Mixed Topics

Microplastics have been found in the lungs, liver, blood, and heart. Now, researchers report they have found the first evidence of the substances in human brains.

In a recent case series study that examined olfactory bulb tissue from deceased individuals, 8 of the 15 decedent brains showed the presence of microplastics, most commonly polypropylene, a plastic typically used in food packaging and water bottles.

Measuring less than 5 mm in size, microplastics are formed over time as plastic materials break down but don’t biodegrade. Exposure to these substances can come through food, air, and skin absorption.

While scientists are learning more about how these substances are absorbed by the body, questions remain about how much exposure is safe, what effect — if any — microplastics could have on brain function, and what clinicians should tell their patients.

 

What Are the Major Health Concerns?

The Plastic Health Council estimates that more than 500 million metric tons of plastic are produced worldwide each year. In addition, it reports that plastic products can contain more than 16,000 chemicals, about a quarter of which have been found to be hazardous to human health and the environment. Microplastics and nanoplastics can enter the body through the air, in food, or absorption through the skin.

A study published in March showed that patients with carotid plaques and the presence of microplastics and nanoplastics were at an increased risk for death or major cardiovascular events.

Other studies have shown a link between these substances and placental inflammation and preterm births, reduced male fertility, and endocrine disruption — as well as accelerated spread of cancer cells in the gut.

There is also evidence suggesting that microplastics may facilitate the development of antibiotic resistance in bacteria and could contribute to the rise in food allergies.

And now, Thais Mauad, MD, PhD, and colleagues have found the substances in the brain.

 

How Is the Brain Affected?

The investigators examined olfactory bulb tissues from 15 deceased Sao Paulo, Brazil, residents ranging in age from 33 to 100 years who underwent routine coroner autopsies. All but three of the participants were men.

Exclusion criteria included having undergone previous neurosurgical interventions. The tissues were analyzed using micro–Fourier transform infrared spectroscopy (µFTIR).

In addition, the researchers practiced a “plastic-free approach” in their analysis, which included using filters and covering glassware and samples with aluminum foil.

Study findings showed microplastics in 8 of the 15 participants — including in the centenarian. In total, there were 16 synthetic polymer particles and fibers detected, with up to four microplastics detected per olfactory bulb. Polypropylene was the most common polymer found (44%), followed by polyamide, nylon, and polyethylene vinyl acetate. These substances are commonly used in a wide range of products, including food packaging, textiles, kitchen utensils, medical devices, and adhesives.

The microplastic particles ranged in length from 5.5 to 26 microns (one millionth of a meter), with a width that ranged from 3 to 25 microns. The mean fiber length and width was 21 and 4 microns, respectively. For comparison, the diameter of one human hair averages about 70 microns, according to the US Food and Drug Administration (FDA).

“To our knowledge, this is the first study in which the presence of microplastics in the human brain was identified and characterized using µFTIR,” the researchers wrote.

 

How Do Microplastics Reach the Brain?

Although the possibility of microplastics crossing the blood-brain barrier has been questioned, senior investigator Mauad, associate professor in the Department of Pathology, the University of Sao Paulo in Brazil, noted that the olfactory pathway could offer an entry route through inhalation of the particles.

This means that “breathing within indoor environments could be a major source of plastic pollution in the brain,” she said in a press release.

“With much smaller nanoplastics entering the body with greater ease, the total level of plastic particles may be much higher. What is worrying is the capacity of such particles to be internalized by cells and alter how our bodies function,” she added.

Mauad said that although questions remain regarding the health implications of their findings, some animal studies have shown that the presence of microplastics in the brain is linked to neurotoxic effects, including oxidative stress.

In addition, exposure to particulate matter has been linked previously to such neurologic conditions as dementia and neurodegenerative conditions such as Parkinson’s disease “seem to have a connection with nasal abnormalities as initial symptoms,” the investigators noted.

While the olfactory pathway appears to be a likely route of exposure the researchers noted that other potential entry routes, including through blood circulation, may also be involved.

The research suggests that inhaling microplastics while indoors may be unavoidable, Mauad said, making it unlikely individuals can eliminate exposure to these substances.

“Everything that surrounds us is plastic. So we can’t really get rid of it,” she said.

 

Are Microplastics Regulated?

The most effective solution would be stricter regulations, Mauad said.

“The industry has chosen to sell many things in plastic, and I think this has to change. We need more policies to decrease plastic production — especially single-use plastic,” she said.

Federal, state, and local regulations for microplastics are “virtually nonexistent,” reported the Interstate Technology and Regulatory Council (ITRC), a state-led coalition that produces documents and trainings related to regulatory issues.

In 2021, the ITRC sent a survey to all US states asking about microplastics regulations. Of the 26 states that responded, only 4 said they had conducted sampling for microplastics. None of the responders indicated they had established any criteria or standards for microplastics, although eight states indicated they had plans to pursue them in the future.

Although federal regulations include the Microbead-Free Waters Act of 2015 and the Save Our Seas Act 2.0, the rules don’t directly pertain to microplastics.

There are also no regulations currently in place regarding microplastics or nanoplastics in food. A report issued in July by the FDA claimed that “the overall scientific evidence does not demonstrate that levels of microplastics or nanoplastics found in foods pose a risk to human health.”

International efforts to regulate microplastics are much further along. First created in 2022, the treaty would forge an international, legally binding agreement.

While it is a step in the right direction, the Plastic Health Council has cautioned about “the omission of measures in draft provisions that fully address the impact of plastic pollution on human health.” The treaty should reduce plastic production, eliminate single-use plastic items, and call for testing of all chemicals in plastics, the council argues.

The final round of negotiations for the UN Global Plastic Treaty is set for completion before the end of the year.

 

What Should Clinicians Know?

Much remains unknown about the potential health effects of microplastic exposure. So how can clinicians respond to questions from concerned patients?

“We don’t yet have enough evidence about the plastic particle itself, like those highlighted in the current study — and even more so when it comes to nanoplastics, which are a thousand times smaller,” said Phoebe Stapleton, PhD, associated professor in the Department of Pharmacology and Toxicology at the Ernest Mario School of Pharmacy at Rutgers University, Piscataway, New Jersey.

“But we do have a lot of evidence about the chemicals that are used to make plastics, and we’ve already seen regulation there from the EPA. That’s one conversation that clinicians could have with patients: about those chemicals,” she added.

Stapleton recommended clinicians stay current on the latest research and be ready to respond should a patient raise the issue. She also noted the importance of exercising caution when interpreting these new findings.

While the study is important — especially because it highlights inhalation as a viable route of entry — exposure through the olfactory area is still just a theory and hasn’t yet been fully proven.

In addition, Stapleton wonders whether there are tissues where these substances are not found. A discovery like that “would be really exciting because that means that that tissue has mechanisms protecting it, and maybe, we could learn more about how to keep microplastics out,” she said.

She would also like to see more studies on specific adverse health effects from microplastics in the body.

Mauad agreed.

“That’s the next set of questions: What are the toxicities or lack thereof in those tissues? That will give us more information as it pertains to human health. It doesn’t feel good to know they’re in our tissues, but we still don’t have a real understanding of what they’re doing when they’re there,” she said.

The current study was funded by the Alexander von Humboldt Foundation and by grants from the Brazilian Research Council and the Soa State Research Agency. It was also funded by the Plastic Soup Foundation — which, together with A Plastic Planet, forms the Plastic Health Council. The investigators and Stapleton reported no relevant financial relationships.

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

Microplastics have been found in the lungs, liver, blood, and heart. Now, researchers report they have found the first evidence of the substances in human brains.

In a recent case series study that examined olfactory bulb tissue from deceased individuals, 8 of the 15 decedent brains showed the presence of microplastics, most commonly polypropylene, a plastic typically used in food packaging and water bottles.

Measuring less than 5 mm in size, microplastics are formed over time as plastic materials break down but don’t biodegrade. Exposure to these substances can come through food, air, and skin absorption.

While scientists are learning more about how these substances are absorbed by the body, questions remain about how much exposure is safe, what effect — if any — microplastics could have on brain function, and what clinicians should tell their patients.

 

What Are the Major Health Concerns?

The Plastic Health Council estimates that more than 500 million metric tons of plastic are produced worldwide each year. In addition, it reports that plastic products can contain more than 16,000 chemicals, about a quarter of which have been found to be hazardous to human health and the environment. Microplastics and nanoplastics can enter the body through the air, in food, or absorption through the skin.

A study published in March showed that patients with carotid plaques and the presence of microplastics and nanoplastics were at an increased risk for death or major cardiovascular events.

Other studies have shown a link between these substances and placental inflammation and preterm births, reduced male fertility, and endocrine disruption — as well as accelerated spread of cancer cells in the gut.

There is also evidence suggesting that microplastics may facilitate the development of antibiotic resistance in bacteria and could contribute to the rise in food allergies.

And now, Thais Mauad, MD, PhD, and colleagues have found the substances in the brain.

 

How Is the Brain Affected?

The investigators examined olfactory bulb tissues from 15 deceased Sao Paulo, Brazil, residents ranging in age from 33 to 100 years who underwent routine coroner autopsies. All but three of the participants were men.

Exclusion criteria included having undergone previous neurosurgical interventions. The tissues were analyzed using micro–Fourier transform infrared spectroscopy (µFTIR).

In addition, the researchers practiced a “plastic-free approach” in their analysis, which included using filters and covering glassware and samples with aluminum foil.

Study findings showed microplastics in 8 of the 15 participants — including in the centenarian. In total, there were 16 synthetic polymer particles and fibers detected, with up to four microplastics detected per olfactory bulb. Polypropylene was the most common polymer found (44%), followed by polyamide, nylon, and polyethylene vinyl acetate. These substances are commonly used in a wide range of products, including food packaging, textiles, kitchen utensils, medical devices, and adhesives.

The microplastic particles ranged in length from 5.5 to 26 microns (one millionth of a meter), with a width that ranged from 3 to 25 microns. The mean fiber length and width was 21 and 4 microns, respectively. For comparison, the diameter of one human hair averages about 70 microns, according to the US Food and Drug Administration (FDA).

“To our knowledge, this is the first study in which the presence of microplastics in the human brain was identified and characterized using µFTIR,” the researchers wrote.

 

How Do Microplastics Reach the Brain?

Although the possibility of microplastics crossing the blood-brain barrier has been questioned, senior investigator Mauad, associate professor in the Department of Pathology, the University of Sao Paulo in Brazil, noted that the olfactory pathway could offer an entry route through inhalation of the particles.

This means that “breathing within indoor environments could be a major source of plastic pollution in the brain,” she said in a press release.

“With much smaller nanoplastics entering the body with greater ease, the total level of plastic particles may be much higher. What is worrying is the capacity of such particles to be internalized by cells and alter how our bodies function,” she added.

Mauad said that although questions remain regarding the health implications of their findings, some animal studies have shown that the presence of microplastics in the brain is linked to neurotoxic effects, including oxidative stress.

In addition, exposure to particulate matter has been linked previously to such neurologic conditions as dementia and neurodegenerative conditions such as Parkinson’s disease “seem to have a connection with nasal abnormalities as initial symptoms,” the investigators noted.

While the olfactory pathway appears to be a likely route of exposure the researchers noted that other potential entry routes, including through blood circulation, may also be involved.

The research suggests that inhaling microplastics while indoors may be unavoidable, Mauad said, making it unlikely individuals can eliminate exposure to these substances.

“Everything that surrounds us is plastic. So we can’t really get rid of it,” she said.

 

Are Microplastics Regulated?

The most effective solution would be stricter regulations, Mauad said.

“The industry has chosen to sell many things in plastic, and I think this has to change. We need more policies to decrease plastic production — especially single-use plastic,” she said.

Federal, state, and local regulations for microplastics are “virtually nonexistent,” reported the Interstate Technology and Regulatory Council (ITRC), a state-led coalition that produces documents and trainings related to regulatory issues.

In 2021, the ITRC sent a survey to all US states asking about microplastics regulations. Of the 26 states that responded, only 4 said they had conducted sampling for microplastics. None of the responders indicated they had established any criteria or standards for microplastics, although eight states indicated they had plans to pursue them in the future.

Although federal regulations include the Microbead-Free Waters Act of 2015 and the Save Our Seas Act 2.0, the rules don’t directly pertain to microplastics.

There are also no regulations currently in place regarding microplastics or nanoplastics in food. A report issued in July by the FDA claimed that “the overall scientific evidence does not demonstrate that levels of microplastics or nanoplastics found in foods pose a risk to human health.”

International efforts to regulate microplastics are much further along. First created in 2022, the treaty would forge an international, legally binding agreement.

While it is a step in the right direction, the Plastic Health Council has cautioned about “the omission of measures in draft provisions that fully address the impact of plastic pollution on human health.” The treaty should reduce plastic production, eliminate single-use plastic items, and call for testing of all chemicals in plastics, the council argues.

The final round of negotiations for the UN Global Plastic Treaty is set for completion before the end of the year.

 

What Should Clinicians Know?

Much remains unknown about the potential health effects of microplastic exposure. So how can clinicians respond to questions from concerned patients?

“We don’t yet have enough evidence about the plastic particle itself, like those highlighted in the current study — and even more so when it comes to nanoplastics, which are a thousand times smaller,” said Phoebe Stapleton, PhD, associated professor in the Department of Pharmacology and Toxicology at the Ernest Mario School of Pharmacy at Rutgers University, Piscataway, New Jersey.

“But we do have a lot of evidence about the chemicals that are used to make plastics, and we’ve already seen regulation there from the EPA. That’s one conversation that clinicians could have with patients: about those chemicals,” she added.

Stapleton recommended clinicians stay current on the latest research and be ready to respond should a patient raise the issue. She also noted the importance of exercising caution when interpreting these new findings.

While the study is important — especially because it highlights inhalation as a viable route of entry — exposure through the olfactory area is still just a theory and hasn’t yet been fully proven.

In addition, Stapleton wonders whether there are tissues where these substances are not found. A discovery like that “would be really exciting because that means that that tissue has mechanisms protecting it, and maybe, we could learn more about how to keep microplastics out,” she said.

She would also like to see more studies on specific adverse health effects from microplastics in the body.

Mauad agreed.

“That’s the next set of questions: What are the toxicities or lack thereof in those tissues? That will give us more information as it pertains to human health. It doesn’t feel good to know they’re in our tissues, but we still don’t have a real understanding of what they’re doing when they’re there,” she said.

The current study was funded by the Alexander von Humboldt Foundation and by grants from the Brazilian Research Council and the Soa State Research Agency. It was also funded by the Plastic Soup Foundation — which, together with A Plastic Planet, forms the Plastic Health Council. The investigators and Stapleton reported no relevant financial relationships.

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

Microplastics have been found in the lungs, liver, blood, and heart. Now, researchers report they have found the first evidence of the substances in human brains.

In a recent case series study that examined olfactory bulb tissue from deceased individuals, 8 of the 15 decedent brains showed the presence of microplastics, most commonly polypropylene, a plastic typically used in food packaging and water bottles.

Measuring less than 5 mm in size, microplastics are formed over time as plastic materials break down but don’t biodegrade. Exposure to these substances can come through food, air, and skin absorption.

While scientists are learning more about how these substances are absorbed by the body, questions remain about how much exposure is safe, what effect — if any — microplastics could have on brain function, and what clinicians should tell their patients.

 

What Are the Major Health Concerns?

The Plastic Health Council estimates that more than 500 million metric tons of plastic are produced worldwide each year. In addition, it reports that plastic products can contain more than 16,000 chemicals, about a quarter of which have been found to be hazardous to human health and the environment. Microplastics and nanoplastics can enter the body through the air, in food, or absorption through the skin.

A study published in March showed that patients with carotid plaques and the presence of microplastics and nanoplastics were at an increased risk for death or major cardiovascular events.

Other studies have shown a link between these substances and placental inflammation and preterm births, reduced male fertility, and endocrine disruption — as well as accelerated spread of cancer cells in the gut.

There is also evidence suggesting that microplastics may facilitate the development of antibiotic resistance in bacteria and could contribute to the rise in food allergies.

And now, Thais Mauad, MD, PhD, and colleagues have found the substances in the brain.

 

How Is the Brain Affected?

The investigators examined olfactory bulb tissues from 15 deceased Sao Paulo, Brazil, residents ranging in age from 33 to 100 years who underwent routine coroner autopsies. All but three of the participants were men.

Exclusion criteria included having undergone previous neurosurgical interventions. The tissues were analyzed using micro–Fourier transform infrared spectroscopy (µFTIR).

In addition, the researchers practiced a “plastic-free approach” in their analysis, which included using filters and covering glassware and samples with aluminum foil.

Study findings showed microplastics in 8 of the 15 participants — including in the centenarian. In total, there were 16 synthetic polymer particles and fibers detected, with up to four microplastics detected per olfactory bulb. Polypropylene was the most common polymer found (44%), followed by polyamide, nylon, and polyethylene vinyl acetate. These substances are commonly used in a wide range of products, including food packaging, textiles, kitchen utensils, medical devices, and adhesives.

The microplastic particles ranged in length from 5.5 to 26 microns (one millionth of a meter), with a width that ranged from 3 to 25 microns. The mean fiber length and width was 21 and 4 microns, respectively. For comparison, the diameter of one human hair averages about 70 microns, according to the US Food and Drug Administration (FDA).

“To our knowledge, this is the first study in which the presence of microplastics in the human brain was identified and characterized using µFTIR,” the researchers wrote.

 

How Do Microplastics Reach the Brain?

Although the possibility of microplastics crossing the blood-brain barrier has been questioned, senior investigator Mauad, associate professor in the Department of Pathology, the University of Sao Paulo in Brazil, noted that the olfactory pathway could offer an entry route through inhalation of the particles.

This means that “breathing within indoor environments could be a major source of plastic pollution in the brain,” she said in a press release.

“With much smaller nanoplastics entering the body with greater ease, the total level of plastic particles may be much higher. What is worrying is the capacity of such particles to be internalized by cells and alter how our bodies function,” she added.

Mauad said that although questions remain regarding the health implications of their findings, some animal studies have shown that the presence of microplastics in the brain is linked to neurotoxic effects, including oxidative stress.

In addition, exposure to particulate matter has been linked previously to such neurologic conditions as dementia and neurodegenerative conditions such as Parkinson’s disease “seem to have a connection with nasal abnormalities as initial symptoms,” the investigators noted.

While the olfactory pathway appears to be a likely route of exposure the researchers noted that other potential entry routes, including through blood circulation, may also be involved.

The research suggests that inhaling microplastics while indoors may be unavoidable, Mauad said, making it unlikely individuals can eliminate exposure to these substances.

“Everything that surrounds us is plastic. So we can’t really get rid of it,” she said.

 

Are Microplastics Regulated?

The most effective solution would be stricter regulations, Mauad said.

“The industry has chosen to sell many things in plastic, and I think this has to change. We need more policies to decrease plastic production — especially single-use plastic,” she said.

Federal, state, and local regulations for microplastics are “virtually nonexistent,” reported the Interstate Technology and Regulatory Council (ITRC), a state-led coalition that produces documents and trainings related to regulatory issues.

In 2021, the ITRC sent a survey to all US states asking about microplastics regulations. Of the 26 states that responded, only 4 said they had conducted sampling for microplastics. None of the responders indicated they had established any criteria or standards for microplastics, although eight states indicated they had plans to pursue them in the future.

Although federal regulations include the Microbead-Free Waters Act of 2015 and the Save Our Seas Act 2.0, the rules don’t directly pertain to microplastics.

There are also no regulations currently in place regarding microplastics or nanoplastics in food. A report issued in July by the FDA claimed that “the overall scientific evidence does not demonstrate that levels of microplastics or nanoplastics found in foods pose a risk to human health.”

International efforts to regulate microplastics are much further along. First created in 2022, the treaty would forge an international, legally binding agreement.

