Kara Grant

The Centers for Disease Control and Prevention and the World Health Organization have dubbed the BA 2.86 variant of COVID-19 as a variant to watch. 

So far, only 26 cases of “Pirola,” as the new variant is being called, have been identified: 10 in Denmark, four each in Sweden and the United States, three in South Africa, two in Portugal, and one each the United Kingdom, Israel, and Canada. BA 2.86 is a subvariant of Omicron, but according to reports from the CDC, the strain has many more mutations than the ones that came before it. 

With so many facts still unknown about this new variant, this news organization asked experts what people need to be aware of as it continues to spread.
 

What is unique about the BA 2.86 variant? 

“It is unique in that it has more than three mutations on the spike protein,” said Purvi S. Parikh, MD, an infectious disease expert at New York University’s Langone Health. The virus uses the spike proteins to enter our cells. 

This “may mean it will be more transmissible, cause more severe disease, and/or our vaccines and treatments may not work as well, as compared to other variants,” she said.
 

What do we need to watch with BA 2.86 going forward? 

“We don’t know if this variant will be associated with a change in the disease severity. We currently see increased numbers of cases in general, even though we don’t yet see the BA.2.86 in our system,” said Heba Mostafa, PhD, director of the molecular virology laboratory at Johns Hopkins Hospital in Baltimore. 

“It is important to monitor BA.2.86 (and other variants) and understand how its evolution impacts the number of cases and disease outcomes,” she said. “We should all be aware of the current increase in cases, though, and try to get tested and be treated as soon as possible, as antivirals should be effective against the circulating variants.” 
 

What should doctors know?

Dr. Parikh said doctors should generally expect more COVID cases in their clinics and make sure to screen patients even if their symptoms are mild.

“We have tools that can be used – antivirals like Paxlovid are still efficacious with current dominant strains such as EG.5,” she said. “And encourage your patients to get their boosters, mask, wash hands, and social distance.”
 

How well can our vaccines fight BA 2.86?

“Vaccine coverage for the BA.2.86 is an area of uncertainty right now,” said Dr. Mostafa. 

In its report, the CDC said scientists are still figuring out how well the updated COVID vaccine works. It’s expected to be available in the fall, and for now, they believe the new shot will still make infections less severe, new variants and all. 

Prior vaccinations and infections have created antibodies in many people, and that will likely provide some protection, Dr. Mostafa said. “When we experienced the Omicron wave in December 2021, even though the variant was distant from what circulated before its emergence and was associated with a very large increase in the number of cases, vaccinations were still protective against severe disease.” 
 

What is the most important thing to keep track of when it comes to this variant?

According to Dr. Parikh, “it’s most important to monitor how transmissible [BA 2.86] is, how severe it is, and if our current treatments and vaccines work.” 

Dr. Mostafa said how well the new variants escape existing antibody protection should also be studied and watched closely. 
 

What does this stage of the virus mutation tell us about where we are in the pandemic?

The history of the coronavirus over the past few years shows that variants with many changes evolve and can spread very quickly, Dr. Mostafa said. “Now that the virus is endemic, it is essential to monitor, update vaccinations if necessary, diagnose, treat, and implement infection control measures when necessary.”

With the limited data we have so far, experts seem to agree that while the variant’s makeup raises some red flags, it is too soon to jump to any conclusions about how easy it is to catch it and the ways it may change how the virus impacts those who contract it.
 

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

The Centers for Disease Control and Prevention and the World Health Organization have dubbed the BA 2.86 variant of COVID-19 as a variant to watch. 

So far, only 26 cases of “Pirola,” as the new variant is being called, have been identified: 10 in Denmark, four each in Sweden and the United States, three in South Africa, two in Portugal, and one each the United Kingdom, Israel, and Canada. BA 2.86 is a subvariant of Omicron, but according to reports from the CDC, the strain has many more mutations than the ones that came before it. 

With so many facts still unknown about this new variant, this news organization asked experts what people need to be aware of as it continues to spread.
 

What is unique about the BA 2.86 variant? 

“It is unique in that it has more than three mutations on the spike protein,” said Purvi S. Parikh, MD, an infectious disease expert at New York University’s Langone Health. The virus uses the spike proteins to enter our cells. 

This “may mean it will be more transmissible, cause more severe disease, and/or our vaccines and treatments may not work as well, as compared to other variants,” she said.
 

What do we need to watch with BA 2.86 going forward? 

“We don’t know if this variant will be associated with a change in the disease severity. We currently see increased numbers of cases in general, even though we don’t yet see the BA.2.86 in our system,” said Heba Mostafa, PhD, director of the molecular virology laboratory at Johns Hopkins Hospital in Baltimore. 

“It is important to monitor BA.2.86 (and other variants) and understand how its evolution impacts the number of cases and disease outcomes,” she said. “We should all be aware of the current increase in cases, though, and try to get tested and be treated as soon as possible, as antivirals should be effective against the circulating variants.” 
 

What should doctors know?

Dr. Parikh said doctors should generally expect more COVID cases in their clinics and make sure to screen patients even if their symptoms are mild.

“We have tools that can be used – antivirals like Paxlovid are still efficacious with current dominant strains such as EG.5,” she said. “And encourage your patients to get their boosters, mask, wash hands, and social distance.”
 

How well can our vaccines fight BA 2.86?

“Vaccine coverage for the BA.2.86 is an area of uncertainty right now,” said Dr. Mostafa. 

In its report, the CDC said scientists are still figuring out how well the updated COVID vaccine works. It’s expected to be available in the fall, and for now, they believe the new shot will still make infections less severe, new variants and all. 

Prior vaccinations and infections have created antibodies in many people, and that will likely provide some protection, Dr. Mostafa said. “When we experienced the Omicron wave in December 2021, even though the variant was distant from what circulated before its emergence and was associated with a very large increase in the number of cases, vaccinations were still protective against severe disease.” 
 

What is the most important thing to keep track of when it comes to this variant?

According to Dr. Parikh, “it’s most important to monitor how transmissible [BA 2.86] is, how severe it is, and if our current treatments and vaccines work.” 

Dr. Mostafa said how well the new variants escape existing antibody protection should also be studied and watched closely. 
 

What does this stage of the virus mutation tell us about where we are in the pandemic?

The history of the coronavirus over the past few years shows that variants with many changes evolve and can spread very quickly, Dr. Mostafa said. “Now that the virus is endemic, it is essential to monitor, update vaccinations if necessary, diagnose, treat, and implement infection control measures when necessary.”

With the limited data we have so far, experts seem to agree that while the variant’s makeup raises some red flags, it is too soon to jump to any conclusions about how easy it is to catch it and the ways it may change how the virus impacts those who contract it.
 

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

The Centers for Disease Control and Prevention and the World Health Organization have dubbed the BA 2.86 variant of COVID-19 as a variant to watch. 

So far, only 26 cases of “Pirola,” as the new variant is being called, have been identified: 10 in Denmark, four each in Sweden and the United States, three in South Africa, two in Portugal, and one each the United Kingdom, Israel, and Canada. BA 2.86 is a subvariant of Omicron, but according to reports from the CDC, the strain has many more mutations than the ones that came before it. 

With so many facts still unknown about this new variant, this news organization asked experts what people need to be aware of as it continues to spread.
 

What is unique about the BA 2.86 variant? 

“It is unique in that it has more than three mutations on the spike protein,” said Purvi S. Parikh, MD, an infectious disease expert at New York University’s Langone Health. The virus uses the spike proteins to enter our cells. 

This “may mean it will be more transmissible, cause more severe disease, and/or our vaccines and treatments may not work as well, as compared to other variants,” she said.
 

What do we need to watch with BA 2.86 going forward? 

“We don’t know if this variant will be associated with a change in the disease severity. We currently see increased numbers of cases in general, even though we don’t yet see the BA.2.86 in our system,” said Heba Mostafa, PhD, director of the molecular virology laboratory at Johns Hopkins Hospital in Baltimore. 

“It is important to monitor BA.2.86 (and other variants) and understand how its evolution impacts the number of cases and disease outcomes,” she said. “We should all be aware of the current increase in cases, though, and try to get tested and be treated as soon as possible, as antivirals should be effective against the circulating variants.” 
 

What should doctors know?

Dr. Parikh said doctors should generally expect more COVID cases in their clinics and make sure to screen patients even if their symptoms are mild.

“We have tools that can be used – antivirals like Paxlovid are still efficacious with current dominant strains such as EG.5,” she said. “And encourage your patients to get their boosters, mask, wash hands, and social distance.”
 

How well can our vaccines fight BA 2.86?

“Vaccine coverage for the BA.2.86 is an area of uncertainty right now,” said Dr. Mostafa. 

In its report, the CDC said scientists are still figuring out how well the updated COVID vaccine works. It’s expected to be available in the fall, and for now, they believe the new shot will still make infections less severe, new variants and all. 

Prior vaccinations and infections have created antibodies in many people, and that will likely provide some protection, Dr. Mostafa said. “When we experienced the Omicron wave in December 2021, even though the variant was distant from what circulated before its emergence and was associated with a very large increase in the number of cases, vaccinations were still protective against severe disease.” 
 

What is the most important thing to keep track of when it comes to this variant?

According to Dr. Parikh, “it’s most important to monitor how transmissible [BA 2.86] is, how severe it is, and if our current treatments and vaccines work.” 

Dr. Mostafa said how well the new variants escape existing antibody protection should also be studied and watched closely. 
 

What does this stage of the virus mutation tell us about where we are in the pandemic?

The history of the coronavirus over the past few years shows that variants with many changes evolve and can spread very quickly, Dr. Mostafa said. “Now that the virus is endemic, it is essential to monitor, update vaccinations if necessary, diagnose, treat, and implement infection control measures when necessary.”

With the limited data we have so far, experts seem to agree that while the variant’s makeup raises some red flags, it is too soon to jump to any conclusions about how easy it is to catch it and the ways it may change how the virus impacts those who contract it.
 

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

Severe COVID infections may lead to lasting damage to the immune system, new research finds.

The small study, published in Cell and funded by the National Institutes of Health, details how immune cells were analyzed through blood samples collected from 38 patients recovering from severe COVID and other critical illnesses, and from 19 healthy people. Researchers from Weill Cornell Medicine, New York, and The Jackson Laboratory for Genomic Medicine, Farmington, Conn., found through isolating hematopoietic stem cells that people recovering from severe bouts of COVID had changes to their DNA that were passed down to offspring cells.

The research team, led by Steven Josefowicz, PhD, of Weill Cornell’s pathology department, and Duygu Ucar, PhD, associate professor at The Jackson Laboratory for Genomic Medicine, discovered that this chain reaction of stem cell changes caused a boost in the production of monocytes. The authors found that, due to the innate cellular changes from a severe case of COVID, patients in recovery ended up producing a larger amount of inflammatory cytokines, rather than monocytes – distinct from samples collected from healthy patients and those recovering from other critical illnesses.

These changes to patients’ epigenetic landscapes were observed even a year after the initial COVID-19 infection. While the small participant pool meant that the research team could not establish a direct line between these innate changes and any ensuing health outcomes, the research provides us with clues as to why patients continue to struggle with inflammation and long COVID symptoms well after they recover.

While the authors reiterate the study’s limitations and hesitate to make any clear-cut associations between the results and long-term health outcomes, Wolfgang Leitner, PhD, from the NIH’s National Institute of Allergy and Infectious Diseases, predicts that long COVID can, at least in part, be explained by the changes in innate immune responses.

“Ideally, the authors would have had cells from each patient before they got infected, as a comparator, to see what the epigenetic landscape was before COVID changed it,” said Dr. Leitner. “Clear links between the severity of COVID and genetics were discovered already early in the pandemic and this paper should prompt follow-up studies that link mutations in immune genes with the epigenetic changes described here.”

Dr. Leitner said he had some initial predictions about the long-term impact of COVID-19, but he had not anticipated some of what the study’s findings now show.

“Unlike in the case of, for example, influenza, where the lungs go into ‘repair mode’ after the infection has been resolved – which leaves people susceptible to secondary infections for up to several months – this study shows that after severe COVID, the immune system remains in ‘emergency mode’ and in a heightened state of inflammation,” said Dr. Leitner.

“That further aggravates the problem the initial strong inflammation causes: even higher risk of autoimmune disease, but also, cancer.”

Commenting on the findings, Eric Topol, MD, editor-in-chief of Medscape Medical News, said the study presents “evidence that a key line of immune cells are essentially irrevocably, epigenetically altered and activated.

“You do not want to have this [COVID],” he added.

The study also highlights the researchers’ novel approach to isolating hematopoietic stem cells, found largely in bone marrow. This type of research has been limited in the past because of how costly and invasive it can be to analyze cells in bone marrow. But, by isolating and enriching hematopoietic stem cells, the team can decipher the full cellular diversity of the cells’ bone marrow counterparts.

“This revelation opened the doors to study, at single-cell resolution, how stem cells are affected upon infection and vaccination with a simple blood draw,” representatives from the Jackson lab said in a press release.

A version of this article appeared on Medscape.com.

Severe COVID infections may lead to lasting damage to the immune system, new research finds.

The small study, published in Cell and funded by the National Institutes of Health, details how immune cells were analyzed through blood samples collected from 38 patients recovering from severe COVID and other critical illnesses, and from 19 healthy people. Researchers from Weill Cornell Medicine, New York, and The Jackson Laboratory for Genomic Medicine, Farmington, Conn., found through isolating hematopoietic stem cells that people recovering from severe bouts of COVID had changes to their DNA that were passed down to offspring cells.

The research team, led by Steven Josefowicz, PhD, of Weill Cornell’s pathology department, and Duygu Ucar, PhD, associate professor at The Jackson Laboratory for Genomic Medicine, discovered that this chain reaction of stem cell changes caused a boost in the production of monocytes. The authors found that, due to the innate cellular changes from a severe case of COVID, patients in recovery ended up producing a larger amount of inflammatory cytokines, rather than monocytes – distinct from samples collected from healthy patients and those recovering from other critical illnesses.

These changes to patients’ epigenetic landscapes were observed even a year after the initial COVID-19 infection. While the small participant pool meant that the research team could not establish a direct line between these innate changes and any ensuing health outcomes, the research provides us with clues as to why patients continue to struggle with inflammation and long COVID symptoms well after they recover.

While the authors reiterate the study’s limitations and hesitate to make any clear-cut associations between the results and long-term health outcomes, Wolfgang Leitner, PhD, from the NIH’s National Institute of Allergy and Infectious Diseases, predicts that long COVID can, at least in part, be explained by the changes in innate immune responses.

