Another frustrated patient awaits transfer from the hospital to a nursing home. The do-not-resuscitate form must be signed by a physician. I – a physician assistant (PA) – am available, but the physician is with a medically unstable patient. Another patient in the ED waits for this hospital bed, lying uncomfortably on a stretcher in the hallway.

As a Florida PA who has practiced in other states with far fewer barriers to medical care, I applaud the advancement of HB 431. PAs can now sign certain documents, ensuring accelerated access to therapeutic interventions and honoring end-of-life wishes with timely do-not-resuscitate orders. Children now have improved access to psychiatric medications without a lengthy wait for an appointment with a psychiatrist, given the demand for mental health services and limited physician availability.

HB 431 expands medical care to patients in a state experiencing exponential growth in patient health care demands. HB 431 removes the following barriers to patient care as summarized by the Florida Academy of Physician Assistants. HB 431:

• Changes the physician:PA ratio from 1:4 to 1:10
• Allows PAs to authenticate documents such as death certificates and involuntary examinations; to order durable medical equipment, home health services, physical therapy, occupational therapy, and speech-language therapy
• Allows do-not-resuscitate orders, workers’ compensation claims, and school physical examinations with the exception of medical marijuana documents and maximum medical improvement/impairment rating documents for workman’s compensation
• Allows a fully licensed PA to procure medical devices and drugs
• Codifies that a PA can supervise a medical assistant
• Allows PAs to receive direct payment for services rendered
• Removes the long-standing restriction of PAs to prescribe any controlled psychiatric medication to patients aged under 18 years, and now allows PAs working with a pediatrician, family practice physician, internal medicine physician, or psychiatrist to prescribe a 14-day supply of schedule II psychiatric medications for those aged under 18 years
• Removes the requirement that a PA must inform a patient that they have the right to see the physician before a prescription is prescribed or dispensed
• Removes outdated language regarding prescriber number
• Improves the supervision data form submission process

Oregon HB 3036, also passed this year, significantly expands medical care provided by PAs. The Oregon legislation allows collaborative agreements with physicians at the practice level and removes the submission requirement for board approval. In contrast to Florida, Oregon completely eliminated PA ratios, improved PA prescriptive and dispensing regulations, and developed an environment that fosters team-based collaboration with accelerated patient access to quality care.

Many other states reduced these supervisory barriers during the pandemic. Even before the pandemic, federal systems such as the Veterans Affairs Medical Centers and the military had removed supervisory restrictions, which subsequently reduced the overall cost of care.

PAs are trained to be flexible and meet the needs of the patient through a medical rather than nursing model. By allowing PAs to determine how best to collaborate with their clinical teams, patients are provided more efficient, patient-centered health care. Team members rely on each other for operational and clinical support through a degree of autonomy that contributes to effective patient management. These skills are expanded with the modernization of PA clinical practice and the removal of legislative barriers. A benefit to physicians through collaborative practice agreements is the reduction of their own liability for the care that PAs provide. Unlike Oregon, the state of Florida has not approved collaborative practice agreements and has retained physician supervisory barriers.

There are misconceptions in the medical community regarding the PA profession’s legislative goals. These efforts are not aimed at replacing physicians and competing for employment. The goal is to expand access and reduce barriers to patient care. There are not enough providers available to support comprehensive patient care. This is a fact.

Gaps in medical care exist and have existed since the PA profession was developed in the 1970s. Our vision has been to expand medical care through collaboration with physicians and assist with recruitment and retention challenges in various medical disciplines, particularly primary care. This is why all PA programs are based on a primary care medical model to care for patients across the lifespan, from infant care to geriatrics.

The spirit of collaboration in a team-based environment is challenged by these misconceptions and compounded by supervisory legislative and outdated practice requirements. PAs not only collaborate but also consult with and refer patients to other health care providers whenever the patient›s condition falls outside the PA’s education, training, and experience.

The changes in Florida’s HB 431 do not remove the requirement to clearly identify our roles. PAs still continue to identify themselves as physician assistants, and should a patient refuse to see a PA, they have the right to see any other provider they choose. Finally, patients are safe in the hands of a PA, as supported by numerous patient studies comparing PA clinical skills with other providers, including nurse practitioners, medical students, residents, fellows, and physicians.

Nonetheless, Florida is still behind other states in providing patients access to collaborative, team-based medical care with skilled PAs practicing as trained. Removing the remaining legislative barriers, hospital credentialing barriers, and health care perspectives will successfully provide patients superior medical care and improve the health outcomes of Florida residents.

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucie, Fla., a member of the Hospitalist’s editorial advisory board, and also serves as a physician assistant program director at South University in West Palm Beach, Fla.

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

Another frustrated patient awaits transfer from the hospital to a nursing home. The do-not-resuscitate form must be signed by a physician. I – a physician assistant (PA) – am available, but the physician is with a medically unstable patient. Another patient in the ED waits for this hospital bed, lying uncomfortably on a stretcher in the hallway.

As a Florida PA who has practiced in other states with far fewer barriers to medical care, I applaud the advancement of HB 431. PAs can now sign certain documents, ensuring accelerated access to therapeutic interventions and honoring end-of-life wishes with timely do-not-resuscitate orders. Children now have improved access to psychiatric medications without a lengthy wait for an appointment with a psychiatrist, given the demand for mental health services and limited physician availability.

HB 431 expands medical care to patients in a state experiencing exponential growth in patient health care demands. HB 431 removes the following barriers to patient care as summarized by the Florida Academy of Physician Assistants. HB 431:

• Changes the physician:PA ratio from 1:4 to 1:10
• Allows PAs to authenticate documents such as death certificates and involuntary examinations; to order durable medical equipment, home health services, physical therapy, occupational therapy, and speech-language therapy
• Allows do-not-resuscitate orders, workers’ compensation claims, and school physical examinations with the exception of medical marijuana documents and maximum medical improvement/impairment rating documents for workman’s compensation
• Allows a fully licensed PA to procure medical devices and drugs
• Codifies that a PA can supervise a medical assistant
• Allows PAs to receive direct payment for services rendered
• Removes the long-standing restriction of PAs to prescribe any controlled psychiatric medication to patients aged under 18 years, and now allows PAs working with a pediatrician, family practice physician, internal medicine physician, or psychiatrist to prescribe a 14-day supply of schedule II psychiatric medications for those aged under 18 years
• Removes the requirement that a PA must inform a patient that they have the right to see the physician before a prescription is prescribed or dispensed
• Removes outdated language regarding prescriber number
• Improves the supervision data form submission process

Oregon HB 3036, also passed this year, significantly expands medical care provided by PAs. The Oregon legislation allows collaborative agreements with physicians at the practice level and removes the submission requirement for board approval. In contrast to Florida, Oregon completely eliminated PA ratios, improved PA prescriptive and dispensing regulations, and developed an environment that fosters team-based collaboration with accelerated patient access to quality care.

Many other states reduced these supervisory barriers during the pandemic. Even before the pandemic, federal systems such as the Veterans Affairs Medical Centers and the military had removed supervisory restrictions, which subsequently reduced the overall cost of care.

PAs are trained to be flexible and meet the needs of the patient through a medical rather than nursing model. By allowing PAs to determine how best to collaborate with their clinical teams, patients are provided more efficient, patient-centered health care. Team members rely on each other for operational and clinical support through a degree of autonomy that contributes to effective patient management. These skills are expanded with the modernization of PA clinical practice and the removal of legislative barriers. A benefit to physicians through collaborative practice agreements is the reduction of their own liability for the care that PAs provide. Unlike Oregon, the state of Florida has not approved collaborative practice agreements and has retained physician supervisory barriers.

There are misconceptions in the medical community regarding the PA profession’s legislative goals. These efforts are not aimed at replacing physicians and competing for employment. The goal is to expand access and reduce barriers to patient care. There are not enough providers available to support comprehensive patient care. This is a fact.

Gaps in medical care exist and have existed since the PA profession was developed in the 1970s. Our vision has been to expand medical care through collaboration with physicians and assist with recruitment and retention challenges in various medical disciplines, particularly primary care. This is why all PA programs are based on a primary care medical model to care for patients across the lifespan, from infant care to geriatrics.

The spirit of collaboration in a team-based environment is challenged by these misconceptions and compounded by supervisory legislative and outdated practice requirements. PAs not only collaborate but also consult with and refer patients to other health care providers whenever the patient›s condition falls outside the PA’s education, training, and experience.

The changes in Florida’s HB 431 do not remove the requirement to clearly identify our roles. PAs still continue to identify themselves as physician assistants, and should a patient refuse to see a PA, they have the right to see any other provider they choose. Finally, patients are safe in the hands of a PA, as supported by numerous patient studies comparing PA clinical skills with other providers, including nurse practitioners, medical students, residents, fellows, and physicians.

Nonetheless, Florida is still behind other states in providing patients access to collaborative, team-based medical care with skilled PAs practicing as trained. Removing the remaining legislative barriers, hospital credentialing barriers, and health care perspectives will successfully provide patients superior medical care and improve the health outcomes of Florida residents.

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucie, Fla., a member of the Hospitalist’s editorial advisory board, and also serves as a physician assistant program director at South University in West Palm Beach, Fla.

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

Another frustrated patient awaits transfer from the hospital to a nursing home. The do-not-resuscitate form must be signed by a physician. I – a physician assistant (PA) – am available, but the physician is with a medically unstable patient. Another patient in the ED waits for this hospital bed, lying uncomfortably on a stretcher in the hallway.

As a Florida PA who has practiced in other states with far fewer barriers to medical care, I applaud the advancement of HB 431. PAs can now sign certain documents, ensuring accelerated access to therapeutic interventions and honoring end-of-life wishes with timely do-not-resuscitate orders. Children now have improved access to psychiatric medications without a lengthy wait for an appointment with a psychiatrist, given the demand for mental health services and limited physician availability.

HB 431 expands medical care to patients in a state experiencing exponential growth in patient health care demands. HB 431 removes the following barriers to patient care as summarized by the Florida Academy of Physician Assistants. HB 431:

• Changes the physician:PA ratio from 1:4 to 1:10
• Allows PAs to authenticate documents such as death certificates and involuntary examinations; to order durable medical equipment, home health services, physical therapy, occupational therapy, and speech-language therapy
• Allows do-not-resuscitate orders, workers’ compensation claims, and school physical examinations with the exception of medical marijuana documents and maximum medical improvement/impairment rating documents for workman’s compensation
• Allows a fully licensed PA to procure medical devices and drugs
• Codifies that a PA can supervise a medical assistant
• Allows PAs to receive direct payment for services rendered
• Removes the long-standing restriction of PAs to prescribe any controlled psychiatric medication to patients aged under 18 years, and now allows PAs working with a pediatrician, family practice physician, internal medicine physician, or psychiatrist to prescribe a 14-day supply of schedule II psychiatric medications for those aged under 18 years
• Removes the requirement that a PA must inform a patient that they have the right to see the physician before a prescription is prescribed or dispensed
• Removes outdated language regarding prescriber number
• Improves the supervision data form submission process

Oregon HB 3036, also passed this year, significantly expands medical care provided by PAs. The Oregon legislation allows collaborative agreements with physicians at the practice level and removes the submission requirement for board approval. In contrast to Florida, Oregon completely eliminated PA ratios, improved PA prescriptive and dispensing regulations, and developed an environment that fosters team-based collaboration with accelerated patient access to quality care.

Many other states reduced these supervisory barriers during the pandemic. Even before the pandemic, federal systems such as the Veterans Affairs Medical Centers and the military had removed supervisory restrictions, which subsequently reduced the overall cost of care.

PAs are trained to be flexible and meet the needs of the patient through a medical rather than nursing model. By allowing PAs to determine how best to collaborate with their clinical teams, patients are provided more efficient, patient-centered health care. Team members rely on each other for operational and clinical support through a degree of autonomy that contributes to effective patient management. These skills are expanded with the modernization of PA clinical practice and the removal of legislative barriers. A benefit to physicians through collaborative practice agreements is the reduction of their own liability for the care that PAs provide. Unlike Oregon, the state of Florida has not approved collaborative practice agreements and has retained physician supervisory barriers.

There are misconceptions in the medical community regarding the PA profession’s legislative goals. These efforts are not aimed at replacing physicians and competing for employment. The goal is to expand access and reduce barriers to patient care. There are not enough providers available to support comprehensive patient care. This is a fact.

Gaps in medical care exist and have existed since the PA profession was developed in the 1970s. Our vision has been to expand medical care through collaboration with physicians and assist with recruitment and retention challenges in various medical disciplines, particularly primary care. This is why all PA programs are based on a primary care medical model to care for patients across the lifespan, from infant care to geriatrics.

The spirit of collaboration in a team-based environment is challenged by these misconceptions and compounded by supervisory legislative and outdated practice requirements. PAs not only collaborate but also consult with and refer patients to other health care providers whenever the patient›s condition falls outside the PA’s education, training, and experience.

The changes in Florida’s HB 431 do not remove the requirement to clearly identify our roles. PAs still continue to identify themselves as physician assistants, and should a patient refuse to see a PA, they have the right to see any other provider they choose. Finally, patients are safe in the hands of a PA, as supported by numerous patient studies comparing PA clinical skills with other providers, including nurse practitioners, medical students, residents, fellows, and physicians.

Nonetheless, Florida is still behind other states in providing patients access to collaborative, team-based medical care with skilled PAs practicing as trained. Removing the remaining legislative barriers, hospital credentialing barriers, and health care perspectives will successfully provide patients superior medical care and improve the health outcomes of Florida residents.

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucie, Fla., a member of the Hospitalist’s editorial advisory board, and also serves as a physician assistant program director at South University in West Palm Beach, Fla.

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

I was rounding at the nursing home and my day began as it often did. I reviewed the doctor communication book at the nursing station to see which patients I needed to visit and checked in with the floor nurse for any important updates. I had about a dozen patients who needed to be seen. But by day’s end, four of my patients would stand out in my mind for the one thing they had in common – and the many things they did not.

A mother waiting for her son to visit

The first patient on my list was Rose. She had become increasingly withdrawn and less mobile. She used to walk the corridors asking when her son, Billy, would visit. We would all remind her that Billy visited her two or three times a week, but she never remembered the visits and blamed him for moving her out of her comfortable home in New Jersey where she’d lived with her husband before his death several years earlier.

Rose was declining, and we were trying to optimize her function and quality of life. She fell frequently while trying to get up at night to use the bathroom. None of our fall-reduction strategies had worked, and she had broken her hip a year prior. She’d fully recovered, but the combination of mental and physical frailty was becoming obvious to everyone, including her son. She had lost another five pounds and was approaching the end of her life.

“Good morning, Rose.” (She had demanded that I use her first name.) “How are you doing today?”

“I am doing okay, doctor. Have you seen Billy? When is he going to visit me?”

“I really can’t say when he’ll visit next, but I saw in a note that he was here yesterday.”

“No, he didn’t come to see me,” she said. “He doesn’t care about me. He spends more time with his wife and family than with his own mother.”

“Well, is there anything special that I can do for you?”

“Yes. Please tell Billy to visit his mother,” she said.

I completed her evaluation and made my way down the hall.
 

A wife ready to rejoin her husband

Next on my list was a widow named Violet. She reminded me of Whistler’s mother. As was her custom, she was sitting up in her chair reading her Bible when I came in. Her husband had been a minister, and she enjoyed reading the Bible or meditating for several hours each morning. Her bedside table had the most recent devotional and a picture of her husband in his vestments.

Violet was quiet and direct, and she had steely blue eyes that could communicate with your soul. Her nun-like quality was not overpowering; her manner was warm and welcoming.

“Good morning!” I said. “I hope I’m not bothering you.”

“Good morning, doctor. It’s always nice to see you.”

“I haven’t been by in a while, and I wanted to check your heart and lungs and make sure everything is going okay for you.”

“Of course; help yourself,” she said. “I feel fine. And as you know, I am ready to join my husband whenever the Lord calls me. I have lived a blessed life and do not wish to prolong it unless it is God’s will.”

“You certainly have made your wishes clear to me, and you are still in excellent health,” I said.

She really was in good health, and I made a quick note to call her daughter – who lived on the other side of the country – with an update.
 

A beauty queen ready for her close-up

Gabby was next on my list. She was a former beauty queen who had competed in local and state beauty contests. Her looks were the cornerstone of her identity, and she had done a truly remarkable job of maintaining her physical appearance.

Gabby had three attentive daughters who lived locally and supplied her with the latest makeup, beauty creams, and anti-aging nostrums. She always managed to look natural (and not like a caricature) with her face made up and her blond wig in place. Over the years, she’d made good use of the services offered by the local plastic surgeons and dermatologists. And to her credit – and theirs – she looked 30 years younger than her chronological age. In fairness, she had also taken good care of her overall health.

Gabby’s nickname was appropriate as she was chatty, to the extreme. She enjoyed being the center of attention.

When I entered her room, she was putting on her makeup. She was seated near her bedside table, which looked like it belonged in the backstage dressing room of a Broadway star. Lined up on the table were various bottles, brushes, and a mirror surrounded by lights.

“Oh, doctor, you can’t come in now. I’m a dreadful mess,” she said. “Please come back in 10 minutes. I am so embarrassed that you are seeing me this way. I just have a few things to fix, and then I will be presentable. My daughters are taking me out for lunch at the club, and I do not want to look like an old lady.”

“Gabby,” I said, “I have seen you before without your makeup. Do you remember last year when you developed pneumonia? You were really sick, and frankly, we were not sure you were going to pull through. One of the clues that you were getting ill was your smeared mascara and lipstick.”

I pressed on, and she let me examine her while she continued to apply her eyeliner.

“Everything sounds good. And I like your fresh pedicure,” I said. “Is there anything I can do for you?”

“No, thank you. Have a nice day, doctor!”
 

A mother devoted to her daughter’s care

Unlike my other patients, Mabel shared a room with a family member – her daughter, Hope. Mabel’s daughter had a congenital illness with significant physical, functional, and cognitive deficits. Mabel had considerable guilt regarding her daughter’s condition. Mabel’s husband had divorced her decades earlier, and she had devoted her life to caring for Hope. When Mabel’s health began to decline and she realized she could no longer care for Hope alone, the two moved into the facility together. Mabel told me that she simply couldn’t die before her daughter, because no one could oversee her care like she could.

Mabel was frail physically but sharp and vigilant mentally. Hope had had numerous hospitalizations, and Mabel had been with her through each experience. Hope could not communicate with others, but Mabel could express Hope’s concerns.

“How are you doing today?” I asked.

“Not well. I am concerned about Hope. She has not had a bowel movement in two days and does not want to eat breakfast.”

I checked out Hope, and her examination was reassuring. She looked up at me with her distorted features and managed a broad smile. I went back over to Mabel.

“She likes you, doctor. She thinks you smell good.”

I turned to Hope and thanked her for the compliment.

“I will check with the nurse and see if we can give you something simple to help your bowels.”

“Warm prune juice often works,” said Mabel. “Please come by again tomorrow to check on her. I don’t want this to progress. She is miserable.”

“I will be back tomorrow, and I will make a special trip to see you both.”
 

Upon reflection ...

When I sat down to write my clinical notes for the day, I realized that Rose, Violet, Gabby, and Mabel were each over 100 years old. I had seen four centenarians in a single day! Each of them manifested a fundamental principle of geriatrics: The older we are, the more unique and differentiated we become. A one-size approach to geriatric care does not fit all. Our care must be personalized to the unique individual in front of us.

Patients’ names and some details have been changed to protect their privacy. Dr. Williams is the Emeritus Ward K. Ensminger Distinguished Professor of Geriatric Medicine, University of Virginia, Charlottesville and attending physician, internal medicine and geriatrics, New Hanover Regional Medical Center, Wilmington, N.C. He disclosed no relevant financial disclosures.

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

I was rounding at the nursing home and my day began as it often did. I reviewed the doctor communication book at the nursing station to see which patients I needed to visit and checked in with the floor nurse for any important updates. I had about a dozen patients who needed to be seen. But by day’s end, four of my patients would stand out in my mind for the one thing they had in common – and the many things they did not.

A mother waiting for her son to visit

The first patient on my list was Rose. She had become increasingly withdrawn and less mobile. She used to walk the corridors asking when her son, Billy, would visit. We would all remind her that Billy visited her two or three times a week, but she never remembered the visits and blamed him for moving her out of her comfortable home in New Jersey where she’d lived with her husband before his death several years earlier.

Rose was declining, and we were trying to optimize her function and quality of life. She fell frequently while trying to get up at night to use the bathroom. None of our fall-reduction strategies had worked, and she had broken her hip a year prior. She’d fully recovered, but the combination of mental and physical frailty was becoming obvious to everyone, including her son. She had lost another five pounds and was approaching the end of her life.

“Good morning, Rose.” (She had demanded that I use her first name.) “How are you doing today?”

“I am doing okay, doctor. Have you seen Billy? When is he going to visit me?”

