Kathleen Doheny

LONG BEACH, CALIF. – For years, clinicians have debated whether prescribing statins to patients older than 75 for the prevention of cardiovascular events is appropriate.

In 2022, the U.S. Preventive Services Task Force concluded that scientific evidence was insufficient to assess the balance between the benefits and harms of the therapy for this older population.

At a session of the annual meeting of the American Geriatrics Society, experts laid out new preliminary recommendations of the AGS and the National Lipid Association on assessing risk and deciding on treatment.

The group concluded that LDL cholesterol levels are associated with incident arteriosclerotic cardiovascular disease (ASCVD), that the coronary artery calcium (CAC) score can be a valuable measure, and that statins may be reasonable to prescribe, even given the risks that have been linked to statins, such as that for muscle pain. Final recommendations are expected by fall 2023.

“This is still a work in progress,” said Daniel E. Forman, MD, professor of medicine and chair of geriatric cardiology at the University of Pittsburgh.

The AGS-NLA panel concluded that, for those aged 75 or older without established ASCVD, LDL cholesterol is associated with incident ASCVD, the only recommendation to be given a class I (strong) rating; others were classed as moderate or weak.

Dr. Forman reviewed the evidence for lowering LDL cholesterol to decrease ASCVD, citing a 2018 study that concluded, “Reverse causation may contribute to the association of lower TC with higher mortality in nonrandomized studies.”

However, research overall shows that, as LDL cholesterol levels increase, patients are more likely to experience a heart event.

Dr. Forman noted that the utility of equations for assessing 5- or 10-year risk of ASCVD is uncertain. However, he said, traditional risk factors, such as family history and ethnicity, still have value.

Assessing risk “has been enriched in the past few years by the introduction of the coronary artery calcium [CAC] score,” he said.

Lower scores predict lower rates of CVD events, Forman said. The AGS-NLA recommends measuring CAC if clinical uncertainty exists about the value of statins.

“It’s reasonable to measure CAC and to withhold statins when the CAC is zero,” Dr. Forman said. “When the CAC score is zero ... the risk of having a cardiovascular event is really next to nil. Patients are happy to know they have a CAC of zero.”

Likewise, patients appreciate knowing whether their score is high, which would indicate increased risk. He said the CAC score is underused by geriatric physicians.

The group also determined, after reviewing the research, that starting treatment is reasonable for patients with an LDL cholesterol level of 70-189 if they have no life-limiting illness and their life expectancy is over 5 years.

Other preliminary recommendations include the use of statins for those aged 75 and older, irrespective of risk for statin-associated muscle symptoms, type 2 diabetes, or impaired cognition. These associations are often weak, Dr. Forman added.
 

Focusing on person-centered decisions

Ariel Green, MD, MPH, PhD, associate professor of medicine at Johns Hopkins University, Baltimore, said statin therapy “should be individualized” to weigh benefits, noncardiac risks, and other considerations.

Clinicians can incorporate life expectancy into prevention decisions using tools such as ePrognosis, from the University of California, San Francisco, Dr. Green said.

If life expectancy is greater than the time to benefit, statin therapy may help. Dr. Green cited research that showed that 2.5 years of statin therapy was needed to prevent one major adverse cardiovascular event (MACE) per 100 patients in a population aged 50-75. Other data show reductions in MACE for those older than 75, but overall, the data are limited in this population.

The proposed recommendation is to use tools such as life tables that include comorbid conditions and functional status to guide clinical decisions.

“Another aspect of assessing net benefits of statin therapy is to consider competing health risks,” Dr. Green said.

The group recommends considering using competing risk-adjusted CVD models, though these are not widely used.

The group also recommends integrating screenings for frailty (Clinical Frailty Scale), dementia (Mini-Cog), and functional status (Vulnerable Elders Scale–13) into assessments.

“The presence of these syndromes should prompt elicitation of patient values and preferences related to prevention and medication use,” Dr. Green said.

Clinicians can use decision aids, but these are not always practical, owing to obstacles such as patients’ cognitive problems, Dr. Green said.

“Another approach is asking people to prioritize a set of universal health outcomes that apply across health conditions, such as maintaining independence, staying alive, reducing, or eliminating symptoms and focusing on comfort,” Dr. Green said.

She addressed the evidence about deprescribing statins, with a focus on those with a life expectancy of less than a year. Researchers have found an increase in quality of life and no increases in cardiovascular events or death when statins were deprescribed.
 

A welcome framework

Cory Krueger, MD, an internal medicine and geriatric physician in Cornville, Ariz., who attended the talk, said he welcomed the presentation, in which preliminary recommendations were explained.

“This has been a controversial area in geriatrics,” Dr. Krueger said. “At least this gave me a framework for discussing this with my patients in a reasonable way.”

Dr. Forman and Dr. Krueger disclosed no relevant financial relationships. Dr. Green receives funding from the National Institute of Aging and Impact Collaboratory.

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

LONG BEACH, CALIF. – For years, clinicians have debated whether prescribing statins to patients older than 75 for the prevention of cardiovascular events is appropriate.

In 2022, the U.S. Preventive Services Task Force concluded that scientific evidence was insufficient to assess the balance between the benefits and harms of the therapy for this older population.

At a session of the annual meeting of the American Geriatrics Society, experts laid out new preliminary recommendations of the AGS and the National Lipid Association on assessing risk and deciding on treatment.

The group concluded that LDL cholesterol levels are associated with incident arteriosclerotic cardiovascular disease (ASCVD), that the coronary artery calcium (CAC) score can be a valuable measure, and that statins may be reasonable to prescribe, even given the risks that have been linked to statins, such as that for muscle pain. Final recommendations are expected by fall 2023.

“This is still a work in progress,” said Daniel E. Forman, MD, professor of medicine and chair of geriatric cardiology at the University of Pittsburgh.

The AGS-NLA panel concluded that, for those aged 75 or older without established ASCVD, LDL cholesterol is associated with incident ASCVD, the only recommendation to be given a class I (strong) rating; others were classed as moderate or weak.

Dr. Forman reviewed the evidence for lowering LDL cholesterol to decrease ASCVD, citing a 2018 study that concluded, “Reverse causation may contribute to the association of lower TC with higher mortality in nonrandomized studies.”

However, research overall shows that, as LDL cholesterol levels increase, patients are more likely to experience a heart event.

Dr. Forman noted that the utility of equations for assessing 5- or 10-year risk of ASCVD is uncertain. However, he said, traditional risk factors, such as family history and ethnicity, still have value.

Assessing risk “has been enriched in the past few years by the introduction of the coronary artery calcium [CAC] score,” he said.

Lower scores predict lower rates of CVD events, Forman said. The AGS-NLA recommends measuring CAC if clinical uncertainty exists about the value of statins.

“It’s reasonable to measure CAC and to withhold statins when the CAC is zero,” Dr. Forman said. “When the CAC score is zero ... the risk of having a cardiovascular event is really next to nil. Patients are happy to know they have a CAC of zero.”

Likewise, patients appreciate knowing whether their score is high, which would indicate increased risk. He said the CAC score is underused by geriatric physicians.

The group also determined, after reviewing the research, that starting treatment is reasonable for patients with an LDL cholesterol level of 70-189 if they have no life-limiting illness and their life expectancy is over 5 years.

Other preliminary recommendations include the use of statins for those aged 75 and older, irrespective of risk for statin-associated muscle symptoms, type 2 diabetes, or impaired cognition. These associations are often weak, Dr. Forman added.
 

Focusing on person-centered decisions

Ariel Green, MD, MPH, PhD, associate professor of medicine at Johns Hopkins University, Baltimore, said statin therapy “should be individualized” to weigh benefits, noncardiac risks, and other considerations.

Clinicians can incorporate life expectancy into prevention decisions using tools such as ePrognosis, from the University of California, San Francisco, Dr. Green said.

If life expectancy is greater than the time to benefit, statin therapy may help. Dr. Green cited research that showed that 2.5 years of statin therapy was needed to prevent one major adverse cardiovascular event (MACE) per 100 patients in a population aged 50-75. Other data show reductions in MACE for those older than 75, but overall, the data are limited in this population.

The proposed recommendation is to use tools such as life tables that include comorbid conditions and functional status to guide clinical decisions.

“Another aspect of assessing net benefits of statin therapy is to consider competing health risks,” Dr. Green said.

The group recommends considering using competing risk-adjusted CVD models, though these are not widely used.

The group also recommends integrating screenings for frailty (Clinical Frailty Scale), dementia (Mini-Cog), and functional status (Vulnerable Elders Scale–13) into assessments.

“The presence of these syndromes should prompt elicitation of patient values and preferences related to prevention and medication use,” Dr. Green said.

Clinicians can use decision aids, but these are not always practical, owing to obstacles such as patients’ cognitive problems, Dr. Green said.

“Another approach is asking people to prioritize a set of universal health outcomes that apply across health conditions, such as maintaining independence, staying alive, reducing, or eliminating symptoms and focusing on comfort,” Dr. Green said.

She addressed the evidence about deprescribing statins, with a focus on those with a life expectancy of less than a year. Researchers have found an increase in quality of life and no increases in cardiovascular events or death when statins were deprescribed.
 

A welcome framework

Cory Krueger, MD, an internal medicine and geriatric physician in Cornville, Ariz., who attended the talk, said he welcomed the presentation, in which preliminary recommendations were explained.

“This has been a controversial area in geriatrics,” Dr. Krueger said. “At least this gave me a framework for discussing this with my patients in a reasonable way.”

Dr. Forman and Dr. Krueger disclosed no relevant financial relationships. Dr. Green receives funding from the National Institute of Aging and Impact Collaboratory.

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

LONG BEACH, CALIF. – For years, clinicians have debated whether prescribing statins to patients older than 75 for the prevention of cardiovascular events is appropriate.

In 2022, the U.S. Preventive Services Task Force concluded that scientific evidence was insufficient to assess the balance between the benefits and harms of the therapy for this older population.

At a session of the annual meeting of the American Geriatrics Society, experts laid out new preliminary recommendations of the AGS and the National Lipid Association on assessing risk and deciding on treatment.

The group concluded that LDL cholesterol levels are associated with incident arteriosclerotic cardiovascular disease (ASCVD), that the coronary artery calcium (CAC) score can be a valuable measure, and that statins may be reasonable to prescribe, even given the risks that have been linked to statins, such as that for muscle pain. Final recommendations are expected by fall 2023.

“This is still a work in progress,” said Daniel E. Forman, MD, professor of medicine and chair of geriatric cardiology at the University of Pittsburgh.

The AGS-NLA panel concluded that, for those aged 75 or older without established ASCVD, LDL cholesterol is associated with incident ASCVD, the only recommendation to be given a class I (strong) rating; others were classed as moderate or weak.

Dr. Forman reviewed the evidence for lowering LDL cholesterol to decrease ASCVD, citing a 2018 study that concluded, “Reverse causation may contribute to the association of lower TC with higher mortality in nonrandomized studies.”

However, research overall shows that, as LDL cholesterol levels increase, patients are more likely to experience a heart event.

Dr. Forman noted that the utility of equations for assessing 5- or 10-year risk of ASCVD is uncertain. However, he said, traditional risk factors, such as family history and ethnicity, still have value.

Assessing risk “has been enriched in the past few years by the introduction of the coronary artery calcium [CAC] score,” he said.

Lower scores predict lower rates of CVD events, Forman said. The AGS-NLA recommends measuring CAC if clinical uncertainty exists about the value of statins.

“It’s reasonable to measure CAC and to withhold statins when the CAC is zero,” Dr. Forman said. “When the CAC score is zero ... the risk of having a cardiovascular event is really next to nil. Patients are happy to know they have a CAC of zero.”

Likewise, patients appreciate knowing whether their score is high, which would indicate increased risk. He said the CAC score is underused by geriatric physicians.

The group also determined, after reviewing the research, that starting treatment is reasonable for patients with an LDL cholesterol level of 70-189 if they have no life-limiting illness and their life expectancy is over 5 years.

Other preliminary recommendations include the use of statins for those aged 75 and older, irrespective of risk for statin-associated muscle symptoms, type 2 diabetes, or impaired cognition. These associations are often weak, Dr. Forman added.
 

Focusing on person-centered decisions

Ariel Green, MD, MPH, PhD, associate professor of medicine at Johns Hopkins University, Baltimore, said statin therapy “should be individualized” to weigh benefits, noncardiac risks, and other considerations.

Clinicians can incorporate life expectancy into prevention decisions using tools such as ePrognosis, from the University of California, San Francisco, Dr. Green said.

If life expectancy is greater than the time to benefit, statin therapy may help. Dr. Green cited research that showed that 2.5 years of statin therapy was needed to prevent one major adverse cardiovascular event (MACE) per 100 patients in a population aged 50-75. Other data show reductions in MACE for those older than 75, but overall, the data are limited in this population.

The proposed recommendation is to use tools such as life tables that include comorbid conditions and functional status to guide clinical decisions.

“Another aspect of assessing net benefits of statin therapy is to consider competing health risks,” Dr. Green said.

The group recommends considering using competing risk-adjusted CVD models, though these are not widely used.

The group also recommends integrating screenings for frailty (Clinical Frailty Scale), dementia (Mini-Cog), and functional status (Vulnerable Elders Scale–13) into assessments.

“The presence of these syndromes should prompt elicitation of patient values and preferences related to prevention and medication use,” Dr. Green said.

Clinicians can use decision aids, but these are not always practical, owing to obstacles such as patients’ cognitive problems, Dr. Green said.

“Another approach is asking people to prioritize a set of universal health outcomes that apply across health conditions, such as maintaining independence, staying alive, reducing, or eliminating symptoms and focusing on comfort,” Dr. Green said.

She addressed the evidence about deprescribing statins, with a focus on those with a life expectancy of less than a year. Researchers have found an increase in quality of life and no increases in cardiovascular events or death when statins were deprescribed.
 

A welcome framework

Cory Krueger, MD, an internal medicine and geriatric physician in Cornville, Ariz., who attended the talk, said he welcomed the presentation, in which preliminary recommendations were explained.

“This has been a controversial area in geriatrics,” Dr. Krueger said. “At least this gave me a framework for discussing this with my patients in a reasonable way.”

Dr. Forman and Dr. Krueger disclosed no relevant financial relationships. Dr. Green receives funding from the National Institute of Aging and Impact Collaboratory.

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

The 30-second commercial, part of the government’s We Can Do This campaign, shows everyday people going about their lives, then reminds them that, “because COVID is still out there and so are you,” it might be time to update your vaccine.

But in real life, the message that COVID-19 is still a major concern is muffled if not absent for many. Many data tracking sources, both federal and others, are no longer reporting, as often, the number of COVID cases, hospitalizations, and deaths. 

The Department of Health & Human Services in February stopped updating its public COVID data site, instead directing all queries to the Centers for Disease Control and Prevention, which itself has been updating only weekly instead of daily since 2022. 

Nongovernmental sources, such as John Hopkins University, stopped reporting pandemic data in March, The New York Times also ended its COVID data-gathering project in March, stating that “the comprehensive real-time reporting that The Times has prioritized is no longer possible.” It will rely on reporting weekly CDC data moving forward. 

Along with the tracking sites, masking and social distancing mandates have mostly disappeared. President Joe Biden signed a bipartisan bill on April 10 that ended the national emergency for COVID. While some programs will stay in place for now, such as free vaccines, treatments, and tests, that too will go away when the federal public health emergency expires on May 11. The HHS already has issued its transition roadmap.

Many Americans, meanwhile, are still on the fence about the pandemic. A Gallup poll from March shows that about half of the American public say it’s over, and about half disagree. 

Are we closing up shop on COVID-19 too soon, or is it time? Not surprisingly, experts don’t agree. Some say the pandemic is now endemic – which broadly means the virus and its patterns are predictable and steady in designated regions – and that it’s critical to catch up on health needs neglected during the pandemic, such as screenings and other vaccinations

But others don’t think it’s reached that stage yet, saying that we are letting our guard down too soon and we can’t be blind to the possibility of another strong variant – or pandemic – emerging. Surveillance must continue, not decline, and be improved.
 

Time to move on?

In its transition roadmap released in February, the HHS notes that daily COVID reported cases are down over 90%, compared with the peak of the Omicron surge at the end of January 2022; deaths have declined by over 80%; and new hospitalizations caused by COVID have dropped by nearly 80%.

It is time to move on, said Ali Mokdad, PhD, a professor and chief strategy officer of population health at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle. 

“Many people were delaying a lot of medical care, because they were afraid” during COVID’s height, he said, explaining that elective surgeries were postponed, prenatal care went down, as did screenings for blood pressure and diabetes.

His institute was tracking COVID projections every week but stopped in December.

As for emerging variants, “we haven’t seen a variant that scares us since Omicron” in November 2021, said Dr. Mokdad, who agrees that COVID is endemic now. The subvariants that followed it are very similar, and the current vaccines are working. 

“We can move on, but we cannot drop the ball on keeping an eye on the genetic sequencing of the virus,” he said. That will enable quick identification of new variants.

If a worrisome new variant does surface, Dr. Mokdad said, certain locations and resources will be able to gear up quickly, while others won’t be as fast, but overall the United States is in a much better position now. 

Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore, also believes the pandemic phase is behind us

“This can’t be an emergency in perpetuity,” he said “Just because something is not a pandemic [anymore] does not mean that all activities related to it cease.”

COVID is highly unlikely to overwhelm hospitals again, and that was the main reason for the emergency declaration, he said. 

“It’s not all or none – collapsing COVID-related [monitoring] activities into the routine monitoring that is done for other infectious disease should be seen as an achievement in taming the virus,” he said.
 

Not endemic yet

Closing up shop too early could mean we are blindsided, said Rajendram Rajnarayanan, PhD, an assistant dean of research and associate professor at the New York Institute of Technology College of Osteopathic Medicine at Arkansas State University in Jonesboro. 

Already, he said, large labs have closed or scaled down as testing demand has declined, and many centers that offered community testing have also closed. Plus, home test results are often not reported.

Continued monitoring is key, he said. “You have to maintain a base level of sequencing for new variants,” he said. “Right now, the variant that is ‘top dog’ in the world is XBB.1.16.” 

That’s an Omicron subvariant that the World Health Organization is currently keeping its eye on, according to a media briefing on March 29. There are about 800 sequences of it from 22 countries, mostly India, and it’s been in circulation a few months. 

Dr. Rajnarayanan said he’s not overly worried about this variant, but surveillance must continue. His own breakdown of XBB.1.16 found the subvariant in 27 countries, including the United States, as of April 10.

Ideally, Dr. Rajnarayanan would suggest four areas to keep focusing on, moving forward:

• Active, random surveillance for new variants, especially in hot spots.
• Hospital surveillance and surveillance of long-term care, especially in congregate settings where people can more easily spread the virus.
• Travelers’ surveillance, now at , according to the CDC.
• Surveillance of animals such as mink and deer, because these animals can not only pick up the virus, but the virus can mutate in the animals, which could then transmit it back to people. 

With less testing, baseline surveillance for new variants has declined. The other three surveillance areas need improvement, too, he said, as the reporting is often delayed. 

Continued surveillance is crucial, agreed Katelyn Jetelina, PhD, an epidemiologist and data scientist who publishes a newsletter, Your Local Epidemiologist, updating developments in COVID and other pressing health issues. 

“It’s a bit ironic to have a date for the end of a public health emergency; viruses don’t care about calendars,” said Dr. Jetelina, who is also director of population health analytics for the Meadows Mental Health Policy Institute. “COVID-19 is still going to be here, it’s still going to mutate,” and still cause grief for those affected. “I’m most concerned about our ability to track the virus. It’s not clear what surveillance we will still have in the states and around the globe.” 

It’s a bit ironic to have a date for the end of a public health emergency; viruses don’t care about calendars.

For surveillance, she calls wastewater monitoring “the lowest-hanging fruit.” That’s because it “is not based on bias testing and has the potential to help with other outbreaks, too.” Hospitalization data is also essential, she said, as that information is the basis for public health decisions on updated vaccines and other protective measures.

While Dr. Jetelina is hopeful that COVID will someday be universally viewed as endemic, with predictable seasonal patterns, “I don’t think we are there yet. We still need to approach this virus with humility; that’s at least what I will continue to do.”

Dr. Rajnarayanan agreed that the pandemic has not yet reached endemic phase, though the situation is much improved. “Our vaccines are still protecting us from severe disease and hospitalization, and [the antiviral drug] Paxlovid is a great tool that works.”
 

Keeping tabs

While some data tracking has been eliminated, not all has, or will be. The CDC, as mentioned, continues to post cases, deaths, and a daily average of new hospital admissions weekly. The WHO’s dashboard tracks deaths, cases, and vaccine doses globally. 

In March, the WHO updated its working definitions and tracking system for SARS-CoV-2 variants of concern and variants of interest, with goals of evaluating the sublineages independently and to classify new variants more clearly when that’s needed. 

Still, WHO is considering ending its declaration of COVID as a public health emergency of international concern sometime in 2023.

Some public companies are staying vigilant. The drugstore chain Walgreens said it plans to maintain its COVID-19 Index, which launched in January 2022. 

“Data regarding spread of variants is important to our understanding of viral transmission and, as new variants emerge, it will be critical to continue to track this information quickly to predict which communities are most at risk,” Anita Patel, PharmD, vice president of pharmacy services development for Walgreens, said in a statement.

The data also reinforces the importance of vaccinations and testing in helping to stop the spread of COVID-19, she said.

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

The 30-second commercial, part of the government’s We Can Do This campaign, shows everyday people going about their lives, then reminds them that, “because COVID is still out there and so are you,” it might be time to update your vaccine.

But in real life, the message that COVID-19 is still a major concern is muffled if not absent for many. Many data tracking sources, both federal and others, are no longer reporting, as often, the number of COVID cases, hospitalizations, and deaths. 

The Department of Health & Human Services in February stopped updating its public COVID data site, instead directing all queries to the Centers for Disease Control and Prevention, which itself has been updating only weekly instead of daily since 2022. 

Nongovernmental sources, such as John Hopkins University, stopped reporting pandemic data in March, The New York Times also ended its COVID data-gathering project in March, stating that “the comprehensive real-time reporting that The Times has prioritized is no longer possible.” It will rely on reporting weekly CDC data moving forward. 

Along with the tracking sites, masking and social distancing mandates have mostly disappeared. President Joe Biden signed a bipartisan bill on April 10 that ended the national emergency for COVID. While some programs will stay in place for now, such as free vaccines, treatments, and tests, that too will go away when the federal public health emergency expires on May 11. The HHS already has issued its transition roadmap.

Many Americans, meanwhile, are still on the fence about the pandemic. A Gallup poll from March shows that about half of the American public say it’s over, and about half disagree. 

Are we closing up shop on COVID-19 too soon, or is it time? Not surprisingly, experts don’t agree. Some say the pandemic is now endemic – which broadly means the virus and its patterns are predictable and steady in designated regions – and that it’s critical to catch up on health needs neglected during the pandemic, such as screenings and other vaccinations

But others don’t think it’s reached that stage yet, saying that we are letting our guard down too soon and we can’t be blind to the possibility of another strong variant – or pandemic – emerging. Surveillance must continue, not decline, and be improved.
 

Time to move on?

