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ORLANDO — “Itch may not be as sexy as Mohs surgery or aesthetic procedures,” but treating it is important and meaningful to patients, particularly those who’ve found little relief previously, Shawn G. Kwatra, MD, said at the annual ODAC Dermatology, Aesthetic & Surgery Conference.

Chronic itch is common, with presentations that range from annoying to debilitating. There are many over-the-counter and prescription treatments patients can and likely have tried by the time they seek a dermatologist for help.

In doctors’ defense, it can be highly challenging to know which approach is optimal for each individual with pruritus, added Dr. Kwatra, associate professor of dermatology at Johns Hopkins University, Baltimore, Maryland.

Cooling agents, topical capsaicin, topical anesthetics like pramoxine 1%, various forms of lidocaine, strontium, opioid modulators like naltrexone, oral Janus kinase inhibitor (JAK) inhibitors, and medical marijuana are among some of the “outside the box” tools in Dr. Kwatra’s itch toolbox.
 

Often a Medical Puzzle

Frequently, patients come to the dermatologist complaining of itch, “but you don’t see much on their skin.” After a trial of antihistamines, and some topical steroids, the doctor might put up their hands and think: I tried, but I don’t know what else to do. “This actually happens a lot,” said Dr. Kwatra, who is also director of the Johns Hopkins Itch Center.

This means itch can frustrate providers as well. But for patients, the impact on their quality of life can be on the same level as recovering from a stroke or living with heart failure, Dr. Kwatra said. Finding relief for their itch is where “we can make a big difference for patients.”
 

Consider Cooling Agents

Many of these therapies are inexpensive and widely available. Cooling agents like menthol, camphor, or calamine can reduce activity of the transient receptor potential (TRP) channels in the skin associated with itch. This ion channel also senses temperature, pressure, and other sensations.

Another option is topical capsaicin, which works through the same ion channels. It binds to the TRPV1 receptors in sensory nerve fibers and causes desensitization. Initially, four to six applications a day are required to reduce itch. After that, patients can apply the medication less frequently. “You have to tell folks we know it’s going to work, but it’s going to burn a lot initially,” Dr. Kwatra said. “In real world practice, I’m not using it often.”

A 1.8% capsaicin patch, approved for treating postherpetic neuralgia, can be used to treat pruritus as well. “You put the patch on for one hour and you can have a true clinical response,” he noted.

Another option for itch relief, the topical anesthetic pramoxine 1%, “is probably underutilized for our patients,” Dr. Kwatra said. Pramoxine 1% works fast — as quickly as 2 minutes — and lasts up to 8 hours and is well-tolerated with low toxicity, he added. The agent is applied three to four times a day and relieves itch by reducing the transmembrane permeability of sodium ions on the skin. “This is something widely available and cheap.”

Lidocaine, another topical anesthetic, is available compounded, over the counter, and as a spray or patch. “I would be careful before you use high doses, like 10%” because of tolerability issues, Dr. Kwatra cautioned. He generally starts with lower concentrations.

Topical strontium is really interesting as a strategy, Dr. Kwatra said. Strontium is a soft, white metal that competes with calcium for receptor binding. There are over-the-counter formulations available as a scalp solution or lotion, which, he said, “are ways to go with more episodic itching.”

Topical oatmeal can also relieve itch in some patients. “There is actually some good scientific evidence for topical oatmeal preparations,” he said.
 

Steroid-Sparing Novel Topicals

Topical ruxolitinib (a JAK inhibitor approved for atopic dermatitis and vitiligo); topical roflumilast (a phosphodiesterase-4 inhibitor) and topical tapinarof (an aryl hydrocarbon receptor agonist), both approved for treating psoriasis; and the atopic dermatitis drug crisaborole fall into this category of topicals with potential for treating itch, he said, noting that use for treating itch is off label.

Off-label use of biologic agents are also possible treatment options for itch, dupilumab and tralokinumab, both US Food and Drug Administration (FDA)–approved for treating atopic dermatitis. Emerging agents that may prove useful for treating itch include lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab, he said.

In terms of oral therapies, the FDA has approved two oral JAK inhibitors for atopic dermatitis, abrocitinib and upadacitinib, which could prove useful for itch as an off-label indication, according to Dr. Kwatra.
 

Naltrexone Off Label

An emerging therapeutic concept for treating itch is using an opioid antagonist like naltrexone. Morphine causes more itch, so the theory is a reversal agent might help reduce it. The challenge is that naltrexone only comes as a 50 mg tablet, “and I find the high dose makes people nauseous and vomit,” he added.

Don’t Forget Devices

He referred to a “great paper” that he said has been “totally overlooked,” published in 2001, which evaluated a device that stimulates C fibers in the skin to reduce itch. In the study, 19 patients used the device to treat local areas 20 minutes daily for 5 weeks. Punch biopsies of the affected areas were taken at baseline and after treatment. Mean itch ratings decreased from 78% to 42%, and the number of immunoreactive nerve fibers in the epidermis decreased by 40% at the end of treatment.

“Electrical neurostimulation is better for localized pruritus. There is limited case series evidence, but it’s something to think about,” Dr. Kwatra said.

He and his colleagues also have a case study in press that explored the use of injected botulinum toxin to relieve recalcitrant, chronic itch in a 65-year-old man “who failed everything.”

Dr. Kwatra is a consultant or advisory board member for AbbVie, Amgen, Arcutis Biotherapeutics, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi.

A version of this article appeared on Medscape.com.

ORLANDO — “Itch may not be as sexy as Mohs surgery or aesthetic procedures,” but treating it is important and meaningful to patients, particularly those who’ve found little relief previously, Shawn G. Kwatra, MD, said at the annual ODAC Dermatology, Aesthetic & Surgery Conference.

Chronic itch is common, with presentations that range from annoying to debilitating. There are many over-the-counter and prescription treatments patients can and likely have tried by the time they seek a dermatologist for help.

In doctors’ defense, it can be highly challenging to know which approach is optimal for each individual with pruritus, added Dr. Kwatra, associate professor of dermatology at Johns Hopkins University, Baltimore, Maryland.

Cooling agents, topical capsaicin, topical anesthetics like pramoxine 1%, various forms of lidocaine, strontium, opioid modulators like naltrexone, oral Janus kinase inhibitor (JAK) inhibitors, and medical marijuana are among some of the “outside the box” tools in Dr. Kwatra’s itch toolbox.
 

Often a Medical Puzzle

Frequently, patients come to the dermatologist complaining of itch, “but you don’t see much on their skin.” After a trial of antihistamines, and some topical steroids, the doctor might put up their hands and think: I tried, but I don’t know what else to do. “This actually happens a lot,” said Dr. Kwatra, who is also director of the Johns Hopkins Itch Center.

This means itch can frustrate providers as well. But for patients, the impact on their quality of life can be on the same level as recovering from a stroke or living with heart failure, Dr. Kwatra said. Finding relief for their itch is where “we can make a big difference for patients.”
 

Consider Cooling Agents

Many of these therapies are inexpensive and widely available. Cooling agents like menthol, camphor, or calamine can reduce activity of the transient receptor potential (TRP) channels in the skin associated with itch. This ion channel also senses temperature, pressure, and other sensations.

Another option is topical capsaicin, which works through the same ion channels. It binds to the TRPV1 receptors in sensory nerve fibers and causes desensitization. Initially, four to six applications a day are required to reduce itch. After that, patients can apply the medication less frequently. “You have to tell folks we know it’s going to work, but it’s going to burn a lot initially,” Dr. Kwatra said. “In real world practice, I’m not using it often.”

A 1.8% capsaicin patch, approved for treating postherpetic neuralgia, can be used to treat pruritus as well. “You put the patch on for one hour and you can have a true clinical response,” he noted.

Another option for itch relief, the topical anesthetic pramoxine 1%, “is probably underutilized for our patients,” Dr. Kwatra said. Pramoxine 1% works fast — as quickly as 2 minutes — and lasts up to 8 hours and is well-tolerated with low toxicity, he added. The agent is applied three to four times a day and relieves itch by reducing the transmembrane permeability of sodium ions on the skin. “This is something widely available and cheap.”

Lidocaine, another topical anesthetic, is available compounded, over the counter, and as a spray or patch. “I would be careful before you use high doses, like 10%” because of tolerability issues, Dr. Kwatra cautioned. He generally starts with lower concentrations.

Topical strontium is really interesting as a strategy, Dr. Kwatra said. Strontium is a soft, white metal that competes with calcium for receptor binding. There are over-the-counter formulations available as a scalp solution or lotion, which, he said, “are ways to go with more episodic itching.”

Topical oatmeal can also relieve itch in some patients. “There is actually some good scientific evidence for topical oatmeal preparations,” he said.
 

Steroid-Sparing Novel Topicals

Topical ruxolitinib (a JAK inhibitor approved for atopic dermatitis and vitiligo); topical roflumilast (a phosphodiesterase-4 inhibitor) and topical tapinarof (an aryl hydrocarbon receptor agonist), both approved for treating psoriasis; and the atopic dermatitis drug crisaborole fall into this category of topicals with potential for treating itch, he said, noting that use for treating itch is off label.

Off-label use of biologic agents are also possible treatment options for itch, dupilumab and tralokinumab, both US Food and Drug Administration (FDA)–approved for treating atopic dermatitis. Emerging agents that may prove useful for treating itch include lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab, he said.

In terms of oral therapies, the FDA has approved two oral JAK inhibitors for atopic dermatitis, abrocitinib and upadacitinib, which could prove useful for itch as an off-label indication, according to Dr. Kwatra.
 

Naltrexone Off Label

An emerging therapeutic concept for treating itch is using an opioid antagonist like naltrexone. Morphine causes more itch, so the theory is a reversal agent might help reduce it. The challenge is that naltrexone only comes as a 50 mg tablet, “and I find the high dose makes people nauseous and vomit,” he added.

Don’t Forget Devices

He referred to a “great paper” that he said has been “totally overlooked,” published in 2001, which evaluated a device that stimulates C fibers in the skin to reduce itch. In the study, 19 patients used the device to treat local areas 20 minutes daily for 5 weeks. Punch biopsies of the affected areas were taken at baseline and after treatment. Mean itch ratings decreased from 78% to 42%, and the number of immunoreactive nerve fibers in the epidermis decreased by 40% at the end of treatment.

“Electrical neurostimulation is better for localized pruritus. There is limited case series evidence, but it’s something to think about,” Dr. Kwatra said.

He and his colleagues also have a case study in press that explored the use of injected botulinum toxin to relieve recalcitrant, chronic itch in a 65-year-old man “who failed everything.”

Dr. Kwatra is a consultant or advisory board member for AbbVie, Amgen, Arcutis Biotherapeutics, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi.

A version of this article appeared on Medscape.com.

ORLANDO — “Itch may not be as sexy as Mohs surgery or aesthetic procedures,” but treating it is important and meaningful to patients, particularly those who’ve found little relief previously, Shawn G. Kwatra, MD, said at the annual ODAC Dermatology, Aesthetic & Surgery Conference.

Chronic itch is common, with presentations that range from annoying to debilitating. There are many over-the-counter and prescription treatments patients can and likely have tried by the time they seek a dermatologist for help.

In doctors’ defense, it can be highly challenging to know which approach is optimal for each individual with pruritus, added Dr. Kwatra, associate professor of dermatology at Johns Hopkins University, Baltimore, Maryland.

Cooling agents, topical capsaicin, topical anesthetics like pramoxine 1%, various forms of lidocaine, strontium, opioid modulators like naltrexone, oral Janus kinase inhibitor (JAK) inhibitors, and medical marijuana are among some of the “outside the box” tools in Dr. Kwatra’s itch toolbox.
 

Often a Medical Puzzle

Frequently, patients come to the dermatologist complaining of itch, “but you don’t see much on their skin.” After a trial of antihistamines, and some topical steroids, the doctor might put up their hands and think: I tried, but I don’t know what else to do. “This actually happens a lot,” said Dr. Kwatra, who is also director of the Johns Hopkins Itch Center.

This means itch can frustrate providers as well. But for patients, the impact on their quality of life can be on the same level as recovering from a stroke or living with heart failure, Dr. Kwatra said. Finding relief for their itch is where “we can make a big difference for patients.”
 

Consider Cooling Agents

Many of these therapies are inexpensive and widely available. Cooling agents like menthol, camphor, or calamine can reduce activity of the transient receptor potential (TRP) channels in the skin associated with itch. This ion channel also senses temperature, pressure, and other sensations.

Another option is topical capsaicin, which works through the same ion channels. It binds to the TRPV1 receptors in sensory nerve fibers and causes desensitization. Initially, four to six applications a day are required to reduce itch. After that, patients can apply the medication less frequently. “You have to tell folks we know it’s going to work, but it’s going to burn a lot initially,” Dr. Kwatra said. “In real world practice, I’m not using it often.”

