MDedge Infectious Disease

When they started the open biopsy, surgeons didn’t know what they were going to find, but they certainly didn’t expect this.

The stringlike worm was five-sixteenths of an inch long, was alive, and wiggled.

“It stunned everyone in that operating theater,” Sanjaya Senanayake, MBBS, an associate professor of infectious disease at Australian National University, Canberra, and senior author of the case report, said in an interview. “When you operate on a brain, you don’t expect to find anything alive.”

The parasitic worm was about half the width of a dime. Helminths like it can usually be seen with the naked eye but are often found in the intestines after being transmitted by soil and infecting the gastrointestinal tract. But this one made it into a woman’s brain in a first-of-its-kind case reported in the journal Emerging Infectious Diseases).

“We weren’t suspecting a worm at all,” Dr. Senanayake said. “There was something abnormal there. Was it going to be granulomatous lesion? Was it going to be cancer? Who knows, but it needed to be biopsied, and a worm was the last thing at the back of anyone’s mind,” he said.
 

A year of inexplicable symptoms

The 64-year-old woman was diagnosed with pneumonia and had a high white blood cell count, low hemoglobin, high platelets, and a very high C-reactive protein of 102 mg/L.

She hadn’t fully recovered from her illness when the abdominal pain and diarrhea started. And then she had a dry cough and night sweats.

After 3 weeks of discomfort, she was admitted to the hospital. She had a history of diabetes, hypothyroidism, and depression, and doctors began looking for answers to her acute illness.

They tested for autoimmune diseases and parasitic infections and prescribed prednisolone to help ease symptoms.

But 3 weeks later, her fever and cough persisted, and she was readmitted to the hospital. Doctors ordered more tests, and her eosinophils were still high, plus there were lesions on her liver, spleen, and lungs.

But tests were negative for bacterial, fungal, and mycobacterial cultures. Her stools showed no evidence of parasites.

She was prescribed mycophenolate and then ivermectin in case her tests for roundworm were a false negative. Doctors suspected Strongyloides, but lesions remained on her spleen even as the liver and lung lesions improved.

Reducing the prednisolone dose affected respiratory symptoms, so by January 2022, a year after initial symptoms began, the medical team added the monoclonal antibody mepolizumab. But her symptoms worsened, and she developed forgetfulness and more depression.

After a brain MRI revealed a right frontal lobe lesion, the team recommended an open biopsy and discovered the worm. The specimen was Ophidascaris robertsi, the intestinal roundworm typically of the carpet python. Never before seen in a human, the only other animals in its life cycle are small marsupials or mammals consumed by pythons.
 

A snake’s bug

Although this is the first case of an Ophidascaris infection in a human, other cases could occur, warn the doctors in their case report.

The best guess for how the patient contracted the infection was by inadvertently consuming larval eggs on wild vegetation that she collected near her home to eat. She lived near a lake known to be home to carpet pythons, so the eggs could have been on the plants she collected or on her hands or kitchen equipment.

“If you’re foraging or using native grasses or plants in recipes, it would be a good idea to cook those instead of having a salad,” Dr. Senanayake said. “That would make the chance of getting something really rare even less likely.”

It’s unclear how or why the worm, which usually stays in the gut, made its way into the patient’s brain, but her long course of immunosuppressing drugs may have played a role, the team points out. “If the normal immune barriers are reduced, then it’s easier for the parasite to move around between organ systems,” Dr. Senanayake said.

Doctors also wondered if she may have been getting re-infected when she went home between hospital admissions. After removing the worm, she received 4 weeks of treatment with albendazole to eliminate any other possible larvae in other organs, especially since Ophidascaris larvae have been known to survive for long periods – more than 4 years in laboratory rats. “The hope is that she’s been cured of this parasitic infection,” Dr. Senanayake said.

As people around the world contend with the global COVID pandemic, they might not realize that new infections are arising around the world every year, he explained.
 

Novel parasitic infections

“The reality is that 30 new infections appeared in the last 30 years, and three-quarters of them are zoonotic, animal infections spilling over into the human world,” Dr. Senanayake said.

Though some of that number is the result of improved surveillance and diagnostics, a real increase has been occurring as human settlements continue expanding.

“This is just a reflection of how burgeoning human populations are encroaching upon animal habitats, and we’re getting more interactions between humans and wild animals, domestic animals and wild animals, and humans and natural flora, which is increasing the risk of this type of infection being recognized,” he explained.

The Ophidascaris worm found in this instance is in other snake species in different continents around the world, too. “Awareness of this case will hopefully lead to the diagnosis and treatment of other cases,” Dr. Senanayake added.

Though it’s certainly surprising to find this particular parasite in a human, finding a zoonotic organism in a person isn’t that strange, according to Janet Foley, DVM, PhD, a professor of veterinary medicine at the University of California, Davis. This is especially true if the usual host is closely related to humans, like primates, or spends a lot of time around them, like rats.

“There are still a lot of parasites and diseases out there in wildlife that haven’t been discovered, and we don’t know the risk,” said Dr. Foley. “But still, the risk would have to be low, generally, or we would see more human cases.”

In the United States, the roundworm common in raccoon feces is Baylisascaris procyonis and can be dangerous for people. “There have been deaths in people exposed to these worms, which do seem to prefer to travel to a human brain,” Dr. Foley said.

A 2016 Centers for Disease Control and Prevention report described seven U.S. cases identified between May 2013 and December 2015, including six that caused central nervous system disease. Another case report in 2018 involved a toddler who had eaten dirt and animal feces in his backyard.

And this past June, an Emerging Infectious Diseases case report described a B. procyonis infection in a 7-year-old with autism spectrum disorder and a history of pica. He had put material in his mouth from the ground near a tree where epidemiologists later found raccoon feces.

Still, Dr. Senanayake cautions against people jumping to conclusions about parasitic infections when they experience symptoms that aren’t otherwise immediately explainable.

The typical person who develops forgetfulness, depression, and a fever probably doesn’t have a worm in their brain or need an immediate MRI, he pointed out. “There may be other cases out there, but common things happen commonly, and this is likely to be rare,” Dr. Senanayake said.

This case demonstrates the challenge in picking a course of treatment when the differential diagnoses for hypereosinophilic syndromes is so broad.
 

Tricky hypereosinophilic syndromes

One of those differentials for the syndromes is parasitic infections, for which treatment would be antiparasitic agents, but another differential is an autoimmune condition that would call for immunosuppression.

“Obviously, as with this case, you don’t want to give someone immunosuppressive treatment if they’ve got a parasite, so you want to look really hard for a parasite before you start them on immunosuppressive treatment for an immunological condition,” Dr. Senanayake said.

But all the blood tests for different antibodies came back negative for parasites, “and this parasite was simply difficult to find until they pulled it from her brain,” he said.

Infectious disease physicians are always looking for the unusual and exotic, Dr. Senanayake explained. But it’s important to exclude the common, easy things first, he added. It’s after exhausting all the likely culprits that “you have to start really thinking laterally and putting resources into unusual tests.”

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

When they started the open biopsy, surgeons didn’t know what they were going to find, but they certainly didn’t expect this.

The stringlike worm was five-sixteenths of an inch long, was alive, and wiggled.

“It stunned everyone in that operating theater,” Sanjaya Senanayake, MBBS, an associate professor of infectious disease at Australian National University, Canberra, and senior author of the case report, said in an interview. “When you operate on a brain, you don’t expect to find anything alive.”

The parasitic worm was about half the width of a dime. Helminths like it can usually be seen with the naked eye but are often found in the intestines after being transmitted by soil and infecting the gastrointestinal tract. But this one made it into a woman’s brain in a first-of-its-kind case reported in the journal Emerging Infectious Diseases).

“We weren’t suspecting a worm at all,” Dr. Senanayake said. “There was something abnormal there. Was it going to be granulomatous lesion? Was it going to be cancer? Who knows, but it needed to be biopsied, and a worm was the last thing at the back of anyone’s mind,” he said.
 

A year of inexplicable symptoms

The 64-year-old woman was diagnosed with pneumonia and had a high white blood cell count, low hemoglobin, high platelets, and a very high C-reactive protein of 102 mg/L.

She hadn’t fully recovered from her illness when the abdominal pain and diarrhea started. And then she had a dry cough and night sweats.

After 3 weeks of discomfort, she was admitted to the hospital. She had a history of diabetes, hypothyroidism, and depression, and doctors began looking for answers to her acute illness.

They tested for autoimmune diseases and parasitic infections and prescribed prednisolone to help ease symptoms.

But 3 weeks later, her fever and cough persisted, and she was readmitted to the hospital. Doctors ordered more tests, and her eosinophils were still high, plus there were lesions on her liver, spleen, and lungs.

But tests were negative for bacterial, fungal, and mycobacterial cultures. Her stools showed no evidence of parasites.

She was prescribed mycophenolate and then ivermectin in case her tests for roundworm were a false negative. Doctors suspected Strongyloides, but lesions remained on her spleen even as the liver and lung lesions improved.

Reducing the prednisolone dose affected respiratory symptoms, so by January 2022, a year after initial symptoms began, the medical team added the monoclonal antibody mepolizumab. But her symptoms worsened, and she developed forgetfulness and more depression.

After a brain MRI revealed a right frontal lobe lesion, the team recommended an open biopsy and discovered the worm. The specimen was Ophidascaris robertsi, the intestinal roundworm typically of the carpet python. Never before seen in a human, the only other animals in its life cycle are small marsupials or mammals consumed by pythons.
 

A snake’s bug

Although this is the first case of an Ophidascaris infection in a human, other cases could occur, warn the doctors in their case report.

The best guess for how the patient contracted the infection was by inadvertently consuming larval eggs on wild vegetation that she collected near her home to eat. She lived near a lake known to be home to carpet pythons, so the eggs could have been on the plants she collected or on her hands or kitchen equipment.

“If you’re foraging or using native grasses or plants in recipes, it would be a good idea to cook those instead of having a salad,” Dr. Senanayake said. “That would make the chance of getting something really rare even less likely.”

It’s unclear how or why the worm, which usually stays in the gut, made its way into the patient’s brain, but her long course of immunosuppressing drugs may have played a role, the team points out. “If the normal immune barriers are reduced, then it’s easier for the parasite to move around between organ systems,” Dr. Senanayake said.

Doctors also wondered if she may have been getting re-infected when she went home between hospital admissions. After removing the worm, she received 4 weeks of treatment with albendazole to eliminate any other possible larvae in other organs, especially since Ophidascaris larvae have been known to survive for long periods – more than 4 years in laboratory rats. “The hope is that she’s been cured of this parasitic infection,” Dr. Senanayake said.

As people around the world contend with the global COVID pandemic, they might not realize that new infections are arising around the world every year, he explained.
 

Novel parasitic infections

“The reality is that 30 new infections appeared in the last 30 years, and three-quarters of them are zoonotic, animal infections spilling over into the human world,” Dr. Senanayake said.

Though some of that number is the result of improved surveillance and diagnostics, a real increase has been occurring as human settlements continue expanding.

“This is just a reflection of how burgeoning human populations are encroaching upon animal habitats, and we’re getting more interactions between humans and wild animals, domestic animals and wild animals, and humans and natural flora, which is increasing the risk of this type of infection being recognized,” he explained.

The Ophidascaris worm found in this instance is in other snake species in different continents around the world, too. “Awareness of this case will hopefully lead to the diagnosis and treatment of other cases,” Dr. Senanayake added.

Though it’s certainly surprising to find this particular parasite in a human, finding a zoonotic organism in a person isn’t that strange, according to Janet Foley, DVM, PhD, a professor of veterinary medicine at the University of California, Davis. This is especially true if the usual host is closely related to humans, like primates, or spends a lot of time around them, like rats.

“There are still a lot of parasites and diseases out there in wildlife that haven’t been discovered, and we don’t know the risk,” said Dr. Foley. “But still, the risk would have to be low, generally, or we would see more human cases.”

In the United States, the roundworm common in raccoon feces is Baylisascaris procyonis and can be dangerous for people. “There have been deaths in people exposed to these worms, which do seem to prefer to travel to a human brain,” Dr. Foley said.

A 2016 Centers for Disease Control and Prevention report described seven U.S. cases identified between May 2013 and December 2015, including six that caused central nervous system disease. Another case report in 2018 involved a toddler who had eaten dirt and animal feces in his backyard.

And this past June, an Emerging Infectious Diseases case report described a B. procyonis infection in a 7-year-old with autism spectrum disorder and a history of pica. He had put material in his mouth from the ground near a tree where epidemiologists later found raccoon feces.

Still, Dr. Senanayake cautions against people jumping to conclusions about parasitic infections when they experience symptoms that aren’t otherwise immediately explainable.

The typical person who develops forgetfulness, depression, and a fever probably doesn’t have a worm in their brain or need an immediate MRI, he pointed out. “There may be other cases out there, but common things happen commonly, and this is likely to be rare,” Dr. Senanayake said.

This case demonstrates the challenge in picking a course of treatment when the differential diagnoses for hypereosinophilic syndromes is so broad.
 

Tricky hypereosinophilic syndromes

One of those differentials for the syndromes is parasitic infections, for which treatment would be antiparasitic agents, but another differential is an autoimmune condition that would call for immunosuppression.

“Obviously, as with this case, you don’t want to give someone immunosuppressive treatment if they’ve got a parasite, so you want to look really hard for a parasite before you start them on immunosuppressive treatment for an immunological condition,” Dr. Senanayake said.

But all the blood tests for different antibodies came back negative for parasites, “and this parasite was simply difficult to find until they pulled it from her brain,” he said.

Infectious disease physicians are always looking for the unusual and exotic, Dr. Senanayake explained. But it’s important to exclude the common, easy things first, he added. It’s after exhausting all the likely culprits that “you have to start really thinking laterally and putting resources into unusual tests.”

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

When they started the open biopsy, surgeons didn’t know what they were going to find, but they certainly didn’t expect this.

The stringlike worm was five-sixteenths of an inch long, was alive, and wiggled.

“It stunned everyone in that operating theater,” Sanjaya Senanayake, MBBS, an associate professor of infectious disease at Australian National University, Canberra, and senior author of the case report, said in an interview. “When you operate on a brain, you don’t expect to find anything alive.”

The parasitic worm was about half the width of a dime. Helminths like it can usually be seen with the naked eye but are often found in the intestines after being transmitted by soil and infecting the gastrointestinal tract. But this one made it into a woman’s brain in a first-of-its-kind case reported in the journal Emerging Infectious Diseases).

“We weren’t suspecting a worm at all,” Dr. Senanayake said. “There was something abnormal there. Was it going to be granulomatous lesion? Was it going to be cancer? Who knows, but it needed to be biopsied, and a worm was the last thing at the back of anyone’s mind,” he said.
 

A year of inexplicable symptoms

The 64-year-old woman was diagnosed with pneumonia and had a high white blood cell count, low hemoglobin, high platelets, and a very high C-reactive protein of 102 mg/L.

She hadn’t fully recovered from her illness when the abdominal pain and diarrhea started. And then she had a dry cough and night sweats.

After 3 weeks of discomfort, she was admitted to the hospital. She had a history of diabetes, hypothyroidism, and depression, and doctors began looking for answers to her acute illness.

They tested for autoimmune diseases and parasitic infections and prescribed prednisolone to help ease symptoms.

But 3 weeks later, her fever and cough persisted, and she was readmitted to the hospital. Doctors ordered more tests, and her eosinophils were still high, plus there were lesions on her liver, spleen, and lungs.

But tests were negative for bacterial, fungal, and mycobacterial cultures. Her stools showed no evidence of parasites.

She was prescribed mycophenolate and then ivermectin in case her tests for roundworm were a false negative. Doctors suspected Strongyloides, but lesions remained on her spleen even as the liver and lung lesions improved.

Reducing the prednisolone dose affected respiratory symptoms, so by January 2022, a year after initial symptoms began, the medical team added the monoclonal antibody mepolizumab. But her symptoms worsened, and she developed forgetfulness and more depression.

After a brain MRI revealed a right frontal lobe lesion, the team recommended an open biopsy and discovered the worm. The specimen was Ophidascaris robertsi, the intestinal roundworm typically of the carpet python. Never before seen in a human, the only other animals in its life cycle are small marsupials or mammals consumed by pythons.
 

A snake’s bug

Although this is the first case of an Ophidascaris infection in a human, other cases could occur, warn the doctors in their case report.

The best guess for how the patient contracted the infection was by inadvertently consuming larval eggs on wild vegetation that she collected near her home to eat. She lived near a lake known to be home to carpet pythons, so the eggs could have been on the plants she collected or on her hands or kitchen equipment.

“If you’re foraging or using native grasses or plants in recipes, it would be a good idea to cook those instead of having a salad,” Dr. Senanayake said. “That would make the chance of getting something really rare even less likely.”

It’s unclear how or why the worm, which usually stays in the gut, made its way into the patient’s brain, but her long course of immunosuppressing drugs may have played a role, the team points out. “If the normal immune barriers are reduced, then it’s easier for the parasite to move around between organ systems,” Dr. Senanayake said.

Doctors also wondered if she may have been getting re-infected when she went home between hospital admissions. After removing the worm, she received 4 weeks of treatment with albendazole to eliminate any other possible larvae in other organs, especially since Ophidascaris larvae have been known to survive for long periods – more than 4 years in laboratory rats. “The hope is that she’s been cured of this parasitic infection,” Dr. Senanayake said.

As people around the world contend with the global COVID pandemic, they might not realize that new infections are arising around the world every year, he explained.
 

Novel parasitic infections

“The reality is that 30 new infections appeared in the last 30 years, and three-quarters of them are zoonotic, animal infections spilling over into the human world,” Dr. Senanayake said.

Though some of that number is the result of improved surveillance and diagnostics, a real increase has been occurring as human settlements continue expanding.

“This is just a reflection of how burgeoning human populations are encroaching upon animal habitats, and we’re getting more interactions between humans and wild animals, domestic animals and wild animals, and humans and natural flora, which is increasing the risk of this type of infection being recognized,” he explained.

The Ophidascaris worm found in this instance is in other snake species in different continents around the world, too. “Awareness of this case will hopefully lead to the diagnosis and treatment of other cases,” Dr. Senanayake added.

Though it’s certainly surprising to find this particular parasite in a human, finding a zoonotic organism in a person isn’t that strange, according to Janet Foley, DVM, PhD, a professor of veterinary medicine at the University of California, Davis. This is especially true if the usual host is closely related to humans, like primates, or spends a lot of time around them, like rats.

“There are still a lot of parasites and diseases out there in wildlife that haven’t been discovered, and we don’t know the risk,” said Dr. Foley. “But still, the risk would have to be low, generally, or we would see more human cases.”

In the United States, the roundworm common in raccoon feces is Baylisascaris procyonis and can be dangerous for people. “There have been deaths in people exposed to these worms, which do seem to prefer to travel to a human brain,” Dr. Foley said.

A 2016 Centers for Disease Control and Prevention report described seven U.S. cases identified between May 2013 and December 2015, including six that caused central nervous system disease. Another case report in 2018 involved a toddler who had eaten dirt and animal feces in his backyard.

And this past June, an Emerging Infectious Diseases case report described a B. procyonis infection in a 7-year-old with autism spectrum disorder and a history of pica. He had put material in his mouth from the ground near a tree where epidemiologists later found raccoon feces.

Still, Dr. Senanayake cautions against people jumping to conclusions about parasitic infections when they experience symptoms that aren’t otherwise immediately explainable.

The typical person who develops forgetfulness, depression, and a fever probably doesn’t have a worm in their brain or need an immediate MRI, he pointed out. “There may be other cases out there, but common things happen commonly, and this is likely to be rare,” Dr. Senanayake said.

This case demonstrates the challenge in picking a course of treatment when the differential diagnoses for hypereosinophilic syndromes is so broad.
 

Tricky hypereosinophilic syndromes

One of those differentials for the syndromes is parasitic infections, for which treatment would be antiparasitic agents, but another differential is an autoimmune condition that would call for immunosuppression.

“Obviously, as with this case, you don’t want to give someone immunosuppressive treatment if they’ve got a parasite, so you want to look really hard for a parasite before you start them on immunosuppressive treatment for an immunological condition,” Dr. Senanayake said.

But all the blood tests for different antibodies came back negative for parasites, “and this parasite was simply difficult to find until they pulled it from her brain,” he said.