In its transition roadmap released in February, the HHS notes that daily COVID reported cases are down over 90%, compared with the peak of the Omicron surge at the end of January 2022; deaths have declined by over 80%; and new hospitalizations caused by COVID have dropped by nearly 80%.

It is time to move on, said Ali Mokdad, PhD, a professor and chief strategy officer of population health at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle. 

“Many people were delaying a lot of medical care, because they were afraid” during COVID’s height, he said, explaining that elective surgeries were postponed, prenatal care went down, as did screenings for blood pressure and diabetes.

His institute was tracking COVID projections every week but stopped in December.

As for emerging variants, “we haven’t seen a variant that scares us since Omicron” in November 2021, said Dr. Mokdad, who agrees that COVID is endemic now. The subvariants that followed it are very similar, and the current vaccines are working. 

“We can move on, but we cannot drop the ball on keeping an eye on the genetic sequencing of the virus,” he said. That will enable quick identification of new variants.

If a worrisome new variant does surface, Dr. Mokdad said, certain locations and resources will be able to gear up quickly, while others won’t be as fast, but overall the United States is in a much better position now. 

Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore, also believes the pandemic phase is behind us

“This can’t be an emergency in perpetuity,” he said “Just because something is not a pandemic [anymore] does not mean that all activities related to it cease.”

COVID is highly unlikely to overwhelm hospitals again, and that was the main reason for the emergency declaration, he said. 

“It’s not all or none – collapsing COVID-related [monitoring] activities into the routine monitoring that is done for other infectious disease should be seen as an achievement in taming the virus,” he said.
 

Not endemic yet

Closing up shop too early could mean we are blindsided, said Rajendram Rajnarayanan, PhD, an assistant dean of research and associate professor at the New York Institute of Technology College of Osteopathic Medicine at Arkansas State University in Jonesboro. 

Already, he said, large labs have closed or scaled down as testing demand has declined, and many centers that offered community testing have also closed. Plus, home test results are often not reported.

Continued monitoring is key, he said. “You have to maintain a base level of sequencing for new variants,” he said. “Right now, the variant that is ‘top dog’ in the world is XBB.1.16.” 

That’s an Omicron subvariant that the World Health Organization is currently keeping its eye on, according to a media briefing on March 29. There are about 800 sequences of it from 22 countries, mostly India, and it’s been in circulation a few months. 

Dr. Rajnarayanan said he’s not overly worried about this variant, but surveillance must continue. His own breakdown of XBB.1.16 found the subvariant in 27 countries, including the United States, as of April 10.

Ideally, Dr. Rajnarayanan would suggest four areas to keep focusing on, moving forward:

• Active, random surveillance for new variants, especially in hot spots.
• Hospital surveillance and surveillance of long-term care, especially in congregate settings where people can more easily spread the virus.
• Travelers’ surveillance, now at , according to the CDC.
• Surveillance of animals such as mink and deer, because these animals can not only pick up the virus, but the virus can mutate in the animals, which could then transmit it back to people. 

With less testing, baseline surveillance for new variants has declined. The other three surveillance areas need improvement, too, he said, as the reporting is often delayed. 

Continued surveillance is crucial, agreed Katelyn Jetelina, PhD, an epidemiologist and data scientist who publishes a newsletter, Your Local Epidemiologist, updating developments in COVID and other pressing health issues. 

“It’s a bit ironic to have a date for the end of a public health emergency; viruses don’t care about calendars,” said Dr. Jetelina, who is also director of population health analytics for the Meadows Mental Health Policy Institute. “COVID-19 is still going to be here, it’s still going to mutate,” and still cause grief for those affected. “I’m most concerned about our ability to track the virus. It’s not clear what surveillance we will still have in the states and around the globe.” 

It’s a bit ironic to have a date for the end of a public health emergency; viruses don’t care about calendars.

For surveillance, she calls wastewater monitoring “the lowest-hanging fruit.” That’s because it “is not based on bias testing and has the potential to help with other outbreaks, too.” Hospitalization data is also essential, she said, as that information is the basis for public health decisions on updated vaccines and other protective measures.

While Dr. Jetelina is hopeful that COVID will someday be universally viewed as endemic, with predictable seasonal patterns, “I don’t think we are there yet. We still need to approach this virus with humility; that’s at least what I will continue to do.”

Dr. Rajnarayanan agreed that the pandemic has not yet reached endemic phase, though the situation is much improved. “Our vaccines are still protecting us from severe disease and hospitalization, and [the antiviral drug] Paxlovid is a great tool that works.”
 

Keeping tabs

While some data tracking has been eliminated, not all has, or will be. The CDC, as mentioned, continues to post cases, deaths, and a daily average of new hospital admissions weekly. The WHO’s dashboard tracks deaths, cases, and vaccine doses globally. 

In March, the WHO updated its working definitions and tracking system for SARS-CoV-2 variants of concern and variants of interest, with goals of evaluating the sublineages independently and to classify new variants more clearly when that’s needed. 

Still, WHO is considering ending its declaration of COVID as a public health emergency of international concern sometime in 2023.

Some public companies are staying vigilant. The drugstore chain Walgreens said it plans to maintain its COVID-19 Index, which launched in January 2022. 

“Data regarding spread of variants is important to our understanding of viral transmission and, as new variants emerge, it will be critical to continue to track this information quickly to predict which communities are most at risk,” Anita Patel, PharmD, vice president of pharmacy services development for Walgreens, said in a statement.

The data also reinforces the importance of vaccinations and testing in helping to stop the spread of COVID-19, she said.

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

The 30-second commercial, part of the government’s We Can Do This campaign, shows everyday people going about their lives, then reminds them that, “because COVID is still out there and so are you,” it might be time to update your vaccine.

But in real life, the message that COVID-19 is still a major concern is muffled if not absent for many. Many data tracking sources, both federal and others, are no longer reporting, as often, the number of COVID cases, hospitalizations, and deaths. 

The Department of Health & Human Services in February stopped updating its public COVID data site, instead directing all queries to the Centers for Disease Control and Prevention, which itself has been updating only weekly instead of daily since 2022. 

Nongovernmental sources, such as John Hopkins University, stopped reporting pandemic data in March, The New York Times also ended its COVID data-gathering project in March, stating that “the comprehensive real-time reporting that The Times has prioritized is no longer possible.” It will rely on reporting weekly CDC data moving forward. 

Along with the tracking sites, masking and social distancing mandates have mostly disappeared. President Joe Biden signed a bipartisan bill on April 10 that ended the national emergency for COVID. While some programs will stay in place for now, such as free vaccines, treatments, and tests, that too will go away when the federal public health emergency expires on May 11. The HHS already has issued its transition roadmap.

Many Americans, meanwhile, are still on the fence about the pandemic. A Gallup poll from March shows that about half of the American public say it’s over, and about half disagree. 

Are we closing up shop on COVID-19 too soon, or is it time? Not surprisingly, experts don’t agree. Some say the pandemic is now endemic – which broadly means the virus and its patterns are predictable and steady in designated regions – and that it’s critical to catch up on health needs neglected during the pandemic, such as screenings and other vaccinations

But others don’t think it’s reached that stage yet, saying that we are letting our guard down too soon and we can’t be blind to the possibility of another strong variant – or pandemic – emerging. Surveillance must continue, not decline, and be improved.
 

Time to move on?

In its transition roadmap released in February, the HHS notes that daily COVID reported cases are down over 90%, compared with the peak of the Omicron surge at the end of January 2022; deaths have declined by over 80%; and new hospitalizations caused by COVID have dropped by nearly 80%.

It is time to move on, said Ali Mokdad, PhD, a professor and chief strategy officer of population health at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle. 

“Many people were delaying a lot of medical care, because they were afraid” during COVID’s height, he said, explaining that elective surgeries were postponed, prenatal care went down, as did screenings for blood pressure and diabetes.

His institute was tracking COVID projections every week but stopped in December.

As for emerging variants, “we haven’t seen a variant that scares us since Omicron” in November 2021, said Dr. Mokdad, who agrees that COVID is endemic now. The subvariants that followed it are very similar, and the current vaccines are working. 

“We can move on, but we cannot drop the ball on keeping an eye on the genetic sequencing of the virus,” he said. That will enable quick identification of new variants.

If a worrisome new variant does surface, Dr. Mokdad said, certain locations and resources will be able to gear up quickly, while others won’t be as fast, but overall the United States is in a much better position now. 

Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore, also believes the pandemic phase is behind us

“This can’t be an emergency in perpetuity,” he said “Just because something is not a pandemic [anymore] does not mean that all activities related to it cease.”

COVID is highly unlikely to overwhelm hospitals again, and that was the main reason for the emergency declaration, he said. 

“It’s not all or none – collapsing COVID-related [monitoring] activities into the routine monitoring that is done for other infectious disease should be seen as an achievement in taming the virus,” he said.
 

Not endemic yet

Closing up shop too early could mean we are blindsided, said Rajendram Rajnarayanan, PhD, an assistant dean of research and associate professor at the New York Institute of Technology College of Osteopathic Medicine at Arkansas State University in Jonesboro. 

Already, he said, large labs have closed or scaled down as testing demand has declined, and many centers that offered community testing have also closed. Plus, home test results are often not reported.

Continued monitoring is key, he said. “You have to maintain a base level of sequencing for new variants,” he said. “Right now, the variant that is ‘top dog’ in the world is XBB.1.16.” 

That’s an Omicron subvariant that the World Health Organization is currently keeping its eye on, according to a media briefing on March 29. There are about 800 sequences of it from 22 countries, mostly India, and it’s been in circulation a few months. 

Dr. Rajnarayanan said he’s not overly worried about this variant, but surveillance must continue. His own breakdown of XBB.1.16 found the subvariant in 27 countries, including the United States, as of April 10.

Ideally, Dr. Rajnarayanan would suggest four areas to keep focusing on, moving forward:

• Active, random surveillance for new variants, especially in hot spots.
• Hospital surveillance and surveillance of long-term care, especially in congregate settings where people can more easily spread the virus.
• Travelers’ surveillance, now at , according to the CDC.
• Surveillance of animals such as mink and deer, because these animals can not only pick up the virus, but the virus can mutate in the animals, which could then transmit it back to people. 

With less testing, baseline surveillance for new variants has declined. The other three surveillance areas need improvement, too, he said, as the reporting is often delayed. 

Continued surveillance is crucial, agreed Katelyn Jetelina, PhD, an epidemiologist and data scientist who publishes a newsletter, Your Local Epidemiologist, updating developments in COVID and other pressing health issues. 

“It’s a bit ironic to have a date for the end of a public health emergency; viruses don’t care about calendars,” said Dr. Jetelina, who is also director of population health analytics for the Meadows Mental Health Policy Institute. “COVID-19 is still going to be here, it’s still going to mutate,” and still cause grief for those affected. “I’m most concerned about our ability to track the virus. It’s not clear what surveillance we will still have in the states and around the globe.” 

It’s a bit ironic to have a date for the end of a public health emergency; viruses don’t care about calendars.

For surveillance, she calls wastewater monitoring “the lowest-hanging fruit.” That’s because it “is not based on bias testing and has the potential to help with other outbreaks, too.” Hospitalization data is also essential, she said, as that information is the basis for public health decisions on updated vaccines and other protective measures.

While Dr. Jetelina is hopeful that COVID will someday be universally viewed as endemic, with predictable seasonal patterns, “I don’t think we are there yet. We still need to approach this virus with humility; that’s at least what I will continue to do.”

Dr. Rajnarayanan agreed that the pandemic has not yet reached endemic phase, though the situation is much improved. “Our vaccines are still protecting us from severe disease and hospitalization, and [the antiviral drug] Paxlovid is a great tool that works.”
 

Keeping tabs

While some data tracking has been eliminated, not all has, or will be. The CDC, as mentioned, continues to post cases, deaths, and a daily average of new hospital admissions weekly. The WHO’s dashboard tracks deaths, cases, and vaccine doses globally. 

In March, the WHO updated its working definitions and tracking system for SARS-CoV-2 variants of concern and variants of interest, with goals of evaluating the sublineages independently and to classify new variants more clearly when that’s needed. 

Still, WHO is considering ending its declaration of COVID as a public health emergency of international concern sometime in 2023.

Some public companies are staying vigilant. The drugstore chain Walgreens said it plans to maintain its COVID-19 Index, which launched in January 2022. 

“Data regarding spread of variants is important to our understanding of viral transmission and, as new variants emerge, it will be critical to continue to track this information quickly to predict which communities are most at risk,” Anita Patel, PharmD, vice president of pharmacy services development for Walgreens, said in a statement.

The data also reinforces the importance of vaccinations and testing in helping to stop the spread of COVID-19, she said.

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

As a field service representative for a slot machine company, Ryan Alexander, 37, of Louisville, Ky., spends his working hours in casinos, covering a large territory including Norfolk, Va., Indianapolis, and Charlotte. Social distancing in the casinos is not the norm. Despite all this up-close contact with people, he said he is still COVID-free, 3 years into the pandemic.

There was one nervous night when his temperature rose to 101° F, and he figured the virus had caught up with him. “I took a test and was fine,” he said, relieved that the result was negative. The fever disappeared, and he was back to normal soon. “Maybe it was just an exhausting day.”

Mr. Alexander is one of those people who have managed – or at least think they have managed – to avoid getting COVID-19.

He is, some say, a NOVID. While some scientists cringe at the term, it’s caught on to describe these virus super-dodgers. Online entrepreneurs offer NOVID-19 T-shirts, masks, and stickers, in case these super-healthy or super-lucky folks want to publicize their good luck. On Twitter, NOVIDs share stories of how they’ve done it.
 

How many NOVIDs?

As of March 16, according to the CDC, almost 104 million cases of COVID – about one-third of the U.S. population – have been reported, but many cases are known to go unreported. About half of American adults surveyed said they have had COVID, according to a December report by the COVID States Project, a multiuniversity effort to supply pandemic data.

As the numbers settle over time, though, it becomes clearer that some in the U.S. have apparently managed to avoid the virus.

While the exact number of people who have remained uninfected isn’t known with certainty, a review of comprehensive serologic data shows about 15% of Americans may not have gotten infected with COVID, Eric Topol, MD, editor-in-chief of Medscape (WebMD’s sister site for medical professionals) wrote in his substack Ground Truths.

But some scientists bristle at the term NOVIDs. They prefer the term “resisters,” according to Elena Hsieh, MD, associate professor of pediatrics and immunology at the University of Colorado at Denver, Aurora. Currently, she said, there is much more information on who is more susceptible to contracting severe COVID than who is resistant.

Dr. Hsieh is one of the regional coordinators for the COVID Human Genetic Effort, an international consortium of more than 250 researchers and doctors dedicated to discovering the genetic and immunological bases of the forms of SARS-CoV-2 infection. These researchers and others are looking for explanations for why some people get severe COVID while others seem resistant despite repeated exposure.
 

Resistance research

In determining explanations for resistance to infection, “the needle in the haystack that we are looking for is a change in the genetic code that would allow for you to avoid entry of the virus into the cell,” Dr. Hsieh said. “That is what being resistant to infection is.”

Part of the reason it’s so difficult to study resistance is defining a resister, she said. While many people consider themselves among that group because they’re been exposed multiple times – even with close family members infected and sick, yet they still felt fine – that doesn’t necessarily make them a resister, she said.

Those people could have been infected but remained without symptoms. “Resistance means the virus was inside you, it was near your cell and it did not infect your cell,” Dr. Hsieh said.

“I don’t think we know a lot so far,” Dr. Hsieh said about resisters. “I do believe that, just like there are genetic defects that make someone more susceptible, there are likely to be genetic defects that make somebody less susceptible.’’

“To identify genetic variants that are protective is a really challenging thing to do,” agreed Peter K. Gregersen, MD, professor of genetics at the Feinstein Institutes for Medical Research at Northwell Health in Manhasset, N.Y. Dr. Gregersen is also a regional coordinator for the COVID Human Genetic Effort.

He suspects the number found to be truly resistant to COVID – versus dodging it so far – is going to be very small or not found at all.

“It may exist for COVID or it may not,” he said. Some people may simply have what he calls a robust immune response in the upper part of the throat, perhaps killing off the virus quickly as soon as it enters, so they don’t get a positive test.

Genetic resistance has been found for other diseases, such as HIV.

“For HIV, scientists have been able to identify a specific gene that codes for a protein that can prevent individuals from getting infected,” said Sabrina Assoumou, MD, MPH, professor of medicine at Boston University, who researches HIV.

However, she said, “we haven’t yet found a similar gene or protein that can prevent people from getting infected with SARS-CoV-2.”

What has been found “is that some people might have a mutation in a gene that encodes for what’s called human leukocyte antigen (HLA),” Dr. Assoumou said. HLA, a molecule found on the surface of most cells, has a crucial role in the immune response to foreign substances. “A mutation in HLA can make people less likely to have symptoms if they get infected. Individuals still get infected, but they are less likely to have symptoms.”

Other research has found that those with food allergies are also less likely to be infected. The researchers have speculated that the inflammation characteristic of allergic conditions may reduce levels of a protein called the ACE2 receptor on the surface of airway cells. The SARS-CoV-2 virus uses the receptor to enter the cells, so if levels are low, that could reduce the ability of the virus to infect people.

The COVID Human Genetic Effort continues to search for participants, both those who were admitted to a hospital or repeatedly seen at a hospital because of COVID, as well as those who did not get infected, even after “intense and repeated” exposure.

The number of people likely to be resistant is much smaller, Dr. Hsieh said, than the number of people susceptible to severe disease.
 

The testing ... or lack thereof factor

The timing of testing and a person’s “infection profile” may be factors in people incorrectly declaring themselves NOVIDs, said Anne Wyllie, PhD, a research scientist in epidemiology at the Yale School of Public Health in New Haven, Conn., and a codeveloper of a saliva PCR test for COVID.

“Infection profiles can vary between individuals,” she said. For some, the infection may start in the lower respiratory tract, others in the higher respiratory tract. “Depending on where the virus takes up residence, that can affect test results.”

Then there’s the following-instructions factor. “It’s very likely that due to tests not being done at the right time, with the right sample, or not repeated if there is ongoing evidence of symptoms, that there are individuals out there who believe they are NOVIDs but just missed catching their infection at the window of opportunity.” Dr. Wyllie said.
 

Susceptibility research

“The part we have proven is the genetic defect that would make you more susceptible to having severe disease,” Dr. Hsieh said.

Many published papers report that inherited and/or autoimmune deficiencies of type I interferon immunity, important for combating viral infections and modulating the immune response, can be a significant cause of life-threatening COVID pneumonia.

More recently, researchers, including Jean-Laurent Casanova, MD, PhD, professor at Rockefeller University, New York, and cofounder of the COVID Human Genome Effort, reported that deficiencies in a gene that plays a role in built-in immunity (the early response), and a gene involved in signaling within the immune cells, impair interferon production and may be the basis of severe COVID pneumonia.
 

NOVIDs’ habits run the gamut

As scientists continue their research, the NOVIDs have their own ideas about why they’ve dodged the pandemic bullet, and they have a variety of approaches to handling the pandemic now.

Ryan Alexander, the field rep who travels to casinos, is up to date on his vaccinations and has gotten all the recommended COVID shots. “I was wearing a mask when told to wear masks,” he said.

He still observes the social distance habit but lives life. “I’ve been to three or four concerts in the past couple of years.”

And does he worry his number will eventually be up? “Not at this point, no,” he said.

Joe Asher, 46, said he has not gotten COVID despite being in contact with about 100 people a day, on average. He works as a bartender at an Evansville, Ind., brewery.

“On a Friday night, we can get 500 people,” he said. “I feel like almost everyone at the brewery got it. There’s no way I wasn’t exposed to it all the time.”

However, he said, his coworkers who did get sick were very cautious about not infecting others, partly to help protect a coworker’s family with newborn twins, so that may have helped him stay uninfected, too.

Mr. Asher said he’s in good physical shape, and he’s worked around the public for a long time, so figures maybe that has strengthened his immune system. He’s always been careful about handwashing and said he’s perhaps a bit more conscious of germs than others might be.

Roselyn Mena, 68, a retired teacher in Richmond, Calif., about 16 miles northeast of San Francisco, said she’s managed to avoid the virus even though her husband, Jesus Mena, got infected, as did her two adult children. Now, she remains vigilant about wearing a mask. She tries not to eat inside at restaurants. “I’m super careful,” she said.

Besides her teacher training, Ms. Mena had training as a medical assistant and learned a lot about sanitizing methods. She gets an annual flu shot, washes her hands often, and uses hand sanitizer.

When she shops, she will ask salespeople not wearing masks to please mask. “Only one refused, and she got someone else [to wait on her].”

One reason she is always careful about hygiene, Ms. Mena said, is that “when I get a cold, I get really sick. It last and lasts.” Now, she does worry she might still get it, she said, with the prospect of getting long COVID driving that worry.

In the beginning of the pandemic, Rhonda Fleming, 68, of Los Angeles, lived in a “COVID bubble,” interacting with just a few close family members. As cases went down, she enlarged the bubble. Her two grown daughters got infected, but her granddaughter did not.

She has been vigilant about masking, she said, “and I do still mask in public places.” She has a mask wardrobe, including basic black as well as glittery masks for dressier occasions. “I always carry a mask because inevitably, a cougher surrounds me.”

Now, she will bypass restaurants if she doesn’t feel comfortable with the environment, choosing ones with good air flow. When she flew to Mexico recently, she masked on the plane.

At this point, she said she doesn’t worry about getting infected but remains careful.

Recently, two friends, who have been as diligent as she has about precautions, got infected, “and they don’t know how they got it.”
 

Bragging rights?

Until researchers separate out the true resisters from those who claim to be, some NOVIDs are simply quietly grateful for their luck, while others mention their COVID-free status to anyone who asks or who will listen, and are proud of it. 

And what about those who wear a “NOVID” T-shirt?

“I would think they have a need to convey to the world they are different, perhaps special, because they beat COVID,” said Richard B. Joelson, a New York–based doctor of social work, a psychotherapist, and the author of Help Me! A Psychotherapist’s Tried-and-True Techniques for a Happier Relationship with Yourself and the People You Love. “They didn’t beat COVID, they just didn’t get it.”

Or they may be relieved they didn’t get sick, he said, because they feel defeated when they do. So “it’s a source of pride.” It might be the same people who tell anyone who will listen they never need a doctor or take no medicines, he said.

Even though science may prove many NOVIDs are inaccurate when they call themselves resisters, Dr. Hsieh understands the temptation to talk about it. “It’s kind of cool to think you are supernatural,” she said. “It’s much more attractive than being susceptible. It’s a lot sexier.” ■

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

As a field service representative for a slot machine company, Ryan Alexander, 37, of Louisville, Ky., spends his working hours in casinos, covering a large territory including Norfolk, Va., Indianapolis, and Charlotte. Social distancing in the casinos is not the norm. Despite all this up-close contact with people, he said he is still COVID-free, 3 years into the pandemic.

There was one nervous night when his temperature rose to 101° F, and he figured the virus had caught up with him. “I took a test and was fine,” he said, relieved that the result was negative. The fever disappeared, and he was back to normal soon. “Maybe it was just an exhausting day.”

Mr. Alexander is one of those people who have managed – or at least think they have managed – to avoid getting COVID-19.

