Clinical Psychiatry News

COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.

If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.

“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.

The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.

“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
 

Still aiming for herd immunity

Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.

Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”

In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.

As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.

Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
 

Masks and the uncommon cold

Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.

Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.

“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
 

Variants: Some good news?

Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.

Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.

“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
 

Hesitancy from misinformation

Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.

“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.

Even celebrities are getting drawn into the misinformation.

“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”

Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
 

The future is subject to change

“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.

However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.

Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”

“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”

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

COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.

If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.

“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.

The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.

“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
 

Still aiming for herd immunity

Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.

Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”

In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.

As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.

Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
 

Masks and the uncommon cold

Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.

Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.

“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
 

Variants: Some good news?

Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.

Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.

“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
 

Hesitancy from misinformation

Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.

“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.

Even celebrities are getting drawn into the misinformation.

“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”

Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
 

The future is subject to change

“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.

However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.

Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”

“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”

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

COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.

If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.

“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.

The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.

“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
 

Still aiming for herd immunity

Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.

Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”

In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.

As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.

Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
 

Masks and the uncommon cold

Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.

Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.

“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
 

Variants: Some good news?

Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.

Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.

“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
 

Hesitancy from misinformation

Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.

“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.

Even celebrities are getting drawn into the misinformation.

“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”

Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
 

The future is subject to change

“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.

However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.

Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”

“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”

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

The percentage of physicians in the United States who are Black has increased only 4% in the past 120 years, and the number of Black male doctors has not changed at all since 1940, according to a new study.

In 1900, 1.3% of physicians were Black. In 1940, 2.8% of physicians were Black, and by 2018 – when almost 13% of the population was Black – 5.4% of doctors were Black, reports Dan Ly, MD, PhD, MPP, an assistant professor of medicine at the University of California, Los Angeles, in a study published online April 19, 2021, in the Journal of General Internal Medicine.

The proportion of male Black physicians was 2.7% in 1940 and 2.6% in 2018.

Dr. Ly also found a significant wage gap. The median income earned by White doctors was $50,000 more than the median income of Black physicians in 2018. Dr. Ly based his findings on the U.S. Census Decennial Census long form, accessed via IPUMS, a free database funded by the National Institutes of Health and other organizations.

“If we care about the health of the population, particularly the health of Black patients, we should care about how small the proportion of our physicians who are Black is and the extremely slow progress we have made as a medical system in increasing that proportion,” Dr. Ly said in an interview.

Dr. Ly said he took on this research in part because previous studies have shown that Black patients are more likely to seek preventive care from Black doctors. Thus, increasing the numbers of Black physicians could narrow gaps in life expectancy between Whites and Blacks.

He also wanted to see whether progress had been made as a result of various medical organizations and the Association of American Medical Colleges undertaking initiatives to increase workforce diversity. There has been “very, very little” progress, he said.

Norma Poll-Hunter, PhD, the AAMC’s senior director of workforce diversity, said Dr. Ly’s report “was not surprising at all.”

The AAMC reported in 2014 that the number of Black men who apply to and matriculate into medical schools has been declining since 1978. That year, there were 1,410 Black male applicants and 542 Black enrollees. In 2014, there were 1,337 applicants and 515 enrollees.

Since 2014, Black male enrollment has increased slightly, rising from 2.4% in the 2014-2015 school year to 2.9% in the 2019-2020 year, the AAMC reported last year.

In addition, among other historically underrepresented minorities, “we really have seen very small progress” despite the increase in the number of medical schools, Dr. Poll-Hunter said in an interview.

The AAMC and the National Medical Association consider the lack of Black male applicants and matriculants to be a national crisis. The two groups started an alliance in 2020 aimed at finding ways to amplify and support Black men’s interest in medicine and the biomedical sciences and to “develop systems-based solutions to address exclusionary practices that create barriers for Black men and prevent them from having equitable opportunities to successfully enroll in medical school.”

Solutions include requiring medical school admissions committees and application screeners to undergo implicit bias awareness and mitigation training, adopting holistic admissions reviews, and incentivizing institutions of higher learning to partner with Black communities in urban and rural school systems to establish K-12 health sciences academies, said NMA President Leon McDougle, MD, MPH.

“There are the systems factors, and racism is a big one that we have to tackle,” said Dr. Poll-Hunter.

Diversity isn’t just about numbers, said Dr. McDougle, a professor of family medicine and associate dean for diversity and inclusion at Ohio State University, Columbus. “We know that medical school graduates who are African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native are more likely to serve those communities as practicing physicians.

“The COVID-19 pandemic highlighted the urgent need for more African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native physicians,” he said. “Inadequate access to culturally competent care has exacerbated existing health disparities, resulting in death and hospitalization rates up to three to four times the rates of European American or White people.”

Dr. Poll-Hunter also said that studies have shown that diversity in the classroom creates a more enriched learning environment and increases civic mindedness and cognitive complexity, “as well as helps us understand people who are different than ourselves.”

The diversity goal “is not about quotas, it’s about excellence,” she said. “We know that there’s talent that exists, and we want to make sure that everyone has an opportunity to be successful.”

Dr. Ly has disclosed no relevant financial relationships.

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

The percentage of physicians in the United States who are Black has increased only 4% in the past 120 years, and the number of Black male doctors has not changed at all since 1940, according to a new study.

In 1900, 1.3% of physicians were Black. In 1940, 2.8% of physicians were Black, and by 2018 – when almost 13% of the population was Black – 5.4% of doctors were Black, reports Dan Ly, MD, PhD, MPP, an assistant professor of medicine at the University of California, Los Angeles, in a study published online April 19, 2021, in the Journal of General Internal Medicine.

The proportion of male Black physicians was 2.7% in 1940 and 2.6% in 2018.

Dr. Ly also found a significant wage gap. The median income earned by White doctors was $50,000 more than the median income of Black physicians in 2018. Dr. Ly based his findings on the U.S. Census Decennial Census long form, accessed via IPUMS, a free database funded by the National Institutes of Health and other organizations.

“If we care about the health of the population, particularly the health of Black patients, we should care about how small the proportion of our physicians who are Black is and the extremely slow progress we have made as a medical system in increasing that proportion,” Dr. Ly said in an interview.

Dr. Ly said he took on this research in part because previous studies have shown that Black patients are more likely to seek preventive care from Black doctors. Thus, increasing the numbers of Black physicians could narrow gaps in life expectancy between Whites and Blacks.

He also wanted to see whether progress had been made as a result of various medical organizations and the Association of American Medical Colleges undertaking initiatives to increase workforce diversity. There has been “very, very little” progress, he said.

Norma Poll-Hunter, PhD, the AAMC’s senior director of workforce diversity, said Dr. Ly’s report “was not surprising at all.”

The AAMC reported in 2014 that the number of Black men who apply to and matriculate into medical schools has been declining since 1978. That year, there were 1,410 Black male applicants and 542 Black enrollees. In 2014, there were 1,337 applicants and 515 enrollees.

Since 2014, Black male enrollment has increased slightly, rising from 2.4% in the 2014-2015 school year to 2.9% in the 2019-2020 year, the AAMC reported last year.

In addition, among other historically underrepresented minorities, “we really have seen very small progress” despite the increase in the number of medical schools, Dr. Poll-Hunter said in an interview.

The AAMC and the National Medical Association consider the lack of Black male applicants and matriculants to be a national crisis. The two groups started an alliance in 2020 aimed at finding ways to amplify and support Black men’s interest in medicine and the biomedical sciences and to “develop systems-based solutions to address exclusionary practices that create barriers for Black men and prevent them from having equitable opportunities to successfully enroll in medical school.”

Solutions include requiring medical school admissions committees and application screeners to undergo implicit bias awareness and mitigation training, adopting holistic admissions reviews, and incentivizing institutions of higher learning to partner with Black communities in urban and rural school systems to establish K-12 health sciences academies, said NMA President Leon McDougle, MD, MPH.

“There are the systems factors, and racism is a big one that we have to tackle,” said Dr. Poll-Hunter.

Diversity isn’t just about numbers, said Dr. McDougle, a professor of family medicine and associate dean for diversity and inclusion at Ohio State University, Columbus. “We know that medical school graduates who are African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native are more likely to serve those communities as practicing physicians.

“The COVID-19 pandemic highlighted the urgent need for more African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native physicians,” he said. “Inadequate access to culturally competent care has exacerbated existing health disparities, resulting in death and hospitalization rates up to three to four times the rates of European American or White people.”

Dr. Poll-Hunter also said that studies have shown that diversity in the classroom creates a more enriched learning environment and increases civic mindedness and cognitive complexity, “as well as helps us understand people who are different than ourselves.”

The diversity goal “is not about quotas, it’s about excellence,” she said. “We know that there’s talent that exists, and we want to make sure that everyone has an opportunity to be successful.”

Dr. Ly has disclosed no relevant financial relationships.

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

The percentage of physicians in the United States who are Black has increased only 4% in the past 120 years, and the number of Black male doctors has not changed at all since 1940, according to a new study.

In 1900, 1.3% of physicians were Black. In 1940, 2.8% of physicians were Black, and by 2018 – when almost 13% of the population was Black – 5.4% of doctors were Black, reports Dan Ly, MD, PhD, MPP, an assistant professor of medicine at the University of California, Los Angeles, in a study published online April 19, 2021, in the Journal of General Internal Medicine.

The proportion of male Black physicians was 2.7% in 1940 and 2.6% in 2018.

Dr. Ly also found a significant wage gap. The median income earned by White doctors was $50,000 more than the median income of Black physicians in 2018. Dr. Ly based his findings on the U.S. Census Decennial Census long form, accessed via IPUMS, a free database funded by the National Institutes of Health and other organizations.

“If we care about the health of the population, particularly the health of Black patients, we should care about how small the proportion of our physicians who are Black is and the extremely slow progress we have made as a medical system in increasing that proportion,” Dr. Ly said in an interview.

Dr. Ly said he took on this research in part because previous studies have shown that Black patients are more likely to seek preventive care from Black doctors. Thus, increasing the numbers of Black physicians could narrow gaps in life expectancy between Whites and Blacks.

He also wanted to see whether progress had been made as a result of various medical organizations and the Association of American Medical Colleges undertaking initiatives to increase workforce diversity. There has been “very, very little” progress, he said.

Norma Poll-Hunter, PhD, the AAMC’s senior director of workforce diversity, said Dr. Ly’s report “was not surprising at all.”

The AAMC reported in 2014 that the number of Black men who apply to and matriculate into medical schools has been declining since 1978. That year, there were 1,410 Black male applicants and 542 Black enrollees. In 2014, there were 1,337 applicants and 515 enrollees.

Since 2014, Black male enrollment has increased slightly, rising from 2.4% in the 2014-2015 school year to 2.9% in the 2019-2020 year, the AAMC reported last year.

In addition, among other historically underrepresented minorities, “we really have seen very small progress” despite the increase in the number of medical schools, Dr. Poll-Hunter said in an interview.

The AAMC and the National Medical Association consider the lack of Black male applicants and matriculants to be a national crisis. The two groups started an alliance in 2020 aimed at finding ways to amplify and support Black men’s interest in medicine and the biomedical sciences and to “develop systems-based solutions to address exclusionary practices that create barriers for Black men and prevent them from having equitable opportunities to successfully enroll in medical school.”

Solutions include requiring medical school admissions committees and application screeners to undergo implicit bias awareness and mitigation training, adopting holistic admissions reviews, and incentivizing institutions of higher learning to partner with Black communities in urban and rural school systems to establish K-12 health sciences academies, said NMA President Leon McDougle, MD, MPH.

“There are the systems factors, and racism is a big one that we have to tackle,” said Dr. Poll-Hunter.

Diversity isn’t just about numbers, said Dr. McDougle, a professor of family medicine and associate dean for diversity and inclusion at Ohio State University, Columbus. “We know that medical school graduates who are African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native are more likely to serve those communities as practicing physicians.

“The COVID-19 pandemic highlighted the urgent need for more African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native physicians,” he said. “Inadequate access to culturally competent care has exacerbated existing health disparities, resulting in death and hospitalization rates up to three to four times the rates of European American or White people.”

Dr. Poll-Hunter also said that studies have shown that diversity in the classroom creates a more enriched learning environment and increases civic mindedness and cognitive complexity, “as well as helps us understand people who are different than ourselves.”

The diversity goal “is not about quotas, it’s about excellence,” she said. “We know that there’s talent that exists, and we want to make sure that everyone has an opportunity to be successful.”

Dr. Ly has disclosed no relevant financial relationships.

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

Do your patients think that getting COVID-19 is fully protective against subsequent reinfection? Tell it to the Marines.

A study of U.S. Marine recruits on their way to boot camp at Parris Island, S.C., showed that those who were seropositive at baseline, indicating prior exposure to SARS-CoV-2, remained at some risk for reinfection. They had about one-fifth the risk of subsequent infection, compared with seronegative recruits during basic training, but reinfections did occur.

The study, by Stuart C. Sealfon, MD, of Icahn School of Medicine at Mount Sinai in New York, and colleagues, was published in The Lancet Respiratory Medicine.

“Although antibodies induced by initial infection are largely protective, they do not guarantee effective SARS-CoV-2 neutralization activity or immunity against subsequent infection,” they wrote.

An infectious disease specialist who was not involved in the study said that the findings provide further evidence about the level of immunity acquired after an infection.

“It’s quite clear that reinfections do occur, they are of public health importance, and they’re something we need to be mindful of in terms of advising patients about whether a prior infection protects them from reinfection,” Mark Siedner, MD, MPH, a clinician and researcher in the division of infectious diseases at Massachusetts General Hospital, Boston, said in an interview.

The study results reinforce that “not all antibodies are the same,” said Sachin Gupta, MD, an attending physician in pulmonary and critical care medicine at Alameda Health System in Oakland, Calif. “We’re seeing still that 10% of folks who have antibodies can get infected again,” he said in an interview.

CHARM initiative

Dr. Sealfon and colleagues presented an analysis of data from the ironically named CHARM (COVID-19 Health Action Response for Marines) prospective study.

CHARM included U.S. Marine recruits, most of them male, aged 18-20 years, who were instructed to follow a 2-week unsupervised quarantine at home, after which they reported to a Marine-supervised facility for an additional 2-week quarantine.

At baseline, participants were tested for SARS-CoV-2 immunoglobulin G (IgG) seropositivity, defined as a dilution of 1:150 or more on receptor-binding domain and full-length spike protein enzyme-linked immunosorbent assay (ELISA).

The recruits filled out questionnaires asking them to report any of 14 specific COVID-19–related symptoms or any other unspecified symptom, as well as demographic information, risk factors, and a brief medical history.

Investigators tested recruits for SARS-CoV-2 infection by polymerase chain reaction (PCR) assay at weeks 0, 1, and 2 of quarantine, and any who had positive PCR results during quarantine were excluded.

Participants who had three negative swab PCR results during quarantine and a baseline serology test at the beginning of the supervised quarantine period – either seronegative or seropositive – then went on to enjoy their basic training at the Marine Corps Recruit Depot, Parris Island, S.C.

The participants were followed prospectively with PCR tests at weeks 2, 4, and 6 in both the seropositive and seronegative groups, and sera were obtained at the same time.
 

Holes in immunologic armor

Full data were available for a total of 189 participants who were seropositive and 2,247 who were seronegative at enrollment.

In all, 19 of 189 seropositive recruits (10%) had at least one PCR test positive for SARS-CoV-2 infection during the 6-week follow-up period. This translated into an incidence of 1.1 cases per person-year.

Of the 2,247 participants seronegative at baseline, 1,079 tested positive (6.2 cases per person-year; incidence rate ratio 0.18).

It appeared that antibodies provided some protection for seropositive recruits, as evidenced by a higher likelihood of infection among those with lower baseline full-length spike protein IgG titers than in those with higher baseline titers (hazard ratio 0.4, P < .001).

Among the seropositive participants who did acquire a second SARS-CoV-2 infection, viral loads in mid-turbinate nasal swabs were about 10-fold lower than in seronegative recruits who acquired infections during follow-up.

“This finding suggests that some reinfected individuals could have a similar capacity to transmit infection as those who are infected for the first time. The rate at which reinfection occurs after vaccines and natural immunity is important for estimating the proportion of the population that needs to be vaccinated to suppress the pandemic,” the investigators wrote.

Baseline neutralizing antibody titers were detected in 45 of the first 54 seropositive recruits who remained PCR negative throughout follow-up, but also in 6 of 19 seropositive participants who became infected during the 6 weeks of observation.
 

Lessons

Both Dr. Siedner and Dr. Gupta agreed with the authors that the risks for reinfection that were observed in young, physically fit people may differ for other populations, such as women (only 10% of seropositive recruits and 8% of seronegative recruits were female), older patients, or those who are immunocompromised.

Given that the adjusted odds ratio for reinfection in this study was nearly identical to that of a recent British study comparing infection rates between seropositive and seronegative health care workers, the risk of reinfection for other young adults and for the general population may be similar, Dr. Sealfon and colleagues wrote.

Adding to the challenge of reaching herd immunity is the observation that some patients who have recovered from COVID-19 are skeptical about the need for further protection.

“There are patients who feel like vaccination is of low benefit to them, and I think these are the same people who would be hesitant to get the vaccine anyway,” Dr. Gupta said.

Although no vaccine is perfect – the vaccine failure rate from the mRNA-based vaccines from Moderna and Pfizer/Biontech is about 5% – the protections they afford are unmistakable, Dr. Siedner said.

“I think it’s important to make the distinction that most postvaccination infections by and large have been very mild,” he said. “In people with normal immune systems, we have not seen an onslaught of postvaccination infections requiring hospitalization. Even if people do get infected after vaccination, the vaccines protect people from severe infection, and that’s what we want them to do.”

The investigators stated, “Young adults, of whom a high proportion are asymptomatically infected and become seropositive in the absence of known infection, can be an important source of transmission to more vulnerable populations. Evaluating the protection against subsequent SARS-CoV-2 infection conferred by seropositivity in young adults is important for determining the need for vaccinating previously infected individuals in this age group.”

The study was funded by the Defense Health Agency and Defense Advanced Research Projects Agency. Dr. Sealfon, Dr. Siedner, and Dr. Gupta have no conflicts of interest to report. Dr. Gupta is a member of the editorial advisory board for this publication.

