Clinical Psychiatry News

I remember a conversation I had at the end of my training with an older psychiatrist who was closing his practice. I was very excited to finally be a psychiatrist, and therefore a bit shocked that someone would voluntarily end a career I was just beginning. After all, psychiatry is a field where people can practice with flexibility, and a private practice is not an all-or-none endeavor.

“Dinah,” this gentleman said to me, sensing my dismay, “I’m 74. I’m allowed to retire.”

Like many retired psychiatrists, this one continued to come to grand rounds every Monday, dressed in a suit, which was followed by lunch with friends in the dining room. He continued to be involved in professional activities and lived to be 96.

Another dear friend practiced psychiatry until she entered hospice after a 2-year battle with cancer. Others have whittled down their practices, hanging on to a few hours of patient care along with supervision, teaching, and involvement with professional organizations.

In discussing retirement with some of my peers, it’s become immediately clear that each psychiatrist approaches this decision – and how they choose to live after it’s made – with a unique set of concerns and goals.
 

Fatigued by bureaucracy

Robin Weiss, MD, is in the process of “shrinking” her private practice. She is quick to say she is not retiring, but planning to scale back to 1 day a week starting next summer.

“I want to work less so I have more time for my grandchildren, friends, and travel, and to finally write more.” She also hopes to improve her ping-pong game and exercise habits.

“I’m so tired of prior authorizations, and the one day a week of patients I’ve been committed to feels just about right.”

During the pandemic, Dr. Weiss relinquished her office and she plans to continue with a virtual practice, which allows her more flexibility in terms of where she is physically located.

“The pandemic didn’t influence my decision to scale back, but it did play a role in deciding to give up my office,” she said.

A decision precipitated by medical reasons

Stephen Warres, MD, is a child and adolescent psychiatrist in Maryland who fully retired from practice in June 2021. He started scaling back a few years ago, when he had to give up his office because the building was undergoing renovations.

“I was seeing some patients from my home, but for 2 years I had been working 1 or 2 weekends a month at the Baltimore city jail, and I thought of that as my final act. It was a setting I had never worked in, and I left there 4 months before the pandemic started.”

Dr. Warres noted that his decision to retire was propelled by his diagnosis of Parkinson’s disease at the end of 2019.

“So far I only have a resting tremor, but this is an illness in which cognitive decline is a possibility.”
 

The emotional roller-coaster that can await

Dr. Warres said a myriad of emotions come with retirement, beginning with a sense of guilt.

“Why am I leaving when others practice longer? I read about a psychiatrist in California who was still practicing when he died at 102. And the last patient whom I saw when I left practice was a man I started treating just 2 days after I started residency in 1976! When I told him I would be retiring, he found a new psychiatrist who is 82 years old.”

This was followed, he said, by a sense of shame.

“My father was a radiologist and he retired at 76, the same age that I am now, but he volunteered 2 days a week for the state attorney’s office until he was 92, and I’m not doing that.”

What Dr. Warres is choosing to do instead is indulge his many interests, including reading; writing; and practicing on the instrument he’s recently taken up, the harmonium.

This cascade of emotions led to one that was arguably more pleasurable: a sense of immense relief.

“When I got my first request after retirement for a prior authorization, I felt jubilant, like I wanted to throw a party! I felt like I had been walking with a backpack full of weights, and only after the weights were removed did I realize how much lighter it was.

“I loved doing psychotherapy, but more and more psychiatry was not what I had signed up for. I’m relieved that I no longer have to keep up with psychopharmacology. In a way, the Parkinson’s diagnosis sealed the deal. I felt that it gave me license, like a get out of jail card, to retire.”

But even this sense of palpable relief hasn’t closed the cycle of emotions Dr. Warres is experiencing over his retirement.

“You know, the more relieved I am, the more guilt I feel.”
 

As intellectually adventurous as ever

Marshal Folstein, MD, of Miami retired over a decade ago after a long academic career at Johns Hopkins University, Baltimore, and as chairman of psychiatry at Tufts University, Boston. His Facebook profile states: “Leading the quiet life of a retired professor.”

He said retirement was an easy decision for he and his wife Susan, herself a former academic psychiatrist, which allowed them to immediately change gears.

“At the beginning, we traveled a bit. I wanted to continue with music, so I took flute lessons, and then I played flute in my synagogue, so now I have recently retired from that. I spend my time reading Talmud and the Bible and I keep asking questions. I found a new group of people, some are physicians, and we study and argue. I just turned 80 and I’m intellectually busy and happy.”

The retirement coach

Barbara Fowler, PhD, is a lifespan services consultant at Johns Hopkins who works with faculty and staff getting ready to retire. She said that the university has methods in place to make this decision less jarring.

“The school of medicine has a faculty transition plan that lets people cut back over a set period of time while still keeping benefits. It gives doctors a way to wind up their research and clinical responsibilities, and this is negotiated on an individual level.”

When she’s discussing with someone the possibility of retirement, Dr. Fowler likes to begin by asking them to define what exactly they mean by that word.

“The stereotyped concept is that someone stops what they are doing completely and spends their time playing golf or canasta,” she said. “But the baby boomers are redefining that. Physicians often continue to see some patients or participate in professional organizations. Some people are happy to stop doing the work they have done for years and go do something different, whereas others are interested in scaling back on work activities while adding new ones.”
 

Timing it right

So, when should psychiatrists retire? The most obvious time to reconsider is when the doctor is no longer able to perform work-related obligations owing to physical or cognitive limitations.

Financial constraints are another factor that comes into play. How necessary is it to work to pay the bills?

“When the kids are out of college and the mortgage is paid off, then there may be the financial means to reconceptualize work life and how you want to rebuild it,” Dr. Fowler said. “Because whether or not people are getting paid, they want to be productive.”

For some, this may come in the form of working in a reduced capacity. Certain practices are more amenable to part-time work or a gradual decrease in hours. A private practice may allow for more control than a position with an institution where an employee may have to continue working full time or not at all.

For others, that productivity might be measured in pursuing their own interests or assisting with family members who need their help. Grandchildren can be an important factor, especially if they live at a distance or childcare is needed. These issues became all the more salient when the pandemic shuttered day care centers and schools, and people limited contact with those outside their households.

Retirement for all physicians is wrapped in issues of identity; for those who have not cultivated other interests, retirement can be a huge loss with no clear path forward. And in an environment where there is a psychiatrist shortage, health care workers are deemed heroes, and human distress is mounting, retirement may come with mixed feelings of guilt, even when the psychiatrist wants a change and is ready for the next chapter. Finally, for those who have launched programs or research projects, there may be the fear that there is no one else who can or will carry on, and that all will be lost.

Yet these considerations focus on the negative, whereas Dr. Fowler said she likes to frame retirement in a positive light. “The key is having more choices; looking for activities that inspire passion; and asking, how can you live your best life?”

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. A version of this article first appeared on Medscape.com.

I remember a conversation I had at the end of my training with an older psychiatrist who was closing his practice. I was very excited to finally be a psychiatrist, and therefore a bit shocked that someone would voluntarily end a career I was just beginning. After all, psychiatry is a field where people can practice with flexibility, and a private practice is not an all-or-none endeavor.

“Dinah,” this gentleman said to me, sensing my dismay, “I’m 74. I’m allowed to retire.”

Like many retired psychiatrists, this one continued to come to grand rounds every Monday, dressed in a suit, which was followed by lunch with friends in the dining room. He continued to be involved in professional activities and lived to be 96.

Another dear friend practiced psychiatry until she entered hospice after a 2-year battle with cancer. Others have whittled down their practices, hanging on to a few hours of patient care along with supervision, teaching, and involvement with professional organizations.

In discussing retirement with some of my peers, it’s become immediately clear that each psychiatrist approaches this decision – and how they choose to live after it’s made – with a unique set of concerns and goals.
 

Fatigued by bureaucracy

Robin Weiss, MD, is in the process of “shrinking” her private practice. She is quick to say she is not retiring, but planning to scale back to 1 day a week starting next summer.

“I want to work less so I have more time for my grandchildren, friends, and travel, and to finally write more.” She also hopes to improve her ping-pong game and exercise habits.

“I’m so tired of prior authorizations, and the one day a week of patients I’ve been committed to feels just about right.”

During the pandemic, Dr. Weiss relinquished her office and she plans to continue with a virtual practice, which allows her more flexibility in terms of where she is physically located.

“The pandemic didn’t influence my decision to scale back, but it did play a role in deciding to give up my office,” she said.

A decision precipitated by medical reasons

Stephen Warres, MD, is a child and adolescent psychiatrist in Maryland who fully retired from practice in June 2021. He started scaling back a few years ago, when he had to give up his office because the building was undergoing renovations.

“I was seeing some patients from my home, but for 2 years I had been working 1 or 2 weekends a month at the Baltimore city jail, and I thought of that as my final act. It was a setting I had never worked in, and I left there 4 months before the pandemic started.”

Dr. Warres noted that his decision to retire was propelled by his diagnosis of Parkinson’s disease at the end of 2019.

“So far I only have a resting tremor, but this is an illness in which cognitive decline is a possibility.”
 

The emotional roller-coaster that can await

Dr. Warres said a myriad of emotions come with retirement, beginning with a sense of guilt.

“Why am I leaving when others practice longer? I read about a psychiatrist in California who was still practicing when he died at 102. And the last patient whom I saw when I left practice was a man I started treating just 2 days after I started residency in 1976! When I told him I would be retiring, he found a new psychiatrist who is 82 years old.”

This was followed, he said, by a sense of shame.

“My father was a radiologist and he retired at 76, the same age that I am now, but he volunteered 2 days a week for the state attorney’s office until he was 92, and I’m not doing that.”

What Dr. Warres is choosing to do instead is indulge his many interests, including reading; writing; and practicing on the instrument he’s recently taken up, the harmonium.

This cascade of emotions led to one that was arguably more pleasurable: a sense of immense relief.

“When I got my first request after retirement for a prior authorization, I felt jubilant, like I wanted to throw a party! I felt like I had been walking with a backpack full of weights, and only after the weights were removed did I realize how much lighter it was.

“I loved doing psychotherapy, but more and more psychiatry was not what I had signed up for. I’m relieved that I no longer have to keep up with psychopharmacology. In a way, the Parkinson’s diagnosis sealed the deal. I felt that it gave me license, like a get out of jail card, to retire.”

But even this sense of palpable relief hasn’t closed the cycle of emotions Dr. Warres is experiencing over his retirement.

“You know, the more relieved I am, the more guilt I feel.”
 

As intellectually adventurous as ever

Marshal Folstein, MD, of Miami retired over a decade ago after a long academic career at Johns Hopkins University, Baltimore, and as chairman of psychiatry at Tufts University, Boston. His Facebook profile states: “Leading the quiet life of a retired professor.”

He said retirement was an easy decision for he and his wife Susan, herself a former academic psychiatrist, which allowed them to immediately change gears.

“At the beginning, we traveled a bit. I wanted to continue with music, so I took flute lessons, and then I played flute in my synagogue, so now I have recently retired from that. I spend my time reading Talmud and the Bible and I keep asking questions. I found a new group of people, some are physicians, and we study and argue. I just turned 80 and I’m intellectually busy and happy.”

The retirement coach

Barbara Fowler, PhD, is a lifespan services consultant at Johns Hopkins who works with faculty and staff getting ready to retire. She said that the university has methods in place to make this decision less jarring.

“The school of medicine has a faculty transition plan that lets people cut back over a set period of time while still keeping benefits. It gives doctors a way to wind up their research and clinical responsibilities, and this is negotiated on an individual level.”

When she’s discussing with someone the possibility of retirement, Dr. Fowler likes to begin by asking them to define what exactly they mean by that word.

“The stereotyped concept is that someone stops what they are doing completely and spends their time playing golf or canasta,” she said. “But the baby boomers are redefining that. Physicians often continue to see some patients or participate in professional organizations. Some people are happy to stop doing the work they have done for years and go do something different, whereas others are interested in scaling back on work activities while adding new ones.”
 

Timing it right

So, when should psychiatrists retire? The most obvious time to reconsider is when the doctor is no longer able to perform work-related obligations owing to physical or cognitive limitations.

Financial constraints are another factor that comes into play. How necessary is it to work to pay the bills?

“When the kids are out of college and the mortgage is paid off, then there may be the financial means to reconceptualize work life and how you want to rebuild it,” Dr. Fowler said. “Because whether or not people are getting paid, they want to be productive.”

For some, this may come in the form of working in a reduced capacity. Certain practices are more amenable to part-time work or a gradual decrease in hours. A private practice may allow for more control than a position with an institution where an employee may have to continue working full time or not at all.

For others, that productivity might be measured in pursuing their own interests or assisting with family members who need their help. Grandchildren can be an important factor, especially if they live at a distance or childcare is needed. These issues became all the more salient when the pandemic shuttered day care centers and schools, and people limited contact with those outside their households.

Retirement for all physicians is wrapped in issues of identity; for those who have not cultivated other interests, retirement can be a huge loss with no clear path forward. And in an environment where there is a psychiatrist shortage, health care workers are deemed heroes, and human distress is mounting, retirement may come with mixed feelings of guilt, even when the psychiatrist wants a change and is ready for the next chapter. Finally, for those who have launched programs or research projects, there may be the fear that there is no one else who can or will carry on, and that all will be lost.

Yet these considerations focus on the negative, whereas Dr. Fowler said she likes to frame retirement in a positive light. “The key is having more choices; looking for activities that inspire passion; and asking, how can you live your best life?”