He is, some say, a NOVID. While some scientists cringe at the term, it’s caught on to describe these virus super-dodgers. Online entrepreneurs offer NOVID-19 T-shirts, masks, and stickers, in case these super-healthy or super-lucky folks want to publicize their good luck. On Twitter, NOVIDs share stories of how they’ve done it.
 

How many NOVIDs?

As of March 16, according to the CDC, almost 104 million cases of COVID – about one-third of the U.S. population – have been reported, but many cases are known to go unreported. About half of American adults surveyed said they have had COVID, according to a December report by the COVID States Project, a multiuniversity effort to supply pandemic data.

As the numbers settle over time, though, it becomes clearer that some in the U.S. have apparently managed to avoid the virus.

While the exact number of people who have remained uninfected isn’t known with certainty, a review of comprehensive serologic data shows about 15% of Americans may not have gotten infected with COVID, Eric Topol, MD, editor-in-chief of Medscape (WebMD’s sister site for medical professionals) wrote in his substack Ground Truths.

But some scientists bristle at the term NOVIDs. They prefer the term “resisters,” according to Elena Hsieh, MD, associate professor of pediatrics and immunology at the University of Colorado at Denver, Aurora. Currently, she said, there is much more information on who is more susceptible to contracting severe COVID than who is resistant.

Dr. Hsieh is one of the regional coordinators for the COVID Human Genetic Effort, an international consortium of more than 250 researchers and doctors dedicated to discovering the genetic and immunological bases of the forms of SARS-CoV-2 infection. These researchers and others are looking for explanations for why some people get severe COVID while others seem resistant despite repeated exposure.
 

Resistance research

In determining explanations for resistance to infection, “the needle in the haystack that we are looking for is a change in the genetic code that would allow for you to avoid entry of the virus into the cell,” Dr. Hsieh said. “That is what being resistant to infection is.”

Part of the reason it’s so difficult to study resistance is defining a resister, she said. While many people consider themselves among that group because they’re been exposed multiple times – even with close family members infected and sick, yet they still felt fine – that doesn’t necessarily make them a resister, she said.

Those people could have been infected but remained without symptoms. “Resistance means the virus was inside you, it was near your cell and it did not infect your cell,” Dr. Hsieh said.

“I don’t think we know a lot so far,” Dr. Hsieh said about resisters. “I do believe that, just like there are genetic defects that make someone more susceptible, there are likely to be genetic defects that make somebody less susceptible.’’

“To identify genetic variants that are protective is a really challenging thing to do,” agreed Peter K. Gregersen, MD, professor of genetics at the Feinstein Institutes for Medical Research at Northwell Health in Manhasset, N.Y. Dr. Gregersen is also a regional coordinator for the COVID Human Genetic Effort.

He suspects the number found to be truly resistant to COVID – versus dodging it so far – is going to be very small or not found at all.

“It may exist for COVID or it may not,” he said. Some people may simply have what he calls a robust immune response in the upper part of the throat, perhaps killing off the virus quickly as soon as it enters, so they don’t get a positive test.

Genetic resistance has been found for other diseases, such as HIV.

“For HIV, scientists have been able to identify a specific gene that codes for a protein that can prevent individuals from getting infected,” said Sabrina Assoumou, MD, MPH, professor of medicine at Boston University, who researches HIV.

However, she said, “we haven’t yet found a similar gene or protein that can prevent people from getting infected with SARS-CoV-2.”

What has been found “is that some people might have a mutation in a gene that encodes for what’s called human leukocyte antigen (HLA),” Dr. Assoumou said. HLA, a molecule found on the surface of most cells, has a crucial role in the immune response to foreign substances. “A mutation in HLA can make people less likely to have symptoms if they get infected. Individuals still get infected, but they are less likely to have symptoms.”

Other research has found that those with food allergies are also less likely to be infected. The researchers have speculated that the inflammation characteristic of allergic conditions may reduce levels of a protein called the ACE2 receptor on the surface of airway cells. The SARS-CoV-2 virus uses the receptor to enter the cells, so if levels are low, that could reduce the ability of the virus to infect people.

The COVID Human Genetic Effort continues to search for participants, both those who were admitted to a hospital or repeatedly seen at a hospital because of COVID, as well as those who did not get infected, even after “intense and repeated” exposure.

The number of people likely to be resistant is much smaller, Dr. Hsieh said, than the number of people susceptible to severe disease.
 

The testing ... or lack thereof factor

The timing of testing and a person’s “infection profile” may be factors in people incorrectly declaring themselves NOVIDs, said Anne Wyllie, PhD, a research scientist in epidemiology at the Yale School of Public Health in New Haven, Conn., and a codeveloper of a saliva PCR test for COVID.

“Infection profiles can vary between individuals,” she said. For some, the infection may start in the lower respiratory tract, others in the higher respiratory tract. “Depending on where the virus takes up residence, that can affect test results.”

Then there’s the following-instructions factor. “It’s very likely that due to tests not being done at the right time, with the right sample, or not repeated if there is ongoing evidence of symptoms, that there are individuals out there who believe they are NOVIDs but just missed catching their infection at the window of opportunity.” Dr. Wyllie said.
 

Susceptibility research

“The part we have proven is the genetic defect that would make you more susceptible to having severe disease,” Dr. Hsieh said.

Many published papers report that inherited and/or autoimmune deficiencies of type I interferon immunity, important for combating viral infections and modulating the immune response, can be a significant cause of life-threatening COVID pneumonia.

More recently, researchers, including Jean-Laurent Casanova, MD, PhD, professor at Rockefeller University, New York, and cofounder of the COVID Human Genome Effort, reported that deficiencies in a gene that plays a role in built-in immunity (the early response), and a gene involved in signaling within the immune cells, impair interferon production and may be the basis of severe COVID pneumonia.
 

NOVIDs’ habits run the gamut

As scientists continue their research, the NOVIDs have their own ideas about why they’ve dodged the pandemic bullet, and they have a variety of approaches to handling the pandemic now.

Ryan Alexander, the field rep who travels to casinos, is up to date on his vaccinations and has gotten all the recommended COVID shots. “I was wearing a mask when told to wear masks,” he said.

He still observes the social distance habit but lives life. “I’ve been to three or four concerts in the past couple of years.”

And does he worry his number will eventually be up? “Not at this point, no,” he said.

Joe Asher, 46, said he has not gotten COVID despite being in contact with about 100 people a day, on average. He works as a bartender at an Evansville, Ind., brewery.

“On a Friday night, we can get 500 people,” he said. “I feel like almost everyone at the brewery got it. There’s no way I wasn’t exposed to it all the time.”

However, he said, his coworkers who did get sick were very cautious about not infecting others, partly to help protect a coworker’s family with newborn twins, so that may have helped him stay uninfected, too.

Mr. Asher said he’s in good physical shape, and he’s worked around the public for a long time, so figures maybe that has strengthened his immune system. He’s always been careful about handwashing and said he’s perhaps a bit more conscious of germs than others might be.

Roselyn Mena, 68, a retired teacher in Richmond, Calif., about 16 miles northeast of San Francisco, said she’s managed to avoid the virus even though her husband, Jesus Mena, got infected, as did her two adult children. Now, she remains vigilant about wearing a mask. She tries not to eat inside at restaurants. “I’m super careful,” she said.

Besides her teacher training, Ms. Mena had training as a medical assistant and learned a lot about sanitizing methods. She gets an annual flu shot, washes her hands often, and uses hand sanitizer.

When she shops, she will ask salespeople not wearing masks to please mask. “Only one refused, and she got someone else [to wait on her].”

One reason she is always careful about hygiene, Ms. Mena said, is that “when I get a cold, I get really sick. It last and lasts.” Now, she does worry she might still get it, she said, with the prospect of getting long COVID driving that worry.

In the beginning of the pandemic, Rhonda Fleming, 68, of Los Angeles, lived in a “COVID bubble,” interacting with just a few close family members. As cases went down, she enlarged the bubble. Her two grown daughters got infected, but her granddaughter did not.

She has been vigilant about masking, she said, “and I do still mask in public places.” She has a mask wardrobe, including basic black as well as glittery masks for dressier occasions. “I always carry a mask because inevitably, a cougher surrounds me.”

Now, she will bypass restaurants if she doesn’t feel comfortable with the environment, choosing ones with good air flow. When she flew to Mexico recently, she masked on the plane.

At this point, she said she doesn’t worry about getting infected but remains careful.

Recently, two friends, who have been as diligent as she has about precautions, got infected, “and they don’t know how they got it.”
 

Bragging rights?

Until researchers separate out the true resisters from those who claim to be, some NOVIDs are simply quietly grateful for their luck, while others mention their COVID-free status to anyone who asks or who will listen, and are proud of it. 

And what about those who wear a “NOVID” T-shirt?

“I would think they have a need to convey to the world they are different, perhaps special, because they beat COVID,” said Richard B. Joelson, a New York–based doctor of social work, a psychotherapist, and the author of Help Me! A Psychotherapist’s Tried-and-True Techniques for a Happier Relationship with Yourself and the People You Love. “They didn’t beat COVID, they just didn’t get it.”

Or they may be relieved they didn’t get sick, he said, because they feel defeated when they do. So “it’s a source of pride.” It might be the same people who tell anyone who will listen they never need a doctor or take no medicines, he said.

Even though science may prove many NOVIDs are inaccurate when they call themselves resisters, Dr. Hsieh understands the temptation to talk about it. “It’s kind of cool to think you are supernatural,” she said. “It’s much more attractive than being susceptible. It’s a lot sexier.” ■

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

As a field service representative for a slot machine company, Ryan Alexander, 37, of Louisville, Ky., spends his working hours in casinos, covering a large territory including Norfolk, Va., Indianapolis, and Charlotte. Social distancing in the casinos is not the norm. Despite all this up-close contact with people, he said he is still COVID-free, 3 years into the pandemic.

There was one nervous night when his temperature rose to 101° F, and he figured the virus had caught up with him. “I took a test and was fine,” he said, relieved that the result was negative. The fever disappeared, and he was back to normal soon. “Maybe it was just an exhausting day.”

Mr. Alexander is one of those people who have managed – or at least think they have managed – to avoid getting COVID-19.

He is, some say, a NOVID. While some scientists cringe at the term, it’s caught on to describe these virus super-dodgers. Online entrepreneurs offer NOVID-19 T-shirts, masks, and stickers, in case these super-healthy or super-lucky folks want to publicize their good luck. On Twitter, NOVIDs share stories of how they’ve done it.
 

How many NOVIDs?

As of March 16, according to the CDC, almost 104 million cases of COVID – about one-third of the U.S. population – have been reported, but many cases are known to go unreported. About half of American adults surveyed said they have had COVID, according to a December report by the COVID States Project, a multiuniversity effort to supply pandemic data.

As the numbers settle over time, though, it becomes clearer that some in the U.S. have apparently managed to avoid the virus.

While the exact number of people who have remained uninfected isn’t known with certainty, a review of comprehensive serologic data shows about 15% of Americans may not have gotten infected with COVID, Eric Topol, MD, editor-in-chief of Medscape (WebMD’s sister site for medical professionals) wrote in his substack Ground Truths.

But some scientists bristle at the term NOVIDs. They prefer the term “resisters,” according to Elena Hsieh, MD, associate professor of pediatrics and immunology at the University of Colorado at Denver, Aurora. Currently, she said, there is much more information on who is more susceptible to contracting severe COVID than who is resistant.

Dr. Hsieh is one of the regional coordinators for the COVID Human Genetic Effort, an international consortium of more than 250 researchers and doctors dedicated to discovering the genetic and immunological bases of the forms of SARS-CoV-2 infection. These researchers and others are looking for explanations for why some people get severe COVID while others seem resistant despite repeated exposure.
 

Resistance research

In determining explanations for resistance to infection, “the needle in the haystack that we are looking for is a change in the genetic code that would allow for you to avoid entry of the virus into the cell,” Dr. Hsieh said. “That is what being resistant to infection is.”

Part of the reason it’s so difficult to study resistance is defining a resister, she said. While many people consider themselves among that group because they’re been exposed multiple times – even with close family members infected and sick, yet they still felt fine – that doesn’t necessarily make them a resister, she said.

Those people could have been infected but remained without symptoms. “Resistance means the virus was inside you, it was near your cell and it did not infect your cell,” Dr. Hsieh said.

“I don’t think we know a lot so far,” Dr. Hsieh said about resisters. “I do believe that, just like there are genetic defects that make someone more susceptible, there are likely to be genetic defects that make somebody less susceptible.’’

“To identify genetic variants that are protective is a really challenging thing to do,” agreed Peter K. Gregersen, MD, professor of genetics at the Feinstein Institutes for Medical Research at Northwell Health in Manhasset, N.Y. Dr. Gregersen is also a regional coordinator for the COVID Human Genetic Effort.

He suspects the number found to be truly resistant to COVID – versus dodging it so far – is going to be very small or not found at all.

“It may exist for COVID or it may not,” he said. Some people may simply have what he calls a robust immune response in the upper part of the throat, perhaps killing off the virus quickly as soon as it enters, so they don’t get a positive test.

Genetic resistance has been found for other diseases, such as HIV.

“For HIV, scientists have been able to identify a specific gene that codes for a protein that can prevent individuals from getting infected,” said Sabrina Assoumou, MD, MPH, professor of medicine at Boston University, who researches HIV.

However, she said, “we haven’t yet found a similar gene or protein that can prevent people from getting infected with SARS-CoV-2.”

What has been found “is that some people might have a mutation in a gene that encodes for what’s called human leukocyte antigen (HLA),” Dr. Assoumou said. HLA, a molecule found on the surface of most cells, has a crucial role in the immune response to foreign substances. “A mutation in HLA can make people less likely to have symptoms if they get infected. Individuals still get infected, but they are less likely to have symptoms.”

Other research has found that those with food allergies are also less likely to be infected. The researchers have speculated that the inflammation characteristic of allergic conditions may reduce levels of a protein called the ACE2 receptor on the surface of airway cells. The SARS-CoV-2 virus uses the receptor to enter the cells, so if levels are low, that could reduce the ability of the virus to infect people.

The COVID Human Genetic Effort continues to search for participants, both those who were admitted to a hospital or repeatedly seen at a hospital because of COVID, as well as those who did not get infected, even after “intense and repeated” exposure.

The number of people likely to be resistant is much smaller, Dr. Hsieh said, than the number of people susceptible to severe disease.
 

The testing ... or lack thereof factor

The timing of testing and a person’s “infection profile” may be factors in people incorrectly declaring themselves NOVIDs, said Anne Wyllie, PhD, a research scientist in epidemiology at the Yale School of Public Health in New Haven, Conn., and a codeveloper of a saliva PCR test for COVID.

“Infection profiles can vary between individuals,” she said. For some, the infection may start in the lower respiratory tract, others in the higher respiratory tract. “Depending on where the virus takes up residence, that can affect test results.”

Then there’s the following-instructions factor. “It’s very likely that due to tests not being done at the right time, with the right sample, or not repeated if there is ongoing evidence of symptoms, that there are individuals out there who believe they are NOVIDs but just missed catching their infection at the window of opportunity.” Dr. Wyllie said.
 

Susceptibility research

“The part we have proven is the genetic defect that would make you more susceptible to having severe disease,” Dr. Hsieh said.

Many published papers report that inherited and/or autoimmune deficiencies of type I interferon immunity, important for combating viral infections and modulating the immune response, can be a significant cause of life-threatening COVID pneumonia.

More recently, researchers, including Jean-Laurent Casanova, MD, PhD, professor at Rockefeller University, New York, and cofounder of the COVID Human Genome Effort, reported that deficiencies in a gene that plays a role in built-in immunity (the early response), and a gene involved in signaling within the immune cells, impair interferon production and may be the basis of severe COVID pneumonia.
 

NOVIDs’ habits run the gamut

As scientists continue their research, the NOVIDs have their own ideas about why they’ve dodged the pandemic bullet, and they have a variety of approaches to handling the pandemic now.

Ryan Alexander, the field rep who travels to casinos, is up to date on his vaccinations and has gotten all the recommended COVID shots. “I was wearing a mask when told to wear masks,” he said.

He still observes the social distance habit but lives life. “I’ve been to three or four concerts in the past couple of years.”

And does he worry his number will eventually be up? “Not at this point, no,” he said.

Joe Asher, 46, said he has not gotten COVID despite being in contact with about 100 people a day, on average. He works as a bartender at an Evansville, Ind., brewery.

“On a Friday night, we can get 500 people,” he said. “I feel like almost everyone at the brewery got it. There’s no way I wasn’t exposed to it all the time.”

However, he said, his coworkers who did get sick were very cautious about not infecting others, partly to help protect a coworker’s family with newborn twins, so that may have helped him stay uninfected, too.

Mr. Asher said he’s in good physical shape, and he’s worked around the public for a long time, so figures maybe that has strengthened his immune system. He’s always been careful about handwashing and said he’s perhaps a bit more conscious of germs than others might be.

Roselyn Mena, 68, a retired teacher in Richmond, Calif., about 16 miles northeast of San Francisco, said she’s managed to avoid the virus even though her husband, Jesus Mena, got infected, as did her two adult children. Now, she remains vigilant about wearing a mask. She tries not to eat inside at restaurants. “I’m super careful,” she said.

Besides her teacher training, Ms. Mena had training as a medical assistant and learned a lot about sanitizing methods. She gets an annual flu shot, washes her hands often, and uses hand sanitizer.

When she shops, she will ask salespeople not wearing masks to please mask. “Only one refused, and she got someone else [to wait on her].”

One reason she is always careful about hygiene, Ms. Mena said, is that “when I get a cold, I get really sick. It last and lasts.” Now, she does worry she might still get it, she said, with the prospect of getting long COVID driving that worry.

In the beginning of the pandemic, Rhonda Fleming, 68, of Los Angeles, lived in a “COVID bubble,” interacting with just a few close family members. As cases went down, she enlarged the bubble. Her two grown daughters got infected, but her granddaughter did not.

She has been vigilant about masking, she said, “and I do still mask in public places.” She has a mask wardrobe, including basic black as well as glittery masks for dressier occasions. “I always carry a mask because inevitably, a cougher surrounds me.”

Now, she will bypass restaurants if she doesn’t feel comfortable with the environment, choosing ones with good air flow. When she flew to Mexico recently, she masked on the plane.

At this point, she said she doesn’t worry about getting infected but remains careful.

Recently, two friends, who have been as diligent as she has about precautions, got infected, “and they don’t know how they got it.”
 

Bragging rights?

Until researchers separate out the true resisters from those who claim to be, some NOVIDs are simply quietly grateful for their luck, while others mention their COVID-free status to anyone who asks or who will listen, and are proud of it. 

And what about those who wear a “NOVID” T-shirt?

“I would think they have a need to convey to the world they are different, perhaps special, because they beat COVID,” said Richard B. Joelson, a New York–based doctor of social work, a psychotherapist, and the author of Help Me! A Psychotherapist’s Tried-and-True Techniques for a Happier Relationship with Yourself and the People You Love. “They didn’t beat COVID, they just didn’t get it.”

Or they may be relieved they didn’t get sick, he said, because they feel defeated when they do. So “it’s a source of pride.” It might be the same people who tell anyone who will listen they never need a doctor or take no medicines, he said.

Even though science may prove many NOVIDs are inaccurate when they call themselves resisters, Dr. Hsieh understands the temptation to talk about it. “It’s kind of cool to think you are supernatural,” she said. “It’s much more attractive than being susceptible. It’s a lot sexier.” ■

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

Three patients were waiting in a queue for their telemedicine visit. Four others were in exam rooms, waiting for their appointments. Another patient was on the phone, requesting a prescription renewal.

On a sunny Wednesday afternoon in February, David Ahdoot, MD, FACOG, an ob.gyn. in Burbank, Calif., about 10 miles north of downtown Los Angeles, knows he’ll be working late.

“Normally, we would be closed on Wednesday afternoon,” he said. That time would ordinarily be used to schedule surgeries, make dictation, and perform other tasks. But those were the old days, before the COVID-19 pandemic, before the ob.gyn. shortage got even worse, and before many of the other obstacles that make his practice more burdensome worsened.

Those Wednesday afternoon tasks must be done another time. “There are too many patients to see in the office,” said Dr. Ahdoot, who’s also an assistant clinical professor at UCLA. Because of the shortage of primary care physicians, he has taken on new patients, although he said he would like to focus on his existing ones.

Many of those existing patients have been coming to Dr. Ahdoot for years. “I love my job,” he said, and it shows.

His patient reviews online include the usual grumblings about waiting time and being rushed, but many, especially those from new parents, praise him as caring, compassionate, exceptional – the kind of doctor women trust to deliver their first baby and their next ones, then guide them through menopause and other issues.

The shortage of ob.gyns. in California, as elsewhere, is real, as Dr. Ahdoot’s day-to-day attests. The implications are in evidence well beyond his higher patient loads. Lately, Dr. Ahdoot said, the calls from headhunters seeking to fill positions for locum tenens have increased from twice a month to three times a day. Despite his love for his practice, he admits he thinks about stepping away. He is 56, 8 years short of the average retirement age for ob.gyns. nationally, according to a 2018 report.
 

Projected shortages

The shortage of primary care doctors, including ob.gyns., is nationwide. Dr. Ahdoot is one of many faces behind the statistics. According to a 2021 update from the U.S. Department of Health & Human Services, the number of ob.gyns. nationwide is expected to decrease 7% between 2018 and 2030, from 50,850 to 47,490. Meanwhile, demand is headed in the other direction – it is projected to rise 4%, from 50,850 to 52,660 ob.gyns. needed. The need for nurse-midwives, nurse-practitioners, and physician assistants who provide women’s health care is also expected to exceed the supply in coming years.

Some areas are harder hit. The Northeast is expected to have enough maternal health care providers to meet the current average level of care nationally but the West, Midwest, and South will not, according to HHS.

California will likely need an additional 4,700 primary care clinicians by 2025, according to projections by the HealthForce Center at the University of California, San Francisco.
 

Solutions in sight?

Efforts are increasing to make it easier or more appealing for ob.gyns. to practice, or remain in practice, in California. Some existing programs have received funding, while new initiatives to improve the situation are launching.

Some of these efforts and programs will be viewed as a model by some other states, said Janet Coffman, PhD, associate professor at UC San Francisco and a health policy expert who is familiar with new programs and established ones.

“I would say that California offers an example of a multifaceted approach to addressing the shortage of reproductive health providers in general and abortion providers in particular.”

The state has not sat idly in the face of dire predictions of shortfalls in the number of ob.gyns. Over the past decade, Dr. Coffman said, the legislature has “substantially” boosted funding for grants to support ob.gyn. residency programs through CalMedForce and the Song-Brown Healthcare Workforce Training Program. The result: an 18% increase in the number of residents entering the field over the past decade.

“These programs have also substantially increased funding for family medicine residency programs, which are important because family physicians are trained to provide preventive reproductive health services and manage low-risk deliveries,” she added. “Funding for midwifery, nurse midwifery, and nurse practitioner education has been more modest, which I find disappointing because they are qualified to provide many reproductive health services and are more likely to care for underserved populations.”

Other new programs and legislation are focused on expanding the scope of practice for nonphysician health care providers who care for women. Many of these measures are meant to ensure continued access to abortion services not just for California residents, who are guaranteed that right in the state constitution, but for the influx of women expected from states that limited or prohibited abortion after the overturn of Roe v. Wade.

