’s statement announcing the approval.
“With the FDA approval of Vyjuvek, the DEB population has reached a monumental milestone in the treatment of this horrible disorder,” said Brett Kopelan, executive director of debra of America, a national advocacy group for people with DEB, in a statement issued by Krystal Biotech. “Our hopes have now been realized for a safe and effective treatment for one of the most devastating symptoms of the disorder,” said Mr. Kopelan.
“This is a devastating disease,” said M. Peter Marinkovich, MD, primary investigator of Krystal’s pivotal GEM-3 trial and director of the Blistering Disease Clinic at Stanford Health Care, in the statement issued by Krystal. “Until now, doctors and nurses had no way to stop blisters and wounds from developing on dystrophic EB patient skin, and all we could do was to give them bandages and helplessly watch as new blisters formed,” said Dr. Marinkovich, who is also associate professor of dermatology at Stanford (Calif.) University School of Medicine.
“Because it’s safe and easy to apply directly to wounds, it doesn’t require a lot of supporting technology or specialized expertise, making Vyjuvek highly accessible even to patients who live far away from specialized centers,” he said.
Paras P. Vakharia, MD, PharmD, assistant professor of dermatology at Northwestern University, Chicago, said that Vyjuvek is an important advance for DEB. “This to me would be a treatment that I would consider for almost all patients,” Dr. Vakharia said in an interview.
Dr. Vakharia, who was not involved with trials of Vyjuvek, said he had concerns about whether patients might develop antibodies to either HSV or C7 but that the greater initial worry is if Vyjuvek will be affordable and accessible. “I envision that it will be a costly medication,” he said.
Mr. Kopelan, the patient advocate, said that his organization “will continue to work closely with Krystal to assure patients have ready access to Vyjuvek.”
Krystal did not respond before press time to a request for comment on pricing.
Dystrophic epidermolysis bullosa affects 1 to 3 people per million in the United States. It is caused by mutations in the COL7A1 gene, which encodes the alpha-1 chain of collagen type VII (C7) protein. C7 forms the anchoring fibrils that attach the epidermis to the underlying dermal connective tissue. COL71A mutations that lead to defective, decreased, or absent C7 can make the skin so fragile that it tears with the slightest touch.
DEB usually presents at birth and is divided into two major types depending on the inheritance pattern: recessive dystrophic epidermolysis bullosa and dominant dystrophic epidermolysis bullosa.
People with the dominant form typically have mild cases with blistering primarily on the hands, feet, knees, and elbows. The recessive form can be painful and debilitating, causing widespread blistering. Depending on the severity, it can lead to nonhealing wounds, fusing of fingers and toes, anemia, weak bones, and esophageal and genitourinary strictures. Squamous cell cancers are a frequent cause of death.
Vyjuvek is mixed into an inactive gel and is evenly applied to a wound once a week by a health care professional, according to the FDA.
The agency recommends the following precautions for patients and caregivers:
- Avoid direct contact with treated wounds and dressings of treated wounds for 24 hours following application. Clean any area that is accidentally exposed.
- Wash hands and wear protective gloves when changing wound dressings.
- Disinfect the bandages used for the first dressing with a viricidal agent, such as 70% isopropyl alcohol, 6% hydrogen peroxide, or less than 0.4% ammonium chloride, and dispose of them in a separate, sealed plastic bag in household waste. Subsequent used dressings and cleaning materials should be disposed of in sealed plastic bags in household waste.
FDA approval of Vyjuvek was based on a randomized, double-blinded, placebo-controlled, 31-patient, phase 3 trial published in the New England Journal of Medicine, which showed that 71% of wounds treated with the gene therapy had complete healing at 3 months, compared with 20% of those treated with placebo (95% confidence interval, 29-73; P < .001). At 6 months, 67% of wounds treated with the gene therapy had complete healing, compared with 22% of wounds treated with placebo (95% CI, 24-68; P = .002).
Almost two-thirds of the patients had at least one adverse event. Most were mild or moderate. The most common events were pruritus, chills, and squamous cell carcinoma, reported in three patients each. SCC cases occurred at wound sites that had not been exposed to Vyjuvek or placebo. Serious adverse events, which were unrelated to the treatment, occurred in three patients and included diarrhea, anemia, and cellulitis.
Krystal will also be seeking marketing approval for Vyjuvek in the European Union, likely in 2024, said the company. In September, the European Medicines Agency’s Pediatric Committee issued a positive opinion on the gene therapy and Krystal’s plan to test B-VEC in children.