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. A version of this article first appeared on Medscape.com.

I remember a conversation I had at the end of my training with an older psychiatrist who was closing his practice. I was very excited to finally be a psychiatrist, and therefore a bit shocked that someone would voluntarily end a career I was just beginning. After all, psychiatry is a field where people can practice with flexibility, and a private practice is not an all-or-none endeavor.

“Dinah,” this gentleman said to me, sensing my dismay, “I’m 74. I’m allowed to retire.”

Like many retired psychiatrists, this one continued to come to grand rounds every Monday, dressed in a suit, which was followed by lunch with friends in the dining room. He continued to be involved in professional activities and lived to be 96.

Another dear friend practiced psychiatry until she entered hospice after a 2-year battle with cancer. Others have whittled down their practices, hanging on to a few hours of patient care along with supervision, teaching, and involvement with professional organizations.

In discussing retirement with some of my peers, it’s become immediately clear that each psychiatrist approaches this decision – and how they choose to live after it’s made – with a unique set of concerns and goals.
 

Fatigued by bureaucracy

Robin Weiss, MD, is in the process of “shrinking” her private practice. She is quick to say she is not retiring, but planning to scale back to 1 day a week starting next summer.

“I want to work less so I have more time for my grandchildren, friends, and travel, and to finally write more.” She also hopes to improve her ping-pong game and exercise habits.

“I’m so tired of prior authorizations, and the one day a week of patients I’ve been committed to feels just about right.”

During the pandemic, Dr. Weiss relinquished her office and she plans to continue with a virtual practice, which allows her more flexibility in terms of where she is physically located.

“The pandemic didn’t influence my decision to scale back, but it did play a role in deciding to give up my office,” she said.

A decision precipitated by medical reasons

Stephen Warres, MD, is a child and adolescent psychiatrist in Maryland who fully retired from practice in June 2021. He started scaling back a few years ago, when he had to give up his office because the building was undergoing renovations.

“I was seeing some patients from my home, but for 2 years I had been working 1 or 2 weekends a month at the Baltimore city jail, and I thought of that as my final act. It was a setting I had never worked in, and I left there 4 months before the pandemic started.”

Dr. Warres noted that his decision to retire was propelled by his diagnosis of Parkinson’s disease at the end of 2019.

“So far I only have a resting tremor, but this is an illness in which cognitive decline is a possibility.”
 

The emotional roller-coaster that can await

Dr. Warres said a myriad of emotions come with retirement, beginning with a sense of guilt.

“Why am I leaving when others practice longer? I read about a psychiatrist in California who was still practicing when he died at 102. And the last patient whom I saw when I left practice was a man I started treating just 2 days after I started residency in 1976! When I told him I would be retiring, he found a new psychiatrist who is 82 years old.”

This was followed, he said, by a sense of shame.

“My father was a radiologist and he retired at 76, the same age that I am now, but he volunteered 2 days a week for the state attorney’s office until he was 92, and I’m not doing that.”

What Dr. Warres is choosing to do instead is indulge his many interests, including reading; writing; and practicing on the instrument he’s recently taken up, the harmonium.

This cascade of emotions led to one that was arguably more pleasurable: a sense of immense relief.

“When I got my first request after retirement for a prior authorization, I felt jubilant, like I wanted to throw a party! I felt like I had been walking with a backpack full of weights, and only after the weights were removed did I realize how much lighter it was.

“I loved doing psychotherapy, but more and more psychiatry was not what I had signed up for. I’m relieved that I no longer have to keep up with psychopharmacology. In a way, the Parkinson’s diagnosis sealed the deal. I felt that it gave me license, like a get out of jail card, to retire.”

But even this sense of palpable relief hasn’t closed the cycle of emotions Dr. Warres is experiencing over his retirement.

“You know, the more relieved I am, the more guilt I feel.”
 

As intellectually adventurous as ever

Marshal Folstein, MD, of Miami retired over a decade ago after a long academic career at Johns Hopkins University, Baltimore, and as chairman of psychiatry at Tufts University, Boston. His Facebook profile states: “Leading the quiet life of a retired professor.”

He said retirement was an easy decision for he and his wife Susan, herself a former academic psychiatrist, which allowed them to immediately change gears.

“At the beginning, we traveled a bit. I wanted to continue with music, so I took flute lessons, and then I played flute in my synagogue, so now I have recently retired from that. I spend my time reading Talmud and the Bible and I keep asking questions. I found a new group of people, some are physicians, and we study and argue. I just turned 80 and I’m intellectually busy and happy.”

The retirement coach

Barbara Fowler, PhD, is a lifespan services consultant at Johns Hopkins who works with faculty and staff getting ready to retire. She said that the university has methods in place to make this decision less jarring.

“The school of medicine has a faculty transition plan that lets people cut back over a set period of time while still keeping benefits. It gives doctors a way to wind up their research and clinical responsibilities, and this is negotiated on an individual level.”

When she’s discussing with someone the possibility of retirement, Dr. Fowler likes to begin by asking them to define what exactly they mean by that word.

“The stereotyped concept is that someone stops what they are doing completely and spends their time playing golf or canasta,” she said. “But the baby boomers are redefining that. Physicians often continue to see some patients or participate in professional organizations. Some people are happy to stop doing the work they have done for years and go do something different, whereas others are interested in scaling back on work activities while adding new ones.”
 

Timing it right

So, when should psychiatrists retire? The most obvious time to reconsider is when the doctor is no longer able to perform work-related obligations owing to physical or cognitive limitations.

Financial constraints are another factor that comes into play. How necessary is it to work to pay the bills?

“When the kids are out of college and the mortgage is paid off, then there may be the financial means to reconceptualize work life and how you want to rebuild it,” Dr. Fowler said. “Because whether or not people are getting paid, they want to be productive.”

For some, this may come in the form of working in a reduced capacity. Certain practices are more amenable to part-time work or a gradual decrease in hours. A private practice may allow for more control than a position with an institution where an employee may have to continue working full time or not at all.

For others, that productivity might be measured in pursuing their own interests or assisting with family members who need their help. Grandchildren can be an important factor, especially if they live at a distance or childcare is needed. These issues became all the more salient when the pandemic shuttered day care centers and schools, and people limited contact with those outside their households.

Retirement for all physicians is wrapped in issues of identity; for those who have not cultivated other interests, retirement can be a huge loss with no clear path forward. And in an environment where there is a psychiatrist shortage, health care workers are deemed heroes, and human distress is mounting, retirement may come with mixed feelings of guilt, even when the psychiatrist wants a change and is ready for the next chapter. Finally, for those who have launched programs or research projects, there may be the fear that there is no one else who can or will carry on, and that all will be lost.

Yet these considerations focus on the negative, whereas Dr. Fowler said she likes to frame retirement in a positive light. “The key is having more choices; looking for activities that inspire passion; and asking, how can you live your best life?”

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. A version of this article first appeared on Medscape.com.

Some 30% of health care personnel who worked at the thousands of hospitals in the United States were still not fully vaccinated against COVID-19 as of mid-September, according to a new survey by the Centers for Disease Control and Prevention.

The snapshot in time – Jan. 20, 2021 to Sept. 15, 2021 – is based on voluntary weekly reports from hospitals. Only about 48% of the 5,085 hospitals in the U.S. Health and Human Services department’s Unified Hospital Data Surveillance System reported data on vaccination coverage during the period, and, after validation checks, the study included reports from 2,086 facilities, or just 41% of all hospitals, covering 3.35 million workers.

Overall, the number who were fully vaccinated rose from 36.1% in Jan. 2021 to 60.2% in April 2021, and then crept slowly up to 70% by Sept. 15, the CDC researchers reported in the American Journal of Infection Control.

The slowdown among hospital workers seems to mirror the same decline as in the general population.  

Arjun Srinivasan, MD, associate director for health care–associated infection prevention programs at the CDC, said the decline in part may be the result of misinformation.

Health care personnel “are not fully immune from vaccine misinformation,” he said, adding that such misinformation “is contributing to decreased vaccine uptake among non–health care personnel.”

“The take-home message is that there is a lot of work to do in health care settings in order to get all of our health care personnel vaccinated,” Dr. Srinivasan told this news organization. “We need them to be vaccinated to protect themselves. It is also really important that we as health care personnel get vaccinated to protect our patients.”
 

Vaccine mandates

The analysis shows that workers were more likely to be vaccinated if they worked at a children’s hospital (77%), lived in metropolitan counties (71%), or worked in a hospital with lower cumulative admissions of COVID-19 patients, or lower cumulative COVID-19 cases.

The odds of being fully vaccinated were lower if the surrounding community had lower vaccination coverage. Workers in non-metropolitan counties (63.3%) and in rural counties (65.1%) were also less likely to be fully vaccinated, as well as those who were in critical access hospitals (64%) or long-term acute care hospitals (68.8%).

Surveys have shown that health care personnel who are vaccine-hesitant cited concerns they had about vaccine efficacy, adverse effects, the speed of vaccine development, and lack of full Food and Drug Administration approval, the study authors noted. In addition, many reported low trust in the government.

A Medscape survey this past April found that 25% of health care workers said they did not plan to be fully vaccinated. Some 40% of the 9,349 workers who responded said that employers should never require a COVID-19 vaccine for clinicians.

But the Centers for Medicare & Medicaid Services is attempting to require all health care facilities that receive Medicare or Medicaid payment to vaccinate workers. All eligible staff must receive the first dose of a two-dose COVID-19 vaccine or a one-dose vaccine by Dec. 6, and a second dose by Jan. 4, 2022. The policy allows exemptions based on recognized medical conditions or religious beliefs.

Some hospitals and health systems and various states and cities have already begun implementing vaccine mandates. Northwell Health in New York, for instance, lost 1,400 workers (evenly split between clinical and nonclinical staff), or 2% of its 77,000 employees, as a result of the state’s mandate.

Northwell’s workforce is now considered 100% vaccinated, a hospital spokesman said in an interview. In addition, “we have allowed for team members who changed their minds and presented proof of vaccination to return,” said the spokesman, adding that “a couple of hundred employees have done just that.”

Ten states sued the Biden administration recently, aiming to stop the health care worker vaccine mandate. Other challenges to vaccine mandates have generally been unsuccessful. The U.S. Supreme Court, for example, in October declined to hear a challenge to Maine’s mandate for health care workers, even though it did not allow religious exemptions, according to the Washington Post.

“The courts seem to agree that health care personnel are different, and could be subject to these mandates,” said Dr. Srinivasan.

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

Some 30% of health care personnel who worked at the thousands of hospitals in the United States were still not fully vaccinated against COVID-19 as of mid-September, according to a new survey by the Centers for Disease Control and Prevention.

The snapshot in time – Jan. 20, 2021 to Sept. 15, 2021 – is based on voluntary weekly reports from hospitals. Only about 48% of the 5,085 hospitals in the U.S. Health and Human Services department’s Unified Hospital Data Surveillance System reported data on vaccination coverage during the period, and, after validation checks, the study included reports from 2,086 facilities, or just 41% of all hospitals, covering 3.35 million workers.

Overall, the number who were fully vaccinated rose from 36.1% in Jan. 2021 to 60.2% in April 2021, and then crept slowly up to 70% by Sept. 15, the CDC researchers reported in the American Journal of Infection Control.

The slowdown among hospital workers seems to mirror the same decline as in the general population.  

Arjun Srinivasan, MD, associate director for health care–associated infection prevention programs at the CDC, said the decline in part may be the result of misinformation.

Health care personnel “are not fully immune from vaccine misinformation,” he said, adding that such misinformation “is contributing to decreased vaccine uptake among non–health care personnel.”

“The take-home message is that there is a lot of work to do in health care settings in order to get all of our health care personnel vaccinated,” Dr. Srinivasan told this news organization. “We need them to be vaccinated to protect themselves. It is also really important that we as health care personnel get vaccinated to protect our patients.”
 

Vaccine mandates

The analysis shows that workers were more likely to be vaccinated if they worked at a children’s hospital (77%), lived in metropolitan counties (71%), or worked in a hospital with lower cumulative admissions of COVID-19 patients, or lower cumulative COVID-19 cases.

The odds of being fully vaccinated were lower if the surrounding community had lower vaccination coverage. Workers in non-metropolitan counties (63.3%) and in rural counties (65.1%) were also less likely to be fully vaccinated, as well as those who were in critical access hospitals (64%) or long-term acute care hospitals (68.8%).

Surveys have shown that health care personnel who are vaccine-hesitant cited concerns they had about vaccine efficacy, adverse effects, the speed of vaccine development, and lack of full Food and Drug Administration approval, the study authors noted. In addition, many reported low trust in the government.

A Medscape survey this past April found that 25% of health care workers said they did not plan to be fully vaccinated. Some 40% of the 9,349 workers who responded said that employers should never require a COVID-19 vaccine for clinicians.

But the Centers for Medicare & Medicaid Services is attempting to require all health care facilities that receive Medicare or Medicaid payment to vaccinate workers. All eligible staff must receive the first dose of a two-dose COVID-19 vaccine or a one-dose vaccine by Dec. 6, and a second dose by Jan. 4, 2022. The policy allows exemptions based on recognized medical conditions or religious beliefs.

Some hospitals and health systems and various states and cities have already begun implementing vaccine mandates. Northwell Health in New York, for instance, lost 1,400 workers (evenly split between clinical and nonclinical staff), or 2% of its 77,000 employees, as a result of the state’s mandate.