Gavin Newsom, the state’s Democratic governor, has promoted California as a safe haven for women seeking abortions. In September, Gov. Newsom’s reelection campaign rented billboards in six states that have restrictive abortion laws with messages directing women to a website informing them “abortion is legal and protected in California.” The website includes a search function for women looking for providers – representing a further potential strain on the already stressed pool of clinicians. Each year, an estimated 8,000 to 16,100 more people are expected to travel to California for abortions, according to projections made in 2022 by the UCLA Center on Reproductive Health, Law, and Policy.

The questions are, will the efforts be enough to stall or reverse the shortage, and will the efforts to expand other health care providers’ scope of practice be met with cooperation or resistance by MDs?
 

Just launched: California reproductive health service corps

Brand new, as of January 2023, is the California Reproductive Health Service Corps, created by a bill Gov. Newsom signed into law last September. The program operates within the Department of Health Care Access and Information. Rajeena Victoria Bisla, a spokesperson for assemblywoman Cottie Petrie-Norris (D-Irvine), who authored the bill, said: “The Corps will be responsible for recruiting, training, and retaining a diverse workforce of health care professionals who will be part of reproductive health care teams assigned to work in underserved areas.”

The teams will include MDs as well as licensed midwives, nurses, physician’s assistants, doulas, and medical assistants. They will provide abortion care, contraception, perinatal care, gynecology services, and gender-affirming care, among other needs, Ms. Bisla said.

The California Medical Association’s philanthropic arm, Physicians for a Healthy California (PHC), has two programs that aim to grow and diversify the physician workforce and invest in the state’s underserved areas, according to Lupe Alonzo-Diaz, CEO and president of PHC.

CalMedForce gives annual grants to fund new residency positions at graduate medical education (GME) programs throughout the state. The goal, Ms. Alonzo-Diaz said, is to expand the physician training pool. Funds were generated by Proposition 56, which was passed in 2016. The legislation generates tax on tobacco products. To date, GME programs have received more than $112 million to retain and expand primary care GME programs.

A second program, CalHealthCares, also funded by Proposition 56, offers a loan repayment program of up to $300,000 for physicians who meet certain criteria. “We are incentivizing young physicians and dentists to practice in Medi-Cal communities,” Ms. Alonzo-Diaz said, referring to the state’s Medicaid program. Clinicians must have graduated within the past 5 years (since Jan. 1, 2018) or will be graduating from a residency or fellowship program no later than June 30, 2023. Dentists applying for the practice support grant must have graduated from dental school or residency program within the past 15 years (since Jan. 1, 2008).

In exchange for the loan repayment, the health care providers are asked to commit to 5 years of service in the underserved community. So far, about 800 providers are part of the program, she said. According to Ms. Alonzo-Diaz, the average educational debt for health care providers in California is $315,000 to $350,000. That is as much as $100,000 above the national average.

What else is needed? Shannan Velayas, a spokesperson for the California Medical Association, said the state should invest in the Medi-Cal system to improve “meaningful access” to health care services and to expand loan repayment and residency programs like CalHealthCares and CalMedForce.

“Workforce shortages are not a reason to sacrifice quality of care or compromise patient safety but do warrant additional investment to increase access to medical providers working within their scope of practice,” Ms. Velayas said.
 

Widening scopes

Efforts are also underway to expand the scope of practice for nurse-practitioners, certified nurse-midwives, and physician assistants. Triggering these efforts has been the fallout and expected consequences of the overturning of Roe v. Wade, removing the federal right to abortion care.

Effective January 2023, trained and qualified nurse-practitioners and certified nurse-midwives in California can perform first-trimester abortions without a doctor’s supervision. Toni Atkins (D-San Diego), now president pro tempore of the California State Senate, authored the bill, SB1375. The measure builds on a 2013 law she spearheaded that allowed certain advanced-practice providers to perform first-trimester abortions with physician supervision.

On Feb. 13, Ms. Atkins introduced SB385, which gives physician assistants the same ability to become qualified in abortion care.

Ms. Atkins expressed confidence that teamwork would prevail in the efforts to have enough providers in the state. “One of the biggest lessons I learned working at a women’s health clinic [prior to her assuming her legislative positions] is that providers put their patients above all else, whether they are doctors, registered nurses, nurse practitioners, certified nurse-midwives, or physician assistants,” she said. “Everyone is on the same team when it comes to breaking down barriers and ensuring all Californians get the care they need without delay.”

Will other states follow suit? “This is pure speculation, but I believe states in which the political leadership supports abortion rights may see the California Reproductive Service Corps and the changes to scope-of-practice laws that allow specially trained CNMs, NPs, and PAs to provide abortions as a model for preserving access to abortion in their states,” Dr. Coffman said.

However, she said, “other states are less likely to view CalMedForce and CalHealthCares as models, because other states have had similar programs for many years, and some have historically invested larger shares of state budget resources into these programs, especially some rural states.”
 

Reports from the trenches

Laurie Love, DNP, RN, is a family nurse practitioner in Valencia and a clinical instructor and lecturer at the UCLA School of Nursing. When a patient becomes pregnant, she refers her to one of four local ob.gyns.

The working relationships she has with them, she said, “are extremely collaborative. There is no animosity or lack of respect because I don’t have an MD behind my name.”

One of those doctors is Dr. Ahdoot, who said he welcomes the expansion of scope of practice for non-MD health care providers. Some of his colleagues, he said, have tried to fight it, but many have come to the point of welcoming the help. “The consensus is you can’t practice without a nurse practitioner anymore,” Dr. Ahdoot told this news organization.

Expanding the scope of practice for other clinicians helps everyone, including patients, he said. He thinks about how the shortage affects them. “For patients, there is frustration,” he said. He said he often hears women saying they can’t schedule a pap smear for 3 months, or they can’t get a return call from their doctor.

Nalo Hamilton, PhD, an ob.gyn. nurse practitioner and associate professor at UCLA, said the physicians she interacts with support the expanded scope of practice. “Many are confused about details, about what it means and how it will impact them,” she said. “Those who understand it, yes, they agree with it. Doctors will simply have more health care providers who are able to do independent practice.” And she makes another point clear: “We won’t replace ob.gyns.”

None of the persons quoted in this story have disclosed any relevant financial relationships.

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

Three patients were waiting in a queue for their telemedicine visit. Four others were in exam rooms, waiting for their appointments. Another patient was on the phone, requesting a prescription renewal.

On a sunny Wednesday afternoon in February, David Ahdoot, MD, FACOG, an ob.gyn. in Burbank, Calif., about 10 miles north of downtown Los Angeles, knows he’ll be working late.

“Normally, we would be closed on Wednesday afternoon,” he said. That time would ordinarily be used to schedule surgeries, make dictation, and perform other tasks. But those were the old days, before the COVID-19 pandemic, before the ob.gyn. shortage got even worse, and before many of the other obstacles that make his practice more burdensome worsened.

Those Wednesday afternoon tasks must be done another time. “There are too many patients to see in the office,” said Dr. Ahdoot, who’s also an assistant clinical professor at UCLA. Because of the shortage of primary care physicians, he has taken on new patients, although he said he would like to focus on his existing ones.

Many of those existing patients have been coming to Dr. Ahdoot for years. “I love my job,” he said, and it shows.

His patient reviews online include the usual grumblings about waiting time and being rushed, but many, especially those from new parents, praise him as caring, compassionate, exceptional – the kind of doctor women trust to deliver their first baby and their next ones, then guide them through menopause and other issues.

The shortage of ob.gyns. in California, as elsewhere, is real, as Dr. Ahdoot’s day-to-day attests. The implications are in evidence well beyond his higher patient loads. Lately, Dr. Ahdoot said, the calls from headhunters seeking to fill positions for locum tenens have increased from twice a month to three times a day. Despite his love for his practice, he admits he thinks about stepping away. He is 56, 8 years short of the average retirement age for ob.gyns. nationally, according to a 2018 report.
 

Projected shortages

The shortage of primary care doctors, including ob.gyns., is nationwide. Dr. Ahdoot is one of many faces behind the statistics. According to a 2021 update from the U.S. Department of Health & Human Services, the number of ob.gyns. nationwide is expected to decrease 7% between 2018 and 2030, from 50,850 to 47,490. Meanwhile, demand is headed in the other direction – it is projected to rise 4%, from 50,850 to 52,660 ob.gyns. needed. The need for nurse-midwives, nurse-practitioners, and physician assistants who provide women’s health care is also expected to exceed the supply in coming years.

Some areas are harder hit. The Northeast is expected to have enough maternal health care providers to meet the current average level of care nationally but the West, Midwest, and South will not, according to HHS.

California will likely need an additional 4,700 primary care clinicians by 2025, according to projections by the HealthForce Center at the University of California, San Francisco.
 

Solutions in sight?

Efforts are increasing to make it easier or more appealing for ob.gyns. to practice, or remain in practice, in California. Some existing programs have received funding, while new initiatives to improve the situation are launching.

Some of these efforts and programs will be viewed as a model by some other states, said Janet Coffman, PhD, associate professor at UC San Francisco and a health policy expert who is familiar with new programs and established ones.

“I would say that California offers an example of a multifaceted approach to addressing the shortage of reproductive health providers in general and abortion providers in particular.”

The state has not sat idly in the face of dire predictions of shortfalls in the number of ob.gyns. Over the past decade, Dr. Coffman said, the legislature has “substantially” boosted funding for grants to support ob.gyn. residency programs through CalMedForce and the Song-Brown Healthcare Workforce Training Program. The result: an 18% increase in the number of residents entering the field over the past decade.

“These programs have also substantially increased funding for family medicine residency programs, which are important because family physicians are trained to provide preventive reproductive health services and manage low-risk deliveries,” she added. “Funding for midwifery, nurse midwifery, and nurse practitioner education has been more modest, which I find disappointing because they are qualified to provide many reproductive health services and are more likely to care for underserved populations.”

Other new programs and legislation are focused on expanding the scope of practice for nonphysician health care providers who care for women. Many of these measures are meant to ensure continued access to abortion services not just for California residents, who are guaranteed that right in the state constitution, but for the influx of women expected from states that limited or prohibited abortion after the overturn of Roe v. Wade.

Gavin Newsom, the state’s Democratic governor, has promoted California as a safe haven for women seeking abortions. In September, Gov. Newsom’s reelection campaign rented billboards in six states that have restrictive abortion laws with messages directing women to a website informing them “abortion is legal and protected in California.” The website includes a search function for women looking for providers – representing a further potential strain on the already stressed pool of clinicians. Each year, an estimated 8,000 to 16,100 more people are expected to travel to California for abortions, according to projections made in 2022 by the UCLA Center on Reproductive Health, Law, and Policy.

The questions are, will the efforts be enough to stall or reverse the shortage, and will the efforts to expand other health care providers’ scope of practice be met with cooperation or resistance by MDs?
 

Just launched: California reproductive health service corps

Brand new, as of January 2023, is the California Reproductive Health Service Corps, created by a bill Gov. Newsom signed into law last September. The program operates within the Department of Health Care Access and Information. Rajeena Victoria Bisla, a spokesperson for assemblywoman Cottie Petrie-Norris (D-Irvine), who authored the bill, said: “The Corps will be responsible for recruiting, training, and retaining a diverse workforce of health care professionals who will be part of reproductive health care teams assigned to work in underserved areas.”

The teams will include MDs as well as licensed midwives, nurses, physician’s assistants, doulas, and medical assistants. They will provide abortion care, contraception, perinatal care, gynecology services, and gender-affirming care, among other needs, Ms. Bisla said.

The California Medical Association’s philanthropic arm, Physicians for a Healthy California (PHC), has two programs that aim to grow and diversify the physician workforce and invest in the state’s underserved areas, according to Lupe Alonzo-Diaz, CEO and president of PHC.

CalMedForce gives annual grants to fund new residency positions at graduate medical education (GME) programs throughout the state. The goal, Ms. Alonzo-Diaz said, is to expand the physician training pool. Funds were generated by Proposition 56, which was passed in 2016. The legislation generates tax on tobacco products. To date, GME programs have received more than $112 million to retain and expand primary care GME programs.

A second program, CalHealthCares, also funded by Proposition 56, offers a loan repayment program of up to $300,000 for physicians who meet certain criteria. “We are incentivizing young physicians and dentists to practice in Medi-Cal communities,” Ms. Alonzo-Diaz said, referring to the state’s Medicaid program. Clinicians must have graduated within the past 5 years (since Jan. 1, 2018) or will be graduating from a residency or fellowship program no later than June 30, 2023. Dentists applying for the practice support grant must have graduated from dental school or residency program within the past 15 years (since Jan. 1, 2008).

In exchange for the loan repayment, the health care providers are asked to commit to 5 years of service in the underserved community. So far, about 800 providers are part of the program, she said. According to Ms. Alonzo-Diaz, the average educational debt for health care providers in California is $315,000 to $350,000. That is as much as $100,000 above the national average.

What else is needed? Shannan Velayas, a spokesperson for the California Medical Association, said the state should invest in the Medi-Cal system to improve “meaningful access” to health care services and to expand loan repayment and residency programs like CalHealthCares and CalMedForce.

“Workforce shortages are not a reason to sacrifice quality of care or compromise patient safety but do warrant additional investment to increase access to medical providers working within their scope of practice,” Ms. Velayas said.
 

Widening scopes

Efforts are also underway to expand the scope of practice for nurse-practitioners, certified nurse-midwives, and physician assistants. Triggering these efforts has been the fallout and expected consequences of the overturning of Roe v. Wade, removing the federal right to abortion care.

Effective January 2023, trained and qualified nurse-practitioners and certified nurse-midwives in California can perform first-trimester abortions without a doctor’s supervision. Toni Atkins (D-San Diego), now president pro tempore of the California State Senate, authored the bill, SB1375. The measure builds on a 2013 law she spearheaded that allowed certain advanced-practice providers to perform first-trimester abortions with physician supervision.

On Feb. 13, Ms. Atkins introduced SB385, which gives physician assistants the same ability to become qualified in abortion care.

Ms. Atkins expressed confidence that teamwork would prevail in the efforts to have enough providers in the state. “One of the biggest lessons I learned working at a women’s health clinic [prior to her assuming her legislative positions] is that providers put their patients above all else, whether they are doctors, registered nurses, nurse practitioners, certified nurse-midwives, or physician assistants,” she said. “Everyone is on the same team when it comes to breaking down barriers and ensuring all Californians get the care they need without delay.”

Will other states follow suit? “This is pure speculation, but I believe states in which the political leadership supports abortion rights may see the California Reproductive Service Corps and the changes to scope-of-practice laws that allow specially trained CNMs, NPs, and PAs to provide abortions as a model for preserving access to abortion in their states,” Dr. Coffman said.

However, she said, “other states are less likely to view CalMedForce and CalHealthCares as models, because other states have had similar programs for many years, and some have historically invested larger shares of state budget resources into these programs, especially some rural states.”
 

Reports from the trenches

Laurie Love, DNP, RN, is a family nurse practitioner in Valencia and a clinical instructor and lecturer at the UCLA School of Nursing. When a patient becomes pregnant, she refers her to one of four local ob.gyns.

The working relationships she has with them, she said, “are extremely collaborative. There is no animosity or lack of respect because I don’t have an MD behind my name.”

One of those doctors is Dr. Ahdoot, who said he welcomes the expansion of scope of practice for non-MD health care providers. Some of his colleagues, he said, have tried to fight it, but many have come to the point of welcoming the help. “The consensus is you can’t practice without a nurse practitioner anymore,” Dr. Ahdoot told this news organization.

Expanding the scope of practice for other clinicians helps everyone, including patients, he said. He thinks about how the shortage affects them. “For patients, there is frustration,” he said. He said he often hears women saying they can’t schedule a pap smear for 3 months, or they can’t get a return call from their doctor.

Nalo Hamilton, PhD, an ob.gyn. nurse practitioner and associate professor at UCLA, said the physicians she interacts with support the expanded scope of practice. “Many are confused about details, about what it means and how it will impact them,” she said. “Those who understand it, yes, they agree with it. Doctors will simply have more health care providers who are able to do independent practice.” And she makes another point clear: “We won’t replace ob.gyns.”

None of the persons quoted in this story have disclosed any relevant financial relationships.

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

Three patients were waiting in a queue for their telemedicine visit. Four others were in exam rooms, waiting for their appointments. Another patient was on the phone, requesting a prescription renewal.

On a sunny Wednesday afternoon in February, David Ahdoot, MD, FACOG, an ob.gyn. in Burbank, Calif., about 10 miles north of downtown Los Angeles, knows he’ll be working late.

“Normally, we would be closed on Wednesday afternoon,” he said. That time would ordinarily be used to schedule surgeries, make dictation, and perform other tasks. But those were the old days, before the COVID-19 pandemic, before the ob.gyn. shortage got even worse, and before many of the other obstacles that make his practice more burdensome worsened.

Those Wednesday afternoon tasks must be done another time. “There are too many patients to see in the office,” said Dr. Ahdoot, who’s also an assistant clinical professor at UCLA. Because of the shortage of primary care physicians, he has taken on new patients, although he said he would like to focus on his existing ones.

Many of those existing patients have been coming to Dr. Ahdoot for years. “I love my job,” he said, and it shows.

His patient reviews online include the usual grumblings about waiting time and being rushed, but many, especially those from new parents, praise him as caring, compassionate, exceptional – the kind of doctor women trust to deliver their first baby and their next ones, then guide them through menopause and other issues.

The shortage of ob.gyns. in California, as elsewhere, is real, as Dr. Ahdoot’s day-to-day attests. The implications are in evidence well beyond his higher patient loads. Lately, Dr. Ahdoot said, the calls from headhunters seeking to fill positions for locum tenens have increased from twice a month to three times a day. Despite his love for his practice, he admits he thinks about stepping away. He is 56, 8 years short of the average retirement age for ob.gyns. nationally, according to a 2018 report.
 

Projected shortages

The shortage of primary care doctors, including ob.gyns., is nationwide. Dr. Ahdoot is one of many faces behind the statistics. According to a 2021 update from the U.S. Department of Health & Human Services, the number of ob.gyns. nationwide is expected to decrease 7% between 2018 and 2030, from 50,850 to 47,490. Meanwhile, demand is headed in the other direction – it is projected to rise 4%, from 50,850 to 52,660 ob.gyns. needed. The need for nurse-midwives, nurse-practitioners, and physician assistants who provide women’s health care is also expected to exceed the supply in coming years.

Some areas are harder hit. The Northeast is expected to have enough maternal health care providers to meet the current average level of care nationally but the West, Midwest, and South will not, according to HHS.

California will likely need an additional 4,700 primary care clinicians by 2025, according to projections by the HealthForce Center at the University of California, San Francisco.
 

Solutions in sight?

Efforts are increasing to make it easier or more appealing for ob.gyns. to practice, or remain in practice, in California. Some existing programs have received funding, while new initiatives to improve the situation are launching.

Some of these efforts and programs will be viewed as a model by some other states, said Janet Coffman, PhD, associate professor at UC San Francisco and a health policy expert who is familiar with new programs and established ones.

“I would say that California offers an example of a multifaceted approach to addressing the shortage of reproductive health providers in general and abortion providers in particular.”

The state has not sat idly in the face of dire predictions of shortfalls in the number of ob.gyns. Over the past decade, Dr. Coffman said, the legislature has “substantially” boosted funding for grants to support ob.gyn. residency programs through CalMedForce and the Song-Brown Healthcare Workforce Training Program. The result: an 18% increase in the number of residents entering the field over the past decade.

“These programs have also substantially increased funding for family medicine residency programs, which are important because family physicians are trained to provide preventive reproductive health services and manage low-risk deliveries,” she added. “Funding for midwifery, nurse midwifery, and nurse practitioner education has been more modest, which I find disappointing because they are qualified to provide many reproductive health services and are more likely to care for underserved populations.”

Other new programs and legislation are focused on expanding the scope of practice for nonphysician health care providers who care for women. Many of these measures are meant to ensure continued access to abortion services not just for California residents, who are guaranteed that right in the state constitution, but for the influx of women expected from states that limited or prohibited abortion after the overturn of Roe v. Wade.

Gavin Newsom, the state’s Democratic governor, has promoted California as a safe haven for women seeking abortions. In September, Gov. Newsom’s reelection campaign rented billboards in six states that have restrictive abortion laws with messages directing women to a website informing them “abortion is legal and protected in California.” The website includes a search function for women looking for providers – representing a further potential strain on the already stressed pool of clinicians. Each year, an estimated 8,000 to 16,100 more people are expected to travel to California for abortions, according to projections made in 2022 by the UCLA Center on Reproductive Health, Law, and Policy.

The questions are, will the efforts be enough to stall or reverse the shortage, and will the efforts to expand other health care providers’ scope of practice be met with cooperation or resistance by MDs?
 

Just launched: California reproductive health service corps

Brand new, as of January 2023, is the California Reproductive Health Service Corps, created by a bill Gov. Newsom signed into law last September. The program operates within the Department of Health Care Access and Information. Rajeena Victoria Bisla, a spokesperson for assemblywoman Cottie Petrie-Norris (D-Irvine), who authored the bill, said: “The Corps will be responsible for recruiting, training, and retaining a diverse workforce of health care professionals who will be part of reproductive health care teams assigned to work in underserved areas.”

The teams will include MDs as well as licensed midwives, nurses, physician’s assistants, doulas, and medical assistants. They will provide abortion care, contraception, perinatal care, gynecology services, and gender-affirming care, among other needs, Ms. Bisla said.

The California Medical Association’s philanthropic arm, Physicians for a Healthy California (PHC), has two programs that aim to grow and diversify the physician workforce and invest in the state’s underserved areas, according to Lupe Alonzo-Diaz, CEO and president of PHC.

CalMedForce gives annual grants to fund new residency positions at graduate medical education (GME) programs throughout the state. The goal, Ms. Alonzo-Diaz said, is to expand the physician training pool. Funds were generated by Proposition 56, which was passed in 2016. The legislation generates tax on tobacco products. To date, GME programs have received more than $112 million to retain and expand primary care GME programs.

A second program, CalHealthCares, also funded by Proposition 56, offers a loan repayment program of up to $300,000 for physicians who meet certain criteria. “We are incentivizing young physicians and dentists to practice in Medi-Cal communities,” Ms. Alonzo-Diaz said, referring to the state’s Medicaid program. Clinicians must have graduated within the past 5 years (since Jan. 1, 2018) or will be graduating from a residency or fellowship program no later than June 30, 2023. Dentists applying for the practice support grant must have graduated from dental school or residency program within the past 15 years (since Jan. 1, 2008).

In exchange for the loan repayment, the health care providers are asked to commit to 5 years of service in the underserved community. So far, about 800 providers are part of the program, she said. According to Ms. Alonzo-Diaz, the average educational debt for health care providers in California is $315,000 to $350,000. That is as much as $100,000 above the national average.

What else is needed? Shannan Velayas, a spokesperson for the California Medical Association, said the state should invest in the Medi-Cal system to improve “meaningful access” to health care services and to expand loan repayment and residency programs like CalHealthCares and CalMedForce.

“Workforce shortages are not a reason to sacrifice quality of care or compromise patient safety but do warrant additional investment to increase access to medical providers working within their scope of practice,” Ms. Velayas said.
 