Infectious disease physicians are always looking for the unusual and exotic, Dr. Senanayake explained. But it’s important to exclude the common, easy things first, he added. It’s after exhausting all the likely culprits that “you have to start really thinking laterally and putting resources into unusual tests.”

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

A real-world study published in  JAMA Open Network found that Pfizer’s COVID-19 antiviral Paxlovid is now less effective at preventing hospitalization or death in high-risk patients, compared with earlier studies. But when looking at death alone, the antiviral was still highly effective. 

Paxlovid was about 37% effective at preventing death or hospitalization in high-risk patients, compared with no treatment. The study also looked at the antiviral Lagevrio, made by Merck, and found it was about 41% effective. In preventing death alone, Paxlovid was about 84% effective, compared with no treatment, and Lagevrio was about 77% effective.

The investigators, of the University of North Carolina at Chapel Hill and the Cleveland Clinic, examined electronic health records of 68,867 patients at hospitals in Cleveland and Florida who were diagnosed with COVID from April 1, 2022, to Feb. 20, 2023.

For Paxlovid, the effectiveness against death and hospitalization was lower than the effectiveness rate of about 86% found in clinical trials in 2021, according to Bloomberg. 

The difference in effectiveness in the real-world and clinical studies may have occurred because the early studies were conducted with unvaccinated people. Also, the virus has evolved since those first studies, Bloomberg reported. 

The researchers said Paxlovid and Lagevrio are recommended for use because they reduce hospitalization and death among high-risk patients who get COVID, even taking recent Omicron subvariants into account.

“These findings suggest that the use of either nirmatrelvir (Paxlovid) or molnupiravir (Lagevrio) is associated with reductions in mortality and hospitalization in patients infected with Omicron, regardless of age, race and ethnicity, virus strain, vaccination status, previous infection status, or coexisting conditions,” the researchers wrote. “Both drugs can, therefore, be used to treat nonhospitalized patients who are at high risk of progressing to severe COVID-19.”

Both drugs should be taken within 5 days of the onset of COVID symptoms.

The study was supported by the National Institutes of Health. Three coauthors reported conflicts of interest with various companies and organizations.

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

A real-world study published in  JAMA Open Network found that Pfizer’s COVID-19 antiviral Paxlovid is now less effective at preventing hospitalization or death in high-risk patients, compared with earlier studies. But when looking at death alone, the antiviral was still highly effective. 

Paxlovid was about 37% effective at preventing death or hospitalization in high-risk patients, compared with no treatment. The study also looked at the antiviral Lagevrio, made by Merck, and found it was about 41% effective. In preventing death alone, Paxlovid was about 84% effective, compared with no treatment, and Lagevrio was about 77% effective.

The investigators, of the University of North Carolina at Chapel Hill and the Cleveland Clinic, examined electronic health records of 68,867 patients at hospitals in Cleveland and Florida who were diagnosed with COVID from April 1, 2022, to Feb. 20, 2023.

For Paxlovid, the effectiveness against death and hospitalization was lower than the effectiveness rate of about 86% found in clinical trials in 2021, according to Bloomberg. 

The difference in effectiveness in the real-world and clinical studies may have occurred because the early studies were conducted with unvaccinated people. Also, the virus has evolved since those first studies, Bloomberg reported. 

The researchers said Paxlovid and Lagevrio are recommended for use because they reduce hospitalization and death among high-risk patients who get COVID, even taking recent Omicron subvariants into account.

“These findings suggest that the use of either nirmatrelvir (Paxlovid) or molnupiravir (Lagevrio) is associated with reductions in mortality and hospitalization in patients infected with Omicron, regardless of age, race and ethnicity, virus strain, vaccination status, previous infection status, or coexisting conditions,” the researchers wrote. “Both drugs can, therefore, be used to treat nonhospitalized patients who are at high risk of progressing to severe COVID-19.”

Both drugs should be taken within 5 days of the onset of COVID symptoms.

The study was supported by the National Institutes of Health. Three coauthors reported conflicts of interest with various companies and organizations.

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

A real-world study published in  JAMA Open Network found that Pfizer’s COVID-19 antiviral Paxlovid is now less effective at preventing hospitalization or death in high-risk patients, compared with earlier studies. But when looking at death alone, the antiviral was still highly effective. 

Paxlovid was about 37% effective at preventing death or hospitalization in high-risk patients, compared with no treatment. The study also looked at the antiviral Lagevrio, made by Merck, and found it was about 41% effective. In preventing death alone, Paxlovid was about 84% effective, compared with no treatment, and Lagevrio was about 77% effective.

The investigators, of the University of North Carolina at Chapel Hill and the Cleveland Clinic, examined electronic health records of 68,867 patients at hospitals in Cleveland and Florida who were diagnosed with COVID from April 1, 2022, to Feb. 20, 2023.

For Paxlovid, the effectiveness against death and hospitalization was lower than the effectiveness rate of about 86% found in clinical trials in 2021, according to Bloomberg. 

The difference in effectiveness in the real-world and clinical studies may have occurred because the early studies were conducted with unvaccinated people. Also, the virus has evolved since those first studies, Bloomberg reported. 

The researchers said Paxlovid and Lagevrio are recommended for use because they reduce hospitalization and death among high-risk patients who get COVID, even taking recent Omicron subvariants into account.

“These findings suggest that the use of either nirmatrelvir (Paxlovid) or molnupiravir (Lagevrio) is associated with reductions in mortality and hospitalization in patients infected with Omicron, regardless of age, race and ethnicity, virus strain, vaccination status, previous infection status, or coexisting conditions,” the researchers wrote. “Both drugs can, therefore, be used to treat nonhospitalized patients who are at high risk of progressing to severe COVID-19.”

Both drugs should be taken within 5 days of the onset of COVID symptoms.

The study was supported by the National Institutes of Health. Three coauthors reported conflicts of interest with various companies and organizations.

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

Adults with nonsevere community-acquired pneumonia (CAP) responded nearly equally to three first-line and alternative antibiotic regimens, based on data from more than 23,000 individuals.

Current recommendations for the treatment of CAP vary across guidelines, wrote Anthony D. Bai, MD, of Queen’s University, Kingston, Ont., and colleagues. However, most guidelines were based on studies that were not powered to examine the effect of treatments on mortality, they said.

“Large observational studies could fill this gap by comparing multiple treatment arms, including patients not well represented in trials, and having a large sample size powered to detect a difference in mortality,” they noted.

In a study published in Chest, the researchers reviewed data from 23,512 consecutive patients admitted to 19 hospitals in Canada for CAP between 2015 and 2021. Patients were treated with one of four initial antibiotic regimens: beta-lactam plus macrolide (BL+M), beta-lactam alone (BL), respiratory fluoroquinolone (FQ), or beta-lactam plus doxycycline (BL+D). Of these, BL+M is generally considered the first-line regimen, the researchers noted.

Patients were divided into four groups according to their initial antibiotic treatment within 48 hours of admission; 9,340 patients received BL+M, 9,146 received BL, 4,510 received FQ, and 516 received BL+D. The duration of any antibiotic that was active against CAP was at least 4 days, or until hospital discharge or death.

The primary outcome was all-cause in-hospital mortality, which was 7.5%, 9.7%, 6.7%, and 6.0% for patients in each of the four treatment groups, respectively. Relative to the first-line therapy of BL+M, the adjusted risk differences for BL, FQ, and BL+D were 1.5%, –0.9%, and –1.9%, respectively.

The adjusted in-hospital mortality was not significantly different between BL+M and either FQ or BL+D, but the difference of 1.5% seen with BL alone suggested a “small but clinically important difference,” the researchers noted.

Key secondary outcomes were the length of hospital stay and being discharged alive. The median length of stay was 4.6 days for BL+M, 5.2 days for BL, 4.6 days for FQ, and 6.0 days for BL+D. Patients treated with BL also had a longer time to hospital discharge, which suggests that BL may not be as effective as the other regimens, the researchers said. In addition, patients in the BL group had a subdistribution hazard ratio of 0.90 for being discharged alive, compared with the BL+M group after adjustment with propensity scores and overlap weighting.

Overall, the results support dropping BL as a first-line regimen in the current ATS/IDSA guidelines, and support the recommendation of BL+M, FQ, and BL+D as similarly effective options as listed in other guidelines, applied according to other patient characteristics. For example, “Doxycycline may be preferred over a macrolide in many cases such as macrolide allergy, prolonged QT, or high [Clostridioides] difficile risk,” the researchers said.

The findings were limited by several factors including the lack of follow-up data after hospital discharge.

However, the results were strengthened by the large sample size and use of a comprehensive database that allowed adjustment for many variables, as well as the availability of complete follow-up data for the time spent in the hospital. Based on this study, clinicians may choose a respiratory fluoroquinolone, a beta-lactam plus macrolide, or a beta-lactam plus doxycycline for equally effective antibiotic treatment of CAP, based on the best fit for each individual patient, the researchers concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Adults with nonsevere community-acquired pneumonia (CAP) responded nearly equally to three first-line and alternative antibiotic regimens, based on data from more than 23,000 individuals.

Current recommendations for the treatment of CAP vary across guidelines, wrote Anthony D. Bai, MD, of Queen’s University, Kingston, Ont., and colleagues. However, most guidelines were based on studies that were not powered to examine the effect of treatments on mortality, they said.

“Large observational studies could fill this gap by comparing multiple treatment arms, including patients not well represented in trials, and having a large sample size powered to detect a difference in mortality,” they noted.

In a study published in Chest, the researchers reviewed data from 23,512 consecutive patients admitted to 19 hospitals in Canada for CAP between 2015 and 2021. Patients were treated with one of four initial antibiotic regimens: beta-lactam plus macrolide (BL+M), beta-lactam alone (BL), respiratory fluoroquinolone (FQ), or beta-lactam plus doxycycline (BL+D). Of these, BL+M is generally considered the first-line regimen, the researchers noted.

Patients were divided into four groups according to their initial antibiotic treatment within 48 hours of admission; 9,340 patients received BL+M, 9,146 received BL, 4,510 received FQ, and 516 received BL+D. The duration of any antibiotic that was active against CAP was at least 4 days, or until hospital discharge or death.

The primary outcome was all-cause in-hospital mortality, which was 7.5%, 9.7%, 6.7%, and 6.0% for patients in each of the four treatment groups, respectively. Relative to the first-line therapy of BL+M, the adjusted risk differences for BL, FQ, and BL+D were 1.5%, –0.9%, and –1.9%, respectively.

The adjusted in-hospital mortality was not significantly different between BL+M and either FQ or BL+D, but the difference of 1.5% seen with BL alone suggested a “small but clinically important difference,” the researchers noted.

Key secondary outcomes were the length of hospital stay and being discharged alive. The median length of stay was 4.6 days for BL+M, 5.2 days for BL, 4.6 days for FQ, and 6.0 days for BL+D. Patients treated with BL also had a longer time to hospital discharge, which suggests that BL may not be as effective as the other regimens, the researchers said. In addition, patients in the BL group had a subdistribution hazard ratio of 0.90 for being discharged alive, compared with the BL+M group after adjustment with propensity scores and overlap weighting.

Overall, the results support dropping BL as a first-line regimen in the current ATS/IDSA guidelines, and support the recommendation of BL+M, FQ, and BL+D as similarly effective options as listed in other guidelines, applied according to other patient characteristics. For example, “Doxycycline may be preferred over a macrolide in many cases such as macrolide allergy, prolonged QT, or high [Clostridioides] difficile risk,” the researchers said.

The findings were limited by several factors including the lack of follow-up data after hospital discharge.

However, the results were strengthened by the large sample size and use of a comprehensive database that allowed adjustment for many variables, as well as the availability of complete follow-up data for the time spent in the hospital. Based on this study, clinicians may choose a respiratory fluoroquinolone, a beta-lactam plus macrolide, or a beta-lactam plus doxycycline for equally effective antibiotic treatment of CAP, based on the best fit for each individual patient, the researchers concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Adults with nonsevere community-acquired pneumonia (CAP) responded nearly equally to three first-line and alternative antibiotic regimens, based on data from more than 23,000 individuals.

Current recommendations for the treatment of CAP vary across guidelines, wrote Anthony D. Bai, MD, of Queen’s University, Kingston, Ont., and colleagues. However, most guidelines were based on studies that were not powered to examine the effect of treatments on mortality, they said.

“Large observational studies could fill this gap by comparing multiple treatment arms, including patients not well represented in trials, and having a large sample size powered to detect a difference in mortality,” they noted.

In a study published in Chest, the researchers reviewed data from 23,512 consecutive patients admitted to 19 hospitals in Canada for CAP between 2015 and 2021. Patients were treated with one of four initial antibiotic regimens: beta-lactam plus macrolide (BL+M), beta-lactam alone (BL), respiratory fluoroquinolone (FQ), or beta-lactam plus doxycycline (BL+D). Of these, BL+M is generally considered the first-line regimen, the researchers noted.

Patients were divided into four groups according to their initial antibiotic treatment within 48 hours of admission; 9,340 patients received BL+M, 9,146 received BL, 4,510 received FQ, and 516 received BL+D. The duration of any antibiotic that was active against CAP was at least 4 days, or until hospital discharge or death.

The primary outcome was all-cause in-hospital mortality, which was 7.5%, 9.7%, 6.7%, and 6.0% for patients in each of the four treatment groups, respectively. Relative to the first-line therapy of BL+M, the adjusted risk differences for BL, FQ, and BL+D were 1.5%, –0.9%, and –1.9%, respectively.

The adjusted in-hospital mortality was not significantly different between BL+M and either FQ or BL+D, but the difference of 1.5% seen with BL alone suggested a “small but clinically important difference,” the researchers noted.

Key secondary outcomes were the length of hospital stay and being discharged alive. The median length of stay was 4.6 days for BL+M, 5.2 days for BL, 4.6 days for FQ, and 6.0 days for BL+D. Patients treated with BL also had a longer time to hospital discharge, which suggests that BL may not be as effective as the other regimens, the researchers said. In addition, patients in the BL group had a subdistribution hazard ratio of 0.90 for being discharged alive, compared with the BL+M group after adjustment with propensity scores and overlap weighting.

Overall, the results support dropping BL as a first-line regimen in the current ATS/IDSA guidelines, and support the recommendation of BL+M, FQ, and BL+D as similarly effective options as listed in other guidelines, applied according to other patient characteristics. For example, “Doxycycline may be preferred over a macrolide in many cases such as macrolide allergy, prolonged QT, or high [Clostridioides] difficile risk,” the researchers said.

The findings were limited by several factors including the lack of follow-up data after hospital discharge.

However, the results were strengthened by the large sample size and use of a comprehensive database that allowed adjustment for many variables, as well as the availability of complete follow-up data for the time spent in the hospital. Based on this study, clinicians may choose a respiratory fluoroquinolone, a beta-lactam plus macrolide, or a beta-lactam plus doxycycline for equally effective antibiotic treatment of CAP, based on the best fit for each individual patient, the researchers concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Taking creatine as a supplement for 6 months appears to significantly improve clinical features of post–COVID-19 fatigue syndrome (PVFS or long COVID), a small randomized, placebo-controlled, double-blinded study suggests.

Researchers, led by Jelena Slankamenac, with Applied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Serbia, published their findings in Food, Science & Nutrition .

“This is the first human study known to the authors that evaluated the efficacy and safety of supplemental creatine for fatigue, tissue bioenergetics, and patient-reported outcomes in patients with post–COVID-19 fatigue syndrome,” the authors write.

They say the findings may be attributed to creatine’s “energy-replenishing and neuroprotective activity.”
 

Significant reductions in symptoms

Researchers randomized the 12 participants into two groups of 6 each. The creatine group received 4 g creatine monohydrate per day, while the placebo group received the same amount of inulin.

At 3 months, dietary creatine supplements produced a significant reduction in fatigue, compared with baseline values ( P = .04) and significantly improved scores for several long COVID–related symptoms, including loss of taste, breathing difficulties, body aches, headache, and difficulties concentrating) ( P < .05), the researchers report.

Intervention effect sizes were assessed by Cohen statistics, with a d of at least 0.8 indicating a large effect.

Among highlights of the results were that patients reported a significant 77.8% drop in scores for concentration difficulties at the 3-month follow-up (Cohen’s effect, d = 1.19) and no concentration difficulties at the 6-month follow-up (Cohen’s effect, d = 2.46).

Total creatine levels increased in several locations across the brain (as much as 33% for right parietal white matter). No changes in tissue creatine levels were found in the placebo group during the trial.

“Since PVFS is characterized by impaired tissue bioenergetics ..., supplemental creatine might be an effective dietary intervention to uphold brain creatine in post–COVID-19 fatigue syndrome,” the authors write.

The authors add that creatine supplements for long COVID patients could benefit organs beyond the brain as participants saw “a significant drop in lung and body pain after the intervention.”
 

Unanswered questions

Some experts said the results should be interpreted with caution.

“This research paper is very interesting,” says Nisha Viswanathan, MD, director of the long COVID program at University of California, Los Angeles, “but the limited number of patients makes the results difficult to generalize.”

Dr. Viswanathan, who was not part of the study, pointed out that the patients included in this study had a recent COVID infection (under 3 months).

“Acute COVID infection can take up to 3 months to resolve,” she says. “We define patients with long COVID as those with symptoms lasting greater than 3 months. Therefore, these patients could have had improvements in their fatigue due to the natural course of the illness rather than creatine supplementation.”

Alba Azola, MD, assistant professor in the department of physical medicine and rehabilitation at Johns Hopkins University, Baltimore, said she also was troubled by the window of 3 months for recent COVID infection.

She said she would like to see results for patients who have ongoing symptoms for at least 6 months after infection, especially given creatine supplements’ history in research.

Creatine supplements for other conditions, such as fibromyalgia and chronic fatigue syndrome, have been tested for nearly 2 decades, she pointed out, with conflicting findings, something the authors acknowledge in the paper.

“I think it’s premature to say (creatine) is the key,” she says. She added that the small sample size is important to consider given the heterogeneity of patients with long COVID.

That said, Dr. Azola says, she applauds all efforts to find treatments for long COVID, especially randomized, controlled studies like this one.
 

No major side effects

No major side effects were reported for either intervention, except for transient mild nausea reported by one patient after taking creatine.

Compliance with the intervention was 90.6% ± 3.5% in the creatine group and 95.3% ± 5.0% in the control group (P = .04).

Participants were eligible for inclusion if they were 18-65 years old, had a positive COVID test within the last 3 months (documented by a valid polymerase chain reaction [PCR] or antigen test performed in a COVID-19–certified lab); had moderate to severe fatigue; and at least one additional COVID-related symptom, including loss of taste or smell, breathing trouble, lung pain, body aches, headaches, or difficulties concentrating.

The authors acknowledge that they selected a sample of young to middle-aged adults experiencing moderate long COVID symptoms, and it’s unknown whether creatine is equally effective in other PVFS populations, such as elderly people, children, or patients with less or more severe disease.

Senior author Dr. Sergei Ostojic serves as a member of the Scientific Advisory Board on creatine in health and medicine (AlzChem LLC). He co-owns a patent for “Supplements Based on Liquid Creatine” at the European Patent Office. He has received research support related to creatine during the past 36 months from the Serbian Ministry of Education, Science, and Technological Development; Provincial Secretariat for Higher Education and Scientific Research; Alzchem GmbH; ThermoLife International; and Hueston Hennigan LLP. He does not own stocks and shares in any organization. Other authors declare no known relevant financial interests. Dr. Viswanathan and Dr. Azola report no relevant financial relationships.
 

Taking creatine as a supplement for 6 months appears to significantly improve clinical features of post–COVID-19 fatigue syndrome (PVFS or long COVID), a small randomized, placebo-controlled, double-blinded study suggests.

Researchers, led by Jelena Slankamenac, with Applied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Serbia, published their findings in Food, Science & Nutrition .

“This is the first human study known to the authors that evaluated the efficacy and safety of supplemental creatine for fatigue, tissue bioenergetics, and patient-reported outcomes in patients with post–COVID-19 fatigue syndrome,” the authors write.

They say the findings may be attributed to creatine’s “energy-replenishing and neuroprotective activity.”
 

Significant reductions in symptoms

Researchers randomized the 12 participants into two groups of 6 each. The creatine group received 4 g creatine monohydrate per day, while the placebo group received the same amount of inulin.

