Vaccine holdouts embrace COVID antibody treatment, mystifying doctors

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Tue, 10/05/2021 - 15:37

Houston architect Lanson Jones is one of the nearly 80 million Americans who refuse to get a COVID-19 vaccine, arguing the shots are experimental, were rushed to market, may cause side effects, and aren’t all fully approved by federal officials.

But when he contracted COVID in September, he didn’t hesitate to seek treatment with monoclonal antibodies -- a year-old, laboratory-created therapy no less experimental than the vaccines that is not fully approved by the FDA and can also cause rare side effects.

“I haven’t done the shot because I hear a lot -- a lot -- of information about what are some of the effects of these vaccines and how it’s really not being reported, and I just felt I didn’t want to put something in me that has some question,” says Mr. Jones, 65.

“But with this monoclonal antibody treatment, I didn’t hesitate. I had no doubt in my mind -- not even one ounce of doubt about it. Not one person said, ‘Oh, well some people have had a reaction to it.’”

Mr. Jones, who was treated at Houston Methodist Hospital, is one of more than a million Americans who have received antibody IVs after getting the virus.

Those numbers are growing, with the federal government recently taking over distribution of the supplies of the drugs, which are limited in many states.

The treatment has been effective against COVID, in helping patients recover, stay out of the hospital, or die from the illness.

But what doctors and public health experts say is most surprising is that so many of those embracing it are unvaccinated Americans who have refused the shot for reasons that could very well apply to the newly developed and experimental monoclonal antibody therapy, as well.

“I think it’s irrational, quite frankly, if you have to boil it down to one word,” says Howard Huang, MD, who heads up Houston Methodist’s infusion program, which is providing up to 900 doses a week. “It really doesn’t make any sense on multiple levels.”

For one thing, he says, the FDA has just granted full approval for the COVID vaccine produced by Pfizer and BioNTech, upgrading its status from its emergency use authorization (EUA). Many experts expect the FDA to grant similar full approvals to the Moderna vaccine and possibly the Johnson and Johnson shot, which currently have EUA designations.

Many vaccine holdouts have cited the EUA status of the COVID vaccines -- one step shy of full approval -- as a reason they don’t trust the shot. But the antibody treatments have also been granted only EUA approval, which hasn’t stopped vaccine-resistant Americans from seeking them.

“So, they’re refusing an FDA-approved and tested [vaccine], and then they’re seeking something that’s still under an FDA EUA,” says Dr. Huang. “I just don’t get it. I really don’t.”

Amesh Adalja, MD, an emerging infectious diseases specialist with the Johns Hopkins University Center for Health Security, calls it “paradoxical” thinking for vaccine holdouts to refuse a shot that boosts your natural antibodies to prevent COVID, but take an antibody drug to treat it after infection.

“I don’t understand it, I can’t,” he says. “But the pandemic has been politicized and … I think consistency is not something to expect from people who are thinking about this irrationally [and] for people engaging in these conspiracies about the vaccine.

“I do think the fact that people like Joe Rogan and Gov. Abbot and Donald Trump received the monoclonal antibodies does probably play a role in some of the thinking in some of these individuals.”

Terry Scoggin, CEO of Titus Regional Medical Center in Mount Pleasant, Tex., says even the hospital’s doctors have been shocked by the demand for the new therapy among unvaccinated Texans.

“It’s mind-blowing that there’s been such resistance to the vaccine, but that demand for the monoclonal antibodies is so high,” he says, noting only 47% of adults in the region have received at least one dose of the shot. That’s far below CDC estimates that say 75.2% of American adults have received one shot, while 64.7% are fully vaccinated.

“But our doctors believe in the monoclonal antibodies, so it’s a trust factor -- they trust our community physicians,” Mr. Scoggin says. “I’ve never put the two and two together about the fear of the vaccine vs. [lack of fear] of the treatment. But it’s really interesting.”
 

 

 

Treatments effective, costly

Like the COVID vaccines given to nearly 214 million Americans, the antibody treatments taken by more than 1 million in the United States are highly effective and cause only rare (and usually minor) side effects.

Federal health officials say the infusions have helped keep the U.S. death toll -- now about 2,000 per day-- from soaring even higher, even as vaccine hesitancy persists, particularly in Southern states.

The FDA first authorized monoclonal antibody drugs in November 2020 -- just weeks before the vaccines were approved. But their popularity has soared as the Delta variant of the virus that causes COVID-19 has surged in recent months.

Clinical trials show that the drugs can cut COVID-related hospitalization or death in high-risk patients by as much as 70%-80%. They also can prevent infection in healthy people who have been exposed to an infected person, according to research published this month in The New England Journal of Medicine.

Monoclonal antibodies have been used for decades to treat cancer, autoimmune disorders, and other diseases, with the FDA approving nearly 100 such treatments since 1994.

The FDA has granted EUA approvals to four antibody treatments for COVID-19.