“Ideally, the authors would have had cells from each patient before they got infected, as a comparator, to see what the epigenetic landscape was before COVID changed it,” said Dr. Leitner. “Clear links between the severity of COVID and genetics were discovered already early in the pandemic and this paper should prompt follow-up studies that link mutations in immune genes with the epigenetic changes described here.”

Dr. Leitner said he had some initial predictions about the long-term impact of COVID-19, but he had not anticipated some of what the study’s findings now show.

“Unlike in the case of, for example, influenza, where the lungs go into ‘repair mode’ after the infection has been resolved – which leaves people susceptible to secondary infections for up to several months – this study shows that after severe COVID, the immune system remains in ‘emergency mode’ and in a heightened state of inflammation,” said Dr. Leitner.

“That further aggravates the problem the initial strong inflammation causes: even higher risk of autoimmune disease, but also, cancer.”

Commenting on the findings, Eric Topol, MD, editor-in-chief of Medscape Medical News, said the study presents “evidence that a key line of immune cells are essentially irrevocably, epigenetically altered and activated.

“You do not want to have this [COVID],” he added.

The study also highlights the researchers’ novel approach to isolating hematopoietic stem cells, found largely in bone marrow. This type of research has been limited in the past because of how costly and invasive it can be to analyze cells in bone marrow. But, by isolating and enriching hematopoietic stem cells, the team can decipher the full cellular diversity of the cells’ bone marrow counterparts.

“This revelation opened the doors to study, at single-cell resolution, how stem cells are affected upon infection and vaccination with a simple blood draw,” representatives from the Jackson lab said in a press release.

A version of this article appeared on Medscape.com.

Severe COVID infections may lead to lasting damage to the immune system, new research finds.

The small study, published in Cell and funded by the National Institutes of Health, details how immune cells were analyzed through blood samples collected from 38 patients recovering from severe COVID and other critical illnesses, and from 19 healthy people. Researchers from Weill Cornell Medicine, New York, and The Jackson Laboratory for Genomic Medicine, Farmington, Conn., found through isolating hematopoietic stem cells that people recovering from severe bouts of COVID had changes to their DNA that were passed down to offspring cells.

The research team, led by Steven Josefowicz, PhD, of Weill Cornell’s pathology department, and Duygu Ucar, PhD, associate professor at The Jackson Laboratory for Genomic Medicine, discovered that this chain reaction of stem cell changes caused a boost in the production of monocytes. The authors found that, due to the innate cellular changes from a severe case of COVID, patients in recovery ended up producing a larger amount of inflammatory cytokines, rather than monocytes – distinct from samples collected from healthy patients and those recovering from other critical illnesses.

These changes to patients’ epigenetic landscapes were observed even a year after the initial COVID-19 infection. While the small participant pool meant that the research team could not establish a direct line between these innate changes and any ensuing health outcomes, the research provides us with clues as to why patients continue to struggle with inflammation and long COVID symptoms well after they recover.

While the authors reiterate the study’s limitations and hesitate to make any clear-cut associations between the results and long-term health outcomes, Wolfgang Leitner, PhD, from the NIH’s National Institute of Allergy and Infectious Diseases, predicts that long COVID can, at least in part, be explained by the changes in innate immune responses.

“Ideally, the authors would have had cells from each patient before they got infected, as a comparator, to see what the epigenetic landscape was before COVID changed it,” said Dr. Leitner. “Clear links between the severity of COVID and genetics were discovered already early in the pandemic and this paper should prompt follow-up studies that link mutations in immune genes with the epigenetic changes described here.”

Dr. Leitner said he had some initial predictions about the long-term impact of COVID-19, but he had not anticipated some of what the study’s findings now show.

“Unlike in the case of, for example, influenza, where the lungs go into ‘repair mode’ after the infection has been resolved – which leaves people susceptible to secondary infections for up to several months – this study shows that after severe COVID, the immune system remains in ‘emergency mode’ and in a heightened state of inflammation,” said Dr. Leitner.

“That further aggravates the problem the initial strong inflammation causes: even higher risk of autoimmune disease, but also, cancer.”

Commenting on the findings, Eric Topol, MD, editor-in-chief of Medscape Medical News, said the study presents “evidence that a key line of immune cells are essentially irrevocably, epigenetically altered and activated.

“You do not want to have this [COVID],” he added.

The study also highlights the researchers’ novel approach to isolating hematopoietic stem cells, found largely in bone marrow. This type of research has been limited in the past because of how costly and invasive it can be to analyze cells in bone marrow. But, by isolating and enriching hematopoietic stem cells, the team can decipher the full cellular diversity of the cells’ bone marrow counterparts.

“This revelation opened the doors to study, at single-cell resolution, how stem cells are affected upon infection and vaccination with a simple blood draw,” representatives from the Jackson lab said in a press release.

A version of this article appeared on Medscape.com.

More than 3 years into the COVID-19 era, most Americans have settled back into their prepandemic lifestyles. But a new dominant variant and rising hospitalization numbers may give way to another summer surge.

Since April, a new COVID variant has cropped up. According to recent Centers for Disease Control and Prevention data, EG.5 – from the Omicron family – now makes up 17% of all cases in the United States, up from 7.5% in the first week of July. 

A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed “Eris” by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation. 

Along with the news of EG.5’s growing prevalence, COVID-related hospitalization rates have increased by 12.5% during the week ending on July 29 – the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.
 

Cause for concern?

The COVID virus has a great tendency to mutate, said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University, Nashville, Tenn. 

“Fortunately, these are relatively minor mutations.” Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. “There isn’t any doubt that it’s spreading – but it’s not more serious.”

So, Dr. Schaffner doesn’t think it’s time to panic. He prefers calling it an “uptick” in cases instead of a “surge,” because a surge “sounds too big.”

While the numbers are still low, compared with 2022’s summer surge, experts still urge people to stay aware of changes in the virus. “I do not think that there is any cause for alarm,” agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital, New York.

So why the higher number of cases? “There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking,” said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford (Calif.) University. Even so, “because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges.”
 

What the official numbers say

The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.

But the agency continues to track COVID-19 cases, hospitalizations, ED visits, and deaths in different ways. The key takeaways include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared with July 30, 2022, when the weekly new hospitalization numbers topped 44,000. 

“Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year,” said Pavitra Roychoudhury, PhD, an assistant professor and researcher in the vaccine and infectious disease division at the University of Washington, Seattle. 

“It’s unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year.” 

For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency’s local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing. 

So, while it’s good news that hospitalization numbers are smaller, it means the agency’s ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited. 

It’s not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including ED visits, positive tests, and wastewater levels, are increasing across the United States. 

In terms of other metrics: 

• On June 19, 0.47% of ED visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%. 
• On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown. 
• The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That’s low, compared with previous rates. For example, for the week ending July 30, 2022, it was 5.8%.

What about new COVID vaccines?

As long as the general public continue to make informed decisions and get the new Omicron vaccine or booster once it’s available, experts predict lower hospitalization rates this winter. 

“Everyone should get the Omicron booster when it becomes available,” recommended Dean Winslow, MD, a professor of medicine at Stanford University. 

In the meantime, “it is important to emphasize that COVID-19 is going to be with us for the foreseeable future,” he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, “if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease.”

Dr. Schaffner remains optimistic for now. “We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus.”

Although it’s difficult to predict an exact time line, Dr. Schaffner said they could be available by the end of September. 

His predictions assume “that we don’t have a new nasty variant that crops up somewhere in the world,” he said. “[If] things continue to move the way they have been, we anticipate that this vaccine ... will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again.” 

Asked for his outlook on vaccine recommendations, Dr. Camins was less certain. “It is too soon to tell.” Guidance on COVID shots will be based on results of ongoing studies. “It would be prudent, however, for everyone to plan on getting the flu shot in September.”

Stay alert and stay realistic

Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared with past scenarios, “it makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Dr. Liu said. 

“It’s just advisable for everyone – especially those who are at higher risk for hospitalization or death – to be aware,” Dr. Camins said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”

While respiratory virus work best at keeping people with the flu, COVID, or RSV out of the hospital, they’re not as good at preventing milder infections. Dr. Schaffner said: “If we don’t expect perfection, we won’t be so disappointed.”

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

More than 3 years into the COVID-19 era, most Americans have settled back into their prepandemic lifestyles. But a new dominant variant and rising hospitalization numbers may give way to another summer surge.

Since April, a new COVID variant has cropped up. According to recent Centers for Disease Control and Prevention data, EG.5 – from the Omicron family – now makes up 17% of all cases in the United States, up from 7.5% in the first week of July. 

A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed “Eris” by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation. 

Along with the news of EG.5’s growing prevalence, COVID-related hospitalization rates have increased by 12.5% during the week ending on July 29 – the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.
 

Cause for concern?

The COVID virus has a great tendency to mutate, said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University, Nashville, Tenn. 

“Fortunately, these are relatively minor mutations.” Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. “There isn’t any doubt that it’s spreading – but it’s not more serious.”

So, Dr. Schaffner doesn’t think it’s time to panic. He prefers calling it an “uptick” in cases instead of a “surge,” because a surge “sounds too big.”

While the numbers are still low, compared with 2022’s summer surge, experts still urge people to stay aware of changes in the virus. “I do not think that there is any cause for alarm,” agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital, New York.

So why the higher number of cases? “There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking,” said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford (Calif.) University. Even so, “because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges.”
 

What the official numbers say

The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.

But the agency continues to track COVID-19 cases, hospitalizations, ED visits, and deaths in different ways. The key takeaways include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared with July 30, 2022, when the weekly new hospitalization numbers topped 44,000. 

“Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year,” said Pavitra Roychoudhury, PhD, an assistant professor and researcher in the vaccine and infectious disease division at the University of Washington, Seattle. 

“It’s unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year.” 

For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency’s local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing. 

So, while it’s good news that hospitalization numbers are smaller, it means the agency’s ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited. 

It’s not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including ED visits, positive tests, and wastewater levels, are increasing across the United States. 

In terms of other metrics: 

• On June 19, 0.47% of ED visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%. 
• On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown. 
• The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That’s low, compared with previous rates. For example, for the week ending July 30, 2022, it was 5.8%.

What about new COVID vaccines?

As long as the general public continue to make informed decisions and get the new Omicron vaccine or booster once it’s available, experts predict lower hospitalization rates this winter. 

“Everyone should get the Omicron booster when it becomes available,” recommended Dean Winslow, MD, a professor of medicine at Stanford University. 

In the meantime, “it is important to emphasize that COVID-19 is going to be with us for the foreseeable future,” he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, “if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease.”

Dr. Schaffner remains optimistic for now. “We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus.”

Although it’s difficult to predict an exact time line, Dr. Schaffner said they could be available by the end of September. 

His predictions assume “that we don’t have a new nasty variant that crops up somewhere in the world,” he said. “[If] things continue to move the way they have been, we anticipate that this vaccine ... will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again.” 

Asked for his outlook on vaccine recommendations, Dr. Camins was less certain. “It is too soon to tell.” Guidance on COVID shots will be based on results of ongoing studies. “It would be prudent, however, for everyone to plan on getting the flu shot in September.”

Stay alert and stay realistic

Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared with past scenarios, “it makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Dr. Liu said. 

“It’s just advisable for everyone – especially those who are at higher risk for hospitalization or death – to be aware,” Dr. Camins said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”

While respiratory virus work best at keeping people with the flu, COVID, or RSV out of the hospital, they’re not as good at preventing milder infections. Dr. Schaffner said: “If we don’t expect perfection, we won’t be so disappointed.”

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

More than 3 years into the COVID-19 era, most Americans have settled back into their prepandemic lifestyles. But a new dominant variant and rising hospitalization numbers may give way to another summer surge.

Since April, a new COVID variant has cropped up. According to recent Centers for Disease Control and Prevention data, EG.5 – from the Omicron family – now makes up 17% of all cases in the United States, up from 7.5% in the first week of July. 

A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed “Eris” by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation. 

Along with the news of EG.5’s growing prevalence, COVID-related hospitalization rates have increased by 12.5% during the week ending on July 29 – the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.
 

Cause for concern?

The COVID virus has a great tendency to mutate, said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University, Nashville, Tenn. 

“Fortunately, these are relatively minor mutations.” Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. “There isn’t any doubt that it’s spreading – but it’s not more serious.”

So, Dr. Schaffner doesn’t think it’s time to panic. He prefers calling it an “uptick” in cases instead of a “surge,” because a surge “sounds too big.”

While the numbers are still low, compared with 2022’s summer surge, experts still urge people to stay aware of changes in the virus. “I do not think that there is any cause for alarm,” agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital, New York.

So why the higher number of cases? “There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking,” said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford (Calif.) University. Even so, “because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges.”
 

What the official numbers say

The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.

But the agency continues to track COVID-19 cases, hospitalizations, ED visits, and deaths in different ways. The key takeaways include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared with July 30, 2022, when the weekly new hospitalization numbers topped 44,000. 

“Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year,” said Pavitra Roychoudhury, PhD, an assistant professor and researcher in the vaccine and infectious disease division at the University of Washington, Seattle. 

“It’s unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year.” 

For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency’s local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing. 

So, while it’s good news that hospitalization numbers are smaller, it means the agency’s ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited. 

It’s not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including ED visits, positive tests, and wastewater levels, are increasing across the United States. 

In terms of other metrics: 

• On June 19, 0.47% of ED visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%. 
• On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown. 
• The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That’s low, compared with previous rates. For example, for the week ending July 30, 2022, it was 5.8%.

What about new COVID vaccines?

As long as the general public continue to make informed decisions and get the new Omicron vaccine or booster once it’s available, experts predict lower hospitalization rates this winter. 

“Everyone should get the Omicron booster when it becomes available,” recommended Dean Winslow, MD, a professor of medicine at Stanford University. 

In the meantime, “it is important to emphasize that COVID-19 is going to be with us for the foreseeable future,” he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, “if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease.”

Dr. Schaffner remains optimistic for now. “We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus.”

Although it’s difficult to predict an exact time line, Dr. Schaffner said they could be available by the end of September. 

His predictions assume “that we don’t have a new nasty variant that crops up somewhere in the world,” he said. “[If] things continue to move the way they have been, we anticipate that this vaccine ... will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again.” 

Asked for his outlook on vaccine recommendations, Dr. Camins was less certain. “It is too soon to tell.” Guidance on COVID shots will be based on results of ongoing studies. “It would be prudent, however, for everyone to plan on getting the flu shot in September.”

Stay alert and stay realistic

Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared with past scenarios, “it makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Dr. Liu said. 

“It’s just advisable for everyone – especially those who are at higher risk for hospitalization or death – to be aware,” Dr. Camins said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”

While respiratory virus work best at keeping people with the flu, COVID, or RSV out of the hospital, they’re not as good at preventing milder infections. Dr. Schaffner said: “If we don’t expect perfection, we won’t be so disappointed.”