A 1.8% capsaicin patch, approved for treating postherpetic neuralgia, can be used to treat pruritus as well. “You put the patch on for one hour and you can have a true clinical response,” he noted.

Another option for itch relief, the topical anesthetic pramoxine 1%, “is probably underutilized for our patients,” Dr. Kwatra said. Pramoxine 1% works fast — as quickly as 2 minutes — and lasts up to 8 hours and is well-tolerated with low toxicity, he added. The agent is applied three to four times a day and relieves itch by reducing the transmembrane permeability of sodium ions on the skin. “This is something widely available and cheap.”

Lidocaine, another topical anesthetic, is available compounded, over the counter, and as a spray or patch. “I would be careful before you use high doses, like 10%” because of tolerability issues, Dr. Kwatra cautioned. He generally starts with lower concentrations.

Topical strontium is really interesting as a strategy, Dr. Kwatra said. Strontium is a soft, white metal that competes with calcium for receptor binding. There are over-the-counter formulations available as a scalp solution or lotion, which, he said, “are ways to go with more episodic itching.”

Topical oatmeal can also relieve itch in some patients. “There is actually some good scientific evidence for topical oatmeal preparations,” he said.
 

Steroid-Sparing Novel Topicals

Topical ruxolitinib (a JAK inhibitor approved for atopic dermatitis and vitiligo); topical roflumilast (a phosphodiesterase-4 inhibitor) and topical tapinarof (an aryl hydrocarbon receptor agonist), both approved for treating psoriasis; and the atopic dermatitis drug crisaborole fall into this category of topicals with potential for treating itch, he said, noting that use for treating itch is off label.

Off-label use of biologic agents are also possible treatment options for itch, dupilumab and tralokinumab, both US Food and Drug Administration (FDA)–approved for treating atopic dermatitis. Emerging agents that may prove useful for treating itch include lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab, he said.

In terms of oral therapies, the FDA has approved two oral JAK inhibitors for atopic dermatitis, abrocitinib and upadacitinib, which could prove useful for itch as an off-label indication, according to Dr. Kwatra.
 

Naltrexone Off Label

An emerging therapeutic concept for treating itch is using an opioid antagonist like naltrexone. Morphine causes more itch, so the theory is a reversal agent might help reduce it. The challenge is that naltrexone only comes as a 50 mg tablet, “and I find the high dose makes people nauseous and vomit,” he added.

Don’t Forget Devices

He referred to a “great paper” that he said has been “totally overlooked,” published in 2001, which evaluated a device that stimulates C fibers in the skin to reduce itch. In the study, 19 patients used the device to treat local areas 20 minutes daily for 5 weeks. Punch biopsies of the affected areas were taken at baseline and after treatment. Mean itch ratings decreased from 78% to 42%, and the number of immunoreactive nerve fibers in the epidermis decreased by 40% at the end of treatment.

“Electrical neurostimulation is better for localized pruritus. There is limited case series evidence, but it’s something to think about,” Dr. Kwatra said.

He and his colleagues also have a case study in press that explored the use of injected botulinum toxin to relieve recalcitrant, chronic itch in a 65-year-old man “who failed everything.”

Dr. Kwatra is a consultant or advisory board member for AbbVie, Amgen, Arcutis Biotherapeutics, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi.

A version of this article appeared on Medscape.com.

Officials at Dana-Farber Cancer Institute are moving to retract at least six published research papers and correct 31 others amid allegations of data manipulation.

News of the investigation follows a blog post by British molecular biologist Sholto David, MD, who flagged almost 60 papers published between 1997 and 2017 that contained image manipulation and other errors. Some of the papers were published by Dana-Farber’s chief executive officer, Laurie Glimcher, MD, and chief operating officer, William Hahn, MD, on topics including multiple myeloma and immune cells.

Mr. David, who blogs about research integrity, highlighted numerous errors and irregularities, including copying and pasting images across multiple experiments to represent different days within the same experiment, sometimes rotating or stretching images.

In one case, Mr. David equated the manipulation with tactics used by “hapless Chinese papermills” and concluded that “a swathe of research coming out of [Dana-Farber] authored by the most senior researchers and managers appears to be hopelessly corrupt with errors that are obvious from just a cursory reading the papers.” 

“Imagine what mistakes might be found in the raw data if anyone was allowed to look!” he wrote.

Barrett Rollins, MD, PhD, Dana-Farber Cancer Institute’s research integrity officer, declined to comment on whether the errors represent scientific misconduct, according to STAT. Rollins told ScienceInsider that the “presence of image discrepancies in a paper is not evidence of an author’s intent to deceive.” 

Access to new artificial intelligence tools is making it easier for data sleuths, like Mr. David, to unearth data manipulation and errors. 

The current investigation closely follows two other investigations into the published work of Harvard University’s former president, Claudine Gay, and Stanford University’s former president, Marc Tessier-Lavigne, which led both to resign their posts. 

A version of this article appeared on Medscape.com.

Officials at Dana-Farber Cancer Institute are moving to retract at least six published research papers and correct 31 others amid allegations of data manipulation.

News of the investigation follows a blog post by British molecular biologist Sholto David, MD, who flagged almost 60 papers published between 1997 and 2017 that contained image manipulation and other errors. Some of the papers were published by Dana-Farber’s chief executive officer, Laurie Glimcher, MD, and chief operating officer, William Hahn, MD, on topics including multiple myeloma and immune cells.

Mr. David, who blogs about research integrity, highlighted numerous errors and irregularities, including copying and pasting images across multiple experiments to represent different days within the same experiment, sometimes rotating or stretching images.

In one case, Mr. David equated the manipulation with tactics used by “hapless Chinese papermills” and concluded that “a swathe of research coming out of [Dana-Farber] authored by the most senior researchers and managers appears to be hopelessly corrupt with errors that are obvious from just a cursory reading the papers.” 

“Imagine what mistakes might be found in the raw data if anyone was allowed to look!” he wrote.

Barrett Rollins, MD, PhD, Dana-Farber Cancer Institute’s research integrity officer, declined to comment on whether the errors represent scientific misconduct, according to STAT. Rollins told ScienceInsider that the “presence of image discrepancies in a paper is not evidence of an author’s intent to deceive.” 

Access to new artificial intelligence tools is making it easier for data sleuths, like Mr. David, to unearth data manipulation and errors. 

The current investigation closely follows two other investigations into the published work of Harvard University’s former president, Claudine Gay, and Stanford University’s former president, Marc Tessier-Lavigne, which led both to resign their posts. 

A version of this article appeared on Medscape.com.

Officials at Dana-Farber Cancer Institute are moving to retract at least six published research papers and correct 31 others amid allegations of data manipulation.

News of the investigation follows a blog post by British molecular biologist Sholto David, MD, who flagged almost 60 papers published between 1997 and 2017 that contained image manipulation and other errors. Some of the papers were published by Dana-Farber’s chief executive officer, Laurie Glimcher, MD, and chief operating officer, William Hahn, MD, on topics including multiple myeloma and immune cells.

Mr. David, who blogs about research integrity, highlighted numerous errors and irregularities, including copying and pasting images across multiple experiments to represent different days within the same experiment, sometimes rotating or stretching images.

In one case, Mr. David equated the manipulation with tactics used by “hapless Chinese papermills” and concluded that “a swathe of research coming out of [Dana-Farber] authored by the most senior researchers and managers appears to be hopelessly corrupt with errors that are obvious from just a cursory reading the papers.” 

“Imagine what mistakes might be found in the raw data if anyone was allowed to look!” he wrote.

Barrett Rollins, MD, PhD, Dana-Farber Cancer Institute’s research integrity officer, declined to comment on whether the errors represent scientific misconduct, according to STAT. Rollins told ScienceInsider that the “presence of image discrepancies in a paper is not evidence of an author’s intent to deceive.” 

Access to new artificial intelligence tools is making it easier for data sleuths, like Mr. David, to unearth data manipulation and errors. 

The current investigation closely follows two other investigations into the published work of Harvard University’s former president, Claudine Gay, and Stanford University’s former president, Marc Tessier-Lavigne, which led both to resign their posts. 

A version of this article appeared on Medscape.com.

Foreign-trained doctors can supplement the nation’s waning physician workforce and bring diverse perspectives to patient care, but a new study finds that most never enter comparable roles after immigration, raising questions about the feasibility of educational and licensing pathways for international medical graduates (IMGs). 

Conducted by the Federal Reserve Bank of Minneapolis and the nonprofit Upwardly Global, the study analyzed the data of 300 physicians who immigrated to the United States between 2004 and 2022. 

Although 85% of IMGs found employment, only 1 in 3 became a medical resident or doctor. 

Despite the study’s small sample size, it highlights the hurdles IMGs face, the authors noted. Even though they have a medical degree and potentially years of clinical experience in another country, they typically must start all over again in the US — passing the United States Medical Licensing Examination (USMLE), obtaining clinical experience, and securing a residency spot. 

If unable to complete these steps, IMGs may pursue other healthcare jobs for which they’re overqualified and underpaid, given their experience. The study found that 23% of IMGs who were not on track to become physicians worked as medical assistants. Others became clinical researchers, medical interpreters, and case managers. 

Russian ob/gyn Maxim Nikolaevskiy moved to the US in 2018 and understands why some IMGs switch career paths. His wife, who also trained as a physician in Russia, opted to enroll in a respiratory therapy program after they immigrated to Minnesota, whereas he found work as a research coordinator. The pressure to find housing, enroll their kids in school, and establish new routines took much of their focus. 

Dr. Nikolaevskiy told this news organization that IMGs often struggle to find a residency program willing to consider their unique career trajectory, which looks markedly different from that of someone trained in the US. 

“Multiple residency programs refuse IMGs’ applications, saying they graduated too long ago, without understanding they worked as a physician before,” he said. Immigrant doctors accepting nonphysician jobs once in the US, often out of financial necessity, only adds to this confusion. 

New federal and state legislation aim to reduce practice barriers for IMGs and shore up physician shortages and access for some of the nation›s most vulnerable counties. 

The Conrad State 30 and Physician Access Reauthorization Act, supported by the American Medical Association, would revamp the J-1 visa waiver program to permit more immigrant physicians to work in medically underserved areas instead of returning to their home countries. 

Last year, Alabama streamlined rules to allow IMGs to practice earlier. Effective July 1, those residing in Tennessee may skip residency requirements and receive a temporary medical license once they pass the state medical board and prove they have completed a 3-year postgraduate training program in their licensing country or recently fulfilled physician duties outside the US. 

Washington state now issues 2-year medical licenses to foreign-trained doctors, no residency required, with the possibility of renewal. Doctors must meet other requirements, including passing all steps of the USMLE and establishing a practice agreement with a supervising physician. Illinois recently passed a similar law that will take effect in January 2025. 

Beyond laws, communities can embrace IMGs and offer career guidance and clinical opportunities. Daniel Weber, MD, founded the International Healthcare Professionals Program in Lancaster, Pennsylvania, to provide this critical support. 

“It is daunting to master a new language and pass medical licensing and English proficiency exams while working full time to support themselves and their families,” Dr. Weber said. 

Some participants have entered US residency training programs, but Weber told this news organization that many others have earned nursing degrees and are on track to become nurse practitioners. 

More than 5 years after leaving Russia, Dr. Nikolaevskiy is inching closer to practicing medicine again. 

He recently completed the Bridge to Residency for Immigrant International Doctor Graduates (BRIIDGE) program at the University of Minnesota Medical School. The 9-month program offers clinical experiences in community settings, outpatient primary care, and inpatient general medicine and pediatrics, clearing the way for him to apply for family medicine residency and possibly match in this cycle. 

“If not for the BRIIDGE program, I would still be [doing] medical monitoring in clinical trials or pharmacovigilance jobs. I’m grateful for the clinical experience and the people and institutions ready to give me a second chance,” he said.

A version of this article appeared on Medscape.com.

Foreign-trained doctors can supplement the nation’s waning physician workforce and bring diverse perspectives to patient care, but a new study finds that most never enter comparable roles after immigration, raising questions about the feasibility of educational and licensing pathways for international medical graduates (IMGs). 

Conducted by the Federal Reserve Bank of Minneapolis and the nonprofit Upwardly Global, the study analyzed the data of 300 physicians who immigrated to the United States between 2004 and 2022. 

Although 85% of IMGs found employment, only 1 in 3 became a medical resident or doctor. 

Despite the study’s small sample size, it highlights the hurdles IMGs face, the authors noted. Even though they have a medical degree and potentially years of clinical experience in another country, they typically must start all over again in the US — passing the United States Medical Licensing Examination (USMLE), obtaining clinical experience, and securing a residency spot. 

If unable to complete these steps, IMGs may pursue other healthcare jobs for which they’re overqualified and underpaid, given their experience. The study found that 23% of IMGs who were not on track to become physicians worked as medical assistants. Others became clinical researchers, medical interpreters, and case managers. 