“I really can’t say when he’ll visit next, but I saw in a note that he was here yesterday.”

“No, he didn’t come to see me,” she said. “He doesn’t care about me. He spends more time with his wife and family than with his own mother.”

“Well, is there anything special that I can do for you?”

“Yes. Please tell Billy to visit his mother,” she said.

I completed her evaluation and made my way down the hall.
 

A wife ready to rejoin her husband

Next on my list was a widow named Violet. She reminded me of Whistler’s mother. As was her custom, she was sitting up in her chair reading her Bible when I came in. Her husband had been a minister, and she enjoyed reading the Bible or meditating for several hours each morning. Her bedside table had the most recent devotional and a picture of her husband in his vestments.

Violet was quiet and direct, and she had steely blue eyes that could communicate with your soul. Her nun-like quality was not overpowering; her manner was warm and welcoming.

“Good morning!” I said. “I hope I’m not bothering you.”

“Good morning, doctor. It’s always nice to see you.”

“I haven’t been by in a while, and I wanted to check your heart and lungs and make sure everything is going okay for you.”

“Of course; help yourself,” she said. “I feel fine. And as you know, I am ready to join my husband whenever the Lord calls me. I have lived a blessed life and do not wish to prolong it unless it is God’s will.”

“You certainly have made your wishes clear to me, and you are still in excellent health,” I said.

She really was in good health, and I made a quick note to call her daughter – who lived on the other side of the country – with an update.
 

A beauty queen ready for her close-up

Gabby was next on my list. She was a former beauty queen who had competed in local and state beauty contests. Her looks were the cornerstone of her identity, and she had done a truly remarkable job of maintaining her physical appearance.

Gabby had three attentive daughters who lived locally and supplied her with the latest makeup, beauty creams, and anti-aging nostrums. She always managed to look natural (and not like a caricature) with her face made up and her blond wig in place. Over the years, she’d made good use of the services offered by the local plastic surgeons and dermatologists. And to her credit – and theirs – she looked 30 years younger than her chronological age. In fairness, she had also taken good care of her overall health.

Gabby’s nickname was appropriate as she was chatty, to the extreme. She enjoyed being the center of attention.

When I entered her room, she was putting on her makeup. She was seated near her bedside table, which looked like it belonged in the backstage dressing room of a Broadway star. Lined up on the table were various bottles, brushes, and a mirror surrounded by lights.

“Oh, doctor, you can’t come in now. I’m a dreadful mess,” she said. “Please come back in 10 minutes. I am so embarrassed that you are seeing me this way. I just have a few things to fix, and then I will be presentable. My daughters are taking me out for lunch at the club, and I do not want to look like an old lady.”

“Gabby,” I said, “I have seen you before without your makeup. Do you remember last year when you developed pneumonia? You were really sick, and frankly, we were not sure you were going to pull through. One of the clues that you were getting ill was your smeared mascara and lipstick.”

I pressed on, and she let me examine her while she continued to apply her eyeliner.

“Everything sounds good. And I like your fresh pedicure,” I said. “Is there anything I can do for you?”

“No, thank you. Have a nice day, doctor!”
 

A mother devoted to her daughter’s care

Unlike my other patients, Mabel shared a room with a family member – her daughter, Hope. Mabel’s daughter had a congenital illness with significant physical, functional, and cognitive deficits. Mabel had considerable guilt regarding her daughter’s condition. Mabel’s husband had divorced her decades earlier, and she had devoted her life to caring for Hope. When Mabel’s health began to decline and she realized she could no longer care for Hope alone, the two moved into the facility together. Mabel told me that she simply couldn’t die before her daughter, because no one could oversee her care like she could.

Mabel was frail physically but sharp and vigilant mentally. Hope had had numerous hospitalizations, and Mabel had been with her through each experience. Hope could not communicate with others, but Mabel could express Hope’s concerns.

“How are you doing today?” I asked.

“Not well. I am concerned about Hope. She has not had a bowel movement in two days and does not want to eat breakfast.”

I checked out Hope, and her examination was reassuring. She looked up at me with her distorted features and managed a broad smile. I went back over to Mabel.

“She likes you, doctor. She thinks you smell good.”

I turned to Hope and thanked her for the compliment.

“I will check with the nurse and see if we can give you something simple to help your bowels.”

“Warm prune juice often works,” said Mabel. “Please come by again tomorrow to check on her. I don’t want this to progress. She is miserable.”

“I will be back tomorrow, and I will make a special trip to see you both.”
 

Upon reflection ...

When I sat down to write my clinical notes for the day, I realized that Rose, Violet, Gabby, and Mabel were each over 100 years old. I had seen four centenarians in a single day! Each of them manifested a fundamental principle of geriatrics: The older we are, the more unique and differentiated we become. A one-size approach to geriatric care does not fit all. Our care must be personalized to the unique individual in front of us.

Patients’ names and some details have been changed to protect their privacy. Dr. Williams is the Emeritus Ward K. Ensminger Distinguished Professor of Geriatric Medicine, University of Virginia, Charlottesville and attending physician, internal medicine and geriatrics, New Hanover Regional Medical Center, Wilmington, N.C. He disclosed no relevant financial disclosures.

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

I was rounding at the nursing home and my day began as it often did. I reviewed the doctor communication book at the nursing station to see which patients I needed to visit and checked in with the floor nurse for any important updates. I had about a dozen patients who needed to be seen. But by day’s end, four of my patients would stand out in my mind for the one thing they had in common – and the many things they did not.

A mother waiting for her son to visit

The first patient on my list was Rose. She had become increasingly withdrawn and less mobile. She used to walk the corridors asking when her son, Billy, would visit. We would all remind her that Billy visited her two or three times a week, but she never remembered the visits and blamed him for moving her out of her comfortable home in New Jersey where she’d lived with her husband before his death several years earlier.

Rose was declining, and we were trying to optimize her function and quality of life. She fell frequently while trying to get up at night to use the bathroom. None of our fall-reduction strategies had worked, and she had broken her hip a year prior. She’d fully recovered, but the combination of mental and physical frailty was becoming obvious to everyone, including her son. She had lost another five pounds and was approaching the end of her life.

“Good morning, Rose.” (She had demanded that I use her first name.) “How are you doing today?”

“I am doing okay, doctor. Have you seen Billy? When is he going to visit me?”

“I really can’t say when he’ll visit next, but I saw in a note that he was here yesterday.”

“No, he didn’t come to see me,” she said. “He doesn’t care about me. He spends more time with his wife and family than with his own mother.”

“Well, is there anything special that I can do for you?”

“Yes. Please tell Billy to visit his mother,” she said.

I completed her evaluation and made my way down the hall.
 

A wife ready to rejoin her husband

Next on my list was a widow named Violet. She reminded me of Whistler’s mother. As was her custom, she was sitting up in her chair reading her Bible when I came in. Her husband had been a minister, and she enjoyed reading the Bible or meditating for several hours each morning. Her bedside table had the most recent devotional and a picture of her husband in his vestments.

Violet was quiet and direct, and she had steely blue eyes that could communicate with your soul. Her nun-like quality was not overpowering; her manner was warm and welcoming.

“Good morning!” I said. “I hope I’m not bothering you.”

“Good morning, doctor. It’s always nice to see you.”

“I haven’t been by in a while, and I wanted to check your heart and lungs and make sure everything is going okay for you.”

“Of course; help yourself,” she said. “I feel fine. And as you know, I am ready to join my husband whenever the Lord calls me. I have lived a blessed life and do not wish to prolong it unless it is God’s will.”

“You certainly have made your wishes clear to me, and you are still in excellent health,” I said.

She really was in good health, and I made a quick note to call her daughter – who lived on the other side of the country – with an update.
 

A beauty queen ready for her close-up

Gabby was next on my list. She was a former beauty queen who had competed in local and state beauty contests. Her looks were the cornerstone of her identity, and she had done a truly remarkable job of maintaining her physical appearance.

Gabby had three attentive daughters who lived locally and supplied her with the latest makeup, beauty creams, and anti-aging nostrums. She always managed to look natural (and not like a caricature) with her face made up and her blond wig in place. Over the years, she’d made good use of the services offered by the local plastic surgeons and dermatologists. And to her credit – and theirs – she looked 30 years younger than her chronological age. In fairness, she had also taken good care of her overall health.

Gabby’s nickname was appropriate as she was chatty, to the extreme. She enjoyed being the center of attention.

When I entered her room, she was putting on her makeup. She was seated near her bedside table, which looked like it belonged in the backstage dressing room of a Broadway star. Lined up on the table were various bottles, brushes, and a mirror surrounded by lights.

“Oh, doctor, you can’t come in now. I’m a dreadful mess,” she said. “Please come back in 10 minutes. I am so embarrassed that you are seeing me this way. I just have a few things to fix, and then I will be presentable. My daughters are taking me out for lunch at the club, and I do not want to look like an old lady.”

“Gabby,” I said, “I have seen you before without your makeup. Do you remember last year when you developed pneumonia? You were really sick, and frankly, we were not sure you were going to pull through. One of the clues that you were getting ill was your smeared mascara and lipstick.”

I pressed on, and she let me examine her while she continued to apply her eyeliner.

“Everything sounds good. And I like your fresh pedicure,” I said. “Is there anything I can do for you?”

“No, thank you. Have a nice day, doctor!”
 

A mother devoted to her daughter’s care

Unlike my other patients, Mabel shared a room with a family member – her daughter, Hope. Mabel’s daughter had a congenital illness with significant physical, functional, and cognitive deficits. Mabel had considerable guilt regarding her daughter’s condition. Mabel’s husband had divorced her decades earlier, and she had devoted her life to caring for Hope. When Mabel’s health began to decline and she realized she could no longer care for Hope alone, the two moved into the facility together. Mabel told me that she simply couldn’t die before her daughter, because no one could oversee her care like she could.

Mabel was frail physically but sharp and vigilant mentally. Hope had had numerous hospitalizations, and Mabel had been with her through each experience. Hope could not communicate with others, but Mabel could express Hope’s concerns.

“How are you doing today?” I asked.

“Not well. I am concerned about Hope. She has not had a bowel movement in two days and does not want to eat breakfast.”

I checked out Hope, and her examination was reassuring. She looked up at me with her distorted features and managed a broad smile. I went back over to Mabel.

“She likes you, doctor. She thinks you smell good.”

I turned to Hope and thanked her for the compliment.

“I will check with the nurse and see if we can give you something simple to help your bowels.”

“Warm prune juice often works,” said Mabel. “Please come by again tomorrow to check on her. I don’t want this to progress. She is miserable.”

“I will be back tomorrow, and I will make a special trip to see you both.”
 

Upon reflection ...

When I sat down to write my clinical notes for the day, I realized that Rose, Violet, Gabby, and Mabel were each over 100 years old. I had seen four centenarians in a single day! Each of them manifested a fundamental principle of geriatrics: The older we are, the more unique and differentiated we become. A one-size approach to geriatric care does not fit all. Our care must be personalized to the unique individual in front of us.

Patients’ names and some details have been changed to protect their privacy. Dr. Williams is the Emeritus Ward K. Ensminger Distinguished Professor of Geriatric Medicine, University of Virginia, Charlottesville and attending physician, internal medicine and geriatrics, New Hanover Regional Medical Center, Wilmington, N.C. He disclosed no relevant financial disclosures.

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

With the approval by the Food and Drug Administration of the calcineurin inhibitor voclosporin (Lupkynis) in January and belimumab (Benlysta) a month before that, clinicians now have new options for treating lupus nephritis in combination with a background immunosuppressive agent, such as mycophenolate mofetil.

But which combination should clinicians choose?

Brad Rovin, MD, a nephrologist with the Ohio State University Wexner Medical Center, Columbus, who worked on the phase 3 voclosprin trial, pointed to that drug’s fast reduction in proteinuria in a session of the Pan American League of Associations for Rheumatology (PANLAR) 2021 Annual Meeting. That effect on proteinuria is likely due to its effect on podocytes, special epithelial cells that cover the outside of capillaries in the kidney, he said.

These crucial cells have an elaborate cytoskeleton that is stabilized by the protein synaptopodin, which can be subject to harm from calcineurin. But because voclosporin blocks calcineurin, synaptopodin is protected, which consequently protects podocytes and the kidney, Dr. Rovin said.

“There’s a lot of data in the nephrology literature that suggests as you lose podocytes, you actually can develop glomerular sclerosis and loss of renal function,” he said. “In fact, if you lose a critical number of podocytes, then no matter what you do, the kidney is likely to progress to end-stage kidney disease.

“The way I think about it now is, what else do these drugs add? And this idea of preserving the histology of the kidney is really important, and this can be done with voclosporin,” Dr. Rovin said.

Belimumab is also hailed as an effective tool, particularly for the prevention of flares. In the trial leading to its approval), just under 16% of patients experienced a renal-related event or death over 2 years, compared with 28% of the group that received placebo. Those receiving belimumab had a 50% greater chance of reaching the primary efficacy renal response, which was defined as a ratio of urinary protein to creatinine of 0.7 or less, an estimated glomerular filtration rate that was no worse than 20% below the pre-flare value or at least 60 mL/min per 1.73 m², and no use of rescue therapy for treatment failure.

The endpoints in the belimumab lupus nephritis trial were “quite rigorous,” Richard A. Furie, MD, said in the same session at the meeting. Patients with class V lupus nephritis were included in the trial, although disease of this severity is known to be particularly difficult to treat, he noted.

“There’s little question that our patients with lupus nephritis will benefit from such a therapeutic approach” with belimumab and mycophenolate, said Dr. Furie, professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, in Hempstead, N.Y. “But regardless of which combination clinicians use, we are making advances, and that means better outcomes for our patients with lupus and lupus nephritis.”

Graciela Alarcon, MD, MPH, professor emeritus of medicine at the University of Alabama at Birmingham, who moderated the discussion, said there is no sure answer regarding the best choice for clinicians.

“As long as there’s no head-to-head comparison between the two new compounds, I don’t think that the question can be answered,” she said.

Indeed, the answer for many clinicians might be that for certain patients, dual therapy isn’t necessary, Dr. Furie said.

“The fundamental question, before we choose the second drug, is whether a second drug should be chosen,” he said. “There’s a lot of people in the community who are just sticking to the old-fashioned algorithm and that is just choosing one drug, like mycophenolate. ... Others might pick a second drug, but not until they see that mycophenolate is not doing an effective job.”

All agreed that the response rates are still not optimal for patients with lupus nephritis, even with these new combinations – they are still only in the 30%-40% range.

“We haven’t really boosted the response rate to where we want it to be, at least as measured by our current measurements and composite renal response,” Dr. Rovin said.

With voclosporin’s protective effects and belimumab’s flare prevention, the two could potentially be used together at some point, he suggested.

“I think these two drugs show us the possibility that we might use them together and get rid of the older drugs, and really minimize the older drugs and then use them on a longer-term basis to preserve kidney function, as well as keep the lupus in check,” he said.

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

With the approval by the Food and Drug Administration of the calcineurin inhibitor voclosporin (Lupkynis) in January and belimumab (Benlysta) a month before that, clinicians now have new options for treating lupus nephritis in combination with a background immunosuppressive agent, such as mycophenolate mofetil.

But which combination should clinicians choose?

Brad Rovin, MD, a nephrologist with the Ohio State University Wexner Medical Center, Columbus, who worked on the phase 3 voclosprin trial, pointed to that drug’s fast reduction in proteinuria in a session of the Pan American League of Associations for Rheumatology (PANLAR) 2021 Annual Meeting. That effect on proteinuria is likely due to its effect on podocytes, special epithelial cells that cover the outside of capillaries in the kidney, he said.

These crucial cells have an elaborate cytoskeleton that is stabilized by the protein synaptopodin, which can be subject to harm from calcineurin. But because voclosporin blocks calcineurin, synaptopodin is protected, which consequently protects podocytes and the kidney, Dr. Rovin said.

“There’s a lot of data in the nephrology literature that suggests as you lose podocytes, you actually can develop glomerular sclerosis and loss of renal function,” he said. “In fact, if you lose a critical number of podocytes, then no matter what you do, the kidney is likely to progress to end-stage kidney disease.

“The way I think about it now is, what else do these drugs add? And this idea of preserving the histology of the kidney is really important, and this can be done with voclosporin,” Dr. Rovin said.

Belimumab is also hailed as an effective tool, particularly for the prevention of flares. In the trial leading to its approval), just under 16% of patients experienced a renal-related event or death over 2 years, compared with 28% of the group that received placebo. Those receiving belimumab had a 50% greater chance of reaching the primary efficacy renal response, which was defined as a ratio of urinary protein to creatinine of 0.7 or less, an estimated glomerular filtration rate that was no worse than 20% below the pre-flare value or at least 60 mL/min per 1.73 m², and no use of rescue therapy for treatment failure.

The endpoints in the belimumab lupus nephritis trial were “quite rigorous,” Richard A. Furie, MD, said in the same session at the meeting. Patients with class V lupus nephritis were included in the trial, although disease of this severity is known to be particularly difficult to treat, he noted.

“There’s little question that our patients with lupus nephritis will benefit from such a therapeutic approach” with belimumab and mycophenolate, said Dr. Furie, professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, in Hempstead, N.Y. “But regardless of which combination clinicians use, we are making advances, and that means better outcomes for our patients with lupus and lupus nephritis.”

Graciela Alarcon, MD, MPH, professor emeritus of medicine at the University of Alabama at Birmingham, who moderated the discussion, said there is no sure answer regarding the best choice for clinicians.

“As long as there’s no head-to-head comparison between the two new compounds, I don’t think that the question can be answered,” she said.

Indeed, the answer for many clinicians might be that for certain patients, dual therapy isn’t necessary, Dr. Furie said.

“The fundamental question, before we choose the second drug, is whether a second drug should be chosen,” he said. “There’s a lot of people in the community who are just sticking to the old-fashioned algorithm and that is just choosing one drug, like mycophenolate. ... Others might pick a second drug, but not until they see that mycophenolate is not doing an effective job.”

All agreed that the response rates are still not optimal for patients with lupus nephritis, even with these new combinations – they are still only in the 30%-40% range.

“We haven’t really boosted the response rate to where we want it to be, at least as measured by our current measurements and composite renal response,” Dr. Rovin said.

With voclosporin’s protective effects and belimumab’s flare prevention, the two could potentially be used together at some point, he suggested.

“I think these two drugs show us the possibility that we might use them together and get rid of the older drugs, and really minimize the older drugs and then use them on a longer-term basis to preserve kidney function, as well as keep the lupus in check,” he said.

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

With the approval by the Food and Drug Administration of the calcineurin inhibitor voclosporin (Lupkynis) in January and belimumab (Benlysta) a month before that, clinicians now have new options for treating lupus nephritis in combination with a background immunosuppressive agent, such as mycophenolate mofetil.

But which combination should clinicians choose?

Brad Rovin, MD, a nephrologist with the Ohio State University Wexner Medical Center, Columbus, who worked on the phase 3 voclosprin trial, pointed to that drug’s fast reduction in proteinuria in a session of the Pan American League of Associations for Rheumatology (PANLAR) 2021 Annual Meeting. That effect on proteinuria is likely due to its effect on podocytes, special epithelial cells that cover the outside of capillaries in the kidney, he said.

These crucial cells have an elaborate cytoskeleton that is stabilized by the protein synaptopodin, which can be subject to harm from calcineurin. But because voclosporin blocks calcineurin, synaptopodin is protected, which consequently protects podocytes and the kidney, Dr. Rovin said.

“There’s a lot of data in the nephrology literature that suggests as you lose podocytes, you actually can develop glomerular sclerosis and loss of renal function,” he said. “In fact, if you lose a critical number of podocytes, then no matter what you do, the kidney is likely to progress to end-stage kidney disease.

“The way I think about it now is, what else do these drugs add? And this idea of preserving the histology of the kidney is really important, and this can be done with voclosporin,” Dr. Rovin said.

Belimumab is also hailed as an effective tool, particularly for the prevention of flares. In the trial leading to its approval), just under 16% of patients experienced a renal-related event or death over 2 years, compared with 28% of the group that received placebo. Those receiving belimumab had a 50% greater chance of reaching the primary efficacy renal response, which was defined as a ratio of urinary protein to creatinine of 0.7 or less, an estimated glomerular filtration rate that was no worse than 20% below the pre-flare value or at least 60 mL/min per 1.73 m², and no use of rescue therapy for treatment failure.

The endpoints in the belimumab lupus nephritis trial were “quite rigorous,” Richard A. Furie, MD, said in the same session at the meeting. Patients with class V lupus nephritis were included in the trial, although disease of this severity is known to be particularly difficult to treat, he noted.

“There’s little question that our patients with lupus nephritis will benefit from such a therapeutic approach” with belimumab and mycophenolate, said Dr. Furie, professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, in Hempstead, N.Y. “But regardless of which combination clinicians use, we are making advances, and that means better outcomes for our patients with lupus and lupus nephritis.”