Widening scopes

Efforts are also underway to expand the scope of practice for nurse-practitioners, certified nurse-midwives, and physician assistants. Triggering these efforts has been the fallout and expected consequences of the overturning of Roe v. Wade, removing the federal right to abortion care.

Effective January 2023, trained and qualified nurse-practitioners and certified nurse-midwives in California can perform first-trimester abortions without a doctor’s supervision. Toni Atkins (D-San Diego), now president pro tempore of the California State Senate, authored the bill, SB1375. The measure builds on a 2013 law she spearheaded that allowed certain advanced-practice providers to perform first-trimester abortions with physician supervision.

On Feb. 13, Ms. Atkins introduced SB385, which gives physician assistants the same ability to become qualified in abortion care.

Ms. Atkins expressed confidence that teamwork would prevail in the efforts to have enough providers in the state. “One of the biggest lessons I learned working at a women’s health clinic [prior to her assuming her legislative positions] is that providers put their patients above all else, whether they are doctors, registered nurses, nurse practitioners, certified nurse-midwives, or physician assistants,” she said. “Everyone is on the same team when it comes to breaking down barriers and ensuring all Californians get the care they need without delay.”

Will other states follow suit? “This is pure speculation, but I believe states in which the political leadership supports abortion rights may see the California Reproductive Service Corps and the changes to scope-of-practice laws that allow specially trained CNMs, NPs, and PAs to provide abortions as a model for preserving access to abortion in their states,” Dr. Coffman said.

However, she said, “other states are less likely to view CalMedForce and CalHealthCares as models, because other states have had similar programs for many years, and some have historically invested larger shares of state budget resources into these programs, especially some rural states.”
 

Reports from the trenches

Laurie Love, DNP, RN, is a family nurse practitioner in Valencia and a clinical instructor and lecturer at the UCLA School of Nursing. When a patient becomes pregnant, she refers her to one of four local ob.gyns.

The working relationships she has with them, she said, “are extremely collaborative. There is no animosity or lack of respect because I don’t have an MD behind my name.”

One of those doctors is Dr. Ahdoot, who said he welcomes the expansion of scope of practice for non-MD health care providers. Some of his colleagues, he said, have tried to fight it, but many have come to the point of welcoming the help. “The consensus is you can’t practice without a nurse practitioner anymore,” Dr. Ahdoot told this news organization.

Expanding the scope of practice for other clinicians helps everyone, including patients, he said. He thinks about how the shortage affects them. “For patients, there is frustration,” he said. He said he often hears women saying they can’t schedule a pap smear for 3 months, or they can’t get a return call from their doctor.

Nalo Hamilton, PhD, an ob.gyn. nurse practitioner and associate professor at UCLA, said the physicians she interacts with support the expanded scope of practice. “Many are confused about details, about what it means and how it will impact them,” she said. “Those who understand it, yes, they agree with it. Doctors will simply have more health care providers who are able to do independent practice.” And she makes another point clear: “We won’t replace ob.gyns.”

None of the persons quoted in this story have disclosed any relevant financial relationships.

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

In December 2021, major changes took effect in the iPLEDGE program, the Food and Drug Administration–required safety program for managing the risks of isotretinoin’s teratogenicity and preventing exposure during pregnancy. Now, more modifications may be coming to the acne drug’s safety program.

The FDA has scheduled a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee for March 28-29 to discuss proposed changes to the iPLEDGE risk evaluation and mitigation strategy (REMS) requirements. The aim, according to the FDA meeting announcement, is “to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”

Ocskay Bence/Fotolia.com

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. Its former brand name was Accutane.

Problems began to surface days after a new, gender-neutral approach to the risk mitigation program was launched on Dec. 13, 2021. That program had been approved earlier by the FDA.

However, the problems that were encountered were a result of glitches in changes in the platform that had been planned, and were not related to the gender-neutral changes. The iPLEDGE program had transitioned to the new platform, and the rollout was far from smooth. Dermatologists, pharmacists, patients, parents of patients, and others were frustrated and angry that they could not access the new platform and obtain the medication promptly. Reaching the help line to sort out problems was another exercise in frustration. Wait times while on hold were unbearably long, or problems were not resolved over the phone.

(The new gender-neutral approach, which advocates said was needed to preserve inclusiveness of their patients, including transgender patients, places potential patients into two categories: those who can become pregnant, and those who cannot. Previously, there were three categories into which patients were classified: females who have reproductive potential, females who do not have reproductive potential, and males.)

Before pharmacists can fill a prescription for isotretinoin, a medical provider must confirm a patient’s negative pregnancy test and inform a patient with reproductive potential of the risks of the medication.

In January 2022, to deal with the chaotic launch and subsequent problems, the FDA said it would continue to meet with the Isotretinoin Products Manufacturers Group (IPMG) to resolve the problems reported by clinicians, pharmacists, and patients.

The American Academy of Dermatology Association formed an iPLEDGE work group to address the issues and suggest solutions. It has made several requests of and suggestions for the IPMG, which manages the program, according to Andrea L. Zaenglein, MD, professor of dermatology and pediatrics at Penn State Hershey (Pa.) Medical Center, and a member of the work group.

“We are asking them to eliminate the monthly attestation for patients who can’t get pregnant and to review and modify restrictive and punitive waiting and lockout periods for all patients,” she told this news organization.

As of February 2023, most of the platform glitches had been smoothed out, Dr. Zaenglein said. Still, “improvements to the design of the website could improve the user interface,” she added.


The FDA has established a docket for the public to submit comments before the meeting. The docket number is FDA-2022-N-3071. The electronic filing system will accept comments until 11:59 p.m. Eastern time on March 27. Background material and a link to the live webcast of the panel meeting will be available to the public no later than 2 days before the meeting and will be posted on the FDA web page or at the time of the meeting.

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

In December 2021, major changes took effect in the iPLEDGE program, the Food and Drug Administration–required safety program for managing the risks of isotretinoin’s teratogenicity and preventing exposure during pregnancy. Now, more modifications may be coming to the acne drug’s safety program.

The FDA has scheduled a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee for March 28-29 to discuss proposed changes to the iPLEDGE risk evaluation and mitigation strategy (REMS) requirements. The aim, according to the FDA meeting announcement, is “to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”

Ocskay Bence/Fotolia.com

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. Its former brand name was Accutane.

Problems began to surface days after a new, gender-neutral approach to the risk mitigation program was launched on Dec. 13, 2021. That program had been approved earlier by the FDA.

However, the problems that were encountered were a result of glitches in changes in the platform that had been planned, and were not related to the gender-neutral changes. The iPLEDGE program had transitioned to the new platform, and the rollout was far from smooth. Dermatologists, pharmacists, patients, parents of patients, and others were frustrated and angry that they could not access the new platform and obtain the medication promptly. Reaching the help line to sort out problems was another exercise in frustration. Wait times while on hold were unbearably long, or problems were not resolved over the phone.

(The new gender-neutral approach, which advocates said was needed to preserve inclusiveness of their patients, including transgender patients, places potential patients into two categories: those who can become pregnant, and those who cannot. Previously, there were three categories into which patients were classified: females who have reproductive potential, females who do not have reproductive potential, and males.)

Before pharmacists can fill a prescription for isotretinoin, a medical provider must confirm a patient’s negative pregnancy test and inform a patient with reproductive potential of the risks of the medication.

In January 2022, to deal with the chaotic launch and subsequent problems, the FDA said it would continue to meet with the Isotretinoin Products Manufacturers Group (IPMG) to resolve the problems reported by clinicians, pharmacists, and patients.

The American Academy of Dermatology Association formed an iPLEDGE work group to address the issues and suggest solutions. It has made several requests of and suggestions for the IPMG, which manages the program, according to Andrea L. Zaenglein, MD, professor of dermatology and pediatrics at Penn State Hershey (Pa.) Medical Center, and a member of the work group.

“We are asking them to eliminate the monthly attestation for patients who can’t get pregnant and to review and modify restrictive and punitive waiting and lockout periods for all patients,” she told this news organization.

As of February 2023, most of the platform glitches had been smoothed out, Dr. Zaenglein said. Still, “improvements to the design of the website could improve the user interface,” she added.


The FDA has established a docket for the public to submit comments before the meeting. The docket number is FDA-2022-N-3071. The electronic filing system will accept comments until 11:59 p.m. Eastern time on March 27. Background material and a link to the live webcast of the panel meeting will be available to the public no later than 2 days before the meeting and will be posted on the FDA web page or at the time of the meeting.

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

In December 2021, major changes took effect in the iPLEDGE program, the Food and Drug Administration–required safety program for managing the risks of isotretinoin’s teratogenicity and preventing exposure during pregnancy. Now, more modifications may be coming to the acne drug’s safety program.

The FDA has scheduled a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee for March 28-29 to discuss proposed changes to the iPLEDGE risk evaluation and mitigation strategy (REMS) requirements. The aim, according to the FDA meeting announcement, is “to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”

Ocskay Bence/Fotolia.com

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. Its former brand name was Accutane.

Problems began to surface days after a new, gender-neutral approach to the risk mitigation program was launched on Dec. 13, 2021. That program had been approved earlier by the FDA.

However, the problems that were encountered were a result of glitches in changes in the platform that had been planned, and were not related to the gender-neutral changes. The iPLEDGE program had transitioned to the new platform, and the rollout was far from smooth. Dermatologists, pharmacists, patients, parents of patients, and others were frustrated and angry that they could not access the new platform and obtain the medication promptly. Reaching the help line to sort out problems was another exercise in frustration. Wait times while on hold were unbearably long, or problems were not resolved over the phone.

(The new gender-neutral approach, which advocates said was needed to preserve inclusiveness of their patients, including transgender patients, places potential patients into two categories: those who can become pregnant, and those who cannot. Previously, there were three categories into which patients were classified: females who have reproductive potential, females who do not have reproductive potential, and males.)

Before pharmacists can fill a prescription for isotretinoin, a medical provider must confirm a patient’s negative pregnancy test and inform a patient with reproductive potential of the risks of the medication.

In January 2022, to deal with the chaotic launch and subsequent problems, the FDA said it would continue to meet with the Isotretinoin Products Manufacturers Group (IPMG) to resolve the problems reported by clinicians, pharmacists, and patients.

The American Academy of Dermatology Association formed an iPLEDGE work group to address the issues and suggest solutions. It has made several requests of and suggestions for the IPMG, which manages the program, according to Andrea L. Zaenglein, MD, professor of dermatology and pediatrics at Penn State Hershey (Pa.) Medical Center, and a member of the work group.

“We are asking them to eliminate the monthly attestation for patients who can’t get pregnant and to review and modify restrictive and punitive waiting and lockout periods for all patients,” she told this news organization.

As of February 2023, most of the platform glitches had been smoothed out, Dr. Zaenglein said. Still, “improvements to the design of the website could improve the user interface,” she added.


The FDA has established a docket for the public to submit comments before the meeting. The docket number is FDA-2022-N-3071. The electronic filing system will accept comments until 11:59 p.m. Eastern time on March 27. Background material and a link to the live webcast of the panel meeting will be available to the public no later than 2 days before the meeting and will be posted on the FDA web page or at the time of the meeting.

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

On Twitter, as in real life, it’s a question on many minds: When should we think about the next COVID-19 vaccine? Or should we?

For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?

At this point, no one knows for sure, but new guidance may be on the docket.

On Jan. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.

According to the FDA announcement, after the meeting, “the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.”

From there, the CDC will take up the issue and decide on recommendations.

The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That’s up from 346 a day for the week ending Dec. 28.

Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan. 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.
 

COVID vaccines, 2023 and beyond

Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.

“I think we probably will need another booster,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and codirector of the Center for Vaccine Development at Texas Children’s Hospital in Houston. “The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?” 

The trivalent booster, he suggested, might include something more protective against XBB.1.5.

The bivalent booster gives “broadened immunity” that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, WebMD’s sister site for health professionals.

In his publication Ground Truths, Dr. Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.

Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation. 

While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that’s population-wide.

“People who fall into those three groups do benefit,” he says, “but the recommendation is everyone over 6 months get the bivalent, and what I’m asking is, ‘Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?’ ”
 

Evolving research

“We are trying to understand how to stay one step ahead rather than several steps behind [the virus],“ says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?

Much more research has become available recently about the bivalent vaccine and its effectiveness, Dr. Osterholm says. “The bivalent vaccine is working as well as we could have expected,” he says, especially in high-risk people and in those over age 65. “The challenge we have is, what does that mean going forward?”

In his review, Dr. Topol concludes: “There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent’s benefit over the original booster.”

Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared with the original booster shots. Two others showed no real difference.

“The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots,” Dr. Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.

Dr. Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.

Boosters do matter, Dr. Offit says. “But not for all.” In a perspective published Jan. 11 in the New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Dr. Offit wrote that boosting is best reserved for vulnerable groups.

Chasing the variants with a bivalent vaccine, he says, “has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other.”

Dr. Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them “with vaccines containing mRNA from strains that might disappear a few months later.”

The CDC needs to parse the data by subgroups, Dr. Offit says. “The critical question is, ‘Who gets hospitalized and who is dying? Who are they?’ ”

That data should take into account age, ethnicity, vaccine history, and other factors, Dr. Offit says, because right now, there is no great data to say, “OK, everyone gets a boost.”
 

Future vaccine costs

Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared with the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.

The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.

The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-Vt.), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.

“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients.”

He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.

While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?

“I think so, yes,” Dr. Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.

“The government is balking at paying for the boosters,” he says. “I think it’s very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they’ve gotten from the American people, I think they should not be gouging at this point.”

He noted that the federal government provided not just money to the companies for the vaccines, but a “glide path” through the FDA for the vaccine approvals.
 

Are new, variant-specific boosters coming?

Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?

Novavax, approved in July 2022 as a primary series and in some cases as a booster, is “also developing an Omicron-containing bivalent vaccine at the direction of public health agencies,” says spokesperson Alison Chartan.

Pfizer responded: “When and if we have something to share we will let you know.”

Moderna did not respond.

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

On Twitter, as in real life, it’s a question on many minds: When should we think about the next COVID-19 vaccine? Or should we?

For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?

At this point, no one knows for sure, but new guidance may be on the docket.

On Jan. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.

According to the FDA announcement, after the meeting, “the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.”

From there, the CDC will take up the issue and decide on recommendations.

The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That’s up from 346 a day for the week ending Dec. 28.

Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan. 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.
 

COVID vaccines, 2023 and beyond

Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.

“I think we probably will need another booster,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and codirector of the Center for Vaccine Development at Texas Children’s Hospital in Houston. “The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?” 

The trivalent booster, he suggested, might include something more protective against XBB.1.5.

The bivalent booster gives “broadened immunity” that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, WebMD’s sister site for health professionals.

In his publication Ground Truths, Dr. Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.

Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation. 

While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that’s population-wide.

“People who fall into those three groups do benefit,” he says, “but the recommendation is everyone over 6 months get the bivalent, and what I’m asking is, ‘Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?’ ”
 

Evolving research

“We are trying to understand how to stay one step ahead rather than several steps behind [the virus],“ says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?

Much more research has become available recently about the bivalent vaccine and its effectiveness, Dr. Osterholm says. “The bivalent vaccine is working as well as we could have expected,” he says, especially in high-risk people and in those over age 65. “The challenge we have is, what does that mean going forward?”

In his review, Dr. Topol concludes: “There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent’s benefit over the original booster.”

Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared with the original booster shots. Two others showed no real difference.

“The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots,” Dr. Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.

Dr. Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.

Boosters do matter, Dr. Offit says. “But not for all.” In a perspective published Jan. 11 in the New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Dr. Offit wrote that boosting is best reserved for vulnerable groups.

Chasing the variants with a bivalent vaccine, he says, “has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other.”

Dr. Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them “with vaccines containing mRNA from strains that might disappear a few months later.”

The CDC needs to parse the data by subgroups, Dr. Offit says. “The critical question is, ‘Who gets hospitalized and who is dying? Who are they?’ ”

That data should take into account age, ethnicity, vaccine history, and other factors, Dr. Offit says, because right now, there is no great data to say, “OK, everyone gets a boost.”
 

Future vaccine costs

Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared with the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.

The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.

The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-Vt.), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.

“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients.”

He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.

While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?

“I think so, yes,” Dr. Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.

“The government is balking at paying for the boosters,” he says. “I think it’s very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they’ve gotten from the American people, I think they should not be gouging at this point.”

He noted that the federal government provided not just money to the companies for the vaccines, but a “glide path” through the FDA for the vaccine approvals.
 

Are new, variant-specific boosters coming?

Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?

Novavax, approved in July 2022 as a primary series and in some cases as a booster, is “also developing an Omicron-containing bivalent vaccine at the direction of public health agencies,” says spokesperson Alison Chartan.

Pfizer responded: “When and if we have something to share we will let you know.”

Moderna did not respond.

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

On Twitter, as in real life, it’s a question on many minds: When should we think about the next COVID-19 vaccine? Or should we?

For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?

At this point, no one knows for sure, but new guidance may be on the docket.

On Jan. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.

According to the FDA announcement, after the meeting, “the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.”

From there, the CDC will take up the issue and decide on recommendations.

The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That’s up from 346 a day for the week ending Dec. 28.

Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan. 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.
 

COVID vaccines, 2023 and beyond

Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.

“I think we probably will need another booster,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and codirector of the Center for Vaccine Development at Texas Children’s Hospital in Houston. “The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?” 

The trivalent booster, he suggested, might include something more protective against XBB.1.5.

The bivalent booster gives “broadened immunity” that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, WebMD’s sister site for health professionals.

In his publication Ground Truths, Dr. Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.

Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation. 

While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that’s population-wide.

“People who fall into those three groups do benefit,” he says, “but the recommendation is everyone over 6 months get the bivalent, and what I’m asking is, ‘Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?’ ”
 

Evolving research

“We are trying to understand how to stay one step ahead rather than several steps behind [the virus],“ says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?

Much more research has become available recently about the bivalent vaccine and its effectiveness, Dr. Osterholm says. “The bivalent vaccine is working as well as we could have expected,” he says, especially in high-risk people and in those over age 65. “The challenge we have is, what does that mean going forward?”

In his review, Dr. Topol concludes: “There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent’s benefit over the original booster.”

Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared with the original booster shots. Two others showed no real difference.

“The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots,” Dr. Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.

Dr. Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.

Boosters do matter, Dr. Offit says. “But not for all.” In a perspective published Jan. 11 in the New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Dr. Offit wrote that boosting is best reserved for vulnerable groups.

Chasing the variants with a bivalent vaccine, he says, “has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other.”

Dr. Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them “with vaccines containing mRNA from strains that might disappear a few months later.”

The CDC needs to parse the data by subgroups, Dr. Offit says. “The critical question is, ‘Who gets hospitalized and who is dying? Who are they?’ ”

That data should take into account age, ethnicity, vaccine history, and other factors, Dr. Offit says, because right now, there is no great data to say, “OK, everyone gets a boost.”
 

Future vaccine costs

Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared with the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.

The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.

The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-Vt.), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.

“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients.”

He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.

While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?

“I think so, yes,” Dr. Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.

“The government is balking at paying for the boosters,” he says. “I think it’s very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they’ve gotten from the American people, I think they should not be gouging at this point.”

He noted that the federal government provided not just money to the companies for the vaccines, but a “glide path” through the FDA for the vaccine approvals.
 

Are new, variant-specific boosters coming?

Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?

Novavax, approved in July 2022 as a primary series and in some cases as a booster, is “also developing an Omicron-containing bivalent vaccine at the direction of public health agencies,” says spokesperson Alison Chartan.

Pfizer responded: “When and if we have something to share we will let you know.”

Moderna did not respond.

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

As holiday celebrations wind down in the United States, COVID is on the rise.

While many would like to take a vacation from even thinking about COVID, the question of what’s next with the virus is always looming. Will there be another winter surge? If so, can we minimize it? How big a role might the boosters play in that? Are more mandates coming, along with a return to closed offices and businesses? Read on for a look at the latest info. 
 

Cases, hospitalizations, deaths

As of Dec. 27, the latest statistics, the Centers for Disease Control and Prevention reports more than 487,000 weekly cases, compared to about 265,000 for the week ending Oct. 12. On average, 4,938 people were admitted to the hospital daily from Dec. 19 to 25, down about 6% from the 5,257 admitted daily the week before. 

Deaths totaled 2,952 weekly as of Dec. 21, up from 2,699 on Dec. 14.  

“What’s sobering overall is still seeing about 400 deaths a day in the U.S.,” said Peter Chin-Hong, MD, professor of medicine and infectious disease specialist at the University of California, San Francisco. “It’s still very high.”

As of Dec. 17, the variants predominating are BQ.1, BQ.1.1, and XBB. Experts said they are paying close attention to XBB, which is increasing quickly in the Northeast. 
 

Predicting a winter surge

Experts tracking the pandemic agree there will be a surge. 

“We are in the midst of it now,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape (MDedge’s sister site). “It’s not nearly like what we’ve had in Omicron or other waves; it’s not as severe. But it’s being particularly felt by seniors.”  

One bit of good news: “Outside of that group it doesn’t look like – so far – it is going to be as bad a wave [as in the past],” Dr. Topol said. 

Predicting the extent of the post-holiday surge “is the billion-dollar question right now,” said Katelyn Jetelina, PhD, a San Diego epidemiologist and author of the newsletter Your Local Epidemiologist.

“Much of these waves are not being driven by subvariants of concern but rather behavior,” she said. 

People are opening up their social networks to gather for celebrations and family time. That’s unique to this winter, she said.

“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.

Others point out that the surge doesn’t involve just COVID. 

“We are expecting a Christmas surge and we are concerned it might be a triple surge,” said William Schaffner, MD, professor of infectious diseases at Vanderbilt University, Nashville, Tenn., referring to the rising cases of flu and RSV (respiratory syncytial virus). 

Dr. Jetelina shares that concern, worrying that those illnesses may be what overwhelms hospital capacity.

Another wild card is the situation in China. With the easing of China’s “zero COVID” policies, cases there are rising dramatically. Some models are predicting up to 1 million COVID deaths could occur in China in 2023. (The United States is now requiring travelers from China to show a negative COVID test before entering. Italy and Japan have taken similar measures.) 

“The suffering that is going to occur in China is not good news at all,” Dr. Topol said. “We are going to be seeing that for many weeks if not months ahead.” 

Theoretically, uncontained spread such as what is expected there could generate a whole new family of variants, he said. But “the main hit is going to be in China,” he predicted. “But it’s hard to project with accuracy.”

“China is 20% of the global population, so we can’t ignore it,” Dr. Jetelina said. “The question is, what’s the probability of a subvariant of concern coming from China? I think the probability is pretty low, but the possibility is there.”

What happens with cases in China may “throw a wrench” in the transition from pandemic to endemic, Dr. Chin-Hong said. But even if the rising cases in China do result in a new variant, “there’s so much T cell and B cell immunity [here], your average person is still not going to get seriously ill, even if the variant looks really scary.”


 

Minimizing the damage

Experts echo the same advice on stemming the surge, especially for adults who are 65 or older: Get the bivalent booster, and get it now. 

“The same with the influenza vaccine,” Dr. Schaffner said. 

Both the booster vaccine and the flu vaccine have been underused this year, he said. “It’s part of the general vaccine fatigue.”

The low uptake of the booster vaccine is concerning, Dr. Topol said, especially among adults aged 65 and older, the age group most vulnerable to severe disease. Just 35.7% of U.S. adults 65 and older have gotten the booster, according to the CDC. Dr. Topol calls that a tragedy.