Northwell’s workforce is now considered 100% vaccinated, a hospital spokesman said in an interview. In addition, “we have allowed for team members who changed their minds and presented proof of vaccination to return,” said the spokesman, adding that “a couple of hundred employees have done just that.”

Ten states sued the Biden administration recently, aiming to stop the health care worker vaccine mandate. Other challenges to vaccine mandates have generally been unsuccessful. The U.S. Supreme Court, for example, in October declined to hear a challenge to Maine’s mandate for health care workers, even though it did not allow religious exemptions, according to the Washington Post.

“The courts seem to agree that health care personnel are different, and could be subject to these mandates,” said Dr. Srinivasan.

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

Some 30% of health care personnel who worked at the thousands of hospitals in the United States were still not fully vaccinated against COVID-19 as of mid-September, according to a new survey by the Centers for Disease Control and Prevention.

The snapshot in time – Jan. 20, 2021 to Sept. 15, 2021 – is based on voluntary weekly reports from hospitals. Only about 48% of the 5,085 hospitals in the U.S. Health and Human Services department’s Unified Hospital Data Surveillance System reported data on vaccination coverage during the period, and, after validation checks, the study included reports from 2,086 facilities, or just 41% of all hospitals, covering 3.35 million workers.

Overall, the number who were fully vaccinated rose from 36.1% in Jan. 2021 to 60.2% in April 2021, and then crept slowly up to 70% by Sept. 15, the CDC researchers reported in the American Journal of Infection Control.

The slowdown among hospital workers seems to mirror the same decline as in the general population.  

Arjun Srinivasan, MD, associate director for health care–associated infection prevention programs at the CDC, said the decline in part may be the result of misinformation.

Health care personnel “are not fully immune from vaccine misinformation,” he said, adding that such misinformation “is contributing to decreased vaccine uptake among non–health care personnel.”

“The take-home message is that there is a lot of work to do in health care settings in order to get all of our health care personnel vaccinated,” Dr. Srinivasan told this news organization. “We need them to be vaccinated to protect themselves. It is also really important that we as health care personnel get vaccinated to protect our patients.”
 

Vaccine mandates

The analysis shows that workers were more likely to be vaccinated if they worked at a children’s hospital (77%), lived in metropolitan counties (71%), or worked in a hospital with lower cumulative admissions of COVID-19 patients, or lower cumulative COVID-19 cases.

The odds of being fully vaccinated were lower if the surrounding community had lower vaccination coverage. Workers in non-metropolitan counties (63.3%) and in rural counties (65.1%) were also less likely to be fully vaccinated, as well as those who were in critical access hospitals (64%) or long-term acute care hospitals (68.8%).

Surveys have shown that health care personnel who are vaccine-hesitant cited concerns they had about vaccine efficacy, adverse effects, the speed of vaccine development, and lack of full Food and Drug Administration approval, the study authors noted. In addition, many reported low trust in the government.

A Medscape survey this past April found that 25% of health care workers said they did not plan to be fully vaccinated. Some 40% of the 9,349 workers who responded said that employers should never require a COVID-19 vaccine for clinicians.

But the Centers for Medicare & Medicaid Services is attempting to require all health care facilities that receive Medicare or Medicaid payment to vaccinate workers. All eligible staff must receive the first dose of a two-dose COVID-19 vaccine or a one-dose vaccine by Dec. 6, and a second dose by Jan. 4, 2022. The policy allows exemptions based on recognized medical conditions or religious beliefs.

Some hospitals and health systems and various states and cities have already begun implementing vaccine mandates. Northwell Health in New York, for instance, lost 1,400 workers (evenly split between clinical and nonclinical staff), or 2% of its 77,000 employees, as a result of the state’s mandate.

Northwell’s workforce is now considered 100% vaccinated, a hospital spokesman said in an interview. In addition, “we have allowed for team members who changed their minds and presented proof of vaccination to return,” said the spokesman, adding that “a couple of hundred employees have done just that.”

Ten states sued the Biden administration recently, aiming to stop the health care worker vaccine mandate. Other challenges to vaccine mandates have generally been unsuccessful. The U.S. Supreme Court, for example, in October declined to hear a challenge to Maine’s mandate for health care workers, even though it did not allow religious exemptions, according to the Washington Post.

“The courts seem to agree that health care personnel are different, and could be subject to these mandates,” said Dr. Srinivasan.

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

Medical practices will likely have to confront a doctor at some point who treats staff badly or is too impaired to practice safely. Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.

Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .

“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.

She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.

After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
 

Confront, correct, and/or counsel

The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.

Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.

She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.

She also recommends implementing these strategies to prevent and deal with disruptive physicians:

• Implement a code of conduct and share it during interviews;
• Have zero tolerance policies and procedures for documenting behavior;
• Get advice from a good employment attorney;
• Implement written performance improvement plans;
• Provide resources to change the behavior;
• Follow through with suspension and termination; and
• Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.

Getting impaired doctors help

Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.

Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.

She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”

Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.

Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:

• Include “fit for duty” examinations, especially after age 65.
• Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
• Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
• Establish a voting mechanism for terminating a physician.

Aging doctors who won’t retire

Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.

She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.

Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.

She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”

Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.

“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.

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

Medical practices will likely have to confront a doctor at some point who treats staff badly or is too impaired to practice safely. Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.

Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .

“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.

She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.

After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
 

Confront, correct, and/or counsel

The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.

Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.

She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.

She also recommends implementing these strategies to prevent and deal with disruptive physicians:

• Implement a code of conduct and share it during interviews;
• Have zero tolerance policies and procedures for documenting behavior;
• Get advice from a good employment attorney;
• Implement written performance improvement plans;
• Provide resources to change the behavior;
• Follow through with suspension and termination; and
• Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.

Getting impaired doctors help

Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.

Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.

She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”

Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.

Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:

• Include “fit for duty” examinations, especially after age 65.
• Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
• Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
• Establish a voting mechanism for terminating a physician.

Aging doctors who won’t retire

Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.

She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.

Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.

She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”

Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.

“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.

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

Medical practices will likely have to confront a doctor at some point who treats staff badly or is too impaired to practice safely. Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.

Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .

“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.

She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.

After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
 

Confront, correct, and/or counsel

The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.

Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.

She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.

She also recommends implementing these strategies to prevent and deal with disruptive physicians:

• Implement a code of conduct and share it during interviews;
• Have zero tolerance policies and procedures for documenting behavior;
• Get advice from a good employment attorney;
• Implement written performance improvement plans;
• Provide resources to change the behavior;
• Follow through with suspension and termination; and
• Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.

Getting impaired doctors help

Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.

Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.

She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”

Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.

Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:

• Include “fit for duty” examinations, especially after age 65.
• Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
• Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
• Establish a voting mechanism for terminating a physician.

Aging doctors who won’t retire

Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.

She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.

Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.

She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”

Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.

“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.

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

The Food and Drug Administration has given the green light to third, or booster doses of the Pfizer and Moderna vaccines for everyone over the age of 18, ahead of the busy winter holiday season.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.

Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.

FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.

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

The Food and Drug Administration has given the green light to third, or booster doses of the Pfizer and Moderna vaccines for everyone over the age of 18, ahead of the busy winter holiday season.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.

Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.

FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.

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

The Food and Drug Administration has given the green light to third, or booster doses of the Pfizer and Moderna vaccines for everyone over the age of 18, ahead of the busy winter holiday season.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.

Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.

FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.

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

When people wear face masks to reduce the spread of the coronavirus, the number of new COVID-19 infections drops by 53%, according to a new study published Nov. 18 in the British Medical Journal.

Social distancing and handwashing were also effective at lowering the number of cases, but wearing masks was the most effective tool against the coronavirus.

“Personal and social measures, including handwashing, mask wearing, and physical distancing are effective at reducing the incidence of COVID-19,” the study authors wrote.

The research team, which included public health and infectious disease specialists in Australia, China, and the U.K., evaluated 72 studies of COVID-19 precautions during the pandemic. They later looked at eight studies that focused on handwashing, mask wearing, and physical distancing.

Among six studies that looked at mask wearing, the researchers found a 53% reduction in COVID-19 cases. In the broader analysis with additional studies, wearing a mask reduced coronavirus transmission, cases, and deaths.

In one study across 200 countries, mandatory mask wearing resulted in nearly 46% fewer negative outcomes from COVID-19. In another study in the U.S., coronavirus transmission was reduced 29% in states where masks were mandatory.

But the research team couldn’t analyze the impact of the type of face mask used, the frequency of mask wearing, or the overall compliance with wearing face masks.

Among five studies that looked at physical distancing, the researchers found a 25% reduction in the rate of COVID-19. A study in the U.S. showed a 12% decrease in coronavirus transmission, while another study in Iran reported a reduction in COVID-19 mortality.

Handwashing interventions also suggested a substantial reduction of COVID-19 cases up to 53%, the researchers wrote. But in adjusted models, the results weren’t statistically significant due to the small number of studies included.

Other studies found significant decreases related to other public health measures, such as quarantines, broad lockdowns, border closures, school closures, business closures, and travel restrictions. Still, the research team couldn’t analyze the overall effectiveness of these measures due to the different ways the studies were conducted.

The study lines up with other research conducted so far during the pandemic, the research team wrote, which indicates that wearing masks and physical distancing can reduce transmission, cases, and deaths.

That said, more studies are needed, particularly now that vaccinations are available and contagious coronavirus variants have become prevalent.

“Further research is needed to assess the effectiveness of public health measures after adequate vaccination coverage has been achieved,” they wrote.

“It is likely that further control of the COVID-19 pandemic depends not only on high vaccination coverage and its effectiveness but also on ongoing adherence to effective and sustainable public health measures,” they concluded.

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

When people wear face masks to reduce the spread of the coronavirus, the number of new COVID-19 infections drops by 53%, according to a new study published Nov. 18 in the British Medical Journal.

Social distancing and handwashing were also effective at lowering the number of cases, but wearing masks was the most effective tool against the coronavirus.

“Personal and social measures, including handwashing, mask wearing, and physical distancing are effective at reducing the incidence of COVID-19,” the study authors wrote.

The research team, which included public health and infectious disease specialists in Australia, China, and the U.K., evaluated 72 studies of COVID-19 precautions during the pandemic. They later looked at eight studies that focused on handwashing, mask wearing, and physical distancing.

Among six studies that looked at mask wearing, the researchers found a 53% reduction in COVID-19 cases. In the broader analysis with additional studies, wearing a mask reduced coronavirus transmission, cases, and deaths.

In one study across 200 countries, mandatory mask wearing resulted in nearly 46% fewer negative outcomes from COVID-19. In another study in the U.S., coronavirus transmission was reduced 29% in states where masks were mandatory.

But the research team couldn’t analyze the impact of the type of face mask used, the frequency of mask wearing, or the overall compliance with wearing face masks.

Among five studies that looked at physical distancing, the researchers found a 25% reduction in the rate of COVID-19. A study in the U.S. showed a 12% decrease in coronavirus transmission, while another study in Iran reported a reduction in COVID-19 mortality.

Handwashing interventions also suggested a substantial reduction of COVID-19 cases up to 53%, the researchers wrote. But in adjusted models, the results weren’t statistically significant due to the small number of studies included.

Other studies found significant decreases related to other public health measures, such as quarantines, broad lockdowns, border closures, school closures, business closures, and travel restrictions. Still, the research team couldn’t analyze the overall effectiveness of these measures due to the different ways the studies were conducted.

The study lines up with other research conducted so far during the pandemic, the research team wrote, which indicates that wearing masks and physical distancing can reduce transmission, cases, and deaths.

That said, more studies are needed, particularly now that vaccinations are available and contagious coronavirus variants have become prevalent.

“Further research is needed to assess the effectiveness of public health measures after adequate vaccination coverage has been achieved,” they wrote.

“It is likely that further control of the COVID-19 pandemic depends not only on high vaccination coverage and its effectiveness but also on ongoing adherence to effective and sustainable public health measures,” they concluded.

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

When people wear face masks to reduce the spread of the coronavirus, the number of new COVID-19 infections drops by 53%, according to a new study published Nov. 18 in the British Medical Journal.

Social distancing and handwashing were also effective at lowering the number of cases, but wearing masks was the most effective tool against the coronavirus.

“Personal and social measures, including handwashing, mask wearing, and physical distancing are effective at reducing the incidence of COVID-19,” the study authors wrote.

The research team, which included public health and infectious disease specialists in Australia, China, and the U.K., evaluated 72 studies of COVID-19 precautions during the pandemic. They later looked at eight studies that focused on handwashing, mask wearing, and physical distancing.

Among six studies that looked at mask wearing, the researchers found a 53% reduction in COVID-19 cases. In the broader analysis with additional studies, wearing a mask reduced coronavirus transmission, cases, and deaths.

In one study across 200 countries, mandatory mask wearing resulted in nearly 46% fewer negative outcomes from COVID-19. In another study in the U.S., coronavirus transmission was reduced 29% in states where masks were mandatory.

But the research team couldn’t analyze the impact of the type of face mask used, the frequency of mask wearing, or the overall compliance with wearing face masks.

Among five studies that looked at physical distancing, the researchers found a 25% reduction in the rate of COVID-19. A study in the U.S. showed a 12% decrease in coronavirus transmission, while another study in Iran reported a reduction in COVID-19 mortality.

Handwashing interventions also suggested a substantial reduction of COVID-19 cases up to 53%, the researchers wrote. But in adjusted models, the results weren’t statistically significant due to the small number of studies included.