Dr. Marinkovich and Dr. Vakharia have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New guidance on neurological complications of long COVID
also known as postacute sequelae of SARS-CoV-2 infection (PASC).
The new recommendations, which were published online in Physical Medicine & Rehabilitation, are the result of a collaboration between experts from a variety of medical specialties at 41 long COVID clinics across the United States.
Because physical medicine specialists treat individuals with disability and functional impairments, the AAPM&R was among the first organizations to initiate guidance for the assessment and treatment of long COVID and issued its first consensus statement that addressed long COVID–related fatigue in 2021.
Even though the number of COVID cases and hospitalizations has declined from the peak, long COVID continues to be a major public health issue, Steven R. Flanagan, MD, AAPM&R president-elect and Howard A. Rusk Professor of Rehabilitation Medicine at NYU Langone Health, New York, told reporters attending a press briefing.
“There is some evidence that some of the antivirals may actually help reduce the incidence but not everybody gets them,” said Dr. Flanagan. “In our own clinic here, we continue to see many, many people with problems associated with long COVID,” he added.
According to the consensus guidelines, about 80% of patients hospitalized with acute COVID-19 have neurological symptoms. But these symptoms are not just limited to people who had severe illness, said Leslie Rydberg, MD, coauthor of the neurology long COVID guidance statement.
“What we know is that many people with mild or moderate COVID infection end up with neurologic sequelae that last longer than 4 weeks,” said Dr. Rydberg, the Henry and Monika Betts Medical Student Education Chair and assistant residency program director at Shirley Ryan AbilityLab, Chicago.
Dr. Rydberg added that patients who have symptoms for longer than a month after the initial infection should be evaluated. Although the definition of what constitutes PASC is evolving, the guidance states that the literature indicates that it should be defined as the persistence of symptoms 4 weeks beyond the initial infection.
The most common neurological symptoms are headache, weakness, muscular pain, nerve pain, tremors, peripheral nerve issues, sleep issues, and cognitive effects, Dr. Rydberg told reporters.
She added that “identifying patients with progressive or ominous ‘red flag’ neurological symptoms is essential for emergent triaging.”
Among the red flags are sudden or progressive weakness or sudden or progressive sensory changes, because those could indicate an acute neurologic condition – either due to long COVID or other illnesses – such as a stroke or a problem with the spinal cord, Guillain-Barré syndrome, or myopathy.
While those signs and symptoms would likely be flagged by most clinicians, some of the emergent or urgent signs – such as upper motor neuron changes on physical exam – are more subtle, said Dr. Rydberg.
The new guidance spells out steps for initial evaluation, including identification of red flag symptoms, and also provides treatment recommendations.
Experts also recommend clinicians do the following:
- Treat underlying medical conditions such as pain, psychiatric, cardiovascular, respiratory, and other conditions that may be contributing to neurologic symptoms.
- Consider polypharmacy reduction, looking especially closely at medications with a known impact on neurologic symptoms.
- Urge patients to get regular physical activity, as tolerated, while avoiding overuse syndrome.
- Work with physical, occupational, and speech therapists to increase function and independence.
- Refer patients to counseling and community resources for risk factor modification.
The treatment recommendations are more in-depth for specific long-COVID conditions including headache, cranial neuropathies, sleep disturbances, and neuropathies.
The guidance includes a special statement on the importance of ensuring equitable access to care. Underserved, marginalized, and socioeconomically disadvantaged communities had notably higher rates of infection, hospitalization, and death with less access to rehabilitation services before the pandemic, said Monica Verduzco-Gutierrez, MD, chair of the department of rehabilitation medicine at Long School of Medicine, UT Health San Antonio, and a guideline coauthor.
“We know that these communities have been historically underserved, that there’s already access issues, and that they’re disproportionately impacted by the pandemic,” said Dr. Verduzco-Gutierrez. “This continues as patients develop PASC, or long COVID,” she said, adding that these individuals are still less likely to receive rehabilitation services. “This can lead to poorer outcomes and widened disparities.”
The AAPM&R PASC Multi-Disciplinary Collaborative has previously issued consensus guidance on fatigue, breathing discomfort and respiratory distress, cognitive symptoms, cardiovascular complications, pediatrics, and autonomic dysfunction, and will be publishing guidance on mental health soon.
The collaborative is also putting together a compilation of all the guidance – “a ‘greatest hits’ if you like,” said Dr. Verduzco-Gutierrez.