Do your patients think that getting COVID-19 is fully protective against subsequent reinfection? Tell it to the Marines.

A study of U.S. Marine recruits on their way to boot camp at Parris Island, S.C., showed that those who were seropositive at baseline, indicating prior exposure to SARS-CoV-2, remained at some risk for reinfection. They had about one-fifth the risk of subsequent infection, compared with seronegative recruits during basic training, but reinfections did occur.

The study, by Stuart C. Sealfon, MD, of Icahn School of Medicine at Mount Sinai in New York, and colleagues, was published in The Lancet Respiratory Medicine.

“Although antibodies induced by initial infection are largely protective, they do not guarantee effective SARS-CoV-2 neutralization activity or immunity against subsequent infection,” they wrote.

An infectious disease specialist who was not involved in the study said that the findings provide further evidence about the level of immunity acquired after an infection.

“It’s quite clear that reinfections do occur, they are of public health importance, and they’re something we need to be mindful of in terms of advising patients about whether a prior infection protects them from reinfection,” Mark Siedner, MD, MPH, a clinician and researcher in the division of infectious diseases at Massachusetts General Hospital, Boston, said in an interview.

The study results reinforce that “not all antibodies are the same,” said Sachin Gupta, MD, an attending physician in pulmonary and critical care medicine at Alameda Health System in Oakland, Calif. “We’re seeing still that 10% of folks who have antibodies can get infected again,” he said in an interview.

CHARM initiative

Dr. Sealfon and colleagues presented an analysis of data from the ironically named CHARM (COVID-19 Health Action Response for Marines) prospective study.

CHARM included U.S. Marine recruits, most of them male, aged 18-20 years, who were instructed to follow a 2-week unsupervised quarantine at home, after which they reported to a Marine-supervised facility for an additional 2-week quarantine.

At baseline, participants were tested for SARS-CoV-2 immunoglobulin G (IgG) seropositivity, defined as a dilution of 1:150 or more on receptor-binding domain and full-length spike protein enzyme-linked immunosorbent assay (ELISA).

The recruits filled out questionnaires asking them to report any of 14 specific COVID-19–related symptoms or any other unspecified symptom, as well as demographic information, risk factors, and a brief medical history.

Investigators tested recruits for SARS-CoV-2 infection by polymerase chain reaction (PCR) assay at weeks 0, 1, and 2 of quarantine, and any who had positive PCR results during quarantine were excluded.

Participants who had three negative swab PCR results during quarantine and a baseline serology test at the beginning of the supervised quarantine period – either seronegative or seropositive – then went on to enjoy their basic training at the Marine Corps Recruit Depot, Parris Island, S.C.

The participants were followed prospectively with PCR tests at weeks 2, 4, and 6 in both the seropositive and seronegative groups, and sera were obtained at the same time.
 

Holes in immunologic armor

Full data were available for a total of 189 participants who were seropositive and 2,247 who were seronegative at enrollment.

In all, 19 of 189 seropositive recruits (10%) had at least one PCR test positive for SARS-CoV-2 infection during the 6-week follow-up period. This translated into an incidence of 1.1 cases per person-year.

Of the 2,247 participants seronegative at baseline, 1,079 tested positive (6.2 cases per person-year; incidence rate ratio 0.18).

It appeared that antibodies provided some protection for seropositive recruits, as evidenced by a higher likelihood of infection among those with lower baseline full-length spike protein IgG titers than in those with higher baseline titers (hazard ratio 0.4, P < .001).

Among the seropositive participants who did acquire a second SARS-CoV-2 infection, viral loads in mid-turbinate nasal swabs were about 10-fold lower than in seronegative recruits who acquired infections during follow-up.

“This finding suggests that some reinfected individuals could have a similar capacity to transmit infection as those who are infected for the first time. The rate at which reinfection occurs after vaccines and natural immunity is important for estimating the proportion of the population that needs to be vaccinated to suppress the pandemic,” the investigators wrote.

Baseline neutralizing antibody titers were detected in 45 of the first 54 seropositive recruits who remained PCR negative throughout follow-up, but also in 6 of 19 seropositive participants who became infected during the 6 weeks of observation.
 

Lessons

Both Dr. Siedner and Dr. Gupta agreed with the authors that the risks for reinfection that were observed in young, physically fit people may differ for other populations, such as women (only 10% of seropositive recruits and 8% of seronegative recruits were female), older patients, or those who are immunocompromised.

Given that the adjusted odds ratio for reinfection in this study was nearly identical to that of a recent British study comparing infection rates between seropositive and seronegative health care workers, the risk of reinfection for other young adults and for the general population may be similar, Dr. Sealfon and colleagues wrote.

Adding to the challenge of reaching herd immunity is the observation that some patients who have recovered from COVID-19 are skeptical about the need for further protection.

“There are patients who feel like vaccination is of low benefit to them, and I think these are the same people who would be hesitant to get the vaccine anyway,” Dr. Gupta said.

Although no vaccine is perfect – the vaccine failure rate from the mRNA-based vaccines from Moderna and Pfizer/Biontech is about 5% – the protections they afford are unmistakable, Dr. Siedner said.

“I think it’s important to make the distinction that most postvaccination infections by and large have been very mild,” he said. “In people with normal immune systems, we have not seen an onslaught of postvaccination infections requiring hospitalization. Even if people do get infected after vaccination, the vaccines protect people from severe infection, and that’s what we want them to do.”

The investigators stated, “Young adults, of whom a high proportion are asymptomatically infected and become seropositive in the absence of known infection, can be an important source of transmission to more vulnerable populations. Evaluating the protection against subsequent SARS-CoV-2 infection conferred by seropositivity in young adults is important for determining the need for vaccinating previously infected individuals in this age group.”

The study was funded by the Defense Health Agency and Defense Advanced Research Projects Agency. Dr. Sealfon, Dr. Siedner, and Dr. Gupta have no conflicts of interest to report. Dr. Gupta is a member of the editorial advisory board for this publication.

Do your patients think that getting COVID-19 is fully protective against subsequent reinfection? Tell it to the Marines.

A study of U.S. Marine recruits on their way to boot camp at Parris Island, S.C., showed that those who were seropositive at baseline, indicating prior exposure to SARS-CoV-2, remained at some risk for reinfection. They had about one-fifth the risk of subsequent infection, compared with seronegative recruits during basic training, but reinfections did occur.

The study, by Stuart C. Sealfon, MD, of Icahn School of Medicine at Mount Sinai in New York, and colleagues, was published in The Lancet Respiratory Medicine.

“Although antibodies induced by initial infection are largely protective, they do not guarantee effective SARS-CoV-2 neutralization activity or immunity against subsequent infection,” they wrote.

An infectious disease specialist who was not involved in the study said that the findings provide further evidence about the level of immunity acquired after an infection.

“It’s quite clear that reinfections do occur, they are of public health importance, and they’re something we need to be mindful of in terms of advising patients about whether a prior infection protects them from reinfection,” Mark Siedner, MD, MPH, a clinician and researcher in the division of infectious diseases at Massachusetts General Hospital, Boston, said in an interview.

The study results reinforce that “not all antibodies are the same,” said Sachin Gupta, MD, an attending physician in pulmonary and critical care medicine at Alameda Health System in Oakland, Calif. “We’re seeing still that 10% of folks who have antibodies can get infected again,” he said in an interview.

CHARM initiative

Dr. Sealfon and colleagues presented an analysis of data from the ironically named CHARM (COVID-19 Health Action Response for Marines) prospective study.

CHARM included U.S. Marine recruits, most of them male, aged 18-20 years, who were instructed to follow a 2-week unsupervised quarantine at home, after which they reported to a Marine-supervised facility for an additional 2-week quarantine.

At baseline, participants were tested for SARS-CoV-2 immunoglobulin G (IgG) seropositivity, defined as a dilution of 1:150 or more on receptor-binding domain and full-length spike protein enzyme-linked immunosorbent assay (ELISA).

The recruits filled out questionnaires asking them to report any of 14 specific COVID-19–related symptoms or any other unspecified symptom, as well as demographic information, risk factors, and a brief medical history.

Investigators tested recruits for SARS-CoV-2 infection by polymerase chain reaction (PCR) assay at weeks 0, 1, and 2 of quarantine, and any who had positive PCR results during quarantine were excluded.

Participants who had three negative swab PCR results during quarantine and a baseline serology test at the beginning of the supervised quarantine period – either seronegative or seropositive – then went on to enjoy their basic training at the Marine Corps Recruit Depot, Parris Island, S.C.

The participants were followed prospectively with PCR tests at weeks 2, 4, and 6 in both the seropositive and seronegative groups, and sera were obtained at the same time.
 

Holes in immunologic armor

Full data were available for a total of 189 participants who were seropositive and 2,247 who were seronegative at enrollment.

In all, 19 of 189 seropositive recruits (10%) had at least one PCR test positive for SARS-CoV-2 infection during the 6-week follow-up period. This translated into an incidence of 1.1 cases per person-year.

Of the 2,247 participants seronegative at baseline, 1,079 tested positive (6.2 cases per person-year; incidence rate ratio 0.18).

It appeared that antibodies provided some protection for seropositive recruits, as evidenced by a higher likelihood of infection among those with lower baseline full-length spike protein IgG titers than in those with higher baseline titers (hazard ratio 0.4, P < .001).

Among the seropositive participants who did acquire a second SARS-CoV-2 infection, viral loads in mid-turbinate nasal swabs were about 10-fold lower than in seronegative recruits who acquired infections during follow-up.

“This finding suggests that some reinfected individuals could have a similar capacity to transmit infection as those who are infected for the first time. The rate at which reinfection occurs after vaccines and natural immunity is important for estimating the proportion of the population that needs to be vaccinated to suppress the pandemic,” the investigators wrote.

Baseline neutralizing antibody titers were detected in 45 of the first 54 seropositive recruits who remained PCR negative throughout follow-up, but also in 6 of 19 seropositive participants who became infected during the 6 weeks of observation.
 

Lessons

Both Dr. Siedner and Dr. Gupta agreed with the authors that the risks for reinfection that were observed in young, physically fit people may differ for other populations, such as women (only 10% of seropositive recruits and 8% of seronegative recruits were female), older patients, or those who are immunocompromised.

Given that the adjusted odds ratio for reinfection in this study was nearly identical to that of a recent British study comparing infection rates between seropositive and seronegative health care workers, the risk of reinfection for other young adults and for the general population may be similar, Dr. Sealfon and colleagues wrote.

Adding to the challenge of reaching herd immunity is the observation that some patients who have recovered from COVID-19 are skeptical about the need for further protection.

“There are patients who feel like vaccination is of low benefit to them, and I think these are the same people who would be hesitant to get the vaccine anyway,” Dr. Gupta said.

Although no vaccine is perfect – the vaccine failure rate from the mRNA-based vaccines from Moderna and Pfizer/Biontech is about 5% – the protections they afford are unmistakable, Dr. Siedner said.

“I think it’s important to make the distinction that most postvaccination infections by and large have been very mild,” he said. “In people with normal immune systems, we have not seen an onslaught of postvaccination infections requiring hospitalization. Even if people do get infected after vaccination, the vaccines protect people from severe infection, and that’s what we want them to do.”

The investigators stated, “Young adults, of whom a high proportion are asymptomatically infected and become seropositive in the absence of known infection, can be an important source of transmission to more vulnerable populations. Evaluating the protection against subsequent SARS-CoV-2 infection conferred by seropositivity in young adults is important for determining the need for vaccinating previously infected individuals in this age group.”

The study was funded by the Defense Health Agency and Defense Advanced Research Projects Agency. Dr. Sealfon, Dr. Siedner, and Dr. Gupta have no conflicts of interest to report. Dr. Gupta is a member of the editorial advisory board for this publication.

A study of U.S. children across ethnic and racial groups found that Asians were least likely to receive therapy for ADHD, compared with White children – who had the highest odds of getting some kind of treatment over other groups.

Other studies have identified disparity problems in ADHD diagnosis, although results have varied on inequality metrics. Few studies have looked at Asians separately, according to the study’s lead author, Yu Shi, MD, MPH. “They were usually just classified as ‘other’ or as non-White,” Dr. Shi, a consultant with the Mayo Clinic’s division of pediatric anesthesia in Rochester, Minn., said in an interview.

Disparities might stem from cultural and socioeconomic factors, and the way in which clinicians interpret behavior and apply diagnostic criteria.

“Further understanding of how treatment patterns for ADHD may differ based on race, at the time of initial diagnosis and in the early stages of treatment, may help all children receive appropriate evidence-based care,” Dr. Shi and colleagues reported in JAMA Network Open.
 

Researchers develop large birth cohort

Dr. Shi and colleagues hypothesized that non-Hispanic White children had a greater chance of getting diagnosed and treated within the first year of diagnosis than that of other ethnic and racial cohorts. Using administrative claims data with socioeconomic status information from a national commercial insurance warehouse, they constructed a retrospective birth cohort of children born between Jan. 1, 2006, and Dec. 31, 2012. The children had continuous insurance coverage for at least 4 years, and represented non-Hispanic Whites, Blacks, Hispanics, and Asians. Self-reporting identified the race/ethnicity groups.

Investigators analyzed ADHD diagnosis and treatment data on 238,011 children between October 2019 and December 2020, using a multivariate Cox regression model to adjust for sex, region, and household income. Primary and secondary outcomes included ADHD diagnosis as defined by recent ICD codes, ADHD behavior, and medication therapies in the clinical setting after initial diagnosis, respectively.

Whites made up most of the cohort (72.7%), followed by Hispanics (9.8%), Asians (6.7%), and Blacks (6.2%). Nearly half the population was female (48.8%). During the follow-up period with these children, 11,401, or 4.8%, had received an ADHD diagnosis. Mean age of diagnosis was 6.5 years, and overall incidence of ADHD was 69 per 10,000 person years (95% confidence interval, 68-70).

Pediatricians were most likely to make an ADHD diagnosis, although the study cited other clinicians, such as psychiatrists, neurologists, psychologists, and family practice clinicians, as responsible for these decisions.

Children diagnosed with ADHD had more years of coverage in the data set, and were more likely to be White and male. The Southern census region had a higher representation of diagnoses (50.6%) than did the Northeast region (11.8%).
 

Asians at highest odds for no treatment

Taking a closer look at race and ethnicity, Whites had the highest cumulative incidence of ADHD (14.19%), versus Asian children, who had lowest incidence (6.08%). “The curves for Black and Hispanic children were similar in shape and slightly lower than that for White children,” reported the investigators.

White children had higher odds of receiving some kind of treatment, compared with the other groups.

Incidence of medication treatment was lower among Asians and Hispanics. In a striking finding, Asians were most likely to receive no treatment at all (odds ratio compared with White children, 0.54; 95% confidence interval, 0.42-0.70). “However, the percentage of Asian children receiving psychotherapy was not significantly lower than other groups, which is different than a 2013 study finding that Asian children with ADHD were less likely to use mental health services,” they noted.

Most of the patients received medication (32.4%) in the first year after diagnosis, whereas (19.4%) received behavioral therapy only. Nineteen percent had both. More than 29% of these cases had no claims associated with either treatment. Among school-aged children, 65.5% were prescribed medications, compared with just 14.4% who received therapy. Twenty percent had no treatment.

Diagnosis with another disorder often preceded ADHD diagnosis. Results varied among racial groups. White children were more likely than were Black children to be diagnosed with an anxiety or adjustment disorder. Relative to White children, Asians were more likely to be diagnosed with autism spectrum disorder, speech sound disorders, or unspecified neurodevelopmental disorders. Even after an ADHD diagnosis, clinicians were more likely to diagnose Asian children with autism.
 

Parents may influence treatment decisions

Parental views and preferences may explain some of the variations in diagnosis and treatment among the racial/ethnic groups.

“In order for a diagnosis of ADHD to happen, a parent has first to recognize a problem and bring a child for clinical evaluation,” said Dr. Shi. “A certain behavior could be viewed as normal or a problem depending on a person’s cultural or racial background.” It’s unclear whether clinicians played any role in diagnosis disparities, he added. Patients’ concerns about racism might also influence the desire to get treated in health care systems.

Overall, the findings underscore the presence of racial and ethnic disparities in ADHD diagnosis and treatment. Future research should explore the underlying mechanisms, Dr. Shi suggested. While he and his colleagues have no immediate plans to do another ADHD study, “we’re planning on research to understand disparities in surgery in children,” he said.

The authors cited numerous limitations with their study. Use of ICD codes to identify cases might not have represented true clinical diagnosis, since the data were collected for billing, not research purposes. Investigators drew participants from a commercial insurance database, which did not necessarily reflect all U.S. children. The results might not represent a large number of children covered by Medicaid, for example, noted Dr. Shi. “It is more difficult to work with Medicaid data because there’s no national-level Medicaid data for research. Only state-level data is available.”

Because of other data gaps, Dr. Shi and colleagues might have underestimated the number of children in therapy.
 

A need for ‘culturally sensitive care’

The findings “ultimately demonstrate the need for culturally sensitive care in the diagnosis and treatment of children and adolescents,” said Tiffani L. Bell, MD, a psychiatrist in Winston-Salem, N.C., who was not involved with the study. She specializes in child and adolescent psychiatry.

The exact cause for racial disparity in diagnosis and treatment of ADHD is unknown and likely multifaceted, she continued. “It may be due to differences in the way that disruptive behaviors are interrupted based on factors such as race. This study found that Asian parents often brought their children in for evaluation for reasons other than ADHD. Concerns surrounding the stigma of mental health treatment and racism also could contribute to the disparity in diagnosis and treatment,” she said.

Dr. Bell said she hopes to see future studies that address the impact of social determinants of health on mental illness and investigate underlying causes that contribute to disparities in treatment and diagnosis.

The Mayo Clinic supported the study but had no role in its design or research methods. The authors reported no conflicts of interest.

A study of U.S. children across ethnic and racial groups found that Asians were least likely to receive therapy for ADHD, compared with White children – who had the highest odds of getting some kind of treatment over other groups.