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

Ashley Raibick is familiar with the weight loss yo-yo. She’s bounced through the big names: Weight Watchers, Jenny Craig, and so on. She drops 10 pounds and then slides off the plan only to see her weight pop back up.

But a day at her local med spa – where she gets facials, Botox, and fillers – changed all that for the 28-year-old hairstylist who just wanted to lose 18 pounds.

During one of her visits, she noticed that the spa’s owner was thinner. When Ms. Raibick asked her how she did it, the owner explained that she was on semaglutide and talked Ms. Raibick through the process. Ms. Raibick was convinced. That same day, she got a prescription from a doctor at the spa and got her first shot.

“Are people going to think I’m crazy for doing this?” she recalls thinking.

At 5 foot 4, her starting weight before the drug was 158, which would put her in the overweight, but not obese, category based on body mass index (BMI). And she really just wanted to get down to 140 and stop there.

Ozempic is part of an ever-growing group of GLP-1 receptor agonists that contain a peptide called semaglutide as its main ingredient. Although first meant to treat type 2 diabetes, the reputation of Ozempic and its siblings picked up when already-thin celebrities were suspected of using the injectable drugs to become even slimmer.

The FDA approved Ozempic’s cousin, Wegovy, for “weight management” in patients with obesity a few years ago, whereas Ozempic is currently approved only for diabetes treatment. Curious patients who don’t fit the criteria can – and do – get off-label prescriptions if they can afford to pay out of pocket, often to the tune of more than $1,400 a month. But is Ozempic worth it, especially if one has a relatively minor amount of weight to lose?

For many – mainly those who have been on the drug for a couple of months and have lost weight as a result – taking Ozempic has not only helped them shed stubborn weight, but has also freed them from the constant internal chatter around eating, commonly called “food noise.” But experts do not all agree that semaglutide is the right path for those who aren’t technically obese – especially in the long term.

After her first 9 weeks on semaglutide, Ms. Raibick had already lost 18 pounds. That’s when she decided to post about it on TikTok, and her videos on GLP-1s were viewed hundreds of thousands of times.

For the time being, there is no data on how many semaglutide takers are using the drug for diabetes and/or obesity, and how many are using it off-label for weight loss alone. But the company that makes Ozempic, Novo Nordisk, has reported sharp increases in sales and projects more profits down the road.

Ms. Raibick knows of others like her, who sought out the drug for more minor weight loss but aren’t as candid about their journeys. Some feel a stigma about having to resort to a weight-loss drug intended to treat obesity, rather than achieving their goals with diet and lifestyle change alone.

Another reason for the secrecy is the guilt some who take Ozempic feel about using their financial privilege to get a drug that had serious shortages, which made it harder for some patients who need the drug for diabetes or obesity treatment to get their doses.

That’s what Diana Thiara, MD, the medical director of the University of California, San Francisco’s weight management program, has been seeing on the ground.

“It’s one of the most depressing things I’ve experienced as a physician,” she said. In her practice, she has seen patients who have finally been able to access GLP-1s and have started to lose weight, only for them to regain the weight in the time it takes to find another prescription under their insurance coverage.

“It’s just horrible, there are patients spending all day calling dozens of pharmacies. I’ve never had a situation like this in my career,” said Dr. Thiara.

Ann, 48, a mom who works from home full-time, has been taking Ozempic since the end of January. (Ann is not her real name; she asked that we use a pseudonym in order to feel comfortable speaking publicly about her use of Ozempic). Like Ms. Raibick, she has been paying out of pocket for her shots. At first, she was going to have to pay $1,400 a month, but she found a pharmacy in Canada that offers the medication for $350. It’s sourced globally, she said, so sometimes her Ozempic boxes will be in Czech or another foreign language.

Unlike a lot of women, Ann never had any qualms with her weight or the way her body looked. She was never big on exercise, but it wasn’t until the pandemic that she started to gain weight. She noticed the changes in her body once places started opening back up, and her clothes didn’t fit anymore.

She tried moving more and eating healthier. She tried former Real Housewives of Beverly Hills cast member Teddi Mellencamp’s controversial weight-loss program, infamous for its incredibly restrictive dietary plan and excessive cardio recommendations. Nothing worked until another mom at her daughter’s school mentioned that she was on Ozempic.

Ann also started to get hot flashes and missed periods. The doctor who prescribed her Ozempic confirmed that she was perimenopausal and that, for women in this stage of life, losing weight can be harder than ever.

Ann, who is 5 foot 7, started out at 176 pounds (considered overweight) and now weighs in at 151, which is considered a normal weight by BMI measurements. She’s still on Ozempic but continues to struggle with the shame around the idea she’s potentially taking the drug away from someone else who might desperately need it. And she doesn’t know how long she’ll have to stay on Ozempic to maintain her weight loss.

Ann has reason for concern. A 2022 study found that most people regain the weight they lost within a year of stopping Ozempic.

Once Ms. Raibick hit her initial goal weight, she felt that she could keep going and lose a little more. It wasn’t until she got into the 120-pound range that she decided it was time to wean off the dose of semaglutide she had been taking.

“I got to the point where my mom was like, ‘All right, you’re a little too thin.’ But I’m just so happy where I’m at. I’m not mentally stressed out about fitting into clothes or getting into a bathing suit,” said Ms. Raibick, who has now lost around 30 pounds in total since she started the shots.

At one point, she stopped taking the drug altogether, and all of the hunger cravings and food noise semaglutide had suppressed came back to the surface. She didn’t gain any weight that month, she said, but the internal chatter around food was enough to make her start back on a lower dose, geared toward weight maintenance.

There’s also the issue of side effects. Ms. Raibick says she never had the overwhelming nausea and digestive problems that so many on the drug – including Ann – have reported. But Dr. Thiara said that even beyond these more common side effects, there are a number of other concerns – like the long-lasting effects on thyroid and reproductive health, especially for women – that we still don’t know enough about. And just recently, CNN reported that some Ozempic users have developed stomach paralysis due to the drug’s ability to slow down the passage of food through the digestive tract.

For Ms. Raibick, the out-of-pocket cost for the drug is around $600 a month. It’s an expense she’s willing to keep paying for, even just for the peace of mind the drug provides. She doesn’t have any plans to stop her semaglutide shots soon.

“There is nothing stopping me from – a year from now, when I’ve put a little weight back on – looking back at photos from this time and thinking I was way too skinny.”

Dan Azagury, MD, a bariatric surgeon and associate professor of surgery at Stanford (Calif.) University, tries GLP-1s for patients with obesity before considering bariatric surgery. For his patient population, it’s possible that drugs like Ozempic will be part of their lifelong treatment plans.

“We’re not doing it for the cosmetic part of it, we’re doing it for health,” he said. “What I tell my patients is, if you’re planning to start on this medication, you should be OK with the idea of staying on it forever.”

For doctors like Dr. Thiara who specialize in weight management, using Ozempic long-term for patients in a healthy weight range is the wrong approach.

“It’s not about the way people look, it’s about health. If you’re a normal weight or even in an overweight category, but not showing signs of risk of having elevated cardiometabolic disease ... You don’t need to be taking medications for weight loss,” she said. “This idea of using medications for aesthetic reasons is really more related to societal ills around how we value fitness above anything else. That’s not the goal, and it’s not safe.”

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

Ashley Raibick is familiar with the weight loss yo-yo. She’s bounced through the big names: Weight Watchers, Jenny Craig, and so on. She drops 10 pounds and then slides off the plan only to see her weight pop back up.

But a day at her local med spa – where she gets facials, Botox, and fillers – changed all that for the 28-year-old hairstylist who just wanted to lose 18 pounds.

During one of her visits, she noticed that the spa’s owner was thinner. When Ms. Raibick asked her how she did it, the owner explained that she was on semaglutide and talked Ms. Raibick through the process. Ms. Raibick was convinced. That same day, she got a prescription from a doctor at the spa and got her first shot.

“Are people going to think I’m crazy for doing this?” she recalls thinking.

At 5 foot 4, her starting weight before the drug was 158, which would put her in the overweight, but not obese, category based on body mass index (BMI). And she really just wanted to get down to 140 and stop there.

Ozempic is part of an ever-growing group of GLP-1 receptor agonists that contain a peptide called semaglutide as its main ingredient. Although first meant to treat type 2 diabetes, the reputation of Ozempic and its siblings picked up when already-thin celebrities were suspected of using the injectable drugs to become even slimmer.

The FDA approved Ozempic’s cousin, Wegovy, for “weight management” in patients with obesity a few years ago, whereas Ozempic is currently approved only for diabetes treatment. Curious patients who don’t fit the criteria can – and do – get off-label prescriptions if they can afford to pay out of pocket, often to the tune of more than $1,400 a month. But is Ozempic worth it, especially if one has a relatively minor amount of weight to lose?

For many – mainly those who have been on the drug for a couple of months and have lost weight as a result – taking Ozempic has not only helped them shed stubborn weight, but has also freed them from the constant internal chatter around eating, commonly called “food noise.” But experts do not all agree that semaglutide is the right path for those who aren’t technically obese – especially in the long term.

After her first 9 weeks on semaglutide, Ms. Raibick had already lost 18 pounds. That’s when she decided to post about it on TikTok, and her videos on GLP-1s were viewed hundreds of thousands of times.

For the time being, there is no data on how many semaglutide takers are using the drug for diabetes and/or obesity, and how many are using it off-label for weight loss alone. But the company that makes Ozempic, Novo Nordisk, has reported sharp increases in sales and projects more profits down the road.

Ms. Raibick knows of others like her, who sought out the drug for more minor weight loss but aren’t as candid about their journeys. Some feel a stigma about having to resort to a weight-loss drug intended to treat obesity, rather than achieving their goals with diet and lifestyle change alone.

Another reason for the secrecy is the guilt some who take Ozempic feel about using their financial privilege to get a drug that had serious shortages, which made it harder for some patients who need the drug for diabetes or obesity treatment to get their doses.

That’s what Diana Thiara, MD, the medical director of the University of California, San Francisco’s weight management program, has been seeing on the ground.

“It’s one of the most depressing things I’ve experienced as a physician,” she said. In her practice, she has seen patients who have finally been able to access GLP-1s and have started to lose weight, only for them to regain the weight in the time it takes to find another prescription under their insurance coverage.

“It’s just horrible, there are patients spending all day calling dozens of pharmacies. I’ve never had a situation like this in my career,” said Dr. Thiara.

Ann, 48, a mom who works from home full-time, has been taking Ozempic since the end of January. (Ann is not her real name; she asked that we use a pseudonym in order to feel comfortable speaking publicly about her use of Ozempic). Like Ms. Raibick, she has been paying out of pocket for her shots. At first, she was going to have to pay $1,400 a month, but she found a pharmacy in Canada that offers the medication for $350. It’s sourced globally, she said, so sometimes her Ozempic boxes will be in Czech or another foreign language.

Unlike a lot of women, Ann never had any qualms with her weight or the way her body looked. She was never big on exercise, but it wasn’t until the pandemic that she started to gain weight. She noticed the changes in her body once places started opening back up, and her clothes didn’t fit anymore.

She tried moving more and eating healthier. She tried former Real Housewives of Beverly Hills cast member Teddi Mellencamp’s controversial weight-loss program, infamous for its incredibly restrictive dietary plan and excessive cardio recommendations. Nothing worked until another mom at her daughter’s school mentioned that she was on Ozempic.

Ann also started to get hot flashes and missed periods. The doctor who prescribed her Ozempic confirmed that she was perimenopausal and that, for women in this stage of life, losing weight can be harder than ever.

Ann, who is 5 foot 7, started out at 176 pounds (considered overweight) and now weighs in at 151, which is considered a normal weight by BMI measurements. She’s still on Ozempic but continues to struggle with the shame around the idea she’s potentially taking the drug away from someone else who might desperately need it. And she doesn’t know how long she’ll have to stay on Ozempic to maintain her weight loss.

Ann has reason for concern. A 2022 study found that most people regain the weight they lost within a year of stopping Ozempic.

Once Ms. Raibick hit her initial goal weight, she felt that she could keep going and lose a little more. It wasn’t until she got into the 120-pound range that she decided it was time to wean off the dose of semaglutide she had been taking.

“I got to the point where my mom was like, ‘All right, you’re a little too thin.’ But I’m just so happy where I’m at. I’m not mentally stressed out about fitting into clothes or getting into a bathing suit,” said Ms. Raibick, who has now lost around 30 pounds in total since she started the shots.

At one point, she stopped taking the drug altogether, and all of the hunger cravings and food noise semaglutide had suppressed came back to the surface. She didn’t gain any weight that month, she said, but the internal chatter around food was enough to make her start back on a lower dose, geared toward weight maintenance.

There’s also the issue of side effects. Ms. Raibick says she never had the overwhelming nausea and digestive problems that so many on the drug – including Ann – have reported. But Dr. Thiara said that even beyond these more common side effects, there are a number of other concerns – like the long-lasting effects on thyroid and reproductive health, especially for women – that we still don’t know enough about. And just recently, CNN reported that some Ozempic users have developed stomach paralysis due to the drug’s ability to slow down the passage of food through the digestive tract.

For Ms. Raibick, the out-of-pocket cost for the drug is around $600 a month. It’s an expense she’s willing to keep paying for, even just for the peace of mind the drug provides. She doesn’t have any plans to stop her semaglutide shots soon.

“There is nothing stopping me from – a year from now, when I’ve put a little weight back on – looking back at photos from this time and thinking I was way too skinny.”

Dan Azagury, MD, a bariatric surgeon and associate professor of surgery at Stanford (Calif.) University, tries GLP-1s for patients with obesity before considering bariatric surgery. For his patient population, it’s possible that drugs like Ozempic will be part of their lifelong treatment plans.

“We’re not doing it for the cosmetic part of it, we’re doing it for health,” he said. “What I tell my patients is, if you’re planning to start on this medication, you should be OK with the idea of staying on it forever.”

For doctors like Dr. Thiara who specialize in weight management, using Ozempic long-term for patients in a healthy weight range is the wrong approach.

“It’s not about the way people look, it’s about health. If you’re a normal weight or even in an overweight category, but not showing signs of risk of having elevated cardiometabolic disease ... You don’t need to be taking medications for weight loss,” she said. “This idea of using medications for aesthetic reasons is really more related to societal ills around how we value fitness above anything else. That’s not the goal, and it’s not safe.”

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

Ashley Raibick is familiar with the weight loss yo-yo. She’s bounced through the big names: Weight Watchers, Jenny Craig, and so on. She drops 10 pounds and then slides off the plan only to see her weight pop back up.