Graciela Alarcon, MD, MPH, professor emeritus of medicine at the University of Alabama at Birmingham, who moderated the discussion, said there is no sure answer regarding the best choice for clinicians.

“As long as there’s no head-to-head comparison between the two new compounds, I don’t think that the question can be answered,” she said.

Indeed, the answer for many clinicians might be that for certain patients, dual therapy isn’t necessary, Dr. Furie said.

“The fundamental question, before we choose the second drug, is whether a second drug should be chosen,” he said. “There’s a lot of people in the community who are just sticking to the old-fashioned algorithm and that is just choosing one drug, like mycophenolate. ... Others might pick a second drug, but not until they see that mycophenolate is not doing an effective job.”

All agreed that the response rates are still not optimal for patients with lupus nephritis, even with these new combinations – they are still only in the 30%-40% range.

“We haven’t really boosted the response rate to where we want it to be, at least as measured by our current measurements and composite renal response,” Dr. Rovin said.

With voclosporin’s protective effects and belimumab’s flare prevention, the two could potentially be used together at some point, he suggested.

“I think these two drugs show us the possibility that we might use them together and get rid of the older drugs, and really minimize the older drugs and then use them on a longer-term basis to preserve kidney function, as well as keep the lupus in check,” he said.

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

Postpartum depression, in many respects, has become a household term. Over the last decade, there has been increasing awareness of the importance of screening for postpartum depression, with increased systematic screening across clinical settings where care is delivered to women during pregnancy and the postpartum period. There have also been greater efforts to identify women who are suffering postpartum depression and to support them with appropriate clinical interventions, whether through psychotherapy and/or pharmacologic therapy. Clinical interventions are supplemented by the increasing awareness of the value of community-based support groups for women who are suffering from postpartum mood and anxiety disorders.

Despite the growing, appropriate focus on recognition and acute treatment of postpartum depression as well as assessing clinical outcomes for those who suffer from postpartum mood and anxiety disorders, less attention has been given to postpartum psychosis, the most severe form of postpartum depression. It is indeed, the least common postpartum psychiatric syndrome (1 in 1,000 births) and comes to public attention when there has been a tragedy during the acute postpartum period such as maternal suicide or infanticide. In this sense, postpartum psychosis is ironically an underappreciated clinical entity across America given its severity, the effect it has on longer-term psychiatric morbidity, and its effect on children and families.

Our group at the Center for Women’s Mental Health has been interested in postpartum psychosis for years and started the Postpartum Psychosis Project in an effort to better understand the phenomenology, course, treatment, outcome, and genomic underpinnings of postpartum psychosis. Risk factors that are well established for postpartum psychosis have been described and overwhelmingly include patients with bipolar disorder. The risk for recurrent postpartum psychosis in women who have had a previous episode is as great as 75%-90% in the absence of prophylactic intervention. With that said, we are extremely interested in understanding the etiology of postpartum psychosis. Various studies over the last 5 years have looked at a whole host of psychosocial as well as neurobiologic variables that may contribute to risk for postpartum psychosis, including dysregulation of the stress axis, heightened inflammation as well as a history of child adversity and heightened experience of stress during the perinatal period.

There have also been anecdotal reports during Virtual Rounds at the Center for Women’s Mental Health of higher recent rates of postpartum psychosis manifesting during the postpartum period. This is a clinical observation and has not been systematically studied. However, one can wonder whether the experience of the pandemic has constituted a stressor for at-risk women, tipping the scales toward women becoming ill, or whether clinicians are seeing this finding more because of our ability to observe it more within the context of the pandemic.

Precise quantification of risk for postpartum psychosis is complicated; as noted, women with bipolar disorder have a predictably high risk for getting ill during the postpartum period and many go on to have clinical courses consistent with recurrent bipolar disorder. However, there are other women who have circumscribed episodes of psychotic illness in the postpartum period who recover and are totally well without any evidence of psychiatric disorder until they have another child, at which time the risk for recurrence of postpartum psychosis is very high. Interest in developing a model of risk that could reliably predict an illness as serious as postpartum psychosis is on the minds of researchers around the world.

One recent study that highlights the multiple factors involved in risk of postpartum psychosis involved a prospective longitudinal study of a group of women who were followed across the peripartum period from the third trimester until 4 weeks postpartum. In this group, 51 women were at increased risk for postpartum psychosis based on their diagnosis of bipolar disorder, schizoaffective disorder, or a previous episode of postpartum psychosis. These women were matched with a control group with no past or current diagnosis of psychiatric disorder or family history of postpartum psychosis. The findings suggested that women at risk for postpartum psychosis who experienced a psychiatric relapse during the first 4 weeks postpartum relative to women at risk who remained well had histories of severe childhood adversity as well as biomarkers consistent with a dysregulated stress axis (a statistically higher daily cortisol level). This is consistent with other data that have implicated the complex role between psychosocial variables as well as neurobiologic variables, such as a dysregulation in the hypothalamic pituitary adrenal axis and other studies that suggest that dysregulated inflammatory status may also drive risk for postpartum psychosis (Hazelgrove K et al. Psychoneuroendocrinology. 2021 Jun. doi: 10.1016/j.psyneuen.2021.105218).

At the end of the day, postpartum psychosis is a psychiatric and obstetrical emergency. In our center, it is rare for women not to be hospitalized with this condition to ensure the safety of the mother as well as her newborn, and to also get her recompensated and functioning as quickly and as significantly as possible. However, an interesting extrapolation of the findings noted by Hazelgrove and colleagues is that it raises the question of what effective treatments might be used to mitigate risk for those at greatest risk for postpartum psychosis. For example, are there other treatments over and above the few effective ones that have been studied as prophylactic pharmacologic interventions that might mitigate risk for recurrence of an illness as serious as postpartum psychosis?

The data suggesting dysregulation of the stress axis as a predictor variable for risk in women vulnerable to postpartum psychosis opens an array of opportunities that are nonpharmacologic, such as mindfulness-based cognitive therapy or other interventions that help to modulate the stress axis. This is a terrific opportunity to have pharmacologic intervention meet nonpharmacologic intervention to potentially mitigate risk for postpartum psychosis with its attendant serious sequelae.

In our own work, where we are evaluating genomic data in an extremely well-characterized group of women with known histories of postpartum psychosis, we are interested to see if we can enhance understanding of the model of risk for postpartum psychosis by factoring in genomic underpinning, history of diagnosis, and psychosocial variables to optimally craft interventions for this population of at-risk women. This brings us one step closer to the future in women’s mental health, to the practice of “precision reproductive psychiatry,” matching interventions to specific presentations across perinatal populations.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Postpartum depression, in many respects, has become a household term. Over the last decade, there has been increasing awareness of the importance of screening for postpartum depression, with increased systematic screening across clinical settings where care is delivered to women during pregnancy and the postpartum period. There have also been greater efforts to identify women who are suffering postpartum depression and to support them with appropriate clinical interventions, whether through psychotherapy and/or pharmacologic therapy. Clinical interventions are supplemented by the increasing awareness of the value of community-based support groups for women who are suffering from postpartum mood and anxiety disorders.

Despite the growing, appropriate focus on recognition and acute treatment of postpartum depression as well as assessing clinical outcomes for those who suffer from postpartum mood and anxiety disorders, less attention has been given to postpartum psychosis, the most severe form of postpartum depression. It is indeed, the least common postpartum psychiatric syndrome (1 in 1,000 births) and comes to public attention when there has been a tragedy during the acute postpartum period such as maternal suicide or infanticide. In this sense, postpartum psychosis is ironically an underappreciated clinical entity across America given its severity, the effect it has on longer-term psychiatric morbidity, and its effect on children and families.

Our group at the Center for Women’s Mental Health has been interested in postpartum psychosis for years and started the Postpartum Psychosis Project in an effort to better understand the phenomenology, course, treatment, outcome, and genomic underpinnings of postpartum psychosis. Risk factors that are well established for postpartum psychosis have been described and overwhelmingly include patients with bipolar disorder. The risk for recurrent postpartum psychosis in women who have had a previous episode is as great as 75%-90% in the absence of prophylactic intervention. With that said, we are extremely interested in understanding the etiology of postpartum psychosis. Various studies over the last 5 years have looked at a whole host of psychosocial as well as neurobiologic variables that may contribute to risk for postpartum psychosis, including dysregulation of the stress axis, heightened inflammation as well as a history of child adversity and heightened experience of stress during the perinatal period.

There have also been anecdotal reports during Virtual Rounds at the Center for Women’s Mental Health of higher recent rates of postpartum psychosis manifesting during the postpartum period. This is a clinical observation and has not been systematically studied. However, one can wonder whether the experience of the pandemic has constituted a stressor for at-risk women, tipping the scales toward women becoming ill, or whether clinicians are seeing this finding more because of our ability to observe it more within the context of the pandemic.

Precise quantification of risk for postpartum psychosis is complicated; as noted, women with bipolar disorder have a predictably high risk for getting ill during the postpartum period and many go on to have clinical courses consistent with recurrent bipolar disorder. However, there are other women who have circumscribed episodes of psychotic illness in the postpartum period who recover and are totally well without any evidence of psychiatric disorder until they have another child, at which time the risk for recurrence of postpartum psychosis is very high. Interest in developing a model of risk that could reliably predict an illness as serious as postpartum psychosis is on the minds of researchers around the world.

One recent study that highlights the multiple factors involved in risk of postpartum psychosis involved a prospective longitudinal study of a group of women who were followed across the peripartum period from the third trimester until 4 weeks postpartum. In this group, 51 women were at increased risk for postpartum psychosis based on their diagnosis of bipolar disorder, schizoaffective disorder, or a previous episode of postpartum psychosis. These women were matched with a control group with no past or current diagnosis of psychiatric disorder or family history of postpartum psychosis. The findings suggested that women at risk for postpartum psychosis who experienced a psychiatric relapse during the first 4 weeks postpartum relative to women at risk who remained well had histories of severe childhood adversity as well as biomarkers consistent with a dysregulated stress axis (a statistically higher daily cortisol level). This is consistent with other data that have implicated the complex role between psychosocial variables as well as neurobiologic variables, such as a dysregulation in the hypothalamic pituitary adrenal axis and other studies that suggest that dysregulated inflammatory status may also drive risk for postpartum psychosis (Hazelgrove K et al. Psychoneuroendocrinology. 2021 Jun. doi: 10.1016/j.psyneuen.2021.105218).

At the end of the day, postpartum psychosis is a psychiatric and obstetrical emergency. In our center, it is rare for women not to be hospitalized with this condition to ensure the safety of the mother as well as her newborn, and to also get her recompensated and functioning as quickly and as significantly as possible. However, an interesting extrapolation of the findings noted by Hazelgrove and colleagues is that it raises the question of what effective treatments might be used to mitigate risk for those at greatest risk for postpartum psychosis. For example, are there other treatments over and above the few effective ones that have been studied as prophylactic pharmacologic interventions that might mitigate risk for recurrence of an illness as serious as postpartum psychosis?

The data suggesting dysregulation of the stress axis as a predictor variable for risk in women vulnerable to postpartum psychosis opens an array of opportunities that are nonpharmacologic, such as mindfulness-based cognitive therapy or other interventions that help to modulate the stress axis. This is a terrific opportunity to have pharmacologic intervention meet nonpharmacologic intervention to potentially mitigate risk for postpartum psychosis with its attendant serious sequelae.

In our own work, where we are evaluating genomic data in an extremely well-characterized group of women with known histories of postpartum psychosis, we are interested to see if we can enhance understanding of the model of risk for postpartum psychosis by factoring in genomic underpinning, history of diagnosis, and psychosocial variables to optimally craft interventions for this population of at-risk women. This brings us one step closer to the future in women’s mental health, to the practice of “precision reproductive psychiatry,” matching interventions to specific presentations across perinatal populations.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Postpartum depression, in many respects, has become a household term. Over the last decade, there has been increasing awareness of the importance of screening for postpartum depression, with increased systematic screening across clinical settings where care is delivered to women during pregnancy and the postpartum period. There have also been greater efforts to identify women who are suffering postpartum depression and to support them with appropriate clinical interventions, whether through psychotherapy and/or pharmacologic therapy. Clinical interventions are supplemented by the increasing awareness of the value of community-based support groups for women who are suffering from postpartum mood and anxiety disorders.

Despite the growing, appropriate focus on recognition and acute treatment of postpartum depression as well as assessing clinical outcomes for those who suffer from postpartum mood and anxiety disorders, less attention has been given to postpartum psychosis, the most severe form of postpartum depression. It is indeed, the least common postpartum psychiatric syndrome (1 in 1,000 births) and comes to public attention when there has been a tragedy during the acute postpartum period such as maternal suicide or infanticide. In this sense, postpartum psychosis is ironically an underappreciated clinical entity across America given its severity, the effect it has on longer-term psychiatric morbidity, and its effect on children and families.

Our group at the Center for Women’s Mental Health has been interested in postpartum psychosis for years and started the Postpartum Psychosis Project in an effort to better understand the phenomenology, course, treatment, outcome, and genomic underpinnings of postpartum psychosis. Risk factors that are well established for postpartum psychosis have been described and overwhelmingly include patients with bipolar disorder. The risk for recurrent postpartum psychosis in women who have had a previous episode is as great as 75%-90% in the absence of prophylactic intervention. With that said, we are extremely interested in understanding the etiology of postpartum psychosis. Various studies over the last 5 years have looked at a whole host of psychosocial as well as neurobiologic variables that may contribute to risk for postpartum psychosis, including dysregulation of the stress axis, heightened inflammation as well as a history of child adversity and heightened experience of stress during the perinatal period.

There have also been anecdotal reports during Virtual Rounds at the Center for Women’s Mental Health of higher recent rates of postpartum psychosis manifesting during the postpartum period. This is a clinical observation and has not been systematically studied. However, one can wonder whether the experience of the pandemic has constituted a stressor for at-risk women, tipping the scales toward women becoming ill, or whether clinicians are seeing this finding more because of our ability to observe it more within the context of the pandemic.

Precise quantification of risk for postpartum psychosis is complicated; as noted, women with bipolar disorder have a predictably high risk for getting ill during the postpartum period and many go on to have clinical courses consistent with recurrent bipolar disorder. However, there are other women who have circumscribed episodes of psychotic illness in the postpartum period who recover and are totally well without any evidence of psychiatric disorder until they have another child, at which time the risk for recurrence of postpartum psychosis is very high. Interest in developing a model of risk that could reliably predict an illness as serious as postpartum psychosis is on the minds of researchers around the world.

One recent study that highlights the multiple factors involved in risk of postpartum psychosis involved a prospective longitudinal study of a group of women who were followed across the peripartum period from the third trimester until 4 weeks postpartum. In this group, 51 women were at increased risk for postpartum psychosis based on their diagnosis of bipolar disorder, schizoaffective disorder, or a previous episode of postpartum psychosis. These women were matched with a control group with no past or current diagnosis of psychiatric disorder or family history of postpartum psychosis. The findings suggested that women at risk for postpartum psychosis who experienced a psychiatric relapse during the first 4 weeks postpartum relative to women at risk who remained well had histories of severe childhood adversity as well as biomarkers consistent with a dysregulated stress axis (a statistically higher daily cortisol level). This is consistent with other data that have implicated the complex role between psychosocial variables as well as neurobiologic variables, such as a dysregulation in the hypothalamic pituitary adrenal axis and other studies that suggest that dysregulated inflammatory status may also drive risk for postpartum psychosis (Hazelgrove K et al. Psychoneuroendocrinology. 2021 Jun. doi: 10.1016/j.psyneuen.2021.105218).

At the end of the day, postpartum psychosis is a psychiatric and obstetrical emergency. In our center, it is rare for women not to be hospitalized with this condition to ensure the safety of the mother as well as her newborn, and to also get her recompensated and functioning as quickly and as significantly as possible. However, an interesting extrapolation of the findings noted by Hazelgrove and colleagues is that it raises the question of what effective treatments might be used to mitigate risk for those at greatest risk for postpartum psychosis. For example, are there other treatments over and above the few effective ones that have been studied as prophylactic pharmacologic interventions that might mitigate risk for recurrence of an illness as serious as postpartum psychosis?

The data suggesting dysregulation of the stress axis as a predictor variable for risk in women vulnerable to postpartum psychosis opens an array of opportunities that are nonpharmacologic, such as mindfulness-based cognitive therapy or other interventions that help to modulate the stress axis. This is a terrific opportunity to have pharmacologic intervention meet nonpharmacologic intervention to potentially mitigate risk for postpartum psychosis with its attendant serious sequelae.

In our own work, where we are evaluating genomic data in an extremely well-characterized group of women with known histories of postpartum psychosis, we are interested to see if we can enhance understanding of the model of risk for postpartum psychosis by factoring in genomic underpinning, history of diagnosis, and psychosocial variables to optimally craft interventions for this population of at-risk women. This brings us one step closer to the future in women’s mental health, to the practice of “precision reproductive psychiatry,” matching interventions to specific presentations across perinatal populations.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Kieran Bhattacharya was slated to graduate from University of Virginia (UVA) Medical School in 2021. But in late 2018, he was suspended. In early 2019, the University Threat Assessment Team went a step further, issuing Mr. Bhattacharya a no-trespass warning.

Mr. Bhattacharya claims the unraveling of his medical training was because of questions he asked at a UVA-hosted panel on microaggressions that took place 1 month before his suspension. His attorneys argue that, after making some admittedly less-than-collegial statements at a forum, the institution branded him as a threat. The school counters that Mr. Bhattacharya had a pattern of concerning, unprofessional behavior. The matter will now be settled in court.

UVA initially attempted to have Mr. Bhattacharya’s suit thrown out. A federal judge did dismiss three of four counts; however, he also ruled the lawsuit could move forward on the grounds that Mr. Bhattacharya’s First Amendment right to free speech was infringed.

Supporters claim that Mr. Bhattacharya was a student in good standing with the university, until he spoke publicly at the panel. They say the discipline he’s faced for those remarks is an egregious breach of free speech. Several experts say his case highlights the use – or rather misuse – of professionalism policies to undermine student freedoms and valuable discourse.

UVA argues that it’s not so simple and that the facts considered by the judge this spring were only part of the story. According to the defense, Mr. Bhattacharya’s side leaves out key details leading up to his suspension. The institution says Mr. Bhattacharya did and said things that provoked medical school officials to question the safety of the campus and his fitness to practice medicine. This news organization attempted to contact Mr. Bhattacharya several times through his attorneys and did not receive a response.

Both sides will now have to prove their claims, and the whole of medical education may feel the impact of the impending ruling.
 

What happened at the microaggression panel

On this, both parties agree: A panel on microaggressions took place on Oct. 25, 2018. Mr. Bhattacharya, then a 2nd-year UVA medical student, was the first volunteer to speak when the floor was opened for questioning.

“Thank you for your presentation,” said Mr. Bhattacharya, according to an audio recording of the event. “I had a few questions, just to clarify your definition of microaggressions.” He then asked his first question: “Is it a requirement, to be a victim of microaggression, that you are a member of a marginalized group?”

The presenter, Beverly Colwell Adams, PhD, associate professor emeritus in the department of psychology and previously the assistant dean of UVA’s College of Arts and Sciences, said it was not. But before she could go on to explain, Mr. Bhattacharya interrupted, speaking quickly. “But in the definition, it just said you had to be a member of a marginalized group, in the definition you used on the last slide. So that’s contradictory.” Dr. Adams responded. “What I had there is kind of the generalized definition,” she said. “In fact, I extend it beyond that.”

Mr. Bhattacharya asked a second question – to which Dr. Adams responded – about defining a marginalized group. Then, during a third question about differentiating between microaggressions and unintentional rude statements, Mr. Bhattacharya sped up again, repeating some of Dr. Adams’ own presentation back to her. He then asked if she had done any other research on microaggression, after calling the evidence she provided “one anecdotal case.” Dr. Adams responded with an example.

Mr. Bhattacharya’s fourth question was then intercepted by a fellow panelist, Sara Rasmussen, MD. She offered an anecdote about her own experience with microaggression, as a person from rural West Virginia. She offered some advice on understanding the impact of your actions and then advised, “You have to learn to uncouple the intent of what you’re saying and the impact it has on the audience.”

Mr. Bhattacharya briefly disagreed with Dr. Rasmussen, and then called the evidence Dr. Adams presented “anecdotal” a second time. At that point, Dr. Rasmussen interrupted him to say that Dr. Adams had offered “a lot of citations from the literature” and then called on another student to ask a question.

In total, Mr. Bhattacharya engaged with the panel for just over 5 minutes. He is now arguing in court that those 5 minutes forever changed his life.
 