Other studies have identified disparity problems in ADHD diagnosis, although results have varied on inequality metrics. Few studies have looked at Asians separately, according to the study’s lead author, Yu Shi, MD, MPH. “They were usually just classified as ‘other’ or as non-White,” Dr. Shi, a consultant with the Mayo Clinic’s division of pediatric anesthesia in Rochester, Minn., said in an interview.

Disparities might stem from cultural and socioeconomic factors, and the way in which clinicians interpret behavior and apply diagnostic criteria.

“Further understanding of how treatment patterns for ADHD may differ based on race, at the time of initial diagnosis and in the early stages of treatment, may help all children receive appropriate evidence-based care,” Dr. Shi and colleagues reported in JAMA Network Open.
 

Researchers develop large birth cohort

Dr. Shi and colleagues hypothesized that non-Hispanic White children had a greater chance of getting diagnosed and treated within the first year of diagnosis than that of other ethnic and racial cohorts. Using administrative claims data with socioeconomic status information from a national commercial insurance warehouse, they constructed a retrospective birth cohort of children born between Jan. 1, 2006, and Dec. 31, 2012. The children had continuous insurance coverage for at least 4 years, and represented non-Hispanic Whites, Blacks, Hispanics, and Asians. Self-reporting identified the race/ethnicity groups.

Investigators analyzed ADHD diagnosis and treatment data on 238,011 children between October 2019 and December 2020, using a multivariate Cox regression model to adjust for sex, region, and household income. Primary and secondary outcomes included ADHD diagnosis as defined by recent ICD codes, ADHD behavior, and medication therapies in the clinical setting after initial diagnosis, respectively.

Whites made up most of the cohort (72.7%), followed by Hispanics (9.8%), Asians (6.7%), and Blacks (6.2%). Nearly half the population was female (48.8%). During the follow-up period with these children, 11,401, or 4.8%, had received an ADHD diagnosis. Mean age of diagnosis was 6.5 years, and overall incidence of ADHD was 69 per 10,000 person years (95% confidence interval, 68-70).

Pediatricians were most likely to make an ADHD diagnosis, although the study cited other clinicians, such as psychiatrists, neurologists, psychologists, and family practice clinicians, as responsible for these decisions.

Children diagnosed with ADHD had more years of coverage in the data set, and were more likely to be White and male. The Southern census region had a higher representation of diagnoses (50.6%) than did the Northeast region (11.8%).
 

Asians at highest odds for no treatment

Taking a closer look at race and ethnicity, Whites had the highest cumulative incidence of ADHD (14.19%), versus Asian children, who had lowest incidence (6.08%). “The curves for Black and Hispanic children were similar in shape and slightly lower than that for White children,” reported the investigators.

White children had higher odds of receiving some kind of treatment, compared with the other groups.

Incidence of medication treatment was lower among Asians and Hispanics. In a striking finding, Asians were most likely to receive no treatment at all (odds ratio compared with White children, 0.54; 95% confidence interval, 0.42-0.70). “However, the percentage of Asian children receiving psychotherapy was not significantly lower than other groups, which is different than a 2013 study finding that Asian children with ADHD were less likely to use mental health services,” they noted.

Most of the patients received medication (32.4%) in the first year after diagnosis, whereas (19.4%) received behavioral therapy only. Nineteen percent had both. More than 29% of these cases had no claims associated with either treatment. Among school-aged children, 65.5% were prescribed medications, compared with just 14.4% who received therapy. Twenty percent had no treatment.

Diagnosis with another disorder often preceded ADHD diagnosis. Results varied among racial groups. White children were more likely than were Black children to be diagnosed with an anxiety or adjustment disorder. Relative to White children, Asians were more likely to be diagnosed with autism spectrum disorder, speech sound disorders, or unspecified neurodevelopmental disorders. Even after an ADHD diagnosis, clinicians were more likely to diagnose Asian children with autism.
 

Parents may influence treatment decisions

Parental views and preferences may explain some of the variations in diagnosis and treatment among the racial/ethnic groups.

“In order for a diagnosis of ADHD to happen, a parent has first to recognize a problem and bring a child for clinical evaluation,” said Dr. Shi. “A certain behavior could be viewed as normal or a problem depending on a person’s cultural or racial background.” It’s unclear whether clinicians played any role in diagnosis disparities, he added. Patients’ concerns about racism might also influence the desire to get treated in health care systems.

Overall, the findings underscore the presence of racial and ethnic disparities in ADHD diagnosis and treatment. Future research should explore the underlying mechanisms, Dr. Shi suggested. While he and his colleagues have no immediate plans to do another ADHD study, “we’re planning on research to understand disparities in surgery in children,” he said.

The authors cited numerous limitations with their study. Use of ICD codes to identify cases might not have represented true clinical diagnosis, since the data were collected for billing, not research purposes. Investigators drew participants from a commercial insurance database, which did not necessarily reflect all U.S. children. The results might not represent a large number of children covered by Medicaid, for example, noted Dr. Shi. “It is more difficult to work with Medicaid data because there’s no national-level Medicaid data for research. Only state-level data is available.”

Because of other data gaps, Dr. Shi and colleagues might have underestimated the number of children in therapy.
 

A need for ‘culturally sensitive care’

The findings “ultimately demonstrate the need for culturally sensitive care in the diagnosis and treatment of children and adolescents,” said Tiffani L. Bell, MD, a psychiatrist in Winston-Salem, N.C., who was not involved with the study. She specializes in child and adolescent psychiatry.

The exact cause for racial disparity in diagnosis and treatment of ADHD is unknown and likely multifaceted, she continued. “It may be due to differences in the way that disruptive behaviors are interrupted based on factors such as race. This study found that Asian parents often brought their children in for evaluation for reasons other than ADHD. Concerns surrounding the stigma of mental health treatment and racism also could contribute to the disparity in diagnosis and treatment,” she said.

Dr. Bell said she hopes to see future studies that address the impact of social determinants of health on mental illness and investigate underlying causes that contribute to disparities in treatment and diagnosis.

The Mayo Clinic supported the study but had no role in its design or research methods. The authors reported no conflicts of interest.

A study of U.S. children across ethnic and racial groups found that Asians were least likely to receive therapy for ADHD, compared with White children – who had the highest odds of getting some kind of treatment over other groups.

Other studies have identified disparity problems in ADHD diagnosis, although results have varied on inequality metrics. Few studies have looked at Asians separately, according to the study’s lead author, Yu Shi, MD, MPH. “They were usually just classified as ‘other’ or as non-White,” Dr. Shi, a consultant with the Mayo Clinic’s division of pediatric anesthesia in Rochester, Minn., said in an interview.

Disparities might stem from cultural and socioeconomic factors, and the way in which clinicians interpret behavior and apply diagnostic criteria.

“Further understanding of how treatment patterns for ADHD may differ based on race, at the time of initial diagnosis and in the early stages of treatment, may help all children receive appropriate evidence-based care,” Dr. Shi and colleagues reported in JAMA Network Open.
 

Researchers develop large birth cohort

Dr. Shi and colleagues hypothesized that non-Hispanic White children had a greater chance of getting diagnosed and treated within the first year of diagnosis than that of other ethnic and racial cohorts. Using administrative claims data with socioeconomic status information from a national commercial insurance warehouse, they constructed a retrospective birth cohort of children born between Jan. 1, 2006, and Dec. 31, 2012. The children had continuous insurance coverage for at least 4 years, and represented non-Hispanic Whites, Blacks, Hispanics, and Asians. Self-reporting identified the race/ethnicity groups.

Investigators analyzed ADHD diagnosis and treatment data on 238,011 children between October 2019 and December 2020, using a multivariate Cox regression model to adjust for sex, region, and household income. Primary and secondary outcomes included ADHD diagnosis as defined by recent ICD codes, ADHD behavior, and medication therapies in the clinical setting after initial diagnosis, respectively.

Whites made up most of the cohort (72.7%), followed by Hispanics (9.8%), Asians (6.7%), and Blacks (6.2%). Nearly half the population was female (48.8%). During the follow-up period with these children, 11,401, or 4.8%, had received an ADHD diagnosis. Mean age of diagnosis was 6.5 years, and overall incidence of ADHD was 69 per 10,000 person years (95% confidence interval, 68-70).

Pediatricians were most likely to make an ADHD diagnosis, although the study cited other clinicians, such as psychiatrists, neurologists, psychologists, and family practice clinicians, as responsible for these decisions.

Children diagnosed with ADHD had more years of coverage in the data set, and were more likely to be White and male. The Southern census region had a higher representation of diagnoses (50.6%) than did the Northeast region (11.8%).
 

Asians at highest odds for no treatment

Taking a closer look at race and ethnicity, Whites had the highest cumulative incidence of ADHD (14.19%), versus Asian children, who had lowest incidence (6.08%). “The curves for Black and Hispanic children were similar in shape and slightly lower than that for White children,” reported the investigators.

White children had higher odds of receiving some kind of treatment, compared with the other groups.

Incidence of medication treatment was lower among Asians and Hispanics. In a striking finding, Asians were most likely to receive no treatment at all (odds ratio compared with White children, 0.54; 95% confidence interval, 0.42-0.70). “However, the percentage of Asian children receiving psychotherapy was not significantly lower than other groups, which is different than a 2013 study finding that Asian children with ADHD were less likely to use mental health services,” they noted.

Most of the patients received medication (32.4%) in the first year after diagnosis, whereas (19.4%) received behavioral therapy only. Nineteen percent had both. More than 29% of these cases had no claims associated with either treatment. Among school-aged children, 65.5% were prescribed medications, compared with just 14.4% who received therapy. Twenty percent had no treatment.

Diagnosis with another disorder often preceded ADHD diagnosis. Results varied among racial groups. White children were more likely than were Black children to be diagnosed with an anxiety or adjustment disorder. Relative to White children, Asians were more likely to be diagnosed with autism spectrum disorder, speech sound disorders, or unspecified neurodevelopmental disorders. Even after an ADHD diagnosis, clinicians were more likely to diagnose Asian children with autism.
 

Parents may influence treatment decisions

Parental views and preferences may explain some of the variations in diagnosis and treatment among the racial/ethnic groups.

“In order for a diagnosis of ADHD to happen, a parent has first to recognize a problem and bring a child for clinical evaluation,” said Dr. Shi. “A certain behavior could be viewed as normal or a problem depending on a person’s cultural or racial background.” It’s unclear whether clinicians played any role in diagnosis disparities, he added. Patients’ concerns about racism might also influence the desire to get treated in health care systems.

Overall, the findings underscore the presence of racial and ethnic disparities in ADHD diagnosis and treatment. Future research should explore the underlying mechanisms, Dr. Shi suggested. While he and his colleagues have no immediate plans to do another ADHD study, “we’re planning on research to understand disparities in surgery in children,” he said.

The authors cited numerous limitations with their study. Use of ICD codes to identify cases might not have represented true clinical diagnosis, since the data were collected for billing, not research purposes. Investigators drew participants from a commercial insurance database, which did not necessarily reflect all U.S. children. The results might not represent a large number of children covered by Medicaid, for example, noted Dr. Shi. “It is more difficult to work with Medicaid data because there’s no national-level Medicaid data for research. Only state-level data is available.”

Because of other data gaps, Dr. Shi and colleagues might have underestimated the number of children in therapy.
 

A need for ‘culturally sensitive care’

The findings “ultimately demonstrate the need for culturally sensitive care in the diagnosis and treatment of children and adolescents,” said Tiffani L. Bell, MD, a psychiatrist in Winston-Salem, N.C., who was not involved with the study. She specializes in child and adolescent psychiatry.

The exact cause for racial disparity in diagnosis and treatment of ADHD is unknown and likely multifaceted, she continued. “It may be due to differences in the way that disruptive behaviors are interrupted based on factors such as race. This study found that Asian parents often brought their children in for evaluation for reasons other than ADHD. Concerns surrounding the stigma of mental health treatment and racism also could contribute to the disparity in diagnosis and treatment,” she said.

Dr. Bell said she hopes to see future studies that address the impact of social determinants of health on mental illness and investigate underlying causes that contribute to disparities in treatment and diagnosis.

The Mayo Clinic supported the study but had no role in its design or research methods. The authors reported no conflicts of interest.

The federal government’s temporary pause on use of the Johnson & Johnson COVID-19 vaccine last month underscores the significant challenges facing one of the most vulnerable groups – homebound patients.

Courtesy Dr. Peter Gliatto

There are about 2 million to 4 million homebound patients in the United States, according to a webinar from The Trust for America’s Health, which was broadcast in March. But many of these individuals have not been vaccinated yet because of logistical challenges.

Some homebound COVID-19 immunization programs are administering Moderna and Pfizer vaccines to their patients, but many state, city, and local programs administered the Johnson & Johnson vaccine after it was cleared for use by the Food and Drug Administration in February 2021. The efficacy of the one-shot vaccine, as well as it being easier to store and ship than the Moderna and Pfizer vaccines, makes getting it to homebound patients less challenging.

“With Pfizer and Moderna, transportation is a challenge because the temperature demands and the fragility of [messenger] RNA–based vaccines,” Brent Feorene, executive director of the American Academy of Home Care Medicine, said in an interview. That’s why [the Johnson & Johnson] vaccine held such promise – it’s less fragile, [can be stored in] higher temperatures, and was a one shot.”

Other hurdles to getting homebound patients vaccinated had already been in place prior to the 10-day-pause on using the J&J vaccine that occurred for federal agencies to consider possible serious side effects linked to it.
 

Many roadblocks to vaccination

Although many homebound patients can’t readily go out into the community and be exposed to the COVID-19 virus themselves, they are dependent on caregivers and family members who do go out into the community.

“Their friends, family, neighbors, home health aides, and other kinds of health care workers come into the home,” said Shawn Amer, clinical program director at Central Ohio Primary Care in Columbus.

Nurses from Ms. Amer’s practice vaccinated approximately ten homebound patients with the J&J vaccine through a pilot program in March. Then on April 24, nurses from Central Ohio Primary Care vaccinated just under 40 homebound patients and about a handful of their caregivers who were not able to get their vaccines elsewhere, according to Ms. Amer. This time they used the Pfizer vaccine and will be returning to these patients’ homes on May 15 to administer the second dose.

Courtesy Central Ohio Primary Care

“Any time you are getting in the car and adding miles, it adds complexity,” Ms. Amer said.

“We called patients 24 to 36 hours before coming to their homes to make sure they were ready, but we learned that just because the healthcare power of attorney agrees to a patient getting vaccinated does not mean that patient will be willing to get the vaccine when the nurse shows up," she noted.

Ms. Amer elaborated that three patients with dementia refused the vaccine when nurses arrived at their home on April 24.

“We had to pivot and find other people,” Ms. Amer. Her practice ended up having to waste one shot.
 

Expenses are greater

The higher costs of getting homebound patients vaccinated is an additional hurdle to getting these vulnerable individuals protected by COVID-19 shots.

Vaccinating patients in their homes “doesn’t require a lot of technology, but it does require a lot of time” and the staffing expense becomes part of the challenge, Ms. Amer noted.

For each of the two days that Central Ohio Primary Care provides the Pfizer vaccine to homebound patients, the practice needs to pay seven nurses to administer the vaccine, Ms. Amer explained.

There have also been reports of organizations that administer the vaccines – which are free for patients because the federal government is paying for them – not being paid enough by Medicare to cover staff time and efforts to vaccinate patients in their homes, Kaiser Health News reported. According to the Centers for Medicare & Medicaid Services, they pay $40 for the administration of a single-dose COVID-19 vaccine and, for COVID-19 vaccines requiring multiple doses, Medicare pays approximately $40 for each dose in the series. These rates were implemented after March 15. Before that date, the rates were even lower, with the Medicare reimbursement rates for initial doses of COVID-19 vaccines being $16.94 and final doses being $28.39.

William Dombi, president of the National Association for Home Care & Hospice, told Kaiser Health News that the actual cost of these homebound visits are closer to $150 or $160.

“The reimbursement for the injection is pretty minimal,” Mr. Feorene said. “So unless you’re a larger organization and able to have staff to deploy some of your smaller practices, just couldn’t afford to do it.”

Many homebound patients have also been unable to get the lifesaving shots because of logistical roadblocks and many practices not being able to do home visits.

“I think that initially when the [Centers for Disease Control and Prevention] came out with vaccine guidance for medical providers, they offered no guidance for in-home medical providers and we had to go back and ask for that, which they did produce,” Mr. Feorene said. “And we’re grateful for that. But I think just this general understanding that there is a population of folks that are [limited to their home], that they do receive medical care and other care in the home, and that we have to remember that the medical providers who provide care in the home are also primary care providers.”

Furthermore, trying to navigate or find programs delivering vaccines to the homebound can be difficult depending on where a patient lives.

While some programs have been launched on the country or city level – the New York Fire Department launched a pilot program to bring the Johnson & Johnson vaccine to homebound seniors – other programs have been spearheaded by hospital networks like Northwell and Mount Sinai. However, many of these hospital networks only reach out to people who already have a relationship with the hospital.

Ms Amer said identifying homebound patients and reaching out to them can be tough and can contribute to the logistics and time involved in setting patients up for the vaccine.

“Reaching some of these patients is difficult,” Ms. Amer noted. “Sometimes the best way to reach them or get a hold of them is through their caregiver. And so do you have the right phone number? Do you have the right name?”
 

Overcoming the challenges

With the absence of a national plan targeting homebound patients, many local initiatives were launched to help these individuals get vaccinated. Local fire department paramedics have gone door to door to administer the COVID-19 vaccine in cities like Chicago, New York, and Miami. The suspension of the Johnson & Johnson vaccine resulted in the suspension of in-home vaccinations for some people in New York City. However, the program resumed after the FDA and CDC lifted the pause on April 24.

Courtesy Central Ohio Primary Care

Health systems like Mount Sinai vaccinated approximately 530 people through the Mount Sinai Visiting Doctors Program, including patients and their caregivers, according to Peter Gliatto, MD, associate director of the Mount Sinai Visiting Doctors Program. 

“In different cities, townships, and jurisdictions, different health departments and different provider groups are approaching [the distribution of the COVID-19 vaccine] slightly differently,” Ms. Amer said. So a lot of the decisions surrounding the distribution of shots are local or dependent on local resourcing.

