Federal Practitioner

Editor in Chief of this news organization Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and professor of molecular medicine, has been closely following COVID-19 data since the pandemic began. He spoke with writer Miriam E. Tucker about the latest on SARS-CoV-2 variants and their impact on vaccine efficacy. The conversation serves as a follow-up to his April 13, 2021, New York Times opinion piece, in which he advised readers that “all variants are innocent until proven guilty.”

You have expressed overall confidence in the efficacy of the vaccines thus far despite the emergence of variants, with some caveats. How do you see the current situation?

The Centers for Disease Control and Prevention has designated five “variants of concern,” but only three of them are real concerns – B.1.1.7, first detected in the United Kingdom; P.1, in Brazil and Japan; and B.1.351, in South Africa. Yet, all three are susceptible to our current vaccines.

The U.K. B.1.1.7 is the worst variant of all because it’s hypertransmissible, so I call it a “superspreader strain.” It also causes more severe illness independent of the spread, so it’s a double whammy. It’s clear that it also causes more deaths. The only arguable point is whether it’s 30% or 50% more deaths, but regardless, it’s more lethal and more transmissible.

The B.1.1.7 is going to be the dominant strain worldwide. It could develop new mutations within it that could come back to haunt us. We must keep watch.

But for now, it’s fully responsive to all the vaccines, which is great because if we didn’t have them, we wouldn’t have gotten through this U.S. pandemic like we have, and neither would Israel and the United Kingdom and other countries that have been able to get out of the crisis. We met the enemy and put it in check.

As for the South Africa variant of concern, B.1.351, we just got some encouraging news showing that it›s very responsive to the Pfizer/BioNTech mRNA vaccine in large numbers of people. The study was conducted in Qatar following that country’s mass immunization campaign in which a total of 385,853 people had received at least one vaccine dose and 265,410 had completed the two doses as of March 31, 2021.

At 2 weeks past the second dose, the vaccine was 75% effective at preventing any documented infection with the B.1.351 variant and 89.5% effective against B.1.1.7. The vaccine’s effectiveness against severe, critical, or fatal COVID-19 was greater than 97.4% for all circulating strains in Qatar, where B.1.1.7 and B.1.351 are most prominent.

We also know that B.1.351 is very responsive to the Johnson & Johnson vaccine and the Novavax [vaccine in development] to a lesser degree. It is the most immune-evading variant we’ve seen thus far, with the highest likelihood of providing some vaccine resistance, yet not enough to interfere with vaccination campaigns. So that’s great news.

The caveats here are that you definitely need two doses of the mRNA vaccines to combat the B.1.351 variant. Also, the AstraZeneca vaccine failed to prevent it in South Africa. However, that study was hard to judge because it was underpowered for number of people with mild infections. So, it didn’t look as if it had any efficacy, but maybe it would if tested in a real trial.

The P.1 (Brazil) variant is the second-highest concern after B.1.1.7 because it’s the only one in the United States that’s still headed up. It seems to be competing a bit with B.1.1.7 here. We know it was associated with the crisis in Brazil, in Chile, and some other South American countries. It has some immune escape, but not as bad as B.1.351. It also appears to have somewhat greater transmissibility but not as much as B.1.1.7.

With P.1, we just don’t know enough yet. It was difficult to assess in Brazil because they were in the midst of a catastrophe – like India is now – and you don’t know how much of it is dragged by the catastrophe vs driving it.

We have to respond to P.1 carefully. There are some good data that it does respond to the Chinese vaccine Sinovac and the AstraZeneca vaccine, and it appears to respond to the others as well, based on serum studies. So it doesn’t look like vaccines will be the worry with this variant. Rather, it could be competing with B.1.1.7 and could lead to breakthrough infections in vaccinated people or reinfections in unvaccinated people who had COVID-19. We need several more weeks to sort it out.

Although the B.1.427 and B.1.429 variants initially seen in California remain on the CDC’s concern list, I’m not worried about them.
 

You mentioned the current COVID-19 crisis in India, where a new variant has been described as a “double mutant,” but on Twitter you called it a “scariant.” Why?

First of all, the B.1.617 variant isn’t a double mutant. It has 15 mutations. It’s a stupid term, focusing on two mutations which largely have been put aside as to concern. One of them is the L452R, which is the same as one of the California variants, and that hasn’t proved to be particularly serious or concerning. The other is the 484Q, and it’s not clear whether that has any function.

The B.1.617 is not the driver of the catastrophe in India. It may be contributing a small amount, but it has been overhyped as the double mutant that’s causing it all. Adding to that are what I call “scariant” headlines here in the United States when a few cases of that variant have been seen.

I coined the term scariant in early February because it was a pretty clear trend. People don’t know what variants are. They know a little bit about mutations but not variants, and they’re scared. A few variants are concerning, but we keep learning more and more things to decrease the concern. That’s why I wrote the New York Times op-ed, to try to provide some reassurance, since there’s such paranoia.
 

Do you think booster vaccinations will be necessary? If so, will those be of the original vaccines or new ones that incorporate the variants?

As we go forward, there’s still potential for new variants that we haven’t seen yet that combine the worst of all features – transmissibility and immune evasion – especially since we have a world where COVID-19 is unchecked. So, we’re not out of it yet, but at least for the moment, we have vaccines that are capable of protecting against all variants.

In most people, the immune response against SARS-CoV-2 is very durable and strong and may well last for years. With the most closely related SARS-CoV-1, people still had immune responses up to 18 years later. However, some people will have less robust vaccine responses, including the elderly and the immunocompromised. If they don’t have great responses to the vaccine to start with, over time they’re likely to become more vulnerable, especially if they’re exposed to the variants with some degree of immune evasion.

I think we need to study these individuals post vaccination. A lot of people fit into those categories, including seniors, people being treated for cancer or autoimmune conditions, or post organ transplant. We could set up a prospective study to see whether they develop symptomatic COVID-19 and if so, from what – the original strain, B.1.1.7, or the newer variants.

That’s where I think booster shots may be needed. They may not be necessary across the board, but perhaps just in these special subgroups.

All of the current vaccines can be tweaked to include new variants, but the need for that is uncertain as of now. Moderna is working on a so-called bivalent vaccine that includes the original SARS-CoV-2 strain plus the B.1.351 variant, but it isn’t clear that that’s going to be necessary.

Currently, at least 200 COVID-19 vaccines are in development. There will be vaccines you can inhale, room temperature mRNA vaccines, and potentially even oral vaccines.

In the near future, Novavax is close, and there will likely be a two-dose Johnson & Johnson version that has the same potency as the mRNA vaccines. There are a lot of moving parts here.

There may be a step down in efficacy from mRNA to the others, though, and that shouldn’t be discounted. All of the available vaccines so far protect very well against severe disease and death, but some are less effective against mild to moderate infections, which may then lead to long COVID. We don’t yet know whether those who get mild infection post vaccination can still get long COVID.
 

What do you think it will take to achieve herd immunity?

I prefer the term “containment.” It’s quantitative. If you get to an infection rate of less than 1 in 100,000 people, as they’ve done in Israel, with 0.8 per 100,000, then you have the virus in check, and there will be very little spread when it’s at that controlled rate, with no outbreaks. The United States is currently at about 15 per 100,000. California is at 4. That still has to get lower.

It will be a challenge to get to President Biden’s goal of having 70% of U.S. adults given at least one dose by July 4. We’re now at about 57%. To get that next 13% of adults is going to take an all-out effort: mobile units, going to homes, making it ultraconvenient, education for people with safety concerns, incentivization, and days off.

We also need to get employers, universities, and health systems to get to the mandatory level. We haven’t done that yet. Some universities have mandated it for students, faculty, and staff. We need it in more health care systems. Right now, we only have a couple. We mandate flu shots, and flu is nothing, compared with COVID-19. And the COVID-19 vaccine is far more efficacious – flu shots are 40% efficacious, while these are 95%. COVID-19 is a tenfold more lethal and serious disease, and much more spreadable.

People are using the lack of full licensure by the Food and Drug Administration – as opposed to emergency use authorization – as an excuse not to get vaccinated. A biologics license application takes time to approve. Meanwhile, we have hundreds of millions of doses that have been well tolerated and incredibly effective.

Another aspect to consider regarding containment is that about 110 million Americans have already had COVID-19, even though only about 30 million cases have been confirmed. Most of these people have immune protection, although it’s not as good as if they have one vaccine dose. But they have enough protection to be part of the story here of the wall against COVID-19 and will help us get through this.

That’s a silver lining of having an unchecked epidemic for the entire year of 2020. The good part is that’s helping to get us to achieve an incredible level of containment when we haven’t even been close. Right now, we’re as good as the country has been in the pandemic, but we still have a long gap to get down to that 1 per 100,000. That’s what we should be working toward, and we can get there.

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

Editor in Chief of this news organization Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and professor of molecular medicine, has been closely following COVID-19 data since the pandemic began. He spoke with writer Miriam E. Tucker about the latest on SARS-CoV-2 variants and their impact on vaccine efficacy. The conversation serves as a follow-up to his April 13, 2021, New York Times opinion piece, in which he advised readers that “all variants are innocent until proven guilty.”

You have expressed overall confidence in the efficacy of the vaccines thus far despite the emergence of variants, with some caveats. How do you see the current situation?

The Centers for Disease Control and Prevention has designated five “variants of concern,” but only three of them are real concerns – B.1.1.7, first detected in the United Kingdom; P.1, in Brazil and Japan; and B.1.351, in South Africa. Yet, all three are susceptible to our current vaccines.

The U.K. B.1.1.7 is the worst variant of all because it’s hypertransmissible, so I call it a “superspreader strain.” It also causes more severe illness independent of the spread, so it’s a double whammy. It’s clear that it also causes more deaths. The only arguable point is whether it’s 30% or 50% more deaths, but regardless, it’s more lethal and more transmissible.

The B.1.1.7 is going to be the dominant strain worldwide. It could develop new mutations within it that could come back to haunt us. We must keep watch.

But for now, it’s fully responsive to all the vaccines, which is great because if we didn’t have them, we wouldn’t have gotten through this U.S. pandemic like we have, and neither would Israel and the United Kingdom and other countries that have been able to get out of the crisis. We met the enemy and put it in check.

As for the South Africa variant of concern, B.1.351, we just got some encouraging news showing that it›s very responsive to the Pfizer/BioNTech mRNA vaccine in large numbers of people. The study was conducted in Qatar following that country’s mass immunization campaign in which a total of 385,853 people had received at least one vaccine dose and 265,410 had completed the two doses as of March 31, 2021.

At 2 weeks past the second dose, the vaccine was 75% effective at preventing any documented infection with the B.1.351 variant and 89.5% effective against B.1.1.7. The vaccine’s effectiveness against severe, critical, or fatal COVID-19 was greater than 97.4% for all circulating strains in Qatar, where B.1.1.7 and B.1.351 are most prominent.

We also know that B.1.351 is very responsive to the Johnson & Johnson vaccine and the Novavax [vaccine in development] to a lesser degree. It is the most immune-evading variant we’ve seen thus far, with the highest likelihood of providing some vaccine resistance, yet not enough to interfere with vaccination campaigns. So that’s great news.

The caveats here are that you definitely need two doses of the mRNA vaccines to combat the B.1.351 variant. Also, the AstraZeneca vaccine failed to prevent it in South Africa. However, that study was hard to judge because it was underpowered for number of people with mild infections. So, it didn’t look as if it had any efficacy, but maybe it would if tested in a real trial.

The P.1 (Brazil) variant is the second-highest concern after B.1.1.7 because it’s the only one in the United States that’s still headed up. It seems to be competing a bit with B.1.1.7 here. We know it was associated with the crisis in Brazil, in Chile, and some other South American countries. It has some immune escape, but not as bad as B.1.351. It also appears to have somewhat greater transmissibility but not as much as B.1.1.7.

With P.1, we just don’t know enough yet. It was difficult to assess in Brazil because they were in the midst of a catastrophe – like India is now – and you don’t know how much of it is dragged by the catastrophe vs driving it.

We have to respond to P.1 carefully. There are some good data that it does respond to the Chinese vaccine Sinovac and the AstraZeneca vaccine, and it appears to respond to the others as well, based on serum studies. So it doesn’t look like vaccines will be the worry with this variant. Rather, it could be competing with B.1.1.7 and could lead to breakthrough infections in vaccinated people or reinfections in unvaccinated people who had COVID-19. We need several more weeks to sort it out.

Although the B.1.427 and B.1.429 variants initially seen in California remain on the CDC’s concern list, I’m not worried about them.
 

You mentioned the current COVID-19 crisis in India, where a new variant has been described as a “double mutant,” but on Twitter you called it a “scariant.” Why?

First of all, the B.1.617 variant isn’t a double mutant. It has 15 mutations. It’s a stupid term, focusing on two mutations which largely have been put aside as to concern. One of them is the L452R, which is the same as one of the California variants, and that hasn’t proved to be particularly serious or concerning. The other is the 484Q, and it’s not clear whether that has any function.

The B.1.617 is not the driver of the catastrophe in India. It may be contributing a small amount, but it has been overhyped as the double mutant that’s causing it all. Adding to that are what I call “scariant” headlines here in the United States when a few cases of that variant have been seen.

I coined the term scariant in early February because it was a pretty clear trend. People don’t know what variants are. They know a little bit about mutations but not variants, and they’re scared. A few variants are concerning, but we keep learning more and more things to decrease the concern. That’s why I wrote the New York Times op-ed, to try to provide some reassurance, since there’s such paranoia.
 