At 3 months, dietary creatine supplements produced a significant reduction in fatigue, compared with baseline values ( P = .04) and significantly improved scores for several long COVID–related symptoms, including loss of taste, breathing difficulties, body aches, headache, and difficulties concentrating) ( P < .05), the researchers report.

Intervention effect sizes were assessed by Cohen statistics, with a d of at least 0.8 indicating a large effect.

Among highlights of the results were that patients reported a significant 77.8% drop in scores for concentration difficulties at the 3-month follow-up (Cohen’s effect, d = 1.19) and no concentration difficulties at the 6-month follow-up (Cohen’s effect, d = 2.46).

Total creatine levels increased in several locations across the brain (as much as 33% for right parietal white matter). No changes in tissue creatine levels were found in the placebo group during the trial.

“Since PVFS is characterized by impaired tissue bioenergetics ..., supplemental creatine might be an effective dietary intervention to uphold brain creatine in post–COVID-19 fatigue syndrome,” the authors write.

The authors add that creatine supplements for long COVID patients could benefit organs beyond the brain as participants saw “a significant drop in lung and body pain after the intervention.”
 

Unanswered questions

Some experts said the results should be interpreted with caution.

“This research paper is very interesting,” says Nisha Viswanathan, MD, director of the long COVID program at University of California, Los Angeles, “but the limited number of patients makes the results difficult to generalize.”

Dr. Viswanathan, who was not part of the study, pointed out that the patients included in this study had a recent COVID infection (under 3 months).

“Acute COVID infection can take up to 3 months to resolve,” she says. “We define patients with long COVID as those with symptoms lasting greater than 3 months. Therefore, these patients could have had improvements in their fatigue due to the natural course of the illness rather than creatine supplementation.”

Alba Azola, MD, assistant professor in the department of physical medicine and rehabilitation at Johns Hopkins University, Baltimore, said she also was troubled by the window of 3 months for recent COVID infection.

She said she would like to see results for patients who have ongoing symptoms for at least 6 months after infection, especially given creatine supplements’ history in research.

Creatine supplements for other conditions, such as fibromyalgia and chronic fatigue syndrome, have been tested for nearly 2 decades, she pointed out, with conflicting findings, something the authors acknowledge in the paper.

“I think it’s premature to say (creatine) is the key,” she says. She added that the small sample size is important to consider given the heterogeneity of patients with long COVID.

That said, Dr. Azola says, she applauds all efforts to find treatments for long COVID, especially randomized, controlled studies like this one.
 

No major side effects

No major side effects were reported for either intervention, except for transient mild nausea reported by one patient after taking creatine.

Compliance with the intervention was 90.6% ± 3.5% in the creatine group and 95.3% ± 5.0% in the control group (P = .04).

Participants were eligible for inclusion if they were 18-65 years old, had a positive COVID test within the last 3 months (documented by a valid polymerase chain reaction [PCR] or antigen test performed in a COVID-19–certified lab); had moderate to severe fatigue; and at least one additional COVID-related symptom, including loss of taste or smell, breathing trouble, lung pain, body aches, headaches, or difficulties concentrating.

The authors acknowledge that they selected a sample of young to middle-aged adults experiencing moderate long COVID symptoms, and it’s unknown whether creatine is equally effective in other PVFS populations, such as elderly people, children, or patients with less or more severe disease.

Senior author Dr. Sergei Ostojic serves as a member of the Scientific Advisory Board on creatine in health and medicine (AlzChem LLC). He co-owns a patent for “Supplements Based on Liquid Creatine” at the European Patent Office. He has received research support related to creatine during the past 36 months from the Serbian Ministry of Education, Science, and Technological Development; Provincial Secretariat for Higher Education and Scientific Research; Alzchem GmbH; ThermoLife International; and Hueston Hennigan LLP. He does not own stocks and shares in any organization. Other authors declare no known relevant financial interests. Dr. Viswanathan and Dr. Azola report no relevant financial relationships.
 

Taking creatine as a supplement for 6 months appears to significantly improve clinical features of post–COVID-19 fatigue syndrome (PVFS or long COVID), a small randomized, placebo-controlled, double-blinded study suggests.

Researchers, led by Jelena Slankamenac, with Applied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Serbia, published their findings in Food, Science & Nutrition .

“This is the first human study known to the authors that evaluated the efficacy and safety of supplemental creatine for fatigue, tissue bioenergetics, and patient-reported outcomes in patients with post–COVID-19 fatigue syndrome,” the authors write.

They say the findings may be attributed to creatine’s “energy-replenishing and neuroprotective activity.”
 

Significant reductions in symptoms

Researchers randomized the 12 participants into two groups of 6 each. The creatine group received 4 g creatine monohydrate per day, while the placebo group received the same amount of inulin.

At 3 months, dietary creatine supplements produced a significant reduction in fatigue, compared with baseline values ( P = .04) and significantly improved scores for several long COVID–related symptoms, including loss of taste, breathing difficulties, body aches, headache, and difficulties concentrating) ( P < .05), the researchers report.

Intervention effect sizes were assessed by Cohen statistics, with a d of at least 0.8 indicating a large effect.

Among highlights of the results were that patients reported a significant 77.8% drop in scores for concentration difficulties at the 3-month follow-up (Cohen’s effect, d = 1.19) and no concentration difficulties at the 6-month follow-up (Cohen’s effect, d = 2.46).

Total creatine levels increased in several locations across the brain (as much as 33% for right parietal white matter). No changes in tissue creatine levels were found in the placebo group during the trial.

“Since PVFS is characterized by impaired tissue bioenergetics ..., supplemental creatine might be an effective dietary intervention to uphold brain creatine in post–COVID-19 fatigue syndrome,” the authors write.

The authors add that creatine supplements for long COVID patients could benefit organs beyond the brain as participants saw “a significant drop in lung and body pain after the intervention.”
 

Unanswered questions

Some experts said the results should be interpreted with caution.

“This research paper is very interesting,” says Nisha Viswanathan, MD, director of the long COVID program at University of California, Los Angeles, “but the limited number of patients makes the results difficult to generalize.”

Dr. Viswanathan, who was not part of the study, pointed out that the patients included in this study had a recent COVID infection (under 3 months).

“Acute COVID infection can take up to 3 months to resolve,” she says. “We define patients with long COVID as those with symptoms lasting greater than 3 months. Therefore, these patients could have had improvements in their fatigue due to the natural course of the illness rather than creatine supplementation.”

Alba Azola, MD, assistant professor in the department of physical medicine and rehabilitation at Johns Hopkins University, Baltimore, said she also was troubled by the window of 3 months for recent COVID infection.

She said she would like to see results for patients who have ongoing symptoms for at least 6 months after infection, especially given creatine supplements’ history in research.

Creatine supplements for other conditions, such as fibromyalgia and chronic fatigue syndrome, have been tested for nearly 2 decades, she pointed out, with conflicting findings, something the authors acknowledge in the paper.

“I think it’s premature to say (creatine) is the key,” she says. She added that the small sample size is important to consider given the heterogeneity of patients with long COVID.

That said, Dr. Azola says, she applauds all efforts to find treatments for long COVID, especially randomized, controlled studies like this one.
 

No major side effects

No major side effects were reported for either intervention, except for transient mild nausea reported by one patient after taking creatine.

Compliance with the intervention was 90.6% ± 3.5% in the creatine group and 95.3% ± 5.0% in the control group (P = .04).

Participants were eligible for inclusion if they were 18-65 years old, had a positive COVID test within the last 3 months (documented by a valid polymerase chain reaction [PCR] or antigen test performed in a COVID-19–certified lab); had moderate to severe fatigue; and at least one additional COVID-related symptom, including loss of taste or smell, breathing trouble, lung pain, body aches, headaches, or difficulties concentrating.

The authors acknowledge that they selected a sample of young to middle-aged adults experiencing moderate long COVID symptoms, and it’s unknown whether creatine is equally effective in other PVFS populations, such as elderly people, children, or patients with less or more severe disease.

Senior author Dr. Sergei Ostojic serves as a member of the Scientific Advisory Board on creatine in health and medicine (AlzChem LLC). He co-owns a patent for “Supplements Based on Liquid Creatine” at the European Patent Office. He has received research support related to creatine during the past 36 months from the Serbian Ministry of Education, Science, and Technological Development; Provincial Secretariat for Higher Education and Scientific Research; Alzchem GmbH; ThermoLife International; and Hueston Hennigan LLP. He does not own stocks and shares in any organization. Other authors declare no known relevant financial interests. Dr. Viswanathan and Dr. Azola report no relevant financial relationships.
 

HIV continues to be a significant public health concern in the United States, with an estimated 1.2 million people currently living with the virus and more than 30,000 new diagnoses in 2020 alone.

Primary care clinicians can help decrease rates of HIV infection by prescribing pre-exposure prophylaxis to people who are sexually active.

But many do not.

“In medical school, we don’t spend much time discussing sexuality, sexual behavior, sexually transmitted infections, and such, so providers may feel uncomfortable asking what kind of sex their patient is having and with whom, whether they use a condom, and other basics,” said Matthew M. Hamill, MBChB, PhD, MPH, a specialist in sexually transmitted diseases at Johns Hopkins Medicine, Baltimore.

PrEP (pre-exposure prophylaxis) is an antiviral medication that cuts the risk of contracting HIV through sex by around 99% when taken as prescribed, according to the Centers for Disease Control and Prevention.

“Many people who would benefit from PrEP are not receiving this highly effective medication,” said John B. Wong, MD, a primary care internist and professor of medicine at Tufts University, Boston. The gap is particularly acute among Black, Hispanic, and Latino people, who are significantly more likely to be diagnosed with HIV but are much less likely than Whites to receive PrEP, he said.

Dr. Wong, a member of the U.S. Preventive Services Task Force, helped write the group’s new PrEP recommendations. Published in August, the guidelines call for clinicians to prescribe the drugs to adolescents and adults who do not have HIV but are at an increased risk for infection.

“Primary care physicians are ideally positioned to prescribe PrEP for their patients because they have longitudinal relationships: They get to know their patients, and hopefully their patients feel comfortable talking with them about their sexual health,” said Brandon Pollak, MD, a primary care physician and HIV specialist at the Ohio State University College of Medicine, Columbus.

Dr. Pollak, who was not involved with the USPSTF recommendations, cares for patients who are heterosexual and living with HIV.

Clinicians should consider PrEP for all patients who have sex with someone who has HIV, do not use condoms, or have had a sexually transmitted infection within the previous 6 months. Men who have sex with men, transgender women who have sex with men, people who inject illicit drugs or engage in transactional sex, and Black, Hispanic, and Latino individuals also are at increased risk for the infection.

“The vast majority of patients on PrEP in any form sail through with no problems; they have regular lab work and can follow up in person or by telemedicine,” Dr. Hamill said. “They tend to be young, fit people without complicated medical histories, and the medications are very well-tolerated, particularly if people expect some short-term side effects.”
 

What you need to know when prescribing PrEP

Prescribing PrEP is similar in complexity to prescribing hypertension or diabetes medications, Dr. Hamill said.

Because taking the medications while already infected with the virus can lead to the emergence of drug-resistant HIV, patients must have a negative HIV test before starting PrEP. In addition, the USPSTF recommends testing for other sexually transmitted infections and for pregnancy, if appropriate. The task force also recommends conducting kidney function and hepatitis B tests, and a lipid profile before starting specific types of PrEP.

HIV screening is also recommended at 3-month intervals.

“Providers may order labs done at 3- to 4-month intervals but only see patients in clinic once or twice per year, depending on patient needs and risk behaviors,” said Jill S. Blumenthal, MD, associate professor of medicine at UC San Diego Health.

Clinicians should consider medication adherence and whether a patient is likely to take a pill once a day or could benefit from receiving an injection every 2 months. Patients may experience side effects such as diarrhea or headache with oral PrEP or soreness at the injection site. In rare cases, some of the drugs may cause kidney toxicity or bone mineral loss, according to Dr. Hamill.

Three similarly effective forms of PrEP approved by the U.S. Food and Drug Administration enable clinicians to tailor the medications to the specific needs and preferences of each patient. Truvada (emtricitabine and tenofovir disoproxil fumarate) and Descovy (emtricitabine and tenofovir alafenamide) are both daily tablets, although the latter is not advised for people assigned female sex at birth who have receptive vaginal sex. Apretude (cabotegravir), an injectable agent, is not recommended for people who inject illegal drugs.

Patients with renal or bone disease are not good candidates for Truvada.

“Truvada can decrease bone density, so for someone with osteoporosis, you might choose Descovy or Apretude,” Dr. Pollak said. “For someone with chronic kidney disease, consider Descovy or Apretude. “If a patient has hepatitis B, Truvada or Descovy are appropriate, because hepatitis B is treatable.”

Patients taking an injectable PrEP may need more attention, because the concentration of the medication in the body decreases slowly and may linger for many months at low levels that don’t prevent HIV, according to Dr. Hamill. Someone who acquires HIV during that “tail” period might develop resistance to PrEP.

New research also showed that Descovy users were at elevated risk of developing hypertension and statin initiation, especially among those over age 40 years.

Primary care physicians may want to consult with renal specialists about medication safety in patients with severe kidney disease or with rheumatologists or endocrinologists about metabolic bone disease concerns, Dr. Hamill said.

Meanwhile, if a person begins a monogamous relationship and their risk for HIV drops, “it’s fine to stop taking PrEP tablets,” Dr. Pollak said. “I would still recommend routine HIV screening every 6 or 12 months or however often, depending on other risk factors.”

Caring for these patients entails ensuring labs are completed, monitoring adherence, ordering refills, and scheduling regular follow-up visits.

“For the vast majority of patients, the primary care physician is perfectly equipped for their care through the entire PrEP journey, from discussion and initiation to provision of PrEP,” and most cases do not require specialist care, Dr. Hamill said.

However, “if PrEP fails, which is exceedingly rare, primary care physicians should refer patients immediately, preferably with a warm handoff, for linkage to HIV care,” Dr. Blumenthal said.

Talking about PrEP opens the door to conversations with patients about sexual health and broader health issues, Dr. Hamill said. Although these may not come naturally to primary care clinicians, training is available. The National Network of STD Clinical Prevention Training Centers, funded by the CDC, trains providers on how to overcome their anxiety and have open, inclusive conversations about sexuality and sexual behaviors with transgender and gender-diverse, nonbinary people.

“People worry about saying the wrong thing, about causing offense,” Dr. Hamill said. “But once you get comfortable discussing sexuality, you may open conversations around other health issues.”
 

Barriers for patients

The task force identified several barriers to PrEP access for patients because of lack of trusting relationships with health care, the effects of structural racism on health disparities, and persistent biases within the health care system.

Racial and ethnic disparities in HIV incidence persist, with 42% of new diagnoses occurring among Black people, 27% among Hispanic or Latino people, and 26% among White people in 2020.

Rates of PrEP usage for a year or longer are also low. Sometimes the patient no longer needs PrEP, but barriers often involve the costs of taking time off from work and arranging transportation to clinic visits.

Although nearly all insurance plans and state Medicaid programs cover PrEP, if a patient does not have coverage, the drugs and required tests and office visits can be expensive.

“One of the biggest barriers for all providers is navigating our complicated health system and drug assistance programs,” said Mehri S. McKellar, MD, associate professor of medicine at Duke University School of Medicine, Durham, N.C.

But lower-cost FDA-approved generic emtricitabine/tenofovir disoproxil fumarate is now available, and clinicians can direct patients to programs that help provide the medications at low or no cost.

“Providing PrEP care is straightforward, beneficial, and satisfying,” Dr. Hamill said. “You help people protect themselves from a life-changing diagnosis, and the health system doesn’t need to pay the cost of treating HIV. Everyone wins.”

Dr. Hamill, Dr. McKellar, Dr. Pollak, and Dr. Wong have reported no relevant financial relationships. Dr. Blumenthal has reported a financial relationship with Gilead Sciences.

A version of this article appeared on Medscape.com.

HIV continues to be a significant public health concern in the United States, with an estimated 1.2 million people currently living with the virus and more than 30,000 new diagnoses in 2020 alone.

Primary care clinicians can help decrease rates of HIV infection by prescribing pre-exposure prophylaxis to people who are sexually active.

But many do not.

“In medical school, we don’t spend much time discussing sexuality, sexual behavior, sexually transmitted infections, and such, so providers may feel uncomfortable asking what kind of sex their patient is having and with whom, whether they use a condom, and other basics,” said Matthew M. Hamill, MBChB, PhD, MPH, a specialist in sexually transmitted diseases at Johns Hopkins Medicine, Baltimore.

PrEP (pre-exposure prophylaxis) is an antiviral medication that cuts the risk of contracting HIV through sex by around 99% when taken as prescribed, according to the Centers for Disease Control and Prevention.

“Many people who would benefit from PrEP are not receiving this highly effective medication,” said John B. Wong, MD, a primary care internist and professor of medicine at Tufts University, Boston. The gap is particularly acute among Black, Hispanic, and Latino people, who are significantly more likely to be diagnosed with HIV but are much less likely than Whites to receive PrEP, he said.

Dr. Wong, a member of the U.S. Preventive Services Task Force, helped write the group’s new PrEP recommendations. Published in August, the guidelines call for clinicians to prescribe the drugs to adolescents and adults who do not have HIV but are at an increased risk for infection.

“Primary care physicians are ideally positioned to prescribe PrEP for their patients because they have longitudinal relationships: They get to know their patients, and hopefully their patients feel comfortable talking with them about their sexual health,” said Brandon Pollak, MD, a primary care physician and HIV specialist at the Ohio State University College of Medicine, Columbus.

Dr. Pollak, who was not involved with the USPSTF recommendations, cares for patients who are heterosexual and living with HIV.

Clinicians should consider PrEP for all patients who have sex with someone who has HIV, do not use condoms, or have had a sexually transmitted infection within the previous 6 months. Men who have sex with men, transgender women who have sex with men, people who inject illicit drugs or engage in transactional sex, and Black, Hispanic, and Latino individuals also are at increased risk for the infection.

“The vast majority of patients on PrEP in any form sail through with no problems; they have regular lab work and can follow up in person or by telemedicine,” Dr. Hamill said. “They tend to be young, fit people without complicated medical histories, and the medications are very well-tolerated, particularly if people expect some short-term side effects.”
 

What you need to know when prescribing PrEP

Prescribing PrEP is similar in complexity to prescribing hypertension or diabetes medications, Dr. Hamill said.

Because taking the medications while already infected with the virus can lead to the emergence of drug-resistant HIV, patients must have a negative HIV test before starting PrEP. In addition, the USPSTF recommends testing for other sexually transmitted infections and for pregnancy, if appropriate. The task force also recommends conducting kidney function and hepatitis B tests, and a lipid profile before starting specific types of PrEP.

HIV screening is also recommended at 3-month intervals.

“Providers may order labs done at 3- to 4-month intervals but only see patients in clinic once or twice per year, depending on patient needs and risk behaviors,” said Jill S. Blumenthal, MD, associate professor of medicine at UC San Diego Health.

Clinicians should consider medication adherence and whether a patient is likely to take a pill once a day or could benefit from receiving an injection every 2 months. Patients may experience side effects such as diarrhea or headache with oral PrEP or soreness at the injection site. In rare cases, some of the drugs may cause kidney toxicity or bone mineral loss, according to Dr. Hamill.

Three similarly effective forms of PrEP approved by the U.S. Food and Drug Administration enable clinicians to tailor the medications to the specific needs and preferences of each patient. Truvada (emtricitabine and tenofovir disoproxil fumarate) and Descovy (emtricitabine and tenofovir alafenamide) are both daily tablets, although the latter is not advised for people assigned female sex at birth who have receptive vaginal sex. Apretude (cabotegravir), an injectable agent, is not recommended for people who inject illegal drugs.

Patients with renal or bone disease are not good candidates for Truvada.

“Truvada can decrease bone density, so for someone with osteoporosis, you might choose Descovy or Apretude,” Dr. Pollak said. “For someone with chronic kidney disease, consider Descovy or Apretude. “If a patient has hepatitis B, Truvada or Descovy are appropriate, because hepatitis B is treatable.”

Patients taking an injectable PrEP may need more attention, because the concentration of the medication in the body decreases slowly and may linger for many months at low levels that don’t prevent HIV, according to Dr. Hamill. Someone who acquires HIV during that “tail” period might develop resistance to PrEP.