While it is a step in the right direction, the Plastic Health Council has cautioned about “the omission of measures in draft provisions that fully address the impact of plastic pollution on human health.” The treaty should reduce plastic production, eliminate single-use plastic items, and call for testing of all chemicals in plastics, the council argues.

The final round of negotiations for the UN Global Plastic Treaty is set for completion before the end of the year.

 

What Should Clinicians Know?

Much remains unknown about the potential health effects of microplastic exposure. So how can clinicians respond to questions from concerned patients?

“We don’t yet have enough evidence about the plastic particle itself, like those highlighted in the current study — and even more so when it comes to nanoplastics, which are a thousand times smaller,” said Phoebe Stapleton, PhD, associated professor in the Department of Pharmacology and Toxicology at the Ernest Mario School of Pharmacy at Rutgers University, Piscataway, New Jersey.

“But we do have a lot of evidence about the chemicals that are used to make plastics, and we’ve already seen regulation there from the EPA. That’s one conversation that clinicians could have with patients: about those chemicals,” she added.

Stapleton recommended clinicians stay current on the latest research and be ready to respond should a patient raise the issue. She also noted the importance of exercising caution when interpreting these new findings.

While the study is important — especially because it highlights inhalation as a viable route of entry — exposure through the olfactory area is still just a theory and hasn’t yet been fully proven.

In addition, Stapleton wonders whether there are tissues where these substances are not found. A discovery like that “would be really exciting because that means that that tissue has mechanisms protecting it, and maybe, we could learn more about how to keep microplastics out,” she said.

She would also like to see more studies on specific adverse health effects from microplastics in the body.

Mauad agreed.

“That’s the next set of questions: What are the toxicities or lack thereof in those tissues? That will give us more information as it pertains to human health. It doesn’t feel good to know they’re in our tissues, but we still don’t have a real understanding of what they’re doing when they’re there,” she said.

The current study was funded by the Alexander von Humboldt Foundation and by grants from the Brazilian Research Council and the Soa State Research Agency. It was also funded by the Plastic Soup Foundation — which, together with A Plastic Planet, forms the Plastic Health Council. The investigators and Stapleton reported no relevant financial relationships.

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

Recently published consensus guidelines for low-dose oral minoxidil (LDOM) treatment of hair loss provide best-practice recommendations in areas ranging from pretreatment considerations and counseling to patient monitoring. With large randomized, controlled trials lacking, the guidelines authors and other dermatologists said the paper provides practical pointers that should increase clinicians’ confidence in prescribing LDOM for hair loss.

Comfort and Confidence

Benjamin N. Ungar, MD, director of the Alopecia Center of Excellence at Mount Sinai Icahn School of Medicine, New York City, said he hopes that the guidelines will “make dermatologists in practice more comfortable with the use of low-dose oral minoxidil to treat different kinds of hair loss, and therefore, more patients will benefit.” He was not an author of the paper, which was published online in JAMA Dermatology on November 20, but was asked to comment.

Members of the multidisciplinary Low-Dose Oral Minoxidil Initiation steering committee recruited dermatologists with hair loss expertise from 12 countries. Using a modified four-round Delphi process that required at least 70% agreement, the group of 43 dermatologists crafted 76 consensus statements. “Notably,” said Co-senior author Jennifer Fu, MD, director of the Hair Disorders Clinic at the University of California, San Francisco, “27 items achieved at least 90% consensus after the first two rounds, indicating broad agreement in expert practice.”

Indications for LDOM

At least 90% of experts concurred regarding the appropriateness of LDOM use for androgenetic alopecia (AGA) and age-related thinning and in cases where topical minoxidil proves ineffective or problematic. Additional situations in which LDOM might provide direct benefit involve follicular miniaturization, such as alopecia areata, or hair cycle disruption, such as chemotherapy. The authors also recommended considering LDOM over topical minoxidil when the latter is more expensive and when patients desire enhanced hypertrichosis.

 

Contraindications and Precautions

Before prescribing LDOM, the authors wrote, clinicians may consult with primary care or cardiology when contraindications (cardiovascular issues, pregnancy/nursing, and potential drug interactions) or precautions (history of tachycardia or arrhythmia, hypotension, or impaired kidney function) exist. Patients with precautions may require blood pressure monitoring, as well as monitoring for adverse effects of treatment. The panel also suggested the latter for all patients at the time of LDOM initiation and dose escalation. The authors advised against routine baseline laboratory and EKG testing in cases without relevant precautions.

Dosing Considerations

Along with systemic adverse event risk and baseline hair loss severity, key dosing considerations include patient age, sex, and whether patients desire hypertrichosis. Consensus on daily doses for adolescent females and males begins at 0.625 mg and 1.25 mg, respectively, and ranges up to 2.5 mg for adolescent females vs 5 mg for adult females and adolescent and adult males.

Presently, said Ungar, many dermatologists — including some who prescribe LDOM — remain uncomfortable even with very low doses, perhaps because of an invalid perception of cardiovascular safety issues including potential hypotension and pericardial effusions. However, recently published data include a review published November 7 in the Journal of the American Academy of Dermatology, which showed no significant effect of LDOM on blood pressure. And in a September Journal of Drugs in Dermatology article the authors found no impact on pericardial effusions in a 100-patient cohort.

Some dermatologists worry about the impact hypertrichosis may have on patients, Ungar added. Although incidence estimates range from 15% to 30%, he said, more than half of his patients experience hypertrichosis. “However, most continue treatment because the beneficial effects outweigh the effect of hypertrichosis.”



 

Practical Roadmap

Adam Friedman, MD, who was not involved with the publication, applauds its inclusion of pragmatic clinical guidance, which he said consensus papers often lack. “This paper sets a great roadmap for working low-dose oral minoxidil into your clinical practice, Friedman, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.

Rather than limiting LDOM use to AGA, he said, the paper is most helpful in showing the spectrum of disease states for which the expert panel prescribes LDOM. “We use it as adjunctive therapy for many other things, both scarring and nonscarring hair loss,” he added.

In appropriate clinical contexts, the authors wrote, clinicians may consider combining LDOM with spironolactone or beta-blockers. Friedman said that in his hands, combining LDOM with a 5-alpha reductase inhibitor (5ARI) is “absolutely outstanding.” Minoxidil increases blood flow to the scalp, he explained, while 5ARIs prevent production of dihydrotestosterone, which miniaturizes hair.

Fu said, “We hope these consensus outcomes will be helpful to dermatology colleagues as they consider using LDOM to treat hair loss in their adult and adolescent patient populations. We anticipate that these guidelines will be updated as additional evidence-based data emerges and are encouraged that we are already seeing new publications on this topic.”

Important areas for future research, she noted, include pediatric use of LDOM, the comparative efficacy of topical vs oral minoxidil, the safety of oral minoxidil for patients with a history of allergic contact dermatitis to topical minoxidil, and the use of other off-label forms of minoxidil, such as compounded oral minoxidil and sublingual minoxidil.

The study was funded by the University of California, San Francisco, Department of Dermatology Medical Student Summer Research Fellowship Program. Fu reported personal fees from Pfizer, Eli Lilly and Company, and Sun Pharma outside of the study. The full list of author disclosures can be found in the paper. Ungar and Friedman reported no relevant financial relationships.

 

A version of this article appeared on Medscape.com.

Recently published consensus guidelines for low-dose oral minoxidil (LDOM) treatment of hair loss provide best-practice recommendations in areas ranging from pretreatment considerations and counseling to patient monitoring. With large randomized, controlled trials lacking, the guidelines authors and other dermatologists said the paper provides practical pointers that should increase clinicians’ confidence in prescribing LDOM for hair loss.

Comfort and Confidence

Benjamin N. Ungar, MD, director of the Alopecia Center of Excellence at Mount Sinai Icahn School of Medicine, New York City, said he hopes that the guidelines will “make dermatologists in practice more comfortable with the use of low-dose oral minoxidil to treat different kinds of hair loss, and therefore, more patients will benefit.” He was not an author of the paper, which was published online in JAMA Dermatology on November 20, but was asked to comment.

Members of the multidisciplinary Low-Dose Oral Minoxidil Initiation steering committee recruited dermatologists with hair loss expertise from 12 countries. Using a modified four-round Delphi process that required at least 70% agreement, the group of 43 dermatologists crafted 76 consensus statements. “Notably,” said Co-senior author Jennifer Fu, MD, director of the Hair Disorders Clinic at the University of California, San Francisco, “27 items achieved at least 90% consensus after the first two rounds, indicating broad agreement in expert practice.”

Indications for LDOM

At least 90% of experts concurred regarding the appropriateness of LDOM use for androgenetic alopecia (AGA) and age-related thinning and in cases where topical minoxidil proves ineffective or problematic. Additional situations in which LDOM might provide direct benefit involve follicular miniaturization, such as alopecia areata, or hair cycle disruption, such as chemotherapy. The authors also recommended considering LDOM over topical minoxidil when the latter is more expensive and when patients desire enhanced hypertrichosis.

 

Contraindications and Precautions

Before prescribing LDOM, the authors wrote, clinicians may consult with primary care or cardiology when contraindications (cardiovascular issues, pregnancy/nursing, and potential drug interactions) or precautions (history of tachycardia or arrhythmia, hypotension, or impaired kidney function) exist. Patients with precautions may require blood pressure monitoring, as well as monitoring for adverse effects of treatment. The panel also suggested the latter for all patients at the time of LDOM initiation and dose escalation. The authors advised against routine baseline laboratory and EKG testing in cases without relevant precautions.

Dosing Considerations

Along with systemic adverse event risk and baseline hair loss severity, key dosing considerations include patient age, sex, and whether patients desire hypertrichosis. Consensus on daily doses for adolescent females and males begins at 0.625 mg and 1.25 mg, respectively, and ranges up to 2.5 mg for adolescent females vs 5 mg for adult females and adolescent and adult males.

Presently, said Ungar, many dermatologists — including some who prescribe LDOM — remain uncomfortable even with very low doses, perhaps because of an invalid perception of cardiovascular safety issues including potential hypotension and pericardial effusions. However, recently published data include a review published November 7 in the Journal of the American Academy of Dermatology, which showed no significant effect of LDOM on blood pressure. And in a September Journal of Drugs in Dermatology article the authors found no impact on pericardial effusions in a 100-patient cohort.

Some dermatologists worry about the impact hypertrichosis may have on patients, Ungar added. Although incidence estimates range from 15% to 30%, he said, more than half of his patients experience hypertrichosis. “However, most continue treatment because the beneficial effects outweigh the effect of hypertrichosis.”



 

Practical Roadmap

Adam Friedman, MD, who was not involved with the publication, applauds its inclusion of pragmatic clinical guidance, which he said consensus papers often lack. “This paper sets a great roadmap for working low-dose oral minoxidil into your clinical practice, Friedman, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.

Rather than limiting LDOM use to AGA, he said, the paper is most helpful in showing the spectrum of disease states for which the expert panel prescribes LDOM. “We use it as adjunctive therapy for many other things, both scarring and nonscarring hair loss,” he added.

In appropriate clinical contexts, the authors wrote, clinicians may consider combining LDOM with spironolactone or beta-blockers. Friedman said that in his hands, combining LDOM with a 5-alpha reductase inhibitor (5ARI) is “absolutely outstanding.” Minoxidil increases blood flow to the scalp, he explained, while 5ARIs prevent production of dihydrotestosterone, which miniaturizes hair.

Fu said, “We hope these consensus outcomes will be helpful to dermatology colleagues as they consider using LDOM to treat hair loss in their adult and adolescent patient populations. We anticipate that these guidelines will be updated as additional evidence-based data emerges and are encouraged that we are already seeing new publications on this topic.”

Important areas for future research, she noted, include pediatric use of LDOM, the comparative efficacy of topical vs oral minoxidil, the safety of oral minoxidil for patients with a history of allergic contact dermatitis to topical minoxidil, and the use of other off-label forms of minoxidil, such as compounded oral minoxidil and sublingual minoxidil.

The study was funded by the University of California, San Francisco, Department of Dermatology Medical Student Summer Research Fellowship Program. Fu reported personal fees from Pfizer, Eli Lilly and Company, and Sun Pharma outside of the study. The full list of author disclosures can be found in the paper. Ungar and Friedman reported no relevant financial relationships.

 

A version of this article appeared on Medscape.com.

Recently published consensus guidelines for low-dose oral minoxidil (LDOM) treatment of hair loss provide best-practice recommendations in areas ranging from pretreatment considerations and counseling to patient monitoring. With large randomized, controlled trials lacking, the guidelines authors and other dermatologists said the paper provides practical pointers that should increase clinicians’ confidence in prescribing LDOM for hair loss.

Comfort and Confidence

Benjamin N. Ungar, MD, director of the Alopecia Center of Excellence at Mount Sinai Icahn School of Medicine, New York City, said he hopes that the guidelines will “make dermatologists in practice more comfortable with the use of low-dose oral minoxidil to treat different kinds of hair loss, and therefore, more patients will benefit.” He was not an author of the paper, which was published online in JAMA Dermatology on November 20, but was asked to comment.

Members of the multidisciplinary Low-Dose Oral Minoxidil Initiation steering committee recruited dermatologists with hair loss expertise from 12 countries. Using a modified four-round Delphi process that required at least 70% agreement, the group of 43 dermatologists crafted 76 consensus statements. “Notably,” said Co-senior author Jennifer Fu, MD, director of the Hair Disorders Clinic at the University of California, San Francisco, “27 items achieved at least 90% consensus after the first two rounds, indicating broad agreement in expert practice.”

Indications for LDOM

At least 90% of experts concurred regarding the appropriateness of LDOM use for androgenetic alopecia (AGA) and age-related thinning and in cases where topical minoxidil proves ineffective or problematic. Additional situations in which LDOM might provide direct benefit involve follicular miniaturization, such as alopecia areata, or hair cycle disruption, such as chemotherapy. The authors also recommended considering LDOM over topical minoxidil when the latter is more expensive and when patients desire enhanced hypertrichosis.

 

Contraindications and Precautions

Before prescribing LDOM, the authors wrote, clinicians may consult with primary care or cardiology when contraindications (cardiovascular issues, pregnancy/nursing, and potential drug interactions) or precautions (history of tachycardia or arrhythmia, hypotension, or impaired kidney function) exist. Patients with precautions may require blood pressure monitoring, as well as monitoring for adverse effects of treatment. The panel also suggested the latter for all patients at the time of LDOM initiation and dose escalation. The authors advised against routine baseline laboratory and EKG testing in cases without relevant precautions.

Dosing Considerations

Along with systemic adverse event risk and baseline hair loss severity, key dosing considerations include patient age, sex, and whether patients desire hypertrichosis. Consensus on daily doses for adolescent females and males begins at 0.625 mg and 1.25 mg, respectively, and ranges up to 2.5 mg for adolescent females vs 5 mg for adult females and adolescent and adult males.

Presently, said Ungar, many dermatologists — including some who prescribe LDOM — remain uncomfortable even with very low doses, perhaps because of an invalid perception of cardiovascular safety issues including potential hypotension and pericardial effusions. However, recently published data include a review published November 7 in the Journal of the American Academy of Dermatology, which showed no significant effect of LDOM on blood pressure. And in a September Journal of Drugs in Dermatology article the authors found no impact on pericardial effusions in a 100-patient cohort.

Some dermatologists worry about the impact hypertrichosis may have on patients, Ungar added. Although incidence estimates range from 15% to 30%, he said, more than half of his patients experience hypertrichosis. “However, most continue treatment because the beneficial effects outweigh the effect of hypertrichosis.”



 

Practical Roadmap

Adam Friedman, MD, who was not involved with the publication, applauds its inclusion of pragmatic clinical guidance, which he said consensus papers often lack. “This paper sets a great roadmap for working low-dose oral minoxidil into your clinical practice, Friedman, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.

Rather than limiting LDOM use to AGA, he said, the paper is most helpful in showing the spectrum of disease states for which the expert panel prescribes LDOM. “We use it as adjunctive therapy for many other things, both scarring and nonscarring hair loss,” he added.

In appropriate clinical contexts, the authors wrote, clinicians may consider combining LDOM with spironolactone or beta-blockers. Friedman said that in his hands, combining LDOM with a 5-alpha reductase inhibitor (5ARI) is “absolutely outstanding.” Minoxidil increases blood flow to the scalp, he explained, while 5ARIs prevent production of dihydrotestosterone, which miniaturizes hair.

Fu said, “We hope these consensus outcomes will be helpful to dermatology colleagues as they consider using LDOM to treat hair loss in their adult and adolescent patient populations. We anticipate that these guidelines will be updated as additional evidence-based data emerges and are encouraged that we are already seeing new publications on this topic.”

Important areas for future research, she noted, include pediatric use of LDOM, the comparative efficacy of topical vs oral minoxidil, the safety of oral minoxidil for patients with a history of allergic contact dermatitis to topical minoxidil, and the use of other off-label forms of minoxidil, such as compounded oral minoxidil and sublingual minoxidil.

The study was funded by the University of California, San Francisco, Department of Dermatology Medical Student Summer Research Fellowship Program. Fu reported personal fees from Pfizer, Eli Lilly and Company, and Sun Pharma outside of the study. The full list of author disclosures can be found in the paper. Ungar and Friedman reported no relevant financial relationships.

 

A version of this article appeared on Medscape.com.

The National Comprehensive Cancer Network (NCCN) has expanded two cancer genetic risk assessment guidelines to meet the growing understanding of hereditary cancer risk and use of genetic tests in cancer prevention, screening, and treatment. 

Additional cancer types were included in the title and content for both guidelines. Prostate cancer was added to Genetic/Familial High-Risk Assessment: Breast, Ovarian, Pancreatic, and Prostate, and endometrial and gastric cancer were added to Genetic/Familial High-Risk Assessment: Colorectal, Endometrial, and Gastric.

For these cancers, the expanded guidelines include information on when genetic testing is recommended and what type of testing may be best. These guidelines also detail the hereditary conditions and genetic mutations associated with elevated cancer risk and include appropriate “next steps” for individuals who have them, which may involve increased screening or prevention surgeries.

“These updates include the spectrum of genes associated with genetic syndromes, the range of risk associated with each pathogenic variant, the improvements in screening and prevention strategies, the role of genetic data to inform cancer treatment, and the expansion of the role of genetic counseling as this field moves forward,” Mary B. Daly, MD, PhD, with Fox Chase Cancer Center, Philadelphia, Pennsylvania, said in a news release. Daly chaired the panel that updated the breast, ovarian, pancreatic, and prostate cancer guidelines.

Oncologists should, for instance, ask patients about their family and personal history of cancer and known germline variants at time of initial diagnosis. With prostate cancer, if patients meet criteria for germline testing, multigene testing should include a host of variants, including BRCA1, BRCA2, ATM, PALB2, CHEK2, HOXB13, MLH1, MSH2, MSH6, and PMS2.

The updated guidelines on genetic risk assessment of colorectal, endometrial, and gastric cancer include new recommendations to consider for hereditary cancer screening in patients with newly diagnosed endometrial cancer, for evaluating and managing CDH1-associated gastric cancer risk, and for managing gastric cancer risk in patients with APC pathogenic variants. 

For CDH1-associated gastric cancer, for instance, the guidelines recommend carriers be referred to institutions with expertise in managing risks for cancer associated with CDH1, “given the still limited understanding and rarity of this syndrome.” 

“These expanded guidelines reflect the recommendations from leading experts on genetic testing based on the latest scientific research across the cancer spectrum, consolidated into two convenient resources,” said NCCN CEO Crystal S. Denlinger, MD, with Fox Chase Cancer Center, in a news release. 

“This information is critical for guiding shared decision-making between health care providers and their patients, enhancing screening practices as appropriate, and potentially choosing options for prevention and targeted treatment choices. Genetic testing guidelines enable us to better care for people with cancer and their family members,” Denlinger added.