Do you think booster vaccinations will be necessary? If so, will those be of the original vaccines or new ones that incorporate the variants?

As we go forward, there’s still potential for new variants that we haven’t seen yet that combine the worst of all features – transmissibility and immune evasion – especially since we have a world where COVID-19 is unchecked. So, we’re not out of it yet, but at least for the moment, we have vaccines that are capable of protecting against all variants.

In most people, the immune response against SARS-CoV-2 is very durable and strong and may well last for years. With the most closely related SARS-CoV-1, people still had immune responses up to 18 years later. However, some people will have less robust vaccine responses, including the elderly and the immunocompromised. If they don’t have great responses to the vaccine to start with, over time they’re likely to become more vulnerable, especially if they’re exposed to the variants with some degree of immune evasion.

I think we need to study these individuals post vaccination. A lot of people fit into those categories, including seniors, people being treated for cancer or autoimmune conditions, or post organ transplant. We could set up a prospective study to see whether they develop symptomatic COVID-19 and if so, from what – the original strain, B.1.1.7, or the newer variants.

That’s where I think booster shots may be needed. They may not be necessary across the board, but perhaps just in these special subgroups.

All of the current vaccines can be tweaked to include new variants, but the need for that is uncertain as of now. Moderna is working on a so-called bivalent vaccine that includes the original SARS-CoV-2 strain plus the B.1.351 variant, but it isn’t clear that that’s going to be necessary.

Currently, at least 200 COVID-19 vaccines are in development. There will be vaccines you can inhale, room temperature mRNA vaccines, and potentially even oral vaccines.

In the near future, Novavax is close, and there will likely be a two-dose Johnson & Johnson version that has the same potency as the mRNA vaccines. There are a lot of moving parts here.

There may be a step down in efficacy from mRNA to the others, though, and that shouldn’t be discounted. All of the available vaccines so far protect very well against severe disease and death, but some are less effective against mild to moderate infections, which may then lead to long COVID. We don’t yet know whether those who get mild infection post vaccination can still get long COVID.
 

What do you think it will take to achieve herd immunity?

I prefer the term “containment.” It’s quantitative. If you get to an infection rate of less than 1 in 100,000 people, as they’ve done in Israel, with 0.8 per 100,000, then you have the virus in check, and there will be very little spread when it’s at that controlled rate, with no outbreaks. The United States is currently at about 15 per 100,000. California is at 4. That still has to get lower.

It will be a challenge to get to President Biden’s goal of having 70% of U.S. adults given at least one dose by July 4. We’re now at about 57%. To get that next 13% of adults is going to take an all-out effort: mobile units, going to homes, making it ultraconvenient, education for people with safety concerns, incentivization, and days off.

We also need to get employers, universities, and health systems to get to the mandatory level. We haven’t done that yet. Some universities have mandated it for students, faculty, and staff. We need it in more health care systems. Right now, we only have a couple. We mandate flu shots, and flu is nothing, compared with COVID-19. And the COVID-19 vaccine is far more efficacious – flu shots are 40% efficacious, while these are 95%. COVID-19 is a tenfold more lethal and serious disease, and much more spreadable.

People are using the lack of full licensure by the Food and Drug Administration – as opposed to emergency use authorization – as an excuse not to get vaccinated. A biologics license application takes time to approve. Meanwhile, we have hundreds of millions of doses that have been well tolerated and incredibly effective.

Another aspect to consider regarding containment is that about 110 million Americans have already had COVID-19, even though only about 30 million cases have been confirmed. Most of these people have immune protection, although it’s not as good as if they have one vaccine dose. But they have enough protection to be part of the story here of the wall against COVID-19 and will help us get through this.

That’s a silver lining of having an unchecked epidemic for the entire year of 2020. The good part is that’s helping to get us to achieve an incredible level of containment when we haven’t even been close. Right now, we’re as good as the country has been in the pandemic, but we still have a long gap to get down to that 1 per 100,000. That’s what we should be working toward, and we can get there.

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

Editor in Chief of this news organization Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and professor of molecular medicine, has been closely following COVID-19 data since the pandemic began. He spoke with writer Miriam E. Tucker about the latest on SARS-CoV-2 variants and their impact on vaccine efficacy. The conversation serves as a follow-up to his April 13, 2021, New York Times opinion piece, in which he advised readers that “all variants are innocent until proven guilty.”

You have expressed overall confidence in the efficacy of the vaccines thus far despite the emergence of variants, with some caveats. How do you see the current situation?

The Centers for Disease Control and Prevention has designated five “variants of concern,” but only three of them are real concerns – B.1.1.7, first detected in the United Kingdom; P.1, in Brazil and Japan; and B.1.351, in South Africa. Yet, all three are susceptible to our current vaccines.

The U.K. B.1.1.7 is the worst variant of all because it’s hypertransmissible, so I call it a “superspreader strain.” It also causes more severe illness independent of the spread, so it’s a double whammy. It’s clear that it also causes more deaths. The only arguable point is whether it’s 30% or 50% more deaths, but regardless, it’s more lethal and more transmissible.

The B.1.1.7 is going to be the dominant strain worldwide. It could develop new mutations within it that could come back to haunt us. We must keep watch.

But for now, it’s fully responsive to all the vaccines, which is great because if we didn’t have them, we wouldn’t have gotten through this U.S. pandemic like we have, and neither would Israel and the United Kingdom and other countries that have been able to get out of the crisis. We met the enemy and put it in check.

As for the South Africa variant of concern, B.1.351, we just got some encouraging news showing that it›s very responsive to the Pfizer/BioNTech mRNA vaccine in large numbers of people. The study was conducted in Qatar following that country’s mass immunization campaign in which a total of 385,853 people had received at least one vaccine dose and 265,410 had completed the two doses as of March 31, 2021.

At 2 weeks past the second dose, the vaccine was 75% effective at preventing any documented infection with the B.1.351 variant and 89.5% effective against B.1.1.7. The vaccine’s effectiveness against severe, critical, or fatal COVID-19 was greater than 97.4% for all circulating strains in Qatar, where B.1.1.7 and B.1.351 are most prominent.

We also know that B.1.351 is very responsive to the Johnson & Johnson vaccine and the Novavax [vaccine in development] to a lesser degree. It is the most immune-evading variant we’ve seen thus far, with the highest likelihood of providing some vaccine resistance, yet not enough to interfere with vaccination campaigns. So that’s great news.

The caveats here are that you definitely need two doses of the mRNA vaccines to combat the B.1.351 variant. Also, the AstraZeneca vaccine failed to prevent it in South Africa. However, that study was hard to judge because it was underpowered for number of people with mild infections. So, it didn’t look as if it had any efficacy, but maybe it would if tested in a real trial.

The P.1 (Brazil) variant is the second-highest concern after B.1.1.7 because it’s the only one in the United States that’s still headed up. It seems to be competing a bit with B.1.1.7 here. We know it was associated with the crisis in Brazil, in Chile, and some other South American countries. It has some immune escape, but not as bad as B.1.351. It also appears to have somewhat greater transmissibility but not as much as B.1.1.7.

With P.1, we just don’t know enough yet. It was difficult to assess in Brazil because they were in the midst of a catastrophe – like India is now – and you don’t know how much of it is dragged by the catastrophe vs driving it.

We have to respond to P.1 carefully. There are some good data that it does respond to the Chinese vaccine Sinovac and the AstraZeneca vaccine, and it appears to respond to the others as well, based on serum studies. So it doesn’t look like vaccines will be the worry with this variant. Rather, it could be competing with B.1.1.7 and could lead to breakthrough infections in vaccinated people or reinfections in unvaccinated people who had COVID-19. We need several more weeks to sort it out.

Although the B.1.427 and B.1.429 variants initially seen in California remain on the CDC’s concern list, I’m not worried about them.
 

You mentioned the current COVID-19 crisis in India, where a new variant has been described as a “double mutant,” but on Twitter you called it a “scariant.” Why?

First of all, the B.1.617 variant isn’t a double mutant. It has 15 mutations. It’s a stupid term, focusing on two mutations which largely have been put aside as to concern. One of them is the L452R, which is the same as one of the California variants, and that hasn’t proved to be particularly serious or concerning. The other is the 484Q, and it’s not clear whether that has any function.

The B.1.617 is not the driver of the catastrophe in India. It may be contributing a small amount, but it has been overhyped as the double mutant that’s causing it all. Adding to that are what I call “scariant” headlines here in the United States when a few cases of that variant have been seen.

I coined the term scariant in early February because it was a pretty clear trend. People don’t know what variants are. They know a little bit about mutations but not variants, and they’re scared. A few variants are concerning, but we keep learning more and more things to decrease the concern. That’s why I wrote the New York Times op-ed, to try to provide some reassurance, since there’s such paranoia.
 

Do you think booster vaccinations will be necessary? If so, will those be of the original vaccines or new ones that incorporate the variants?

As we go forward, there’s still potential for new variants that we haven’t seen yet that combine the worst of all features – transmissibility and immune evasion – especially since we have a world where COVID-19 is unchecked. So, we’re not out of it yet, but at least for the moment, we have vaccines that are capable of protecting against all variants.

In most people, the immune response against SARS-CoV-2 is very durable and strong and may well last for years. With the most closely related SARS-CoV-1, people still had immune responses up to 18 years later. However, some people will have less robust vaccine responses, including the elderly and the immunocompromised. If they don’t have great responses to the vaccine to start with, over time they’re likely to become more vulnerable, especially if they’re exposed to the variants with some degree of immune evasion.

I think we need to study these individuals post vaccination. A lot of people fit into those categories, including seniors, people being treated for cancer or autoimmune conditions, or post organ transplant. We could set up a prospective study to see whether they develop symptomatic COVID-19 and if so, from what – the original strain, B.1.1.7, or the newer variants.

That’s where I think booster shots may be needed. They may not be necessary across the board, but perhaps just in these special subgroups.

All of the current vaccines can be tweaked to include new variants, but the need for that is uncertain as of now. Moderna is working on a so-called bivalent vaccine that includes the original SARS-CoV-2 strain plus the B.1.351 variant, but it isn’t clear that that’s going to be necessary.

Currently, at least 200 COVID-19 vaccines are in development. There will be vaccines you can inhale, room temperature mRNA vaccines, and potentially even oral vaccines.

In the near future, Novavax is close, and there will likely be a two-dose Johnson & Johnson version that has the same potency as the mRNA vaccines. There are a lot of moving parts here.

There may be a step down in efficacy from mRNA to the others, though, and that shouldn’t be discounted. All of the available vaccines so far protect very well against severe disease and death, but some are less effective against mild to moderate infections, which may then lead to long COVID. We don’t yet know whether those who get mild infection post vaccination can still get long COVID.
 

What do you think it will take to achieve herd immunity?

I prefer the term “containment.” It’s quantitative. If you get to an infection rate of less than 1 in 100,000 people, as they’ve done in Israel, with 0.8 per 100,000, then you have the virus in check, and there will be very little spread when it’s at that controlled rate, with no outbreaks. The United States is currently at about 15 per 100,000. California is at 4. That still has to get lower.

It will be a challenge to get to President Biden’s goal of having 70% of U.S. adults given at least one dose by July 4. We’re now at about 57%. To get that next 13% of adults is going to take an all-out effort: mobile units, going to homes, making it ultraconvenient, education for people with safety concerns, incentivization, and days off.

We also need to get employers, universities, and health systems to get to the mandatory level. We haven’t done that yet. Some universities have mandated it for students, faculty, and staff. We need it in more health care systems. Right now, we only have a couple. We mandate flu shots, and flu is nothing, compared with COVID-19. And the COVID-19 vaccine is far more efficacious – flu shots are 40% efficacious, while these are 95%. COVID-19 is a tenfold more lethal and serious disease, and much more spreadable.

People are using the lack of full licensure by the Food and Drug Administration – as opposed to emergency use authorization – as an excuse not to get vaccinated. A biologics license application takes time to approve. Meanwhile, we have hundreds of millions of doses that have been well tolerated and incredibly effective.

Another aspect to consider regarding containment is that about 110 million Americans have already had COVID-19, even though only about 30 million cases have been confirmed. Most of these people have immune protection, although it’s not as good as if they have one vaccine dose. But they have enough protection to be part of the story here of the wall against COVID-19 and will help us get through this.

That’s a silver lining of having an unchecked epidemic for the entire year of 2020. The good part is that’s helping to get us to achieve an incredible level of containment when we haven’t even been close. Right now, we’re as good as the country has been in the pandemic, but we still have a long gap to get down to that 1 per 100,000. That’s what we should be working toward, and we can get there.

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

Clinicians’ well-being is a “crisis” of grave import to the public health and a top issue that he hopes to get more squarely on the public radar screen, Surgeon General Vivek Murthy, MD, MBA, said May 6 in a “fireside chat” with SHM president Danielle Scheurer, MD, MSRC, SFHM, at SHM Converge, the annual conference of the Society of Hospital Medicine.

“This is a crisis that I don’t know that the country recognizes is fully important,” Dr. Murthy said. “I don’t think that most people in the public recognize just how extraordinarily difficult it is, for many clinicians, to come to practice. And if the clinicians continue to burn out at the rate that they are – in addition to the humanitarian crisis of people who are struggling that we should all feel concern about – it will impact care in a profound way.” He said part of his plan is a “national agenda” for clinician well-being, with a clear pathway for creating an environment more conducive to providing quality patient care.