New research also showed that Descovy users were at elevated risk of developing hypertension and statin initiation, especially among those over age 40 years.

Primary care physicians may want to consult with renal specialists about medication safety in patients with severe kidney disease or with rheumatologists or endocrinologists about metabolic bone disease concerns, Dr. Hamill said.

Meanwhile, if a person begins a monogamous relationship and their risk for HIV drops, “it’s fine to stop taking PrEP tablets,” Dr. Pollak said. “I would still recommend routine HIV screening every 6 or 12 months or however often, depending on other risk factors.”

Caring for these patients entails ensuring labs are completed, monitoring adherence, ordering refills, and scheduling regular follow-up visits.

“For the vast majority of patients, the primary care physician is perfectly equipped for their care through the entire PrEP journey, from discussion and initiation to provision of PrEP,” and most cases do not require specialist care, Dr. Hamill said.

However, “if PrEP fails, which is exceedingly rare, primary care physicians should refer patients immediately, preferably with a warm handoff, for linkage to HIV care,” Dr. Blumenthal said.

Talking about PrEP opens the door to conversations with patients about sexual health and broader health issues, Dr. Hamill said. Although these may not come naturally to primary care clinicians, training is available. The National Network of STD Clinical Prevention Training Centers, funded by the CDC, trains providers on how to overcome their anxiety and have open, inclusive conversations about sexuality and sexual behaviors with transgender and gender-diverse, nonbinary people.

“People worry about saying the wrong thing, about causing offense,” Dr. Hamill said. “But once you get comfortable discussing sexuality, you may open conversations around other health issues.”
 

Barriers for patients

The task force identified several barriers to PrEP access for patients because of lack of trusting relationships with health care, the effects of structural racism on health disparities, and persistent biases within the health care system.

Racial and ethnic disparities in HIV incidence persist, with 42% of new diagnoses occurring among Black people, 27% among Hispanic or Latino people, and 26% among White people in 2020.

Rates of PrEP usage for a year or longer are also low. Sometimes the patient no longer needs PrEP, but barriers often involve the costs of taking time off from work and arranging transportation to clinic visits.

Although nearly all insurance plans and state Medicaid programs cover PrEP, if a patient does not have coverage, the drugs and required tests and office visits can be expensive.

“One of the biggest barriers for all providers is navigating our complicated health system and drug assistance programs,” said Mehri S. McKellar, MD, associate professor of medicine at Duke University School of Medicine, Durham, N.C.

But lower-cost FDA-approved generic emtricitabine/tenofovir disoproxil fumarate is now available, and clinicians can direct patients to programs that help provide the medications at low or no cost.

“Providing PrEP care is straightforward, beneficial, and satisfying,” Dr. Hamill said. “You help people protect themselves from a life-changing diagnosis, and the health system doesn’t need to pay the cost of treating HIV. Everyone wins.”

Dr. Hamill, Dr. McKellar, Dr. Pollak, and Dr. Wong have reported no relevant financial relationships. Dr. Blumenthal has reported a financial relationship with Gilead Sciences.

A version of this article appeared on Medscape.com.

HIV continues to be a significant public health concern in the United States, with an estimated 1.2 million people currently living with the virus and more than 30,000 new diagnoses in 2020 alone.

Primary care clinicians can help decrease rates of HIV infection by prescribing pre-exposure prophylaxis to people who are sexually active.

But many do not.

“In medical school, we don’t spend much time discussing sexuality, sexual behavior, sexually transmitted infections, and such, so providers may feel uncomfortable asking what kind of sex their patient is having and with whom, whether they use a condom, and other basics,” said Matthew M. Hamill, MBChB, PhD, MPH, a specialist in sexually transmitted diseases at Johns Hopkins Medicine, Baltimore.

PrEP (pre-exposure prophylaxis) is an antiviral medication that cuts the risk of contracting HIV through sex by around 99% when taken as prescribed, according to the Centers for Disease Control and Prevention.

“Many people who would benefit from PrEP are not receiving this highly effective medication,” said John B. Wong, MD, a primary care internist and professor of medicine at Tufts University, Boston. The gap is particularly acute among Black, Hispanic, and Latino people, who are significantly more likely to be diagnosed with HIV but are much less likely than Whites to receive PrEP, he said.

Dr. Wong, a member of the U.S. Preventive Services Task Force, helped write the group’s new PrEP recommendations. Published in August, the guidelines call for clinicians to prescribe the drugs to adolescents and adults who do not have HIV but are at an increased risk for infection.

“Primary care physicians are ideally positioned to prescribe PrEP for their patients because they have longitudinal relationships: They get to know their patients, and hopefully their patients feel comfortable talking with them about their sexual health,” said Brandon Pollak, MD, a primary care physician and HIV specialist at the Ohio State University College of Medicine, Columbus.

Dr. Pollak, who was not involved with the USPSTF recommendations, cares for patients who are heterosexual and living with HIV.

Clinicians should consider PrEP for all patients who have sex with someone who has HIV, do not use condoms, or have had a sexually transmitted infection within the previous 6 months. Men who have sex with men, transgender women who have sex with men, people who inject illicit drugs or engage in transactional sex, and Black, Hispanic, and Latino individuals also are at increased risk for the infection.

“The vast majority of patients on PrEP in any form sail through with no problems; they have regular lab work and can follow up in person or by telemedicine,” Dr. Hamill said. “They tend to be young, fit people without complicated medical histories, and the medications are very well-tolerated, particularly if people expect some short-term side effects.”
 

What you need to know when prescribing PrEP

Prescribing PrEP is similar in complexity to prescribing hypertension or diabetes medications, Dr. Hamill said.

Because taking the medications while already infected with the virus can lead to the emergence of drug-resistant HIV, patients must have a negative HIV test before starting PrEP. In addition, the USPSTF recommends testing for other sexually transmitted infections and for pregnancy, if appropriate. The task force also recommends conducting kidney function and hepatitis B tests, and a lipid profile before starting specific types of PrEP.

HIV screening is also recommended at 3-month intervals.

“Providers may order labs done at 3- to 4-month intervals but only see patients in clinic once or twice per year, depending on patient needs and risk behaviors,” said Jill S. Blumenthal, MD, associate professor of medicine at UC San Diego Health.

Clinicians should consider medication adherence and whether a patient is likely to take a pill once a day or could benefit from receiving an injection every 2 months. Patients may experience side effects such as diarrhea or headache with oral PrEP or soreness at the injection site. In rare cases, some of the drugs may cause kidney toxicity or bone mineral loss, according to Dr. Hamill.

Three similarly effective forms of PrEP approved by the U.S. Food and Drug Administration enable clinicians to tailor the medications to the specific needs and preferences of each patient. Truvada (emtricitabine and tenofovir disoproxil fumarate) and Descovy (emtricitabine and tenofovir alafenamide) are both daily tablets, although the latter is not advised for people assigned female sex at birth who have receptive vaginal sex. Apretude (cabotegravir), an injectable agent, is not recommended for people who inject illegal drugs.

Patients with renal or bone disease are not good candidates for Truvada.

“Truvada can decrease bone density, so for someone with osteoporosis, you might choose Descovy or Apretude,” Dr. Pollak said. “For someone with chronic kidney disease, consider Descovy or Apretude. “If a patient has hepatitis B, Truvada or Descovy are appropriate, because hepatitis B is treatable.”

Patients taking an injectable PrEP may need more attention, because the concentration of the medication in the body decreases slowly and may linger for many months at low levels that don’t prevent HIV, according to Dr. Hamill. Someone who acquires HIV during that “tail” period might develop resistance to PrEP.

New research also showed that Descovy users were at elevated risk of developing hypertension and statin initiation, especially among those over age 40 years.

Primary care physicians may want to consult with renal specialists about medication safety in patients with severe kidney disease or with rheumatologists or endocrinologists about metabolic bone disease concerns, Dr. Hamill said.

Meanwhile, if a person begins a monogamous relationship and their risk for HIV drops, “it’s fine to stop taking PrEP tablets,” Dr. Pollak said. “I would still recommend routine HIV screening every 6 or 12 months or however often, depending on other risk factors.”

Caring for these patients entails ensuring labs are completed, monitoring adherence, ordering refills, and scheduling regular follow-up visits.

“For the vast majority of patients, the primary care physician is perfectly equipped for their care through the entire PrEP journey, from discussion and initiation to provision of PrEP,” and most cases do not require specialist care, Dr. Hamill said.

However, “if PrEP fails, which is exceedingly rare, primary care physicians should refer patients immediately, preferably with a warm handoff, for linkage to HIV care,” Dr. Blumenthal said.

Talking about PrEP opens the door to conversations with patients about sexual health and broader health issues, Dr. Hamill said. Although these may not come naturally to primary care clinicians, training is available. The National Network of STD Clinical Prevention Training Centers, funded by the CDC, trains providers on how to overcome their anxiety and have open, inclusive conversations about sexuality and sexual behaviors with transgender and gender-diverse, nonbinary people.

“People worry about saying the wrong thing, about causing offense,” Dr. Hamill said. “But once you get comfortable discussing sexuality, you may open conversations around other health issues.”
 

Barriers for patients

The task force identified several barriers to PrEP access for patients because of lack of trusting relationships with health care, the effects of structural racism on health disparities, and persistent biases within the health care system.

Racial and ethnic disparities in HIV incidence persist, with 42% of new diagnoses occurring among Black people, 27% among Hispanic or Latino people, and 26% among White people in 2020.

Rates of PrEP usage for a year or longer are also low. Sometimes the patient no longer needs PrEP, but barriers often involve the costs of taking time off from work and arranging transportation to clinic visits.

Although nearly all insurance plans and state Medicaid programs cover PrEP, if a patient does not have coverage, the drugs and required tests and office visits can be expensive.

“One of the biggest barriers for all providers is navigating our complicated health system and drug assistance programs,” said Mehri S. McKellar, MD, associate professor of medicine at Duke University School of Medicine, Durham, N.C.

But lower-cost FDA-approved generic emtricitabine/tenofovir disoproxil fumarate is now available, and clinicians can direct patients to programs that help provide the medications at low or no cost.

“Providing PrEP care is straightforward, beneficial, and satisfying,” Dr. Hamill said. “You help people protect themselves from a life-changing diagnosis, and the health system doesn’t need to pay the cost of treating HIV. Everyone wins.”

Dr. Hamill, Dr. McKellar, Dr. Pollak, and Dr. Wong have reported no relevant financial relationships. Dr. Blumenthal has reported a financial relationship with Gilead Sciences.

A version of this article appeared on Medscape.com.

A radiologist who claims he was forced to resign after requesting to work from home has settled his discrimination lawsuit with a New York hospital.

Although the case was resolved without a definitive win, legal analysts say the complaint raises important questions about whether some physicians have the right to work from home.

Since the pandemic, employers across the country have become more accepting of professionals working remotely. But are some doctors legally entitled to the accommodation? And if so, how do physicians prove the allowance is reasonable for their circumstances?

Richard Heiden, MD, sued New York City Health and Hospitals in 2020, claiming discrimination and retaliation violations under the American with Disabilities Act (ADA) and the New York State Human Rights Law. Dr. Heiden, who has ulcerative colitis, had asked to work off-site during the start of the pandemic, but the hospital denied his accommodation request. Shortly later, administrators accused Dr. Heiden of poor performance and requested he resign or administrators would terminate him, according to his lawsuit.

Attorneys for New York City Health and Hospitals contended that Dr. Heiden was a poorly performing radiologist who was undergoing a performance review at the time of his accommodation request. The radiologist’s departure was related to the results of the review and had nothing to do with his disability or accommodation request, according to the hospital.

The undisclosed settlement ends a 3-year court battle between Dr. Heiden and the hospital corporation.

In an email, Laura Williams, an attorney for the hospital corporation, said that “the settlement was in the best interest of all parties.”

Dr. Heiden and his attorneys also did not respond to requests for comment.

A critical piece to the puzzle is understanding who is protected under the ADA and is therefore entitled to reasonable accommodations, said Doron Dorfman, JSD, an associate professor at Seton Hall University Law School in Newark, N.J., who focuses on disability law.

A common misconception is that only physicians with a physical disability are “disabled,” he said. However, under the law, a disabled individual is anyone with a physical or mental impairment – including mental illness – that limits major life activities; a person with a history of such impairment; or a person who is perceived by others as having an impairment.

“The law is much broader than many people think,” he said. “I think a lot of people don’t think about those with invisible disabilities, such as people with allergies, those who are immunocompromised, those with chronic illnesses. A lot of people don’t see themselves as disabled, and a lot of employers don’t see them as disabled.”

Working from home has not historically been considered a “reasonable accommodation” under the ADA, Mr. Dorfman said. However, that appears to be changing.

“There has been a sea change,” Mr. Dorfman said. “The question is coming before the courts more frequently, and recent legal decisions show judges may be altering their views on the subject.”
 

What led to the doctor’s lawsuit?

Dr. Heiden, a longtime radiologist, had practiced at Lincoln Medical and Mental Health Center for about a year when he requested to work remotely. (Lincoln is operated by New York City Health and Hospitals.) At the time, the governor of New York had ordered a statewide lockdown because of COVID-19, and Dr. Heiden expressed concern that his ulcerative colitis made him a high-risk individual for the virus, according to court documents.

In his March 22, 2020, request, Dr. Heiden said that, except for fluoroscopy, his job could be done entirely from his home, according to a district court summary of the case. He also offered to pay for any costs associated with the remote work setup.

Around the same time, New York City Health and Hospitals permitted its facilities to issue a limited number of workstations to radiologists to facilitate remote work in the event of COVID-related staffing shortages. Administrators were in the process of acquiring remote radiology workstations and determining which radiologists at Lincoln would receive them, according to the case summary.

On March 24, the chair of radiology at Lincoln met with Dr. Heiden to review the results of a recent focused professional practice evaluation (FPPE). An FPPE refers to an intensive review of an expansive selection of patient cases handled by the subject physician. During the meeting, the chair that claimed Dr. Heiden was a poor performer and was accurate in his assessments 93.8% of the time, which was below the hospital’s 97% threshold, according to Dr. Heiden’s lawsuit. Dr. Heiden disagreed with the results, and the two engaged in several more meetings.

Meanwhile, Dr. Heiden’s accommodation request was forwarded to other administrators. In an email introduced into court evidence, the chair indicated he did not support the accommodation, writing that Dr. Heiden’s “skill set does not meet the criteria for the initial installations” of the workstations.

On March 26, 2020, the chair allegedly asked Dr. Heiden to either resign or he would be terminated and reported to the New York State Office of Professional Medical Conduct. Four days later, Dr. Heiden learned that his accommodation request had been denied. He resigned on April 2, 2020.

In his lawsuit, Dr. Heiden claimed that the hospital discriminated against him on the basis of his disability in violation of ADA by denying him equal terms and conditions of employment and failing to provide a reasonable accommodation.

The defendants, who included the radiology chair, did not dispute that Dr. Heiden was asked to resign or that administrators warned termination, but they argued the impetus was his FPPE results and a history of inaccurate interpretations. Other clinicians and physicians had expressed concerns about Dr. Heiden’s “lack of clarity [and] interpretive errors,” according to deposition testimony. The hospital emphasized the FPPE had concluded before Dr. Heiden’s accommodation request was made.

New York City Health and Hospitals requested a federal judge dismiss the lawsuit for lack of valid claims. In January 2023, U.S. District Judge Lewis Liman allowed the case to proceed, ruling that some of Dr. Heiden’s claims had merit.

“Plaintiff has satisfied his obligation to proffer sufficient evidence to create an inference of retaliatory or discriminatory intent,” Judge Liman wrote in his decision. “[The chair] had not always planned to ask for plaintiff’s resignation based on the results of the FPPE completed on March 10, 2020. The decision to ask for that resignation arose shortly after the request for the accommodation. And there is evidence from which the jury could find that [the chair] was not receptive to making the accommodation.”

A jury trial was scheduled for July 2023, but the parties reached a settlement on May 31, 2023.
 

Is working from home reasonable for physicians?

The widespread swing to remote work in recent years has paved a smoother road for physicians who request the accommodation, said Peter Poullos, MD, clinical associate professor of radiology, gastroenterology, and hepatology at Stanford (Calif.) University and founder and cochair of the Stanford Medicine Alliance for Disability Inclusion and Equity.

“There is now a precedent and examples all over that working from home for some is a viable alternative to working in the hospital or a clinic,” Dr. Poullos said. “If a lawyer can point to instances of other people having received the same accommodation, even if the accommodation was given to someone without a disability, it’s much harder for an employer to say: ‘It’s not possible.’ Because clearly, it is.”

A key factor is the employee’s job duties and whether the employee can complete them remotely, said Mr. Dorfman. With physicians, the reasonableness would heavily depend on their specialty.

A radiologist, for example, would probably have a stronger case for performing their duties remotely compared with a surgeon, Dr. Poullos said.

In general, whether an accommodation is reasonable is decided on a case-by-case basis and usually includes reviewing supporting documentation from a medical provider, said Emily Harvey, a Denver-based disability law attorney. Employers are allowed to deny accommodations if they would cause an undue burden to the employer or fundamentally alter the nature or operation of the job or business.

“When it comes to the ADA, and disability rights in general, the analysis is based on the need of the individual,” she said. “Two people with identical diagnoses could need vastly different accommodations to be successful in the same job.”

Mr. Dorfman added that employers are only required to provide an accommodation that is reasonable under the circumstances, whether or not that accommodation meets the preferred request of the employee. For instance, if an immunocompromised physician asked to work from home, but the employer could ensure that all those working around the physician will mask, that could be reasonable enough.

A recent case analysis by Bloomberg Law shows that more courts are siding with employees who request remote work, compared with in past years. Employees who made disability-related remote work requests prevailed in 40% of federal court rulings from 2021 to 2023 versusa success rate of 30% from 2017 to 2019, according to the July 2023 analysis.

The analysis shows that employers still win the majority of the time, but that the gap is closing, Mr. Dorfman said.

In a September 2020 decision, for example, a Massachusetts District Court ruled in favor of an employee with asthma who was precluding from working at home by a behavioral and mental health agency. U.S. Magistrate Judge Katherine Robertson said that the manager was entitled to telework as a reasonable accommodation under the ADA for 60 days or until further notice. The lawsuit was settled in 2021.

“I think judges are much more used to working from home themselves,” Mr. Dorfman said. “That may affect their sense of accepting remote work as a reasonable accommodation. Their personal experience with it [may] actually inform their view of the topic.”
 

Your accommodation request was denied: Now what?

If you are unsure about your rights under the ADA, a first step is understanding the law’s protections and learning the obligations of your employer. 

Keep in mind that not everyone at your workplace may understand the law and what is required, said Dr. Poullos. When making a request to work from home, ensure that you’re using the right words and asking the right people, he advised. Some physicians, for instance, may only discuss the request with their direct supervisor and give up when the request is denied. “The employee might say, ‘I’ve been dealing with some medical issues and I’m really tired and need to adjust my schedule.’ They don’t mention the word ‘disability,’ they don’t mention the ADA, they don’t mention the word ‘accommodation,’ and so that might not trigger the appropriate response.”

Lisa Meeks, PhD, an expert and researcher in disabilities in medical education, encourages physicians and others to follow the appeals process at their institution if they feel their accommodation request has been unjustly denied.

Research shows that physicians who make accommodation requests rarely escalate denials to an appeal, grievance, or complaint, said Dr. Meeks, cohost of the Docs With Disabilities podcast and director of the Docs With Disabilities Initiative. The initiative aims to use research, education, and stories to drive change in perceptions, disability policy, and procedures in health professions and in biomedical and science education.

If an accommodation cannot be agreed on, doctors can reach out the Equal Employment Opportunity Commission and file a discrimination charge. The agency will review the case and provide an opinion on whether the charge has merit. The EEOC’s decision is not binding in court, and even if the agency believes the charge has no merit, employees still have the right to sue, he said.

Ms. Harvey added that the EEOC has many resources on its website, and that most states also have civil rights agencies that have additional resources. Every state and U.S. territory also has a protection and advocacy organization that may be able to help. Physicians can also review their state bar to locate and consult with disability rights attorneys.

Although it may seem like an uphill battle to push for an accommodation, it can be worth it in the end, said Michael Argenyi, MD, an addiction medicine specialist and assistant professor at the University of Massachusetts, Worcester. Dr. Argenyi, who has hearing loss, was featured on the Docs With Disabilities podcast.