But a day at her local med spa – where she gets facials, Botox, and fillers – changed all that for the 28-year-old hairstylist who just wanted to lose 18 pounds.

During one of her visits, she noticed that the spa’s owner was thinner. When Ms. Raibick asked her how she did it, the owner explained that she was on semaglutide and talked Ms. Raibick through the process. Ms. Raibick was convinced. That same day, she got a prescription from a doctor at the spa and got her first shot.

“Are people going to think I’m crazy for doing this?” she recalls thinking.

At 5 foot 4, her starting weight before the drug was 158, which would put her in the overweight, but not obese, category based on body mass index (BMI). And she really just wanted to get down to 140 and stop there.

Ozempic is part of an ever-growing group of GLP-1 receptor agonists that contain a peptide called semaglutide as its main ingredient. Although first meant to treat type 2 diabetes, the reputation of Ozempic and its siblings picked up when already-thin celebrities were suspected of using the injectable drugs to become even slimmer.

The FDA approved Ozempic’s cousin, Wegovy, for “weight management” in patients with obesity a few years ago, whereas Ozempic is currently approved only for diabetes treatment. Curious patients who don’t fit the criteria can – and do – get off-label prescriptions if they can afford to pay out of pocket, often to the tune of more than $1,400 a month. But is Ozempic worth it, especially if one has a relatively minor amount of weight to lose?

For many – mainly those who have been on the drug for a couple of months and have lost weight as a result – taking Ozempic has not only helped them shed stubborn weight, but has also freed them from the constant internal chatter around eating, commonly called “food noise.” But experts do not all agree that semaglutide is the right path for those who aren’t technically obese – especially in the long term.

After her first 9 weeks on semaglutide, Ms. Raibick had already lost 18 pounds. That’s when she decided to post about it on TikTok, and her videos on GLP-1s were viewed hundreds of thousands of times.

For the time being, there is no data on how many semaglutide takers are using the drug for diabetes and/or obesity, and how many are using it off-label for weight loss alone. But the company that makes Ozempic, Novo Nordisk, has reported sharp increases in sales and projects more profits down the road.

Ms. Raibick knows of others like her, who sought out the drug for more minor weight loss but aren’t as candid about their journeys. Some feel a stigma about having to resort to a weight-loss drug intended to treat obesity, rather than achieving their goals with diet and lifestyle change alone.

Another reason for the secrecy is the guilt some who take Ozempic feel about using their financial privilege to get a drug that had serious shortages, which made it harder for some patients who need the drug for diabetes or obesity treatment to get their doses.

That’s what Diana Thiara, MD, the medical director of the University of California, San Francisco’s weight management program, has been seeing on the ground.

“It’s one of the most depressing things I’ve experienced as a physician,” she said. In her practice, she has seen patients who have finally been able to access GLP-1s and have started to lose weight, only for them to regain the weight in the time it takes to find another prescription under their insurance coverage.

“It’s just horrible, there are patients spending all day calling dozens of pharmacies. I’ve never had a situation like this in my career,” said Dr. Thiara.

Ann, 48, a mom who works from home full-time, has been taking Ozempic since the end of January. (Ann is not her real name; she asked that we use a pseudonym in order to feel comfortable speaking publicly about her use of Ozempic). Like Ms. Raibick, she has been paying out of pocket for her shots. At first, she was going to have to pay $1,400 a month, but she found a pharmacy in Canada that offers the medication for $350. It’s sourced globally, she said, so sometimes her Ozempic boxes will be in Czech or another foreign language.

Unlike a lot of women, Ann never had any qualms with her weight or the way her body looked. She was never big on exercise, but it wasn’t until the pandemic that she started to gain weight. She noticed the changes in her body once places started opening back up, and her clothes didn’t fit anymore.

She tried moving more and eating healthier. She tried former Real Housewives of Beverly Hills cast member Teddi Mellencamp’s controversial weight-loss program, infamous for its incredibly restrictive dietary plan and excessive cardio recommendations. Nothing worked until another mom at her daughter’s school mentioned that she was on Ozempic.

Ann also started to get hot flashes and missed periods. The doctor who prescribed her Ozempic confirmed that she was perimenopausal and that, for women in this stage of life, losing weight can be harder than ever.

Ann, who is 5 foot 7, started out at 176 pounds (considered overweight) and now weighs in at 151, which is considered a normal weight by BMI measurements. She’s still on Ozempic but continues to struggle with the shame around the idea she’s potentially taking the drug away from someone else who might desperately need it. And she doesn’t know how long she’ll have to stay on Ozempic to maintain her weight loss.

Ann has reason for concern. A 2022 study found that most people regain the weight they lost within a year of stopping Ozempic.

Once Ms. Raibick hit her initial goal weight, she felt that she could keep going and lose a little more. It wasn’t until she got into the 120-pound range that she decided it was time to wean off the dose of semaglutide she had been taking.

“I got to the point where my mom was like, ‘All right, you’re a little too thin.’ But I’m just so happy where I’m at. I’m not mentally stressed out about fitting into clothes or getting into a bathing suit,” said Ms. Raibick, who has now lost around 30 pounds in total since she started the shots.

At one point, she stopped taking the drug altogether, and all of the hunger cravings and food noise semaglutide had suppressed came back to the surface. She didn’t gain any weight that month, she said, but the internal chatter around food was enough to make her start back on a lower dose, geared toward weight maintenance.

There’s also the issue of side effects. Ms. Raibick says she never had the overwhelming nausea and digestive problems that so many on the drug – including Ann – have reported. But Dr. Thiara said that even beyond these more common side effects, there are a number of other concerns – like the long-lasting effects on thyroid and reproductive health, especially for women – that we still don’t know enough about. And just recently, CNN reported that some Ozempic users have developed stomach paralysis due to the drug’s ability to slow down the passage of food through the digestive tract.

For Ms. Raibick, the out-of-pocket cost for the drug is around $600 a month. It’s an expense she’s willing to keep paying for, even just for the peace of mind the drug provides. She doesn’t have any plans to stop her semaglutide shots soon.

“There is nothing stopping me from – a year from now, when I’ve put a little weight back on – looking back at photos from this time and thinking I was way too skinny.”

Dan Azagury, MD, a bariatric surgeon and associate professor of surgery at Stanford (Calif.) University, tries GLP-1s for patients with obesity before considering bariatric surgery. For his patient population, it’s possible that drugs like Ozempic will be part of their lifelong treatment plans.

“We’re not doing it for the cosmetic part of it, we’re doing it for health,” he said. “What I tell my patients is, if you’re planning to start on this medication, you should be OK with the idea of staying on it forever.”

For doctors like Dr. Thiara who specialize in weight management, using Ozempic long-term for patients in a healthy weight range is the wrong approach.

“It’s not about the way people look, it’s about health. If you’re a normal weight or even in an overweight category, but not showing signs of risk of having elevated cardiometabolic disease ... You don’t need to be taking medications for weight loss,” she said. “This idea of using medications for aesthetic reasons is really more related to societal ills around how we value fitness above anything else. That’s not the goal, and it’s not safe.”

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

It’s a devastating series of setbacks for long COVID patients. First, they get the debilitating symptoms of their condition. Then they are forced to give up their jobs, or severely curtail their work hours, as their symptoms linger. And next, for many, they lose their employer-sponsored health insurance. 

While not all long COVID patients are debilitated, the CDC’s ongoing survey on long COVID found a quarter of adults with long COVID report it significantly affects their day-to-day living activities.

Estimates have shown that long COVID has disrupted the lives of anywhere from 16 million to 34 million Americans between the ages of 18 and 65. 

While hard data is still limited, a Kaiser Family Foundation analysis found that more than half of adults with long COVID who worked before getting the virus are now either out of work or working fewer hours. 

According to data from the Census Bureau’s Household Pulse Survey, out of the estimated 16 million working-age adults who currently have long COVID, 2 million to 4 million of them are out of work because of their symptoms. The cost of those lost wages ranges from $170 billion a year to as much as $230 billion, the Census Bureau says. And given that approximately 155 million Americans have employer-sponsored health insurance, the welfare of working-age adults may be under serious threat. 

“Millions of people are now impacted by long COVID, and oftentimes along with that comes the inability to work,” says Megan Cole Brahim, PhD, an assistant professor in the department of health law, policy, and management at Boston University and codirector of the school’s Medicaid policy lab. “And because a lot of people get their health insurance coverage through employer-sponsored coverage, no longer being able to work means you may not have access to the health insurance that you once had.”

The CDC defines long COVID as a wide array of health conditions, including malaise, fatigue, shortness of breath, mental health issues, problems with the part of the nervous system that controls body functions, and more. 

Gwen Bishop was working remotely for the human resources department at the University of Washington Medical Centers, Seattle, when she got COVID-19. When the infection passed, Ms. Bishop, 39, thought she’d start feeling well enough to get back to work – but that didn’t happen. 

“When I would log in to work and just try to read emails,” she says, “it was like they were written in Greek. It made no sense and was incredibly stressful.”

This falls in line with what researchers have found out about the nervous system issues reported by people with long COVID. People who have survived acute COVID infections have reported lasting sensory and motor function problems, brain fog, and memory problems. 

Ms. Bishop, who was diagnosed with ADHD when she was in grade school, says another complication she got from her long COVID was a new intolerance to stimulants like coffee and her ADHD medication, Vyvanse, which were normal parts of her everyday life. 

“Every time I would take my ADHD medicine or have a cup of coffee, I would have a panic attack until it wore off,” says Ms. Bishop. “Vyvanse is a very long-acting stimulant, so that would be an entire day of an endless panic attack.” 

In order for her to get a medical leave approved, Ms. Bishop needed to get documents by a certain date from her doctor’s office that confirmed her long COVID diagnosis. She was able to get a couple of extensions, but Bishop says that with the burden that has been placed on our medical systems, getting in to see a doctor through her employer insurance was taking much longer than expected. By the time she got an appointment, she says, she had already been fired for missing too much work. Emails she provided showing exchanges between her and her employer verify her story. And without her health insurance, her appointment through that provider would no longer have been covered.

In July 2021, the U.S. Department of Health & Human Services issued guidance recognizing long COVID as a disability “if the person’s condition or any of its symptoms is a ‘physical or mental’ impairment that ‘substantially limits’ one or more major life activities.” 

But getting access to disability benefits hasn’t been easy for people with long COVID. On top of having to be out of work for 12 months before being able to qualify for Social Security Disability Insurance, some of those who have applied say they have had to put up a fight to actually gain access to disability insurance. The Social Security Administration has yet to reveal just how many applications that cited long COVID have been denied so far.  

David Barnett, a former bartender in the Seattle area in his early 40s, got COVID-19 in March 2020. Before his infection, he spent much of his time working on his feet, bodybuilding, and hiking with his partner. But for the last nearly 3 years, even just going for a walk has been a major challenge. He says he has spent much of his post-COVID life either chair-bound or bed-bound because of his symptoms. 

He is currently on his partner’s health insurance plan but is still responsible for copays and out-of-network appointments and treatments. After being unable to bartend any more, he started a GoFundMe account and dug into his personal savings. He says he applied for food stamps and is getting ready to sell his truck. Mr. Barnett applied for disability in March of this year but says he was denied benefits by the Social Security Administration and has hired a lawyer to appeal.

He runs a 24-hour online support group on Zoom for people with long COVID and says that no one in his close circle has successfully gotten access to disability payments. 

Alba Azola, MD, codirector of Johns Hopkins University’s Post-Acute COVID-19 Team, says at least half of her patients need some level of accommodations to get back to work; most can, if given the proper accommodations, such as switching to a job that can be done sitting down, or with limited time standing. But there are still patients who have been more severely disabled by their long COVID symptoms. 

“Work is such a part of people’s identity. The people who are very impaired, all they want to do is to get back to work and their normal lives,” she says.

Many of Dr. Azola’s long COVID patients aren’t able to return to their original jobs. She says they often have to find new positions more tailored to their new realities. One patient, a nurse and mother of five who previously worked in a facility where she got COVID-19, was out of work for 9 months after her infection. She ultimately lost her job, and Dr. Azola says the patient’s employer was hesitant to provide her with any accommodations. The patient was finally able to find a different job as a nurse coordinator where she doesn’t have to be standing for more than 10 minutes at a time. 

Ge Bai, PhD, a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, says the novelty of long COVID and the continued uncertainty around it raise questions for health insurance providers. 

“There’s no well-defined pathway to treat or cure this condition,” Dr. Bai says. “Right now, employers have discretion to determine when a condition is being covered or not being covered. So people with long COVID do have a risk that their treatments won’t be covered.”

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

It’s a devastating series of setbacks for long COVID patients. First, they get the debilitating symptoms of their condition. Then they are forced to give up their jobs, or severely curtail their work hours, as their symptoms linger. And next, for many, they lose their employer-sponsored health insurance. 

While not all long COVID patients are debilitated, the CDC’s ongoing survey on long COVID found a quarter of adults with long COVID report it significantly affects their day-to-day living activities.

Estimates have shown that long COVID has disrupted the lives of anywhere from 16 million to 34 million Americans between the ages of 18 and 65. 

While hard data is still limited, a Kaiser Family Foundation analysis found that more than half of adults with long COVID who worked before getting the virus are now either out of work or working fewer hours. 

According to data from the Census Bureau’s Household Pulse Survey, out of the estimated 16 million working-age adults who currently have long COVID, 2 million to 4 million of them are out of work because of their symptoms. The cost of those lost wages ranges from $170 billion a year to as much as $230 billion, the Census Bureau says. And given that approximately 155 million Americans have employer-sponsored health insurance, the welfare of working-age adults may be under serious threat. 

“Millions of people are now impacted by long COVID, and oftentimes along with that comes the inability to work,” says Megan Cole Brahim, PhD, an assistant professor in the department of health law, policy, and management at Boston University and codirector of the school’s Medicaid policy lab. “And because a lot of people get their health insurance coverage through employer-sponsored coverage, no longer being able to work means you may not have access to the health insurance that you once had.”

The CDC defines long COVID as a wide array of health conditions, including malaise, fatigue, shortness of breath, mental health issues, problems with the part of the nervous system that controls body functions, and more. 

Gwen Bishop was working remotely for the human resources department at the University of Washington Medical Centers, Seattle, when she got COVID-19. When the infection passed, Ms. Bishop, 39, thought she’d start feeling well enough to get back to work – but that didn’t happen. 

“When I would log in to work and just try to read emails,” she says, “it was like they were written in Greek. It made no sense and was incredibly stressful.”

This falls in line with what researchers have found out about the nervous system issues reported by people with long COVID. People who have survived acute COVID infections have reported lasting sensory and motor function problems, brain fog, and memory problems. 