Dr. Scheurer said that this was “welcome news and wonderful to hear.”

“Fortunately or unfortunately, now I do think it’s more in the front seat,” she said, adding that “this notion of ‘heal thyself,’ we know doesn’t work and these are really systemic ailments that we all have to tackle together.”

Dr. Murthy, a hospitalist by training, recently began his second term as Surgeon General, having served under President Obama and appointed to the post again by President Biden. This second appointment is different in the knowledge he has about the job from the start, in the enormity of the public health challenges posed by the COVID-19 pandemic, and in the political tenor of the country.

He said one of his main priorities is to “recenter our public health response” with scientists and public health leaders regaining their proper role.

“Have them be the voices that are actually speaking directly to the public, not in a way that’s biased by the politics or by politicians, but it’s really guided again by the science and substance of what we know needs to happen,” he said.

The response to COVID goes beyond continuing an aggressive vaccination and testing campaign, he said. The pandemic has given rise to worse mental health issues such as depression and anxiety, substance use disorders, and delays in care for other medical conditions for fear of infection – and these are all priorities, Dr. Murthy said.

One “silver lining” of the pandemic is the expansion of telehealth, but this needs refining and persistence to make it work optimally for all patients, he said.

“We have to ensure that that expansion continues and that it’s even – meaning that there are so many parts of the country where broadband access is a challenge for patients, so they don’t have the benefits of telemedicine,” he said. “We also need to ensure that these systems are integrated across our current systems, across hospitals so that we’re not creating more work for clinicians when it comes to utilizing this technology to reach their patients.”

Clinicians – typically viewed as coming to Capitol Hill only to push for higher payment or changes to medical liability laws – need to use their trusted voices to raise the profile of preventive care and identifying and fixing social barriers related to health, such as transportation issues and unsafe neighborhoods, Dr. Murthy said.

“No one really celebrates the heart attack that was prevented or the asthma that was prevented – we celebrate the illness that took place and was cured,” he said. “We know as clinicians that if you really want to reduce human suffering that you have to focus on the prevention side of the house, and I think that unless our colleagues in medicine and in public health come together and advocate for greater investments in prevention, or a national agenda around prevention, my worry is that it won’t naturally develop.”

On vaccine hesitancy, Dr. Murthy said that the United States needs to work more in increasing confidence that the vaccines will work, and in access to vaccines, but, mostly, in motivation.

“What we’ve learned is that ultimately trusted voices are what make all the difference when it comes to vaccination,” he said. “It’s one of these large, people-powered movements that we have to build in our community.”

Dr. Scheurer noted that, with hospitalists in 90% of U.S. hospitals, they can play a big role. “If we can all do our part then we’ll at least take the ball further down the field.”

Dr. Murthy added that, since residency, when he cared for young cancer patients near his own age, he has focused on “finding meaning now” in his work and life. The pandemic has reinforced this, and he doesn’t necessarily want life to go back to exactly how it was before the pandemic.

“Many of us are thinking – ‘Is there actually a better way for us to live our lives and design our workdays and our choices other than what we were doing prepandemic? Can we center our lives more around the people we love and care about, can we design our work to accommodate our family as opposed to the other way around, to always make our families accommodate our work?’ – These are the kinds of choices that we have to make as a society.”

Clinicians’ well-being is a “crisis” of grave import to the public health and a top issue that he hopes to get more squarely on the public radar screen, Surgeon General Vivek Murthy, MD, MBA, said May 6 in a “fireside chat” with SHM president Danielle Scheurer, MD, MSRC, SFHM, at SHM Converge, the annual conference of the Society of Hospital Medicine.

“This is a crisis that I don’t know that the country recognizes is fully important,” Dr. Murthy said. “I don’t think that most people in the public recognize just how extraordinarily difficult it is, for many clinicians, to come to practice. And if the clinicians continue to burn out at the rate that they are – in addition to the humanitarian crisis of people who are struggling that we should all feel concern about – it will impact care in a profound way.” He said part of his plan is a “national agenda” for clinician well-being, with a clear pathway for creating an environment more conducive to providing quality patient care.

Dr. Scheurer said that this was “welcome news and wonderful to hear.”

“Fortunately or unfortunately, now I do think it’s more in the front seat,” she said, adding that “this notion of ‘heal thyself,’ we know doesn’t work and these are really systemic ailments that we all have to tackle together.”

Dr. Murthy, a hospitalist by training, recently began his second term as Surgeon General, having served under President Obama and appointed to the post again by President Biden. This second appointment is different in the knowledge he has about the job from the start, in the enormity of the public health challenges posed by the COVID-19 pandemic, and in the political tenor of the country.

He said one of his main priorities is to “recenter our public health response” with scientists and public health leaders regaining their proper role.

“Have them be the voices that are actually speaking directly to the public, not in a way that’s biased by the politics or by politicians, but it’s really guided again by the science and substance of what we know needs to happen,” he said.

The response to COVID goes beyond continuing an aggressive vaccination and testing campaign, he said. The pandemic has given rise to worse mental health issues such as depression and anxiety, substance use disorders, and delays in care for other medical conditions for fear of infection – and these are all priorities, Dr. Murthy said.

One “silver lining” of the pandemic is the expansion of telehealth, but this needs refining and persistence to make it work optimally for all patients, he said.

“We have to ensure that that expansion continues and that it’s even – meaning that there are so many parts of the country where broadband access is a challenge for patients, so they don’t have the benefits of telemedicine,” he said. “We also need to ensure that these systems are integrated across our current systems, across hospitals so that we’re not creating more work for clinicians when it comes to utilizing this technology to reach their patients.”

Clinicians – typically viewed as coming to Capitol Hill only to push for higher payment or changes to medical liability laws – need to use their trusted voices to raise the profile of preventive care and identifying and fixing social barriers related to health, such as transportation issues and unsafe neighborhoods, Dr. Murthy said.

“No one really celebrates the heart attack that was prevented or the asthma that was prevented – we celebrate the illness that took place and was cured,” he said. “We know as clinicians that if you really want to reduce human suffering that you have to focus on the prevention side of the house, and I think that unless our colleagues in medicine and in public health come together and advocate for greater investments in prevention, or a national agenda around prevention, my worry is that it won’t naturally develop.”

On vaccine hesitancy, Dr. Murthy said that the United States needs to work more in increasing confidence that the vaccines will work, and in access to vaccines, but, mostly, in motivation.

“What we’ve learned is that ultimately trusted voices are what make all the difference when it comes to vaccination,” he said. “It’s one of these large, people-powered movements that we have to build in our community.”

Dr. Scheurer noted that, with hospitalists in 90% of U.S. hospitals, they can play a big role. “If we can all do our part then we’ll at least take the ball further down the field.”

Dr. Murthy added that, since residency, when he cared for young cancer patients near his own age, he has focused on “finding meaning now” in his work and life. The pandemic has reinforced this, and he doesn’t necessarily want life to go back to exactly how it was before the pandemic.

“Many of us are thinking – ‘Is there actually a better way for us to live our lives and design our workdays and our choices other than what we were doing prepandemic? Can we center our lives more around the people we love and care about, can we design our work to accommodate our family as opposed to the other way around, to always make our families accommodate our work?’ – These are the kinds of choices that we have to make as a society.”

Clinicians’ well-being is a “crisis” of grave import to the public health and a top issue that he hopes to get more squarely on the public radar screen, Surgeon General Vivek Murthy, MD, MBA, said May 6 in a “fireside chat” with SHM president Danielle Scheurer, MD, MSRC, SFHM, at SHM Converge, the annual conference of the Society of Hospital Medicine.

“This is a crisis that I don’t know that the country recognizes is fully important,” Dr. Murthy said. “I don’t think that most people in the public recognize just how extraordinarily difficult it is, for many clinicians, to come to practice. And if the clinicians continue to burn out at the rate that they are – in addition to the humanitarian crisis of people who are struggling that we should all feel concern about – it will impact care in a profound way.” He said part of his plan is a “national agenda” for clinician well-being, with a clear pathway for creating an environment more conducive to providing quality patient care.

Dr. Scheurer said that this was “welcome news and wonderful to hear.”

“Fortunately or unfortunately, now I do think it’s more in the front seat,” she said, adding that “this notion of ‘heal thyself,’ we know doesn’t work and these are really systemic ailments that we all have to tackle together.”

Dr. Murthy, a hospitalist by training, recently began his second term as Surgeon General, having served under President Obama and appointed to the post again by President Biden. This second appointment is different in the knowledge he has about the job from the start, in the enormity of the public health challenges posed by the COVID-19 pandemic, and in the political tenor of the country.

He said one of his main priorities is to “recenter our public health response” with scientists and public health leaders regaining their proper role.

“Have them be the voices that are actually speaking directly to the public, not in a way that’s biased by the politics or by politicians, but it’s really guided again by the science and substance of what we know needs to happen,” he said.

The response to COVID goes beyond continuing an aggressive vaccination and testing campaign, he said. The pandemic has given rise to worse mental health issues such as depression and anxiety, substance use disorders, and delays in care for other medical conditions for fear of infection – and these are all priorities, Dr. Murthy said.

One “silver lining” of the pandemic is the expansion of telehealth, but this needs refining and persistence to make it work optimally for all patients, he said.

“We have to ensure that that expansion continues and that it’s even – meaning that there are so many parts of the country where broadband access is a challenge for patients, so they don’t have the benefits of telemedicine,” he said. “We also need to ensure that these systems are integrated across our current systems, across hospitals so that we’re not creating more work for clinicians when it comes to utilizing this technology to reach their patients.”

Clinicians – typically viewed as coming to Capitol Hill only to push for higher payment or changes to medical liability laws – need to use their trusted voices to raise the profile of preventive care and identifying and fixing social barriers related to health, such as transportation issues and unsafe neighborhoods, Dr. Murthy said.

“No one really celebrates the heart attack that was prevented or the asthma that was prevented – we celebrate the illness that took place and was cured,” he said. “We know as clinicians that if you really want to reduce human suffering that you have to focus on the prevention side of the house, and I think that unless our colleagues in medicine and in public health come together and advocate for greater investments in prevention, or a national agenda around prevention, my worry is that it won’t naturally develop.”

On vaccine hesitancy, Dr. Murthy said that the United States needs to work more in increasing confidence that the vaccines will work, and in access to vaccines, but, mostly, in motivation.

“What we’ve learned is that ultimately trusted voices are what make all the difference when it comes to vaccination,” he said. “It’s one of these large, people-powered movements that we have to build in our community.”

Dr. Scheurer noted that, with hospitalists in 90% of U.S. hospitals, they can play a big role. “If we can all do our part then we’ll at least take the ball further down the field.”

Dr. Murthy added that, since residency, when he cared for young cancer patients near his own age, he has focused on “finding meaning now” in his work and life. The pandemic has reinforced this, and he doesn’t necessarily want life to go back to exactly how it was before the pandemic.

“Many of us are thinking – ‘Is there actually a better way for us to live our lives and design our workdays and our choices other than what we were doing prepandemic? Can we center our lives more around the people we love and care about, can we design our work to accommodate our family as opposed to the other way around, to always make our families accommodate our work?’ – These are the kinds of choices that we have to make as a society.”

The first clinical trial of fecal microbiota transplantation in patients with psoriatic arthritis has found the procedure to be as safe as a sham procedure, but it didn’t show any effectiveness in decreasing PsA symptoms over 6 months, a team of researchers in Denmark reported in Annals of the Rheumatic Diseases (2021 Apr 29. 10.1136/annrheumdis-2020-219511).

ChrisChrisW/Getty Images

Nonetheless, the investigators said the trial indicates fecal microbiota transplantation (FMT) is worthy of further study.

“Overall, we think that the results are very interesting and that the feasibility and safety aspects as well as the clinical results of the trial may encourage more research into the potential of FMT in the treatment of inflammatory arthritis and may help guide the direction of future trials within the field,” lead author Maja S. Kragsnaes, MD, PhD, and principal investigator Torkell Ellingsen, MD, PhD, of Odense (Denmark) University Hospital said together in an interview.

“The most important findings from this trial is that FMT appears to be safe in patients with PsA and that the patients find the treatment acceptable, and it supports future research into the therapeutic potential of FMT in PsA,” they said.

The study evaluated 6-month outcomes of 31 patients randomized to the FMT and sham groups. FMT patients were three times more likely to experience treatment failure – defined by the need for treatment intensification – with failure rates of 60% versus 20% in the sham group.

As a secondary endpoint, the study used 6-month change in the Health Assessment Questionnaire Disability Index (HAQ-DI) and 20% improvement in American College of Rheumatology criteria (ACR20). The sham group demonstrated a greater decrease in HAQ-DI, indicating better physical function (–0.30 vs. –0.07; P = .031). The proportion of ACR20 responders was similar between both groups: 47% for the FMT patients (7 of 15) and 53% for sham (8 of 15).

The study included adults aged 18-75 years with active peripheral disease, defined as three or more swollen joints, who’d been taking at least15 mg methotrexate a week for at least 3 months before enrolling in the study, with a washout period of 12 weeks (26 weeks for those on biologic agents). Four healthy donors provided the stool transplants.

In the study, Dr. Kragsnaes and Dr. Ellingsen acknowledged that FMT has been shown to be safe for Clostridioides difficile infection or inflammatory bowel disease when “thoroughly screened stool” is used. “Hence,” they wrote, “our findings add to the growing body of evidence suggesting a gut-joint axis in the pathogenesis of PsA.”

