MDedge ObGyn

Like many colleagues, I have been working to change the minds and behaviors of acquaintances and patients who are opting to forgo a COVID vaccine. The large numbers of these unvaccinated Americans, combined with the surging Delta coronavirus variant, are endangering the health of us all.

When I spoke with the 22-year-old daughter of a family friend about what was holding her back, she told me that she would “never” get vaccinated. I shared my vaccination experience and told her that, except for a sore arm both times for a day, I felt no side effects. Likewise, I said, all of my adult family members are vaccinated, and everyone is fine. She was neither moved nor convinced.

Finally, I asked her whether she attended school (knowing that she was a college graduate), and she said “yes.” So I told her that all 50 states require children attending public schools to be vaccinated for diseases such as diphtheria, tetanus, polio, and the chickenpox – with certain religious, philosophical, and medical exemptions. Her response was simple: “I didn’t know that. Anyway, my parents were in charge.” Suddenly, her thinking shifted. “You’re right,” she said. She got a COVID shot the next day. Success for me.

When I asked another acquaintance whether he’d been vaccinated, he said he’d heard people were getting very sick from the vaccine – and was going to wait. Another gentleman I spoke with said that, at age 45, he was healthy. Besides, he added, he “doesn’t get sick.” When I asked another acquaintance about her vaccination status, her retort was that this was none of my business. So far, I’m batting about .300.

But as a physician, I believe that we – and other health care providers – must continue to encourage the people in our lives to care for themselves and others by getting vaccinated. One concrete step advised by the Centers for Disease Control and Prevention is to help people make an appointment for a shot. Some sites no longer require appointments, and New York City, for example, offers in-home vaccinations to all NYC residents.

Also, NYC Mayor Bill de Blasio announced Aug. 3 the “Key to NYC Pass,” which he called a “first-in-the-nation approach” to vaccination. Under this new policy, vaccine-eligible people aged 12 and older in New York City will need to prove with a vaccination card, an app, or an Excelsior Pass that they have received at least one dose of vaccine before participating in indoor venues such as restaurants, bars, gyms, and movie theaters within the city. Mayor de Blasio said the new initiative, which is still being finalized, will be phased in starting the week of Aug. 16. I see this as a major public health measure that will keep people healthy – and get them vaccinated.

The medical community should support this move by the city of New York and encourage people to follow CDC guidance on wearing face coverings in public settings, especially schools. New research shows that physicians continue to be among the most trusted sources of vaccine-related information.

Another strategy we might use is to point to the longtime practices of surgeons. We could ask: Why do surgeons wear face masks in the operating room? For years, these coverings have been used to protect patients from the nasal and oral bacteria generated by operating room staff. Likewise, we can tell those who remain on the fence that, by wearing face masks, we are protecting others from all variants, but specifically from Delta – which the CDC now says can be transmitted by people who are fully vaccinated.

Why did the CDC lift face mask guidance for fully vaccinated people in indoor spaces in May? It was clear to me and other colleagues back then that this was not a good idea. Despite that guidance, I continued to wear a mask in public places and advised anyone who would listen to do the same.

The development of vaccines in the 20th and 21st centuries has saved millions of lives. The World Health Organization reports that 4 million to 5 million lives a year are saved by immunizations. In addition, research shows that, before the emergence of SARS-CoV-2, vaccinations led to the eradication of smallpox and polio, and a 74% drop in measles-related deaths between 2004 and 2014.
 

Protecting the most vulnerable

With COVID cases surging, particularly in parts of the South and Midwest, I am concerned about children under age 12 who do not yet qualify for a vaccine. Certainly, unvaccinated parents could spread the virus to their young children, and unvaccinated children could transmit the illness to immediate and extended family. Now that the CDC has said that there is a risk of SARS-CoV-2 breakthrough infection among fully vaccinated people in areas with high community transmission, should we worry about unvaccinated young children with vaccinated parents? I recently spoke with James C. Fagin, MD, a board-certified pediatrician and immunologist, to get his views on this issue.

Dr. Fagin, who is retired, said he is in complete agreement with the Food and Drug Administration when it comes to approving medications for children. However, given the seriousness of the pandemic and the need to get our children back to in-person learning, he would like to see the approval process safely expedited. Large numbers of unvaccinated people increase the pool for the Delta variant and could increase the likelihood of a new variant that is more resistant to the vaccines, said Dr. Fagin, former chief of academic pediatrics at North Shore University Hospital and a former faculty member in the allergy/immunology division of Cohen Children’s Medical Center, both in New York.

Meanwhile, I agree with the American Academy of Pediatrics’ recommendations that children, teachers, and school staff and other adults in school settings should wear masks regardless of vaccination status. Kids adjust well to masks – as my grandchildren and their friends have.

The bottom line is that we need to get as many people as possible vaccinated as soon as possible, and while doing so, we must continue to wear face coverings in public spaces. As clinicians, we have a special responsibility to do all that we can to change minds – and behaviors.

Dr. London is a practicing psychiatrist who has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

Like many colleagues, I have been working to change the minds and behaviors of acquaintances and patients who are opting to forgo a COVID vaccine. The large numbers of these unvaccinated Americans, combined with the surging Delta coronavirus variant, are endangering the health of us all.

When I spoke with the 22-year-old daughter of a family friend about what was holding her back, she told me that she would “never” get vaccinated. I shared my vaccination experience and told her that, except for a sore arm both times for a day, I felt no side effects. Likewise, I said, all of my adult family members are vaccinated, and everyone is fine. She was neither moved nor convinced.

Finally, I asked her whether she attended school (knowing that she was a college graduate), and she said “yes.” So I told her that all 50 states require children attending public schools to be vaccinated for diseases such as diphtheria, tetanus, polio, and the chickenpox – with certain religious, philosophical, and medical exemptions. Her response was simple: “I didn’t know that. Anyway, my parents were in charge.” Suddenly, her thinking shifted. “You’re right,” she said. She got a COVID shot the next day. Success for me.

When I asked another acquaintance whether he’d been vaccinated, he said he’d heard people were getting very sick from the vaccine – and was going to wait. Another gentleman I spoke with said that, at age 45, he was healthy. Besides, he added, he “doesn’t get sick.” When I asked another acquaintance about her vaccination status, her retort was that this was none of my business. So far, I’m batting about .300.

But as a physician, I believe that we – and other health care providers – must continue to encourage the people in our lives to care for themselves and others by getting vaccinated. One concrete step advised by the Centers for Disease Control and Prevention is to help people make an appointment for a shot. Some sites no longer require appointments, and New York City, for example, offers in-home vaccinations to all NYC residents.

Also, NYC Mayor Bill de Blasio announced Aug. 3 the “Key to NYC Pass,” which he called a “first-in-the-nation approach” to vaccination. Under this new policy, vaccine-eligible people aged 12 and older in New York City will need to prove with a vaccination card, an app, or an Excelsior Pass that they have received at least one dose of vaccine before participating in indoor venues such as restaurants, bars, gyms, and movie theaters within the city. Mayor de Blasio said the new initiative, which is still being finalized, will be phased in starting the week of Aug. 16. I see this as a major public health measure that will keep people healthy – and get them vaccinated.

The medical community should support this move by the city of New York and encourage people to follow CDC guidance on wearing face coverings in public settings, especially schools. New research shows that physicians continue to be among the most trusted sources of vaccine-related information.

Another strategy we might use is to point to the longtime practices of surgeons. We could ask: Why do surgeons wear face masks in the operating room? For years, these coverings have been used to protect patients from the nasal and oral bacteria generated by operating room staff. Likewise, we can tell those who remain on the fence that, by wearing face masks, we are protecting others from all variants, but specifically from Delta – which the CDC now says can be transmitted by people who are fully vaccinated.

Why did the CDC lift face mask guidance for fully vaccinated people in indoor spaces in May? It was clear to me and other colleagues back then that this was not a good idea. Despite that guidance, I continued to wear a mask in public places and advised anyone who would listen to do the same.

The development of vaccines in the 20th and 21st centuries has saved millions of lives. The World Health Organization reports that 4 million to 5 million lives a year are saved by immunizations. In addition, research shows that, before the emergence of SARS-CoV-2, vaccinations led to the eradication of smallpox and polio, and a 74% drop in measles-related deaths between 2004 and 2014.
 