Blindsided

After the event, according to court documents, Nora Kern, MD, and one of the panelists filed a professionalism concern card about Mr. Bhattacharya’s discourse. “This student asked a series of questions that were quite antagonistic toward the panel. He pressed on and stated one faculty member was being contradictory. His level of frustration/anger seemed to escalate until another faculty member defused the situation by calling on another student for questions,” Dr. Kern wrote on the card that was later included in Mr. Bhattacharya’s case filing.

According to Regina Rini, PhD, Canada research chair in philosophy of moral and social cognition at York University in Toronto, there are two layers to Mr. Bhattacharya’s discussion with the panel. She told this news organization that the first level is the content of the conversation: “His very first question was a very reasonable one.” Since the 1970s, when Chester Pierce first coined the term microaggression, most experts have agreed that the action must be directed at a person within a marginalized group. “It sounds like the presenter has a nuanced view,” Dr. Rini said. She added that his “was a fair question to ask.”

However, Dr. Rini said the second layer – the way conversation took place – is a separate concern. “Maybe two rounds of questions later, he starts speaking quickly” and fires off multiple questions one after the other, when asking if Dr. Adams had any evidence, and called her support anecdotal, Dr. Rini said. “That’s not a cooperative attempt to hear an answer.”

“He’s a little antagonistic,” Alana Nichols, JD, MD, attorney and a medical pediatrics intern at the University of Alabama at Birmingham, said after listening to the recording. “He did sound like he had an agenda and was not being receptive to what they were saying.” However, Dr. Nichols said, “What brought me pause as someone in medicine was the way it escalated.”

After Dr. Kern filed the professionalism concern card, two faculty members contacted Mr. Bhattacharya. Christine Peterson, MD, assistant dean for medical education, emailed to ask if he wanted to discuss how to navigate uncomfortable conversations and how to cope with “unintended consequences of conversations.” The day after the panel, John Densmore, MD, associate dean for admissions and student affairs, emailed Mr. Bhattacharya, asking to meet the following week.

Mr. Bhattacharya met with both deans. Dr. Peterson only briefly mentioned the panel. Dr. Densmore didn’t at all, according to court documents. Dr. Densmore also didn’t mention the professionalism concern card to Mr. Bhattacharya. However, the Academic Standards and Achievement Committee discussed it about 2 weeks later, at their monthly meeting.

Dr. Kern was the only voting member present who actually witnessed the microaggression panel. Dr. Peterson was there as a guest. The committee voted unanimously to send Mr. Bhattacharya a letter, reminding him of the importance of showing respect to everyone. The letter was sent the following day, Nov. 14, 2018. Mr. Bhattacharya still had no knowledge of the professionalism concern card.

On Nov. 26, Dr. Densmore sent Mr. Bhattacharya an email that read: “We were notified by the Dean of Students Office that you were heading back to Charlottesville. You will need to be seen by CAPS [Counseling and Psychological Services] before you can return to classes.”

On Nov. 27, court records show Mr. Bhattacharya emailed Dr. Densmore, questioning the school’s ability to mandate psychiatric evaluation. The decision was reinforced with an email from the then senior associate dean for education at UVA Medical School. Mr. Bhattacharya was not permitted to return to class without the evaluation.

“If I were in his situation, I would feel kind of blindsided,” Dr. Nichols said. Mr. Bhattacharya met with two deans immediately after the event, during which he said his conduct with the panel was barely or not at all mentioned. To him, the situation could well have seemed to be over, Dr. Nichols said. In her opinion, as a lawyer and doctor in training, the situation “escalated very quickly and not very transparently.”
 

More than microaggressions

UVA points to an entirely different timeline. In fact, the school claims that neither Mr. Bhattacharya’s statements at the panel nor the tone with which he spoke there had any bearing on the decision to suspend him.

According to court documents, UVA denies that Mr. Bhattacharya “ever faced discipline because of the content of [his] speech at the panel discussion.” It also denies that the mandate for psychological evaluation was related to or in any way triggered by his behavior at the panel discussion.

UVA’s official statement on the case states: “The student in question was dismissed from the School of Medicine after a series of incidents and repeated instances of erratic behavior that raised security concerns as well as questions about his professionalism and fitness to practice medicine.”

The university cites two such incidents. The first is a meeting with Dr. Densmore at which Mr. Bhattacharya’s behavior was so concerning that he was escorted to the counseling center. After meeting with the counselor, Mr. Bhattacharya was involuntarily hospitalized afterward. At a second meeting with Dr. Densmore, UVA’s filing alleges that Mr. Bhattacharya’s behavior was so “erratic, aggressive, and concerning” that Dr. Densmore called the police. The school also cites a second involuntarily hospitalization and a restraining order against Mr. Bhattacharya by his girlfriend, a fellow medical student, as reasons for his suspension.

Mr. Bhattacharya’s girlfriend, Angel Hsu, a recent graduate of UVA medical school, has since been added to the list of defendants. Mr. Bhattacharya’s attorneys have called her a third-party coconspirator, working with Dr. Peterson and Dr. Densmore to have Mr. Bhattacharya removed from the university. Mr. Bhattacharya alleges that Dr. Hsu’s schemes started when he broke up with her the day before the microaggression panel. He claims that, during their relationship, she admitted to framing two other men for sexual misconduct during her undergraduate education at Emory. All of this is detailed in the 87-page document filed by Mr. Bhattacharya’s attorneys regarding his relationship with Dr. Hsu.

Alex Morey, JD, an attorney at the Foundation for Individual Rights in Education, said Mr. Bhattacharya is also alleged to have exhibited other threatening behavior on social media and in chat rooms. However, if Mr. Bhattacharya was suspended for reasons other than what he said at the panel, Ms. Morey said, the burden of proof is on the school. They’ll need to prove that the incidents listed, and not his speech, are the motivation for Mr. Bhattacharya’s removal from the program. “We haven’t seen [that] yet,” she said.

In a statement sent to this news organization by UVA Health Public Information Officer Eric Swensen, the school said, “It is worth noting, however, that the court’s recent ruling is based only on the facts as alleged by the plaintiff and must accept all of those allegations as true at this stage of the proceedings.”
 

Problems with professionalism policies

The case brings into focus concerns about professionalism policies in medical education. “Traditionally it’s been assumed that a physician has certain values, attributes, and behaviors that constitute professionals, which, in some ways, boil down to inspiring trust in him or her,” said Edward Krupat, PhD, associate professor of medicine at Harvard University.

However, many feel that these binding codes of student conduct allow institutions to inhibit civil rights under the guise of professionalism, a standard critics say is inconsistently and often ill-defined.

“They just didn’t like what he said and the way he said it,” Ms. Morey said about Mr. Bhattacharya. “That is not the same as someone engaging in behavior that fundamentally undermines the profession they are in.”

UVA Health’s professionalism policy prohibits conduct that is perceived as rude and says that a pattern of unprofessionalism – defined as three or more recorded events – or one egregious act of unprofessionalism can be punished with removal from the school. What remains to be seen is documented proof of the specific unprofessional or egregious acts that got Mr. Bhattacharya suspended. “Clearly it’s subjective,” Dr. Krupat said. And “there’s an ever-widening gray area” when it comes to these policies.

In a 2020 study of 108 medical graduates, Dr. Krupat and his collaborators found that those who had to go before their review board for professionalism concerns as students were more than five times more likely undergo disciplinary review during residency. They were two times more likely to be sued or sanctioned during their practice.

Dr. Krupat said that a traditional approach would be to look at the list of documented offenses and ask, “Would this be your first choice for a physician?” If the facts the dean alleges are true of Mr. Bhattacharya, then the answer may be no, Dr. Krupat said, based on his limited familiarity with the case. However, he said the situation may be “more complex than the dean says.”

What is unlikely, according to Dr. Krupat, is that medical staff were eager to quickly get rid of a student. In his experience, medical faculty often take extra precautions to understand, justify, and support medical students. There’s even a term in the medical education literature to describe faculty’s unrelenting tendency to stick with students: “failure to fail.” Dr. Krupat finds it “highly unusual that someone would say something in a gray area and be asked to leave.”
 

What a ruling may mean

Despite the many seemingly contradictory and gray areas, Ms. Morey sees it as cut-and-dried. “It’s a pretty clear First Amendment violation,” she said in an interview. “It’s been one of the more egregious cases we’ve seen lately.”

There are exceptions to free speech on college campuses, Ms. Morey said. Students have First Amendment rights; however, in the classroom setting, the professor and school also have the right to maintain an orderly environment. The panel opened the floor for questions. Thus, Mr. Bhattacharya’s counsel is arguing that the faculty essentially turned the program over to the students. According to Ms. Morey, because UVA hasn’t been able to prove that Mr. Bhattacharya’s discourse caused a “material disruption,” the First Amendment suit is moving forward.

“In a Q&A, the school has essentially created a public forum,” Ms. Morey said. “What they can’t do is open a forum for public speech and punish the speech [they] don’t like.” She said that the courts have historically ruled that a student still has their rights.

“A ruling against Kieran Bhattacharya, in this case, would hugely undermine the First Amendment rights of professional students at every program across the country,” Ms. Morey said.

However, Dr. Nichols said that there have also been cases where the judiciary chooses not to get involved with the self-governing of an individual institution. “It could be an uphill battle for the student,” she said. If UVA can prove their claim that Bhattacharya’s pattern of behavior – and not his commentary on microaggressions – is what put others at risk and was the cause of suspension, then the school’s decision will likely hold.

Dr. Krupat said this case comes at a time when everyone – both students and faculty – feel like they are walking on eggshells. Power dynamics are rightfully being called into question but “a pendulum stuck at one end never just swings to the middle and stops,” he said. Students are frightened that faculty will be insensitive. Faculty fear that if they give negative feedback they might be accused of bias. He does think this tension is “something that will resolve itself for the better in the future,” he said.

The jury trial is currently set for early January 2022. In the meantime, First Amendment advocates are “heartened” that the judge allowed the case to proceed while those concerned with professionalism policies continue to closely watch what happens next.

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

Kieran Bhattacharya was slated to graduate from University of Virginia (UVA) Medical School in 2021. But in late 2018, he was suspended. In early 2019, the University Threat Assessment Team went a step further, issuing Mr. Bhattacharya a no-trespass warning.

Mr. Bhattacharya claims the unraveling of his medical training was because of questions he asked at a UVA-hosted panel on microaggressions that took place 1 month before his suspension. His attorneys argue that, after making some admittedly less-than-collegial statements at a forum, the institution branded him as a threat. The school counters that Mr. Bhattacharya had a pattern of concerning, unprofessional behavior. The matter will now be settled in court.

UVA initially attempted to have Mr. Bhattacharya’s suit thrown out. A federal judge did dismiss three of four counts; however, he also ruled the lawsuit could move forward on the grounds that Mr. Bhattacharya’s First Amendment right to free speech was infringed.

Supporters claim that Mr. Bhattacharya was a student in good standing with the university, until he spoke publicly at the panel. They say the discipline he’s faced for those remarks is an egregious breach of free speech. Several experts say his case highlights the use – or rather misuse – of professionalism policies to undermine student freedoms and valuable discourse.

UVA argues that it’s not so simple and that the facts considered by the judge this spring were only part of the story. According to the defense, Mr. Bhattacharya’s side leaves out key details leading up to his suspension. The institution says Mr. Bhattacharya did and said things that provoked medical school officials to question the safety of the campus and his fitness to practice medicine. This news organization attempted to contact Mr. Bhattacharya several times through his attorneys and did not receive a response.

Both sides will now have to prove their claims, and the whole of medical education may feel the impact of the impending ruling.
 

What happened at the microaggression panel

On this, both parties agree: A panel on microaggressions took place on Oct. 25, 2018. Mr. Bhattacharya, then a 2nd-year UVA medical student, was the first volunteer to speak when the floor was opened for questioning.

“Thank you for your presentation,” said Mr. Bhattacharya, according to an audio recording of the event. “I had a few questions, just to clarify your definition of microaggressions.” He then asked his first question: “Is it a requirement, to be a victim of microaggression, that you are a member of a marginalized group?”

The presenter, Beverly Colwell Adams, PhD, associate professor emeritus in the department of psychology and previously the assistant dean of UVA’s College of Arts and Sciences, said it was not. But before she could go on to explain, Mr. Bhattacharya interrupted, speaking quickly. “But in the definition, it just said you had to be a member of a marginalized group, in the definition you used on the last slide. So that’s contradictory.” Dr. Adams responded. “What I had there is kind of the generalized definition,” she said. “In fact, I extend it beyond that.”

Mr. Bhattacharya asked a second question – to which Dr. Adams responded – about defining a marginalized group. Then, during a third question about differentiating between microaggressions and unintentional rude statements, Mr. Bhattacharya sped up again, repeating some of Dr. Adams’ own presentation back to her. He then asked if she had done any other research on microaggression, after calling the evidence she provided “one anecdotal case.” Dr. Adams responded with an example.

Mr. Bhattacharya’s fourth question was then intercepted by a fellow panelist, Sara Rasmussen, MD. She offered an anecdote about her own experience with microaggression, as a person from rural West Virginia. She offered some advice on understanding the impact of your actions and then advised, “You have to learn to uncouple the intent of what you’re saying and the impact it has on the audience.”

Mr. Bhattacharya briefly disagreed with Dr. Rasmussen, and then called the evidence Dr. Adams presented “anecdotal” a second time. At that point, Dr. Rasmussen interrupted him to say that Dr. Adams had offered “a lot of citations from the literature” and then called on another student to ask a question.

In total, Mr. Bhattacharya engaged with the panel for just over 5 minutes. He is now arguing in court that those 5 minutes forever changed his life.
 

Blindsided

After the event, according to court documents, Nora Kern, MD, and one of the panelists filed a professionalism concern card about Mr. Bhattacharya’s discourse. “This student asked a series of questions that were quite antagonistic toward the panel. He pressed on and stated one faculty member was being contradictory. His level of frustration/anger seemed to escalate until another faculty member defused the situation by calling on another student for questions,” Dr. Kern wrote on the card that was later included in Mr. Bhattacharya’s case filing.

According to Regina Rini, PhD, Canada research chair in philosophy of moral and social cognition at York University in Toronto, there are two layers to Mr. Bhattacharya’s discussion with the panel. She told this news organization that the first level is the content of the conversation: “His very first question was a very reasonable one.” Since the 1970s, when Chester Pierce first coined the term microaggression, most experts have agreed that the action must be directed at a person within a marginalized group. “It sounds like the presenter has a nuanced view,” Dr. Rini said. She added that his “was a fair question to ask.”

However, Dr. Rini said the second layer – the way conversation took place – is a separate concern. “Maybe two rounds of questions later, he starts speaking quickly” and fires off multiple questions one after the other, when asking if Dr. Adams had any evidence, and called her support anecdotal, Dr. Rini said. “That’s not a cooperative attempt to hear an answer.”

“He’s a little antagonistic,” Alana Nichols, JD, MD, attorney and a medical pediatrics intern at the University of Alabama at Birmingham, said after listening to the recording. “He did sound like he had an agenda and was not being receptive to what they were saying.” However, Dr. Nichols said, “What brought me pause as someone in medicine was the way it escalated.”

After Dr. Kern filed the professionalism concern card, two faculty members contacted Mr. Bhattacharya. Christine Peterson, MD, assistant dean for medical education, emailed to ask if he wanted to discuss how to navigate uncomfortable conversations and how to cope with “unintended consequences of conversations.” The day after the panel, John Densmore, MD, associate dean for admissions and student affairs, emailed Mr. Bhattacharya, asking to meet the following week.

Mr. Bhattacharya met with both deans. Dr. Peterson only briefly mentioned the panel. Dr. Densmore didn’t at all, according to court documents. Dr. Densmore also didn’t mention the professionalism concern card to Mr. Bhattacharya. However, the Academic Standards and Achievement Committee discussed it about 2 weeks later, at their monthly meeting.

Dr. Kern was the only voting member present who actually witnessed the microaggression panel. Dr. Peterson was there as a guest. The committee voted unanimously to send Mr. Bhattacharya a letter, reminding him of the importance of showing respect to everyone. The letter was sent the following day, Nov. 14, 2018. Mr. Bhattacharya still had no knowledge of the professionalism concern card.

On Nov. 26, Dr. Densmore sent Mr. Bhattacharya an email that read: “We were notified by the Dean of Students Office that you were heading back to Charlottesville. You will need to be seen by CAPS [Counseling and Psychological Services] before you can return to classes.”

On Nov. 27, court records show Mr. Bhattacharya emailed Dr. Densmore, questioning the school’s ability to mandate psychiatric evaluation. The decision was reinforced with an email from the then senior associate dean for education at UVA Medical School. Mr. Bhattacharya was not permitted to return to class without the evaluation.

“If I were in his situation, I would feel kind of blindsided,” Dr. Nichols said. Mr. Bhattacharya met with two deans immediately after the event, during which he said his conduct with the panel was barely or not at all mentioned. To him, the situation could well have seemed to be over, Dr. Nichols said. In her opinion, as a lawyer and doctor in training, the situation “escalated very quickly and not very transparently.”
 

More than microaggressions

UVA points to an entirely different timeline. In fact, the school claims that neither Mr. Bhattacharya’s statements at the panel nor the tone with which he spoke there had any bearing on the decision to suspend him.

According to court documents, UVA denies that Mr. Bhattacharya “ever faced discipline because of the content of [his] speech at the panel discussion.” It also denies that the mandate for psychological evaluation was related to or in any way triggered by his behavior at the panel discussion.

UVA’s official statement on the case states: “The student in question was dismissed from the School of Medicine after a series of incidents and repeated instances of erratic behavior that raised security concerns as well as questions about his professionalism and fitness to practice medicine.”

The university cites two such incidents. The first is a meeting with Dr. Densmore at which Mr. Bhattacharya’s behavior was so concerning that he was escorted to the counseling center. After meeting with the counselor, Mr. Bhattacharya was involuntarily hospitalized afterward. At a second meeting with Dr. Densmore, UVA’s filing alleges that Mr. Bhattacharya’s behavior was so “erratic, aggressive, and concerning” that Dr. Densmore called the police. The school also cites a second involuntarily hospitalization and a restraining order against Mr. Bhattacharya by his girlfriend, a fellow medical student, as reasons for his suspension.

Mr. Bhattacharya’s girlfriend, Angel Hsu, a recent graduate of UVA medical school, has since been added to the list of defendants. Mr. Bhattacharya’s attorneys have called her a third-party coconspirator, working with Dr. Peterson and Dr. Densmore to have Mr. Bhattacharya removed from the university. Mr. Bhattacharya alleges that Dr. Hsu’s schemes started when he broke up with her the day before the microaggression panel. He claims that, during their relationship, she admitted to framing two other men for sexual misconduct during her undergraduate education at Emory. All of this is detailed in the 87-page document filed by Mr. Bhattacharya’s attorneys regarding his relationship with Dr. Hsu.

Alex Morey, JD, an attorney at the Foundation for Individual Rights in Education, said Mr. Bhattacharya is also alleged to have exhibited other threatening behavior on social media and in chat rooms. However, if Mr. Bhattacharya was suspended for reasons other than what he said at the panel, Ms. Morey said, the burden of proof is on the school. They’ll need to prove that the incidents listed, and not his speech, are the motivation for Mr. Bhattacharya’s removal from the program. “We haven’t seen [that] yet,” she said.

In a statement sent to this news organization by UVA Health Public Information Officer Eric Swensen, the school said, “It is worth noting, however, that the court’s recent ruling is based only on the facts as alleged by the plaintiff and must accept all of those allegations as true at this stage of the proceedings.”
 

Problems with professionalism policies

The case brings into focus concerns about professionalism policies in medical education. “Traditionally it’s been assumed that a physician has certain values, attributes, and behaviors that constitute professionals, which, in some ways, boil down to inspiring trust in him or her,” said Edward Krupat, PhD, associate professor of medicine at Harvard University.

However, many feel that these binding codes of student conduct allow institutions to inhibit civil rights under the guise of professionalism, a standard critics say is inconsistently and often ill-defined.

“They just didn’t like what he said and the way he said it,” Ms. Morey said about Mr. Bhattacharya. “That is not the same as someone engaging in behavior that fundamentally undermines the profession they are in.”

UVA Health’s professionalism policy prohibits conduct that is perceived as rude and says that a pattern of unprofessionalism – defined as three or more recorded events – or one egregious act of unprofessionalism can be punished with removal from the school. What remains to be seen is documented proof of the specific unprofessional or egregious acts that got Mr. Bhattacharya suspended. “Clearly it’s subjective,” Dr. Krupat said. And “there’s an ever-widening gray area” when it comes to these policies.

In a 2020 study of 108 medical graduates, Dr. Krupat and his collaborators found that those who had to go before their review board for professionalism concerns as students were more than five times more likely undergo disciplinary review during residency. They were two times more likely to be sued or sanctioned during their practice.

Dr. Krupat said that a traditional approach would be to look at the list of documented offenses and ask, “Would this be your first choice for a physician?” If the facts the dean alleges are true of Mr. Bhattacharya, then the answer may be no, Dr. Krupat said, based on his limited familiarity with the case. However, he said the situation may be “more complex than the dean says.”