For clinicians who are unaccustomed to caring for patients with long COVID, the hope is that this new guidance will help them manage the condition, Dr. Rydberg said.
The guidance was written with the support of the AAPM&R. Dr. Verduzco-Gutierrez and two coauthors have disclosed grants, contracts, or honoraria from various funding sources, some paid to their institutions and some personal reimbursement for activities related to PASC and broader areas of research and expertise. However, none of the authors have any conflicts relative to the work on the guidance.
A version of this article originally appeared on Medscape.com.
also known as postacute sequelae of SARS-CoV-2 infection (PASC).
The new recommendations, which were published online in Physical Medicine & Rehabilitation, are the result of a collaboration between experts from a variety of medical specialties at 41 long COVID clinics across the United States.
Because physical medicine specialists treat individuals with disability and functional impairments, the AAPM&R was among the first organizations to initiate guidance for the assessment and treatment of long COVID and issued its first consensus statement that addressed long COVID–related fatigue in 2021.
Even though the number of COVID cases and hospitalizations has declined from the peak, long COVID continues to be a major public health issue, Steven R. Flanagan, MD, AAPM&R president-elect and Howard A. Rusk Professor of Rehabilitation Medicine at NYU Langone Health, New York, told reporters attending a press briefing.
“There is some evidence that some of the antivirals may actually help reduce the incidence but not everybody gets them,” said Dr. Flanagan. “In our own clinic here, we continue to see many, many people with problems associated with long COVID,” he added.
According to the consensus guidelines, about 80% of patients hospitalized with acute COVID-19 have neurological symptoms. But these symptoms are not just limited to people who had severe illness, said Leslie Rydberg, MD, coauthor of the neurology long COVID guidance statement.
“What we know is that many people with mild or moderate COVID infection end up with neurologic sequelae that last longer than 4 weeks,” said Dr. Rydberg, the Henry and Monika Betts Medical Student Education Chair and assistant residency program director at Shirley Ryan AbilityLab, Chicago.
Dr. Rydberg added that patients who have symptoms for longer than a month after the initial infection should be evaluated. Although the definition of what constitutes PASC is evolving, the guidance states that the literature indicates that it should be defined as the persistence of symptoms 4 weeks beyond the initial infection.
The most common neurological symptoms are headache, weakness, muscular pain, nerve pain, tremors, peripheral nerve issues, sleep issues, and cognitive effects, Dr. Rydberg told reporters.
She added that “identifying patients with progressive or ominous ‘red flag’ neurological symptoms is essential for emergent triaging.”
Among the red flags are sudden or progressive weakness or sudden or progressive sensory changes, because those could indicate an acute neurologic condition – either due to long COVID or other illnesses – such as a stroke or a problem with the spinal cord, Guillain-Barré syndrome, or myopathy.
While those signs and symptoms would likely be flagged by most clinicians, some of the emergent or urgent signs – such as upper motor neuron changes on physical exam – are more subtle, said Dr. Rydberg.
The new guidance spells out steps for initial evaluation, including identification of red flag symptoms, and also provides treatment recommendations.
Experts also recommend clinicians do the following:
- Treat underlying medical conditions such as pain, psychiatric, cardiovascular, respiratory, and other conditions that may be contributing to neurologic symptoms.
- Consider polypharmacy reduction, looking especially closely at medications with a known impact on neurologic symptoms.
- Urge patients to get regular physical activity, as tolerated, while avoiding overuse syndrome.
- Work with physical, occupational, and speech therapists to increase function and independence.
- Refer patients to counseling and community resources for risk factor modification.
The treatment recommendations are more in-depth for specific long-COVID conditions including headache, cranial neuropathies, sleep disturbances, and neuropathies.
The guidance includes a special statement on the importance of ensuring equitable access to care. Underserved, marginalized, and socioeconomically disadvantaged communities had notably higher rates of infection, hospitalization, and death with less access to rehabilitation services before the pandemic, said Monica Verduzco-Gutierrez, MD, chair of the department of rehabilitation medicine at Long School of Medicine, UT Health San Antonio, and a guideline coauthor.
“We know that these communities have been historically underserved, that there’s already access issues, and that they’re disproportionately impacted by the pandemic,” said Dr. Verduzco-Gutierrez. “This continues as patients develop PASC, or long COVID,” she said, adding that these individuals are still less likely to receive rehabilitation services. “This can lead to poorer outcomes and widened disparities.”