Younger people have not taken to the booster, either. Overall, only 14.1% of people aged 5 and up have gotten an updated booster dose, according to the CDC. 

Recent studies find value in the boosters. One study looked only at adults age 65 or older, finding that the bivalent booster reduced the risk of hospitalization by 84% compared to someone not vaccinated, and 73% compared to someone who had received only the monovalent vaccine. Another study of adults found those who had gotten the bivalent were less likely to need COVID-related emergency room care or urgent care.  

In a Dec. 21 report in the New England Journal of Medicine, researchers took plasma samples from people who had gotten either one or two monovalent boosters or the bivalent to determine how well they worked against the circulating Omicron subvariants BA.1, BA.5, BA.2.75.2, BQ.1.1, and XBB. The bivalent worked better than the monovalent against all the Omicron subvariants, but especially against BA.2.75.2, BQ.1.1, and XBB.

Rapid testing can help minimize transmission. On Dec. 15, the Biden administration announced its Winter Preparedness Plan, urging Americans to test before and after travel as well as indoor visiting with vulnerable individuals, providing another round of free at-home tests, continuing to make community testing available and continuing to provide vaccines. 

Besides the general precautions, Dr. Schaffner suggested: “Look at yourself. Who are you? If you are older than 65, or have underlying illness or are immunocompromised, or are pregnant, please put your mask back on. And think about social distancing. It might be time to worship at home and stream a movie,” instead of going to the theaters, he said. 
 

Back to mandates?

On Dec. 9, the New York City Commissioner of Health and Mental Hygiene urged a return to masking indoors, saying people “should” mask up, including in schools, stores, offices, and when in crowded outdoor settings.

On the same date, the County of Los Angeles Public Health urged a return to masking for everyone aged 2 and older when indoors, including at schools, in transit, or in work sites when around others.

While the CDC order requiring masks on public transportation is no longer in effect,  the agency continues to recommend that those using public transportation do so.

But some are taking that further. In Philadelphia, for example, School Superintendent Tony B. Watlington Sr., EdD, announced before the winter break that indoor masking would be required for all students and staff for the first 2 weeks of school return, through Jan. 13, citing guidance from the Philadelphia Department of Public Health.

Universal masking in schools does reduce COVID transmission, as a study published in late November suggests. After Massachusetts dropped the statewide universal masking policy in public schools in February 2022, researchers compared the incidence of COVID in 70 school districts there that dropped the mandate with two school districts that kept it. In the 15 weeks after the policy was rescinded, the lifting of the mandate was linked with an additional 44.9 cases of COVID per 1,000 students and staff. That corresponded to an estimated 11,901 cases and to nearly 30% of the cases in all districts during that time.

That said, experts see mandates as the exception rather than the rule, at least for now, citing public backlash against mandates to mask or follow other restrictions. 

“Mandating, we know, it shuts people off,” Dr. Topol said. “It’s unenforceable. If you have a very strong recommendation, that’s probably as good as you’re going to be able to do right now.”

There may be communities where mandates go over better than others, Dr. Schaffner said, such as communities where people have confidence in their public health authorities.
 

Glimmers of hope

Despite uncertainties, experts offered some not-so-dismal perspectives as well. 

“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.

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

As holiday celebrations wind down in the United States, COVID is on the rise.

While many would like to take a vacation from even thinking about COVID, the question of what’s next with the virus is always looming. Will there be another winter surge? If so, can we minimize it? How big a role might the boosters play in that? Are more mandates coming, along with a return to closed offices and businesses? Read on for a look at the latest info. 
 

Cases, hospitalizations, deaths

As of Dec. 27, the latest statistics, the Centers for Disease Control and Prevention reports more than 487,000 weekly cases, compared to about 265,000 for the week ending Oct. 12. On average, 4,938 people were admitted to the hospital daily from Dec. 19 to 25, down about 6% from the 5,257 admitted daily the week before. 

Deaths totaled 2,952 weekly as of Dec. 21, up from 2,699 on Dec. 14.  

“What’s sobering overall is still seeing about 400 deaths a day in the U.S.,” said Peter Chin-Hong, MD, professor of medicine and infectious disease specialist at the University of California, San Francisco. “It’s still very high.”

As of Dec. 17, the variants predominating are BQ.1, BQ.1.1, and XBB. Experts said they are paying close attention to XBB, which is increasing quickly in the Northeast. 
 

Predicting a winter surge

Experts tracking the pandemic agree there will be a surge. 

“We are in the midst of it now,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape (MDedge’s sister site). “It’s not nearly like what we’ve had in Omicron or other waves; it’s not as severe. But it’s being particularly felt by seniors.”  

One bit of good news: “Outside of that group it doesn’t look like – so far – it is going to be as bad a wave [as in the past],” Dr. Topol said. 

Predicting the extent of the post-holiday surge “is the billion-dollar question right now,” said Katelyn Jetelina, PhD, a San Diego epidemiologist and author of the newsletter Your Local Epidemiologist.

“Much of these waves are not being driven by subvariants of concern but rather behavior,” she said. 

People are opening up their social networks to gather for celebrations and family time. That’s unique to this winter, she said.

“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.

Others point out that the surge doesn’t involve just COVID. 

“We are expecting a Christmas surge and we are concerned it might be a triple surge,” said William Schaffner, MD, professor of infectious diseases at Vanderbilt University, Nashville, Tenn., referring to the rising cases of flu and RSV (respiratory syncytial virus). 

Dr. Jetelina shares that concern, worrying that those illnesses may be what overwhelms hospital capacity.

Another wild card is the situation in China. With the easing of China’s “zero COVID” policies, cases there are rising dramatically. Some models are predicting up to 1 million COVID deaths could occur in China in 2023. (The United States is now requiring travelers from China to show a negative COVID test before entering. Italy and Japan have taken similar measures.) 

“The suffering that is going to occur in China is not good news at all,” Dr. Topol said. “We are going to be seeing that for many weeks if not months ahead.” 

Theoretically, uncontained spread such as what is expected there could generate a whole new family of variants, he said. But “the main hit is going to be in China,” he predicted. “But it’s hard to project with accuracy.”

“China is 20% of the global population, so we can’t ignore it,” Dr. Jetelina said. “The question is, what’s the probability of a subvariant of concern coming from China? I think the probability is pretty low, but the possibility is there.”

What happens with cases in China may “throw a wrench” in the transition from pandemic to endemic, Dr. Chin-Hong said. But even if the rising cases in China do result in a new variant, “there’s so much T cell and B cell immunity [here], your average person is still not going to get seriously ill, even if the variant looks really scary.”


 

Minimizing the damage

Experts echo the same advice on stemming the surge, especially for adults who are 65 or older: Get the bivalent booster, and get it now. 

“The same with the influenza vaccine,” Dr. Schaffner said. 

Both the booster vaccine and the flu vaccine have been underused this year, he said. “It’s part of the general vaccine fatigue.”

The low uptake of the booster vaccine is concerning, Dr. Topol said, especially among adults aged 65 and older, the age group most vulnerable to severe disease. Just 35.7% of U.S. adults 65 and older have gotten the booster, according to the CDC. Dr. Topol calls that a tragedy.

Younger people have not taken to the booster, either. Overall, only 14.1% of people aged 5 and up have gotten an updated booster dose, according to the CDC. 

Recent studies find value in the boosters. One study looked only at adults age 65 or older, finding that the bivalent booster reduced the risk of hospitalization by 84% compared to someone not vaccinated, and 73% compared to someone who had received only the monovalent vaccine. Another study of adults found those who had gotten the bivalent were less likely to need COVID-related emergency room care or urgent care.  

In a Dec. 21 report in the New England Journal of Medicine, researchers took plasma samples from people who had gotten either one or two monovalent boosters or the bivalent to determine how well they worked against the circulating Omicron subvariants BA.1, BA.5, BA.2.75.2, BQ.1.1, and XBB. The bivalent worked better than the monovalent against all the Omicron subvariants, but especially against BA.2.75.2, BQ.1.1, and XBB.

Rapid testing can help minimize transmission. On Dec. 15, the Biden administration announced its Winter Preparedness Plan, urging Americans to test before and after travel as well as indoor visiting with vulnerable individuals, providing another round of free at-home tests, continuing to make community testing available and continuing to provide vaccines. 

Besides the general precautions, Dr. Schaffner suggested: “Look at yourself. Who are you? If you are older than 65, or have underlying illness or are immunocompromised, or are pregnant, please put your mask back on. And think about social distancing. It might be time to worship at home and stream a movie,” instead of going to the theaters, he said. 
 

Back to mandates?

On Dec. 9, the New York City Commissioner of Health and Mental Hygiene urged a return to masking indoors, saying people “should” mask up, including in schools, stores, offices, and when in crowded outdoor settings.

On the same date, the County of Los Angeles Public Health urged a return to masking for everyone aged 2 and older when indoors, including at schools, in transit, or in work sites when around others.

While the CDC order requiring masks on public transportation is no longer in effect,  the agency continues to recommend that those using public transportation do so.

But some are taking that further. In Philadelphia, for example, School Superintendent Tony B. Watlington Sr., EdD, announced before the winter break that indoor masking would be required for all students and staff for the first 2 weeks of school return, through Jan. 13, citing guidance from the Philadelphia Department of Public Health.

Universal masking in schools does reduce COVID transmission, as a study published in late November suggests. After Massachusetts dropped the statewide universal masking policy in public schools in February 2022, researchers compared the incidence of COVID in 70 school districts there that dropped the mandate with two school districts that kept it. In the 15 weeks after the policy was rescinded, the lifting of the mandate was linked with an additional 44.9 cases of COVID per 1,000 students and staff. That corresponded to an estimated 11,901 cases and to nearly 30% of the cases in all districts during that time.

That said, experts see mandates as the exception rather than the rule, at least for now, citing public backlash against mandates to mask or follow other restrictions. 

“Mandating, we know, it shuts people off,” Dr. Topol said. “It’s unenforceable. If you have a very strong recommendation, that’s probably as good as you’re going to be able to do right now.”

There may be communities where mandates go over better than others, Dr. Schaffner said, such as communities where people have confidence in their public health authorities.
 

Glimmers of hope

Despite uncertainties, experts offered some not-so-dismal perspectives as well. 

“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.

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

As holiday celebrations wind down in the United States, COVID is on the rise.

While many would like to take a vacation from even thinking about COVID, the question of what’s next with the virus is always looming. Will there be another winter surge? If so, can we minimize it? How big a role might the boosters play in that? Are more mandates coming, along with a return to closed offices and businesses? Read on for a look at the latest info. 
 

Cases, hospitalizations, deaths

As of Dec. 27, the latest statistics, the Centers for Disease Control and Prevention reports more than 487,000 weekly cases, compared to about 265,000 for the week ending Oct. 12. On average, 4,938 people were admitted to the hospital daily from Dec. 19 to 25, down about 6% from the 5,257 admitted daily the week before. 

Deaths totaled 2,952 weekly as of Dec. 21, up from 2,699 on Dec. 14.  

“What’s sobering overall is still seeing about 400 deaths a day in the U.S.,” said Peter Chin-Hong, MD, professor of medicine and infectious disease specialist at the University of California, San Francisco. “It’s still very high.”

As of Dec. 17, the variants predominating are BQ.1, BQ.1.1, and XBB. Experts said they are paying close attention to XBB, which is increasing quickly in the Northeast. 
 

Predicting a winter surge

Experts tracking the pandemic agree there will be a surge. 

“We are in the midst of it now,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape (MDedge’s sister site). “It’s not nearly like what we’ve had in Omicron or other waves; it’s not as severe. But it’s being particularly felt by seniors.”  

One bit of good news: “Outside of that group it doesn’t look like – so far – it is going to be as bad a wave [as in the past],” Dr. Topol said. 

Predicting the extent of the post-holiday surge “is the billion-dollar question right now,” said Katelyn Jetelina, PhD, a San Diego epidemiologist and author of the newsletter Your Local Epidemiologist.

“Much of these waves are not being driven by subvariants of concern but rather behavior,” she said. 

People are opening up their social networks to gather for celebrations and family time. That’s unique to this winter, she said.

“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.

Others point out that the surge doesn’t involve just COVID. 

“We are expecting a Christmas surge and we are concerned it might be a triple surge,” said William Schaffner, MD, professor of infectious diseases at Vanderbilt University, Nashville, Tenn., referring to the rising cases of flu and RSV (respiratory syncytial virus). 

Dr. Jetelina shares that concern, worrying that those illnesses may be what overwhelms hospital capacity.

Another wild card is the situation in China. With the easing of China’s “zero COVID” policies, cases there are rising dramatically. Some models are predicting up to 1 million COVID deaths could occur in China in 2023. (The United States is now requiring travelers from China to show a negative COVID test before entering. Italy and Japan have taken similar measures.) 

“The suffering that is going to occur in China is not good news at all,” Dr. Topol said. “We are going to be seeing that for many weeks if not months ahead.” 

Theoretically, uncontained spread such as what is expected there could generate a whole new family of variants, he said. But “the main hit is going to be in China,” he predicted. “But it’s hard to project with accuracy.”

“China is 20% of the global population, so we can’t ignore it,” Dr. Jetelina said. “The question is, what’s the probability of a subvariant of concern coming from China? I think the probability is pretty low, but the possibility is there.”

What happens with cases in China may “throw a wrench” in the transition from pandemic to endemic, Dr. Chin-Hong said. But even if the rising cases in China do result in a new variant, “there’s so much T cell and B cell immunity [here], your average person is still not going to get seriously ill, even if the variant looks really scary.”


 

Minimizing the damage

Experts echo the same advice on stemming the surge, especially for adults who are 65 or older: Get the bivalent booster, and get it now. 

“The same with the influenza vaccine,” Dr. Schaffner said. 

Both the booster vaccine and the flu vaccine have been underused this year, he said. “It’s part of the general vaccine fatigue.”

The low uptake of the booster vaccine is concerning, Dr. Topol said, especially among adults aged 65 and older, the age group most vulnerable to severe disease. Just 35.7% of U.S. adults 65 and older have gotten the booster, according to the CDC. Dr. Topol calls that a tragedy.

Younger people have not taken to the booster, either. Overall, only 14.1% of people aged 5 and up have gotten an updated booster dose, according to the CDC. 

Recent studies find value in the boosters. One study looked only at adults age 65 or older, finding that the bivalent booster reduced the risk of hospitalization by 84% compared to someone not vaccinated, and 73% compared to someone who had received only the monovalent vaccine. Another study of adults found those who had gotten the bivalent were less likely to need COVID-related emergency room care or urgent care.  

In a Dec. 21 report in the New England Journal of Medicine, researchers took plasma samples from people who had gotten either one or two monovalent boosters or the bivalent to determine how well they worked against the circulating Omicron subvariants BA.1, BA.5, BA.2.75.2, BQ.1.1, and XBB. The bivalent worked better than the monovalent against all the Omicron subvariants, but especially against BA.2.75.2, BQ.1.1, and XBB.

Rapid testing can help minimize transmission. On Dec. 15, the Biden administration announced its Winter Preparedness Plan, urging Americans to test before and after travel as well as indoor visiting with vulnerable individuals, providing another round of free at-home tests, continuing to make community testing available and continuing to provide vaccines. 

Besides the general precautions, Dr. Schaffner suggested: “Look at yourself. Who are you? If you are older than 65, or have underlying illness or are immunocompromised, or are pregnant, please put your mask back on. And think about social distancing. It might be time to worship at home and stream a movie,” instead of going to the theaters, he said. 
 

Back to mandates?

On Dec. 9, the New York City Commissioner of Health and Mental Hygiene urged a return to masking indoors, saying people “should” mask up, including in schools, stores, offices, and when in crowded outdoor settings.

On the same date, the County of Los Angeles Public Health urged a return to masking for everyone aged 2 and older when indoors, including at schools, in transit, or in work sites when around others.

While the CDC order requiring masks on public transportation is no longer in effect,  the agency continues to recommend that those using public transportation do so.

But some are taking that further. In Philadelphia, for example, School Superintendent Tony B. Watlington Sr., EdD, announced before the winter break that indoor masking would be required for all students and staff for the first 2 weeks of school return, through Jan. 13, citing guidance from the Philadelphia Department of Public Health.

Universal masking in schools does reduce COVID transmission, as a study published in late November suggests. After Massachusetts dropped the statewide universal masking policy in public schools in February 2022, researchers compared the incidence of COVID in 70 school districts there that dropped the mandate with two school districts that kept it. In the 15 weeks after the policy was rescinded, the lifting of the mandate was linked with an additional 44.9 cases of COVID per 1,000 students and staff. That corresponded to an estimated 11,901 cases and to nearly 30% of the cases in all districts during that time.

That said, experts see mandates as the exception rather than the rule, at least for now, citing public backlash against mandates to mask or follow other restrictions. 

“Mandating, we know, it shuts people off,” Dr. Topol said. “It’s unenforceable. If you have a very strong recommendation, that’s probably as good as you’re going to be able to do right now.”

There may be communities where mandates go over better than others, Dr. Schaffner said, such as communities where people have confidence in their public health authorities.
 

Glimmers of hope

Despite uncertainties, experts offered some not-so-dismal perspectives as well. 

“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.

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

It’s officially 2023, and if history repeats, millions of Americans are likely vowing that this year will be one when they drop those unwanted pounds for good. After all, weight loss usually lands one of the top spots on New Year’s resolution surveys. 

And just in time, there’s guidance to pick the best plan, as U.S. News & World Report’s annual rankings of the best diet plans were released on Jan. 3.

Once again, the Mediterranean diet, which emphasizes fruits, vegetables, olive oil, and fish, got the top spot, as best diet overall. It’s the sixth consecutive year for that win. But many other diets got top marks as well.

In 2023, U.S. News, with the help of more than 30 nutritionists, doctors, and epidemiologists, ranked 24 diets in several categories to help people find a plan that meets their goals, whether it’s finding the best weight loss diet, easiest one to follow, or plans for other goals, such as managing diabetes or heart disease. Two new categories were added: Best Diets for Bone & Joint Health and Best Family-Friendly Diets. 

In previous years, the publication ranked 40 diets. Even if a diet is no longer ranked, its profile with detailed information remains on the site. 

“Each year we ask ourselves what we can do better or differently next time,” said Gretel Schueller, managing editor of health for U.S. News. When the publication got feedback from their experts this year, they had requests to consider sustainability of diets and whether they meet a busy family’s needs, in addition to considering many other factors. 

This year’s report ranks plans in 11 categories.

The winners and the categories:
 

Best diets overall

After the Mediterranean diet, two others tied for second place:

• DASH (Dietary Approaches to Stop Hypertension) diet, which fights high blood pressure and emphasizes fruits, vegetables, whole grains, lean protein, and low-fat dairy.
• Flexitarian diet, which focuses on fruits, vegetables, and other healthy foods but also allows occasional meat.

Best weight-loss diets

WW, formerly known as Weight Watchers, got first place. The plan emphasizes not only weight loss but healthier eating and regular activity. The Points program, which assigns specific points to foods, with a daily Points budget, is more personalized than in the past.

• DASH got second place.
• Mayo Clinic Diet and TLC diet tied for third place. The Mayo Clinic Diet focuses on fruits, vegetables, and whole grains. It helps people improve their eating habits. The TLC diet (Therapeutic Lifestyle Changes) focuses on vegetables, fruit, lean protein, and reducing cholesterol levels. 

Best fast weight-loss diets

The keto diet got first place. It’s a high-fat, low-carb diet that aims to achieve weight loss through fat burning. Four others tied for second place:

• Atkins, a diet created by the cardiologist Robert Atkins, which begins with very few carbs and then recommends progressively eating more until the weight loss goal is achieved 
• Nutrisystem, a commercial program that includes prepackaged meals and focuses on high-protein, lower-glycemic foods to stabilize blood sugar levels
• Optavia, a plan focused on low-carb, low-calorie foods and including fortified meal replacements 
• SlimFast Diet, a plan of shakes, smoothies, and meal bars to replace two of three meals a day

Best diets for healthy eating

• Mediterranean
• DASH
• Flexitarian

Best heart-healthy diets

• DASH
• Mediterranean
• Flexitarian and Ornish tied for third. The Ornish Diet focuses on plant-based and whole foods and limiting animal products. It recommends daily exercise and stress reduction.

Best diets for diabetes

• DASH
• Mediterranean
• Flexitarian

Best diets for bone and joint health

DASH and Mediterranean are in a first-place tie, followed by the flexitarian diet.

Best family-friendly diets

This category has a three-way tie: the flexitarian, Mediterranean, and TLC diets. 

Best plant-based diets

Mediterranean was first, then flexitarian and the MIND diet. The MIND diet combines the DASH and Mediterranean diets and focuses on “brain-healthy” foods.

Easiest diets to follow

Flexitarian and TLC tied for first, followed by a tie between DASH and Mediterranean.

Best diet programs (formerly called commercial plans)

• WW
• There was a tie for second place between Jenny Craig and Noom, the latter of which focuses on low-calorie foods, with personalized calorie ranges and coaching to help meet goals.

Methodology

A variety of factors were considered, such as whether a diet includes all food groups, how easy it is to follow, whether it can be customized to meet cultural and personal preferences, and if it has a realistic timeline for weight loss. 

Response from diet plans

Representatives from two plans that received mixed reviews in the rankings responded.

Jenny Craig was ranked second for best diet program but much lower for family friendly, landing at 22nd place of 24. 

“Our program is designed to address the needs of the individual through personalized experiences,” Jenny Craig CEO Mandy Dowson said. “We have many families that participate in our program together but are still evaluated separately to determine appropriate individual goals.”

Its high ranking for best diet program reflects feedback from satisfied members, she said. Among advances will be the new Jenny Fresh program, a line of entrées prepared fresh and delivered to customers’ doors.

Atkins got second place for best fast weight loss but ranked near the bottom for best overall, best weight loss, diabetes, healthy eating, and heart health. In response, Colette Heimowitz, vice president of nutrition and education for Simply Good Foods, which makes Atkins’s food products, said that low-carb eating approaches are a viable option for anyone today.

“There are more than 130 independent, peer-reviewed published studies that show the efficacy and safety of low-carb eating,” she said. “The studies have been conducted for several decades and counting.” 
 

Expert perspective

Samantha Cassetty, a registered dietitian, nutritionist, and wellness expert in New York and author of Sugar Shock, reviewed the report for this news organization. She was not involved in the rankings.

“I think what this shows you is, the best diet overall is also the best for various conditions,” she said. For instance, the Mediterranean, the No. 1 overall, also got high ranking for diabetes, heart health, and bone and joint health.

For consumers trying to lose weight: “If you see fast weight loss, that should be a red flag. A healthy diet for weight loss is one you can sustain,” she said. 

She’s not a fan of the programs with prepackaged foods. “It takes the guesswork out, but the portion sizes tend to be unsatisfying. They don’t teach you how to deal with some of the challenges [such as realizing an ‘ideal’ portion size].”
 

How to use the report

Ms. Schueller’s advice: “Recognize that no diet fits everyone.” When considering which plan to choose, she suggests thinking long-term. 

“Whatever we choose has to work in the long run,” she said.

Consumers should consider expenses, meal prep time, and whether the diet fits their lifestyle.