What is unlikely, according to Dr. Krupat, is that medical staff were eager to quickly get rid of a student. In his experience, medical faculty often take extra precautions to understand, justify, and support medical students. There’s even a term in the medical education literature to describe faculty’s unrelenting tendency to stick with students: “failure to fail.” Dr. Krupat finds it “highly unusual that someone would say something in a gray area and be asked to leave.”
 

What a ruling may mean

Despite the many seemingly contradictory and gray areas, Ms. Morey sees it as cut-and-dried. “It’s a pretty clear First Amendment violation,” she said in an interview. “It’s been one of the more egregious cases we’ve seen lately.”

There are exceptions to free speech on college campuses, Ms. Morey said. Students have First Amendment rights; however, in the classroom setting, the professor and school also have the right to maintain an orderly environment. The panel opened the floor for questions. Thus, Mr. Bhattacharya’s counsel is arguing that the faculty essentially turned the program over to the students. According to Ms. Morey, because UVA hasn’t been able to prove that Mr. Bhattacharya’s discourse caused a “material disruption,” the First Amendment suit is moving forward.

“In a Q&A, the school has essentially created a public forum,” Ms. Morey said. “What they can’t do is open a forum for public speech and punish the speech [they] don’t like.” She said that the courts have historically ruled that a student still has their rights.

“A ruling against Kieran Bhattacharya, in this case, would hugely undermine the First Amendment rights of professional students at every program across the country,” Ms. Morey said.

However, Dr. Nichols said that there have also been cases where the judiciary chooses not to get involved with the self-governing of an individual institution. “It could be an uphill battle for the student,” she said. If UVA can prove their claim that Bhattacharya’s pattern of behavior – and not his commentary on microaggressions – is what put others at risk and was the cause of suspension, then the school’s decision will likely hold.

Dr. Krupat said this case comes at a time when everyone – both students and faculty – feel like they are walking on eggshells. Power dynamics are rightfully being called into question but “a pendulum stuck at one end never just swings to the middle and stops,” he said. Students are frightened that faculty will be insensitive. Faculty fear that if they give negative feedback they might be accused of bias. He does think this tension is “something that will resolve itself for the better in the future,” he said.

The jury trial is currently set for early January 2022. In the meantime, First Amendment advocates are “heartened” that the judge allowed the case to proceed while those concerned with professionalism policies continue to closely watch what happens next.

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

Kieran Bhattacharya was slated to graduate from University of Virginia (UVA) Medical School in 2021. But in late 2018, he was suspended. In early 2019, the University Threat Assessment Team went a step further, issuing Mr. Bhattacharya a no-trespass warning.

Mr. Bhattacharya claims the unraveling of his medical training was because of questions he asked at a UVA-hosted panel on microaggressions that took place 1 month before his suspension. His attorneys argue that, after making some admittedly less-than-collegial statements at a forum, the institution branded him as a threat. The school counters that Mr. Bhattacharya had a pattern of concerning, unprofessional behavior. The matter will now be settled in court.

UVA initially attempted to have Mr. Bhattacharya’s suit thrown out. A federal judge did dismiss three of four counts; however, he also ruled the lawsuit could move forward on the grounds that Mr. Bhattacharya’s First Amendment right to free speech was infringed.

Supporters claim that Mr. Bhattacharya was a student in good standing with the university, until he spoke publicly at the panel. They say the discipline he’s faced for those remarks is an egregious breach of free speech. Several experts say his case highlights the use – or rather misuse – of professionalism policies to undermine student freedoms and valuable discourse.

UVA argues that it’s not so simple and that the facts considered by the judge this spring were only part of the story. According to the defense, Mr. Bhattacharya’s side leaves out key details leading up to his suspension. The institution says Mr. Bhattacharya did and said things that provoked medical school officials to question the safety of the campus and his fitness to practice medicine. This news organization attempted to contact Mr. Bhattacharya several times through his attorneys and did not receive a response.

Both sides will now have to prove their claims, and the whole of medical education may feel the impact of the impending ruling.
 

What happened at the microaggression panel

On this, both parties agree: A panel on microaggressions took place on Oct. 25, 2018. Mr. Bhattacharya, then a 2nd-year UVA medical student, was the first volunteer to speak when the floor was opened for questioning.

“Thank you for your presentation,” said Mr. Bhattacharya, according to an audio recording of the event. “I had a few questions, just to clarify your definition of microaggressions.” He then asked his first question: “Is it a requirement, to be a victim of microaggression, that you are a member of a marginalized group?”

The presenter, Beverly Colwell Adams, PhD, associate professor emeritus in the department of psychology and previously the assistant dean of UVA’s College of Arts and Sciences, said it was not. But before she could go on to explain, Mr. Bhattacharya interrupted, speaking quickly. “But in the definition, it just said you had to be a member of a marginalized group, in the definition you used on the last slide. So that’s contradictory.” Dr. Adams responded. “What I had there is kind of the generalized definition,” she said. “In fact, I extend it beyond that.”

Mr. Bhattacharya asked a second question – to which Dr. Adams responded – about defining a marginalized group. Then, during a third question about differentiating between microaggressions and unintentional rude statements, Mr. Bhattacharya sped up again, repeating some of Dr. Adams’ own presentation back to her. He then asked if she had done any other research on microaggression, after calling the evidence she provided “one anecdotal case.” Dr. Adams responded with an example.

Mr. Bhattacharya’s fourth question was then intercepted by a fellow panelist, Sara Rasmussen, MD. She offered an anecdote about her own experience with microaggression, as a person from rural West Virginia. She offered some advice on understanding the impact of your actions and then advised, “You have to learn to uncouple the intent of what you’re saying and the impact it has on the audience.”

Mr. Bhattacharya briefly disagreed with Dr. Rasmussen, and then called the evidence Dr. Adams presented “anecdotal” a second time. At that point, Dr. Rasmussen interrupted him to say that Dr. Adams had offered “a lot of citations from the literature” and then called on another student to ask a question.

In total, Mr. Bhattacharya engaged with the panel for just over 5 minutes. He is now arguing in court that those 5 minutes forever changed his life.
 

Blindsided

After the event, according to court documents, Nora Kern, MD, and one of the panelists filed a professionalism concern card about Mr. Bhattacharya’s discourse. “This student asked a series of questions that were quite antagonistic toward the panel. He pressed on and stated one faculty member was being contradictory. His level of frustration/anger seemed to escalate until another faculty member defused the situation by calling on another student for questions,” Dr. Kern wrote on the card that was later included in Mr. Bhattacharya’s case filing.

According to Regina Rini, PhD, Canada research chair in philosophy of moral and social cognition at York University in Toronto, there are two layers to Mr. Bhattacharya’s discussion with the panel. She told this news organization that the first level is the content of the conversation: “His very first question was a very reasonable one.” Since the 1970s, when Chester Pierce first coined the term microaggression, most experts have agreed that the action must be directed at a person within a marginalized group. “It sounds like the presenter has a nuanced view,” Dr. Rini said. She added that his “was a fair question to ask.”

However, Dr. Rini said the second layer – the way conversation took place – is a separate concern. “Maybe two rounds of questions later, he starts speaking quickly” and fires off multiple questions one after the other, when asking if Dr. Adams had any evidence, and called her support anecdotal, Dr. Rini said. “That’s not a cooperative attempt to hear an answer.”

“He’s a little antagonistic,” Alana Nichols, JD, MD, attorney and a medical pediatrics intern at the University of Alabama at Birmingham, said after listening to the recording. “He did sound like he had an agenda and was not being receptive to what they were saying.” However, Dr. Nichols said, “What brought me pause as someone in medicine was the way it escalated.”

After Dr. Kern filed the professionalism concern card, two faculty members contacted Mr. Bhattacharya. Christine Peterson, MD, assistant dean for medical education, emailed to ask if he wanted to discuss how to navigate uncomfortable conversations and how to cope with “unintended consequences of conversations.” The day after the panel, John Densmore, MD, associate dean for admissions and student affairs, emailed Mr. Bhattacharya, asking to meet the following week.

Mr. Bhattacharya met with both deans. Dr. Peterson only briefly mentioned the panel. Dr. Densmore didn’t at all, according to court documents. Dr. Densmore also didn’t mention the professionalism concern card to Mr. Bhattacharya. However, the Academic Standards and Achievement Committee discussed it about 2 weeks later, at their monthly meeting.

Dr. Kern was the only voting member present who actually witnessed the microaggression panel. Dr. Peterson was there as a guest. The committee voted unanimously to send Mr. Bhattacharya a letter, reminding him of the importance of showing respect to everyone. The letter was sent the following day, Nov. 14, 2018. Mr. Bhattacharya still had no knowledge of the professionalism concern card.

On Nov. 26, Dr. Densmore sent Mr. Bhattacharya an email that read: “We were notified by the Dean of Students Office that you were heading back to Charlottesville. You will need to be seen by CAPS [Counseling and Psychological Services] before you can return to classes.”

On Nov. 27, court records show Mr. Bhattacharya emailed Dr. Densmore, questioning the school’s ability to mandate psychiatric evaluation. The decision was reinforced with an email from the then senior associate dean for education at UVA Medical School. Mr. Bhattacharya was not permitted to return to class without the evaluation.

“If I were in his situation, I would feel kind of blindsided,” Dr. Nichols said. Mr. Bhattacharya met with two deans immediately after the event, during which he said his conduct with the panel was barely or not at all mentioned. To him, the situation could well have seemed to be over, Dr. Nichols said. In her opinion, as a lawyer and doctor in training, the situation “escalated very quickly and not very transparently.”
 

More than microaggressions

UVA points to an entirely different timeline. In fact, the school claims that neither Mr. Bhattacharya’s statements at the panel nor the tone with which he spoke there had any bearing on the decision to suspend him.

According to court documents, UVA denies that Mr. Bhattacharya “ever faced discipline because of the content of [his] speech at the panel discussion.” It also denies that the mandate for psychological evaluation was related to or in any way triggered by his behavior at the panel discussion.

UVA’s official statement on the case states: “The student in question was dismissed from the School of Medicine after a series of incidents and repeated instances of erratic behavior that raised security concerns as well as questions about his professionalism and fitness to practice medicine.”

The university cites two such incidents. The first is a meeting with Dr. Densmore at which Mr. Bhattacharya’s behavior was so concerning that he was escorted to the counseling center. After meeting with the counselor, Mr. Bhattacharya was involuntarily hospitalized afterward. At a second meeting with Dr. Densmore, UVA’s filing alleges that Mr. Bhattacharya’s behavior was so “erratic, aggressive, and concerning” that Dr. Densmore called the police. The school also cites a second involuntarily hospitalization and a restraining order against Mr. Bhattacharya by his girlfriend, a fellow medical student, as reasons for his suspension.

Mr. Bhattacharya’s girlfriend, Angel Hsu, a recent graduate of UVA medical school, has since been added to the list of defendants. Mr. Bhattacharya’s attorneys have called her a third-party coconspirator, working with Dr. Peterson and Dr. Densmore to have Mr. Bhattacharya removed from the university. Mr. Bhattacharya alleges that Dr. Hsu’s schemes started when he broke up with her the day before the microaggression panel. He claims that, during their relationship, she admitted to framing two other men for sexual misconduct during her undergraduate education at Emory. All of this is detailed in the 87-page document filed by Mr. Bhattacharya’s attorneys regarding his relationship with Dr. Hsu.

Alex Morey, JD, an attorney at the Foundation for Individual Rights in Education, said Mr. Bhattacharya is also alleged to have exhibited other threatening behavior on social media and in chat rooms. However, if Mr. Bhattacharya was suspended for reasons other than what he said at the panel, Ms. Morey said, the burden of proof is on the school. They’ll need to prove that the incidents listed, and not his speech, are the motivation for Mr. Bhattacharya’s removal from the program. “We haven’t seen [that] yet,” she said.

In a statement sent to this news organization by UVA Health Public Information Officer Eric Swensen, the school said, “It is worth noting, however, that the court’s recent ruling is based only on the facts as alleged by the plaintiff and must accept all of those allegations as true at this stage of the proceedings.”
 

Problems with professionalism policies

The case brings into focus concerns about professionalism policies in medical education. “Traditionally it’s been assumed that a physician has certain values, attributes, and behaviors that constitute professionals, which, in some ways, boil down to inspiring trust in him or her,” said Edward Krupat, PhD, associate professor of medicine at Harvard University.

However, many feel that these binding codes of student conduct allow institutions to inhibit civil rights under the guise of professionalism, a standard critics say is inconsistently and often ill-defined.

“They just didn’t like what he said and the way he said it,” Ms. Morey said about Mr. Bhattacharya. “That is not the same as someone engaging in behavior that fundamentally undermines the profession they are in.”

UVA Health’s professionalism policy prohibits conduct that is perceived as rude and says that a pattern of unprofessionalism – defined as three or more recorded events – or one egregious act of unprofessionalism can be punished with removal from the school. What remains to be seen is documented proof of the specific unprofessional or egregious acts that got Mr. Bhattacharya suspended. “Clearly it’s subjective,” Dr. Krupat said. And “there’s an ever-widening gray area” when it comes to these policies.

In a 2020 study of 108 medical graduates, Dr. Krupat and his collaborators found that those who had to go before their review board for professionalism concerns as students were more than five times more likely undergo disciplinary review during residency. They were two times more likely to be sued or sanctioned during their practice.

Dr. Krupat said that a traditional approach would be to look at the list of documented offenses and ask, “Would this be your first choice for a physician?” If the facts the dean alleges are true of Mr. Bhattacharya, then the answer may be no, Dr. Krupat said, based on his limited familiarity with the case. However, he said the situation may be “more complex than the dean says.”

What is unlikely, according to Dr. Krupat, is that medical staff were eager to quickly get rid of a student. In his experience, medical faculty often take extra precautions to understand, justify, and support medical students. There’s even a term in the medical education literature to describe faculty’s unrelenting tendency to stick with students: “failure to fail.” Dr. Krupat finds it “highly unusual that someone would say something in a gray area and be asked to leave.”
 

What a ruling may mean

Despite the many seemingly contradictory and gray areas, Ms. Morey sees it as cut-and-dried. “It’s a pretty clear First Amendment violation,” she said in an interview. “It’s been one of the more egregious cases we’ve seen lately.”

There are exceptions to free speech on college campuses, Ms. Morey said. Students have First Amendment rights; however, in the classroom setting, the professor and school also have the right to maintain an orderly environment. The panel opened the floor for questions. Thus, Mr. Bhattacharya’s counsel is arguing that the faculty essentially turned the program over to the students. According to Ms. Morey, because UVA hasn’t been able to prove that Mr. Bhattacharya’s discourse caused a “material disruption,” the First Amendment suit is moving forward.

“In a Q&A, the school has essentially created a public forum,” Ms. Morey said. “What they can’t do is open a forum for public speech and punish the speech [they] don’t like.” She said that the courts have historically ruled that a student still has their rights.

“A ruling against Kieran Bhattacharya, in this case, would hugely undermine the First Amendment rights of professional students at every program across the country,” Ms. Morey said.

However, Dr. Nichols said that there have also been cases where the judiciary chooses not to get involved with the self-governing of an individual institution. “It could be an uphill battle for the student,” she said. If UVA can prove their claim that Bhattacharya’s pattern of behavior – and not his commentary on microaggressions – is what put others at risk and was the cause of suspension, then the school’s decision will likely hold.

Dr. Krupat said this case comes at a time when everyone – both students and faculty – feel like they are walking on eggshells. Power dynamics are rightfully being called into question but “a pendulum stuck at one end never just swings to the middle and stops,” he said. Students are frightened that faculty will be insensitive. Faculty fear that if they give negative feedback they might be accused of bias. He does think this tension is “something that will resolve itself for the better in the future,” he said.

The jury trial is currently set for early January 2022. In the meantime, First Amendment advocates are “heartened” that the judge allowed the case to proceed while those concerned with professionalism policies continue to closely watch what happens next.

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

Thanks to the rollout of the COVID-19 vaccines, more than just flowers were blooming this past spring. People came out of lockdown like bears emerging from hibernation, making plans to reunite with friends and loved ones they hadn’t seen in months. But with the tremendous surge in cases brought by the Delta variant, this summer has been anything but sunny and carefree. Case counts have once more reached prevaccination levels. In a repeat of last summer, people are canceling travel plans, and the lead-up to the new school year has become fraught and stressful.

“This whiplash is causing people to feel a variety of emotions: disappointment, uncertainty, anxiety, possibly anger and frustration,” says Vaile Wright, Ph.D., senior director of health care innovation at the American Psychological Association. “When it seemed like there was a light at the end of the tunnel, and we have the tools to overcome [the virus], and we’re not really using them, it can be hard for people to understand.”
 

The importance of hope

For decades, researchers have been digging into the crucial role hopefulness plays in mental health. The vaccine rollout, earlier than anticipated, provided a much needed burst of hope after months of bad news.

“It was a feeling of almost euphoria in June: ‘We’re going to see everybody!’” says Rachel Goldenberg, a rabbi in Jackson Heights, NY. “We have a theme for our High Holidays, and this year’s is very hopeful: Sow in tears, reap in joy. It felt like the sowing in tears part was behind us, and we were looking forward to reaping in joy. Slowly but surely, with Delta, everything has turned upside down.”

For Roxanne Hawn, a writer in Golden, Colo., vaccination offered a glimpse of something like normal life.

“I wore cute clothes. I stopped and got takeout for lunch. I bought myself flowers. I even had a little uplifting soundtrack for that time of hope and relief,” she says. “With the Delta variant, it feels like that window of normalcy closed quickly.”

Having that little bit of hope dashed can wear down even the sturdiest spirits, says Marissa King, PhD, author of “Social Chemistry: Decoding the Elements of Human Connection”.

“There was a moment when we were able to reconnect, to experience joy and the hope of being able to revitalize relationships,” she says. “The loss of that hope and the fear of being isolated again is causing so much distress.”
 

A new kind of loneliness

When the pandemic started, mom of three Julie Schwietert Collazo formed a WhatsApp group with several friends who were taking lockdown seriously. They got each other through months of isolation and celebrated the idea of reopening. Then Ms. Collazo’s oldest got COVID, just 5 weeks before her 12th birthday, and their family went back into quarantine. Her moms’ group is no longer on the same page about precautions.

“Last year we were doing it together, and it made it feel a bit easier,” she says. “As things started to normalize, everybody started thinking and moving in different directions. It feels like we’re not working through the same issues collectively like before.”

Dr. King says the feeling Ms. Collazo describes is quite common these days.

“A profound sense of loneliness comes from feeling like you’re the only one,” she says. “There’s such disagreement about the best path forward, it can feel lonely just because you think differently.”
 

An epidemic of anxiety

As the Delta variant drives case numbers back up again, worries increase as well.

“Is this ever going to end?” asks Ms. Collazo. “Is this our new reality, constantly having to order our lives around COVID?”

This uneasiness affects our well-being.

The National Center for Health Statistics and the Census Bureau have monitored the nation’s mental health via the ongoing Household Pulse Survey during the pandemic. It asks participants about their symptoms of either anxiety or depression. Throughout, more people have reported feeling anxious than depressed.

Anxiety peaked around Thanksgiving and Christmas, with nearly 38% of people reporting symptoms. The first vaccines began to roll out around that time, and anxiety levels steadily went down through the spring and early summer, dipping below 25% in late June. But those numbers have begun to creep back up – the most recent data, which goes through Aug. 2, found 27% of Americans reporting symptoms of anxiety.

“Nervous is the new normal,” says Vivian Pender, MD, president of the American Psychiatric Association. “Uncertainty makes people feel anxious.”
 

Empathy vs. anger

The way politics play into basic measures like mask-wearing and vaccination adds its own layer of stress. Physical altercations have resulted: In Los Angeles, a participant was stabbed at an antivaccination protest. At an Austin, Tex., elementary school, angry parents physically and verbally assaulted teachers who wore masks. Things have gotten so heated, the Department of Homeland Security issued a National Terrorism Advisory System bulletin last week. It warns that extremists could use new COVID-driven public health restrictions as an excuse to commit domestic terrorism.

Anger goes in the opposite direction, too, with people who’ve been following recommended procedures becoming increasingly fed up with those who flout them. Those intense emotions may not lead to violence, but they do make it harder for us to feel secure.

“It’s a public health crisis, and it’s turned into something different. When we get into us/them situations, we start to lose empathy. Empathy is important to identify solutions and work together as a community,” says Dr. Wright. “That’s what sparks the anger: the sense of ‘You aren’t doing what you’re supposed to be doing.’”
 