Russian ob/gyn Maxim Nikolaevskiy moved to the US in 2018 and understands why some IMGs switch career paths. His wife, who also trained as a physician in Russia, opted to enroll in a respiratory therapy program after they immigrated to Minnesota, whereas he found work as a research coordinator. The pressure to find housing, enroll their kids in school, and establish new routines took much of their focus. 

Dr. Nikolaevskiy told this news organization that IMGs often struggle to find a residency program willing to consider their unique career trajectory, which looks markedly different from that of someone trained in the US. 

“Multiple residency programs refuse IMGs’ applications, saying they graduated too long ago, without understanding they worked as a physician before,” he said. Immigrant doctors accepting nonphysician jobs once in the US, often out of financial necessity, only adds to this confusion. 

New federal and state legislation aim to reduce practice barriers for IMGs and shore up physician shortages and access for some of the nation›s most vulnerable counties. 

The Conrad State 30 and Physician Access Reauthorization Act, supported by the American Medical Association, would revamp the J-1 visa waiver program to permit more immigrant physicians to work in medically underserved areas instead of returning to their home countries. 

Last year, Alabama streamlined rules to allow IMGs to practice earlier. Effective July 1, those residing in Tennessee may skip residency requirements and receive a temporary medical license once they pass the state medical board and prove they have completed a 3-year postgraduate training program in their licensing country or recently fulfilled physician duties outside the US. 

Washington state now issues 2-year medical licenses to foreign-trained doctors, no residency required, with the possibility of renewal. Doctors must meet other requirements, including passing all steps of the USMLE and establishing a practice agreement with a supervising physician. Illinois recently passed a similar law that will take effect in January 2025. 

Beyond laws, communities can embrace IMGs and offer career guidance and clinical opportunities. Daniel Weber, MD, founded the International Healthcare Professionals Program in Lancaster, Pennsylvania, to provide this critical support. 

“It is daunting to master a new language and pass medical licensing and English proficiency exams while working full time to support themselves and their families,” Dr. Weber said. 

Some participants have entered US residency training programs, but Weber told this news organization that many others have earned nursing degrees and are on track to become nurse practitioners. 

More than 5 years after leaving Russia, Dr. Nikolaevskiy is inching closer to practicing medicine again. 

He recently completed the Bridge to Residency for Immigrant International Doctor Graduates (BRIIDGE) program at the University of Minnesota Medical School. The 9-month program offers clinical experiences in community settings, outpatient primary care, and inpatient general medicine and pediatrics, clearing the way for him to apply for family medicine residency and possibly match in this cycle. 

“If not for the BRIIDGE program, I would still be [doing] medical monitoring in clinical trials or pharmacovigilance jobs. I’m grateful for the clinical experience and the people and institutions ready to give me a second chance,” he said.

A version of this article appeared on Medscape.com.

Foreign-trained doctors can supplement the nation’s waning physician workforce and bring diverse perspectives to patient care, but a new study finds that most never enter comparable roles after immigration, raising questions about the feasibility of educational and licensing pathways for international medical graduates (IMGs). 

Conducted by the Federal Reserve Bank of Minneapolis and the nonprofit Upwardly Global, the study analyzed the data of 300 physicians who immigrated to the United States between 2004 and 2022. 

Although 85% of IMGs found employment, only 1 in 3 became a medical resident or doctor. 

Despite the study’s small sample size, it highlights the hurdles IMGs face, the authors noted. Even though they have a medical degree and potentially years of clinical experience in another country, they typically must start all over again in the US — passing the United States Medical Licensing Examination (USMLE), obtaining clinical experience, and securing a residency spot. 

If unable to complete these steps, IMGs may pursue other healthcare jobs for which they’re overqualified and underpaid, given their experience. The study found that 23% of IMGs who were not on track to become physicians worked as medical assistants. Others became clinical researchers, medical interpreters, and case managers. 

Russian ob/gyn Maxim Nikolaevskiy moved to the US in 2018 and understands why some IMGs switch career paths. His wife, who also trained as a physician in Russia, opted to enroll in a respiratory therapy program after they immigrated to Minnesota, whereas he found work as a research coordinator. The pressure to find housing, enroll their kids in school, and establish new routines took much of their focus. 

Dr. Nikolaevskiy told this news organization that IMGs often struggle to find a residency program willing to consider their unique career trajectory, which looks markedly different from that of someone trained in the US. 

“Multiple residency programs refuse IMGs’ applications, saying they graduated too long ago, without understanding they worked as a physician before,” he said. Immigrant doctors accepting nonphysician jobs once in the US, often out of financial necessity, only adds to this confusion. 

New federal and state legislation aim to reduce practice barriers for IMGs and shore up physician shortages and access for some of the nation›s most vulnerable counties. 

The Conrad State 30 and Physician Access Reauthorization Act, supported by the American Medical Association, would revamp the J-1 visa waiver program to permit more immigrant physicians to work in medically underserved areas instead of returning to their home countries. 

Last year, Alabama streamlined rules to allow IMGs to practice earlier. Effective July 1, those residing in Tennessee may skip residency requirements and receive a temporary medical license once they pass the state medical board and prove they have completed a 3-year postgraduate training program in their licensing country or recently fulfilled physician duties outside the US. 

Washington state now issues 2-year medical licenses to foreign-trained doctors, no residency required, with the possibility of renewal. Doctors must meet other requirements, including passing all steps of the USMLE and establishing a practice agreement with a supervising physician. Illinois recently passed a similar law that will take effect in January 2025. 

Beyond laws, communities can embrace IMGs and offer career guidance and clinical opportunities. Daniel Weber, MD, founded the International Healthcare Professionals Program in Lancaster, Pennsylvania, to provide this critical support. 

“It is daunting to master a new language and pass medical licensing and English proficiency exams while working full time to support themselves and their families,” Dr. Weber said. 

Some participants have entered US residency training programs, but Weber told this news organization that many others have earned nursing degrees and are on track to become nurse practitioners. 

More than 5 years after leaving Russia, Dr. Nikolaevskiy is inching closer to practicing medicine again. 

He recently completed the Bridge to Residency for Immigrant International Doctor Graduates (BRIIDGE) program at the University of Minnesota Medical School. The 9-month program offers clinical experiences in community settings, outpatient primary care, and inpatient general medicine and pediatrics, clearing the way for him to apply for family medicine residency and possibly match in this cycle. 

“If not for the BRIIDGE program, I would still be [doing] medical monitoring in clinical trials or pharmacovigilance jobs. I’m grateful for the clinical experience and the people and institutions ready to give me a second chance,” he said.

A version of this article appeared on Medscape.com.

Sexually transmitted infections (STIs) continue to have a significant impact on the lives of adolescents and young adults. According to the Centers for Disease Control and Prevention’s (CDC) 2021 surveillance report, rates of gonorrhea and syphilis in the United States were at their highest since the early 1990s. Chlamydia, one of the most common STIs, had a peak rate in 2019, but more recent rates may have been impacted by the COVID-19 pandemic. In 2021, those 15-24 years of age accounted for 58.5% of all chlamydia infections, 40.4% of all gonorrhea infections, and 18.3% of all syphilis infections in the US.

While pediatricians should discuss sexual health and STI screening with all their adolescent and young adult patients, LGBTQ+ youth are disproportionately impacted by STIs. For example, cisgender men who have sex with men have significantly higher rates of HIV, gonorrhea, and syphilis. These disparities are likely related to unequal access to care, systemic homophobia/transphobia, stigma, and differences in sexual networks and are even more pronounced for those with intersectional minoritized identities such as LGBTQ+ youth of color.¹

Courtesy Dr. Warus

In the past 12 years, there have been significant advances in HIV prevention methods, including the approval and use of pre-exposure prophylaxis or “PrEP” (a medication regimen that is taken on an ongoing basis to provide highly effective protection against HIV infection) and more widespread use of post-exposure prophylaxis or “PEP” (a medication regimen taken for 1 month after a potential exposure to HIV to prevent HIV from establishing an ongoing infection) outside of the medical setting. While these interventions have the potential to decrease rates of HIV infection, they do not prevent any other STIs.^2-3

The current strategies to prevent bacterial STIs include discussions of sexual practices, counseling on risk reduction strategies such as decreased number of partners and condom use, routine screening in those at risk every 3-12 months, and timely diagnosis and treatment of infections in patients and their partners to avoid further transmission.⁴ Given the increasing rates of bacterial STIs (gonorrhea, chlamydia, and syphilis), additional biomedical prevention methods are greatly needed.
 

Doxycycline as post-exposure prophylaxis

Doxycycline is a tetracycline antibiotic effective against a wide range of bacteria and is commonly used in the treatment of acne, skin infections, Lyme disease, and STIs, and can also be used in the treatment and prevention of malaria.⁵ For STIs, doxycycline is currently the recommended treatment for chlamydia and is also an alternate therapy for syphilis in nonpregnant patients when penicillin is not accessible or in those with severe penicillin allergy.⁴ This medication is often well tolerated with the most common side effects including gastrointestinal irritation and photosensitivity. Doxycycline is contraindicated in pregnancy due to its potential impact on tooth and bone development.⁵

Given its general tolerability and activity against bacterial STIs, new and emerging studies have examined doxycycline as post-exposure prophylaxis (DoxyPEP: one dose of doxycycline 200 mg PO within 72 hours after unprotected sex) in an attempt to decrease the incidence of new bacterial STIs in populations at risk. Three of the studies cited in the preliminary CDC DoxyPEP guidelines were conducted in cisgender men who have sex with men and transgender women either living with HIV or taking PrEP for HIV prevention. All three studies demonstrated significantly lower risk of chlamydia and syphilis, while two of the studies also showed a significantly lower risk of gonorrhea. One additional study was conducted in cisgender women in Kenya. This study did not show any statistically significant difference in the risk of chlamydia or gonorrhea in the intervention group, but may have been limited by low adherence to the DoxyPEP regimen. There were no serious adverse events reported in any of the studies attributed to doxycycline.⁶

Avoiding antibiotic resistance

With the increased use of antibiotics, attention must always be paid to the potential for increasing antibiotic resistance. The preliminary CDC DoxyPEP guidelines outline mixed results in the DoxyPEP studies that had limited follow-up timeframes, making it difficult to draw conclusions: “Current data suggest overall benefit of the use of doxycycline PEP, but potential risks related to the development of resistance and impacts on the microbiome will need to be closely monitored after implementation of these guidelines.” Official guideline recommendations from the CDC regarding DoxyPEP are currently pending after a period of public comment on the preliminary drafted guidelines.⁶ However, the New York State Department of Health AIDS Institute released guidelines for DoxyPEP in September 2023 and several large urban public health departments have also issued their own guidance that largely align with the preliminary CDC guidelines.⁷

Recommendations currently emphasize that the goal is to allow for implementation of DoxyPEP in those who would benefit the most from the intervention (i.e., cisgender men who have sex with men and transgender women with a history of at least one bacterial STI in the last 12 months with ongoing risk of infection), while also minimizing antibiotic use. It should also be considered for those without a recent infection who have increased likelihood of exposure to bacterial STIs. DoxyPEP is likely to be effective in other populations (e.g., cisgender women, cisgender men who have sex with women, transgender men), but data are currently limited, and the risk/benefit ratio may be different in these populations. The recommended dose for DoxyPEP is doxycycline 200 mg once as soon as possible (within 72 hours) of unprotected oral, vaginal, or anal sex with a maximum of one dose every 24 hours. For those being prescribed DoxyPEP, gonorrhea and chlamydia screening of all anatomic sites of exposure (urine sample or frontal swab, throat swab, and/or rectal swab) should be conducted at baseline and then every 3-6 months in addition to blood testing for syphilis and HIV if indicated.^6-7

Another option in our toolkit

DoxyPEP should be viewed as one more option in our toolkit of sexual health services alongside risk reduction strategies (e.g., open discussions with partners, decreased number of partners, and condom use), routine STI screening and treatment, PrEP and PEP for HIV prevention, and pregnancy prevention. Not all of these tools will be relevant to each individual and discussions around sexual health should be patient-centered and focused on their own personal goals. As pediatricians, we should provide guidance to all adolescents and young adults on options to improve their sexual health and empower them to embrace their bodily autonomy.

Dr. Warus is in the division of adolescent and young adult medicine at Children’s Hospital of Los Angeles, where he specializes in care for transgender and gender-nonconforming youth, and LGBTQ health for youth. He is an assistant professor of pediatrics at USC.

Resources

CDC – Sexually Transmitted Infection Treatment Guidelines, 2021

CDC – [Preliminary] Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection (STI) Prevention

New York State Department of Health AIDS Institute – Doxycycline Post-Exposure Prophylaxis to Prevent Bacterial Sexually Transmitted Infections

Los Angeles County Department of Public Health – DoxyPEP for STI Prevention
 

References

1. Division of STD Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2021: National Overview of STDs, 2021. Last Reviewed May 16, 2023.