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

The National Comprehensive Cancer Network (NCCN) has expanded two cancer genetic risk assessment guidelines to meet the growing understanding of hereditary cancer risk and use of genetic tests in cancer prevention, screening, and treatment. 

Additional cancer types were included in the title and content for both guidelines. Prostate cancer was added to Genetic/Familial High-Risk Assessment: Breast, Ovarian, Pancreatic, and Prostate, and endometrial and gastric cancer were added to Genetic/Familial High-Risk Assessment: Colorectal, Endometrial, and Gastric.

For these cancers, the expanded guidelines include information on when genetic testing is recommended and what type of testing may be best. These guidelines also detail the hereditary conditions and genetic mutations associated with elevated cancer risk and include appropriate “next steps” for individuals who have them, which may involve increased screening or prevention surgeries.

“These updates include the spectrum of genes associated with genetic syndromes, the range of risk associated with each pathogenic variant, the improvements in screening and prevention strategies, the role of genetic data to inform cancer treatment, and the expansion of the role of genetic counseling as this field moves forward,” Mary B. Daly, MD, PhD, with Fox Chase Cancer Center, Philadelphia, Pennsylvania, said in a news release. Daly chaired the panel that updated the breast, ovarian, pancreatic, and prostate cancer guidelines.

Oncologists should, for instance, ask patients about their family and personal history of cancer and known germline variants at time of initial diagnosis. With prostate cancer, if patients meet criteria for germline testing, multigene testing should include a host of variants, including BRCA1, BRCA2, ATM, PALB2, CHEK2, HOXB13, MLH1, MSH2, MSH6, and PMS2.

The updated guidelines on genetic risk assessment of colorectal, endometrial, and gastric cancer include new recommendations to consider for hereditary cancer screening in patients with newly diagnosed endometrial cancer, for evaluating and managing CDH1-associated gastric cancer risk, and for managing gastric cancer risk in patients with APC pathogenic variants. 

For CDH1-associated gastric cancer, for instance, the guidelines recommend carriers be referred to institutions with expertise in managing risks for cancer associated with CDH1, “given the still limited understanding and rarity of this syndrome.” 

“These expanded guidelines reflect the recommendations from leading experts on genetic testing based on the latest scientific research across the cancer spectrum, consolidated into two convenient resources,” said NCCN CEO Crystal S. Denlinger, MD, with Fox Chase Cancer Center, in a news release. 

“This information is critical for guiding shared decision-making between health care providers and their patients, enhancing screening practices as appropriate, and potentially choosing options for prevention and targeted treatment choices. Genetic testing guidelines enable us to better care for people with cancer and their family members,” Denlinger added.

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

The National Comprehensive Cancer Network (NCCN) has expanded two cancer genetic risk assessment guidelines to meet the growing understanding of hereditary cancer risk and use of genetic tests in cancer prevention, screening, and treatment. 

Additional cancer types were included in the title and content for both guidelines. Prostate cancer was added to Genetic/Familial High-Risk Assessment: Breast, Ovarian, Pancreatic, and Prostate, and endometrial and gastric cancer were added to Genetic/Familial High-Risk Assessment: Colorectal, Endometrial, and Gastric.

For these cancers, the expanded guidelines include information on when genetic testing is recommended and what type of testing may be best. These guidelines also detail the hereditary conditions and genetic mutations associated with elevated cancer risk and include appropriate “next steps” for individuals who have them, which may involve increased screening or prevention surgeries.

“These updates include the spectrum of genes associated with genetic syndromes, the range of risk associated with each pathogenic variant, the improvements in screening and prevention strategies, the role of genetic data to inform cancer treatment, and the expansion of the role of genetic counseling as this field moves forward,” Mary B. Daly, MD, PhD, with Fox Chase Cancer Center, Philadelphia, Pennsylvania, said in a news release. Daly chaired the panel that updated the breast, ovarian, pancreatic, and prostate cancer guidelines.

Oncologists should, for instance, ask patients about their family and personal history of cancer and known germline variants at time of initial diagnosis. With prostate cancer, if patients meet criteria for germline testing, multigene testing should include a host of variants, including BRCA1, BRCA2, ATM, PALB2, CHEK2, HOXB13, MLH1, MSH2, MSH6, and PMS2.

The updated guidelines on genetic risk assessment of colorectal, endometrial, and gastric cancer include new recommendations to consider for hereditary cancer screening in patients with newly diagnosed endometrial cancer, for evaluating and managing CDH1-associated gastric cancer risk, and for managing gastric cancer risk in patients with APC pathogenic variants. 

For CDH1-associated gastric cancer, for instance, the guidelines recommend carriers be referred to institutions with expertise in managing risks for cancer associated with CDH1, “given the still limited understanding and rarity of this syndrome.” 

“These expanded guidelines reflect the recommendations from leading experts on genetic testing based on the latest scientific research across the cancer spectrum, consolidated into two convenient resources,” said NCCN CEO Crystal S. Denlinger, MD, with Fox Chase Cancer Center, in a news release. 

“This information is critical for guiding shared decision-making between health care providers and their patients, enhancing screening practices as appropriate, and potentially choosing options for prevention and targeted treatment choices. Genetic testing guidelines enable us to better care for people with cancer and their family members,” Denlinger added.

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

TOPLINE:

The increase in incidence of pancreatic cancer among young Americans is largely caused by improved detection of early-stage endocrine cancer, not an increase in pancreatic adenocarcinoma. Given the stable mortality rates in this population, the increase in incidence likely reflects previously undetected cases instead of a true rise in new cases, researchers say.

METHODOLOGY:

• Data from several registries have indicated that the incidence of pancreatic cancer among younger individuals, particularly women, is on the rise in the United States and worldwide.
• In a new analysis, researchers wanted to see if the observed increase in pancreatic cancer incidence among young Americans represented a true rise in cancer occurrence or indicated greater diagnostic scrutiny. If pancreatic cancer incidence is really increasing, “incidence and mortality would be expected to increase concurrently, as would early- and late-stage diagnoses,” the researchers explained.
• The researchers collected data on pancreatic cancer incidence, histology, and stage distribution for individuals aged 15-39 years from US Cancer Statistics, a database covering almost the entire US population from 2001 to 2020. Pancreatic cancer mortality data from the same timeframe came from the National Vital Statistics System.
• The researchers looked at four histologic categories: Adenocarcinoma, the dominant pancreatic cancer histology, as well as more rare subtypes — endocrine and solid pseudopapillary — and “other” category. Researchers also categorized stage-specific incidence as early stage (in situ or localized) or late stage (regional or distant).

TAKEAWAY:

• The incidence of pancreatic cancer increased 2.1-fold in young women (incidence, 3.3-6.9 per million) and 1.6-fold in young men (incidence, 3.9-6.2 per million) between 2001 and 2019. However, mortality rates remained stable for women (1.5 deaths per million; annual percent change [AAPC], −0.5%; 95% CI, –1.4% to 0.5%) and men (2.5 deaths per million; AAPC, –0.1%; 95% CI, –0.8% to 0.6%) over this period.
• Looking at cancer subtypes, the increase in incidence was largely caused by early-stage endocrine cancer and solid pseudopapillary neoplasms in women, not adenocarcinoma (which remained stable over the study period).
• Looking at cancer stage, most of the increase in incidence came from detection of smaller tumors (< 2 cm) and early-stage cancer, which rose from 0.6 to 3.7 per million in women and from 0.4 to 2.2 per million in men. The authors also found no statistically significant change in the incidence of late-stage cancer in women or men.
• Rates of surgical treatment for pancreatic cancer increased, more than tripling among women (from 1.5 to 4.7 per million) and more than doubling among men (from 1.1 to 2.3 per million).

IN PRACTICE:

“Pancreatic cancer now can be another cancer subject to overdiagnosis: The detection of disease not destined to cause symptoms or death,” the authors concluded. “Although the observed changes in incidence are small, overdiagnosis is especially concerning for pancreatic cancer, as pancreatic surgery has substantial risk for morbidity (in particular, pancreatic fistulas) and mortality.”

SOURCE:

The study, with first author Vishal R. Patel, MD, MPH, and corresponding author H. Gilbert Welch, MD, MPH, from Brigham and Women’s Hospital, Boston, was published online on November 19 in Annals of Internal Medicine.

LIMITATIONS:

The study was limited by the lack of data on the method of cancer detection, which may have affected the interpretation of the findings.

DISCLOSURES:

Disclosure forms are available with the article online.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The increase in incidence of pancreatic cancer among young Americans is largely caused by improved detection of early-stage endocrine cancer, not an increase in pancreatic adenocarcinoma. Given the stable mortality rates in this population, the increase in incidence likely reflects previously undetected cases instead of a true rise in new cases, researchers say.

METHODOLOGY:

• Data from several registries have indicated that the incidence of pancreatic cancer among younger individuals, particularly women, is on the rise in the United States and worldwide.
• In a new analysis, researchers wanted to see if the observed increase in pancreatic cancer incidence among young Americans represented a true rise in cancer occurrence or indicated greater diagnostic scrutiny. If pancreatic cancer incidence is really increasing, “incidence and mortality would be expected to increase concurrently, as would early- and late-stage diagnoses,” the researchers explained.
• The researchers collected data on pancreatic cancer incidence, histology, and stage distribution for individuals aged 15-39 years from US Cancer Statistics, a database covering almost the entire US population from 2001 to 2020. Pancreatic cancer mortality data from the same timeframe came from the National Vital Statistics System.
• The researchers looked at four histologic categories: Adenocarcinoma, the dominant pancreatic cancer histology, as well as more rare subtypes — endocrine and solid pseudopapillary — and “other” category. Researchers also categorized stage-specific incidence as early stage (in situ or localized) or late stage (regional or distant).

TAKEAWAY:

• The incidence of pancreatic cancer increased 2.1-fold in young women (incidence, 3.3-6.9 per million) and 1.6-fold in young men (incidence, 3.9-6.2 per million) between 2001 and 2019. However, mortality rates remained stable for women (1.5 deaths per million; annual percent change [AAPC], −0.5%; 95% CI, –1.4% to 0.5%) and men (2.5 deaths per million; AAPC, –0.1%; 95% CI, –0.8% to 0.6%) over this period.
• Looking at cancer subtypes, the increase in incidence was largely caused by early-stage endocrine cancer and solid pseudopapillary neoplasms in women, not adenocarcinoma (which remained stable over the study period).
• Looking at cancer stage, most of the increase in incidence came from detection of smaller tumors (< 2 cm) and early-stage cancer, which rose from 0.6 to 3.7 per million in women and from 0.4 to 2.2 per million in men. The authors also found no statistically significant change in the incidence of late-stage cancer in women or men.
• Rates of surgical treatment for pancreatic cancer increased, more than tripling among women (from 1.5 to 4.7 per million) and more than doubling among men (from 1.1 to 2.3 per million).

IN PRACTICE:

“Pancreatic cancer now can be another cancer subject to overdiagnosis: The detection of disease not destined to cause symptoms or death,” the authors concluded. “Although the observed changes in incidence are small, overdiagnosis is especially concerning for pancreatic cancer, as pancreatic surgery has substantial risk for morbidity (in particular, pancreatic fistulas) and mortality.”

SOURCE:

The study, with first author Vishal R. Patel, MD, MPH, and corresponding author H. Gilbert Welch, MD, MPH, from Brigham and Women’s Hospital, Boston, was published online on November 19 in Annals of Internal Medicine.

LIMITATIONS:

The study was limited by the lack of data on the method of cancer detection, which may have affected the interpretation of the findings.

DISCLOSURES:

Disclosure forms are available with the article online.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The increase in incidence of pancreatic cancer among young Americans is largely caused by improved detection of early-stage endocrine cancer, not an increase in pancreatic adenocarcinoma. Given the stable mortality rates in this population, the increase in incidence likely reflects previously undetected cases instead of a true rise in new cases, researchers say.

METHODOLOGY:

• Data from several registries have indicated that the incidence of pancreatic cancer among younger individuals, particularly women, is on the rise in the United States and worldwide.
• In a new analysis, researchers wanted to see if the observed increase in pancreatic cancer incidence among young Americans represented a true rise in cancer occurrence or indicated greater diagnostic scrutiny. If pancreatic cancer incidence is really increasing, “incidence and mortality would be expected to increase concurrently, as would early- and late-stage diagnoses,” the researchers explained.
• The researchers collected data on pancreatic cancer incidence, histology, and stage distribution for individuals aged 15-39 years from US Cancer Statistics, a database covering almost the entire US population from 2001 to 2020. Pancreatic cancer mortality data from the same timeframe came from the National Vital Statistics System.
• The researchers looked at four histologic categories: Adenocarcinoma, the dominant pancreatic cancer histology, as well as more rare subtypes — endocrine and solid pseudopapillary — and “other” category. Researchers also categorized stage-specific incidence as early stage (in situ or localized) or late stage (regional or distant).

TAKEAWAY:

• The incidence of pancreatic cancer increased 2.1-fold in young women (incidence, 3.3-6.9 per million) and 1.6-fold in young men (incidence, 3.9-6.2 per million) between 2001 and 2019. However, mortality rates remained stable for women (1.5 deaths per million; annual percent change [AAPC], −0.5%; 95% CI, –1.4% to 0.5%) and men (2.5 deaths per million; AAPC, –0.1%; 95% CI, –0.8% to 0.6%) over this period.
• Looking at cancer subtypes, the increase in incidence was largely caused by early-stage endocrine cancer and solid pseudopapillary neoplasms in women, not adenocarcinoma (which remained stable over the study period).
• Looking at cancer stage, most of the increase in incidence came from detection of smaller tumors (< 2 cm) and early-stage cancer, which rose from 0.6 to 3.7 per million in women and from 0.4 to 2.2 per million in men. The authors also found no statistically significant change in the incidence of late-stage cancer in women or men.
• Rates of surgical treatment for pancreatic cancer increased, more than tripling among women (from 1.5 to 4.7 per million) and more than doubling among men (from 1.1 to 2.3 per million).

IN PRACTICE:

“Pancreatic cancer now can be another cancer subject to overdiagnosis: The detection of disease not destined to cause symptoms or death,” the authors concluded. “Although the observed changes in incidence are small, overdiagnosis is especially concerning for pancreatic cancer, as pancreatic surgery has substantial risk for morbidity (in particular, pancreatic fistulas) and mortality.”

SOURCE:

The study, with first author Vishal R. Patel, MD, MPH, and corresponding author H. Gilbert Welch, MD, MPH, from Brigham and Women’s Hospital, Boston, was published online on November 19 in Annals of Internal Medicine.

LIMITATIONS:

The study was limited by the lack of data on the method of cancer detection, which may have affected the interpretation of the findings.

DISCLOSURES:

Disclosure forms are available with the article online.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Supporting meaningful research that has a positive impact on the health and quality of life of veterans is a priority of the US Department of Veterans Affairs Office of Research and Development.¹ For nearly a century, VA researchers have been conducting high quality studies. To continue this trajectory, it is imperative to attract, train, and retain exceptional investigators while nurturing their development throughout their careers.²

Mentorship is defined as guidance provided by an experienced and trusted party to another (usually junior) individual with the intent of helping the person succeed. It benefits the mentee, mentor, and their institutions.³ Mentorship is crucial for personal and professional development as well as productivity, which may help reduce clinician burnout.^4-7 Conversely, a lack of mentorship could have negative effects on work satisfaction and stagnate career progression.⁸

Mentorship is vital for developing and advancing a VA investigator’s research agenda. Funding, grant writing, and research design were among the most discussed topics in a large comprehensive mentorship program for academic faculty.⁹ However, there are several known barriers to effective research mentorship; among them include a lack of resources, time constraints, and competing clinical priorities.^10,11

Finding time for effective one-on-one research mentoring is difficult within the time constraints of clinical duties; a group mentorship model may help overcome this barrier. Group mentorship can aid in personal and professional development because no single mentor can effectively meet every mentoring need of an individual.¹² Group mentorship also allows for the exchange of ideas among individuals with different backgrounds and the ability to utilize the strengths of each member of the group. For example, a member may have methodological expertise, while another may be skilled in grantsmanship. A team of mentors may be more beneficial for both the mentors (eg, establish a more manageable workload) and the mentee (eg, gains a broader perspective of expertise) when compared to having a single mentor.³

Peer mentorship within the group setting may also yield additional benefits. For example, having a supportive peer group may help reduce stress levels and burnout, while also improving overall well-being.^3,13 Formal mentorship programs do not frequently discuss concerns such as work-life balance, so including peers as mentors may help fill this void.⁹ Peer mentorship has also been found to be beneficial in providing mentees with pooled resources and shared learning.^12,13 This article describes the components, benefits, impacts, and challenges of a group research mentorship program for VA clinicians interested in conducting VArelevant research.

Program Description

The VA Clinical Research Mentorship Program was initiated at the VA Ann Arbor Healthcare System (VAAAHS) in October 2015 by the Chief of Medicine to assist VA clinician investigators with developing and submitting VA clinical science and health services research grant applications. The program offers group and one-on-one consultation services through the expertise of 2 experienced investigators/faculty mentors who also serve as program directors, each of whom devote about 3 to 5 hours per month to activities associated with the mentorship program (eg, attending the meeting, reviewing materials sent by mentees, and one-on-one discussions with mentees).

The program also fostered peer-led mentorship. This encourages all attendees to provide feedback during group sessions and communication by mentees outside the group sessions. An experienced project manager serves as program coordinator and contributes about 4 hours per month for activities such as attending, scheduling, and sending reminders for each meeting, distributing handouts, reviewing materials, and answering mentee’s questions via email. A statistician and additional research staff (ie, an epidemiologist and research assistant) do not attend the recurring meetings, but are available for offline consultation as needed. The program runs on a 12-month cycle with regular meetings occurring twice monthly during the 9-month academic period. Resources to support the program, primarily program director(s) and project coordinator effort, are provided by the Chief of Medicine and through the VAAAHS affiliated VA Health Systems Research (formerly Health Services Research & Development) Center of Innovation.

Invitations for new mentees are sent annually. Mentees expressing interest in the program outside of its annual recruitment period are evaluated for inclusion on a rolling basis. Recruitment begins with the program coordinator sending email notifications to all VAAAHS Medicine Service faculty, section chiefs, and division chiefs at the VAAAHS academic affiliate. Recipients are encouraged to distribute the announcement to eligible applicants and refer them to the application materials for entry consideration into the program. The application consists of the applicant’s curriculum vitae and a 1-page summary that includes a description of their research area of interest, how it is relevant to the VA, in addition to an idea for a research study, its potential significance, and proposed methodology. Applicant materials are reviewed by the program coordinator and program directors. The applicants are evaluated using a simple scoring approach that focuses on the applicant’s research area and agenda, past research training, past research productivity, potential for obtaining VA funding, and whether they have sufficient research time.

Program eligibility initially required being a physician with ≥ 1/8 VA appointment from the Medicine Service. However, clinicians with clinical appointments from other VA services are also accepted for participation as needed. Applicants must have previous research experience and have a career goal to obtain external funding for conducting and publishing original research. Those who have previously served as a principal investigator on a funded VA grant proposal are not eligible as new applicants but can remain in the program as peer mentors. The number of annual applicants varies and ranges from 1 to 11; on average, about 90% of applicants receive invitations to join the program.

Sessions

The program holds recurring meetings twice monthly for 1 hour during the 9-month academic year. However, program directors are available year-round, and mentees are encouraged to communicate questions or concerns via email during nonacademic months. Prior to the COVID-19 pandemic, all meetings were held in-person. However, the group pivoted to virtual meetings and continues to utilize this format. The dedicated program coordinator is responsible for coordinating meetings and distributing meeting materials.

Each session is informal, flexible, and supportive. Attendance is not enforced, and mentees are allowed to join meetings as their schedules permit; however, program directors and program coordinator attend each meeting. In advance of each session, the program coordinator sends out a call for agenda items to all active members invited to discuss any research related items. Each mentee presents their ideas to lead the discussion for their portion of the meeting with no defined format required.