Ms. Bishop, who was diagnosed with ADHD when she was in grade school, says another complication she got from her long COVID was a new intolerance to stimulants like coffee and her ADHD medication, Vyvanse, which were normal parts of her everyday life. 

“Every time I would take my ADHD medicine or have a cup of coffee, I would have a panic attack until it wore off,” says Ms. Bishop. “Vyvanse is a very long-acting stimulant, so that would be an entire day of an endless panic attack.” 

In order for her to get a medical leave approved, Ms. Bishop needed to get documents by a certain date from her doctor’s office that confirmed her long COVID diagnosis. She was able to get a couple of extensions, but Bishop says that with the burden that has been placed on our medical systems, getting in to see a doctor through her employer insurance was taking much longer than expected. By the time she got an appointment, she says, she had already been fired for missing too much work. Emails she provided showing exchanges between her and her employer verify her story. And without her health insurance, her appointment through that provider would no longer have been covered.

In July 2021, the U.S. Department of Health & Human Services issued guidance recognizing long COVID as a disability “if the person’s condition or any of its symptoms is a ‘physical or mental’ impairment that ‘substantially limits’ one or more major life activities.” 

But getting access to disability benefits hasn’t been easy for people with long COVID. On top of having to be out of work for 12 months before being able to qualify for Social Security Disability Insurance, some of those who have applied say they have had to put up a fight to actually gain access to disability insurance. The Social Security Administration has yet to reveal just how many applications that cited long COVID have been denied so far.  

David Barnett, a former bartender in the Seattle area in his early 40s, got COVID-19 in March 2020. Before his infection, he spent much of his time working on his feet, bodybuilding, and hiking with his partner. But for the last nearly 3 years, even just going for a walk has been a major challenge. He says he has spent much of his post-COVID life either chair-bound or bed-bound because of his symptoms. 

He is currently on his partner’s health insurance plan but is still responsible for copays and out-of-network appointments and treatments. After being unable to bartend any more, he started a GoFundMe account and dug into his personal savings. He says he applied for food stamps and is getting ready to sell his truck. Mr. Barnett applied for disability in March of this year but says he was denied benefits by the Social Security Administration and has hired a lawyer to appeal.

He runs a 24-hour online support group on Zoom for people with long COVID and says that no one in his close circle has successfully gotten access to disability payments. 

Alba Azola, MD, codirector of Johns Hopkins University’s Post-Acute COVID-19 Team, says at least half of her patients need some level of accommodations to get back to work; most can, if given the proper accommodations, such as switching to a job that can be done sitting down, or with limited time standing. But there are still patients who have been more severely disabled by their long COVID symptoms. 

“Work is such a part of people’s identity. The people who are very impaired, all they want to do is to get back to work and their normal lives,” she says.

Many of Dr. Azola’s long COVID patients aren’t able to return to their original jobs. She says they often have to find new positions more tailored to their new realities. One patient, a nurse and mother of five who previously worked in a facility where she got COVID-19, was out of work for 9 months after her infection. She ultimately lost her job, and Dr. Azola says the patient’s employer was hesitant to provide her with any accommodations. The patient was finally able to find a different job as a nurse coordinator where she doesn’t have to be standing for more than 10 minutes at a time. 

Ge Bai, PhD, a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, says the novelty of long COVID and the continued uncertainty around it raise questions for health insurance providers. 

“There’s no well-defined pathway to treat or cure this condition,” Dr. Bai says. “Right now, employers have discretion to determine when a condition is being covered or not being covered. So people with long COVID do have a risk that their treatments won’t be covered.”

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

It’s a devastating series of setbacks for long COVID patients. First, they get the debilitating symptoms of their condition. Then they are forced to give up their jobs, or severely curtail their work hours, as their symptoms linger. And next, for many, they lose their employer-sponsored health insurance. 

While not all long COVID patients are debilitated, the CDC’s ongoing survey on long COVID found a quarter of adults with long COVID report it significantly affects their day-to-day living activities.

Estimates have shown that long COVID has disrupted the lives of anywhere from 16 million to 34 million Americans between the ages of 18 and 65. 

While hard data is still limited, a Kaiser Family Foundation analysis found that more than half of adults with long COVID who worked before getting the virus are now either out of work or working fewer hours. 

According to data from the Census Bureau’s Household Pulse Survey, out of the estimated 16 million working-age adults who currently have long COVID, 2 million to 4 million of them are out of work because of their symptoms. The cost of those lost wages ranges from $170 billion a year to as much as $230 billion, the Census Bureau says. And given that approximately 155 million Americans have employer-sponsored health insurance, the welfare of working-age adults may be under serious threat. 

“Millions of people are now impacted by long COVID, and oftentimes along with that comes the inability to work,” says Megan Cole Brahim, PhD, an assistant professor in the department of health law, policy, and management at Boston University and codirector of the school’s Medicaid policy lab. “And because a lot of people get their health insurance coverage through employer-sponsored coverage, no longer being able to work means you may not have access to the health insurance that you once had.”

The CDC defines long COVID as a wide array of health conditions, including malaise, fatigue, shortness of breath, mental health issues, problems with the part of the nervous system that controls body functions, and more. 

Gwen Bishop was working remotely for the human resources department at the University of Washington Medical Centers, Seattle, when she got COVID-19. When the infection passed, Ms. Bishop, 39, thought she’d start feeling well enough to get back to work – but that didn’t happen. 

“When I would log in to work and just try to read emails,” she says, “it was like they were written in Greek. It made no sense and was incredibly stressful.”

This falls in line with what researchers have found out about the nervous system issues reported by people with long COVID. People who have survived acute COVID infections have reported lasting sensory and motor function problems, brain fog, and memory problems. 

Ms. Bishop, who was diagnosed with ADHD when she was in grade school, says another complication she got from her long COVID was a new intolerance to stimulants like coffee and her ADHD medication, Vyvanse, which were normal parts of her everyday life. 

“Every time I would take my ADHD medicine or have a cup of coffee, I would have a panic attack until it wore off,” says Ms. Bishop. “Vyvanse is a very long-acting stimulant, so that would be an entire day of an endless panic attack.” 

In order for her to get a medical leave approved, Ms. Bishop needed to get documents by a certain date from her doctor’s office that confirmed her long COVID diagnosis. She was able to get a couple of extensions, but Bishop says that with the burden that has been placed on our medical systems, getting in to see a doctor through her employer insurance was taking much longer than expected. By the time she got an appointment, she says, she had already been fired for missing too much work. Emails she provided showing exchanges between her and her employer verify her story. And without her health insurance, her appointment through that provider would no longer have been covered.

In July 2021, the U.S. Department of Health & Human Services issued guidance recognizing long COVID as a disability “if the person’s condition or any of its symptoms is a ‘physical or mental’ impairment that ‘substantially limits’ one or more major life activities.” 

But getting access to disability benefits hasn’t been easy for people with long COVID. On top of having to be out of work for 12 months before being able to qualify for Social Security Disability Insurance, some of those who have applied say they have had to put up a fight to actually gain access to disability insurance. The Social Security Administration has yet to reveal just how many applications that cited long COVID have been denied so far.  

David Barnett, a former bartender in the Seattle area in his early 40s, got COVID-19 in March 2020. Before his infection, he spent much of his time working on his feet, bodybuilding, and hiking with his partner. But for the last nearly 3 years, even just going for a walk has been a major challenge. He says he has spent much of his post-COVID life either chair-bound or bed-bound because of his symptoms. 

He is currently on his partner’s health insurance plan but is still responsible for copays and out-of-network appointments and treatments. After being unable to bartend any more, he started a GoFundMe account and dug into his personal savings. He says he applied for food stamps and is getting ready to sell his truck. Mr. Barnett applied for disability in March of this year but says he was denied benefits by the Social Security Administration and has hired a lawyer to appeal.

He runs a 24-hour online support group on Zoom for people with long COVID and says that no one in his close circle has successfully gotten access to disability payments. 

Alba Azola, MD, codirector of Johns Hopkins University’s Post-Acute COVID-19 Team, says at least half of her patients need some level of accommodations to get back to work; most can, if given the proper accommodations, such as switching to a job that can be done sitting down, or with limited time standing. But there are still patients who have been more severely disabled by their long COVID symptoms. 

“Work is such a part of people’s identity. The people who are very impaired, all they want to do is to get back to work and their normal lives,” she says.

Many of Dr. Azola’s long COVID patients aren’t able to return to their original jobs. She says they often have to find new positions more tailored to their new realities. One patient, a nurse and mother of five who previously worked in a facility where she got COVID-19, was out of work for 9 months after her infection. She ultimately lost her job, and Dr. Azola says the patient’s employer was hesitant to provide her with any accommodations. The patient was finally able to find a different job as a nurse coordinator where she doesn’t have to be standing for more than 10 minutes at a time. 

Ge Bai, PhD, a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, says the novelty of long COVID and the continued uncertainty around it raise questions for health insurance providers. 

“There’s no well-defined pathway to treat or cure this condition,” Dr. Bai says. “Right now, employers have discretion to determine when a condition is being covered or not being covered. So people with long COVID do have a risk that their treatments won’t be covered.”

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

When a mass shooting happens, another often follows in close succession. That’s not just a feeling – it’s a fact.

The devastating shooting on May 24 in Uvalde, Tex., which killed 19 children, two teachers, and injured 17 others, occurred 10 days after a supermarket shooting in Buffalo, N.Y., which resulted in 10 deaths. In 2021, a shooting at a massage parlor in Atlanta, which left eight dead, came less than a week before a shooting at a supermarket in Boulder, Colo., that killed 10. And a 2019 shooting in Dayton, Ohio, on Aug. 4 that killed nine people took place only a day after a Walmart shooting in El Paso, Tex., which claimed 22 lives.
 

Contagion theory

Researchers argue that the clustering of mass shootings suggests that this type of violence spreads like a virus and should be treated as one.

This theory – called the “contagion effect” – has been examined at length in cases of suicide, especially among teens and young adults. Studies have demonstrated that the majority of adolescents who attempt suicide have previously been exposed to the suicidal behavior of a peer.

In many cases, mass shootings are also suicides, with shooters taking their own lives at the time of the shooting or not long after.

“They have literally and figuratively given up on their life as they know it.” said Joel Dvoskin, PhD, a clinical and forensic psychologist at the University of Arizona, Tucson, and former acting commissioner of mental health for New York state.

According to contagion theory, mass shootings – and the round-the-clock media coverage they generate – lead to even more killings.

A team of researchers at Arizona State University led by Sherry Towers, PhD, analyzed mass shooting data in 2015 to find out whether those events followed a similar pattern. Dr. Towers spent much of her career modeling the spread of infectious diseases, such as influenza, Ebola, and Zika.

Dr. Towers and colleagues discovered that a mass killing tended to give rise to more killings in its immediate aftermath. According to her evaluation of USA Today’s mass shooting database, a second incident was most likely to occur within 13 days of the initial event.
 

What defines a mass shooting?

The FBI defines a mass shooting as any incident in which four or more people die by gunfire. That definition, however, is not universally accepted. The lack of a standard definition complicates the work of researchers who study contagion theory.

Mother Jones magazine created an open-source database of mass killings that employs a similar definition but that includes only incidents that involve a person shooting indiscriminately in a public place.

With this narrower definition, shootings involving organized crime, robberies, and domestic violence – which make up the vast majority of shootings in which multiple fatalities occur in this country – are excluded. Events such as those that occurred in Sandy Hook or the killings in Highland Park, Ill.,  this past July would be included.

The Gun Violence Archive categorizes mass shootings as any incident in which four or more people are shot but not necessarily killed, while Everytown for Gun Safety tallies mass shootings that take at least four lives.

James Meindl, PhD, a professor of behavioral analysis at the University of Memphis who studies mass shootings, said parsing the differences between what happened in Uvalde and what happens during a shooting involving organized crime or domestic violence is crucial when thinking about intervention and prevention.

“If you want to intervene, you have to know why the person engaged in this behavior in the first place,” Dr. Meindl said. “The factors that led a person to commit gang violence, the factors in domestic violence, the factors in indiscriminate mass shootings – those are all very different factors that would call for very different interventions.”
 

So, should mass shootings be treated like an infectious disease?

Rather than using contagion theory, Dr. Meindl said he prefers to view mass shootings through the lens of “generalized imitation,” a psychological concept involving the learned ability to mimic behaviors observed either in person or through the media. Behaviors “are not diseases that can spread on contact.”

Gary Slutkin, MD, is an epidemiologist who pivoted from studying the spread of diseases such as tuberculosis, HIV, and cholera to trying to understand the epidemic of gun violence.

“The more you’re exposed [to violence], the more likely you are to repeat it, just like the more you’re exposed to COVID, the more likely you are to get it and give it to somebody else,” Dr. Slutkin said. And just as people have varying degrees of susceptibility to COVID-19 and other infectious diseases, he argued that some are more susceptible to committing a mass shooting, depending on their level of isolation, personal “grievances, and their need for belonging or credit.”

To Dr. Slutkin, mass shootings, and other forms of violence, should be treated with the standard methods that public health officials would use to stop the spread of a contagious disease: detection and interdiction that would put a stop to potential events. The nonprofit organization that he founded, Cure Violence Global, employs “violence interrupters” to reach out to and engage with community members who might be at risk of being a victim of violence or of committing an act of violence, much as a public health worker would approach epidemic control.

Research conducted on the effects of this method of reducing rates of violence suggests the approach works. In 2017, New York City saw a 63% reduction in gun injuries, according to a study from the John Jay College of Criminal Justice. And after evaluating the effects of this approach in Chicago in 2014, researchers from the University of Illinois and the University of Chicago determined that there was a 19% reduction in shootings in the city.

“The results of stopping an epidemic come really fast,” Dr. Slutkin said. “But getting people to switch gears to the right kind of treatment happens really slowly.”

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

When a mass shooting happens, another often follows in close succession. That’s not just a feeling – it’s a fact.

The devastating shooting on May 24 in Uvalde, Tex., which killed 19 children, two teachers, and injured 17 others, occurred 10 days after a supermarket shooting in Buffalo, N.Y., which resulted in 10 deaths. In 2021, a shooting at a massage parlor in Atlanta, which left eight dead, came less than a week before a shooting at a supermarket in Boulder, Colo., that killed 10. And a 2019 shooting in Dayton, Ohio, on Aug. 4 that killed nine people took place only a day after a Walmart shooting in El Paso, Tex., which claimed 22 lives.
 

Contagion theory

Researchers argue that the clustering of mass shootings suggests that this type of violence spreads like a virus and should be treated as one.