People who live in rural areas present a unique challenge, but Mr. Feorene said reaching out to local emergency medical services or the local health departments can provide some insight on what their town is doing to vaccinate homebound patients.

“I think understanding what a [public health department] is doing would be the very first place to start,” Mr. Feorene said in an interview.

If a patient is bedridden and is mobile enough to sit in a car, Mr. Feorene also recommends finding out if there are vaccine fairs “within a reasonable driving distance.”

Ms. Amer said continuing this mission of getting homebound patients vaccinated is necessary for public health.

“Even if it’s going to take longer to vaccinate these homebound patients, we still have to make an effort. So much of the country’s vaccine efforts have been focused on getting as many shots in as many arms as quickly as possible. And that is definitely super important,” she said.

Ms. Amer is working with her practice’s primary care physicians to try to identify all of those patients who are functionally debilitated or unable to leave their home to get vaccinated and that Central Ohio Primary Care will vaccinate more homebound patients, she added.

The experts interviewed in this article have no conflicts.

Katie Lennon contributed to this report.

This article was updated 4/29/21.

The federal government’s temporary pause on use of the Johnson & Johnson COVID-19 vaccine last month underscores the significant challenges facing one of the most vulnerable groups – homebound patients.

Courtesy Dr. Peter Gliatto

There are about 2 million to 4 million homebound patients in the United States, according to a webinar from The Trust for America’s Health, which was broadcast in March. But many of these individuals have not been vaccinated yet because of logistical challenges.

Some homebound COVID-19 immunization programs are administering Moderna and Pfizer vaccines to their patients, but many state, city, and local programs administered the Johnson & Johnson vaccine after it was cleared for use by the Food and Drug Administration in February 2021. The efficacy of the one-shot vaccine, as well as it being easier to store and ship than the Moderna and Pfizer vaccines, makes getting it to homebound patients less challenging.

“With Pfizer and Moderna, transportation is a challenge because the temperature demands and the fragility of [messenger] RNA–based vaccines,” Brent Feorene, executive director of the American Academy of Home Care Medicine, said in an interview. That’s why [the Johnson & Johnson] vaccine held such promise – it’s less fragile, [can be stored in] higher temperatures, and was a one shot.”

Other hurdles to getting homebound patients vaccinated had already been in place prior to the 10-day-pause on using the J&J vaccine that occurred for federal agencies to consider possible serious side effects linked to it.
 

Many roadblocks to vaccination

Although many homebound patients can’t readily go out into the community and be exposed to the COVID-19 virus themselves, they are dependent on caregivers and family members who do go out into the community.

“Their friends, family, neighbors, home health aides, and other kinds of health care workers come into the home,” said Shawn Amer, clinical program director at Central Ohio Primary Care in Columbus.

Nurses from Ms. Amer’s practice vaccinated approximately ten homebound patients with the J&J vaccine through a pilot program in March. Then on April 24, nurses from Central Ohio Primary Care vaccinated just under 40 homebound patients and about a handful of their caregivers who were not able to get their vaccines elsewhere, according to Ms. Amer. This time they used the Pfizer vaccine and will be returning to these patients’ homes on May 15 to administer the second dose.

Courtesy Central Ohio Primary Care

“Any time you are getting in the car and adding miles, it adds complexity,” Ms. Amer said.

“We called patients 24 to 36 hours before coming to their homes to make sure they were ready, but we learned that just because the healthcare power of attorney agrees to a patient getting vaccinated does not mean that patient will be willing to get the vaccine when the nurse shows up," she noted.

Ms. Amer elaborated that three patients with dementia refused the vaccine when nurses arrived at their home on April 24.

“We had to pivot and find other people,” Ms. Amer. Her practice ended up having to waste one shot.
 

Expenses are greater

The higher costs of getting homebound patients vaccinated is an additional hurdle to getting these vulnerable individuals protected by COVID-19 shots.

Vaccinating patients in their homes “doesn’t require a lot of technology, but it does require a lot of time” and the staffing expense becomes part of the challenge, Ms. Amer noted.

For each of the two days that Central Ohio Primary Care provides the Pfizer vaccine to homebound patients, the practice needs to pay seven nurses to administer the vaccine, Ms. Amer explained.

There have also been reports of organizations that administer the vaccines – which are free for patients because the federal government is paying for them – not being paid enough by Medicare to cover staff time and efforts to vaccinate patients in their homes, Kaiser Health News reported. According to the Centers for Medicare & Medicaid Services, they pay $40 for the administration of a single-dose COVID-19 vaccine and, for COVID-19 vaccines requiring multiple doses, Medicare pays approximately $40 for each dose in the series. These rates were implemented after March 15. Before that date, the rates were even lower, with the Medicare reimbursement rates for initial doses of COVID-19 vaccines being $16.94 and final doses being $28.39.

William Dombi, president of the National Association for Home Care & Hospice, told Kaiser Health News that the actual cost of these homebound visits are closer to $150 or $160.

“The reimbursement for the injection is pretty minimal,” Mr. Feorene said. “So unless you’re a larger organization and able to have staff to deploy some of your smaller practices, just couldn’t afford to do it.”

Many homebound patients have also been unable to get the lifesaving shots because of logistical roadblocks and many practices not being able to do home visits.

“I think that initially when the [Centers for Disease Control and Prevention] came out with vaccine guidance for medical providers, they offered no guidance for in-home medical providers and we had to go back and ask for that, which they did produce,” Mr. Feorene said. “And we’re grateful for that. But I think just this general understanding that there is a population of folks that are [limited to their home], that they do receive medical care and other care in the home, and that we have to remember that the medical providers who provide care in the home are also primary care providers.”

Furthermore, trying to navigate or find programs delivering vaccines to the homebound can be difficult depending on where a patient lives.

While some programs have been launched on the country or city level – the New York Fire Department launched a pilot program to bring the Johnson & Johnson vaccine to homebound seniors – other programs have been spearheaded by hospital networks like Northwell and Mount Sinai. However, many of these hospital networks only reach out to people who already have a relationship with the hospital.

Ms Amer said identifying homebound patients and reaching out to them can be tough and can contribute to the logistics and time involved in setting patients up for the vaccine.

“Reaching some of these patients is difficult,” Ms. Amer noted. “Sometimes the best way to reach them or get a hold of them is through their caregiver. And so do you have the right phone number? Do you have the right name?”
 

Overcoming the challenges

With the absence of a national plan targeting homebound patients, many local initiatives were launched to help these individuals get vaccinated. Local fire department paramedics have gone door to door to administer the COVID-19 vaccine in cities like Chicago, New York, and Miami. The suspension of the Johnson & Johnson vaccine resulted in the suspension of in-home vaccinations for some people in New York City. However, the program resumed after the FDA and CDC lifted the pause on April 24.

Courtesy Central Ohio Primary Care

Health systems like Mount Sinai vaccinated approximately 530 people through the Mount Sinai Visiting Doctors Program, including patients and their caregivers, according to Peter Gliatto, MD, associate director of the Mount Sinai Visiting Doctors Program. 

“In different cities, townships, and jurisdictions, different health departments and different provider groups are approaching [the distribution of the COVID-19 vaccine] slightly differently,” Ms. Amer said. So a lot of the decisions surrounding the distribution of shots are local or dependent on local resourcing.

People who live in rural areas present a unique challenge, but Mr. Feorene said reaching out to local emergency medical services or the local health departments can provide some insight on what their town is doing to vaccinate homebound patients.

“I think understanding what a [public health department] is doing would be the very first place to start,” Mr. Feorene said in an interview.

If a patient is bedridden and is mobile enough to sit in a car, Mr. Feorene also recommends finding out if there are vaccine fairs “within a reasonable driving distance.”

Ms. Amer said continuing this mission of getting homebound patients vaccinated is necessary for public health.

“Even if it’s going to take longer to vaccinate these homebound patients, we still have to make an effort. So much of the country’s vaccine efforts have been focused on getting as many shots in as many arms as quickly as possible. And that is definitely super important,” she said.

Ms. Amer is working with her practice’s primary care physicians to try to identify all of those patients who are functionally debilitated or unable to leave their home to get vaccinated and that Central Ohio Primary Care will vaccinate more homebound patients, she added.

The experts interviewed in this article have no conflicts.

Katie Lennon contributed to this report.

This article was updated 4/29/21.

The federal government’s temporary pause on use of the Johnson & Johnson COVID-19 vaccine last month underscores the significant challenges facing one of the most vulnerable groups – homebound patients.

Courtesy Dr. Peter Gliatto

There are about 2 million to 4 million homebound patients in the United States, according to a webinar from The Trust for America’s Health, which was broadcast in March. But many of these individuals have not been vaccinated yet because of logistical challenges.

Some homebound COVID-19 immunization programs are administering Moderna and Pfizer vaccines to their patients, but many state, city, and local programs administered the Johnson & Johnson vaccine after it was cleared for use by the Food and Drug Administration in February 2021. The efficacy of the one-shot vaccine, as well as it being easier to store and ship than the Moderna and Pfizer vaccines, makes getting it to homebound patients less challenging.

“With Pfizer and Moderna, transportation is a challenge because the temperature demands and the fragility of [messenger] RNA–based vaccines,” Brent Feorene, executive director of the American Academy of Home Care Medicine, said in an interview. That’s why [the Johnson & Johnson] vaccine held such promise – it’s less fragile, [can be stored in] higher temperatures, and was a one shot.”

Other hurdles to getting homebound patients vaccinated had already been in place prior to the 10-day-pause on using the J&J vaccine that occurred for federal agencies to consider possible serious side effects linked to it.
 

Many roadblocks to vaccination

Although many homebound patients can’t readily go out into the community and be exposed to the COVID-19 virus themselves, they are dependent on caregivers and family members who do go out into the community.

“Their friends, family, neighbors, home health aides, and other kinds of health care workers come into the home,” said Shawn Amer, clinical program director at Central Ohio Primary Care in Columbus.

Nurses from Ms. Amer’s practice vaccinated approximately ten homebound patients with the J&J vaccine through a pilot program in March. Then on April 24, nurses from Central Ohio Primary Care vaccinated just under 40 homebound patients and about a handful of their caregivers who were not able to get their vaccines elsewhere, according to Ms. Amer. This time they used the Pfizer vaccine and will be returning to these patients’ homes on May 15 to administer the second dose.

Courtesy Central Ohio Primary Care

“Any time you are getting in the car and adding miles, it adds complexity,” Ms. Amer said.

“We called patients 24 to 36 hours before coming to their homes to make sure they were ready, but we learned that just because the healthcare power of attorney agrees to a patient getting vaccinated does not mean that patient will be willing to get the vaccine when the nurse shows up," she noted.

Ms. Amer elaborated that three patients with dementia refused the vaccine when nurses arrived at their home on April 24.

“We had to pivot and find other people,” Ms. Amer. Her practice ended up having to waste one shot.
 

Expenses are greater

The higher costs of getting homebound patients vaccinated is an additional hurdle to getting these vulnerable individuals protected by COVID-19 shots.

Vaccinating patients in their homes “doesn’t require a lot of technology, but it does require a lot of time” and the staffing expense becomes part of the challenge, Ms. Amer noted.

For each of the two days that Central Ohio Primary Care provides the Pfizer vaccine to homebound patients, the practice needs to pay seven nurses to administer the vaccine, Ms. Amer explained.

There have also been reports of organizations that administer the vaccines – which are free for patients because the federal government is paying for them – not being paid enough by Medicare to cover staff time and efforts to vaccinate patients in their homes, Kaiser Health News reported. According to the Centers for Medicare & Medicaid Services, they pay $40 for the administration of a single-dose COVID-19 vaccine and, for COVID-19 vaccines requiring multiple doses, Medicare pays approximately $40 for each dose in the series. These rates were implemented after March 15. Before that date, the rates were even lower, with the Medicare reimbursement rates for initial doses of COVID-19 vaccines being $16.94 and final doses being $28.39.

William Dombi, president of the National Association for Home Care & Hospice, told Kaiser Health News that the actual cost of these homebound visits are closer to $150 or $160.

“The reimbursement for the injection is pretty minimal,” Mr. Feorene said. “So unless you’re a larger organization and able to have staff to deploy some of your smaller practices, just couldn’t afford to do it.”

Many homebound patients have also been unable to get the lifesaving shots because of logistical roadblocks and many practices not being able to do home visits.

“I think that initially when the [Centers for Disease Control and Prevention] came out with vaccine guidance for medical providers, they offered no guidance for in-home medical providers and we had to go back and ask for that, which they did produce,” Mr. Feorene said. “And we’re grateful for that. But I think just this general understanding that there is a population of folks that are [limited to their home], that they do receive medical care and other care in the home, and that we have to remember that the medical providers who provide care in the home are also primary care providers.”

Furthermore, trying to navigate or find programs delivering vaccines to the homebound can be difficult depending on where a patient lives.

While some programs have been launched on the country or city level – the New York Fire Department launched a pilot program to bring the Johnson & Johnson vaccine to homebound seniors – other programs have been spearheaded by hospital networks like Northwell and Mount Sinai. However, many of these hospital networks only reach out to people who already have a relationship with the hospital.

Ms Amer said identifying homebound patients and reaching out to them can be tough and can contribute to the logistics and time involved in setting patients up for the vaccine.

“Reaching some of these patients is difficult,” Ms. Amer noted. “Sometimes the best way to reach them or get a hold of them is through their caregiver. And so do you have the right phone number? Do you have the right name?”
 

Overcoming the challenges

With the absence of a national plan targeting homebound patients, many local initiatives were launched to help these individuals get vaccinated. Local fire department paramedics have gone door to door to administer the COVID-19 vaccine in cities like Chicago, New York, and Miami. The suspension of the Johnson & Johnson vaccine resulted in the suspension of in-home vaccinations for some people in New York City. However, the program resumed after the FDA and CDC lifted the pause on April 24.

Courtesy Central Ohio Primary Care

Health systems like Mount Sinai vaccinated approximately 530 people through the Mount Sinai Visiting Doctors Program, including patients and their caregivers, according to Peter Gliatto, MD, associate director of the Mount Sinai Visiting Doctors Program. 

“In different cities, townships, and jurisdictions, different health departments and different provider groups are approaching [the distribution of the COVID-19 vaccine] slightly differently,” Ms. Amer said. So a lot of the decisions surrounding the distribution of shots are local or dependent on local resourcing.

People who live in rural areas present a unique challenge, but Mr. Feorene said reaching out to local emergency medical services or the local health departments can provide some insight on what their town is doing to vaccinate homebound patients.

“I think understanding what a [public health department] is doing would be the very first place to start,” Mr. Feorene said in an interview.

If a patient is bedridden and is mobile enough to sit in a car, Mr. Feorene also recommends finding out if there are vaccine fairs “within a reasonable driving distance.”

Ms. Amer said continuing this mission of getting homebound patients vaccinated is necessary for public health.

“Even if it’s going to take longer to vaccinate these homebound patients, we still have to make an effort. So much of the country’s vaccine efforts have been focused on getting as many shots in as many arms as quickly as possible. And that is definitely super important,” she said.

Ms. Amer is working with her practice’s primary care physicians to try to identify all of those patients who are functionally debilitated or unable to leave their home to get vaccinated and that Central Ohio Primary Care will vaccinate more homebound patients, she added.

The experts interviewed in this article have no conflicts.

Katie Lennon contributed to this report.

This article was updated 4/29/21.

Patients with chronic migraine who turn to cannabis to relieve headache pain may be setting themselves up for medication overuse headache, preliminary research suggests, although the direction of the relationship is unclear. Researchers at Stanford (Calif.) University found a significant increase in the likelihood of medication overuse headache (rebound headache) in chronic migraine patients who use cannabis.

“This study shows that there is some kind of association between cannabis use and medication overuse headache in people with chronic migraine,” said lead investigator Niushen Zhang, MD, a clinical assistant professor at Stanford.

“But it is unclear at this time whether patients are using cannabis to treat medication overuse headache or if cannabis is contributing to the development medication overuse headache, or both,” she said.

The findings were presented at the American Academy of Neurology’s 2021 annual meeting.
 

Sixfold increase

“Medication overuse occurs in about 1% to 3% of the general population. It affects nearly one-third of the patients (mostly patients with chronic migraine) seen at tertiary care centers such as the Stanford Headache Center,” Dr. Zhang said.

From clinical observations, patients with chronic migraine and medication overuse headache appear to be concomitantly using cannabis products, yet there is currently very little research on this topic, she added.

To investigate, the researchers reviewed the records of 368 adults who experienced chronic migraine (15 or more migraine days per month) for at least 1 year. Of the 368 patients, 150 were using cannabis, and 218 were not. In addition, 212 had medication overuse headache, and 156 did not.

Results showed that patients who used cannabis were nearly six times more likely to have medication overuse headache than those who did not use cannabis (odds ratio, 5.99; 95% confidence interval, 3.45-10.43; P < .0001).

There were significant bidirectional relationships between current cannabis use, opioid use, and medication overuse headache.
 

Jury out on cannabis for migraine

Commenting on the findings, Teshamae Monteith, MD, of the University of Miami, noted, “With increased legalization, greater access, and less stigmatization, there are more individuals using cannabis for migraine, but there is no solid evidence to suggest that cannabis is effective for acute or preventive treatment of migraine.”

The study is “interesting,” Dr. Monteith said, but, owing to methodologic limitations, it is not clear that cannabis contributes to medication overuse headache. “Patients with medication overuse headaches may have more comorbidities, such as anxiety, depression, and sleep disorders, that are driving the cannabis use. The patients on cannabis also had higher rates of opiate use, which itself is a stronger contributor to medication overuse headache and may indicate the presence of other pain disorders,” Dr. Monteith said.

“It is not clear if these patients were appropriately treated with migraine prevention; patients that use cannabis sometimes report that they prefer to avoid pharmaceutical treatments, such as antidepressants, etc., used for migraine,” Dr. Monteith noted.

She said that at this point, she would advise clinicians to ask about cannabis use “and let patients know that we do not know enough about the long-term effects of cannabis on the migraine brain.”

Most importantly, Dr. Monteith said, she would “encourage clinicians to be sensitive to the high prevalence of migraine, chronic migraine, and medication overuse. If we can treat more effectively and prevent migraine progression, which includes addressing comorbidities, there would be a lot less medication overuse headache.”