2. Centers for Disease Control and Prevention: US Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Published 2021.

3. Centers for Disease Control and Prevention: US Department of Health and Human Services: Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV – United States, 2016. Published 2016. .

4. Workowski KA et al. Sexually Transmitted Infection Treatment Guidelines, 2021. MMWR Recomm Rep. 2021;70(4):2-10.

5. Patel RS and Parmar M. Doxycycline Hyclate. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. Last Updated May 22, 2023.

6. Centers for Disease Control and Prevention. [Preliminary] Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection (STI) Prevention. Published Oct 1, 2023.

7. DiMarco DE, et al. Doxycycline Post-Exposure Prophylaxis to Prevent Bacterial Sexually Transmitted Infections. New York State Department of Health AIDS Institute. Published September 25, 2023.

Sexually transmitted infections (STIs) continue to have a significant impact on the lives of adolescents and young adults. According to the Centers for Disease Control and Prevention’s (CDC) 2021 surveillance report, rates of gonorrhea and syphilis in the United States were at their highest since the early 1990s. Chlamydia, one of the most common STIs, had a peak rate in 2019, but more recent rates may have been impacted by the COVID-19 pandemic. In 2021, those 15-24 years of age accounted for 58.5% of all chlamydia infections, 40.4% of all gonorrhea infections, and 18.3% of all syphilis infections in the US.

While pediatricians should discuss sexual health and STI screening with all their adolescent and young adult patients, LGBTQ+ youth are disproportionately impacted by STIs. For example, cisgender men who have sex with men have significantly higher rates of HIV, gonorrhea, and syphilis. These disparities are likely related to unequal access to care, systemic homophobia/transphobia, stigma, and differences in sexual networks and are even more pronounced for those with intersectional minoritized identities such as LGBTQ+ youth of color.¹

Courtesy Dr. Warus

In the past 12 years, there have been significant advances in HIV prevention methods, including the approval and use of pre-exposure prophylaxis or “PrEP” (a medication regimen that is taken on an ongoing basis to provide highly effective protection against HIV infection) and more widespread use of post-exposure prophylaxis or “PEP” (a medication regimen taken for 1 month after a potential exposure to HIV to prevent HIV from establishing an ongoing infection) outside of the medical setting. While these interventions have the potential to decrease rates of HIV infection, they do not prevent any other STIs.^2-3

The current strategies to prevent bacterial STIs include discussions of sexual practices, counseling on risk reduction strategies such as decreased number of partners and condom use, routine screening in those at risk every 3-12 months, and timely diagnosis and treatment of infections in patients and their partners to avoid further transmission.⁴ Given the increasing rates of bacterial STIs (gonorrhea, chlamydia, and syphilis), additional biomedical prevention methods are greatly needed.
 

Doxycycline as post-exposure prophylaxis

Doxycycline is a tetracycline antibiotic effective against a wide range of bacteria and is commonly used in the treatment of acne, skin infections, Lyme disease, and STIs, and can also be used in the treatment and prevention of malaria.⁵ For STIs, doxycycline is currently the recommended treatment for chlamydia and is also an alternate therapy for syphilis in nonpregnant patients when penicillin is not accessible or in those with severe penicillin allergy.⁴ This medication is often well tolerated with the most common side effects including gastrointestinal irritation and photosensitivity. Doxycycline is contraindicated in pregnancy due to its potential impact on tooth and bone development.⁵

Given its general tolerability and activity against bacterial STIs, new and emerging studies have examined doxycycline as post-exposure prophylaxis (DoxyPEP: one dose of doxycycline 200 mg PO within 72 hours after unprotected sex) in an attempt to decrease the incidence of new bacterial STIs in populations at risk. Three of the studies cited in the preliminary CDC DoxyPEP guidelines were conducted in cisgender men who have sex with men and transgender women either living with HIV or taking PrEP for HIV prevention. All three studies demonstrated significantly lower risk of chlamydia and syphilis, while two of the studies also showed a significantly lower risk of gonorrhea. One additional study was conducted in cisgender women in Kenya. This study did not show any statistically significant difference in the risk of chlamydia or gonorrhea in the intervention group, but may have been limited by low adherence to the DoxyPEP regimen. There were no serious adverse events reported in any of the studies attributed to doxycycline.⁶

Avoiding antibiotic resistance

With the increased use of antibiotics, attention must always be paid to the potential for increasing antibiotic resistance. The preliminary CDC DoxyPEP guidelines outline mixed results in the DoxyPEP studies that had limited follow-up timeframes, making it difficult to draw conclusions: “Current data suggest overall benefit of the use of doxycycline PEP, but potential risks related to the development of resistance and impacts on the microbiome will need to be closely monitored after implementation of these guidelines.” Official guideline recommendations from the CDC regarding DoxyPEP are currently pending after a period of public comment on the preliminary drafted guidelines.⁶ However, the New York State Department of Health AIDS Institute released guidelines for DoxyPEP in September 2023 and several large urban public health departments have also issued their own guidance that largely align with the preliminary CDC guidelines.⁷

Recommendations currently emphasize that the goal is to allow for implementation of DoxyPEP in those who would benefit the most from the intervention (i.e., cisgender men who have sex with men and transgender women with a history of at least one bacterial STI in the last 12 months with ongoing risk of infection), while also minimizing antibiotic use. It should also be considered for those without a recent infection who have increased likelihood of exposure to bacterial STIs. DoxyPEP is likely to be effective in other populations (e.g., cisgender women, cisgender men who have sex with women, transgender men), but data are currently limited, and the risk/benefit ratio may be different in these populations. The recommended dose for DoxyPEP is doxycycline 200 mg once as soon as possible (within 72 hours) of unprotected oral, vaginal, or anal sex with a maximum of one dose every 24 hours. For those being prescribed DoxyPEP, gonorrhea and chlamydia screening of all anatomic sites of exposure (urine sample or frontal swab, throat swab, and/or rectal swab) should be conducted at baseline and then every 3-6 months in addition to blood testing for syphilis and HIV if indicated.^6-7

Another option in our toolkit

DoxyPEP should be viewed as one more option in our toolkit of sexual health services alongside risk reduction strategies (e.g., open discussions with partners, decreased number of partners, and condom use), routine STI screening and treatment, PrEP and PEP for HIV prevention, and pregnancy prevention. Not all of these tools will be relevant to each individual and discussions around sexual health should be patient-centered and focused on their own personal goals. As pediatricians, we should provide guidance to all adolescents and young adults on options to improve their sexual health and empower them to embrace their bodily autonomy.

Dr. Warus is in the division of adolescent and young adult medicine at Children’s Hospital of Los Angeles, where he specializes in care for transgender and gender-nonconforming youth, and LGBTQ health for youth. He is an assistant professor of pediatrics at USC.

Resources

CDC – Sexually Transmitted Infection Treatment Guidelines, 2021

CDC – [Preliminary] Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection (STI) Prevention

New York State Department of Health AIDS Institute – Doxycycline Post-Exposure Prophylaxis to Prevent Bacterial Sexually Transmitted Infections

Los Angeles County Department of Public Health – DoxyPEP for STI Prevention
 

References

1. Division of STD Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2021: National Overview of STDs, 2021. Last Reviewed May 16, 2023.

2. Centers for Disease Control and Prevention: US Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Published 2021.

3. Centers for Disease Control and Prevention: US Department of Health and Human Services: Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV – United States, 2016. Published 2016. .

4. Workowski KA et al. Sexually Transmitted Infection Treatment Guidelines, 2021. MMWR Recomm Rep. 2021;70(4):2-10.

5. Patel RS and Parmar M. Doxycycline Hyclate. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. Last Updated May 22, 2023.

6. Centers for Disease Control and Prevention. [Preliminary] Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection (STI) Prevention. Published Oct 1, 2023.

7. DiMarco DE, et al. Doxycycline Post-Exposure Prophylaxis to Prevent Bacterial Sexually Transmitted Infections. New York State Department of Health AIDS Institute. Published September 25, 2023.

Sexually transmitted infections (STIs) continue to have a significant impact on the lives of adolescents and young adults. According to the Centers for Disease Control and Prevention’s (CDC) 2021 surveillance report, rates of gonorrhea and syphilis in the United States were at their highest since the early 1990s. Chlamydia, one of the most common STIs, had a peak rate in 2019, but more recent rates may have been impacted by the COVID-19 pandemic. In 2021, those 15-24 years of age accounted for 58.5% of all chlamydia infections, 40.4% of all gonorrhea infections, and 18.3% of all syphilis infections in the US.

While pediatricians should discuss sexual health and STI screening with all their adolescent and young adult patients, LGBTQ+ youth are disproportionately impacted by STIs. For example, cisgender men who have sex with men have significantly higher rates of HIV, gonorrhea, and syphilis. These disparities are likely related to unequal access to care, systemic homophobia/transphobia, stigma, and differences in sexual networks and are even more pronounced for those with intersectional minoritized identities such as LGBTQ+ youth of color.¹

Courtesy Dr. Warus

In the past 12 years, there have been significant advances in HIV prevention methods, including the approval and use of pre-exposure prophylaxis or “PrEP” (a medication regimen that is taken on an ongoing basis to provide highly effective protection against HIV infection) and more widespread use of post-exposure prophylaxis or “PEP” (a medication regimen taken for 1 month after a potential exposure to HIV to prevent HIV from establishing an ongoing infection) outside of the medical setting. While these interventions have the potential to decrease rates of HIV infection, they do not prevent any other STIs.^2-3

The current strategies to prevent bacterial STIs include discussions of sexual practices, counseling on risk reduction strategies such as decreased number of partners and condom use, routine screening in those at risk every 3-12 months, and timely diagnosis and treatment of infections in patients and their partners to avoid further transmission.⁴ Given the increasing rates of bacterial STIs (gonorrhea, chlamydia, and syphilis), additional biomedical prevention methods are greatly needed.
 

Doxycycline as post-exposure prophylaxis

Doxycycline is a tetracycline antibiotic effective against a wide range of bacteria and is commonly used in the treatment of acne, skin infections, Lyme disease, and STIs, and can also be used in the treatment and prevention of malaria.⁵ For STIs, doxycycline is currently the recommended treatment for chlamydia and is also an alternate therapy for syphilis in nonpregnant patients when penicillin is not accessible or in those with severe penicillin allergy.⁴ This medication is often well tolerated with the most common side effects including gastrointestinal irritation and photosensitivity. Doxycycline is contraindicated in pregnancy due to its potential impact on tooth and bone development.⁵

Given its general tolerability and activity against bacterial STIs, new and emerging studies have examined doxycycline as post-exposure prophylaxis (DoxyPEP: one dose of doxycycline 200 mg PO within 72 hours after unprotected sex) in an attempt to decrease the incidence of new bacterial STIs in populations at risk. Three of the studies cited in the preliminary CDC DoxyPEP guidelines were conducted in cisgender men who have sex with men and transgender women either living with HIV or taking PrEP for HIV prevention. All three studies demonstrated significantly lower risk of chlamydia and syphilis, while two of the studies also showed a significantly lower risk of gonorrhea. One additional study was conducted in cisgender women in Kenya. This study did not show any statistically significant difference in the risk of chlamydia or gonorrhea in the intervention group, but may have been limited by low adherence to the DoxyPEP regimen. There were no serious adverse events reported in any of the studies attributed to doxycycline.⁶

Avoiding antibiotic resistance

With the increased use of antibiotics, attention must always be paid to the potential for increasing antibiotic resistance. The preliminary CDC DoxyPEP guidelines outline mixed results in the DoxyPEP studies that had limited follow-up timeframes, making it difficult to draw conclusions: “Current data suggest overall benefit of the use of doxycycline PEP, but potential risks related to the development of resistance and impacts on the microbiome will need to be closely monitored after implementation of these guidelines.” Official guideline recommendations from the CDC regarding DoxyPEP are currently pending after a period of public comment on the preliminary drafted guidelines.⁶ However, the New York State Department of Health AIDS Institute released guidelines for DoxyPEP in September 2023 and several large urban public health departments have also issued their own guidance that largely align with the preliminary CDC guidelines.⁷

Recommendations currently emphasize that the goal is to allow for implementation of DoxyPEP in those who would benefit the most from the intervention (i.e., cisgender men who have sex with men and transgender women with a history of at least one bacterial STI in the last 12 months with ongoing risk of infection), while also minimizing antibiotic use. It should also be considered for those without a recent infection who have increased likelihood of exposure to bacterial STIs. DoxyPEP is likely to be effective in other populations (e.g., cisgender women, cisgender men who have sex with women, transgender men), but data are currently limited, and the risk/benefit ratio may be different in these populations. The recommended dose for DoxyPEP is doxycycline 200 mg once as soon as possible (within 72 hours) of unprotected oral, vaginal, or anal sex with a maximum of one dose every 24 hours. For those being prescribed DoxyPEP, gonorrhea and chlamydia screening of all anatomic sites of exposure (urine sample or frontal swab, throat swab, and/or rectal swab) should be conducted at baseline and then every 3-6 months in addition to blood testing for syphilis and HIV if indicated.^6-7

Another option in our toolkit

DoxyPEP should be viewed as one more option in our toolkit of sexual health services alongside risk reduction strategies (e.g., open discussions with partners, decreased number of partners, and condom use), routine STI screening and treatment, PrEP and PEP for HIV prevention, and pregnancy prevention. Not all of these tools will be relevant to each individual and discussions around sexual health should be patient-centered and focused on their own personal goals. As pediatricians, we should provide guidance to all adolescents and young adults on options to improve their sexual health and empower them to embrace their bodily autonomy.