Factors that may influence the effectiveness of FMT in PsA merit further investigation, Dr. Kragsnaes and Dr. Ellingsen said. “From FMT trials in patients with active ulcerative colitis, higher dose and repeated administration appear to be effective and safe in inducing remission,” they said in their joint statement, pointing to research from China.

“Moreover,” they added, “successes of FMT in inflammatory bowel disease appear to have been driven by ‘superdonors’ characterized by the presence or absence of specific bacteria species.”

They said will continue to investigate the effectiveness of FMT in immune-mediated diseases, including how to characterize superdonors.

“We will conduct new randomized trials using different FMT strategies – by changing the type of administration form, dose, and treatment frequency – to explore whether microbial dysbiosis or specific bacteria are common or decisive mediators of disease activity in inflammatory diseases and whether this proposed relation can be modified without exacerbating the disease,” Dr. Kragsnaes and Dr. Ellingsen said.

Dr. Kragsnaes and Dr. Ellingsen had no relevant financial relationships to disclose.

The first clinical trial of fecal microbiota transplantation in patients with psoriatic arthritis has found the procedure to be as safe as a sham procedure, but it didn’t show any effectiveness in decreasing PsA symptoms over 6 months, a team of researchers in Denmark reported in Annals of the Rheumatic Diseases (2021 Apr 29. 10.1136/annrheumdis-2020-219511).

ChrisChrisW/Getty Images

Nonetheless, the investigators said the trial indicates fecal microbiota transplantation (FMT) is worthy of further study.

“Overall, we think that the results are very interesting and that the feasibility and safety aspects as well as the clinical results of the trial may encourage more research into the potential of FMT in the treatment of inflammatory arthritis and may help guide the direction of future trials within the field,” lead author Maja S. Kragsnaes, MD, PhD, and principal investigator Torkell Ellingsen, MD, PhD, of Odense (Denmark) University Hospital said together in an interview.

“The most important findings from this trial is that FMT appears to be safe in patients with PsA and that the patients find the treatment acceptable, and it supports future research into the therapeutic potential of FMT in PsA,” they said.

The study evaluated 6-month outcomes of 31 patients randomized to the FMT and sham groups. FMT patients were three times more likely to experience treatment failure – defined by the need for treatment intensification – with failure rates of 60% versus 20% in the sham group.

As a secondary endpoint, the study used 6-month change in the Health Assessment Questionnaire Disability Index (HAQ-DI) and 20% improvement in American College of Rheumatology criteria (ACR20). The sham group demonstrated a greater decrease in HAQ-DI, indicating better physical function (–0.30 vs. –0.07; P = .031). The proportion of ACR20 responders was similar between both groups: 47% for the FMT patients (7 of 15) and 53% for sham (8 of 15).

The study included adults aged 18-75 years with active peripheral disease, defined as three or more swollen joints, who’d been taking at least15 mg methotrexate a week for at least 3 months before enrolling in the study, with a washout period of 12 weeks (26 weeks for those on biologic agents). Four healthy donors provided the stool transplants.

In the study, Dr. Kragsnaes and Dr. Ellingsen acknowledged that FMT has been shown to be safe for Clostridioides difficile infection or inflammatory bowel disease when “thoroughly screened stool” is used. “Hence,” they wrote, “our findings add to the growing body of evidence suggesting a gut-joint axis in the pathogenesis of PsA.”

Factors that may influence the effectiveness of FMT in PsA merit further investigation, Dr. Kragsnaes and Dr. Ellingsen said. “From FMT trials in patients with active ulcerative colitis, higher dose and repeated administration appear to be effective and safe in inducing remission,” they said in their joint statement, pointing to research from China.

“Moreover,” they added, “successes of FMT in inflammatory bowel disease appear to have been driven by ‘superdonors’ characterized by the presence or absence of specific bacteria species.”

They said will continue to investigate the effectiveness of FMT in immune-mediated diseases, including how to characterize superdonors.

“We will conduct new randomized trials using different FMT strategies – by changing the type of administration form, dose, and treatment frequency – to explore whether microbial dysbiosis or specific bacteria are common or decisive mediators of disease activity in inflammatory diseases and whether this proposed relation can be modified without exacerbating the disease,” Dr. Kragsnaes and Dr. Ellingsen said.

Dr. Kragsnaes and Dr. Ellingsen had no relevant financial relationships to disclose.

The first clinical trial of fecal microbiota transplantation in patients with psoriatic arthritis has found the procedure to be as safe as a sham procedure, but it didn’t show any effectiveness in decreasing PsA symptoms over 6 months, a team of researchers in Denmark reported in Annals of the Rheumatic Diseases (2021 Apr 29. 10.1136/annrheumdis-2020-219511).

ChrisChrisW/Getty Images

Nonetheless, the investigators said the trial indicates fecal microbiota transplantation (FMT) is worthy of further study.

“Overall, we think that the results are very interesting and that the feasibility and safety aspects as well as the clinical results of the trial may encourage more research into the potential of FMT in the treatment of inflammatory arthritis and may help guide the direction of future trials within the field,” lead author Maja S. Kragsnaes, MD, PhD, and principal investigator Torkell Ellingsen, MD, PhD, of Odense (Denmark) University Hospital said together in an interview.

“The most important findings from this trial is that FMT appears to be safe in patients with PsA and that the patients find the treatment acceptable, and it supports future research into the therapeutic potential of FMT in PsA,” they said.

The study evaluated 6-month outcomes of 31 patients randomized to the FMT and sham groups. FMT patients were three times more likely to experience treatment failure – defined by the need for treatment intensification – with failure rates of 60% versus 20% in the sham group.

As a secondary endpoint, the study used 6-month change in the Health Assessment Questionnaire Disability Index (HAQ-DI) and 20% improvement in American College of Rheumatology criteria (ACR20). The sham group demonstrated a greater decrease in HAQ-DI, indicating better physical function (–0.30 vs. –0.07; P = .031). The proportion of ACR20 responders was similar between both groups: 47% for the FMT patients (7 of 15) and 53% for sham (8 of 15).

The study included adults aged 18-75 years with active peripheral disease, defined as three or more swollen joints, who’d been taking at least15 mg methotrexate a week for at least 3 months before enrolling in the study, with a washout period of 12 weeks (26 weeks for those on biologic agents). Four healthy donors provided the stool transplants.

In the study, Dr. Kragsnaes and Dr. Ellingsen acknowledged that FMT has been shown to be safe for Clostridioides difficile infection or inflammatory bowel disease when “thoroughly screened stool” is used. “Hence,” they wrote, “our findings add to the growing body of evidence suggesting a gut-joint axis in the pathogenesis of PsA.”

Factors that may influence the effectiveness of FMT in PsA merit further investigation, Dr. Kragsnaes and Dr. Ellingsen said. “From FMT trials in patients with active ulcerative colitis, higher dose and repeated administration appear to be effective and safe in inducing remission,” they said in their joint statement, pointing to research from China.

“Moreover,” they added, “successes of FMT in inflammatory bowel disease appear to have been driven by ‘superdonors’ characterized by the presence or absence of specific bacteria species.”

They said will continue to investigate the effectiveness of FMT in immune-mediated diseases, including how to characterize superdonors.

“We will conduct new randomized trials using different FMT strategies – by changing the type of administration form, dose, and treatment frequency – to explore whether microbial dysbiosis or specific bacteria are common or decisive mediators of disease activity in inflammatory diseases and whether this proposed relation can be modified without exacerbating the disease,” Dr. Kragsnaes and Dr. Ellingsen said.

Dr. Kragsnaes and Dr. Ellingsen had no relevant financial relationships to disclose.

Chronic insomnia is often underrecognized and misunderstood in primary care, sleep expert Christopher Lettieri, MD, told attendees at the annual meeting of the American College of Physicians.

Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Dr. Lettieri, professor in pulmonary, critical care, and sleep medicine at Johns Hopkins University, Baltimore.

However, medications alone won’t work without other behavior modifications and they come with potential side effects, he said in his talk. Prescription medications typically don’t treat the cause of the insomnia, just the symptoms.

“In the 15 years I’ve been practicing sleep medicine, I can honestly say I only have a handful of patients that I treat with long-term pharmacotherapy,” Dr. Lettieri said.

He said he typically uses pharmacotherapy only when conservative measures have failed or to help jump-start patients to behavior modifications.

Restricted sleep is a good place to start for chronic insomnia, he continued.

Physicians should ask patients the latest time they can wake up to make it to school, work, etc. If that time is 6 a.m., the goal is to move bedtime back to 10 p.m.–11 p.m. If the patient, however, is unable to sleep until 12:30 a.m., move bedtime there, he said.

Though the 5.5-hour window is not ideal, it’s better to get into bed when ready for sleep. From there, try to get the patient to move bedtime back 15 minutes each week as they train themselves to fall asleep earlier, he said.

“I promise you this works in the majority of patients and doesn’t require any medication. You can also accomplish this with one or two office visits, so it is not a huge drain on resources,” he said.
 

Sleep specialists in short supply

Cognitive-behavioral therapy (CBT) is “without question the best way to treat chronic insomnia and it’s recommended as first-line therapy by all published guidelines,” Dr. Lettieri said.

He defined chronic insomnia as happening most nights over at least 3 months. It affects twice as many women as men.

CBT offers a formalized way of changing sleep patterns with the help of an expert in sleep behavior disorders. It combines cognitive therapies with education about sleep and stimulus control and uses techniques such as mindfulness and relaxation.

However, most programs take 4-8 sessions with a sleep medicine provider and are usually not covered by insurance. In addition, the number of insomnia specialists is not nearly adequate to meet demand, he added.

Online and mobile-platform CBT programs are widely effective, Dr. Lettieri said. Many are free and all are convenient for patients to use. He said many of his patients use Sleepio, but many other online programs are effective.

“You can provide sufficient therapy for many of your patients and reserve CBT for patients who can’t be fixed with more conservative measures,” he said.
 

Insomnia among older patients

Interest in helping older patients with insomnia dominated the chat session associated with the talk.

Insomnia increases with age and older patients have often been using prescription or over-the-counter sleep aids for decades.

Additionally, “insomnia is the second-most common reason why people get admitted to long-term care facilities, second only to urinary incontinence,” Dr. Lettieri said.

If physicians use medications with older patients, he said, extra caution is needed. Older people have more neurocognitive impairments than younger adults and may already be taking several other medications. Sleep medications may come with longer elimination half-lives. Polypharmacy may increase risk for falls and have other consequences.

“If you have to go to a medication, try something simple like melatonin,” he said, adding that it should be pharmaceutical grade and extended release.

Also, bright lights during the day, movement throughout the day, and dim lights closer to bedtime are especially important for the elderly, Dr. Lettieri said.

Andrew Corr, MD, a geriatric specialist in primary care with the Riverside (Calif.) Medical Clinic, said in an interview the main message he will take back to his physician group is more CBT and less medication.

He said that, although he has long known CBT is the top first-line treatment, it is difficult to find experts in his area who are trained to do CBT for insomnia, so he was glad to hear online programs and self-directed reading are typically effective.

He also said there’s a common misperception that there’s no harm in prescribing medications such as trazodone (Desyrel), an antidepressant commonly used off label as a sleep aid.

Dr. Lettieri’s talk highlighted his recommendation against using trazodone for sleep. “Despite several recommendations against its use for insomnia, it is still commonly prescribed. You just shouldn’t use it for insomnia,” Dr. Lettieri said.

“It has no measurable effect in a third of patients and at least unacceptable side effects in another third.  Right off the bat, it’s not efficacious in two thirds of patients.”

Additionally, priapism, a prolonged erection, has been associated with trazodone, Dr. Lettieri said, “and I have literally never met a patient on trazodone who was counseled about this.”

Trazodone also has a black box warning from the Food and Drug Administration warning about increased risk for suicidal thoughts.

Dr. Lettieri and Dr. Corr disclosed no relevant financial relationships.

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

Chronic insomnia is often underrecognized and misunderstood in primary care, sleep expert Christopher Lettieri, MD, told attendees at the annual meeting of the American College of Physicians.

Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Dr. Lettieri, professor in pulmonary, critical care, and sleep medicine at Johns Hopkins University, Baltimore.

However, medications alone won’t work without other behavior modifications and they come with potential side effects, he said in his talk. Prescription medications typically don’t treat the cause of the insomnia, just the symptoms.

“In the 15 years I’ve been practicing sleep medicine, I can honestly say I only have a handful of patients that I treat with long-term pharmacotherapy,” Dr. Lettieri said.

He said he typically uses pharmacotherapy only when conservative measures have failed or to help jump-start patients to behavior modifications.

Restricted sleep is a good place to start for chronic insomnia, he continued.

Physicians should ask patients the latest time they can wake up to make it to school, work, etc. If that time is 6 a.m., the goal is to move bedtime back to 10 p.m.–11 p.m. If the patient, however, is unable to sleep until 12:30 a.m., move bedtime there, he said.

Though the 5.5-hour window is not ideal, it’s better to get into bed when ready for sleep. From there, try to get the patient to move bedtime back 15 minutes each week as they train themselves to fall asleep earlier, he said.

“I promise you this works in the majority of patients and doesn’t require any medication. You can also accomplish this with one or two office visits, so it is not a huge drain on resources,” he said.
 

