MDedge Infectious Disease

A psychiatric diagnosis for patients hospitalized with COVID-19 is linked to a significantly increased risk for death, new research shows.

Investigators found that patients who were hospitalized with COVID-19 and who had been diagnosed with a psychiatric disorder had a 50% increased risk for a COVID-related death in comparison with COVID-19 patients who had not received a psychiatric diagnosis.

“Pay attention and potentially address/treat a prior psychiatric diagnosis if a patient is hospitalized for COVID-19, as this risk factor can impact the patient’s outcome – death – while in the hospital,” lead investigator Luming Li, MD, assistant professor of psychiatry and associate medical director of quality improvement, Yale New Haven Psychiatric Hospital, New Haven, Conn., said in an interview.

The study was published Sept. 30 in JAMA Network Open.
 

Negative impact

“We were interested to learn more about the impact of psychiatric diagnoses on COVID-19 mortality, as prior large cohort studies included neurological and other medical conditions but did not assess for a priori psychiatric diagnoses,” said Dr. Li.

“We know from the literature that prior psychiatric diagnoses can have a negative impact on the outcomes of medical conditions, and therefore we tested our hypothesis on a cohort of patients who were hospitalized with COVID-19,” she added.

To investigate, the researchers analyzed data on 1,685 patients hospitalized with COVID-19 between Feb. 15 and April 25, 2020, and whose cases were followed to May 27, 2020. The patients (mean age, 65.2 years; 52.6% men) were drawn from the Yale New Haven Health System.

The median follow-up period was 8 days (interquartile range, 4-16 days) .

Of these patients, 28% had received a psychiatric diagnosis prior to hospitalization. The patients with psychiatric disorders were significantly older and were more likely to be women, White, non-Hispanic, and to have medical comorbidities (i.e., cancer, cerebrovascular disease, heart failure, diabetes, kidney disease, liver disease, MI, and/or HIV).

Psychiatric diagnoses were defined in accordance with ICD codes that included mental and behavioral health, Alzheimer’s disease, and self-injury.
 

Vulnerability to stress

In the unadjusted model, the risk for COVID-19–related hospital death was greater for those who had received any psychiatric diagnosis, compared with those had not (hazard ratio, 2.3; 95% CI, 1.8-2.9; P < .001).

In the adjusted model that controlled for demographic characteristics, other medical comorbidities, and hospital location, the mortality risk somewhat decreased but still remained significantly higher (HR, 1.5; 95% CI, 1.1-1.9; P = .003).

Dr. Li noted a number of factors that might account for the higher mortality rate among psychiatric patients who had COVID-19 in comparison with COVD-19 patients who did not have a psychiatric disorder. These included “potential inflammatory and stress responses that the body experiences related to prior psychiatric conditions,” she said.

Having been previously diagnosed with a psychiatric disorder may also “reflect existing neurochemical differences, compared to those who do not have a prior psychiatric diagnosis, [and] these differences may make the population with the prior psychiatric diagnosis more vulnerable to respond to an acute stressor such as COVID-19,” she said.
 

Quality care

Harold Pincus, MD, professor and vice chair of the department of psychiatry at Columbia University, New York, said it “adds to the fairly well-known and well-established phenomenon that people with mental illnesses have a high risk of all sorts of morbidity and mortality for non–mental health conditions.”

The researchers “adjusted for various expected [mortality] risks that would be independent of the presence of COVID-19,” so “there was something else going on associated with mortality,” said Dr. Pincus, who is also codirector of the Irving Institute for Clinical and Translation Research. He was not involved with the study.

Beyond the possibility of “some basic immunologic process affected by the presence of a mental disorder,” it is possible that the vulnerability is “related to access to quality care for the comorbid general condition that is not being effectively treated,” he said.

“The take-home message is that people with mental disorders are at higher risk for death, and we need to make sure that, irrespective of COVID-19, they get adequate preventive and chronic-disease care, which would be the most effective way to intervene and protect the impact of a serious disease like COVID-19,” he noted. This would include being appropriately vaccinated and receiving preventive healthcare to reduce smoking and encourage weight loss.

No source of funding for the study was provided. Dr. Li reported receiving grants from a Health and Aging Policy Fellowship during the conduct of the study. Dr. Pincus reported no relevant financial relationships.

A psychiatric diagnosis for patients hospitalized with COVID-19 is linked to a significantly increased risk for death, new research shows.

Investigators found that patients who were hospitalized with COVID-19 and who had been diagnosed with a psychiatric disorder had a 50% increased risk for a COVID-related death in comparison with COVID-19 patients who had not received a psychiatric diagnosis.

“Pay attention and potentially address/treat a prior psychiatric diagnosis if a patient is hospitalized for COVID-19, as this risk factor can impact the patient’s outcome – death – while in the hospital,” lead investigator Luming Li, MD, assistant professor of psychiatry and associate medical director of quality improvement, Yale New Haven Psychiatric Hospital, New Haven, Conn., said in an interview.

The study was published Sept. 30 in JAMA Network Open.
 

Negative impact

“We were interested to learn more about the impact of psychiatric diagnoses on COVID-19 mortality, as prior large cohort studies included neurological and other medical conditions but did not assess for a priori psychiatric diagnoses,” said Dr. Li.

“We know from the literature that prior psychiatric diagnoses can have a negative impact on the outcomes of medical conditions, and therefore we tested our hypothesis on a cohort of patients who were hospitalized with COVID-19,” she added.

To investigate, the researchers analyzed data on 1,685 patients hospitalized with COVID-19 between Feb. 15 and April 25, 2020, and whose cases were followed to May 27, 2020. The patients (mean age, 65.2 years; 52.6% men) were drawn from the Yale New Haven Health System.

The median follow-up period was 8 days (interquartile range, 4-16 days) .

Of these patients, 28% had received a psychiatric diagnosis prior to hospitalization. The patients with psychiatric disorders were significantly older and were more likely to be women, White, non-Hispanic, and to have medical comorbidities (i.e., cancer, cerebrovascular disease, heart failure, diabetes, kidney disease, liver disease, MI, and/or HIV).

Psychiatric diagnoses were defined in accordance with ICD codes that included mental and behavioral health, Alzheimer’s disease, and self-injury.
 

Vulnerability to stress

In the unadjusted model, the risk for COVID-19–related hospital death was greater for those who had received any psychiatric diagnosis, compared with those had not (hazard ratio, 2.3; 95% CI, 1.8-2.9; P < .001).

In the adjusted model that controlled for demographic characteristics, other medical comorbidities, and hospital location, the mortality risk somewhat decreased but still remained significantly higher (HR, 1.5; 95% CI, 1.1-1.9; P = .003).

Dr. Li noted a number of factors that might account for the higher mortality rate among psychiatric patients who had COVID-19 in comparison with COVD-19 patients who did not have a psychiatric disorder. These included “potential inflammatory and stress responses that the body experiences related to prior psychiatric conditions,” she said.

Having been previously diagnosed with a psychiatric disorder may also “reflect existing neurochemical differences, compared to those who do not have a prior psychiatric diagnosis, [and] these differences may make the population with the prior psychiatric diagnosis more vulnerable to respond to an acute stressor such as COVID-19,” she said.
 

Quality care

Harold Pincus, MD, professor and vice chair of the department of psychiatry at Columbia University, New York, said it “adds to the fairly well-known and well-established phenomenon that people with mental illnesses have a high risk of all sorts of morbidity and mortality for non–mental health conditions.”

The researchers “adjusted for various expected [mortality] risks that would be independent of the presence of COVID-19,” so “there was something else going on associated with mortality,” said Dr. Pincus, who is also codirector of the Irving Institute for Clinical and Translation Research. He was not involved with the study.

Beyond the possibility of “some basic immunologic process affected by the presence of a mental disorder,” it is possible that the vulnerability is “related to access to quality care for the comorbid general condition that is not being effectively treated,” he said.

“The take-home message is that people with mental disorders are at higher risk for death, and we need to make sure that, irrespective of COVID-19, they get adequate preventive and chronic-disease care, which would be the most effective way to intervene and protect the impact of a serious disease like COVID-19,” he noted. This would include being appropriately vaccinated and receiving preventive healthcare to reduce smoking and encourage weight loss.

No source of funding for the study was provided. Dr. Li reported receiving grants from a Health and Aging Policy Fellowship during the conduct of the study. Dr. Pincus reported no relevant financial relationships.

A psychiatric diagnosis for patients hospitalized with COVID-19 is linked to a significantly increased risk for death, new research shows.

Investigators found that patients who were hospitalized with COVID-19 and who had been diagnosed with a psychiatric disorder had a 50% increased risk for a COVID-related death in comparison with COVID-19 patients who had not received a psychiatric diagnosis.

“Pay attention and potentially address/treat a prior psychiatric diagnosis if a patient is hospitalized for COVID-19, as this risk factor can impact the patient’s outcome – death – while in the hospital,” lead investigator Luming Li, MD, assistant professor of psychiatry and associate medical director of quality improvement, Yale New Haven Psychiatric Hospital, New Haven, Conn., said in an interview.

The study was published Sept. 30 in JAMA Network Open.
 

Negative impact

“We were interested to learn more about the impact of psychiatric diagnoses on COVID-19 mortality, as prior large cohort studies included neurological and other medical conditions but did not assess for a priori psychiatric diagnoses,” said Dr. Li.

“We know from the literature that prior psychiatric diagnoses can have a negative impact on the outcomes of medical conditions, and therefore we tested our hypothesis on a cohort of patients who were hospitalized with COVID-19,” she added.

To investigate, the researchers analyzed data on 1,685 patients hospitalized with COVID-19 between Feb. 15 and April 25, 2020, and whose cases were followed to May 27, 2020. The patients (mean age, 65.2 years; 52.6% men) were drawn from the Yale New Haven Health System.

The median follow-up period was 8 days (interquartile range, 4-16 days) .

Of these patients, 28% had received a psychiatric diagnosis prior to hospitalization. The patients with psychiatric disorders were significantly older and were more likely to be women, White, non-Hispanic, and to have medical comorbidities (i.e., cancer, cerebrovascular disease, heart failure, diabetes, kidney disease, liver disease, MI, and/or HIV).

Psychiatric diagnoses were defined in accordance with ICD codes that included mental and behavioral health, Alzheimer’s disease, and self-injury.
 

Vulnerability to stress

In the unadjusted model, the risk for COVID-19–related hospital death was greater for those who had received any psychiatric diagnosis, compared with those had not (hazard ratio, 2.3; 95% CI, 1.8-2.9; P < .001).

In the adjusted model that controlled for demographic characteristics, other medical comorbidities, and hospital location, the mortality risk somewhat decreased but still remained significantly higher (HR, 1.5; 95% CI, 1.1-1.9; P = .003).

Dr. Li noted a number of factors that might account for the higher mortality rate among psychiatric patients who had COVID-19 in comparison with COVD-19 patients who did not have a psychiatric disorder. These included “potential inflammatory and stress responses that the body experiences related to prior psychiatric conditions,” she said.

Having been previously diagnosed with a psychiatric disorder may also “reflect existing neurochemical differences, compared to those who do not have a prior psychiatric diagnosis, [and] these differences may make the population with the prior psychiatric diagnosis more vulnerable to respond to an acute stressor such as COVID-19,” she said.
 

Quality care

Harold Pincus, MD, professor and vice chair of the department of psychiatry at Columbia University, New York, said it “adds to the fairly well-known and well-established phenomenon that people with mental illnesses have a high risk of all sorts of morbidity and mortality for non–mental health conditions.”

The researchers “adjusted for various expected [mortality] risks that would be independent of the presence of COVID-19,” so “there was something else going on associated with mortality,” said Dr. Pincus, who is also codirector of the Irving Institute for Clinical and Translation Research. He was not involved with the study.

Beyond the possibility of “some basic immunologic process affected by the presence of a mental disorder,” it is possible that the vulnerability is “related to access to quality care for the comorbid general condition that is not being effectively treated,” he said.

“The take-home message is that people with mental disorders are at higher risk for death, and we need to make sure that, irrespective of COVID-19, they get adequate preventive and chronic-disease care, which would be the most effective way to intervene and protect the impact of a serious disease like COVID-19,” he noted. This would include being appropriately vaccinated and receiving preventive healthcare to reduce smoking and encourage weight loss.

No source of funding for the study was provided. Dr. Li reported receiving grants from a Health and Aging Policy Fellowship during the conduct of the study. Dr. Pincus reported no relevant financial relationships.

U.S. regulators eventually could safely approve vaccines for COVID-19 if the process is kept free of political pressure regarding time lines, study protocols, and safety standards, expert witnesses told a House panel investigating the process on Wednesday.

The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.

FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.

“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.

“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”

Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.

“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.

President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.

In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.

Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.

In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.

In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
 

Pushback on politics

Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.

“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”

Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.

Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.

Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.

“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.

Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.

“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.

Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.

COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.

Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
 

Debate on approaches for vaccine effectiveness

In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.

Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”

“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”

There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.

“Do you agree with those concerns? And either way, tell me why,” Griffith asked.

“I don’t agree,” Offit responded.

“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”

But other researchers also question the approaches used with the current crop of COVID-19 vaccines.

“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.

He fears consumers will not get what they might expect from the vaccines being tested.

“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.

This article first appeared on Medscape.com.