Also weighing in on the study, Jessica Ailani, MD, director, Medstar Georgetown Headache Center, Washington, D.C., noted that there is no conclusive evidence that cannabis is an effective acute or preventive treatment for migraine. “There is a suggestion that cannabis can help treat a migraine attack, but there is uncertainty about concentration of cannabidiol (CBD) to tetrahydrocannabinol (THC) needed to achieve pain freedom,” Dr. Ailani said.

“There has also been some concern about interactions between CBD and other medications used to treat migraine and that CBD can cause a condition known as reversible cerebral vasoconstrictive syndrome. These are reasons to be cautious with CBD,” Dr. Ailani added.

“At this time there is limited advice we can give our patients except that more studies need to be done. If cannabis is used, it should be reported, and medications that may interact with cannabis should be avoided. A headache calendar should be kept to ensure frequency of migraine and headache attacks do not go up,” said Dr. Ailani.

The study had no specific funding. Dr. Zhang, Dr. Monteith, and Dr. Ailani have disclosed no relevant financial relationships.

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

Patients with chronic migraine who turn to cannabis to relieve headache pain may be setting themselves up for medication overuse headache, preliminary research suggests, although the direction of the relationship is unclear. Researchers at Stanford (Calif.) University found a significant increase in the likelihood of medication overuse headache (rebound headache) in chronic migraine patients who use cannabis.

“This study shows that there is some kind of association between cannabis use and medication overuse headache in people with chronic migraine,” said lead investigator Niushen Zhang, MD, a clinical assistant professor at Stanford.

“But it is unclear at this time whether patients are using cannabis to treat medication overuse headache or if cannabis is contributing to the development medication overuse headache, or both,” she said.

The findings were presented at the American Academy of Neurology’s 2021 annual meeting.
 

Sixfold increase

“Medication overuse occurs in about 1% to 3% of the general population. It affects nearly one-third of the patients (mostly patients with chronic migraine) seen at tertiary care centers such as the Stanford Headache Center,” Dr. Zhang said.

From clinical observations, patients with chronic migraine and medication overuse headache appear to be concomitantly using cannabis products, yet there is currently very little research on this topic, she added.

To investigate, the researchers reviewed the records of 368 adults who experienced chronic migraine (15 or more migraine days per month) for at least 1 year. Of the 368 patients, 150 were using cannabis, and 218 were not. In addition, 212 had medication overuse headache, and 156 did not.

Results showed that patients who used cannabis were nearly six times more likely to have medication overuse headache than those who did not use cannabis (odds ratio, 5.99; 95% confidence interval, 3.45-10.43; P < .0001).

There were significant bidirectional relationships between current cannabis use, opioid use, and medication overuse headache.
 

Jury out on cannabis for migraine

Commenting on the findings, Teshamae Monteith, MD, of the University of Miami, noted, “With increased legalization, greater access, and less stigmatization, there are more individuals using cannabis for migraine, but there is no solid evidence to suggest that cannabis is effective for acute or preventive treatment of migraine.”

The study is “interesting,” Dr. Monteith said, but, owing to methodologic limitations, it is not clear that cannabis contributes to medication overuse headache. “Patients with medication overuse headaches may have more comorbidities, such as anxiety, depression, and sleep disorders, that are driving the cannabis use. The patients on cannabis also had higher rates of opiate use, which itself is a stronger contributor to medication overuse headache and may indicate the presence of other pain disorders,” Dr. Monteith said.

“It is not clear if these patients were appropriately treated with migraine prevention; patients that use cannabis sometimes report that they prefer to avoid pharmaceutical treatments, such as antidepressants, etc., used for migraine,” Dr. Monteith noted.

She said that at this point, she would advise clinicians to ask about cannabis use “and let patients know that we do not know enough about the long-term effects of cannabis on the migraine brain.”

Most importantly, Dr. Monteith said, she would “encourage clinicians to be sensitive to the high prevalence of migraine, chronic migraine, and medication overuse. If we can treat more effectively and prevent migraine progression, which includes addressing comorbidities, there would be a lot less medication overuse headache.”

Also weighing in on the study, Jessica Ailani, MD, director, Medstar Georgetown Headache Center, Washington, D.C., noted that there is no conclusive evidence that cannabis is an effective acute or preventive treatment for migraine. “There is a suggestion that cannabis can help treat a migraine attack, but there is uncertainty about concentration of cannabidiol (CBD) to tetrahydrocannabinol (THC) needed to achieve pain freedom,” Dr. Ailani said.

“There has also been some concern about interactions between CBD and other medications used to treat migraine and that CBD can cause a condition known as reversible cerebral vasoconstrictive syndrome. These are reasons to be cautious with CBD,” Dr. Ailani added.

“At this time there is limited advice we can give our patients except that more studies need to be done. If cannabis is used, it should be reported, and medications that may interact with cannabis should be avoided. A headache calendar should be kept to ensure frequency of migraine and headache attacks do not go up,” said Dr. Ailani.

The study had no specific funding. Dr. Zhang, Dr. Monteith, and Dr. Ailani have disclosed no relevant financial relationships.

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

Patients with chronic migraine who turn to cannabis to relieve headache pain may be setting themselves up for medication overuse headache, preliminary research suggests, although the direction of the relationship is unclear. Researchers at Stanford (Calif.) University found a significant increase in the likelihood of medication overuse headache (rebound headache) in chronic migraine patients who use cannabis.

“This study shows that there is some kind of association between cannabis use and medication overuse headache in people with chronic migraine,” said lead investigator Niushen Zhang, MD, a clinical assistant professor at Stanford.

“But it is unclear at this time whether patients are using cannabis to treat medication overuse headache or if cannabis is contributing to the development medication overuse headache, or both,” she said.

The findings were presented at the American Academy of Neurology’s 2021 annual meeting.
 

Sixfold increase

“Medication overuse occurs in about 1% to 3% of the general population. It affects nearly one-third of the patients (mostly patients with chronic migraine) seen at tertiary care centers such as the Stanford Headache Center,” Dr. Zhang said.

From clinical observations, patients with chronic migraine and medication overuse headache appear to be concomitantly using cannabis products, yet there is currently very little research on this topic, she added.

To investigate, the researchers reviewed the records of 368 adults who experienced chronic migraine (15 or more migraine days per month) for at least 1 year. Of the 368 patients, 150 were using cannabis, and 218 were not. In addition, 212 had medication overuse headache, and 156 did not.

Results showed that patients who used cannabis were nearly six times more likely to have medication overuse headache than those who did not use cannabis (odds ratio, 5.99; 95% confidence interval, 3.45-10.43; P < .0001).

There were significant bidirectional relationships between current cannabis use, opioid use, and medication overuse headache.
 

Jury out on cannabis for migraine

Commenting on the findings, Teshamae Monteith, MD, of the University of Miami, noted, “With increased legalization, greater access, and less stigmatization, there are more individuals using cannabis for migraine, but there is no solid evidence to suggest that cannabis is effective for acute or preventive treatment of migraine.”

The study is “interesting,” Dr. Monteith said, but, owing to methodologic limitations, it is not clear that cannabis contributes to medication overuse headache. “Patients with medication overuse headaches may have more comorbidities, such as anxiety, depression, and sleep disorders, that are driving the cannabis use. The patients on cannabis also had higher rates of opiate use, which itself is a stronger contributor to medication overuse headache and may indicate the presence of other pain disorders,” Dr. Monteith said.

“It is not clear if these patients were appropriately treated with migraine prevention; patients that use cannabis sometimes report that they prefer to avoid pharmaceutical treatments, such as antidepressants, etc., used for migraine,” Dr. Monteith noted.

She said that at this point, she would advise clinicians to ask about cannabis use “and let patients know that we do not know enough about the long-term effects of cannabis on the migraine brain.”

Most importantly, Dr. Monteith said, she would “encourage clinicians to be sensitive to the high prevalence of migraine, chronic migraine, and medication overuse. If we can treat more effectively and prevent migraine progression, which includes addressing comorbidities, there would be a lot less medication overuse headache.”

Also weighing in on the study, Jessica Ailani, MD, director, Medstar Georgetown Headache Center, Washington, D.C., noted that there is no conclusive evidence that cannabis is an effective acute or preventive treatment for migraine. “There is a suggestion that cannabis can help treat a migraine attack, but there is uncertainty about concentration of cannabidiol (CBD) to tetrahydrocannabinol (THC) needed to achieve pain freedom,” Dr. Ailani said.

“There has also been some concern about interactions between CBD and other medications used to treat migraine and that CBD can cause a condition known as reversible cerebral vasoconstrictive syndrome. These are reasons to be cautious with CBD,” Dr. Ailani added.

“At this time there is limited advice we can give our patients except that more studies need to be done. If cannabis is used, it should be reported, and medications that may interact with cannabis should be avoided. A headache calendar should be kept to ensure frequency of migraine and headache attacks do not go up,” said Dr. Ailani.

The study had no specific funding. Dr. Zhang, Dr. Monteith, and Dr. Ailani have disclosed no relevant financial relationships.

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

SEP-363856, an investigational nondopamine antipsychotic that’s been the focus of a trial in schizophrenia, has shown signals that it may improve psychosis symptoms in patients with Parkinson’s disease without worsening motor symptoms, according to results of a proof-of-principle study presented at the 2021 annual meeting of the American Academy of Neurology.

In presenting study results, Stuart H. Isaacson, MD, of the Parkinson’s Disease and Movement Disorders Center in Boca Raton, Fla., noted the one potential advantage of SEP-363856 is that it does not require blood monitoring, unlike clozapine, often used as an alternative to pimavanserin, the only Food and Drug Administration–approved treatment for Parkinson’s disease psychosis.* Quetiapine has also been used off label for Parkinson’s disease psychosis, but Dr. Isaacson said this lacks the evidence supporting the other two options and has side effects including sedation and orthostatic hypotension.

“Other non–FDA-approved treatment options are limited due to their lack of efficacy, safety concerns, and exacerbation of motor symptoms,” he said.

The study involved 38 patients, 24 of whom received SEP-363856 and the rest placebo, and evaluated total scores for the novel Scale for the Assessment of Positive Symptoms for Parkinson’s Disease Psychosis (SAPS-PD) after 6 weeks of treatment. The treatment group was given one of three doses: 25 mg (n = 11), 50 mg (n = 9), and 75 mg (n = 10).

Dr. Isaacson described SEP-363856 as a novel molecule that has agonist activity at TARR1, which regulates dopamine, norepinephrine, and serotonin, as well as serotonin receptor 5-HT1A, but has no activity at the dopamine receptor D₂.

“There did appear to be improvement with this medication in patients’ psychosis symptoms, using the SAPS-PD subscale to identify the frequency and severity of hallucinations and delusions, but there was also improvement in the placebo group in this small study,” Dr. Isaacson said. “That did not demonstrate significance.” The improvement was maintained through the study period.

But the gap between the treatment and placebo groups widened as the degree of response increased. The rates were identical for the 30% or above response and the 50% or above response subgroups: 27.3% and 37.5% for placebo and treatment groups, respectively. However, 25% of patients taking SEP-363856 had a 100% response in terms of SAPS-PD score versus 0% in the placebo group, Dr. Isaacson said.

The study also found Mini-Mental State Examination (MMSE) scores improved more in the treatment group, with the gap wider in those with baseline MMSE scores below 24 versus scores above 24: –5.2 (standard deviation, 2.81) versus –2.1 (SD, 3.00; P = .460).

“The scope of daytime and nighttime sleep both showed improvement, with the score for daytime sleep being significant,” Dr. Isaacson said of the treatment group. “Importantly, UPDRS [Unified Parkinson’s Disease Rating Scale] Part III motor scores showed no difference from placebo. Indeed, there was a trend toward improvement, but this again was not significant.” That’s noteworthy, he said, because other antipsychotics, with the exception of clozapine – which requires blood monitoring – are contraindicated in PDP because of their effect on motor function.

During question-and-answer, Dr. Isaacson noted that the complete response rate of 25% with SEP-363856 compared favorably with the 14% complete response rate reported with pimavanserin in the pivotal trial.

“Hopefully greater-powered studies will be performed to further identify and determine the safety and efficacy and tolerably of SEP-363856 in Parkinson’s psychosis, aiming to minimize the placebo effect and to try to hopefully identify its efficacy in relationship to other treatments,” Dr. Isaacson said.

“Right now with only one approved treatment, one that has efficacy but requires blood monitoring, and another treatment that may be fraught sometimes with sleepiness and other side effects, we need other alternatives for our patients as many of them resort to lowering and lowering their dopaminergic therapies with the consequence [of] worsening motor activity,” Dr. Isaacson said.

“This study further supports the concept that Parkinson’s disease psychosis involves much more than simply dopamine,” said Daniel E. Kremens, MD, codirector of the Parkinson’s disease and movement disorders division at Thomas Jefferson University, Philadelphia. “Targeting nondopaminergic targets allows us to treat the psychosis without worsening motor symptoms. By targeting TAAR-1 along with 5HT1A, SEP-363856 is a novel compound that appears to be well tolerated and may treat PDP without worsening motor symptoms,”

Sunovion Pharmaceuticals provided funding for the study. Dr. Isaacson has no financial relationships to disclose. Three study coauthors are employees of Sunovion. Dr. Kremens reported serving as a consultant to Sunovion.

*Correction, 5/17/21: An earlier version of this article misstated the blood monitoring requirements for pimavanserin.

SEP-363856, an investigational nondopamine antipsychotic that’s been the focus of a trial in schizophrenia, has shown signals that it may improve psychosis symptoms in patients with Parkinson’s disease without worsening motor symptoms, according to results of a proof-of-principle study presented at the 2021 annual meeting of the American Academy of Neurology.

In presenting study results, Stuart H. Isaacson, MD, of the Parkinson’s Disease and Movement Disorders Center in Boca Raton, Fla., noted the one potential advantage of SEP-363856 is that it does not require blood monitoring, unlike clozapine, often used as an alternative to pimavanserin, the only Food and Drug Administration–approved treatment for Parkinson’s disease psychosis.* Quetiapine has also been used off label for Parkinson’s disease psychosis, but Dr. Isaacson said this lacks the evidence supporting the other two options and has side effects including sedation and orthostatic hypotension.

“Other non–FDA-approved treatment options are limited due to their lack of efficacy, safety concerns, and exacerbation of motor symptoms,” he said.

The study involved 38 patients, 24 of whom received SEP-363856 and the rest placebo, and evaluated total scores for the novel Scale for the Assessment of Positive Symptoms for Parkinson’s Disease Psychosis (SAPS-PD) after 6 weeks of treatment. The treatment group was given one of three doses: 25 mg (n = 11), 50 mg (n = 9), and 75 mg (n = 10).

Dr. Isaacson described SEP-363856 as a novel molecule that has agonist activity at TARR1, which regulates dopamine, norepinephrine, and serotonin, as well as serotonin receptor 5-HT1A, but has no activity at the dopamine receptor D₂.

“There did appear to be improvement with this medication in patients’ psychosis symptoms, using the SAPS-PD subscale to identify the frequency and severity of hallucinations and delusions, but there was also improvement in the placebo group in this small study,” Dr. Isaacson said. “That did not demonstrate significance.” The improvement was maintained through the study period.

But the gap between the treatment and placebo groups widened as the degree of response increased. The rates were identical for the 30% or above response and the 50% or above response subgroups: 27.3% and 37.5% for placebo and treatment groups, respectively. However, 25% of patients taking SEP-363856 had a 100% response in terms of SAPS-PD score versus 0% in the placebo group, Dr. Isaacson said.

The study also found Mini-Mental State Examination (MMSE) scores improved more in the treatment group, with the gap wider in those with baseline MMSE scores below 24 versus scores above 24: –5.2 (standard deviation, 2.81) versus –2.1 (SD, 3.00; P = .460).

“The scope of daytime and nighttime sleep both showed improvement, with the score for daytime sleep being significant,” Dr. Isaacson said of the treatment group. “Importantly, UPDRS [Unified Parkinson’s Disease Rating Scale] Part III motor scores showed no difference from placebo. Indeed, there was a trend toward improvement, but this again was not significant.” That’s noteworthy, he said, because other antipsychotics, with the exception of clozapine – which requires blood monitoring – are contraindicated in PDP because of their effect on motor function.

During question-and-answer, Dr. Isaacson noted that the complete response rate of 25% with SEP-363856 compared favorably with the 14% complete response rate reported with pimavanserin in the pivotal trial.

“Hopefully greater-powered studies will be performed to further identify and determine the safety and efficacy and tolerably of SEP-363856 in Parkinson’s psychosis, aiming to minimize the placebo effect and to try to hopefully identify its efficacy in relationship to other treatments,” Dr. Isaacson said.

“Right now with only one approved treatment, one that has efficacy but requires blood monitoring, and another treatment that may be fraught sometimes with sleepiness and other side effects, we need other alternatives for our patients as many of them resort to lowering and lowering their dopaminergic therapies with the consequence [of] worsening motor activity,” Dr. Isaacson said.

“This study further supports the concept that Parkinson’s disease psychosis involves much more than simply dopamine,” said Daniel E. Kremens, MD, codirector of the Parkinson’s disease and movement disorders division at Thomas Jefferson University, Philadelphia. “Targeting nondopaminergic targets allows us to treat the psychosis without worsening motor symptoms. By targeting TAAR-1 along with 5HT1A, SEP-363856 is a novel compound that appears to be well tolerated and may treat PDP without worsening motor symptoms,”

Sunovion Pharmaceuticals provided funding for the study. Dr. Isaacson has no financial relationships to disclose. Three study coauthors are employees of Sunovion. Dr. Kremens reported serving as a consultant to Sunovion.

*Correction, 5/17/21: An earlier version of this article misstated the blood monitoring requirements for pimavanserin.

SEP-363856, an investigational nondopamine antipsychotic that’s been the focus of a trial in schizophrenia, has shown signals that it may improve psychosis symptoms in patients with Parkinson’s disease without worsening motor symptoms, according to results of a proof-of-principle study presented at the 2021 annual meeting of the American Academy of Neurology.