A variety of topics are covered including, but not limited to: (1) grant-specific concerns (eg, questions related to specific aim pages, grantsmanship, postsubmission comments from reviewers, or postaward logistics); (2) research procedures (eg, questions related to methodological practices or institutional review board concerns); (3) manuscript or presentation preparation; and (4) careerrelated issues. The program coordinator distributes handouts prior to meetings and mentees may record their presentations. These handouts may include, but are not limited to, specific aims pages, analytical plans, grant solicitations, and PowerPoint presentations. If a resource that can benefit the entire group is mentioned during the meeting, the program coordinator is responsible for distribution.

The program follows a group facilitated discussion format. Program directors facilitate each meeting, but input is encouraged from all attendees. This model allows for mentees to learn from the faculty mentors as well as peer mentees in a simultaneous and efficient fashion. Group discussions foster collective problem solving, peer support, and resource sharing that would not be possible through individualized mentorship. Participants have access to varied expertise during each session which reduces the need to seek specialized help elsewhere. Participants are also encouraged to contact the program directors or research staff for consultation as needed. Some one-on-one consultations have transitioned to a more sustained and ongoing mentorship relationship between a program director and mentee, but most are often brief email exchanges or a single meeting.

Participants

Since its inception in 2015, 35 clinicians have enrolled in the program. The mentees are equally distributed by sex and practice in a variety of disciplines including gastroenterology, hematology/oncology, cardiology, and general medicine (Table 1). Mentees have submitted 33 grant proposals addressing a variety of health care issues to a diverse group of federal and nonfederal funding agencies (Table 2). As of May 15, 2024, 19 (58%) of the submitted applications have been funded.

Many factors contribute to a successfully funded grant application, and several mentees report that participating in the mentorship program was helpful. For example, a mentee became the first lead investigator for a VA Cooperative Studies Program funded at VAAAHS. The VA Cooperative Studies Program, a division of the Office of Research and Development, plans and conducts large multicenter clinical trials and epidemiological studies within the VA via a vast network of clinician investigators, statisticians, and other key research experts.¹⁴

Several program mentees have also received VA Clinical Science Research and Development Career Development Awards. The VA Career Development program supports investigators during their early research careers with a goal of retaining talented researchers committed to improving the health and care of veterans.¹⁵

Survey Responses

Mentee productivity and updates are tracked through direct mentee input, as requested by the program coordinator. Since 2022, participants could complete an end-of-year survey based on an assessment tool used in a VAAAHS nonresearch mentorship program.¹⁶ The survey, distributed to mentees and program directors, requests feedback on logistics (eg, if the meeting was a good use of time and barriers to attendance); perceptions of effectiveness (eg, ability to discuss agenda items, helpfulness with setting and reaching research goals, and quality of mentors’ feedback); and the impact of the mentoring program on work satisfaction and clinician burnout. Respondents are also encouraged to leave open-ended qualitative feedback.

To date the survey has elicited 19 responses. Seventeen (89%) indicated that they agree or strongly agree the meetings were an effective use of their time and 11 (58%) indicated that they were able to discuss all or most of the items they wanted to during the meeting. Sixteen respondents (84%) agreed the program helped them set and achieve their research goals and 14 respondents (74%) agreed the feedback they received during the meeting was specific, actionable, and focused on how to improve their research agenda. Seventeen respondents (89%) agreed the program increased their work satisfaction, while 13 respondents (68%) felt the program reduced levels of clinician burnout.

As attendance was not mandatory, the survey asked participants how often they attended meetings during the past year. Responses were mixed: 4 (21%) respondents attended regularly (12 to 16 times per year) and 8 (42%) attended most sessions (8 to 11 times per year). Noted barriers to attendance included conflicts with patient care activities and conflicts with other high priority meetings.

Mentees also provided qualitive feedback regarding the program. They highlighted the supportive environment, valuable expertise of the mentors, and usefulness of obtaining tailored feedback from the group. “This group is an amazing resource to anyone developing a research career,” a mentee noted, adding that the program directors “fostered an incredibly supportive group where research ideas and methodology can be explored in a nonthreatening and creative environment.”

Conclusions

This mentorship program aims to help aspiring VA clinician investigators develop and submit competitive research grant applications. The addition of the program to the existing robust research environments at VAAAHS and its academic affiliate appears to have contributed to this success, with 58% of applications submitted by program mentees receiving funding.

In addition to funding success, we also found that most participants have a favorable impression of the program. Of the participants who responded to the program evaluation survey, nearly all indicated the program was an effective use of their time. The program also appeared to increase work satisfaction and reduce levels of clinician burnout. Barriers to attendance were also noted, with the most frequent being scheduling conflicts.

This program’s format includes facilitated group discussion as well as peer mentorship. This collaborative structure allows for an efficient and rich learning experience. Feedback from multiple perspectives encourages natural networking and relationship building. Incorporating the collective wisdom of the faculty mentors and peer mentees is beneficial; it not only empowers the mentees but also enriches the experience for the mentors. This program can serve as a model for other VA facilities—or non-VA academic medical centers—to enhance their research programs.

Supporting meaningful research that has a positive impact on the health and quality of life of veterans is a priority of the US Department of Veterans Affairs Office of Research and Development.¹ For nearly a century, VA researchers have been conducting high quality studies. To continue this trajectory, it is imperative to attract, train, and retain exceptional investigators while nurturing their development throughout their careers.²

Mentorship is defined as guidance provided by an experienced and trusted party to another (usually junior) individual with the intent of helping the person succeed. It benefits the mentee, mentor, and their institutions.³ Mentorship is crucial for personal and professional development as well as productivity, which may help reduce clinician burnout.^4-7 Conversely, a lack of mentorship could have negative effects on work satisfaction and stagnate career progression.⁸

Mentorship is vital for developing and advancing a VA investigator’s research agenda. Funding, grant writing, and research design were among the most discussed topics in a large comprehensive mentorship program for academic faculty.⁹ However, there are several known barriers to effective research mentorship; among them include a lack of resources, time constraints, and competing clinical priorities.^10,11

Finding time for effective one-on-one research mentoring is difficult within the time constraints of clinical duties; a group mentorship model may help overcome this barrier. Group mentorship can aid in personal and professional development because no single mentor can effectively meet every mentoring need of an individual.¹² Group mentorship also allows for the exchange of ideas among individuals with different backgrounds and the ability to utilize the strengths of each member of the group. For example, a member may have methodological expertise, while another may be skilled in grantsmanship. A team of mentors may be more beneficial for both the mentors (eg, establish a more manageable workload) and the mentee (eg, gains a broader perspective of expertise) when compared to having a single mentor.³

Peer mentorship within the group setting may also yield additional benefits. For example, having a supportive peer group may help reduce stress levels and burnout, while also improving overall well-being.^3,13 Formal mentorship programs do not frequently discuss concerns such as work-life balance, so including peers as mentors may help fill this void.⁹ Peer mentorship has also been found to be beneficial in providing mentees with pooled resources and shared learning.^12,13 This article describes the components, benefits, impacts, and challenges of a group research mentorship program for VA clinicians interested in conducting VArelevant research.

Program Description

The VA Clinical Research Mentorship Program was initiated at the VA Ann Arbor Healthcare System (VAAAHS) in October 2015 by the Chief of Medicine to assist VA clinician investigators with developing and submitting VA clinical science and health services research grant applications. The program offers group and one-on-one consultation services through the expertise of 2 experienced investigators/faculty mentors who also serve as program directors, each of whom devote about 3 to 5 hours per month to activities associated with the mentorship program (eg, attending the meeting, reviewing materials sent by mentees, and one-on-one discussions with mentees).

The program also fostered peer-led mentorship. This encourages all attendees to provide feedback during group sessions and communication by mentees outside the group sessions. An experienced project manager serves as program coordinator and contributes about 4 hours per month for activities such as attending, scheduling, and sending reminders for each meeting, distributing handouts, reviewing materials, and answering mentee’s questions via email. A statistician and additional research staff (ie, an epidemiologist and research assistant) do not attend the recurring meetings, but are available for offline consultation as needed. The program runs on a 12-month cycle with regular meetings occurring twice monthly during the 9-month academic period. Resources to support the program, primarily program director(s) and project coordinator effort, are provided by the Chief of Medicine and through the VAAAHS affiliated VA Health Systems Research (formerly Health Services Research & Development) Center of Innovation.

Invitations for new mentees are sent annually. Mentees expressing interest in the program outside of its annual recruitment period are evaluated for inclusion on a rolling basis. Recruitment begins with the program coordinator sending email notifications to all VAAAHS Medicine Service faculty, section chiefs, and division chiefs at the VAAAHS academic affiliate. Recipients are encouraged to distribute the announcement to eligible applicants and refer them to the application materials for entry consideration into the program. The application consists of the applicant’s curriculum vitae and a 1-page summary that includes a description of their research area of interest, how it is relevant to the VA, in addition to an idea for a research study, its potential significance, and proposed methodology. Applicant materials are reviewed by the program coordinator and program directors. The applicants are evaluated using a simple scoring approach that focuses on the applicant’s research area and agenda, past research training, past research productivity, potential for obtaining VA funding, and whether they have sufficient research time.

Program eligibility initially required being a physician with ≥ 1/8 VA appointment from the Medicine Service. However, clinicians with clinical appointments from other VA services are also accepted for participation as needed. Applicants must have previous research experience and have a career goal to obtain external funding for conducting and publishing original research. Those who have previously served as a principal investigator on a funded VA grant proposal are not eligible as new applicants but can remain in the program as peer mentors. The number of annual applicants varies and ranges from 1 to 11; on average, about 90% of applicants receive invitations to join the program.

Sessions

The program holds recurring meetings twice monthly for 1 hour during the 9-month academic year. However, program directors are available year-round, and mentees are encouraged to communicate questions or concerns via email during nonacademic months. Prior to the COVID-19 pandemic, all meetings were held in-person. However, the group pivoted to virtual meetings and continues to utilize this format. The dedicated program coordinator is responsible for coordinating meetings and distributing meeting materials.

Each session is informal, flexible, and supportive. Attendance is not enforced, and mentees are allowed to join meetings as their schedules permit; however, program directors and program coordinator attend each meeting. In advance of each session, the program coordinator sends out a call for agenda items to all active members invited to discuss any research related items. Each mentee presents their ideas to lead the discussion for their portion of the meeting with no defined format required.

A variety of topics are covered including, but not limited to: (1) grant-specific concerns (eg, questions related to specific aim pages, grantsmanship, postsubmission comments from reviewers, or postaward logistics); (2) research procedures (eg, questions related to methodological practices or institutional review board concerns); (3) manuscript or presentation preparation; and (4) careerrelated issues. The program coordinator distributes handouts prior to meetings and mentees may record their presentations. These handouts may include, but are not limited to, specific aims pages, analytical plans, grant solicitations, and PowerPoint presentations. If a resource that can benefit the entire group is mentioned during the meeting, the program coordinator is responsible for distribution.

The program follows a group facilitated discussion format. Program directors facilitate each meeting, but input is encouraged from all attendees. This model allows for mentees to learn from the faculty mentors as well as peer mentees in a simultaneous and efficient fashion. Group discussions foster collective problem solving, peer support, and resource sharing that would not be possible through individualized mentorship. Participants have access to varied expertise during each session which reduces the need to seek specialized help elsewhere. Participants are also encouraged to contact the program directors or research staff for consultation as needed. Some one-on-one consultations have transitioned to a more sustained and ongoing mentorship relationship between a program director and mentee, but most are often brief email exchanges or a single meeting.

Participants

Since its inception in 2015, 35 clinicians have enrolled in the program. The mentees are equally distributed by sex and practice in a variety of disciplines including gastroenterology, hematology/oncology, cardiology, and general medicine (Table 1). Mentees have submitted 33 grant proposals addressing a variety of health care issues to a diverse group of federal and nonfederal funding agencies (Table 2). As of May 15, 2024, 19 (58%) of the submitted applications have been funded.

Many factors contribute to a successfully funded grant application, and several mentees report that participating in the mentorship program was helpful. For example, a mentee became the first lead investigator for a VA Cooperative Studies Program funded at VAAAHS. The VA Cooperative Studies Program, a division of the Office of Research and Development, plans and conducts large multicenter clinical trials and epidemiological studies within the VA via a vast network of clinician investigators, statisticians, and other key research experts.¹⁴

Several program mentees have also received VA Clinical Science Research and Development Career Development Awards. The VA Career Development program supports investigators during their early research careers with a goal of retaining talented researchers committed to improving the health and care of veterans.¹⁵

Survey Responses

Mentee productivity and updates are tracked through direct mentee input, as requested by the program coordinator. Since 2022, participants could complete an end-of-year survey based on an assessment tool used in a VAAAHS nonresearch mentorship program.¹⁶ The survey, distributed to mentees and program directors, requests feedback on logistics (eg, if the meeting was a good use of time and barriers to attendance); perceptions of effectiveness (eg, ability to discuss agenda items, helpfulness with setting and reaching research goals, and quality of mentors’ feedback); and the impact of the mentoring program on work satisfaction and clinician burnout. Respondents are also encouraged to leave open-ended qualitative feedback.

To date the survey has elicited 19 responses. Seventeen (89%) indicated that they agree or strongly agree the meetings were an effective use of their time and 11 (58%) indicated that they were able to discuss all or most of the items they wanted to during the meeting. Sixteen respondents (84%) agreed the program helped them set and achieve their research goals and 14 respondents (74%) agreed the feedback they received during the meeting was specific, actionable, and focused on how to improve their research agenda. Seventeen respondents (89%) agreed the program increased their work satisfaction, while 13 respondents (68%) felt the program reduced levels of clinician burnout.

As attendance was not mandatory, the survey asked participants how often they attended meetings during the past year. Responses were mixed: 4 (21%) respondents attended regularly (12 to 16 times per year) and 8 (42%) attended most sessions (8 to 11 times per year). Noted barriers to attendance included conflicts with patient care activities and conflicts with other high priority meetings.

Mentees also provided qualitive feedback regarding the program. They highlighted the supportive environment, valuable expertise of the mentors, and usefulness of obtaining tailored feedback from the group. “This group is an amazing resource to anyone developing a research career,” a mentee noted, adding that the program directors “fostered an incredibly supportive group where research ideas and methodology can be explored in a nonthreatening and creative environment.”

Conclusions

This mentorship program aims to help aspiring VA clinician investigators develop and submit competitive research grant applications. The addition of the program to the existing robust research environments at VAAAHS and its academic affiliate appears to have contributed to this success, with 58% of applications submitted by program mentees receiving funding.

In addition to funding success, we also found that most participants have a favorable impression of the program. Of the participants who responded to the program evaluation survey, nearly all indicated the program was an effective use of their time. The program also appeared to increase work satisfaction and reduce levels of clinician burnout. Barriers to attendance were also noted, with the most frequent being scheduling conflicts.

This program’s format includes facilitated group discussion as well as peer mentorship. This collaborative structure allows for an efficient and rich learning experience. Feedback from multiple perspectives encourages natural networking and relationship building. Incorporating the collective wisdom of the faculty mentors and peer mentees is beneficial; it not only empowers the mentees but also enriches the experience for the mentors. This program can serve as a model for other VA facilities—or non-VA academic medical centers—to enhance their research programs.

Supporting meaningful research that has a positive impact on the health and quality of life of veterans is a priority of the US Department of Veterans Affairs Office of Research and Development.¹ For nearly a century, VA researchers have been conducting high quality studies. To continue this trajectory, it is imperative to attract, train, and retain exceptional investigators while nurturing their development throughout their careers.²

Mentorship is defined as guidance provided by an experienced and trusted party to another (usually junior) individual with the intent of helping the person succeed. It benefits the mentee, mentor, and their institutions.³ Mentorship is crucial for personal and professional development as well as productivity, which may help reduce clinician burnout.^4-7 Conversely, a lack of mentorship could have negative effects on work satisfaction and stagnate career progression.⁸

Mentorship is vital for developing and advancing a VA investigator’s research agenda. Funding, grant writing, and research design were among the most discussed topics in a large comprehensive mentorship program for academic faculty.⁹ However, there are several known barriers to effective research mentorship; among them include a lack of resources, time constraints, and competing clinical priorities.^10,11

Finding time for effective one-on-one research mentoring is difficult within the time constraints of clinical duties; a group mentorship model may help overcome this barrier. Group mentorship can aid in personal and professional development because no single mentor can effectively meet every mentoring need of an individual.¹² Group mentorship also allows for the exchange of ideas among individuals with different backgrounds and the ability to utilize the strengths of each member of the group. For example, a member may have methodological expertise, while another may be skilled in grantsmanship. A team of mentors may be more beneficial for both the mentors (eg, establish a more manageable workload) and the mentee (eg, gains a broader perspective of expertise) when compared to having a single mentor.³

Peer mentorship within the group setting may also yield additional benefits. For example, having a supportive peer group may help reduce stress levels and burnout, while also improving overall well-being.^3,13 Formal mentorship programs do not frequently discuss concerns such as work-life balance, so including peers as mentors may help fill this void.⁹ Peer mentorship has also been found to be beneficial in providing mentees with pooled resources and shared learning.^12,13 This article describes the components, benefits, impacts, and challenges of a group research mentorship program for VA clinicians interested in conducting VArelevant research.

Program Description

The VA Clinical Research Mentorship Program was initiated at the VA Ann Arbor Healthcare System (VAAAHS) in October 2015 by the Chief of Medicine to assist VA clinician investigators with developing and submitting VA clinical science and health services research grant applications. The program offers group and one-on-one consultation services through the expertise of 2 experienced investigators/faculty mentors who also serve as program directors, each of whom devote about 3 to 5 hours per month to activities associated with the mentorship program (eg, attending the meeting, reviewing materials sent by mentees, and one-on-one discussions with mentees).

The program also fostered peer-led mentorship. This encourages all attendees to provide feedback during group sessions and communication by mentees outside the group sessions. An experienced project manager serves as program coordinator and contributes about 4 hours per month for activities such as attending, scheduling, and sending reminders for each meeting, distributing handouts, reviewing materials, and answering mentee’s questions via email. A statistician and additional research staff (ie, an epidemiologist and research assistant) do not attend the recurring meetings, but are available for offline consultation as needed. The program runs on a 12-month cycle with regular meetings occurring twice monthly during the 9-month academic period. Resources to support the program, primarily program director(s) and project coordinator effort, are provided by the Chief of Medicine and through the VAAAHS affiliated VA Health Systems Research (formerly Health Services Research & Development) Center of Innovation.

Invitations for new mentees are sent annually. Mentees expressing interest in the program outside of its annual recruitment period are evaluated for inclusion on a rolling basis. Recruitment begins with the program coordinator sending email notifications to all VAAAHS Medicine Service faculty, section chiefs, and division chiefs at the VAAAHS academic affiliate. Recipients are encouraged to distribute the announcement to eligible applicants and refer them to the application materials for entry consideration into the program. The application consists of the applicant’s curriculum vitae and a 1-page summary that includes a description of their research area of interest, how it is relevant to the VA, in addition to an idea for a research study, its potential significance, and proposed methodology. Applicant materials are reviewed by the program coordinator and program directors. The applicants are evaluated using a simple scoring approach that focuses on the applicant’s research area and agenda, past research training, past research productivity, potential for obtaining VA funding, and whether they have sufficient research time.

Program eligibility initially required being a physician with ≥ 1/8 VA appointment from the Medicine Service. However, clinicians with clinical appointments from other VA services are also accepted for participation as needed. Applicants must have previous research experience and have a career goal to obtain external funding for conducting and publishing original research. Those who have previously served as a principal investigator on a funded VA grant proposal are not eligible as new applicants but can remain in the program as peer mentors. The number of annual applicants varies and ranges from 1 to 11; on average, about 90% of applicants receive invitations to join the program.