Ideally, she said, the best diet “teaches you smart food preparation and how to make healthy choices, allows the flexibility to be social and eat with groups, whether family or friends.”

Before choosing a diet to follow, consult a medical professional for input on the decision, U.S. News cautioned.

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

It’s officially 2023, and if history repeats, millions of Americans are likely vowing that this year will be one when they drop those unwanted pounds for good. After all, weight loss usually lands one of the top spots on New Year’s resolution surveys. 

And just in time, there’s guidance to pick the best plan, as U.S. News & World Report’s annual rankings of the best diet plans were released on Jan. 3.

Once again, the Mediterranean diet, which emphasizes fruits, vegetables, olive oil, and fish, got the top spot, as best diet overall. It’s the sixth consecutive year for that win. But many other diets got top marks as well.

In 2023, U.S. News, with the help of more than 30 nutritionists, doctors, and epidemiologists, ranked 24 diets in several categories to help people find a plan that meets their goals, whether it’s finding the best weight loss diet, easiest one to follow, or plans for other goals, such as managing diabetes or heart disease. Two new categories were added: Best Diets for Bone & Joint Health and Best Family-Friendly Diets. 

In previous years, the publication ranked 40 diets. Even if a diet is no longer ranked, its profile with detailed information remains on the site. 

“Each year we ask ourselves what we can do better or differently next time,” said Gretel Schueller, managing editor of health for U.S. News. When the publication got feedback from their experts this year, they had requests to consider sustainability of diets and whether they meet a busy family’s needs, in addition to considering many other factors. 

This year’s report ranks plans in 11 categories.

The winners and the categories:
 

Best diets overall

After the Mediterranean diet, two others tied for second place:

• DASH (Dietary Approaches to Stop Hypertension) diet, which fights high blood pressure and emphasizes fruits, vegetables, whole grains, lean protein, and low-fat dairy.
• Flexitarian diet, which focuses on fruits, vegetables, and other healthy foods but also allows occasional meat.

Best weight-loss diets

WW, formerly known as Weight Watchers, got first place. The plan emphasizes not only weight loss but healthier eating and regular activity. The Points program, which assigns specific points to foods, with a daily Points budget, is more personalized than in the past.

• DASH got second place.
• Mayo Clinic Diet and TLC diet tied for third place. The Mayo Clinic Diet focuses on fruits, vegetables, and whole grains. It helps people improve their eating habits. The TLC diet (Therapeutic Lifestyle Changes) focuses on vegetables, fruit, lean protein, and reducing cholesterol levels. 

Best fast weight-loss diets

The keto diet got first place. It’s a high-fat, low-carb diet that aims to achieve weight loss through fat burning. Four others tied for second place:

• Atkins, a diet created by the cardiologist Robert Atkins, which begins with very few carbs and then recommends progressively eating more until the weight loss goal is achieved 
• Nutrisystem, a commercial program that includes prepackaged meals and focuses on high-protein, lower-glycemic foods to stabilize blood sugar levels
• Optavia, a plan focused on low-carb, low-calorie foods and including fortified meal replacements 
• SlimFast Diet, a plan of shakes, smoothies, and meal bars to replace two of three meals a day

Best diets for healthy eating

• Mediterranean
• DASH
• Flexitarian

Best heart-healthy diets

• DASH
• Mediterranean
• Flexitarian and Ornish tied for third. The Ornish Diet focuses on plant-based and whole foods and limiting animal products. It recommends daily exercise and stress reduction.

Best diets for diabetes

• DASH
• Mediterranean
• Flexitarian

Best diets for bone and joint health

DASH and Mediterranean are in a first-place tie, followed by the flexitarian diet.

Best family-friendly diets

This category has a three-way tie: the flexitarian, Mediterranean, and TLC diets. 

Best plant-based diets

Mediterranean was first, then flexitarian and the MIND diet. The MIND diet combines the DASH and Mediterranean diets and focuses on “brain-healthy” foods.

Easiest diets to follow

Flexitarian and TLC tied for first, followed by a tie between DASH and Mediterranean.

Best diet programs (formerly called commercial plans)

• WW
• There was a tie for second place between Jenny Craig and Noom, the latter of which focuses on low-calorie foods, with personalized calorie ranges and coaching to help meet goals.

Methodology

A variety of factors were considered, such as whether a diet includes all food groups, how easy it is to follow, whether it can be customized to meet cultural and personal preferences, and if it has a realistic timeline for weight loss. 

Response from diet plans

Representatives from two plans that received mixed reviews in the rankings responded.

Jenny Craig was ranked second for best diet program but much lower for family friendly, landing at 22nd place of 24. 

“Our program is designed to address the needs of the individual through personalized experiences,” Jenny Craig CEO Mandy Dowson said. “We have many families that participate in our program together but are still evaluated separately to determine appropriate individual goals.”

Its high ranking for best diet program reflects feedback from satisfied members, she said. Among advances will be the new Jenny Fresh program, a line of entrées prepared fresh and delivered to customers’ doors.

Atkins got second place for best fast weight loss but ranked near the bottom for best overall, best weight loss, diabetes, healthy eating, and heart health. In response, Colette Heimowitz, vice president of nutrition and education for Simply Good Foods, which makes Atkins’s food products, said that low-carb eating approaches are a viable option for anyone today.

“There are more than 130 independent, peer-reviewed published studies that show the efficacy and safety of low-carb eating,” she said. “The studies have been conducted for several decades and counting.” 
 

Expert perspective

Samantha Cassetty, a registered dietitian, nutritionist, and wellness expert in New York and author of Sugar Shock, reviewed the report for this news organization. She was not involved in the rankings.

“I think what this shows you is, the best diet overall is also the best for various conditions,” she said. For instance, the Mediterranean, the No. 1 overall, also got high ranking for diabetes, heart health, and bone and joint health.

For consumers trying to lose weight: “If you see fast weight loss, that should be a red flag. A healthy diet for weight loss is one you can sustain,” she said. 

She’s not a fan of the programs with prepackaged foods. “It takes the guesswork out, but the portion sizes tend to be unsatisfying. They don’t teach you how to deal with some of the challenges [such as realizing an ‘ideal’ portion size].”
 

How to use the report

Ms. Schueller’s advice: “Recognize that no diet fits everyone.” When considering which plan to choose, she suggests thinking long-term. 

“Whatever we choose has to work in the long run,” she said.

Consumers should consider expenses, meal prep time, and whether the diet fits their lifestyle.

Ideally, she said, the best diet “teaches you smart food preparation and how to make healthy choices, allows the flexibility to be social and eat with groups, whether family or friends.”

Before choosing a diet to follow, consult a medical professional for input on the decision, U.S. News cautioned.

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

It’s officially 2023, and if history repeats, millions of Americans are likely vowing that this year will be one when they drop those unwanted pounds for good. After all, weight loss usually lands one of the top spots on New Year’s resolution surveys. 

And just in time, there’s guidance to pick the best plan, as U.S. News & World Report’s annual rankings of the best diet plans were released on Jan. 3.

Once again, the Mediterranean diet, which emphasizes fruits, vegetables, olive oil, and fish, got the top spot, as best diet overall. It’s the sixth consecutive year for that win. But many other diets got top marks as well.

In 2023, U.S. News, with the help of more than 30 nutritionists, doctors, and epidemiologists, ranked 24 diets in several categories to help people find a plan that meets their goals, whether it’s finding the best weight loss diet, easiest one to follow, or plans for other goals, such as managing diabetes or heart disease. Two new categories were added: Best Diets for Bone & Joint Health and Best Family-Friendly Diets. 

In previous years, the publication ranked 40 diets. Even if a diet is no longer ranked, its profile with detailed information remains on the site. 

“Each year we ask ourselves what we can do better or differently next time,” said Gretel Schueller, managing editor of health for U.S. News. When the publication got feedback from their experts this year, they had requests to consider sustainability of diets and whether they meet a busy family’s needs, in addition to considering many other factors. 

This year’s report ranks plans in 11 categories.

The winners and the categories:
 

Best diets overall

After the Mediterranean diet, two others tied for second place:

• DASH (Dietary Approaches to Stop Hypertension) diet, which fights high blood pressure and emphasizes fruits, vegetables, whole grains, lean protein, and low-fat dairy.
• Flexitarian diet, which focuses on fruits, vegetables, and other healthy foods but also allows occasional meat.

Best weight-loss diets

WW, formerly known as Weight Watchers, got first place. The plan emphasizes not only weight loss but healthier eating and regular activity. The Points program, which assigns specific points to foods, with a daily Points budget, is more personalized than in the past.

• DASH got second place.
• Mayo Clinic Diet and TLC diet tied for third place. The Mayo Clinic Diet focuses on fruits, vegetables, and whole grains. It helps people improve their eating habits. The TLC diet (Therapeutic Lifestyle Changes) focuses on vegetables, fruit, lean protein, and reducing cholesterol levels. 

Best fast weight-loss diets

The keto diet got first place. It’s a high-fat, low-carb diet that aims to achieve weight loss through fat burning. Four others tied for second place:

• Atkins, a diet created by the cardiologist Robert Atkins, which begins with very few carbs and then recommends progressively eating more until the weight loss goal is achieved 
• Nutrisystem, a commercial program that includes prepackaged meals and focuses on high-protein, lower-glycemic foods to stabilize blood sugar levels
• Optavia, a plan focused on low-carb, low-calorie foods and including fortified meal replacements 
• SlimFast Diet, a plan of shakes, smoothies, and meal bars to replace two of three meals a day

Best diets for healthy eating

• Mediterranean
• DASH
• Flexitarian

Best heart-healthy diets

• DASH
• Mediterranean
• Flexitarian and Ornish tied for third. The Ornish Diet focuses on plant-based and whole foods and limiting animal products. It recommends daily exercise and stress reduction.

Best diets for diabetes

• DASH
• Mediterranean
• Flexitarian

Best diets for bone and joint health

DASH and Mediterranean are in a first-place tie, followed by the flexitarian diet.

Best family-friendly diets

This category has a three-way tie: the flexitarian, Mediterranean, and TLC diets. 

Best plant-based diets

Mediterranean was first, then flexitarian and the MIND diet. The MIND diet combines the DASH and Mediterranean diets and focuses on “brain-healthy” foods.

Easiest diets to follow

Flexitarian and TLC tied for first, followed by a tie between DASH and Mediterranean.

Best diet programs (formerly called commercial plans)

• WW
• There was a tie for second place between Jenny Craig and Noom, the latter of which focuses on low-calorie foods, with personalized calorie ranges and coaching to help meet goals.

Methodology

A variety of factors were considered, such as whether a diet includes all food groups, how easy it is to follow, whether it can be customized to meet cultural and personal preferences, and if it has a realistic timeline for weight loss. 

Response from diet plans

Representatives from two plans that received mixed reviews in the rankings responded.

Jenny Craig was ranked second for best diet program but much lower for family friendly, landing at 22nd place of 24. 

“Our program is designed to address the needs of the individual through personalized experiences,” Jenny Craig CEO Mandy Dowson said. “We have many families that participate in our program together but are still evaluated separately to determine appropriate individual goals.”

Its high ranking for best diet program reflects feedback from satisfied members, she said. Among advances will be the new Jenny Fresh program, a line of entrées prepared fresh and delivered to customers’ doors.

Atkins got second place for best fast weight loss but ranked near the bottom for best overall, best weight loss, diabetes, healthy eating, and heart health. In response, Colette Heimowitz, vice president of nutrition and education for Simply Good Foods, which makes Atkins’s food products, said that low-carb eating approaches are a viable option for anyone today.

“There are more than 130 independent, peer-reviewed published studies that show the efficacy and safety of low-carb eating,” she said. “The studies have been conducted for several decades and counting.” 
 

Expert perspective

Samantha Cassetty, a registered dietitian, nutritionist, and wellness expert in New York and author of Sugar Shock, reviewed the report for this news organization. She was not involved in the rankings.

“I think what this shows you is, the best diet overall is also the best for various conditions,” she said. For instance, the Mediterranean, the No. 1 overall, also got high ranking for diabetes, heart health, and bone and joint health.

For consumers trying to lose weight: “If you see fast weight loss, that should be a red flag. A healthy diet for weight loss is one you can sustain,” she said. 

She’s not a fan of the programs with prepackaged foods. “It takes the guesswork out, but the portion sizes tend to be unsatisfying. They don’t teach you how to deal with some of the challenges [such as realizing an ‘ideal’ portion size].”
 

How to use the report

Ms. Schueller’s advice: “Recognize that no diet fits everyone.” When considering which plan to choose, she suggests thinking long-term. 

“Whatever we choose has to work in the long run,” she said.

Consumers should consider expenses, meal prep time, and whether the diet fits their lifestyle.

Ideally, she said, the best diet “teaches you smart food preparation and how to make healthy choices, allows the flexibility to be social and eat with groups, whether family or friends.”

Before choosing a diet to follow, consult a medical professional for input on the decision, U.S. News cautioned.

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

It was the last monoclonal antibody treatment standing. But less than 10 months after the U.S. Food and Drug Administration gave bebtelovimab its emergency use authorization (EUA) to fight COVID-19, it earlier this month de-authorized it, just as it had for other monoclonal antibody treatments, and for the same reason: The treatments were outwitted by the viral mutations.
 

Bebtelovimab couldn’t neutralize the Omicron subvariants BQ.1 and BQ.1.1, the cause of nearly 60% of COVID cases nationally as of November 30.

Next on the chopping block, some predict, will be Evusheld, the combination of tixagevimab and cilgavimab given as a preventive monoclonal antibody to people who are immunocompromised and at high risk of contracting COVID and to those who can’t take the vaccine. In October, the FDA warned that Evusheld was not neutralizing circulating COVID variants.

As the options for treating and preventing COVID decline, will companies rally quickly to develop new ones, or cut their losses in developing treatments that may work for only a few months, given the speed of viral mutations?

But although monoclonal antibody treatments are off the table, at least for now, antiviral drugs – including Paxlovid – are still very much available, and some say underused.

Others suggest it’s time to resurrect interest in convalescent plasma, a treatment used early in the pandemic before drugs or vaccines were here and still authorized for use in those who are immunosuppressed or receiving immunosuppressive treatment.

And on the prevention front, staying up to date with booster vaccines, masking, and taking other precautions should be stressed more, others say, regardless of the number of treatment options, and especially now, as cases rise and people gather for the winter holidays.
 

‘A major setback’

The bebtelovimab de-authorization was “a major setback,” but an understandable one, said Arturo Casadevall, MD, PhD, professor and chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “Monoclonal antibodies are great drugs. We are in an unfortunate situation in that they are vulnerable to changes in the virus” and can’t offer long-lasting protection.

Supplies of bebtelovimab will be retained, according to the FDA, in case variants susceptible to it return.

“What happened to bebtelovimab is no surprise,” agreed Amesh Adalja, MD, senior scholar at Johns Hopkins Center for Health Security. “This is what is going to happen when you are targeting a virus that mutates a lot.”

Monoclonal antibodies work by binding to the spike protein on the virus surface to prevent it from entering cells.

However, Dr. Adalja doesn’t view the disappearance of monoclonal antibody treatments as a major setback. Monoclonal antibodies were not the primary way COVID was treated, he said.

While he does believe it’s important that more monoclonal antibody treatments be developed, “I think it’s important to remember we still have Paxlovid while everyone is lamenting the loss of bebtelovimab.’’
 

Antivirals: What’s here, what’s coming

Compared with monoclonal antibodies, “Paxlovid remains a much easier drug to give,” Dr. Adalja told this news organization, because it is taken orally, not intravenously.

And it’s effective. In a recent study, researchers found that adults diagnosed with COVID given Paxlovid within 5 days of diagnosis had a 51% lower hospitalization rate within the next 30 days than those not given it. Another study shows it could also reduce a person’s risk of developing long COVID by 26%.

Paxlovid is underused, Dr. Adalja said, partly because the rebound potential got more press than the effectiveness. When a celebrity got rebound from Paxlovid, he said, that would make the news, overshadowing the research on its effectiveness.

Besides Paxlovid, the antivirals remdesivir (Veklury), given intravenously for 3 days, and molnupiravir (Lagevrio), taken orally, are also still available. Antivirals work by targeting specific parts of the virus to prevent it from multiplying.

In the lab, remdesivir, molnupiravir, and another antiviral, nirmatrelvir, all appear to be effective against both BQ.1.1 (a BA.5 subvariant) and XBB (a BA.2 subvariant), both rapidly rising in the United States, according to a report last week in the New England Journal of Medicine.

The researchers also tested several monoclonal antibodies and found they did not neutralize either of the subvariants BQ.1.1 and XBB.

A new oral antiviral, Xocova (ensitrelvir fumaric acid), from Japanese manufacturer Shionogi, received emergency approval in Japan on November 22. It’s taken once a day for 5 days. The goal is to expand access to it globally, according to the company.

Pardes Biosciences launched a phase 2 trial in September for its oral antiviral drug (PBI-0451), under study as a treatment and preventive for COVID. It expects data by the first quarter of 2023.

Pfizer, which makes Paxlovid, has partnered with Clear Creek Bio to develop another oral antiviral COVID drug.
 

Other approaches

A receptor protein known as ACE2 (angiotensin-converting enzyme 2) is the main “doorway” that SARS-CoV-2 uses to enter and infect cells.

Dana-Farber Cancer Institute scientists are developing a “decoy” drug that works by mimicking the ACE2 receptor on the surface of cells; when the virus tries to bind to it, the spike protein is destroyed. Human trials have not yet started.

Other researchers are investigating whether an already-approved drug used to treat a liver disease, Actigall (UDCA/ursodeoxycholic acid), could protect against COVID infection by reducing ACE2.

So far, the researchers have found in early research that people taking UDCA for liver conditions were less likely than those not taking the drug to have severe COVID. They also found that UDCA reduced SARS-CoV-2 infection in human lungs maintained outside the body.
 

Monoclonal antibody treatments?

After the FDA decision to withdraw the bebtelovimab EUA, which Eli Lilly said it agreed with, the company issued a statement, promising it wasn’t giving up on monoclonal antibody treatments.

“Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants,” it read in part.

AstraZeneca, which makes Evusheld, is also continuing to work on monoclonal antibody development. According to a spokesperson, “We are also developing a new long-acting antibody combination – AZD5156 – which has been shown in the lab to neutralize emerging new variants and all known variants to date. We are working to accelerate the development of AZD5156 to make it available at the end of 2023.”

The AstraZeneca spokesperson said he could share no more information about what the combination would include.
 

A convalescent plasma comeback?

Although Paxlovid can help, there are many contraindications to it, such as drug-drug interactions, Dr. Casadevall told this news organization. And now that the monoclonal antibody treatments have been paused, convalescent plasma “is the only antibody-based therapy that is reliably available. Convalescent plasma includes thousands of different antibodies.”

With his colleagues, Dr. Casadevall evaluated plasma samples from 740 patients. Some had received booster vaccines and been infected with Omicron, others had received boosters and not been infected, and still others had not been vaccinated and became infected.

In a report (not yet peer-reviewed), they found the plasma from those who had been infected or boosted within the past 6 months neutralized the new Omicron variants BQ.1.1, XBB.1, and BF.7.
 

A push for boosters, masks

To get through the coming months, taking precautions like masking and distancing and staying up to date on booster vaccinations, especially for older adults, can make a difference, other experts say.

In a Twitter thread in early December, Peter Hotez, MD, PhD, professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, Houston, urged people to take COVID seriously as holiday parties and gatherings occur.

“The single most impactful thing you can do is get your bivalent booster,” he tweeted, as well as give your kids the booster, citing preliminary research that the bivalent mRNA booster broadens immunity against the Omicron subvariants.

For seniors, he said, ‘‘if you get breakthrough COVID, [it’s] really important to get Paxlovid.” Masks will help not only for COVID but also influenza, respiratory syncytial virus (RSV), and other conditions.

Mitigation measures have largely been abandoned, according to Eric Topol, MD, director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape. In an op-ed in the Los Angeles Times, and on his Twitter feed, he reminds people about masking and urges people to get the bivalent booster.

According to the Centers for Disease Control and Prevention, as of Dec. 8, only 13.5% of people aged 5 and older have gotten an updated booster, despite research that shows an increase in antibodies to BQ.1.1. Recent research has found that the bivalent booster increases antibodies to BQ.1.1 by up to 10-fold, Dr. Topol said.

Dr. Adalja is on advisory boards for Shionogi, GSK, and Pardes. Dr. Casadevall reports no relevant financial relationships.

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

It was the last monoclonal antibody treatment standing. But less than 10 months after the U.S. Food and Drug Administration gave bebtelovimab its emergency use authorization (EUA) to fight COVID-19, it earlier this month de-authorized it, just as it had for other monoclonal antibody treatments, and for the same reason: The treatments were outwitted by the viral mutations.
 

Bebtelovimab couldn’t neutralize the Omicron subvariants BQ.1 and BQ.1.1, the cause of nearly 60% of COVID cases nationally as of November 30.

Next on the chopping block, some predict, will be Evusheld, the combination of tixagevimab and cilgavimab given as a preventive monoclonal antibody to people who are immunocompromised and at high risk of contracting COVID and to those who can’t take the vaccine. In October, the FDA warned that Evusheld was not neutralizing circulating COVID variants.

As the options for treating and preventing COVID decline, will companies rally quickly to develop new ones, or cut their losses in developing treatments that may work for only a few months, given the speed of viral mutations?

But although monoclonal antibody treatments are off the table, at least for now, antiviral drugs – including Paxlovid – are still very much available, and some say underused.

Others suggest it’s time to resurrect interest in convalescent plasma, a treatment used early in the pandemic before drugs or vaccines were here and still authorized for use in those who are immunosuppressed or receiving immunosuppressive treatment.

And on the prevention front, staying up to date with booster vaccines, masking, and taking other precautions should be stressed more, others say, regardless of the number of treatment options, and especially now, as cases rise and people gather for the winter holidays.
 

‘A major setback’

The bebtelovimab de-authorization was “a major setback,” but an understandable one, said Arturo Casadevall, MD, PhD, professor and chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “Monoclonal antibodies are great drugs. We are in an unfortunate situation in that they are vulnerable to changes in the virus” and can’t offer long-lasting protection.

Supplies of bebtelovimab will be retained, according to the FDA, in case variants susceptible to it return.

“What happened to bebtelovimab is no surprise,” agreed Amesh Adalja, MD, senior scholar at Johns Hopkins Center for Health Security. “This is what is going to happen when you are targeting a virus that mutates a lot.”

Monoclonal antibodies work by binding to the spike protein on the virus surface to prevent it from entering cells.

However, Dr. Adalja doesn’t view the disappearance of monoclonal antibody treatments as a major setback. Monoclonal antibodies were not the primary way COVID was treated, he said.

While he does believe it’s important that more monoclonal antibody treatments be developed, “I think it’s important to remember we still have Paxlovid while everyone is lamenting the loss of bebtelovimab.’’
 

Antivirals: What’s here, what’s coming

Compared with monoclonal antibodies, “Paxlovid remains a much easier drug to give,” Dr. Adalja told this news organization, because it is taken orally, not intravenously.

And it’s effective. In a recent study, researchers found that adults diagnosed with COVID given Paxlovid within 5 days of diagnosis had a 51% lower hospitalization rate within the next 30 days than those not given it. Another study shows it could also reduce a person’s risk of developing long COVID by 26%.