In presenting study results, Stuart H. Isaacson, MD, of the Parkinson’s Disease and Movement Disorders Center in Boca Raton, Fla., noted the one potential advantage of SEP-363856 is that it does not require blood monitoring, unlike clozapine, often used as an alternative to pimavanserin, the only Food and Drug Administration–approved treatment for Parkinson’s disease psychosis.* Quetiapine has also been used off label for Parkinson’s disease psychosis, but Dr. Isaacson said this lacks the evidence supporting the other two options and has side effects including sedation and orthostatic hypotension.

“Other non–FDA-approved treatment options are limited due to their lack of efficacy, safety concerns, and exacerbation of motor symptoms,” he said.

The study involved 38 patients, 24 of whom received SEP-363856 and the rest placebo, and evaluated total scores for the novel Scale for the Assessment of Positive Symptoms for Parkinson’s Disease Psychosis (SAPS-PD) after 6 weeks of treatment. The treatment group was given one of three doses: 25 mg (n = 11), 50 mg (n = 9), and 75 mg (n = 10).

Dr. Isaacson described SEP-363856 as a novel molecule that has agonist activity at TARR1, which regulates dopamine, norepinephrine, and serotonin, as well as serotonin receptor 5-HT1A, but has no activity at the dopamine receptor D₂.

“There did appear to be improvement with this medication in patients’ psychosis symptoms, using the SAPS-PD subscale to identify the frequency and severity of hallucinations and delusions, but there was also improvement in the placebo group in this small study,” Dr. Isaacson said. “That did not demonstrate significance.” The improvement was maintained through the study period.

But the gap between the treatment and placebo groups widened as the degree of response increased. The rates were identical for the 30% or above response and the 50% or above response subgroups: 27.3% and 37.5% for placebo and treatment groups, respectively. However, 25% of patients taking SEP-363856 had a 100% response in terms of SAPS-PD score versus 0% in the placebo group, Dr. Isaacson said.

The study also found Mini-Mental State Examination (MMSE) scores improved more in the treatment group, with the gap wider in those with baseline MMSE scores below 24 versus scores above 24: –5.2 (standard deviation, 2.81) versus –2.1 (SD, 3.00; P = .460).

“The scope of daytime and nighttime sleep both showed improvement, with the score for daytime sleep being significant,” Dr. Isaacson said of the treatment group. “Importantly, UPDRS [Unified Parkinson’s Disease Rating Scale] Part III motor scores showed no difference from placebo. Indeed, there was a trend toward improvement, but this again was not significant.” That’s noteworthy, he said, because other antipsychotics, with the exception of clozapine – which requires blood monitoring – are contraindicated in PDP because of their effect on motor function.

During question-and-answer, Dr. Isaacson noted that the complete response rate of 25% with SEP-363856 compared favorably with the 14% complete response rate reported with pimavanserin in the pivotal trial.

“Hopefully greater-powered studies will be performed to further identify and determine the safety and efficacy and tolerably of SEP-363856 in Parkinson’s psychosis, aiming to minimize the placebo effect and to try to hopefully identify its efficacy in relationship to other treatments,” Dr. Isaacson said.

“Right now with only one approved treatment, one that has efficacy but requires blood monitoring, and another treatment that may be fraught sometimes with sleepiness and other side effects, we need other alternatives for our patients as many of them resort to lowering and lowering their dopaminergic therapies with the consequence [of] worsening motor activity,” Dr. Isaacson said.

“This study further supports the concept that Parkinson’s disease psychosis involves much more than simply dopamine,” said Daniel E. Kremens, MD, codirector of the Parkinson’s disease and movement disorders division at Thomas Jefferson University, Philadelphia. “Targeting nondopaminergic targets allows us to treat the psychosis without worsening motor symptoms. By targeting TAAR-1 along with 5HT1A, SEP-363856 is a novel compound that appears to be well tolerated and may treat PDP without worsening motor symptoms,”

Sunovion Pharmaceuticals provided funding for the study. Dr. Isaacson has no financial relationships to disclose. Three study coauthors are employees of Sunovion. Dr. Kremens reported serving as a consultant to Sunovion.

*Correction, 5/17/21: An earlier version of this article misstated the blood monitoring requirements for pimavanserin.

Long-haul neurologic symptoms of COVID-19 seem to be distinct from neurologic conditions found in acute disease. Among the patient population of long-haulers complaining of brain fog, muscular ache, and other issues, many had mild COVID-19. Much work remains to be done to understand the biological mechanisms behind these problems, but inflammation and autoimmune responses may play a role in some cases.

Those were some of the takeaways from a talk by Serena Spudich, MD, who presented her research at the 2021 annual meeting of the American Academy of Neurology. Dr. Spudich is the division chief of neurologic infections and global neurology and codirector of the Center for Neuroepidemiology and Clinical Neurological Research at Yale University, New Haven, Conn.
 

Examining the nervous system’s involvement in COVID-19

Even early on in the pandemic, it became clear that there were lingering complaints of neuromuscular problems, cognitive dysfunction, and mood and psychiatric issues. Breathing and heart rate problems also can arise. “There seems to be a preponderance of syndromes that reflect involvement of the nervous system,” said Dr. Spudich.

To try to understand the etiology of these persistent problems, Dr. Spudich said it’s important to examine the nervous system’s involvement in acute COVID-19. She has been involved in these efforts since early in the pandemic, when she ran an inpatient consult service at Yale dedicated to neurologic effects of acute COVID-19. She witnessed complications including stroke, encephalopathy, and seizures, among others.

Stroke during acute COVID-19 seemed to be associated with inflammation and endothelial activation or endotheliopathy. SARS-CoV-2 has been undetectable in the cerebrospinal fluid (CSF) of patients with acute COVID-19 and neurologic symptoms, but inflammatory cytokines can be present along with increased frequency of B cells. Anti–SARS-CoV-2 antibodies have also been found in CSF, some of which were auto reactive to brain tissue. The immune response was altered, compared with healthy controls, and in the CNS, compared with in the blood, “raising the question of whether inflammation and autoimmunity may be underlying causes of these syndromes,” said Dr. Spudich.

She also pointed to an MRI study of autopsied brain tissue of patients with COVID-19 and neurologic complications, which showed indications of both hemorrhagic and ischemic microvascular injury. “It’s just a reminder that, during acute COVID-19, there may be inflammation in the brain, there may be autoimmune reactions, and there may be vascular changes that underlie some of the neurologic syndromes that are seen,” said Dr. Spudich.
 

A panoply of different syndromes

In October, Yale set up a post-COVID neurologic clinic that brought together pulmonary, cardiology, and psychiatric specialists, many of whom saw the same patients, about 60% of whom had cognitive impairment, more than 40% had neuromuscular problems, and over 30% headache. “There’s not a single entity of a post-COVID neurologic syndrome. There’s a panoply of different syndromes that may have similar or distinct etiologies,” said Dr. Spudich.

Most patients were in their 30s, 40s, or 50s. That doesn’t necessarily mean this is the most common age range for these issues, though. There could be some bias if these individuals are seeking specialty care because they expected to recover from COVID-19 quickly. But it could be that there is something biologically unique among this age group that predisposes them to complications. Regardless, two out of three patients were never hospitalized, “suggesting that even mild COVID-19 can lead to some long-term sequelae,” said Dr. Spudich.

One potential explanation for long-term neurologic syndromes is that they are an extension of the inflammation, autoimmunity, and immune perturbation occurring during acute disease. One study looked at 18 cancer patients who had neurologic complications with COVID-19. Two months after onset, they had elevated markers of neuroinflammation and neuronal injury in the cerebral spinal fluid compared to cancer patients with no history of COVID-19.
 

Looking for biologic markers

An Italian study looked at patients who were evaluated during acute hospitalization and again 3 months later, and found that some markers of inflation in the blood were associated with later cognitive impairment. The patients were more severely ill, so it’s not clear what the findings mean for patients who present with neurologic symptoms after milder illness.

A PET scan study of 35 patients with persistent neurologic symptoms found patterns of reduced fluorodeoxyglucose uptake in some regions of the brain that are believed to be associated with some symptoms. Lower values were associated with greater severity for symptoms like memory dysfunction, and anosmia. “Why there might be hypometabolism in these regions I think needs to be assessed and used as a biomarker to associate hypometabolism with other kinds of processes in blood and spinal fluid,” said Dr. Spudich.

Along with colleagues at Yale, Dr. Spudich is conducting the MIND study, which is using PET and MRI imaging along with blood and CSF biomarkers to track the progress of patients after COVID-19. There are few results to discuss since only 20 patients have been recruited so far, except that brain imaging and blood values are generally normal despite neurologic complaints. Most were not hospitalized for COVID-19. Dr. Spudich highlighted one man in his 30s who developed new-onset psychosis, despite no previous history. Although clinical tests were all negative, a novel autoantibody detection method revealed a previously unknown autoreactive antibody in his spinal fluid. “This may suggest that there is autoantibody production in some individuals with post–COVID-19 psychosis, and potentially other syndromes,” said Dr. Spudich.
 

The research task ahead

The case illustrates the task ahead for neurology. “There’s a real research mandate to understand the biological substrates of these diverse disorders, not only to address the emergent public health concern and reduce the stigma in our patients, but to develop targeted therapeutic interventions,” said Dr. Spudich.

Anna Cervantes-Arslanian, MD, an associate professor of neurology at Boston University who also treats and studies patients with post-COVID neurologic symptoms, agreed with that assessment. “It’s not like every patient that has muscle aches and fatigue also has brain fog. It’s really hard to parse them out into specific phenotypes that are pretty classic. Some people will have all of those things, some will have very few of them,” said Dr. Cervantes-Arslanian. “We need to be able to identify them sand see if there is clustering of symptoms so we can better look into what the biological underpinnings are. That’s the first step to thinking about a therapeutic target.”

Dr. Spudich and Dr. Cervantes-Arslanian had no relevant financial disclosures.

Long-haul neurologic symptoms of COVID-19 seem to be distinct from neurologic conditions found in acute disease. Among the patient population of long-haulers complaining of brain fog, muscular ache, and other issues, many had mild COVID-19. Much work remains to be done to understand the biological mechanisms behind these problems, but inflammation and autoimmune responses may play a role in some cases.

Those were some of the takeaways from a talk by Serena Spudich, MD, who presented her research at the 2021 annual meeting of the American Academy of Neurology. Dr. Spudich is the division chief of neurologic infections and global neurology and codirector of the Center for Neuroepidemiology and Clinical Neurological Research at Yale University, New Haven, Conn.
 

Examining the nervous system’s involvement in COVID-19

Even early on in the pandemic, it became clear that there were lingering complaints of neuromuscular problems, cognitive dysfunction, and mood and psychiatric issues. Breathing and heart rate problems also can arise. “There seems to be a preponderance of syndromes that reflect involvement of the nervous system,” said Dr. Spudich.

To try to understand the etiology of these persistent problems, Dr. Spudich said it’s important to examine the nervous system’s involvement in acute COVID-19. She has been involved in these efforts since early in the pandemic, when she ran an inpatient consult service at Yale dedicated to neurologic effects of acute COVID-19. She witnessed complications including stroke, encephalopathy, and seizures, among others.

Stroke during acute COVID-19 seemed to be associated with inflammation and endothelial activation or endotheliopathy. SARS-CoV-2 has been undetectable in the cerebrospinal fluid (CSF) of patients with acute COVID-19 and neurologic symptoms, but inflammatory cytokines can be present along with increased frequency of B cells. Anti–SARS-CoV-2 antibodies have also been found in CSF, some of which were auto reactive to brain tissue. The immune response was altered, compared with healthy controls, and in the CNS, compared with in the blood, “raising the question of whether inflammation and autoimmunity may be underlying causes of these syndromes,” said Dr. Spudich.

She also pointed to an MRI study of autopsied brain tissue of patients with COVID-19 and neurologic complications, which showed indications of both hemorrhagic and ischemic microvascular injury. “It’s just a reminder that, during acute COVID-19, there may be inflammation in the brain, there may be autoimmune reactions, and there may be vascular changes that underlie some of the neurologic syndromes that are seen,” said Dr. Spudich.
 

A panoply of different syndromes

In October, Yale set up a post-COVID neurologic clinic that brought together pulmonary, cardiology, and psychiatric specialists, many of whom saw the same patients, about 60% of whom had cognitive impairment, more than 40% had neuromuscular problems, and over 30% headache. “There’s not a single entity of a post-COVID neurologic syndrome. There’s a panoply of different syndromes that may have similar or distinct etiologies,” said Dr. Spudich.

Most patients were in their 30s, 40s, or 50s. That doesn’t necessarily mean this is the most common age range for these issues, though. There could be some bias if these individuals are seeking specialty care because they expected to recover from COVID-19 quickly. But it could be that there is something biologically unique among this age group that predisposes them to complications. Regardless, two out of three patients were never hospitalized, “suggesting that even mild COVID-19 can lead to some long-term sequelae,” said Dr. Spudich.

One potential explanation for long-term neurologic syndromes is that they are an extension of the inflammation, autoimmunity, and immune perturbation occurring during acute disease. One study looked at 18 cancer patients who had neurologic complications with COVID-19. Two months after onset, they had elevated markers of neuroinflammation and neuronal injury in the cerebral spinal fluid compared to cancer patients with no history of COVID-19.
 

Looking for biologic markers

An Italian study looked at patients who were evaluated during acute hospitalization and again 3 months later, and found that some markers of inflation in the blood were associated with later cognitive impairment. The patients were more severely ill, so it’s not clear what the findings mean for patients who present with neurologic symptoms after milder illness.

A PET scan study of 35 patients with persistent neurologic symptoms found patterns of reduced fluorodeoxyglucose uptake in some regions of the brain that are believed to be associated with some symptoms. Lower values were associated with greater severity for symptoms like memory dysfunction, and anosmia. “Why there might be hypometabolism in these regions I think needs to be assessed and used as a biomarker to associate hypometabolism with other kinds of processes in blood and spinal fluid,” said Dr. Spudich.

Along with colleagues at Yale, Dr. Spudich is conducting the MIND study, which is using PET and MRI imaging along with blood and CSF biomarkers to track the progress of patients after COVID-19. There are few results to discuss since only 20 patients have been recruited so far, except that brain imaging and blood values are generally normal despite neurologic complaints. Most were not hospitalized for COVID-19. Dr. Spudich highlighted one man in his 30s who developed new-onset psychosis, despite no previous history. Although clinical tests were all negative, a novel autoantibody detection method revealed a previously unknown autoreactive antibody in his spinal fluid. “This may suggest that there is autoantibody production in some individuals with post–COVID-19 psychosis, and potentially other syndromes,” said Dr. Spudich.
 

The research task ahead

The case illustrates the task ahead for neurology. “There’s a real research mandate to understand the biological substrates of these diverse disorders, not only to address the emergent public health concern and reduce the stigma in our patients, but to develop targeted therapeutic interventions,” said Dr. Spudich.

Anna Cervantes-Arslanian, MD, an associate professor of neurology at Boston University who also treats and studies patients with post-COVID neurologic symptoms, agreed with that assessment. “It’s not like every patient that has muscle aches and fatigue also has brain fog. It’s really hard to parse them out into specific phenotypes that are pretty classic. Some people will have all of those things, some will have very few of them,” said Dr. Cervantes-Arslanian. “We need to be able to identify them sand see if there is clustering of symptoms so we can better look into what the biological underpinnings are. That’s the first step to thinking about a therapeutic target.”

Dr. Spudich and Dr. Cervantes-Arslanian had no relevant financial disclosures.

Long-haul neurologic symptoms of COVID-19 seem to be distinct from neurologic conditions found in acute disease. Among the patient population of long-haulers complaining of brain fog, muscular ache, and other issues, many had mild COVID-19. Much work remains to be done to understand the biological mechanisms behind these problems, but inflammation and autoimmune responses may play a role in some cases.

Those were some of the takeaways from a talk by Serena Spudich, MD, who presented her research at the 2021 annual meeting of the American Academy of Neurology. Dr. Spudich is the division chief of neurologic infections and global neurology and codirector of the Center for Neuroepidemiology and Clinical Neurological Research at Yale University, New Haven, Conn.
 

Examining the nervous system’s involvement in COVID-19

Even early on in the pandemic, it became clear that there were lingering complaints of neuromuscular problems, cognitive dysfunction, and mood and psychiatric issues. Breathing and heart rate problems also can arise. “There seems to be a preponderance of syndromes that reflect involvement of the nervous system,” said Dr. Spudich.

To try to understand the etiology of these persistent problems, Dr. Spudich said it’s important to examine the nervous system’s involvement in acute COVID-19. She has been involved in these efforts since early in the pandemic, when she ran an inpatient consult service at Yale dedicated to neurologic effects of acute COVID-19. She witnessed complications including stroke, encephalopathy, and seizures, among others.

Stroke during acute COVID-19 seemed to be associated with inflammation and endothelial activation or endotheliopathy. SARS-CoV-2 has been undetectable in the cerebrospinal fluid (CSF) of patients with acute COVID-19 and neurologic symptoms, but inflammatory cytokines can be present along with increased frequency of B cells. Anti–SARS-CoV-2 antibodies have also been found in CSF, some of which were auto reactive to brain tissue. The immune response was altered, compared with healthy controls, and in the CNS, compared with in the blood, “raising the question of whether inflammation and autoimmunity may be underlying causes of these syndromes,” said Dr. Spudich.

She also pointed to an MRI study of autopsied brain tissue of patients with COVID-19 and neurologic complications, which showed indications of both hemorrhagic and ischemic microvascular injury. “It’s just a reminder that, during acute COVID-19, there may be inflammation in the brain, there may be autoimmune reactions, and there may be vascular changes that underlie some of the neurologic syndromes that are seen,” said Dr. Spudich.
 

A panoply of different syndromes

In October, Yale set up a post-COVID neurologic clinic that brought together pulmonary, cardiology, and psychiatric specialists, many of whom saw the same patients, about 60% of whom had cognitive impairment, more than 40% had neuromuscular problems, and over 30% headache. “There’s not a single entity of a post-COVID neurologic syndrome. There’s a panoply of different syndromes that may have similar or distinct etiologies,” said Dr. Spudich.