Sessions

The program holds recurring meetings twice monthly for 1 hour during the 9-month academic year. However, program directors are available year-round, and mentees are encouraged to communicate questions or concerns via email during nonacademic months. Prior to the COVID-19 pandemic, all meetings were held in-person. However, the group pivoted to virtual meetings and continues to utilize this format. The dedicated program coordinator is responsible for coordinating meetings and distributing meeting materials.

Each session is informal, flexible, and supportive. Attendance is not enforced, and mentees are allowed to join meetings as their schedules permit; however, program directors and program coordinator attend each meeting. In advance of each session, the program coordinator sends out a call for agenda items to all active members invited to discuss any research related items. Each mentee presents their ideas to lead the discussion for their portion of the meeting with no defined format required.

A variety of topics are covered including, but not limited to: (1) grant-specific concerns (eg, questions related to specific aim pages, grantsmanship, postsubmission comments from reviewers, or postaward logistics); (2) research procedures (eg, questions related to methodological practices or institutional review board concerns); (3) manuscript or presentation preparation; and (4) careerrelated issues. The program coordinator distributes handouts prior to meetings and mentees may record their presentations. These handouts may include, but are not limited to, specific aims pages, analytical plans, grant solicitations, and PowerPoint presentations. If a resource that can benefit the entire group is mentioned during the meeting, the program coordinator is responsible for distribution.

The program follows a group facilitated discussion format. Program directors facilitate each meeting, but input is encouraged from all attendees. This model allows for mentees to learn from the faculty mentors as well as peer mentees in a simultaneous and efficient fashion. Group discussions foster collective problem solving, peer support, and resource sharing that would not be possible through individualized mentorship. Participants have access to varied expertise during each session which reduces the need to seek specialized help elsewhere. Participants are also encouraged to contact the program directors or research staff for consultation as needed. Some one-on-one consultations have transitioned to a more sustained and ongoing mentorship relationship between a program director and mentee, but most are often brief email exchanges or a single meeting.

Participants

Since its inception in 2015, 35 clinicians have enrolled in the program. The mentees are equally distributed by sex and practice in a variety of disciplines including gastroenterology, hematology/oncology, cardiology, and general medicine (Table 1). Mentees have submitted 33 grant proposals addressing a variety of health care issues to a diverse group of federal and nonfederal funding agencies (Table 2). As of May 15, 2024, 19 (58%) of the submitted applications have been funded.

Many factors contribute to a successfully funded grant application, and several mentees report that participating in the mentorship program was helpful. For example, a mentee became the first lead investigator for a VA Cooperative Studies Program funded at VAAAHS. The VA Cooperative Studies Program, a division of the Office of Research and Development, plans and conducts large multicenter clinical trials and epidemiological studies within the VA via a vast network of clinician investigators, statisticians, and other key research experts.¹⁴

Several program mentees have also received VA Clinical Science Research and Development Career Development Awards. The VA Career Development program supports investigators during their early research careers with a goal of retaining talented researchers committed to improving the health and care of veterans.¹⁵

Survey Responses

Mentee productivity and updates are tracked through direct mentee input, as requested by the program coordinator. Since 2022, participants could complete an end-of-year survey based on an assessment tool used in a VAAAHS nonresearch mentorship program.¹⁶ The survey, distributed to mentees and program directors, requests feedback on logistics (eg, if the meeting was a good use of time and barriers to attendance); perceptions of effectiveness (eg, ability to discuss agenda items, helpfulness with setting and reaching research goals, and quality of mentors’ feedback); and the impact of the mentoring program on work satisfaction and clinician burnout. Respondents are also encouraged to leave open-ended qualitative feedback.

To date the survey has elicited 19 responses. Seventeen (89%) indicated that they agree or strongly agree the meetings were an effective use of their time and 11 (58%) indicated that they were able to discuss all or most of the items they wanted to during the meeting. Sixteen respondents (84%) agreed the program helped them set and achieve their research goals and 14 respondents (74%) agreed the feedback they received during the meeting was specific, actionable, and focused on how to improve their research agenda. Seventeen respondents (89%) agreed the program increased their work satisfaction, while 13 respondents (68%) felt the program reduced levels of clinician burnout.

As attendance was not mandatory, the survey asked participants how often they attended meetings during the past year. Responses were mixed: 4 (21%) respondents attended regularly (12 to 16 times per year) and 8 (42%) attended most sessions (8 to 11 times per year). Noted barriers to attendance included conflicts with patient care activities and conflicts with other high priority meetings.

Mentees also provided qualitive feedback regarding the program. They highlighted the supportive environment, valuable expertise of the mentors, and usefulness of obtaining tailored feedback from the group. “This group is an amazing resource to anyone developing a research career,” a mentee noted, adding that the program directors “fostered an incredibly supportive group where research ideas and methodology can be explored in a nonthreatening and creative environment.”

Conclusions

This mentorship program aims to help aspiring VA clinician investigators develop and submit competitive research grant applications. The addition of the program to the existing robust research environments at VAAAHS and its academic affiliate appears to have contributed to this success, with 58% of applications submitted by program mentees receiving funding.

In addition to funding success, we also found that most participants have a favorable impression of the program. Of the participants who responded to the program evaluation survey, nearly all indicated the program was an effective use of their time. The program also appeared to increase work satisfaction and reduce levels of clinician burnout. Barriers to attendance were also noted, with the most frequent being scheduling conflicts.

This program’s format includes facilitated group discussion as well as peer mentorship. This collaborative structure allows for an efficient and rich learning experience. Feedback from multiple perspectives encourages natural networking and relationship building. Incorporating the collective wisdom of the faculty mentors and peer mentees is beneficial; it not only empowers the mentees but also enriches the experience for the mentors. This program can serve as a model for other VA facilities—or non-VA academic medical centers—to enhance their research programs.

Dear Friends,

One of the challenges I faced during training was managing my life outside of work. Many astute trainees started their financial empowerment journey early. However, I was too overwhelmed with what I did not know (the financial world) and just avoided it. Over the last year, I finally decided to embrace my lack of knowledge and find the support of experts, just as we would in medicine. A lot of questions from my journey translated into several articles in the “Finance” section of The New Gastroenterologist, so I encourage those who need guidance on embarking on their financial journeys to explore that section!

This issue of The New Gastroenterologist reviews common topics seen in gastroenterology clinic visits. In the “In Focus” section, Dr. Patrick Chang, Dr. Supisara Tintara, and Dr. Jennifer Phan – all from the University of Southern California – review diagnostic modalities to assess gastroesophageal reflux disease with an emphasis on medical, endoscopic, and surgical managements.

 

With the rise in metabolic dysfunction–associated steatotic liver disease (MASLD), patient education is starting in the primary care and gastroenterologist’s office. Dr. Newsha Nikzad, medical student Daniel Huynh, and Dr. Nikki Duong share their approach to ask effectively about and communicate lifestyle modifications, with examples of using sensitive language and prompts to help guide patients, in the “Short Clinical Review” section.

The “Finance” section highlights the ins and outs of a physician mortgage loan and additional information for first time home buyers, reviewed by John G. Kelley II, a physician mortgage specialist and vice president of mortgage lending at Arvest Bank. 

Lastly, in the “Early Career” section, Dr. Neil Gupta shares his experiences of transitioning from academic medicine to building a private practice group. He reflects on lessons learned from the first year after establishing his practice. 

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu) or Danielle Kiefer (dkiefer@gastro.org), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The first proton pump inhibitor was omeprazole, discovered 45 years ago in 1979 in Sweden, and clinically available in the United States only 36 years ago in 1988.

 

Yours truly, 

Judy A. Trieu, MD, MPH

Editor-in-Chief

Assistant Professor of Medicine

Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

Dear Friends,

One of the challenges I faced during training was managing my life outside of work. Many astute trainees started their financial empowerment journey early. However, I was too overwhelmed with what I did not know (the financial world) and just avoided it. Over the last year, I finally decided to embrace my lack of knowledge and find the support of experts, just as we would in medicine. A lot of questions from my journey translated into several articles in the “Finance” section of The New Gastroenterologist, so I encourage those who need guidance on embarking on their financial journeys to explore that section!

This issue of The New Gastroenterologist reviews common topics seen in gastroenterology clinic visits. In the “In Focus” section, Dr. Patrick Chang, Dr. Supisara Tintara, and Dr. Jennifer Phan – all from the University of Southern California – review diagnostic modalities to assess gastroesophageal reflux disease with an emphasis on medical, endoscopic, and surgical managements.

 

With the rise in metabolic dysfunction–associated steatotic liver disease (MASLD), patient education is starting in the primary care and gastroenterologist’s office. Dr. Newsha Nikzad, medical student Daniel Huynh, and Dr. Nikki Duong share their approach to ask effectively about and communicate lifestyle modifications, with examples of using sensitive language and prompts to help guide patients, in the “Short Clinical Review” section.

The “Finance” section highlights the ins and outs of a physician mortgage loan and additional information for first time home buyers, reviewed by John G. Kelley II, a physician mortgage specialist and vice president of mortgage lending at Arvest Bank. 

Lastly, in the “Early Career” section, Dr. Neil Gupta shares his experiences of transitioning from academic medicine to building a private practice group. He reflects on lessons learned from the first year after establishing his practice. 

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu) or Danielle Kiefer (dkiefer@gastro.org), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The first proton pump inhibitor was omeprazole, discovered 45 years ago in 1979 in Sweden, and clinically available in the United States only 36 years ago in 1988.

 

Yours truly, 

Judy A. Trieu, MD, MPH

Editor-in-Chief

Assistant Professor of Medicine

Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

Dear Friends,

One of the challenges I faced during training was managing my life outside of work. Many astute trainees started their financial empowerment journey early. However, I was too overwhelmed with what I did not know (the financial world) and just avoided it. Over the last year, I finally decided to embrace my lack of knowledge and find the support of experts, just as we would in medicine. A lot of questions from my journey translated into several articles in the “Finance” section of The New Gastroenterologist, so I encourage those who need guidance on embarking on their financial journeys to explore that section!

This issue of The New Gastroenterologist reviews common topics seen in gastroenterology clinic visits. In the “In Focus” section, Dr. Patrick Chang, Dr. Supisara Tintara, and Dr. Jennifer Phan – all from the University of Southern California – review diagnostic modalities to assess gastroesophageal reflux disease with an emphasis on medical, endoscopic, and surgical managements.

 

With the rise in metabolic dysfunction–associated steatotic liver disease (MASLD), patient education is starting in the primary care and gastroenterologist’s office. Dr. Newsha Nikzad, medical student Daniel Huynh, and Dr. Nikki Duong share their approach to ask effectively about and communicate lifestyle modifications, with examples of using sensitive language and prompts to help guide patients, in the “Short Clinical Review” section.

The “Finance” section highlights the ins and outs of a physician mortgage loan and additional information for first time home buyers, reviewed by John G. Kelley II, a physician mortgage specialist and vice president of mortgage lending at Arvest Bank. 

Lastly, in the “Early Career” section, Dr. Neil Gupta shares his experiences of transitioning from academic medicine to building a private practice group. He reflects on lessons learned from the first year after establishing his practice. 

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu) or Danielle Kiefer (dkiefer@gastro.org), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The first proton pump inhibitor was omeprazole, discovered 45 years ago in 1979 in Sweden, and clinically available in the United States only 36 years ago in 1988.

 

Yours truly, 

Judy A. Trieu, MD, MPH

Editor-in-Chief

Assistant Professor of Medicine

Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

A population-based study has shown a slightly elevated risk for patients’ developing skin disorders, including alopecia areata (AA), alopecia totalis (AT), vitiligo, and bullous pemphigoid (BP), more than 6 months after COVID-19 infection. In addition, the authors reported that COVID-19 vaccination appears to reduce these risks.

The study was published in JAMA Dermatology.

 

‘Compelling Evidence’

“This well-executed study by Heo et al provides compelling evidence to support an association between COVID-19 infection and the development of subsequent autoimmune and autoinflammatory skin diseases,” wrote authors led by Lisa M. Arkin, MD, of the Department of Dermatology, University of Wisconsin School of Medicine and Public Health in Madison, in an accompanying editorial.

Using databases from Korea’s National Health Insurance Service and the Korea Disease Control and Prevention Agency, investigators led by Yeon-Woo Heo, MD, a dermatology resident at Yonsei University Wonju College of Medicine, Wonju, Republic of Korea, compared 3.1 million people who had COVID-19 with 3.8 million controls, all with at least 180 days’ follow-up through December 31, 2022.

At a mean follow-up of 287 days in both cohorts, authors found significantly elevated risks for AA and vitiligo (adjusted hazard ratio [aHR], 1.11 for both), AT (aHR, 1.24), Behçet disease (aHR, 1.45), and BP (aHR, 1.62) in the post–COVID-19 cohort. The infection also raised the risk for other conditions such as systemic lupus erythematosus (aHR, 1.14) and Crohn’s disease (aHR, 1.35).

In subgroup analyses, demographic factors were associated with diverse effects: COVID-19 infection was associated with significantly higher odds of developing AA (for both men and women), vitiligo (men), Behçet disease (men and women), Crohn’s disease (men), ulcerative colitis (men), rheumatoid arthritis (men and women), systemic lupus erythematosus (men), ankylosing spondylitis (men), AT (women), and BP (women) than controls.

Those aged under 40 years were more likely to develop AA, primary cicatricial alopecia, Behçet disease, and ulcerative colitis, while those aged 40 years or older were more likely to develop AA, AT, vitiligo, Behçet disease, Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis, and BP.

Additionally, severe COVID-19 requiring intensive care unit admission was associated with a significantly increased risk for autoimmune diseases, including AA, psoriasis, BP, and sarcoidosis. By timeframe, risks for AA, AT, and psoriasis were significantly higher during the initial Delta-dominant period.

 

Vaccination Effect

Moreover, vaccinated individuals were less likely to develop AA, AT, psoriasis, Behçet disease, and various nondermatologic conditions than were those who were unvaccinated. This finding, wrote Heo and colleagues, “may provide evidence to support the hypothesis that COVID-19 vaccines can help prevent autoimmune diseases.”

“That’s the part we all need to take into our offices tomorrow,” said Brett King, MD, PhD, a Fairfield, Connecticut–based dermatologist in private practice. He was not involved with the study but was asked to comment.

Overall, King said, the study carries two main messages. “The first is that COVID-19 infection increases the likelihood of developing an autoimmune or autoinflammatory disease in a large population.” The second and very important message is that being vaccinated against COVID-19 provides protection against developing an autoimmune or autoinflammatory disease.

“My concern is that the popular media highlights the first part,” said King, “and everybody who develops alopecia areata, vitiligo, or sarcoidosis blames COVID-19. That’s not what this work says.”

The foregoing distinction is especially important during the fall and winter, he added, when people getting influenza vaccines are routinely offered COVID-19 vaccines. “Many patients have said, ‘I got the COVID vaccine and developed alopecia areata 6 months later.’ Nearly everybody who has developed a new or worsening health condition in the last almost 5 years has had the perfect fall guy — the COVID vaccine or infection.”

With virtually all patients asking if they should get an updated COVID-19 vaccine or booster, he added, many report having heard that such vaccines cause AA, vitiligo, or other diseases. “To anchor these conversations in real data and not just anecdotes from a blog or Facebook is very useful,” said King, “and now we have very good data saying that the COVID vaccine is protective against these disorders.”

George Han, MD, PhD, associate professor of dermatology at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, applauds investigators’ use of a large, robust database but suggests interpreting results cautiously. He was not involved with the study but was asked to comment.

“You could do a large, well-done study,” Han said, “but it could still not necessarily be generalizable. These autoimmune conditions they’re looking at have clear ethnic and racial biases.” Heo and colleagues acknowledged shortcomings including their study population’s monomorphic nature.

Additional issues that limit the study’s impact, said Han, include the difficulty of conceptualizing a 10%-20% increase in conditions that at baseline are rare. And many of the findings reflected natural patterns, he said. For instance, BP more commonly affects older people, COVID-19 notwithstanding.

Han said that for him, the study’s main value going forward is helping to explain a rash of worsening inflammatory skin disease that many dermatologists saw early in the pandemic. “We would regularly see patients who were well controlled with, for example, psoriasis or eczema. But after COVID-19 infection or a vaccine (usually mRNA-type), in some cases they would come in flaring badly.” This happened at least a dozen times during the first year of post-shutdown appointments, he said.

“We’ve seen patients who have flared multiple times — they get the booster, then flare again,” Han added. Similar patterns occurred with pyoderma gangrenosum and other inflammatory skin diseases, he said.

Given the modest effect sizes of the associations reported in the Korean study, Arkin and colleagues wrote in their JAMA Dermatology editorial that surveillance for autoimmune disease is probably not warranted without new examination findings or symptoms. “For certain,” King said, “we should not go hunting for things that aren’t obviously there.”

Rather, Arkin and colleagues wrote, the higher autoimmunity rates seen among the unvaccinated, as well as during the Delta phase (when patients were sicker and hospitalizations were more likely) and in patients requiring intensive care, suggest that “interventions that reduce disease severity could also potentially reduce long-term risk of subsequent autoimmune sequelae.”

Future research addressing whether people with preexisting autoimmune conditions are at greater risk for flares or developing new autoimmune diseases following COVID-19 infection “would help to frame an evidence-based approach for patients with autoimmune disorders who develop COVID-19 infection, including the role for antiviral treatments,” they added.

The study was supported by grants from the Research Program of the Korea Medical Institute, the Korea Health Industry Development Institute, and the National Research Foundation of Korea. Han and King reported no relevant financial relationships. Arkin disclosed receiving research grants to her institution from Amgen and Eli Lilly, personal fees from Sanofi/Regeneron for consulting, and personal consulting fees from Merck outside the submitted work. Another author reported personal consulting fees from Dexcel Pharma and Honeydew outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

A population-based study has shown a slightly elevated risk for patients’ developing skin disorders, including alopecia areata (AA), alopecia totalis (AT), vitiligo, and bullous pemphigoid (BP), more than 6 months after COVID-19 infection. In addition, the authors reported that COVID-19 vaccination appears to reduce these risks.

The study was published in JAMA Dermatology.

 

‘Compelling Evidence’

“This well-executed study by Heo et al provides compelling evidence to support an association between COVID-19 infection and the development of subsequent autoimmune and autoinflammatory skin diseases,” wrote authors led by Lisa M. Arkin, MD, of the Department of Dermatology, University of Wisconsin School of Medicine and Public Health in Madison, in an accompanying editorial.

Using databases from Korea’s National Health Insurance Service and the Korea Disease Control and Prevention Agency, investigators led by Yeon-Woo Heo, MD, a dermatology resident at Yonsei University Wonju College of Medicine, Wonju, Republic of Korea, compared 3.1 million people who had COVID-19 with 3.8 million controls, all with at least 180 days’ follow-up through December 31, 2022.

At a mean follow-up of 287 days in both cohorts, authors found significantly elevated risks for AA and vitiligo (adjusted hazard ratio [aHR], 1.11 for both), AT (aHR, 1.24), Behçet disease (aHR, 1.45), and BP (aHR, 1.62) in the post–COVID-19 cohort. The infection also raised the risk for other conditions such as systemic lupus erythematosus (aHR, 1.14) and Crohn’s disease (aHR, 1.35).

In subgroup analyses, demographic factors were associated with diverse effects: COVID-19 infection was associated with significantly higher odds of developing AA (for both men and women), vitiligo (men), Behçet disease (men and women), Crohn’s disease (men), ulcerative colitis (men), rheumatoid arthritis (men and women), systemic lupus erythematosus (men), ankylosing spondylitis (men), AT (women), and BP (women) than controls.

Those aged under 40 years were more likely to develop AA, primary cicatricial alopecia, Behçet disease, and ulcerative colitis, while those aged 40 years or older were more likely to develop AA, AT, vitiligo, Behçet disease, Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis, and BP.