U.S. regulators eventually could safely approve vaccines for COVID-19 if the process is kept free of political pressure regarding time lines, study protocols, and safety standards, expert witnesses told a House panel investigating the process on Wednesday.

The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.

FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.

“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.

“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”

Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.

“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.

President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.

In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.

Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.

In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.

In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
 

Pushback on politics

Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.

“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”

Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.

Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.

Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.

“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.

Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.

“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.

Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.

COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.

Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
 

Debate on approaches for vaccine effectiveness

In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.

Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”

“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”

There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.

“Do you agree with those concerns? And either way, tell me why,” Griffith asked.

“I don’t agree,” Offit responded.

“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”

But other researchers also question the approaches used with the current crop of COVID-19 vaccines.

“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.

He fears consumers will not get what they might expect from the vaccines being tested.

“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.

This article first appeared on Medscape.com.

U.S. regulators eventually could safely approve vaccines for COVID-19 if the process is kept free of political pressure regarding time lines, study protocols, and safety standards, expert witnesses told a House panel investigating the process on Wednesday.

The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.

FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.

“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.

“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”

Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.

“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.

President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.

In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.

Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.

In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.

In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
 

Pushback on politics

Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.

“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”

Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.

Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.

Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.

“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.

Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.

“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.

Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.

COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.

Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
 

Debate on approaches for vaccine effectiveness

In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.

Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”

“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”

There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.

“Do you agree with those concerns? And either way, tell me why,” Griffith asked.

“I don’t agree,” Offit responded.

“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”

But other researchers also question the approaches used with the current crop of COVID-19 vaccines.

“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.

He fears consumers will not get what they might expect from the vaccines being tested.

“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.

This article first appeared on Medscape.com.

Clarence Troutman survived a 2-month hospital stay with COVID-19, then went home in early June. But he’s far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.

“Before COVID, I was a 59-year-old, relatively healthy man,” said the broadband technician from Denver. “If I had to say where I’m at now, I’d say about 50% of where I was, but when I first went home, I was at 20%.”

He credits much of his progress to the “motivation and education” gleaned from a new program for post-COVID patients at the University of Colorado at Denver, Aurora, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable coronavirus.

As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurologic concerns, anxiety, and depression.

“We need to think about how we’re going to provide care for patients who may be recovering for years after the virus,” said Sarah Jolley, MD, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth’s Post-Covid Clinic, where Mr. Troutman is seen.

That need has jump-started post-COVID clinics, which bring together a range of specialists into a one-stop shop.

One of the first and largest such clinics is at Mount Sinai in New York City, but programs have also launched at the University of California,San Francisco; Stanford (Calif.) University Medical Center; and the University of Pennsylvania, Philadelphia. The Cleveland Clinic plans to open one early next year. And it’s not just academic medical centers: St. John’s Well Child and Family Center, part of a network of community clinics in south central Los Angeles, said this month it aims to test thousands of its patients who were diagnosed with COVID-19 since March for long-term effects.

The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues, and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists. Many of the centers also do research studies, aiming to better understand why the virus hits certain patients so hard.

“Some of our patients, even those on a ventilator on death’s door, will come out remarkably unscathed,” said Lekshmi Santhosh, MD, an assistant professor of pulmonary critical care and a leader of the post-COVID program at UCSF, called the OPTIMAL clinic. “Others, even those who were never hospitalized, have disabling fatigue, ongoing chest pain, and shortness of breath, and there’s a whole spectrum in between.”
 

‘Staggering’ medical need

It’s too early to know how long the persistent medical effects and symptoms will linger, or to make accurate estimates on the percentage of patients affected.

Some early studies are sobering. An Austrian report released this month found that 76 of the first 86 patients studied had evidence of lung damage 6 weeks after hospital discharge, but that dropped to 48 patients at 12 weeks.

Some researchers and clinics say about 10% of U.S. COVID patients they see may have longer-running effects, said Zijian Chen, MD, medical director of the Center for Post-COVID Care at Mount Sinai, which has enrolled 400 patients so far.

If that estimate is correct – and Dr. Chen emphasized that more research is needed to make sure – it translates to patients entering the medical system in droves, often with multiple issues.

How health systems and insurers respond will be key, he said. More than 6.5 million U.S. residents have tested positive for the disease. If fewer than 10% – say 500,000 – already have long-lasting symptoms, “that number is staggering,” Dr. Chen said. “How much medical care will be needed for that?”

Though start-up costs could be a hurdle, the clinics themselves may eventually draw much-needed revenue to medical centers by attracting patients, many of whom have insurance to cover some or all of the cost of repeated visits.

Dr. Chen said the specialized centers can help lower health spending by providing more cost effective, coordinated care that avoids duplicative testing a patient might otherwise undergo.

“We’ve seen patients that when they come in, they’ve already had four MRI or CT scans and a stack of bloodwork,” he said.

The program consolidates those earlier results and determines if any additional testing is needed. Sometimes the answer to what’s causing patients’ long-lasting symptoms remains elusive. One problem for patients seeking help outside of dedicated clinics is that when there is no clear cause for their condition, they may be told the symptoms are imagined.

“I believe in the patients,” said Dr. Chen.

About half the clinic’s patients have received test results showing damage, said Dr. Chen, an endocrinologist and internal medicine physician. For those patients, the clinic can develop a treatment plan. But, frustratingly, the other half have inconclusive test results yet exhibit a range of symptoms.

“That makes it more difficult to treat,” said Dr. Chen.

Experts see parallels to a push in the past decade to establish special clinics to treat patients released from ICU wards, who may have problems related to long-term bed rest or the delirium many experience while hospitalized. Some of the current post-COVID clinics are modeled after the post-ICU clinics or are expanded versions of them.

The ICU Recovery Center at Vanderbilt University Medical Center, Nashville, Tenn., for instance, which opened in 2012, is accepting post-COVID patients.

There are about a dozen post-ICU clinics nationally, some of which are also now working with COVID patients, said James Jackson, director of long-term outcomes at the Vanderbilt center. In addition, he’s heard of at least another dozen post-COVID centers in development.

The centers generally do an initial assessment a few weeks after a patient is diagnosed or discharged from the hospital, often by video call. Check-in and repeat visits are scheduled every month or so after that.

“In an ideal world, with these post-COVID clinics, you can identify the patients and get them into rehab,” he said. “Even if the primary thing these clinics did was to say to patients: ‘This is real, it is not all in your head,’ that impact would be important.”
 

A question of feasibility

Financing is the largest obstacle, program proponents said. Many hospitals lost substantial revenue to canceled elective procedures during stay-at-home periods.

“So, it’s not a great time to be pitching a new activity that requires a start-up subsidy,” said Glenn Melnick, PhD, a professor of health economics at the University of Southern California.

At UCSF, a select group of faculty members staff the post-COVID clinics and some mental health professionals volunteer their time, said Dr. Santhosh.

Dr. Chen said he was able to recruit team members and support staff from the ranks of those whose elective patient caseload had dropped.

Dr. Jackson said unfortunately there’s not been enough research into the cost-and-clinical effectiveness of post-ICU centers.

“In the early days, there may have been questions about how much value does this add,” he noted. “Now, the question is not so much is it a good idea, but is it feasible?”

Right now, the post-COVID centers are foremost a research effort, said Len Nichols, an economist and nonresident fellow at the Urban Institute. “If these guys get good at treating long-term symptoms, that’s good for all of us. There’s not enough patients to make it a business model yet, but if they become the place to go when you get it, it could become a business model for some of the elite institutions.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Clarence Troutman survived a 2-month hospital stay with COVID-19, then went home in early June. But he’s far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.

“Before COVID, I was a 59-year-old, relatively healthy man,” said the broadband technician from Denver. “If I had to say where I’m at now, I’d say about 50% of where I was, but when I first went home, I was at 20%.”

He credits much of his progress to the “motivation and education” gleaned from a new program for post-COVID patients at the University of Colorado at Denver, Aurora, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable coronavirus.

As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurologic concerns, anxiety, and depression.

“We need to think about how we’re going to provide care for patients who may be recovering for years after the virus,” said Sarah Jolley, MD, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth’s Post-Covid Clinic, where Mr. Troutman is seen.

That need has jump-started post-COVID clinics, which bring together a range of specialists into a one-stop shop.

One of the first and largest such clinics is at Mount Sinai in New York City, but programs have also launched at the University of California,San Francisco; Stanford (Calif.) University Medical Center; and the University of Pennsylvania, Philadelphia. The Cleveland Clinic plans to open one early next year. And it’s not just academic medical centers: St. John’s Well Child and Family Center, part of a network of community clinics in south central Los Angeles, said this month it aims to test thousands of its patients who were diagnosed with COVID-19 since March for long-term effects.

The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues, and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists. Many of the centers also do research studies, aiming to better understand why the virus hits certain patients so hard.

“Some of our patients, even those on a ventilator on death’s door, will come out remarkably unscathed,” said Lekshmi Santhosh, MD, an assistant professor of pulmonary critical care and a leader of the post-COVID program at UCSF, called the OPTIMAL clinic. “Others, even those who were never hospitalized, have disabling fatigue, ongoing chest pain, and shortness of breath, and there’s a whole spectrum in between.”
 

‘Staggering’ medical need

It’s too early to know how long the persistent medical effects and symptoms will linger, or to make accurate estimates on the percentage of patients affected.

Some early studies are sobering. An Austrian report released this month found that 76 of the first 86 patients studied had evidence of lung damage 6 weeks after hospital discharge, but that dropped to 48 patients at 12 weeks.

Some researchers and clinics say about 10% of U.S. COVID patients they see may have longer-running effects, said Zijian Chen, MD, medical director of the Center for Post-COVID Care at Mount Sinai, which has enrolled 400 patients so far.

If that estimate is correct – and Dr. Chen emphasized that more research is needed to make sure – it translates to patients entering the medical system in droves, often with multiple issues.

How health systems and insurers respond will be key, he said. More than 6.5 million U.S. residents have tested positive for the disease. If fewer than 10% – say 500,000 – already have long-lasting symptoms, “that number is staggering,” Dr. Chen said. “How much medical care will be needed for that?”

Though start-up costs could be a hurdle, the clinics themselves may eventually draw much-needed revenue to medical centers by attracting patients, many of whom have insurance to cover some or all of the cost of repeated visits.

Dr. Chen said the specialized centers can help lower health spending by providing more cost effective, coordinated care that avoids duplicative testing a patient might otherwise undergo.

“We’ve seen patients that when they come in, they’ve already had four MRI or CT scans and a stack of bloodwork,” he said.

The program consolidates those earlier results and determines if any additional testing is needed. Sometimes the answer to what’s causing patients’ long-lasting symptoms remains elusive. One problem for patients seeking help outside of dedicated clinics is that when there is no clear cause for their condition, they may be told the symptoms are imagined.

“I believe in the patients,” said Dr. Chen.

About half the clinic’s patients have received test results showing damage, said Dr. Chen, an endocrinologist and internal medicine physician. For those patients, the clinic can develop a treatment plan. But, frustratingly, the other half have inconclusive test results yet exhibit a range of symptoms.

“That makes it more difficult to treat,” said Dr. Chen.

Experts see parallels to a push in the past decade to establish special clinics to treat patients released from ICU wards, who may have problems related to long-term bed rest or the delirium many experience while hospitalized. Some of the current post-COVID clinics are modeled after the post-ICU clinics or are expanded versions of them.

The ICU Recovery Center at Vanderbilt University Medical Center, Nashville, Tenn., for instance, which opened in 2012, is accepting post-COVID patients.

There are about a dozen post-ICU clinics nationally, some of which are also now working with COVID patients, said James Jackson, director of long-term outcomes at the Vanderbilt center. In addition, he’s heard of at least another dozen post-COVID centers in development.

The centers generally do an initial assessment a few weeks after a patient is diagnosed or discharged from the hospital, often by video call. Check-in and repeat visits are scheduled every month or so after that.

“In an ideal world, with these post-COVID clinics, you can identify the patients and get them into rehab,” he said. “Even if the primary thing these clinics did was to say to patients: ‘This is real, it is not all in your head,’ that impact would be important.”
 

A question of feasibility

Financing is the largest obstacle, program proponents said. Many hospitals lost substantial revenue to canceled elective procedures during stay-at-home periods.

“So, it’s not a great time to be pitching a new activity that requires a start-up subsidy,” said Glenn Melnick, PhD, a professor of health economics at the University of Southern California.

At UCSF, a select group of faculty members staff the post-COVID clinics and some mental health professionals volunteer their time, said Dr. Santhosh.

Dr. Chen said he was able to recruit team members and support staff from the ranks of those whose elective patient caseload had dropped.

Dr. Jackson said unfortunately there’s not been enough research into the cost-and-clinical effectiveness of post-ICU centers.

“In the early days, there may have been questions about how much value does this add,” he noted. “Now, the question is not so much is it a good idea, but is it feasible?”

Right now, the post-COVID centers are foremost a research effort, said Len Nichols, an economist and nonresident fellow at the Urban Institute. “If these guys get good at treating long-term symptoms, that’s good for all of us. There’s not enough patients to make it a business model yet, but if they become the place to go when you get it, it could become a business model for some of the elite institutions.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Clarence Troutman survived a 2-month hospital stay with COVID-19, then went home in early June. But he’s far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.