Protecting the most vulnerable

With COVID cases surging, particularly in parts of the South and Midwest, I am concerned about children under age 12 who do not yet qualify for a vaccine. Certainly, unvaccinated parents could spread the virus to their young children, and unvaccinated children could transmit the illness to immediate and extended family. Now that the CDC has said that there is a risk of SARS-CoV-2 breakthrough infection among fully vaccinated people in areas with high community transmission, should we worry about unvaccinated young children with vaccinated parents? I recently spoke with James C. Fagin, MD, a board-certified pediatrician and immunologist, to get his views on this issue.

Dr. Fagin, who is retired, said he is in complete agreement with the Food and Drug Administration when it comes to approving medications for children. However, given the seriousness of the pandemic and the need to get our children back to in-person learning, he would like to see the approval process safely expedited. Large numbers of unvaccinated people increase the pool for the Delta variant and could increase the likelihood of a new variant that is more resistant to the vaccines, said Dr. Fagin, former chief of academic pediatrics at North Shore University Hospital and a former faculty member in the allergy/immunology division of Cohen Children’s Medical Center, both in New York.

Meanwhile, I agree with the American Academy of Pediatrics’ recommendations that children, teachers, and school staff and other adults in school settings should wear masks regardless of vaccination status. Kids adjust well to masks – as my grandchildren and their friends have.

The bottom line is that we need to get as many people as possible vaccinated as soon as possible, and while doing so, we must continue to wear face coverings in public spaces. As clinicians, we have a special responsibility to do all that we can to change minds – and behaviors.

Dr. London is a practicing psychiatrist who has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

Like many colleagues, I have been working to change the minds and behaviors of acquaintances and patients who are opting to forgo a COVID vaccine. The large numbers of these unvaccinated Americans, combined with the surging Delta coronavirus variant, are endangering the health of us all.

When I spoke with the 22-year-old daughter of a family friend about what was holding her back, she told me that she would “never” get vaccinated. I shared my vaccination experience and told her that, except for a sore arm both times for a day, I felt no side effects. Likewise, I said, all of my adult family members are vaccinated, and everyone is fine. She was neither moved nor convinced.

Finally, I asked her whether she attended school (knowing that she was a college graduate), and she said “yes.” So I told her that all 50 states require children attending public schools to be vaccinated for diseases such as diphtheria, tetanus, polio, and the chickenpox – with certain religious, philosophical, and medical exemptions. Her response was simple: “I didn’t know that. Anyway, my parents were in charge.” Suddenly, her thinking shifted. “You’re right,” she said. She got a COVID shot the next day. Success for me.

When I asked another acquaintance whether he’d been vaccinated, he said he’d heard people were getting very sick from the vaccine – and was going to wait. Another gentleman I spoke with said that, at age 45, he was healthy. Besides, he added, he “doesn’t get sick.” When I asked another acquaintance about her vaccination status, her retort was that this was none of my business. So far, I’m batting about .300.

But as a physician, I believe that we – and other health care providers – must continue to encourage the people in our lives to care for themselves and others by getting vaccinated. One concrete step advised by the Centers for Disease Control and Prevention is to help people make an appointment for a shot. Some sites no longer require appointments, and New York City, for example, offers in-home vaccinations to all NYC residents.

Also, NYC Mayor Bill de Blasio announced Aug. 3 the “Key to NYC Pass,” which he called a “first-in-the-nation approach” to vaccination. Under this new policy, vaccine-eligible people aged 12 and older in New York City will need to prove with a vaccination card, an app, or an Excelsior Pass that they have received at least one dose of vaccine before participating in indoor venues such as restaurants, bars, gyms, and movie theaters within the city. Mayor de Blasio said the new initiative, which is still being finalized, will be phased in starting the week of Aug. 16. I see this as a major public health measure that will keep people healthy – and get them vaccinated.

The medical community should support this move by the city of New York and encourage people to follow CDC guidance on wearing face coverings in public settings, especially schools. New research shows that physicians continue to be among the most trusted sources of vaccine-related information.

Another strategy we might use is to point to the longtime practices of surgeons. We could ask: Why do surgeons wear face masks in the operating room? For years, these coverings have been used to protect patients from the nasal and oral bacteria generated by operating room staff. Likewise, we can tell those who remain on the fence that, by wearing face masks, we are protecting others from all variants, but specifically from Delta – which the CDC now says can be transmitted by people who are fully vaccinated.

Why did the CDC lift face mask guidance for fully vaccinated people in indoor spaces in May? It was clear to me and other colleagues back then that this was not a good idea. Despite that guidance, I continued to wear a mask in public places and advised anyone who would listen to do the same.

The development of vaccines in the 20th and 21st centuries has saved millions of lives. The World Health Organization reports that 4 million to 5 million lives a year are saved by immunizations. In addition, research shows that, before the emergence of SARS-CoV-2, vaccinations led to the eradication of smallpox and polio, and a 74% drop in measles-related deaths between 2004 and 2014.
 

Protecting the most vulnerable

With COVID cases surging, particularly in parts of the South and Midwest, I am concerned about children under age 12 who do not yet qualify for a vaccine. Certainly, unvaccinated parents could spread the virus to their young children, and unvaccinated children could transmit the illness to immediate and extended family. Now that the CDC has said that there is a risk of SARS-CoV-2 breakthrough infection among fully vaccinated people in areas with high community transmission, should we worry about unvaccinated young children with vaccinated parents? I recently spoke with James C. Fagin, MD, a board-certified pediatrician and immunologist, to get his views on this issue.

Dr. Fagin, who is retired, said he is in complete agreement with the Food and Drug Administration when it comes to approving medications for children. However, given the seriousness of the pandemic and the need to get our children back to in-person learning, he would like to see the approval process safely expedited. Large numbers of unvaccinated people increase the pool for the Delta variant and could increase the likelihood of a new variant that is more resistant to the vaccines, said Dr. Fagin, former chief of academic pediatrics at North Shore University Hospital and a former faculty member in the allergy/immunology division of Cohen Children’s Medical Center, both in New York.

Meanwhile, I agree with the American Academy of Pediatrics’ recommendations that children, teachers, and school staff and other adults in school settings should wear masks regardless of vaccination status. Kids adjust well to masks – as my grandchildren and their friends have.

The bottom line is that we need to get as many people as possible vaccinated as soon as possible, and while doing so, we must continue to wear face coverings in public spaces. As clinicians, we have a special responsibility to do all that we can to change minds – and behaviors.

Dr. London is a practicing psychiatrist who has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

Internal Centers for Disease Control and Prevention documents support the high transmission rate of the Delta variant and put the risk in easier to understand terms.

In addition, the agency released a new study that shows that breakthrough infections in the vaccinated make people about as contagious as those who are unvaccinated. The new report, published July 30 in Morbidity and Mortality Weekly Report (MMWR), also reveals that the Delta variant likely causes more severe COVID-19 illness.

Given these recent findings, the internal CDC slide show advises that the agency  should “acknowledge the war has changed.”
 

A ‘pivotal discovery’

CDC Director Rochelle Walensky, MD, MPH, said in a statement that the MMWR report demonstrates “that [D]elta infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people.

“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with [D]elta can transmit the virus,” she added. “This finding is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation.”

The investigators analyzed 469 COVID-19 cases reported in Massachusetts residents July 3 through 17, 2021. The infections were associated with an outbreak following multiple events and large gatherings in Provincetown in that state’s easternmost Barnstable County, also known as Cape Cod.

Notably, 346 infections, or 74%, of the cases occurred in fully vaccinated individuals. This group had a median age of 42, and 87% were male. Also, 79% of the breakthrough infections were symptomatic.

Researchers also identified the Delta variant in 90% of 133 specimens collected for analysis. Furthermore, viral loads were about the same between samples taken from people who were fully vaccinated and those who were not.

Four of the five people hospitalized were fully vaccinated. No deaths were reported. 

The publication of these results was highly anticipated following the CDC’s updated mask recommendations on July 27.

Outside the scope of the MMWR report is the total number of cases associated with the outbreak, including visitors from outside Massachusetts, which now approach 900 infections, NBC Boston reported.
 

‘Very sobering’ data

“The new information from the CDC around the [D]elta variant is very sobering,” David Hirschwerk, MD, infectious disease specialist at Northwell Health in New Hyde Park, N.Y., said in an interview.

“The CDC is trying to convey and present this uncertain situation clearly to the public based on new, accumulated data,” he said. For example, given the evidence for higher contagiousness of the Delta variant, Dr. Hirschwerk added, “there will be situations where vaccinated people get infected, because the amount of the virus overwhelms the immune protection.

“What is new that is concerning is that people who are vaccinated still have the potential to transmit the virus to the same degree,” he said.