Sleep specialists in short supply

Cognitive-behavioral therapy (CBT) is “without question the best way to treat chronic insomnia and it’s recommended as first-line therapy by all published guidelines,” Dr. Lettieri said.

He defined chronic insomnia as happening most nights over at least 3 months. It affects twice as many women as men.

CBT offers a formalized way of changing sleep patterns with the help of an expert in sleep behavior disorders. It combines cognitive therapies with education about sleep and stimulus control and uses techniques such as mindfulness and relaxation.

However, most programs take 4-8 sessions with a sleep medicine provider and are usually not covered by insurance. In addition, the number of insomnia specialists is not nearly adequate to meet demand, he added.

Online and mobile-platform CBT programs are widely effective, Dr. Lettieri said. Many are free and all are convenient for patients to use. He said many of his patients use Sleepio, but many other online programs are effective.

“You can provide sufficient therapy for many of your patients and reserve CBT for patients who can’t be fixed with more conservative measures,” he said.
 

Insomnia among older patients

Interest in helping older patients with insomnia dominated the chat session associated with the talk.

Insomnia increases with age and older patients have often been using prescription or over-the-counter sleep aids for decades.

Additionally, “insomnia is the second-most common reason why people get admitted to long-term care facilities, second only to urinary incontinence,” Dr. Lettieri said.

If physicians use medications with older patients, he said, extra caution is needed. Older people have more neurocognitive impairments than younger adults and may already be taking several other medications. Sleep medications may come with longer elimination half-lives. Polypharmacy may increase risk for falls and have other consequences.

“If you have to go to a medication, try something simple like melatonin,” he said, adding that it should be pharmaceutical grade and extended release.

Also, bright lights during the day, movement throughout the day, and dim lights closer to bedtime are especially important for the elderly, Dr. Lettieri said.

Andrew Corr, MD, a geriatric specialist in primary care with the Riverside (Calif.) Medical Clinic, said in an interview the main message he will take back to his physician group is more CBT and less medication.

He said that, although he has long known CBT is the top first-line treatment, it is difficult to find experts in his area who are trained to do CBT for insomnia, so he was glad to hear online programs and self-directed reading are typically effective.

He also said there’s a common misperception that there’s no harm in prescribing medications such as trazodone (Desyrel), an antidepressant commonly used off label as a sleep aid.

Dr. Lettieri’s talk highlighted his recommendation against using trazodone for sleep. “Despite several recommendations against its use for insomnia, it is still commonly prescribed. You just shouldn’t use it for insomnia,” Dr. Lettieri said.

“It has no measurable effect in a third of patients and at least unacceptable side effects in another third.  Right off the bat, it’s not efficacious in two thirds of patients.”

Additionally, priapism, a prolonged erection, has been associated with trazodone, Dr. Lettieri said, “and I have literally never met a patient on trazodone who was counseled about this.”

Trazodone also has a black box warning from the Food and Drug Administration warning about increased risk for suicidal thoughts.

Dr. Lettieri and Dr. Corr disclosed no relevant financial relationships.

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

Chronic insomnia is often underrecognized and misunderstood in primary care, sleep expert Christopher Lettieri, MD, told attendees at the annual meeting of the American College of Physicians.

Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Dr. Lettieri, professor in pulmonary, critical care, and sleep medicine at Johns Hopkins University, Baltimore.

However, medications alone won’t work without other behavior modifications and they come with potential side effects, he said in his talk. Prescription medications typically don’t treat the cause of the insomnia, just the symptoms.

“In the 15 years I’ve been practicing sleep medicine, I can honestly say I only have a handful of patients that I treat with long-term pharmacotherapy,” Dr. Lettieri said.

He said he typically uses pharmacotherapy only when conservative measures have failed or to help jump-start patients to behavior modifications.

Restricted sleep is a good place to start for chronic insomnia, he continued.

Physicians should ask patients the latest time they can wake up to make it to school, work, etc. If that time is 6 a.m., the goal is to move bedtime back to 10 p.m.–11 p.m. If the patient, however, is unable to sleep until 12:30 a.m., move bedtime there, he said.

Though the 5.5-hour window is not ideal, it’s better to get into bed when ready for sleep. From there, try to get the patient to move bedtime back 15 minutes each week as they train themselves to fall asleep earlier, he said.

“I promise you this works in the majority of patients and doesn’t require any medication. You can also accomplish this with one or two office visits, so it is not a huge drain on resources,” he said.
 

Sleep specialists in short supply

Cognitive-behavioral therapy (CBT) is “without question the best way to treat chronic insomnia and it’s recommended as first-line therapy by all published guidelines,” Dr. Lettieri said.

He defined chronic insomnia as happening most nights over at least 3 months. It affects twice as many women as men.

CBT offers a formalized way of changing sleep patterns with the help of an expert in sleep behavior disorders. It combines cognitive therapies with education about sleep and stimulus control and uses techniques such as mindfulness and relaxation.

However, most programs take 4-8 sessions with a sleep medicine provider and are usually not covered by insurance. In addition, the number of insomnia specialists is not nearly adequate to meet demand, he added.

Online and mobile-platform CBT programs are widely effective, Dr. Lettieri said. Many are free and all are convenient for patients to use. He said many of his patients use Sleepio, but many other online programs are effective.

“You can provide sufficient therapy for many of your patients and reserve CBT for patients who can’t be fixed with more conservative measures,” he said.
 

Insomnia among older patients

Interest in helping older patients with insomnia dominated the chat session associated with the talk.

Insomnia increases with age and older patients have often been using prescription or over-the-counter sleep aids for decades.

Additionally, “insomnia is the second-most common reason why people get admitted to long-term care facilities, second only to urinary incontinence,” Dr. Lettieri said.

If physicians use medications with older patients, he said, extra caution is needed. Older people have more neurocognitive impairments than younger adults and may already be taking several other medications. Sleep medications may come with longer elimination half-lives. Polypharmacy may increase risk for falls and have other consequences.

“If you have to go to a medication, try something simple like melatonin,” he said, adding that it should be pharmaceutical grade and extended release.

Also, bright lights during the day, movement throughout the day, and dim lights closer to bedtime are especially important for the elderly, Dr. Lettieri said.

Andrew Corr, MD, a geriatric specialist in primary care with the Riverside (Calif.) Medical Clinic, said in an interview the main message he will take back to his physician group is more CBT and less medication.

He said that, although he has long known CBT is the top first-line treatment, it is difficult to find experts in his area who are trained to do CBT for insomnia, so he was glad to hear online programs and self-directed reading are typically effective.

He also said there’s a common misperception that there’s no harm in prescribing medications such as trazodone (Desyrel), an antidepressant commonly used off label as a sleep aid.

Dr. Lettieri’s talk highlighted his recommendation against using trazodone for sleep. “Despite several recommendations against its use for insomnia, it is still commonly prescribed. You just shouldn’t use it for insomnia,” Dr. Lettieri said.

“It has no measurable effect in a third of patients and at least unacceptable side effects in another third.  Right off the bat, it’s not efficacious in two thirds of patients.”

Additionally, priapism, a prolonged erection, has been associated with trazodone, Dr. Lettieri said, “and I have literally never met a patient on trazodone who was counseled about this.”

Trazodone also has a black box warning from the Food and Drug Administration warning about increased risk for suicidal thoughts.

Dr. Lettieri and Dr. Corr disclosed no relevant financial relationships.

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

Intramuscular injections of glucocorticoids have efficacy similar to that of intra-articular injections in reducing pain in knee osteoarthritis but without the concerns about joint infection and the challenges of administration, according to results from a randomized, controlled trial reported at the OARSI 2021 World Congress.

Intra-articular injections of glucocorticoids are commonly used to relieve OA pain, but some general practitioners have difficulty administering them to patients, said Qiuke Wang, a PhD candidate at Erasmus University Medical Center in Rotterdam, the Netherlands. There are also concerns about whether intra-articular injections may cause damage to knee cartilage, Mr. Wang said at the conference, which is sponsored by the Osteoarthritis Research Society International.

Mr. Wang and colleagues conducted a randomized, controlled trial in which 145 patients with symptomatic knee OA received either an intramuscular or intra-articular injection of 40 mg triamcinolone acetonide, and then followed up at regular intervals for 24 weeks.

The study showed that Knee Injury and Osteoarthritis Outcome Scores for pain improved in both the intra-articular and intramuscular groups. Improvements in pain scores peaked in the intra-articular injection group at the 4-week mark, when the difference with intramuscular injections was statistically significant. However, the two groups showed no significant differences in pain improvement at the 8-, 12-, and 24-week follow-up points.

“Intra-articular injection can act immediately on inhibiting joint inflammation after injection,” Mr. Wang said in an interview. “In contrast, for intramuscular injection, glucocorticoid needs firstly to be absorbed by muscle into blood and then travel into the knee via the circulatory system.”

The study also showed no significant differences between the two groups in the secondary outcomes of patient symptoms, stiffness, function, and sport and quality of life scores. There were more adverse events in the intra-articular injection group: 42% of patients reported an adverse event, compared to 33% in the intramuscular group, and the adverse events reported in the intramuscular group were nonserious events, such as headache and flushing.

Mr. Wang told the conference that while the intramuscular injection was inferior to intra-articular injections at 4 weeks, it was noninferior at 8 and 24 weeks and should be considered an effective way to reduce pain in patients with knee OA.

“This trial provides evidence for shared decision making because in some cases a patient may have a preference for specific injection and the GP may feel incompetent to administer the intra-articular injection,” he said.

An audience member pointed out that there was now a growing body of evidence suggesting that intra-articular injections may contribute to faster progression of knee OA because of effects on knee cartilage.

Mr. Wang acknowledged that their own research had shown these side effects of intra-articular injections, which was why the trial was intended to examine whether intramuscular injections might achieve the same pain relief.

“In the real practice, I would say that both injections are effective, but the intra-articular injection may provide a slightly [better] effect in the short term,” he said.

Commenting on the findings, Martin van der Esch, PhD, of Amsterdam University of Applied Sciences, said there were no guidelines as to whether intra-articular or intramuscular injections were the best option, so it really came down to the clinician’s decision.

“Therefore this is really an interesting study, because it gives some light – not the answer – but some light in what direction it could go for specific groups of patients,” Dr. van der Esch said in an interview.

Dr. van der Esch suggested that intramuscular injections might be more appropriate for patients with more systemic disease affecting multiple joints, but intra-articular injections might offer greater benefits in a patient with severe and long-lasting disease in a single joint.

No conflicts of interest were declared.

Intramuscular injections of glucocorticoids have efficacy similar to that of intra-articular injections in reducing pain in knee osteoarthritis but without the concerns about joint infection and the challenges of administration, according to results from a randomized, controlled trial reported at the OARSI 2021 World Congress.

Intra-articular injections of glucocorticoids are commonly used to relieve OA pain, but some general practitioners have difficulty administering them to patients, said Qiuke Wang, a PhD candidate at Erasmus University Medical Center in Rotterdam, the Netherlands. There are also concerns about whether intra-articular injections may cause damage to knee cartilage, Mr. Wang said at the conference, which is sponsored by the Osteoarthritis Research Society International.

Mr. Wang and colleagues conducted a randomized, controlled trial in which 145 patients with symptomatic knee OA received either an intramuscular or intra-articular injection of 40 mg triamcinolone acetonide, and then followed up at regular intervals for 24 weeks.

The study showed that Knee Injury and Osteoarthritis Outcome Scores for pain improved in both the intra-articular and intramuscular groups. Improvements in pain scores peaked in the intra-articular injection group at the 4-week mark, when the difference with intramuscular injections was statistically significant. However, the two groups showed no significant differences in pain improvement at the 8-, 12-, and 24-week follow-up points.

“Intra-articular injection can act immediately on inhibiting joint inflammation after injection,” Mr. Wang said in an interview. “In contrast, for intramuscular injection, glucocorticoid needs firstly to be absorbed by muscle into blood and then travel into the knee via the circulatory system.”

The study also showed no significant differences between the two groups in the secondary outcomes of patient symptoms, stiffness, function, and sport and quality of life scores. There were more adverse events in the intra-articular injection group: 42% of patients reported an adverse event, compared to 33% in the intramuscular group, and the adverse events reported in the intramuscular group were nonserious events, such as headache and flushing.

Mr. Wang told the conference that while the intramuscular injection was inferior to intra-articular injections at 4 weeks, it was noninferior at 8 and 24 weeks and should be considered an effective way to reduce pain in patients with knee OA.

“This trial provides evidence for shared decision making because in some cases a patient may have a preference for specific injection and the GP may feel incompetent to administer the intra-articular injection,” he said.

An audience member pointed out that there was now a growing body of evidence suggesting that intra-articular injections may contribute to faster progression of knee OA because of effects on knee cartilage.

Mr. Wang acknowledged that their own research had shown these side effects of intra-articular injections, which was why the trial was intended to examine whether intramuscular injections might achieve the same pain relief.

“In the real practice, I would say that both injections are effective, but the intra-articular injection may provide a slightly [better] effect in the short term,” he said.

Commenting on the findings, Martin van der Esch, PhD, of Amsterdam University of Applied Sciences, said there were no guidelines as to whether intra-articular or intramuscular injections were the best option, so it really came down to the clinician’s decision.

“Therefore this is really an interesting study, because it gives some light – not the answer – but some light in what direction it could go for specific groups of patients,” Dr. van der Esch said in an interview.