Dr. Warus is in the division of adolescent and young adult medicine at Children’s Hospital of Los Angeles, where he specializes in care for transgender and gender-nonconforming youth, and LGBTQ health for youth. He is an assistant professor of pediatrics at USC.

Resources

CDC – Sexually Transmitted Infection Treatment Guidelines, 2021

CDC – [Preliminary] Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection (STI) Prevention

New York State Department of Health AIDS Institute – Doxycycline Post-Exposure Prophylaxis to Prevent Bacterial Sexually Transmitted Infections

Los Angeles County Department of Public Health – DoxyPEP for STI Prevention
 

References

1. Division of STD Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2021: National Overview of STDs, 2021. Last Reviewed May 16, 2023.

2. Centers for Disease Control and Prevention: US Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Published 2021.

3. Centers for Disease Control and Prevention: US Department of Health and Human Services: Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV – United States, 2016. Published 2016. .

4. Workowski KA et al. Sexually Transmitted Infection Treatment Guidelines, 2021. MMWR Recomm Rep. 2021;70(4):2-10.

5. Patel RS and Parmar M. Doxycycline Hyclate. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. Last Updated May 22, 2023.

6. Centers for Disease Control and Prevention. [Preliminary] Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection (STI) Prevention. Published Oct 1, 2023.

7. DiMarco DE, et al. Doxycycline Post-Exposure Prophylaxis to Prevent Bacterial Sexually Transmitted Infections. New York State Department of Health AIDS Institute. Published September 25, 2023.

Recent evidence suggests that more cardiologists are failing to pass their boards. Pass rates declined from a high of 96% in 2018 to a low of 86% in 2021 and 2022. COVID disruptions to training may be largely to blame, experts said.

Among the 1061 candidates who took their first American Board of Internal Medicine (ABIM) cardiovascular (CV) disease exam in 2022, about 80 fellows failed who might have passed had they trained in 2016-2019, according to Anis John Kadado, MD, University of Massachusetts Medical School–Baystate Campus, Springfield, Massachusetts, and colleagues, writing in a viewpoint article published in the Journal of the American College of Cardiology.

“The purpose of board examinations is to test the knowledge, core concepts, and fundamental principles of trainees as they deliver patient care,” said Dr. Kadado. “The decline in CV board pass rates reflects a potential gap in training, which may translate to suboptimal patient care.”

Why the Downturn?

Reasons for the increased failures are likely multifactorial, Dr. Kadado said. While some blame the ABIM, the exam has remained about the same over the past 6 years, so the test itself seems unlikely to explain the decline.

The main culprit, according to the viewpoint authors, is “the educational fallout from the disruptions caused by changes made in response to the COVID pandemic.” Changes that Dr. Kadado and colleagues said put the current class of graduating fellows at “high risk” of failing their boards in the fall.

The typical cardiology fellowship is 3 years or more for subspecialty training. Candidates who took the ABIM exam in 2021 had 18 months of training that overlapped with the pandemic response, and those who took the exam in 2022 had about 30 months of training disrupted by COVID. However, fellows who first took the exam in 2023 had essentially 36 months of training affected by COVID, potentially reducing their odds of passing.

“It is hard, if not impossible, to understand the driving forces for this recent decrease in performance on the initial ABIM certification examination, nor is it possible to forecast if there will be an end to this slide,” Jeffrey T. Kuvin, MD, chair of cardiology at the Zucker School of Medicine at Northwell Health, Manhasset, New York, and colleagues wrote in response to the viewpoint article.

The authors acknowledged that COVID disrupted graduate medical training and that the long-term effects of the disruption are now emerging. However, they also pinpoint other potential issues affecting fellows, including information/technology overload, a focus on patient volume over education, lack of attention to core concepts, and, as Dr. Kadado and colleagues noted, high burnout rates among fellows and knowledge gaps due to easy access to electronic resources rather than reading and studying to retain information.

COVID disruptions included limits on in-person learning, clinic exposure, research opportunities, and conference travel, according to the authors. From a 2020 viewpoint, Dr. Kuvin also noted the loss of bedside teaching and on-site grand rounds.

Furthermore, with deferrals of elective cardiac, endovascular, and structural catheterization procedures during the pandemic, elective cases normally done by fellows were postponed or canceled.

Restoring Education, Board Passing Rates

“Having recently passed the ABIM cardiovascular board exam myself, my take-home message at this point is for current fellows-in-training to remain organized, track training milestones, and foresee any training shortcomings,” Dr. Kadado said. Adding that fellows, graduates and leadership should “identify deficiencies and work on overcoming them.”

The viewpoint authors suggested strategies that fellowship leadership can use. These include:

• Regularly assessing faculty emotional well-being and burnout to ensure that they are engaged in meaningful teaching activities
• Emphasizing in-person learning, meaningful participation in conferences, and faculty oversight
• Encouraging fellows to pursue “self-directed learning” during off-hours
• Developing and implementing checklists, competency-based models, curricula, and rotations to ensure that training milestones are being met
• Returning to in-person imaging interpretation for imaging modalities such as echocardiography, cardiac CT, and cardiac MRI
• Ensuring that fellows take the American College of Cardiology in-training examination
• Providing practice question banks so that fellows can assess their knowledge gaps

“This might also be an opportune time to assess the assessment,” Dr. Kuvin and colleagues noted. “There are likely alternative or additional approaches that could provide a more comprehensive, modern tool to gauge clinical competence in a supportive manner.”

They suggested that these tools could include assessment by simulation for interventional cardiology and electrophysiology, oral case reviews, objective structured clinical exams, and evaluations of nonclinical competencies such as professionalism and health equity.

Implications for the New Cardiology Board

While the ABIM cardiology board exam days may be numbered, board certification via some type of exam process is not going away.

The American College of Cardiology and four other US CV societies — the American Heart Association, the Heart Failure Society of America, the Heart Rhythm Society, and the Society for Cardiovascular Angiography & Interventions — formally announced in September that they have joined forces to propose a new professional certification board called the American Board of Cardiovascular Medicine (ABCVM). The application to the ABMS for a separate cardiology board is still ongoing and will take time.

An initial certification exam would still be required after fellowship training, but the maintenance of certification process would be completely restructured.

Preparing for the new board will likely be “largely the same” as for the ABIM board, Dr. Kadado said. “This includes access to practice question banks, faculty oversight, strong clinical exposure and practice, regular didactic sessions, and self-directed learning.”

“Passing the board exam is just one step in our ongoing journey as a cardiologist,” he added. “Our field is rapidly evolving, and continuous learning and adaptation are part of the very essence of being a healthcare professional.”

Dr. Kadado had no relevant relationships to disclose. Dr. Kuvin is an ACC trustee and has been heading up the working group to develop the ABCVM.

A version of this article appeared on Medscape.com.

Recent evidence suggests that more cardiologists are failing to pass their boards. Pass rates declined from a high of 96% in 2018 to a low of 86% in 2021 and 2022. COVID disruptions to training may be largely to blame, experts said.

Among the 1061 candidates who took their first American Board of Internal Medicine (ABIM) cardiovascular (CV) disease exam in 2022, about 80 fellows failed who might have passed had they trained in 2016-2019, according to Anis John Kadado, MD, University of Massachusetts Medical School–Baystate Campus, Springfield, Massachusetts, and colleagues, writing in a viewpoint article published in the Journal of the American College of Cardiology.

“The purpose of board examinations is to test the knowledge, core concepts, and fundamental principles of trainees as they deliver patient care,” said Dr. Kadado. “The decline in CV board pass rates reflects a potential gap in training, which may translate to suboptimal patient care.”

Why the Downturn?

Reasons for the increased failures are likely multifactorial, Dr. Kadado said. While some blame the ABIM, the exam has remained about the same over the past 6 years, so the test itself seems unlikely to explain the decline.

The main culprit, according to the viewpoint authors, is “the educational fallout from the disruptions caused by changes made in response to the COVID pandemic.” Changes that Dr. Kadado and colleagues said put the current class of graduating fellows at “high risk” of failing their boards in the fall.

The typical cardiology fellowship is 3 years or more for subspecialty training. Candidates who took the ABIM exam in 2021 had 18 months of training that overlapped with the pandemic response, and those who took the exam in 2022 had about 30 months of training disrupted by COVID. However, fellows who first took the exam in 2023 had essentially 36 months of training affected by COVID, potentially reducing their odds of passing.

“It is hard, if not impossible, to understand the driving forces for this recent decrease in performance on the initial ABIM certification examination, nor is it possible to forecast if there will be an end to this slide,” Jeffrey T. Kuvin, MD, chair of cardiology at the Zucker School of Medicine at Northwell Health, Manhasset, New York, and colleagues wrote in response to the viewpoint article.

The authors acknowledged that COVID disrupted graduate medical training and that the long-term effects of the disruption are now emerging. However, they also pinpoint other potential issues affecting fellows, including information/technology overload, a focus on patient volume over education, lack of attention to core concepts, and, as Dr. Kadado and colleagues noted, high burnout rates among fellows and knowledge gaps due to easy access to electronic resources rather than reading and studying to retain information.

COVID disruptions included limits on in-person learning, clinic exposure, research opportunities, and conference travel, according to the authors. From a 2020 viewpoint, Dr. Kuvin also noted the loss of bedside teaching and on-site grand rounds.

Furthermore, with deferrals of elective cardiac, endovascular, and structural catheterization procedures during the pandemic, elective cases normally done by fellows were postponed or canceled.

Restoring Education, Board Passing Rates

“Having recently passed the ABIM cardiovascular board exam myself, my take-home message at this point is for current fellows-in-training to remain organized, track training milestones, and foresee any training shortcomings,” Dr. Kadado said. Adding that fellows, graduates and leadership should “identify deficiencies and work on overcoming them.”

The viewpoint authors suggested strategies that fellowship leadership can use. These include:

• Regularly assessing faculty emotional well-being and burnout to ensure that they are engaged in meaningful teaching activities
• Emphasizing in-person learning, meaningful participation in conferences, and faculty oversight
• Encouraging fellows to pursue “self-directed learning” during off-hours
• Developing and implementing checklists, competency-based models, curricula, and rotations to ensure that training milestones are being met
• Returning to in-person imaging interpretation for imaging modalities such as echocardiography, cardiac CT, and cardiac MRI
• Ensuring that fellows take the American College of Cardiology in-training examination
• Providing practice question banks so that fellows can assess their knowledge gaps

“This might also be an opportune time to assess the assessment,” Dr. Kuvin and colleagues noted. “There are likely alternative or additional approaches that could provide a more comprehensive, modern tool to gauge clinical competence in a supportive manner.”

They suggested that these tools could include assessment by simulation for interventional cardiology and electrophysiology, oral case reviews, objective structured clinical exams, and evaluations of nonclinical competencies such as professionalism and health equity.

Implications for the New Cardiology Board

While the ABIM cardiology board exam days may be numbered, board certification via some type of exam process is not going away.

The American College of Cardiology and four other US CV societies — the American Heart Association, the Heart Failure Society of America, the Heart Rhythm Society, and the Society for Cardiovascular Angiography & Interventions — formally announced in September that they have joined forces to propose a new professional certification board called the American Board of Cardiovascular Medicine (ABCVM). The application to the ABMS for a separate cardiology board is still ongoing and will take time.

An initial certification exam would still be required after fellowship training, but the maintenance of certification process would be completely restructured.

Preparing for the new board will likely be “largely the same” as for the ABIM board, Dr. Kadado said. “This includes access to practice question banks, faculty oversight, strong clinical exposure and practice, regular didactic sessions, and self-directed learning.”

“Passing the board exam is just one step in our ongoing journey as a cardiologist,” he added. “Our field is rapidly evolving, and continuous learning and adaptation are part of the very essence of being a healthcare professional.”

Dr. Kadado had no relevant relationships to disclose. Dr. Kuvin is an ACC trustee and has been heading up the working group to develop the ABCVM.