How to cope

Loneliness, anxiety, and anger may be swirling all around you right now. But that doesn’t make you powerless to boost your mental health. These suggestions may help:

• Trust your gut. If your community is reopening faster than feels comfortable to you, do whatever makes your family feel safe. “Ask yourself how you’re feeling, and use your feelings to guide your decisions,” says Dr. Pender. “Get more information, then follow the science.”
• Stop judging yourself. If you’re feeling lonely or mourning the losses COVID has brought, don’t fight it, says Wright. “Let it be an emotion that comes and goes, and try to find ways to feel connected to other people.”
• Practice self-care. It may sound simplistic, but eating healthy foods, exercising, and getting a good night’s sleep can all contribute to a more positive 
• Try to ease anxiety. Meditation, calming self-talk, and soothing music can all lift your spirits. Or try diaphragmatic breathing: Breathe in for 5 seconds, hold for 2, and breathe out for 5. Even squeezing a stress ball can give you a tangible sense of 
• Take action. Both Rabbi Goldenberg and Ms. Collazo, who runs a nonprofit that works to reunite immigrant families, say helping their community helps them feel better. “To sing and lead Shabbat services, even on Zoom, to see the faces of my people, it’s very healing,” says Rabbi Goldenberg. One small thing you can do: If you have family or friends who are hesitant about vaccination, Dr. Wright suggests having gentle conversations to convince them. “You can be way more influential than a celebrity,” she says.
• Remember you’re not alone. Whether you’re physically isolated from others or just feel like nobody else is following the same protocols as you, there are ways to feel connected. “Reach out to people you’ve been close with in the past, but you may have lost touch,” says Dr. King. “It gives you an opportunity to rekindle joy. Particularly in this moment, when a lot of people are so afraid, it’s easier to reach out to those you already know than try to meet new people.” Dr. King’s research has found it takes as few as two close connections to make people feel supported.
• Stay in the present. Instead of stressing over what’s already happened or worrying about what might still come, just think about today. “We’ve learned a lot about the coronavirus, and we’re still learning more,” says Dr. Wright. “We don’t know what the future looks like, but it won’t be like this forever.”

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

Thanks to the rollout of the COVID-19 vaccines, more than just flowers were blooming this past spring. People came out of lockdown like bears emerging from hibernation, making plans to reunite with friends and loved ones they hadn’t seen in months. But with the tremendous surge in cases brought by the Delta variant, this summer has been anything but sunny and carefree. Case counts have once more reached prevaccination levels. In a repeat of last summer, people are canceling travel plans, and the lead-up to the new school year has become fraught and stressful.

“This whiplash is causing people to feel a variety of emotions: disappointment, uncertainty, anxiety, possibly anger and frustration,” says Vaile Wright, Ph.D., senior director of health care innovation at the American Psychological Association. “When it seemed like there was a light at the end of the tunnel, and we have the tools to overcome [the virus], and we’re not really using them, it can be hard for people to understand.”
 

The importance of hope

For decades, researchers have been digging into the crucial role hopefulness plays in mental health. The vaccine rollout, earlier than anticipated, provided a much needed burst of hope after months of bad news.

“It was a feeling of almost euphoria in June: ‘We’re going to see everybody!’” says Rachel Goldenberg, a rabbi in Jackson Heights, NY. “We have a theme for our High Holidays, and this year’s is very hopeful: Sow in tears, reap in joy. It felt like the sowing in tears part was behind us, and we were looking forward to reaping in joy. Slowly but surely, with Delta, everything has turned upside down.”

For Roxanne Hawn, a writer in Golden, Colo., vaccination offered a glimpse of something like normal life.

“I wore cute clothes. I stopped and got takeout for lunch. I bought myself flowers. I even had a little uplifting soundtrack for that time of hope and relief,” she says. “With the Delta variant, it feels like that window of normalcy closed quickly.”

Having that little bit of hope dashed can wear down even the sturdiest spirits, says Marissa King, PhD, author of “Social Chemistry: Decoding the Elements of Human Connection”.

“There was a moment when we were able to reconnect, to experience joy and the hope of being able to revitalize relationships,” she says. “The loss of that hope and the fear of being isolated again is causing so much distress.”
 

A new kind of loneliness

When the pandemic started, mom of three Julie Schwietert Collazo formed a WhatsApp group with several friends who were taking lockdown seriously. They got each other through months of isolation and celebrated the idea of reopening. Then Ms. Collazo’s oldest got COVID, just 5 weeks before her 12th birthday, and their family went back into quarantine. Her moms’ group is no longer on the same page about precautions.

“Last year we were doing it together, and it made it feel a bit easier,” she says. “As things started to normalize, everybody started thinking and moving in different directions. It feels like we’re not working through the same issues collectively like before.”

Dr. King says the feeling Ms. Collazo describes is quite common these days.

“A profound sense of loneliness comes from feeling like you’re the only one,” she says. “There’s such disagreement about the best path forward, it can feel lonely just because you think differently.”
 

An epidemic of anxiety

As the Delta variant drives case numbers back up again, worries increase as well.

“Is this ever going to end?” asks Ms. Collazo. “Is this our new reality, constantly having to order our lives around COVID?”

This uneasiness affects our well-being.

The National Center for Health Statistics and the Census Bureau have monitored the nation’s mental health via the ongoing Household Pulse Survey during the pandemic. It asks participants about their symptoms of either anxiety or depression. Throughout, more people have reported feeling anxious than depressed.

Anxiety peaked around Thanksgiving and Christmas, with nearly 38% of people reporting symptoms. The first vaccines began to roll out around that time, and anxiety levels steadily went down through the spring and early summer, dipping below 25% in late June. But those numbers have begun to creep back up – the most recent data, which goes through Aug. 2, found 27% of Americans reporting symptoms of anxiety.

“Nervous is the new normal,” says Vivian Pender, MD, president of the American Psychiatric Association. “Uncertainty makes people feel anxious.”
 

Empathy vs. anger

The way politics play into basic measures like mask-wearing and vaccination adds its own layer of stress. Physical altercations have resulted: In Los Angeles, a participant was stabbed at an antivaccination protest. At an Austin, Tex., elementary school, angry parents physically and verbally assaulted teachers who wore masks. Things have gotten so heated, the Department of Homeland Security issued a National Terrorism Advisory System bulletin last week. It warns that extremists could use new COVID-driven public health restrictions as an excuse to commit domestic terrorism.

Anger goes in the opposite direction, too, with people who’ve been following recommended procedures becoming increasingly fed up with those who flout them. Those intense emotions may not lead to violence, but they do make it harder for us to feel secure.

“It’s a public health crisis, and it’s turned into something different. When we get into us/them situations, we start to lose empathy. Empathy is important to identify solutions and work together as a community,” says Dr. Wright. “That’s what sparks the anger: the sense of ‘You aren’t doing what you’re supposed to be doing.’”
 

How to cope

Loneliness, anxiety, and anger may be swirling all around you right now. But that doesn’t make you powerless to boost your mental health. These suggestions may help:

• Trust your gut. If your community is reopening faster than feels comfortable to you, do whatever makes your family feel safe. “Ask yourself how you’re feeling, and use your feelings to guide your decisions,” says Dr. Pender. “Get more information, then follow the science.”
• Stop judging yourself. If you’re feeling lonely or mourning the losses COVID has brought, don’t fight it, says Wright. “Let it be an emotion that comes and goes, and try to find ways to feel connected to other people.”
• Practice self-care. It may sound simplistic, but eating healthy foods, exercising, and getting a good night’s sleep can all contribute to a more positive 
• Try to ease anxiety. Meditation, calming self-talk, and soothing music can all lift your spirits. Or try diaphragmatic breathing: Breathe in for 5 seconds, hold for 2, and breathe out for 5. Even squeezing a stress ball can give you a tangible sense of 
• Take action. Both Rabbi Goldenberg and Ms. Collazo, who runs a nonprofit that works to reunite immigrant families, say helping their community helps them feel better. “To sing and lead Shabbat services, even on Zoom, to see the faces of my people, it’s very healing,” says Rabbi Goldenberg. One small thing you can do: If you have family or friends who are hesitant about vaccination, Dr. Wright suggests having gentle conversations to convince them. “You can be way more influential than a celebrity,” she says.
• Remember you’re not alone. Whether you’re physically isolated from others or just feel like nobody else is following the same protocols as you, there are ways to feel connected. “Reach out to people you’ve been close with in the past, but you may have lost touch,” says Dr. King. “It gives you an opportunity to rekindle joy. Particularly in this moment, when a lot of people are so afraid, it’s easier to reach out to those you already know than try to meet new people.” Dr. King’s research has found it takes as few as two close connections to make people feel supported.
• Stay in the present. Instead of stressing over what’s already happened or worrying about what might still come, just think about today. “We’ve learned a lot about the coronavirus, and we’re still learning more,” says Dr. Wright. “We don’t know what the future looks like, but it won’t be like this forever.”

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

Thanks to the rollout of the COVID-19 vaccines, more than just flowers were blooming this past spring. People came out of lockdown like bears emerging from hibernation, making plans to reunite with friends and loved ones they hadn’t seen in months. But with the tremendous surge in cases brought by the Delta variant, this summer has been anything but sunny and carefree. Case counts have once more reached prevaccination levels. In a repeat of last summer, people are canceling travel plans, and the lead-up to the new school year has become fraught and stressful.

“This whiplash is causing people to feel a variety of emotions: disappointment, uncertainty, anxiety, possibly anger and frustration,” says Vaile Wright, Ph.D., senior director of health care innovation at the American Psychological Association. “When it seemed like there was a light at the end of the tunnel, and we have the tools to overcome [the virus], and we’re not really using them, it can be hard for people to understand.”
 

The importance of hope

For decades, researchers have been digging into the crucial role hopefulness plays in mental health. The vaccine rollout, earlier than anticipated, provided a much needed burst of hope after months of bad news.

“It was a feeling of almost euphoria in June: ‘We’re going to see everybody!’” says Rachel Goldenberg, a rabbi in Jackson Heights, NY. “We have a theme for our High Holidays, and this year’s is very hopeful: Sow in tears, reap in joy. It felt like the sowing in tears part was behind us, and we were looking forward to reaping in joy. Slowly but surely, with Delta, everything has turned upside down.”

For Roxanne Hawn, a writer in Golden, Colo., vaccination offered a glimpse of something like normal life.

“I wore cute clothes. I stopped and got takeout for lunch. I bought myself flowers. I even had a little uplifting soundtrack for that time of hope and relief,” she says. “With the Delta variant, it feels like that window of normalcy closed quickly.”

Having that little bit of hope dashed can wear down even the sturdiest spirits, says Marissa King, PhD, author of “Social Chemistry: Decoding the Elements of Human Connection”.

“There was a moment when we were able to reconnect, to experience joy and the hope of being able to revitalize relationships,” she says. “The loss of that hope and the fear of being isolated again is causing so much distress.”
 

A new kind of loneliness

When the pandemic started, mom of three Julie Schwietert Collazo formed a WhatsApp group with several friends who were taking lockdown seriously. They got each other through months of isolation and celebrated the idea of reopening. Then Ms. Collazo’s oldest got COVID, just 5 weeks before her 12th birthday, and their family went back into quarantine. Her moms’ group is no longer on the same page about precautions.

“Last year we were doing it together, and it made it feel a bit easier,” she says. “As things started to normalize, everybody started thinking and moving in different directions. It feels like we’re not working through the same issues collectively like before.”

Dr. King says the feeling Ms. Collazo describes is quite common these days.

“A profound sense of loneliness comes from feeling like you’re the only one,” she says. “There’s such disagreement about the best path forward, it can feel lonely just because you think differently.”
 

An epidemic of anxiety

As the Delta variant drives case numbers back up again, worries increase as well.

“Is this ever going to end?” asks Ms. Collazo. “Is this our new reality, constantly having to order our lives around COVID?”

This uneasiness affects our well-being.

The National Center for Health Statistics and the Census Bureau have monitored the nation’s mental health via the ongoing Household Pulse Survey during the pandemic. It asks participants about their symptoms of either anxiety or depression. Throughout, more people have reported feeling anxious than depressed.

Anxiety peaked around Thanksgiving and Christmas, with nearly 38% of people reporting symptoms. The first vaccines began to roll out around that time, and anxiety levels steadily went down through the spring and early summer, dipping below 25% in late June. But those numbers have begun to creep back up – the most recent data, which goes through Aug. 2, found 27% of Americans reporting symptoms of anxiety.

“Nervous is the new normal,” says Vivian Pender, MD, president of the American Psychiatric Association. “Uncertainty makes people feel anxious.”
 

Empathy vs. anger

The way politics play into basic measures like mask-wearing and vaccination adds its own layer of stress. Physical altercations have resulted: In Los Angeles, a participant was stabbed at an antivaccination protest. At an Austin, Tex., elementary school, angry parents physically and verbally assaulted teachers who wore masks. Things have gotten so heated, the Department of Homeland Security issued a National Terrorism Advisory System bulletin last week. It warns that extremists could use new COVID-driven public health restrictions as an excuse to commit domestic terrorism.

Anger goes in the opposite direction, too, with people who’ve been following recommended procedures becoming increasingly fed up with those who flout them. Those intense emotions may not lead to violence, but they do make it harder for us to feel secure.

“It’s a public health crisis, and it’s turned into something different. When we get into us/them situations, we start to lose empathy. Empathy is important to identify solutions and work together as a community,” says Dr. Wright. “That’s what sparks the anger: the sense of ‘You aren’t doing what you’re supposed to be doing.’”
 

How to cope

Loneliness, anxiety, and anger may be swirling all around you right now. But that doesn’t make you powerless to boost your mental health. These suggestions may help:

• Trust your gut. If your community is reopening faster than feels comfortable to you, do whatever makes your family feel safe. “Ask yourself how you’re feeling, and use your feelings to guide your decisions,” says Dr. Pender. “Get more information, then follow the science.”
• Stop judging yourself. If you’re feeling lonely or mourning the losses COVID has brought, don’t fight it, says Wright. “Let it be an emotion that comes and goes, and try to find ways to feel connected to other people.”
• Practice self-care. It may sound simplistic, but eating healthy foods, exercising, and getting a good night’s sleep can all contribute to a more positive 
• Try to ease anxiety. Meditation, calming self-talk, and soothing music can all lift your spirits. Or try diaphragmatic breathing: Breathe in for 5 seconds, hold for 2, and breathe out for 5. Even squeezing a stress ball can give you a tangible sense of 
• Take action. Both Rabbi Goldenberg and Ms. Collazo, who runs a nonprofit that works to reunite immigrant families, say helping their community helps them feel better. “To sing and lead Shabbat services, even on Zoom, to see the faces of my people, it’s very healing,” says Rabbi Goldenberg. One small thing you can do: If you have family or friends who are hesitant about vaccination, Dr. Wright suggests having gentle conversations to convince them. “You can be way more influential than a celebrity,” she says.
• Remember you’re not alone. Whether you’re physically isolated from others or just feel like nobody else is following the same protocols as you, there are ways to feel connected. “Reach out to people you’ve been close with in the past, but you may have lost touch,” says Dr. King. “It gives you an opportunity to rekindle joy. Particularly in this moment, when a lot of people are so afraid, it’s easier to reach out to those you already know than try to meet new people.” Dr. King’s research has found it takes as few as two close connections to make people feel supported.
• Stay in the present. Instead of stressing over what’s already happened or worrying about what might still come, just think about today. “We’ve learned a lot about the coronavirus, and we’re still learning more,” says Dr. Wright. “We don’t know what the future looks like, but it won’t be like this forever.”

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

The Centers for Disease Control and Prevention is setting up a new hub to watch for early warning signs of future infectious outbreaks, the agency announced on Aug. 18.

Epidemiologists learn about emerging outbreaks by tracking information, and the quality of their analysis depends on their access to high-quality data. Gaps in existing systems became obvious during the COVID-19 pandemic as experts were challenged by the crisis.

The new Center for Forecasting and Outbreak Analytics will, in part, work like a meteorological office that tracks weather-related changes, only the center will track possible flareups in infectious disease.

The day after he took office, President Joe Biden pledged to modernize the country’s system for public health data. First funding for the initiative will come from the American Rescue Plan.

“We are excited to have the expertise and ability to model and forecast public health concerns and share information in real-time to activate governmental, private sector, and public actions in anticipation of threats both domestically and abroad,” CDC Director Rochelle Walensky, MD, said in a statement.
 

Devastating toll of COVID-19

Many world leaders are now responding to the destruction of the health crisis and are investing in new infrastructure. A July report from a G-20 panel calls for $75 billion in international financing for pandemic prevention and preparedness –twice as much as current spending levels.

Testifying in a congressional hearing, epidemiologist Caitlin Rivers, PhD, from the Johns Hopkins Center for Health Security, Baltimore, voiced the importance of never being caught unprepared again.

“We were unprepared to manage the emergence and swift global spread of the novel coronavirus, and we were late to recognize when it reached our shores. Those delays set us on a worse trajectory than we might have otherwise faced,” she said.

Dr. Rivers will join the new center’s leadership team as associate director working alongside Marc Lipsitch, PhD, director for science.

“The new center will meet a longstanding need for a national focal point to analyze data and forecast the trajectory of pandemics with the express goal of informing and improving decisions with the best available evidence,” Dr. Lipsitch said in the CDC’s news release announcing the new center.

Experts will map what data sources are needed to assist disease modelers and public health emergency responders tracking emerging problems that they can share with decision-makers. They will expand tracking capability and data sharing using open-source software and application programming with existing and new data streams from the public health ecosystem and elsewhere.

Dylan George, PhD, who will be the center’s director for operations, said in the CDC news release that the center will provide critical information to communities so they can respond.

“Pandemics threaten our families and communities at speed and scale – our response needs to move at speed and scale, too,” he said.

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

The Centers for Disease Control and Prevention is setting up a new hub to watch for early warning signs of future infectious outbreaks, the agency announced on Aug. 18.

Epidemiologists learn about emerging outbreaks by tracking information, and the quality of their analysis depends on their access to high-quality data. Gaps in existing systems became obvious during the COVID-19 pandemic as experts were challenged by the crisis.

The new Center for Forecasting and Outbreak Analytics will, in part, work like a meteorological office that tracks weather-related changes, only the center will track possible flareups in infectious disease.

The day after he took office, President Joe Biden pledged to modernize the country’s system for public health data. First funding for the initiative will come from the American Rescue Plan.

“We are excited to have the expertise and ability to model and forecast public health concerns and share information in real-time to activate governmental, private sector, and public actions in anticipation of threats both domestically and abroad,” CDC Director Rochelle Walensky, MD, said in a statement.
 

Devastating toll of COVID-19

Many world leaders are now responding to the destruction of the health crisis and are investing in new infrastructure. A July report from a G-20 panel calls for $75 billion in international financing for pandemic prevention and preparedness –twice as much as current spending levels.

Testifying in a congressional hearing, epidemiologist Caitlin Rivers, PhD, from the Johns Hopkins Center for Health Security, Baltimore, voiced the importance of never being caught unprepared again.

“We were unprepared to manage the emergence and swift global spread of the novel coronavirus, and we were late to recognize when it reached our shores. Those delays set us on a worse trajectory than we might have otherwise faced,” she said.

Dr. Rivers will join the new center’s leadership team as associate director working alongside Marc Lipsitch, PhD, director for science.

“The new center will meet a longstanding need for a national focal point to analyze data and forecast the trajectory of pandemics with the express goal of informing and improving decisions with the best available evidence,” Dr. Lipsitch said in the CDC’s news release announcing the new center.

Experts will map what data sources are needed to assist disease modelers and public health emergency responders tracking emerging problems that they can share with decision-makers. They will expand tracking capability and data sharing using open-source software and application programming with existing and new data streams from the public health ecosystem and elsewhere.

Dylan George, PhD, who will be the center’s director for operations, said in the CDC news release that the center will provide critical information to communities so they can respond.

“Pandemics threaten our families and communities at speed and scale – our response needs to move at speed and scale, too,” he said.

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

The Centers for Disease Control and Prevention is setting up a new hub to watch for early warning signs of future infectious outbreaks, the agency announced on Aug. 18.

Epidemiologists learn about emerging outbreaks by tracking information, and the quality of their analysis depends on their access to high-quality data. Gaps in existing systems became obvious during the COVID-19 pandemic as experts were challenged by the crisis.

The new Center for Forecasting and Outbreak Analytics will, in part, work like a meteorological office that tracks weather-related changes, only the center will track possible flareups in infectious disease.

The day after he took office, President Joe Biden pledged to modernize the country’s system for public health data. First funding for the initiative will come from the American Rescue Plan.

“We are excited to have the expertise and ability to model and forecast public health concerns and share information in real-time to activate governmental, private sector, and public actions in anticipation of threats both domestically and abroad,” CDC Director Rochelle Walensky, MD, said in a statement.
 

Devastating toll of COVID-19

Many world leaders are now responding to the destruction of the health crisis and are investing in new infrastructure. A July report from a G-20 panel calls for $75 billion in international financing for pandemic prevention and preparedness –twice as much as current spending levels.