“It’s difficult to ‘rock the boat’ and ask for support from the C-suite for employees with disabilities, or to rearrange a small medical office budget to establish a byline just for accommodations,” Dr. Argenyi said. “Yet, the payoff is worthwhile – patients and fellow colleagues notice commitments to diversity building and inclusion.”

A version of this article appeared on Medscape.com.

A radiologist who claims he was forced to resign after requesting to work from home has settled his discrimination lawsuit with a New York hospital.

Although the case was resolved without a definitive win, legal analysts say the complaint raises important questions about whether some physicians have the right to work from home.

Since the pandemic, employers across the country have become more accepting of professionals working remotely. But are some doctors legally entitled to the accommodation? And if so, how do physicians prove the allowance is reasonable for their circumstances?

Richard Heiden, MD, sued New York City Health and Hospitals in 2020, claiming discrimination and retaliation violations under the American with Disabilities Act (ADA) and the New York State Human Rights Law. Dr. Heiden, who has ulcerative colitis, had asked to work off-site during the start of the pandemic, but the hospital denied his accommodation request. Shortly later, administrators accused Dr. Heiden of poor performance and requested he resign or administrators would terminate him, according to his lawsuit.

Attorneys for New York City Health and Hospitals contended that Dr. Heiden was a poorly performing radiologist who was undergoing a performance review at the time of his accommodation request. The radiologist’s departure was related to the results of the review and had nothing to do with his disability or accommodation request, according to the hospital.

The undisclosed settlement ends a 3-year court battle between Dr. Heiden and the hospital corporation.

In an email, Laura Williams, an attorney for the hospital corporation, said that “the settlement was in the best interest of all parties.”

Dr. Heiden and his attorneys also did not respond to requests for comment.

A critical piece to the puzzle is understanding who is protected under the ADA and is therefore entitled to reasonable accommodations, said Doron Dorfman, JSD, an associate professor at Seton Hall University Law School in Newark, N.J., who focuses on disability law.

A common misconception is that only physicians with a physical disability are “disabled,” he said. However, under the law, a disabled individual is anyone with a physical or mental impairment – including mental illness – that limits major life activities; a person with a history of such impairment; or a person who is perceived by others as having an impairment.

“The law is much broader than many people think,” he said. “I think a lot of people don’t think about those with invisible disabilities, such as people with allergies, those who are immunocompromised, those with chronic illnesses. A lot of people don’t see themselves as disabled, and a lot of employers don’t see them as disabled.”

Working from home has not historically been considered a “reasonable accommodation” under the ADA, Mr. Dorfman said. However, that appears to be changing.

“There has been a sea change,” Mr. Dorfman said. “The question is coming before the courts more frequently, and recent legal decisions show judges may be altering their views on the subject.”
 

What led to the doctor’s lawsuit?

Dr. Heiden, a longtime radiologist, had practiced at Lincoln Medical and Mental Health Center for about a year when he requested to work remotely. (Lincoln is operated by New York City Health and Hospitals.) At the time, the governor of New York had ordered a statewide lockdown because of COVID-19, and Dr. Heiden expressed concern that his ulcerative colitis made him a high-risk individual for the virus, according to court documents.

In his March 22, 2020, request, Dr. Heiden said that, except for fluoroscopy, his job could be done entirely from his home, according to a district court summary of the case. He also offered to pay for any costs associated with the remote work setup.

Around the same time, New York City Health and Hospitals permitted its facilities to issue a limited number of workstations to radiologists to facilitate remote work in the event of COVID-related staffing shortages. Administrators were in the process of acquiring remote radiology workstations and determining which radiologists at Lincoln would receive them, according to the case summary.

On March 24, the chair of radiology at Lincoln met with Dr. Heiden to review the results of a recent focused professional practice evaluation (FPPE). An FPPE refers to an intensive review of an expansive selection of patient cases handled by the subject physician. During the meeting, the chair that claimed Dr. Heiden was a poor performer and was accurate in his assessments 93.8% of the time, which was below the hospital’s 97% threshold, according to Dr. Heiden’s lawsuit. Dr. Heiden disagreed with the results, and the two engaged in several more meetings.

Meanwhile, Dr. Heiden’s accommodation request was forwarded to other administrators. In an email introduced into court evidence, the chair indicated he did not support the accommodation, writing that Dr. Heiden’s “skill set does not meet the criteria for the initial installations” of the workstations.

On March 26, 2020, the chair allegedly asked Dr. Heiden to either resign or he would be terminated and reported to the New York State Office of Professional Medical Conduct. Four days later, Dr. Heiden learned that his accommodation request had been denied. He resigned on April 2, 2020.

In his lawsuit, Dr. Heiden claimed that the hospital discriminated against him on the basis of his disability in violation of ADA by denying him equal terms and conditions of employment and failing to provide a reasonable accommodation.

The defendants, who included the radiology chair, did not dispute that Dr. Heiden was asked to resign or that administrators warned termination, but they argued the impetus was his FPPE results and a history of inaccurate interpretations. Other clinicians and physicians had expressed concerns about Dr. Heiden’s “lack of clarity [and] interpretive errors,” according to deposition testimony. The hospital emphasized the FPPE had concluded before Dr. Heiden’s accommodation request was made.

New York City Health and Hospitals requested a federal judge dismiss the lawsuit for lack of valid claims. In January 2023, U.S. District Judge Lewis Liman allowed the case to proceed, ruling that some of Dr. Heiden’s claims had merit.

“Plaintiff has satisfied his obligation to proffer sufficient evidence to create an inference of retaliatory or discriminatory intent,” Judge Liman wrote in his decision. “[The chair] had not always planned to ask for plaintiff’s resignation based on the results of the FPPE completed on March 10, 2020. The decision to ask for that resignation arose shortly after the request for the accommodation. And there is evidence from which the jury could find that [the chair] was not receptive to making the accommodation.”

A jury trial was scheduled for July 2023, but the parties reached a settlement on May 31, 2023.
 

Is working from home reasonable for physicians?

The widespread swing to remote work in recent years has paved a smoother road for physicians who request the accommodation, said Peter Poullos, MD, clinical associate professor of radiology, gastroenterology, and hepatology at Stanford (Calif.) University and founder and cochair of the Stanford Medicine Alliance for Disability Inclusion and Equity.

“There is now a precedent and examples all over that working from home for some is a viable alternative to working in the hospital or a clinic,” Dr. Poullos said. “If a lawyer can point to instances of other people having received the same accommodation, even if the accommodation was given to someone without a disability, it’s much harder for an employer to say: ‘It’s not possible.’ Because clearly, it is.”

A key factor is the employee’s job duties and whether the employee can complete them remotely, said Mr. Dorfman. With physicians, the reasonableness would heavily depend on their specialty.

A radiologist, for example, would probably have a stronger case for performing their duties remotely compared with a surgeon, Dr. Poullos said.

In general, whether an accommodation is reasonable is decided on a case-by-case basis and usually includes reviewing supporting documentation from a medical provider, said Emily Harvey, a Denver-based disability law attorney. Employers are allowed to deny accommodations if they would cause an undue burden to the employer or fundamentally alter the nature or operation of the job or business.

“When it comes to the ADA, and disability rights in general, the analysis is based on the need of the individual,” she said. “Two people with identical diagnoses could need vastly different accommodations to be successful in the same job.”

Mr. Dorfman added that employers are only required to provide an accommodation that is reasonable under the circumstances, whether or not that accommodation meets the preferred request of the employee. For instance, if an immunocompromised physician asked to work from home, but the employer could ensure that all those working around the physician will mask, that could be reasonable enough.

A recent case analysis by Bloomberg Law shows that more courts are siding with employees who request remote work, compared with in past years. Employees who made disability-related remote work requests prevailed in 40% of federal court rulings from 2021 to 2023 versusa success rate of 30% from 2017 to 2019, according to the July 2023 analysis.

The analysis shows that employers still win the majority of the time, but that the gap is closing, Mr. Dorfman said.

In a September 2020 decision, for example, a Massachusetts District Court ruled in favor of an employee with asthma who was precluding from working at home by a behavioral and mental health agency. U.S. Magistrate Judge Katherine Robertson said that the manager was entitled to telework as a reasonable accommodation under the ADA for 60 days or until further notice. The lawsuit was settled in 2021.

“I think judges are much more used to working from home themselves,” Mr. Dorfman said. “That may affect their sense of accepting remote work as a reasonable accommodation. Their personal experience with it [may] actually inform their view of the topic.”
 

Your accommodation request was denied: Now what?

If you are unsure about your rights under the ADA, a first step is understanding the law’s protections and learning the obligations of your employer. 

Keep in mind that not everyone at your workplace may understand the law and what is required, said Dr. Poullos. When making a request to work from home, ensure that you’re using the right words and asking the right people, he advised. Some physicians, for instance, may only discuss the request with their direct supervisor and give up when the request is denied. “The employee might say, ‘I’ve been dealing with some medical issues and I’m really tired and need to adjust my schedule.’ They don’t mention the word ‘disability,’ they don’t mention the ADA, they don’t mention the word ‘accommodation,’ and so that might not trigger the appropriate response.”

Lisa Meeks, PhD, an expert and researcher in disabilities in medical education, encourages physicians and others to follow the appeals process at their institution if they feel their accommodation request has been unjustly denied.

Research shows that physicians who make accommodation requests rarely escalate denials to an appeal, grievance, or complaint, said Dr. Meeks, cohost of the Docs With Disabilities podcast and director of the Docs With Disabilities Initiative. The initiative aims to use research, education, and stories to drive change in perceptions, disability policy, and procedures in health professions and in biomedical and science education.

If an accommodation cannot be agreed on, doctors can reach out the Equal Employment Opportunity Commission and file a discrimination charge. The agency will review the case and provide an opinion on whether the charge has merit. The EEOC’s decision is not binding in court, and even if the agency believes the charge has no merit, employees still have the right to sue, he said.

Ms. Harvey added that the EEOC has many resources on its website, and that most states also have civil rights agencies that have additional resources. Every state and U.S. territory also has a protection and advocacy organization that may be able to help. Physicians can also review their state bar to locate and consult with disability rights attorneys.

Although it may seem like an uphill battle to push for an accommodation, it can be worth it in the end, said Michael Argenyi, MD, an addiction medicine specialist and assistant professor at the University of Massachusetts, Worcester. Dr. Argenyi, who has hearing loss, was featured on the Docs With Disabilities podcast.

“It’s difficult to ‘rock the boat’ and ask for support from the C-suite for employees with disabilities, or to rearrange a small medical office budget to establish a byline just for accommodations,” Dr. Argenyi said. “Yet, the payoff is worthwhile – patients and fellow colleagues notice commitments to diversity building and inclusion.”

A version of this article appeared on Medscape.com.

A radiologist who claims he was forced to resign after requesting to work from home has settled his discrimination lawsuit with a New York hospital.

Although the case was resolved without a definitive win, legal analysts say the complaint raises important questions about whether some physicians have the right to work from home.

Since the pandemic, employers across the country have become more accepting of professionals working remotely. But are some doctors legally entitled to the accommodation? And if so, how do physicians prove the allowance is reasonable for their circumstances?

Richard Heiden, MD, sued New York City Health and Hospitals in 2020, claiming discrimination and retaliation violations under the American with Disabilities Act (ADA) and the New York State Human Rights Law. Dr. Heiden, who has ulcerative colitis, had asked to work off-site during the start of the pandemic, but the hospital denied his accommodation request. Shortly later, administrators accused Dr. Heiden of poor performance and requested he resign or administrators would terminate him, according to his lawsuit.

Attorneys for New York City Health and Hospitals contended that Dr. Heiden was a poorly performing radiologist who was undergoing a performance review at the time of his accommodation request. The radiologist’s departure was related to the results of the review and had nothing to do with his disability or accommodation request, according to the hospital.

The undisclosed settlement ends a 3-year court battle between Dr. Heiden and the hospital corporation.

In an email, Laura Williams, an attorney for the hospital corporation, said that “the settlement was in the best interest of all parties.”

Dr. Heiden and his attorneys also did not respond to requests for comment.

A critical piece to the puzzle is understanding who is protected under the ADA and is therefore entitled to reasonable accommodations, said Doron Dorfman, JSD, an associate professor at Seton Hall University Law School in Newark, N.J., who focuses on disability law.

A common misconception is that only physicians with a physical disability are “disabled,” he said. However, under the law, a disabled individual is anyone with a physical or mental impairment – including mental illness – that limits major life activities; a person with a history of such impairment; or a person who is perceived by others as having an impairment.

“The law is much broader than many people think,” he said. “I think a lot of people don’t think about those with invisible disabilities, such as people with allergies, those who are immunocompromised, those with chronic illnesses. A lot of people don’t see themselves as disabled, and a lot of employers don’t see them as disabled.”

Working from home has not historically been considered a “reasonable accommodation” under the ADA, Mr. Dorfman said. However, that appears to be changing.

“There has been a sea change,” Mr. Dorfman said. “The question is coming before the courts more frequently, and recent legal decisions show judges may be altering their views on the subject.”
 

What led to the doctor’s lawsuit?

Dr. Heiden, a longtime radiologist, had practiced at Lincoln Medical and Mental Health Center for about a year when he requested to work remotely. (Lincoln is operated by New York City Health and Hospitals.) At the time, the governor of New York had ordered a statewide lockdown because of COVID-19, and Dr. Heiden expressed concern that his ulcerative colitis made him a high-risk individual for the virus, according to court documents.

In his March 22, 2020, request, Dr. Heiden said that, except for fluoroscopy, his job could be done entirely from his home, according to a district court summary of the case. He also offered to pay for any costs associated with the remote work setup.

Around the same time, New York City Health and Hospitals permitted its facilities to issue a limited number of workstations to radiologists to facilitate remote work in the event of COVID-related staffing shortages. Administrators were in the process of acquiring remote radiology workstations and determining which radiologists at Lincoln would receive them, according to the case summary.

On March 24, the chair of radiology at Lincoln met with Dr. Heiden to review the results of a recent focused professional practice evaluation (FPPE). An FPPE refers to an intensive review of an expansive selection of patient cases handled by the subject physician. During the meeting, the chair that claimed Dr. Heiden was a poor performer and was accurate in his assessments 93.8% of the time, which was below the hospital’s 97% threshold, according to Dr. Heiden’s lawsuit. Dr. Heiden disagreed with the results, and the two engaged in several more meetings.

Meanwhile, Dr. Heiden’s accommodation request was forwarded to other administrators. In an email introduced into court evidence, the chair indicated he did not support the accommodation, writing that Dr. Heiden’s “skill set does not meet the criteria for the initial installations” of the workstations.

On March 26, 2020, the chair allegedly asked Dr. Heiden to either resign or he would be terminated and reported to the New York State Office of Professional Medical Conduct. Four days later, Dr. Heiden learned that his accommodation request had been denied. He resigned on April 2, 2020.

In his lawsuit, Dr. Heiden claimed that the hospital discriminated against him on the basis of his disability in violation of ADA by denying him equal terms and conditions of employment and failing to provide a reasonable accommodation.

The defendants, who included the radiology chair, did not dispute that Dr. Heiden was asked to resign or that administrators warned termination, but they argued the impetus was his FPPE results and a history of inaccurate interpretations. Other clinicians and physicians had expressed concerns about Dr. Heiden’s “lack of clarity [and] interpretive errors,” according to deposition testimony. The hospital emphasized the FPPE had concluded before Dr. Heiden’s accommodation request was made.

New York City Health and Hospitals requested a federal judge dismiss the lawsuit for lack of valid claims. In January 2023, U.S. District Judge Lewis Liman allowed the case to proceed, ruling that some of Dr. Heiden’s claims had merit.

“Plaintiff has satisfied his obligation to proffer sufficient evidence to create an inference of retaliatory or discriminatory intent,” Judge Liman wrote in his decision. “[The chair] had not always planned to ask for plaintiff’s resignation based on the results of the FPPE completed on March 10, 2020. The decision to ask for that resignation arose shortly after the request for the accommodation. And there is evidence from which the jury could find that [the chair] was not receptive to making the accommodation.”

A jury trial was scheduled for July 2023, but the parties reached a settlement on May 31, 2023.
 

Is working from home reasonable for physicians?

The widespread swing to remote work in recent years has paved a smoother road for physicians who request the accommodation, said Peter Poullos, MD, clinical associate professor of radiology, gastroenterology, and hepatology at Stanford (Calif.) University and founder and cochair of the Stanford Medicine Alliance for Disability Inclusion and Equity.

“There is now a precedent and examples all over that working from home for some is a viable alternative to working in the hospital or a clinic,” Dr. Poullos said. “If a lawyer can point to instances of other people having received the same accommodation, even if the accommodation was given to someone without a disability, it’s much harder for an employer to say: ‘It’s not possible.’ Because clearly, it is.”

A key factor is the employee’s job duties and whether the employee can complete them remotely, said Mr. Dorfman. With physicians, the reasonableness would heavily depend on their specialty.

A radiologist, for example, would probably have a stronger case for performing their duties remotely compared with a surgeon, Dr. Poullos said.

In general, whether an accommodation is reasonable is decided on a case-by-case basis and usually includes reviewing supporting documentation from a medical provider, said Emily Harvey, a Denver-based disability law attorney. Employers are allowed to deny accommodations if they would cause an undue burden to the employer or fundamentally alter the nature or operation of the job or business.

“When it comes to the ADA, and disability rights in general, the analysis is based on the need of the individual,” she said. “Two people with identical diagnoses could need vastly different accommodations to be successful in the same job.”

Mr. Dorfman added that employers are only required to provide an accommodation that is reasonable under the circumstances, whether or not that accommodation meets the preferred request of the employee. For instance, if an immunocompromised physician asked to work from home, but the employer could ensure that all those working around the physician will mask, that could be reasonable enough.

A recent case analysis by Bloomberg Law shows that more courts are siding with employees who request remote work, compared with in past years. Employees who made disability-related remote work requests prevailed in 40% of federal court rulings from 2021 to 2023 versusa success rate of 30% from 2017 to 2019, according to the July 2023 analysis.

The analysis shows that employers still win the majority of the time, but that the gap is closing, Mr. Dorfman said.

In a September 2020 decision, for example, a Massachusetts District Court ruled in favor of an employee with asthma who was precluding from working at home by a behavioral and mental health agency. U.S. Magistrate Judge Katherine Robertson said that the manager was entitled to telework as a reasonable accommodation under the ADA for 60 days or until further notice. The lawsuit was settled in 2021.

“I think judges are much more used to working from home themselves,” Mr. Dorfman said. “That may affect their sense of accepting remote work as a reasonable accommodation. Their personal experience with it [may] actually inform their view of the topic.”
 

Your accommodation request was denied: Now what?

If you are unsure about your rights under the ADA, a first step is understanding the law’s protections and learning the obligations of your employer. 

Keep in mind that not everyone at your workplace may understand the law and what is required, said Dr. Poullos. When making a request to work from home, ensure that you’re using the right words and asking the right people, he advised. Some physicians, for instance, may only discuss the request with their direct supervisor and give up when the request is denied. “The employee might say, ‘I’ve been dealing with some medical issues and I’m really tired and need to adjust my schedule.’ They don’t mention the word ‘disability,’ they don’t mention the ADA, they don’t mention the word ‘accommodation,’ and so that might not trigger the appropriate response.”

Lisa Meeks, PhD, an expert and researcher in disabilities in medical education, encourages physicians and others to follow the appeals process at their institution if they feel their accommodation request has been unjustly denied.

Research shows that physicians who make accommodation requests rarely escalate denials to an appeal, grievance, or complaint, said Dr. Meeks, cohost of the Docs With Disabilities podcast and director of the Docs With Disabilities Initiative. The initiative aims to use research, education, and stories to drive change in perceptions, disability policy, and procedures in health professions and in biomedical and science education.

If an accommodation cannot be agreed on, doctors can reach out the Equal Employment Opportunity Commission and file a discrimination charge. The agency will review the case and provide an opinion on whether the charge has merit. The EEOC’s decision is not binding in court, and even if the agency believes the charge has no merit, employees still have the right to sue, he said.

Ms. Harvey added that the EEOC has many resources on its website, and that most states also have civil rights agencies that have additional resources. Every state and U.S. territory also has a protection and advocacy organization that may be able to help. Physicians can also review their state bar to locate and consult with disability rights attorneys.