“Before COVID, I was a 59-year-old, relatively healthy man,” said the broadband technician from Denver. “If I had to say where I’m at now, I’d say about 50% of where I was, but when I first went home, I was at 20%.”

He credits much of his progress to the “motivation and education” gleaned from a new program for post-COVID patients at the University of Colorado at Denver, Aurora, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable coronavirus.

As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurologic concerns, anxiety, and depression.

“We need to think about how we’re going to provide care for patients who may be recovering for years after the virus,” said Sarah Jolley, MD, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth’s Post-Covid Clinic, where Mr. Troutman is seen.

That need has jump-started post-COVID clinics, which bring together a range of specialists into a one-stop shop.

One of the first and largest such clinics is at Mount Sinai in New York City, but programs have also launched at the University of California,San Francisco; Stanford (Calif.) University Medical Center; and the University of Pennsylvania, Philadelphia. The Cleveland Clinic plans to open one early next year. And it’s not just academic medical centers: St. John’s Well Child and Family Center, part of a network of community clinics in south central Los Angeles, said this month it aims to test thousands of its patients who were diagnosed with COVID-19 since March for long-term effects.

The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues, and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists. Many of the centers also do research studies, aiming to better understand why the virus hits certain patients so hard.

“Some of our patients, even those on a ventilator on death’s door, will come out remarkably unscathed,” said Lekshmi Santhosh, MD, an assistant professor of pulmonary critical care and a leader of the post-COVID program at UCSF, called the OPTIMAL clinic. “Others, even those who were never hospitalized, have disabling fatigue, ongoing chest pain, and shortness of breath, and there’s a whole spectrum in between.”
 

‘Staggering’ medical need

It’s too early to know how long the persistent medical effects and symptoms will linger, or to make accurate estimates on the percentage of patients affected.

Some early studies are sobering. An Austrian report released this month found that 76 of the first 86 patients studied had evidence of lung damage 6 weeks after hospital discharge, but that dropped to 48 patients at 12 weeks.

Some researchers and clinics say about 10% of U.S. COVID patients they see may have longer-running effects, said Zijian Chen, MD, medical director of the Center for Post-COVID Care at Mount Sinai, which has enrolled 400 patients so far.

If that estimate is correct – and Dr. Chen emphasized that more research is needed to make sure – it translates to patients entering the medical system in droves, often with multiple issues.

How health systems and insurers respond will be key, he said. More than 6.5 million U.S. residents have tested positive for the disease. If fewer than 10% – say 500,000 – already have long-lasting symptoms, “that number is staggering,” Dr. Chen said. “How much medical care will be needed for that?”

Though start-up costs could be a hurdle, the clinics themselves may eventually draw much-needed revenue to medical centers by attracting patients, many of whom have insurance to cover some or all of the cost of repeated visits.

Dr. Chen said the specialized centers can help lower health spending by providing more cost effective, coordinated care that avoids duplicative testing a patient might otherwise undergo.

“We’ve seen patients that when they come in, they’ve already had four MRI or CT scans and a stack of bloodwork,” he said.

The program consolidates those earlier results and determines if any additional testing is needed. Sometimes the answer to what’s causing patients’ long-lasting symptoms remains elusive. One problem for patients seeking help outside of dedicated clinics is that when there is no clear cause for their condition, they may be told the symptoms are imagined.

“I believe in the patients,” said Dr. Chen.

About half the clinic’s patients have received test results showing damage, said Dr. Chen, an endocrinologist and internal medicine physician. For those patients, the clinic can develop a treatment plan. But, frustratingly, the other half have inconclusive test results yet exhibit a range of symptoms.

“That makes it more difficult to treat,” said Dr. Chen.

Experts see parallels to a push in the past decade to establish special clinics to treat patients released from ICU wards, who may have problems related to long-term bed rest or the delirium many experience while hospitalized. Some of the current post-COVID clinics are modeled after the post-ICU clinics or are expanded versions of them.

The ICU Recovery Center at Vanderbilt University Medical Center, Nashville, Tenn., for instance, which opened in 2012, is accepting post-COVID patients.

There are about a dozen post-ICU clinics nationally, some of which are also now working with COVID patients, said James Jackson, director of long-term outcomes at the Vanderbilt center. In addition, he’s heard of at least another dozen post-COVID centers in development.

The centers generally do an initial assessment a few weeks after a patient is diagnosed or discharged from the hospital, often by video call. Check-in and repeat visits are scheduled every month or so after that.

“In an ideal world, with these post-COVID clinics, you can identify the patients and get them into rehab,” he said. “Even if the primary thing these clinics did was to say to patients: ‘This is real, it is not all in your head,’ that impact would be important.”
 

A question of feasibility

Financing is the largest obstacle, program proponents said. Many hospitals lost substantial revenue to canceled elective procedures during stay-at-home periods.

“So, it’s not a great time to be pitching a new activity that requires a start-up subsidy,” said Glenn Melnick, PhD, a professor of health economics at the University of Southern California.

At UCSF, a select group of faculty members staff the post-COVID clinics and some mental health professionals volunteer their time, said Dr. Santhosh.

Dr. Chen said he was able to recruit team members and support staff from the ranks of those whose elective patient caseload had dropped.

Dr. Jackson said unfortunately there’s not been enough research into the cost-and-clinical effectiveness of post-ICU centers.

“In the early days, there may have been questions about how much value does this add,” he noted. “Now, the question is not so much is it a good idea, but is it feasible?”

Right now, the post-COVID centers are foremost a research effort, said Len Nichols, an economist and nonresident fellow at the Urban Institute. “If these guys get good at treating long-term symptoms, that’s good for all of us. There’s not enough patients to make it a business model yet, but if they become the place to go when you get it, it could become a business model for some of the elite institutions.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Among COVID-19 patients who undergo mechanical ventilation, lying in the prone position has been associated with lasting nerve damage. A new case series describes peripheral nerve injuries associated with this type of positioning and suggests ways to minimize the potential damage.

“Physicians should remain aware of increased susceptibility to peripheral nerve damage in patients with severe COVID-19 after prone positioning, since it is surprisingly common among these patients, and should refine standard protocols accordingly to reduce that risk,” said senior author Colin Franz, MD, PhD, director of the Electrodiagnostic Laboratory, Shirley Ryan AbilityLab, Chicago.

The article was published online Sept. 4 in the British Journal of Anaesthesiology.
 

Unique type of nerve injury

Many patients who are admitted to the intensive care unit with COVID-19 undergo invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). Clinical guidelines recommend that such patients lie in the prone position 12-16 hours per day.

“Prone positioning for up to 16 hours is a therapy we use for patients with more severe forms of ARDS, and high-level evidence points to mortality benefit in patients with moderate to severe ARDS if [mechanical] ventilation occurs,” said study coauthor James McCauley Walter, MD, of the pulmonary division at Northwestern University, Chicago.

With a “significant number of COVID-19 patients flooding the ICU, we quickly started to prone a lot of them, but if you are in a specific position for multiple hours a day, coupled with the neurotoxic effects of the SARS-CoV-2 virus itself, you may be exposed to a unique type of nerve injury,” he said.

Dr. Walter said that the “incidence of asymmetric neuropathies seems out of proportion to what has been reported in non–COVID-19 settings, which is what caught our attention.”

Many of these patients are discharged to rehabilitation hospitals, and “what we noticed, which was unique about COVID-19 patients coming to our rehab hospital, was that, compared with other patients who had been critically ill with a long hospital stay, there was a significantly higher percentage of COVID-19 patients who had peripheral nerve damage,” Dr. Franz said.

The authors described 12 of these patients who were admitted between April 24 and June 30, 2020 (mean age, 60.3 years; range, 23-80 years). The sample included White, Black, and Hispanic individuals. Eleven of the 12 post–COVID-19 patients with peripheral nerve damage had experienced prone positioning during acute management.

The average number of days patients received mechanical ventilation was 33.6 (range, 12-62 days). The average number of proning sessions was 4.5 (range, 1-16) with an average of 81.2 hours (range, 16-252 hours) spent prone.
 

A major contributor

Dr. Franz suggested that prone positioning is likely not the only cause of peripheral nerve damage but “may play a big role in these patients who are vulnerable because of viral infection and the critical illness that causes damage and nerve injuries.”

“The first component of lifesaving care for the critically ill in the ICU is intravenous fluids, mechanical ventilation, steroids, and antibiotics for infection,” said Dr. Walter.

“We are trying to come up with ways to place patients in prone position in safer ways, to pay attention to pressure points and areas of injury that we have seen and try to offload them, to see if we can decrease the rate of these injuries,” he added.

The researchers’ article includes a heat map diagram as a “template for where to focus the most efforts, in terms of decreasing pressure,” Dr. Walter said.

“The nerves are accepting too much force for gravely ill COVID-19 patients to handle, so we suggest using the template to determine where extra padding might be needed, or a protocol that might include changes in positioning,” he added.

Dr. Franz described the interventions used for COVID-19 patients with prone positioning–related peripheral nerve damage. “The first step is trying to address the problems one by one, either trying to solve them through exercise or teaching new skills, new ways to compensate, beginning with basic activities, such as getting out of bed and self-care,” he said.

Long-term recovery of nerve injuries depends on how severe the injuries are. Some nerves can slowly regenerate – possibly at the rate of 1 inch per month – which can be a long process, taking between a year and 18 months.

Dr. Franz said that therapies for this condition are “extrapolated from clinical trial work” on promoting nerve regeneration after surgery using electrical stimulation to enable nerves to regrow at a faster rate.

“Regeneration is not only slow, but it may not happen completely, leaving the patient with permanent nerve damage – in fact, based on our experience and what has been reported, the percentage of patients with full recovery is only 10%,” he said.

The most common symptomatic complaint other than lack of movement or feeling is neuropathic pain, “which may require medication to take the edge off the pain,” Dr. Franz added.
 

Irreversible damage?

Commenting on the study, Tae Chung, MD, of the departments of physical medicine, rehabilitation, and neurology, Johns Hopkins University, Baltimore, said the study “provides one of the first and the largest description of peripheral nerve injury associated with prone positioning for management of ARDS from COVID-19.”

Dr. Chung, who was not involved in the research, noted that “various neurological complications from COVID-19 have been reported, and some of them may result in irreversible neurological damage or delay the recovery from COVID-19 infection,” so “accurate and timely diagnosis of such neurological complications is critical for rehabilitation of the COVID-19 survivors.”

The study received no funding. Dr. Franz, Dr. Walter, study coauthors, and Dr. Chung report no relevant financial relationships.

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

Among COVID-19 patients who undergo mechanical ventilation, lying in the prone position has been associated with lasting nerve damage. A new case series describes peripheral nerve injuries associated with this type of positioning and suggests ways to minimize the potential damage.

“Physicians should remain aware of increased susceptibility to peripheral nerve damage in patients with severe COVID-19 after prone positioning, since it is surprisingly common among these patients, and should refine standard protocols accordingly to reduce that risk,” said senior author Colin Franz, MD, PhD, director of the Electrodiagnostic Laboratory, Shirley Ryan AbilityLab, Chicago.

The article was published online Sept. 4 in the British Journal of Anaesthesiology.
 

Unique type of nerve injury

Many patients who are admitted to the intensive care unit with COVID-19 undergo invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). Clinical guidelines recommend that such patients lie in the prone position 12-16 hours per day.

“Prone positioning for up to 16 hours is a therapy we use for patients with more severe forms of ARDS, and high-level evidence points to mortality benefit in patients with moderate to severe ARDS if [mechanical] ventilation occurs,” said study coauthor James McCauley Walter, MD, of the pulmonary division at Northwestern University, Chicago.

With a “significant number of COVID-19 patients flooding the ICU, we quickly started to prone a lot of them, but if you are in a specific position for multiple hours a day, coupled with the neurotoxic effects of the SARS-CoV-2 virus itself, you may be exposed to a unique type of nerve injury,” he said.

Dr. Walter said that the “incidence of asymmetric neuropathies seems out of proportion to what has been reported in non–COVID-19 settings, which is what caught our attention.”

Many of these patients are discharged to rehabilitation hospitals, and “what we noticed, which was unique about COVID-19 patients coming to our rehab hospital, was that, compared with other patients who had been critically ill with a long hospital stay, there was a significantly higher percentage of COVID-19 patients who had peripheral nerve damage,” Dr. Franz said.

The authors described 12 of these patients who were admitted between April 24 and June 30, 2020 (mean age, 60.3 years; range, 23-80 years). The sample included White, Black, and Hispanic individuals. Eleven of the 12 post–COVID-19 patients with peripheral nerve damage had experienced prone positioning during acute management.

The average number of days patients received mechanical ventilation was 33.6 (range, 12-62 days). The average number of proning sessions was 4.5 (range, 1-16) with an average of 81.2 hours (range, 16-252 hours) spent prone.
 

A major contributor

Dr. Franz suggested that prone positioning is likely not the only cause of peripheral nerve damage but “may play a big role in these patients who are vulnerable because of viral infection and the critical illness that causes damage and nerve injuries.”

“The first component of lifesaving care for the critically ill in the ICU is intravenous fluids, mechanical ventilation, steroids, and antibiotics for infection,” said Dr. Walter.

“We are trying to come up with ways to place patients in prone position in safer ways, to pay attention to pressure points and areas of injury that we have seen and try to offload them, to see if we can decrease the rate of these injuries,” he added.