Other studies found significant decreases related to other public health measures, such as quarantines, broad lockdowns, border closures, school closures, business closures, and travel restrictions. Still, the research team couldn’t analyze the overall effectiveness of these measures due to the different ways the studies were conducted.

The study lines up with other research conducted so far during the pandemic, the research team wrote, which indicates that wearing masks and physical distancing can reduce transmission, cases, and deaths.

That said, more studies are needed, particularly now that vaccinations are available and contagious coronavirus variants have become prevalent.

“Further research is needed to assess the effectiveness of public health measures after adequate vaccination coverage has been achieved,” they wrote.

“It is likely that further control of the COVID-19 pandemic depends not only on high vaccination coverage and its effectiveness but also on ongoing adherence to effective and sustainable public health measures,” they concluded.

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

Mounting evidence suggests selective serotonin reuptake inhibitors (SSRI) are associated with lower COVID-19 severity.

A large analysis of health records shows patients with COVID-19 taking an SSRI were significantly less likely to die of COVID-19 than a matched control group.

Data-driven approach

Investigators analyzed data from the Cerner Real World Data COVID-19 deidentified electronic health records database of 490,373 patients with COVID-19 across 87 health centers, including 3,401 patients who were prescribed SSRIs.

When compared with matched patients with COVID-19 taking SSRIs, patients taking fluoxetine were 28% less likely to die (relative risk, 0.72; 95% CI, 0.54-0.97; adjusted P = .03) and those taking either fluoxetine or fluvoxamine were 26% less likely to die (RR, 0.74; 95% CI, 0.55-0.99; adjusted P = .04) versus those not on these medications.

Patients with COVID-19 taking any kind of SSRI were 8% less likely to die than the matched controls (RR, 0.92; 95% CI, 0.85-0.99; adjusted P = .03).

“We observed a statistically significant reduction in mortality of COVID-19 patients who were already taking SSRIs. This is a demonstration of a data-driven approach for identifying new uses for existing drugs,” Dr. Sirota said in an interview.

“Our study simply shows an association between SSRIs and COVID-19 outcomes and doesn’t investigate the mechanism of action of why the drugs might work. Additional clinical trials need to be carried out before these drugs can be used in patients going forward,” she cautioned.

“There is currently an open-label trial investigating fluoxetine to reduce intubation and death after COVID-19. To our knowledge, there are no phase 3 randomized controlled trials taking place or planned,” study investigator Tomiko Oskotsky, MD, with UCSF, told this news organization.

Urgent need

The current results “confirm and expand on prior findings from observational, preclinical, and clinical studies suggesting that certain SSRI antidepressants, including fluoxetine or fluvoxamine, could be beneficial against COVID-19,” Nicolas Hoertel, MD, PhD, MPH, with Paris University and Corentin-Celton Hospital, France, writes in a linked editorial.

Dr. Hoertel notes that the anti-inflammatory properties of SSRIs may underlie their potential action against COVID-19, and other potential mechanisms may include reduction in platelet aggregation, decreased mast cell degranulation, increased melatonin levels, interference with endolysosomal viral trafficking, and antioxidant activities.

“Because most of the world’s population is currently unvaccinated and the COVID-19 pandemic is still active, effective treatments of COVID-19 – especially those that are easy to use, show good tolerability, can be administered orally, and have widespread availability at low cost to allow their use in resource-poor countries – are urgently needed to reduce COVID-19-related mortality and morbidity,” Dr. Hoertel points out.

“In this context, short-term use of fluoxetine or fluvoxamine, if proven effective, should be considered as a potential means of reaching this goal,” he adds.

The study was supported by the Christopher Hess Research Fund and, in part, by UCSF and the National Institutes of Health. Dr. Sirota has reported serving as a scientific advisor at Aria Pharmaceuticals. Dr. Hoertel has reported being listed as an inventor on a patent application related to methods of treating COVID-19, filed by Assistance Publique-Hopitaux de Paris, and receiving consulting fees and nonfinancial support from Lundbeck.

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

Mounting evidence suggests selective serotonin reuptake inhibitors (SSRI) are associated with lower COVID-19 severity.

A large analysis of health records shows patients with COVID-19 taking an SSRI were significantly less likely to die of COVID-19 than a matched control group.

Data-driven approach

Investigators analyzed data from the Cerner Real World Data COVID-19 deidentified electronic health records database of 490,373 patients with COVID-19 across 87 health centers, including 3,401 patients who were prescribed SSRIs.

When compared with matched patients with COVID-19 taking SSRIs, patients taking fluoxetine were 28% less likely to die (relative risk, 0.72; 95% CI, 0.54-0.97; adjusted P = .03) and those taking either fluoxetine or fluvoxamine were 26% less likely to die (RR, 0.74; 95% CI, 0.55-0.99; adjusted P = .04) versus those not on these medications.

Patients with COVID-19 taking any kind of SSRI were 8% less likely to die than the matched controls (RR, 0.92; 95% CI, 0.85-0.99; adjusted P = .03).

“We observed a statistically significant reduction in mortality of COVID-19 patients who were already taking SSRIs. This is a demonstration of a data-driven approach for identifying new uses for existing drugs,” Dr. Sirota said in an interview.

“Our study simply shows an association between SSRIs and COVID-19 outcomes and doesn’t investigate the mechanism of action of why the drugs might work. Additional clinical trials need to be carried out before these drugs can be used in patients going forward,” she cautioned.

“There is currently an open-label trial investigating fluoxetine to reduce intubation and death after COVID-19. To our knowledge, there are no phase 3 randomized controlled trials taking place or planned,” study investigator Tomiko Oskotsky, MD, with UCSF, told this news organization.

Urgent need

The current results “confirm and expand on prior findings from observational, preclinical, and clinical studies suggesting that certain SSRI antidepressants, including fluoxetine or fluvoxamine, could be beneficial against COVID-19,” Nicolas Hoertel, MD, PhD, MPH, with Paris University and Corentin-Celton Hospital, France, writes in a linked editorial.

Dr. Hoertel notes that the anti-inflammatory properties of SSRIs may underlie their potential action against COVID-19, and other potential mechanisms may include reduction in platelet aggregation, decreased mast cell degranulation, increased melatonin levels, interference with endolysosomal viral trafficking, and antioxidant activities.

“Because most of the world’s population is currently unvaccinated and the COVID-19 pandemic is still active, effective treatments of COVID-19 – especially those that are easy to use, show good tolerability, can be administered orally, and have widespread availability at low cost to allow their use in resource-poor countries – are urgently needed to reduce COVID-19-related mortality and morbidity,” Dr. Hoertel points out.

“In this context, short-term use of fluoxetine or fluvoxamine, if proven effective, should be considered as a potential means of reaching this goal,” he adds.

The study was supported by the Christopher Hess Research Fund and, in part, by UCSF and the National Institutes of Health. Dr. Sirota has reported serving as a scientific advisor at Aria Pharmaceuticals. Dr. Hoertel has reported being listed as an inventor on a patent application related to methods of treating COVID-19, filed by Assistance Publique-Hopitaux de Paris, and receiving consulting fees and nonfinancial support from Lundbeck.

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

Mounting evidence suggests selective serotonin reuptake inhibitors (SSRI) are associated with lower COVID-19 severity.

A large analysis of health records shows patients with COVID-19 taking an SSRI were significantly less likely to die of COVID-19 than a matched control group.

Data-driven approach

Investigators analyzed data from the Cerner Real World Data COVID-19 deidentified electronic health records database of 490,373 patients with COVID-19 across 87 health centers, including 3,401 patients who were prescribed SSRIs.

When compared with matched patients with COVID-19 taking SSRIs, patients taking fluoxetine were 28% less likely to die (relative risk, 0.72; 95% CI, 0.54-0.97; adjusted P = .03) and those taking either fluoxetine or fluvoxamine were 26% less likely to die (RR, 0.74; 95% CI, 0.55-0.99; adjusted P = .04) versus those not on these medications.

Patients with COVID-19 taking any kind of SSRI were 8% less likely to die than the matched controls (RR, 0.92; 95% CI, 0.85-0.99; adjusted P = .03).

“We observed a statistically significant reduction in mortality of COVID-19 patients who were already taking SSRIs. This is a demonstration of a data-driven approach for identifying new uses for existing drugs,” Dr. Sirota said in an interview.

“Our study simply shows an association between SSRIs and COVID-19 outcomes and doesn’t investigate the mechanism of action of why the drugs might work. Additional clinical trials need to be carried out before these drugs can be used in patients going forward,” she cautioned.

“There is currently an open-label trial investigating fluoxetine to reduce intubation and death after COVID-19. To our knowledge, there are no phase 3 randomized controlled trials taking place or planned,” study investigator Tomiko Oskotsky, MD, with UCSF, told this news organization.

Urgent need

The current results “confirm and expand on prior findings from observational, preclinical, and clinical studies suggesting that certain SSRI antidepressants, including fluoxetine or fluvoxamine, could be beneficial against COVID-19,” Nicolas Hoertel, MD, PhD, MPH, with Paris University and Corentin-Celton Hospital, France, writes in a linked editorial.

Dr. Hoertel notes that the anti-inflammatory properties of SSRIs may underlie their potential action against COVID-19, and other potential mechanisms may include reduction in platelet aggregation, decreased mast cell degranulation, increased melatonin levels, interference with endolysosomal viral trafficking, and antioxidant activities.

“Because most of the world’s population is currently unvaccinated and the COVID-19 pandemic is still active, effective treatments of COVID-19 – especially those that are easy to use, show good tolerability, can be administered orally, and have widespread availability at low cost to allow their use in resource-poor countries – are urgently needed to reduce COVID-19-related mortality and morbidity,” Dr. Hoertel points out.

“In this context, short-term use of fluoxetine or fluvoxamine, if proven effective, should be considered as a potential means of reaching this goal,” he adds.

The study was supported by the Christopher Hess Research Fund and, in part, by UCSF and the National Institutes of Health. Dr. Sirota has reported serving as a scientific advisor at Aria Pharmaceuticals. Dr. Hoertel has reported being listed as an inventor on a patent application related to methods of treating COVID-19, filed by Assistance Publique-Hopitaux de Paris, and receiving consulting fees and nonfinancial support from Lundbeck.

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

When parents of children with autism spectrum disorder (ASD) participating in the largest clinical trial of intranasal oxytocin to date came in for follow-up visits with investigators, they reported marked improvement in the children’s social functioning.

Kids who rarely communicated with their families began to interact more. Those who usually preferred to isolate themselves started joining their parents for meals. It all seemed so promising – until the data came in.

“Those sounded like real improvements to me, and it seemed like they increased over the period of the study,” lead investigator Linmarie Sikich, MD, an associate clinical professor of psychiatry with Duke University School of Medicine and the Duke Center for Autism and Brain Development, Durham, N.C., told this news organization. “Turns out it wasn’t oxytocin that was making that difference.”

Researchers found that after 24 weeks of daily treatment with intranasal oxytocin, there were no significant differences in social functioning between children who received active treatment and those in the placebo group.

The much-anticipated results were published online in The New England Journal of Medicine. To say that they are disappointing, Dr. Sikich said, is an understatement.
 

Increase in off-label use

Most studies in mouse models of ASD and small trials in children produced conflicting results, although there were modest improvements in social functioning associated with the use of intranasal oxytocin. Some clinicians were already prescribing it off label.

On the basis of this research and early feedback from parents of children, Dr. Sikich and colleagues were hopeful.

However, results from a rigorous, 5-year, $11.4 million randomized trial were negative. Yet, parents were convinced their child improved during the study, and there was a significant increase in off-label prescribing of a treatment her research says doesn’t work. What’s next for oxytocin?

Known as the “love hormone,” oxytocin is a neurotransmitter that is primarily synthesized in the hypothalamus. It plays a role in childbirth and lactation and is also involved in the regulation of social functioning and emotions. Research suggests low oxytocin levels are associated with diminished social functioning, regardless of ASD status.

Its potential as an autism therapy for children has been under study for a decade. Some findings link its use to improvements in core deficits associated with ASD, including repetitive behaviors, fixated or restricted interest, and social communication. A study published in 2020 showed that the treatment improved symptoms in high-functioning adults with ASD.

These were mostly small studies and were underpowered to reliably detect an effect of the therapy on social functioning. They often involved only a single dose of oxytocin. Some studies showed improvements, but others did not.

Still, interest in the treatment grew. Physicians began prescribing it for children with ASD, and parents began buying products containing oxytocin on the internet. Researchers feared this off-label use was becoming widespread, despite inconclusive evidence of efficacy.
 

High hopes

With support from a National Institutes of Health grant, Dr. Sikich and her team designed a phase 2, multicenter, randomized, double-blind, placebo-controlled study to determine whether the use of oxytocin in children with ASD works and is safe.

The challenges began before they even enrolled a single child. A number of behavioral assessment tools are used to measure social function in ASD, but there is no consensus on which one is best.

A simple blood test could determine how much oxytocin from the nasal spray was absorbed in the blood, but identifying how much made it to the brain would require fMRI, which is expensive and is challenging to use in this study population. Then there was the acquisition of the drug itself.

The Food and Drug Administration has approved intravenous oxytocin for inducing labor. Intranasal oxytocin is not approved for any indication and isn’t available commercially in the United States. Patients or researchers must secure the drug from a manufacturer in a country where it is approved or order it from a U.S. pharmacy that is capable of compounding IV oxytocin into an intranasal formulation.