A version of this article appeared on Medscape.com.

Recent evidence suggests that more cardiologists are failing to pass their boards. Pass rates declined from a high of 96% in 2018 to a low of 86% in 2021 and 2022. COVID disruptions to training may be largely to blame, experts said.

Among the 1061 candidates who took their first American Board of Internal Medicine (ABIM) cardiovascular (CV) disease exam in 2022, about 80 fellows failed who might have passed had they trained in 2016-2019, according to Anis John Kadado, MD, University of Massachusetts Medical School–Baystate Campus, Springfield, Massachusetts, and colleagues, writing in a viewpoint article published in the Journal of the American College of Cardiology.

“The purpose of board examinations is to test the knowledge, core concepts, and fundamental principles of trainees as they deliver patient care,” said Dr. Kadado. “The decline in CV board pass rates reflects a potential gap in training, which may translate to suboptimal patient care.”

Why the Downturn?

Reasons for the increased failures are likely multifactorial, Dr. Kadado said. While some blame the ABIM, the exam has remained about the same over the past 6 years, so the test itself seems unlikely to explain the decline.

The main culprit, according to the viewpoint authors, is “the educational fallout from the disruptions caused by changes made in response to the COVID pandemic.” Changes that Dr. Kadado and colleagues said put the current class of graduating fellows at “high risk” of failing their boards in the fall.

The typical cardiology fellowship is 3 years or more for subspecialty training. Candidates who took the ABIM exam in 2021 had 18 months of training that overlapped with the pandemic response, and those who took the exam in 2022 had about 30 months of training disrupted by COVID. However, fellows who first took the exam in 2023 had essentially 36 months of training affected by COVID, potentially reducing their odds of passing.

“It is hard, if not impossible, to understand the driving forces for this recent decrease in performance on the initial ABIM certification examination, nor is it possible to forecast if there will be an end to this slide,” Jeffrey T. Kuvin, MD, chair of cardiology at the Zucker School of Medicine at Northwell Health, Manhasset, New York, and colleagues wrote in response to the viewpoint article.

The authors acknowledged that COVID disrupted graduate medical training and that the long-term effects of the disruption are now emerging. However, they also pinpoint other potential issues affecting fellows, including information/technology overload, a focus on patient volume over education, lack of attention to core concepts, and, as Dr. Kadado and colleagues noted, high burnout rates among fellows and knowledge gaps due to easy access to electronic resources rather than reading and studying to retain information.

COVID disruptions included limits on in-person learning, clinic exposure, research opportunities, and conference travel, according to the authors. From a 2020 viewpoint, Dr. Kuvin also noted the loss of bedside teaching and on-site grand rounds.

Furthermore, with deferrals of elective cardiac, endovascular, and structural catheterization procedures during the pandemic, elective cases normally done by fellows were postponed or canceled.

Restoring Education, Board Passing Rates

“Having recently passed the ABIM cardiovascular board exam myself, my take-home message at this point is for current fellows-in-training to remain organized, track training milestones, and foresee any training shortcomings,” Dr. Kadado said. Adding that fellows, graduates and leadership should “identify deficiencies and work on overcoming them.”

The viewpoint authors suggested strategies that fellowship leadership can use. These include:

• Regularly assessing faculty emotional well-being and burnout to ensure that they are engaged in meaningful teaching activities
• Emphasizing in-person learning, meaningful participation in conferences, and faculty oversight
• Encouraging fellows to pursue “self-directed learning” during off-hours
• Developing and implementing checklists, competency-based models, curricula, and rotations to ensure that training milestones are being met
• Returning to in-person imaging interpretation for imaging modalities such as echocardiography, cardiac CT, and cardiac MRI
• Ensuring that fellows take the American College of Cardiology in-training examination
• Providing practice question banks so that fellows can assess their knowledge gaps

“This might also be an opportune time to assess the assessment,” Dr. Kuvin and colleagues noted. “There are likely alternative or additional approaches that could provide a more comprehensive, modern tool to gauge clinical competence in a supportive manner.”

They suggested that these tools could include assessment by simulation for interventional cardiology and electrophysiology, oral case reviews, objective structured clinical exams, and evaluations of nonclinical competencies such as professionalism and health equity.

Implications for the New Cardiology Board

While the ABIM cardiology board exam days may be numbered, board certification via some type of exam process is not going away.

The American College of Cardiology and four other US CV societies — the American Heart Association, the Heart Failure Society of America, the Heart Rhythm Society, and the Society for Cardiovascular Angiography & Interventions — formally announced in September that they have joined forces to propose a new professional certification board called the American Board of Cardiovascular Medicine (ABCVM). The application to the ABMS for a separate cardiology board is still ongoing and will take time.

An initial certification exam would still be required after fellowship training, but the maintenance of certification process would be completely restructured.

Preparing for the new board will likely be “largely the same” as for the ABIM board, Dr. Kadado said. “This includes access to practice question banks, faculty oversight, strong clinical exposure and practice, regular didactic sessions, and self-directed learning.”

“Passing the board exam is just one step in our ongoing journey as a cardiologist,” he added. “Our field is rapidly evolving, and continuous learning and adaptation are part of the very essence of being a healthcare professional.”

Dr. Kadado had no relevant relationships to disclose. Dr. Kuvin is an ACC trustee and has been heading up the working group to develop the ABCVM.

A version of this article appeared on Medscape.com.

Annette Gillaspie, a nurse in a small Oregon hospital, hoped she would be back working with patients by now. She contracted COVID-19 on the job early in the pandemic and ended up with long COVID.

After recovering a bit, her fatigue and dizziness returned, and today she is still working a desk job. She has also experienced more severe menstrual periods than before she had COVID.

“Being a female with long COVID definitely does add to the roller-coaster effect of symptoms,” Ms. Gillaspie said.

Long COVID affects nearly twice as many women as men, with 6.6% of women reporting long COVID compared with 4% of men, according to a recent Census Bureau survey reported by the Centers for Disease Control and Prevention (CDC). Researchers are trying to determine why, what causes the gender disparity, and how best to treat it.

Scientists are also starting to look at the impact of long COVID on female reproductive health, including menstruation, pregnancy, and menopause.

Sex differences are common in infection-associated illnesses, said Beth Pollack, MS, a research scientist specializing in long COVID in the Massachusetts Institute of Technology’s Department of Biological Engineering, Cambridge, Massachusetts. “It informs research priorities and the lens with which we understand long COVID.”

For example, reproductive health issues for women, such as puberty, pregnancy, and menopause, can alter the course of illness in a subset of women in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and postural orthostatic tachycardia syndrome (POTS), a condition that can cause dizziness and worse.

“This suggests that sex hormones may play key roles in immune responses to infections,” Ms. Pollack said.

ME/CFS and a Possible Link to Long COVID in Women

Some of the research into long COVID is being led by teams studying infection-associated chronic illnesses like ME/CFS.

The problem: Advocates say ME/CFS has been under-researched. Poorly understood for years, the condition is one of a handful of chronic illnesses linked to infections, including Lyme disease and now long COVID. Perhaps not coincidently, they are more likely to affect women.

Many of the research findings about long COVID mirror data that emerged in past ME/CFS research, said Jaime Seltzer, the scientific director at #MEAction, Santa Monica, California, an advocacy group. One point in particular: ME/CFS strikes women about twice as much as men, according to the CDC.

Ms. Seltzer said the response to long COVID could be much further ahead if the research community acknowledged the work done over the years on ME/CFS. Many of the potential biomarkers and risk factors emerging for long COVID were also suspected in ME/CFS, but not thoroughly studied, she said.

She also said not enough work has been done to unravel the links between gender and these chronic conditions.

“We’re stuck in this Groundhog Day situation,” she said. “There isn’t any research, so we can’t say anything definitively.”

Some New Research, Some New Clues

Scientists like Ms. Pollack are slowly making inroads. She was lead author on a 2023 review investigating the impact of long COVID on female reproductive health. The paper highlights long COVID links to ME/CFS, POTS, and Ehlers-Danlos syndrome (EDS), as well as a resulting laundry list of female reproductive health issues. The hope is physicians will examine how the menstrual cycle, pregnancy, and menopause affect symptoms and illness progression of long COVID.

The Tal Research group at MIT (where Ms. Pollack works) has also added long COVID to the list of infection-associated illnesses it studies. The lab is conducting a large study looking into both Lyme disease and long COVID. The goals are to identify biomarkers that can predict who will not recover and to advance available treatments.

Another MIT program, “SEXX + Immunity” holds seminars and networking sessions for scientists looking into the role of female and male biology in immune responses to infection.

Barriers to Progress Remain

On the clinical side, female patients with long COVID also have to deal with a historical bias that still lurks in medicine when it comes to women’s health, said Alba Azola, MD, an assistant professor of physical medicine at Johns Hopkins Medicine, Baltimore, Maryland.

Dr. Azola said she has discovered clinical descriptions of ME/CFE in the literature archives that describe it as “neurasthenia” and dismiss it as psychological.

Patients say that it is still happening, and while it may not be so blunt, “you can read between the lines,” Dr. Azola said.

Dr. Azola, who has worked with long COVID patients and is now seeing people with ME/CFS, said the symptoms of infection-associated chronic illness can mimic menopause, and many of her patients received that misdiagnosis. She recommends that doctors rule out long COVID for women with multiple symptoms before attributing symptoms to menopause.

Seeing that some long COVID patients were developing ME/CFS, staff at the Bateman Horne Center in Salt Lake City, Utah, set up a program for the condition in 2021. They were already treating patients with ME/CFS and what they call “multi-symptom chronic complex diseases.”

Jennifer Bell, a certified nurse practitioner at the center, said she has not seen any patients with ovarian failure but plenty with reproductive health issues.

“There definitely is a hormonal connection, but I don’t think there’s a good understanding about what is happening,” she said.

Most of her patients are female, and the more serious patients tend to go through a worsening of their symptoms in the week prior to getting a period, she said.

One thing Ms. Bell said she’s noticed in the past year is an increase in patients with EDS, which is also more common in women.

Like long COVID, many of the conditions traditionally treated at the center have no cure. But Ms. Bell said the center has developed an expertise in treating post-exertional malaise, a common symptom of long COVID, and keeps up with the literature for treatments to try, like the combination of guanfacine and the antioxidant N-acetyl cysteine to treat brain fog, an approach developed at Yale.

“It’s a very challenging illness to treat,” Ms. Bell said.

Since the emergence of long COVID, researchers have warned that symptoms vary so much from person to person that treatment will need to be targeted.

Ms. Pollack of MIT agrees and sees a big role for personalized medicine.

We need to “identify phenotypes within and across these overlapping and co-occurring illnesses so that we can identify the right therapeutics for each person,” she said.

As for Annette Gillaspie, she still hopes her long COVID will subside so she can get out from behind the desk and return to her normal nursing duties.

“I just got to a point where I realized I’m likely never going to be able to do my job,” she said. “It was incredibly heart breaking, but it’s the reality of long COVID, and I know I’m not the only one to have to step away from a job I loved.”

A version of this article appeared on Medscape.com.

Annette Gillaspie, a nurse in a small Oregon hospital, hoped she would be back working with patients by now. She contracted COVID-19 on the job early in the pandemic and ended up with long COVID.

After recovering a bit, her fatigue and dizziness returned, and today she is still working a desk job. She has also experienced more severe menstrual periods than before she had COVID.

“Being a female with long COVID definitely does add to the roller-coaster effect of symptoms,” Ms. Gillaspie said.

Long COVID affects nearly twice as many women as men, with 6.6% of women reporting long COVID compared with 4% of men, according to a recent Census Bureau survey reported by the Centers for Disease Control and Prevention (CDC). Researchers are trying to determine why, what causes the gender disparity, and how best to treat it.

Scientists are also starting to look at the impact of long COVID on female reproductive health, including menstruation, pregnancy, and menopause.

Sex differences are common in infection-associated illnesses, said Beth Pollack, MS, a research scientist specializing in long COVID in the Massachusetts Institute of Technology’s Department of Biological Engineering, Cambridge, Massachusetts. “It informs research priorities and the lens with which we understand long COVID.”

For example, reproductive health issues for women, such as puberty, pregnancy, and menopause, can alter the course of illness in a subset of women in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and postural orthostatic tachycardia syndrome (POTS), a condition that can cause dizziness and worse.

“This suggests that sex hormones may play key roles in immune responses to infections,” Ms. Pollack said.

ME/CFS and a Possible Link to Long COVID in Women

Some of the research into long COVID is being led by teams studying infection-associated chronic illnesses like ME/CFS.

The problem: Advocates say ME/CFS has been under-researched. Poorly understood for years, the condition is one of a handful of chronic illnesses linked to infections, including Lyme disease and now long COVID. Perhaps not coincidently, they are more likely to affect women.