Testifying in a congressional hearing, epidemiologist Caitlin Rivers, PhD, from the Johns Hopkins Center for Health Security, Baltimore, voiced the importance of never being caught unprepared again.

“We were unprepared to manage the emergence and swift global spread of the novel coronavirus, and we were late to recognize when it reached our shores. Those delays set us on a worse trajectory than we might have otherwise faced,” she said.

Dr. Rivers will join the new center’s leadership team as associate director working alongside Marc Lipsitch, PhD, director for science.

“The new center will meet a longstanding need for a national focal point to analyze data and forecast the trajectory of pandemics with the express goal of informing and improving decisions with the best available evidence,” Dr. Lipsitch said in the CDC’s news release announcing the new center.

Experts will map what data sources are needed to assist disease modelers and public health emergency responders tracking emerging problems that they can share with decision-makers. They will expand tracking capability and data sharing using open-source software and application programming with existing and new data streams from the public health ecosystem and elsewhere.

Dylan George, PhD, who will be the center’s director for operations, said in the CDC news release that the center will provide critical information to communities so they can respond.

“Pandemics threaten our families and communities at speed and scale – our response needs to move at speed and scale, too,” he said.

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

One essential back-to-school item for children this fall is a face mask – the Centers for Disease Control and Prevention and the American Academy of Pediatrics both recommend them – but finding one that’s actually protective for a child is not a straightforward task, as many parents can attest. 

There’s little in the way of official guidance or research to inform evidence-based recommendations on what type of face masks works best for children. 

Search for children’s face masks on Amazon and you’ll run into a smorgasbord of options: masks with three, four, or five layers, different designs, and different materials. There’s one company selling a mask it calls an m95 model, a term the company devised. 

It’s almost impossible to verify many of the claims being made by the manufacturers, or to know if they will fit your child’s face until you order some, which can get expensive.

But it’s worth looking for a good mask.  A large study of more than 1 million people being conducted online by Facebook and Carnegie Mellon University found that students who wore face masks in school had a reduced risk for testing positive for the virus and getting sick with COVID-19 symptoms. The study was published in June in the journal Science.
 

Delta more contagious

The Delta variant of the new coronavirus is much more contagious than previous versions of the virus. Studies have shown that infected people carry 1,000 times more virus in their noses and throats than with the viruses that circulated last winter and spring. They shed more viral particles into the air when they talk or yell or sing, making this COVID-19–causing virus much more transmissible than in the past.

What that means, says Kimberly Prather, PhD, an aerosol scientist and distinguished professor at the Scripps Institution of Oceanography in La Jolla, California, is that if it once took about 15 minutes of proximity to an infected person to catch the infection, that window of risk is now much shorter.

“If you believe the 15-minute magical number, now if you take 1,000 times the viral load, basically in 1 second you could inhale that same amount of virus. So it’s gone from 15 minutes to 1 second,” Dr. Prather said in an online seminar on school safety she helped to organize. 
 

A better mask

What that means is that we need to upgrade our face masks, switching away from ill-fitting fabric masks, which can offer varying degrees of protection depending on the number of layers and type of fabric that’s used, to more highly protective surgical masks or better yet, N95 respirators, which provide the highest level of filtration.

That’s harder to do for children, who have much smaller faces.

Any masks that gapes around the edges isn’t going to work well, no matter how well it filters.

“N95s are not made to fit kids. They do not come in kid sizes, so I do not recommend N95s for kids,” said Linsey Marr, an environmental engineer at Virginia Tech, who tests face masks in her lab.

Ms. Marr says parents need to consider the attributes masks in this order of priority: 

Comfort: “If your kid won’t wear it, it’s not helping at all,” she said.

Fit: “Leaks around the sides are like having a hole in your mask and aerosols carrying the virus can get right through,” Ms. Marr said.

Filtration: How well the mask blocks small particles.

One option to improve fit is to layer a fabric mask over a surgical mask. The fabric mask helps to hold the edges of the surgical mask more tightly to a person’s face.  The surgical mask creates better filtration.

Ms. Marr said KN94 or KN95 masks, which are being manufactured in China and Korea, are good choices. They offer nearly the same degree of filtration as an N95, and they fit closely to the face, to minimize leaks.
 

Check for counterfeits

The KN94 and KN95 masks for children are widely available, but Ms. Marr said parents do need to watch out for counterfeits, which don’t perform as well.

The National Institute for Occupational Safety and Health gives examples of counterfeit products here.

There’s also a type of cloth mask that has a built-in, edge-to-edge filter layer that is made for children.

“Some of these filter out more than 99% of particles and those can be very effective, if they fit well,” Ms. Marr said.

She has compiled and publicly posted a list of her recommendations for masks for children.

There’s also a new standard for face masks. It’s called ASTM F3502-21, and it’s published by an international organization that sets voluntary standards for thousands of products. To claim that a mask meets this standard, a manufacturer has to have its mask tested and demonstrate that it provides a certain level of filtration and breathability.

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

One essential back-to-school item for children this fall is a face mask – the Centers for Disease Control and Prevention and the American Academy of Pediatrics both recommend them – but finding one that’s actually protective for a child is not a straightforward task, as many parents can attest. 

There’s little in the way of official guidance or research to inform evidence-based recommendations on what type of face masks works best for children. 

Search for children’s face masks on Amazon and you’ll run into a smorgasbord of options: masks with three, four, or five layers, different designs, and different materials. There’s one company selling a mask it calls an m95 model, a term the company devised. 

It’s almost impossible to verify many of the claims being made by the manufacturers, or to know if they will fit your child’s face until you order some, which can get expensive.

But it’s worth looking for a good mask.  A large study of more than 1 million people being conducted online by Facebook and Carnegie Mellon University found that students who wore face masks in school had a reduced risk for testing positive for the virus and getting sick with COVID-19 symptoms. The study was published in June in the journal Science.
 

Delta more contagious

The Delta variant of the new coronavirus is much more contagious than previous versions of the virus. Studies have shown that infected people carry 1,000 times more virus in their noses and throats than with the viruses that circulated last winter and spring. They shed more viral particles into the air when they talk or yell or sing, making this COVID-19–causing virus much more transmissible than in the past.

What that means, says Kimberly Prather, PhD, an aerosol scientist and distinguished professor at the Scripps Institution of Oceanography in La Jolla, California, is that if it once took about 15 minutes of proximity to an infected person to catch the infection, that window of risk is now much shorter.

“If you believe the 15-minute magical number, now if you take 1,000 times the viral load, basically in 1 second you could inhale that same amount of virus. So it’s gone from 15 minutes to 1 second,” Dr. Prather said in an online seminar on school safety she helped to organize. 
 

A better mask

What that means is that we need to upgrade our face masks, switching away from ill-fitting fabric masks, which can offer varying degrees of protection depending on the number of layers and type of fabric that’s used, to more highly protective surgical masks or better yet, N95 respirators, which provide the highest level of filtration.

That’s harder to do for children, who have much smaller faces.

Any masks that gapes around the edges isn’t going to work well, no matter how well it filters.

“N95s are not made to fit kids. They do not come in kid sizes, so I do not recommend N95s for kids,” said Linsey Marr, an environmental engineer at Virginia Tech, who tests face masks in her lab.

Ms. Marr says parents need to consider the attributes masks in this order of priority: 

Comfort: “If your kid won’t wear it, it’s not helping at all,” she said.

Fit: “Leaks around the sides are like having a hole in your mask and aerosols carrying the virus can get right through,” Ms. Marr said.

Filtration: How well the mask blocks small particles.

One option to improve fit is to layer a fabric mask over a surgical mask. The fabric mask helps to hold the edges of the surgical mask more tightly to a person’s face.  The surgical mask creates better filtration.

Ms. Marr said KN94 or KN95 masks, which are being manufactured in China and Korea, are good choices. They offer nearly the same degree of filtration as an N95, and they fit closely to the face, to minimize leaks.
 

Check for counterfeits

The KN94 and KN95 masks for children are widely available, but Ms. Marr said parents do need to watch out for counterfeits, which don’t perform as well.

The National Institute for Occupational Safety and Health gives examples of counterfeit products here.

There’s also a type of cloth mask that has a built-in, edge-to-edge filter layer that is made for children.

“Some of these filter out more than 99% of particles and those can be very effective, if they fit well,” Ms. Marr said.

She has compiled and publicly posted a list of her recommendations for masks for children.

There’s also a new standard for face masks. It’s called ASTM F3502-21, and it’s published by an international organization that sets voluntary standards for thousands of products. To claim that a mask meets this standard, a manufacturer has to have its mask tested and demonstrate that it provides a certain level of filtration and breathability.

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

One essential back-to-school item for children this fall is a face mask – the Centers for Disease Control and Prevention and the American Academy of Pediatrics both recommend them – but finding one that’s actually protective for a child is not a straightforward task, as many parents can attest. 

There’s little in the way of official guidance or research to inform evidence-based recommendations on what type of face masks works best for children. 

Search for children’s face masks on Amazon and you’ll run into a smorgasbord of options: masks with three, four, or five layers, different designs, and different materials. There’s one company selling a mask it calls an m95 model, a term the company devised. 

It’s almost impossible to verify many of the claims being made by the manufacturers, or to know if they will fit your child’s face until you order some, which can get expensive.

But it’s worth looking for a good mask.  A large study of more than 1 million people being conducted online by Facebook and Carnegie Mellon University found that students who wore face masks in school had a reduced risk for testing positive for the virus and getting sick with COVID-19 symptoms. The study was published in June in the journal Science.
 

Delta more contagious

The Delta variant of the new coronavirus is much more contagious than previous versions of the virus. Studies have shown that infected people carry 1,000 times more virus in their noses and throats than with the viruses that circulated last winter and spring. They shed more viral particles into the air when they talk or yell or sing, making this COVID-19–causing virus much more transmissible than in the past.

What that means, says Kimberly Prather, PhD, an aerosol scientist and distinguished professor at the Scripps Institution of Oceanography in La Jolla, California, is that if it once took about 15 minutes of proximity to an infected person to catch the infection, that window of risk is now much shorter.

“If you believe the 15-minute magical number, now if you take 1,000 times the viral load, basically in 1 second you could inhale that same amount of virus. So it’s gone from 15 minutes to 1 second,” Dr. Prather said in an online seminar on school safety she helped to organize. 
 

A better mask

What that means is that we need to upgrade our face masks, switching away from ill-fitting fabric masks, which can offer varying degrees of protection depending on the number of layers and type of fabric that’s used, to more highly protective surgical masks or better yet, N95 respirators, which provide the highest level of filtration.

That’s harder to do for children, who have much smaller faces.

Any masks that gapes around the edges isn’t going to work well, no matter how well it filters.

“N95s are not made to fit kids. They do not come in kid sizes, so I do not recommend N95s for kids,” said Linsey Marr, an environmental engineer at Virginia Tech, who tests face masks in her lab.

Ms. Marr says parents need to consider the attributes masks in this order of priority: 

Comfort: “If your kid won’t wear it, it’s not helping at all,” she said.

Fit: “Leaks around the sides are like having a hole in your mask and aerosols carrying the virus can get right through,” Ms. Marr said.

Filtration: How well the mask blocks small particles.

One option to improve fit is to layer a fabric mask over a surgical mask. The fabric mask helps to hold the edges of the surgical mask more tightly to a person’s face.  The surgical mask creates better filtration.

Ms. Marr said KN94 or KN95 masks, which are being manufactured in China and Korea, are good choices. They offer nearly the same degree of filtration as an N95, and they fit closely to the face, to minimize leaks.
 

Check for counterfeits

The KN94 and KN95 masks for children are widely available, but Ms. Marr said parents do need to watch out for counterfeits, which don’t perform as well.

The National Institute for Occupational Safety and Health gives examples of counterfeit products here.

There’s also a type of cloth mask that has a built-in, edge-to-edge filter layer that is made for children.

“Some of these filter out more than 99% of particles and those can be very effective, if they fit well,” Ms. Marr said.

She has compiled and publicly posted a list of her recommendations for masks for children.

There’s also a new standard for face masks. It’s called ASTM F3502-21, and it’s published by an international organization that sets voluntary standards for thousands of products. To claim that a mask meets this standard, a manufacturer has to have its mask tested and demonstrate that it provides a certain level of filtration and breathability.

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

The use fluoroquinolones or macrolides reduced immunogenicity risk in inflammatory bowel disease (IBD) patients on anti–tumor necrosis factor (anti-TNF) therapy, according to data from nearly 2,000 individuals.

luchschen/Thinkstock

Anti-TNF therapy with monoclonal antibodies is an established treatment for Crohn’s disease and ulcerative colitis, but approximately 40% of patients fail to respond initially and even more fail to achieve complete remission, wrote Yuri Gorelik, MD, of Rambam Health Care Campus, Haifa, Israel, and colleagues.

“Immunogenicity, which refers to the development of antidrug antibodies [ADA] is considered as the main factor driving secondary loss of response and is likely involved in primary nonresponse as well,” but data on how to predict the risk for ADA formation are limited, they said.

In a study published in Gut, the researchers identified data from 1,946 IBD patients using the epi-IIRN (epidemiology group of the Israeli IBD research nucleus), a nationwide registry of all IBD patients in Israel.

A total of 363 patients had positive ADA after a median follow-up period of 651 days after starting therapy. Overall, the risk of ADA development was significantly higher in patients on cephalosporins (adjusted hazard ratio, 1.97; 95% confidence interval, 1.58-2.44) or penicillin with beta-lactamase inhibitors (BLIs) (aHR, 1.38; 95% CI, 1.13-1.74) during anti-TNF therapy, and it was higher still for patients using both. By contrast, the risk was lower in patients on macrolides (aHR, 0.36; 95% CI, 0.16-0.82) or fluoroquinolones (aHR, 0.20; 95% CI; 95% CI, 0.12-0.35). All P values were less than .05 when compared with nontreated groups.

In the same study, the researchers reported data on mice treated with antibiotics and challenged with infliximab to evaluate the causative effect of antibiotics and the associated disruption to the gut microbiome on the formation of ADA. After 14 days, the researchers found significantly increased ADA production in mice treated with cephalosporins, compared with those treated with macrolides, but germ-free mice produced no ADA, which supports the role of microbial composition on ADA production.

The investigators cited previous research into the microbiome as a biomarker for prediction response to anti-TNF therapy; past results have also suggested that the effect of cephalosporins and penicillin-BLIs could be explained by the particular dysbiosis induced by those agents.

The study findings were limited by several factors including the retrospective design and potential for selection bias, as well as the inability to adjust antibiotic exposure according to type and severity of infection, they noted. However, “this is the first large scale study that extensively evaluated the effect of different antibiotic classes on immunogenicity of anti-TNF therapy,” and the results suggest that ADA development during anti-TNF therapy may to reduced by the use of fluoroquinolones and macrolides.

“Specific microbial manipulation may serve as a tool to modify immunogenicity which is preferably turned on for protective immunizations and off for biological therapy,” they noted. “Further studies involving detailed analysis of the antibiotic effects on the human microbiome and immune milieu are needed, as well as comparative experiments with other medications used to reduce immunogenicity.”
 

Unexpected findings may drive future drug choices

“Development of antidrug antibodies in patients on biologics for inflammatory bowel disease is an important mechanism for loss of response to a therapeutic agent,” Kim L. Isaacs, MD, AGAF, of the University of North Carolina at Chapel Hill, said in an interview. “To date the causes of development of ADAs is relatively understudied. Our approach to prevent ADA includes increasing immunosuppression in patients most commonly with combination therapy with thiopurines. If factors that provoke or prevent antibody formation are elucidated, therapy can be tailored to prevent ADAs and maximize the duration of response of many of our biologic therapies.”

A prior study performed by the ABIRISK European consortium demonstrated associations with antibiotics. “In the current study, there was a differential effect of cephalosporins/penicillins (increased immunogenicity) and macrolides (decreased immunogenicity),” she said. “These studies suggest that the microbiome may be important in ADA formation to biologics – this is a concept that is novel and unexpected.

“The rationale for the choice of antibiotics in the population studied is not known, and it is possible that different infections may have led to different antibiotic choices, which in turn may have affected immunogenicity,” said Dr. Isaacs. However, clinicians might be able to tailor antibiotic choice in the future if the microbiome is playing a major role in risk for development of ADA.

“Further research is needed to further correlate microbiome changes with immunogenicity, to look at other classes of antibiotics and their role in immunogenicity, and to clarify the infections or reasons that these patients are receiving antibiotics,” Dr. Isaacs concluded.
 

Understanding the microbiome

Recent observations have shown associations between clinical response to anti-TNF and gut microbiota composition, noted Jatin Roper, MD, of Duke University, Durham, N.C. “More broadly, a growing body of evidence suggests that the gut microbiota modulates the metabolism of many therapeutic agents, as well as immune responses to infections.”

That said, Dr. Roper was surprised that “clinical use of different antibiotics, often short term, had such distinct effects on ADA levels.” Furthermore, “these findings suggest that distinct microbiota or microbial metabolic products impact antibody development to common immunomodulatory therapies in opposite ways,” which is itself a surprising finding.

Such antibodies to anti-TNF therapy are common in IBD, he said, but one implication of the study is how antibiotics could be carefully used “to reduce risk of ADAs and enhance efficacy of anti-TNF therapy.”

However, because any antibiotic therapy will modify the gut microbiome and lead to unwanted effects, “further research is needed on how these agents impact the gut microbiome, with the ultimate goal of identifying specific microbiota or microbial metabolic products that can reproduce the intriguing findings of this paper.”

The study was supported in part by the Leona M. and Harry B. Helmsley Charitable Trust and the Israeli Ministry of Science and Technology. Dr. Gorelik had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple pharmaceutical companies including AbbVie, CytoReason, Takeda, and Pfizer. Dr. Isaacs had no financial conflicts to disclose, but serves on the GI&Hepatology News board of editors. Dr. Roper had no relevant disclosures.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

The use fluoroquinolones or macrolides reduced immunogenicity risk in inflammatory bowel disease (IBD) patients on anti–tumor necrosis factor (anti-TNF) therapy, according to data from nearly 2,000 individuals.

luchschen/Thinkstock

Anti-TNF therapy with monoclonal antibodies is an established treatment for Crohn’s disease and ulcerative colitis, but approximately 40% of patients fail to respond initially and even more fail to achieve complete remission, wrote Yuri Gorelik, MD, of Rambam Health Care Campus, Haifa, Israel, and colleagues.

“Immunogenicity, which refers to the development of antidrug antibodies [ADA] is considered as the main factor driving secondary loss of response and is likely involved in primary nonresponse as well,” but data on how to predict the risk for ADA formation are limited, they said.

In a study published in Gut, the researchers identified data from 1,946 IBD patients using the epi-IIRN (epidemiology group of the Israeli IBD research nucleus), a nationwide registry of all IBD patients in Israel.

A total of 363 patients had positive ADA after a median follow-up period of 651 days after starting therapy. Overall, the risk of ADA development was significantly higher in patients on cephalosporins (adjusted hazard ratio, 1.97; 95% confidence interval, 1.58-2.44) or penicillin with beta-lactamase inhibitors (BLIs) (aHR, 1.38; 95% CI, 1.13-1.74) during anti-TNF therapy, and it was higher still for patients using both. By contrast, the risk was lower in patients on macrolides (aHR, 0.36; 95% CI, 0.16-0.82) or fluoroquinolones (aHR, 0.20; 95% CI; 95% CI, 0.12-0.35). All P values were less than .05 when compared with nontreated groups.

In the same study, the researchers reported data on mice treated with antibiotics and challenged with infliximab to evaluate the causative effect of antibiotics and the associated disruption to the gut microbiome on the formation of ADA. After 14 days, the researchers found significantly increased ADA production in mice treated with cephalosporins, compared with those treated with macrolides, but germ-free mice produced no ADA, which supports the role of microbial composition on ADA production.

The investigators cited previous research into the microbiome as a biomarker for prediction response to anti-TNF therapy; past results have also suggested that the effect of cephalosporins and penicillin-BLIs could be explained by the particular dysbiosis induced by those agents.

The study findings were limited by several factors including the retrospective design and potential for selection bias, as well as the inability to adjust antibiotic exposure according to type and severity of infection, they noted. However, “this is the first large scale study that extensively evaluated the effect of different antibiotic classes on immunogenicity of anti-TNF therapy,” and the results suggest that ADA development during anti-TNF therapy may to reduced by the use of fluoroquinolones and macrolides.

“Specific microbial manipulation may serve as a tool to modify immunogenicity which is preferably turned on for protective immunizations and off for biological therapy,” they noted. “Further studies involving detailed analysis of the antibiotic effects on the human microbiome and immune milieu are needed, as well as comparative experiments with other medications used to reduce immunogenicity.”
 