The pharmacy in Switzerland Dr. Sikich planned to use couldn’t make enough for the study. Contracting with a compounding pharmacy in the United States was significantly more expensive and time consuming, but it was the researchers’ only option.

“If it hadn’t been something we expected to have a major benefit, I think we would have given up the project at multiple points along the line due to all of these challenges,” said Dr. Sikich.

In August 2014, with all the pieces finally in place, researchers began enrolling children aged 3-17 years. The final cohort included 290 participants with ASD, 146 in the oxytocin group and 144 in the placebo group. Of these, 48% had minimal verbal fluency, and 52% had fluent verbal speech.

Participants received daily synthetic oxytocin or placebo via a nasal spray for 24 weeks. The daily oxytocin dose was 48 IU for the first 7 weeks. After that, the dosage could be titrated to a maximum of 80 IU/d. The mean maximal total daily dose of oxytocin throughout the study was 67.6 ± 16.9 IU.
 

‘It just didn’t work’

Both study groups showed improvement in social withdrawal beginning at 4 weeks and continuing throughout the trial, as determined on the basis of caretakers’ responses on the Aberrant Behavior Checklist Modified Social Withdrawal Subscale, the study’s primary outcome measure.

Sociability and social motivation also improved in both groups, as measured by the Pervasive Developmental Disorders Behavior Inventory and the Social Responsiveness Scale.

But by the end of the trial, the difference between the groups in improvement of social function wasn’t significant (difference, -0.2 points; P = .61) after adjusting for age, verbal fluency, and baseline oxytocin level.

“We were so convinced that it would work,” Dr. Sikich said, “but it just didn’t.”

From observation, parents were also convinced the therapy was working. At the trial’s conclusion, fewer than half of caregivers correctly guessed whether their child was in the treatment group or the placebo group.

A lot of development changes can happen in a child over 6 months. It’s possible the improvements would have occurred regardless of the trial, Dr. Sikich said. Parents’ perceptions could also be a placebo effect. Their child was in a clinical trial of a drug they believed could improve social functioning, so in their mind, it did.

Caregivers received training in how to identify certain behavioral changes, which may have helped them spot an existing positive change they had previously overlooked. Or they may have worked with their child more intently as a result of their participation in the trial.

“People may start doing more things or doing them more intensively or purposefully, consciously or subconsciously, to try to help their child improve the skills or behaviors targeted by the active therapy in the study,” Dr. Sikich said. “These are things that might really help the child move forward which are completely separate from the medication being studied.”

The safety analysis offered more hopeful results. Only one serious adverse event from the treatment was reported: A 17-year-old participant taking a daily dose of 48 IU experienced a sedating effect while driving and had an accident.
 

Too soon to walk away?

Perhaps the most important take-away from the study is that even if it’s safe, intranasal oxytocin as it is currently used doesn’t work and clinicians shouldn’t prescribe it, said Daniel Geschwind, MD, PhD, director of the University of California, Los Angeles (UCLA) Center for Autism Research, who penned a commentary on the study and discussed the findings with this news organization.

“This study shows that using oxytocin the way it’s used in the community right now is not helping anybody, so why put a child through that?” added Dr. Geschwind, who also is a professor of genetics, neurology, and psychiatry at UCLA.

The trial highlights areas that need to be addressed in order to improve research in the field, he said. Establishing a consensus process to measure social functioning and figuring out a better way to access intranasal oxytocin would lead to studies that are more conclusive, comparable, and less expensive. Dr. Sikich agrees.

Despite the findings, Dr. Geschwind and other autism researchers say it’s too soon to walk away from oxytocin altogether, although it may be time to change the approach to autism research.

“We have to take a page from the playbook of modern medicine in other areas and begin to recognize that these syndromes are incredibly heterogeneous,” Dr. Geschwind says. “We can surmise, although we don’t know, that there might be different biological forms of autism that have different pathways involved that are going to respond differently to different medications.”

Calling the researchers’ efforts “heroic,” Karen Parker, PhD, an associate professor and associate chair of psychiatry and behavioral sciences at Stanford (Calif.) University, says efficacy trials such as this one are critical. However, Dr. Parker said in an interview, there are a number of questions that the study didn’t address.

The majority of medication dispensed in a standard intranasal device is sprayed into the back of the throat. Regular blood tests confirmed that oxytocin was getting into participants’ system, but, given how quickly oxytocin degrades in the blood, Dr. Parker said it’s hard to know just how much reached the brain.

It’s also unclear whether the results would have been different had the treatment been paired with behavioral therapy, an approach Dr. Parker suggests might benefit a subset of children with ASD.

A 2017 study from Dr. Parker’s lab found that children with ASD whose use of oxytocin at baseline was low derived greater benefit from synthetic oxytocin, something the new study failed to find. Still, Dr. Parker said, it’s possible oxytocin might increase social motivation and increase a child’s receptiveness to behavioral therapy.

“When you see a negative trial like this, it decreases enthusiasm for the therapy for autism in this context,” Dr. Parker said. “I hope people who are studying these syndromes will continue to explore oxytocin as a therapy.”

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development through the Autism Centers of Excellence Program and the Department of Psychiatry and Behavioral Sciences at Duke University. Full disclosures of the authors’ possible conflicts of interest are available online.

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

When parents of children with autism spectrum disorder (ASD) participating in the largest clinical trial of intranasal oxytocin to date came in for follow-up visits with investigators, they reported marked improvement in the children’s social functioning.

Kids who rarely communicated with their families began to interact more. Those who usually preferred to isolate themselves started joining their parents for meals. It all seemed so promising – until the data came in.

“Those sounded like real improvements to me, and it seemed like they increased over the period of the study,” lead investigator Linmarie Sikich, MD, an associate clinical professor of psychiatry with Duke University School of Medicine and the Duke Center for Autism and Brain Development, Durham, N.C., told this news organization. “Turns out it wasn’t oxytocin that was making that difference.”

Researchers found that after 24 weeks of daily treatment with intranasal oxytocin, there were no significant differences in social functioning between children who received active treatment and those in the placebo group.

The much-anticipated results were published online in The New England Journal of Medicine. To say that they are disappointing, Dr. Sikich said, is an understatement.
 

Increase in off-label use

Most studies in mouse models of ASD and small trials in children produced conflicting results, although there were modest improvements in social functioning associated with the use of intranasal oxytocin. Some clinicians were already prescribing it off label.

On the basis of this research and early feedback from parents of children, Dr. Sikich and colleagues were hopeful.

However, results from a rigorous, 5-year, $11.4 million randomized trial were negative. Yet, parents were convinced their child improved during the study, and there was a significant increase in off-label prescribing of a treatment her research says doesn’t work. What’s next for oxytocin?

Known as the “love hormone,” oxytocin is a neurotransmitter that is primarily synthesized in the hypothalamus. It plays a role in childbirth and lactation and is also involved in the regulation of social functioning and emotions. Research suggests low oxytocin levels are associated with diminished social functioning, regardless of ASD status.

Its potential as an autism therapy for children has been under study for a decade. Some findings link its use to improvements in core deficits associated with ASD, including repetitive behaviors, fixated or restricted interest, and social communication. A study published in 2020 showed that the treatment improved symptoms in high-functioning adults with ASD.

These were mostly small studies and were underpowered to reliably detect an effect of the therapy on social functioning. They often involved only a single dose of oxytocin. Some studies showed improvements, but others did not.

Still, interest in the treatment grew. Physicians began prescribing it for children with ASD, and parents began buying products containing oxytocin on the internet. Researchers feared this off-label use was becoming widespread, despite inconclusive evidence of efficacy.
 

High hopes

With support from a National Institutes of Health grant, Dr. Sikich and her team designed a phase 2, multicenter, randomized, double-blind, placebo-controlled study to determine whether the use of oxytocin in children with ASD works and is safe.

The challenges began before they even enrolled a single child. A number of behavioral assessment tools are used to measure social function in ASD, but there is no consensus on which one is best.

A simple blood test could determine how much oxytocin from the nasal spray was absorbed in the blood, but identifying how much made it to the brain would require fMRI, which is expensive and is challenging to use in this study population. Then there was the acquisition of the drug itself.

The Food and Drug Administration has approved intravenous oxytocin for inducing labor. Intranasal oxytocin is not approved for any indication and isn’t available commercially in the United States. Patients or researchers must secure the drug from a manufacturer in a country where it is approved or order it from a U.S. pharmacy that is capable of compounding IV oxytocin into an intranasal formulation.

The pharmacy in Switzerland Dr. Sikich planned to use couldn’t make enough for the study. Contracting with a compounding pharmacy in the United States was significantly more expensive and time consuming, but it was the researchers’ only option.

“If it hadn’t been something we expected to have a major benefit, I think we would have given up the project at multiple points along the line due to all of these challenges,” said Dr. Sikich.

In August 2014, with all the pieces finally in place, researchers began enrolling children aged 3-17 years. The final cohort included 290 participants with ASD, 146 in the oxytocin group and 144 in the placebo group. Of these, 48% had minimal verbal fluency, and 52% had fluent verbal speech.

Participants received daily synthetic oxytocin or placebo via a nasal spray for 24 weeks. The daily oxytocin dose was 48 IU for the first 7 weeks. After that, the dosage could be titrated to a maximum of 80 IU/d. The mean maximal total daily dose of oxytocin throughout the study was 67.6 ± 16.9 IU.
 

‘It just didn’t work’

Both study groups showed improvement in social withdrawal beginning at 4 weeks and continuing throughout the trial, as determined on the basis of caretakers’ responses on the Aberrant Behavior Checklist Modified Social Withdrawal Subscale, the study’s primary outcome measure.

Sociability and social motivation also improved in both groups, as measured by the Pervasive Developmental Disorders Behavior Inventory and the Social Responsiveness Scale.

But by the end of the trial, the difference between the groups in improvement of social function wasn’t significant (difference, -0.2 points; P = .61) after adjusting for age, verbal fluency, and baseline oxytocin level.

“We were so convinced that it would work,” Dr. Sikich said, “but it just didn’t.”

From observation, parents were also convinced the therapy was working. At the trial’s conclusion, fewer than half of caregivers correctly guessed whether their child was in the treatment group or the placebo group.

A lot of development changes can happen in a child over 6 months. It’s possible the improvements would have occurred regardless of the trial, Dr. Sikich said. Parents’ perceptions could also be a placebo effect. Their child was in a clinical trial of a drug they believed could improve social functioning, so in their mind, it did.

Caregivers received training in how to identify certain behavioral changes, which may have helped them spot an existing positive change they had previously overlooked. Or they may have worked with their child more intently as a result of their participation in the trial.

“People may start doing more things or doing them more intensively or purposefully, consciously or subconsciously, to try to help their child improve the skills or behaviors targeted by the active therapy in the study,” Dr. Sikich said. “These are things that might really help the child move forward which are completely separate from the medication being studied.”

The safety analysis offered more hopeful results. Only one serious adverse event from the treatment was reported: A 17-year-old participant taking a daily dose of 48 IU experienced a sedating effect while driving and had an accident.
 

Too soon to walk away?

Perhaps the most important take-away from the study is that even if it’s safe, intranasal oxytocin as it is currently used doesn’t work and clinicians shouldn’t prescribe it, said Daniel Geschwind, MD, PhD, director of the University of California, Los Angeles (UCLA) Center for Autism Research, who penned a commentary on the study and discussed the findings with this news organization.

“This study shows that using oxytocin the way it’s used in the community right now is not helping anybody, so why put a child through that?” added Dr. Geschwind, who also is a professor of genetics, neurology, and psychiatry at UCLA.

The trial highlights areas that need to be addressed in order to improve research in the field, he said. Establishing a consensus process to measure social functioning and figuring out a better way to access intranasal oxytocin would lead to studies that are more conclusive, comparable, and less expensive. Dr. Sikich agrees.

Despite the findings, Dr. Geschwind and other autism researchers say it’s too soon to walk away from oxytocin altogether, although it may be time to change the approach to autism research.

“We have to take a page from the playbook of modern medicine in other areas and begin to recognize that these syndromes are incredibly heterogeneous,” Dr. Geschwind says. “We can surmise, although we don’t know, that there might be different biological forms of autism that have different pathways involved that are going to respond differently to different medications.”

Calling the researchers’ efforts “heroic,” Karen Parker, PhD, an associate professor and associate chair of psychiatry and behavioral sciences at Stanford (Calif.) University, says efficacy trials such as this one are critical. However, Dr. Parker said in an interview, there are a number of questions that the study didn’t address.

The majority of medication dispensed in a standard intranasal device is sprayed into the back of the throat. Regular blood tests confirmed that oxytocin was getting into participants’ system, but, given how quickly oxytocin degrades in the blood, Dr. Parker said it’s hard to know just how much reached the brain.

It’s also unclear whether the results would have been different had the treatment been paired with behavioral therapy, an approach Dr. Parker suggests might benefit a subset of children with ASD.

A 2017 study from Dr. Parker’s lab found that children with ASD whose use of oxytocin at baseline was low derived greater benefit from synthetic oxytocin, something the new study failed to find. Still, Dr. Parker said, it’s possible oxytocin might increase social motivation and increase a child’s receptiveness to behavioral therapy.

“When you see a negative trial like this, it decreases enthusiasm for the therapy for autism in this context,” Dr. Parker said. “I hope people who are studying these syndromes will continue to explore oxytocin as a therapy.”