The researchers’ article includes a heat map diagram as a “template for where to focus the most efforts, in terms of decreasing pressure,” Dr. Walter said.

“The nerves are accepting too much force for gravely ill COVID-19 patients to handle, so we suggest using the template to determine where extra padding might be needed, or a protocol that might include changes in positioning,” he added.

Dr. Franz described the interventions used for COVID-19 patients with prone positioning–related peripheral nerve damage. “The first step is trying to address the problems one by one, either trying to solve them through exercise or teaching new skills, new ways to compensate, beginning with basic activities, such as getting out of bed and self-care,” he said.

Long-term recovery of nerve injuries depends on how severe the injuries are. Some nerves can slowly regenerate – possibly at the rate of 1 inch per month – which can be a long process, taking between a year and 18 months.

Dr. Franz said that therapies for this condition are “extrapolated from clinical trial work” on promoting nerve regeneration after surgery using electrical stimulation to enable nerves to regrow at a faster rate.

“Regeneration is not only slow, but it may not happen completely, leaving the patient with permanent nerve damage – in fact, based on our experience and what has been reported, the percentage of patients with full recovery is only 10%,” he said.

The most common symptomatic complaint other than lack of movement or feeling is neuropathic pain, “which may require medication to take the edge off the pain,” Dr. Franz added.
 

Irreversible damage?

Commenting on the study, Tae Chung, MD, of the departments of physical medicine, rehabilitation, and neurology, Johns Hopkins University, Baltimore, said the study “provides one of the first and the largest description of peripheral nerve injury associated with prone positioning for management of ARDS from COVID-19.”

Dr. Chung, who was not involved in the research, noted that “various neurological complications from COVID-19 have been reported, and some of them may result in irreversible neurological damage or delay the recovery from COVID-19 infection,” so “accurate and timely diagnosis of such neurological complications is critical for rehabilitation of the COVID-19 survivors.”

The study received no funding. Dr. Franz, Dr. Walter, study coauthors, and Dr. Chung report no relevant financial relationships.

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

Among COVID-19 patients who undergo mechanical ventilation, lying in the prone position has been associated with lasting nerve damage. A new case series describes peripheral nerve injuries associated with this type of positioning and suggests ways to minimize the potential damage.

“Physicians should remain aware of increased susceptibility to peripheral nerve damage in patients with severe COVID-19 after prone positioning, since it is surprisingly common among these patients, and should refine standard protocols accordingly to reduce that risk,” said senior author Colin Franz, MD, PhD, director of the Electrodiagnostic Laboratory, Shirley Ryan AbilityLab, Chicago.

The article was published online Sept. 4 in the British Journal of Anaesthesiology.
 

Unique type of nerve injury

Many patients who are admitted to the intensive care unit with COVID-19 undergo invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). Clinical guidelines recommend that such patients lie in the prone position 12-16 hours per day.

“Prone positioning for up to 16 hours is a therapy we use for patients with more severe forms of ARDS, and high-level evidence points to mortality benefit in patients with moderate to severe ARDS if [mechanical] ventilation occurs,” said study coauthor James McCauley Walter, MD, of the pulmonary division at Northwestern University, Chicago.

With a “significant number of COVID-19 patients flooding the ICU, we quickly started to prone a lot of them, but if you are in a specific position for multiple hours a day, coupled with the neurotoxic effects of the SARS-CoV-2 virus itself, you may be exposed to a unique type of nerve injury,” he said.

Dr. Walter said that the “incidence of asymmetric neuropathies seems out of proportion to what has been reported in non–COVID-19 settings, which is what caught our attention.”

Many of these patients are discharged to rehabilitation hospitals, and “what we noticed, which was unique about COVID-19 patients coming to our rehab hospital, was that, compared with other patients who had been critically ill with a long hospital stay, there was a significantly higher percentage of COVID-19 patients who had peripheral nerve damage,” Dr. Franz said.

The authors described 12 of these patients who were admitted between April 24 and June 30, 2020 (mean age, 60.3 years; range, 23-80 years). The sample included White, Black, and Hispanic individuals. Eleven of the 12 post–COVID-19 patients with peripheral nerve damage had experienced prone positioning during acute management.

The average number of days patients received mechanical ventilation was 33.6 (range, 12-62 days). The average number of proning sessions was 4.5 (range, 1-16) with an average of 81.2 hours (range, 16-252 hours) spent prone.
 

A major contributor

Dr. Franz suggested that prone positioning is likely not the only cause of peripheral nerve damage but “may play a big role in these patients who are vulnerable because of viral infection and the critical illness that causes damage and nerve injuries.”

“The first component of lifesaving care for the critically ill in the ICU is intravenous fluids, mechanical ventilation, steroids, and antibiotics for infection,” said Dr. Walter.

“We are trying to come up with ways to place patients in prone position in safer ways, to pay attention to pressure points and areas of injury that we have seen and try to offload them, to see if we can decrease the rate of these injuries,” he added.

The researchers’ article includes a heat map diagram as a “template for where to focus the most efforts, in terms of decreasing pressure,” Dr. Walter said.

“The nerves are accepting too much force for gravely ill COVID-19 patients to handle, so we suggest using the template to determine where extra padding might be needed, or a protocol that might include changes in positioning,” he added.

Dr. Franz described the interventions used for COVID-19 patients with prone positioning–related peripheral nerve damage. “The first step is trying to address the problems one by one, either trying to solve them through exercise or teaching new skills, new ways to compensate, beginning with basic activities, such as getting out of bed and self-care,” he said.

Long-term recovery of nerve injuries depends on how severe the injuries are. Some nerves can slowly regenerate – possibly at the rate of 1 inch per month – which can be a long process, taking between a year and 18 months.

Dr. Franz said that therapies for this condition are “extrapolated from clinical trial work” on promoting nerve regeneration after surgery using electrical stimulation to enable nerves to regrow at a faster rate.

“Regeneration is not only slow, but it may not happen completely, leaving the patient with permanent nerve damage – in fact, based on our experience and what has been reported, the percentage of patients with full recovery is only 10%,” he said.

The most common symptomatic complaint other than lack of movement or feeling is neuropathic pain, “which may require medication to take the edge off the pain,” Dr. Franz added.
 

Irreversible damage?

Commenting on the study, Tae Chung, MD, of the departments of physical medicine, rehabilitation, and neurology, Johns Hopkins University, Baltimore, said the study “provides one of the first and the largest description of peripheral nerve injury associated with prone positioning for management of ARDS from COVID-19.”

Dr. Chung, who was not involved in the research, noted that “various neurological complications from COVID-19 have been reported, and some of them may result in irreversible neurological damage or delay the recovery from COVID-19 infection,” so “accurate and timely diagnosis of such neurological complications is critical for rehabilitation of the COVID-19 survivors.”

The study received no funding. Dr. Franz, Dr. Walter, study coauthors, and Dr. Chung report no relevant financial relationships.

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

President Trump on Oct. 1 signed a bill to keep the federal government running through December 11. This “continuing resolution” (CR), which was approved by the Senate Wednesday on an 84-10 vote, according to The New York Times, includes provisions to delay repayment by physicians of pandemic-related Medicare loans and to reduce the loans’ interest rate.

In an earlier news release, the American Medical Association reported that Congress and the White House had agreed to include the provisions on Medicare loans in the CR.

Under the Medicare Accelerated and Advance Payments (AAP) program, the Centers for Medicare & Medicaid Services advanced money to physicians who were financially impacted by the pandemic. The program, created in March, was suspended in late April.

Physicians who received the Medicare loans were supposed to start paying them back 120 days after they were made. CMS planned to recoup the advances by offsetting them against Medicare claims payments due to physicians. Practices had up to 210 days (7 months) to repay the loans through this process before being asked to repay them directly with interest of 10.25%.

For the practices that received these advances, that meant their Medicare cash flow was scheduled to dry up, starting in August. However, CMS quietly abstained from collecting these payments when they came due, according to Modern Healthcare.
 

New terms

Under the new loan repayment terms in the CR, recoupment of the disbursed funds is postponed until 365 days after the date on which a practice received the money. The balance is due by September 2022.

The amount to be recouped from each claim is reduced from 100% to 25% of the claim for the first 11 months and to 50% of claims withheld for an additional 6 months. If the loan is not repaid in full by then, the provider must pay the balance with interest of 4%.

More than 80% of the $100 billion that CMS loaned to healthcare providers through May 2 went to hospitals, Modern Healthcare calculated. Of the remainder, specialty or multispecialty practices received $3.5 billion, internal medicine specialists got $24 million, family physicians were loaned $15 million, and federally qualified health centers received $20 million.

In the AMA’s news release, AMA President Susan Bailey, MD, who assumed the post in June, called the original loan repayment plan an “economic sword hanging over physician practices.”
 

This article first appeared on Medscape.com.

President Trump on Oct. 1 signed a bill to keep the federal government running through December 11. This “continuing resolution” (CR), which was approved by the Senate Wednesday on an 84-10 vote, according to The New York Times, includes provisions to delay repayment by physicians of pandemic-related Medicare loans and to reduce the loans’ interest rate.

In an earlier news release, the American Medical Association reported that Congress and the White House had agreed to include the provisions on Medicare loans in the CR.

Under the Medicare Accelerated and Advance Payments (AAP) program, the Centers for Medicare & Medicaid Services advanced money to physicians who were financially impacted by the pandemic. The program, created in March, was suspended in late April.

Physicians who received the Medicare loans were supposed to start paying them back 120 days after they were made. CMS planned to recoup the advances by offsetting them against Medicare claims payments due to physicians. Practices had up to 210 days (7 months) to repay the loans through this process before being asked to repay them directly with interest of 10.25%.

For the practices that received these advances, that meant their Medicare cash flow was scheduled to dry up, starting in August. However, CMS quietly abstained from collecting these payments when they came due, according to Modern Healthcare.
 

New terms

Under the new loan repayment terms in the CR, recoupment of the disbursed funds is postponed until 365 days after the date on which a practice received the money. The balance is due by September 2022.

The amount to be recouped from each claim is reduced from 100% to 25% of the claim for the first 11 months and to 50% of claims withheld for an additional 6 months. If the loan is not repaid in full by then, the provider must pay the balance with interest of 4%.

More than 80% of the $100 billion that CMS loaned to healthcare providers through May 2 went to hospitals, Modern Healthcare calculated. Of the remainder, specialty or multispecialty practices received $3.5 billion, internal medicine specialists got $24 million, family physicians were loaned $15 million, and federally qualified health centers received $20 million.

In the AMA’s news release, AMA President Susan Bailey, MD, who assumed the post in June, called the original loan repayment plan an “economic sword hanging over physician practices.”
 

This article first appeared on Medscape.com.

President Trump on Oct. 1 signed a bill to keep the federal government running through December 11. This “continuing resolution” (CR), which was approved by the Senate Wednesday on an 84-10 vote, according to The New York Times, includes provisions to delay repayment by physicians of pandemic-related Medicare loans and to reduce the loans’ interest rate.

In an earlier news release, the American Medical Association reported that Congress and the White House had agreed to include the provisions on Medicare loans in the CR.

Under the Medicare Accelerated and Advance Payments (AAP) program, the Centers for Medicare & Medicaid Services advanced money to physicians who were financially impacted by the pandemic. The program, created in March, was suspended in late April.

Physicians who received the Medicare loans were supposed to start paying them back 120 days after they were made. CMS planned to recoup the advances by offsetting them against Medicare claims payments due to physicians. Practices had up to 210 days (7 months) to repay the loans through this process before being asked to repay them directly with interest of 10.25%.

For the practices that received these advances, that meant their Medicare cash flow was scheduled to dry up, starting in August. However, CMS quietly abstained from collecting these payments when they came due, according to Modern Healthcare.
 

New terms

Under the new loan repayment terms in the CR, recoupment of the disbursed funds is postponed until 365 days after the date on which a practice received the money. The balance is due by September 2022.

The amount to be recouped from each claim is reduced from 100% to 25% of the claim for the first 11 months and to 50% of claims withheld for an additional 6 months. If the loan is not repaid in full by then, the provider must pay the balance with interest of 4%.

More than 80% of the $100 billion that CMS loaned to healthcare providers through May 2 went to hospitals, Modern Healthcare calculated. Of the remainder, specialty or multispecialty practices received $3.5 billion, internal medicine specialists got $24 million, family physicians were loaned $15 million, and federally qualified health centers received $20 million.

In the AMA’s news release, AMA President Susan Bailey, MD, who assumed the post in June, called the original loan repayment plan an “economic sword hanging over physician practices.”
 

This article first appeared on Medscape.com.

During normal times, the U.K.-based charity No Panic offers itself as an easily accessible service to those with anxiety disorders and phobias. Visitors to the website who can receive immediate, remote support from trained volunteers. But this spring was anything but normal, as the reality of COVID-19’s worldwide spread became terrifyingly clear.

COVID-19 cases peaked in the United Kingdom in early April. Nationwide lockdown efforts contributed to a gradual but ultimately substantial decline in cases, yet, despite the favorable trend lines, No Panic has remained busier than ever.

Beyond the physical symptoms associated with COVID-19, the psychological outcomes are vast and, it seems, prolonged. Researchers have now formalized a definition of the long-term mental maladies associated with the pandemic, collectively deeming them “coronaphobia.”