The MMWR study “helps us better understand the question related to whether or not a person who has completed a COVID-19 series can spread the infection,” agreed Michelle Barron, MD, a professor in the division of infectious disease at the University of Colorado, Aurora.

“The message is that, because the [D]elta variant is much more contagious than the original strain, unvaccinated persons need to get vaccinated because it is nearly impossible to avoid the virus indefinitely,” Michael Lin, MD, MPH, infectious diseases specialist and epidemiologist at Rush University Medical Center, Chicago, said when asked to comment.

The new data highlight “that vaccinated persons, if they become sick, should still seek COVID-19 testing and should still isolate, as they are likely contagious,” Dr. Lin added.
 

More contagious than other infections

The internal CDC slide presentation also puts the new transmission risk in simple terms. Saying that the Delta variant is about as contagious as chicken pox, for example, immediately brings back vivid memories for some of staying indoors and away from friends during childhood or teenage outbreaks.

“A lot of people will remember getting chicken pox and then having their siblings get it shortly thereafter,” Dr. Barron said. “The only key thing to note is that this does not mean that the COVID-19 [D]elta variant mechanism of spread is the same as chicken pox and Ebola. The primary means of spread of COVID-19, even the Delta variant, is via droplets.”

This also means each person infected with the Delta variant could infect an average of eight or nine others.

In contrast, the original strain of the SARS-CoV-2 virus was about as infectious as the common cold. In other words, someone was likely to infect about two other people on average.

In addition to the cold, the CDC notes that the Delta variant is now more contagious than Ebola, the seasonal flu, or small pox.

These Delta variant comparisons are one tangible way of explaining why the CDC on July 27 recommended a return to masking in schools and other indoor spaces for people – vaccinated and unvaccinated – in about 70% of the counties across the United States.

In comparing the Delta variant with other infections, “I think the CDC is trying to help people understand a little bit better the situation we now face since the information is so new. We are in a very different position now than just a few weeks ago, and it is hard for people to accept this,” Dr. Hirschwerk said.

The Delta variant is so different that the CDC considers it almost acting like a new virus altogether.

The CDC’s internal documents were first released by The Washington Post on July 29. The slides cite communication challenges for the agency to continue promoting vaccination while also acknowledging that breakthrough cases are occurring and therefore the fully vaccinated, in some instances, are likely infecting others.

Moving back to science talk, the CDC used the recent outbreak in Barnstable County as an example. The cycle threshold, or Ct values, a measure of viral load, were about the same between 80 vaccinated people linked to the outbreak who had a mean Ct value of 21.9, compared with 65 other unvaccinated people with a Ct of 21.5.

Many experts are quick to note that vaccination remains essential, in part because a vaccinated person also walks around with a much lower risk for severe outcomes, hospitalization, and death. In the internal slide show, the CDC points out that vaccination reduces the risk for infection threefold.

“Even with this high amount of virus, [the Delta variant] did not necessarily make the vaccinated individuals as sick,” Dr. Barron said.

In her statement, Dr. Walensky credited collaboration with the Commonwealth of Massachusetts Department of Public Health and the CDC for the new data. She also thanked the residents of Barnstable County for participating in interviews done by contact tracers and their willingness to get tested and adhere to safety protocols after learning of their exposure.
 

Next moves by CDC?

The agency notes that next steps include consideration of prevention measures such as vaccine mandates for healthcare professionals to protect vulnerable populations, universal masking for source control and prevention, and reconsidering other community mitigation strategies.

Asked if this potential policy is appropriate and feasible, Dr. Lin said, “Yes, I believe that every person working in health care should be vaccinated for COVID-19, and it is feasible.”

Dr. Barron agreed as well. “We as health care providers choose to work in health care, and we should be doing everything feasible to ensure that we are protecting our patients and keeping our coworkers safe.”

“Whether you are a health care professional or not, I would urge everyone to get the COVID-19 vaccine, especially as cases across the country continue to rise,” Dr. Hirschwerk said. “Unequivocally vaccines protect you from the virus.”

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

Internal Centers for Disease Control and Prevention documents support the high transmission rate of the Delta variant and put the risk in easier to understand terms.

In addition, the agency released a new study that shows that breakthrough infections in the vaccinated make people about as contagious as those who are unvaccinated. The new report, published July 30 in Morbidity and Mortality Weekly Report (MMWR), also reveals that the Delta variant likely causes more severe COVID-19 illness.

Given these recent findings, the internal CDC slide show advises that the agency  should “acknowledge the war has changed.”
 

A ‘pivotal discovery’

CDC Director Rochelle Walensky, MD, MPH, said in a statement that the MMWR report demonstrates “that [D]elta infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people.

“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with [D]elta can transmit the virus,” she added. “This finding is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation.”

The investigators analyzed 469 COVID-19 cases reported in Massachusetts residents July 3 through 17, 2021. The infections were associated with an outbreak following multiple events and large gatherings in Provincetown in that state’s easternmost Barnstable County, also known as Cape Cod.

Notably, 346 infections, or 74%, of the cases occurred in fully vaccinated individuals. This group had a median age of 42, and 87% were male. Also, 79% of the breakthrough infections were symptomatic.

Researchers also identified the Delta variant in 90% of 133 specimens collected for analysis. Furthermore, viral loads were about the same between samples taken from people who were fully vaccinated and those who were not.

Four of the five people hospitalized were fully vaccinated. No deaths were reported. 

The publication of these results was highly anticipated following the CDC’s updated mask recommendations on July 27.

Outside the scope of the MMWR report is the total number of cases associated with the outbreak, including visitors from outside Massachusetts, which now approach 900 infections, NBC Boston reported.
 

‘Very sobering’ data

“The new information from the CDC around the [D]elta variant is very sobering,” David Hirschwerk, MD, infectious disease specialist at Northwell Health in New Hyde Park, N.Y., said in an interview.

“The CDC is trying to convey and present this uncertain situation clearly to the public based on new, accumulated data,” he said. For example, given the evidence for higher contagiousness of the Delta variant, Dr. Hirschwerk added, “there will be situations where vaccinated people get infected, because the amount of the virus overwhelms the immune protection.

“What is new that is concerning is that people who are vaccinated still have the potential to transmit the virus to the same degree,” he said.

The MMWR study “helps us better understand the question related to whether or not a person who has completed a COVID-19 series can spread the infection,” agreed Michelle Barron, MD, a professor in the division of infectious disease at the University of Colorado, Aurora.

“The message is that, because the [D]elta variant is much more contagious than the original strain, unvaccinated persons need to get vaccinated because it is nearly impossible to avoid the virus indefinitely,” Michael Lin, MD, MPH, infectious diseases specialist and epidemiologist at Rush University Medical Center, Chicago, said when asked to comment.

The new data highlight “that vaccinated persons, if they become sick, should still seek COVID-19 testing and should still isolate, as they are likely contagious,” Dr. Lin added.
 

More contagious than other infections

The internal CDC slide presentation also puts the new transmission risk in simple terms. Saying that the Delta variant is about as contagious as chicken pox, for example, immediately brings back vivid memories for some of staying indoors and away from friends during childhood or teenage outbreaks.

“A lot of people will remember getting chicken pox and then having their siblings get it shortly thereafter,” Dr. Barron said. “The only key thing to note is that this does not mean that the COVID-19 [D]elta variant mechanism of spread is the same as chicken pox and Ebola. The primary means of spread of COVID-19, even the Delta variant, is via droplets.”

This also means each person infected with the Delta variant could infect an average of eight or nine others.

In contrast, the original strain of the SARS-CoV-2 virus was about as infectious as the common cold. In other words, someone was likely to infect about two other people on average.

In addition to the cold, the CDC notes that the Delta variant is now more contagious than Ebola, the seasonal flu, or small pox.

These Delta variant comparisons are one tangible way of explaining why the CDC on July 27 recommended a return to masking in schools and other indoor spaces for people – vaccinated and unvaccinated – in about 70% of the counties across the United States.

In comparing the Delta variant with other infections, “I think the CDC is trying to help people understand a little bit better the situation we now face since the information is so new. We are in a very different position now than just a few weeks ago, and it is hard for people to accept this,” Dr. Hirschwerk said.

The Delta variant is so different that the CDC considers it almost acting like a new virus altogether.

The CDC’s internal documents were first released by The Washington Post on July 29. The slides cite communication challenges for the agency to continue promoting vaccination while also acknowledging that breakthrough cases are occurring and therefore the fully vaccinated, in some instances, are likely infecting others.