This theory – called the “contagion effect” – has been examined at length in cases of suicide, especially among teens and young adults. Studies have demonstrated that the majority of adolescents who attempt suicide have previously been exposed to the suicidal behavior of a peer.

In many cases, mass shootings are also suicides, with shooters taking their own lives at the time of the shooting or not long after.

“They have literally and figuratively given up on their life as they know it.” said Joel Dvoskin, PhD, a clinical and forensic psychologist at the University of Arizona, Tucson, and former acting commissioner of mental health for New York state.

According to contagion theory, mass shootings – and the round-the-clock media coverage they generate – lead to even more killings.

A team of researchers at Arizona State University led by Sherry Towers, PhD, analyzed mass shooting data in 2015 to find out whether those events followed a similar pattern. Dr. Towers spent much of her career modeling the spread of infectious diseases, such as influenza, Ebola, and Zika.

Dr. Towers and colleagues discovered that a mass killing tended to give rise to more killings in its immediate aftermath. According to her evaluation of USA Today’s mass shooting database, a second incident was most likely to occur within 13 days of the initial event.
 

What defines a mass shooting?

The FBI defines a mass shooting as any incident in which four or more people die by gunfire. That definition, however, is not universally accepted. The lack of a standard definition complicates the work of researchers who study contagion theory.

Mother Jones magazine created an open-source database of mass killings that employs a similar definition but that includes only incidents that involve a person shooting indiscriminately in a public place.

With this narrower definition, shootings involving organized crime, robberies, and domestic violence – which make up the vast majority of shootings in which multiple fatalities occur in this country – are excluded. Events such as those that occurred in Sandy Hook or the killings in Highland Park, Ill.,  this past July would be included.

The Gun Violence Archive categorizes mass shootings as any incident in which four or more people are shot but not necessarily killed, while Everytown for Gun Safety tallies mass shootings that take at least four lives.

James Meindl, PhD, a professor of behavioral analysis at the University of Memphis who studies mass shootings, said parsing the differences between what happened in Uvalde and what happens during a shooting involving organized crime or domestic violence is crucial when thinking about intervention and prevention.

“If you want to intervene, you have to know why the person engaged in this behavior in the first place,” Dr. Meindl said. “The factors that led a person to commit gang violence, the factors in domestic violence, the factors in indiscriminate mass shootings – those are all very different factors that would call for very different interventions.”
 

So, should mass shootings be treated like an infectious disease?

Rather than using contagion theory, Dr. Meindl said he prefers to view mass shootings through the lens of “generalized imitation,” a psychological concept involving the learned ability to mimic behaviors observed either in person or through the media. Behaviors “are not diseases that can spread on contact.”

Gary Slutkin, MD, is an epidemiologist who pivoted from studying the spread of diseases such as tuberculosis, HIV, and cholera to trying to understand the epidemic of gun violence.

“The more you’re exposed [to violence], the more likely you are to repeat it, just like the more you’re exposed to COVID, the more likely you are to get it and give it to somebody else,” Dr. Slutkin said. And just as people have varying degrees of susceptibility to COVID-19 and other infectious diseases, he argued that some are more susceptible to committing a mass shooting, depending on their level of isolation, personal “grievances, and their need for belonging or credit.”

To Dr. Slutkin, mass shootings, and other forms of violence, should be treated with the standard methods that public health officials would use to stop the spread of a contagious disease: detection and interdiction that would put a stop to potential events. The nonprofit organization that he founded, Cure Violence Global, employs “violence interrupters” to reach out to and engage with community members who might be at risk of being a victim of violence or of committing an act of violence, much as a public health worker would approach epidemic control.

Research conducted on the effects of this method of reducing rates of violence suggests the approach works. In 2017, New York City saw a 63% reduction in gun injuries, according to a study from the John Jay College of Criminal Justice. And after evaluating the effects of this approach in Chicago in 2014, researchers from the University of Illinois and the University of Chicago determined that there was a 19% reduction in shootings in the city.

“The results of stopping an epidemic come really fast,” Dr. Slutkin said. “But getting people to switch gears to the right kind of treatment happens really slowly.”

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

When a mass shooting happens, another often follows in close succession. That’s not just a feeling – it’s a fact.

The devastating shooting on May 24 in Uvalde, Tex., which killed 19 children, two teachers, and injured 17 others, occurred 10 days after a supermarket shooting in Buffalo, N.Y., which resulted in 10 deaths. In 2021, a shooting at a massage parlor in Atlanta, which left eight dead, came less than a week before a shooting at a supermarket in Boulder, Colo., that killed 10. And a 2019 shooting in Dayton, Ohio, on Aug. 4 that killed nine people took place only a day after a Walmart shooting in El Paso, Tex., which claimed 22 lives.
 

Contagion theory

Researchers argue that the clustering of mass shootings suggests that this type of violence spreads like a virus and should be treated as one.

This theory – called the “contagion effect” – has been examined at length in cases of suicide, especially among teens and young adults. Studies have demonstrated that the majority of adolescents who attempt suicide have previously been exposed to the suicidal behavior of a peer.

In many cases, mass shootings are also suicides, with shooters taking their own lives at the time of the shooting or not long after.

“They have literally and figuratively given up on their life as they know it.” said Joel Dvoskin, PhD, a clinical and forensic psychologist at the University of Arizona, Tucson, and former acting commissioner of mental health for New York state.

According to contagion theory, mass shootings – and the round-the-clock media coverage they generate – lead to even more killings.

A team of researchers at Arizona State University led by Sherry Towers, PhD, analyzed mass shooting data in 2015 to find out whether those events followed a similar pattern. Dr. Towers spent much of her career modeling the spread of infectious diseases, such as influenza, Ebola, and Zika.

Dr. Towers and colleagues discovered that a mass killing tended to give rise to more killings in its immediate aftermath. According to her evaluation of USA Today’s mass shooting database, a second incident was most likely to occur within 13 days of the initial event.
 

What defines a mass shooting?

The FBI defines a mass shooting as any incident in which four or more people die by gunfire. That definition, however, is not universally accepted. The lack of a standard definition complicates the work of researchers who study contagion theory.

Mother Jones magazine created an open-source database of mass killings that employs a similar definition but that includes only incidents that involve a person shooting indiscriminately in a public place.

With this narrower definition, shootings involving organized crime, robberies, and domestic violence – which make up the vast majority of shootings in which multiple fatalities occur in this country – are excluded. Events such as those that occurred in Sandy Hook or the killings in Highland Park, Ill.,  this past July would be included.

The Gun Violence Archive categorizes mass shootings as any incident in which four or more people are shot but not necessarily killed, while Everytown for Gun Safety tallies mass shootings that take at least four lives.

James Meindl, PhD, a professor of behavioral analysis at the University of Memphis who studies mass shootings, said parsing the differences between what happened in Uvalde and what happens during a shooting involving organized crime or domestic violence is crucial when thinking about intervention and prevention.

“If you want to intervene, you have to know why the person engaged in this behavior in the first place,” Dr. Meindl said. “The factors that led a person to commit gang violence, the factors in domestic violence, the factors in indiscriminate mass shootings – those are all very different factors that would call for very different interventions.”
 

So, should mass shootings be treated like an infectious disease?

Rather than using contagion theory, Dr. Meindl said he prefers to view mass shootings through the lens of “generalized imitation,” a psychological concept involving the learned ability to mimic behaviors observed either in person or through the media. Behaviors “are not diseases that can spread on contact.”

Gary Slutkin, MD, is an epidemiologist who pivoted from studying the spread of diseases such as tuberculosis, HIV, and cholera to trying to understand the epidemic of gun violence.

“The more you’re exposed [to violence], the more likely you are to repeat it, just like the more you’re exposed to COVID, the more likely you are to get it and give it to somebody else,” Dr. Slutkin said. And just as people have varying degrees of susceptibility to COVID-19 and other infectious diseases, he argued that some are more susceptible to committing a mass shooting, depending on their level of isolation, personal “grievances, and their need for belonging or credit.”

To Dr. Slutkin, mass shootings, and other forms of violence, should be treated with the standard methods that public health officials would use to stop the spread of a contagious disease: detection and interdiction that would put a stop to potential events. The nonprofit organization that he founded, Cure Violence Global, employs “violence interrupters” to reach out to and engage with community members who might be at risk of being a victim of violence or of committing an act of violence, much as a public health worker would approach epidemic control.

Research conducted on the effects of this method of reducing rates of violence suggests the approach works. In 2017, New York City saw a 63% reduction in gun injuries, according to a study from the John Jay College of Criminal Justice. And after evaluating the effects of this approach in Chicago in 2014, researchers from the University of Illinois and the University of Chicago determined that there was a 19% reduction in shootings in the city.

“The results of stopping an epidemic come really fast,” Dr. Slutkin said. “But getting people to switch gears to the right kind of treatment happens really slowly.”

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

The names of the doctors in this story have been changed at their request because of fear of legal repercussions and/or professional retaliation.

When an Ohio ob.gyn. had a patient in need of an abortion in July 2022, he knew he had to move quickly.

Daniel, who also sees patients at an abortion clinic, was treating a woman who came in for an abortion around 5 weeks into her pregnancy. And after going through the mandatory waiting periods, the required ultrasounds at each appointment, the consent process, and the options counseling, she was set for a surgical abortion the following Monday.

But on Monday, pre-op tests showed that her blood pressure was very high, posing a serious health risk if Daniel proceeded with the surgery.

Before the Supreme Court overturned Roe v. Wade in June, Daniel would have sent the patient home with instructions on how to lower her blood pressure over time. But the patient now had just four days to show the necessary improvement.

In this case, everything worked out. The patient returned Thursday and was able to have the procedure. But this is just one of the many day-to-day medical decisions abortion providers are now having to make with the changing legal risks being as top-of-mind to doctors as the safety of their patients.

Daniel said he doesn’t want the Ohio abortion law to change the way he communicates with his patients. As far as he knows, it’s still legal to talk to patients about self-managed abortions, as long as everything is unbiased and clearly stated, he says.

“But I don’t think I would get a lot of institutional support to have those conversations with patients because of the perceived legal liability,” says Daniel. “I will still have those conversations, but I’m not going to tell my employer that I’m having them and I’m not going to document them in the chart.”

Daniel is aware that having these kinds of discussions, or entertaining the possibility of omitting certain information from patient records, runs the risk of legal and professional consequences. Enforcement of these rules is foggy, too.

Under the Ohio law, if a fellow staff member suspects you of violating a law, you could be reported to a supervisor or licensing body. Abortion providers are aware they must be cautious about what they say because anti-abortion activitists, posing as patients, have secretly recorded conversations in the past, Daniel says.
 

Enforcement: The past, present, and future legal risks

Before Roe, enforcement of illegal abortion was spotty, says Mary Ziegler, JD, a professor at Florida State University College of Law, who specializes in the legal history of reproductive rights. At the start of the late 19th century, the doctors who provided illegal abortions would, in most cases, be prosecuted if a patient died as a result of the procedure.

A doctor in Ashland, Pa., named Robert Spencer was known for providing abortions in the small mining town where he practiced in the 1920s. He was reportedly arrested three times – once after a patient died as a result of abortion complications – but was ultimately acquitted.

For many doctors performing abortions at the time, “it was very much a kind of roll of the dice,” Ms. Ziegler says. “There was a sense that these laws were not enforced very much.”

Carole Joffe, PhD, a sociologist with expertise in reproductive health, recalls that there were very few doctors arrested, given the sheer number of abortions that were performed. The American College of Obstetricians and Gynecologists estimates that, in the years leading up to the original Roe decision, about 1.2 million women in the U.S. had illegal abortions – a number that exceeds today’s estimates.

Among the most notable cases of a doctor being detained was the arrest of gynecologist Jane Hodgson, MD, in 1970. Dr. Hodgson intentionally violated Minnesota law, which prohibited all abortions except in cases that were life-threatening to the patient.

After performing an abortion on a patient who had contracted rubella, also known as German measles, Dr. Hodgson was arrested, sentenced to 30 days in jail, and put on a year-long probation. She did not end up serving any time in jail, and her conviction was overturned after the Roe decision in 1973.

Now, the abortion restrictions being passed in many states have authorized much more sweeping penalties than those that existed in the pre-Roe era. According to Joffe, there is one key reason why we can anticipate more doctor arrests now.

“There simply was not the modern anti-abortion movement that we have come to know,” she says. “In the old days, there was not that much legal surveillance, and things were very unsafe. Fast forward to the present, we have much safer options now – like medication abortion pills – but we have a very different legal environment.”

Carmel Shachar, JD, MPH, a law and health policy expert at Harvard Law School, also expects that we will see more frequent prosecutions of doctors who provide abortion.

“There’s so much more data available through medical record-keeping and information generated by our phones and internet searches, that I think it would be much harder for a physician to fly under the radar,” Ms. Shachar says.

Also, Ms. Shachar emphasizes the power of prosecutorial discretion in abortion cases, where one prosecutor may choose to apply a law much more aggressively than another prosecutor in the next county over. Such has been seen in DeKalb County, Ga., which includes parts of Atlanta, where District Attorney Sherry Boston says she plans to use her prosecutorial discretion to address crimes like rape and murder, rather than “potentially investigat[ing] women and doctors for medical decisions,” Bloomberg Law reported. State Sen. Jen Jordan, the Democratic nominee for Georgia attorney general, has also said that, if elected, she would not enforce the state’s new 6-week abortion ban.
 

Is there a legal path forward for abortion care in states that forbid it?

Robin, an ob.gyn., became a complex family planning fellow in Utah to seek out further medical training and education in abortion care. Her plan was to solidify this as an area of expertise, so that, upon completing her fellowship, she could move back to her home state of Arizona to provide services there.

In Utah, where she currently practices, abortion is banned after 18 weeks. In Arizona, abortion is still allowed up to 24-26 weeks, until a pregnancy reaches “viability” (when a fetus is developed enough that it is able to survive outside the uterus with medical assistance). But new restrictions in Arizona may go into effect as early as September which would prohibit abortions after 15 weeks.

Despite the uncertain future of abortion access in Arizona, Robin still plans on moving there after her fellowship, but she hopes to travel to surrounding states to help provide abortion care where it’s less restricted. Even if she isn’t able to provide abortions at all, she says that there are still ways to help patients get safe, above-board abortions so as not to repeat the dangerous and often gruesome outcomes of self-induced abortions or those done by illegitimate practitioners before Roe.

“One of the roles that I think I can have as a physician is helping people with wraparound care for self-managed abortion,” says Robin. “If they can get the [abortion] pills online, then I can do the ultrasound beforehand, I can do the ultrasound after, I can talk them through it. I can help them with all the aspects of this care, I just can’t give them the pills myself.”