Although it may seem like an uphill battle to push for an accommodation, it can be worth it in the end, said Michael Argenyi, MD, an addiction medicine specialist and assistant professor at the University of Massachusetts, Worcester. Dr. Argenyi, who has hearing loss, was featured on the Docs With Disabilities podcast.

“It’s difficult to ‘rock the boat’ and ask for support from the C-suite for employees with disabilities, or to rearrange a small medical office budget to establish a byline just for accommodations,” Dr. Argenyi said. “Yet, the payoff is worthwhile – patients and fellow colleagues notice commitments to diversity building and inclusion.”

A version of this article appeared on Medscape.com.

The American College of Physicians has issued an updated version of its living, rapid practice point guideline on the best treatment options for outpatients with confirmed COVID-19 in the era of the dominant Omicron variant of SARS-CoV-2. The recommendations in version 2 apply to persons presenting with mild to moderate infection and symptom onset in the past 5 days who are at high risk for progression to severe disease and potential hospitalization or death.

Version 1 appeared in late 2022.

While outpatient management is appropriate for most patients, treatment should be personalized and based on careful risk stratification and informed decision-making, said the guideline authors, led by Amir Qaseem, MD, PhD, MHA, vice president of clinical policy and the Center for Evidence Reviews at the ACP in Philadelphia.
 

Practice points

• Consider the oral antivirals nirmatrelvir-ritonavir (Paxlovid) or molnupiravir (Lagevrio) for symptomatic outpatients with confirmed mild to moderate COVID-19 who are within 5 days of the onset of symptoms and at high risk for progressing to severe disease.

New evidence for the Omicron variant suggests a possible net benefit of the antiviral molnupiravir versus standard or no treatment in terms of reducing recovery time if treatment is initiated within 5 days of symptom onset. Nirmatrelvir-ritonavir was associated with reductions in COVID-19 hospitalization and all-cause mortality.

“The practice points only address [whether] treatments work compared to placebo, no treatment, or usual care,” cautioned Linda L. Humphrey, MD, MPH, MACP, chair of the ACP’s Population Health and Medical Science Committee and a professor of medicine at Oregon Health and Science University VA Portland Health Care System. The ACP continues to monitor the evidence. “Once enough evidence has emerged, it will be possible to compare treatments to each other. Until that time we are unable to determine if there is an advantage to using one treatment over another.”

• Do not use the antiparasitic ivermectin (Stromectol) or the monoclonal antibody sotrovimab (Xevudy) to treat this patient population. “It is not expected to be effective against the Omicron variant,” Dr. Humphrey said.

There was no evidence to support the use of medications such as corticosteroids, antibiotics, antihistamines, SSRIs, and multiple other agents.

“The guideline is not a departure from previous knowledge and reflects what appears in other guidelines and is already being done generally in practice,” said Mirella Salvatore, MD, an associate professor of medicine and population health sciences at Weill Cornell Medicine, New York, who was not involved in the ACP statement. It is therefore unlikely the recommendations will trigger controversy or negative feedback, added Dr. Salvatore, who is also a spokesperson for the Infectious Diseases Society of America. “We believe that our evidence-based approach, which considers the balance of benefits and harms of various treatments, will be embraced by the physician community,” Dr. Humphrey said.

The updated recommendations are based on new data from the evidence review of multiple treatments, which concluded that both nirmatrelvir-ritonavir and molnupiravir likely improve outcomes for outpatients with mild to moderate COVID-19. The review was conducted after the emergence of the Omicron variant by the ACP Center for Evidence Reviews at Cochrane Austria/University for Continuing Education Krems (Austria).


 

Review details

Inclusion criteria were modified to focus on the Omicron variant by limiting eligible studies to only those enrolling patients on or after Nov. 26, 2021. The investigators included two randomized controlled trials and six retrospective cohort studies and ranked quality of evidence for the effectiveness of the following treatments, compared with usual care or no treatment: azithromycin, camostat mesylate, chloroquine-hydroxychloroquine, chlorpheniramine, colchicine, convalescent plasma, corticosteroids, ensitrelvir, favipiravir, fluvoxamine, ivermectin, lopinavir-ritonavir, molnupiravir, neutralizing monoclonal antibodies, metformin, niclosamide, nitazoxanide, nirmatrelvir-ritonavir, and remdesivir.

It compared results for all-cause and COVID-specific mortality, recovery, time to recovery, COVID hospitalization, and adverse and serious adverse events.

Nirmatrelvir-ritonavir was associated with a reduction in hospitalization caused by COVID-19 of 0.7% versus 1.2% (moderate certainty of evidence [COE]) and a reduction in all-cause mortality of less than 0.1% versus 0.2% (moderate COE).

Molnupiravir led to a higher recovery rate of 31.8% versus 22.6% (moderate COE) and a reduced time to recovery of 9 versus 15 median days (moderate COE). It had no effect, however, on all-cause mortality: 0.02% versus 0.04% (moderate COE). Nor did it affect the incidence of serious adverse events: 0.4% versus 0.3% (moderate COE).

“There have been no head-to-head comparative studies of these two treatments, but nirmatrelvir-ritonavir appears to be the preferred treatment,” Dr. Salvatore said. She noted that molnupiravir cannot be used in pregnant women or young persons under age 18, while nirmatrelvir-ritonavir carries the risk of drug interactions. Viral rebound and recurrence of symptoms have been reported in some patients receiving nirmatrelvir-ritonavir.

In other review findings, ivermectin had no effect on time to recovery (moderate COE) and adverse events versus placebo (low COE). Sotrovimab resulted in no difference in all-cause mortality, compared with no treatment (low COE). There were no eligible studies for all of the other treatments of interest nor were there any that specifically evaluated the benefits and harms of treatments for the Omicron variant.

The panel pointed to the need for more evaluation of the efficacy, effectiveness, and comparative effectiveness, as well as harms of pharmacologic and biologic treatments of COVID-19 in the outpatient setting, particularly in the context of changing dominant SARS-CoV-2 variants and subvariants.

Another area requiring further research is the effectiveness of retreatment in patients with previous COVID-19 infection. Subgroup analyses are also needed to assess whether the efficacy and effectiveness of outpatient treatments vary by age, sex, socioeconomic status, and comorbid conditions – or by SARS-CoV-2 variant, immunity status (prior SARS-CoV-2 infection, vaccination status, or time since infection or vaccination), symptom duration, or disease severity.

Dr. Salvatore agreed that more research is needed in special convalescent groups. “For instance, those with cancer who are immunocompromised may need longer treatment and adjunctive treatment with convalescent plasma. But is difficult to find a large enough study with 5,000 immunocompromised patients.”

Financial support for the development of the practice points came exclusively from the ACP operating budget. The evidence review was funded by the ACP. The authors disclosed no relevant high-level competing interests with regard to this guidance, although several authors reported intellectual interests in various areas of research. Dr. Salvatore disclosed no conflicts of interest relevant to her comments but is engaged in influenza research for Genentech.

The American College of Physicians has issued an updated version of its living, rapid practice point guideline on the best treatment options for outpatients with confirmed COVID-19 in the era of the dominant Omicron variant of SARS-CoV-2. The recommendations in version 2 apply to persons presenting with mild to moderate infection and symptom onset in the past 5 days who are at high risk for progression to severe disease and potential hospitalization or death.

Version 1 appeared in late 2022.

While outpatient management is appropriate for most patients, treatment should be personalized and based on careful risk stratification and informed decision-making, said the guideline authors, led by Amir Qaseem, MD, PhD, MHA, vice president of clinical policy and the Center for Evidence Reviews at the ACP in Philadelphia.
 

Practice points

• Consider the oral antivirals nirmatrelvir-ritonavir (Paxlovid) or molnupiravir (Lagevrio) for symptomatic outpatients with confirmed mild to moderate COVID-19 who are within 5 days of the onset of symptoms and at high risk for progressing to severe disease.

New evidence for the Omicron variant suggests a possible net benefit of the antiviral molnupiravir versus standard or no treatment in terms of reducing recovery time if treatment is initiated within 5 days of symptom onset. Nirmatrelvir-ritonavir was associated with reductions in COVID-19 hospitalization and all-cause mortality.

“The practice points only address [whether] treatments work compared to placebo, no treatment, or usual care,” cautioned Linda L. Humphrey, MD, MPH, MACP, chair of the ACP’s Population Health and Medical Science Committee and a professor of medicine at Oregon Health and Science University VA Portland Health Care System. The ACP continues to monitor the evidence. “Once enough evidence has emerged, it will be possible to compare treatments to each other. Until that time we are unable to determine if there is an advantage to using one treatment over another.”

• Do not use the antiparasitic ivermectin (Stromectol) or the monoclonal antibody sotrovimab (Xevudy) to treat this patient population. “It is not expected to be effective against the Omicron variant,” Dr. Humphrey said.

There was no evidence to support the use of medications such as corticosteroids, antibiotics, antihistamines, SSRIs, and multiple other agents.

“The guideline is not a departure from previous knowledge and reflects what appears in other guidelines and is already being done generally in practice,” said Mirella Salvatore, MD, an associate professor of medicine and population health sciences at Weill Cornell Medicine, New York, who was not involved in the ACP statement. It is therefore unlikely the recommendations will trigger controversy or negative feedback, added Dr. Salvatore, who is also a spokesperson for the Infectious Diseases Society of America. “We believe that our evidence-based approach, which considers the balance of benefits and harms of various treatments, will be embraced by the physician community,” Dr. Humphrey said.

The updated recommendations are based on new data from the evidence review of multiple treatments, which concluded that both nirmatrelvir-ritonavir and molnupiravir likely improve outcomes for outpatients with mild to moderate COVID-19. The review was conducted after the emergence of the Omicron variant by the ACP Center for Evidence Reviews at Cochrane Austria/University for Continuing Education Krems (Austria).


 

Review details

Inclusion criteria were modified to focus on the Omicron variant by limiting eligible studies to only those enrolling patients on or after Nov. 26, 2021. The investigators included two randomized controlled trials and six retrospective cohort studies and ranked quality of evidence for the effectiveness of the following treatments, compared with usual care or no treatment: azithromycin, camostat mesylate, chloroquine-hydroxychloroquine, chlorpheniramine, colchicine, convalescent plasma, corticosteroids, ensitrelvir, favipiravir, fluvoxamine, ivermectin, lopinavir-ritonavir, molnupiravir, neutralizing monoclonal antibodies, metformin, niclosamide, nitazoxanide, nirmatrelvir-ritonavir, and remdesivir.

It compared results for all-cause and COVID-specific mortality, recovery, time to recovery, COVID hospitalization, and adverse and serious adverse events.

Nirmatrelvir-ritonavir was associated with a reduction in hospitalization caused by COVID-19 of 0.7% versus 1.2% (moderate certainty of evidence [COE]) and a reduction in all-cause mortality of less than 0.1% versus 0.2% (moderate COE).

Molnupiravir led to a higher recovery rate of 31.8% versus 22.6% (moderate COE) and a reduced time to recovery of 9 versus 15 median days (moderate COE). It had no effect, however, on all-cause mortality: 0.02% versus 0.04% (moderate COE). Nor did it affect the incidence of serious adverse events: 0.4% versus 0.3% (moderate COE).

“There have been no head-to-head comparative studies of these two treatments, but nirmatrelvir-ritonavir appears to be the preferred treatment,” Dr. Salvatore said. She noted that molnupiravir cannot be used in pregnant women or young persons under age 18, while nirmatrelvir-ritonavir carries the risk of drug interactions. Viral rebound and recurrence of symptoms have been reported in some patients receiving nirmatrelvir-ritonavir.

In other review findings, ivermectin had no effect on time to recovery (moderate COE) and adverse events versus placebo (low COE). Sotrovimab resulted in no difference in all-cause mortality, compared with no treatment (low COE). There were no eligible studies for all of the other treatments of interest nor were there any that specifically evaluated the benefits and harms of treatments for the Omicron variant.

The panel pointed to the need for more evaluation of the efficacy, effectiveness, and comparative effectiveness, as well as harms of pharmacologic and biologic treatments of COVID-19 in the outpatient setting, particularly in the context of changing dominant SARS-CoV-2 variants and subvariants.

Another area requiring further research is the effectiveness of retreatment in patients with previous COVID-19 infection. Subgroup analyses are also needed to assess whether the efficacy and effectiveness of outpatient treatments vary by age, sex, socioeconomic status, and comorbid conditions – or by SARS-CoV-2 variant, immunity status (prior SARS-CoV-2 infection, vaccination status, or time since infection or vaccination), symptom duration, or disease severity.

Dr. Salvatore agreed that more research is needed in special convalescent groups. “For instance, those with cancer who are immunocompromised may need longer treatment and adjunctive treatment with convalescent plasma. But is difficult to find a large enough study with 5,000 immunocompromised patients.”

Financial support for the development of the practice points came exclusively from the ACP operating budget. The evidence review was funded by the ACP. The authors disclosed no relevant high-level competing interests with regard to this guidance, although several authors reported intellectual interests in various areas of research. Dr. Salvatore disclosed no conflicts of interest relevant to her comments but is engaged in influenza research for Genentech.

The American College of Physicians has issued an updated version of its living, rapid practice point guideline on the best treatment options for outpatients with confirmed COVID-19 in the era of the dominant Omicron variant of SARS-CoV-2. The recommendations in version 2 apply to persons presenting with mild to moderate infection and symptom onset in the past 5 days who are at high risk for progression to severe disease and potential hospitalization or death.

Version 1 appeared in late 2022.

While outpatient management is appropriate for most patients, treatment should be personalized and based on careful risk stratification and informed decision-making, said the guideline authors, led by Amir Qaseem, MD, PhD, MHA, vice president of clinical policy and the Center for Evidence Reviews at the ACP in Philadelphia.
 

Practice points

• Consider the oral antivirals nirmatrelvir-ritonavir (Paxlovid) or molnupiravir (Lagevrio) for symptomatic outpatients with confirmed mild to moderate COVID-19 who are within 5 days of the onset of symptoms and at high risk for progressing to severe disease.

New evidence for the Omicron variant suggests a possible net benefit of the antiviral molnupiravir versus standard or no treatment in terms of reducing recovery time if treatment is initiated within 5 days of symptom onset. Nirmatrelvir-ritonavir was associated with reductions in COVID-19 hospitalization and all-cause mortality.

“The practice points only address [whether] treatments work compared to placebo, no treatment, or usual care,” cautioned Linda L. Humphrey, MD, MPH, MACP, chair of the ACP’s Population Health and Medical Science Committee and a professor of medicine at Oregon Health and Science University VA Portland Health Care System. The ACP continues to monitor the evidence. “Once enough evidence has emerged, it will be possible to compare treatments to each other. Until that time we are unable to determine if there is an advantage to using one treatment over another.”

• Do not use the antiparasitic ivermectin (Stromectol) or the monoclonal antibody sotrovimab (Xevudy) to treat this patient population. “It is not expected to be effective against the Omicron variant,” Dr. Humphrey said.

There was no evidence to support the use of medications such as corticosteroids, antibiotics, antihistamines, SSRIs, and multiple other agents.

“The guideline is not a departure from previous knowledge and reflects what appears in other guidelines and is already being done generally in practice,” said Mirella Salvatore, MD, an associate professor of medicine and population health sciences at Weill Cornell Medicine, New York, who was not involved in the ACP statement. It is therefore unlikely the recommendations will trigger controversy or negative feedback, added Dr. Salvatore, who is also a spokesperson for the Infectious Diseases Society of America. “We believe that our evidence-based approach, which considers the balance of benefits and harms of various treatments, will be embraced by the physician community,” Dr. Humphrey said.

The updated recommendations are based on new data from the evidence review of multiple treatments, which concluded that both nirmatrelvir-ritonavir and molnupiravir likely improve outcomes for outpatients with mild to moderate COVID-19. The review was conducted after the emergence of the Omicron variant by the ACP Center for Evidence Reviews at Cochrane Austria/University for Continuing Education Krems (Austria).


 

Review details

Inclusion criteria were modified to focus on the Omicron variant by limiting eligible studies to only those enrolling patients on or after Nov. 26, 2021. The investigators included two randomized controlled trials and six retrospective cohort studies and ranked quality of evidence for the effectiveness of the following treatments, compared with usual care or no treatment: azithromycin, camostat mesylate, chloroquine-hydroxychloroquine, chlorpheniramine, colchicine, convalescent plasma, corticosteroids, ensitrelvir, favipiravir, fluvoxamine, ivermectin, lopinavir-ritonavir, molnupiravir, neutralizing monoclonal antibodies, metformin, niclosamide, nitazoxanide, nirmatrelvir-ritonavir, and remdesivir.

It compared results for all-cause and COVID-specific mortality, recovery, time to recovery, COVID hospitalization, and adverse and serious adverse events.

Nirmatrelvir-ritonavir was associated with a reduction in hospitalization caused by COVID-19 of 0.7% versus 1.2% (moderate certainty of evidence [COE]) and a reduction in all-cause mortality of less than 0.1% versus 0.2% (moderate COE).

Molnupiravir led to a higher recovery rate of 31.8% versus 22.6% (moderate COE) and a reduced time to recovery of 9 versus 15 median days (moderate COE). It had no effect, however, on all-cause mortality: 0.02% versus 0.04% (moderate COE). Nor did it affect the incidence of serious adverse events: 0.4% versus 0.3% (moderate COE).

“There have been no head-to-head comparative studies of these two treatments, but nirmatrelvir-ritonavir appears to be the preferred treatment,” Dr. Salvatore said. She noted that molnupiravir cannot be used in pregnant women or young persons under age 18, while nirmatrelvir-ritonavir carries the risk of drug interactions. Viral rebound and recurrence of symptoms have been reported in some patients receiving nirmatrelvir-ritonavir.

In other review findings, ivermectin had no effect on time to recovery (moderate COE) and adverse events versus placebo (low COE). Sotrovimab resulted in no difference in all-cause mortality, compared with no treatment (low COE). There were no eligible studies for all of the other treatments of interest nor were there any that specifically evaluated the benefits and harms of treatments for the Omicron variant.

The panel pointed to the need for more evaluation of the efficacy, effectiveness, and comparative effectiveness, as well as harms of pharmacologic and biologic treatments of COVID-19 in the outpatient setting, particularly in the context of changing dominant SARS-CoV-2 variants and subvariants.

Another area requiring further research is the effectiveness of retreatment in patients with previous COVID-19 infection. Subgroup analyses are also needed to assess whether the efficacy and effectiveness of outpatient treatments vary by age, sex, socioeconomic status, and comorbid conditions – or by SARS-CoV-2 variant, immunity status (prior SARS-CoV-2 infection, vaccination status, or time since infection or vaccination), symptom duration, or disease severity.

Dr. Salvatore agreed that more research is needed in special convalescent groups. “For instance, those with cancer who are immunocompromised may need longer treatment and adjunctive treatment with convalescent plasma. But is difficult to find a large enough study with 5,000 immunocompromised patients.”

Financial support for the development of the practice points came exclusively from the ACP operating budget. The evidence review was funded by the ACP. The authors disclosed no relevant high-level competing interests with regard to this guidance, although several authors reported intellectual interests in various areas of research. Dr. Salvatore disclosed no conflicts of interest relevant to her comments but is engaged in influenza research for Genentech.

Antibiotic resistance is a major public health problem. Few new molecules are in development, but a new antibiotic called clovibactin brings hope.

This drug, isolated from bacteria that haven’t previously been studied, seems to be capable of combating multidrug-resistant “superbugs” thanks to unusual mechanisms of action.

The drug was discovered and has been studied by scientists from Utrecht University in the Netherlands, the University of Bonn in Germany, the German Center for Infection Research, Northeastern University in Boston, and NovoBiotic Pharmaceuticals in Cambridge, Mass.

Their research was published in Cell.

“Since clovibactin was isolated from bacteria that could not be grown before, pathogenic bacteria have not seen such an antibiotic before and had no time to develop resistance,” Markus Weingarth, MD, PhD, a researcher in Utrecht University’s chemistry department, said in a press release.
 

Microbial “dark matter”

Researchers isolated clovibactin from sandy soil from North Carolina and studied it using the iChip device, which was developed in 2015. This technique allowed them to grow “bacterial dark matter,” so-called unculturable bacteria, which compose a group to which 99% of bacteria belong.