Paxlovid is underused, Dr. Adalja said, partly because the rebound potential got more press than the effectiveness. When a celebrity got rebound from Paxlovid, he said, that would make the news, overshadowing the research on its effectiveness.

Besides Paxlovid, the antivirals remdesivir (Veklury), given intravenously for 3 days, and molnupiravir (Lagevrio), taken orally, are also still available. Antivirals work by targeting specific parts of the virus to prevent it from multiplying.

In the lab, remdesivir, molnupiravir, and another antiviral, nirmatrelvir, all appear to be effective against both BQ.1.1 (a BA.5 subvariant) and XBB (a BA.2 subvariant), both rapidly rising in the United States, according to a report last week in the New England Journal of Medicine.

The researchers also tested several monoclonal antibodies and found they did not neutralize either of the subvariants BQ.1.1 and XBB.

A new oral antiviral, Xocova (ensitrelvir fumaric acid), from Japanese manufacturer Shionogi, received emergency approval in Japan on November 22. It’s taken once a day for 5 days. The goal is to expand access to it globally, according to the company.

Pardes Biosciences launched a phase 2 trial in September for its oral antiviral drug (PBI-0451), under study as a treatment and preventive for COVID. It expects data by the first quarter of 2023.

Pfizer, which makes Paxlovid, has partnered with Clear Creek Bio to develop another oral antiviral COVID drug.
 

Other approaches

A receptor protein known as ACE2 (angiotensin-converting enzyme 2) is the main “doorway” that SARS-CoV-2 uses to enter and infect cells.

Dana-Farber Cancer Institute scientists are developing a “decoy” drug that works by mimicking the ACE2 receptor on the surface of cells; when the virus tries to bind to it, the spike protein is destroyed. Human trials have not yet started.

Other researchers are investigating whether an already-approved drug used to treat a liver disease, Actigall (UDCA/ursodeoxycholic acid), could protect against COVID infection by reducing ACE2.

So far, the researchers have found in early research that people taking UDCA for liver conditions were less likely than those not taking the drug to have severe COVID. They also found that UDCA reduced SARS-CoV-2 infection in human lungs maintained outside the body.
 

Monoclonal antibody treatments?

After the FDA decision to withdraw the bebtelovimab EUA, which Eli Lilly said it agreed with, the company issued a statement, promising it wasn’t giving up on monoclonal antibody treatments.

“Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants,” it read in part.

AstraZeneca, which makes Evusheld, is also continuing to work on monoclonal antibody development. According to a spokesperson, “We are also developing a new long-acting antibody combination – AZD5156 – which has been shown in the lab to neutralize emerging new variants and all known variants to date. We are working to accelerate the development of AZD5156 to make it available at the end of 2023.”

The AstraZeneca spokesperson said he could share no more information about what the combination would include.
 

A convalescent plasma comeback?

Although Paxlovid can help, there are many contraindications to it, such as drug-drug interactions, Dr. Casadevall told this news organization. And now that the monoclonal antibody treatments have been paused, convalescent plasma “is the only antibody-based therapy that is reliably available. Convalescent plasma includes thousands of different antibodies.”

With his colleagues, Dr. Casadevall evaluated plasma samples from 740 patients. Some had received booster vaccines and been infected with Omicron, others had received boosters and not been infected, and still others had not been vaccinated and became infected.

In a report (not yet peer-reviewed), they found the plasma from those who had been infected or boosted within the past 6 months neutralized the new Omicron variants BQ.1.1, XBB.1, and BF.7.
 

A push for boosters, masks

To get through the coming months, taking precautions like masking and distancing and staying up to date on booster vaccinations, especially for older adults, can make a difference, other experts say.

In a Twitter thread in early December, Peter Hotez, MD, PhD, professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, Houston, urged people to take COVID seriously as holiday parties and gatherings occur.

“The single most impactful thing you can do is get your bivalent booster,” he tweeted, as well as give your kids the booster, citing preliminary research that the bivalent mRNA booster broadens immunity against the Omicron subvariants.

For seniors, he said, ‘‘if you get breakthrough COVID, [it’s] really important to get Paxlovid.” Masks will help not only for COVID but also influenza, respiratory syncytial virus (RSV), and other conditions.

Mitigation measures have largely been abandoned, according to Eric Topol, MD, director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape. In an op-ed in the Los Angeles Times, and on his Twitter feed, he reminds people about masking and urges people to get the bivalent booster.

According to the Centers for Disease Control and Prevention, as of Dec. 8, only 13.5% of people aged 5 and older have gotten an updated booster, despite research that shows an increase in antibodies to BQ.1.1. Recent research has found that the bivalent booster increases antibodies to BQ.1.1 by up to 10-fold, Dr. Topol said.

Dr. Adalja is on advisory boards for Shionogi, GSK, and Pardes. Dr. Casadevall reports no relevant financial relationships.

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

It was the last monoclonal antibody treatment standing. But less than 10 months after the U.S. Food and Drug Administration gave bebtelovimab its emergency use authorization (EUA) to fight COVID-19, it earlier this month de-authorized it, just as it had for other monoclonal antibody treatments, and for the same reason: The treatments were outwitted by the viral mutations.
 

Bebtelovimab couldn’t neutralize the Omicron subvariants BQ.1 and BQ.1.1, the cause of nearly 60% of COVID cases nationally as of November 30.

Next on the chopping block, some predict, will be Evusheld, the combination of tixagevimab and cilgavimab given as a preventive monoclonal antibody to people who are immunocompromised and at high risk of contracting COVID and to those who can’t take the vaccine. In October, the FDA warned that Evusheld was not neutralizing circulating COVID variants.

As the options for treating and preventing COVID decline, will companies rally quickly to develop new ones, or cut their losses in developing treatments that may work for only a few months, given the speed of viral mutations?

But although monoclonal antibody treatments are off the table, at least for now, antiviral drugs – including Paxlovid – are still very much available, and some say underused.

Others suggest it’s time to resurrect interest in convalescent plasma, a treatment used early in the pandemic before drugs or vaccines were here and still authorized for use in those who are immunosuppressed or receiving immunosuppressive treatment.

And on the prevention front, staying up to date with booster vaccines, masking, and taking other precautions should be stressed more, others say, regardless of the number of treatment options, and especially now, as cases rise and people gather for the winter holidays.
 

‘A major setback’

The bebtelovimab de-authorization was “a major setback,” but an understandable one, said Arturo Casadevall, MD, PhD, professor and chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “Monoclonal antibodies are great drugs. We are in an unfortunate situation in that they are vulnerable to changes in the virus” and can’t offer long-lasting protection.

Supplies of bebtelovimab will be retained, according to the FDA, in case variants susceptible to it return.

“What happened to bebtelovimab is no surprise,” agreed Amesh Adalja, MD, senior scholar at Johns Hopkins Center for Health Security. “This is what is going to happen when you are targeting a virus that mutates a lot.”

Monoclonal antibodies work by binding to the spike protein on the virus surface to prevent it from entering cells.

However, Dr. Adalja doesn’t view the disappearance of monoclonal antibody treatments as a major setback. Monoclonal antibodies were not the primary way COVID was treated, he said.

While he does believe it’s important that more monoclonal antibody treatments be developed, “I think it’s important to remember we still have Paxlovid while everyone is lamenting the loss of bebtelovimab.’’
 

Antivirals: What’s here, what’s coming

Compared with monoclonal antibodies, “Paxlovid remains a much easier drug to give,” Dr. Adalja told this news organization, because it is taken orally, not intravenously.

And it’s effective. In a recent study, researchers found that adults diagnosed with COVID given Paxlovid within 5 days of diagnosis had a 51% lower hospitalization rate within the next 30 days than those not given it. Another study shows it could also reduce a person’s risk of developing long COVID by 26%.

Paxlovid is underused, Dr. Adalja said, partly because the rebound potential got more press than the effectiveness. When a celebrity got rebound from Paxlovid, he said, that would make the news, overshadowing the research on its effectiveness.

Besides Paxlovid, the antivirals remdesivir (Veklury), given intravenously for 3 days, and molnupiravir (Lagevrio), taken orally, are also still available. Antivirals work by targeting specific parts of the virus to prevent it from multiplying.

In the lab, remdesivir, molnupiravir, and another antiviral, nirmatrelvir, all appear to be effective against both BQ.1.1 (a BA.5 subvariant) and XBB (a BA.2 subvariant), both rapidly rising in the United States, according to a report last week in the New England Journal of Medicine.

The researchers also tested several monoclonal antibodies and found they did not neutralize either of the subvariants BQ.1.1 and XBB.

A new oral antiviral, Xocova (ensitrelvir fumaric acid), from Japanese manufacturer Shionogi, received emergency approval in Japan on November 22. It’s taken once a day for 5 days. The goal is to expand access to it globally, according to the company.

Pardes Biosciences launched a phase 2 trial in September for its oral antiviral drug (PBI-0451), under study as a treatment and preventive for COVID. It expects data by the first quarter of 2023.

Pfizer, which makes Paxlovid, has partnered with Clear Creek Bio to develop another oral antiviral COVID drug.
 

Other approaches

A receptor protein known as ACE2 (angiotensin-converting enzyme 2) is the main “doorway” that SARS-CoV-2 uses to enter and infect cells.

Dana-Farber Cancer Institute scientists are developing a “decoy” drug that works by mimicking the ACE2 receptor on the surface of cells; when the virus tries to bind to it, the spike protein is destroyed. Human trials have not yet started.

Other researchers are investigating whether an already-approved drug used to treat a liver disease, Actigall (UDCA/ursodeoxycholic acid), could protect against COVID infection by reducing ACE2.

So far, the researchers have found in early research that people taking UDCA for liver conditions were less likely than those not taking the drug to have severe COVID. They also found that UDCA reduced SARS-CoV-2 infection in human lungs maintained outside the body.
 

Monoclonal antibody treatments?

After the FDA decision to withdraw the bebtelovimab EUA, which Eli Lilly said it agreed with, the company issued a statement, promising it wasn’t giving up on monoclonal antibody treatments.

“Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants,” it read in part.

AstraZeneca, which makes Evusheld, is also continuing to work on monoclonal antibody development. According to a spokesperson, “We are also developing a new long-acting antibody combination – AZD5156 – which has been shown in the lab to neutralize emerging new variants and all known variants to date. We are working to accelerate the development of AZD5156 to make it available at the end of 2023.”

The AstraZeneca spokesperson said he could share no more information about what the combination would include.
 

A convalescent plasma comeback?

Although Paxlovid can help, there are many contraindications to it, such as drug-drug interactions, Dr. Casadevall told this news organization. And now that the monoclonal antibody treatments have been paused, convalescent plasma “is the only antibody-based therapy that is reliably available. Convalescent plasma includes thousands of different antibodies.”

With his colleagues, Dr. Casadevall evaluated plasma samples from 740 patients. Some had received booster vaccines and been infected with Omicron, others had received boosters and not been infected, and still others had not been vaccinated and became infected.

In a report (not yet peer-reviewed), they found the plasma from those who had been infected or boosted within the past 6 months neutralized the new Omicron variants BQ.1.1, XBB.1, and BF.7.
 

A push for boosters, masks

To get through the coming months, taking precautions like masking and distancing and staying up to date on booster vaccinations, especially for older adults, can make a difference, other experts say.

In a Twitter thread in early December, Peter Hotez, MD, PhD, professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, Houston, urged people to take COVID seriously as holiday parties and gatherings occur.

“The single most impactful thing you can do is get your bivalent booster,” he tweeted, as well as give your kids the booster, citing preliminary research that the bivalent mRNA booster broadens immunity against the Omicron subvariants.

For seniors, he said, ‘‘if you get breakthrough COVID, [it’s] really important to get Paxlovid.” Masks will help not only for COVID but also influenza, respiratory syncytial virus (RSV), and other conditions.

Mitigation measures have largely been abandoned, according to Eric Topol, MD, director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape. In an op-ed in the Los Angeles Times, and on his Twitter feed, he reminds people about masking and urges people to get the bivalent booster.

According to the Centers for Disease Control and Prevention, as of Dec. 8, only 13.5% of people aged 5 and older have gotten an updated booster, despite research that shows an increase in antibodies to BQ.1.1. Recent research has found that the bivalent booster increases antibodies to BQ.1.1 by up to 10-fold, Dr. Topol said.

Dr. Adalja is on advisory boards for Shionogi, GSK, and Pardes. Dr. Casadevall reports no relevant financial relationships.

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

Asking knee osteoarthritis patients a simple question – do you have difficulty climbing stairs? – may predict the risk of future functional limitation, according to research presented at the annual meeting of the American College of Rheumatology. Finding out that the patient has difficulty also opens avenues for further evaluation and intervention, said Jason Jakiela, a PhD candidate at the University of Delaware, Newark, who led the study. “We like to view it as a kind of yellow flag,” Mr. Jakiela said in an interview.

Another expert agreed. “I think this is useful for clinical rheumatologists,” said C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona, Tucson, and director of the University of Arizona Arthritis Center. He commented on the study findings but was not involved in the study. Another common question asked of OA patients, about pain, may not be as useful as asking about difficulty climbing stairs, he said. “Their pain level can go up and down and can be quite varied.”

decade3d/Thinkstock

Study details, results

Mr. Jakiela and his team, including Daniel White, PT, ScD, MSC, associate professor of physical therapy at the University of Delaware, Newark, used data from the Osteoarthritis Initiative (OAI). They assessed stair climbing difficulty at baseline with the question: Does your health now limit you in climbing several flights of stairs? Respondents could answer that they were limited a lot, a little, or not at all.

The researchers evaluated functional limitation using two measures: Walking speed and Western Ontario and McMaster Universities Osteoarthritis Index physical function (WOMAC-PF) scores. A walking speed of < 1.22 m/s over 20 meters, the speed needed to safely cross a timed intersection, represented poor function. A WOMAC-PF score of 28/68 or more was also used to define low functioning.

The analyses included only people free of functional limitations at baseline. Each measure was conducted at the start and then at 12, 24, 36, 48, 72, and 96 months’ follow-up visits.

While 2,952 participants (mean age 60.1, 54% female, mean body mass index 27.9) were in the walking speed sample, 3,983 participants (mean age 61.2, 57% female, mean BMI 28.2) were in the WOMAC-PF sample.

Starting the conversation

The question about stair climbing difficulty is a good “jumping-off point,” Mr. Jakiela said. “It opens up a line of questioning.” With knee OA, stair climbing difficulty is often the first reported limitation. That difficulty could capture a variety of issues, he said. Patients could be struggling with strength issues, cardiovascular problems, or balance deficits, for instance.

It signals there may be a trajectory of slow decline coming in this patient, Mr. Jakiela said.

“It’s a signal that something is not right,” Dr. White said in an interview. “We don’t know what is wrong.” While questions about stairs have routinely been asked of OA patients, the study findings suggest the answer to the question about having difficulty could help predict a patient’s future course, he said.

After patients reported a little or a lot of difficulty with stair climbing, the average time to reach functional limitation status was about 3 years, Mr. Jakiela said. That gives health care providers time to ask more questions about the patient’s condition and potentially intervene, depending on the details of the difficulty. If it’s a balance issue, physical therapy might help, for example.

While gait speed is a tried-and-true indication, collecting answers about stair climbing difficulty is easier and quicker for clinicians than assessing gait speed, which requires more time as well as office space, Mr. Jakiela said. It’s also intuitive for the patients to recall, the researchers said.
 

More practical takeaways

Finding out whether functional limitation is likely, based on the stair question, can help health care providers consider nonpharmacologic interventions, Dr. Kwoh agreed, such as physical therapy or braces. “It doesn’t have to be drugs. We have limited drugs for OA at the moment. We don’t have a so-called DMARD drug [for OA].”

NSAIDs have side effects, and people are very familiar with the issues of opioids, he said. It’s important, he added, for the health care provider, if referring to a physical therapist, to find the right one. To help those dealing with knee OA, a PT in sports medicine might be a good choice, he said.

Mr. Jakiela has no disclosures. Dr. Kwoh and Dr. White have no relevant disclosures.

Asking knee osteoarthritis patients a simple question – do you have difficulty climbing stairs? – may predict the risk of future functional limitation, according to research presented at the annual meeting of the American College of Rheumatology. Finding out that the patient has difficulty also opens avenues for further evaluation and intervention, said Jason Jakiela, a PhD candidate at the University of Delaware, Newark, who led the study. “We like to view it as a kind of yellow flag,” Mr. Jakiela said in an interview.

Another expert agreed. “I think this is useful for clinical rheumatologists,” said C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona, Tucson, and director of the University of Arizona Arthritis Center. He commented on the study findings but was not involved in the study. Another common question asked of OA patients, about pain, may not be as useful as asking about difficulty climbing stairs, he said. “Their pain level can go up and down and can be quite varied.”

decade3d/Thinkstock

Study details, results

Mr. Jakiela and his team, including Daniel White, PT, ScD, MSC, associate professor of physical therapy at the University of Delaware, Newark, used data from the Osteoarthritis Initiative (OAI). They assessed stair climbing difficulty at baseline with the question: Does your health now limit you in climbing several flights of stairs? Respondents could answer that they were limited a lot, a little, or not at all.

The researchers evaluated functional limitation using two measures: Walking speed and Western Ontario and McMaster Universities Osteoarthritis Index physical function (WOMAC-PF) scores. A walking speed of < 1.22 m/s over 20 meters, the speed needed to safely cross a timed intersection, represented poor function. A WOMAC-PF score of 28/68 or more was also used to define low functioning.

The analyses included only people free of functional limitations at baseline. Each measure was conducted at the start and then at 12, 24, 36, 48, 72, and 96 months’ follow-up visits.

While 2,952 participants (mean age 60.1, 54% female, mean body mass index 27.9) were in the walking speed sample, 3,983 participants (mean age 61.2, 57% female, mean BMI 28.2) were in the WOMAC-PF sample.

Starting the conversation

The question about stair climbing difficulty is a good “jumping-off point,” Mr. Jakiela said. “It opens up a line of questioning.” With knee OA, stair climbing difficulty is often the first reported limitation. That difficulty could capture a variety of issues, he said. Patients could be struggling with strength issues, cardiovascular problems, or balance deficits, for instance.

It signals there may be a trajectory of slow decline coming in this patient, Mr. Jakiela said.

“It’s a signal that something is not right,” Dr. White said in an interview. “We don’t know what is wrong.” While questions about stairs have routinely been asked of OA patients, the study findings suggest the answer to the question about having difficulty could help predict a patient’s future course, he said.

After patients reported a little or a lot of difficulty with stair climbing, the average time to reach functional limitation status was about 3 years, Mr. Jakiela said. That gives health care providers time to ask more questions about the patient’s condition and potentially intervene, depending on the details of the difficulty. If it’s a balance issue, physical therapy might help, for example.

While gait speed is a tried-and-true indication, collecting answers about stair climbing difficulty is easier and quicker for clinicians than assessing gait speed, which requires more time as well as office space, Mr. Jakiela said. It’s also intuitive for the patients to recall, the researchers said.
 

More practical takeaways

Finding out whether functional limitation is likely, based on the stair question, can help health care providers consider nonpharmacologic interventions, Dr. Kwoh agreed, such as physical therapy or braces. “It doesn’t have to be drugs. We have limited drugs for OA at the moment. We don’t have a so-called DMARD drug [for OA].”

NSAIDs have side effects, and people are very familiar with the issues of opioids, he said. It’s important, he added, for the health care provider, if referring to a physical therapist, to find the right one. To help those dealing with knee OA, a PT in sports medicine might be a good choice, he said.

Mr. Jakiela has no disclosures. Dr. Kwoh and Dr. White have no relevant disclosures.

Asking knee osteoarthritis patients a simple question – do you have difficulty climbing stairs? – may predict the risk of future functional limitation, according to research presented at the annual meeting of the American College of Rheumatology. Finding out that the patient has difficulty also opens avenues for further evaluation and intervention, said Jason Jakiela, a PhD candidate at the University of Delaware, Newark, who led the study. “We like to view it as a kind of yellow flag,” Mr. Jakiela said in an interview.

Another expert agreed. “I think this is useful for clinical rheumatologists,” said C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona, Tucson, and director of the University of Arizona Arthritis Center. He commented on the study findings but was not involved in the study. Another common question asked of OA patients, about pain, may not be as useful as asking about difficulty climbing stairs, he said. “Their pain level can go up and down and can be quite varied.”

decade3d/Thinkstock

Study details, results

Mr. Jakiela and his team, including Daniel White, PT, ScD, MSC, associate professor of physical therapy at the University of Delaware, Newark, used data from the Osteoarthritis Initiative (OAI). They assessed stair climbing difficulty at baseline with the question: Does your health now limit you in climbing several flights of stairs? Respondents could answer that they were limited a lot, a little, or not at all.

The researchers evaluated functional limitation using two measures: Walking speed and Western Ontario and McMaster Universities Osteoarthritis Index physical function (WOMAC-PF) scores. A walking speed of < 1.22 m/s over 20 meters, the speed needed to safely cross a timed intersection, represented poor function. A WOMAC-PF score of 28/68 or more was also used to define low functioning.

The analyses included only people free of functional limitations at baseline. Each measure was conducted at the start and then at 12, 24, 36, 48, 72, and 96 months’ follow-up visits.

While 2,952 participants (mean age 60.1, 54% female, mean body mass index 27.9) were in the walking speed sample, 3,983 participants (mean age 61.2, 57% female, mean BMI 28.2) were in the WOMAC-PF sample.

Starting the conversation

The question about stair climbing difficulty is a good “jumping-off point,” Mr. Jakiela said. “It opens up a line of questioning.” With knee OA, stair climbing difficulty is often the first reported limitation. That difficulty could capture a variety of issues, he said. Patients could be struggling with strength issues, cardiovascular problems, or balance deficits, for instance.

It signals there may be a trajectory of slow decline coming in this patient, Mr. Jakiela said.

“It’s a signal that something is not right,” Dr. White said in an interview. “We don’t know what is wrong.” While questions about stairs have routinely been asked of OA patients, the study findings suggest the answer to the question about having difficulty could help predict a patient’s future course, he said.

After patients reported a little or a lot of difficulty with stair climbing, the average time to reach functional limitation status was about 3 years, Mr. Jakiela said. That gives health care providers time to ask more questions about the patient’s condition and potentially intervene, depending on the details of the difficulty. If it’s a balance issue, physical therapy might help, for example.

While gait speed is a tried-and-true indication, collecting answers about stair climbing difficulty is easier and quicker for clinicians than assessing gait speed, which requires more time as well as office space, Mr. Jakiela said. It’s also intuitive for the patients to recall, the researchers said.
 

More practical takeaways

Finding out whether functional limitation is likely, based on the stair question, can help health care providers consider nonpharmacologic interventions, Dr. Kwoh agreed, such as physical therapy or braces. “It doesn’t have to be drugs. We have limited drugs for OA at the moment. We don’t have a so-called DMARD drug [for OA].”

NSAIDs have side effects, and people are very familiar with the issues of opioids, he said. It’s important, he added, for the health care provider, if referring to a physical therapist, to find the right one. To help those dealing with knee OA, a PT in sports medicine might be a good choice, he said.

Mr. Jakiela has no disclosures. Dr. Kwoh and Dr. White have no relevant disclosures.