Whether a doctor can be penalized for “aiding and abetting” abortions that happen in different states remains an open question. In Texas, for example, Senate Bill 8 – which took effect Sept. 1, 2021 – not only established a fetal heartbeat law but added language that would allow private citizens to sue anyone who “knowingly engages in conduct that aids or abets the performance or inducement of an abortion” or anyone who even intends to do so.

That’s what happened to Alan Braid, MD, an ob.gyn. based in San Antonio. He confessed in a Washington Post op-ed that he had performed an abortion after cardiac activity had been detected in the pregnancy. Aware of the legal risks, he has since been sued by three people, and those cases are still underway.

But Ms. Ziegler says the chances of a doctor from a progressive state actually getting extradited and prosecuted by a state with restrictive abortion laws is pretty low – not zero, but low.

Like Robin, Natalie – an ob.gyn. in her early 30s – is a complex family planning fellow in Massachusetts. After her fellowship, she wants to return to Texas, where she completed her residency training.

“I’m at the point in my training where everyone starts looking for jobs and figuring out their next steps,” says Natalie. “The Dobbs decision introduced a ton of chaos due to the vagueness in the laws and how they get enforced, and then there’s chaos within institutions themselves and what kind of risk tolerance they have.”

Looking towards her future career path, Natalie says that she would not consider a job at an institution that didn’t allow her to teach abortion care to students, speak publicly about abortion rights, or let her travel outside of Texas to continue providing abortion care. She’s also preemptively seeking legal counsel and general guidance – advice that Ms. Ziegler strongly urges doctors to heed, sooner rather than later.

In states that have strict abortion bans with exceptions for life-threatening cases, there is still a lack of clarity around what is actually considered life-threatening enough to pass as an exception.

“Is it life-threatening in the next 6 hours? 24 hours? Seven days? One month?” Robin asks. “In medicine, we don’t necessarily talk about if something is life-threatening or not, we just say that there’s a high risk of X thing happening in X period of time. What’s the threshold at which that meets legal criteria? Nobody has an answer for that.”

Robin explains that, in her patients who have cancer, a pregnancy wouldn’t “necessarily kill them within the span of the next 9 months, but it could certainly accelerate their disease that could kill them within the next year or two.”

Right now, she says she doesn’t know what she would do if and when she is put in that position as a doctor.

“I didn’t go to medical school and become a doctor to become a felon,” says Robin. “Our goal is to make as many legal changes as we can to protect our patients and then practice as much harm reduction and as much care as we can within the letter of the law.”

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

The names of the doctors in this story have been changed at their request because of fear of legal repercussions and/or professional retaliation.

When an Ohio ob.gyn. had a patient in need of an abortion in July 2022, he knew he had to move quickly.

Daniel, who also sees patients at an abortion clinic, was treating a woman who came in for an abortion around 5 weeks into her pregnancy. And after going through the mandatory waiting periods, the required ultrasounds at each appointment, the consent process, and the options counseling, she was set for a surgical abortion the following Monday.

But on Monday, pre-op tests showed that her blood pressure was very high, posing a serious health risk if Daniel proceeded with the surgery.

Before the Supreme Court overturned Roe v. Wade in June, Daniel would have sent the patient home with instructions on how to lower her blood pressure over time. But the patient now had just four days to show the necessary improvement.

In this case, everything worked out. The patient returned Thursday and was able to have the procedure. But this is just one of the many day-to-day medical decisions abortion providers are now having to make with the changing legal risks being as top-of-mind to doctors as the safety of their patients.

Daniel said he doesn’t want the Ohio abortion law to change the way he communicates with his patients. As far as he knows, it’s still legal to talk to patients about self-managed abortions, as long as everything is unbiased and clearly stated, he says.

“But I don’t think I would get a lot of institutional support to have those conversations with patients because of the perceived legal liability,” says Daniel. “I will still have those conversations, but I’m not going to tell my employer that I’m having them and I’m not going to document them in the chart.”

Daniel is aware that having these kinds of discussions, or entertaining the possibility of omitting certain information from patient records, runs the risk of legal and professional consequences. Enforcement of these rules is foggy, too.

Under the Ohio law, if a fellow staff member suspects you of violating a law, you could be reported to a supervisor or licensing body. Abortion providers are aware they must be cautious about what they say because anti-abortion activitists, posing as patients, have secretly recorded conversations in the past, Daniel says.
 

Enforcement: The past, present, and future legal risks

Before Roe, enforcement of illegal abortion was spotty, says Mary Ziegler, JD, a professor at Florida State University College of Law, who specializes in the legal history of reproductive rights. At the start of the late 19th century, the doctors who provided illegal abortions would, in most cases, be prosecuted if a patient died as a result of the procedure.

A doctor in Ashland, Pa., named Robert Spencer was known for providing abortions in the small mining town where he practiced in the 1920s. He was reportedly arrested three times – once after a patient died as a result of abortion complications – but was ultimately acquitted.

For many doctors performing abortions at the time, “it was very much a kind of roll of the dice,” Ms. Ziegler says. “There was a sense that these laws were not enforced very much.”

Carole Joffe, PhD, a sociologist with expertise in reproductive health, recalls that there were very few doctors arrested, given the sheer number of abortions that were performed. The American College of Obstetricians and Gynecologists estimates that, in the years leading up to the original Roe decision, about 1.2 million women in the U.S. had illegal abortions – a number that exceeds today’s estimates.

Among the most notable cases of a doctor being detained was the arrest of gynecologist Jane Hodgson, MD, in 1970. Dr. Hodgson intentionally violated Minnesota law, which prohibited all abortions except in cases that were life-threatening to the patient.

After performing an abortion on a patient who had contracted rubella, also known as German measles, Dr. Hodgson was arrested, sentenced to 30 days in jail, and put on a year-long probation. She did not end up serving any time in jail, and her conviction was overturned after the Roe decision in 1973.

Now, the abortion restrictions being passed in many states have authorized much more sweeping penalties than those that existed in the pre-Roe era. According to Joffe, there is one key reason why we can anticipate more doctor arrests now.

“There simply was not the modern anti-abortion movement that we have come to know,” she says. “In the old days, there was not that much legal surveillance, and things were very unsafe. Fast forward to the present, we have much safer options now – like medication abortion pills – but we have a very different legal environment.”

Carmel Shachar, JD, MPH, a law and health policy expert at Harvard Law School, also expects that we will see more frequent prosecutions of doctors who provide abortion.

“There’s so much more data available through medical record-keeping and information generated by our phones and internet searches, that I think it would be much harder for a physician to fly under the radar,” Ms. Shachar says.

Also, Ms. Shachar emphasizes the power of prosecutorial discretion in abortion cases, where one prosecutor may choose to apply a law much more aggressively than another prosecutor in the next county over. Such has been seen in DeKalb County, Ga., which includes parts of Atlanta, where District Attorney Sherry Boston says she plans to use her prosecutorial discretion to address crimes like rape and murder, rather than “potentially investigat[ing] women and doctors for medical decisions,” Bloomberg Law reported. State Sen. Jen Jordan, the Democratic nominee for Georgia attorney general, has also said that, if elected, she would not enforce the state’s new 6-week abortion ban.
 

Is there a legal path forward for abortion care in states that forbid it?

Robin, an ob.gyn., became a complex family planning fellow in Utah to seek out further medical training and education in abortion care. Her plan was to solidify this as an area of expertise, so that, upon completing her fellowship, she could move back to her home state of Arizona to provide services there.

In Utah, where she currently practices, abortion is banned after 18 weeks. In Arizona, abortion is still allowed up to 24-26 weeks, until a pregnancy reaches “viability” (when a fetus is developed enough that it is able to survive outside the uterus with medical assistance). But new restrictions in Arizona may go into effect as early as September which would prohibit abortions after 15 weeks.

Despite the uncertain future of abortion access in Arizona, Robin still plans on moving there after her fellowship, but she hopes to travel to surrounding states to help provide abortion care where it’s less restricted. Even if she isn’t able to provide abortions at all, she says that there are still ways to help patients get safe, above-board abortions so as not to repeat the dangerous and often gruesome outcomes of self-induced abortions or those done by illegitimate practitioners before Roe.

“One of the roles that I think I can have as a physician is helping people with wraparound care for self-managed abortion,” says Robin. “If they can get the [abortion] pills online, then I can do the ultrasound beforehand, I can do the ultrasound after, I can talk them through it. I can help them with all the aspects of this care, I just can’t give them the pills myself.”

Whether a doctor can be penalized for “aiding and abetting” abortions that happen in different states remains an open question. In Texas, for example, Senate Bill 8 – which took effect Sept. 1, 2021 – not only established a fetal heartbeat law but added language that would allow private citizens to sue anyone who “knowingly engages in conduct that aids or abets the performance or inducement of an abortion” or anyone who even intends to do so.

That’s what happened to Alan Braid, MD, an ob.gyn. based in San Antonio. He confessed in a Washington Post op-ed that he had performed an abortion after cardiac activity had been detected in the pregnancy. Aware of the legal risks, he has since been sued by three people, and those cases are still underway.

But Ms. Ziegler says the chances of a doctor from a progressive state actually getting extradited and prosecuted by a state with restrictive abortion laws is pretty low – not zero, but low.

Like Robin, Natalie – an ob.gyn. in her early 30s – is a complex family planning fellow in Massachusetts. After her fellowship, she wants to return to Texas, where she completed her residency training.

“I’m at the point in my training where everyone starts looking for jobs and figuring out their next steps,” says Natalie. “The Dobbs decision introduced a ton of chaos due to the vagueness in the laws and how they get enforced, and then there’s chaos within institutions themselves and what kind of risk tolerance they have.”

Looking towards her future career path, Natalie says that she would not consider a job at an institution that didn’t allow her to teach abortion care to students, speak publicly about abortion rights, or let her travel outside of Texas to continue providing abortion care. She’s also preemptively seeking legal counsel and general guidance – advice that Ms. Ziegler strongly urges doctors to heed, sooner rather than later.

In states that have strict abortion bans with exceptions for life-threatening cases, there is still a lack of clarity around what is actually considered life-threatening enough to pass as an exception.

“Is it life-threatening in the next 6 hours? 24 hours? Seven days? One month?” Robin asks. “In medicine, we don’t necessarily talk about if something is life-threatening or not, we just say that there’s a high risk of X thing happening in X period of time. What’s the threshold at which that meets legal criteria? Nobody has an answer for that.”

Robin explains that, in her patients who have cancer, a pregnancy wouldn’t “necessarily kill them within the span of the next 9 months, but it could certainly accelerate their disease that could kill them within the next year or two.”

Right now, she says she doesn’t know what she would do if and when she is put in that position as a doctor.

“I didn’t go to medical school and become a doctor to become a felon,” says Robin. “Our goal is to make as many legal changes as we can to protect our patients and then practice as much harm reduction and as much care as we can within the letter of the law.”

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

The names of the doctors in this story have been changed at their request because of fear of legal repercussions and/or professional retaliation.

When an Ohio ob.gyn. had a patient in need of an abortion in July 2022, he knew he had to move quickly.

Daniel, who also sees patients at an abortion clinic, was treating a woman who came in for an abortion around 5 weeks into her pregnancy. And after going through the mandatory waiting periods, the required ultrasounds at each appointment, the consent process, and the options counseling, she was set for a surgical abortion the following Monday.

But on Monday, pre-op tests showed that her blood pressure was very high, posing a serious health risk if Daniel proceeded with the surgery.

Before the Supreme Court overturned Roe v. Wade in June, Daniel would have sent the patient home with instructions on how to lower her blood pressure over time. But the patient now had just four days to show the necessary improvement.

In this case, everything worked out. The patient returned Thursday and was able to have the procedure. But this is just one of the many day-to-day medical decisions abortion providers are now having to make with the changing legal risks being as top-of-mind to doctors as the safety of their patients.

Daniel said he doesn’t want the Ohio abortion law to change the way he communicates with his patients. As far as he knows, it’s still legal to talk to patients about self-managed abortions, as long as everything is unbiased and clearly stated, he says.

“But I don’t think I would get a lot of institutional support to have those conversations with patients because of the perceived legal liability,” says Daniel. “I will still have those conversations, but I’m not going to tell my employer that I’m having them and I’m not going to document them in the chart.”

Daniel is aware that having these kinds of discussions, or entertaining the possibility of omitting certain information from patient records, runs the risk of legal and professional consequences. Enforcement of these rules is foggy, too.

Under the Ohio law, if a fellow staff member suspects you of violating a law, you could be reported to a supervisor or licensing body. Abortion providers are aware they must be cautious about what they say because anti-abortion activitists, posing as patients, have secretly recorded conversations in the past, Daniel says.
 

Enforcement: The past, present, and future legal risks

Before Roe, enforcement of illegal abortion was spotty, says Mary Ziegler, JD, a professor at Florida State University College of Law, who specializes in the legal history of reproductive rights. At the start of the late 19th century, the doctors who provided illegal abortions would, in most cases, be prosecuted if a patient died as a result of the procedure.

A doctor in Ashland, Pa., named Robert Spencer was known for providing abortions in the small mining town where he practiced in the 1920s. He was reportedly arrested three times – once after a patient died as a result of abortion complications – but was ultimately acquitted.

For many doctors performing abortions at the time, “it was very much a kind of roll of the dice,” Ms. Ziegler says. “There was a sense that these laws were not enforced very much.”

Carole Joffe, PhD, a sociologist with expertise in reproductive health, recalls that there were very few doctors arrested, given the sheer number of abortions that were performed. The American College of Obstetricians and Gynecologists estimates that, in the years leading up to the original Roe decision, about 1.2 million women in the U.S. had illegal abortions – a number that exceeds today’s estimates.

Among the most notable cases of a doctor being detained was the arrest of gynecologist Jane Hodgson, MD, in 1970. Dr. Hodgson intentionally violated Minnesota law, which prohibited all abortions except in cases that were life-threatening to the patient.

After performing an abortion on a patient who had contracted rubella, also known as German measles, Dr. Hodgson was arrested, sentenced to 30 days in jail, and put on a year-long probation. She did not end up serving any time in jail, and her conviction was overturned after the Roe decision in 1973.

Now, the abortion restrictions being passed in many states have authorized much more sweeping penalties than those that existed in the pre-Roe era. According to Joffe, there is one key reason why we can anticipate more doctor arrests now.

“There simply was not the modern anti-abortion movement that we have come to know,” she says. “In the old days, there was not that much legal surveillance, and things were very unsafe. Fast forward to the present, we have much safer options now – like medication abortion pills – but we have a very different legal environment.”

Carmel Shachar, JD, MPH, a law and health policy expert at Harvard Law School, also expects that we will see more frequent prosecutions of doctors who provide abortion.