This device also paved the way for the discovery of the antibiotic teixobactin in 2020. Teixobactin is effective against gram-positive bacteria and is one of the first truly new antibiotics in decades. Its mechanism of action is like that of clovibactin.
 

Combats resistant bacteria

In the Cell article, the researchers showed that clovibactin acts via several mechanisms and that it successfully treated mice infected with the superbug Staphylococcus aureus.

Clovibactin exhibited antibacterial activity against a broad range of gram-positive pathogens, including methicillin-resistant S. aureus, daptomycin-resistant and vancomycin-resistant S. aureus strains, and difficult-to-treat vancomycin-resistant Enterococcus faecalis and E faecium (vancomycin-resistant enterococci). Escherichia coli was only marginally affected “compared with an outer membrane deficient E. coli WO153 strain, probably reflecting insufficient penetration of the compound,” the authors wrote.
 

Original mechanism of action

Clovibactin acts not on one but three molecules, all of which are essential to the construction of bacterial walls: C55PP, lipid II, and lipid IIIWTA, which are from different cell wall biosynthetic pathways. Clovibactin binds to the pyrophosphate portion of these precursors.

“Clovibactin wraps around the pyrophosphate like [a] tight glove, like a cage that encloses its target,” said Dr. Weingarth. This is what gives clovibactin its name, which is derived from Greek word klouvi, meaning cage.

The remarkable aspect of clovibactin’s mechanism is that it only binds to the immutable pyrophosphate that is common to cell wall precursors, but it also ignores the variable sugar-peptide part of the targets. The bacteria therefore have a much harder time developing resistance against it. “In fact, we did not observe any resistance to clovibactin in our studies,” Dr. Weingarth confirmed.

Upon binding the target molecules, it self-assembles into large fibrils on the surface of bacterial membranes. These fibrils are stable for a long time and thereby ensure that the target molecules remain sequestered for as long as necessary to kill bacteria.
 

Few side effects

Because of the mechanism of action of the antibiotic, few side effects are predicted. Indeed, clovibactin targets bacteria cells but not human cells.

“Since these fibrils only form on bacterial membranes and not on human membranes, they are presumably also the reason why clovibactin selectively damages bacterial cells but is not toxic to human cells,” said Dr. Weingarth.

Other studies – in particular, studies in humans – are needed before the antibiotic can be considered a potential treatment. In the meantime, regulations regarding the proper use of antibiotics must continue to be applied to limit antibiotic resistance.

In 2019, 4.95 million deaths worldwide were associated with bacterial antimicrobial resistance, including 1.27 million deaths directly attributable to bacterial antimicrobial resistance. If this trend continues without new medicines becoming available to treat bacterial infections, it is estimated that by 2050, 10 million people will die every year from antimicrobial drug resistance.
 

This article was translated from the Medscape French Edition. A version appeared on Medscape.com.

Antibiotic resistance is a major public health problem. Few new molecules are in development, but a new antibiotic called clovibactin brings hope.

This drug, isolated from bacteria that haven’t previously been studied, seems to be capable of combating multidrug-resistant “superbugs” thanks to unusual mechanisms of action.

The drug was discovered and has been studied by scientists from Utrecht University in the Netherlands, the University of Bonn in Germany, the German Center for Infection Research, Northeastern University in Boston, and NovoBiotic Pharmaceuticals in Cambridge, Mass.

Their research was published in Cell.

“Since clovibactin was isolated from bacteria that could not be grown before, pathogenic bacteria have not seen such an antibiotic before and had no time to develop resistance,” Markus Weingarth, MD, PhD, a researcher in Utrecht University’s chemistry department, said in a press release.
 

Microbial “dark matter”

Researchers isolated clovibactin from sandy soil from North Carolina and studied it using the iChip device, which was developed in 2015. This technique allowed them to grow “bacterial dark matter,” so-called unculturable bacteria, which compose a group to which 99% of bacteria belong.

This device also paved the way for the discovery of the antibiotic teixobactin in 2020. Teixobactin is effective against gram-positive bacteria and is one of the first truly new antibiotics in decades. Its mechanism of action is like that of clovibactin.
 

Combats resistant bacteria

In the Cell article, the researchers showed that clovibactin acts via several mechanisms and that it successfully treated mice infected with the superbug Staphylococcus aureus.

Clovibactin exhibited antibacterial activity against a broad range of gram-positive pathogens, including methicillin-resistant S. aureus, daptomycin-resistant and vancomycin-resistant S. aureus strains, and difficult-to-treat vancomycin-resistant Enterococcus faecalis and E faecium (vancomycin-resistant enterococci). Escherichia coli was only marginally affected “compared with an outer membrane deficient E. coli WO153 strain, probably reflecting insufficient penetration of the compound,” the authors wrote.
 

Original mechanism of action

Clovibactin acts not on one but three molecules, all of which are essential to the construction of bacterial walls: C55PP, lipid II, and lipid IIIWTA, which are from different cell wall biosynthetic pathways. Clovibactin binds to the pyrophosphate portion of these precursors.

“Clovibactin wraps around the pyrophosphate like [a] tight glove, like a cage that encloses its target,” said Dr. Weingarth. This is what gives clovibactin its name, which is derived from Greek word klouvi, meaning cage.

The remarkable aspect of clovibactin’s mechanism is that it only binds to the immutable pyrophosphate that is common to cell wall precursors, but it also ignores the variable sugar-peptide part of the targets. The bacteria therefore have a much harder time developing resistance against it. “In fact, we did not observe any resistance to clovibactin in our studies,” Dr. Weingarth confirmed.

Upon binding the target molecules, it self-assembles into large fibrils on the surface of bacterial membranes. These fibrils are stable for a long time and thereby ensure that the target molecules remain sequestered for as long as necessary to kill bacteria.
 

Few side effects

Because of the mechanism of action of the antibiotic, few side effects are predicted. Indeed, clovibactin targets bacteria cells but not human cells.

“Since these fibrils only form on bacterial membranes and not on human membranes, they are presumably also the reason why clovibactin selectively damages bacterial cells but is not toxic to human cells,” said Dr. Weingarth.

Other studies – in particular, studies in humans – are needed before the antibiotic can be considered a potential treatment. In the meantime, regulations regarding the proper use of antibiotics must continue to be applied to limit antibiotic resistance.

In 2019, 4.95 million deaths worldwide were associated with bacterial antimicrobial resistance, including 1.27 million deaths directly attributable to bacterial antimicrobial resistance. If this trend continues without new medicines becoming available to treat bacterial infections, it is estimated that by 2050, 10 million people will die every year from antimicrobial drug resistance.
 

This article was translated from the Medscape French Edition. A version appeared on Medscape.com.

Antibiotic resistance is a major public health problem. Few new molecules are in development, but a new antibiotic called clovibactin brings hope.

This drug, isolated from bacteria that haven’t previously been studied, seems to be capable of combating multidrug-resistant “superbugs” thanks to unusual mechanisms of action.

The drug was discovered and has been studied by scientists from Utrecht University in the Netherlands, the University of Bonn in Germany, the German Center for Infection Research, Northeastern University in Boston, and NovoBiotic Pharmaceuticals in Cambridge, Mass.

Their research was published in Cell.

“Since clovibactin was isolated from bacteria that could not be grown before, pathogenic bacteria have not seen such an antibiotic before and had no time to develop resistance,” Markus Weingarth, MD, PhD, a researcher in Utrecht University’s chemistry department, said in a press release.
 

Microbial “dark matter”

Researchers isolated clovibactin from sandy soil from North Carolina and studied it using the iChip device, which was developed in 2015. This technique allowed them to grow “bacterial dark matter,” so-called unculturable bacteria, which compose a group to which 99% of bacteria belong.

This device also paved the way for the discovery of the antibiotic teixobactin in 2020. Teixobactin is effective against gram-positive bacteria and is one of the first truly new antibiotics in decades. Its mechanism of action is like that of clovibactin.
 

Combats resistant bacteria

In the Cell article, the researchers showed that clovibactin acts via several mechanisms and that it successfully treated mice infected with the superbug Staphylococcus aureus.

Clovibactin exhibited antibacterial activity against a broad range of gram-positive pathogens, including methicillin-resistant S. aureus, daptomycin-resistant and vancomycin-resistant S. aureus strains, and difficult-to-treat vancomycin-resistant Enterococcus faecalis and E faecium (vancomycin-resistant enterococci). Escherichia coli was only marginally affected “compared with an outer membrane deficient E. coli WO153 strain, probably reflecting insufficient penetration of the compound,” the authors wrote.
 

Original mechanism of action

Clovibactin acts not on one but three molecules, all of which are essential to the construction of bacterial walls: C55PP, lipid II, and lipid IIIWTA, which are from different cell wall biosynthetic pathways. Clovibactin binds to the pyrophosphate portion of these precursors.

“Clovibactin wraps around the pyrophosphate like [a] tight glove, like a cage that encloses its target,” said Dr. Weingarth. This is what gives clovibactin its name, which is derived from Greek word klouvi, meaning cage.

The remarkable aspect of clovibactin’s mechanism is that it only binds to the immutable pyrophosphate that is common to cell wall precursors, but it also ignores the variable sugar-peptide part of the targets. The bacteria therefore have a much harder time developing resistance against it. “In fact, we did not observe any resistance to clovibactin in our studies,” Dr. Weingarth confirmed.

Upon binding the target molecules, it self-assembles into large fibrils on the surface of bacterial membranes. These fibrils are stable for a long time and thereby ensure that the target molecules remain sequestered for as long as necessary to kill bacteria.
 

Few side effects

Because of the mechanism of action of the antibiotic, few side effects are predicted. Indeed, clovibactin targets bacteria cells but not human cells.

“Since these fibrils only form on bacterial membranes and not on human membranes, they are presumably also the reason why clovibactin selectively damages bacterial cells but is not toxic to human cells,” said Dr. Weingarth.

Other studies – in particular, studies in humans – are needed before the antibiotic can be considered a potential treatment. In the meantime, regulations regarding the proper use of antibiotics must continue to be applied to limit antibiotic resistance.

In 2019, 4.95 million deaths worldwide were associated with bacterial antimicrobial resistance, including 1.27 million deaths directly attributable to bacterial antimicrobial resistance. If this trend continues without new medicines becoming available to treat bacterial infections, it is estimated that by 2050, 10 million people will die every year from antimicrobial drug resistance.
 

This article was translated from the Medscape French Edition. A version appeared on Medscape.com.

Before the pandemic, most of the public probably had a fleeting and limited familiarity with lateral flow tests (LFTs), also known as rapid antigen tests. Perhaps they used, or awaited the results of, a lateral flow home pregnancy test, which detects human chorionic gonadotropin in urine.

Then came COVID-19, and the need for large-scale testing. By late 2022, more than 3 billion tests for SARS-CoV-2 had been done worldwide. Although testing with reverse-transcription polymerase chain reaction (PCR) is the gold standard for diagnosing COVID, LFTs made possible large-scale testing at low cost with rapid results.

As of Sept. 12, the Food and Drug Administration lists 32 rapid antigen tests with emergency use authorizations (EUAs) for home use.

Now, many experts conclude, it’s time to expand the role of LFTs so the technology can help detect a host of other diseases. In a Nature Reviews bioengineering report, global experts from the United States, the United Kingdom, and other countries pointed out that commercial LFTs are currently not available for four of the eight known priority diseases of epidemic potential: Crimean-Congo hemorrhagic fever, Middle East respiratory syndrome coronavirus, Nipah and other henipaviruses, and Rift Valley fever.

It is prime time, these experts and others contend, to build a global network of LFT research and development hubs to strengthen diagnostic capability.

Expansion should not only include more tests for more diseases, some experts say, but also make use of existing technology to provide “full-circle” care. After a rapid test, for instance, users could download a mobile phone app, transmit the results to their health care provider, and then set up an appointment if needed or get a prescribed medication at the pharmacy.
 

Medical community on board

Clinicians support increased availability of LFTs, said Eric J. Topol, MD, professor and executive vice president of Scripps Research, La Jolla, Calif.“Rapid antigen tests are critical, made a big difference in the pandemic, and will be used increasingly for many other applications in the years ahead,” Dr. Topol said in an email.

Physicians welcome their potential, agreed William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. At the start of the pandemic, when he was briefed about a lateral flow device in development, he said, “I was blown away by the technology, ease of use, rapidity of getting a result, its reasonable accuracy and its anticipated relatively low price.”

Clinicians would probably see many advantages to having more LFTs for more diseases, Dr. Schaffner said, because they are of use not only at home but also in doctors’ offices and in emergency departments. Their increased use “would help [people] make quick decisions about treatment, especially for flu and COVID.”
 

How LFTs work

LFTs are capable of targeting antigens, such as for the COVID tests, and antibodies such as IgG or IgM. The tests are also capable of detecting nucleic acids, although the availability of these tests is currently rare.

First, a sample from blood, urine, saliva or other bodily sources is placed onto a sample pad. It travels to a conjugate pad containing antibodies. If the target being looked for is present, the target and antibodies bind and, as the sample moves along to the test line, produces a positive result line along with the control line (to show that the test worked).
 

Global market outlook

By 2030, the lateral flow assays market is predicted to rise to $14.1 billion, according to a report issued in September by the firm Research and Markets. In 2022, the market was estimated at $9.4 billion, with $3.6 billion of that in the United States.

The report details the performances of 55 major competitors, such as Abbott Laboratories, Siemens, and QuidelOrtho, but smaller companies and start-ups are also involved in LFT development.
 

LFTs: Pros and cons

Although LFTs give rapid results, their accuracy is lower than that of PCR, especially the sensitivity. For COVID antigen LFTs, the sensitivity ranges from 34.1% to 88.1%, with an overall specificity of 99.6%, according to a Cochrane Review report. The analytical sensitivity performance of PCR testing for COVID is near 100%.

Everyone acknowledges the accuracy challenge of LFTs. The technologies “are generally thought to have limitations of detection that for some applications may present a challenge,” said Douglas C. Bryant, president and CEO of QuidelOrtho, San Diego, which counts the QuickVue rapid test for COVID detection among its products.

However, Mr. Bryant added, “as we saw during the pandemic, there was a place for more sensitive PCR-based technologies that are often run in a lab and there was a place for the use of rapid tests: The key is knowing the strengths and best use cases when applying the different technologies.”

One strength, he said, was that the tests “were shown to be highly effective at detecting active, infectious cases of SARS-CoV-2 and the rapid turnaround time allowed patients to isolate themselves from others quickly to help curb the spread of infection to others.” Another advantage was the ability to screen high-risk populations such as nursing homes to detect positive cases and help prevent outbreaks.

The pandemic familiarized people with the tests, said Jeremy Stackawitz, CEO of Senzo, a start-up in vitro diagnostics company developing an amplified LFT platform for rapid tests for flu, tuberculosis, COVID, and Clostridioides difficile. People liked using them. Physicians generally accepted them. It works great with tele-doc. It works great with personalized medicine.

Now, he said, people used to the COVID self-tests are asking: “Where is my strep test? Where is my sexual health test?”
 

FDA’s perspective on LFTs

The FDA has no one-size-fits-all standard for evaluating LFTs.

“LFTs are evaluated with respect to their individual indications and the pathway under which they are being reviewed,” said James McKinney, an FDA spokesperson. “A performance recommendation for one type of lateral flow test may not be appropriate for another.”

EUAs, such as those given for the COVID at-home tests, require different levels of evidence than traditional premarket review, he said, whether de novo marketing authorization, 510(k) premarket notification, or premarket approval. The EUAs are evaluated with a risk-benefit analysis to speed up the time it takes to make the devices available.

And, Mr. McKinney said, for some devices, the FDA provides recommendations on the expected performance through guidance documents. For instance, for rapid devices developed to detect influenza A virus antigen, the FDA recommends including enough sample to generate sensitivity of greater than 60% and testing at least 50 samples.
 

LFTs: The potential, the challenges

Mr. Stackawitz predicted that, as more LFT self-tests become available, more people will seek care, just as they did with the COVID rapid tests. A 22-year-old who thinks he has chlamydia may balk at going to a doctor right away. However, “if he can go buy a soda and a test at CVS, it’s different, it really is. With a little anonymity, people will seek care.”

He has a vision shared by other experts: That testing technology will evolve so that after getting the results at home, people would follow through by sending those results to their health care provider and obtaining needed care or medication. In his opinion, this is superior to the traditional way, which often involves visiting a doctor with symptoms, going for tests, waiting for results, and then beginning treatment.

“It would make more sense if you came in knowing your results,” Mr. Stackawitz said. “It’s a much smarter pathway, gives better outcomes for the patient, is much quicker and at much less cost. And it frees up time for doctors. I think most physicians would embrace that.”

Although rapid testing is gaining well-deserved recognition, funding is an issue, according to the Nature Reviews report. Those experts warned that “a reduction in funding for LFT research post COVID-19 may hamper efforts to capitalize on gains in decentralized testing, especially self-testing, which may be critical to address future pandemic threats.”

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

Before the pandemic, most of the public probably had a fleeting and limited familiarity with lateral flow tests (LFTs), also known as rapid antigen tests. Perhaps they used, or awaited the results of, a lateral flow home pregnancy test, which detects human chorionic gonadotropin in urine.

Then came COVID-19, and the need for large-scale testing. By late 2022, more than 3 billion tests for SARS-CoV-2 had been done worldwide. Although testing with reverse-transcription polymerase chain reaction (PCR) is the gold standard for diagnosing COVID, LFTs made possible large-scale testing at low cost with rapid results.

As of Sept. 12, the Food and Drug Administration lists 32 rapid antigen tests with emergency use authorizations (EUAs) for home use.

Now, many experts conclude, it’s time to expand the role of LFTs so the technology can help detect a host of other diseases. In a Nature Reviews bioengineering report, global experts from the United States, the United Kingdom, and other countries pointed out that commercial LFTs are currently not available for four of the eight known priority diseases of epidemic potential: Crimean-Congo hemorrhagic fever, Middle East respiratory syndrome coronavirus, Nipah and other henipaviruses, and Rift Valley fever.

It is prime time, these experts and others contend, to build a global network of LFT research and development hubs to strengthen diagnostic capability.

Expansion should not only include more tests for more diseases, some experts say, but also make use of existing technology to provide “full-circle” care. After a rapid test, for instance, users could download a mobile phone app, transmit the results to their health care provider, and then set up an appointment if needed or get a prescribed medication at the pharmacy.
 

Medical community on board

Clinicians support increased availability of LFTs, said Eric J. Topol, MD, professor and executive vice president of Scripps Research, La Jolla, Calif.“Rapid antigen tests are critical, made a big difference in the pandemic, and will be used increasingly for many other applications in the years ahead,” Dr. Topol said in an email.

Physicians welcome their potential, agreed William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. At the start of the pandemic, when he was briefed about a lateral flow device in development, he said, “I was blown away by the technology, ease of use, rapidity of getting a result, its reasonable accuracy and its anticipated relatively low price.”

Clinicians would probably see many advantages to having more LFTs for more diseases, Dr. Schaffner said, because they are of use not only at home but also in doctors’ offices and in emergency departments. Their increased use “would help [people] make quick decisions about treatment, especially for flu and COVID.”
 

How LFTs work

LFTs are capable of targeting antigens, such as for the COVID tests, and antibodies such as IgG or IgM. The tests are also capable of detecting nucleic acids, although the availability of these tests is currently rare.

First, a sample from blood, urine, saliva or other bodily sources is placed onto a sample pad. It travels to a conjugate pad containing antibodies. If the target being looked for is present, the target and antibodies bind and, as the sample moves along to the test line, produces a positive result line along with the control line (to show that the test worked).
 

Global market outlook

By 2030, the lateral flow assays market is predicted to rise to $14.1 billion, according to a report issued in September by the firm Research and Markets. In 2022, the market was estimated at $9.4 billion, with $3.6 billion of that in the United States.

The report details the performances of 55 major competitors, such as Abbott Laboratories, Siemens, and QuidelOrtho, but smaller companies and start-ups are also involved in LFT development.
 

LFTs: Pros and cons

Although LFTs give rapid results, their accuracy is lower than that of PCR, especially the sensitivity. For COVID antigen LFTs, the sensitivity ranges from 34.1% to 88.1%, with an overall specificity of 99.6%, according to a Cochrane Review report. The analytical sensitivity performance of PCR testing for COVID is near 100%.