Dr. van der Esch suggested that intramuscular injections might be more appropriate for patients with more systemic disease affecting multiple joints, but intra-articular injections might offer greater benefits in a patient with severe and long-lasting disease in a single joint.

No conflicts of interest were declared.

Intramuscular injections of glucocorticoids have efficacy similar to that of intra-articular injections in reducing pain in knee osteoarthritis but without the concerns about joint infection and the challenges of administration, according to results from a randomized, controlled trial reported at the OARSI 2021 World Congress.

Intra-articular injections of glucocorticoids are commonly used to relieve OA pain, but some general practitioners have difficulty administering them to patients, said Qiuke Wang, a PhD candidate at Erasmus University Medical Center in Rotterdam, the Netherlands. There are also concerns about whether intra-articular injections may cause damage to knee cartilage, Mr. Wang said at the conference, which is sponsored by the Osteoarthritis Research Society International.

Mr. Wang and colleagues conducted a randomized, controlled trial in which 145 patients with symptomatic knee OA received either an intramuscular or intra-articular injection of 40 mg triamcinolone acetonide, and then followed up at regular intervals for 24 weeks.

The study showed that Knee Injury and Osteoarthritis Outcome Scores for pain improved in both the intra-articular and intramuscular groups. Improvements in pain scores peaked in the intra-articular injection group at the 4-week mark, when the difference with intramuscular injections was statistically significant. However, the two groups showed no significant differences in pain improvement at the 8-, 12-, and 24-week follow-up points.

“Intra-articular injection can act immediately on inhibiting joint inflammation after injection,” Mr. Wang said in an interview. “In contrast, for intramuscular injection, glucocorticoid needs firstly to be absorbed by muscle into blood and then travel into the knee via the circulatory system.”

The study also showed no significant differences between the two groups in the secondary outcomes of patient symptoms, stiffness, function, and sport and quality of life scores. There were more adverse events in the intra-articular injection group: 42% of patients reported an adverse event, compared to 33% in the intramuscular group, and the adverse events reported in the intramuscular group were nonserious events, such as headache and flushing.

Mr. Wang told the conference that while the intramuscular injection was inferior to intra-articular injections at 4 weeks, it was noninferior at 8 and 24 weeks and should be considered an effective way to reduce pain in patients with knee OA.

“This trial provides evidence for shared decision making because in some cases a patient may have a preference for specific injection and the GP may feel incompetent to administer the intra-articular injection,” he said.

An audience member pointed out that there was now a growing body of evidence suggesting that intra-articular injections may contribute to faster progression of knee OA because of effects on knee cartilage.

Mr. Wang acknowledged that their own research had shown these side effects of intra-articular injections, which was why the trial was intended to examine whether intramuscular injections might achieve the same pain relief.

“In the real practice, I would say that both injections are effective, but the intra-articular injection may provide a slightly [better] effect in the short term,” he said.

Commenting on the findings, Martin van der Esch, PhD, of Amsterdam University of Applied Sciences, said there were no guidelines as to whether intra-articular or intramuscular injections were the best option, so it really came down to the clinician’s decision.

“Therefore this is really an interesting study, because it gives some light – not the answer – but some light in what direction it could go for specific groups of patients,” Dr. van der Esch said in an interview.

Dr. van der Esch suggested that intramuscular injections might be more appropriate for patients with more systemic disease affecting multiple joints, but intra-articular injections might offer greater benefits in a patient with severe and long-lasting disease in a single joint.

No conflicts of interest were declared.

Asking a patient who has concerns about memory loss–particular questions can guide referral decisions, according to new research.

Initial questions should zero in on what the patient is forgetting, said Megan Richie, MD, a neurohospitalist at the University of California, San Francisco, who spoke to a virtual audience at the American College of Physicians (ACP) annual Internal Medicine meeting.

Is the patient forgetting to buy things in a store, having trouble recalling events, forgetting important dates? How often do these incidents occur?

These questions “will help get at how pervasive and how likely the memory loss is affecting their lives, versus a subjective complaint that doesn’t have much impact on the day-to-day function,” she said.

It’s also important to ask whether other neurocognitive symptoms accompany the memory loss, Dr. Richie noted.

Does the patient search for words, struggle with attention, or have problems with executive function? Does the patient have psychiatric symptoms, such as hallucinations or delusions, or other neurologic complaints, including weakness, numbness, vision change, or movement disorders?

“When you know how many neurocognitive symptoms they have, think about how [those symptoms] are affecting their safety and functional status. How are they on their activities of daily living?” Dr. Richie suggests.

Also ask whether the patient is taking medications and whether they drive a vehicle. If they do drive, do they get lost?

“These are all going to help you determine the acuity of the workup,” she said.

After a thorough history, cognitive screening is the next consideration.
 

Cognitive screening can be performed in minutes

One of the tests Dr. Richie recommends is the Mini-Cog. It takes 3 minutes to administer and has been formally recommended by the Alzheimer’s Association because it can be completed in the time frame of a Medicare wellness visit, she said.

It entails a three-word recall and clock-drawing test.

Dr. Richie said it’s important to eliminate some key causes first: “Certainly if the patient has signs and symptoms of depression, pseudodementia is a very real and treatable disease you do not want to miss and should consider in these patients,” she pointed out.

Systemic medical conditions can also lead to memory loss.

If there’s an acute component to the complaint, a new infection or medication withdrawal or a side effect could be driving it, so that’s key in questioning.

Dr. Richie explained that the American Academy of Neurology recommends a very limited workup.

“It’s really just to check their thyroid, their vitamin B12 levels, and then a one-time picture of their brain, which can be either MRI or a CT, to look for structural problems or vascular dementia or hydrocephalus, etc.”

“You do not routinely need spinal fluid testing or an EEG,” she emphasized.

Signs that a neurologist should be involved include a rapid decline, signs of potential seizures, or that the patient doesn’t seem safe in their condition.

Neuropsychological testing is helpful, but it takes nearly 3 hours and may not be a good choice for restless or aggressive patients, Dr. Richie said.

Such testing is often not available, and if it is, insurance coverage is often a barrier because many plans don’t cover it.

Patients often ask about drugs and supplements they see advertised to help with memory loss. Medications are not helpful for mild cognitive impairment, although there is evidence that some are beneficial for patients with dementia, Dr. Richie said.

Celine Goetz, MD, assistant professor of internal medicine at Rush University Medical Center, Chicago, Illinois, told this news organization that it’s easy to relate to the fear that patients and families feel when cognitive impairment begins to emerge.

“[Dr.] Richie’s talk was right on point for internists like myself who see many patients with memory complaints, cognitive impairment, and dementia. I think we’re all terrified of losing our memory and the social and functional impairment that comes with that,” she said.

Although cognitive impairment and dementia aren’t curable or reversible, Dr. Goetz noted, internists can help patients optimize management of conditions such as diabetes and heart disease, which can affect cognitive function.

Dr. Richie pointed out that some interventions lack evidence for the treatment of mild cognitive impairment, but Dr. Goetz emphasized that resources are plentiful and can be effective in combination.

“Engaging social workers, pharmacists, nutritionists, physical and occupational therapists, and, on the inpatient side, delirium protocols, chaplains, and music therapists make a huge difference in patient care,” she said.

Dr. Richie and Dr. Goetz report no relevant financial relationships.

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

Asking a patient who has concerns about memory loss–particular questions can guide referral decisions, according to new research.

Initial questions should zero in on what the patient is forgetting, said Megan Richie, MD, a neurohospitalist at the University of California, San Francisco, who spoke to a virtual audience at the American College of Physicians (ACP) annual Internal Medicine meeting.

Is the patient forgetting to buy things in a store, having trouble recalling events, forgetting important dates? How often do these incidents occur?

These questions “will help get at how pervasive and how likely the memory loss is affecting their lives, versus a subjective complaint that doesn’t have much impact on the day-to-day function,” she said.

It’s also important to ask whether other neurocognitive symptoms accompany the memory loss, Dr. Richie noted.

Does the patient search for words, struggle with attention, or have problems with executive function? Does the patient have psychiatric symptoms, such as hallucinations or delusions, or other neurologic complaints, including weakness, numbness, vision change, or movement disorders?

“When you know how many neurocognitive symptoms they have, think about how [those symptoms] are affecting their safety and functional status. How are they on their activities of daily living?” Dr. Richie suggests.

Also ask whether the patient is taking medications and whether they drive a vehicle. If they do drive, do they get lost?

“These are all going to help you determine the acuity of the workup,” she said.

After a thorough history, cognitive screening is the next consideration.
 

Cognitive screening can be performed in minutes

One of the tests Dr. Richie recommends is the Mini-Cog. It takes 3 minutes to administer and has been formally recommended by the Alzheimer’s Association because it can be completed in the time frame of a Medicare wellness visit, she said.

It entails a three-word recall and clock-drawing test.

Dr. Richie said it’s important to eliminate some key causes first: “Certainly if the patient has signs and symptoms of depression, pseudodementia is a very real and treatable disease you do not want to miss and should consider in these patients,” she pointed out.

Systemic medical conditions can also lead to memory loss.

If there’s an acute component to the complaint, a new infection or medication withdrawal or a side effect could be driving it, so that’s key in questioning.

Dr. Richie explained that the American Academy of Neurology recommends a very limited workup.

“It’s really just to check their thyroid, their vitamin B12 levels, and then a one-time picture of their brain, which can be either MRI or a CT, to look for structural problems or vascular dementia or hydrocephalus, etc.”

“You do not routinely need spinal fluid testing or an EEG,” she emphasized.

Signs that a neurologist should be involved include a rapid decline, signs of potential seizures, or that the patient doesn’t seem safe in their condition.

Neuropsychological testing is helpful, but it takes nearly 3 hours and may not be a good choice for restless or aggressive patients, Dr. Richie said.

Such testing is often not available, and if it is, insurance coverage is often a barrier because many plans don’t cover it.

Patients often ask about drugs and supplements they see advertised to help with memory loss. Medications are not helpful for mild cognitive impairment, although there is evidence that some are beneficial for patients with dementia, Dr. Richie said.

Celine Goetz, MD, assistant professor of internal medicine at Rush University Medical Center, Chicago, Illinois, told this news organization that it’s easy to relate to the fear that patients and families feel when cognitive impairment begins to emerge.

“[Dr.] Richie’s talk was right on point for internists like myself who see many patients with memory complaints, cognitive impairment, and dementia. I think we’re all terrified of losing our memory and the social and functional impairment that comes with that,” she said.

Although cognitive impairment and dementia aren’t curable or reversible, Dr. Goetz noted, internists can help patients optimize management of conditions such as diabetes and heart disease, which can affect cognitive function.

Dr. Richie pointed out that some interventions lack evidence for the treatment of mild cognitive impairment, but Dr. Goetz emphasized that resources are plentiful and can be effective in combination.

“Engaging social workers, pharmacists, nutritionists, physical and occupational therapists, and, on the inpatient side, delirium protocols, chaplains, and music therapists make a huge difference in patient care,” she said.

Dr. Richie and Dr. Goetz report no relevant financial relationships.

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

Asking a patient who has concerns about memory loss–particular questions can guide referral decisions, according to new research.

Initial questions should zero in on what the patient is forgetting, said Megan Richie, MD, a neurohospitalist at the University of California, San Francisco, who spoke to a virtual audience at the American College of Physicians (ACP) annual Internal Medicine meeting.

Is the patient forgetting to buy things in a store, having trouble recalling events, forgetting important dates? How often do these incidents occur?

These questions “will help get at how pervasive and how likely the memory loss is affecting their lives, versus a subjective complaint that doesn’t have much impact on the day-to-day function,” she said.

It’s also important to ask whether other neurocognitive symptoms accompany the memory loss, Dr. Richie noted.

Does the patient search for words, struggle with attention, or have problems with executive function? Does the patient have psychiatric symptoms, such as hallucinations or delusions, or other neurologic complaints, including weakness, numbness, vision change, or movement disorders?

“When you know how many neurocognitive symptoms they have, think about how [those symptoms] are affecting their safety and functional status. How are they on their activities of daily living?” Dr. Richie suggests.

Also ask whether the patient is taking medications and whether they drive a vehicle. If they do drive, do they get lost?

“These are all going to help you determine the acuity of the workup,” she said.

After a thorough history, cognitive screening is the next consideration.
 

Cognitive screening can be performed in minutes

One of the tests Dr. Richie recommends is the Mini-Cog. It takes 3 minutes to administer and has been formally recommended by the Alzheimer’s Association because it can be completed in the time frame of a Medicare wellness visit, she said.

It entails a three-word recall and clock-drawing test.

Dr. Richie said it’s important to eliminate some key causes first: “Certainly if the patient has signs and symptoms of depression, pseudodementia is a very real and treatable disease you do not want to miss and should consider in these patients,” she pointed out.

Systemic medical conditions can also lead to memory loss.

If there’s an acute component to the complaint, a new infection or medication withdrawal or a side effect could be driving it, so that’s key in questioning.

Dr. Richie explained that the American Academy of Neurology recommends a very limited workup.

“It’s really just to check their thyroid, their vitamin B12 levels, and then a one-time picture of their brain, which can be either MRI or a CT, to look for structural problems or vascular dementia or hydrocephalus, etc.”

“You do not routinely need spinal fluid testing or an EEG,” she emphasized.

Signs that a neurologist should be involved include a rapid decline, signs of potential seizures, or that the patient doesn’t seem safe in their condition.

Neuropsychological testing is helpful, but it takes nearly 3 hours and may not be a good choice for restless or aggressive patients, Dr. Richie said.