The term is a catch-all phrase for the fear and the emotional and social strain experienced by the general public in response to COVID-19. Obsessive behaviors, distress, avoidance reaction, panic, anxiety, hoarding, paranoia, and depression are some of the responses associated with coronaphobia. On the surface, these appear to be normal, somewhat fitting reactions to this surreal and frightening moment in time. However, for those experiencing coronaphobia, they are distinctly maladaptive and harmful.

“We had a serious rise in the use of our services, notably the helpline and email enquiries,” explained Sarah Floyd, No Panic’s volunteer advisor and social media coordinator. “It has been up and down all along, but more of an up since lockdown is easing.”

The group’s experience offers yet more evidence that the anxieties and fears caused by this global pandemic don’t flatten alongside the curve but instead linger as chronic problems requiring ongoing care.

“Every week in my clinic, I’m seeing people who are experiencing more anxiety and hopelessness and having an emotional response that is perhaps out of proportion to what one would expect, which is directly related to what is going on in the world right now with coronavirus,” said Gregory Scott Brown, MD, founder and director of the Center for Green Psychiatry in West Lake Hills, Tex. “Simply put, I think what we are looking at is adjustment disorder. That is probably how the DSM would define it.”

Adjustment disorder is one of the most frequently diagnosed mental health conditions, although it is also relatively understudied. It is really a set of disorders that follow in the wake of a significant stressor, which can vary from serious illness or the death of a loved one to relocating or experiencing work problems. The resulting dysfunction and distress that the person experiences are considered out of proportion in duration or scale with what would normally be expected. Diagnosing an adjustment disorder is made difficult by the lack of a valid and reliable screening measure.

Recent literature suggests that coronaphobia may be likely to occur in those who feel vulnerable to disease, are predisposed to anxiety, or are intolerant of uncertainty. Preexisting mental health conditions can also be exacerbated by periods of quarantine, self-isolation, and lockdown, which can lead to panic attacks, chronophobia (fear of passing time), and suicidality.

Although imperfect comparisons, findings from earlier 21st century disease outbreaks, such as severe acute respiratory syndrome and the Ebola virus, signal that containment efforts themselves play a role in deteriorating mental health. A recent rapid review found that, in studies comparing persons who had previously undergone quarantines and those who had not, the former were significantly more likely to experience acute stress disorder, posttraumatic stress symptoms, and depression. Quarantine was found to result in long-term behavioral changes, such as avoiding crowds, among the general public and health care practitioners.

That tremendous psychological morbidity should accompany a global pandemic of this scale is not surprising, according to Amit Anand, MD, vice chair for research for the Center for Behavioral Health and director of the Mood and Emotional Disorders Across the Life Span program at the Cleveland Clinic.

“The technical definition of anxiety is an impending sense of doom, and I think all of us are living with that,” Dr. Anand said. “The basic question then becomes, what is normal and when does it become abnormal?”

He added that most classifications of psychiatric disorders are set during periods of relative stability, which the current moment is most certainly not.

“This is such an unusual situation, so I think it will depend on case-by-case basis, keeping the whole context in mind as whether the patient is thinking or behaving with an abnormal amount of anxiety,” Dr. Anand said.

Investigators are currently trying to give clinicians the tools to better make that determination. In the first scientific study of this clinical condition, Sherman Lee, MD, reported that five symptoms – dizziness, sleep disturbances, tonic immobility, appetite loss, and nausea/abdominal distress – were strong factors for distinguishing coronaphobia from otherwise normal concerns about COVID-19 that did not result in functional impairment. Dr. Lee and colleagues have since published further evidence that coronaphobia “is a unique predictor of psychological distress during the COVID-19 crisis.” They are working on validating a self-reported mental health screener for this condition.

Having the tools to identify patients struggling with coronaphobia may go some ways toward addressing another area of declining health. At the outset of the COVID-19 pandemic, there was a question as to whether doctors would be beset by a surge of the “worried well” – persons mistakenly believing themselves to be infected. Now months into the pandemic, the converse phenomenon – a fear of contracting COVID-19 that is driving patients away from practitioners – appears to be the more valid concern.

In early spring, the pandemic’s first surge was accompanied by reports of approximately 40% and 60% drops in visits to EDs and ambulatory centers, respectively. Stories of acute stroke patients avoiding treatment began to appear in the press. Major U.S. cities saw noteworthy declines in 911 calls, indicating a hesitancy to be taken to a hospital. That COVID-19 has been accompanied by mass unemployment and subsequent loss of insurance complicates the notion that fear alone is keeping people from treatment. In other countries, it has been explicitly linked. Investigators in Singapore noted that coronaphobia played a role in reducing willingness to attend in-person visits among adolescents with eating disorders. Similarly, case reports in Israel suggest that coronaphobia has contributed to delays in diagnoses of common pediatric diseases.

There is also a concern, colloquially termed “reentry anxiety,” that mental health problems caused by the pandemic, the accompanying lockdown, self-isolation, and quarantine practices will prove alarmingly durable. Even after this challenging moment in history draws to a close, many people may face substantial stress in returning to the normal activities of life – social, professional, familial – once taken for granted.

“We are in the beginning phase of that now,” said Dr. Anand. “Lots of people are decompensating, getting depressed, and needing treatment. I think the longer it goes on for, the more difficult it will be.”

In the United States, that day may seem far away. Nonetheless, it is important to begin laying the therapeutic groundwork now, according to Dr. Brown.

“I am recommending unconventional therapies like meet-up groups, online forums,” he said. “Everything has shifted online, and so there are a lot of support groups that patients can participate to learn coping skills and really hear what other people are going through.”

Before reaching that stage, Dr. Brown recommends that clinicians first simply discuss such anxieties with their patients in order to normalize them.

“Realize that everyone essentially is going through some degree of this right now. The coronavirus pandemic is literally impacting every person on the face of the planet. Sometimes just pointing that out to people can really help,” he said.

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

During normal times, the U.K.-based charity No Panic offers itself as an easily accessible service to those with anxiety disorders and phobias. Visitors to the website who can receive immediate, remote support from trained volunteers. But this spring was anything but normal, as the reality of COVID-19’s worldwide spread became terrifyingly clear.

COVID-19 cases peaked in the United Kingdom in early April. Nationwide lockdown efforts contributed to a gradual but ultimately substantial decline in cases, yet, despite the favorable trend lines, No Panic has remained busier than ever.

Beyond the physical symptoms associated with COVID-19, the psychological outcomes are vast and, it seems, prolonged. Researchers have now formalized a definition of the long-term mental maladies associated with the pandemic, collectively deeming them “coronaphobia.”

The term is a catch-all phrase for the fear and the emotional and social strain experienced by the general public in response to COVID-19. Obsessive behaviors, distress, avoidance reaction, panic, anxiety, hoarding, paranoia, and depression are some of the responses associated with coronaphobia. On the surface, these appear to be normal, somewhat fitting reactions to this surreal and frightening moment in time. However, for those experiencing coronaphobia, they are distinctly maladaptive and harmful.

“We had a serious rise in the use of our services, notably the helpline and email enquiries,” explained Sarah Floyd, No Panic’s volunteer advisor and social media coordinator. “It has been up and down all along, but more of an up since lockdown is easing.”

The group’s experience offers yet more evidence that the anxieties and fears caused by this global pandemic don’t flatten alongside the curve but instead linger as chronic problems requiring ongoing care.

“Every week in my clinic, I’m seeing people who are experiencing more anxiety and hopelessness and having an emotional response that is perhaps out of proportion to what one would expect, which is directly related to what is going on in the world right now with coronavirus,” said Gregory Scott Brown, MD, founder and director of the Center for Green Psychiatry in West Lake Hills, Tex. “Simply put, I think what we are looking at is adjustment disorder. That is probably how the DSM would define it.”

Adjustment disorder is one of the most frequently diagnosed mental health conditions, although it is also relatively understudied. It is really a set of disorders that follow in the wake of a significant stressor, which can vary from serious illness or the death of a loved one to relocating or experiencing work problems. The resulting dysfunction and distress that the person experiences are considered out of proportion in duration or scale with what would normally be expected. Diagnosing an adjustment disorder is made difficult by the lack of a valid and reliable screening measure.

Recent literature suggests that coronaphobia may be likely to occur in those who feel vulnerable to disease, are predisposed to anxiety, or are intolerant of uncertainty. Preexisting mental health conditions can also be exacerbated by periods of quarantine, self-isolation, and lockdown, which can lead to panic attacks, chronophobia (fear of passing time), and suicidality.

Although imperfect comparisons, findings from earlier 21st century disease outbreaks, such as severe acute respiratory syndrome and the Ebola virus, signal that containment efforts themselves play a role in deteriorating mental health. A recent rapid review found that, in studies comparing persons who had previously undergone quarantines and those who had not, the former were significantly more likely to experience acute stress disorder, posttraumatic stress symptoms, and depression. Quarantine was found to result in long-term behavioral changes, such as avoiding crowds, among the general public and health care practitioners.

That tremendous psychological morbidity should accompany a global pandemic of this scale is not surprising, according to Amit Anand, MD, vice chair for research for the Center for Behavioral Health and director of the Mood and Emotional Disorders Across the Life Span program at the Cleveland Clinic.

“The technical definition of anxiety is an impending sense of doom, and I think all of us are living with that,” Dr. Anand said. “The basic question then becomes, what is normal and when does it become abnormal?”

He added that most classifications of psychiatric disorders are set during periods of relative stability, which the current moment is most certainly not.

“This is such an unusual situation, so I think it will depend on case-by-case basis, keeping the whole context in mind as whether the patient is thinking or behaving with an abnormal amount of anxiety,” Dr. Anand said.

Investigators are currently trying to give clinicians the tools to better make that determination. In the first scientific study of this clinical condition, Sherman Lee, MD, reported that five symptoms – dizziness, sleep disturbances, tonic immobility, appetite loss, and nausea/abdominal distress – were strong factors for distinguishing coronaphobia from otherwise normal concerns about COVID-19 that did not result in functional impairment. Dr. Lee and colleagues have since published further evidence that coronaphobia “is a unique predictor of psychological distress during the COVID-19 crisis.” They are working on validating a self-reported mental health screener for this condition.

Having the tools to identify patients struggling with coronaphobia may go some ways toward addressing another area of declining health. At the outset of the COVID-19 pandemic, there was a question as to whether doctors would be beset by a surge of the “worried well” – persons mistakenly believing themselves to be infected. Now months into the pandemic, the converse phenomenon – a fear of contracting COVID-19 that is driving patients away from practitioners – appears to be the more valid concern.

In early spring, the pandemic’s first surge was accompanied by reports of approximately 40% and 60% drops in visits to EDs and ambulatory centers, respectively. Stories of acute stroke patients avoiding treatment began to appear in the press. Major U.S. cities saw noteworthy declines in 911 calls, indicating a hesitancy to be taken to a hospital. That COVID-19 has been accompanied by mass unemployment and subsequent loss of insurance complicates the notion that fear alone is keeping people from treatment. In other countries, it has been explicitly linked. Investigators in Singapore noted that coronaphobia played a role in reducing willingness to attend in-person visits among adolescents with eating disorders. Similarly, case reports in Israel suggest that coronaphobia has contributed to delays in diagnoses of common pediatric diseases.

There is also a concern, colloquially termed “reentry anxiety,” that mental health problems caused by the pandemic, the accompanying lockdown, self-isolation, and quarantine practices will prove alarmingly durable. Even after this challenging moment in history draws to a close, many people may face substantial stress in returning to the normal activities of life – social, professional, familial – once taken for granted.

“We are in the beginning phase of that now,” said Dr. Anand. “Lots of people are decompensating, getting depressed, and needing treatment. I think the longer it goes on for, the more difficult it will be.”

In the United States, that day may seem far away. Nonetheless, it is important to begin laying the therapeutic groundwork now, according to Dr. Brown.

“I am recommending unconventional therapies like meet-up groups, online forums,” he said. “Everything has shifted online, and so there are a lot of support groups that patients can participate to learn coping skills and really hear what other people are going through.”

Before reaching that stage, Dr. Brown recommends that clinicians first simply discuss such anxieties with their patients in order to normalize them.

“Realize that everyone essentially is going through some degree of this right now. The coronavirus pandemic is literally impacting every person on the face of the planet. Sometimes just pointing that out to people can really help,” he said.

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

During normal times, the U.K.-based charity No Panic offers itself as an easily accessible service to those with anxiety disorders and phobias. Visitors to the website who can receive immediate, remote support from trained volunteers. But this spring was anything but normal, as the reality of COVID-19’s worldwide spread became terrifyingly clear.

COVID-19 cases peaked in the United Kingdom in early April. Nationwide lockdown efforts contributed to a gradual but ultimately substantial decline in cases, yet, despite the favorable trend lines, No Panic has remained busier than ever.

Beyond the physical symptoms associated with COVID-19, the psychological outcomes are vast and, it seems, prolonged. Researchers have now formalized a definition of the long-term mental maladies associated with the pandemic, collectively deeming them “coronaphobia.”

The term is a catch-all phrase for the fear and the emotional and social strain experienced by the general public in response to COVID-19. Obsessive behaviors, distress, avoidance reaction, panic, anxiety, hoarding, paranoia, and depression are some of the responses associated with coronaphobia. On the surface, these appear to be normal, somewhat fitting reactions to this surreal and frightening moment in time. However, for those experiencing coronaphobia, they are distinctly maladaptive and harmful.