Everyone acknowledges the accuracy challenge of LFTs. The technologies “are generally thought to have limitations of detection that for some applications may present a challenge,” said Douglas C. Bryant, president and CEO of QuidelOrtho, San Diego, which counts the QuickVue rapid test for COVID detection among its products.

However, Mr. Bryant added, “as we saw during the pandemic, there was a place for more sensitive PCR-based technologies that are often run in a lab and there was a place for the use of rapid tests: The key is knowing the strengths and best use cases when applying the different technologies.”

One strength, he said, was that the tests “were shown to be highly effective at detecting active, infectious cases of SARS-CoV-2 and the rapid turnaround time allowed patients to isolate themselves from others quickly to help curb the spread of infection to others.” Another advantage was the ability to screen high-risk populations such as nursing homes to detect positive cases and help prevent outbreaks.

The pandemic familiarized people with the tests, said Jeremy Stackawitz, CEO of Senzo, a start-up in vitro diagnostics company developing an amplified LFT platform for rapid tests for flu, tuberculosis, COVID, and Clostridioides difficile. People liked using them. Physicians generally accepted them. It works great with tele-doc. It works great with personalized medicine.

Now, he said, people used to the COVID self-tests are asking: “Where is my strep test? Where is my sexual health test?”
 

FDA’s perspective on LFTs

The FDA has no one-size-fits-all standard for evaluating LFTs.

“LFTs are evaluated with respect to their individual indications and the pathway under which they are being reviewed,” said James McKinney, an FDA spokesperson. “A performance recommendation for one type of lateral flow test may not be appropriate for another.”

EUAs, such as those given for the COVID at-home tests, require different levels of evidence than traditional premarket review, he said, whether de novo marketing authorization, 510(k) premarket notification, or premarket approval. The EUAs are evaluated with a risk-benefit analysis to speed up the time it takes to make the devices available.

And, Mr. McKinney said, for some devices, the FDA provides recommendations on the expected performance through guidance documents. For instance, for rapid devices developed to detect influenza A virus antigen, the FDA recommends including enough sample to generate sensitivity of greater than 60% and testing at least 50 samples.
 

LFTs: The potential, the challenges

Mr. Stackawitz predicted that, as more LFT self-tests become available, more people will seek care, just as they did with the COVID rapid tests. A 22-year-old who thinks he has chlamydia may balk at going to a doctor right away. However, “if he can go buy a soda and a test at CVS, it’s different, it really is. With a little anonymity, people will seek care.”

He has a vision shared by other experts: That testing technology will evolve so that after getting the results at home, people would follow through by sending those results to their health care provider and obtaining needed care or medication. In his opinion, this is superior to the traditional way, which often involves visiting a doctor with symptoms, going for tests, waiting for results, and then beginning treatment.

“It would make more sense if you came in knowing your results,” Mr. Stackawitz said. “It’s a much smarter pathway, gives better outcomes for the patient, is much quicker and at much less cost. And it frees up time for doctors. I think most physicians would embrace that.”

Although rapid testing is gaining well-deserved recognition, funding is an issue, according to the Nature Reviews report. Those experts warned that “a reduction in funding for LFT research post COVID-19 may hamper efforts to capitalize on gains in decentralized testing, especially self-testing, which may be critical to address future pandemic threats.”

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

Before the pandemic, most of the public probably had a fleeting and limited familiarity with lateral flow tests (LFTs), also known as rapid antigen tests. Perhaps they used, or awaited the results of, a lateral flow home pregnancy test, which detects human chorionic gonadotropin in urine.

Then came COVID-19, and the need for large-scale testing. By late 2022, more than 3 billion tests for SARS-CoV-2 had been done worldwide. Although testing with reverse-transcription polymerase chain reaction (PCR) is the gold standard for diagnosing COVID, LFTs made possible large-scale testing at low cost with rapid results.

As of Sept. 12, the Food and Drug Administration lists 32 rapid antigen tests with emergency use authorizations (EUAs) for home use.

Now, many experts conclude, it’s time to expand the role of LFTs so the technology can help detect a host of other diseases. In a Nature Reviews bioengineering report, global experts from the United States, the United Kingdom, and other countries pointed out that commercial LFTs are currently not available for four of the eight known priority diseases of epidemic potential: Crimean-Congo hemorrhagic fever, Middle East respiratory syndrome coronavirus, Nipah and other henipaviruses, and Rift Valley fever.

It is prime time, these experts and others contend, to build a global network of LFT research and development hubs to strengthen diagnostic capability.

Expansion should not only include more tests for more diseases, some experts say, but also make use of existing technology to provide “full-circle” care. After a rapid test, for instance, users could download a mobile phone app, transmit the results to their health care provider, and then set up an appointment if needed or get a prescribed medication at the pharmacy.
 

Medical community on board

Clinicians support increased availability of LFTs, said Eric J. Topol, MD, professor and executive vice president of Scripps Research, La Jolla, Calif.“Rapid antigen tests are critical, made a big difference in the pandemic, and will be used increasingly for many other applications in the years ahead,” Dr. Topol said in an email.

Physicians welcome their potential, agreed William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. At the start of the pandemic, when he was briefed about a lateral flow device in development, he said, “I was blown away by the technology, ease of use, rapidity of getting a result, its reasonable accuracy and its anticipated relatively low price.”

Clinicians would probably see many advantages to having more LFTs for more diseases, Dr. Schaffner said, because they are of use not only at home but also in doctors’ offices and in emergency departments. Their increased use “would help [people] make quick decisions about treatment, especially for flu and COVID.”
 

How LFTs work

LFTs are capable of targeting antigens, such as for the COVID tests, and antibodies such as IgG or IgM. The tests are also capable of detecting nucleic acids, although the availability of these tests is currently rare.

First, a sample from blood, urine, saliva or other bodily sources is placed onto a sample pad. It travels to a conjugate pad containing antibodies. If the target being looked for is present, the target and antibodies bind and, as the sample moves along to the test line, produces a positive result line along with the control line (to show that the test worked).
 

Global market outlook

By 2030, the lateral flow assays market is predicted to rise to $14.1 billion, according to a report issued in September by the firm Research and Markets. In 2022, the market was estimated at $9.4 billion, with $3.6 billion of that in the United States.

The report details the performances of 55 major competitors, such as Abbott Laboratories, Siemens, and QuidelOrtho, but smaller companies and start-ups are also involved in LFT development.
 

LFTs: Pros and cons

Although LFTs give rapid results, their accuracy is lower than that of PCR, especially the sensitivity. For COVID antigen LFTs, the sensitivity ranges from 34.1% to 88.1%, with an overall specificity of 99.6%, according to a Cochrane Review report. The analytical sensitivity performance of PCR testing for COVID is near 100%.

Everyone acknowledges the accuracy challenge of LFTs. The technologies “are generally thought to have limitations of detection that for some applications may present a challenge,” said Douglas C. Bryant, president and CEO of QuidelOrtho, San Diego, which counts the QuickVue rapid test for COVID detection among its products.

However, Mr. Bryant added, “as we saw during the pandemic, there was a place for more sensitive PCR-based technologies that are often run in a lab and there was a place for the use of rapid tests: The key is knowing the strengths and best use cases when applying the different technologies.”

One strength, he said, was that the tests “were shown to be highly effective at detecting active, infectious cases of SARS-CoV-2 and the rapid turnaround time allowed patients to isolate themselves from others quickly to help curb the spread of infection to others.” Another advantage was the ability to screen high-risk populations such as nursing homes to detect positive cases and help prevent outbreaks.

The pandemic familiarized people with the tests, said Jeremy Stackawitz, CEO of Senzo, a start-up in vitro diagnostics company developing an amplified LFT platform for rapid tests for flu, tuberculosis, COVID, and Clostridioides difficile. People liked using them. Physicians generally accepted them. It works great with tele-doc. It works great with personalized medicine.

Now, he said, people used to the COVID self-tests are asking: “Where is my strep test? Where is my sexual health test?”
 

FDA’s perspective on LFTs

The FDA has no one-size-fits-all standard for evaluating LFTs.

“LFTs are evaluated with respect to their individual indications and the pathway under which they are being reviewed,” said James McKinney, an FDA spokesperson. “A performance recommendation for one type of lateral flow test may not be appropriate for another.”

EUAs, such as those given for the COVID at-home tests, require different levels of evidence than traditional premarket review, he said, whether de novo marketing authorization, 510(k) premarket notification, or premarket approval. The EUAs are evaluated with a risk-benefit analysis to speed up the time it takes to make the devices available.

And, Mr. McKinney said, for some devices, the FDA provides recommendations on the expected performance through guidance documents. For instance, for rapid devices developed to detect influenza A virus antigen, the FDA recommends including enough sample to generate sensitivity of greater than 60% and testing at least 50 samples.
 

LFTs: The potential, the challenges

Mr. Stackawitz predicted that, as more LFT self-tests become available, more people will seek care, just as they did with the COVID rapid tests. A 22-year-old who thinks he has chlamydia may balk at going to a doctor right away. However, “if he can go buy a soda and a test at CVS, it’s different, it really is. With a little anonymity, people will seek care.”

He has a vision shared by other experts: That testing technology will evolve so that after getting the results at home, people would follow through by sending those results to their health care provider and obtaining needed care or medication. In his opinion, this is superior to the traditional way, which often involves visiting a doctor with symptoms, going for tests, waiting for results, and then beginning treatment.

“It would make more sense if you came in knowing your results,” Mr. Stackawitz said. “It’s a much smarter pathway, gives better outcomes for the patient, is much quicker and at much less cost. And it frees up time for doctors. I think most physicians would embrace that.”

Although rapid testing is gaining well-deserved recognition, funding is an issue, according to the Nature Reviews report. Those experts warned that “a reduction in funding for LFT research post COVID-19 may hamper efforts to capitalize on gains in decentralized testing, especially self-testing, which may be critical to address future pandemic threats.”

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

It is difficult to go through any publication or website these days without finding an article about artificial intelligence (AI). Many discuss its current status, while others speculate on potential future applications. Often, AI is described as an “existential threat to human health” by commentators who aren’t even aware of the definition of that term as Kierkegaard conceived it, the role of the individual to breathe meaning into life. Others characterize such cataclysmic predictions as “overblown and misdirected”.

The long-term potential for abuse of AI requires discussion, and should be addressed by policy makers, but that is beyond the scope of this column.

Meanwhile, there are many near-term opportunities for AI to improve health care and reduce tedious and time consuming tasks. Specifically, some AI-based tools are available to use in your office right now, with no “existential” threat to anybody.

The most popular current AI-based medical applications are automated scribes. They transcribe live consultations between physician and patient automatically and create a searchable report, plus notes for charts and billing.

I’ve written about AI scribes before, but the quality and user-friendliness of these products have improved dramatically in recent years. Language processing capabilities now permit you to speak naturally, without having to memorize specific commands. Some scribes can mimic your writing style based on sample notes that you enter into the system. Others allow you to integrate your own knowledge base, or a bibliography of research studies. With some systems, you can dictate notes directly into most EHR software, ask questions regarding medication dosages, or access a patient’s medical history from hospitals or other offices.

Current popular medical scribe products include DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, and ScribeLink. Amazon Web Services recently launched its own product, HealthScribe, as well. (As always, I have no financial interest in any product or service mentioned in this column.)

AI scribes aren’t entirely autonomous, of course; you need to read the output and check for potential inaccuracies. Still, users claim that they substantially reduce documentation and charting time, permitting more patient visits and less after-hours work.

AI can also be used to provide useful content for your patients. If you are not particularly good at writing, or don’t have the time for it, generative algorithms like the much-vaunted ChatGPT can generate posts, FAQs, and other informational content for your website, blog, or social media pages. You can ask for ideas about timely health topics and write general information articles, or create content specific to your location or specialty. You can use it to write emails informing your patients about upcoming office events or educate them on a range of topics, from getting their annual flu shots to scheduling regular screening skin exams.

With some of the same techniques and additional software, you can create entire videos for your website at a fraction of the cost of hiring a video production team. After using ChatGPT to write the content – for example, a 5-minute script on the importance of sunscreen in preventing skin cancer – you can employ a text-to-speech algorithm such as Revoicer to transform the script into audio content, and then a preproduction algorithm like Yepic or Synthesia to generate a video with a synthetic human. 

If you are unhappy with your current online presence, you can use AI to create an entire website. Through a series of questions, AI website builders such as Wix ADI, Jimdo, Hostinger, and 10Web gather all the information needed to set up a website draft that is already personalized with medical-specific content. Most offer the option to connect to Instagram, Facebook, Google My Business, and similar sites, to which they can import your office’s logo, images, and descriptive texts.

Some of them are capable of pulling up responsive site pages that automatically adjust to the device – mobile or computer – that the visitor is using. This is important, as I’ve written before, because more than half of all searches for doctors are now made on smartphones, so the more “mobile friendly” your site is, the higher it will be ranked. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test.

If you give talks at medical meetings, you know how cumbersome and time-consuming it can be to create Powerpoint presentations. Once again, AI can save you time and trouble. Presentation designers such as Presentations.AI, Deck Robot, iA Presenter, and Beautiful.AI can assemble very acceptable presentations from your primary inputs. You typically choose a template, input your basic data, and AI will format the slides and offer you visuals, animations, voice-overs, and other fancy features. You will also have flexibility in changing segments or images or sizes you don’t like.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It is difficult to go through any publication or website these days without finding an article about artificial intelligence (AI). Many discuss its current status, while others speculate on potential future applications. Often, AI is described as an “existential threat to human health” by commentators who aren’t even aware of the definition of that term as Kierkegaard conceived it, the role of the individual to breathe meaning into life. Others characterize such cataclysmic predictions as “overblown and misdirected”.

The long-term potential for abuse of AI requires discussion, and should be addressed by policy makers, but that is beyond the scope of this column.

Meanwhile, there are many near-term opportunities for AI to improve health care and reduce tedious and time consuming tasks. Specifically, some AI-based tools are available to use in your office right now, with no “existential” threat to anybody.

The most popular current AI-based medical applications are automated scribes. They transcribe live consultations between physician and patient automatically and create a searchable report, plus notes for charts and billing.

I’ve written about AI scribes before, but the quality and user-friendliness of these products have improved dramatically in recent years. Language processing capabilities now permit you to speak naturally, without having to memorize specific commands. Some scribes can mimic your writing style based on sample notes that you enter into the system. Others allow you to integrate your own knowledge base, or a bibliography of research studies. With some systems, you can dictate notes directly into most EHR software, ask questions regarding medication dosages, or access a patient’s medical history from hospitals or other offices.

Current popular medical scribe products include DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, and ScribeLink. Amazon Web Services recently launched its own product, HealthScribe, as well. (As always, I have no financial interest in any product or service mentioned in this column.)

AI scribes aren’t entirely autonomous, of course; you need to read the output and check for potential inaccuracies. Still, users claim that they substantially reduce documentation and charting time, permitting more patient visits and less after-hours work.

AI can also be used to provide useful content for your patients. If you are not particularly good at writing, or don’t have the time for it, generative algorithms like the much-vaunted ChatGPT can generate posts, FAQs, and other informational content for your website, blog, or social media pages. You can ask for ideas about timely health topics and write general information articles, or create content specific to your location or specialty. You can use it to write emails informing your patients about upcoming office events or educate them on a range of topics, from getting their annual flu shots to scheduling regular screening skin exams.

With some of the same techniques and additional software, you can create entire videos for your website at a fraction of the cost of hiring a video production team. After using ChatGPT to write the content – for example, a 5-minute script on the importance of sunscreen in preventing skin cancer – you can employ a text-to-speech algorithm such as Revoicer to transform the script into audio content, and then a preproduction algorithm like Yepic or Synthesia to generate a video with a synthetic human. 

If you are unhappy with your current online presence, you can use AI to create an entire website. Through a series of questions, AI website builders such as Wix ADI, Jimdo, Hostinger, and 10Web gather all the information needed to set up a website draft that is already personalized with medical-specific content. Most offer the option to connect to Instagram, Facebook, Google My Business, and similar sites, to which they can import your office’s logo, images, and descriptive texts.

Some of them are capable of pulling up responsive site pages that automatically adjust to the device – mobile or computer – that the visitor is using. This is important, as I’ve written before, because more than half of all searches for doctors are now made on smartphones, so the more “mobile friendly” your site is, the higher it will be ranked. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test.

If you give talks at medical meetings, you know how cumbersome and time-consuming it can be to create Powerpoint presentations. Once again, AI can save you time and trouble. Presentation designers such as Presentations.AI, Deck Robot, iA Presenter, and Beautiful.AI can assemble very acceptable presentations from your primary inputs. You typically choose a template, input your basic data, and AI will format the slides and offer you visuals, animations, voice-overs, and other fancy features. You will also have flexibility in changing segments or images or sizes you don’t like.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It is difficult to go through any publication or website these days without finding an article about artificial intelligence (AI). Many discuss its current status, while others speculate on potential future applications. Often, AI is described as an “existential threat to human health” by commentators who aren’t even aware of the definition of that term as Kierkegaard conceived it, the role of the individual to breathe meaning into life. Others characterize such cataclysmic predictions as “overblown and misdirected”.

The long-term potential for abuse of AI requires discussion, and should be addressed by policy makers, but that is beyond the scope of this column.

Meanwhile, there are many near-term opportunities for AI to improve health care and reduce tedious and time consuming tasks. Specifically, some AI-based tools are available to use in your office right now, with no “existential” threat to anybody.

The most popular current AI-based medical applications are automated scribes. They transcribe live consultations between physician and patient automatically and create a searchable report, plus notes for charts and billing.

I’ve written about AI scribes before, but the quality and user-friendliness of these products have improved dramatically in recent years. Language processing capabilities now permit you to speak naturally, without having to memorize specific commands. Some scribes can mimic your writing style based on sample notes that you enter into the system. Others allow you to integrate your own knowledge base, or a bibliography of research studies. With some systems, you can dictate notes directly into most EHR software, ask questions regarding medication dosages, or access a patient’s medical history from hospitals or other offices.

Current popular medical scribe products include DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, and ScribeLink. Amazon Web Services recently launched its own product, HealthScribe, as well. (As always, I have no financial interest in any product or service mentioned in this column.)

AI scribes aren’t entirely autonomous, of course; you need to read the output and check for potential inaccuracies. Still, users claim that they substantially reduce documentation and charting time, permitting more patient visits and less after-hours work.

AI can also be used to provide useful content for your patients. If you are not particularly good at writing, or don’t have the time for it, generative algorithms like the much-vaunted ChatGPT can generate posts, FAQs, and other informational content for your website, blog, or social media pages. You can ask for ideas about timely health topics and write general information articles, or create content specific to your location or specialty. You can use it to write emails informing your patients about upcoming office events or educate them on a range of topics, from getting their annual flu shots to scheduling regular screening skin exams.

With some of the same techniques and additional software, you can create entire videos for your website at a fraction of the cost of hiring a video production team. After using ChatGPT to write the content – for example, a 5-minute script on the importance of sunscreen in preventing skin cancer – you can employ a text-to-speech algorithm such as Revoicer to transform the script into audio content, and then a preproduction algorithm like Yepic or Synthesia to generate a video with a synthetic human. 

If you are unhappy with your current online presence, you can use AI to create an entire website. Through a series of questions, AI website builders such as Wix ADI, Jimdo, Hostinger, and 10Web gather all the information needed to set up a website draft that is already personalized with medical-specific content. Most offer the option to connect to Instagram, Facebook, Google My Business, and similar sites, to which they can import your office’s logo, images, and descriptive texts.

Some of them are capable of pulling up responsive site pages that automatically adjust to the device – mobile or computer – that the visitor is using. This is important, as I’ve written before, because more than half of all searches for doctors are now made on smartphones, so the more “mobile friendly” your site is, the higher it will be ranked. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test.

If you give talks at medical meetings, you know how cumbersome and time-consuming it can be to create Powerpoint presentations. Once again, AI can save you time and trouble. Presentation designers such as Presentations.AI, Deck Robot, iA Presenter, and Beautiful.AI can assemble very acceptable presentations from your primary inputs. You typically choose a template, input your basic data, and AI will format the slides and offer you visuals, animations, voice-overs, and other fancy features. You will also have flexibility in changing segments or images or sizes you don’t like.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].