The AAPM&R PASC Multi-Disciplinary Collaborative has previously issued consensus guidance on fatigue, breathing discomfort and respiratory distress, cognitive symptoms, cardiovascular complications, pediatrics, and autonomic dysfunction, and will be publishing guidance on mental health soon.
The collaborative is also putting together a compilation of all the guidance – “a ‘greatest hits’ if you like,” said Dr. Verduzco-Gutierrez.
For clinicians who are unaccustomed to caring for patients with long COVID, the hope is that this new guidance will help them manage the condition, Dr. Rydberg said.
The guidance was written with the support of the AAPM&R. Dr. Verduzco-Gutierrez and two coauthors have disclosed grants, contracts, or honoraria from various funding sources, some paid to their institutions and some personal reimbursement for activities related to PASC and broader areas of research and expertise. However, none of the authors have any conflicts relative to the work on the guidance.
A version of this article originally appeared on Medscape.com.
also known as postacute sequelae of SARS-CoV-2 infection (PASC).
The new recommendations, which were published online in Physical Medicine & Rehabilitation, are the result of a collaboration between experts from a variety of medical specialties at 41 long COVID clinics across the United States.
Because physical medicine specialists treat individuals with disability and functional impairments, the AAPM&R was among the first organizations to initiate guidance for the assessment and treatment of long COVID and issued its first consensus statement that addressed long COVID–related fatigue in 2021.
Even though the number of COVID cases and hospitalizations has declined from the peak, long COVID continues to be a major public health issue, Steven R. Flanagan, MD, AAPM&R president-elect and Howard A. Rusk Professor of Rehabilitation Medicine at NYU Langone Health, New York, told reporters attending a press briefing.
“There is some evidence that some of the antivirals may actually help reduce the incidence but not everybody gets them,” said Dr. Flanagan. “In our own clinic here, we continue to see many, many people with problems associated with long COVID,” he added.
According to the consensus guidelines, about 80% of patients hospitalized with acute COVID-19 have neurological symptoms. But these symptoms are not just limited to people who had severe illness, said Leslie Rydberg, MD, coauthor of the neurology long COVID guidance statement.
“What we know is that many people with mild or moderate COVID infection end up with neurologic sequelae that last longer than 4 weeks,” said Dr. Rydberg, the Henry and Monika Betts Medical Student Education Chair and assistant residency program director at Shirley Ryan AbilityLab, Chicago.
Dr. Rydberg added that patients who have symptoms for longer than a month after the initial infection should be evaluated. Although the definition of what constitutes PASC is evolving, the guidance states that the literature indicates that it should be defined as the persistence of symptoms 4 weeks beyond the initial infection.
The most common neurological symptoms are headache, weakness, muscular pain, nerve pain, tremors, peripheral nerve issues, sleep issues, and cognitive effects, Dr. Rydberg told reporters.
She added that “identifying patients with progressive or ominous ‘red flag’ neurological symptoms is essential for emergent triaging.”
Among the red flags are sudden or progressive weakness or sudden or progressive sensory changes, because those could indicate an acute neurologic condition – either due to long COVID or other illnesses – such as a stroke or a problem with the spinal cord, Guillain-Barré syndrome, or myopathy.
While those signs and symptoms would likely be flagged by most clinicians, some of the emergent or urgent signs – such as upper motor neuron changes on physical exam – are more subtle, said Dr. Rydberg.
The new guidance spells out steps for initial evaluation, including identification of red flag symptoms, and also provides treatment recommendations.
Experts also recommend clinicians do the following:
- Treat underlying medical conditions such as pain, psychiatric, cardiovascular, respiratory, and other conditions that may be contributing to neurologic symptoms.
- Consider polypharmacy reduction, looking especially closely at medications with a known impact on neurologic symptoms.
- Urge patients to get regular physical activity, as tolerated, while avoiding overuse syndrome.
- Work with physical, occupational, and speech therapists to increase function and independence.
- Refer patients to counseling and community resources for risk factor modification.
The treatment recommendations are more in-depth for specific long-COVID conditions including headache, cranial neuropathies, sleep disturbances, and neuropathies.
The guidance includes a special statement on the importance of ensuring equitable access to care. Underserved, marginalized, and socioeconomically disadvantaged communities had notably higher rates of infection, hospitalization, and death with less access to rehabilitation services before the pandemic, said Monica Verduzco-Gutierrez, MD, chair of the department of rehabilitation medicine at Long School of Medicine, UT Health San Antonio, and a guideline coauthor.