Most patients were in their 30s, 40s, or 50s. That doesn’t necessarily mean this is the most common age range for these issues, though. There could be some bias if these individuals are seeking specialty care because they expected to recover from COVID-19 quickly. But it could be that there is something biologically unique among this age group that predisposes them to complications. Regardless, two out of three patients were never hospitalized, “suggesting that even mild COVID-19 can lead to some long-term sequelae,” said Dr. Spudich.

One potential explanation for long-term neurologic syndromes is that they are an extension of the inflammation, autoimmunity, and immune perturbation occurring during acute disease. One study looked at 18 cancer patients who had neurologic complications with COVID-19. Two months after onset, they had elevated markers of neuroinflammation and neuronal injury in the cerebral spinal fluid compared to cancer patients with no history of COVID-19.
 

Looking for biologic markers

An Italian study looked at patients who were evaluated during acute hospitalization and again 3 months later, and found that some markers of inflation in the blood were associated with later cognitive impairment. The patients were more severely ill, so it’s not clear what the findings mean for patients who present with neurologic symptoms after milder illness.

A PET scan study of 35 patients with persistent neurologic symptoms found patterns of reduced fluorodeoxyglucose uptake in some regions of the brain that are believed to be associated with some symptoms. Lower values were associated with greater severity for symptoms like memory dysfunction, and anosmia. “Why there might be hypometabolism in these regions I think needs to be assessed and used as a biomarker to associate hypometabolism with other kinds of processes in blood and spinal fluid,” said Dr. Spudich.

Along with colleagues at Yale, Dr. Spudich is conducting the MIND study, which is using PET and MRI imaging along with blood and CSF biomarkers to track the progress of patients after COVID-19. There are few results to discuss since only 20 patients have been recruited so far, except that brain imaging and blood values are generally normal despite neurologic complaints. Most were not hospitalized for COVID-19. Dr. Spudich highlighted one man in his 30s who developed new-onset psychosis, despite no previous history. Although clinical tests were all negative, a novel autoantibody detection method revealed a previously unknown autoreactive antibody in his spinal fluid. “This may suggest that there is autoantibody production in some individuals with post–COVID-19 psychosis, and potentially other syndromes,” said Dr. Spudich.
 

The research task ahead

The case illustrates the task ahead for neurology. “There’s a real research mandate to understand the biological substrates of these diverse disorders, not only to address the emergent public health concern and reduce the stigma in our patients, but to develop targeted therapeutic interventions,” said Dr. Spudich.

Anna Cervantes-Arslanian, MD, an associate professor of neurology at Boston University who also treats and studies patients with post-COVID neurologic symptoms, agreed with that assessment. “It’s not like every patient that has muscle aches and fatigue also has brain fog. It’s really hard to parse them out into specific phenotypes that are pretty classic. Some people will have all of those things, some will have very few of them,” said Dr. Cervantes-Arslanian. “We need to be able to identify them sand see if there is clustering of symptoms so we can better look into what the biological underpinnings are. That’s the first step to thinking about a therapeutic target.”

Dr. Spudich and Dr. Cervantes-Arslanian had no relevant financial disclosures.

On Tuesday, April 20, the country braced for the impact of the trial verdict in death of George Floyd. Despite the case having what many would consider an overwhelming amount of evidence pointing toward conviction, if we’re completely honest, the country – and particularly the African American community – had significant doubts that the jury would render a guilty verdict.

Nathan Howard/Stringer/Getty Images News

In the hour leading up to the announcement, people and images dominated my thoughts; Tamir Rice, Breonna Taylor, Eric Garner, Rashard Brooks, and most recently, Daunte Wright. With the deaths of these Black Americans and many others as historical context, I took a stoic stance and held my breath as the verdict was read. Former Minneapolis Police Officer Derek Chauvin was found guilty of second-degree murder, third-degree murder, and second-degree manslaughter.

As Mr. Chauvin was remanded to custody and led away in handcuffs, it was clear there were no “winners” in this verdict. Mr. Floyd is still dead, and violent encounters experienced by Black Americans continue at a vastly disproportionate rate. The result is far from true justice, but what we as a country do have is a moment of accountability – and perhaps an opportunity for true system-level reform.

The final report of the President’s Task Force on 21st Century Policing, released in May 2015, recommended major policy changes at the federal level and developed key pillars aimed at promoting effective crime reduction while building public trust. Based on this report, four key takeaways are relevant to any discussion of police reform. All are vitally important, but two stand out as particularly relevant in the aftermath of the verdict. One of the key recommendations was “embracing a guardian – rather than a warrior mindset” in an effort to build trust and legitimacy. Another was ensuring that “peace officer and standards training (POST) boards include mandatory Crisis Intervention Training.”

As health professionals, we know that the ultimate effectiveness of any intervention is based upon the amount of shared trust and collaboration in the patient-physician relationship. As a consultation-liaison psychiatrist, I’ve been trained to recognize that, when requested to consult on a case, I’m frequently not making a medical diagnosis or delivering an intervention; I’m helping the team and patient reestablish trust in each other. Communication skills and techniques help start a dialogue, but you will ultimately fall short of shared understanding without trust. The underpinning of trust could begin with a commitment to procedural justice. Procedural justice, as described in The Justice Collaboratory of Yale Law School, “speaks to the idea of fair processes and how the quality of their experiences strongly impacts people’s perception of fairness.” There are four central tenets of procedural justice:

• Whether they were treated with dignity and respect.
• Whether they were given voice.
• Whether the decision-maker was neutral and transparent.
• Whether the decision-maker conveyed trustworthy motives.

These four tenets have been researched and shown to improve the trust and confidence a community has in police, and lay the foundation for creating a standard set of shared interests and values.

As health professionals, there are many aspects of procedural justice that we can and should embrace, particularly as we come to our reckoning with the use of restraints in medical settings.

Building on the work of the Task Force on 21st Century Policing, the National Initiative for Building Community Trust and Justice, from January 2015 through December 2018, implemented a six-city intervention aimed at generating measurable improvements in officer behavior, public safety, and community trust in police. The National Initiative was organized around three principal ideas: procedural justice, implicit bias training, and reconciliation and candid conversations about law enforcement’s historic role in racial tensions.

In addition to the recommendations of the federal government and independent institutions, national-level health policy organizations have made clear statements regarding police brutality and the need for systemic reform to address police brutality and systemic racism. In 2018, the American Psychiatric Association released a position statement on Police Brutality and Black Males. This was then followed in 2020 with a joint statement from the National Medical Association and the APA condemning systemic racism and police violence against Black Americans. Other health policy associations, including the American Medical Association and the American Association of Medical Colleges, have made clear statements condemning systemic racism and police brutality.

In the aftermath of the verdict, we also saw something very different. In our partisan country, there appeared to be uniform common ground. Statements were made acknowledging the importance of this historic moment, from police unions, and both political parties, and various invested grassroots organizations. In short, we may have true agreement and motivation to take the next hard steps in police reform for this country. There will be policy discussions and new mandates for training, and certainly a push to ban the use of lethal techniques, such as choke holds. While helpful, these will ultimately fall short unless we hold ourselves accountable for a true culture change.

The challenge of implementing procedural justice shouldn’t be just a law enforcement challenge, and it shouldn’t fall on the shoulders of communities with high crime areas. In other words, no single racial group should own it. Ultimately, procedural justice will need to be embraced by all of us. The road is long, and change is slow, but I am optimistic.

On April 20, as I watched the verdict, my oldest daughter watched with me, and she asked, “What do you think, Dad?” I responded: “It’s accountability and an opportunity.” She nodded her head with resolve. She then grabbed her smartphone and jumped into social media and proclaimed in her very knowledgeable teenage voice, “See Dad, one voice is cool, but many voices in unison is better; time to get to work!” To Darnella Frazier, who captured the crime on video at age 17, and all in your generation who dare to hold us accountable, I salute you. I thank you for forcing us to look even when it was painful and not ignore the humanity of our fellow man. It is indeed time to get to work.

Dr. Norris is associate dean of student affairs and administration at George Washington University, Washington. He has no disclosures.

On Tuesday, April 20, the country braced for the impact of the trial verdict in death of George Floyd. Despite the case having what many would consider an overwhelming amount of evidence pointing toward conviction, if we’re completely honest, the country – and particularly the African American community – had significant doubts that the jury would render a guilty verdict.

Nathan Howard/Stringer/Getty Images News

In the hour leading up to the announcement, people and images dominated my thoughts; Tamir Rice, Breonna Taylor, Eric Garner, Rashard Brooks, and most recently, Daunte Wright. With the deaths of these Black Americans and many others as historical context, I took a stoic stance and held my breath as the verdict was read. Former Minneapolis Police Officer Derek Chauvin was found guilty of second-degree murder, third-degree murder, and second-degree manslaughter.

As Mr. Chauvin was remanded to custody and led away in handcuffs, it was clear there were no “winners” in this verdict. Mr. Floyd is still dead, and violent encounters experienced by Black Americans continue at a vastly disproportionate rate. The result is far from true justice, but what we as a country do have is a moment of accountability – and perhaps an opportunity for true system-level reform.

The final report of the President’s Task Force on 21st Century Policing, released in May 2015, recommended major policy changes at the federal level and developed key pillars aimed at promoting effective crime reduction while building public trust. Based on this report, four key takeaways are relevant to any discussion of police reform. All are vitally important, but two stand out as particularly relevant in the aftermath of the verdict. One of the key recommendations was “embracing a guardian – rather than a warrior mindset” in an effort to build trust and legitimacy. Another was ensuring that “peace officer and standards training (POST) boards include mandatory Crisis Intervention Training.”

As health professionals, we know that the ultimate effectiveness of any intervention is based upon the amount of shared trust and collaboration in the patient-physician relationship. As a consultation-liaison psychiatrist, I’ve been trained to recognize that, when requested to consult on a case, I’m frequently not making a medical diagnosis or delivering an intervention; I’m helping the team and patient reestablish trust in each other. Communication skills and techniques help start a dialogue, but you will ultimately fall short of shared understanding without trust. The underpinning of trust could begin with a commitment to procedural justice. Procedural justice, as described in The Justice Collaboratory of Yale Law School, “speaks to the idea of fair processes and how the quality of their experiences strongly impacts people’s perception of fairness.” There are four central tenets of procedural justice:

• Whether they were treated with dignity and respect.
• Whether they were given voice.
• Whether the decision-maker was neutral and transparent.
• Whether the decision-maker conveyed trustworthy motives.

These four tenets have been researched and shown to improve the trust and confidence a community has in police, and lay the foundation for creating a standard set of shared interests and values.

As health professionals, there are many aspects of procedural justice that we can and should embrace, particularly as we come to our reckoning with the use of restraints in medical settings.

Building on the work of the Task Force on 21st Century Policing, the National Initiative for Building Community Trust and Justice, from January 2015 through December 2018, implemented a six-city intervention aimed at generating measurable improvements in officer behavior, public safety, and community trust in police. The National Initiative was organized around three principal ideas: procedural justice, implicit bias training, and reconciliation and candid conversations about law enforcement’s historic role in racial tensions.

In addition to the recommendations of the federal government and independent institutions, national-level health policy organizations have made clear statements regarding police brutality and the need for systemic reform to address police brutality and systemic racism. In 2018, the American Psychiatric Association released a position statement on Police Brutality and Black Males. This was then followed in 2020 with a joint statement from the National Medical Association and the APA condemning systemic racism and police violence against Black Americans. Other health policy associations, including the American Medical Association and the American Association of Medical Colleges, have made clear statements condemning systemic racism and police brutality.

In the aftermath of the verdict, we also saw something very different. In our partisan country, there appeared to be uniform common ground. Statements were made acknowledging the importance of this historic moment, from police unions, and both political parties, and various invested grassroots organizations. In short, we may have true agreement and motivation to take the next hard steps in police reform for this country. There will be policy discussions and new mandates for training, and certainly a push to ban the use of lethal techniques, such as choke holds. While helpful, these will ultimately fall short unless we hold ourselves accountable for a true culture change.

The challenge of implementing procedural justice shouldn’t be just a law enforcement challenge, and it shouldn’t fall on the shoulders of communities with high crime areas. In other words, no single racial group should own it. Ultimately, procedural justice will need to be embraced by all of us. The road is long, and change is slow, but I am optimistic.

On April 20, as I watched the verdict, my oldest daughter watched with me, and she asked, “What do you think, Dad?” I responded: “It’s accountability and an opportunity.” She nodded her head with resolve. She then grabbed her smartphone and jumped into social media and proclaimed in her very knowledgeable teenage voice, “See Dad, one voice is cool, but many voices in unison is better; time to get to work!” To Darnella Frazier, who captured the crime on video at age 17, and all in your generation who dare to hold us accountable, I salute you. I thank you for forcing us to look even when it was painful and not ignore the humanity of our fellow man. It is indeed time to get to work.

Dr. Norris is associate dean of student affairs and administration at George Washington University, Washington. He has no disclosures.

On Tuesday, April 20, the country braced for the impact of the trial verdict in death of George Floyd. Despite the case having what many would consider an overwhelming amount of evidence pointing toward conviction, if we’re completely honest, the country – and particularly the African American community – had significant doubts that the jury would render a guilty verdict.

Nathan Howard/Stringer/Getty Images News

In the hour leading up to the announcement, people and images dominated my thoughts; Tamir Rice, Breonna Taylor, Eric Garner, Rashard Brooks, and most recently, Daunte Wright. With the deaths of these Black Americans and many others as historical context, I took a stoic stance and held my breath as the verdict was read. Former Minneapolis Police Officer Derek Chauvin was found guilty of second-degree murder, third-degree murder, and second-degree manslaughter.

As Mr. Chauvin was remanded to custody and led away in handcuffs, it was clear there were no “winners” in this verdict. Mr. Floyd is still dead, and violent encounters experienced by Black Americans continue at a vastly disproportionate rate. The result is far from true justice, but what we as a country do have is a moment of accountability – and perhaps an opportunity for true system-level reform.

The final report of the President’s Task Force on 21st Century Policing, released in May 2015, recommended major policy changes at the federal level and developed key pillars aimed at promoting effective crime reduction while building public trust. Based on this report, four key takeaways are relevant to any discussion of police reform. All are vitally important, but two stand out as particularly relevant in the aftermath of the verdict. One of the key recommendations was “embracing a guardian – rather than a warrior mindset” in an effort to build trust and legitimacy. Another was ensuring that “peace officer and standards training (POST) boards include mandatory Crisis Intervention Training.”

As health professionals, we know that the ultimate effectiveness of any intervention is based upon the amount of shared trust and collaboration in the patient-physician relationship. As a consultation-liaison psychiatrist, I’ve been trained to recognize that, when requested to consult on a case, I’m frequently not making a medical diagnosis or delivering an intervention; I’m helping the team and patient reestablish trust in each other. Communication skills and techniques help start a dialogue, but you will ultimately fall short of shared understanding without trust. The underpinning of trust could begin with a commitment to procedural justice. Procedural justice, as described in The Justice Collaboratory of Yale Law School, “speaks to the idea of fair processes and how the quality of their experiences strongly impacts people’s perception of fairness.” There are four central tenets of procedural justice:

• Whether they were treated with dignity and respect.
• Whether they were given voice.
• Whether the decision-maker was neutral and transparent.
• Whether the decision-maker conveyed trustworthy motives.

These four tenets have been researched and shown to improve the trust and confidence a community has in police, and lay the foundation for creating a standard set of shared interests and values.

As health professionals, there are many aspects of procedural justice that we can and should embrace, particularly as we come to our reckoning with the use of restraints in medical settings.

Building on the work of the Task Force on 21st Century Policing, the National Initiative for Building Community Trust and Justice, from January 2015 through December 2018, implemented a six-city intervention aimed at generating measurable improvements in officer behavior, public safety, and community trust in police. The National Initiative was organized around three principal ideas: procedural justice, implicit bias training, and reconciliation and candid conversations about law enforcement’s historic role in racial tensions.

In addition to the recommendations of the federal government and independent institutions, national-level health policy organizations have made clear statements regarding police brutality and the need for systemic reform to address police brutality and systemic racism. In 2018, the American Psychiatric Association released a position statement on Police Brutality and Black Males. This was then followed in 2020 with a joint statement from the National Medical Association and the APA condemning systemic racism and police violence against Black Americans. Other health policy associations, including the American Medical Association and the American Association of Medical Colleges, have made clear statements condemning systemic racism and police brutality.

In the aftermath of the verdict, we also saw something very different. In our partisan country, there appeared to be uniform common ground. Statements were made acknowledging the importance of this historic moment, from police unions, and both political parties, and various invested grassroots organizations. In short, we may have true agreement and motivation to take the next hard steps in police reform for this country. There will be policy discussions and new mandates for training, and certainly a push to ban the use of lethal techniques, such as choke holds. While helpful, these will ultimately fall short unless we hold ourselves accountable for a true culture change.

The challenge of implementing procedural justice shouldn’t be just a law enforcement challenge, and it shouldn’t fall on the shoulders of communities with high crime areas. In other words, no single racial group should own it. Ultimately, procedural justice will need to be embraced by all of us. The road is long, and change is slow, but I am optimistic.

On April 20, as I watched the verdict, my oldest daughter watched with me, and she asked, “What do you think, Dad?” I responded: “It’s accountability and an opportunity.” She nodded her head with resolve. She then grabbed her smartphone and jumped into social media and proclaimed in her very knowledgeable teenage voice, “See Dad, one voice is cool, but many voices in unison is better; time to get to work!” To Darnella Frazier, who captured the crime on video at age 17, and all in your generation who dare to hold us accountable, I salute you. I thank you for forcing us to look even when it was painful and not ignore the humanity of our fellow man. It is indeed time to get to work.

Dr. Norris is associate dean of student affairs and administration at George Washington University, Washington. He has no disclosures.

The psychedelic drug psilocybin performed just as well as a widely used antidepressant in easing the symptoms of major depression, and outperformed the selective serotonin reuptake inhibitor on a range of secondary measures, results of a small-scale, phase 2 study show.

In a 6-week trial that included 59 patients with moderate to severe depression, there was no significant difference between the impact of high-dose psilocybin on the study’s primary yardstick – the 16-item Quick Inventory of Depressive Symptomatology–Self-Report – and that of the SSRI escitalopram.