Additionally, severe COVID-19 requiring intensive care unit admission was associated with a significantly increased risk for autoimmune diseases, including AA, psoriasis, BP, and sarcoidosis. By timeframe, risks for AA, AT, and psoriasis were significantly higher during the initial Delta-dominant period.

 

Vaccination Effect

Moreover, vaccinated individuals were less likely to develop AA, AT, psoriasis, Behçet disease, and various nondermatologic conditions than were those who were unvaccinated. This finding, wrote Heo and colleagues, “may provide evidence to support the hypothesis that COVID-19 vaccines can help prevent autoimmune diseases.”

“That’s the part we all need to take into our offices tomorrow,” said Brett King, MD, PhD, a Fairfield, Connecticut–based dermatologist in private practice. He was not involved with the study but was asked to comment.

Overall, King said, the study carries two main messages. “The first is that COVID-19 infection increases the likelihood of developing an autoimmune or autoinflammatory disease in a large population.” The second and very important message is that being vaccinated against COVID-19 provides protection against developing an autoimmune or autoinflammatory disease.

“My concern is that the popular media highlights the first part,” said King, “and everybody who develops alopecia areata, vitiligo, or sarcoidosis blames COVID-19. That’s not what this work says.”

The foregoing distinction is especially important during the fall and winter, he added, when people getting influenza vaccines are routinely offered COVID-19 vaccines. “Many patients have said, ‘I got the COVID vaccine and developed alopecia areata 6 months later.’ Nearly everybody who has developed a new or worsening health condition in the last almost 5 years has had the perfect fall guy — the COVID vaccine or infection.”

With virtually all patients asking if they should get an updated COVID-19 vaccine or booster, he added, many report having heard that such vaccines cause AA, vitiligo, or other diseases. “To anchor these conversations in real data and not just anecdotes from a blog or Facebook is very useful,” said King, “and now we have very good data saying that the COVID vaccine is protective against these disorders.”

George Han, MD, PhD, associate professor of dermatology at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, applauds investigators’ use of a large, robust database but suggests interpreting results cautiously. He was not involved with the study but was asked to comment.

“You could do a large, well-done study,” Han said, “but it could still not necessarily be generalizable. These autoimmune conditions they’re looking at have clear ethnic and racial biases.” Heo and colleagues acknowledged shortcomings including their study population’s monomorphic nature.

Additional issues that limit the study’s impact, said Han, include the difficulty of conceptualizing a 10%-20% increase in conditions that at baseline are rare. And many of the findings reflected natural patterns, he said. For instance, BP more commonly affects older people, COVID-19 notwithstanding.

Han said that for him, the study’s main value going forward is helping to explain a rash of worsening inflammatory skin disease that many dermatologists saw early in the pandemic. “We would regularly see patients who were well controlled with, for example, psoriasis or eczema. But after COVID-19 infection or a vaccine (usually mRNA-type), in some cases they would come in flaring badly.” This happened at least a dozen times during the first year of post-shutdown appointments, he said.

“We’ve seen patients who have flared multiple times — they get the booster, then flare again,” Han added. Similar patterns occurred with pyoderma gangrenosum and other inflammatory skin diseases, he said.

Given the modest effect sizes of the associations reported in the Korean study, Arkin and colleagues wrote in their JAMA Dermatology editorial that surveillance for autoimmune disease is probably not warranted without new examination findings or symptoms. “For certain,” King said, “we should not go hunting for things that aren’t obviously there.”

Rather, Arkin and colleagues wrote, the higher autoimmunity rates seen among the unvaccinated, as well as during the Delta phase (when patients were sicker and hospitalizations were more likely) and in patients requiring intensive care, suggest that “interventions that reduce disease severity could also potentially reduce long-term risk of subsequent autoimmune sequelae.”

Future research addressing whether people with preexisting autoimmune conditions are at greater risk for flares or developing new autoimmune diseases following COVID-19 infection “would help to frame an evidence-based approach for patients with autoimmune disorders who develop COVID-19 infection, including the role for antiviral treatments,” they added.

The study was supported by grants from the Research Program of the Korea Medical Institute, the Korea Health Industry Development Institute, and the National Research Foundation of Korea. Han and King reported no relevant financial relationships. Arkin disclosed receiving research grants to her institution from Amgen and Eli Lilly, personal fees from Sanofi/Regeneron for consulting, and personal consulting fees from Merck outside the submitted work. Another author reported personal consulting fees from Dexcel Pharma and Honeydew outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

A population-based study has shown a slightly elevated risk for patients’ developing skin disorders, including alopecia areata (AA), alopecia totalis (AT), vitiligo, and bullous pemphigoid (BP), more than 6 months after COVID-19 infection. In addition, the authors reported that COVID-19 vaccination appears to reduce these risks.

The study was published in JAMA Dermatology.

 

‘Compelling Evidence’

“This well-executed study by Heo et al provides compelling evidence to support an association between COVID-19 infection and the development of subsequent autoimmune and autoinflammatory skin diseases,” wrote authors led by Lisa M. Arkin, MD, of the Department of Dermatology, University of Wisconsin School of Medicine and Public Health in Madison, in an accompanying editorial.

Using databases from Korea’s National Health Insurance Service and the Korea Disease Control and Prevention Agency, investigators led by Yeon-Woo Heo, MD, a dermatology resident at Yonsei University Wonju College of Medicine, Wonju, Republic of Korea, compared 3.1 million people who had COVID-19 with 3.8 million controls, all with at least 180 days’ follow-up through December 31, 2022.

At a mean follow-up of 287 days in both cohorts, authors found significantly elevated risks for AA and vitiligo (adjusted hazard ratio [aHR], 1.11 for both), AT (aHR, 1.24), Behçet disease (aHR, 1.45), and BP (aHR, 1.62) in the post–COVID-19 cohort. The infection also raised the risk for other conditions such as systemic lupus erythematosus (aHR, 1.14) and Crohn’s disease (aHR, 1.35).

In subgroup analyses, demographic factors were associated with diverse effects: COVID-19 infection was associated with significantly higher odds of developing AA (for both men and women), vitiligo (men), Behçet disease (men and women), Crohn’s disease (men), ulcerative colitis (men), rheumatoid arthritis (men and women), systemic lupus erythematosus (men), ankylosing spondylitis (men), AT (women), and BP (women) than controls.

Those aged under 40 years were more likely to develop AA, primary cicatricial alopecia, Behçet disease, and ulcerative colitis, while those aged 40 years or older were more likely to develop AA, AT, vitiligo, Behçet disease, Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis, and BP.

Additionally, severe COVID-19 requiring intensive care unit admission was associated with a significantly increased risk for autoimmune diseases, including AA, psoriasis, BP, and sarcoidosis. By timeframe, risks for AA, AT, and psoriasis were significantly higher during the initial Delta-dominant period.

 

Vaccination Effect

Moreover, vaccinated individuals were less likely to develop AA, AT, psoriasis, Behçet disease, and various nondermatologic conditions than were those who were unvaccinated. This finding, wrote Heo and colleagues, “may provide evidence to support the hypothesis that COVID-19 vaccines can help prevent autoimmune diseases.”

“That’s the part we all need to take into our offices tomorrow,” said Brett King, MD, PhD, a Fairfield, Connecticut–based dermatologist in private practice. He was not involved with the study but was asked to comment.

Overall, King said, the study carries two main messages. “The first is that COVID-19 infection increases the likelihood of developing an autoimmune or autoinflammatory disease in a large population.” The second and very important message is that being vaccinated against COVID-19 provides protection against developing an autoimmune or autoinflammatory disease.

“My concern is that the popular media highlights the first part,” said King, “and everybody who develops alopecia areata, vitiligo, or sarcoidosis blames COVID-19. That’s not what this work says.”

The foregoing distinction is especially important during the fall and winter, he added, when people getting influenza vaccines are routinely offered COVID-19 vaccines. “Many patients have said, ‘I got the COVID vaccine and developed alopecia areata 6 months later.’ Nearly everybody who has developed a new or worsening health condition in the last almost 5 years has had the perfect fall guy — the COVID vaccine or infection.”

With virtually all patients asking if they should get an updated COVID-19 vaccine or booster, he added, many report having heard that such vaccines cause AA, vitiligo, or other diseases. “To anchor these conversations in real data and not just anecdotes from a blog or Facebook is very useful,” said King, “and now we have very good data saying that the COVID vaccine is protective against these disorders.”

George Han, MD, PhD, associate professor of dermatology at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, applauds investigators’ use of a large, robust database but suggests interpreting results cautiously. He was not involved with the study but was asked to comment.

“You could do a large, well-done study,” Han said, “but it could still not necessarily be generalizable. These autoimmune conditions they’re looking at have clear ethnic and racial biases.” Heo and colleagues acknowledged shortcomings including their study population’s monomorphic nature.

Additional issues that limit the study’s impact, said Han, include the difficulty of conceptualizing a 10%-20% increase in conditions that at baseline are rare. And many of the findings reflected natural patterns, he said. For instance, BP more commonly affects older people, COVID-19 notwithstanding.

Han said that for him, the study’s main value going forward is helping to explain a rash of worsening inflammatory skin disease that many dermatologists saw early in the pandemic. “We would regularly see patients who were well controlled with, for example, psoriasis or eczema. But after COVID-19 infection or a vaccine (usually mRNA-type), in some cases they would come in flaring badly.” This happened at least a dozen times during the first year of post-shutdown appointments, he said.

“We’ve seen patients who have flared multiple times — they get the booster, then flare again,” Han added. Similar patterns occurred with pyoderma gangrenosum and other inflammatory skin diseases, he said.

Given the modest effect sizes of the associations reported in the Korean study, Arkin and colleagues wrote in their JAMA Dermatology editorial that surveillance for autoimmune disease is probably not warranted without new examination findings or symptoms. “For certain,” King said, “we should not go hunting for things that aren’t obviously there.”

Rather, Arkin and colleagues wrote, the higher autoimmunity rates seen among the unvaccinated, as well as during the Delta phase (when patients were sicker and hospitalizations were more likely) and in patients requiring intensive care, suggest that “interventions that reduce disease severity could also potentially reduce long-term risk of subsequent autoimmune sequelae.”

Future research addressing whether people with preexisting autoimmune conditions are at greater risk for flares or developing new autoimmune diseases following COVID-19 infection “would help to frame an evidence-based approach for patients with autoimmune disorders who develop COVID-19 infection, including the role for antiviral treatments,” they added.

The study was supported by grants from the Research Program of the Korea Medical Institute, the Korea Health Industry Development Institute, and the National Research Foundation of Korea. Han and King reported no relevant financial relationships. Arkin disclosed receiving research grants to her institution from Amgen and Eli Lilly, personal fees from Sanofi/Regeneron for consulting, and personal consulting fees from Merck outside the submitted work. Another author reported personal consulting fees from Dexcel Pharma and Honeydew outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

The addition of dupilumab significantly reduced itching and hives, compared with placebo, in patients with chronic spontaneous urticaria (CSU) that was uncontrolled with H1-antihistamines, based on data from 151 individuals.

“Approximately 50% of patients with chronic spontaneous urticaria do not respond to antihistamines,” said Thomas B. Casale, MD, professor of internal medicine at the University of South Florida, Tampa, in an interview. Omalizumab, the only biologic approved for this condition, is not effective in all patients, and additional treatment options are needed, added Casale, the lead author who presented the new data, at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting.

Dupilumab (Dupixent), a fully human monoclonal antibody that targets the interleukin (IL)–4 and IL-13 pathways, is currently approved in the United States for the treatment of several allergy and dermatology indications, including atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps, and prurigo nodularis.

In the study, known as LIBERTY-CSU CUPID Study C, researchers randomized 74 patients with CSU aged 6 years or older to add-on dupilumab subcutaneously every 2 weeks and 77 to placebo. (Patients were omalizumab-naive and had symptomatic CSU, despite treatment with up to four times the approved dose of standard-of-care H1-antihistamines.) Dupilumab doses were 300 mg for adults and adolescents weighing ≥ 60 kg or 200 mg for adolescents weighing < 60 kg and children weighing ≥ 30 kg.

The primary outcomes were Itch Severity Score over 7 days (ISS7; range, 0-21) and Urticaria Activity Score over 7 days (UAS7; range, 0-42).

Over the 24-week study period, patients in the dupilumab group showed significantly greater change from baseline than those in the placebo group on both measures, with least squares mean changes of 8.6 vs 6.1 for ISS7 and 15.9 vs 11.2 for UAS7 (P = .02 for both).

In addition, at 24 weeks, significantly more patients in the dupilumab group than in the placebo group achieved well-controlled disease based on a UAS of 6 or lower (41% vs 23%; P = .005). Significantly more dupilumab-treated patients also achieved a complete response (defined as a UAS of 0), compared with placebo-treated patients (30% vs 18%; P = .02).

Overall rates of treatment-emergent adverse events were 53% for both groups, and safety data were mainly consistent with dupilumab’s known safety profile, the researchers wrote.

The findings were not surprising, as a previous related study, LIBERTY-CSU CUPID Study A, showed that dupilumab was effective for CSU, Casale told this news organization. “This replicate study confirms the previous study and provides evidence for regulatory approval.”

If approved by the Food and Drug Administration (FDA), “dupilumab will provide another therapeutic option for patients with chronic urticaria unresponsive to antihistamines,” Casale commented.

No new safety signals occurred, and the ability to self-administer the medication at home provides an advantage for patients, he added. As for additional research, “analysis of patient characteristics and potential biomarkers that would predict responsiveness is needed.”

 

More Research Needed to Fine-Tune Management

An unmet need persists for patients with CSU whose disease is not adequately controlled by higher-dose H1-antihistamines, Robert G. Micheletti, MD, associate professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, said in an interview. “It is important not only to identify effective add-on therapies for these patients but also to generate data to support insurance coverage and drug access,” said Micheletti, who was not involved in the study.

Also referring to the similar findings reported in the LIBERTY-CSU CUPID Study A, Micheletti said, “as in the earlier study, the results demonstrate significantly reduced itch and urticaria in treated patients compared to placebo.”

“While many providers currently prescribe dupilumab off-label for refractory CSU, FDA approval would improve access to the drug for patients who need it and provide an alternative for patients who may not be good candidates for omalizumab,” he added. However, more research is needed to define optimal management of patients with CSU with inadequate response to omalizumab.

“The LIBERTY-CSU CUPID Study B showed a small improvement in itch severity and urticaria activity among such patients receiving dupilumab,” he noted. “Future work should aim to identify biomarkers and other features predictive of response to various therapies.” 

Study B involved patients with CSU who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab, according to Regeneron. 

On November 15, after the ACAAI meeting had ended, the company announced that the FDA had accepted the resubmission of an application for approval of dupilumab for the treatment of CSU in adults and pediatric patients aged 12 years or older not adequately controlled with H1-antihistamines.

The study was supported and sponsored by Sanofi and Regeneron Pharmaceuticals. Casale disclosed serving as a consultant for ALK, ARS Pharma, AstraZeneca, Bryn Pharma, Celgene, Eli Lilly, Genentech, GSK, Jasper, Novartis, Regeneron, and Sanofi and as a speaker for Genentech and Regeneron. Micheletti had no relevant financial conflicts to disclose.

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

The addition of dupilumab significantly reduced itching and hives, compared with placebo, in patients with chronic spontaneous urticaria (CSU) that was uncontrolled with H1-antihistamines, based on data from 151 individuals.

“Approximately 50% of patients with chronic spontaneous urticaria do not respond to antihistamines,” said Thomas B. Casale, MD, professor of internal medicine at the University of South Florida, Tampa, in an interview. Omalizumab, the only biologic approved for this condition, is not effective in all patients, and additional treatment options are needed, added Casale, the lead author who presented the new data, at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting.

Dupilumab (Dupixent), a fully human monoclonal antibody that targets the interleukin (IL)–4 and IL-13 pathways, is currently approved in the United States for the treatment of several allergy and dermatology indications, including atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps, and prurigo nodularis.

In the study, known as LIBERTY-CSU CUPID Study C, researchers randomized 74 patients with CSU aged 6 years or older to add-on dupilumab subcutaneously every 2 weeks and 77 to placebo. (Patients were omalizumab-naive and had symptomatic CSU, despite treatment with up to four times the approved dose of standard-of-care H1-antihistamines.) Dupilumab doses were 300 mg for adults and adolescents weighing ≥ 60 kg or 200 mg for adolescents weighing < 60 kg and children weighing ≥ 30 kg.

The primary outcomes were Itch Severity Score over 7 days (ISS7; range, 0-21) and Urticaria Activity Score over 7 days (UAS7; range, 0-42).

Over the 24-week study period, patients in the dupilumab group showed significantly greater change from baseline than those in the placebo group on both measures, with least squares mean changes of 8.6 vs 6.1 for ISS7 and 15.9 vs 11.2 for UAS7 (P = .02 for both).

In addition, at 24 weeks, significantly more patients in the dupilumab group than in the placebo group achieved well-controlled disease based on a UAS of 6 or lower (41% vs 23%; P = .005). Significantly more dupilumab-treated patients also achieved a complete response (defined as a UAS of 0), compared with placebo-treated patients (30% vs 18%; P = .02).

Overall rates of treatment-emergent adverse events were 53% for both groups, and safety data were mainly consistent with dupilumab’s known safety profile, the researchers wrote.

The findings were not surprising, as a previous related study, LIBERTY-CSU CUPID Study A, showed that dupilumab was effective for CSU, Casale told this news organization. “This replicate study confirms the previous study and provides evidence for regulatory approval.”

If approved by the Food and Drug Administration (FDA), “dupilumab will provide another therapeutic option for patients with chronic urticaria unresponsive to antihistamines,” Casale commented.

No new safety signals occurred, and the ability to self-administer the medication at home provides an advantage for patients, he added. As for additional research, “analysis of patient characteristics and potential biomarkers that would predict responsiveness is needed.”

 

More Research Needed to Fine-Tune Management

An unmet need persists for patients with CSU whose disease is not adequately controlled by higher-dose H1-antihistamines, Robert G. Micheletti, MD, associate professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, said in an interview. “It is important not only to identify effective add-on therapies for these patients but also to generate data to support insurance coverage and drug access,” said Micheletti, who was not involved in the study.

Also referring to the similar findings reported in the LIBERTY-CSU CUPID Study A, Micheletti said, “as in the earlier study, the results demonstrate significantly reduced itch and urticaria in treated patients compared to placebo.”

“While many providers currently prescribe dupilumab off-label for refractory CSU, FDA approval would improve access to the drug for patients who need it and provide an alternative for patients who may not be good candidates for omalizumab,” he added. However, more research is needed to define optimal management of patients with CSU with inadequate response to omalizumab.

“The LIBERTY-CSU CUPID Study B showed a small improvement in itch severity and urticaria activity among such patients receiving dupilumab,” he noted. “Future work should aim to identify biomarkers and other features predictive of response to various therapies.” 

Study B involved patients with CSU who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab, according to Regeneron. 

On November 15, after the ACAAI meeting had ended, the company announced that the FDA had accepted the resubmission of an application for approval of dupilumab for the treatment of CSU in adults and pediatric patients aged 12 years or older not adequately controlled with H1-antihistamines.

The study was supported and sponsored by Sanofi and Regeneron Pharmaceuticals. Casale disclosed serving as a consultant for ALK, ARS Pharma, AstraZeneca, Bryn Pharma, Celgene, Eli Lilly, Genentech, GSK, Jasper, Novartis, Regeneron, and Sanofi and as a speaker for Genentech and Regeneron. Micheletti had no relevant financial conflicts to disclose.

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

The addition of dupilumab significantly reduced itching and hives, compared with placebo, in patients with chronic spontaneous urticaria (CSU) that was uncontrolled with H1-antihistamines, based on data from 151 individuals.