Moving back to science talk, the CDC used the recent outbreak in Barnstable County as an example. The cycle threshold, or Ct values, a measure of viral load, were about the same between 80 vaccinated people linked to the outbreak who had a mean Ct value of 21.9, compared with 65 other unvaccinated people with a Ct of 21.5.

Many experts are quick to note that vaccination remains essential, in part because a vaccinated person also walks around with a much lower risk for severe outcomes, hospitalization, and death. In the internal slide show, the CDC points out that vaccination reduces the risk for infection threefold.

“Even with this high amount of virus, [the Delta variant] did not necessarily make the vaccinated individuals as sick,” Dr. Barron said.

In her statement, Dr. Walensky credited collaboration with the Commonwealth of Massachusetts Department of Public Health and the CDC for the new data. She also thanked the residents of Barnstable County for participating in interviews done by contact tracers and their willingness to get tested and adhere to safety protocols after learning of their exposure.
 

Next moves by CDC?

The agency notes that next steps include consideration of prevention measures such as vaccine mandates for healthcare professionals to protect vulnerable populations, universal masking for source control and prevention, and reconsidering other community mitigation strategies.

Asked if this potential policy is appropriate and feasible, Dr. Lin said, “Yes, I believe that every person working in health care should be vaccinated for COVID-19, and it is feasible.”

Dr. Barron agreed as well. “We as health care providers choose to work in health care, and we should be doing everything feasible to ensure that we are protecting our patients and keeping our coworkers safe.”

“Whether you are a health care professional or not, I would urge everyone to get the COVID-19 vaccine, especially as cases across the country continue to rise,” Dr. Hirschwerk said. “Unequivocally vaccines protect you from the virus.”

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

Internal Centers for Disease Control and Prevention documents support the high transmission rate of the Delta variant and put the risk in easier to understand terms.

In addition, the agency released a new study that shows that breakthrough infections in the vaccinated make people about as contagious as those who are unvaccinated. The new report, published July 30 in Morbidity and Mortality Weekly Report (MMWR), also reveals that the Delta variant likely causes more severe COVID-19 illness.

Given these recent findings, the internal CDC slide show advises that the agency  should “acknowledge the war has changed.”
 

A ‘pivotal discovery’

CDC Director Rochelle Walensky, MD, MPH, said in a statement that the MMWR report demonstrates “that [D]elta infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people.

“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with [D]elta can transmit the virus,” she added. “This finding is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation.”

The investigators analyzed 469 COVID-19 cases reported in Massachusetts residents July 3 through 17, 2021. The infections were associated with an outbreak following multiple events and large gatherings in Provincetown in that state’s easternmost Barnstable County, also known as Cape Cod.

Notably, 346 infections, or 74%, of the cases occurred in fully vaccinated individuals. This group had a median age of 42, and 87% were male. Also, 79% of the breakthrough infections were symptomatic.

Researchers also identified the Delta variant in 90% of 133 specimens collected for analysis. Furthermore, viral loads were about the same between samples taken from people who were fully vaccinated and those who were not.

Four of the five people hospitalized were fully vaccinated. No deaths were reported. 

The publication of these results was highly anticipated following the CDC’s updated mask recommendations on July 27.

Outside the scope of the MMWR report is the total number of cases associated with the outbreak, including visitors from outside Massachusetts, which now approach 900 infections, NBC Boston reported.
 

‘Very sobering’ data

“The new information from the CDC around the [D]elta variant is very sobering,” David Hirschwerk, MD, infectious disease specialist at Northwell Health in New Hyde Park, N.Y., said in an interview.

“The CDC is trying to convey and present this uncertain situation clearly to the public based on new, accumulated data,” he said. For example, given the evidence for higher contagiousness of the Delta variant, Dr. Hirschwerk added, “there will be situations where vaccinated people get infected, because the amount of the virus overwhelms the immune protection.

“What is new that is concerning is that people who are vaccinated still have the potential to transmit the virus to the same degree,” he said.

The MMWR study “helps us better understand the question related to whether or not a person who has completed a COVID-19 series can spread the infection,” agreed Michelle Barron, MD, a professor in the division of infectious disease at the University of Colorado, Aurora.

“The message is that, because the [D]elta variant is much more contagious than the original strain, unvaccinated persons need to get vaccinated because it is nearly impossible to avoid the virus indefinitely,” Michael Lin, MD, MPH, infectious diseases specialist and epidemiologist at Rush University Medical Center, Chicago, said when asked to comment.

The new data highlight “that vaccinated persons, if they become sick, should still seek COVID-19 testing and should still isolate, as they are likely contagious,” Dr. Lin added.
 

More contagious than other infections

The internal CDC slide presentation also puts the new transmission risk in simple terms. Saying that the Delta variant is about as contagious as chicken pox, for example, immediately brings back vivid memories for some of staying indoors and away from friends during childhood or teenage outbreaks.

“A lot of people will remember getting chicken pox and then having their siblings get it shortly thereafter,” Dr. Barron said. “The only key thing to note is that this does not mean that the COVID-19 [D]elta variant mechanism of spread is the same as chicken pox and Ebola. The primary means of spread of COVID-19, even the Delta variant, is via droplets.”

This also means each person infected with the Delta variant could infect an average of eight or nine others.

In contrast, the original strain of the SARS-CoV-2 virus was about as infectious as the common cold. In other words, someone was likely to infect about two other people on average.

In addition to the cold, the CDC notes that the Delta variant is now more contagious than Ebola, the seasonal flu, or small pox.

These Delta variant comparisons are one tangible way of explaining why the CDC on July 27 recommended a return to masking in schools and other indoor spaces for people – vaccinated and unvaccinated – in about 70% of the counties across the United States.

In comparing the Delta variant with other infections, “I think the CDC is trying to help people understand a little bit better the situation we now face since the information is so new. We are in a very different position now than just a few weeks ago, and it is hard for people to accept this,” Dr. Hirschwerk said.

The Delta variant is so different that the CDC considers it almost acting like a new virus altogether.

The CDC’s internal documents were first released by The Washington Post on July 29. The slides cite communication challenges for the agency to continue promoting vaccination while also acknowledging that breakthrough cases are occurring and therefore the fully vaccinated, in some instances, are likely infecting others.

Moving back to science talk, the CDC used the recent outbreak in Barnstable County as an example. The cycle threshold, or Ct values, a measure of viral load, were about the same between 80 vaccinated people linked to the outbreak who had a mean Ct value of 21.9, compared with 65 other unvaccinated people with a Ct of 21.5.

Many experts are quick to note that vaccination remains essential, in part because a vaccinated person also walks around with a much lower risk for severe outcomes, hospitalization, and death. In the internal slide show, the CDC points out that vaccination reduces the risk for infection threefold.

“Even with this high amount of virus, [the Delta variant] did not necessarily make the vaccinated individuals as sick,” Dr. Barron said.

In her statement, Dr. Walensky credited collaboration with the Commonwealth of Massachusetts Department of Public Health and the CDC for the new data. She also thanked the residents of Barnstable County for participating in interviews done by contact tracers and their willingness to get tested and adhere to safety protocols after learning of their exposure.
 

Next moves by CDC?

The agency notes that next steps include consideration of prevention measures such as vaccine mandates for healthcare professionals to protect vulnerable populations, universal masking for source control and prevention, and reconsidering other community mitigation strategies.

Asked if this potential policy is appropriate and feasible, Dr. Lin said, “Yes, I believe that every person working in health care should be vaccinated for COVID-19, and it is feasible.”

Dr. Barron agreed as well. “We as health care providers choose to work in health care, and we should be doing everything feasible to ensure that we are protecting our patients and keeping our coworkers safe.”

“Whether you are a health care professional or not, I would urge everyone to get the COVID-19 vaccine, especially as cases across the country continue to rise,” Dr. Hirschwerk said. “Unequivocally vaccines protect you from the virus.”

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

The Centers for Disease Control and Prevention is expected to announce in early August that new data shows people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, the New York Times reported on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the New York Times said. The bottom line is that the CDC data shows people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on Jul 29 that the CDC’s updated mask guidance followed an outbreak on Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

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

The Centers for Disease Control and Prevention is expected to announce in early August that new data shows people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, the New York Times reported on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the New York Times said. The bottom line is that the CDC data shows people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on Jul 29 that the CDC’s updated mask guidance followed an outbreak on Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

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

The Centers for Disease Control and Prevention is expected to announce in early August that new data shows people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, the New York Times reported on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the New York Times said. The bottom line is that the CDC data shows people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on Jul 29 that the CDC’s updated mask guidance followed an outbreak on Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

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

Physicians wearing white coats were rated as significantly more experienced and professional than peers wearing casual attire. Regardless of their attire, however, female physicians were more likely to be judged as appearing less professional and were more likely to be misidentified as medical technicians, physician assistants, or nurses, found research published in JAMA Network Open.

“A white coat with scrubs attire was most preferred for surgeons (mean preference index, 1.3), whereas a white coat with business attire was preferred for family physicians and dermatologists (mean preference indexes, 1.6 and 1.2, respectively; P < .001),” Helen Xun, MD, Johns Hopkins University, Baltimore, and colleagues wrote. “A male model wearing business inner wear with a white coat, fleece jacket, or softshell jacket was perceived as significantly more professional than a female model wearing the same attire (mean professionalism score: male, 65.8; female, 56.2; mean difference in professionalism score: white coat, 12.06; fleece, 7.89; softshell, 8.82; P < .001). ... A male model wearing hospital scrubs or fashion scrubs alone was also perceived as more professional than a female model in the same attire.”

While casual attire, such as fleece or softshell jackets emblazoned with the names of the institution and wearer, has become more popular attire for physicians in recent years, the researchers noted theirs is the first published research to identify associations between gender, attire, and how people distinguish between various health care roles. The study authors launched their web-based survey from May to June 2020 and asked people aged 18 years and older to rate a series of photographs of deidentified models wearing health care attire. Inner wear choices were business attire versus scrubs with and without outer wear options of a long white coat, gray fleece jacket, or black softshell jackets. Survey respondents ranked the images on a 6-point Likert scale with 1 being the least experienced, professional, and friendly and 6 being the most experienced, professional, and friendly. Survey respondents also viewed individual images of male or female models and were asked to rate their professionalism on a scale of 0-100 – with 100 as the “most professional” as well as to identify their profession as either physician, surgeon, nurse, medical technician, or physician assistant.

The study team included 487 (93.3%) of 522 completed surveys in their analyses. Respondents’ mean age was 36.2 years; 260 (53.4%) were female; 372 (76.4%) were White; 33 (6.8%) were Black or African American. Younger respondents and those living in the Western United States who had more exposure to physician casual attire appeared more accepting of it, the authors wrote.

“I remember attending my white-coat ceremony as a medical student, and the symbolism of it all representing me entering the profession. It felt very emotional and heavy and I felt very proud to be there. I also remember taking a ‘selfie’ in my long white coat as a doctor for the first time before my first shift as a resident. But, I’ve also been wearing that same white coat, and a large badge with a ‘DOCTOR’ label on it, and been mistaken by a patient or parent for something other than the physician,” Alexandra M. Sims, a pediatrician and health equity researcher in Cincinnati, said in an interview. “So, I’d really hope that the take-home here is not simply that we must wear our white coats to be considered more professional. I think we have to unpack and dismantle how we’ve even built this notion of ‘professionalism’ in the first place. Women, people of color, and other marginalized groups were certainly not a part of the defining, but we must be a part of the reimagining of an equitable health care profession in this new era.”

As sartorial trends usher in more casual attire, clinicians should redouble efforts to build rapport and enhance communication with patients, such as clarifying team members’ roles when introducing themselves. Dr. Xun and coauthors noted that addressing gender bias is important for all clinicians – not just women – and point to the need for institutional and organizational support for disciplines where gender bias is “especially prevalent,” like surgery. “This responsibility should not be undertaken only by the individuals that experience the biases, which may result in additional cumulative career disadvantages. The promotion of equality and diversity begins with recognition, characterization, and evidence-supported interventions and is a community operation,” Dr. Xun and colleagues concluded.

“I do not equate attire to professionalism or experience, nor is it connected to my satisfaction with the physician. For myself and my daughter, it is the experience of care that ultimately influences our perceptions regarding the professionalism of the physician,” Hala H. Durrah, MTA, parent to a chronically ill child with special health care needs and a Patient and Family Engagement Consultant, said in an interview. “My respect for a physician will ultimately be determined by how my daughter and I were treated, not just from a clinical perspective, but how we felt during those interactions.”

Physicians wearing white coats were rated as significantly more experienced and professional than peers wearing casual attire. Regardless of their attire, however, female physicians were more likely to be judged as appearing less professional and were more likely to be misidentified as medical technicians, physician assistants, or nurses, found research published in JAMA Network Open.

“A white coat with scrubs attire was most preferred for surgeons (mean preference index, 1.3), whereas a white coat with business attire was preferred for family physicians and dermatologists (mean preference indexes, 1.6 and 1.2, respectively; P < .001),” Helen Xun, MD, Johns Hopkins University, Baltimore, and colleagues wrote. “A male model wearing business inner wear with a white coat, fleece jacket, or softshell jacket was perceived as significantly more professional than a female model wearing the same attire (mean professionalism score: male, 65.8; female, 56.2; mean difference in professionalism score: white coat, 12.06; fleece, 7.89; softshell, 8.82; P < .001). ... A male model wearing hospital scrubs or fashion scrubs alone was also perceived as more professional than a female model in the same attire.”

While casual attire, such as fleece or softshell jackets emblazoned with the names of the institution and wearer, has become more popular attire for physicians in recent years, the researchers noted theirs is the first published research to identify associations between gender, attire, and how people distinguish between various health care roles. The study authors launched their web-based survey from May to June 2020 and asked people aged 18 years and older to rate a series of photographs of deidentified models wearing health care attire. Inner wear choices were business attire versus scrubs with and without outer wear options of a long white coat, gray fleece jacket, or black softshell jackets. Survey respondents ranked the images on a 6-point Likert scale with 1 being the least experienced, professional, and friendly and 6 being the most experienced, professional, and friendly. Survey respondents also viewed individual images of male or female models and were asked to rate their professionalism on a scale of 0-100 – with 100 as the “most professional” as well as to identify their profession as either physician, surgeon, nurse, medical technician, or physician assistant.

The study team included 487 (93.3%) of 522 completed surveys in their analyses. Respondents’ mean age was 36.2 years; 260 (53.4%) were female; 372 (76.4%) were White; 33 (6.8%) were Black or African American. Younger respondents and those living in the Western United States who had more exposure to physician casual attire appeared more accepting of it, the authors wrote.

“I remember attending my white-coat ceremony as a medical student, and the symbolism of it all representing me entering the profession. It felt very emotional and heavy and I felt very proud to be there. I also remember taking a ‘selfie’ in my long white coat as a doctor for the first time before my first shift as a resident. But, I’ve also been wearing that same white coat, and a large badge with a ‘DOCTOR’ label on it, and been mistaken by a patient or parent for something other than the physician,” Alexandra M. Sims, a pediatrician and health equity researcher in Cincinnati, said in an interview. “So, I’d really hope that the take-home here is not simply that we must wear our white coats to be considered more professional. I think we have to unpack and dismantle how we’ve even built this notion of ‘professionalism’ in the first place. Women, people of color, and other marginalized groups were certainly not a part of the defining, but we must be a part of the reimagining of an equitable health care profession in this new era.”

As sartorial trends usher in more casual attire, clinicians should redouble efforts to build rapport and enhance communication with patients, such as clarifying team members’ roles when introducing themselves. Dr. Xun and coauthors noted that addressing gender bias is important for all clinicians – not just women – and point to the need for institutional and organizational support for disciplines where gender bias is “especially prevalent,” like surgery. “This responsibility should not be undertaken only by the individuals that experience the biases, which may result in additional cumulative career disadvantages. The promotion of equality and diversity begins with recognition, characterization, and evidence-supported interventions and is a community operation,” Dr. Xun and colleagues concluded.

“I do not equate attire to professionalism or experience, nor is it connected to my satisfaction with the physician. For myself and my daughter, it is the experience of care that ultimately influences our perceptions regarding the professionalism of the physician,” Hala H. Durrah, MTA, parent to a chronically ill child with special health care needs and a Patient and Family Engagement Consultant, said in an interview. “My respect for a physician will ultimately be determined by how my daughter and I were treated, not just from a clinical perspective, but how we felt during those interactions.”

Physicians wearing white coats were rated as significantly more experienced and professional than peers wearing casual attire. Regardless of their attire, however, female physicians were more likely to be judged as appearing less professional and were more likely to be misidentified as medical technicians, physician assistants, or nurses, found research published in JAMA Network Open.

“A white coat with scrubs attire was most preferred for surgeons (mean preference index, 1.3), whereas a white coat with business attire was preferred for family physicians and dermatologists (mean preference indexes, 1.6 and 1.2, respectively; P < .001),” Helen Xun, MD, Johns Hopkins University, Baltimore, and colleagues wrote. “A male model wearing business inner wear with a white coat, fleece jacket, or softshell jacket was perceived as significantly more professional than a female model wearing the same attire (mean professionalism score: male, 65.8; female, 56.2; mean difference in professionalism score: white coat, 12.06; fleece, 7.89; softshell, 8.82; P < .001). ... A male model wearing hospital scrubs or fashion scrubs alone was also perceived as more professional than a female model in the same attire.”

While casual attire, such as fleece or softshell jackets emblazoned with the names of the institution and wearer, has become more popular attire for physicians in recent years, the researchers noted theirs is the first published research to identify associations between gender, attire, and how people distinguish between various health care roles. The study authors launched their web-based survey from May to June 2020 and asked people aged 18 years and older to rate a series of photographs of deidentified models wearing health care attire. Inner wear choices were business attire versus scrubs with and without outer wear options of a long white coat, gray fleece jacket, or black softshell jackets. Survey respondents ranked the images on a 6-point Likert scale with 1 being the least experienced, professional, and friendly and 6 being the most experienced, professional, and friendly. Survey respondents also viewed individual images of male or female models and were asked to rate their professionalism on a scale of 0-100 – with 100 as the “most professional” as well as to identify their profession as either physician, surgeon, nurse, medical technician, or physician assistant.

The study team included 487 (93.3%) of 522 completed surveys in their analyses. Respondents’ mean age was 36.2 years; 260 (53.4%) were female; 372 (76.4%) were White; 33 (6.8%) were Black or African American. Younger respondents and those living in the Western United States who had more exposure to physician casual attire appeared more accepting of it, the authors wrote.

“I remember attending my white-coat ceremony as a medical student, and the symbolism of it all representing me entering the profession. It felt very emotional and heavy and I felt very proud to be there. I also remember taking a ‘selfie’ in my long white coat as a doctor for the first time before my first shift as a resident. But, I’ve also been wearing that same white coat, and a large badge with a ‘DOCTOR’ label on it, and been mistaken by a patient or parent for something other than the physician,” Alexandra M. Sims, a pediatrician and health equity researcher in Cincinnati, said in an interview. “So, I’d really hope that the take-home here is not simply that we must wear our white coats to be considered more professional. I think we have to unpack and dismantle how we’ve even built this notion of ‘professionalism’ in the first place. Women, people of color, and other marginalized groups were certainly not a part of the defining, but we must be a part of the reimagining of an equitable health care profession in this new era.”

As sartorial trends usher in more casual attire, clinicians should redouble efforts to build rapport and enhance communication with patients, such as clarifying team members’ roles when introducing themselves. Dr. Xun and coauthors noted that addressing gender bias is important for all clinicians – not just women – and point to the need for institutional and organizational support for disciplines where gender bias is “especially prevalent,” like surgery. “This responsibility should not be undertaken only by the individuals that experience the biases, which may result in additional cumulative career disadvantages. The promotion of equality and diversity begins with recognition, characterization, and evidence-supported interventions and is a community operation,” Dr. Xun and colleagues concluded.

“I do not equate attire to professionalism or experience, nor is it connected to my satisfaction with the physician. For myself and my daughter, it is the experience of care that ultimately influences our perceptions regarding the professionalism of the physician,” Hala H. Durrah, MTA, parent to a chronically ill child with special health care needs and a Patient and Family Engagement Consultant, said in an interview. “My respect for a physician will ultimately be determined by how my daughter and I were treated, not just from a clinical perspective, but how we felt during those interactions.”

Wrong-site surgery

Florida regulators have imposed a fine and other measures on a Tampa doctor who made a crucial error prior to his patient’s testicular surgery, as a story in the Miami Herald, among other news sites, reports.

On Sept. 10, 2019, a patient referred to in state documents as “C.F.” showed up for a procedure – a varicocelectomy – that would remove the enlarged veins in his left testicle. His doctor that day was Raul Fernandez-Crespo, MD, a urologist who had been licensed to practice in Florida since April of the same year. Dr. Fernandez-Crespo completed his urology residency at the University of Puerto Rico in 2019.

Following a conversation with C.F., Dr. Fernandez-Crespo designated what he believed was the proper surgical site – his patient’s right testicle.

He then proceeded to operate, but at some point during the procedure – news accounts don’t make clear when or how he became aware of his error – he realized C.F. had actually consented to a left-testicle varicocelectomy. With his patient still sedated, Dr. Fernandez-Crespo also completed the second procedure.

His mistake came to the attention of the Department of Health, which filed an administrative complaint against the surgeon. On June 17, 2021, the department’s medical licensing body, the Florida Board of Medicine, handed down its final order about the case.

In addition to imposing a $2,500 fine on Dr. Fernandez-Crespo and issuing “a letter of concern” – a public document that can be used as evidence in any relevant future disciplinary action against him – regulators said the surgeon must reimburse $2,045.56 to the department for its case-related administrative costs; take a 5-hour CME course in risk management or attend 8 hours of board disciplinary hearings; and, finally, give a 1-hour lecture on wrong-site surgeries at a board-approved medical facility.

Before this, Dr. Fernandez-Crespo had no previous disciplinary history with the Florida Board of Medicine.
 

Huge judgment after fertility procedure goes wrong

A Connecticut couple whose fertility and prenatal care at a state university health center proved disastrous will receive millions of dollars in damages, according to a report in the Hartford Courant.

In 2014, Jean-Marie Monroe-Lynch and her husband, Aaron Lynch, went to UConn Health, in Farmington, for treatment of Jean-Marie’s infertility. Her care was overseen by the Center for Advanced Reproductive Services (CARS), a private company then under contract with UConn Health. (The contract, which ended in 2014, obligated UConn to provide CARS providers with medical malpractice coverage.)

There, Jean-Marie was inseminated with sperm from a donor who turned out to be a carrier for cytomegalovirus (CMV), the herpes virus that can cause severe birth defects, or fetal death, when contracted by a pregnant woman. The insemination resulted in a twin pregnancy, a boy and a girl. The girl, Shay, died in utero after several of her organs became infected with CMV; the boy, Joshua, was born with severe mental and physical disabilities.

In their suit, Ms. Monroe-Lynch and her husband alleged that they were never cautioned about the risks associated with using a sperm donor whose blood had tested positive for CMV antibodies. Their suit further alleged that, at the 20-week ultrasound, UConn’s prenatal team failed to detect evidence of congenital CMV infection and again failed, at the 22-week ultrasound, to properly recognize and respond to abnormal findings.

“They totally dropped the ball,” said the couple’s attorney. “If you’re a pregnant woman and contract the virus for the first time, the results can be devastating.” 

CARS disputes this conclusion, arguing that the plaintiffs failed to prove as a “matter of scientific fact” that Ms. Monroe-Lynch was infected with CMV as the result of her intrauterine insemination.

But Superior Court Judge Mark H. Taylor disagreed. In his 107-page ruling, he said that the court “agrees with the vast majority of superior courts, concluding that a physician providing obstetric care owes a direct duty to a mother to prevent harm to her child during gestation and delivery.”

Jean-Marie Monroe-Lynch and Aaron Lynch received a $37.6 million award, consisting of $24.1 million in economic damages and $13.5 million in noneconomic damages.

Their surviving child, Joshua, will reportedly require a lifetime of medical and other care. In the meantime, UConn Health vows to appeal the Superior Court’s decision.
 

COVID patient’s relative demands justice for fatal outcome

An Indiana man whose grandfather recently died after suffering a stroke is calling on state lawmakers to rethink legislation passed earlier this year to protect health care providers during the COVID-19 pandemic, according to a story reported by CBS4Indy.

Late last year, Daniel Enlow’s 83-year-old grandfather, Edward Rigney, was checked into Eskenazi Hospital, in Indianapolis. Mr. Rigney suffered from COPD and had also been diagnosed with COVID-19.

At some point during his hospitalization, medical staff attempted to place what seems to have been an arterial line in order to monitor his condition. During the procedure, or at some point shortly thereafter, an “iatrogenic air embolus” was released into his veins and caused a stroke, according to medical records and Mr. Rigney’s death certificate.

“I started asking for medical records because I wanted to know what was happening leading up to it in black and white in front of me,” said Mr. Enlow, who wished to present his evidence to a medical review panel, as required by Indiana law. The first step in this process would have been to consult with a medical malpractice attorney, but several declined to take his case.

Why? Because a pair of bills passed by Indiana legislators in early 2021 make COVID-19–related suits – even tangentially related ones – potentially difficult to take to court.

The bills raised the bar to file a medical malpractice claim in COVID-19 cases and to allow only those that involve “gross negligence or willful or wanton misconduct.”

“In the vast majority of cases, it’s impossible to prove that,” said Fred Schultz, immediate past president of the Indiana Trial Lawyers Association, who lobbied against the legislation.

The bills were never designed to offer “blanket freedom,” said GOP State Senator Aaron Freeman, sponsor of one of the bills. “If something is being used in a way that it is a complete bar to certain claims, then maybe we need to go back and look at it and open that up a little bit and make it less restrictive. I’m certainly open to having those conversations.”

Meanwhile, Mr. Enlow has vowed to keep pushing in the name of his late grandfather. The hospital’s parent company, Eskenazi Health, has declined to comment.

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

Wrong-site surgery

Florida regulators have imposed a fine and other measures on a Tampa doctor who made a crucial error prior to his patient’s testicular surgery, as a story in the Miami Herald, among other news sites, reports.

On Sept. 10, 2019, a patient referred to in state documents as “C.F.” showed up for a procedure – a varicocelectomy – that would remove the enlarged veins in his left testicle. His doctor that day was Raul Fernandez-Crespo, MD, a urologist who had been licensed to practice in Florida since April of the same year. Dr. Fernandez-Crespo completed his urology residency at the University of Puerto Rico in 2019.

Following a conversation with C.F., Dr. Fernandez-Crespo designated what he believed was the proper surgical site – his patient’s right testicle.

He then proceeded to operate, but at some point during the procedure – news accounts don’t make clear when or how he became aware of his error – he realized C.F. had actually consented to a left-testicle varicocelectomy. With his patient still sedated, Dr. Fernandez-Crespo also completed the second procedure.

His mistake came to the attention of the Department of Health, which filed an administrative complaint against the surgeon. On June 17, 2021, the department’s medical licensing body, the Florida Board of Medicine, handed down its final order about the case.

In addition to imposing a $2,500 fine on Dr. Fernandez-Crespo and issuing “a letter of concern” – a public document that can be used as evidence in any relevant future disciplinary action against him – regulators said the surgeon must reimburse $2,045.56 to the department for its case-related administrative costs; take a 5-hour CME course in risk management or attend 8 hours of board disciplinary hearings; and, finally, give a 1-hour lecture on wrong-site surgeries at a board-approved medical facility.

Before this, Dr. Fernandez-Crespo had no previous disciplinary history with the Florida Board of Medicine.
 

Huge judgment after fertility procedure goes wrong

A Connecticut couple whose fertility and prenatal care at a state university health center proved disastrous will receive millions of dollars in damages, according to a report in the Hartford Courant.

In 2014, Jean-Marie Monroe-Lynch and her husband, Aaron Lynch, went to UConn Health, in Farmington, for treatment of Jean-Marie’s infertility. Her care was overseen by the Center for Advanced Reproductive Services (CARS), a private company then under contract with UConn Health. (The contract, which ended in 2014, obligated UConn to provide CARS providers with medical malpractice coverage.)

There, Jean-Marie was inseminated with sperm from a donor who turned out to be a carrier for cytomegalovirus (CMV), the herpes virus that can cause severe birth defects, or fetal death, when contracted by a pregnant woman. The insemination resulted in a twin pregnancy, a boy and a girl. The girl, Shay, died in utero after several of her organs became infected with CMV; the boy, Joshua, was born with severe mental and physical disabilities.

In their suit, Ms. Monroe-Lynch and her husband alleged that they were never cautioned about the risks associated with using a sperm donor whose blood had tested positive for CMV antibodies. Their suit further alleged that, at the 20-week ultrasound, UConn’s prenatal team failed to detect evidence of congenital CMV infection and again failed, at the 22-week ultrasound, to properly recognize and respond to abnormal findings.

“They totally dropped the ball,” said the couple’s attorney. “If you’re a pregnant woman and contract the virus for the first time, the results can be devastating.” 

CARS disputes this conclusion, arguing that the plaintiffs failed to prove as a “matter of scientific fact” that Ms. Monroe-Lynch was infected with CMV as the result of her intrauterine insemination.

But Superior Court Judge Mark H. Taylor disagreed. In his 107-page ruling, he said that the court “agrees with the vast majority of superior courts, concluding that a physician providing obstetric care owes a direct duty to a mother to prevent harm to her child during gestation and delivery.”

Jean-Marie Monroe-Lynch and Aaron Lynch received a $37.6 million award, consisting of $24.1 million in economic damages and $13.5 million in noneconomic damages.

Their surviving child, Joshua, will reportedly require a lifetime of medical and other care. In the meantime, UConn Health vows to appeal the Superior Court’s decision.
 

COVID patient’s relative demands justice for fatal outcome

An Indiana man whose grandfather recently died after suffering a stroke is calling on state lawmakers to rethink legislation passed earlier this year to protect health care providers during the COVID-19 pandemic, according to a story reported by CBS4Indy.

Late last year, Daniel Enlow’s 83-year-old grandfather, Edward Rigney, was checked into Eskenazi Hospital, in Indianapolis. Mr. Rigney suffered from COPD and had also been diagnosed with COVID-19.

At some point during his hospitalization, medical staff attempted to place what seems to have been an arterial line in order to monitor his condition. During the procedure, or at some point shortly thereafter, an “iatrogenic air embolus” was released into his veins and caused a stroke, according to medical records and Mr. Rigney’s death certificate.

“I started asking for medical records because I wanted to know what was happening leading up to it in black and white in front of me,” said Mr. Enlow, who wished to present his evidence to a medical review panel, as required by Indiana law. The first step in this process would have been to consult with a medical malpractice attorney, but several declined to take his case.

Why? Because a pair of bills passed by Indiana legislators in early 2021 make COVID-19–related suits – even tangentially related ones – potentially difficult to take to court.

The bills raised the bar to file a medical malpractice claim in COVID-19 cases and to allow only those that involve “gross negligence or willful or wanton misconduct.”

“In the vast majority of cases, it’s impossible to prove that,” said Fred Schultz, immediate past president of the Indiana Trial Lawyers Association, who lobbied against the legislation.

The bills were never designed to offer “blanket freedom,” said GOP State Senator Aaron Freeman, sponsor of one of the bills. “If something is being used in a way that it is a complete bar to certain claims, then maybe we need to go back and look at it and open that up a little bit and make it less restrictive. I’m certainly open to having those conversations.”

Meanwhile, Mr. Enlow has vowed to keep pushing in the name of his late grandfather. The hospital’s parent company, Eskenazi Health, has declined to comment.

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

Wrong-site surgery

Florida regulators have imposed a fine and other measures on a Tampa doctor who made a crucial error prior to his patient’s testicular surgery, as a story in the Miami Herald, among other news sites, reports.

On Sept. 10, 2019, a patient referred to in state documents as “C.F.” showed up for a procedure – a varicocelectomy – that would remove the enlarged veins in his left testicle. His doctor that day was Raul Fernandez-Crespo, MD, a urologist who had been licensed to practice in Florida since April of the same year. Dr. Fernandez-Crespo completed his urology residency at the University of Puerto Rico in 2019.

Following a conversation with C.F., Dr. Fernandez-Crespo designated what he believed was the proper surgical site – his patient’s right testicle.

He then proceeded to operate, but at some point during the procedure – news accounts don’t make clear when or how he became aware of his error – he realized C.F. had actually consented to a left-testicle varicocelectomy. With his patient still sedated, Dr. Fernandez-Crespo also completed the second procedure.

His mistake came to the attention of the Department of Health, which filed an administrative complaint against the surgeon. On June 17, 2021, the department’s medical licensing body, the Florida Board of Medicine, handed down its final order about the case.

In addition to imposing a $2,500 fine on Dr. Fernandez-Crespo and issuing “a letter of concern” – a public document that can be used as evidence in any relevant future disciplinary action against him – regulators said the surgeon must reimburse $2,045.56 to the department for its case-related administrative costs; take a 5-hour CME course in risk management or attend 8 hours of board disciplinary hearings; and, finally, give a 1-hour lecture on wrong-site surgeries at a board-approved medical facility.

Before this, Dr. Fernandez-Crespo had no previous disciplinary history with the Florida Board of Medicine.
 

Huge judgment after fertility procedure goes wrong

A Connecticut couple whose fertility and prenatal care at a state university health center proved disastrous will receive millions of dollars in damages, according to a report in the Hartford Courant.

In 2014, Jean-Marie Monroe-Lynch and her husband, Aaron Lynch, went to UConn Health, in Farmington, for treatment of Jean-Marie’s infertility. Her care was overseen by the Center for Advanced Reproductive Services (CARS), a private company then under contract with UConn Health. (The contract, which ended in 2014, obligated UConn to provide CARS providers with medical malpractice coverage.)

There, Jean-Marie was inseminated with sperm from a donor who turned out to be a carrier for cytomegalovirus (CMV), the herpes virus that can cause severe birth defects, or fetal death, when contracted by a pregnant woman. The insemination resulted in a twin pregnancy, a boy and a girl. The girl, Shay, died in utero after several of her organs became infected with CMV; the boy, Joshua, was born with severe mental and physical disabilities.

In their suit, Ms. Monroe-Lynch and her husband alleged that they were never cautioned about the risks associated with using a sperm donor whose blood had tested positive for CMV antibodies. Their suit further alleged that, at the 20-week ultrasound, UConn’s prenatal team failed to detect evidence of congenital CMV infection and again failed, at the 22-week ultrasound, to properly recognize and respond to abnormal findings.

“They totally dropped the ball,” said the couple’s attorney. “If you’re a pregnant woman and contract the virus for the first time, the results can be devastating.” 

CARS disputes this conclusion, arguing that the plaintiffs failed to prove as a “matter of scientific fact” that Ms. Monroe-Lynch was infected with CMV as the result of her intrauterine insemination.

But Superior Court Judge Mark H. Taylor disagreed. In his 107-page ruling, he said that the court “agrees with the vast majority of superior courts, concluding that a physician providing obstetric care owes a direct duty to a mother to prevent harm to her child during gestation and delivery.”

Jean-Marie Monroe-Lynch and Aaron Lynch received a $37.6 million award, consisting of $24.1 million in economic damages and $13.5 million in noneconomic damages.

Their surviving child, Joshua, will reportedly require a lifetime of medical and other care. In the meantime, UConn Health vows to appeal the Superior Court’s decision.
 

COVID patient’s relative demands justice for fatal outcome

An Indiana man whose grandfather recently died after suffering a stroke is calling on state lawmakers to rethink legislation passed earlier this year to protect health care providers during the COVID-19 pandemic, according to a story reported by CBS4Indy.

Late last year, Daniel Enlow’s 83-year-old grandfather, Edward Rigney, was checked into Eskenazi Hospital, in Indianapolis. Mr. Rigney suffered from COPD and had also been diagnosed with COVID-19.

At some point during his hospitalization, medical staff attempted to place what seems to have been an arterial line in order to monitor his condition. During the procedure, or at some point shortly thereafter, an “iatrogenic air embolus” was released into his veins and caused a stroke, according to medical records and Mr. Rigney’s death certificate.

“I started asking for medical records because I wanted to know what was happening leading up to it in black and white in front of me,” said Mr. Enlow, who wished to present his evidence to a medical review panel, as required by Indiana law. The first step in this process would have been to consult with a medical malpractice attorney, but several declined to take his case.

Why? Because a pair of bills passed by Indiana legislators in early 2021 make COVID-19–related suits – even tangentially related ones – potentially difficult to take to court.

The bills raised the bar to file a medical malpractice claim in COVID-19 cases and to allow only those that involve “gross negligence or willful or wanton misconduct.”

“In the vast majority of cases, it’s impossible to prove that,” said Fred Schultz, immediate past president of the Indiana Trial Lawyers Association, who lobbied against the legislation.

The bills were never designed to offer “blanket freedom,” said GOP State Senator Aaron Freeman, sponsor of one of the bills. “If something is being used in a way that it is a complete bar to certain claims, then maybe we need to go back and look at it and open that up a little bit and make it less restrictive. I’m certainly open to having those conversations.”

Meanwhile, Mr. Enlow has vowed to keep pushing in the name of his late grandfather. The hospital’s parent company, Eskenazi Health, has declined to comment.

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

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

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

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

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

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

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

Since the U.S. Food and Drug Administration established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published in The BMJ has determined.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.

The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
 

Required studies rarely completed

As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.

However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.

The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.

In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.

Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.

For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.

As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.

Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.

“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
 

Call for reform

As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.

In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.

“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.

In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.

Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.

One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.

“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.

An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”

“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.

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

Since the U.S. Food and Drug Administration established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published in The BMJ has determined.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.

The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
 

Required studies rarely completed

As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.

However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.

The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.

In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.

Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.

For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.

As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.

Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.

“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
 

Call for reform

As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.

In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.

“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.

In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.

Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.

One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.

“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.

An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”

“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.

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

Since the U.S. Food and Drug Administration established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published in The BMJ has determined.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.

The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
 

Required studies rarely completed

As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.

However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.

The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.

In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.

Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.

For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.

As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.

Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.

“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
 

Call for reform

As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.

In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.

“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.

In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.

Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.

One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.

“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.

An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”

“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.

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

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.

“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus … [becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Dr. Walensky told reporters on July 27. 

A new, more elusive variant could be “just a few mutations away,” she said.

“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School in Newark, told this news organization.

“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”

“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta – that it is so infectious.”

He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”

“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Dr. Ray, vice-chair of medicine for data integrity and analytics and professor in the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.

“The problem is if the virus changes in such a way that the spike protein – which the antibodies from the vaccine are directed against – are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Dr. Nelson said.

If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
 

Technology to the rescue?

The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.

“That’s absolutely reassuring,” Dr. Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.

“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
 

Nothing appears certain

When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Dr. Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.

“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”

Both Dr. Nelson and Dr. Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.

Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Dr. Ray said.
 

Mutations not the only concern

Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.

Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.

“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Dr. Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”

“The more diverse the strains that are circulating, the bigger a possibility this is,” Dr. Ray said.
 

Protected, for now

Dr. Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.

On a positive note, Dr. Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”

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

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.

“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus … [becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Dr. Walensky told reporters on July 27. 

A new, more elusive variant could be “just a few mutations away,” she said.

“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School in Newark, told this news organization.

“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”

“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta – that it is so infectious.”

He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”

“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Dr. Ray, vice-chair of medicine for data integrity and analytics and professor in the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.

“The problem is if the virus changes in such a way that the spike protein – which the antibodies from the vaccine are directed against – are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Dr. Nelson said.

If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
 

Technology to the rescue?

The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.

“That’s absolutely reassuring,” Dr. Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.

“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
 

Nothing appears certain

When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Dr. Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.

“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”

Both Dr. Nelson and Dr. Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.

Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Dr. Ray said.
 

Mutations not the only concern

Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.

Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.

“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Dr. Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”

“The more diverse the strains that are circulating, the bigger a possibility this is,” Dr. Ray said.
 

Protected, for now

Dr. Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.

On a positive note, Dr. Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”

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

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.

“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus … [becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Dr. Walensky told reporters on July 27. 

A new, more elusive variant could be “just a few mutations away,” she said.

“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School in Newark, told this news organization.

“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”

“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta – that it is so infectious.”

He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”

“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Dr. Ray, vice-chair of medicine for data integrity and analytics and professor in the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.

“The problem is if the virus changes in such a way that the spike protein – which the antibodies from the vaccine are directed against – are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Dr. Nelson said.

If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
 

Technology to the rescue?

The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.

“That’s absolutely reassuring,” Dr. Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.

“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
 

Nothing appears certain

When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Dr. Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.

“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”

Both Dr. Nelson and Dr. Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.

Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Dr. Ray said.
 

Mutations not the only concern

Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.

Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.

“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Dr. Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”

“The more diverse the strains that are circulating, the bigger a possibility this is,” Dr. Ray said.
 

Protected, for now

Dr. Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.

On a positive note, Dr. Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”

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

About one-third of U.S. adults struggled with medical debt during the pandemic, according to data from a Commonwealth Fund survey released July 16.

Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.

The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.

For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.

“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.

“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.

Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.

Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.

“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.

When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.

According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.

George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.

“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”

He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.

“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”

For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.

Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.

“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”

Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.

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

About one-third of U.S. adults struggled with medical debt during the pandemic, according to data from a Commonwealth Fund survey released July 16.

Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.

The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.

For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.

“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.

“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.

Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.

Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.

“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.

When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.

According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.

George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.

“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”

He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.

“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”

For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.

Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.

“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”

Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.

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

About one-third of U.S. adults struggled with medical debt during the pandemic, according to data from a Commonwealth Fund survey released July 16.

Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.

The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.

For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.

“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.

“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.

Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.

Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.

“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.

When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.

According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.

George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.

“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”

He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.

“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”

For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.

Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.

“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”

Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.

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