Many of the research findings about long COVID mirror data that emerged in past ME/CFS research, said Jaime Seltzer, the scientific director at #MEAction, Santa Monica, California, an advocacy group. One point in particular: ME/CFS strikes women about twice as much as men, according to the CDC.

Ms. Seltzer said the response to long COVID could be much further ahead if the research community acknowledged the work done over the years on ME/CFS. Many of the potential biomarkers and risk factors emerging for long COVID were also suspected in ME/CFS, but not thoroughly studied, she said.

She also said not enough work has been done to unravel the links between gender and these chronic conditions.

“We’re stuck in this Groundhog Day situation,” she said. “There isn’t any research, so we can’t say anything definitively.”

Some New Research, Some New Clues

Scientists like Ms. Pollack are slowly making inroads. She was lead author on a 2023 review investigating the impact of long COVID on female reproductive health. The paper highlights long COVID links to ME/CFS, POTS, and Ehlers-Danlos syndrome (EDS), as well as a resulting laundry list of female reproductive health issues. The hope is physicians will examine how the menstrual cycle, pregnancy, and menopause affect symptoms and illness progression of long COVID.

The Tal Research group at MIT (where Ms. Pollack works) has also added long COVID to the list of infection-associated illnesses it studies. The lab is conducting a large study looking into both Lyme disease and long COVID. The goals are to identify biomarkers that can predict who will not recover and to advance available treatments.

Another MIT program, “SEXX + Immunity” holds seminars and networking sessions for scientists looking into the role of female and male biology in immune responses to infection.

Barriers to Progress Remain

On the clinical side, female patients with long COVID also have to deal with a historical bias that still lurks in medicine when it comes to women’s health, said Alba Azola, MD, an assistant professor of physical medicine at Johns Hopkins Medicine, Baltimore, Maryland.

Dr. Azola said she has discovered clinical descriptions of ME/CFE in the literature archives that describe it as “neurasthenia” and dismiss it as psychological.

Patients say that it is still happening, and while it may not be so blunt, “you can read between the lines,” Dr. Azola said.

Dr. Azola, who has worked with long COVID patients and is now seeing people with ME/CFS, said the symptoms of infection-associated chronic illness can mimic menopause, and many of her patients received that misdiagnosis. She recommends that doctors rule out long COVID for women with multiple symptoms before attributing symptoms to menopause.

Seeing that some long COVID patients were developing ME/CFS, staff at the Bateman Horne Center in Salt Lake City, Utah, set up a program for the condition in 2021. They were already treating patients with ME/CFS and what they call “multi-symptom chronic complex diseases.”

Jennifer Bell, a certified nurse practitioner at the center, said she has not seen any patients with ovarian failure but plenty with reproductive health issues.

“There definitely is a hormonal connection, but I don’t think there’s a good understanding about what is happening,” she said.

Most of her patients are female, and the more serious patients tend to go through a worsening of their symptoms in the week prior to getting a period, she said.

One thing Ms. Bell said she’s noticed in the past year is an increase in patients with EDS, which is also more common in women.

Like long COVID, many of the conditions traditionally treated at the center have no cure. But Ms. Bell said the center has developed an expertise in treating post-exertional malaise, a common symptom of long COVID, and keeps up with the literature for treatments to try, like the combination of guanfacine and the antioxidant N-acetyl cysteine to treat brain fog, an approach developed at Yale.

“It’s a very challenging illness to treat,” Ms. Bell said.

Since the emergence of long COVID, researchers have warned that symptoms vary so much from person to person that treatment will need to be targeted.

Ms. Pollack of MIT agrees and sees a big role for personalized medicine.

We need to “identify phenotypes within and across these overlapping and co-occurring illnesses so that we can identify the right therapeutics for each person,” she said.

As for Annette Gillaspie, she still hopes her long COVID will subside so she can get out from behind the desk and return to her normal nursing duties.

“I just got to a point where I realized I’m likely never going to be able to do my job,” she said. “It was incredibly heart breaking, but it’s the reality of long COVID, and I know I’m not the only one to have to step away from a job I loved.”

A version of this article appeared on Medscape.com.

Annette Gillaspie, a nurse in a small Oregon hospital, hoped she would be back working with patients by now. She contracted COVID-19 on the job early in the pandemic and ended up with long COVID.

After recovering a bit, her fatigue and dizziness returned, and today she is still working a desk job. She has also experienced more severe menstrual periods than before she had COVID.

“Being a female with long COVID definitely does add to the roller-coaster effect of symptoms,” Ms. Gillaspie said.

Long COVID affects nearly twice as many women as men, with 6.6% of women reporting long COVID compared with 4% of men, according to a recent Census Bureau survey reported by the Centers for Disease Control and Prevention (CDC). Researchers are trying to determine why, what causes the gender disparity, and how best to treat it.

Scientists are also starting to look at the impact of long COVID on female reproductive health, including menstruation, pregnancy, and menopause.

Sex differences are common in infection-associated illnesses, said Beth Pollack, MS, a research scientist specializing in long COVID in the Massachusetts Institute of Technology’s Department of Biological Engineering, Cambridge, Massachusetts. “It informs research priorities and the lens with which we understand long COVID.”

For example, reproductive health issues for women, such as puberty, pregnancy, and menopause, can alter the course of illness in a subset of women in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and postural orthostatic tachycardia syndrome (POTS), a condition that can cause dizziness and worse.

“This suggests that sex hormones may play key roles in immune responses to infections,” Ms. Pollack said.

ME/CFS and a Possible Link to Long COVID in Women

Some of the research into long COVID is being led by teams studying infection-associated chronic illnesses like ME/CFS.

The problem: Advocates say ME/CFS has been under-researched. Poorly understood for years, the condition is one of a handful of chronic illnesses linked to infections, including Lyme disease and now long COVID. Perhaps not coincidently, they are more likely to affect women.

Many of the research findings about long COVID mirror data that emerged in past ME/CFS research, said Jaime Seltzer, the scientific director at #MEAction, Santa Monica, California, an advocacy group. One point in particular: ME/CFS strikes women about twice as much as men, according to the CDC.

Ms. Seltzer said the response to long COVID could be much further ahead if the research community acknowledged the work done over the years on ME/CFS. Many of the potential biomarkers and risk factors emerging for long COVID were also suspected in ME/CFS, but not thoroughly studied, she said.

She also said not enough work has been done to unravel the links between gender and these chronic conditions.

“We’re stuck in this Groundhog Day situation,” she said. “There isn’t any research, so we can’t say anything definitively.”

Some New Research, Some New Clues

Scientists like Ms. Pollack are slowly making inroads. She was lead author on a 2023 review investigating the impact of long COVID on female reproductive health. The paper highlights long COVID links to ME/CFS, POTS, and Ehlers-Danlos syndrome (EDS), as well as a resulting laundry list of female reproductive health issues. The hope is physicians will examine how the menstrual cycle, pregnancy, and menopause affect symptoms and illness progression of long COVID.

The Tal Research group at MIT (where Ms. Pollack works) has also added long COVID to the list of infection-associated illnesses it studies. The lab is conducting a large study looking into both Lyme disease and long COVID. The goals are to identify biomarkers that can predict who will not recover and to advance available treatments.

Another MIT program, “SEXX + Immunity” holds seminars and networking sessions for scientists looking into the role of female and male biology in immune responses to infection.

Barriers to Progress Remain

On the clinical side, female patients with long COVID also have to deal with a historical bias that still lurks in medicine when it comes to women’s health, said Alba Azola, MD, an assistant professor of physical medicine at Johns Hopkins Medicine, Baltimore, Maryland.

Dr. Azola said she has discovered clinical descriptions of ME/CFE in the literature archives that describe it as “neurasthenia” and dismiss it as psychological.

Patients say that it is still happening, and while it may not be so blunt, “you can read between the lines,” Dr. Azola said.

Dr. Azola, who has worked with long COVID patients and is now seeing people with ME/CFS, said the symptoms of infection-associated chronic illness can mimic menopause, and many of her patients received that misdiagnosis. She recommends that doctors rule out long COVID for women with multiple symptoms before attributing symptoms to menopause.

Seeing that some long COVID patients were developing ME/CFS, staff at the Bateman Horne Center in Salt Lake City, Utah, set up a program for the condition in 2021. They were already treating patients with ME/CFS and what they call “multi-symptom chronic complex diseases.”

Jennifer Bell, a certified nurse practitioner at the center, said she has not seen any patients with ovarian failure but plenty with reproductive health issues.

“There definitely is a hormonal connection, but I don’t think there’s a good understanding about what is happening,” she said.

Most of her patients are female, and the more serious patients tend to go through a worsening of their symptoms in the week prior to getting a period, she said.

One thing Ms. Bell said she’s noticed in the past year is an increase in patients with EDS, which is also more common in women.

Like long COVID, many of the conditions traditionally treated at the center have no cure. But Ms. Bell said the center has developed an expertise in treating post-exertional malaise, a common symptom of long COVID, and keeps up with the literature for treatments to try, like the combination of guanfacine and the antioxidant N-acetyl cysteine to treat brain fog, an approach developed at Yale.

“It’s a very challenging illness to treat,” Ms. Bell said.

Since the emergence of long COVID, researchers have warned that symptoms vary so much from person to person that treatment will need to be targeted.

Ms. Pollack of MIT agrees and sees a big role for personalized medicine.

We need to “identify phenotypes within and across these overlapping and co-occurring illnesses so that we can identify the right therapeutics for each person,” she said.

As for Annette Gillaspie, she still hopes her long COVID will subside so she can get out from behind the desk and return to her normal nursing duties.

“I just got to a point where I realized I’m likely never going to be able to do my job,” she said. “It was incredibly heart breaking, but it’s the reality of long COVID, and I know I’m not the only one to have to step away from a job I loved.”

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

A recent article in Cell & Bioscience suggested that regular coffee consumption can reduce the risk of COVID infections.

The study does make some interesting points about the benefits of coffee’s different polyphenols and antioxidants and their effects on different COVID variants. Most of it is based on lab data, although one section, using serum from coffee versus water drinkers, did find that it was more effective at inhibiting the virions. Caffeinated versus decaffeinated didn’t matter.

I’m not saying coffee doesn’t impair the virus. The data are worth looking at. But the majority of adults in North America, Europe, and pretty much the entire planet drink coffee on a regular basis. A large number of them still caught COVID. Would they have had worse cases if they didn’t drink coffee? Maybe, maybe not.

The problem here is that, as always, preliminary data like this get pushed into mass media, making it sound like “COFFEE CURES COVID!!!” Never mind that that’s not what the article said, but it sure gets clicks and retweets and FaceBook “likes.”

Suddenly fringe groups are claiming the coffee cure was there all along, and hidden from them by the evil government-pharma-medical cartel. Others claim the research is flawed because of this or that. The signal gets drowned out by the noise.

Definitely, food can be a medicine. Look at all the benefits proven of the Mediterranean diet. Coffee may help, especially if we can identify and isolate the specific components that reduce COVID risk. But, as they always say at the end, the study is preliminary and further research is needed.

Once or twice a year, an adult with epilepsy comes in, waving a copy of the ketogenic diet around and upset that I never tried it on them — again proof of the evil government-pharma-medical cartel that I’m in league with. I calm them down and explain the diet in detail. Maybe 50% of them decide to go ahead with it. In 25 years of practice, my record for an otherwise normal adult sticking with it is 5 days.

You don’t have to go too far back to remember Linus Pauling, an absolutely brilliant scientist, but not the best of nutritionists. With two Nobel prizes behind him, he took a stab at medicine in the 1970s, arguing that megadoses of vitamin C worked for the common cold. While it may be good for us, and certainly most people like orange juice, but those claims about the common cold never panned out. In fact, we’re no closer to curing it now than we were then.

Just because something seems promising in early studies doesn’t mean it will pan out. It might, but this doesn’t mean the “truth” is being maliciously hidden by an evil cartel. It just means we have (as always) more to learn.

I’ll still drink my single cup of coffee every weekday morning. I’m a creature of habit, and heaven knows I need the caffeine. If it also boosts my immune system, so much the better.

Besides, we still have that universal antimicrobial called chicken soup.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

A recent article in Cell & Bioscience suggested that regular coffee consumption can reduce the risk of COVID infections.

The study does make some interesting points about the benefits of coffee’s different polyphenols and antioxidants and their effects on different COVID variants. Most of it is based on lab data, although one section, using serum from coffee versus water drinkers, did find that it was more effective at inhibiting the virions. Caffeinated versus decaffeinated didn’t matter.

I’m not saying coffee doesn’t impair the virus. The data are worth looking at. But the majority of adults in North America, Europe, and pretty much the entire planet drink coffee on a regular basis. A large number of them still caught COVID. Would they have had worse cases if they didn’t drink coffee? Maybe, maybe not.