Such testing is often not available, and if it is, insurance coverage is often a barrier because many plans don’t cover it.

Patients often ask about drugs and supplements they see advertised to help with memory loss. Medications are not helpful for mild cognitive impairment, although there is evidence that some are beneficial for patients with dementia, Dr. Richie said.

Celine Goetz, MD, assistant professor of internal medicine at Rush University Medical Center, Chicago, Illinois, told this news organization that it’s easy to relate to the fear that patients and families feel when cognitive impairment begins to emerge.

“[Dr.] Richie’s talk was right on point for internists like myself who see many patients with memory complaints, cognitive impairment, and dementia. I think we’re all terrified of losing our memory and the social and functional impairment that comes with that,” she said.

Although cognitive impairment and dementia aren’t curable or reversible, Dr. Goetz noted, internists can help patients optimize management of conditions such as diabetes and heart disease, which can affect cognitive function.

Dr. Richie pointed out that some interventions lack evidence for the treatment of mild cognitive impairment, but Dr. Goetz emphasized that resources are plentiful and can be effective in combination.

“Engaging social workers, pharmacists, nutritionists, physical and occupational therapists, and, on the inpatient side, delirium protocols, chaplains, and music therapists make a huge difference in patient care,” she said.

Dr. Richie and Dr. Goetz report no relevant financial relationships.

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

The Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda) in combination with other agents for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The checkpoint inhibitor is to be used in conjunction with trastuzumab (Herceptin) and fluoropyrimidine- and platinum-containing chemotherapy.

Previously, pembrolizumab was approved as a single agent for these cancers for patients whose tumors express PD-L1 and whose disease progressed after two or more lines of treatment that included chemotherapy and HER2-targeted therapy.

The new approval comes about a year after the FDA’s first-ever approval of a checkpoint inhibitor (nivolumab [Opdivo] in combination with chemotherapies) for the frontline treatment of gastric cancers, as reported by this news organization.

The new approval is based on interim data from the first 264 patients of the ongoing KEYNOTE-811 trial, a randomized, double-blind, placebo-controlled trial involving patients with HER2-positive advanced gastric or GEJ adenocarcinoma who had not previously received systemic therapy for their metastatic disease.

Patients were randomly assigned (1:1) to receive either pembrolizumab at 200 mg or placebo every 3 weeks in combination with trastuzumab and either fluorouracil plus cisplatin or capecitabine plus oxaliplatin.

The overall response rate, which is the primary outcome, was 74% in the pembrolizumab arm and 52% in the placebo arm (one-sided P < .0001).

The median duration of response was 10.6 months in the pembrolizumab arm and 9.5 months in the placebo arm.

The adverse-reaction profile for patients receiving pembrolizumab is consistent with the known pembrolizumab safety profile, the FDA said in a statement.

The recommended pembrolizumab dose in this setting is 200 mg every 3 weeks or 400 mg every 6 weeks.

The FDA’s review, which was granted priority status, used the Real-Time Oncology Review pilot program, which allows streamlined data submission prior to the filing of the full clinical application, and Assessment Aid, a voluntary submission that facilitates the FDA’s assessment.

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

The Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda) in combination with other agents for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The checkpoint inhibitor is to be used in conjunction with trastuzumab (Herceptin) and fluoropyrimidine- and platinum-containing chemotherapy.

Previously, pembrolizumab was approved as a single agent for these cancers for patients whose tumors express PD-L1 and whose disease progressed after two or more lines of treatment that included chemotherapy and HER2-targeted therapy.

The new approval comes about a year after the FDA’s first-ever approval of a checkpoint inhibitor (nivolumab [Opdivo] in combination with chemotherapies) for the frontline treatment of gastric cancers, as reported by this news organization.

The new approval is based on interim data from the first 264 patients of the ongoing KEYNOTE-811 trial, a randomized, double-blind, placebo-controlled trial involving patients with HER2-positive advanced gastric or GEJ adenocarcinoma who had not previously received systemic therapy for their metastatic disease.

Patients were randomly assigned (1:1) to receive either pembrolizumab at 200 mg or placebo every 3 weeks in combination with trastuzumab and either fluorouracil plus cisplatin or capecitabine plus oxaliplatin.

The overall response rate, which is the primary outcome, was 74% in the pembrolizumab arm and 52% in the placebo arm (one-sided P < .0001).

The median duration of response was 10.6 months in the pembrolizumab arm and 9.5 months in the placebo arm.

The adverse-reaction profile for patients receiving pembrolizumab is consistent with the known pembrolizumab safety profile, the FDA said in a statement.

The recommended pembrolizumab dose in this setting is 200 mg every 3 weeks or 400 mg every 6 weeks.

The FDA’s review, which was granted priority status, used the Real-Time Oncology Review pilot program, which allows streamlined data submission prior to the filing of the full clinical application, and Assessment Aid, a voluntary submission that facilitates the FDA’s assessment.

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

The Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda) in combination with other agents for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The checkpoint inhibitor is to be used in conjunction with trastuzumab (Herceptin) and fluoropyrimidine- and platinum-containing chemotherapy.

Previously, pembrolizumab was approved as a single agent for these cancers for patients whose tumors express PD-L1 and whose disease progressed after two or more lines of treatment that included chemotherapy and HER2-targeted therapy.

The new approval comes about a year after the FDA’s first-ever approval of a checkpoint inhibitor (nivolumab [Opdivo] in combination with chemotherapies) for the frontline treatment of gastric cancers, as reported by this news organization.

The new approval is based on interim data from the first 264 patients of the ongoing KEYNOTE-811 trial, a randomized, double-blind, placebo-controlled trial involving patients with HER2-positive advanced gastric or GEJ adenocarcinoma who had not previously received systemic therapy for their metastatic disease.

Patients were randomly assigned (1:1) to receive either pembrolizumab at 200 mg or placebo every 3 weeks in combination with trastuzumab and either fluorouracil plus cisplatin or capecitabine plus oxaliplatin.

The overall response rate, which is the primary outcome, was 74% in the pembrolizumab arm and 52% in the placebo arm (one-sided P < .0001).

The median duration of response was 10.6 months in the pembrolizumab arm and 9.5 months in the placebo arm.

The adverse-reaction profile for patients receiving pembrolizumab is consistent with the known pembrolizumab safety profile, the FDA said in a statement.

The recommended pembrolizumab dose in this setting is 200 mg every 3 weeks or 400 mg every 6 weeks.

The FDA’s review, which was granted priority status, used the Real-Time Oncology Review pilot program, which allows streamlined data submission prior to the filing of the full clinical application, and Assessment Aid, a voluntary submission that facilitates the FDA’s assessment.

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

Genetic biomarkers for atopic dermatitis (AD) vary from one ethnic group to another, with a mutation in the interleukin-17 receptor A (IL-17RA) gene particularly important in Korean patients, researchers say.

The finding moves researchers another step forward in the effort to figure out which patients are most at risk for the disease and who will respond best to which treatments.

“Because atopic dermatitis is considered a complex trait, we think if there is any method to detect AD gene variations simultaneously, it could be possible to prevent the development of AD and then the atopic march,” said Eung Ho Choi, MD, PhD, a dermatology professor at Yonsei University, Wonju, South Korea.

He presented the finding at the International Society of Atopic Dermatitis (ISAD) 2021 Annual Meeting.

Atopic dermatitis is not caused by a single genetic mutation. But genetic factors play an important role, with about 75% concordance between monozygotic twins versus only 23% for dizygotic twins.

“Genetic biomarkers are needed in predicting the occurrence, severity, and treatment response,” as well as determining the prognosis of atopic dermatitis “and applying it to precision medicine,” Dr. Choi said.

Researchers have identified multiple genetic variations related to atopic dermatitis. One of the most significant genetic contributions found so far is the filaggrin gene variation, which can produce a defective skin barrier, Dr. Choi said. Others are involved in the immune response.

Although variations in the filaggrin gene (FLG ) are the most reliable genetic predictor of atopic dermatitis in Korean patients, they are less common in Korean patients than in Northwestern Europeans, Chinese, and Japanese patients. In Korean patients, the most common reported mutations of this gene are 3321delA and K4022X, Dr. Choi said.

To find out what other gene variants are important in Korean patients with atopic dermatitis, Dr. Choi and his colleagues developed the reverse blot hybridization assay (REBA) to detect skin barrier variations in the FLG, SPINK5 and KLK7 genes, and genes involved in immune response variations, KDR, IL-5RA, IL-9, DEFB1 (Defensin Beta 1), IL-12RB1 (interleukin-12 receptor subunit beta 1), and IL-12RB2.

They compared the prevalence of these variations in 279 Koreans with atopic dermatitis to the prevalence in 224 healthy people without atopic dermatitis and found that the odds ratio for atopic dermatitis increased with the number of these variants: People with three or four variants had a 3.75 times greater risk of AD, and those with 5 or more variants had a 10.3 times greater risk. The number of variants did not correlate to the severity of the disease, however.

The filaggrin variation was present in 13.9% of those with atopic dermatitis. About a quarter (28%) of the patients with AD who had this variation had impetigo, 15% had eczema herpeticum, and 5% had prurigo nodularis. By comparison, 14% of the patients with AD who did not have this variation had impetigo, and 5% had eczema herpeticum, but 19% had prurigo nodularis.

In a separate study, Dr. Choi and his colleagues identified a mutation in IL-17RA, present in 8.1% of 332 patients with AD compared with 3.3% of 245 controls. The patients with IL-17RA mutations all had extrinsic AD.

The variation was associated with longer disease duration, more frequent keratosis pilaris, higher blood eosinophil counts, higher serum total immunoglobulin E (IgE) levels, higher house dust mite allergen-specific IgE levels, and a greater need for systemic treatment than patients without the IL-17RA mutation.

Such findings are important for progress in treating atopic dermatitis because the mechanism differs among patients, said Emma Guttman-Yassky, MD, PhD, director of the Center for Excellence in Eczema and professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

“It’s not one size fits all in atopic dermatitis, and we need better biomarkers that will be able to tell us which treatment will work best for each patient,” she said in an interview.

In addition to genetic biomarkers, she and her colleagues are analyzing proteins involved in inflammation. They are using adhesive tape strips to harvest these markers, a less invasive approach than skin biopsies.

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

Genetic biomarkers for atopic dermatitis (AD) vary from one ethnic group to another, with a mutation in the interleukin-17 receptor A (IL-17RA) gene particularly important in Korean patients, researchers say.

The finding moves researchers another step forward in the effort to figure out which patients are most at risk for the disease and who will respond best to which treatments.

“Because atopic dermatitis is considered a complex trait, we think if there is any method to detect AD gene variations simultaneously, it could be possible to prevent the development of AD and then the atopic march,” said Eung Ho Choi, MD, PhD, a dermatology professor at Yonsei University, Wonju, South Korea.

He presented the finding at the International Society of Atopic Dermatitis (ISAD) 2021 Annual Meeting.

Atopic dermatitis is not caused by a single genetic mutation. But genetic factors play an important role, with about 75% concordance between monozygotic twins versus only 23% for dizygotic twins.

“Genetic biomarkers are needed in predicting the occurrence, severity, and treatment response,” as well as determining the prognosis of atopic dermatitis “and applying it to precision medicine,” Dr. Choi said.

Researchers have identified multiple genetic variations related to atopic dermatitis. One of the most significant genetic contributions found so far is the filaggrin gene variation, which can produce a defective skin barrier, Dr. Choi said. Others are involved in the immune response.

Although variations in the filaggrin gene (FLG ) are the most reliable genetic predictor of atopic dermatitis in Korean patients, they are less common in Korean patients than in Northwestern Europeans, Chinese, and Japanese patients. In Korean patients, the most common reported mutations of this gene are 3321delA and K4022X, Dr. Choi said.

To find out what other gene variants are important in Korean patients with atopic dermatitis, Dr. Choi and his colleagues developed the reverse blot hybridization assay (REBA) to detect skin barrier variations in the FLG, SPINK5 and KLK7 genes, and genes involved in immune response variations, KDR, IL-5RA, IL-9, DEFB1 (Defensin Beta 1), IL-12RB1 (interleukin-12 receptor subunit beta 1), and IL-12RB2.

They compared the prevalence of these variations in 279 Koreans with atopic dermatitis to the prevalence in 224 healthy people without atopic dermatitis and found that the odds ratio for atopic dermatitis increased with the number of these variants: People with three or four variants had a 3.75 times greater risk of AD, and those with 5 or more variants had a 10.3 times greater risk. The number of variants did not correlate to the severity of the disease, however.

The filaggrin variation was present in 13.9% of those with atopic dermatitis. About a quarter (28%) of the patients with AD who had this variation had impetigo, 15% had eczema herpeticum, and 5% had prurigo nodularis. By comparison, 14% of the patients with AD who did not have this variation had impetigo, and 5% had eczema herpeticum, but 19% had prurigo nodularis.

In a separate study, Dr. Choi and his colleagues identified a mutation in IL-17RA, present in 8.1% of 332 patients with AD compared with 3.3% of 245 controls. The patients with IL-17RA mutations all had extrinsic AD.

The variation was associated with longer disease duration, more frequent keratosis pilaris, higher blood eosinophil counts, higher serum total immunoglobulin E (IgE) levels, higher house dust mite allergen-specific IgE levels, and a greater need for systemic treatment than patients without the IL-17RA mutation.