“We had a serious rise in the use of our services, notably the helpline and email enquiries,” explained Sarah Floyd, No Panic’s volunteer advisor and social media coordinator. “It has been up and down all along, but more of an up since lockdown is easing.”

The group’s experience offers yet more evidence that the anxieties and fears caused by this global pandemic don’t flatten alongside the curve but instead linger as chronic problems requiring ongoing care.

“Every week in my clinic, I’m seeing people who are experiencing more anxiety and hopelessness and having an emotional response that is perhaps out of proportion to what one would expect, which is directly related to what is going on in the world right now with coronavirus,” said Gregory Scott Brown, MD, founder and director of the Center for Green Psychiatry in West Lake Hills, Tex. “Simply put, I think what we are looking at is adjustment disorder. That is probably how the DSM would define it.”

Adjustment disorder is one of the most frequently diagnosed mental health conditions, although it is also relatively understudied. It is really a set of disorders that follow in the wake of a significant stressor, which can vary from serious illness or the death of a loved one to relocating or experiencing work problems. The resulting dysfunction and distress that the person experiences are considered out of proportion in duration or scale with what would normally be expected. Diagnosing an adjustment disorder is made difficult by the lack of a valid and reliable screening measure.

Recent literature suggests that coronaphobia may be likely to occur in those who feel vulnerable to disease, are predisposed to anxiety, or are intolerant of uncertainty. Preexisting mental health conditions can also be exacerbated by periods of quarantine, self-isolation, and lockdown, which can lead to panic attacks, chronophobia (fear of passing time), and suicidality.

Although imperfect comparisons, findings from earlier 21st century disease outbreaks, such as severe acute respiratory syndrome and the Ebola virus, signal that containment efforts themselves play a role in deteriorating mental health. A recent rapid review found that, in studies comparing persons who had previously undergone quarantines and those who had not, the former were significantly more likely to experience acute stress disorder, posttraumatic stress symptoms, and depression. Quarantine was found to result in long-term behavioral changes, such as avoiding crowds, among the general public and health care practitioners.

That tremendous psychological morbidity should accompany a global pandemic of this scale is not surprising, according to Amit Anand, MD, vice chair for research for the Center for Behavioral Health and director of the Mood and Emotional Disorders Across the Life Span program at the Cleveland Clinic.

“The technical definition of anxiety is an impending sense of doom, and I think all of us are living with that,” Dr. Anand said. “The basic question then becomes, what is normal and when does it become abnormal?”

He added that most classifications of psychiatric disorders are set during periods of relative stability, which the current moment is most certainly not.

“This is such an unusual situation, so I think it will depend on case-by-case basis, keeping the whole context in mind as whether the patient is thinking or behaving with an abnormal amount of anxiety,” Dr. Anand said.

Investigators are currently trying to give clinicians the tools to better make that determination. In the first scientific study of this clinical condition, Sherman Lee, MD, reported that five symptoms – dizziness, sleep disturbances, tonic immobility, appetite loss, and nausea/abdominal distress – were strong factors for distinguishing coronaphobia from otherwise normal concerns about COVID-19 that did not result in functional impairment. Dr. Lee and colleagues have since published further evidence that coronaphobia “is a unique predictor of psychological distress during the COVID-19 crisis.” They are working on validating a self-reported mental health screener for this condition.

Having the tools to identify patients struggling with coronaphobia may go some ways toward addressing another area of declining health. At the outset of the COVID-19 pandemic, there was a question as to whether doctors would be beset by a surge of the “worried well” – persons mistakenly believing themselves to be infected. Now months into the pandemic, the converse phenomenon – a fear of contracting COVID-19 that is driving patients away from practitioners – appears to be the more valid concern.

In early spring, the pandemic’s first surge was accompanied by reports of approximately 40% and 60% drops in visits to EDs and ambulatory centers, respectively. Stories of acute stroke patients avoiding treatment began to appear in the press. Major U.S. cities saw noteworthy declines in 911 calls, indicating a hesitancy to be taken to a hospital. That COVID-19 has been accompanied by mass unemployment and subsequent loss of insurance complicates the notion that fear alone is keeping people from treatment. In other countries, it has been explicitly linked. Investigators in Singapore noted that coronaphobia played a role in reducing willingness to attend in-person visits among adolescents with eating disorders. Similarly, case reports in Israel suggest that coronaphobia has contributed to delays in diagnoses of common pediatric diseases.

There is also a concern, colloquially termed “reentry anxiety,” that mental health problems caused by the pandemic, the accompanying lockdown, self-isolation, and quarantine practices will prove alarmingly durable. Even after this challenging moment in history draws to a close, many people may face substantial stress in returning to the normal activities of life – social, professional, familial – once taken for granted.

“We are in the beginning phase of that now,” said Dr. Anand. “Lots of people are decompensating, getting depressed, and needing treatment. I think the longer it goes on for, the more difficult it will be.”

In the United States, that day may seem far away. Nonetheless, it is important to begin laying the therapeutic groundwork now, according to Dr. Brown.

“I am recommending unconventional therapies like meet-up groups, online forums,” he said. “Everything has shifted online, and so there are a lot of support groups that patients can participate to learn coping skills and really hear what other people are going through.”

Before reaching that stage, Dr. Brown recommends that clinicians first simply discuss such anxieties with their patients in order to normalize them.

“Realize that everyone essentially is going through some degree of this right now. The coronavirus pandemic is literally impacting every person on the face of the planet. Sometimes just pointing that out to people can really help,” he said.

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

Americans sharply increased their alcohol intake last spring as many areas of the country shutdown because of the coronavirus pandemic, results of a national survey show.

Thinkstockphotos.com

The overall frequency of alcohol consumption increased by 14% among adults over age 30 in the spring of 2020 versus the same period a year earlier.

The increase was most evident in adults aged 30-59, women, and non-Hispanic Whites.

“Alcohol consumption can have significant negative health consequences, so this information suggests another way that the pandemic may be affecting the physical and mental health of Americans,” Michael Pollard, PhD, lead investigator and sociologist at Rand, said in a news release.

The results were published online as a research letter Sept. 29 in JAMA Network Open.

Booming business

After some U.S. states issued stay-at-home orders to fight the spread of SARS-CoV-2, one study noted a 54% increase in national sales of alcohol for the week ending March 21, 2020, relative to 1 year earlier and a 262% increase in online alcohol sales.

“We’ve had anecdotal information about people buying and consuming more alcohol,” Dr. Pollard said, but the Rand study provides the first survey-based information that shows how much alcohol consumption has increased during the pandemic.

The findings are based on 1,540 adults (mean age, 56.6 years; 57% women) from the Rand American Life Panel, a nationally representative sample of Americans who were surveyed about their alcohol consumption before the pandemic in the spring of 2019, and again in the spring of 2020 during the early months of the shutdown.

Overall, in spring 2020, respondents reported drinking alcohol 6.22 days in the prior month on average, a 14% increase from the monthly average of 5.48 days reported in spring 2019.

Among adults aged 30 to 59 years, the frequency of alcohol consumption increased from 4.98 days prepandemic to 5.91 days during the pandemic, a 19% increase.

Women reported drinking an average of 5.36 days in the prior month in the early pandemic period, a 17% increase from 4.58 monthly drinking days before the pandemic. 

In addition, compared with spring 2019, in spring 2020 women reported a 41% increase in heavy drinking days – four or more drinks in a couple of hours.

Independent of consumption level, nearly 1 in 10 women had an increase in alcohol-related problems in the pandemic period, based on responses to the Short Inventory of Problems scale.

For non-Hispanic White individuals, the overall frequency of alcohol intake rose 10% during the early pandemic period. 

“The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,” write Dr. Pollard and colleagues.

The authors note it will be important to determine whether increases in alcohol use persist as the pandemic continues, and whether psychological and physical well-being are subsequently affected.

The study was supported by the National Institute of Alcohol Abuse and Alcoholism. The authors have reported no relevant financial relationships.

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

Americans sharply increased their alcohol intake last spring as many areas of the country shutdown because of the coronavirus pandemic, results of a national survey show.

Thinkstockphotos.com

The overall frequency of alcohol consumption increased by 14% among adults over age 30 in the spring of 2020 versus the same period a year earlier.

The increase was most evident in adults aged 30-59, women, and non-Hispanic Whites.

“Alcohol consumption can have significant negative health consequences, so this information suggests another way that the pandemic may be affecting the physical and mental health of Americans,” Michael Pollard, PhD, lead investigator and sociologist at Rand, said in a news release.

The results were published online as a research letter Sept. 29 in JAMA Network Open.

Booming business

After some U.S. states issued stay-at-home orders to fight the spread of SARS-CoV-2, one study noted a 54% increase in national sales of alcohol for the week ending March 21, 2020, relative to 1 year earlier and a 262% increase in online alcohol sales.

“We’ve had anecdotal information about people buying and consuming more alcohol,” Dr. Pollard said, but the Rand study provides the first survey-based information that shows how much alcohol consumption has increased during the pandemic.

The findings are based on 1,540 adults (mean age, 56.6 years; 57% women) from the Rand American Life Panel, a nationally representative sample of Americans who were surveyed about their alcohol consumption before the pandemic in the spring of 2019, and again in the spring of 2020 during the early months of the shutdown.

Overall, in spring 2020, respondents reported drinking alcohol 6.22 days in the prior month on average, a 14% increase from the monthly average of 5.48 days reported in spring 2019.

Among adults aged 30 to 59 years, the frequency of alcohol consumption increased from 4.98 days prepandemic to 5.91 days during the pandemic, a 19% increase.

Women reported drinking an average of 5.36 days in the prior month in the early pandemic period, a 17% increase from 4.58 monthly drinking days before the pandemic. 

In addition, compared with spring 2019, in spring 2020 women reported a 41% increase in heavy drinking days – four or more drinks in a couple of hours.

Independent of consumption level, nearly 1 in 10 women had an increase in alcohol-related problems in the pandemic period, based on responses to the Short Inventory of Problems scale.

For non-Hispanic White individuals, the overall frequency of alcohol intake rose 10% during the early pandemic period. 

“The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,” write Dr. Pollard and colleagues.

The authors note it will be important to determine whether increases in alcohol use persist as the pandemic continues, and whether psychological and physical well-being are subsequently affected.

The study was supported by the National Institute of Alcohol Abuse and Alcoholism. The authors have reported no relevant financial relationships.

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

Americans sharply increased their alcohol intake last spring as many areas of the country shutdown because of the coronavirus pandemic, results of a national survey show.

Thinkstockphotos.com

The overall frequency of alcohol consumption increased by 14% among adults over age 30 in the spring of 2020 versus the same period a year earlier.

The increase was most evident in adults aged 30-59, women, and non-Hispanic Whites.

“Alcohol consumption can have significant negative health consequences, so this information suggests another way that the pandemic may be affecting the physical and mental health of Americans,” Michael Pollard, PhD, lead investigator and sociologist at Rand, said in a news release.

The results were published online as a research letter Sept. 29 in JAMA Network Open.

Booming business

After some U.S. states issued stay-at-home orders to fight the spread of SARS-CoV-2, one study noted a 54% increase in national sales of alcohol for the week ending March 21, 2020, relative to 1 year earlier and a 262% increase in online alcohol sales.

“We’ve had anecdotal information about people buying and consuming more alcohol,” Dr. Pollard said, but the Rand study provides the first survey-based information that shows how much alcohol consumption has increased during the pandemic.

The findings are based on 1,540 adults (mean age, 56.6 years; 57% women) from the Rand American Life Panel, a nationally representative sample of Americans who were surveyed about their alcohol consumption before the pandemic in the spring of 2019, and again in the spring of 2020 during the early months of the shutdown.

Overall, in spring 2020, respondents reported drinking alcohol 6.22 days in the prior month on average, a 14% increase from the monthly average of 5.48 days reported in spring 2019.

Among adults aged 30 to 59 years, the frequency of alcohol consumption increased from 4.98 days prepandemic to 5.91 days during the pandemic, a 19% increase.

Women reported drinking an average of 5.36 days in the prior month in the early pandemic period, a 17% increase from 4.58 monthly drinking days before the pandemic. 

In addition, compared with spring 2019, in spring 2020 women reported a 41% increase in heavy drinking days – four or more drinks in a couple of hours.

Independent of consumption level, nearly 1 in 10 women had an increase in alcohol-related problems in the pandemic period, based on responses to the Short Inventory of Problems scale.

For non-Hispanic White individuals, the overall frequency of alcohol intake rose 10% during the early pandemic period. 

“The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,” write Dr. Pollard and colleagues.

The authors note it will be important to determine whether increases in alcohol use persist as the pandemic continues, and whether psychological and physical well-being are subsequently affected.

The study was supported by the National Institute of Alcohol Abuse and Alcoholism. The authors have reported no relevant financial relationships.

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

The cumulative percentage of COVID-19 cases reported in children continues to climb, but “the history behind that cumulative number shows substantial change,” according to a new analysis of state health department data.

As of Sept. 10, the 549,432 cases in children represented 10.0% of all reported COVID-19 cases in the United States following a substantial rise over the course of the pandemic – the figure was 7.7% on July 16 and 3.2% on May 7, Blake Sisk, PhD, of the American Academy of Pediatrics and associates reported Sept. 29 in Pediatrics.