“Approximately 50% of patients with chronic spontaneous urticaria do not respond to antihistamines,” said Thomas B. Casale, MD, professor of internal medicine at the University of South Florida, Tampa, in an interview. Omalizumab, the only biologic approved for this condition, is not effective in all patients, and additional treatment options are needed, added Casale, the lead author who presented the new data, at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting.

Dupilumab (Dupixent), a fully human monoclonal antibody that targets the interleukin (IL)–4 and IL-13 pathways, is currently approved in the United States for the treatment of several allergy and dermatology indications, including atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps, and prurigo nodularis.

In the study, known as LIBERTY-CSU CUPID Study C, researchers randomized 74 patients with CSU aged 6 years or older to add-on dupilumab subcutaneously every 2 weeks and 77 to placebo. (Patients were omalizumab-naive and had symptomatic CSU, despite treatment with up to four times the approved dose of standard-of-care H1-antihistamines.) Dupilumab doses were 300 mg for adults and adolescents weighing ≥ 60 kg or 200 mg for adolescents weighing < 60 kg and children weighing ≥ 30 kg.

The primary outcomes were Itch Severity Score over 7 days (ISS7; range, 0-21) and Urticaria Activity Score over 7 days (UAS7; range, 0-42).

Over the 24-week study period, patients in the dupilumab group showed significantly greater change from baseline than those in the placebo group on both measures, with least squares mean changes of 8.6 vs 6.1 for ISS7 and 15.9 vs 11.2 for UAS7 (P = .02 for both).

In addition, at 24 weeks, significantly more patients in the dupilumab group than in the placebo group achieved well-controlled disease based on a UAS of 6 or lower (41% vs 23%; P = .005). Significantly more dupilumab-treated patients also achieved a complete response (defined as a UAS of 0), compared with placebo-treated patients (30% vs 18%; P = .02).

Overall rates of treatment-emergent adverse events were 53% for both groups, and safety data were mainly consistent with dupilumab’s known safety profile, the researchers wrote.

The findings were not surprising, as a previous related study, LIBERTY-CSU CUPID Study A, showed that dupilumab was effective for CSU, Casale told this news organization. “This replicate study confirms the previous study and provides evidence for regulatory approval.”

If approved by the Food and Drug Administration (FDA), “dupilumab will provide another therapeutic option for patients with chronic urticaria unresponsive to antihistamines,” Casale commented.

No new safety signals occurred, and the ability to self-administer the medication at home provides an advantage for patients, he added. As for additional research, “analysis of patient characteristics and potential biomarkers that would predict responsiveness is needed.”

 

More Research Needed to Fine-Tune Management

An unmet need persists for patients with CSU whose disease is not adequately controlled by higher-dose H1-antihistamines, Robert G. Micheletti, MD, associate professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, said in an interview. “It is important not only to identify effective add-on therapies for these patients but also to generate data to support insurance coverage and drug access,” said Micheletti, who was not involved in the study.

Also referring to the similar findings reported in the LIBERTY-CSU CUPID Study A, Micheletti said, “as in the earlier study, the results demonstrate significantly reduced itch and urticaria in treated patients compared to placebo.”

“While many providers currently prescribe dupilumab off-label for refractory CSU, FDA approval would improve access to the drug for patients who need it and provide an alternative for patients who may not be good candidates for omalizumab,” he added. However, more research is needed to define optimal management of patients with CSU with inadequate response to omalizumab.

“The LIBERTY-CSU CUPID Study B showed a small improvement in itch severity and urticaria activity among such patients receiving dupilumab,” he noted. “Future work should aim to identify biomarkers and other features predictive of response to various therapies.” 

Study B involved patients with CSU who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab, according to Regeneron. 

On November 15, after the ACAAI meeting had ended, the company announced that the FDA had accepted the resubmission of an application for approval of dupilumab for the treatment of CSU in adults and pediatric patients aged 12 years or older not adequately controlled with H1-antihistamines.

The study was supported and sponsored by Sanofi and Regeneron Pharmaceuticals. Casale disclosed serving as a consultant for ALK, ARS Pharma, AstraZeneca, Bryn Pharma, Celgene, Eli Lilly, Genentech, GSK, Jasper, Novartis, Regeneron, and Sanofi and as a speaker for Genentech and Regeneron. Micheletti had no relevant financial conflicts to disclose.

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

As Veterans Day approaches, stores and restaurants will offer discounts and free meals to veterans. Children will write thank you letters, and citizens nationwide will raise flags to honor and thank veterans. We can never repay those who lost their life, health, or livelihood in defense of the nation. Since the American Revolution, and in gratitude for that incalculable debt, the US government, on behalf of the American public, has seen fit to grant a host of benefits and services to those who wore the uniform.^2,3 Among the best known are health care, burial services, compensation and pensions, home loans, and the GI Bill.

Less recognized yet arguably essential for the fair and consistent provision of these entitlements is a legal principle: the veteran’s canon. A canon is a system of rules or maxims used to interpret legal instruments, such as statutes. They are not rules but serve as a “principle that guides the interpretation of the text.”⁴ Since I am not a lawyer, I will undoubtedly oversimplify this legal principle, but I hope to get enough right to explain why the veteran’s canon should matter to federal health care professionals.

At its core, the veteran’s canon means that when the US Department of Veterans Affairs (VA) and a veteran have a legal dispute about VA benefits, the courts will give deference to the veteran. Underscoring that any ambiguity in the statute is resolved in the veteran’s favor, the canon is known in legal circles as the Gardner deference. This is a reference to a 1994 case in which a Korean War veteran underwent surgery in a VA facility for a herniated disc he alleged caused pain and weakness in his left lower extremity.⁵ Gardner argued that federal statutes 38 USC § 1151 underlying corresponding VA regulation 38 CFR § 3.358(c)(3) granted disability benefits to veterans injured during VA treatment. The VA denied the disability claim, contending the regulation restricted compensation to veterans whose injury was the fault of the VA; thus, the disability had to have been the result of negligent treatment or an unforeseen therapeutic accident.⁵

The case wound its way through various appeals boards and courts until the Supreme Court of the United States (SCOTUS) ruled that the statute’s context left no ambiguity, and that any care provided under VA auspices was covered under the statute. What is important for this column is that the justices opined that had ambiguity been present, it would have legally necessitated, “applying the rule that interpretive doubt is to be resolved in the veteran’s favor.”⁵ In Gardner’s case, the courts reaffirmed nearly 80 years of judicial precedent upholding the veteran’s canon.

Thirty years later, Rudisill v McDonough again questioned the veteran’s canon.⁶ Educational benefits, namely the GI Bill, were the issue in this case. Rudisill served during 3 different periods in the US Army, totaling 8 years. Two educational programs overlapped during Rudisill’s tenure in the military: the Montgomery GI Bill and Post-9/11 Veterans Educational Assistance Act. Rudisill had used a portion of his Montgomery benefits to fund his undergraduate education and now wished to use the more extensive Post-9/11 assistance to finance his graduate degree. Rudisill and the VA disagreed about when his combined benefits would be capped, either at 36 or 48 months. After working its way through appeals courts, SCOTUS was again called upon for judgment.

The justices found that Rudisill qualified under both programs and could use them in any order he wished up to the cap. The majority found no ambiguity in the statute; however, if interpretation was required, the majority of justices indicated that the veteran’s canon would have supported Rudisill. While this sounds like good news for veterans, 2 justices authored a dissenting opinion that questioned the constitutional grounding of the veteran’s canon, noting that the “canon appears to have developed almost by accident.”⁶ The minority opinion suggested that when the veteran’s canon allocates resources to pay for specific veteran benefits, other interests and groups are deprived of those same resources, resulting in potential inequity.⁷

The potential ethical import and clinical impact of striking down the veteran’s canon is serious. It is especially concerning given that in a recent case, the SCOTUS ruling struck down another legal interpretation that also benefited the VA and ultimately veterans: the Chevron deference.⁸ This precedent held that when a legal dispute arises about the meaning of a specific federal agency regulation or policy, the courts should defer to the federal agency’s presumably superior understanding of the matter. The principle places the locus of decision-making with the subject-matter experts of the respective agency rather than the courts.

Ironically, given the legislative purposes of both interpretive principles, their overturning would likely introduce much more uncertainty, variation, and unpredictability in cases involving veteran benefits. This is bad news for both veterans and the VA. Veterans might not prevail as often in court when they have a reasonable claim, leading to more aggressive challenges. In response, the VA would have a heavier and more costly burden of administrative proof to defend sound decisions.⁹ Recently, the VA has tried to reduce the backlog of claims. The inability to have legal recourse to Chevron or Gardener could result in even more delay in adjudicating veterans’ claims that enable them to access benefits and services, already an object of congressional pressure.¹⁰

Courts will continue to debate the issue with another judicial test of the canon on the current SCOTUS docket (Bufkin v McDonough).¹¹ The veteran’s canon was put in place to equalize the power differential between the VA and the veteran: in administrative language, to make it more likely than not that the veteran would prevail when regulations were ambiguous. There are many legal and political rationales for veteran’s canon, including enabling veterans to file claims for service-connected illnesses. The veteran’s cannon helped Vietnam War-era veterans receive VA care while researchers were still studying the sequela of Agent Orange exposure. ¹² The legislative purpose of the veteran’s canon is the same as that of all VA benefits and services commemorated on Veterans Day. As expressed by SCOTUS justices in the wake of World War II, the benefit statutes should be “liberally construed for the benefit of those who left private life to serve their country in its hour of greatest need.”¹³

As Veterans Day approaches, stores and restaurants will offer discounts and free meals to veterans. Children will write thank you letters, and citizens nationwide will raise flags to honor and thank veterans. We can never repay those who lost their life, health, or livelihood in defense of the nation. Since the American Revolution, and in gratitude for that incalculable debt, the US government, on behalf of the American public, has seen fit to grant a host of benefits and services to those who wore the uniform.^2,3 Among the best known are health care, burial services, compensation and pensions, home loans, and the GI Bill.

Less recognized yet arguably essential for the fair and consistent provision of these entitlements is a legal principle: the veteran’s canon. A canon is a system of rules or maxims used to interpret legal instruments, such as statutes. They are not rules but serve as a “principle that guides the interpretation of the text.”⁴ Since I am not a lawyer, I will undoubtedly oversimplify this legal principle, but I hope to get enough right to explain why the veteran’s canon should matter to federal health care professionals.

At its core, the veteran’s canon means that when the US Department of Veterans Affairs (VA) and a veteran have a legal dispute about VA benefits, the courts will give deference to the veteran. Underscoring that any ambiguity in the statute is resolved in the veteran’s favor, the canon is known in legal circles as the Gardner deference. This is a reference to a 1994 case in which a Korean War veteran underwent surgery in a VA facility for a herniated disc he alleged caused pain and weakness in his left lower extremity.⁵ Gardner argued that federal statutes 38 USC § 1151 underlying corresponding VA regulation 38 CFR § 3.358(c)(3) granted disability benefits to veterans injured during VA treatment. The VA denied the disability claim, contending the regulation restricted compensation to veterans whose injury was the fault of the VA; thus, the disability had to have been the result of negligent treatment or an unforeseen therapeutic accident.⁵

The case wound its way through various appeals boards and courts until the Supreme Court of the United States (SCOTUS) ruled that the statute’s context left no ambiguity, and that any care provided under VA auspices was covered under the statute. What is important for this column is that the justices opined that had ambiguity been present, it would have legally necessitated, “applying the rule that interpretive doubt is to be resolved in the veteran’s favor.”⁵ In Gardner’s case, the courts reaffirmed nearly 80 years of judicial precedent upholding the veteran’s canon.

Thirty years later, Rudisill v McDonough again questioned the veteran’s canon.⁶ Educational benefits, namely the GI Bill, were the issue in this case. Rudisill served during 3 different periods in the US Army, totaling 8 years. Two educational programs overlapped during Rudisill’s tenure in the military: the Montgomery GI Bill and Post-9/11 Veterans Educational Assistance Act. Rudisill had used a portion of his Montgomery benefits to fund his undergraduate education and now wished to use the more extensive Post-9/11 assistance to finance his graduate degree. Rudisill and the VA disagreed about when his combined benefits would be capped, either at 36 or 48 months. After working its way through appeals courts, SCOTUS was again called upon for judgment.

The justices found that Rudisill qualified under both programs and could use them in any order he wished up to the cap. The majority found no ambiguity in the statute; however, if interpretation was required, the majority of justices indicated that the veteran’s canon would have supported Rudisill. While this sounds like good news for veterans, 2 justices authored a dissenting opinion that questioned the constitutional grounding of the veteran’s canon, noting that the “canon appears to have developed almost by accident.”⁶ The minority opinion suggested that when the veteran’s canon allocates resources to pay for specific veteran benefits, other interests and groups are deprived of those same resources, resulting in potential inequity.⁷

The potential ethical import and clinical impact of striking down the veteran’s canon is serious. It is especially concerning given that in a recent case, the SCOTUS ruling struck down another legal interpretation that also benefited the VA and ultimately veterans: the Chevron deference.⁸ This precedent held that when a legal dispute arises about the meaning of a specific federal agency regulation or policy, the courts should defer to the federal agency’s presumably superior understanding of the matter. The principle places the locus of decision-making with the subject-matter experts of the respective agency rather than the courts.

Ironically, given the legislative purposes of both interpretive principles, their overturning would likely introduce much more uncertainty, variation, and unpredictability in cases involving veteran benefits. This is bad news for both veterans and the VA. Veterans might not prevail as often in court when they have a reasonable claim, leading to more aggressive challenges. In response, the VA would have a heavier and more costly burden of administrative proof to defend sound decisions.⁹ Recently, the VA has tried to reduce the backlog of claims. The inability to have legal recourse to Chevron or Gardener could result in even more delay in adjudicating veterans’ claims that enable them to access benefits and services, already an object of congressional pressure.¹⁰

Courts will continue to debate the issue with another judicial test of the canon on the current SCOTUS docket (Bufkin v McDonough).¹¹ The veteran’s canon was put in place to equalize the power differential between the VA and the veteran: in administrative language, to make it more likely than not that the veteran would prevail when regulations were ambiguous. There are many legal and political rationales for veteran’s canon, including enabling veterans to file claims for service-connected illnesses. The veteran’s cannon helped Vietnam War-era veterans receive VA care while researchers were still studying the sequela of Agent Orange exposure. ¹² The legislative purpose of the veteran’s canon is the same as that of all VA benefits and services commemorated on Veterans Day. As expressed by SCOTUS justices in the wake of World War II, the benefit statutes should be “liberally construed for the benefit of those who left private life to serve their country in its hour of greatest need.”¹³

As Veterans Day approaches, stores and restaurants will offer discounts and free meals to veterans. Children will write thank you letters, and citizens nationwide will raise flags to honor and thank veterans. We can never repay those who lost their life, health, or livelihood in defense of the nation. Since the American Revolution, and in gratitude for that incalculable debt, the US government, on behalf of the American public, has seen fit to grant a host of benefits and services to those who wore the uniform.^2,3 Among the best known are health care, burial services, compensation and pensions, home loans, and the GI Bill.

Less recognized yet arguably essential for the fair and consistent provision of these entitlements is a legal principle: the veteran’s canon. A canon is a system of rules or maxims used to interpret legal instruments, such as statutes. They are not rules but serve as a “principle that guides the interpretation of the text.”⁴ Since I am not a lawyer, I will undoubtedly oversimplify this legal principle, but I hope to get enough right to explain why the veteran’s canon should matter to federal health care professionals.

At its core, the veteran’s canon means that when the US Department of Veterans Affairs (VA) and a veteran have a legal dispute about VA benefits, the courts will give deference to the veteran. Underscoring that any ambiguity in the statute is resolved in the veteran’s favor, the canon is known in legal circles as the Gardner deference. This is a reference to a 1994 case in which a Korean War veteran underwent surgery in a VA facility for a herniated disc he alleged caused pain and weakness in his left lower extremity.⁵ Gardner argued that federal statutes 38 USC § 1151 underlying corresponding VA regulation 38 CFR § 3.358(c)(3) granted disability benefits to veterans injured during VA treatment. The VA denied the disability claim, contending the regulation restricted compensation to veterans whose injury was the fault of the VA; thus, the disability had to have been the result of negligent treatment or an unforeseen therapeutic accident.⁵

The case wound its way through various appeals boards and courts until the Supreme Court of the United States (SCOTUS) ruled that the statute’s context left no ambiguity, and that any care provided under VA auspices was covered under the statute. What is important for this column is that the justices opined that had ambiguity been present, it would have legally necessitated, “applying the rule that interpretive doubt is to be resolved in the veteran’s favor.”⁵ In Gardner’s case, the courts reaffirmed nearly 80 years of judicial precedent upholding the veteran’s canon.

Thirty years later, Rudisill v McDonough again questioned the veteran’s canon.⁶ Educational benefits, namely the GI Bill, were the issue in this case. Rudisill served during 3 different periods in the US Army, totaling 8 years. Two educational programs overlapped during Rudisill’s tenure in the military: the Montgomery GI Bill and Post-9/11 Veterans Educational Assistance Act. Rudisill had used a portion of his Montgomery benefits to fund his undergraduate education and now wished to use the more extensive Post-9/11 assistance to finance his graduate degree. Rudisill and the VA disagreed about when his combined benefits would be capped, either at 36 or 48 months. After working its way through appeals courts, SCOTUS was again called upon for judgment.

The justices found that Rudisill qualified under both programs and could use them in any order he wished up to the cap. The majority found no ambiguity in the statute; however, if interpretation was required, the majority of justices indicated that the veteran’s canon would have supported Rudisill. While this sounds like good news for veterans, 2 justices authored a dissenting opinion that questioned the constitutional grounding of the veteran’s canon, noting that the “canon appears to have developed almost by accident.”⁶ The minority opinion suggested that when the veteran’s canon allocates resources to pay for specific veteran benefits, other interests and groups are deprived of those same resources, resulting in potential inequity.⁷

The potential ethical import and clinical impact of striking down the veteran’s canon is serious. It is especially concerning given that in a recent case, the SCOTUS ruling struck down another legal interpretation that also benefited the VA and ultimately veterans: the Chevron deference.⁸ This precedent held that when a legal dispute arises about the meaning of a specific federal agency regulation or policy, the courts should defer to the federal agency’s presumably superior understanding of the matter. The principle places the locus of decision-making with the subject-matter experts of the respective agency rather than the courts.

Ironically, given the legislative purposes of both interpretive principles, their overturning would likely introduce much more uncertainty, variation, and unpredictability in cases involving veteran benefits. This is bad news for both veterans and the VA. Veterans might not prevail as often in court when they have a reasonable claim, leading to more aggressive challenges. In response, the VA would have a heavier and more costly burden of administrative proof to defend sound decisions.⁹ Recently, the VA has tried to reduce the backlog of claims. The inability to have legal recourse to Chevron or Gardener could result in even more delay in adjudicating veterans’ claims that enable them to access benefits and services, already an object of congressional pressure.¹⁰

Courts will continue to debate the issue with another judicial test of the canon on the current SCOTUS docket (Bufkin v McDonough).¹¹ The veteran’s canon was put in place to equalize the power differential between the VA and the veteran: in administrative language, to make it more likely than not that the veteran would prevail when regulations were ambiguous. There are many legal and political rationales for veteran’s canon, including enabling veterans to file claims for service-connected illnesses. The veteran’s cannon helped Vietnam War-era veterans receive VA care while researchers were still studying the sequela of Agent Orange exposure. ¹² The legislative purpose of the veteran’s canon is the same as that of all VA benefits and services commemorated on Veterans Day. As expressed by SCOTUS justices in the wake of World War II, the benefit statutes should be “liberally construed for the benefit of those who left private life to serve their country in its hour of greatest need.”¹³

Navigating the path to homeownership can be particularly challenging for physicians, who often face a unique set of financial circumstances. With substantial student loan debt, limited savings, and a delayed peak earning potential, traditional mortgage options may seem out of reach.