Such findings are important for progress in treating atopic dermatitis because the mechanism differs among patients, said Emma Guttman-Yassky, MD, PhD, director of the Center for Excellence in Eczema and professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

“It’s not one size fits all in atopic dermatitis, and we need better biomarkers that will be able to tell us which treatment will work best for each patient,” she said in an interview.

In addition to genetic biomarkers, she and her colleagues are analyzing proteins involved in inflammation. They are using adhesive tape strips to harvest these markers, a less invasive approach than skin biopsies.

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

Genetic biomarkers for atopic dermatitis (AD) vary from one ethnic group to another, with a mutation in the interleukin-17 receptor A (IL-17RA) gene particularly important in Korean patients, researchers say.

The finding moves researchers another step forward in the effort to figure out which patients are most at risk for the disease and who will respond best to which treatments.

“Because atopic dermatitis is considered a complex trait, we think if there is any method to detect AD gene variations simultaneously, it could be possible to prevent the development of AD and then the atopic march,” said Eung Ho Choi, MD, PhD, a dermatology professor at Yonsei University, Wonju, South Korea.

He presented the finding at the International Society of Atopic Dermatitis (ISAD) 2021 Annual Meeting.

Atopic dermatitis is not caused by a single genetic mutation. But genetic factors play an important role, with about 75% concordance between monozygotic twins versus only 23% for dizygotic twins.

“Genetic biomarkers are needed in predicting the occurrence, severity, and treatment response,” as well as determining the prognosis of atopic dermatitis “and applying it to precision medicine,” Dr. Choi said.

Researchers have identified multiple genetic variations related to atopic dermatitis. One of the most significant genetic contributions found so far is the filaggrin gene variation, which can produce a defective skin barrier, Dr. Choi said. Others are involved in the immune response.

Although variations in the filaggrin gene (FLG ) are the most reliable genetic predictor of atopic dermatitis in Korean patients, they are less common in Korean patients than in Northwestern Europeans, Chinese, and Japanese patients. In Korean patients, the most common reported mutations of this gene are 3321delA and K4022X, Dr. Choi said.

To find out what other gene variants are important in Korean patients with atopic dermatitis, Dr. Choi and his colleagues developed the reverse blot hybridization assay (REBA) to detect skin barrier variations in the FLG, SPINK5 and KLK7 genes, and genes involved in immune response variations, KDR, IL-5RA, IL-9, DEFB1 (Defensin Beta 1), IL-12RB1 (interleukin-12 receptor subunit beta 1), and IL-12RB2.

They compared the prevalence of these variations in 279 Koreans with atopic dermatitis to the prevalence in 224 healthy people without atopic dermatitis and found that the odds ratio for atopic dermatitis increased with the number of these variants: People with three or four variants had a 3.75 times greater risk of AD, and those with 5 or more variants had a 10.3 times greater risk. The number of variants did not correlate to the severity of the disease, however.

The filaggrin variation was present in 13.9% of those with atopic dermatitis. About a quarter (28%) of the patients with AD who had this variation had impetigo, 15% had eczema herpeticum, and 5% had prurigo nodularis. By comparison, 14% of the patients with AD who did not have this variation had impetigo, and 5% had eczema herpeticum, but 19% had prurigo nodularis.

In a separate study, Dr. Choi and his colleagues identified a mutation in IL-17RA, present in 8.1% of 332 patients with AD compared with 3.3% of 245 controls. The patients with IL-17RA mutations all had extrinsic AD.

The variation was associated with longer disease duration, more frequent keratosis pilaris, higher blood eosinophil counts, higher serum total immunoglobulin E (IgE) levels, higher house dust mite allergen-specific IgE levels, and a greater need for systemic treatment than patients without the IL-17RA mutation.

Such findings are important for progress in treating atopic dermatitis because the mechanism differs among patients, said Emma Guttman-Yassky, MD, PhD, director of the Center for Excellence in Eczema and professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

“It’s not one size fits all in atopic dermatitis, and we need better biomarkers that will be able to tell us which treatment will work best for each patient,” she said in an interview.

In addition to genetic biomarkers, she and her colleagues are analyzing proteins involved in inflammation. They are using adhesive tape strips to harvest these markers, a less invasive approach than skin biopsies.

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

The use of neoadjuvant endocrine therapy (NET) increased significantly during the first 8 months of the COVID-19 pandemic for women with estrogen receptor–positive (ER+) breast cancer. These patients would normally undergo surgery first, but because of operating room restrictions, those surgeries were delayed because of the pandemic, according to a new study.
 

“We hypothesized that by offering a nontoxic therapy, we would be able to ‘hold over’ patients until such time when personal protective equipment supplies were renewed and we could get into the operating room,” lead author Lee Wilke, MD, professor of surgery, University of Wisconsin, Madison, said in an interview.

“And while a small number of women with ER+ tumors get NET anyway, we found over one-third of patients with ER+ breast cancer were treated with NET due to COVID-19 during the first 8 months of last year,” she said.

“One year later, 31% of the same patient population is still getting NET,” she added.

The study was presented during the online annual meeting of the American Society of Breast Surgeons (ASBrS).
 

COVID-specific registry

Dr. Wilke believes that this study presents an accurate snapshot of changes in treatment caused by the pandemic.

She and her colleagues compared data collected in the ASBrS Mastery Program registry to data collected in an embedded but separate COVID-19 segment. The data were for the period from March 1 to Oct. 28, 2020.

Almost three-quarters of the surgeons who entered patients into the COVID-19 segment were from urban areas; 95% reported stopping mammographic screening during part of this period.

The preliminary analysis focused on data collected from 2,476 patients in the COVID-19 segment and 2,303 patients within the Mastery registry.

For patients with ER+/HER2- breast cancer, NET was described as a usual approach in 6.5% of patients in the COVID-19 registry. In the Mastery registry, 7.8% of patients received NET.

Compared with surgery first/usual practice, which served as the reference, older patients were more likely to receive NET first because of the COVID-19 pandemic than younger patients, and they were more likely to receive NET first if they lived in the Northeast or the Southeast compared to other regions of the United States. Dr. Wilke pointed out that the Northeast and the Southeast were hardest hit by COVID-19 early on in the pandemic.

Genomic testing was carried out in a small subgroup of patients; 24% of those patients underwent testing on the core biopsy specimen because of COVID-19, the investigators noted. Genomic testing on a core biopsy specimen helps determine whether it’s feasible to forgo chemotherapy and use NET instead or whether the patient should proceed directly to surgery. The authors noted that almost 11% of patients required a change in the usual surgical approach because of COVID-19. Such changes were made primarily to avoid hospitalizations during the early phase of the pandemic for patients who were to undergo mastectomy or reconstruction.

“Patients who needed standard approaches still got them,” Dr. Wilke emphasized in a statement. For example, women with aggressive triple-negative and HER2+ tumors were treated with neoadjuvant chemotherapy, she added. “However, NET is a very good approach for a moderate subset of patients, and we think we will see it being used more often in the U.S. now,” Dr. Wilke observed.

“But especially early during the pandemic, these revised treatments were necessary because access to hospital ORs was limited or unavailable, so our algorithmic-based treatment guidelines allowed us to offer high-quality, evidence-based care fine-tuned for a patient’s specific cancer profile,” she affirmed.

Dr. Wilke has disclosed no relevant financial relationships.

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

The use of neoadjuvant endocrine therapy (NET) increased significantly during the first 8 months of the COVID-19 pandemic for women with estrogen receptor–positive (ER+) breast cancer. These patients would normally undergo surgery first, but because of operating room restrictions, those surgeries were delayed because of the pandemic, according to a new study.
 

“We hypothesized that by offering a nontoxic therapy, we would be able to ‘hold over’ patients until such time when personal protective equipment supplies were renewed and we could get into the operating room,” lead author Lee Wilke, MD, professor of surgery, University of Wisconsin, Madison, said in an interview.

“And while a small number of women with ER+ tumors get NET anyway, we found over one-third of patients with ER+ breast cancer were treated with NET due to COVID-19 during the first 8 months of last year,” she said.

“One year later, 31% of the same patient population is still getting NET,” she added.

The study was presented during the online annual meeting of the American Society of Breast Surgeons (ASBrS).
 

COVID-specific registry

Dr. Wilke believes that this study presents an accurate snapshot of changes in treatment caused by the pandemic.

She and her colleagues compared data collected in the ASBrS Mastery Program registry to data collected in an embedded but separate COVID-19 segment. The data were for the period from March 1 to Oct. 28, 2020.

Almost three-quarters of the surgeons who entered patients into the COVID-19 segment were from urban areas; 95% reported stopping mammographic screening during part of this period.

The preliminary analysis focused on data collected from 2,476 patients in the COVID-19 segment and 2,303 patients within the Mastery registry.

For patients with ER+/HER2- breast cancer, NET was described as a usual approach in 6.5% of patients in the COVID-19 registry. In the Mastery registry, 7.8% of patients received NET.

Compared with surgery first/usual practice, which served as the reference, older patients were more likely to receive NET first because of the COVID-19 pandemic than younger patients, and they were more likely to receive NET first if they lived in the Northeast or the Southeast compared to other regions of the United States. Dr. Wilke pointed out that the Northeast and the Southeast were hardest hit by COVID-19 early on in the pandemic.

Genomic testing was carried out in a small subgroup of patients; 24% of those patients underwent testing on the core biopsy specimen because of COVID-19, the investigators noted. Genomic testing on a core biopsy specimen helps determine whether it’s feasible to forgo chemotherapy and use NET instead or whether the patient should proceed directly to surgery. The authors noted that almost 11% of patients required a change in the usual surgical approach because of COVID-19. Such changes were made primarily to avoid hospitalizations during the early phase of the pandemic for patients who were to undergo mastectomy or reconstruction.

“Patients who needed standard approaches still got them,” Dr. Wilke emphasized in a statement. For example, women with aggressive triple-negative and HER2+ tumors were treated with neoadjuvant chemotherapy, she added. “However, NET is a very good approach for a moderate subset of patients, and we think we will see it being used more often in the U.S. now,” Dr. Wilke observed.

“But especially early during the pandemic, these revised treatments were necessary because access to hospital ORs was limited or unavailable, so our algorithmic-based treatment guidelines allowed us to offer high-quality, evidence-based care fine-tuned for a patient’s specific cancer profile,” she affirmed.

Dr. Wilke has disclosed no relevant financial relationships.

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

The use of neoadjuvant endocrine therapy (NET) increased significantly during the first 8 months of the COVID-19 pandemic for women with estrogen receptor–positive (ER+) breast cancer. These patients would normally undergo surgery first, but because of operating room restrictions, those surgeries were delayed because of the pandemic, according to a new study.
 

“We hypothesized that by offering a nontoxic therapy, we would be able to ‘hold over’ patients until such time when personal protective equipment supplies were renewed and we could get into the operating room,” lead author Lee Wilke, MD, professor of surgery, University of Wisconsin, Madison, said in an interview.

“And while a small number of women with ER+ tumors get NET anyway, we found over one-third of patients with ER+ breast cancer were treated with NET due to COVID-19 during the first 8 months of last year,” she said.

“One year later, 31% of the same patient population is still getting NET,” she added.

The study was presented during the online annual meeting of the American Society of Breast Surgeons (ASBrS).
 

COVID-specific registry

Dr. Wilke believes that this study presents an accurate snapshot of changes in treatment caused by the pandemic.

She and her colleagues compared data collected in the ASBrS Mastery Program registry to data collected in an embedded but separate COVID-19 segment. The data were for the period from March 1 to Oct. 28, 2020.

Almost three-quarters of the surgeons who entered patients into the COVID-19 segment were from urban areas; 95% reported stopping mammographic screening during part of this period.

The preliminary analysis focused on data collected from 2,476 patients in the COVID-19 segment and 2,303 patients within the Mastery registry.

For patients with ER+/HER2- breast cancer, NET was described as a usual approach in 6.5% of patients in the COVID-19 registry. In the Mastery registry, 7.8% of patients received NET.

Compared with surgery first/usual practice, which served as the reference, older patients were more likely to receive NET first because of the COVID-19 pandemic than younger patients, and they were more likely to receive NET first if they lived in the Northeast or the Southeast compared to other regions of the United States. Dr. Wilke pointed out that the Northeast and the Southeast were hardest hit by COVID-19 early on in the pandemic.

Genomic testing was carried out in a small subgroup of patients; 24% of those patients underwent testing on the core biopsy specimen because of COVID-19, the investigators noted. Genomic testing on a core biopsy specimen helps determine whether it’s feasible to forgo chemotherapy and use NET instead or whether the patient should proceed directly to surgery. The authors noted that almost 11% of patients required a change in the usual surgical approach because of COVID-19. Such changes were made primarily to avoid hospitalizations during the early phase of the pandemic for patients who were to undergo mastectomy or reconstruction.

“Patients who needed standard approaches still got them,” Dr. Wilke emphasized in a statement. For example, women with aggressive triple-negative and HER2+ tumors were treated with neoadjuvant chemotherapy, she added. “However, NET is a very good approach for a moderate subset of patients, and we think we will see it being used more often in the U.S. now,” Dr. Wilke observed.

“But especially early during the pandemic, these revised treatments were necessary because access to hospital ORs was limited or unavailable, so our algorithmic-based treatment guidelines allowed us to offer high-quality, evidence-based care fine-tuned for a patient’s specific cancer profile,” she affirmed.

Dr. Wilke has disclosed no relevant financial relationships.

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