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development through the Autism Centers of Excellence Program and the Department of Psychiatry and Behavioral Sciences at Duke University. Full disclosures of the authors’ possible conflicts of interest are available online.

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

When parents of children with autism spectrum disorder (ASD) participating in the largest clinical trial of intranasal oxytocin to date came in for follow-up visits with investigators, they reported marked improvement in the children’s social functioning.

Kids who rarely communicated with their families began to interact more. Those who usually preferred to isolate themselves started joining their parents for meals. It all seemed so promising – until the data came in.

“Those sounded like real improvements to me, and it seemed like they increased over the period of the study,” lead investigator Linmarie Sikich, MD, an associate clinical professor of psychiatry with Duke University School of Medicine and the Duke Center for Autism and Brain Development, Durham, N.C., told this news organization. “Turns out it wasn’t oxytocin that was making that difference.”

Researchers found that after 24 weeks of daily treatment with intranasal oxytocin, there were no significant differences in social functioning between children who received active treatment and those in the placebo group.

The much-anticipated results were published online in The New England Journal of Medicine. To say that they are disappointing, Dr. Sikich said, is an understatement.
 

Increase in off-label use

Most studies in mouse models of ASD and small trials in children produced conflicting results, although there were modest improvements in social functioning associated with the use of intranasal oxytocin. Some clinicians were already prescribing it off label.

On the basis of this research and early feedback from parents of children, Dr. Sikich and colleagues were hopeful.

However, results from a rigorous, 5-year, $11.4 million randomized trial were negative. Yet, parents were convinced their child improved during the study, and there was a significant increase in off-label prescribing of a treatment her research says doesn’t work. What’s next for oxytocin?

Known as the “love hormone,” oxytocin is a neurotransmitter that is primarily synthesized in the hypothalamus. It plays a role in childbirth and lactation and is also involved in the regulation of social functioning and emotions. Research suggests low oxytocin levels are associated with diminished social functioning, regardless of ASD status.

Its potential as an autism therapy for children has been under study for a decade. Some findings link its use to improvements in core deficits associated with ASD, including repetitive behaviors, fixated or restricted interest, and social communication. A study published in 2020 showed that the treatment improved symptoms in high-functioning adults with ASD.

These were mostly small studies and were underpowered to reliably detect an effect of the therapy on social functioning. They often involved only a single dose of oxytocin. Some studies showed improvements, but others did not.

Still, interest in the treatment grew. Physicians began prescribing it for children with ASD, and parents began buying products containing oxytocin on the internet. Researchers feared this off-label use was becoming widespread, despite inconclusive evidence of efficacy.
 

High hopes

With support from a National Institutes of Health grant, Dr. Sikich and her team designed a phase 2, multicenter, randomized, double-blind, placebo-controlled study to determine whether the use of oxytocin in children with ASD works and is safe.

The challenges began before they even enrolled a single child. A number of behavioral assessment tools are used to measure social function in ASD, but there is no consensus on which one is best.

A simple blood test could determine how much oxytocin from the nasal spray was absorbed in the blood, but identifying how much made it to the brain would require fMRI, which is expensive and is challenging to use in this study population. Then there was the acquisition of the drug itself.

The Food and Drug Administration has approved intravenous oxytocin for inducing labor. Intranasal oxytocin is not approved for any indication and isn’t available commercially in the United States. Patients or researchers must secure the drug from a manufacturer in a country where it is approved or order it from a U.S. pharmacy that is capable of compounding IV oxytocin into an intranasal formulation.

The pharmacy in Switzerland Dr. Sikich planned to use couldn’t make enough for the study. Contracting with a compounding pharmacy in the United States was significantly more expensive and time consuming, but it was the researchers’ only option.

“If it hadn’t been something we expected to have a major benefit, I think we would have given up the project at multiple points along the line due to all of these challenges,” said Dr. Sikich.

In August 2014, with all the pieces finally in place, researchers began enrolling children aged 3-17 years. The final cohort included 290 participants with ASD, 146 in the oxytocin group and 144 in the placebo group. Of these, 48% had minimal verbal fluency, and 52% had fluent verbal speech.

Participants received daily synthetic oxytocin or placebo via a nasal spray for 24 weeks. The daily oxytocin dose was 48 IU for the first 7 weeks. After that, the dosage could be titrated to a maximum of 80 IU/d. The mean maximal total daily dose of oxytocin throughout the study was 67.6 ± 16.9 IU.
 

‘It just didn’t work’

Both study groups showed improvement in social withdrawal beginning at 4 weeks and continuing throughout the trial, as determined on the basis of caretakers’ responses on the Aberrant Behavior Checklist Modified Social Withdrawal Subscale, the study’s primary outcome measure.

Sociability and social motivation also improved in both groups, as measured by the Pervasive Developmental Disorders Behavior Inventory and the Social Responsiveness Scale.

But by the end of the trial, the difference between the groups in improvement of social function wasn’t significant (difference, -0.2 points; P = .61) after adjusting for age, verbal fluency, and baseline oxytocin level.

“We were so convinced that it would work,” Dr. Sikich said, “but it just didn’t.”

From observation, parents were also convinced the therapy was working. At the trial’s conclusion, fewer than half of caregivers correctly guessed whether their child was in the treatment group or the placebo group.

A lot of development changes can happen in a child over 6 months. It’s possible the improvements would have occurred regardless of the trial, Dr. Sikich said. Parents’ perceptions could also be a placebo effect. Their child was in a clinical trial of a drug they believed could improve social functioning, so in their mind, it did.

Caregivers received training in how to identify certain behavioral changes, which may have helped them spot an existing positive change they had previously overlooked. Or they may have worked with their child more intently as a result of their participation in the trial.

“People may start doing more things or doing them more intensively or purposefully, consciously or subconsciously, to try to help their child improve the skills or behaviors targeted by the active therapy in the study,” Dr. Sikich said. “These are things that might really help the child move forward which are completely separate from the medication being studied.”

The safety analysis offered more hopeful results. Only one serious adverse event from the treatment was reported: A 17-year-old participant taking a daily dose of 48 IU experienced a sedating effect while driving and had an accident.
 

Too soon to walk away?

Perhaps the most important take-away from the study is that even if it’s safe, intranasal oxytocin as it is currently used doesn’t work and clinicians shouldn’t prescribe it, said Daniel Geschwind, MD, PhD, director of the University of California, Los Angeles (UCLA) Center for Autism Research, who penned a commentary on the study and discussed the findings with this news organization.

“This study shows that using oxytocin the way it’s used in the community right now is not helping anybody, so why put a child through that?” added Dr. Geschwind, who also is a professor of genetics, neurology, and psychiatry at UCLA.

The trial highlights areas that need to be addressed in order to improve research in the field, he said. Establishing a consensus process to measure social functioning and figuring out a better way to access intranasal oxytocin would lead to studies that are more conclusive, comparable, and less expensive. Dr. Sikich agrees.

Despite the findings, Dr. Geschwind and other autism researchers say it’s too soon to walk away from oxytocin altogether, although it may be time to change the approach to autism research.

“We have to take a page from the playbook of modern medicine in other areas and begin to recognize that these syndromes are incredibly heterogeneous,” Dr. Geschwind says. “We can surmise, although we don’t know, that there might be different biological forms of autism that have different pathways involved that are going to respond differently to different medications.”

Calling the researchers’ efforts “heroic,” Karen Parker, PhD, an associate professor and associate chair of psychiatry and behavioral sciences at Stanford (Calif.) University, says efficacy trials such as this one are critical. However, Dr. Parker said in an interview, there are a number of questions that the study didn’t address.

The majority of medication dispensed in a standard intranasal device is sprayed into the back of the throat. Regular blood tests confirmed that oxytocin was getting into participants’ system, but, given how quickly oxytocin degrades in the blood, Dr. Parker said it’s hard to know just how much reached the brain.

It’s also unclear whether the results would have been different had the treatment been paired with behavioral therapy, an approach Dr. Parker suggests might benefit a subset of children with ASD.

A 2017 study from Dr. Parker’s lab found that children with ASD whose use of oxytocin at baseline was low derived greater benefit from synthetic oxytocin, something the new study failed to find. Still, Dr. Parker said, it’s possible oxytocin might increase social motivation and increase a child’s receptiveness to behavioral therapy.

“When you see a negative trial like this, it decreases enthusiasm for the therapy for autism in this context,” Dr. Parker said. “I hope people who are studying these syndromes will continue to explore oxytocin as a therapy.”

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development through the Autism Centers of Excellence Program and the Department of Psychiatry and Behavioral Sciences at Duke University. Full disclosures of the authors’ possible conflicts of interest are available online.

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

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

A new survey of U.S. patients with breast cancer found that 42% were using cannabis, primarily to relieve side effects associated with treatment, such as pain, anxiety, nausea, and insomnia.

Most (75%) of the patients who reported using cannabis said it was extremely helpful or very helpful in alleviating symptoms.

The authors warn of potential safety concerns with cannabis, especially with the use of unregulated products.

In addition, the survey found that physicians were not highly regarded as a source of information about cannabis use. Only 39% of patients said that they discussed cannabis with their physicians; 28% reported feeling uncomfortable when broaching the topic. Only 4% indicated that physicians were the most helpful source of information about cannabis.

The survey involved 612 patients with breast cancer. The results were published online Oct. 12 in Cancer.

“Our study highlights an important opportunity for providers to initiate informed conversations about medical cannabis with their patients, as the evidence shows that many are using medical cannabis without our knowledge or guidance,” said lead author Marisa Weiss, MD, of Breastcancer.org and the Lankenau Medical Center, near Philadelphia. “Not knowing whether or not our cancer patients are using cannabis is a major blind spot in our ability to provide optimal care,” she said.

Cannabis in one form or another has been legalized in many states across America, and even in states where it hasn’t been legalized, people are using it.

“Even though many states have relaxed their laws on cannabis, it remains a Schedule I drug on the federal level and is essentially still considered illegal,” commented Donald I. Abrams, MD, professor of medicine at the University of California, San Francisco, and an integrative oncologist at the UCSF Osher Center for Integrative Medicine. “This is why many physicians are uncomfortable discussing it with patients,” he said.

“Cannabis use isn’t taught in medical school, and until that changes, I don’t know how physicians are going to be advisers for this,” said Dr. Abrams, who was approached by this news organization for comment.

This “is a really nice study in that it looks at a large group of breast cancer patients from the community ... It’s not from a single institution [such as this previous study] and so a more representative mix,” Dr. Abrams said.

However, he also commented that the article had a “scent of ‘reefer madness’” about it, given its emphasis on potential harms and safety concerns.

“It’s interesting how alcohol is considered mainstream but cannabis has been demonized,” he said. “Especially for women with breast cancer, it’s so clear that alcohol is related to the development of postmenopausal breast cancer. As a recreational intervention, cannabis in my mind appears to be much safer for women for relaxation.”

“The one thing I worry about are patients who take highly concentrated CBD [cannabidiol] oil, as it can block the metabolism of prescription drugs and allow them to build up in the blood,” Dr. Abrams said. “I advise people against using these products.”
 

Cannabis to relieve symptoms

Previous studies have noted widespread use of cannabis among patients with cancer. For example, a large study from Israel that included nearly 3,000 participants found that cannabis use improved a variety of cancer-related symptoms, including nausea and vomiting, sleep disorders, pain, anxiety, and depression. Among those with cancer who survived to 6 months and who finished the study protocol, 60% achieved “treatment success.” Of note, at 6 months, 36% of patients had stopped taking opioids, and for 9.9%, the dose of opioids had decreased.

In the current study, dubbed the Coala-T-Cannabis study, the investigators approached U.S. members of the Breastcancer.org and Healthline.com communities who self-reported that they had been diagnosed with breast cancer within the past 5 years; 612 surveys were completed.

Half of all respondents said they had looked for information on medical cannabis, but most were unsatisfied with the information that they had received. Only 6% were extremely satisfied; 25% were very satisfied with the information.

Most patients (39%) did not discuss cannabis use with their physicians. Of those who did, 28% reported feeling uncomfortable discussing the topic. Only 4% of survey respondents indicated that physicians were the most helpful source of cannabis information.

Regarding which source of information was most helpful, 22% said websites, 18% said family members or friends, 12% said staffers and pharmacists in dispensaries, and 7% said other patients with breast cancer.

Forty-two percent of the survey respondents said they used cannabis for medical purposes and for relief of symptoms, which included pain (78%), insomnia (70%), anxiety (57%), stress (51%), and nausea/vomiting (46%).

In addition, 49% believed that medical cannabis could be used to treat the cancer itself.

A fair number were also using cannabis for recreational purposes. Of those who used cannabis, only 23% reported that they used it for medical purposes only.

Participants used cannabis in a variety of forms. The most popular form of consumption was as edibles (70%), followed by liquids/tinctures (65%), smoking (51%), topicals (46%), and vape pens (45%). Participants reported using an average of 3.7 different products.
 

Safety concerns?

The authors caution about the use of cannabis while receiving anticancer therapies because such use “raises important efficacy and safety concerns.”

“Many chemotherapy agents as well as cannabinoids are metabolized in the liver’s p450 cytochrome system,” Dr. Weiss and colleagues note, and the mechanism by which cannabinoids interact with particular CYP450 isoenzymes “has the potential to alter the metabolism of other medications and lead to adverse side effects.”

They also question the safety of some of the cannabis products that are being used. Participants reported receiving cannabis from a variety of sources, which included state-regulated dispensaries, “dealers,” and family/friends.