Enter physician mortgage loans—specialized financing designed specifically for medical professionals. These loans offer tailored solutions that address the common barriers faced by doctors, making it easier for them to achieve their homeownership goals. In this article, we’ll explore what physician mortgage loans are, their key benefits and drawbacks, and how to choose the right lender to support your journey to owning a home.

 

What Is a Physician Mortgage Loan?

A physician mortgage loan, also known as a ‘doctor loan,’ is a specialized mortgage product designed for a specific group of qualifying medical professionals. These loans are particularly attractive to new doctors who may have substantial student loan debt, limited savings, and an income that is expected to increase significantly over time. As unique portfolio loans, physician mortgage products can vary considerably between lending institutions. However, a common feature is that they typically require little to no down payment and do not require private mortgage insurance (PMI).

Beyond the common features, loan options and qualifying parameters can vary significantly from one institution to another. Therefore, it’s important to start gathering information as early as possible, giving you ample time to evaluate which institution and loan option best meet your needs.

 

How Do I Know if I Am Eligible for a Physician Mortgage Loan?

Physician loans are typically offered to MDs, DOs, DDSs, DMDs, and ODs, though some institutions expand this list to include DPMs, PAs, CRNAs, NPs, PharmDs, and DVMs. Additionally, most of these loan products are available to residents, fellows, and attending or practicing physicians.

How Do I Know What Physician Mortgage Loan Is Best for Me?

When selecting the optimal physician loan option for your home purchase, consider several important metrics:

• Duration of Stay: Consider how long you expect to live in the home. If you’re in a lengthy residency or fellowship program, or if you plan to move for a new job soon after, a 30-year fixed-rate loan might not be ideal. Instead, evaluate loan options that match your anticipated duration of stay. For example, a 5-year or 7-year ARM (adjustable rate mortgage) could offer a lower interest rate and reduced monthly payments for the initial fixed period, which aligns with your shorter-term stay. This can result in substantial savings if you do not plan to stay in the home for the full term of a traditional mortgage.
• Underwriting Guidelines: Each lender has different underwriting standards and qualifying criteria, so it’s essential to understand these differences. For instance, some lenders may have higher minimum credit score requirements or stricter debt-to-income (DTI) ratio limits. Others might require a larger down payment or have different rules regarding student loan payments and closing costs. Flexibility in these guidelines can impact your ability to qualify for a loan and the terms you receive. For example, some lenders may allow you to include student loan payments at a lower percentage of your income, which could improve your DTI ratio and help you secure a better loan offer.
• Closing Timing: The timing of your home closing relative to your job start date can be crucial, especially if you’re relocating. Some lenders permit closing up to 60-90 days before your job begins, while others offer up to 120 days. If you need to relocate your family before starting your new position, having the ability to close earlier can provide you with more flexibility in finding and moving into a home. This additional time can ease the transition and allow you to settle in before your new job starts.

Given the wide range of options and standards, it’s important to strategically identify which factors are most meaningful to you. Beyond interest rates, consider the overall cost of the loan, the flexibility of terms, and how well the loan aligns with your financial goals and career plans. For example, if you value lower monthly payments over a longer period or need to accommodate significant student loan debt, ensure that the loan program you choose aligns with these priorities.

 

What Attributes Should I Look for in My Loan Officer?

When interviewing multiple loan officers for your upcoming loan needs, it’s essential to use the right metrics—beyond just the interest rate—to determine the best fit for your situation. Some critical factors to consider include the loan officer’s experience working with physicians, that person’s availability and responsiveness, and the potential for building a long-term relationship.

As in most professions, experience is paramount—it’s something that cannot be taught or simply read in a training manual. Physicians, especially those in training or just stepping into an attending role, often have unique financial situations. This makes it crucial to work with a loan officer who has extensive experience serving physician clients. An experienced loan officer will better understand how to customize a loan solution that aligns with your specific needs, resulting in a much more tailored and meaningful mortgage. There is no one-size-fits-all mortgage. You are unique, and your loan officer should be crafting a mortgage solution that reflects your individuality and financial circumstances.

In my opinion, availability and responsiveness are among the most critical attributes your chosen loan officer should possess. Interestingly, this factor doesn’t directly influence the ‘cost’ of your loan but can significantly impact your experience. As a physician with a demanding schedule, it’s unrealistic to expect that all communication will take place strictly during business hours—this is true for any consumer. Pay close attention to how promptly loan officers respond during your initial interactions, and evaluate how thoroughly they explain loan terms, out-of-pocket costs, and the overall loan process. Your loan officer should be your trusted guide as you navigate through the complexities of the loan process, so setting yourself up for success starts with choosing someone who meets your expectations in this regard. 

It’s crucial to build a good rapport with the loan officer you choose, as this likely won’t be the last mortgage or financial need you encounter in your lifetime. Establishing a personal connection with your loan officer fosters a level of trust that is invaluable. Whether you’re considering refinancing your current mortgage or exploring additional loan products for other financial needs, having a trusted advisor you can rely on as a financial resource is immensely beneficial as you progress in your career. A strong, long-standing relationship with a loan officer ensures you receive reliable and sound financial advice tailored to your unique needs.

 

Additional Things to Consider if You Are a First-Time Home Buyer

Interview multiple lenders and make those conversations about more than just interest rates. This approach will help you gauge their knowledge of physician mortgage loans while allowing you to assess who might be the best fit for you in terms of compatibility. Relying solely on an email blast to inquire about rates could easily lead you to a subpar lender and result in an unfavorable experience.

Don’t be afraid to ask a lot of questions! As a first-time home buyer, it’s natural to feel a bit overwhelmed by the process—it can seem daunting if you’ve never been through it before. That’s why it’s crucial to ask any questions that come to mind and to work with a lender who is willing to take the time to answer them while educating you throughout the home-buying journey. With a trusted guide and the right education, the process will feel far less overwhelming, leading to a smoother and more positive experience from start to finish. 

In conclusion, choosing the right lender for a physician mortgage loan is a crucial step in securing your financial future and achieving homeownership. By thoroughly evaluating interest rates, down payment requirements, loan terms, and other key metrics, you can find a lender that offers competitive rates and favorable terms tailored to your unique needs. Consider factors such as customer service, closing costs, and the lender’s experience with physician loans to ensure a smooth and supportive mortgage process. By taking the time to compare options and select the best fit for your financial situation, you can confidently move forward in your home-buying journey and set the stage for a successful and fulfilling homeownership experience.

Mr. Kelley is vice president of mortgage lending and a physician mortgage specialist at Arvest Bank in Overland Park, Kansas.

Navigating the path to homeownership can be particularly challenging for physicians, who often face a unique set of financial circumstances. With substantial student loan debt, limited savings, and a delayed peak earning potential, traditional mortgage options may seem out of reach.

Enter physician mortgage loans—specialized financing designed specifically for medical professionals. These loans offer tailored solutions that address the common barriers faced by doctors, making it easier for them to achieve their homeownership goals. In this article, we’ll explore what physician mortgage loans are, their key benefits and drawbacks, and how to choose the right lender to support your journey to owning a home.

 

What Is a Physician Mortgage Loan?

A physician mortgage loan, also known as a ‘doctor loan,’ is a specialized mortgage product designed for a specific group of qualifying medical professionals. These loans are particularly attractive to new doctors who may have substantial student loan debt, limited savings, and an income that is expected to increase significantly over time. As unique portfolio loans, physician mortgage products can vary considerably between lending institutions. However, a common feature is that they typically require little to no down payment and do not require private mortgage insurance (PMI).

Beyond the common features, loan options and qualifying parameters can vary significantly from one institution to another. Therefore, it’s important to start gathering information as early as possible, giving you ample time to evaluate which institution and loan option best meet your needs.

 

How Do I Know if I Am Eligible for a Physician Mortgage Loan?

Physician loans are typically offered to MDs, DOs, DDSs, DMDs, and ODs, though some institutions expand this list to include DPMs, PAs, CRNAs, NPs, PharmDs, and DVMs. Additionally, most of these loan products are available to residents, fellows, and attending or practicing physicians.

How Do I Know What Physician Mortgage Loan Is Best for Me?

When selecting the optimal physician loan option for your home purchase, consider several important metrics:

• Duration of Stay: Consider how long you expect to live in the home. If you’re in a lengthy residency or fellowship program, or if you plan to move for a new job soon after, a 30-year fixed-rate loan might not be ideal. Instead, evaluate loan options that match your anticipated duration of stay. For example, a 5-year or 7-year ARM (adjustable rate mortgage) could offer a lower interest rate and reduced monthly payments for the initial fixed period, which aligns with your shorter-term stay. This can result in substantial savings if you do not plan to stay in the home for the full term of a traditional mortgage.
• Underwriting Guidelines: Each lender has different underwriting standards and qualifying criteria, so it’s essential to understand these differences. For instance, some lenders may have higher minimum credit score requirements or stricter debt-to-income (DTI) ratio limits. Others might require a larger down payment or have different rules regarding student loan payments and closing costs. Flexibility in these guidelines can impact your ability to qualify for a loan and the terms you receive. For example, some lenders may allow you to include student loan payments at a lower percentage of your income, which could improve your DTI ratio and help you secure a better loan offer.
• Closing Timing: The timing of your home closing relative to your job start date can be crucial, especially if you’re relocating. Some lenders permit closing up to 60-90 days before your job begins, while others offer up to 120 days. If you need to relocate your family before starting your new position, having the ability to close earlier can provide you with more flexibility in finding and moving into a home. This additional time can ease the transition and allow you to settle in before your new job starts.

Given the wide range of options and standards, it’s important to strategically identify which factors are most meaningful to you. Beyond interest rates, consider the overall cost of the loan, the flexibility of terms, and how well the loan aligns with your financial goals and career plans. For example, if you value lower monthly payments over a longer period or need to accommodate significant student loan debt, ensure that the loan program you choose aligns with these priorities.

 

What Attributes Should I Look for in My Loan Officer?

When interviewing multiple loan officers for your upcoming loan needs, it’s essential to use the right metrics—beyond just the interest rate—to determine the best fit for your situation. Some critical factors to consider include the loan officer’s experience working with physicians, that person’s availability and responsiveness, and the potential for building a long-term relationship.

As in most professions, experience is paramount—it’s something that cannot be taught or simply read in a training manual. Physicians, especially those in training or just stepping into an attending role, often have unique financial situations. This makes it crucial to work with a loan officer who has extensive experience serving physician clients. An experienced loan officer will better understand how to customize a loan solution that aligns with your specific needs, resulting in a much more tailored and meaningful mortgage. There is no one-size-fits-all mortgage. You are unique, and your loan officer should be crafting a mortgage solution that reflects your individuality and financial circumstances.

In my opinion, availability and responsiveness are among the most critical attributes your chosen loan officer should possess. Interestingly, this factor doesn’t directly influence the ‘cost’ of your loan but can significantly impact your experience. As a physician with a demanding schedule, it’s unrealistic to expect that all communication will take place strictly during business hours—this is true for any consumer. Pay close attention to how promptly loan officers respond during your initial interactions, and evaluate how thoroughly they explain loan terms, out-of-pocket costs, and the overall loan process. Your loan officer should be your trusted guide as you navigate through the complexities of the loan process, so setting yourself up for success starts with choosing someone who meets your expectations in this regard. 

It’s crucial to build a good rapport with the loan officer you choose, as this likely won’t be the last mortgage or financial need you encounter in your lifetime. Establishing a personal connection with your loan officer fosters a level of trust that is invaluable. Whether you’re considering refinancing your current mortgage or exploring additional loan products for other financial needs, having a trusted advisor you can rely on as a financial resource is immensely beneficial as you progress in your career. A strong, long-standing relationship with a loan officer ensures you receive reliable and sound financial advice tailored to your unique needs.

 

Additional Things to Consider if You Are a First-Time Home Buyer

Interview multiple lenders and make those conversations about more than just interest rates. This approach will help you gauge their knowledge of physician mortgage loans while allowing you to assess who might be the best fit for you in terms of compatibility. Relying solely on an email blast to inquire about rates could easily lead you to a subpar lender and result in an unfavorable experience.

Don’t be afraid to ask a lot of questions! As a first-time home buyer, it’s natural to feel a bit overwhelmed by the process—it can seem daunting if you’ve never been through it before. That’s why it’s crucial to ask any questions that come to mind and to work with a lender who is willing to take the time to answer them while educating you throughout the home-buying journey. With a trusted guide and the right education, the process will feel far less overwhelming, leading to a smoother and more positive experience from start to finish. 

In conclusion, choosing the right lender for a physician mortgage loan is a crucial step in securing your financial future and achieving homeownership. By thoroughly evaluating interest rates, down payment requirements, loan terms, and other key metrics, you can find a lender that offers competitive rates and favorable terms tailored to your unique needs. Consider factors such as customer service, closing costs, and the lender’s experience with physician loans to ensure a smooth and supportive mortgage process. By taking the time to compare options and select the best fit for your financial situation, you can confidently move forward in your home-buying journey and set the stage for a successful and fulfilling homeownership experience.

Mr. Kelley is vice president of mortgage lending and a physician mortgage specialist at Arvest Bank in Overland Park, Kansas.

Navigating the path to homeownership can be particularly challenging for physicians, who often face a unique set of financial circumstances. With substantial student loan debt, limited savings, and a delayed peak earning potential, traditional mortgage options may seem out of reach.

Enter physician mortgage loans—specialized financing designed specifically for medical professionals. These loans offer tailored solutions that address the common barriers faced by doctors, making it easier for them to achieve their homeownership goals. In this article, we’ll explore what physician mortgage loans are, their key benefits and drawbacks, and how to choose the right lender to support your journey to owning a home.

 

What Is a Physician Mortgage Loan?

A physician mortgage loan, also known as a ‘doctor loan,’ is a specialized mortgage product designed for a specific group of qualifying medical professionals. These loans are particularly attractive to new doctors who may have substantial student loan debt, limited savings, and an income that is expected to increase significantly over time. As unique portfolio loans, physician mortgage products can vary considerably between lending institutions. However, a common feature is that they typically require little to no down payment and do not require private mortgage insurance (PMI).

Beyond the common features, loan options and qualifying parameters can vary significantly from one institution to another. Therefore, it’s important to start gathering information as early as possible, giving you ample time to evaluate which institution and loan option best meet your needs.

 

How Do I Know if I Am Eligible for a Physician Mortgage Loan?

Physician loans are typically offered to MDs, DOs, DDSs, DMDs, and ODs, though some institutions expand this list to include DPMs, PAs, CRNAs, NPs, PharmDs, and DVMs. Additionally, most of these loan products are available to residents, fellows, and attending or practicing physicians.

How Do I Know What Physician Mortgage Loan Is Best for Me?

When selecting the optimal physician loan option for your home purchase, consider several important metrics:

• Duration of Stay: Consider how long you expect to live in the home. If you’re in a lengthy residency or fellowship program, or if you plan to move for a new job soon after, a 30-year fixed-rate loan might not be ideal. Instead, evaluate loan options that match your anticipated duration of stay. For example, a 5-year or 7-year ARM (adjustable rate mortgage) could offer a lower interest rate and reduced monthly payments for the initial fixed period, which aligns with your shorter-term stay. This can result in substantial savings if you do not plan to stay in the home for the full term of a traditional mortgage.
• Underwriting Guidelines: Each lender has different underwriting standards and qualifying criteria, so it’s essential to understand these differences. For instance, some lenders may have higher minimum credit score requirements or stricter debt-to-income (DTI) ratio limits. Others might require a larger down payment or have different rules regarding student loan payments and closing costs. Flexibility in these guidelines can impact your ability to qualify for a loan and the terms you receive. For example, some lenders may allow you to include student loan payments at a lower percentage of your income, which could improve your DTI ratio and help you secure a better loan offer.
• Closing Timing: The timing of your home closing relative to your job start date can be crucial, especially if you’re relocating. Some lenders permit closing up to 60-90 days before your job begins, while others offer up to 120 days. If you need to relocate your family before starting your new position, having the ability to close earlier can provide you with more flexibility in finding and moving into a home. This additional time can ease the transition and allow you to settle in before your new job starts.

Given the wide range of options and standards, it’s important to strategically identify which factors are most meaningful to you. Beyond interest rates, consider the overall cost of the loan, the flexibility of terms, and how well the loan aligns with your financial goals and career plans. For example, if you value lower monthly payments over a longer period or need to accommodate significant student loan debt, ensure that the loan program you choose aligns with these priorities.

 

What Attributes Should I Look for in My Loan Officer?

When interviewing multiple loan officers for your upcoming loan needs, it’s essential to use the right metrics—beyond just the interest rate—to determine the best fit for your situation. Some critical factors to consider include the loan officer’s experience working with physicians, that person’s availability and responsiveness, and the potential for building a long-term relationship.

As in most professions, experience is paramount—it’s something that cannot be taught or simply read in a training manual. Physicians, especially those in training or just stepping into an attending role, often have unique financial situations. This makes it crucial to work with a loan officer who has extensive experience serving physician clients. An experienced loan officer will better understand how to customize a loan solution that aligns with your specific needs, resulting in a much more tailored and meaningful mortgage. There is no one-size-fits-all mortgage. You are unique, and your loan officer should be crafting a mortgage solution that reflects your individuality and financial circumstances.

In my opinion, availability and responsiveness are among the most critical attributes your chosen loan officer should possess. Interestingly, this factor doesn’t directly influence the ‘cost’ of your loan but can significantly impact your experience. As a physician with a demanding schedule, it’s unrealistic to expect that all communication will take place strictly during business hours—this is true for any consumer. Pay close attention to how promptly loan officers respond during your initial interactions, and evaluate how thoroughly they explain loan terms, out-of-pocket costs, and the overall loan process. Your loan officer should be your trusted guide as you navigate through the complexities of the loan process, so setting yourself up for success starts with choosing someone who meets your expectations in this regard. 

It’s crucial to build a good rapport with the loan officer you choose, as this likely won’t be the last mortgage or financial need you encounter in your lifetime. Establishing a personal connection with your loan officer fosters a level of trust that is invaluable. Whether you’re considering refinancing your current mortgage or exploring additional loan products for other financial needs, having a trusted advisor you can rely on as a financial resource is immensely beneficial as you progress in your career. A strong, long-standing relationship with a loan officer ensures you receive reliable and sound financial advice tailored to your unique needs.

 

Additional Things to Consider if You Are a First-Time Home Buyer

Interview multiple lenders and make those conversations about more than just interest rates. This approach will help you gauge their knowledge of physician mortgage loans while allowing you to assess who might be the best fit for you in terms of compatibility. Relying solely on an email blast to inquire about rates could easily lead you to a subpar lender and result in an unfavorable experience.

Don’t be afraid to ask a lot of questions! As a first-time home buyer, it’s natural to feel a bit overwhelmed by the process—it can seem daunting if you’ve never been through it before. That’s why it’s crucial to ask any questions that come to mind and to work with a lender who is willing to take the time to answer them while educating you throughout the home-buying journey. With a trusted guide and the right education, the process will feel far less overwhelming, leading to a smoother and more positive experience from start to finish. 

In conclusion, choosing the right lender for a physician mortgage loan is a crucial step in securing your financial future and achieving homeownership. By thoroughly evaluating interest rates, down payment requirements, loan terms, and other key metrics, you can find a lender that offers competitive rates and favorable terms tailored to your unique needs. Consider factors such as customer service, closing costs, and the lender’s experience with physician loans to ensure a smooth and supportive mortgage process. By taking the time to compare options and select the best fit for your financial situation, you can confidently move forward in your home-buying journey and set the stage for a successful and fulfilling homeownership experience.

Mr. Kelley is vice president of mortgage lending and a physician mortgage specialist at Arvest Bank in Overland Park, Kansas.