Patients in the psilocybin cohort did show a much more rapid improvement in the main measure than those taking escitalopram, but this gap narrowed over the span of the trial until it was no longer statistically significant.

“It’s very clear that psilocybin therapy has a faster antidepressant onset than escitalopram. And psilocybin was consistently superior on the ancillary outcomes, but it wasn’t different on the primary,” the study’s lead author Robin Carhart-Harris, PhD, head of the Centre for Psychedelic Research at Imperial College London, told reporters attending a news briefing.

Results of the phase 2, double-blind, randomized study were published online April 15, 2021, in the New England Journal of Medicine.
 

Secondary outcomes

Investigators found that psilocybin bested escitalopram in several secondary outcomes, including feelings of well-being, the ability to express emotion, and social functioning.

eskymaks/iStock/Getty Images

Still, the team cautioned that they could draw no conclusions from these secondary measures because they were not corrected for multiple comparisons. Larger and longer trials are required.

“But the secondaries were highly suggestive – tantalizingly suggestive – of the potential superiority of psilocybin therapy to treat not just depression, but these ancillary symptoms,” Dr. Carhart-Harris said.

After they were selected from 1000 screening calls, the 59 patients were randomly assigned to receive psilocybin and 29 patients to receive escitalopram. Every procedure was mirrored in both groups.

At the 2 “dosing days” scheduled during the 6-week trial, all patients received an oral dose of psilocybin in a clinical setting. However, the escitalopram group received 1 mg versus 25 mg for the psilocybin group.

“And the reason why we did that is because we can standardize expectation. We say to everyone, you will receive psilocybin. It’s just the dosage might differ,” Dr. Carhart-Harris said.

He conceded that most patients – though not all – were able to determine which group they were in following the first dosing day based on the drugs’ effects.

Supportive therapy

Following the oral dose, volunteers would spend 6 hours reclining on a bed, surrounded by pillows and a curated selection of music and supported by two “guides” or therapists. The guides were on hand to support patients through their psychedelic experience but did not chat or otherwise interfere.

The next day, patients attended a session with their two therapists to talk through their experiences.

Between dosing days, patients in the high-dose psilocybin group would take daily capsules containing a placebo. The low-dose group received a course of escitalopram.

The incidence of adverse effects was similar in each group. None was serious.

The study’s principal investigator David Nutt, DM, FRCP, FRCPsych, FSB, FMedSci, the Edmond J. Safra Chair in Neuropsychopharmacology at Imperial College London, said that many patients in the psilocybin group reported revelatory insights during dosing days.

“Very often, for the first time, people have actually come to understand why they’re depressed,” he said.

The word psychedelic, coined in 1957 by psychiatrist Humphry Osmond, derives from the Greek words “psyche,” which means “soul” or “mind,” and “delos,” which means “reveal.”
 

'Profound experiences'

Certainly, patients in the psilocybin group received enough of the compound to induce what Dr. Carhart-Harris called “very profound experiences.”

The researchers said that the results, while promising, should not encourage anyone to self-medicate with psychedelic substances, which are still illegal in most jurisdictions.

“I view this very much – and I think most colleagues do as well – as a combination treatment,” Dr. Carhart-Harris said. “And we strongly believe that the psychotherapy component is as important as the drug action.”

He said the study was inspired by his earlier research into the effects of psilocybin on brain function along with a small open-label trial of the compound’s effects on treatment-resistant depression published in The Lancet Psychiatry in July 2016.

The team stressed that the cohort and the absence of an entirely placebo group limit conclusions that can be drawn about either treatment.

Dr. Carhart-Harris also said he would have liked a more diverse group of patients. Participants were mostly White and mostly male, with a mean age of 41, and a high educational attainment. Of the 59 enrolled, only 34% were women.

Volunteers underwent functional MRI scans at the start and end of the trial. The team will now analyze these results to gain insight into impact on brain function and will gather and assess follow-up data. They also plan a trial examining the effect of psilocybin on anorexia.

“I think it’s fair to say the results signal hope that we may be looking at a promising alternative treatment for depression,” Dr. Carhart-Harris said. “It’s often said that we need novel treatments to treat depression because too many new drugs are what [are] sometimes called ‘me too’ drugs: They work in the same way as drugs that have preceded them. Psilocybin therapy seems to work fundamentally in a different way to SSRIs.”
 

Unanswered questions

In an accompanying editorial, Jeffrey A. Lieberman, MD, Lawrence C. Kolb Professor and chairman of the department of psychiatry at Columbia University, New York, warned that there remain many unanswered questions about using psychedelics for medical purposes.

They were considered potential miracle cures for a range of mental disorders in the 1960s, only to be banned in 1970s America because of “the perceived dangers and corrosive effects” on society, he wrote.

“The Carhart-Harris study notwithstanding, we are still awaiting definitive proof of the therapeutic efficacy of psychedelics and their capacity to improve the human condition,” Dr. Lieberman wrote. “Should the mind-bending properties of the psychedelics prove to be the panacea their proponents professed, informed consent and safety standards must be established. How do we explain mystical, ineffable, and potentially transformative experiences to patients, particularly if they are in a vulnerable state of mind? What is their potential for addiction?”

David Owens, MD, PhD, professor emeritus of clinical psychiatry at the University of Edinburgh, described Lieberman’s comments as “spot on.”

“This is a small, exploratory study with numbers too small to analyze fully,” he said. “The population is not recruited randomly from, for example, consecutive admissions or presentations, and screening of volunteers was by telephone, not face to face. One might say this is an ‘interested’ population, willing to go for novel approaches and with no placebo group, the extent of the placebo response cannot be assessed.”

The study was funded by the Alexander Mosley Charitable Trust and the founders of the Centre for Psychedelic Research. Infrastructure support was provided by the National Institute for Health Research Imperial Biomedical Research Centre and NIHR Imperial Clinical Research Facility.

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

The psychedelic drug psilocybin performed just as well as a widely used antidepressant in easing the symptoms of major depression, and outperformed the selective serotonin reuptake inhibitor on a range of secondary measures, results of a small-scale, phase 2 study show.

In a 6-week trial that included 59 patients with moderate to severe depression, there was no significant difference between the impact of high-dose psilocybin on the study’s primary yardstick – the 16-item Quick Inventory of Depressive Symptomatology–Self-Report – and that of the SSRI escitalopram.

Patients in the psilocybin cohort did show a much more rapid improvement in the main measure than those taking escitalopram, but this gap narrowed over the span of the trial until it was no longer statistically significant.

“It’s very clear that psilocybin therapy has a faster antidepressant onset than escitalopram. And psilocybin was consistently superior on the ancillary outcomes, but it wasn’t different on the primary,” the study’s lead author Robin Carhart-Harris, PhD, head of the Centre for Psychedelic Research at Imperial College London, told reporters attending a news briefing.

Results of the phase 2, double-blind, randomized study were published online April 15, 2021, in the New England Journal of Medicine.
 

Secondary outcomes

Investigators found that psilocybin bested escitalopram in several secondary outcomes, including feelings of well-being, the ability to express emotion, and social functioning.

eskymaks/iStock/Getty Images

Still, the team cautioned that they could draw no conclusions from these secondary measures because they were not corrected for multiple comparisons. Larger and longer trials are required.

“But the secondaries were highly suggestive – tantalizingly suggestive – of the potential superiority of psilocybin therapy to treat not just depression, but these ancillary symptoms,” Dr. Carhart-Harris said.

After they were selected from 1000 screening calls, the 59 patients were randomly assigned to receive psilocybin and 29 patients to receive escitalopram. Every procedure was mirrored in both groups.

At the 2 “dosing days” scheduled during the 6-week trial, all patients received an oral dose of psilocybin in a clinical setting. However, the escitalopram group received 1 mg versus 25 mg for the psilocybin group.

“And the reason why we did that is because we can standardize expectation. We say to everyone, you will receive psilocybin. It’s just the dosage might differ,” Dr. Carhart-Harris said.

He conceded that most patients – though not all – were able to determine which group they were in following the first dosing day based on the drugs’ effects.

Supportive therapy

Following the oral dose, volunteers would spend 6 hours reclining on a bed, surrounded by pillows and a curated selection of music and supported by two “guides” or therapists. The guides were on hand to support patients through their psychedelic experience but did not chat or otherwise interfere.

The next day, patients attended a session with their two therapists to talk through their experiences.

Between dosing days, patients in the high-dose psilocybin group would take daily capsules containing a placebo. The low-dose group received a course of escitalopram.

The incidence of adverse effects was similar in each group. None was serious.

The study’s principal investigator David Nutt, DM, FRCP, FRCPsych, FSB, FMedSci, the Edmond J. Safra Chair in Neuropsychopharmacology at Imperial College London, said that many patients in the psilocybin group reported revelatory insights during dosing days.

“Very often, for the first time, people have actually come to understand why they’re depressed,” he said.

The word psychedelic, coined in 1957 by psychiatrist Humphry Osmond, derives from the Greek words “psyche,” which means “soul” or “mind,” and “delos,” which means “reveal.”
 

'Profound experiences'

Certainly, patients in the psilocybin group received enough of the compound to induce what Dr. Carhart-Harris called “very profound experiences.”

The researchers said that the results, while promising, should not encourage anyone to self-medicate with psychedelic substances, which are still illegal in most jurisdictions.

“I view this very much – and I think most colleagues do as well – as a combination treatment,” Dr. Carhart-Harris said. “And we strongly believe that the psychotherapy component is as important as the drug action.”

He said the study was inspired by his earlier research into the effects of psilocybin on brain function along with a small open-label trial of the compound’s effects on treatment-resistant depression published in The Lancet Psychiatry in July 2016.

The team stressed that the cohort and the absence of an entirely placebo group limit conclusions that can be drawn about either treatment.

Dr. Carhart-Harris also said he would have liked a more diverse group of patients. Participants were mostly White and mostly male, with a mean age of 41, and a high educational attainment. Of the 59 enrolled, only 34% were women.

Volunteers underwent functional MRI scans at the start and end of the trial. The team will now analyze these results to gain insight into impact on brain function and will gather and assess follow-up data. They also plan a trial examining the effect of psilocybin on anorexia.

“I think it’s fair to say the results signal hope that we may be looking at a promising alternative treatment for depression,” Dr. Carhart-Harris said. “It’s often said that we need novel treatments to treat depression because too many new drugs are what [are] sometimes called ‘me too’ drugs: They work in the same way as drugs that have preceded them. Psilocybin therapy seems to work fundamentally in a different way to SSRIs.”
 

Unanswered questions

In an accompanying editorial, Jeffrey A. Lieberman, MD, Lawrence C. Kolb Professor and chairman of the department of psychiatry at Columbia University, New York, warned that there remain many unanswered questions about using psychedelics for medical purposes.

They were considered potential miracle cures for a range of mental disorders in the 1960s, only to be banned in 1970s America because of “the perceived dangers and corrosive effects” on society, he wrote.

“The Carhart-Harris study notwithstanding, we are still awaiting definitive proof of the therapeutic efficacy of psychedelics and their capacity to improve the human condition,” Dr. Lieberman wrote. “Should the mind-bending properties of the psychedelics prove to be the panacea their proponents professed, informed consent and safety standards must be established. How do we explain mystical, ineffable, and potentially transformative experiences to patients, particularly if they are in a vulnerable state of mind? What is their potential for addiction?”

David Owens, MD, PhD, professor emeritus of clinical psychiatry at the University of Edinburgh, described Lieberman’s comments as “spot on.”

“This is a small, exploratory study with numbers too small to analyze fully,” he said. “The population is not recruited randomly from, for example, consecutive admissions or presentations, and screening of volunteers was by telephone, not face to face. One might say this is an ‘interested’ population, willing to go for novel approaches and with no placebo group, the extent of the placebo response cannot be assessed.”

The study was funded by the Alexander Mosley Charitable Trust and the founders of the Centre for Psychedelic Research. Infrastructure support was provided by the National Institute for Health Research Imperial Biomedical Research Centre and NIHR Imperial Clinical Research Facility.

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

The psychedelic drug psilocybin performed just as well as a widely used antidepressant in easing the symptoms of major depression, and outperformed the selective serotonin reuptake inhibitor on a range of secondary measures, results of a small-scale, phase 2 study show.

In a 6-week trial that included 59 patients with moderate to severe depression, there was no significant difference between the impact of high-dose psilocybin on the study’s primary yardstick – the 16-item Quick Inventory of Depressive Symptomatology–Self-Report – and that of the SSRI escitalopram.

Patients in the psilocybin cohort did show a much more rapid improvement in the main measure than those taking escitalopram, but this gap narrowed over the span of the trial until it was no longer statistically significant.

“It’s very clear that psilocybin therapy has a faster antidepressant onset than escitalopram. And psilocybin was consistently superior on the ancillary outcomes, but it wasn’t different on the primary,” the study’s lead author Robin Carhart-Harris, PhD, head of the Centre for Psychedelic Research at Imperial College London, told reporters attending a news briefing.

Results of the phase 2, double-blind, randomized study were published online April 15, 2021, in the New England Journal of Medicine.
 

Secondary outcomes

Investigators found that psilocybin bested escitalopram in several secondary outcomes, including feelings of well-being, the ability to express emotion, and social functioning.

eskymaks/iStock/Getty Images

Still, the team cautioned that they could draw no conclusions from these secondary measures because they were not corrected for multiple comparisons. Larger and longer trials are required.

“But the secondaries were highly suggestive – tantalizingly suggestive – of the potential superiority of psilocybin therapy to treat not just depression, but these ancillary symptoms,” Dr. Carhart-Harris said.

After they were selected from 1000 screening calls, the 59 patients were randomly assigned to receive psilocybin and 29 patients to receive escitalopram. Every procedure was mirrored in both groups.

At the 2 “dosing days” scheduled during the 6-week trial, all patients received an oral dose of psilocybin in a clinical setting. However, the escitalopram group received 1 mg versus 25 mg for the psilocybin group.

“And the reason why we did that is because we can standardize expectation. We say to everyone, you will receive psilocybin. It’s just the dosage might differ,” Dr. Carhart-Harris said.

He conceded that most patients – though not all – were able to determine which group they were in following the first dosing day based on the drugs’ effects.

Supportive therapy

Following the oral dose, volunteers would spend 6 hours reclining on a bed, surrounded by pillows and a curated selection of music and supported by two “guides” or therapists. The guides were on hand to support patients through their psychedelic experience but did not chat or otherwise interfere.

The next day, patients attended a session with their two therapists to talk through their experiences.

Between dosing days, patients in the high-dose psilocybin group would take daily capsules containing a placebo. The low-dose group received a course of escitalopram.

The incidence of adverse effects was similar in each group. None was serious.

The study’s principal investigator David Nutt, DM, FRCP, FRCPsych, FSB, FMedSci, the Edmond J. Safra Chair in Neuropsychopharmacology at Imperial College London, said that many patients in the psilocybin group reported revelatory insights during dosing days.

“Very often, for the first time, people have actually come to understand why they’re depressed,” he said.

The word psychedelic, coined in 1957 by psychiatrist Humphry Osmond, derives from the Greek words “psyche,” which means “soul” or “mind,” and “delos,” which means “reveal.”
 

'Profound experiences'

Certainly, patients in the psilocybin group received enough of the compound to induce what Dr. Carhart-Harris called “very profound experiences.”

The researchers said that the results, while promising, should not encourage anyone to self-medicate with psychedelic substances, which are still illegal in most jurisdictions.

“I view this very much – and I think most colleagues do as well – as a combination treatment,” Dr. Carhart-Harris said. “And we strongly believe that the psychotherapy component is as important as the drug action.”

He said the study was inspired by his earlier research into the effects of psilocybin on brain function along with a small open-label trial of the compound’s effects on treatment-resistant depression published in The Lancet Psychiatry in July 2016.

The team stressed that the cohort and the absence of an entirely placebo group limit conclusions that can be drawn about either treatment.

Dr. Carhart-Harris also said he would have liked a more diverse group of patients. Participants were mostly White and mostly male, with a mean age of 41, and a high educational attainment. Of the 59 enrolled, only 34% were women.

Volunteers underwent functional MRI scans at the start and end of the trial. The team will now analyze these results to gain insight into impact on brain function and will gather and assess follow-up data. They also plan a trial examining the effect of psilocybin on anorexia.

“I think it’s fair to say the results signal hope that we may be looking at a promising alternative treatment for depression,” Dr. Carhart-Harris said. “It’s often said that we need novel treatments to treat depression because too many new drugs are what [are] sometimes called ‘me too’ drugs: They work in the same way as drugs that have preceded them. Psilocybin therapy seems to work fundamentally in a different way to SSRIs.”
 

Unanswered questions

In an accompanying editorial, Jeffrey A. Lieberman, MD, Lawrence C. Kolb Professor and chairman of the department of psychiatry at Columbia University, New York, warned that there remain many unanswered questions about using psychedelics for medical purposes.

They were considered potential miracle cures for a range of mental disorders in the 1960s, only to be banned in 1970s America because of “the perceived dangers and corrosive effects” on society, he wrote.

“The Carhart-Harris study notwithstanding, we are still awaiting definitive proof of the therapeutic efficacy of psychedelics and their capacity to improve the human condition,” Dr. Lieberman wrote. “Should the mind-bending properties of the psychedelics prove to be the panacea their proponents professed, informed consent and safety standards must be established. How do we explain mystical, ineffable, and potentially transformative experiences to patients, particularly if they are in a vulnerable state of mind? What is their potential for addiction?”

David Owens, MD, PhD, professor emeritus of clinical psychiatry at the University of Edinburgh, described Lieberman’s comments as “spot on.”

“This is a small, exploratory study with numbers too small to analyze fully,” he said. “The population is not recruited randomly from, for example, consecutive admissions or presentations, and screening of volunteers was by telephone, not face to face. One might say this is an ‘interested’ population, willing to go for novel approaches and with no placebo group, the extent of the placebo response cannot be assessed.”

The study was funded by the Alexander Mosley Charitable Trust and the founders of the Centre for Psychedelic Research. Infrastructure support was provided by the National Institute for Health Research Imperial Biomedical Research Centre and NIHR Imperial Clinical Research Facility.

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