Three-quarters of respondents believed that cannabis was better than “chemicals” and that the benefits outweighed the risks. But many of the products used are unregulated, the authors point out.

“Providers should communicate clearly about the health and safety concerns associated with certain cannabis products and methods of delivery,” they conclude. “Without these measures, patients may make these decisions without qualified medical guidance, obtain poor-quality cannabis products, and consume them through potentially hazardous delivery methods during various types of cancer therapies.”

The study was supported by research grants from Ananda Health/Ecofibre and the Dr. Philip Reeves Legacy Fund. Several coauthors reported relationships with industry, as noted in the article. Dr. Abrams owns stock in Cannformatics and Lumen; he has received honorarium from Clever Leaves and Maui Grown Therapies and speaker honorarium from GW Pharmaceuticals.

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

A new survey of U.S. patients with breast cancer found that 42% were using cannabis, primarily to relieve side effects associated with treatment, such as pain, anxiety, nausea, and insomnia.

Most (75%) of the patients who reported using cannabis said it was extremely helpful or very helpful in alleviating symptoms.

The authors warn of potential safety concerns with cannabis, especially with the use of unregulated products.

In addition, the survey found that physicians were not highly regarded as a source of information about cannabis use. Only 39% of patients said that they discussed cannabis with their physicians; 28% reported feeling uncomfortable when broaching the topic. Only 4% indicated that physicians were the most helpful source of information about cannabis.

The survey involved 612 patients with breast cancer. The results were published online Oct. 12 in Cancer.

“Our study highlights an important opportunity for providers to initiate informed conversations about medical cannabis with their patients, as the evidence shows that many are using medical cannabis without our knowledge or guidance,” said lead author Marisa Weiss, MD, of Breastcancer.org and the Lankenau Medical Center, near Philadelphia. “Not knowing whether or not our cancer patients are using cannabis is a major blind spot in our ability to provide optimal care,” she said.

Cannabis in one form or another has been legalized in many states across America, and even in states where it hasn’t been legalized, people are using it.

“Even though many states have relaxed their laws on cannabis, it remains a Schedule I drug on the federal level and is essentially still considered illegal,” commented Donald I. Abrams, MD, professor of medicine at the University of California, San Francisco, and an integrative oncologist at the UCSF Osher Center for Integrative Medicine. “This is why many physicians are uncomfortable discussing it with patients,” he said.

“Cannabis use isn’t taught in medical school, and until that changes, I don’t know how physicians are going to be advisers for this,” said Dr. Abrams, who was approached by this news organization for comment.

This “is a really nice study in that it looks at a large group of breast cancer patients from the community ... It’s not from a single institution [such as this previous study] and so a more representative mix,” Dr. Abrams said.

However, he also commented that the article had a “scent of ‘reefer madness’” about it, given its emphasis on potential harms and safety concerns.

“It’s interesting how alcohol is considered mainstream but cannabis has been demonized,” he said. “Especially for women with breast cancer, it’s so clear that alcohol is related to the development of postmenopausal breast cancer. As a recreational intervention, cannabis in my mind appears to be much safer for women for relaxation.”

“The one thing I worry about are patients who take highly concentrated CBD [cannabidiol] oil, as it can block the metabolism of prescription drugs and allow them to build up in the blood,” Dr. Abrams said. “I advise people against using these products.”
 

Cannabis to relieve symptoms

Previous studies have noted widespread use of cannabis among patients with cancer. For example, a large study from Israel that included nearly 3,000 participants found that cannabis use improved a variety of cancer-related symptoms, including nausea and vomiting, sleep disorders, pain, anxiety, and depression. Among those with cancer who survived to 6 months and who finished the study protocol, 60% achieved “treatment success.” Of note, at 6 months, 36% of patients had stopped taking opioids, and for 9.9%, the dose of opioids had decreased.

In the current study, dubbed the Coala-T-Cannabis study, the investigators approached U.S. members of the Breastcancer.org and Healthline.com communities who self-reported that they had been diagnosed with breast cancer within the past 5 years; 612 surveys were completed.

Half of all respondents said they had looked for information on medical cannabis, but most were unsatisfied with the information that they had received. Only 6% were extremely satisfied; 25% were very satisfied with the information.

Most patients (39%) did not discuss cannabis use with their physicians. Of those who did, 28% reported feeling uncomfortable discussing the topic. Only 4% of survey respondents indicated that physicians were the most helpful source of cannabis information.

Regarding which source of information was most helpful, 22% said websites, 18% said family members or friends, 12% said staffers and pharmacists in dispensaries, and 7% said other patients with breast cancer.

Forty-two percent of the survey respondents said they used cannabis for medical purposes and for relief of symptoms, which included pain (78%), insomnia (70%), anxiety (57%), stress (51%), and nausea/vomiting (46%).

In addition, 49% believed that medical cannabis could be used to treat the cancer itself.

A fair number were also using cannabis for recreational purposes. Of those who used cannabis, only 23% reported that they used it for medical purposes only.

Participants used cannabis in a variety of forms. The most popular form of consumption was as edibles (70%), followed by liquids/tinctures (65%), smoking (51%), topicals (46%), and vape pens (45%). Participants reported using an average of 3.7 different products.
 

Safety concerns?

The authors caution about the use of cannabis while receiving anticancer therapies because such use “raises important efficacy and safety concerns.”

“Many chemotherapy agents as well as cannabinoids are metabolized in the liver’s p450 cytochrome system,” Dr. Weiss and colleagues note, and the mechanism by which cannabinoids interact with particular CYP450 isoenzymes “has the potential to alter the metabolism of other medications and lead to adverse side effects.”

They also question the safety of some of the cannabis products that are being used. Participants reported receiving cannabis from a variety of sources, which included state-regulated dispensaries, “dealers,” and family/friends.

Three-quarters of respondents believed that cannabis was better than “chemicals” and that the benefits outweighed the risks. But many of the products used are unregulated, the authors point out.

“Providers should communicate clearly about the health and safety concerns associated with certain cannabis products and methods of delivery,” they conclude. “Without these measures, patients may make these decisions without qualified medical guidance, obtain poor-quality cannabis products, and consume them through potentially hazardous delivery methods during various types of cancer therapies.”

The study was supported by research grants from Ananda Health/Ecofibre and the Dr. Philip Reeves Legacy Fund. Several coauthors reported relationships with industry, as noted in the article. Dr. Abrams owns stock in Cannformatics and Lumen; he has received honorarium from Clever Leaves and Maui Grown Therapies and speaker honorarium from GW Pharmaceuticals.

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

A new survey of U.S. patients with breast cancer found that 42% were using cannabis, primarily to relieve side effects associated with treatment, such as pain, anxiety, nausea, and insomnia.

Most (75%) of the patients who reported using cannabis said it was extremely helpful or very helpful in alleviating symptoms.

The authors warn of potential safety concerns with cannabis, especially with the use of unregulated products.

In addition, the survey found that physicians were not highly regarded as a source of information about cannabis use. Only 39% of patients said that they discussed cannabis with their physicians; 28% reported feeling uncomfortable when broaching the topic. Only 4% indicated that physicians were the most helpful source of information about cannabis.

The survey involved 612 patients with breast cancer. The results were published online Oct. 12 in Cancer.

“Our study highlights an important opportunity for providers to initiate informed conversations about medical cannabis with their patients, as the evidence shows that many are using medical cannabis without our knowledge or guidance,” said lead author Marisa Weiss, MD, of Breastcancer.org and the Lankenau Medical Center, near Philadelphia. “Not knowing whether or not our cancer patients are using cannabis is a major blind spot in our ability to provide optimal care,” she said.

Cannabis in one form or another has been legalized in many states across America, and even in states where it hasn’t been legalized, people are using it.

“Even though many states have relaxed their laws on cannabis, it remains a Schedule I drug on the federal level and is essentially still considered illegal,” commented Donald I. Abrams, MD, professor of medicine at the University of California, San Francisco, and an integrative oncologist at the UCSF Osher Center for Integrative Medicine. “This is why many physicians are uncomfortable discussing it with patients,” he said.

“Cannabis use isn’t taught in medical school, and until that changes, I don’t know how physicians are going to be advisers for this,” said Dr. Abrams, who was approached by this news organization for comment.

This “is a really nice study in that it looks at a large group of breast cancer patients from the community ... It’s not from a single institution [such as this previous study] and so a more representative mix,” Dr. Abrams said.

However, he also commented that the article had a “scent of ‘reefer madness’” about it, given its emphasis on potential harms and safety concerns.

“It’s interesting how alcohol is considered mainstream but cannabis has been demonized,” he said. “Especially for women with breast cancer, it’s so clear that alcohol is related to the development of postmenopausal breast cancer. As a recreational intervention, cannabis in my mind appears to be much safer for women for relaxation.”

“The one thing I worry about are patients who take highly concentrated CBD [cannabidiol] oil, as it can block the metabolism of prescription drugs and allow them to build up in the blood,” Dr. Abrams said. “I advise people against using these products.”
 

Cannabis to relieve symptoms

Previous studies have noted widespread use of cannabis among patients with cancer. For example, a large study from Israel that included nearly 3,000 participants found that cannabis use improved a variety of cancer-related symptoms, including nausea and vomiting, sleep disorders, pain, anxiety, and depression. Among those with cancer who survived to 6 months and who finished the study protocol, 60% achieved “treatment success.” Of note, at 6 months, 36% of patients had stopped taking opioids, and for 9.9%, the dose of opioids had decreased.

In the current study, dubbed the Coala-T-Cannabis study, the investigators approached U.S. members of the Breastcancer.org and Healthline.com communities who self-reported that they had been diagnosed with breast cancer within the past 5 years; 612 surveys were completed.

Half of all respondents said they had looked for information on medical cannabis, but most were unsatisfied with the information that they had received. Only 6% were extremely satisfied; 25% were very satisfied with the information.

Most patients (39%) did not discuss cannabis use with their physicians. Of those who did, 28% reported feeling uncomfortable discussing the topic. Only 4% of survey respondents indicated that physicians were the most helpful source of cannabis information.

Regarding which source of information was most helpful, 22% said websites, 18% said family members or friends, 12% said staffers and pharmacists in dispensaries, and 7% said other patients with breast cancer.

Forty-two percent of the survey respondents said they used cannabis for medical purposes and for relief of symptoms, which included pain (78%), insomnia (70%), anxiety (57%), stress (51%), and nausea/vomiting (46%).

In addition, 49% believed that medical cannabis could be used to treat the cancer itself.

A fair number were also using cannabis for recreational purposes. Of those who used cannabis, only 23% reported that they used it for medical purposes only.

Participants used cannabis in a variety of forms. The most popular form of consumption was as edibles (70%), followed by liquids/tinctures (65%), smoking (51%), topicals (46%), and vape pens (45%). Participants reported using an average of 3.7 different products.
 

Safety concerns?

The authors caution about the use of cannabis while receiving anticancer therapies because such use “raises important efficacy and safety concerns.”

“Many chemotherapy agents as well as cannabinoids are metabolized in the liver’s p450 cytochrome system,” Dr. Weiss and colleagues note, and the mechanism by which cannabinoids interact with particular CYP450 isoenzymes “has the potential to alter the metabolism of other medications and lead to adverse side effects.”

They also question the safety of some of the cannabis products that are being used. Participants reported receiving cannabis from a variety of sources, which included state-regulated dispensaries, “dealers,” and family/friends.

Three-quarters of respondents believed that cannabis was better than “chemicals” and that the benefits outweighed the risks. But many of the products used are unregulated, the authors point out.

“Providers should communicate clearly about the health and safety concerns associated with certain cannabis products and methods of delivery,” they conclude. “Without these measures, patients may make these decisions without qualified medical guidance, obtain poor-quality cannabis products, and consume them through potentially hazardous delivery methods during various types of cancer therapies.”

The study was supported by research grants from Ananda Health/Ecofibre and the Dr. Philip Reeves Legacy Fund. Several coauthors reported relationships with industry, as noted in the article. Dr. Abrams owns stock in Cannformatics and Lumen; he has received honorarium from Clever Leaves and Maui Grown Therapies and speaker honorarium from GW Pharmaceuticals.

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

Mothers who use cannabis during pregnancy risk disrupting immune gene networks in the placenta and potentially increasing the risk of anxiety and hyperactivity in their children.

These findings emerged from a study led by Yasmin Hurd, PhD, a professor of psychiatry and director of the Addiction Institute at the Icahn School of Medicine at Mount Sinai, New York, and Yoko Nomura, PhD, a professor of behavioral neuroscience at Queen’s College, City University of New York, that was published online in Proceedings of the National Academy of Sciences.

The analysis assessed the effects of gestational maternal cannabis use on psychosocial and physiological measures in young children as well as its potentially immunomodulatory effect on the in utero environment as reflected in the placental transcriptome.

Participants were drawn from a larger cohort in a study launched in 2012; the investigators evaluated offspring aged 3-6 years for hair hormone levels, neurobehavioral traits on the Behavioral Assessment System for Children survey, and heart rate variability (HRV) at rest and during auditory startle.

The cohort consisted of 322 mother-child dyads and children with prenatal exposure to cannabis were compared with those having no exposure. The cohort consisted of 251 non–cannabis-using mothers and 71 cannabis-using mothers, with mean maternal ages in the two groups of 28.46 years and 25.91 years, respectively, The mothers gave birth at Mount Sinai and they and their children were assessed annually at affiliated medical centers in Mount Sinai’s catchment area.