“There’s so much more data available through medical record-keeping and information generated by our phones and internet searches, that I think it would be much harder for a physician to fly under the radar,” Ms. Shachar says.

Also, Ms. Shachar emphasizes the power of prosecutorial discretion in abortion cases, where one prosecutor may choose to apply a law much more aggressively than another prosecutor in the next county over. Such has been seen in DeKalb County, Ga., which includes parts of Atlanta, where District Attorney Sherry Boston says she plans to use her prosecutorial discretion to address crimes like rape and murder, rather than “potentially investigat[ing] women and doctors for medical decisions,” Bloomberg Law reported. State Sen. Jen Jordan, the Democratic nominee for Georgia attorney general, has also said that, if elected, she would not enforce the state’s new 6-week abortion ban.
 

Is there a legal path forward for abortion care in states that forbid it?

Robin, an ob.gyn., became a complex family planning fellow in Utah to seek out further medical training and education in abortion care. Her plan was to solidify this as an area of expertise, so that, upon completing her fellowship, she could move back to her home state of Arizona to provide services there.

In Utah, where she currently practices, abortion is banned after 18 weeks. In Arizona, abortion is still allowed up to 24-26 weeks, until a pregnancy reaches “viability” (when a fetus is developed enough that it is able to survive outside the uterus with medical assistance). But new restrictions in Arizona may go into effect as early as September which would prohibit abortions after 15 weeks.

Despite the uncertain future of abortion access in Arizona, Robin still plans on moving there after her fellowship, but she hopes to travel to surrounding states to help provide abortion care where it’s less restricted. Even if she isn’t able to provide abortions at all, she says that there are still ways to help patients get safe, above-board abortions so as not to repeat the dangerous and often gruesome outcomes of self-induced abortions or those done by illegitimate practitioners before Roe.

“One of the roles that I think I can have as a physician is helping people with wraparound care for self-managed abortion,” says Robin. “If they can get the [abortion] pills online, then I can do the ultrasound beforehand, I can do the ultrasound after, I can talk them through it. I can help them with all the aspects of this care, I just can’t give them the pills myself.”

Whether a doctor can be penalized for “aiding and abetting” abortions that happen in different states remains an open question. In Texas, for example, Senate Bill 8 – which took effect Sept. 1, 2021 – not only established a fetal heartbeat law but added language that would allow private citizens to sue anyone who “knowingly engages in conduct that aids or abets the performance or inducement of an abortion” or anyone who even intends to do so.

That’s what happened to Alan Braid, MD, an ob.gyn. based in San Antonio. He confessed in a Washington Post op-ed that he had performed an abortion after cardiac activity had been detected in the pregnancy. Aware of the legal risks, he has since been sued by three people, and those cases are still underway.

But Ms. Ziegler says the chances of a doctor from a progressive state actually getting extradited and prosecuted by a state with restrictive abortion laws is pretty low – not zero, but low.

Like Robin, Natalie – an ob.gyn. in her early 30s – is a complex family planning fellow in Massachusetts. After her fellowship, she wants to return to Texas, where she completed her residency training.

“I’m at the point in my training where everyone starts looking for jobs and figuring out their next steps,” says Natalie. “The Dobbs decision introduced a ton of chaos due to the vagueness in the laws and how they get enforced, and then there’s chaos within institutions themselves and what kind of risk tolerance they have.”

Looking towards her future career path, Natalie says that she would not consider a job at an institution that didn’t allow her to teach abortion care to students, speak publicly about abortion rights, or let her travel outside of Texas to continue providing abortion care. She’s also preemptively seeking legal counsel and general guidance – advice that Ms. Ziegler strongly urges doctors to heed, sooner rather than later.

In states that have strict abortion bans with exceptions for life-threatening cases, there is still a lack of clarity around what is actually considered life-threatening enough to pass as an exception.

“Is it life-threatening in the next 6 hours? 24 hours? Seven days? One month?” Robin asks. “In medicine, we don’t necessarily talk about if something is life-threatening or not, we just say that there’s a high risk of X thing happening in X period of time. What’s the threshold at which that meets legal criteria? Nobody has an answer for that.”

Robin explains that, in her patients who have cancer, a pregnancy wouldn’t “necessarily kill them within the span of the next 9 months, but it could certainly accelerate their disease that could kill them within the next year or two.”

Right now, she says she doesn’t know what she would do if and when she is put in that position as a doctor.

“I didn’t go to medical school and become a doctor to become a felon,” says Robin. “Our goal is to make as many legal changes as we can to protect our patients and then practice as much harm reduction and as much care as we can within the letter of the law.”

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

On the 50th anniversary of Title IX’s inception, the Biden administration has proposed changes to the law that would protect transgender students and assault survivors on college and university campuses.

With these changes, the protections provided by Title IX – a civil rights law that prohibits sex-based discrimination in schools that receive federal funding – would now be extended to students who identify as trans. The update would ensure that government-funded schools make proper accommodations for a trans student population, such as allowing students to use bathrooms and other facilities that align with their gender identity, and enforcing the use of students’ correct pronouns.

The revisions also seek to undo amendments made to the law by Betsy DeVos, who was secretary of education during the Trump presidency, which strengthened due process protections for students accused of sexual assault and narrowed the definition of sexual harassment. These rules “weakened protections for survivors of sexual assault and diminished the promise of an education free from discrimination,” the Biden administration said.

[embed:render:related:node:255430]

“Our proposed changes will allow us to continue that progress and ensure all our nation’s students – no matter where they live, who they are, or whom they love – can learn, grow, and thrive in school,” Education Secretary Miguel Cardona, PhD, said in a news release. “We welcome public comment on these critical regulations so we can further the Biden-Harris Administration’s mission of creating educational environments free from sex discrimination and sexual violence.”

The revisions will go through a long period of public comment before they are set into law. Still, the proposed changes mark a way forward for trans students who are not explicitly protected under Title IX, and they offer solace to assault survivors who may have felt discouraged to come forward and report under Ms. DeVos’s rules.

“The proposed regulations reflect the [Education] Department’s commitment to give full effect to Title IX, ensuring that no person experiences sex discrimination in education, and that school procedures for addressing complaints of sex discrimination, including sexual violence and other forms of sex-based harassment, are clear, effective, and fair to all involved,” said Catherine Lhamon, JD, assistant secretary for the Education Department’s Office Of Civil Rights.

More specific rules about transgender students’ participation in school sports are still to come.

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

On the 50th anniversary of Title IX’s inception, the Biden administration has proposed changes to the law that would protect transgender students and assault survivors on college and university campuses.

With these changes, the protections provided by Title IX – a civil rights law that prohibits sex-based discrimination in schools that receive federal funding – would now be extended to students who identify as trans. The update would ensure that government-funded schools make proper accommodations for a trans student population, such as allowing students to use bathrooms and other facilities that align with their gender identity, and enforcing the use of students’ correct pronouns.

The revisions also seek to undo amendments made to the law by Betsy DeVos, who was secretary of education during the Trump presidency, which strengthened due process protections for students accused of sexual assault and narrowed the definition of sexual harassment. These rules “weakened protections for survivors of sexual assault and diminished the promise of an education free from discrimination,” the Biden administration said.

[embed:render:related:node:255430]

“Our proposed changes will allow us to continue that progress and ensure all our nation’s students – no matter where they live, who they are, or whom they love – can learn, grow, and thrive in school,” Education Secretary Miguel Cardona, PhD, said in a news release. “We welcome public comment on these critical regulations so we can further the Biden-Harris Administration’s mission of creating educational environments free from sex discrimination and sexual violence.”

The revisions will go through a long period of public comment before they are set into law. Still, the proposed changes mark a way forward for trans students who are not explicitly protected under Title IX, and they offer solace to assault survivors who may have felt discouraged to come forward and report under Ms. DeVos’s rules.

“The proposed regulations reflect the [Education] Department’s commitment to give full effect to Title IX, ensuring that no person experiences sex discrimination in education, and that school procedures for addressing complaints of sex discrimination, including sexual violence and other forms of sex-based harassment, are clear, effective, and fair to all involved,” said Catherine Lhamon, JD, assistant secretary for the Education Department’s Office Of Civil Rights.

More specific rules about transgender students’ participation in school sports are still to come.

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

On the 50th anniversary of Title IX’s inception, the Biden administration has proposed changes to the law that would protect transgender students and assault survivors on college and university campuses.

With these changes, the protections provided by Title IX – a civil rights law that prohibits sex-based discrimination in schools that receive federal funding – would now be extended to students who identify as trans. The update would ensure that government-funded schools make proper accommodations for a trans student population, such as allowing students to use bathrooms and other facilities that align with their gender identity, and enforcing the use of students’ correct pronouns.

The revisions also seek to undo amendments made to the law by Betsy DeVos, who was secretary of education during the Trump presidency, which strengthened due process protections for students accused of sexual assault and narrowed the definition of sexual harassment. These rules “weakened protections for survivors of sexual assault and diminished the promise of an education free from discrimination,” the Biden administration said.

[embed:render:related:node:255430]

“Our proposed changes will allow us to continue that progress and ensure all our nation’s students – no matter where they live, who they are, or whom they love – can learn, grow, and thrive in school,” Education Secretary Miguel Cardona, PhD, said in a news release. “We welcome public comment on these critical regulations so we can further the Biden-Harris Administration’s mission of creating educational environments free from sex discrimination and sexual violence.”

The revisions will go through a long period of public comment before they are set into law. Still, the proposed changes mark a way forward for trans students who are not explicitly protected under Title IX, and they offer solace to assault survivors who may have felt discouraged to come forward and report under Ms. DeVos’s rules.

“The proposed regulations reflect the [Education] Department’s commitment to give full effect to Title IX, ensuring that no person experiences sex discrimination in education, and that school procedures for addressing complaints of sex discrimination, including sexual violence and other forms of sex-based harassment, are clear, effective, and fair to all involved,” said Catherine Lhamon, JD, assistant secretary for the Education Department’s Office Of Civil Rights.

More specific rules about transgender students’ participation in school sports are still to come.

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

The Food and Drug Administration has expanded an emergency use authorization (EUA), allowing the Pfizer-BioNTech COVID-19 booster shot for children ages 5 to 11 who are at least 5 months out from their first vaccine series.

FDA_icon3_web.jpg

According to the most recent data from the Centers for Disease Control and Prevention, 28.6% of children in this age group have received both initial doses of Pfizer’s COVID-19 vaccine, and 35.3% have received their first dose.

Pfizer’s vaccine trial involving 4,500 children showed few side effects among children younger than 12 who received a booster, or third dose, according to a company statement.

Pfizer asked the FDA for an amended authorization in April, after submitting data showing that a third dose in children between 5 and 11 raised antibodies targeting the Omicron variant by 36 times.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,” FDA Commissioner Robert M. Califf, MD, said in a news release.

A study done by the New York State Department of Health showed the effectiveness of Pfizer’s two-dose vaccine series fell from 68% to 12% 4-5 months after the second dose was given to children 5 to 11 during the Omicron surge. A CDC study published in March also showed that the Pfizer shot reduced the risk of Omicron by 31% in children 5 to 11, a significantly lower rate than for kids 12 to 15, who had a 59% risk reduction after receiving two doses.

To some experts, this data suggest an even greater need for children under 12 to be eligible for a third dose.

“Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” says Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research.

The CDC still needs to sign off on the shots before they can be allowed. The agency’s Advisory Committee on Immunization Practices is set to meet on May 19 to discuss boosters in this age group.

FDA advisory panels plan to meet next month to discuss allowing Pfizer’s and Moderna’s COVID-19 vaccines for children under 6 years old.

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

The Food and Drug Administration has expanded an emergency use authorization (EUA), allowing the Pfizer-BioNTech COVID-19 booster shot for children ages 5 to 11 who are at least 5 months out from their first vaccine series.

FDA_icon3_web.jpg

According to the most recent data from the Centers for Disease Control and Prevention, 28.6% of children in this age group have received both initial doses of Pfizer’s COVID-19 vaccine, and 35.3% have received their first dose.

Pfizer’s vaccine trial involving 4,500 children showed few side effects among children younger than 12 who received a booster, or third dose, according to a company statement.

Pfizer asked the FDA for an amended authorization in April, after submitting data showing that a third dose in children between 5 and 11 raised antibodies targeting the Omicron variant by 36 times.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,” FDA Commissioner Robert M. Califf, MD, said in a news release.

A study done by the New York State Department of Health showed the effectiveness of Pfizer’s two-dose vaccine series fell from 68% to 12% 4-5 months after the second dose was given to children 5 to 11 during the Omicron surge. A CDC study published in March also showed that the Pfizer shot reduced the risk of Omicron by 31% in children 5 to 11, a significantly lower rate than for kids 12 to 15, who had a 59% risk reduction after receiving two doses.

To some experts, this data suggest an even greater need for children under 12 to be eligible for a third dose.

“Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” says Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research.

The CDC still needs to sign off on the shots before they can be allowed. The agency’s Advisory Committee on Immunization Practices is set to meet on May 19 to discuss boosters in this age group.

FDA advisory panels plan to meet next month to discuss allowing Pfizer’s and Moderna’s COVID-19 vaccines for children under 6 years old.

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

The Food and Drug Administration has expanded an emergency use authorization (EUA), allowing the Pfizer-BioNTech COVID-19 booster shot for children ages 5 to 11 who are at least 5 months out from their first vaccine series.

FDA_icon3_web.jpg

According to the most recent data from the Centers for Disease Control and Prevention, 28.6% of children in this age group have received both initial doses of Pfizer’s COVID-19 vaccine, and 35.3% have received their first dose.

Pfizer’s vaccine trial involving 4,500 children showed few side effects among children younger than 12 who received a booster, or third dose, according to a company statement.

Pfizer asked the FDA for an amended authorization in April, after submitting data showing that a third dose in children between 5 and 11 raised antibodies targeting the Omicron variant by 36 times.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,” FDA Commissioner Robert M. Califf, MD, said in a news release.

A study done by the New York State Department of Health showed the effectiveness of Pfizer’s two-dose vaccine series fell from 68% to 12% 4-5 months after the second dose was given to children 5 to 11 during the Omicron surge. A CDC study published in March also showed that the Pfizer shot reduced the risk of Omicron by 31% in children 5 to 11, a significantly lower rate than for kids 12 to 15, who had a 59% risk reduction after receiving two doses.

To some experts, this data suggest an even greater need for children under 12 to be eligible for a third dose.

“Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” says Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research.

The CDC still needs to sign off on the shots before they can be allowed. The agency’s Advisory Committee on Immunization Practices is set to meet on May 19 to discuss boosters in this age group.

FDA advisory panels plan to meet next month to discuss allowing Pfizer’s and Moderna’s COVID-19 vaccines for children under 6 years old.

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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