“We know that these communities have been historically underserved, that there’s already access issues, and that they’re disproportionately impacted by the pandemic,” said Dr. Verduzco-Gutierrez. “This continues as patients develop PASC, or long COVID,” she said, adding that these individuals are still less likely to receive rehabilitation services. “This can lead to poorer outcomes and widened disparities.”
The AAPM&R PASC Multi-Disciplinary Collaborative has previously issued consensus guidance on fatigue, breathing discomfort and respiratory distress, cognitive symptoms, cardiovascular complications, pediatrics, and autonomic dysfunction, and will be publishing guidance on mental health soon.
The collaborative is also putting together a compilation of all the guidance – “a ‘greatest hits’ if you like,” said Dr. Verduzco-Gutierrez.
For clinicians who are unaccustomed to caring for patients with long COVID, the hope is that this new guidance will help them manage the condition, Dr. Rydberg said.
The guidance was written with the support of the AAPM&R. Dr. Verduzco-Gutierrez and two coauthors have disclosed grants, contracts, or honoraria from various funding sources, some paid to their institutions and some personal reimbursement for activities related to PASC and broader areas of research and expertise. However, none of the authors have any conflicts relative to the work on the guidance.
A version of this article originally appeared on Medscape.com.
FROM PHYSICIAN MEDICINE & REHABILITATION
CDC backs FDA’s call for second COVID booster for those at high risk
This backs the Food and Drug Administration’s authorization April 18 of the additional shot.
“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.
The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP). While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.
But most others who’ve already had the bivalent shot – which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 – should wait until the fall to get whatever updated vaccine is available.
The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, said during the meeting.
People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.
Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Dr. Twentyman said.
If an individual has already received a bivalent mRNA booster – made by either Pfizer/BioNTech or Moderna – “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”
The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.
The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.
‘Unnecessary drama’ over children’s recs
The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.
For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.
All children those ages should get at least two vaccine doses, one of which is bivalent, Dr. Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.
For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.
ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University, Philadelphia, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.
“We picked 60 months for most immunizations in children,” Dr. Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.
“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.
Dr. Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with health care professionals to discuss the updated recommendations on May 11.
New vaccine by fall
CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.
“We all recognize this is a work in progress,” said ACIP Chair Grace M. Lee, MD, MPH, acknowledging that there is continued confusion over COVID-19 vaccination.
“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Dr. Lee, professor of pediatrics, Stanford (Calif.) University.
A version of this article originally appeared on Medscape.com .
This backs the Food and Drug Administration’s authorization April 18 of the additional shot.
“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.
The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP). While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.
But most others who’ve already had the bivalent shot – which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 – should wait until the fall to get whatever updated vaccine is available.
The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, said during the meeting.
People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.
Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Dr. Twentyman said.
If an individual has already received a bivalent mRNA booster – made by either Pfizer/BioNTech or Moderna – “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”
The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.
The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.
‘Unnecessary drama’ over children’s recs
The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.
For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.
All children those ages should get at least two vaccine doses, one of which is bivalent, Dr. Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.
For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.
ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University, Philadelphia, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.
“We picked 60 months for most immunizations in children,” Dr. Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.
“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.
Dr. Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with health care professionals to discuss the updated recommendations on May 11.
New vaccine by fall
CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.
“We all recognize this is a work in progress,” said ACIP Chair Grace M. Lee, MD, MPH, acknowledging that there is continued confusion over COVID-19 vaccination.
“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Dr. Lee, professor of pediatrics, Stanford (Calif.) University.
A version of this article originally appeared on Medscape.com .
This backs the Food and Drug Administration’s authorization April 18 of the additional shot.
“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.
The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP). While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.
But most others who’ve already had the bivalent shot – which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 – should wait until the fall to get whatever updated vaccine is available.
The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, said during the meeting.
People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.
Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Dr. Twentyman said.
If an individual has already received a bivalent mRNA booster – made by either Pfizer/BioNTech or Moderna – “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”
The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.
The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.
‘Unnecessary drama’ over children’s recs
The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.
For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.
All children those ages should get at least two vaccine doses, one of which is bivalent, Dr. Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.
For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.
ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University, Philadelphia, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.
“We picked 60 months for most immunizations in children,” Dr. Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.
“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.
Dr. Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with health care professionals to discuss the updated recommendations on May 11.