Unexpected findings may drive future drug choices

“Development of antidrug antibodies in patients on biologics for inflammatory bowel disease is an important mechanism for loss of response to a therapeutic agent,” Kim L. Isaacs, MD, AGAF, of the University of North Carolina at Chapel Hill, said in an interview. “To date the causes of development of ADAs is relatively understudied. Our approach to prevent ADA includes increasing immunosuppression in patients most commonly with combination therapy with thiopurines. If factors that provoke or prevent antibody formation are elucidated, therapy can be tailored to prevent ADAs and maximize the duration of response of many of our biologic therapies.”

A prior study performed by the ABIRISK European consortium demonstrated associations with antibiotics. “In the current study, there was a differential effect of cephalosporins/penicillins (increased immunogenicity) and macrolides (decreased immunogenicity),” she said. “These studies suggest that the microbiome may be important in ADA formation to biologics – this is a concept that is novel and unexpected.

“The rationale for the choice of antibiotics in the population studied is not known, and it is possible that different infections may have led to different antibiotic choices, which in turn may have affected immunogenicity,” said Dr. Isaacs. However, clinicians might be able to tailor antibiotic choice in the future if the microbiome is playing a major role in risk for development of ADA.

“Further research is needed to further correlate microbiome changes with immunogenicity, to look at other classes of antibiotics and their role in immunogenicity, and to clarify the infections or reasons that these patients are receiving antibiotics,” Dr. Isaacs concluded.
 

Understanding the microbiome

Recent observations have shown associations between clinical response to anti-TNF and gut microbiota composition, noted Jatin Roper, MD, of Duke University, Durham, N.C. “More broadly, a growing body of evidence suggests that the gut microbiota modulates the metabolism of many therapeutic agents, as well as immune responses to infections.”

That said, Dr. Roper was surprised that “clinical use of different antibiotics, often short term, had such distinct effects on ADA levels.” Furthermore, “these findings suggest that distinct microbiota or microbial metabolic products impact antibody development to common immunomodulatory therapies in opposite ways,” which is itself a surprising finding.

Such antibodies to anti-TNF therapy are common in IBD, he said, but one implication of the study is how antibiotics could be carefully used “to reduce risk of ADAs and enhance efficacy of anti-TNF therapy.”

However, because any antibiotic therapy will modify the gut microbiome and lead to unwanted effects, “further research is needed on how these agents impact the gut microbiome, with the ultimate goal of identifying specific microbiota or microbial metabolic products that can reproduce the intriguing findings of this paper.”

The study was supported in part by the Leona M. and Harry B. Helmsley Charitable Trust and the Israeli Ministry of Science and Technology. Dr. Gorelik had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple pharmaceutical companies including AbbVie, CytoReason, Takeda, and Pfizer. Dr. Isaacs had no financial conflicts to disclose, but serves on the GI&Hepatology News board of editors. Dr. Roper had no relevant disclosures.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

The use fluoroquinolones or macrolides reduced immunogenicity risk in inflammatory bowel disease (IBD) patients on anti–tumor necrosis factor (anti-TNF) therapy, according to data from nearly 2,000 individuals.

luchschen/Thinkstock

Anti-TNF therapy with monoclonal antibodies is an established treatment for Crohn’s disease and ulcerative colitis, but approximately 40% of patients fail to respond initially and even more fail to achieve complete remission, wrote Yuri Gorelik, MD, of Rambam Health Care Campus, Haifa, Israel, and colleagues.

“Immunogenicity, which refers to the development of antidrug antibodies [ADA] is considered as the main factor driving secondary loss of response and is likely involved in primary nonresponse as well,” but data on how to predict the risk for ADA formation are limited, they said.

In a study published in Gut, the researchers identified data from 1,946 IBD patients using the epi-IIRN (epidemiology group of the Israeli IBD research nucleus), a nationwide registry of all IBD patients in Israel.

A total of 363 patients had positive ADA after a median follow-up period of 651 days after starting therapy. Overall, the risk of ADA development was significantly higher in patients on cephalosporins (adjusted hazard ratio, 1.97; 95% confidence interval, 1.58-2.44) or penicillin with beta-lactamase inhibitors (BLIs) (aHR, 1.38; 95% CI, 1.13-1.74) during anti-TNF therapy, and it was higher still for patients using both. By contrast, the risk was lower in patients on macrolides (aHR, 0.36; 95% CI, 0.16-0.82) or fluoroquinolones (aHR, 0.20; 95% CI; 95% CI, 0.12-0.35). All P values were less than .05 when compared with nontreated groups.

In the same study, the researchers reported data on mice treated with antibiotics and challenged with infliximab to evaluate the causative effect of antibiotics and the associated disruption to the gut microbiome on the formation of ADA. After 14 days, the researchers found significantly increased ADA production in mice treated with cephalosporins, compared with those treated with macrolides, but germ-free mice produced no ADA, which supports the role of microbial composition on ADA production.

The investigators cited previous research into the microbiome as a biomarker for prediction response to anti-TNF therapy; past results have also suggested that the effect of cephalosporins and penicillin-BLIs could be explained by the particular dysbiosis induced by those agents.

The study findings were limited by several factors including the retrospective design and potential for selection bias, as well as the inability to adjust antibiotic exposure according to type and severity of infection, they noted. However, “this is the first large scale study that extensively evaluated the effect of different antibiotic classes on immunogenicity of anti-TNF therapy,” and the results suggest that ADA development during anti-TNF therapy may to reduced by the use of fluoroquinolones and macrolides.

“Specific microbial manipulation may serve as a tool to modify immunogenicity which is preferably turned on for protective immunizations and off for biological therapy,” they noted. “Further studies involving detailed analysis of the antibiotic effects on the human microbiome and immune milieu are needed, as well as comparative experiments with other medications used to reduce immunogenicity.”
 

Unexpected findings may drive future drug choices

“Development of antidrug antibodies in patients on biologics for inflammatory bowel disease is an important mechanism for loss of response to a therapeutic agent,” Kim L. Isaacs, MD, AGAF, of the University of North Carolina at Chapel Hill, said in an interview. “To date the causes of development of ADAs is relatively understudied. Our approach to prevent ADA includes increasing immunosuppression in patients most commonly with combination therapy with thiopurines. If factors that provoke or prevent antibody formation are elucidated, therapy can be tailored to prevent ADAs and maximize the duration of response of many of our biologic therapies.”

A prior study performed by the ABIRISK European consortium demonstrated associations with antibiotics. “In the current study, there was a differential effect of cephalosporins/penicillins (increased immunogenicity) and macrolides (decreased immunogenicity),” she said. “These studies suggest that the microbiome may be important in ADA formation to biologics – this is a concept that is novel and unexpected.

“The rationale for the choice of antibiotics in the population studied is not known, and it is possible that different infections may have led to different antibiotic choices, which in turn may have affected immunogenicity,” said Dr. Isaacs. However, clinicians might be able to tailor antibiotic choice in the future if the microbiome is playing a major role in risk for development of ADA.

“Further research is needed to further correlate microbiome changes with immunogenicity, to look at other classes of antibiotics and their role in immunogenicity, and to clarify the infections or reasons that these patients are receiving antibiotics,” Dr. Isaacs concluded.
 

Understanding the microbiome

Recent observations have shown associations between clinical response to anti-TNF and gut microbiota composition, noted Jatin Roper, MD, of Duke University, Durham, N.C. “More broadly, a growing body of evidence suggests that the gut microbiota modulates the metabolism of many therapeutic agents, as well as immune responses to infections.”

That said, Dr. Roper was surprised that “clinical use of different antibiotics, often short term, had such distinct effects on ADA levels.” Furthermore, “these findings suggest that distinct microbiota or microbial metabolic products impact antibody development to common immunomodulatory therapies in opposite ways,” which is itself a surprising finding.

Such antibodies to anti-TNF therapy are common in IBD, he said, but one implication of the study is how antibiotics could be carefully used “to reduce risk of ADAs and enhance efficacy of anti-TNF therapy.”

However, because any antibiotic therapy will modify the gut microbiome and lead to unwanted effects, “further research is needed on how these agents impact the gut microbiome, with the ultimate goal of identifying specific microbiota or microbial metabolic products that can reproduce the intriguing findings of this paper.”

The study was supported in part by the Leona M. and Harry B. Helmsley Charitable Trust and the Israeli Ministry of Science and Technology. Dr. Gorelik had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple pharmaceutical companies including AbbVie, CytoReason, Takeda, and Pfizer. Dr. Isaacs had no financial conflicts to disclose, but serves on the GI&Hepatology News board of editors. Dr. Roper had no relevant disclosures.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

In a real-life setting, fecal calprotectin (FC) home testing performed well at predicting disease endoscopic activity in patients with inflammatory bowel disease (IBD) being treated with adalimumab.

The study, published in the European Journal of Gastroenterology & Hepatology, could be a boon to patients and physicians employing the treat-to-target (T2T) strategy, which relies on disease monitoring through methods like endoscopy, histology, and serum and fecal biomarkers.

One goal of T2T is to identify patients who are asymptomatic in order to prevent or minimize flare-ups. Colonoscopy is the preferred approach for achieving this, but cost, risk, and patient reluctance limit its use. FC has gained attention in recent years, as it outperforms serum biomarkers in its correlation with clinical, endoscopic, and histological disease activity. Consecutive FC measurements predict disease relapse among asymptomatic patients with high specificity and sensitivity. There’s also evidence that it could be useful for perioperative monitoring.

FC is typically assessed in a lab, but the recent availability of smartphone-based tests has allowed patients to collect and test their stool at home. The method has been tested through clinical research, but real-world data have so far been lacking.
 

First real-life results

In what they described as the first real-life study of its kind, researchers offered at-home FC testing every 4 months to all 72 current IBD patients taking adalimumab at the University Hospital of Heraklion, University of Crete, Irakleio, Greece; seven patients (10%) declined to take part in at-home FC testing. Of the remaining 65, the mean age was 42.3 years, and 58% were male; 89% had a diagnosis of Crohn’s disease. The mean disease duration was 13.3 years.

Abnormal FC values were confirmed with a follow-up test 1 month later, after which point a colonoscopy was scheduled to inform treatment modification. Twenty-four patients (37% of the population) had two positive tests, and 19 who were able underwent colonoscopy. Twelve patients (19%) underwent adalimumab dose intensification, 9 (14%) switched to a different biologic, and 2 (3%) had surgery.

The group of patients who required treatment modification had a significantly higher median FC concentration of 761 mcg/g (37% had values ≥ 1,000 mcg/g), compared with a median concentration of 108 mcg/g for those who did not have their dose modified (P < .0001). With a cutoff of 250 mcg/g, FC correctly identified a need for treatment with an area under the receiver operating characteristic curve (AUC) value of 0.90 (95% confidence interval, 0.80-0.96).

FC was significantly correlated to endoscopic activity (r = 0.543, P < .001), and patients with endoscopic disease had higher median FC concentrations (689 vs. 99 mcg/g; P < .001).

The researchers calculated that a cutoff value of FC levels greater than 413 mcg/g is optimal for predicting endoscopic disease, with a sensitivity of 75%, a specificity of 76%, a positive likelihood ratio of 3.12, and a negative likelihood ratio of 0.33.
 

Diabeteslike home monitoring for IBD?

“Home monitoring of disease activity and drug levels will be a paradigm shift in management of IBD, because it will place in the patient’s hands the opportunity to assess their disease activity and to have a better understanding of what’s going on when they have symptoms or concerns about their disease control,” commented David Rubin, MD, who did not participate in the study.

He noted that patients are often unsure whether a new symptom is the beginning of another episode of IBD or something unrelated.

“One of the biggest challenges of having IBD is just the perception of loss of control of the disease and knowing when things are going to happen,” said Dr. Rubin, a professor of medicine and the codirector of the digestive diseases center at the University of Chicago, and the chair of the scientific advisory committee for the Crohn’s & Colitis Foundation. “I often explain to people that using a tool like this would be similar to patients with diabetes checking their blood sugar – getting a feel for what’s actually happening closer to the time that it’s happening, rather than waiting for it to progress. I really think that the general idea of home monitoring is going to be a major advance in our field.”

Although the new study proved the technique’s acceptability and efficacy, it isn’t without pitfalls, according to Dr. Rubin. False positives or negatives are a concern, and other factors might influence the results. For example, proton pump inhibitors can increase FC levels. Another concern is that some patients can become obsessed with their FC levels, and may want to test themselves at any sign of illness. They may develop unrealistic expectations about the impact of medications on their FC levels.

“That’s going to open up a whole dialogue with people, so that we all are on the same page about it. But I think that the benefits of having this far outweigh those potential risks,” said Dr. Rubin.

The authors reported no conflicts of interest. Dr. Rubin has consulted for TECHLAB.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

In a real-life setting, fecal calprotectin (FC) home testing performed well at predicting disease endoscopic activity in patients with inflammatory bowel disease (IBD) being treated with adalimumab.

The study, published in the European Journal of Gastroenterology & Hepatology, could be a boon to patients and physicians employing the treat-to-target (T2T) strategy, which relies on disease monitoring through methods like endoscopy, histology, and serum and fecal biomarkers.

One goal of T2T is to identify patients who are asymptomatic in order to prevent or minimize flare-ups. Colonoscopy is the preferred approach for achieving this, but cost, risk, and patient reluctance limit its use. FC has gained attention in recent years, as it outperforms serum biomarkers in its correlation with clinical, endoscopic, and histological disease activity. Consecutive FC measurements predict disease relapse among asymptomatic patients with high specificity and sensitivity. There’s also evidence that it could be useful for perioperative monitoring.

FC is typically assessed in a lab, but the recent availability of smartphone-based tests has allowed patients to collect and test their stool at home. The method has been tested through clinical research, but real-world data have so far been lacking.
 

First real-life results

In what they described as the first real-life study of its kind, researchers offered at-home FC testing every 4 months to all 72 current IBD patients taking adalimumab at the University Hospital of Heraklion, University of Crete, Irakleio, Greece; seven patients (10%) declined to take part in at-home FC testing. Of the remaining 65, the mean age was 42.3 years, and 58% were male; 89% had a diagnosis of Crohn’s disease. The mean disease duration was 13.3 years.

Abnormal FC values were confirmed with a follow-up test 1 month later, after which point a colonoscopy was scheduled to inform treatment modification. Twenty-four patients (37% of the population) had two positive tests, and 19 who were able underwent colonoscopy. Twelve patients (19%) underwent adalimumab dose intensification, 9 (14%) switched to a different biologic, and 2 (3%) had surgery.

The group of patients who required treatment modification had a significantly higher median FC concentration of 761 mcg/g (37% had values ≥ 1,000 mcg/g), compared with a median concentration of 108 mcg/g for those who did not have their dose modified (P < .0001). With a cutoff of 250 mcg/g, FC correctly identified a need for treatment with an area under the receiver operating characteristic curve (AUC) value of 0.90 (95% confidence interval, 0.80-0.96).

FC was significantly correlated to endoscopic activity (r = 0.543, P < .001), and patients with endoscopic disease had higher median FC concentrations (689 vs. 99 mcg/g; P < .001).

The researchers calculated that a cutoff value of FC levels greater than 413 mcg/g is optimal for predicting endoscopic disease, with a sensitivity of 75%, a specificity of 76%, a positive likelihood ratio of 3.12, and a negative likelihood ratio of 0.33.
 

Diabeteslike home monitoring for IBD?

“Home monitoring of disease activity and drug levels will be a paradigm shift in management of IBD, because it will place in the patient’s hands the opportunity to assess their disease activity and to have a better understanding of what’s going on when they have symptoms or concerns about their disease control,” commented David Rubin, MD, who did not participate in the study.

He noted that patients are often unsure whether a new symptom is the beginning of another episode of IBD or something unrelated.

“One of the biggest challenges of having IBD is just the perception of loss of control of the disease and knowing when things are going to happen,” said Dr. Rubin, a professor of medicine and the codirector of the digestive diseases center at the University of Chicago, and the chair of the scientific advisory committee for the Crohn’s & Colitis Foundation. “I often explain to people that using a tool like this would be similar to patients with diabetes checking their blood sugar – getting a feel for what’s actually happening closer to the time that it’s happening, rather than waiting for it to progress. I really think that the general idea of home monitoring is going to be a major advance in our field.”

Although the new study proved the technique’s acceptability and efficacy, it isn’t without pitfalls, according to Dr. Rubin. False positives or negatives are a concern, and other factors might influence the results. For example, proton pump inhibitors can increase FC levels. Another concern is that some patients can become obsessed with their FC levels, and may want to test themselves at any sign of illness. They may develop unrealistic expectations about the impact of medications on their FC levels.

“That’s going to open up a whole dialogue with people, so that we all are on the same page about it. But I think that the benefits of having this far outweigh those potential risks,” said Dr. Rubin.

The authors reported no conflicts of interest. Dr. Rubin has consulted for TECHLAB.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

In a real-life setting, fecal calprotectin (FC) home testing performed well at predicting disease endoscopic activity in patients with inflammatory bowel disease (IBD) being treated with adalimumab.

The study, published in the European Journal of Gastroenterology & Hepatology, could be a boon to patients and physicians employing the treat-to-target (T2T) strategy, which relies on disease monitoring through methods like endoscopy, histology, and serum and fecal biomarkers.

One goal of T2T is to identify patients who are asymptomatic in order to prevent or minimize flare-ups. Colonoscopy is the preferred approach for achieving this, but cost, risk, and patient reluctance limit its use. FC has gained attention in recent years, as it outperforms serum biomarkers in its correlation with clinical, endoscopic, and histological disease activity. Consecutive FC measurements predict disease relapse among asymptomatic patients with high specificity and sensitivity. There’s also evidence that it could be useful for perioperative monitoring.

FC is typically assessed in a lab, but the recent availability of smartphone-based tests has allowed patients to collect and test their stool at home. The method has been tested through clinical research, but real-world data have so far been lacking.
 

First real-life results

In what they described as the first real-life study of its kind, researchers offered at-home FC testing every 4 months to all 72 current IBD patients taking adalimumab at the University Hospital of Heraklion, University of Crete, Irakleio, Greece; seven patients (10%) declined to take part in at-home FC testing. Of the remaining 65, the mean age was 42.3 years, and 58% were male; 89% had a diagnosis of Crohn’s disease. The mean disease duration was 13.3 years.

Abnormal FC values were confirmed with a follow-up test 1 month later, after which point a colonoscopy was scheduled to inform treatment modification. Twenty-four patients (37% of the population) had two positive tests, and 19 who were able underwent colonoscopy. Twelve patients (19%) underwent adalimumab dose intensification, 9 (14%) switched to a different biologic, and 2 (3%) had surgery.

The group of patients who required treatment modification had a significantly higher median FC concentration of 761 mcg/g (37% had values ≥ 1,000 mcg/g), compared with a median concentration of 108 mcg/g for those who did not have their dose modified (P < .0001). With a cutoff of 250 mcg/g, FC correctly identified a need for treatment with an area under the receiver operating characteristic curve (AUC) value of 0.90 (95% confidence interval, 0.80-0.96).

FC was significantly correlated to endoscopic activity (r = 0.543, P < .001), and patients with endoscopic disease had higher median FC concentrations (689 vs. 99 mcg/g; P < .001).

The researchers calculated that a cutoff value of FC levels greater than 413 mcg/g is optimal for predicting endoscopic disease, with a sensitivity of 75%, a specificity of 76%, a positive likelihood ratio of 3.12, and a negative likelihood ratio of 0.33.
 

Diabeteslike home monitoring for IBD?

“Home monitoring of disease activity and drug levels will be a paradigm shift in management of IBD, because it will place in the patient’s hands the opportunity to assess their disease activity and to have a better understanding of what’s going on when they have symptoms or concerns about their disease control,” commented David Rubin, MD, who did not participate in the study.

He noted that patients are often unsure whether a new symptom is the beginning of another episode of IBD or something unrelated.

“One of the biggest challenges of having IBD is just the perception of loss of control of the disease and knowing when things are going to happen,” said Dr. Rubin, a professor of medicine and the codirector of the digestive diseases center at the University of Chicago, and the chair of the scientific advisory committee for the Crohn’s & Colitis Foundation. “I often explain to people that using a tool like this would be similar to patients with diabetes checking their blood sugar – getting a feel for what’s actually happening closer to the time that it’s happening, rather than waiting for it to progress. I really think that the general idea of home monitoring is going to be a major advance in our field.”

Although the new study proved the technique’s acceptability and efficacy, it isn’t without pitfalls, according to Dr. Rubin. False positives or negatives are a concern, and other factors might influence the results. For example, proton pump inhibitors can increase FC levels. Another concern is that some patients can become obsessed with their FC levels, and may want to test themselves at any sign of illness. They may develop unrealistic expectations about the impact of medications on their FC levels.

“That’s going to open up a whole dialogue with people, so that we all are on the same page about it. But I think that the benefits of having this far outweigh those potential risks,” said Dr. Rubin.

The authors reported no conflicts of interest. Dr. Rubin has consulted for TECHLAB.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD.