MDedge Rheumatology

COVID-19 rates are surging again, and many Americans who’ve been vaccinated are turning their anger toward those who refuse to get the shot.

Outraged at vaccine-hesitant people, some are even calling for mandates requiring all Americans to get inoculated, arguing the holdouts are allowing the Delta coronavirus variant to gain traction and reverse the progress the United States was making against the virus.

“I am angry, I am resentful, and I think it’s a fair and appropriate response,” said Jonathan Hyman, a Berea, Ohio, attorney who blames the unvaccinated for the backslide in pandemic progress.

Mr. Hyman has been following the difficult guidelines health experts have been urging from the beginning. He has been masking up, avoiding large gatherings, postponing travel, and he signed up to receive the vaccine as soon as it was available.

“We have been responsible, I did everything I was supposed to do,” said Mr. Hyman, 48, who didn’t visit his parents for 18 months to keep them safe. “Yet here we are, 16, 17 months later, and it feels like we’re in the exact same place we were last summer, and it’s all because some people refuse to do the responsible things they were told to do.”

James Simmons, a retired South Florida high school finance teacher, is also angered by the vaccine holdouts, citing new spikes in COVID-19 infections, hospitalization rates, and deaths across the country – nearly all of which are among unvaccinated people.

“I can’t fathom the fact that people have seen over 600,000 Americans die from COVID, yet are resistant to a vaccine that provides direct protection for themselves and others,” said Mr. Simmons, 63, who received the shot early. “Their irresponsible decision is an affront to those of us who are vaccinated and still wear masks for the benefit of our society.”

Melissa Martin, an Atlanta resident who contracted a serious case of COVID-19 in September 2020, says it is “perplexing and frustrating” that so many Americans are refusing the vaccine. She believes the anger so many vaccinated people feel is tied to fear.

“I believe at the core of this anger is a fear of losing the ones we love,” said Ms. Martin, 55, who has been vaccinated, as has her fiancé, Shane McGeehin. “I was very angry last year after contracting COVID. The experience of having COVID was negative physically, emotionally, and socially.”

She recalled arguing with friends and relatives who downplayed how severe the virus was and who still refuse vaccination, despite seeing how COVID affected her.

“I am trying to understand why they feel the way they do,” she said, “but I would describe the emotions I have now towards those who do not get the vaccine as frustration, confusion, and disbelief.”

Leana Wen, MD, an emergency medicine doctor and public health policy professor at George Washington University, said such sentiments are common and justified.

“I understand that feeling of frustration and anger, because it is the unvaccinated who are setting back the progress that we’ve made [because of] the many sacrifices that many people have undergone,” said Dr. Wen, author of the newly published book “Lifelines: A Doctor’s Journey in the Fight for Public Health.”

“I think it is appropriate for the vaccinated to feel like they’re being punished right now,” she said. “We as a country had the opportunity to beat this virus – to return to prepandemic normal [life] and have our kids go back to school without worrying about coronavirus and our economy fully recovering. We came so close to achieving this, but we didn’t, and now COVID-19 is surging again. The vaccinated are having to pay the price for the choices that some have made to not end this pandemic.”
 

COVID rising, driving anger

The rising anger among vaccinated Americans comes as health officials are reporting huge spikes in new cases, hospitalizations, and deaths. Meanwhile, only about half of all Americans fully vaccinated, according to the Centers for Disease Control and Prevention.

Per Aug. 6 estimates from the CDC, the nation is averaging more than 100,000 new cases every day – the highest levels seen since February.

Southern states, with the lowest vaccination rates in the country, have been particularly hard-hit. Florida and Louisiana recently set 7-day records for new cases and hospitalizations, beating previous peaks last summer. Those two states, along with Mississippi, North Carolina, South Carolina, Tennessee, Kentucky, and Georgia, account for 41% of all new COVID-19 hospitalizations in the country, according to the CDC.

“It’s time to start blaming the unvaccinated folks, not the regular folks,” an angry Gov. Kay Ivey (R) of Alabama, told reporters. “It’s the unvaccinated folks that are letting us down.”

In response to the resurgence in cases, President Joe Biden has ordered new vaccine mandates for millions of federal workers.

California started requiring health care professionals to be vaccinated in August 2021, removing the option for unvaccinated employees to submit to regular testing.

New York City became the first in the country to require proof of vaccination for all workers and customers to enter restaurants, gyms, concert halls, movie theaters, and Broadway venues.

Nearly 60 major medical organizations, including the American Medical Association and the American Nurses Association, have called for mandatory vaccination of all health care workers.

Meanwhile, many businesses are requiring workers to be vaccinated before returning to offices and other workplaces. Colleges across the country are mandating the shots for students and staff. And some states and cities are also returning to mask mandates, including Hawaii; Louisiana; Washington, D.C.; San Francisco; and Los Angeles.

Experts say the 90 million unvaccinated Americans are most at risk from COVID and have helped the new Delta variant gain a foothold and spread, posing a risk of “breakthrough” cases even in vaccinated people.

Delta is more contagious and causes more severe disease than other known variants of the virus, according to the CDC. It is also more contagious than the viruses that cause Middle East respiratory syndrome, severe acute respiratory syndrome, Ebola, the common cold, flu, and smallpox
 

Calls for mandates grow

With Delta helping to drive new spikes in COVID cases, some vaccinated Americans argue that the federal government should be taking a harder line with holdouts. Others have even advocated withholding government stimulus checks or tax credits from vaccine refusers and cutting federal funding to states that don’t meet vaccine targets.

Eric Jaffe, a creative writer and producer from Florida who is vaccinated, said he would like to see government agencies and private businesses do more to put pressure on unvaccinated Americans to get the shot.

“In the interest of public safety, I believe the government and private businesses need to [make] life difficult for the unvaccinated,” said Mr. Jaffe, 29, whose parents both contracted the virus but recovered. “They should not be allowed to dine at restaurants, ride public transportation, attend concerts, or broadly be in spaces with large concentrations of people without passing a COVID test at the door.

“They’ll stand in long lines and be inconvenienced at every turn, while vaccinated people get to fly through security, TSA PreCheck-style. The holdouts at [this] point are beyond convincing. The vaccinated should be able to return to a level of normalcy, and the unvaccinated should face restrictions. Any other dynamic puts the stress on citizens who did the right thing.”

Elif Akcali, 49, who teaches engineering at the University of Florida, Gainesville, worries that the rights of people who refuse the vaccine are being put ahead of those of vaccinated people. She’s also concerned for people who face greater COVID risks, including health care workers and children too young to be inoculated.

“Each infection is an opportunity for the virus to evolve into a stronger version in itself,” said Ms. Akcali, who felt such a sense of relief when she received her vaccination that she teared up. “Each hospitalization is an unnecessary burden to health care workers and the system. Each death brings heartbreak to someone in their circle.”

Ed Berliner, an Emmy Award–winning broadcast journalist and Florida-based media specialist, blames social media for spreading misinformation that has taken root with unvaccinated Americans.

“When America rallied together to combat polio, there were two things we didn’t have. One was a lack of the sewer-dwelling, troll-infested social media, which has become the main source of news for the less intelligent and arrogant,” said Mr. Berliner, CEO of Entourage Media and host of The Man in the Arena, a talk show. “Second, children were dying across the country, and that made people sit up and take notice.”

Mr. Berliner, who knows two people who’ve died from COVID and who received the vaccine early, also believes too many political leaders are still fueling falsehoods that are giving unvaccinated Americans a license to refuse the shot.

“We are also here because governments and officials spend too little time being brutally honest, choosing instead to dance around issues with soft words,” he said. “The first words out of their mouths should have been: ‘What we are doing is trying to save lives. Help us save your life and that of everyone else.’ Would it have made a difference? We will never know.”

Shon Neyland, senior pastor at the Highland Christian Center church in Portland, Ore., said vaccine tensions have divided his congregation, with about half refusing the shot by his estimation. But he said it’s important to understand why some are making that choice, rather than rage at them and hammer home the benefits of the shot.

Many vaccine holdouts don’t trust the government or medical establishment or have bought into political arguments against the shot, he says. Some conservative evangelicals are also swayed by spiritual beliefs that COVID-19 is a sign of “biblical end-times prophesies” and the vaccine is “the mark of the beast.”

But he has tried to counter those beliefs and biases, arguing they are false and unfounded, urging members of his church to get the vaccine, and partnering with local health officials to run clinics to deliver it.

“I gently try to show them that the vaccine is for our own good and, in fact, is a blessing from God, and it’s up to us to accept the blessing [so] we can get back to somewhat of normalcy,” said Mr. Neyland, author of “The Courage to Stand: A New America.”

“I also believe that to get a vaccine this quick, this was nothing short of a miracle to turn the tide so quickly. Now, for us to resist, it would cause us to continue to suffer and lose lives. And you can’t turn away from the lives that have already been lost.”

Mr. Hyman fears we may not have seen the worst of the pandemic and that the Delta variant won’t be the last or most virulent mutation to emerge.

“The number of unvaccinated people is allowing this virus to continue circulating in the community,” he noted. “And while I have a tremendous amount of confidence that the vaccine protects me now from Delta, I have less confidence that it’s going to protect me from whatever [variant] comes next.

“So, I have a tremendous amount of concern for my own health and safety and welfare, and that of the people that I love. But I’m also concerned about what’s it going to do to businesses [and] the economy. Are we going to have more shutdowns if cases continue trending up? I’m very concerned as to what this could do [to] the country.”

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

COVID-19 rates are surging again, and many Americans who’ve been vaccinated are turning their anger toward those who refuse to get the shot.

Outraged at vaccine-hesitant people, some are even calling for mandates requiring all Americans to get inoculated, arguing the holdouts are allowing the Delta coronavirus variant to gain traction and reverse the progress the United States was making against the virus.

“I am angry, I am resentful, and I think it’s a fair and appropriate response,” said Jonathan Hyman, a Berea, Ohio, attorney who blames the unvaccinated for the backslide in pandemic progress.

Mr. Hyman has been following the difficult guidelines health experts have been urging from the beginning. He has been masking up, avoiding large gatherings, postponing travel, and he signed up to receive the vaccine as soon as it was available.

“We have been responsible, I did everything I was supposed to do,” said Mr. Hyman, 48, who didn’t visit his parents for 18 months to keep them safe. “Yet here we are, 16, 17 months later, and it feels like we’re in the exact same place we were last summer, and it’s all because some people refuse to do the responsible things they were told to do.”

James Simmons, a retired South Florida high school finance teacher, is also angered by the vaccine holdouts, citing new spikes in COVID-19 infections, hospitalization rates, and deaths across the country – nearly all of which are among unvaccinated people.

“I can’t fathom the fact that people have seen over 600,000 Americans die from COVID, yet are resistant to a vaccine that provides direct protection for themselves and others,” said Mr. Simmons, 63, who received the shot early. “Their irresponsible decision is an affront to those of us who are vaccinated and still wear masks for the benefit of our society.”

Melissa Martin, an Atlanta resident who contracted a serious case of COVID-19 in September 2020, says it is “perplexing and frustrating” that so many Americans are refusing the vaccine. She believes the anger so many vaccinated people feel is tied to fear.

“I believe at the core of this anger is a fear of losing the ones we love,” said Ms. Martin, 55, who has been vaccinated, as has her fiancé, Shane McGeehin. “I was very angry last year after contracting COVID. The experience of having COVID was negative physically, emotionally, and socially.”

She recalled arguing with friends and relatives who downplayed how severe the virus was and who still refuse vaccination, despite seeing how COVID affected her.

“I am trying to understand why they feel the way they do,” she said, “but I would describe the emotions I have now towards those who do not get the vaccine as frustration, confusion, and disbelief.”

Leana Wen, MD, an emergency medicine doctor and public health policy professor at George Washington University, said such sentiments are common and justified.

“I understand that feeling of frustration and anger, because it is the unvaccinated who are setting back the progress that we’ve made [because of] the many sacrifices that many people have undergone,” said Dr. Wen, author of the newly published book “Lifelines: A Doctor’s Journey in the Fight for Public Health.”

“I think it is appropriate for the vaccinated to feel like they’re being punished right now,” she said. “We as a country had the opportunity to beat this virus – to return to prepandemic normal [life] and have our kids go back to school without worrying about coronavirus and our economy fully recovering. We came so close to achieving this, but we didn’t, and now COVID-19 is surging again. The vaccinated are having to pay the price for the choices that some have made to not end this pandemic.”
 

COVID rising, driving anger

The rising anger among vaccinated Americans comes as health officials are reporting huge spikes in new cases, hospitalizations, and deaths. Meanwhile, only about half of all Americans fully vaccinated, according to the Centers for Disease Control and Prevention.

Per Aug. 6 estimates from the CDC, the nation is averaging more than 100,000 new cases every day – the highest levels seen since February.

Southern states, with the lowest vaccination rates in the country, have been particularly hard-hit. Florida and Louisiana recently set 7-day records for new cases and hospitalizations, beating previous peaks last summer. Those two states, along with Mississippi, North Carolina, South Carolina, Tennessee, Kentucky, and Georgia, account for 41% of all new COVID-19 hospitalizations in the country, according to the CDC.

“It’s time to start blaming the unvaccinated folks, not the regular folks,” an angry Gov. Kay Ivey (R) of Alabama, told reporters. “It’s the unvaccinated folks that are letting us down.”

In response to the resurgence in cases, President Joe Biden has ordered new vaccine mandates for millions of federal workers.

California started requiring health care professionals to be vaccinated in August 2021, removing the option for unvaccinated employees to submit to regular testing.

New York City became the first in the country to require proof of vaccination for all workers and customers to enter restaurants, gyms, concert halls, movie theaters, and Broadway venues.

Nearly 60 major medical organizations, including the American Medical Association and the American Nurses Association, have called for mandatory vaccination of all health care workers.

Meanwhile, many businesses are requiring workers to be vaccinated before returning to offices and other workplaces. Colleges across the country are mandating the shots for students and staff. And some states and cities are also returning to mask mandates, including Hawaii; Louisiana; Washington, D.C.; San Francisco; and Los Angeles.

Experts say the 90 million unvaccinated Americans are most at risk from COVID and have helped the new Delta variant gain a foothold and spread, posing a risk of “breakthrough” cases even in vaccinated people.

Delta is more contagious and causes more severe disease than other known variants of the virus, according to the CDC. It is also more contagious than the viruses that cause Middle East respiratory syndrome, severe acute respiratory syndrome, Ebola, the common cold, flu, and smallpox
 

Calls for mandates grow

With Delta helping to drive new spikes in COVID cases, some vaccinated Americans argue that the federal government should be taking a harder line with holdouts. Others have even advocated withholding government stimulus checks or tax credits from vaccine refusers and cutting federal funding to states that don’t meet vaccine targets.

Eric Jaffe, a creative writer and producer from Florida who is vaccinated, said he would like to see government agencies and private businesses do more to put pressure on unvaccinated Americans to get the shot.

“In the interest of public safety, I believe the government and private businesses need to [make] life difficult for the unvaccinated,” said Mr. Jaffe, 29, whose parents both contracted the virus but recovered. “They should not be allowed to dine at restaurants, ride public transportation, attend concerts, or broadly be in spaces with large concentrations of people without passing a COVID test at the door.

“They’ll stand in long lines and be inconvenienced at every turn, while vaccinated people get to fly through security, TSA PreCheck-style. The holdouts at [this] point are beyond convincing. The vaccinated should be able to return to a level of normalcy, and the unvaccinated should face restrictions. Any other dynamic puts the stress on citizens who did the right thing.”

Elif Akcali, 49, who teaches engineering at the University of Florida, Gainesville, worries that the rights of people who refuse the vaccine are being put ahead of those of vaccinated people. She’s also concerned for people who face greater COVID risks, including health care workers and children too young to be inoculated.

“Each infection is an opportunity for the virus to evolve into a stronger version in itself,” said Ms. Akcali, who felt such a sense of relief when she received her vaccination that she teared up. “Each hospitalization is an unnecessary burden to health care workers and the system. Each death brings heartbreak to someone in their circle.”

Ed Berliner, an Emmy Award–winning broadcast journalist and Florida-based media specialist, blames social media for spreading misinformation that has taken root with unvaccinated Americans.

“When America rallied together to combat polio, there were two things we didn’t have. One was a lack of the sewer-dwelling, troll-infested social media, which has become the main source of news for the less intelligent and arrogant,” said Mr. Berliner, CEO of Entourage Media and host of The Man in the Arena, a talk show. “Second, children were dying across the country, and that made people sit up and take notice.”

Mr. Berliner, who knows two people who’ve died from COVID and who received the vaccine early, also believes too many political leaders are still fueling falsehoods that are giving unvaccinated Americans a license to refuse the shot.

“We are also here because governments and officials spend too little time being brutally honest, choosing instead to dance around issues with soft words,” he said. “The first words out of their mouths should have been: ‘What we are doing is trying to save lives. Help us save your life and that of everyone else.’ Would it have made a difference? We will never know.”

Shon Neyland, senior pastor at the Highland Christian Center church in Portland, Ore., said vaccine tensions have divided his congregation, with about half refusing the shot by his estimation. But he said it’s important to understand why some are making that choice, rather than rage at them and hammer home the benefits of the shot.

Many vaccine holdouts don’t trust the government or medical establishment or have bought into political arguments against the shot, he says. Some conservative evangelicals are also swayed by spiritual beliefs that COVID-19 is a sign of “biblical end-times prophesies” and the vaccine is “the mark of the beast.”

But he has tried to counter those beliefs and biases, arguing they are false and unfounded, urging members of his church to get the vaccine, and partnering with local health officials to run clinics to deliver it.

“I gently try to show them that the vaccine is for our own good and, in fact, is a blessing from God, and it’s up to us to accept the blessing [so] we can get back to somewhat of normalcy,” said Mr. Neyland, author of “The Courage to Stand: A New America.”

“I also believe that to get a vaccine this quick, this was nothing short of a miracle to turn the tide so quickly. Now, for us to resist, it would cause us to continue to suffer and lose lives. And you can’t turn away from the lives that have already been lost.”

Mr. Hyman fears we may not have seen the worst of the pandemic and that the Delta variant won’t be the last or most virulent mutation to emerge.

“The number of unvaccinated people is allowing this virus to continue circulating in the community,” he noted. “And while I have a tremendous amount of confidence that the vaccine protects me now from Delta, I have less confidence that it’s going to protect me from whatever [variant] comes next.

“So, I have a tremendous amount of concern for my own health and safety and welfare, and that of the people that I love. But I’m also concerned about what’s it going to do to businesses [and] the economy. Are we going to have more shutdowns if cases continue trending up? I’m very concerned as to what this could do [to] the country.”

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

COVID-19 rates are surging again, and many Americans who’ve been vaccinated are turning their anger toward those who refuse to get the shot.

Outraged at vaccine-hesitant people, some are even calling for mandates requiring all Americans to get inoculated, arguing the holdouts are allowing the Delta coronavirus variant to gain traction and reverse the progress the United States was making against the virus.

“I am angry, I am resentful, and I think it’s a fair and appropriate response,” said Jonathan Hyman, a Berea, Ohio, attorney who blames the unvaccinated for the backslide in pandemic progress.

Mr. Hyman has been following the difficult guidelines health experts have been urging from the beginning. He has been masking up, avoiding large gatherings, postponing travel, and he signed up to receive the vaccine as soon as it was available.

“We have been responsible, I did everything I was supposed to do,” said Mr. Hyman, 48, who didn’t visit his parents for 18 months to keep them safe. “Yet here we are, 16, 17 months later, and it feels like we’re in the exact same place we were last summer, and it’s all because some people refuse to do the responsible things they were told to do.”

James Simmons, a retired South Florida high school finance teacher, is also angered by the vaccine holdouts, citing new spikes in COVID-19 infections, hospitalization rates, and deaths across the country – nearly all of which are among unvaccinated people.

“I can’t fathom the fact that people have seen over 600,000 Americans die from COVID, yet are resistant to a vaccine that provides direct protection for themselves and others,” said Mr. Simmons, 63, who received the shot early. “Their irresponsible decision is an affront to those of us who are vaccinated and still wear masks for the benefit of our society.”

Melissa Martin, an Atlanta resident who contracted a serious case of COVID-19 in September 2020, says it is “perplexing and frustrating” that so many Americans are refusing the vaccine. She believes the anger so many vaccinated people feel is tied to fear.

“I believe at the core of this anger is a fear of losing the ones we love,” said Ms. Martin, 55, who has been vaccinated, as has her fiancé, Shane McGeehin. “I was very angry last year after contracting COVID. The experience of having COVID was negative physically, emotionally, and socially.”

She recalled arguing with friends and relatives who downplayed how severe the virus was and who still refuse vaccination, despite seeing how COVID affected her.

“I am trying to understand why they feel the way they do,” she said, “but I would describe the emotions I have now towards those who do not get the vaccine as frustration, confusion, and disbelief.”

Leana Wen, MD, an emergency medicine doctor and public health policy professor at George Washington University, said such sentiments are common and justified.

“I understand that feeling of frustration and anger, because it is the unvaccinated who are setting back the progress that we’ve made [because of] the many sacrifices that many people have undergone,” said Dr. Wen, author of the newly published book “Lifelines: A Doctor’s Journey in the Fight for Public Health.”

“I think it is appropriate for the vaccinated to feel like they’re being punished right now,” she said. “We as a country had the opportunity to beat this virus – to return to prepandemic normal [life] and have our kids go back to school without worrying about coronavirus and our economy fully recovering. We came so close to achieving this, but we didn’t, and now COVID-19 is surging again. The vaccinated are having to pay the price for the choices that some have made to not end this pandemic.”
 

COVID rising, driving anger

The rising anger among vaccinated Americans comes as health officials are reporting huge spikes in new cases, hospitalizations, and deaths. Meanwhile, only about half of all Americans fully vaccinated, according to the Centers for Disease Control and Prevention.

Per Aug. 6 estimates from the CDC, the nation is averaging more than 100,000 new cases every day – the highest levels seen since February.

Southern states, with the lowest vaccination rates in the country, have been particularly hard-hit. Florida and Louisiana recently set 7-day records for new cases and hospitalizations, beating previous peaks last summer. Those two states, along with Mississippi, North Carolina, South Carolina, Tennessee, Kentucky, and Georgia, account for 41% of all new COVID-19 hospitalizations in the country, according to the CDC.

“It’s time to start blaming the unvaccinated folks, not the regular folks,” an angry Gov. Kay Ivey (R) of Alabama, told reporters. “It’s the unvaccinated folks that are letting us down.”

In response to the resurgence in cases, President Joe Biden has ordered new vaccine mandates for millions of federal workers.

California started requiring health care professionals to be vaccinated in August 2021, removing the option for unvaccinated employees to submit to regular testing.

New York City became the first in the country to require proof of vaccination for all workers and customers to enter restaurants, gyms, concert halls, movie theaters, and Broadway venues.

Nearly 60 major medical organizations, including the American Medical Association and the American Nurses Association, have called for mandatory vaccination of all health care workers.

Meanwhile, many businesses are requiring workers to be vaccinated before returning to offices and other workplaces. Colleges across the country are mandating the shots for students and staff. And some states and cities are also returning to mask mandates, including Hawaii; Louisiana; Washington, D.C.; San Francisco; and Los Angeles.

Experts say the 90 million unvaccinated Americans are most at risk from COVID and have helped the new Delta variant gain a foothold and spread, posing a risk of “breakthrough” cases even in vaccinated people.

Delta is more contagious and causes more severe disease than other known variants of the virus, according to the CDC. It is also more contagious than the viruses that cause Middle East respiratory syndrome, severe acute respiratory syndrome, Ebola, the common cold, flu, and smallpox
 

Calls for mandates grow

With Delta helping to drive new spikes in COVID cases, some vaccinated Americans argue that the federal government should be taking a harder line with holdouts. Others have even advocated withholding government stimulus checks or tax credits from vaccine refusers and cutting federal funding to states that don’t meet vaccine targets.

Eric Jaffe, a creative writer and producer from Florida who is vaccinated, said he would like to see government agencies and private businesses do more to put pressure on unvaccinated Americans to get the shot.

“In the interest of public safety, I believe the government and private businesses need to [make] life difficult for the unvaccinated,” said Mr. Jaffe, 29, whose parents both contracted the virus but recovered. “They should not be allowed to dine at restaurants, ride public transportation, attend concerts, or broadly be in spaces with large concentrations of people without passing a COVID test at the door.

“They’ll stand in long lines and be inconvenienced at every turn, while vaccinated people get to fly through security, TSA PreCheck-style. The holdouts at [this] point are beyond convincing. The vaccinated should be able to return to a level of normalcy, and the unvaccinated should face restrictions. Any other dynamic puts the stress on citizens who did the right thing.”

Elif Akcali, 49, who teaches engineering at the University of Florida, Gainesville, worries that the rights of people who refuse the vaccine are being put ahead of those of vaccinated people. She’s also concerned for people who face greater COVID risks, including health care workers and children too young to be inoculated.

“Each infection is an opportunity for the virus to evolve into a stronger version in itself,” said Ms. Akcali, who felt such a sense of relief when she received her vaccination that she teared up. “Each hospitalization is an unnecessary burden to health care workers and the system. Each death brings heartbreak to someone in their circle.”

Ed Berliner, an Emmy Award–winning broadcast journalist and Florida-based media specialist, blames social media for spreading misinformation that has taken root with unvaccinated Americans.

“When America rallied together to combat polio, there were two things we didn’t have. One was a lack of the sewer-dwelling, troll-infested social media, which has become the main source of news for the less intelligent and arrogant,” said Mr. Berliner, CEO of Entourage Media and host of The Man in the Arena, a talk show. “Second, children were dying across the country, and that made people sit up and take notice.”

Mr. Berliner, who knows two people who’ve died from COVID and who received the vaccine early, also believes too many political leaders are still fueling falsehoods that are giving unvaccinated Americans a license to refuse the shot.

“We are also here because governments and officials spend too little time being brutally honest, choosing instead to dance around issues with soft words,” he said. “The first words out of their mouths should have been: ‘What we are doing is trying to save lives. Help us save your life and that of everyone else.’ Would it have made a difference? We will never know.”

Shon Neyland, senior pastor at the Highland Christian Center church in Portland, Ore., said vaccine tensions have divided his congregation, with about half refusing the shot by his estimation. But he said it’s important to understand why some are making that choice, rather than rage at them and hammer home the benefits of the shot.

Many vaccine holdouts don’t trust the government or medical establishment or have bought into political arguments against the shot, he says. Some conservative evangelicals are also swayed by spiritual beliefs that COVID-19 is a sign of “biblical end-times prophesies” and the vaccine is “the mark of the beast.”

But he has tried to counter those beliefs and biases, arguing they are false and unfounded, urging members of his church to get the vaccine, and partnering with local health officials to run clinics to deliver it.

“I gently try to show them that the vaccine is for our own good and, in fact, is a blessing from God, and it’s up to us to accept the blessing [so] we can get back to somewhat of normalcy,” said Mr. Neyland, author of “The Courage to Stand: A New America.”

“I also believe that to get a vaccine this quick, this was nothing short of a miracle to turn the tide so quickly. Now, for us to resist, it would cause us to continue to suffer and lose lives. And you can’t turn away from the lives that have already been lost.”

Mr. Hyman fears we may not have seen the worst of the pandemic and that the Delta variant won’t be the last or most virulent mutation to emerge.

“The number of unvaccinated people is allowing this virus to continue circulating in the community,” he noted. “And while I have a tremendous amount of confidence that the vaccine protects me now from Delta, I have less confidence that it’s going to protect me from whatever [variant] comes next.

“So, I have a tremendous amount of concern for my own health and safety and welfare, and that of the people that I love. But I’m also concerned about what’s it going to do to businesses [and] the economy. Are we going to have more shutdowns if cases continue trending up? I’m very concerned as to what this could do [to] the country.”

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

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

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

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

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

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

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

Alcoholic drinks are in the news again, served with a twist. A large cohort study saw a familiar J-shaped curve detailing risk for new atrial fibrillation (AFib) in which the risk rose steadily with greater number of drinks per week, except at the lowest levels of alcohol intake.

Kirby Hamilton/iStockphoto

There, the curve turned the other way. Light drinkers overall showed no higher AFib risk than nondrinkers, and the risk was lowest at any degree of alcohol intake up to 56 g per week.

On closer analysis of risk patterns, the type of alcoholic beverage mattered. Modest weekly intake of red wine, at least one serving but no more than seven, may have actually protected against new AFib, compared with zero intake.

Alcohol content per drink was defined by standards in the United Kingdom, where the cohort was based.

The risk of AFib also didn’t climb at low intake levels of white wine or with “very low” use of liquor or spirits. But it went up consistently at any level of beer or cider consumption, and to be sure, “high intake of any beverage was associated with greater AF[ib] risk,” notes a report on the study published July 27, 2021, in JACC: Clinical Electrophysiology.

The results, based on more than 400,000 adults in the community, “raise the possibility that, for current consumers, drinking red or white wine could potentially be a safer alternative to other types of alcoholic beverages with respect to AF[ib] risk,” the report proposes.

The J-shaped risk curve for new AFib by degree of alcohol consumption follows the pattern sometimes seen for cardiovascular risk in general. But the intake level at which AFib risk is flat or reduced “is at a far lower dose of alcohol than what we’ve seen for cardiovascular disease,” lead author Samuel J. Tu, BHlthMedSc, said in an interview.

“That being said, even with the threshold sitting quite low, it still tells us that cutting down on alcohol is a good thing and perhaps one of the best things for our heart,” said Mr. Tu, University of Adelaide and Royal Adelaide Hospital, who also presented the findings at the Heart Rhythm Society 2021 Scientific Sessions, held in Boston and virtually.
 

How much alcohol is in a drink?

In a caution for anyone looking to beer, wine, or liquor to protect against AFib, or at least not cause it, the weekly number of drinks associated with the lowest AFib risk may be fewer than expected. That bottom of 56 g per week works out to one drink a day or less for British and only four or fewer per week for Americans, according to the study’s internationally varying definitions for the alcohol content of one drink.

For example, a drink was considered to have 8 g of alcohol in the United Kingdom, 14 g in the United States and some other countries, and up to 20 g in Austria. Those numbers came from definitions used by the respective national health agencies, such as the National Health Service in the United Kingdom and Centers for Disease Control and Prevention in the United States, Mr. Tu explained.

“They all defined standard drinks slightly differently. But wherever we looked, the threshold we found was far lower than what our governments recommend” based on what is known about alcohol and overall cardiovascular risk, he said.
 

First to show a hint of protection

The current study “is especially noteworthy because it’s the really the first to demonstrate any hint that there could be a protective effect from any particular amount of alcohol in regard to atrial fibrillation,” Gregory M. Marcus, MD, MAS, University of California, San Francisco, said in an interview. “The J-shaped association fits with what’s been observed with myocardial infarction and overall mortality, and hasn’t previously been seen in the setting of atrial fibrillation.”

Quite interestingly, “it appeared to be the wine drinkers, rather than those who consumed other types of alcohol, that enjoyed this benefit,” said Dr. Marcus, who was not involved in the research but co-authored an accompanying editorial with UCSF colleague Thomas A. Dewland, MD.

“It’s important to recognize the overwhelming evidence that alcohol in general increases the risk for atrial fibrillation,” he said. But “perhaps there’s something in wine that is anti-inflammatory that has some beneficial effect that maybe overwhelms the proarrhythmic aspect.”

The current study “opens the door to the question as to whether there is a small amount of alcohol, perhaps in the form of wine, where there are some benefits that outweigh the risks of atrial fibrillation.”

Still, the findings are observational and “clearly prone to confounding,” Dr. Marcus said. “We need to be very cautious in inferring causality.”

For example, it’s possible that “there is something about individuals that are able to drink alcohol on a regular basis and in small amounts that is the actual causal factor in reducing atrial fibrillation episodes.”

The analysis was based on 403,281 participants in the UK Biobank registry, a prospective cohort study in the United Kingdom, who were aged 40-69 when recruited from 2006 to 2010; it excluded anyone with a history of AFib or who was a former drinker. About 52% were women, the report noted.

Their median alcohol consumption was eight U.K. drinks per week, with 5.5% reporting they had never consumed alcohol. About 21,300 incident cases of AFib or atrial flutter were documented over almost 4.5 million person-years, or a median follow-up of 11.4 years.

The hazard ratio for incident AFib among those with a weekly alcohol consumption corresponding to 1-7 U.K. drinks, compared with intake of less than 1 U.K. drink per week, was 0.95 (95% confidence interval, 0.91-1.00). Within that range of 1-7 drinks, the absolute lowest AFib risk on the J curve was at 5 per week.
 

No increased risk of new AFib was seen in association with weekly U.K. drink levels of 10 for red wine, 8 for white wine, and 3 for spirits.

Compared with weekly intake of less than 1 U.K. drink per week, red wine intake at 1-7 per week showed an HR for AFib of 0.94 (95% CI, 0.91-0.97). Indeed, at no observed consumption level was red wine associated with a significant increase in AFib risk. White wine until the highest observed level of intake, above 28 U.K. drinks per week, at which point the HR for AFib was 1.48 (98% CI 1.19-1.86). The curve for spirit intake followed a similar but steeper curve, its HR risk reaching 1.61 (95% CI, 1.34-1.93) at intake levels beyond 28 U.K. drinks per week.

Consumption of beer or cider showed a linear association with AFib risk, which was elevated at all recorded intake levels, including 8-14 U.K. drinks per week (HR, 1.11; 95% CI 1.06-1.17) and up to 28 or more per week (HR, 1.35; 95% CI, 1.26-1.45).

The analysis is hypothesis generating at best, Dr. Marcus emphasized. “Ultimately, a randomized trial would be the only way to be fairly certain if there is indeed a causal protective relationship between red wine, in low amounts, and atrial fib.”

The message for patients, proposed Dr. Dewland and Dr. Marcus, is that alcohol abstinence is best for secondary AFib prevention, “especially if alcohol is a personal trigger for acute AF[ib] episodes,” and that for primary AFib prevention, “continued consumption of some alcohol may be reasonable, but the exact threshold is unclear and is likely a very low amount.”

Mr. Tu has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Marcus disclosed receiving research funding from Baylis Medical; consulting for Johnson & Johnson and InCarda; and holding equity interest in InCarda. Dr. Dewland reports no relevant financial relationships.

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

Alcoholic drinks are in the news again, served with a twist. A large cohort study saw a familiar J-shaped curve detailing risk for new atrial fibrillation (AFib) in which the risk rose steadily with greater number of drinks per week, except at the lowest levels of alcohol intake.

Kirby Hamilton/iStockphoto

There, the curve turned the other way. Light drinkers overall showed no higher AFib risk than nondrinkers, and the risk was lowest at any degree of alcohol intake up to 56 g per week.

On closer analysis of risk patterns, the type of alcoholic beverage mattered. Modest weekly intake of red wine, at least one serving but no more than seven, may have actually protected against new AFib, compared with zero intake.

Alcohol content per drink was defined by standards in the United Kingdom, where the cohort was based.

The risk of AFib also didn’t climb at low intake levels of white wine or with “very low” use of liquor or spirits. But it went up consistently at any level of beer or cider consumption, and to be sure, “high intake of any beverage was associated with greater AF[ib] risk,” notes a report on the study published July 27, 2021, in JACC: Clinical Electrophysiology.

The results, based on more than 400,000 adults in the community, “raise the possibility that, for current consumers, drinking red or white wine could potentially be a safer alternative to other types of alcoholic beverages with respect to AF[ib] risk,” the report proposes.

The J-shaped risk curve for new AFib by degree of alcohol consumption follows the pattern sometimes seen for cardiovascular risk in general. But the intake level at which AFib risk is flat or reduced “is at a far lower dose of alcohol than what we’ve seen for cardiovascular disease,” lead author Samuel J. Tu, BHlthMedSc, said in an interview.

“That being said, even with the threshold sitting quite low, it still tells us that cutting down on alcohol is a good thing and perhaps one of the best things for our heart,” said Mr. Tu, University of Adelaide and Royal Adelaide Hospital, who also presented the findings at the Heart Rhythm Society 2021 Scientific Sessions, held in Boston and virtually.
 

How much alcohol is in a drink?

In a caution for anyone looking to beer, wine, or liquor to protect against AFib, or at least not cause it, the weekly number of drinks associated with the lowest AFib risk may be fewer than expected. That bottom of 56 g per week works out to one drink a day or less for British and only four or fewer per week for Americans, according to the study’s internationally varying definitions for the alcohol content of one drink.

For example, a drink was considered to have 8 g of alcohol in the United Kingdom, 14 g in the United States and some other countries, and up to 20 g in Austria. Those numbers came from definitions used by the respective national health agencies, such as the National Health Service in the United Kingdom and Centers for Disease Control and Prevention in the United States, Mr. Tu explained.

“They all defined standard drinks slightly differently. But wherever we looked, the threshold we found was far lower than what our governments recommend” based on what is known about alcohol and overall cardiovascular risk, he said.
 

First to show a hint of protection

The current study “is especially noteworthy because it’s the really the first to demonstrate any hint that there could be a protective effect from any particular amount of alcohol in regard to atrial fibrillation,” Gregory M. Marcus, MD, MAS, University of California, San Francisco, said in an interview. “The J-shaped association fits with what’s been observed with myocardial infarction and overall mortality, and hasn’t previously been seen in the setting of atrial fibrillation.”

Quite interestingly, “it appeared to be the wine drinkers, rather than those who consumed other types of alcohol, that enjoyed this benefit,” said Dr. Marcus, who was not involved in the research but co-authored an accompanying editorial with UCSF colleague Thomas A. Dewland, MD.

“It’s important to recognize the overwhelming evidence that alcohol in general increases the risk for atrial fibrillation,” he said. But “perhaps there’s something in wine that is anti-inflammatory that has some beneficial effect that maybe overwhelms the proarrhythmic aspect.”

The current study “opens the door to the question as to whether there is a small amount of alcohol, perhaps in the form of wine, where there are some benefits that outweigh the risks of atrial fibrillation.”

Still, the findings are observational and “clearly prone to confounding,” Dr. Marcus said. “We need to be very cautious in inferring causality.”

For example, it’s possible that “there is something about individuals that are able to drink alcohol on a regular basis and in small amounts that is the actual causal factor in reducing atrial fibrillation episodes.”

The analysis was based on 403,281 participants in the UK Biobank registry, a prospective cohort study in the United Kingdom, who were aged 40-69 when recruited from 2006 to 2010; it excluded anyone with a history of AFib or who was a former drinker. About 52% were women, the report noted.

Their median alcohol consumption was eight U.K. drinks per week, with 5.5% reporting they had never consumed alcohol. About 21,300 incident cases of AFib or atrial flutter were documented over almost 4.5 million person-years, or a median follow-up of 11.4 years.

The hazard ratio for incident AFib among those with a weekly alcohol consumption corresponding to 1-7 U.K. drinks, compared with intake of less than 1 U.K. drink per week, was 0.95 (95% confidence interval, 0.91-1.00). Within that range of 1-7 drinks, the absolute lowest AFib risk on the J curve was at 5 per week.
 

No increased risk of new AFib was seen in association with weekly U.K. drink levels of 10 for red wine, 8 for white wine, and 3 for spirits.

Compared with weekly intake of less than 1 U.K. drink per week, red wine intake at 1-7 per week showed an HR for AFib of 0.94 (95% CI, 0.91-0.97). Indeed, at no observed consumption level was red wine associated with a significant increase in AFib risk. White wine until the highest observed level of intake, above 28 U.K. drinks per week, at which point the HR for AFib was 1.48 (98% CI 1.19-1.86). The curve for spirit intake followed a similar but steeper curve, its HR risk reaching 1.61 (95% CI, 1.34-1.93) at intake levels beyond 28 U.K. drinks per week.

Consumption of beer or cider showed a linear association with AFib risk, which was elevated at all recorded intake levels, including 8-14 U.K. drinks per week (HR, 1.11; 95% CI 1.06-1.17) and up to 28 or more per week (HR, 1.35; 95% CI, 1.26-1.45).

The analysis is hypothesis generating at best, Dr. Marcus emphasized. “Ultimately, a randomized trial would be the only way to be fairly certain if there is indeed a causal protective relationship between red wine, in low amounts, and atrial fib.”

The message for patients, proposed Dr. Dewland and Dr. Marcus, is that alcohol abstinence is best for secondary AFib prevention, “especially if alcohol is a personal trigger for acute AF[ib] episodes,” and that for primary AFib prevention, “continued consumption of some alcohol may be reasonable, but the exact threshold is unclear and is likely a very low amount.”

Mr. Tu has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Marcus disclosed receiving research funding from Baylis Medical; consulting for Johnson & Johnson and InCarda; and holding equity interest in InCarda. Dr. Dewland reports no relevant financial relationships.

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

Alcoholic drinks are in the news again, served with a twist. A large cohort study saw a familiar J-shaped curve detailing risk for new atrial fibrillation (AFib) in which the risk rose steadily with greater number of drinks per week, except at the lowest levels of alcohol intake.

Kirby Hamilton/iStockphoto

There, the curve turned the other way. Light drinkers overall showed no higher AFib risk than nondrinkers, and the risk was lowest at any degree of alcohol intake up to 56 g per week.

On closer analysis of risk patterns, the type of alcoholic beverage mattered. Modest weekly intake of red wine, at least one serving but no more than seven, may have actually protected against new AFib, compared with zero intake.

Alcohol content per drink was defined by standards in the United Kingdom, where the cohort was based.

The risk of AFib also didn’t climb at low intake levels of white wine or with “very low” use of liquor or spirits. But it went up consistently at any level of beer or cider consumption, and to be sure, “high intake of any beverage was associated with greater AF[ib] risk,” notes a report on the study published July 27, 2021, in JACC: Clinical Electrophysiology.

The results, based on more than 400,000 adults in the community, “raise the possibility that, for current consumers, drinking red or white wine could potentially be a safer alternative to other types of alcoholic beverages with respect to AF[ib] risk,” the report proposes.

The J-shaped risk curve for new AFib by degree of alcohol consumption follows the pattern sometimes seen for cardiovascular risk in general. But the intake level at which AFib risk is flat or reduced “is at a far lower dose of alcohol than what we’ve seen for cardiovascular disease,” lead author Samuel J. Tu, BHlthMedSc, said in an interview.

“That being said, even with the threshold sitting quite low, it still tells us that cutting down on alcohol is a good thing and perhaps one of the best things for our heart,” said Mr. Tu, University of Adelaide and Royal Adelaide Hospital, who also presented the findings at the Heart Rhythm Society 2021 Scientific Sessions, held in Boston and virtually.
 

How much alcohol is in a drink?

In a caution for anyone looking to beer, wine, or liquor to protect against AFib, or at least not cause it, the weekly number of drinks associated with the lowest AFib risk may be fewer than expected. That bottom of 56 g per week works out to one drink a day or less for British and only four or fewer per week for Americans, according to the study’s internationally varying definitions for the alcohol content of one drink.

For example, a drink was considered to have 8 g of alcohol in the United Kingdom, 14 g in the United States and some other countries, and up to 20 g in Austria. Those numbers came from definitions used by the respective national health agencies, such as the National Health Service in the United Kingdom and Centers for Disease Control and Prevention in the United States, Mr. Tu explained.

“They all defined standard drinks slightly differently. But wherever we looked, the threshold we found was far lower than what our governments recommend” based on what is known about alcohol and overall cardiovascular risk, he said.
 

First to show a hint of protection

The current study “is especially noteworthy because it’s the really the first to demonstrate any hint that there could be a protective effect from any particular amount of alcohol in regard to atrial fibrillation,” Gregory M. Marcus, MD, MAS, University of California, San Francisco, said in an interview. “The J-shaped association fits with what’s been observed with myocardial infarction and overall mortality, and hasn’t previously been seen in the setting of atrial fibrillation.”

Quite interestingly, “it appeared to be the wine drinkers, rather than those who consumed other types of alcohol, that enjoyed this benefit,” said Dr. Marcus, who was not involved in the research but co-authored an accompanying editorial with UCSF colleague Thomas A. Dewland, MD.

“It’s important to recognize the overwhelming evidence that alcohol in general increases the risk for atrial fibrillation,” he said. But “perhaps there’s something in wine that is anti-inflammatory that has some beneficial effect that maybe overwhelms the proarrhythmic aspect.”

The current study “opens the door to the question as to whether there is a small amount of alcohol, perhaps in the form of wine, where there are some benefits that outweigh the risks of atrial fibrillation.”

Still, the findings are observational and “clearly prone to confounding,” Dr. Marcus said. “We need to be very cautious in inferring causality.”

For example, it’s possible that “there is something about individuals that are able to drink alcohol on a regular basis and in small amounts that is the actual causal factor in reducing atrial fibrillation episodes.”

The analysis was based on 403,281 participants in the UK Biobank registry, a prospective cohort study in the United Kingdom, who were aged 40-69 when recruited from 2006 to 2010; it excluded anyone with a history of AFib or who was a former drinker. About 52% were women, the report noted.

Their median alcohol consumption was eight U.K. drinks per week, with 5.5% reporting they had never consumed alcohol. About 21,300 incident cases of AFib or atrial flutter were documented over almost 4.5 million person-years, or a median follow-up of 11.4 years.

The hazard ratio for incident AFib among those with a weekly alcohol consumption corresponding to 1-7 U.K. drinks, compared with intake of less than 1 U.K. drink per week, was 0.95 (95% confidence interval, 0.91-1.00). Within that range of 1-7 drinks, the absolute lowest AFib risk on the J curve was at 5 per week.
 

No increased risk of new AFib was seen in association with weekly U.K. drink levels of 10 for red wine, 8 for white wine, and 3 for spirits.

Compared with weekly intake of less than 1 U.K. drink per week, red wine intake at 1-7 per week showed an HR for AFib of 0.94 (95% CI, 0.91-0.97). Indeed, at no observed consumption level was red wine associated with a significant increase in AFib risk. White wine until the highest observed level of intake, above 28 U.K. drinks per week, at which point the HR for AFib was 1.48 (98% CI 1.19-1.86). The curve for spirit intake followed a similar but steeper curve, its HR risk reaching 1.61 (95% CI, 1.34-1.93) at intake levels beyond 28 U.K. drinks per week.

Consumption of beer or cider showed a linear association with AFib risk, which was elevated at all recorded intake levels, including 8-14 U.K. drinks per week (HR, 1.11; 95% CI 1.06-1.17) and up to 28 or more per week (HR, 1.35; 95% CI, 1.26-1.45).

The analysis is hypothesis generating at best, Dr. Marcus emphasized. “Ultimately, a randomized trial would be the only way to be fairly certain if there is indeed a causal protective relationship between red wine, in low amounts, and atrial fib.”

The message for patients, proposed Dr. Dewland and Dr. Marcus, is that alcohol abstinence is best for secondary AFib prevention, “especially if alcohol is a personal trigger for acute AF[ib] episodes,” and that for primary AFib prevention, “continued consumption of some alcohol may be reasonable, but the exact threshold is unclear and is likely a very low amount.”

Mr. Tu has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Marcus disclosed receiving research funding from Baylis Medical; consulting for Johnson & Johnson and InCarda; and holding equity interest in InCarda. Dr. Dewland reports no relevant financial relationships.

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

People beginning treatment with the immunosuppressive drugs tocilizumab (Actemra) or tofacitinib (Xeljanz) are infrequently screened for hepatitis B virus (HBV) infection, according to a new study of patients with rheumatic diseases who are starting one of the two treatments.

“Perhaps not unexpectedly, these screening patterns conform more with recommendations from the American College of Rheumatology, which do not explicitly stipulate universal HBV screening,” wrote lead author Amir M. Mohareb, MD, of Massachusetts General Hospital in Boston. The study was published in The Journal of Rheumatology.

To determine the frequency of HBV screening among this specific population, the researchers conducted a retrospective, cross-sectional study of patients 18 years or older within the Mass General Brigham health system in the Boston area who initiated either of the two drugs before Dec. 31, 2018. Tocilizumab was approved by the Food and Drug Administration on Jan. 11, 2010, and tofacitinib was approved on Nov. 6, 2012.

The final study population included 678 patients on tocilizumab and 391 patients on tofacitinib. The mean age of the patients in each group was 61 years for tocilizumab and 60 years for tofacitinib. A large majority were female (78% of the tocilizumab group, 88% of the tofacitinib group) and 84% of patients in both groups were white. Their primary diagnosis was rheumatoid arthritis (53% of the tocilizumab group, 77% of the tofacitinib group), and most of them – 57% of patients on tocilizumab and 72% of patients on tofacitinib – had a history of being on both conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARDs).

HBV screening patterns were classified into three categories: complete (all three of the HBV surface antigen [HBsAg], total core antibody [anti-HBcAb], and surface antibody [HBsAb] tests); partial (any one to two tests); and none. Of the 678 patients on tocilizumab, 194 (29%) underwent complete screening, 307 (45%) underwent partial screening, and 177 (26%) had no screening. Of the 391 patients on tofacitinib, 94 (24%) underwent complete screening, 195 (50%) underwent partial screening, and 102 (26%) had none.

Inappropriate testing – defined as either HBV e-antigen (HBeAg), anti-HBcAb IgM, or HBV DNA without a positive HBsAg or total anti-HBcAb – occurred in 22% of patients on tocilizumab and 23% of patients on tofacitinib. After multivariable analysis, the authors found that Whites were less likely to undergo complete screening (odds ratio, 0.74; 95% confidence interval, 0.57-0.95) compared to non-Whites. Previous use of immunosuppressive agents such as conventional synthetic DMARDs (OR, 1.05; 95% CI, 0.72-1.55) and biologic DMARDs with or without prior csDMARDs (OR, 0.73; 95% CI, 0.48-1.12) was not associated with a likelihood of complete appropriate screening.

“These data add to the evidence indicating that clinicians are not completing pretreatment screening for latent infections prior to patients starting high-risk immunosuppressant drugs,” Gabriela Schmajuk, MD, of the University of California, San Francisco, said in an interview. “It can be dangerous, since a fraction of these patients may reactivate latent infections with HBV that can result in liver failure or death.

“On the bright side,” she added, “we have antivirals that can be given as prophylaxis against reactivation of latent HBV if patients do test positive.”

Dr. Schmajuk was previously the senior author of a similar study from the 2019 American College of Rheumatology annual meeting that found only a small percentage of patients who were new users of biologics or new synthetic DMARDs were screened for HBV or hepatitis C virus.

When asked if anything in the study stood out, she acknowledged being “somewhat surprised that patients with prior immunosuppression did not have higher rates of screening. One might expect that since those patients had more opportunities for screening – since they started new medications more times – they would have higher rates, but this did not appear to be the case.”

As a message to rheumatologists who may be starting their patients on any biologic or new synthetic DMARD, she reinforced that “we need universal HBV screening for patients starting these medications. Many clinicians are used to ordering a hepatitis B surface antigen test, but one key message is that we also need to be ordering hepatitis B core antibody tests. Patients with a positive core antibody are still at risk for reactivation.”

The authors noted their study’s limitations, including the data being retrospectively collected and some of the subjects potentially being screened in laboratories outside of the Mass General Brigham health system. In addition, they stated that their findings “may not be generalizable to nonrheumatologic settings or other immunomodulators,” although they added that studies of other patient populations have also uncovered “similarly low HBV screening frequencies.”

Several of the authors reported being supported by institutes within the National Institutes of Health. Beyond that, they declared no potential conflicts of interest.

People beginning treatment with the immunosuppressive drugs tocilizumab (Actemra) or tofacitinib (Xeljanz) are infrequently screened for hepatitis B virus (HBV) infection, according to a new study of patients with rheumatic diseases who are starting one of the two treatments.

“Perhaps not unexpectedly, these screening patterns conform more with recommendations from the American College of Rheumatology, which do not explicitly stipulate universal HBV screening,” wrote lead author Amir M. Mohareb, MD, of Massachusetts General Hospital in Boston. The study was published in The Journal of Rheumatology.

To determine the frequency of HBV screening among this specific population, the researchers conducted a retrospective, cross-sectional study of patients 18 years or older within the Mass General Brigham health system in the Boston area who initiated either of the two drugs before Dec. 31, 2018. Tocilizumab was approved by the Food and Drug Administration on Jan. 11, 2010, and tofacitinib was approved on Nov. 6, 2012.

The final study population included 678 patients on tocilizumab and 391 patients on tofacitinib. The mean age of the patients in each group was 61 years for tocilizumab and 60 years for tofacitinib. A large majority were female (78% of the tocilizumab group, 88% of the tofacitinib group) and 84% of patients in both groups were white. Their primary diagnosis was rheumatoid arthritis (53% of the tocilizumab group, 77% of the tofacitinib group), and most of them – 57% of patients on tocilizumab and 72% of patients on tofacitinib – had a history of being on both conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARDs).

HBV screening patterns were classified into three categories: complete (all three of the HBV surface antigen [HBsAg], total core antibody [anti-HBcAb], and surface antibody [HBsAb] tests); partial (any one to two tests); and none. Of the 678 patients on tocilizumab, 194 (29%) underwent complete screening, 307 (45%) underwent partial screening, and 177 (26%) had no screening. Of the 391 patients on tofacitinib, 94 (24%) underwent complete screening, 195 (50%) underwent partial screening, and 102 (26%) had none.

Inappropriate testing – defined as either HBV e-antigen (HBeAg), anti-HBcAb IgM, or HBV DNA without a positive HBsAg or total anti-HBcAb – occurred in 22% of patients on tocilizumab and 23% of patients on tofacitinib. After multivariable analysis, the authors found that Whites were less likely to undergo complete screening (odds ratio, 0.74; 95% confidence interval, 0.57-0.95) compared to non-Whites. Previous use of immunosuppressive agents such as conventional synthetic DMARDs (OR, 1.05; 95% CI, 0.72-1.55) and biologic DMARDs with or without prior csDMARDs (OR, 0.73; 95% CI, 0.48-1.12) was not associated with a likelihood of complete appropriate screening.

“These data add to the evidence indicating that clinicians are not completing pretreatment screening for latent infections prior to patients starting high-risk immunosuppressant drugs,” Gabriela Schmajuk, MD, of the University of California, San Francisco, said in an interview. “It can be dangerous, since a fraction of these patients may reactivate latent infections with HBV that can result in liver failure or death.

“On the bright side,” she added, “we have antivirals that can be given as prophylaxis against reactivation of latent HBV if patients do test positive.”

Dr. Schmajuk was previously the senior author of a similar study from the 2019 American College of Rheumatology annual meeting that found only a small percentage of patients who were new users of biologics or new synthetic DMARDs were screened for HBV or hepatitis C virus.

When asked if anything in the study stood out, she acknowledged being “somewhat surprised that patients with prior immunosuppression did not have higher rates of screening. One might expect that since those patients had more opportunities for screening – since they started new medications more times – they would have higher rates, but this did not appear to be the case.”

As a message to rheumatologists who may be starting their patients on any biologic or new synthetic DMARD, she reinforced that “we need universal HBV screening for patients starting these medications. Many clinicians are used to ordering a hepatitis B surface antigen test, but one key message is that we also need to be ordering hepatitis B core antibody tests. Patients with a positive core antibody are still at risk for reactivation.”

The authors noted their study’s limitations, including the data being retrospectively collected and some of the subjects potentially being screened in laboratories outside of the Mass General Brigham health system. In addition, they stated that their findings “may not be generalizable to nonrheumatologic settings or other immunomodulators,” although they added that studies of other patient populations have also uncovered “similarly low HBV screening frequencies.”

Several of the authors reported being supported by institutes within the National Institutes of Health. Beyond that, they declared no potential conflicts of interest.

People beginning treatment with the immunosuppressive drugs tocilizumab (Actemra) or tofacitinib (Xeljanz) are infrequently screened for hepatitis B virus (HBV) infection, according to a new study of patients with rheumatic diseases who are starting one of the two treatments.

“Perhaps not unexpectedly, these screening patterns conform more with recommendations from the American College of Rheumatology, which do not explicitly stipulate universal HBV screening,” wrote lead author Amir M. Mohareb, MD, of Massachusetts General Hospital in Boston. The study was published in The Journal of Rheumatology.

To determine the frequency of HBV screening among this specific population, the researchers conducted a retrospective, cross-sectional study of patients 18 years or older within the Mass General Brigham health system in the Boston area who initiated either of the two drugs before Dec. 31, 2018. Tocilizumab was approved by the Food and Drug Administration on Jan. 11, 2010, and tofacitinib was approved on Nov. 6, 2012.

The final study population included 678 patients on tocilizumab and 391 patients on tofacitinib. The mean age of the patients in each group was 61 years for tocilizumab and 60 years for tofacitinib. A large majority were female (78% of the tocilizumab group, 88% of the tofacitinib group) and 84% of patients in both groups were white. Their primary diagnosis was rheumatoid arthritis (53% of the tocilizumab group, 77% of the tofacitinib group), and most of them – 57% of patients on tocilizumab and 72% of patients on tofacitinib – had a history of being on both conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARDs).

HBV screening patterns were classified into three categories: complete (all three of the HBV surface antigen [HBsAg], total core antibody [anti-HBcAb], and surface antibody [HBsAb] tests); partial (any one to two tests); and none. Of the 678 patients on tocilizumab, 194 (29%) underwent complete screening, 307 (45%) underwent partial screening, and 177 (26%) had no screening. Of the 391 patients on tofacitinib, 94 (24%) underwent complete screening, 195 (50%) underwent partial screening, and 102 (26%) had none.

Inappropriate testing – defined as either HBV e-antigen (HBeAg), anti-HBcAb IgM, or HBV DNA without a positive HBsAg or total anti-HBcAb – occurred in 22% of patients on tocilizumab and 23% of patients on tofacitinib. After multivariable analysis, the authors found that Whites were less likely to undergo complete screening (odds ratio, 0.74; 95% confidence interval, 0.57-0.95) compared to non-Whites. Previous use of immunosuppressive agents such as conventional synthetic DMARDs (OR, 1.05; 95% CI, 0.72-1.55) and biologic DMARDs with or without prior csDMARDs (OR, 0.73; 95% CI, 0.48-1.12) was not associated with a likelihood of complete appropriate screening.

“These data add to the evidence indicating that clinicians are not completing pretreatment screening for latent infections prior to patients starting high-risk immunosuppressant drugs,” Gabriela Schmajuk, MD, of the University of California, San Francisco, said in an interview. “It can be dangerous, since a fraction of these patients may reactivate latent infections with HBV that can result in liver failure or death.

“On the bright side,” she added, “we have antivirals that can be given as prophylaxis against reactivation of latent HBV if patients do test positive.”

Dr. Schmajuk was previously the senior author of a similar study from the 2019 American College of Rheumatology annual meeting that found only a small percentage of patients who were new users of biologics or new synthetic DMARDs were screened for HBV or hepatitis C virus.

When asked if anything in the study stood out, she acknowledged being “somewhat surprised that patients with prior immunosuppression did not have higher rates of screening. One might expect that since those patients had more opportunities for screening – since they started new medications more times – they would have higher rates, but this did not appear to be the case.”

As a message to rheumatologists who may be starting their patients on any biologic or new synthetic DMARD, she reinforced that “we need universal HBV screening for patients starting these medications. Many clinicians are used to ordering a hepatitis B surface antigen test, but one key message is that we also need to be ordering hepatitis B core antibody tests. Patients with a positive core antibody are still at risk for reactivation.”

The authors noted their study’s limitations, including the data being retrospectively collected and some of the subjects potentially being screened in laboratories outside of the Mass General Brigham health system. In addition, they stated that their findings “may not be generalizable to nonrheumatologic settings or other immunomodulators,” although they added that studies of other patient populations have also uncovered “similarly low HBV screening frequencies.”

Several of the authors reported being supported by institutes within the National Institutes of Health. Beyond that, they declared no potential conflicts of interest.

The Centers for Disease Control and Prevention has recommended that everyone get a COVID-19 vaccine, even if they’ve had the virus before. Yet many skeptics have held off getting the shots, believing that immunity generated by their previous infection will protect them if they should encounter the virus again. 

A new study published in the CDC’s Morbidity and Mortality Weekly Report pokes holes in this notion. It shows people who have recovered from COVID-19 but haven’t been vaccinated have more than double the risk of testing positive for the virus again, compared with someone who was vaccinated after an initial infection.

The study looked at 738 Kentucky residents who had an initial bout of COVID-19 in 2020. About 250 of them tested positive for COVID-19 a second time between May and July of 2021, when the Delta variant became dominant in the United States. 

The study matched each person who’d been reinfected with two people of the same sex and roughly the same age who had caught their initial COVID infection within the same week. The researchers then cross-matched those cases with data from Kentucky’s Immunization Registry.

They found that those who were unvaccinated had more than double the risk of being reinfected during the Delta wave. Partial vaccination appeared to have no significant impact on the risk of reinfection.

Among those who were reinfected, 20% were fully vaccinated, while 34% of those who did not get reinfected were fully vaccinated.

The study is observational, meaning it can’t show cause and effect; and the researchers had no information on the severity of the infections. Alyson Cavanaugh, PhD, a member of the CDC’s Epidemic Intelligence Service who led the study, said it is possible that some of the people who tested positive a second time had asymptomatic infections that were picked up through routine screening.

Still, the study backs up previous research and suggests that vaccination offers important additional protection.

“Our laboratory studies have shown that there’s an added benefit of vaccine for people who’ve had previous COVID-19. This is a real-world, epidemiologic study that found that among people who’d previously already had COVID-19, those who were vaccinated had lower odds of being reinfected,” Dr. Cavanaugh said.

“If you have had COVID-19 before, please still get vaccinated,” said CDC Director Rochelle Walensky, MD, in a written media statement. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

In a White House COVID-19 Response Team briefing in May, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease, explained why vaccines create stronger immunity than infection. He highlighted new research showing that two doses of an mRNA vaccine produce levels of neutralizing antibodies that are up to 10 times higher than the levels found in the blood of people who’ve recovered from COVID-19. Vaccines also enhance B cells and T cells in people who’ve recovered from COVID-19, which broadens the spectrum of protection and helps to fend off variants.

The study has some important limitations, which the authors acknowledged. The first is that second infections weren’t confirmed with genetic sequencing, so the researchers couldn’t definitively tell if a person tested positive a second time because they caught a new virus, or if they were somehow still shedding virus from their first infection. Given that the tests were at least 5 months apart, though, the researchers think reinfection is the most likely explanation.

Another bias in the study could have something to do with vaccination. Vaccinated people may have been less likely to be tested for COVID-19 after their vaccines, so the association or reinfection with a lack of vaccination may be overestimated. 

Also, people who were vaccinated at federal sites or in another state were not logged in the state’s immunization registry, which may have skewed the data.

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

The Centers for Disease Control and Prevention has recommended that everyone get a COVID-19 vaccine, even if they’ve had the virus before. Yet many skeptics have held off getting the shots, believing that immunity generated by their previous infection will protect them if they should encounter the virus again. 

A new study published in the CDC’s Morbidity and Mortality Weekly Report pokes holes in this notion. It shows people who have recovered from COVID-19 but haven’t been vaccinated have more than double the risk of testing positive for the virus again, compared with someone who was vaccinated after an initial infection.

The study looked at 738 Kentucky residents who had an initial bout of COVID-19 in 2020. About 250 of them tested positive for COVID-19 a second time between May and July of 2021, when the Delta variant became dominant in the United States. 

The study matched each person who’d been reinfected with two people of the same sex and roughly the same age who had caught their initial COVID infection within the same week. The researchers then cross-matched those cases with data from Kentucky’s Immunization Registry.

They found that those who were unvaccinated had more than double the risk of being reinfected during the Delta wave. Partial vaccination appeared to have no significant impact on the risk of reinfection.

Among those who were reinfected, 20% were fully vaccinated, while 34% of those who did not get reinfected were fully vaccinated.

The study is observational, meaning it can’t show cause and effect; and the researchers had no information on the severity of the infections. Alyson Cavanaugh, PhD, a member of the CDC’s Epidemic Intelligence Service who led the study, said it is possible that some of the people who tested positive a second time had asymptomatic infections that were picked up through routine screening.

Still, the study backs up previous research and suggests that vaccination offers important additional protection.

“Our laboratory studies have shown that there’s an added benefit of vaccine for people who’ve had previous COVID-19. This is a real-world, epidemiologic study that found that among people who’d previously already had COVID-19, those who were vaccinated had lower odds of being reinfected,” Dr. Cavanaugh said.

“If you have had COVID-19 before, please still get vaccinated,” said CDC Director Rochelle Walensky, MD, in a written media statement. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

In a White House COVID-19 Response Team briefing in May, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease, explained why vaccines create stronger immunity than infection. He highlighted new research showing that two doses of an mRNA vaccine produce levels of neutralizing antibodies that are up to 10 times higher than the levels found in the blood of people who’ve recovered from COVID-19. Vaccines also enhance B cells and T cells in people who’ve recovered from COVID-19, which broadens the spectrum of protection and helps to fend off variants.

The study has some important limitations, which the authors acknowledged. The first is that second infections weren’t confirmed with genetic sequencing, so the researchers couldn’t definitively tell if a person tested positive a second time because they caught a new virus, or if they were somehow still shedding virus from their first infection. Given that the tests were at least 5 months apart, though, the researchers think reinfection is the most likely explanation.

Another bias in the study could have something to do with vaccination. Vaccinated people may have been less likely to be tested for COVID-19 after their vaccines, so the association or reinfection with a lack of vaccination may be overestimated. 

Also, people who were vaccinated at federal sites or in another state were not logged in the state’s immunization registry, which may have skewed the data.

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

The Centers for Disease Control and Prevention has recommended that everyone get a COVID-19 vaccine, even if they’ve had the virus before. Yet many skeptics have held off getting the shots, believing that immunity generated by their previous infection will protect them if they should encounter the virus again. 

A new study published in the CDC’s Morbidity and Mortality Weekly Report pokes holes in this notion. It shows people who have recovered from COVID-19 but haven’t been vaccinated have more than double the risk of testing positive for the virus again, compared with someone who was vaccinated after an initial infection.

The study looked at 738 Kentucky residents who had an initial bout of COVID-19 in 2020. About 250 of them tested positive for COVID-19 a second time between May and July of 2021, when the Delta variant became dominant in the United States. 

The study matched each person who’d been reinfected with two people of the same sex and roughly the same age who had caught their initial COVID infection within the same week. The researchers then cross-matched those cases with data from Kentucky’s Immunization Registry.

They found that those who were unvaccinated had more than double the risk of being reinfected during the Delta wave. Partial vaccination appeared to have no significant impact on the risk of reinfection.

Among those who were reinfected, 20% were fully vaccinated, while 34% of those who did not get reinfected were fully vaccinated.

The study is observational, meaning it can’t show cause and effect; and the researchers had no information on the severity of the infections. Alyson Cavanaugh, PhD, a member of the CDC’s Epidemic Intelligence Service who led the study, said it is possible that some of the people who tested positive a second time had asymptomatic infections that were picked up through routine screening.

Still, the study backs up previous research and suggests that vaccination offers important additional protection.

“Our laboratory studies have shown that there’s an added benefit of vaccine for people who’ve had previous COVID-19. This is a real-world, epidemiologic study that found that among people who’d previously already had COVID-19, those who were vaccinated had lower odds of being reinfected,” Dr. Cavanaugh said.

“If you have had COVID-19 before, please still get vaccinated,” said CDC Director Rochelle Walensky, MD, in a written media statement. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

In a White House COVID-19 Response Team briefing in May, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease, explained why vaccines create stronger immunity than infection. He highlighted new research showing that two doses of an mRNA vaccine produce levels of neutralizing antibodies that are up to 10 times higher than the levels found in the blood of people who’ve recovered from COVID-19. Vaccines also enhance B cells and T cells in people who’ve recovered from COVID-19, which broadens the spectrum of protection and helps to fend off variants.

The study has some important limitations, which the authors acknowledged. The first is that second infections weren’t confirmed with genetic sequencing, so the researchers couldn’t definitively tell if a person tested positive a second time because they caught a new virus, or if they were somehow still shedding virus from their first infection. Given that the tests were at least 5 months apart, though, the researchers think reinfection is the most likely explanation.

Another bias in the study could have something to do with vaccination. Vaccinated people may have been less likely to be tested for COVID-19 after their vaccines, so the association or reinfection with a lack of vaccination may be overestimated. 

Also, people who were vaccinated at federal sites or in another state were not logged in the state’s immunization registry, which may have skewed the data.

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

Tumor necrosis factor inhibitors have long been the go-to treatment of choice for patients with psoriasis and psoriatic arthritis (PsA). They’ve served patients well since etanercept was first approved for PsA in 2002, but today, with the availability of more attractive interleukin-17 and IL-23 inhibitors, dermatologists and rheumatologists are asking whether it’s time to reconsider the use of TNF inhibitors as first-line therapy in psoriasis and PsA.

“TNF inhibitors have served psoriasis patients well for many years. The question is, ‘Is it time to move on from them as first-line agents for psoriasis?’ ” said April W. Armstrong, MD, MPH, a dermatologist and associate dean for clinical research at the University of Southern California, Los Angeles. Dr. Armstrong participated in a point/counterpoint debate about the merits of IL-17 and IL-23 inhibitors over TNF inhibitors at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. “For the majority of our patients, IL-17 and IL-23 inhibitors are probably rationally better than TNF inhibitors as first-line agents for moderate to severe plaque psoriasis,” she said.

In this debate, dermatologists and rheumatologists cited studies showing the safety and efficacy of IL-17 and IL-23 inhibitors over TNF inhibitors. TNF inhibitors include etanercept (Enbrel and biosimilars), infliximab (Remicade and biosimilars), adalimumab (Humira and biosimilars), certolizumab pegol (Cimzia), and golimumab (Simponi). IL-12/23 inhibitors are limited to ustekinumab (Stelara). IL-17 inhibitors include secukinumab (Cosentyx), ixekizumab (Taltz), and brodalumab (Siliq). IL-23 inhibitors include guselkumab (Tremfya), tildrakizumab (Ilumya), and risankizumab (Skyrizi).

TNF inhibitors are recommended by the American College of Rheumatology as first-line therapy for treatment-naive patients with active PsA, and they, along with IL-12/23, IL-17, and IL-23 inhibitors are all recommended by the American Academy of Dermatology as monotherapy treatment options in adult patients with moderate to severe plaque psoriasis. However, some studies have shown that non–TNF-inhibitor biologics have a higher efficacy than TNF inhibitors in some cases for some patients, such as those with moderate to severe psoriasis alone or for musculoskeletal efficacy in patients with PsA who have peripheral arthritis, enthesitis, dactylitis, or axial manifestations.

Favorable characteristics of non–TNF-inhibitor biologics

Dr. Armstrong cited a number of head-to-head trials to support her view that IL-17 and IL-23 inhibitors are better than TNF inhibitors as first-line agents for patients with moderate to severe plaque psoriasis. In the first head-to-head study of its kind in patients with moderate to severe psoriasis, ustekinumab proved superior to etanercept. Guselkumab was shown to be superior to adalimumab for patients with moderate to severe psoriasis. Tildrakizumab also proved superior to etanercept for patients with psoriasis. Risankizumab bested adalimumab in patients with moderate to severe psoriasis. Ixekizumab proved superior to etanercept in two pivotal studies of patients with widespread moderate-to-severe psoriasis.

IL-23 and IL-17 inhibitors tend to have less frequent maintenance dosing, with IL-17 inhibitors being once every 2 or 4 weeks and IL-23 inhibitors once every 8 or 12 weeks, compared with frequencies ranging from every week to every 8 weeks with TNF inhibitors, Dr. Armstrong said.

IL-17 and IL-23 inhibitors also appear to have fewer safety concerns than TNF inhibitors, although there is less long-term data for them overall and there are some notable exceptions in certain patient populations. TNF inhibitors should be avoided in patients with a history of demyelinating disease or hepatitis B virus infection, and they are not preferred in patients who have a history of latent tuberculosis or advanced heart failure. IL-17 inhibitors should not be used in patients with a history of inflammatory bowel disease, and their use is associated with a higher rate of oral candidiasis. IL-23 inhibitors have a good safety profile overall, she said.

“The IL-17/23 axis is very important to psoriatic arthritis and should be the focus of our treatments” for PsA, said Deepak Jadon, MBBCh, MRCP, PhD, a rheumatologist and director of the rheumatology research unit at Addenbrooke’s Hospital, Cambridge (England) University Hospitals NHS Foundation Trust. In his presentation, he proposed that IL-17 inhibitors and IL-23 inhibitors be used as first-line therapies in PsA ahead of TNF inhibitors.

One reason to go with IL-17 and IL-23 inhibitors may be to ”get it right immunologically the first time,” Dr. Jadon said. He cited evidence showing substantially better response to guselkumab when given to biologic-naive patients with PsA versus those who had a inadequate response to TNF inhibitors, as well as data indicating better response with secukinumab regardless of previous TNF inhibitor use.

IL-17 inhibitors target more domains of psoriatic disease than do TNF inhibitors, he said, noting that “they have excellent musculoskeletal efficacy in patients with moderate skin psoriasis, not just those with severe psoriasis.” Ixekizumab proved superior to adalimumab in biologic-naive patients with PsA. The results of this study also indicated that IL-17 inhibitors should not be reserved only for patients with severe psoriasis since a higher percentage of patients with moderate psoriasis who were taking ixekizumab achieved very low PsA activity. Secukinumab also beat adalimumab in a head-to-head comparison and showed a greater impact on some measures of health-related quality of life.

IL-17 inhibitors also do not require concomitant methotrexate, he said, “which is a major bonus for our patients. All of my patients wish to stop methotrexate even if tolerated. Not having to cope with prescribed methotrexate improves risk of adverse events and frequency of blood test monitoring.”

IL-17 and IL-23 inhibitors appear to have good efficacy against axial disease in patients with PsA. Randomized trial results for secukinumab versus placebo show high percentages of patients improving either 20% or 40% in Assessment in Spondyloarthritis International Society response criteria and reduced inflammatory MRI lesions in the spine and sacroiliac joints. Analyses of trial results in guselkumab-treated patients with axial manifestations of PsA have shown the IL-23 inhibitor’s efficacy versus placebo across different measures of disease activity.

Dr. Jadon also cited real-world data showing that patients stay longer on IL-17 and IL-12/23 inhibitors versus TNF inhibitors. A 2016 study of patients with psoriasis in the PSOLAR registry showed that patients persisted on treatment longer with ustekinumab than with adalimumab, etanercept, or infliximab. Similarly, a 2020 study of patients with psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register found that both ustekinumab and secukinumab had better sustained drug survival than did adalimumab.


Accessibility weighs heavily in using TNF inhibitor first

Clinical trials data show that IL-17 inhibitors outperform TNF inhibitors for psoriasis, but in clinical practice, TNF inhibitors still perform very well in individual patients and are well tolerated, said Amit Garg, MD, founding chair of the department of dermatology at Hofstra University, Hempstead, N.Y.

He argued in favor of TNF inhibitors as first-line therapy over IL-17 inhibitors for psoriasis. In this case, treatment decisions often come down to accessibility, Dr. Garg said. Not all insurance companies cover the cost of the newer IL-23 inhibitors. Plus, access to TNF inhibitors is widespread and costs are generally lower.

“As a physician, I don’t have complete autonomy in prescribing what I want. The reality is whether it be because of cross indication or discount pricing, [TNF inhibitors] – in particular adalimumab – is widely available on all plans and is usually the preferred treatment plan, at least in our area,” he said. “I’m not a big fan of plans that allow drugs at low or no cost for a year or 2, and then abandon the patients at that point thereafter. I like to use something that insurance will cover sustainably, and, quite frankly, TNFs have served well in that regard.”

However, TNF inhibitors are associated with more safety signals, plus they carry a greater risk of infection, leading to tolerability and persistence issues with patients.

“Psoriasis is a lifelong disease. I wish I could tell you that every drug is going to work well forever for individual patients, but I don’t think we know that yet. From my perspective, for efficacy, general well tolerance, convenience, and access, TNFs are still an important part of our ability to treat psoriasis effectively. I have no problem starting there and transitioning as needed for individual patients.

“In my experience, I think patients on TNFs generally do well. We don’t always get the patients clear and certainly there’s drop off of efficacy over time, but I’m not sure that’s a rationale for [changing treatment],” Dr. Garg said.

Ying Ying (Katy) Leung, MD, a rheumatologist with Singapore General Hospital, and a member of the GRAPPA peripheral arthritis working group, argued against the use of IL-17 and IL-23 inhibitors as first-line treatment for PsA over TNF inhibitors. She reasoned that TNF blockers are more accessible, have more long-term safety data (including data indicating safety during pregnancy), and have better cardiovascular protection. She also noted that GRAPPA treatment recommendations strongly advise using TNF blockers (or IL-17 inhibitors) for treatment-naive patients with PsA.

“Accessibility is very important as I learned along the way of leading the peripheral arthritis [GRAPPA] working group. Accessibility [issues] can be coming from a lot of sources, but if you don’t take good care of accessibility, you might be developing a guideline that is way out of reality and nobody is going to use it,” she said.

In her native Singapore, Dr. Leung said that patients pay for biologics out of pocket, so cost is a key factor for her patients. She stated that adalimumab is available as a biosimilar at about $200 monthly for patients with PsA in Singapore, while the average monthly costs are $1,400 for originator infliximab and $1,500 for originator etanercept. By comparison, secukinumab sells for about $750 monthly, ixekizumab $540 monthly, and guselkumab $2,000 monthly.

Treatment choices should be aligned with the disease manifestations of PsA, Dr. Leung said, keeping in mind that accessibility and individual patient needs and preferences should be considered as well. She conducted an informal comparison that found TNF inhibitors are most effective for patients with uveitis or inflammatory bowel disease. Evidence from head-to-head studies indicates that TNF inhibitors and IL-17 inhibitors have similar efficacy for peripheral arthritis, enthesitis, and dactylitis. But caution is warranted, she suggested, for determining the best biologics for axial disease because no head-to-head comparison trials have been conducted for IL-17 or IL-23 inhibitors versus TNF inhibitors.

Dr. Armstrong has been a consultant to AbbVie, Bristol-Myers Squibb, Dermira, Genzyme, Incyte, Janssen, Leo Pharma, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Jadon has been a consultant to, has been on speakers bureaus for, and has received grant/research support from AbbVie, Amgen, Celgene, Celltrion, Gilead, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, and UCB. Dr. Garg has consulted for AbbVie, Boehringer Ingelheim, Janssen, and UCB. Dr. Leung has been a consultant to AbbVie, Boehringer Ingelheim, Janssen, Eli Lilly, Novartis, and Pfizer. She has been on speakers bureaus for AbbVie, Janssen Eli Lilly, and Novartis. She has received grant/research support from Pfizer and conference support from AbbVie,

Tumor necrosis factor inhibitors have long been the go-to treatment of choice for patients with psoriasis and psoriatic arthritis (PsA). They’ve served patients well since etanercept was first approved for PsA in 2002, but today, with the availability of more attractive interleukin-17 and IL-23 inhibitors, dermatologists and rheumatologists are asking whether it’s time to reconsider the use of TNF inhibitors as first-line therapy in psoriasis and PsA.

“TNF inhibitors have served psoriasis patients well for many years. The question is, ‘Is it time to move on from them as first-line agents for psoriasis?’ ” said April W. Armstrong, MD, MPH, a dermatologist and associate dean for clinical research at the University of Southern California, Los Angeles. Dr. Armstrong participated in a point/counterpoint debate about the merits of IL-17 and IL-23 inhibitors over TNF inhibitors at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. “For the majority of our patients, IL-17 and IL-23 inhibitors are probably rationally better than TNF inhibitors as first-line agents for moderate to severe plaque psoriasis,” she said.

In this debate, dermatologists and rheumatologists cited studies showing the safety and efficacy of IL-17 and IL-23 inhibitors over TNF inhibitors. TNF inhibitors include etanercept (Enbrel and biosimilars), infliximab (Remicade and biosimilars), adalimumab (Humira and biosimilars), certolizumab pegol (Cimzia), and golimumab (Simponi). IL-12/23 inhibitors are limited to ustekinumab (Stelara). IL-17 inhibitors include secukinumab (Cosentyx), ixekizumab (Taltz), and brodalumab (Siliq). IL-23 inhibitors include guselkumab (Tremfya), tildrakizumab (Ilumya), and risankizumab (Skyrizi).

TNF inhibitors are recommended by the American College of Rheumatology as first-line therapy for treatment-naive patients with active PsA, and they, along with IL-12/23, IL-17, and IL-23 inhibitors are all recommended by the American Academy of Dermatology as monotherapy treatment options in adult patients with moderate to severe plaque psoriasis. However, some studies have shown that non–TNF-inhibitor biologics have a higher efficacy than TNF inhibitors in some cases for some patients, such as those with moderate to severe psoriasis alone or for musculoskeletal efficacy in patients with PsA who have peripheral arthritis, enthesitis, dactylitis, or axial manifestations.

Favorable characteristics of non–TNF-inhibitor biologics

Dr. Armstrong cited a number of head-to-head trials to support her view that IL-17 and IL-23 inhibitors are better than TNF inhibitors as first-line agents for patients with moderate to severe plaque psoriasis. In the first head-to-head study of its kind in patients with moderate to severe psoriasis, ustekinumab proved superior to etanercept. Guselkumab was shown to be superior to adalimumab for patients with moderate to severe psoriasis. Tildrakizumab also proved superior to etanercept for patients with psoriasis. Risankizumab bested adalimumab in patients with moderate to severe psoriasis. Ixekizumab proved superior to etanercept in two pivotal studies of patients with widespread moderate-to-severe psoriasis.

IL-23 and IL-17 inhibitors tend to have less frequent maintenance dosing, with IL-17 inhibitors being once every 2 or 4 weeks and IL-23 inhibitors once every 8 or 12 weeks, compared with frequencies ranging from every week to every 8 weeks with TNF inhibitors, Dr. Armstrong said.

IL-17 and IL-23 inhibitors also appear to have fewer safety concerns than TNF inhibitors, although there is less long-term data for them overall and there are some notable exceptions in certain patient populations. TNF inhibitors should be avoided in patients with a history of demyelinating disease or hepatitis B virus infection, and they are not preferred in patients who have a history of latent tuberculosis or advanced heart failure. IL-17 inhibitors should not be used in patients with a history of inflammatory bowel disease, and their use is associated with a higher rate of oral candidiasis. IL-23 inhibitors have a good safety profile overall, she said.

“The IL-17/23 axis is very important to psoriatic arthritis and should be the focus of our treatments” for PsA, said Deepak Jadon, MBBCh, MRCP, PhD, a rheumatologist and director of the rheumatology research unit at Addenbrooke’s Hospital, Cambridge (England) University Hospitals NHS Foundation Trust. In his presentation, he proposed that IL-17 inhibitors and IL-23 inhibitors be used as first-line therapies in PsA ahead of TNF inhibitors.

One reason to go with IL-17 and IL-23 inhibitors may be to ”get it right immunologically the first time,” Dr. Jadon said. He cited evidence showing substantially better response to guselkumab when given to biologic-naive patients with PsA versus those who had a inadequate response to TNF inhibitors, as well as data indicating better response with secukinumab regardless of previous TNF inhibitor use.

IL-17 inhibitors target more domains of psoriatic disease than do TNF inhibitors, he said, noting that “they have excellent musculoskeletal efficacy in patients with moderate skin psoriasis, not just those with severe psoriasis.” Ixekizumab proved superior to adalimumab in biologic-naive patients with PsA. The results of this study also indicated that IL-17 inhibitors should not be reserved only for patients with severe psoriasis since a higher percentage of patients with moderate psoriasis who were taking ixekizumab achieved very low PsA activity. Secukinumab also beat adalimumab in a head-to-head comparison and showed a greater impact on some measures of health-related quality of life.

IL-17 inhibitors also do not require concomitant methotrexate, he said, “which is a major bonus for our patients. All of my patients wish to stop methotrexate even if tolerated. Not having to cope with prescribed methotrexate improves risk of adverse events and frequency of blood test monitoring.”

IL-17 and IL-23 inhibitors appear to have good efficacy against axial disease in patients with PsA. Randomized trial results for secukinumab versus placebo show high percentages of patients improving either 20% or 40% in Assessment in Spondyloarthritis International Society response criteria and reduced inflammatory MRI lesions in the spine and sacroiliac joints. Analyses of trial results in guselkumab-treated patients with axial manifestations of PsA have shown the IL-23 inhibitor’s efficacy versus placebo across different measures of disease activity.

Dr. Jadon also cited real-world data showing that patients stay longer on IL-17 and IL-12/23 inhibitors versus TNF inhibitors. A 2016 study of patients with psoriasis in the PSOLAR registry showed that patients persisted on treatment longer with ustekinumab than with adalimumab, etanercept, or infliximab. Similarly, a 2020 study of patients with psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register found that both ustekinumab and secukinumab had better sustained drug survival than did adalimumab.


Accessibility weighs heavily in using TNF inhibitor first

Clinical trials data show that IL-17 inhibitors outperform TNF inhibitors for psoriasis, but in clinical practice, TNF inhibitors still perform very well in individual patients and are well tolerated, said Amit Garg, MD, founding chair of the department of dermatology at Hofstra University, Hempstead, N.Y.

He argued in favor of TNF inhibitors as first-line therapy over IL-17 inhibitors for psoriasis. In this case, treatment decisions often come down to accessibility, Dr. Garg said. Not all insurance companies cover the cost of the newer IL-23 inhibitors. Plus, access to TNF inhibitors is widespread and costs are generally lower.

“As a physician, I don’t have complete autonomy in prescribing what I want. The reality is whether it be because of cross indication or discount pricing, [TNF inhibitors] – in particular adalimumab – is widely available on all plans and is usually the preferred treatment plan, at least in our area,” he said. “I’m not a big fan of plans that allow drugs at low or no cost for a year or 2, and then abandon the patients at that point thereafter. I like to use something that insurance will cover sustainably, and, quite frankly, TNFs have served well in that regard.”

However, TNF inhibitors are associated with more safety signals, plus they carry a greater risk of infection, leading to tolerability and persistence issues with patients.

“Psoriasis is a lifelong disease. I wish I could tell you that every drug is going to work well forever for individual patients, but I don’t think we know that yet. From my perspective, for efficacy, general well tolerance, convenience, and access, TNFs are still an important part of our ability to treat psoriasis effectively. I have no problem starting there and transitioning as needed for individual patients.

“In my experience, I think patients on TNFs generally do well. We don’t always get the patients clear and certainly there’s drop off of efficacy over time, but I’m not sure that’s a rationale for [changing treatment],” Dr. Garg said.

Ying Ying (Katy) Leung, MD, a rheumatologist with Singapore General Hospital, and a member of the GRAPPA peripheral arthritis working group, argued against the use of IL-17 and IL-23 inhibitors as first-line treatment for PsA over TNF inhibitors. She reasoned that TNF blockers are more accessible, have more long-term safety data (including data indicating safety during pregnancy), and have better cardiovascular protection. She also noted that GRAPPA treatment recommendations strongly advise using TNF blockers (or IL-17 inhibitors) for treatment-naive patients with PsA.

“Accessibility is very important as I learned along the way of leading the peripheral arthritis [GRAPPA] working group. Accessibility [issues] can be coming from a lot of sources, but if you don’t take good care of accessibility, you might be developing a guideline that is way out of reality and nobody is going to use it,” she said.

In her native Singapore, Dr. Leung said that patients pay for biologics out of pocket, so cost is a key factor for her patients. She stated that adalimumab is available as a biosimilar at about $200 monthly for patients with PsA in Singapore, while the average monthly costs are $1,400 for originator infliximab and $1,500 for originator etanercept. By comparison, secukinumab sells for about $750 monthly, ixekizumab $540 monthly, and guselkumab $2,000 monthly.

Treatment choices should be aligned with the disease manifestations of PsA, Dr. Leung said, keeping in mind that accessibility and individual patient needs and preferences should be considered as well. She conducted an informal comparison that found TNF inhibitors are most effective for patients with uveitis or inflammatory bowel disease. Evidence from head-to-head studies indicates that TNF inhibitors and IL-17 inhibitors have similar efficacy for peripheral arthritis, enthesitis, and dactylitis. But caution is warranted, she suggested, for determining the best biologics for axial disease because no head-to-head comparison trials have been conducted for IL-17 or IL-23 inhibitors versus TNF inhibitors.

Dr. Armstrong has been a consultant to AbbVie, Bristol-Myers Squibb, Dermira, Genzyme, Incyte, Janssen, Leo Pharma, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Jadon has been a consultant to, has been on speakers bureaus for, and has received grant/research support from AbbVie, Amgen, Celgene, Celltrion, Gilead, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, and UCB. Dr. Garg has consulted for AbbVie, Boehringer Ingelheim, Janssen, and UCB. Dr. Leung has been a consultant to AbbVie, Boehringer Ingelheim, Janssen, Eli Lilly, Novartis, and Pfizer. She has been on speakers bureaus for AbbVie, Janssen Eli Lilly, and Novartis. She has received grant/research support from Pfizer and conference support from AbbVie,

Tumor necrosis factor inhibitors have long been the go-to treatment of choice for patients with psoriasis and psoriatic arthritis (PsA). They’ve served patients well since etanercept was first approved for PsA in 2002, but today, with the availability of more attractive interleukin-17 and IL-23 inhibitors, dermatologists and rheumatologists are asking whether it’s time to reconsider the use of TNF inhibitors as first-line therapy in psoriasis and PsA.

“TNF inhibitors have served psoriasis patients well for many years. The question is, ‘Is it time to move on from them as first-line agents for psoriasis?’ ” said April W. Armstrong, MD, MPH, a dermatologist and associate dean for clinical research at the University of Southern California, Los Angeles. Dr. Armstrong participated in a point/counterpoint debate about the merits of IL-17 and IL-23 inhibitors over TNF inhibitors at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. “For the majority of our patients, IL-17 and IL-23 inhibitors are probably rationally better than TNF inhibitors as first-line agents for moderate to severe plaque psoriasis,” she said.

In this debate, dermatologists and rheumatologists cited studies showing the safety and efficacy of IL-17 and IL-23 inhibitors over TNF inhibitors. TNF inhibitors include etanercept (Enbrel and biosimilars), infliximab (Remicade and biosimilars), adalimumab (Humira and biosimilars), certolizumab pegol (Cimzia), and golimumab (Simponi). IL-12/23 inhibitors are limited to ustekinumab (Stelara). IL-17 inhibitors include secukinumab (Cosentyx), ixekizumab (Taltz), and brodalumab (Siliq). IL-23 inhibitors include guselkumab (Tremfya), tildrakizumab (Ilumya), and risankizumab (Skyrizi).

TNF inhibitors are recommended by the American College of Rheumatology as first-line therapy for treatment-naive patients with active PsA, and they, along with IL-12/23, IL-17, and IL-23 inhibitors are all recommended by the American Academy of Dermatology as monotherapy treatment options in adult patients with moderate to severe plaque psoriasis. However, some studies have shown that non–TNF-inhibitor biologics have a higher efficacy than TNF inhibitors in some cases for some patients, such as those with moderate to severe psoriasis alone or for musculoskeletal efficacy in patients with PsA who have peripheral arthritis, enthesitis, dactylitis, or axial manifestations.

Favorable characteristics of non–TNF-inhibitor biologics

Dr. Armstrong cited a number of head-to-head trials to support her view that IL-17 and IL-23 inhibitors are better than TNF inhibitors as first-line agents for patients with moderate to severe plaque psoriasis. In the first head-to-head study of its kind in patients with moderate to severe psoriasis, ustekinumab proved superior to etanercept. Guselkumab was shown to be superior to adalimumab for patients with moderate to severe psoriasis. Tildrakizumab also proved superior to etanercept for patients with psoriasis. Risankizumab bested adalimumab in patients with moderate to severe psoriasis. Ixekizumab proved superior to etanercept in two pivotal studies of patients with widespread moderate-to-severe psoriasis.

IL-23 and IL-17 inhibitors tend to have less frequent maintenance dosing, with IL-17 inhibitors being once every 2 or 4 weeks and IL-23 inhibitors once every 8 or 12 weeks, compared with frequencies ranging from every week to every 8 weeks with TNF inhibitors, Dr. Armstrong said.

IL-17 and IL-23 inhibitors also appear to have fewer safety concerns than TNF inhibitors, although there is less long-term data for them overall and there are some notable exceptions in certain patient populations. TNF inhibitors should be avoided in patients with a history of demyelinating disease or hepatitis B virus infection, and they are not preferred in patients who have a history of latent tuberculosis or advanced heart failure. IL-17 inhibitors should not be used in patients with a history of inflammatory bowel disease, and their use is associated with a higher rate of oral candidiasis. IL-23 inhibitors have a good safety profile overall, she said.

“The IL-17/23 axis is very important to psoriatic arthritis and should be the focus of our treatments” for PsA, said Deepak Jadon, MBBCh, MRCP, PhD, a rheumatologist and director of the rheumatology research unit at Addenbrooke’s Hospital, Cambridge (England) University Hospitals NHS Foundation Trust. In his presentation, he proposed that IL-17 inhibitors and IL-23 inhibitors be used as first-line therapies in PsA ahead of TNF inhibitors.

One reason to go with IL-17 and IL-23 inhibitors may be to ”get it right immunologically the first time,” Dr. Jadon said. He cited evidence showing substantially better response to guselkumab when given to biologic-naive patients with PsA versus those who had a inadequate response to TNF inhibitors, as well as data indicating better response with secukinumab regardless of previous TNF inhibitor use.

IL-17 inhibitors target more domains of psoriatic disease than do TNF inhibitors, he said, noting that “they have excellent musculoskeletal efficacy in patients with moderate skin psoriasis, not just those with severe psoriasis.” Ixekizumab proved superior to adalimumab in biologic-naive patients with PsA. The results of this study also indicated that IL-17 inhibitors should not be reserved only for patients with severe psoriasis since a higher percentage of patients with moderate psoriasis who were taking ixekizumab achieved very low PsA activity. Secukinumab also beat adalimumab in a head-to-head comparison and showed a greater impact on some measures of health-related quality of life.

IL-17 inhibitors also do not require concomitant methotrexate, he said, “which is a major bonus for our patients. All of my patients wish to stop methotrexate even if tolerated. Not having to cope with prescribed methotrexate improves risk of adverse events and frequency of blood test monitoring.”

IL-17 and IL-23 inhibitors appear to have good efficacy against axial disease in patients with PsA. Randomized trial results for secukinumab versus placebo show high percentages of patients improving either 20% or 40% in Assessment in Spondyloarthritis International Society response criteria and reduced inflammatory MRI lesions in the spine and sacroiliac joints. Analyses of trial results in guselkumab-treated patients with axial manifestations of PsA have shown the IL-23 inhibitor’s efficacy versus placebo across different measures of disease activity.

Dr. Jadon also cited real-world data showing that patients stay longer on IL-17 and IL-12/23 inhibitors versus TNF inhibitors. A 2016 study of patients with psoriasis in the PSOLAR registry showed that patients persisted on treatment longer with ustekinumab than with adalimumab, etanercept, or infliximab. Similarly, a 2020 study of patients with psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register found that both ustekinumab and secukinumab had better sustained drug survival than did adalimumab.


Accessibility weighs heavily in using TNF inhibitor first

Clinical trials data show that IL-17 inhibitors outperform TNF inhibitors for psoriasis, but in clinical practice, TNF inhibitors still perform very well in individual patients and are well tolerated, said Amit Garg, MD, founding chair of the department of dermatology at Hofstra University, Hempstead, N.Y.

He argued in favor of TNF inhibitors as first-line therapy over IL-17 inhibitors for psoriasis. In this case, treatment decisions often come down to accessibility, Dr. Garg said. Not all insurance companies cover the cost of the newer IL-23 inhibitors. Plus, access to TNF inhibitors is widespread and costs are generally lower.

“As a physician, I don’t have complete autonomy in prescribing what I want. The reality is whether it be because of cross indication or discount pricing, [TNF inhibitors] – in particular adalimumab – is widely available on all plans and is usually the preferred treatment plan, at least in our area,” he said. “I’m not a big fan of plans that allow drugs at low or no cost for a year or 2, and then abandon the patients at that point thereafter. I like to use something that insurance will cover sustainably, and, quite frankly, TNFs have served well in that regard.”

However, TNF inhibitors are associated with more safety signals, plus they carry a greater risk of infection, leading to tolerability and persistence issues with patients.

“Psoriasis is a lifelong disease. I wish I could tell you that every drug is going to work well forever for individual patients, but I don’t think we know that yet. From my perspective, for efficacy, general well tolerance, convenience, and access, TNFs are still an important part of our ability to treat psoriasis effectively. I have no problem starting there and transitioning as needed for individual patients.

“In my experience, I think patients on TNFs generally do well. We don’t always get the patients clear and certainly there’s drop off of efficacy over time, but I’m not sure that’s a rationale for [changing treatment],” Dr. Garg said.

Ying Ying (Katy) Leung, MD, a rheumatologist with Singapore General Hospital, and a member of the GRAPPA peripheral arthritis working group, argued against the use of IL-17 and IL-23 inhibitors as first-line treatment for PsA over TNF inhibitors. She reasoned that TNF blockers are more accessible, have more long-term safety data (including data indicating safety during pregnancy), and have better cardiovascular protection. She also noted that GRAPPA treatment recommendations strongly advise using TNF blockers (or IL-17 inhibitors) for treatment-naive patients with PsA.

“Accessibility is very important as I learned along the way of leading the peripheral arthritis [GRAPPA] working group. Accessibility [issues] can be coming from a lot of sources, but if you don’t take good care of accessibility, you might be developing a guideline that is way out of reality and nobody is going to use it,” she said.

In her native Singapore, Dr. Leung said that patients pay for biologics out of pocket, so cost is a key factor for her patients. She stated that adalimumab is available as a biosimilar at about $200 monthly for patients with PsA in Singapore, while the average monthly costs are $1,400 for originator infliximab and $1,500 for originator etanercept. By comparison, secukinumab sells for about $750 monthly, ixekizumab $540 monthly, and guselkumab $2,000 monthly.

Treatment choices should be aligned with the disease manifestations of PsA, Dr. Leung said, keeping in mind that accessibility and individual patient needs and preferences should be considered as well. She conducted an informal comparison that found TNF inhibitors are most effective for patients with uveitis or inflammatory bowel disease. Evidence from head-to-head studies indicates that TNF inhibitors and IL-17 inhibitors have similar efficacy for peripheral arthritis, enthesitis, and dactylitis. But caution is warranted, she suggested, for determining the best biologics for axial disease because no head-to-head comparison trials have been conducted for IL-17 or IL-23 inhibitors versus TNF inhibitors.

Dr. Armstrong has been a consultant to AbbVie, Bristol-Myers Squibb, Dermira, Genzyme, Incyte, Janssen, Leo Pharma, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Jadon has been a consultant to, has been on speakers bureaus for, and has received grant/research support from AbbVie, Amgen, Celgene, Celltrion, Gilead, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, and UCB. Dr. Garg has consulted for AbbVie, Boehringer Ingelheim, Janssen, and UCB. Dr. Leung has been a consultant to AbbVie, Boehringer Ingelheim, Janssen, Eli Lilly, Novartis, and Pfizer. She has been on speakers bureaus for AbbVie, Janssen Eli Lilly, and Novartis. She has received grant/research support from Pfizer and conference support from AbbVie,

Over the 10 years we’ve been writing this column, we have often found inspiration for topics while traveling – especially while flying. This is not just because of the idle time spent in the air, but instead because of the many ways that air travel and health care experiences are similar. Both industries focus heavily on safety, are tightly regulated, and employ highly trained individuals.

Consumers may recognize the similarities as well – health care and air travel are both well-known for long waits, uncertainty, and implicit risk. Both sectors are also notorious drivers of innovation, constantly leveraging new technologies in pursuit of better outcomes and experiences. Occasionally, however, advancements in technology can present unforeseen challenges and even compromise safety, with the potential to produce unexpected consequences.

A familiar reminder of this potential was provided to us at the commencement of a recent flight, when we were instructed to turn off our personal electronic devices or flip them into “airplane mode.” This same admonishment is often given to patients and visitors in health care settings – everywhere from clinic waiting rooms to intensive care units – though the reason for this is typically left vague. This got us thinking. We wondered, what is the real risk of smart phones in medicine , or aviation, for that matter. More importantly, what other emerging technologies have the potential to create issues we may not have anticipated?

Mayo Clinic findings on radio communication used by mobile phones

Once our flight landed, we did some research to answer our initial question about personal communication technology and its ability to interfere with sensitive electronic devices. Specifically, we wanted to know whether radio communication used by mobile phones could affect the operation of medical equipment, potentially leading to dire consequences for patients. Spoiler alert: There is very little evidence that this can occur. In fact, a well-documented study performed by the Mayo Clinic in 2007 found interference in 0 out of 300 tests performed. To quote the authors, “the incidence of clinically important interference was 0%.”

We could find no other studies since 2007 that strongly contradict Mayo’s findings, except for several anecdotal reports and articles that postulate the theoretical possibility.

This is confirmed by the American Heart Association, who maintains a list of devices that may interfere with ICDs and pacemakers on their website. According to the AHA, “wireless transmissions from the antennae of phones available in the United States are a very small risk to ICDs and even less of a risk for pacemakers.” And in case you’re wondering, the story is quite similar for airplanes as well.

The latest publication from NASA’s Aviation Safety Reporting System (ASRS) documents incidents related to personal electronic devices during air travel. Most involve smoke production – or even small fires – caused by malfunctioning phone batteries during charging. Only a few entries reference wireless interference, and these were all minor and unconfirmed events. As with health care environments, airplanes don’t appear to face significant risks from radio interference. But that doesn’t mean personal electronics are completely harmless to patients.

Smartphones’ risks to patient with cardiac devices

On May 13 of 2021, the FDA issued a warning to cardiac patients about their smart phones and smart watches. Many current personal electronic devices and accessories are equipped with strong magnets, such as those contained in the “MagSafe” connector on the iPhone 12, that can deactivate pacemakers and implanted cardiac defibrillators. These medical devices are designed to be manipulated by magnets for diagnostic and therapeutic purposes, but strong magnetic fields can disable them unintentionally, leading to catastrophic results.

Apple and other manufacturers have acknowledged this risk and recommend that smartphones and other devices be kept at least 6 inches from cardiac devices. Given the ubiquity of offending products, it is also imperative that we warn our patients about this risk to their physical wellbeing.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Over the 10 years we’ve been writing this column, we have often found inspiration for topics while traveling – especially while flying. This is not just because of the idle time spent in the air, but instead because of the many ways that air travel and health care experiences are similar. Both industries focus heavily on safety, are tightly regulated, and employ highly trained individuals.

Consumers may recognize the similarities as well – health care and air travel are both well-known for long waits, uncertainty, and implicit risk. Both sectors are also notorious drivers of innovation, constantly leveraging new technologies in pursuit of better outcomes and experiences. Occasionally, however, advancements in technology can present unforeseen challenges and even compromise safety, with the potential to produce unexpected consequences.

A familiar reminder of this potential was provided to us at the commencement of a recent flight, when we were instructed to turn off our personal electronic devices or flip them into “airplane mode.” This same admonishment is often given to patients and visitors in health care settings – everywhere from clinic waiting rooms to intensive care units – though the reason for this is typically left vague. This got us thinking. We wondered, what is the real risk of smart phones in medicine , or aviation, for that matter. More importantly, what other emerging technologies have the potential to create issues we may not have anticipated?

Mayo Clinic findings on radio communication used by mobile phones

Once our flight landed, we did some research to answer our initial question about personal communication technology and its ability to interfere with sensitive electronic devices. Specifically, we wanted to know whether radio communication used by mobile phones could affect the operation of medical equipment, potentially leading to dire consequences for patients. Spoiler alert: There is very little evidence that this can occur. In fact, a well-documented study performed by the Mayo Clinic in 2007 found interference in 0 out of 300 tests performed. To quote the authors, “the incidence of clinically important interference was 0%.”

We could find no other studies since 2007 that strongly contradict Mayo’s findings, except for several anecdotal reports and articles that postulate the theoretical possibility.

This is confirmed by the American Heart Association, who maintains a list of devices that may interfere with ICDs and pacemakers on their website. According to the AHA, “wireless transmissions from the antennae of phones available in the United States are a very small risk to ICDs and even less of a risk for pacemakers.” And in case you’re wondering, the story is quite similar for airplanes as well.

The latest publication from NASA’s Aviation Safety Reporting System (ASRS) documents incidents related to personal electronic devices during air travel. Most involve smoke production – or even small fires – caused by malfunctioning phone batteries during charging. Only a few entries reference wireless interference, and these were all minor and unconfirmed events. As with health care environments, airplanes don’t appear to face significant risks from radio interference. But that doesn’t mean personal electronics are completely harmless to patients.

Smartphones’ risks to patient with cardiac devices

On May 13 of 2021, the FDA issued a warning to cardiac patients about their smart phones and smart watches. Many current personal electronic devices and accessories are equipped with strong magnets, such as those contained in the “MagSafe” connector on the iPhone 12, that can deactivate pacemakers and implanted cardiac defibrillators. These medical devices are designed to be manipulated by magnets for diagnostic and therapeutic purposes, but strong magnetic fields can disable them unintentionally, leading to catastrophic results.

Apple and other manufacturers have acknowledged this risk and recommend that smartphones and other devices be kept at least 6 inches from cardiac devices. Given the ubiquity of offending products, it is also imperative that we warn our patients about this risk to their physical wellbeing.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Over the 10 years we’ve been writing this column, we have often found inspiration for topics while traveling – especially while flying. This is not just because of the idle time spent in the air, but instead because of the many ways that air travel and health care experiences are similar. Both industries focus heavily on safety, are tightly regulated, and employ highly trained individuals.

Consumers may recognize the similarities as well – health care and air travel are both well-known for long waits, uncertainty, and implicit risk. Both sectors are also notorious drivers of innovation, constantly leveraging new technologies in pursuit of better outcomes and experiences. Occasionally, however, advancements in technology can present unforeseen challenges and even compromise safety, with the potential to produce unexpected consequences.

A familiar reminder of this potential was provided to us at the commencement of a recent flight, when we were instructed to turn off our personal electronic devices or flip them into “airplane mode.” This same admonishment is often given to patients and visitors in health care settings – everywhere from clinic waiting rooms to intensive care units – though the reason for this is typically left vague. This got us thinking. We wondered, what is the real risk of smart phones in medicine , or aviation, for that matter. More importantly, what other emerging technologies have the potential to create issues we may not have anticipated?

Mayo Clinic findings on radio communication used by mobile phones

Once our flight landed, we did some research to answer our initial question about personal communication technology and its ability to interfere with sensitive electronic devices. Specifically, we wanted to know whether radio communication used by mobile phones could affect the operation of medical equipment, potentially leading to dire consequences for patients. Spoiler alert: There is very little evidence that this can occur. In fact, a well-documented study performed by the Mayo Clinic in 2007 found interference in 0 out of 300 tests performed. To quote the authors, “the incidence of clinically important interference was 0%.”

We could find no other studies since 2007 that strongly contradict Mayo’s findings, except for several anecdotal reports and articles that postulate the theoretical possibility.

This is confirmed by the American Heart Association, who maintains a list of devices that may interfere with ICDs and pacemakers on their website. According to the AHA, “wireless transmissions from the antennae of phones available in the United States are a very small risk to ICDs and even less of a risk for pacemakers.” And in case you’re wondering, the story is quite similar for airplanes as well.

The latest publication from NASA’s Aviation Safety Reporting System (ASRS) documents incidents related to personal electronic devices during air travel. Most involve smoke production – or even small fires – caused by malfunctioning phone batteries during charging. Only a few entries reference wireless interference, and these were all minor and unconfirmed events. As with health care environments, airplanes don’t appear to face significant risks from radio interference. But that doesn’t mean personal electronics are completely harmless to patients.

Smartphones’ risks to patient with cardiac devices

On May 13 of 2021, the FDA issued a warning to cardiac patients about their smart phones and smart watches. Many current personal electronic devices and accessories are equipped with strong magnets, such as those contained in the “MagSafe” connector on the iPhone 12, that can deactivate pacemakers and implanted cardiac defibrillators. These medical devices are designed to be manipulated by magnets for diagnostic and therapeutic purposes, but strong magnetic fields can disable them unintentionally, leading to catastrophic results.

Apple and other manufacturers have acknowledged this risk and recommend that smartphones and other devices be kept at least 6 inches from cardiac devices. Given the ubiquity of offending products, it is also imperative that we warn our patients about this risk to their physical wellbeing.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Moderna says neutralizing antibodies generated by its COVID-19 vaccine against three variants of the virus that causes the disease waned substantially 6 months after the second dose.

Because of this, the company expects an increase in breakthrough infections with a need for boosters before winter.

In an experiment, a 50-mg dose of the vaccine, given as a third shot, boosted levels of antibodies in 20 previously vaccinated people by 32 times against the Beta variant, by 44 times against the Gamma variant, and by 42 times against Delta.

The new data was presented in an earnings call to investors and is based on a small study that hasn’t yet been published in medical literature.

The company also said its vaccine remained highly effective at preventing severe COVID outcomes through 6 months.

Last week, Pfizer released early data suggesting a similar drop in protection from its vaccine. The company also showed a third dose substantially boosted protection, including against the Delta variant.

The new results come just 1 day after the World Health Organization implored wealthy nations to hold off on third doses until more of the world’s population could get a first dose.

More than 80% of the 4 billion vaccine doses given around the world have been distributed to high-income countries.

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

Moderna says neutralizing antibodies generated by its COVID-19 vaccine against three variants of the virus that causes the disease waned substantially 6 months after the second dose.

Because of this, the company expects an increase in breakthrough infections with a need for boosters before winter.

In an experiment, a 50-mg dose of the vaccine, given as a third shot, boosted levels of antibodies in 20 previously vaccinated people by 32 times against the Beta variant, by 44 times against the Gamma variant, and by 42 times against Delta.

The new data was presented in an earnings call to investors and is based on a small study that hasn’t yet been published in medical literature.

The company also said its vaccine remained highly effective at preventing severe COVID outcomes through 6 months.

Last week, Pfizer released early data suggesting a similar drop in protection from its vaccine. The company also showed a third dose substantially boosted protection, including against the Delta variant.

The new results come just 1 day after the World Health Organization implored wealthy nations to hold off on third doses until more of the world’s population could get a first dose.

More than 80% of the 4 billion vaccine doses given around the world have been distributed to high-income countries.

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

Moderna says neutralizing antibodies generated by its COVID-19 vaccine against three variants of the virus that causes the disease waned substantially 6 months after the second dose.

Because of this, the company expects an increase in breakthrough infections with a need for boosters before winter.

In an experiment, a 50-mg dose of the vaccine, given as a third shot, boosted levels of antibodies in 20 previously vaccinated people by 32 times against the Beta variant, by 44 times against the Gamma variant, and by 42 times against Delta.

The new data was presented in an earnings call to investors and is based on a small study that hasn’t yet been published in medical literature.

The company also said its vaccine remained highly effective at preventing severe COVID outcomes through 6 months.

Last week, Pfizer released early data suggesting a similar drop in protection from its vaccine. The company also showed a third dose substantially boosted protection, including against the Delta variant.

The new results come just 1 day after the World Health Organization implored wealthy nations to hold off on third doses until more of the world’s population could get a first dose.

More than 80% of the 4 billion vaccine doses given around the world have been distributed to high-income countries.

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

A retracted study on the safety of blood pressure medications in patients with COVID-19 continues to be cited nearly a year later, new research shows.

Floaria Bicher/iStock/Getty Images Plus

The study in question, published on May 1, 2020, in the New England Journal of Medicine, showed no increased risk for in-hospital death with the use of ACE inhibitors or angiotensin-receptor blockers (ARBs) in hospitalized patients with COVID-19.

Concerns about the veracity of the Surgisphere database used for the study, however, led to a June 4 retraction and to the June 13 retraction of a second study, published in the Lancet, that focused on hydroxychloroquine as a COVID-19 treatment.

Although the Surgisphere scandal caused a global reckoning of COVID-19 scientific studies, the new analysis identified 652 citations of the NEJM article as of May 31.

More than a third of the citations occurred in the first 2 months after the retraction, 54% were at least 3 months later, and 2.8% at least 6 months later. In May, 11 months after the article was retracted, it was cited 21 times, senior author Emily G. McDonald, MD, MSc, McGill University, Montreal, and colleagues reported in a research letter in JAMA Internal Medicine.

“In early May and June there were already more than 200 citations in one of the world’s leading scientific journals, so I do believe it was a highly influential article early on and had an impact on different types of studies or research taking place,” she said in an interview.

Dr. McDonald said she’s also “certain that it impacted patient care,” observing that when there are no guidelines available on how to manage patients, physicians will turn to the most recent evidence in the most reputable journals.

“In the case of ACE [inhibitors] and ARBs, although the study was based on fraudulent data, we were lucky that the overall message was in the end probably correct, but that might not have been the case for another study or dataset,” she said.

Early in the pandemic, concerns existed that ACE inhibitors and ARBs could be harmful, increasing the expression of ACE2 receptors, which the SARS-CoV-2 virus uses to gain entry into cells. The first randomized trial to examine the issue, BRACE CORONA, showed no clinical benefit to interrupting use of the agents in hospitalized patients. An observational study suggested ACE inhibitors may even be protective.

Of two high-profile retractions, McDonald said they chose to bypass the hydroxychloroquine study, which had an eye-popping Altmetric attention score of 23,084, compared with 3,727 for the NEJM paper, because it may have been cited for “other” reasons. “We wanted to focus less on the politics and more on the problem of retracted work.”

The team found that researchers across the globe were citing the retracted ACE/ARB paper (18.7% in the United States, 8.1% in Italy, and 44% other countries). Most citations were used to support a statement in the main text of a study, but in nearly 3% of cases, the data were incorporated into new analyses.

Just 17.6% of the studies cited or noted the retraction. “For sure, that was surprising to us. We suspected it, but our study confirmed it,” Dr. McDonald said.

Although retracted articles can be identified by a watermark or line of text, in some cases that can be easily missed, she noted. What’s more, not all citation software points out when a study has been retracted, a fate shared by the copyediting process.

“There are a lot of mechanisms in place and, in general, what’s happening is rare but there isn’t a perfect automated system solution to absolutely prevent this from happening,” she said. “It’s still subject to human error.”

The findings also have to be taken in the context of a rapidly emerging pandemic and the unprecedented torrent of scientific papers released over the past year.

“That might have contributed to why this happened, but the takeaway message is that this can happen despite our best efforts, and we need to challenge ourselves to come up with a system solution to prevent this from happening in the future,” Dr. McDonald said. “Current mechanisms are probably capturing 95% of it, but we need to do better.”

Limitations of the present analysis are that it was limited to the single retracted study; used only a single search engine, Google Scholar, to identify the citing works; and that additional citations may have been missed, the authors noted.

McDonald and coauthor Todd C. Lee, MD, report being signatories on a public letter calling for the retraction of the Surgisphere papers. Dr. Lee also reported receiving research support from Fonds De Recherche du Quebec-Sante during the conduct of the study.

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

A retracted study on the safety of blood pressure medications in patients with COVID-19 continues to be cited nearly a year later, new research shows.

Floaria Bicher/iStock/Getty Images Plus

The study in question, published on May 1, 2020, in the New England Journal of Medicine, showed no increased risk for in-hospital death with the use of ACE inhibitors or angiotensin-receptor blockers (ARBs) in hospitalized patients with COVID-19.

Concerns about the veracity of the Surgisphere database used for the study, however, led to a June 4 retraction and to the June 13 retraction of a second study, published in the Lancet, that focused on hydroxychloroquine as a COVID-19 treatment.

Although the Surgisphere scandal caused a global reckoning of COVID-19 scientific studies, the new analysis identified 652 citations of the NEJM article as of May 31.

More than a third of the citations occurred in the first 2 months after the retraction, 54% were at least 3 months later, and 2.8% at least 6 months later. In May, 11 months after the article was retracted, it was cited 21 times, senior author Emily G. McDonald, MD, MSc, McGill University, Montreal, and colleagues reported in a research letter in JAMA Internal Medicine.

“In early May and June there were already more than 200 citations in one of the world’s leading scientific journals, so I do believe it was a highly influential article early on and had an impact on different types of studies or research taking place,” she said in an interview.

Dr. McDonald said she’s also “certain that it impacted patient care,” observing that when there are no guidelines available on how to manage patients, physicians will turn to the most recent evidence in the most reputable journals.

“In the case of ACE [inhibitors] and ARBs, although the study was based on fraudulent data, we were lucky that the overall message was in the end probably correct, but that might not have been the case for another study or dataset,” she said.

Early in the pandemic, concerns existed that ACE inhibitors and ARBs could be harmful, increasing the expression of ACE2 receptors, which the SARS-CoV-2 virus uses to gain entry into cells. The first randomized trial to examine the issue, BRACE CORONA, showed no clinical benefit to interrupting use of the agents in hospitalized patients. An observational study suggested ACE inhibitors may even be protective.

Of two high-profile retractions, McDonald said they chose to bypass the hydroxychloroquine study, which had an eye-popping Altmetric attention score of 23,084, compared with 3,727 for the NEJM paper, because it may have been cited for “other” reasons. “We wanted to focus less on the politics and more on the problem of retracted work.”

The team found that researchers across the globe were citing the retracted ACE/ARB paper (18.7% in the United States, 8.1% in Italy, and 44% other countries). Most citations were used to support a statement in the main text of a study, but in nearly 3% of cases, the data were incorporated into new analyses.

Just 17.6% of the studies cited or noted the retraction. “For sure, that was surprising to us. We suspected it, but our study confirmed it,” Dr. McDonald said.

Although retracted articles can be identified by a watermark or line of text, in some cases that can be easily missed, she noted. What’s more, not all citation software points out when a study has been retracted, a fate shared by the copyediting process.

“There are a lot of mechanisms in place and, in general, what’s happening is rare but there isn’t a perfect automated system solution to absolutely prevent this from happening,” she said. “It’s still subject to human error.”

The findings also have to be taken in the context of a rapidly emerging pandemic and the unprecedented torrent of scientific papers released over the past year.

“That might have contributed to why this happened, but the takeaway message is that this can happen despite our best efforts, and we need to challenge ourselves to come up with a system solution to prevent this from happening in the future,” Dr. McDonald said. “Current mechanisms are probably capturing 95% of it, but we need to do better.”

Limitations of the present analysis are that it was limited to the single retracted study; used only a single search engine, Google Scholar, to identify the citing works; and that additional citations may have been missed, the authors noted.

McDonald and coauthor Todd C. Lee, MD, report being signatories on a public letter calling for the retraction of the Surgisphere papers. Dr. Lee also reported receiving research support from Fonds De Recherche du Quebec-Sante during the conduct of the study.

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

A retracted study on the safety of blood pressure medications in patients with COVID-19 continues to be cited nearly a year later, new research shows.

Floaria Bicher/iStock/Getty Images Plus

The study in question, published on May 1, 2020, in the New England Journal of Medicine, showed no increased risk for in-hospital death with the use of ACE inhibitors or angiotensin-receptor blockers (ARBs) in hospitalized patients with COVID-19.

Concerns about the veracity of the Surgisphere database used for the study, however, led to a June 4 retraction and to the June 13 retraction of a second study, published in the Lancet, that focused on hydroxychloroquine as a COVID-19 treatment.

Although the Surgisphere scandal caused a global reckoning of COVID-19 scientific studies, the new analysis identified 652 citations of the NEJM article as of May 31.

More than a third of the citations occurred in the first 2 months after the retraction, 54% were at least 3 months later, and 2.8% at least 6 months later. In May, 11 months after the article was retracted, it was cited 21 times, senior author Emily G. McDonald, MD, MSc, McGill University, Montreal, and colleagues reported in a research letter in JAMA Internal Medicine.

“In early May and June there were already more than 200 citations in one of the world’s leading scientific journals, so I do believe it was a highly influential article early on and had an impact on different types of studies or research taking place,” she said in an interview.

Dr. McDonald said she’s also “certain that it impacted patient care,” observing that when there are no guidelines available on how to manage patients, physicians will turn to the most recent evidence in the most reputable journals.

“In the case of ACE [inhibitors] and ARBs, although the study was based on fraudulent data, we were lucky that the overall message was in the end probably correct, but that might not have been the case for another study or dataset,” she said.

Early in the pandemic, concerns existed that ACE inhibitors and ARBs could be harmful, increasing the expression of ACE2 receptors, which the SARS-CoV-2 virus uses to gain entry into cells. The first randomized trial to examine the issue, BRACE CORONA, showed no clinical benefit to interrupting use of the agents in hospitalized patients. An observational study suggested ACE inhibitors may even be protective.

Of two high-profile retractions, McDonald said they chose to bypass the hydroxychloroquine study, which had an eye-popping Altmetric attention score of 23,084, compared with 3,727 for the NEJM paper, because it may have been cited for “other” reasons. “We wanted to focus less on the politics and more on the problem of retracted work.”

The team found that researchers across the globe were citing the retracted ACE/ARB paper (18.7% in the United States, 8.1% in Italy, and 44% other countries). Most citations were used to support a statement in the main text of a study, but in nearly 3% of cases, the data were incorporated into new analyses.

Just 17.6% of the studies cited or noted the retraction. “For sure, that was surprising to us. We suspected it, but our study confirmed it,” Dr. McDonald said.

Although retracted articles can be identified by a watermark or line of text, in some cases that can be easily missed, she noted. What’s more, not all citation software points out when a study has been retracted, a fate shared by the copyediting process.

“There are a lot of mechanisms in place and, in general, what’s happening is rare but there isn’t a perfect automated system solution to absolutely prevent this from happening,” she said. “It’s still subject to human error.”

The findings also have to be taken in the context of a rapidly emerging pandemic and the unprecedented torrent of scientific papers released over the past year.

“That might have contributed to why this happened, but the takeaway message is that this can happen despite our best efforts, and we need to challenge ourselves to come up with a system solution to prevent this from happening in the future,” Dr. McDonald said. “Current mechanisms are probably capturing 95% of it, but we need to do better.”

Limitations of the present analysis are that it was limited to the single retracted study; used only a single search engine, Google Scholar, to identify the citing works; and that additional citations may have been missed, the authors noted.

McDonald and coauthor Todd C. Lee, MD, report being signatories on a public letter calling for the retraction of the Surgisphere papers. Dr. Lee also reported receiving research support from Fonds De Recherche du Quebec-Sante during the conduct of the study.

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

The U.S. health care system ranked last overall among 11 high-income countries in an analysis by the nonprofit Commonwealth Fund, according to a report released on Aug. 4.

The report is the seventh international comparison of countries’ health systems by the Commonwealth Fund since 2004, and the United States has ranked last in every edition, David Blumenthal, MD, president of the Commonwealth Fund, told reporters during a press briefing.

Researchers analyzed survey answers from tens of thousands of patients and physicians in 11 countries. They analyzed performance on 71 measures across five categories – access to care, care process, administrative efficiency, equity, and health care outcomes. Administrative data were gathered from the Organisation for Economic Cooperation and Development and the World Health Organization.

Among contributors to the poor showing by the United States is that half (50%) of lower-income U.S. adults and 27% of higher-income U.S. adults say costs keep them from getting needed health care.

“In no other country does income inequality so profoundly limit access to care,” Dr. Blumenthal said.

In the United Kingdom, only 12% with lower incomes and 7% with higher incomes said costs kept them from care.

In a stark comparison, the researchers found that “a high-income person in the U.S. was more likely to report financial barriers than a low-income person in nearly all the other countries surveyed: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the U.K.”

Norway, the Netherlands, and Australia were ranked at the top overall in that order. Rounding out the 11 in overall ranking were the U.K., Germany, New Zealand, Sweden, France, Switzerland, Canada, and the United States.

“What this report tells us is that our health care system is not working for Americans, particularly those with lower incomes, who are at a severe disadvantage compared to citizens of other countries. And they are paying the price with their health and their lives,” Dr. Blumenthal said in a press release.

“To catch up with other high-income countries, the administration and Congress would have to expand access to health care, equitably, to all Americans, act aggressively to control costs, and invest in the social services we know can lead to a healthier population.”
 

High infant mortality, low life expectancy in U.S.

Several factors contributed to the U.S. ranking at the bottom of the outcomes category. Among them are that the United States has the highest infant mortality rate (5.7 deaths per 1,000 live births) and lowest life expectancy at age 60 (living on average 23.1 years after age 60), compared with the other countries surveyed. The U.S. rate of preventable mortality (177 deaths per 100,000 population) is more than double that of the best-performing country, Switzerland.

Lead author Eric Schneider, MD, senior vice president for policy and research at the Commonwealth Fund, pointed out that, in terms of the change in avoidable mortality over a decade, not only did the United States have the highest rate, compared with the other countries surveyed, “it also experienced the smallest decline in avoidable mortality over that 10-year period.”

The U.S. maternal mortality rate of 17.4 deaths per 100,000 live births is twice that of France, the country with the next-highest rate (7.6 deaths per 100,000 live births).
 

U.S. excelled in only one category

The only category in which the United States did not rank last was in “care process,” where it ranked second behind only New Zealand.

The care process category combines preventive care, safe care, coordinated care, and patient engagement and preferences. The category includes indicators such as mammography screening and influenza vaccination for older adults as well as the percentage of adults counseled by a health care provider about nutrition, smoking, or alcohol use.

The United States and Germany performed best on engagement and patient preferences, although U.S. adults have the lowest rates of continuity with the same doctor.

New Zealand and the United States ranked highest in the safe care category, with higher reported use of computerized alerts and routine review of medications.
 

‘Too little, too late’: Key recommendations for U.S. to improve

Reginald Williams, vice president of International Health Policy and Practice Innovations at the Commonwealth Fund, pointed out that the U.S. shortcomings in health care come despite spending more than twice as much of its GDP (17% in 2019) as the average OECD country.

“It appears that the US delivers too little of the care that is most needed and often delivers that care too late, especially for people with chronic illnesses,” he said.

He then summarized the team’s recommendations on how the United States can change course.

First is expanding insurance coverage, he said, noting that the United States is the only one of the 11 countries that lacks universal coverage and nearly 30 million people remain uninsured.

Top-performing countries in the survey have universal coverage, annual out-of-pocket caps on covered benefits, and full coverage for primary care and treatment for chronic conditions, he said.

The United States must also improve access to care, he said.

“Top-ranking countries like the Netherlands and Norway ensure timely availability to care by telephone on nights and weekends, and in-person follow-up at home, if needed,” he said.

Mr. Williams said reducing administrative burdens is also critical to free up resources for improving health. He gave an example: “Norway determines patient copayments or physician fees on a regional basis, applying standardized copayments to all physicians within a specialty in a geographic area.”

Reducing income-related barriers is important as well, he said.

The fear of unpredictably high bills and other issues prevent people in the United States from getting the care they ultimately need, he said, adding that top-performing countries invest more in social services to reduce health risks.

That could have implications for the COVID-19 response.

Responding effectively to COVID-19 requires that patients can access affordable health care services, Mr. Williams noted.

“We know from our research that more than two-thirds of U.S. adults say their potential out-of-pocket costs would figure prominently in their decisions to get care if they had coronavirus symptoms,” he said.

Dr. Schneider summed up in the press release: “This study makes clear that higher U.S. spending on health care is not producing better health especially as the U.S. continues on a path of deepening inequality. A country that spends as much as we do should have the best health system in the world. We should adapt what works in other high-income countries to build a better health care system that provides affordable, high-quality health care for everyone.”

Dr. Blumenthal, Dr. Schneider, and Mr. Williams reported no relevant financial relationships outside their employment with the Commonwealth Fund. 

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

The U.S. health care system ranked last overall among 11 high-income countries in an analysis by the nonprofit Commonwealth Fund, according to a report released on Aug. 4.

The report is the seventh international comparison of countries’ health systems by the Commonwealth Fund since 2004, and the United States has ranked last in every edition, David Blumenthal, MD, president of the Commonwealth Fund, told reporters during a press briefing.

Researchers analyzed survey answers from tens of thousands of patients and physicians in 11 countries. They analyzed performance on 71 measures across five categories – access to care, care process, administrative efficiency, equity, and health care outcomes. Administrative data were gathered from the Organisation for Economic Cooperation and Development and the World Health Organization.

Among contributors to the poor showing by the United States is that half (50%) of lower-income U.S. adults and 27% of higher-income U.S. adults say costs keep them from getting needed health care.

“In no other country does income inequality so profoundly limit access to care,” Dr. Blumenthal said.

In the United Kingdom, only 12% with lower incomes and 7% with higher incomes said costs kept them from care.

In a stark comparison, the researchers found that “a high-income person in the U.S. was more likely to report financial barriers than a low-income person in nearly all the other countries surveyed: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the U.K.”

Norway, the Netherlands, and Australia were ranked at the top overall in that order. Rounding out the 11 in overall ranking were the U.K., Germany, New Zealand, Sweden, France, Switzerland, Canada, and the United States.

“What this report tells us is that our health care system is not working for Americans, particularly those with lower incomes, who are at a severe disadvantage compared to citizens of other countries. And they are paying the price with their health and their lives,” Dr. Blumenthal said in a press release.

“To catch up with other high-income countries, the administration and Congress would have to expand access to health care, equitably, to all Americans, act aggressively to control costs, and invest in the social services we know can lead to a healthier population.”
 

High infant mortality, low life expectancy in U.S.

Several factors contributed to the U.S. ranking at the bottom of the outcomes category. Among them are that the United States has the highest infant mortality rate (5.7 deaths per 1,000 live births) and lowest life expectancy at age 60 (living on average 23.1 years after age 60), compared with the other countries surveyed. The U.S. rate of preventable mortality (177 deaths per 100,000 population) is more than double that of the best-performing country, Switzerland.

Lead author Eric Schneider, MD, senior vice president for policy and research at the Commonwealth Fund, pointed out that, in terms of the change in avoidable mortality over a decade, not only did the United States have the highest rate, compared with the other countries surveyed, “it also experienced the smallest decline in avoidable mortality over that 10-year period.”

The U.S. maternal mortality rate of 17.4 deaths per 100,000 live births is twice that of France, the country with the next-highest rate (7.6 deaths per 100,000 live births).
 

U.S. excelled in only one category

The only category in which the United States did not rank last was in “care process,” where it ranked second behind only New Zealand.

The care process category combines preventive care, safe care, coordinated care, and patient engagement and preferences. The category includes indicators such as mammography screening and influenza vaccination for older adults as well as the percentage of adults counseled by a health care provider about nutrition, smoking, or alcohol use.

The United States and Germany performed best on engagement and patient preferences, although U.S. adults have the lowest rates of continuity with the same doctor.

New Zealand and the United States ranked highest in the safe care category, with higher reported use of computerized alerts and routine review of medications.
 

‘Too little, too late’: Key recommendations for U.S. to improve

Reginald Williams, vice president of International Health Policy and Practice Innovations at the Commonwealth Fund, pointed out that the U.S. shortcomings in health care come despite spending more than twice as much of its GDP (17% in 2019) as the average OECD country.

“It appears that the US delivers too little of the care that is most needed and often delivers that care too late, especially for people with chronic illnesses,” he said.

He then summarized the team’s recommendations on how the United States can change course.

First is expanding insurance coverage, he said, noting that the United States is the only one of the 11 countries that lacks universal coverage and nearly 30 million people remain uninsured.

Top-performing countries in the survey have universal coverage, annual out-of-pocket caps on covered benefits, and full coverage for primary care and treatment for chronic conditions, he said.

The United States must also improve access to care, he said.

“Top-ranking countries like the Netherlands and Norway ensure timely availability to care by telephone on nights and weekends, and in-person follow-up at home, if needed,” he said.

Mr. Williams said reducing administrative burdens is also critical to free up resources for improving health. He gave an example: “Norway determines patient copayments or physician fees on a regional basis, applying standardized copayments to all physicians within a specialty in a geographic area.”

Reducing income-related barriers is important as well, he said.

The fear of unpredictably high bills and other issues prevent people in the United States from getting the care they ultimately need, he said, adding that top-performing countries invest more in social services to reduce health risks.

That could have implications for the COVID-19 response.

Responding effectively to COVID-19 requires that patients can access affordable health care services, Mr. Williams noted.

“We know from our research that more than two-thirds of U.S. adults say their potential out-of-pocket costs would figure prominently in their decisions to get care if they had coronavirus symptoms,” he said.

Dr. Schneider summed up in the press release: “This study makes clear that higher U.S. spending on health care is not producing better health especially as the U.S. continues on a path of deepening inequality. A country that spends as much as we do should have the best health system in the world. We should adapt what works in other high-income countries to build a better health care system that provides affordable, high-quality health care for everyone.”

Dr. Blumenthal, Dr. Schneider, and Mr. Williams reported no relevant financial relationships outside their employment with the Commonwealth Fund. 

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

The U.S. health care system ranked last overall among 11 high-income countries in an analysis by the nonprofit Commonwealth Fund, according to a report released on Aug. 4.

The report is the seventh international comparison of countries’ health systems by the Commonwealth Fund since 2004, and the United States has ranked last in every edition, David Blumenthal, MD, president of the Commonwealth Fund, told reporters during a press briefing.

Researchers analyzed survey answers from tens of thousands of patients and physicians in 11 countries. They analyzed performance on 71 measures across five categories – access to care, care process, administrative efficiency, equity, and health care outcomes. Administrative data were gathered from the Organisation for Economic Cooperation and Development and the World Health Organization.

Among contributors to the poor showing by the United States is that half (50%) of lower-income U.S. adults and 27% of higher-income U.S. adults say costs keep them from getting needed health care.

“In no other country does income inequality so profoundly limit access to care,” Dr. Blumenthal said.

In the United Kingdom, only 12% with lower incomes and 7% with higher incomes said costs kept them from care.

In a stark comparison, the researchers found that “a high-income person in the U.S. was more likely to report financial barriers than a low-income person in nearly all the other countries surveyed: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the U.K.”

Norway, the Netherlands, and Australia were ranked at the top overall in that order. Rounding out the 11 in overall ranking were the U.K., Germany, New Zealand, Sweden, France, Switzerland, Canada, and the United States.

“What this report tells us is that our health care system is not working for Americans, particularly those with lower incomes, who are at a severe disadvantage compared to citizens of other countries. And they are paying the price with their health and their lives,” Dr. Blumenthal said in a press release.

“To catch up with other high-income countries, the administration and Congress would have to expand access to health care, equitably, to all Americans, act aggressively to control costs, and invest in the social services we know can lead to a healthier population.”
 

High infant mortality, low life expectancy in U.S.

Several factors contributed to the U.S. ranking at the bottom of the outcomes category. Among them are that the United States has the highest infant mortality rate (5.7 deaths per 1,000 live births) and lowest life expectancy at age 60 (living on average 23.1 years after age 60), compared with the other countries surveyed. The U.S. rate of preventable mortality (177 deaths per 100,000 population) is more than double that of the best-performing country, Switzerland.

Lead author Eric Schneider, MD, senior vice president for policy and research at the Commonwealth Fund, pointed out that, in terms of the change in avoidable mortality over a decade, not only did the United States have the highest rate, compared with the other countries surveyed, “it also experienced the smallest decline in avoidable mortality over that 10-year period.”

The U.S. maternal mortality rate of 17.4 deaths per 100,000 live births is twice that of France, the country with the next-highest rate (7.6 deaths per 100,000 live births).
 

U.S. excelled in only one category

The only category in which the United States did not rank last was in “care process,” where it ranked second behind only New Zealand.

The care process category combines preventive care, safe care, coordinated care, and patient engagement and preferences. The category includes indicators such as mammography screening and influenza vaccination for older adults as well as the percentage of adults counseled by a health care provider about nutrition, smoking, or alcohol use.

The United States and Germany performed best on engagement and patient preferences, although U.S. adults have the lowest rates of continuity with the same doctor.

New Zealand and the United States ranked highest in the safe care category, with higher reported use of computerized alerts and routine review of medications.
 

‘Too little, too late’: Key recommendations for U.S. to improve

Reginald Williams, vice president of International Health Policy and Practice Innovations at the Commonwealth Fund, pointed out that the U.S. shortcomings in health care come despite spending more than twice as much of its GDP (17% in 2019) as the average OECD country.

“It appears that the US delivers too little of the care that is most needed and often delivers that care too late, especially for people with chronic illnesses,” he said.

He then summarized the team’s recommendations on how the United States can change course.

First is expanding insurance coverage, he said, noting that the United States is the only one of the 11 countries that lacks universal coverage and nearly 30 million people remain uninsured.

Top-performing countries in the survey have universal coverage, annual out-of-pocket caps on covered benefits, and full coverage for primary care and treatment for chronic conditions, he said.

The United States must also improve access to care, he said.

“Top-ranking countries like the Netherlands and Norway ensure timely availability to care by telephone on nights and weekends, and in-person follow-up at home, if needed,” he said.

Mr. Williams said reducing administrative burdens is also critical to free up resources for improving health. He gave an example: “Norway determines patient copayments or physician fees on a regional basis, applying standardized copayments to all physicians within a specialty in a geographic area.”

Reducing income-related barriers is important as well, he said.

The fear of unpredictably high bills and other issues prevent people in the United States from getting the care they ultimately need, he said, adding that top-performing countries invest more in social services to reduce health risks.

That could have implications for the COVID-19 response.

Responding effectively to COVID-19 requires that patients can access affordable health care services, Mr. Williams noted.

“We know from our research that more than two-thirds of U.S. adults say their potential out-of-pocket costs would figure prominently in their decisions to get care if they had coronavirus symptoms,” he said.

Dr. Schneider summed up in the press release: “This study makes clear that higher U.S. spending on health care is not producing better health especially as the U.S. continues on a path of deepening inequality. A country that spends as much as we do should have the best health system in the world. We should adapt what works in other high-income countries to build a better health care system that provides affordable, high-quality health care for everyone.”

Dr. Blumenthal, Dr. Schneider, and Mr. Williams reported no relevant financial relationships outside their employment with the Commonwealth Fund. 

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