New vaccine by fall
CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.
“We all recognize this is a work in progress,” said ACIP Chair Grace M. Lee, MD, MPH, acknowledging that there is continued confusion over COVID-19 vaccination.
“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Dr. Lee, professor of pediatrics, Stanford (Calif.) University.
A version of this article originally appeared on Medscape.com .
Tranq-contaminated fentanyl now in 48 states, DEA warns
The DEA warning comes on the heels of a Food and Drug Administration announcement that it would begin more closely monitoring imports of the raw materials and bulk shipments of xylazine, also known as “tranq” and “zombie drug.”
Xylazine was first approved by the FDA in 1972 as a sedative and analgesic for use only in animals, but is increasingly being detected in illicit street drugs, and is often mixed with fentanyl, cocaine, and methamphetamine.
The FDA warned in November that naloxone (Narcan) would not reverse xylazine-related overdoses because the tranquilizer is not an opioid. It does suppress respiration and repeated exposures may lead to dependence and withdrawal, said the agency. Users are also experiencing severe necrosis at injection sites.
“Xylazine is making the deadliest drug threat our country has ever faced, fentanyl, even deadlier,” said DEA Administrator Anne Milgram in a statement. “The DEA Laboratory System is reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.”
Xylazine use has spread quickly, from its start in the Philadelphia area to the Northeast, the South, and most recently the West.
Citing data from the Centers for Disease Control and Prevention, the DEA said that 66% of the 107,735 overdose deaths for the year ending August 2022 involved synthetic opioids such as fentanyl. The DEA said that the Sinaloa Cartel and Jalisco Cartel in Mexico, using chemicals sourced from China, are primarily responsible for trafficking fentanyl in the United States.
A version of this article originally appeared on Medscape.com.
The DEA warning comes on the heels of a Food and Drug Administration announcement that it would begin more closely monitoring imports of the raw materials and bulk shipments of xylazine, also known as “tranq” and “zombie drug.”
Xylazine was first approved by the FDA in 1972 as a sedative and analgesic for use only in animals, but is increasingly being detected in illicit street drugs, and is often mixed with fentanyl, cocaine, and methamphetamine.
The FDA warned in November that naloxone (Narcan) would not reverse xylazine-related overdoses because the tranquilizer is not an opioid. It does suppress respiration and repeated exposures may lead to dependence and withdrawal, said the agency. Users are also experiencing severe necrosis at injection sites.
“Xylazine is making the deadliest drug threat our country has ever faced, fentanyl, even deadlier,” said DEA Administrator Anne Milgram in a statement. “The DEA Laboratory System is reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.”
Xylazine use has spread quickly, from its start in the Philadelphia area to the Northeast, the South, and most recently the West.
Citing data from the Centers for Disease Control and Prevention, the DEA said that 66% of the 107,735 overdose deaths for the year ending August 2022 involved synthetic opioids such as fentanyl. The DEA said that the Sinaloa Cartel and Jalisco Cartel in Mexico, using chemicals sourced from China, are primarily responsible for trafficking fentanyl in the United States.
A version of this article originally appeared on Medscape.com.
The DEA warning comes on the heels of a Food and Drug Administration announcement that it would begin more closely monitoring imports of the raw materials and bulk shipments of xylazine, also known as “tranq” and “zombie drug.”
Xylazine was first approved by the FDA in 1972 as a sedative and analgesic for use only in animals, but is increasingly being detected in illicit street drugs, and is often mixed with fentanyl, cocaine, and methamphetamine.
The FDA warned in November that naloxone (Narcan) would not reverse xylazine-related overdoses because the tranquilizer is not an opioid. It does suppress respiration and repeated exposures may lead to dependence and withdrawal, said the agency. Users are also experiencing severe necrosis at injection sites.
“Xylazine is making the deadliest drug threat our country has ever faced, fentanyl, even deadlier,” said DEA Administrator Anne Milgram in a statement. “The DEA Laboratory System is reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.”
Xylazine use has spread quickly, from its start in the Philadelphia area to the Northeast, the South, and most recently the West.
Citing data from the Centers for Disease Control and Prevention, the DEA said that 66% of the 107,735 overdose deaths for the year ending August 2022 involved synthetic opioids such as fentanyl. The DEA said that the Sinaloa Cartel and Jalisco Cartel in Mexico, using chemicals sourced from China, are primarily responsible for trafficking fentanyl in the United States.
A version of this article originally appeared on Medscape.com.