The problem here is that, as always, preliminary data like this get pushed into mass media, making it sound like “COFFEE CURES COVID!!!” Never mind that that’s not what the article said, but it sure gets clicks and retweets and FaceBook “likes.”

Suddenly fringe groups are claiming the coffee cure was there all along, and hidden from them by the evil government-pharma-medical cartel. Others claim the research is flawed because of this or that. The signal gets drowned out by the noise.

Definitely, food can be a medicine. Look at all the benefits proven of the Mediterranean diet. Coffee may help, especially if we can identify and isolate the specific components that reduce COVID risk. But, as they always say at the end, the study is preliminary and further research is needed.

Once or twice a year, an adult with epilepsy comes in, waving a copy of the ketogenic diet around and upset that I never tried it on them — again proof of the evil government-pharma-medical cartel that I’m in league with. I calm them down and explain the diet in detail. Maybe 50% of them decide to go ahead with it. In 25 years of practice, my record for an otherwise normal adult sticking with it is 5 days.

You don’t have to go too far back to remember Linus Pauling, an absolutely brilliant scientist, but not the best of nutritionists. With two Nobel prizes behind him, he took a stab at medicine in the 1970s, arguing that megadoses of vitamin C worked for the common cold. While it may be good for us, and certainly most people like orange juice, but those claims about the common cold never panned out. In fact, we’re no closer to curing it now than we were then.

Just because something seems promising in early studies doesn’t mean it will pan out. It might, but this doesn’t mean the “truth” is being maliciously hidden by an evil cartel. It just means we have (as always) more to learn.

I’ll still drink my single cup of coffee every weekday morning. I’m a creature of habit, and heaven knows I need the caffeine. If it also boosts my immune system, so much the better.

Besides, we still have that universal antimicrobial called chicken soup.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

A recent article in Cell & Bioscience suggested that regular coffee consumption can reduce the risk of COVID infections.

The study does make some interesting points about the benefits of coffee’s different polyphenols and antioxidants and their effects on different COVID variants. Most of it is based on lab data, although one section, using serum from coffee versus water drinkers, did find that it was more effective at inhibiting the virions. Caffeinated versus decaffeinated didn’t matter.

I’m not saying coffee doesn’t impair the virus. The data are worth looking at. But the majority of adults in North America, Europe, and pretty much the entire planet drink coffee on a regular basis. A large number of them still caught COVID. Would they have had worse cases if they didn’t drink coffee? Maybe, maybe not.

The problem here is that, as always, preliminary data like this get pushed into mass media, making it sound like “COFFEE CURES COVID!!!” Never mind that that’s not what the article said, but it sure gets clicks and retweets and FaceBook “likes.”

Suddenly fringe groups are claiming the coffee cure was there all along, and hidden from them by the evil government-pharma-medical cartel. Others claim the research is flawed because of this or that. The signal gets drowned out by the noise.

Definitely, food can be a medicine. Look at all the benefits proven of the Mediterranean diet. Coffee may help, especially if we can identify and isolate the specific components that reduce COVID risk. But, as they always say at the end, the study is preliminary and further research is needed.

Once or twice a year, an adult with epilepsy comes in, waving a copy of the ketogenic diet around and upset that I never tried it on them — again proof of the evil government-pharma-medical cartel that I’m in league with. I calm them down and explain the diet in detail. Maybe 50% of them decide to go ahead with it. In 25 years of practice, my record for an otherwise normal adult sticking with it is 5 days.

You don’t have to go too far back to remember Linus Pauling, an absolutely brilliant scientist, but not the best of nutritionists. With two Nobel prizes behind him, he took a stab at medicine in the 1970s, arguing that megadoses of vitamin C worked for the common cold. While it may be good for us, and certainly most people like orange juice, but those claims about the common cold never panned out. In fact, we’re no closer to curing it now than we were then.

Just because something seems promising in early studies doesn’t mean it will pan out. It might, but this doesn’t mean the “truth” is being maliciously hidden by an evil cartel. It just means we have (as always) more to learn.

I’ll still drink my single cup of coffee every weekday morning. I’m a creature of habit, and heaven knows I need the caffeine. If it also boosts my immune system, so much the better.

Besides, we still have that universal antimicrobial called chicken soup.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Unnecessary or incorrect use of topical antifungal medications is driving the spread of fungal infections like ringworm, which are becoming more difficult to treat, according to a January 11 study published in Morbidity and Mortality Weekly Report. 

If a patient’s condition is not caused by a fungus but is treated as such, treatment will be ineffective.

The authors strongly advise primary care clinicians to confirm ringworm diagnoses through lab testing before prescribing treatments such as clotrimazole or combinations of antifungals and corticosteroids. And because many topical treatments are also available over-the-counter, doctors should advise patients about how to use them correctly.

“In the last few years, there have been many antifungal resistant cases of tinea corporisand onychomycosisreported,” or ringworm and finger or toenail infections, respectively, said Shari Lipner, MD, PhD, a dermatologist at Weill Cornell Medicine in New York, and an author of the study.

Many of these cases originated in South Asia and have also been reported in Europe and Canada. In 2023, the first cases of a new strain of antifungal-resistant ringworm were reported in the United States. This species, Trichophyton indotineae, does not respond to topical medications, requiring oral treatment instead.

“It’s really a serious problem and a huge public health concern,” Dr. Lipner said. 

For the new study, Dr. Lipner and colleagues examined prescription patterns from 2021 Medicare Part D claims of topical antifungals. They report that 6.5 million topical antifungal prescriptions were filled that year, some of which included steroids in the formulation. Primary care clinicians wrote 40% of these prescriptions, the most for any clinician group. The estimate is almost certainly an undercount of topical antifungal use because the database did not include over-the-counter purchases or data from other insurance payers.

The number of prescriptions equate to 1 in every 8 Medicare Part D beneficiary receiving an antifungal, the researchers reported. 

“If I think about the patients that come into my office, I’m certainly not giving an antifungal to 1 in 8 of them, and I see a lot of fungal infections,” Dr. Lipner said. The findings suggest to Dr. Lipner that some clinicians are diagnosing ringworm by eyesight alone rather than confirming the diagnosis with techniques such as microscopy, fungal culture testing, or polymerase chain reaction testing. 

Sometimes what looks like ringworm may actually be eczema, in which case, the topical antifungal would not be appropriate, according to Avrom Caplan, MD, a dermatologist at NYU Langone Health in New York.

“If you’re prescribing something to somebody that they don’t need, you’re basically exposing them to the side effects without the benefit,” Dr. Caplan, who was not part of the study, said. 

Dr. Caplan, who reported the first cases of ringworm that only responded to oral medications in the United States, stressed that topical treatments work fine for many ringworm cases today. But if indiscriminate prescribing spurs the development of more resilient fungi, more situations may arise in which only oral medications work in the future, Dr. Caplan said. In addition, oral medications are inherently more demanding on a patient than something they can rub on their skin, Dr. Caplan added.

“We hope that physicians will really think hard about this study and change their practices if they’re not confirming the diagnosis,” Dr. Lipner said.

Dr. Lipner and Dr. Caplan report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Unnecessary or incorrect use of topical antifungal medications is driving the spread of fungal infections like ringworm, which are becoming more difficult to treat, according to a January 11 study published in Morbidity and Mortality Weekly Report. 

If a patient’s condition is not caused by a fungus but is treated as such, treatment will be ineffective.

The authors strongly advise primary care clinicians to confirm ringworm diagnoses through lab testing before prescribing treatments such as clotrimazole or combinations of antifungals and corticosteroids. And because many topical treatments are also available over-the-counter, doctors should advise patients about how to use them correctly.

“In the last few years, there have been many antifungal resistant cases of tinea corporisand onychomycosisreported,” or ringworm and finger or toenail infections, respectively, said Shari Lipner, MD, PhD, a dermatologist at Weill Cornell Medicine in New York, and an author of the study.

Many of these cases originated in South Asia and have also been reported in Europe and Canada. In 2023, the first cases of a new strain of antifungal-resistant ringworm were reported in the United States. This species, Trichophyton indotineae, does not respond to topical medications, requiring oral treatment instead.

“It’s really a serious problem and a huge public health concern,” Dr. Lipner said. 

For the new study, Dr. Lipner and colleagues examined prescription patterns from 2021 Medicare Part D claims of topical antifungals. They report that 6.5 million topical antifungal prescriptions were filled that year, some of which included steroids in the formulation. Primary care clinicians wrote 40% of these prescriptions, the most for any clinician group. The estimate is almost certainly an undercount of topical antifungal use because the database did not include over-the-counter purchases or data from other insurance payers.

The number of prescriptions equate to 1 in every 8 Medicare Part D beneficiary receiving an antifungal, the researchers reported. 

“If I think about the patients that come into my office, I’m certainly not giving an antifungal to 1 in 8 of them, and I see a lot of fungal infections,” Dr. Lipner said. The findings suggest to Dr. Lipner that some clinicians are diagnosing ringworm by eyesight alone rather than confirming the diagnosis with techniques such as microscopy, fungal culture testing, or polymerase chain reaction testing. 

Sometimes what looks like ringworm may actually be eczema, in which case, the topical antifungal would not be appropriate, according to Avrom Caplan, MD, a dermatologist at NYU Langone Health in New York.

“If you’re prescribing something to somebody that they don’t need, you’re basically exposing them to the side effects without the benefit,” Dr. Caplan, who was not part of the study, said. 

Dr. Caplan, who reported the first cases of ringworm that only responded to oral medications in the United States, stressed that topical treatments work fine for many ringworm cases today. But if indiscriminate prescribing spurs the development of more resilient fungi, more situations may arise in which only oral medications work in the future, Dr. Caplan said. In addition, oral medications are inherently more demanding on a patient than something they can rub on their skin, Dr. Caplan added.

“We hope that physicians will really think hard about this study and change their practices if they’re not confirming the diagnosis,” Dr. Lipner said.

Dr. Lipner and Dr. Caplan report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Unnecessary or incorrect use of topical antifungal medications is driving the spread of fungal infections like ringworm, which are becoming more difficult to treat, according to a January 11 study published in Morbidity and Mortality Weekly Report. 

If a patient’s condition is not caused by a fungus but is treated as such, treatment will be ineffective.

The authors strongly advise primary care clinicians to confirm ringworm diagnoses through lab testing before prescribing treatments such as clotrimazole or combinations of antifungals and corticosteroids. And because many topical treatments are also available over-the-counter, doctors should advise patients about how to use them correctly.

“In the last few years, there have been many antifungal resistant cases of tinea corporisand onychomycosisreported,” or ringworm and finger or toenail infections, respectively, said Shari Lipner, MD, PhD, a dermatologist at Weill Cornell Medicine in New York, and an author of the study.

Many of these cases originated in South Asia and have also been reported in Europe and Canada. In 2023, the first cases of a new strain of antifungal-resistant ringworm were reported in the United States. This species, Trichophyton indotineae, does not respond to topical medications, requiring oral treatment instead.

“It’s really a serious problem and a huge public health concern,” Dr. Lipner said. 

For the new study, Dr. Lipner and colleagues examined prescription patterns from 2021 Medicare Part D claims of topical antifungals. They report that 6.5 million topical antifungal prescriptions were filled that year, some of which included steroids in the formulation. Primary care clinicians wrote 40% of these prescriptions, the most for any clinician group. The estimate is almost certainly an undercount of topical antifungal use because the database did not include over-the-counter purchases or data from other insurance payers.

The number of prescriptions equate to 1 in every 8 Medicare Part D beneficiary receiving an antifungal, the researchers reported. 

“If I think about the patients that come into my office, I’m certainly not giving an antifungal to 1 in 8 of them, and I see a lot of fungal infections,” Dr. Lipner said. The findings suggest to Dr. Lipner that some clinicians are diagnosing ringworm by eyesight alone rather than confirming the diagnosis with techniques such as microscopy, fungal culture testing, or polymerase chain reaction testing. 

Sometimes what looks like ringworm may actually be eczema, in which case, the topical antifungal would not be appropriate, according to Avrom Caplan, MD, a dermatologist at NYU Langone Health in New York.

“If you’re prescribing something to somebody that they don’t need, you’re basically exposing them to the side effects without the benefit,” Dr. Caplan, who was not part of the study, said. 

Dr. Caplan, who reported the first cases of ringworm that only responded to oral medications in the United States, stressed that topical treatments work fine for many ringworm cases today. But if indiscriminate prescribing spurs the development of more resilient fungi, more situations may arise in which only oral medications work in the future, Dr. Caplan said. In addition, oral medications are inherently more demanding on a patient than something they can rub on their skin, Dr. Caplan added.

“We hope that physicians will really think hard about this study and change their practices if they’re not confirming the diagnosis,” Dr. Lipner said.

Dr. Lipner and Dr. Caplan report no relevant financial relationships.

A version of this article appeared on Medscape.com.