Unlike the cumulative number, the weekly proportion of cases in children fell early in the summer but then started climbing again in late July. “In the last 8 weeks, children represented between 12%-15.9% of new weekly reported cases,” Dr. Sisk and associates wrote.

Despite the increase, however, the proportion of pediatric COVID-19 cases is still well below children’s share of the overall population (22.6%). Also, “it is unclear how much of the increase in child cases is due to increased testing capacity, although CDC data from public and commercial laboratories show the share of all tests administered to children ages 0-17 has remained stable at 5%-7% since late April,” they said.

Data for the current report were drawn from 49 state health department websites (New York state does not report ages for COVID-19 cases), along with New York City, the District of Columbia, Puerto Rico, and Guam. Alabama changed its definition of a child case in August and was not included in the trend analysis (see graph), the investigators explained.

Those data show “substantial variation in case growth by region: in April, a preponderance of cases was in the Northeast. In June, cases surged in the South and West, followed by mid-July increases in the Midwest,” Dr. Sisk and associates said.

The increase among children in Midwest states is ongoing with the number of new cases reaching its highest level yet during the week ending Sept. 10, they reported.

rfranki@mdedge.com

SOURCE: Sisk B et al. Pediatrics. 2020 Sep 29. doi: 10.1542/peds.2020-027425.

The cumulative percentage of COVID-19 cases reported in children continues to climb, but “the history behind that cumulative number shows substantial change,” according to a new analysis of state health department data.

As of Sept. 10, the 549,432 cases in children represented 10.0% of all reported COVID-19 cases in the United States following a substantial rise over the course of the pandemic – the figure was 7.7% on July 16 and 3.2% on May 7, Blake Sisk, PhD, of the American Academy of Pediatrics and associates reported Sept. 29 in Pediatrics.

Unlike the cumulative number, the weekly proportion of cases in children fell early in the summer but then started climbing again in late July. “In the last 8 weeks, children represented between 12%-15.9% of new weekly reported cases,” Dr. Sisk and associates wrote.

Despite the increase, however, the proportion of pediatric COVID-19 cases is still well below children’s share of the overall population (22.6%). Also, “it is unclear how much of the increase in child cases is due to increased testing capacity, although CDC data from public and commercial laboratories show the share of all tests administered to children ages 0-17 has remained stable at 5%-7% since late April,” they said.

Data for the current report were drawn from 49 state health department websites (New York state does not report ages for COVID-19 cases), along with New York City, the District of Columbia, Puerto Rico, and Guam. Alabama changed its definition of a child case in August and was not included in the trend analysis (see graph), the investigators explained.

Those data show “substantial variation in case growth by region: in April, a preponderance of cases was in the Northeast. In June, cases surged in the South and West, followed by mid-July increases in the Midwest,” Dr. Sisk and associates said.

The increase among children in Midwest states is ongoing with the number of new cases reaching its highest level yet during the week ending Sept. 10, they reported.

rfranki@mdedge.com

SOURCE: Sisk B et al. Pediatrics. 2020 Sep 29. doi: 10.1542/peds.2020-027425.

The cumulative percentage of COVID-19 cases reported in children continues to climb, but “the history behind that cumulative number shows substantial change,” according to a new analysis of state health department data.

As of Sept. 10, the 549,432 cases in children represented 10.0% of all reported COVID-19 cases in the United States following a substantial rise over the course of the pandemic – the figure was 7.7% on July 16 and 3.2% on May 7, Blake Sisk, PhD, of the American Academy of Pediatrics and associates reported Sept. 29 in Pediatrics.

Unlike the cumulative number, the weekly proportion of cases in children fell early in the summer but then started climbing again in late July. “In the last 8 weeks, children represented between 12%-15.9% of new weekly reported cases,” Dr. Sisk and associates wrote.

Despite the increase, however, the proportion of pediatric COVID-19 cases is still well below children’s share of the overall population (22.6%). Also, “it is unclear how much of the increase in child cases is due to increased testing capacity, although CDC data from public and commercial laboratories show the share of all tests administered to children ages 0-17 has remained stable at 5%-7% since late April,” they said.

Data for the current report were drawn from 49 state health department websites (New York state does not report ages for COVID-19 cases), along with New York City, the District of Columbia, Puerto Rico, and Guam. Alabama changed its definition of a child case in August and was not included in the trend analysis (see graph), the investigators explained.

Those data show “substantial variation in case growth by region: in April, a preponderance of cases was in the Northeast. In June, cases surged in the South and West, followed by mid-July increases in the Midwest,” Dr. Sisk and associates said.

The increase among children in Midwest states is ongoing with the number of new cases reaching its highest level yet during the week ending Sept. 10, they reported.

rfranki@mdedge.com

SOURCE: Sisk B et al. Pediatrics. 2020 Sep 29. doi: 10.1542/peds.2020-027425.

Johnson & Johnson (J&J) on Wednesday said it advanced into phase 3 testing of its COVID-19 vaccine candidate, which uses the same technology as an Ebola vaccine already approved by European regulators.

The National Institute of Allergy and Infectious Diseases, which is aiding Johnson & Johnson with development, described this in a news release as the fourth phase 3 clinical trial of evaluating an investigational vaccine for coronavirus disease.

This NIAID tally tracks products likely to be presented soon for Food and Drug Administration approval. (The World Health Organization’s COVID vaccine tracker lists nine candidates as having reached this stage, including products developed in Russia and China.)

As many as 60,000 volunteers will be enrolled in the trial, with about 215 clinical research sites expected to participate, NIAID said. The vaccine will be tested in the United States and abroad.

The start of this test, known as the ENSEMBLE trial, follows positive results from a Phase 1/2a clinical study, which involved a single vaccination. The results of this study have been submitted to medRxiv and are set to be published online imminently.

New Brunswick, N.J–based J&J said it intends to offer the vaccine on “a not-for-profit basis for emergency pandemic use.” If testing proceeds well, J&J might seek an emergency use clearance for the vaccine, which could possibly allow the first batches to be made available in early 2021.

J&J’s vaccine is unusual in that it will be tested based on a single dose, while other advanced candidates have been tested in two-dose regimens.

J&J on Wednesday also released the study protocol for its phase 3 test. The developers of the other late-stage COVID vaccine candidates also have done this, as reported by Medscape Medical News. Because of the great interest in the COVID vaccine, the American Medical Association had last month asked the FDA to keep physicians informed of their COVID-19 vaccine review process.
 

Trials and tribulations

One of these experimental COVID vaccines already has had a setback in phase 3 testing, which is a fairly routine occurrence in drug development. But with a pandemic still causing deaths and disrupting lives around the world, there has been intense interest in each step of the effort to develop a COVID vaccine.

AstraZeneca PLC earlier this month announced a temporary cessation of all their coronavirus vaccine trials to investigate an “unexplained illness” that arose in a participant, as reported by Medscape Medical News.

On September 12, AstraZeneca announced that clinical trials for the AZD1222, which it developed with Oxford University, had resumed in the United Kingdom. On Wednesday, CNBC said Health and Human Services Secretary Alex Azar told the news station that AstraZeneca’s late-stage coronavirus vaccine trial in the United States remains on hold until safety concerns are resolved, a critical issue with all the fast-track COVID vaccines now being tested.

“Look at the AstraZeneca program, phase 3 clinical trial, a lot of hope. [A] single serious adverse event report in the United Kingdom, global shutdown, and [a] hold of the clinical trials,” Mr. Azar told CNBC.

The New York Times has reported on concerns stemming from serious neurologic illnesses in two participants, both women, who received AstraZeneca’s experimental vaccine in Britain.

The Senate Health, Education, Labor and Pensions Committee on Wednesday separately held a hearing with the leaders of the FDA and the Centers of Disease Control and Prevention, allowing an airing of lawmakers’ concerns about a potential rush to approve a COVID vaccine.
 

Details of J&J trial

The J&J trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also is designed to examine whether the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection, NIAID said.

Principal investigators for the phase 3 trial of the J & J vaccine are Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, MD, PhD, director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh, president and chief executive officer of the South African Medical Research Council and coprincipal investigator of the HIV Vaccine Trials Network.

This article first appeared on Medscape.com.

Johnson & Johnson (J&J) on Wednesday said it advanced into phase 3 testing of its COVID-19 vaccine candidate, which uses the same technology as an Ebola vaccine already approved by European regulators.

The National Institute of Allergy and Infectious Diseases, which is aiding Johnson & Johnson with development, described this in a news release as the fourth phase 3 clinical trial of evaluating an investigational vaccine for coronavirus disease.

This NIAID tally tracks products likely to be presented soon for Food and Drug Administration approval. (The World Health Organization’s COVID vaccine tracker lists nine candidates as having reached this stage, including products developed in Russia and China.)

As many as 60,000 volunteers will be enrolled in the trial, with about 215 clinical research sites expected to participate, NIAID said. The vaccine will be tested in the United States and abroad.

The start of this test, known as the ENSEMBLE trial, follows positive results from a Phase 1/2a clinical study, which involved a single vaccination. The results of this study have been submitted to medRxiv and are set to be published online imminently.

New Brunswick, N.J–based J&J said it intends to offer the vaccine on “a not-for-profit basis for emergency pandemic use.” If testing proceeds well, J&J might seek an emergency use clearance for the vaccine, which could possibly allow the first batches to be made available in early 2021.

J&J’s vaccine is unusual in that it will be tested based on a single dose, while other advanced candidates have been tested in two-dose regimens.

J&J on Wednesday also released the study protocol for its phase 3 test. The developers of the other late-stage COVID vaccine candidates also have done this, as reported by Medscape Medical News. Because of the great interest in the COVID vaccine, the American Medical Association had last month asked the FDA to keep physicians informed of their COVID-19 vaccine review process.
 

Trials and tribulations

One of these experimental COVID vaccines already has had a setback in phase 3 testing, which is a fairly routine occurrence in drug development. But with a pandemic still causing deaths and disrupting lives around the world, there has been intense interest in each step of the effort to develop a COVID vaccine.

AstraZeneca PLC earlier this month announced a temporary cessation of all their coronavirus vaccine trials to investigate an “unexplained illness” that arose in a participant, as reported by Medscape Medical News.

On September 12, AstraZeneca announced that clinical trials for the AZD1222, which it developed with Oxford University, had resumed in the United Kingdom. On Wednesday, CNBC said Health and Human Services Secretary Alex Azar told the news station that AstraZeneca’s late-stage coronavirus vaccine trial in the United States remains on hold until safety concerns are resolved, a critical issue with all the fast-track COVID vaccines now being tested.

“Look at the AstraZeneca program, phase 3 clinical trial, a lot of hope. [A] single serious adverse event report in the United Kingdom, global shutdown, and [a] hold of the clinical trials,” Mr. Azar told CNBC.

The New York Times has reported on concerns stemming from serious neurologic illnesses in two participants, both women, who received AstraZeneca’s experimental vaccine in Britain.

The Senate Health, Education, Labor and Pensions Committee on Wednesday separately held a hearing with the leaders of the FDA and the Centers of Disease Control and Prevention, allowing an airing of lawmakers’ concerns about a potential rush to approve a COVID vaccine.
 

Details of J&J trial

The J&J trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also is designed to examine whether the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection, NIAID said.

Principal investigators for the phase 3 trial of the J & J vaccine are Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, MD, PhD, director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh, president and chief executive officer of the South African Medical Research Council and coprincipal investigator of the HIV Vaccine Trials Network.

This article first appeared on Medscape.com.

Johnson & Johnson (J&J) on Wednesday said it advanced into phase 3 testing of its COVID-19 vaccine candidate, which uses the same technology as an Ebola vaccine already approved by European regulators.

The National Institute of Allergy and Infectious Diseases, which is aiding Johnson & Johnson with development, described this in a news release as the fourth phase 3 clinical trial of evaluating an investigational vaccine for coronavirus disease.

This NIAID tally tracks products likely to be presented soon for Food and Drug Administration approval. (The World Health Organization’s COVID vaccine tracker lists nine candidates as having reached this stage, including products developed in Russia and China.)

As many as 60,000 volunteers will be enrolled in the trial, with about 215 clinical research sites expected to participate, NIAID said. The vaccine will be tested in the United States and abroad.

The start of this test, known as the ENSEMBLE trial, follows positive results from a Phase 1/2a clinical study, which involved a single vaccination. The results of this study have been submitted to medRxiv and are set to be published online imminently.

New Brunswick, N.J–based J&J said it intends to offer the vaccine on “a not-for-profit basis for emergency pandemic use.” If testing proceeds well, J&J might seek an emergency use clearance for the vaccine, which could possibly allow the first batches to be made available in early 2021.

J&J’s vaccine is unusual in that it will be tested based on a single dose, while other advanced candidates have been tested in two-dose regimens.

J&J on Wednesday also released the study protocol for its phase 3 test. The developers of the other late-stage COVID vaccine candidates also have done this, as reported by Medscape Medical News. Because of the great interest in the COVID vaccine, the American Medical Association had last month asked the FDA to keep physicians informed of their COVID-19 vaccine review process.
 

Trials and tribulations

One of these experimental COVID vaccines already has had a setback in phase 3 testing, which is a fairly routine occurrence in drug development. But with a pandemic still causing deaths and disrupting lives around the world, there has been intense interest in each step of the effort to develop a COVID vaccine.