For a subset of children with behavioral assessments, placental specimens collected at birth were processed for RNA sequencing.

Among the findings:

• Maternal cannabis use was associated with reduced maternal and paternal age, more single-mother pregnancies, state anxiety, trait anxiety, depression, cigarette smoking, and African American race.
• Hair hormone analysis revealed increased cortisol levels in the children of cannabis-using mothers, and was associated with greater anxiety, aggression, and hyperactivity.
• Affected children showed a reduction in the high-frequency component of HRV at baseline, reflecting reduced vagal tone.
• In the placenta, there was reduced expression of many genes involved in immune system function. These included genes for type I interferon, neutrophil, and cytokine-signaling pathways.

Several of these genes organized into coexpression networks that correlated with child anxiety and hyperactivity.

The principal active component of cannabis, tetrahydrocannabinol (THC), targets the endocannabinoid system in placental tissue and the developing brain, the authors noted. Exposure during pregnancy is associated with a range of adverse outcomes from fetal growth restriction to low birth weight and preterm birth.

“There are cannabinoid receptors on immune cells, and it is known that cannabinoids can alter immune function, which is important for maintaining maternal tolerance and protecting the fetus,” Dr. Hurd said. “It’s not surprising that something that affects the immune cells can have an impact on the developing fetus.”

“Overall, our findings reveal a relationship between [maternal cannabis use] and immune response gene networks in the placenta as a potential mediator of risk for anxiety-related problems in early childhood,” Dr. Hurd and colleagues wrote, adding that the results have significant implications for defining mental health issues in the children gestated by cannabis-smoking mothers.

Their results align with previous research indicating a greater risk for psychiatric illness in children with prenatal cannabis exposure from maternal use.

“While data are pretty limited in this realm, there are other studies that demonstrate a relationship between early child developmental and behavioral measures and cannabis use during pregnancy,” Camille Hoffman, MD, MSc, a high-risk obstetrics specialist and an associate professor at the University of Colorado at Denver, Aurora, said in an interview. “Our research group found children exposed to cannabis in utero at 10 weeks’ gestation and beyond were less interactive and more withdrawn than children who were not exposed.”

And THC remains in maternal breast milk even 6 weeks after usage stops.

The long-term effects of prenatal cannabis exposure remain to be determined and it is unknown whether the effects of gestational THC might attenuate as a child grows older. “We use early childhood measures in research as a proxy for the later development of diagnosed mental health conditions or behavioral problems,” Dr. Hoffman explained. “We know when we do this that not every child with an abnormal score early will go on to develop an actual condition. Fortunately, or unfortunately, other factors and exposures during childhood can change the trajectory for the better or worse.”

According to Dr. Hurd, child development is a dynamic process and epigenetic events in utero need not be deterministic. “The important thing is to identify children at risk early and to be able to go in and try to improve the environment they’re being raised in – not in terms of impoverishment but in terms of positive nurturing and giving the mother and family support.”

At the prenatal level, what’s the best advice for cannabis-using mothers-to-be? “If a woman doesn’t know she’s pregnant and has been using cannabis, taking extra choline for the remainder of the pregnancy can help buffer the potential negative impact of the cannabis exposure,” Dr. Hoffman said. The Food and Drug Administration and the American Medical Association recommend a dose of 550 mg daily. “The same is true for alcohol, which we know is also very bad for fetal brain development. This is not to say go ahead and use these substances and just take choline. The choline is more to try and salvage damage to the fetal brain that may have already occurred.”

This study was supported by the National Institute of Mental Health and the National Institute on Drug Abuse. The authors declared no competing interests. Dr. Hoffman disclosed no conflicts of interest with respect to her comments.

Mothers who use cannabis during pregnancy risk disrupting immune gene networks in the placenta and potentially increasing the risk of anxiety and hyperactivity in their children.

These findings emerged from a study led by Yasmin Hurd, PhD, a professor of psychiatry and director of the Addiction Institute at the Icahn School of Medicine at Mount Sinai, New York, and Yoko Nomura, PhD, a professor of behavioral neuroscience at Queen’s College, City University of New York, that was published online in Proceedings of the National Academy of Sciences.

The analysis assessed the effects of gestational maternal cannabis use on psychosocial and physiological measures in young children as well as its potentially immunomodulatory effect on the in utero environment as reflected in the placental transcriptome.

Participants were drawn from a larger cohort in a study launched in 2012; the investigators evaluated offspring aged 3-6 years for hair hormone levels, neurobehavioral traits on the Behavioral Assessment System for Children survey, and heart rate variability (HRV) at rest and during auditory startle.

The cohort consisted of 322 mother-child dyads and children with prenatal exposure to cannabis were compared with those having no exposure. The cohort consisted of 251 non–cannabis-using mothers and 71 cannabis-using mothers, with mean maternal ages in the two groups of 28.46 years and 25.91 years, respectively, The mothers gave birth at Mount Sinai and they and their children were assessed annually at affiliated medical centers in Mount Sinai’s catchment area.

For a subset of children with behavioral assessments, placental specimens collected at birth were processed for RNA sequencing.

Among the findings:

• Maternal cannabis use was associated with reduced maternal and paternal age, more single-mother pregnancies, state anxiety, trait anxiety, depression, cigarette smoking, and African American race.
• Hair hormone analysis revealed increased cortisol levels in the children of cannabis-using mothers, and was associated with greater anxiety, aggression, and hyperactivity.
• Affected children showed a reduction in the high-frequency component of HRV at baseline, reflecting reduced vagal tone.
• In the placenta, there was reduced expression of many genes involved in immune system function. These included genes for type I interferon, neutrophil, and cytokine-signaling pathways.

Several of these genes organized into coexpression networks that correlated with child anxiety and hyperactivity.

The principal active component of cannabis, tetrahydrocannabinol (THC), targets the endocannabinoid system in placental tissue and the developing brain, the authors noted. Exposure during pregnancy is associated with a range of adverse outcomes from fetal growth restriction to low birth weight and preterm birth.

“There are cannabinoid receptors on immune cells, and it is known that cannabinoids can alter immune function, which is important for maintaining maternal tolerance and protecting the fetus,” Dr. Hurd said. “It’s not surprising that something that affects the immune cells can have an impact on the developing fetus.”

“Overall, our findings reveal a relationship between [maternal cannabis use] and immune response gene networks in the placenta as a potential mediator of risk for anxiety-related problems in early childhood,” Dr. Hurd and colleagues wrote, adding that the results have significant implications for defining mental health issues in the children gestated by cannabis-smoking mothers.

Their results align with previous research indicating a greater risk for psychiatric illness in children with prenatal cannabis exposure from maternal use.

“While data are pretty limited in this realm, there are other studies that demonstrate a relationship between early child developmental and behavioral measures and cannabis use during pregnancy,” Camille Hoffman, MD, MSc, a high-risk obstetrics specialist and an associate professor at the University of Colorado at Denver, Aurora, said in an interview. “Our research group found children exposed to cannabis in utero at 10 weeks’ gestation and beyond were less interactive and more withdrawn than children who were not exposed.”

And THC remains in maternal breast milk even 6 weeks after usage stops.

The long-term effects of prenatal cannabis exposure remain to be determined and it is unknown whether the effects of gestational THC might attenuate as a child grows older. “We use early childhood measures in research as a proxy for the later development of diagnosed mental health conditions or behavioral problems,” Dr. Hoffman explained. “We know when we do this that not every child with an abnormal score early will go on to develop an actual condition. Fortunately, or unfortunately, other factors and exposures during childhood can change the trajectory for the better or worse.”

According to Dr. Hurd, child development is a dynamic process and epigenetic events in utero need not be deterministic. “The important thing is to identify children at risk early and to be able to go in and try to improve the environment they’re being raised in – not in terms of impoverishment but in terms of positive nurturing and giving the mother and family support.”

At the prenatal level, what’s the best advice for cannabis-using mothers-to-be? “If a woman doesn’t know she’s pregnant and has been using cannabis, taking extra choline for the remainder of the pregnancy can help buffer the potential negative impact of the cannabis exposure,” Dr. Hoffman said. The Food and Drug Administration and the American Medical Association recommend a dose of 550 mg daily. “The same is true for alcohol, which we know is also very bad for fetal brain development. This is not to say go ahead and use these substances and just take choline. The choline is more to try and salvage damage to the fetal brain that may have already occurred.”

This study was supported by the National Institute of Mental Health and the National Institute on Drug Abuse. The authors declared no competing interests. Dr. Hoffman disclosed no conflicts of interest with respect to her comments.

Mothers who use cannabis during pregnancy risk disrupting immune gene networks in the placenta and potentially increasing the risk of anxiety and hyperactivity in their children.

These findings emerged from a study led by Yasmin Hurd, PhD, a professor of psychiatry and director of the Addiction Institute at the Icahn School of Medicine at Mount Sinai, New York, and Yoko Nomura, PhD, a professor of behavioral neuroscience at Queen’s College, City University of New York, that was published online in Proceedings of the National Academy of Sciences.

The analysis assessed the effects of gestational maternal cannabis use on psychosocial and physiological measures in young children as well as its potentially immunomodulatory effect on the in utero environment as reflected in the placental transcriptome.

Participants were drawn from a larger cohort in a study launched in 2012; the investigators evaluated offspring aged 3-6 years for hair hormone levels, neurobehavioral traits on the Behavioral Assessment System for Children survey, and heart rate variability (HRV) at rest and during auditory startle.

The cohort consisted of 322 mother-child dyads and children with prenatal exposure to cannabis were compared with those having no exposure. The cohort consisted of 251 non–cannabis-using mothers and 71 cannabis-using mothers, with mean maternal ages in the two groups of 28.46 years and 25.91 years, respectively, The mothers gave birth at Mount Sinai and they and their children were assessed annually at affiliated medical centers in Mount Sinai’s catchment area.

For a subset of children with behavioral assessments, placental specimens collected at birth were processed for RNA sequencing.

Among the findings:

• Maternal cannabis use was associated with reduced maternal and paternal age, more single-mother pregnancies, state anxiety, trait anxiety, depression, cigarette smoking, and African American race.
• Hair hormone analysis revealed increased cortisol levels in the children of cannabis-using mothers, and was associated with greater anxiety, aggression, and hyperactivity.
• Affected children showed a reduction in the high-frequency component of HRV at baseline, reflecting reduced vagal tone.
• In the placenta, there was reduced expression of many genes involved in immune system function. These included genes for type I interferon, neutrophil, and cytokine-signaling pathways.

Several of these genes organized into coexpression networks that correlated with child anxiety and hyperactivity.

The principal active component of cannabis, tetrahydrocannabinol (THC), targets the endocannabinoid system in placental tissue and the developing brain, the authors noted. Exposure during pregnancy is associated with a range of adverse outcomes from fetal growth restriction to low birth weight and preterm birth.

“There are cannabinoid receptors on immune cells, and it is known that cannabinoids can alter immune function, which is important for maintaining maternal tolerance and protecting the fetus,” Dr. Hurd said. “It’s not surprising that something that affects the immune cells can have an impact on the developing fetus.”

“Overall, our findings reveal a relationship between [maternal cannabis use] and immune response gene networks in the placenta as a potential mediator of risk for anxiety-related problems in early childhood,” Dr. Hurd and colleagues wrote, adding that the results have significant implications for defining mental health issues in the children gestated by cannabis-smoking mothers.

Their results align with previous research indicating a greater risk for psychiatric illness in children with prenatal cannabis exposure from maternal use.

“While data are pretty limited in this realm, there are other studies that demonstrate a relationship between early child developmental and behavioral measures and cannabis use during pregnancy,” Camille Hoffman, MD, MSc, a high-risk obstetrics specialist and an associate professor at the University of Colorado at Denver, Aurora, said in an interview. “Our research group found children exposed to cannabis in utero at 10 weeks’ gestation and beyond were less interactive and more withdrawn than children who were not exposed.”

And THC remains in maternal breast milk even 6 weeks after usage stops.

The long-term effects of prenatal cannabis exposure remain to be determined and it is unknown whether the effects of gestational THC might attenuate as a child grows older. “We use early childhood measures in research as a proxy for the later development of diagnosed mental health conditions or behavioral problems,” Dr. Hoffman explained. “We know when we do this that not every child with an abnormal score early will go on to develop an actual condition. Fortunately, or unfortunately, other factors and exposures during childhood can change the trajectory for the better or worse.”

According to Dr. Hurd, child development is a dynamic process and epigenetic events in utero need not be deterministic. “The important thing is to identify children at risk early and to be able to go in and try to improve the environment they’re being raised in – not in terms of impoverishment but in terms of positive nurturing and giving the mother and family support.”

At the prenatal level, what’s the best advice for cannabis-using mothers-to-be? “If a woman doesn’t know she’s pregnant and has been using cannabis, taking extra choline for the remainder of the pregnancy can help buffer the potential negative impact of the cannabis exposure,” Dr. Hoffman said. The Food and Drug Administration and the American Medical Association recommend a dose of 550 mg daily. “The same is true for alcohol, which we know is also very bad for fetal brain development. This is not to say go ahead and use these substances and just take choline. The choline is more to try and salvage damage to the fetal brain that may have already occurred.”

This study was supported by the National Institute of Mental Health and the National Institute on Drug Abuse. The authors declared no competing interests. Dr. Hoffman disclosed no conflicts of interest with respect to her comments.