AstraZeneca PLC earlier this month announced a temporary cessation of all their coronavirus vaccine trials to investigate an “unexplained illness” that arose in a participant, as reported by Medscape Medical News.

On September 12, AstraZeneca announced that clinical trials for the AZD1222, which it developed with Oxford University, had resumed in the United Kingdom. On Wednesday, CNBC said Health and Human Services Secretary Alex Azar told the news station that AstraZeneca’s late-stage coronavirus vaccine trial in the United States remains on hold until safety concerns are resolved, a critical issue with all the fast-track COVID vaccines now being tested.

“Look at the AstraZeneca program, phase 3 clinical trial, a lot of hope. [A] single serious adverse event report in the United Kingdom, global shutdown, and [a] hold of the clinical trials,” Mr. Azar told CNBC.

The New York Times has reported on concerns stemming from serious neurologic illnesses in two participants, both women, who received AstraZeneca’s experimental vaccine in Britain.

The Senate Health, Education, Labor and Pensions Committee on Wednesday separately held a hearing with the leaders of the FDA and the Centers of Disease Control and Prevention, allowing an airing of lawmakers’ concerns about a potential rush to approve a COVID vaccine.
 

Details of J&J trial

The J&J trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also is designed to examine whether the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection, NIAID said.

Principal investigators for the phase 3 trial of the J & J vaccine are Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, MD, PhD, director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh, president and chief executive officer of the South African Medical Research Council and coprincipal investigator of the HIV Vaccine Trials Network.

This article first appeared on Medscape.com.

Rates of hepatocellular carcinoma (HCC) continue to rise in the United States, but unevenly so given how the incidence has become highest in the Hispanic population, which is reflected in increased rates in the southern and western states, Hashem B. El-Serag, MD, of Baylor College of Medicine, Houston, said in a virtual presentation at the annual Digestive Diseases: New Advances, which is jointly provided by Rutgers and Global Academy for Medical Education.

In addition to this demographic shift, the risk factors for HCC are shifting, he said. Hepatitis C virus (HCV) has been the dominant risk factor for HCC; for patients with active HCV, the factors historically associated with increased HCC risk have included alcohol consumption, obesity, diabetes, coinfection, and genetics, he said.

This pattern is starting to change. In fact, for patients with active HCV, antiviral treatment with a sustained virologic response has surfaced as the most significant risk factor in the development of HCC, said Dr. El-Serag: Among these patients, sustained virologic response from direct-acting antivirals is associated with a significant reduction in HCC risk. However, it is important to recognize that a residual risk of HCC remains that doesn’t go away for several years, he noted.

“Who are those people who got treated, got cured, and still developed HCC? Those with cirrhosis at the time of treatment,” he said. Those with cirrhosis have cumulative incidence of 1.8% per year, but those without cirrhosis had very low risk, he said.

Some good news in HCC is that rates appear to be declining among young men, and this is thought to be one of the groups who are achieving a cure of HCV, he said.

“One would hope, if goals for HCV elimination are met, that will translate into massive reduction of HCC,” he said.

“The issue now for hepatitis is finding infected patients and curing them,” he noted.

Dr. El-Serag touched on hepatitis B (HBV), which continues to be the driving force of hepatitis infections globally. However, in patients who receive and respond to antiviral treatment “there is a significant and considerable reduction in HCC in the context of hepatitis B” similar to that seen with hepatitis C. Vaccination programs for HBV have started to make the desired impact of reducing HCC in HBV-endemic areas, he noted.

However, current risk factors for HCC are related less to HCV and HBV and more to metabolic syndrome because more people are treated for HCV and HBV, Dr. El-Serag said. He went on to address the new dominant global risk factor for HCC: obesity. Based on data from multiple studies, those who are obese, defined as a body mass index greater than 30 kg/m², carry a twofold increased risk of developing HCC, he said.

To reduce this risk, treatment targets might address intermediate factors such as abdominal obesity, said Dr. El-Serag. He cited a study published in Hepatology in which individuals in the highest tertile for waist-hip ratio had a threefold higher risk of HCC, compared with those in the lowest tertile.

In addition, consideration of obesity must include type 2 diabetes, which is often linked to obesity and occurs in approximately one-third of adults in the United States, Dr. El-Serag said.

Treatment of type 2 diabetes may make a difference in HCC risk reduction, Dr. El-Serag noted. “The impact of treatment of diabetes on HCC risk is an area of intense interest,” he said. Based on the latest research, “the bottom line is that those treated with metformin experience a 50% reduction in the risk of HCC,” he said

Dr. El-Serag also acknowledged the impact of other risk factors for HCC: the use of statins and the presence of nonalcoholic fatty liver disease (NAFLD).

Dr. El-Serag noted that, among NAFLD patients, subgroups at even greater risk for HCC include those with diabetes, those older than 65 years, Hispanic race, and those with cirrhosis. These patients should be candidates for surveillance. Metabolic dysfunction traits such as obesity and diabetes are very common conditions, so it’s important to look at other, more specific factors, he added. “I hope that there will be tools to help clinicians classify or risk-stratify patients into different buckets,” he said.

Areas for further research on HCC continue to include risk stratification, mechanisms of action, and HCC prevention related to treatment of metabolic syndrome, he emphasized.

Dr. El-Serag had no financial conflicts to disclose. Global Academy for Medical Education and this news organization are owned by the same parent company.

*This story was updated on Oct. 28, 2020. 

SOURCE: El-Serag HB. Digestive Diseases: New Advances 2020.

Rates of hepatocellular carcinoma (HCC) continue to rise in the United States, but unevenly so given how the incidence has become highest in the Hispanic population, which is reflected in increased rates in the southern and western states, Hashem B. El-Serag, MD, of Baylor College of Medicine, Houston, said in a virtual presentation at the annual Digestive Diseases: New Advances, which is jointly provided by Rutgers and Global Academy for Medical Education.

In addition to this demographic shift, the risk factors for HCC are shifting, he said. Hepatitis C virus (HCV) has been the dominant risk factor for HCC; for patients with active HCV, the factors historically associated with increased HCC risk have included alcohol consumption, obesity, diabetes, coinfection, and genetics, he said.

This pattern is starting to change. In fact, for patients with active HCV, antiviral treatment with a sustained virologic response has surfaced as the most significant risk factor in the development of HCC, said Dr. El-Serag: Among these patients, sustained virologic response from direct-acting antivirals is associated with a significant reduction in HCC risk. However, it is important to recognize that a residual risk of HCC remains that doesn’t go away for several years, he noted.

“Who are those people who got treated, got cured, and still developed HCC? Those with cirrhosis at the time of treatment,” he said. Those with cirrhosis have cumulative incidence of 1.8% per year, but those without cirrhosis had very low risk, he said.

Some good news in HCC is that rates appear to be declining among young men, and this is thought to be one of the groups who are achieving a cure of HCV, he said.

“One would hope, if goals for HCV elimination are met, that will translate into massive reduction of HCC,” he said.

“The issue now for hepatitis is finding infected patients and curing them,” he noted.

Dr. El-Serag touched on hepatitis B (HBV), which continues to be the driving force of hepatitis infections globally. However, in patients who receive and respond to antiviral treatment “there is a significant and considerable reduction in HCC in the context of hepatitis B” similar to that seen with hepatitis C. Vaccination programs for HBV have started to make the desired impact of reducing HCC in HBV-endemic areas, he noted.

However, current risk factors for HCC are related less to HCV and HBV and more to metabolic syndrome because more people are treated for HCV and HBV, Dr. El-Serag said. He went on to address the new dominant global risk factor for HCC: obesity. Based on data from multiple studies, those who are obese, defined as a body mass index greater than 30 kg/m², carry a twofold increased risk of developing HCC, he said.

To reduce this risk, treatment targets might address intermediate factors such as abdominal obesity, said Dr. El-Serag. He cited a study published in Hepatology in which individuals in the highest tertile for waist-hip ratio had a threefold higher risk of HCC, compared with those in the lowest tertile.

In addition, consideration of obesity must include type 2 diabetes, which is often linked to obesity and occurs in approximately one-third of adults in the United States, Dr. El-Serag said.

Treatment of type 2 diabetes may make a difference in HCC risk reduction, Dr. El-Serag noted. “The impact of treatment of diabetes on HCC risk is an area of intense interest,” he said. Based on the latest research, “the bottom line is that those treated with metformin experience a 50% reduction in the risk of HCC,” he said

Dr. El-Serag also acknowledged the impact of other risk factors for HCC: the use of statins and the presence of nonalcoholic fatty liver disease (NAFLD).

Dr. El-Serag noted that, among NAFLD patients, subgroups at even greater risk for HCC include those with diabetes, those older than 65 years, Hispanic race, and those with cirrhosis. These patients should be candidates for surveillance. Metabolic dysfunction traits such as obesity and diabetes are very common conditions, so it’s important to look at other, more specific factors, he added. “I hope that there will be tools to help clinicians classify or risk-stratify patients into different buckets,” he said.

Areas for further research on HCC continue to include risk stratification, mechanisms of action, and HCC prevention related to treatment of metabolic syndrome, he emphasized.

Dr. El-Serag had no financial conflicts to disclose. Global Academy for Medical Education and this news organization are owned by the same parent company.

*This story was updated on Oct. 28, 2020. 

SOURCE: El-Serag HB. Digestive Diseases: New Advances 2020.

Rates of hepatocellular carcinoma (HCC) continue to rise in the United States, but unevenly so given how the incidence has become highest in the Hispanic population, which is reflected in increased rates in the southern and western states, Hashem B. El-Serag, MD, of Baylor College of Medicine, Houston, said in a virtual presentation at the annual Digestive Diseases: New Advances, which is jointly provided by Rutgers and Global Academy for Medical Education.

In addition to this demographic shift, the risk factors for HCC are shifting, he said. Hepatitis C virus (HCV) has been the dominant risk factor for HCC; for patients with active HCV, the factors historically associated with increased HCC risk have included alcohol consumption, obesity, diabetes, coinfection, and genetics, he said.

This pattern is starting to change. In fact, for patients with active HCV, antiviral treatment with a sustained virologic response has surfaced as the most significant risk factor in the development of HCC, said Dr. El-Serag: Among these patients, sustained virologic response from direct-acting antivirals is associated with a significant reduction in HCC risk. However, it is important to recognize that a residual risk of HCC remains that doesn’t go away for several years, he noted.

“Who are those people who got treated, got cured, and still developed HCC? Those with cirrhosis at the time of treatment,” he said. Those with cirrhosis have cumulative incidence of 1.8% per year, but those without cirrhosis had very low risk, he said.

Some good news in HCC is that rates appear to be declining among young men, and this is thought to be one of the groups who are achieving a cure of HCV, he said.

“One would hope, if goals for HCV elimination are met, that will translate into massive reduction of HCC,” he said.

“The issue now for hepatitis is finding infected patients and curing them,” he noted.

Dr. El-Serag touched on hepatitis B (HBV), which continues to be the driving force of hepatitis infections globally. However, in patients who receive and respond to antiviral treatment “there is a significant and considerable reduction in HCC in the context of hepatitis B” similar to that seen with hepatitis C. Vaccination programs for HBV have started to make the desired impact of reducing HCC in HBV-endemic areas, he noted.

However, current risk factors for HCC are related less to HCV and HBV and more to metabolic syndrome because more people are treated for HCV and HBV, Dr. El-Serag said. He went on to address the new dominant global risk factor for HCC: obesity. Based on data from multiple studies, those who are obese, defined as a body mass index greater than 30 kg/m², carry a twofold increased risk of developing HCC, he said.

To reduce this risk, treatment targets might address intermediate factors such as abdominal obesity, said Dr. El-Serag. He cited a study published in Hepatology in which individuals in the highest tertile for waist-hip ratio had a threefold higher risk of HCC, compared with those in the lowest tertile.

In addition, consideration of obesity must include type 2 diabetes, which is often linked to obesity and occurs in approximately one-third of adults in the United States, Dr. El-Serag said.

Treatment of type 2 diabetes may make a difference in HCC risk reduction, Dr. El-Serag noted. “The impact of treatment of diabetes on HCC risk is an area of intense interest,” he said. Based on the latest research, “the bottom line is that those treated with metformin experience a 50% reduction in the risk of HCC,” he said

Dr. El-Serag also acknowledged the impact of other risk factors for HCC: the use of statins and the presence of nonalcoholic fatty liver disease (NAFLD).

Dr. El-Serag noted that, among NAFLD patients, subgroups at even greater risk for HCC include those with diabetes, those older than 65 years, Hispanic race, and those with cirrhosis. These patients should be candidates for surveillance. Metabolic dysfunction traits such as obesity and diabetes are very common conditions, so it’s important to look at other, more specific factors, he added. “I hope that there will be tools to help clinicians classify or risk-stratify patients into different buckets,” he said.

Areas for further research on HCC continue to include risk stratification, mechanisms of action, and HCC prevention related to treatment of metabolic syndrome, he emphasized.

Dr. El-Serag had no financial conflicts to disclose. Global Academy for Medical Education and this news organization are owned by the same parent company.

*This story was updated on Oct. 28, 2020. 

SOURCE: El-Serag HB. Digestive Diseases: New Advances 2020.