A two-antibody drug combination from Regeneron -- containing casirivimab and imdevimab -- has been shown to reduce the risk of hospitalization and death by 70% in people infected with COVID. Sotrovimab, made by GlaxoSmithKline and Vir, has had similar results.

The FDA approved a third treatment -- Eli Lilly’s combination of bamlanivimab and etesevimab -- in 2020, but the agency recommended against its use earlier this year after it proved ineffective against the Delta variant. The combination came back on the market in late August, but only in states where fewer than 5% of COVID infections are from strains, such as Delta, that are resistant to the treatment.

In June, the FDA authorized a fourth drug combination, Genentech’s tocilizumab, for people already hospitalized with COVID. But it is only moderately effective against the disease.

Lab-made monoclonal antibodies mimic the antibodies the body makes to fight viruses and illnesses. They work by targeting the spike protein on the surface of the virus. COVID vaccines work by priming the body’s immune system to recognize this very same spike protein and block it from entering your body’s cells, preventing infection.

Antibody treatments are given as an IV to treat an infection but can also be given as shots into the belly for people who have been exposed to the virus but have not yet been sickened by it, Dr. Huang says.

Timing is critical, he says, noting antibodies are most effective when given in the first few days after symptoms emerge.
 

Demands, concerns on the rise

Orders for monoclonal antibodies have skyrocketed in recent weeks -- to 168,000 doses per week in late August, up from 27,000 in July. The Biden administration, which has been covering the cost of the treatment for most patients, took over its distribution as well this week.

But experts foresee potential problems as patient demand increases.

Federal officials have already warned states of potential shortages ahead. Only about 2.4 million monoclonal antibody doses have been shipped nationally so far, less than half of which have been administered.

More supplies are on the way, with the federal government recently buying another 1.8 million doses for delivery in the months ahead. But for now, some hospitals are uncertain of supplies and are already struggling to meet the demand for the treatments.

Seven Southern states account for 70% of orders: Texas, Alabama, Florida, Mississippi, Tennessee, Georgia, and Louisiana. Those states have among the nation’s lowest vaccine rates and highest infection numbers.

Florida officials said the state’s latest weekly allotment left clinics 41,000 doses short of what they need. Tennessee has begun limiting treatments for unvaccinated patients to give priority to those most at risk of dying from COVID. And in Texas, elective surgeries have been postponed to make room for COVID-19 patients at some hospitals, as operating room nurses have been enlisted to give IVs.

Some strong proponents of monoclonal antibody treatments have been frustrated by Republican governors who are scrambling to push and deliver them, while opposing vaccine and mask mandates.

Raising vaccination rates, scientists say, would make the antibody treatments unnecessary in many cases.

Experts also note the drugs are far more costly than the vaccines -- with a price tag of about $2,100 for each IV, compared to $20-$40 for the shot.

“When you’re talking about just the cost to society as a whole -- turning down a [vaccine] that costs a couple dozen dollars for therapies that cost thousands of dollars -- it just doesn’t make any sense,” says Dr. Huang.

“And the tragedy is that a lot of these infections right now are preventable. It’s not like the pre-vaccine days, when we didn’t have anything better. And for these people, it’s just hard to justify that line of thinking. And so, the challenge is changing people’s minds. And that’s really been the difficult thing.”

In addition, the treatments take 90 minutes to administer, taxing health care workers in hard-hit states that have been slammed by the influx of patients.

Beyond these issues, Dr. Huang cites other public health costs of people choosing treatment over vaccination. The vaccine protects others because it limits transmission of the virus. By contrast, a single antibody IV helps only that patient and does not keep people from infecting others or becoming reinfected, requiring another IV.

“Getting the vaccine helps people beyond yourself; it helps the community, too,” he notes. “There’s just a strong argument for getting the vaccine. I obviously have a very biased opinion, but I would hope I have more of a scientific or expert opinion, but that doesn’t seem to matter these days.”
 

 

 

Vaccine resistance still remains for some

Seth Thurman, an IT technician from Mount Pleasant, Tex., acknowledges he was hesitant to get the vaccine at first because he felt it was fast-tracked, “experimental,” might cause unknown side effects, was developed quickly, and was being pushed by government officials.

“I shared the same sentiments as a lot of other people [as] some of the reasons why I might have been hesitant in the beginning to get the vaccine, says Mr. Thurman, 47. “A lot of people don’t trust what’s out there, maybe what the government is pushing, so I was taking a wait-and-see approach.”

In August, he relented and received the first of the two-shot Moderna vaccine. But several weeks later, he developed COVID and took his doctor’s advice to receive antibody therapy at Titus Regional Medical Center.

The results were almost immediate.

“I noticed within just a few hours of getting that infusion I was feeling better,” he says. “And by the next day, I was feeling great. No more temperature and no cough and no loss of taste and smell. And today, I’m 100%.”

Having had COVID convinced him of the importance of getting the vaccine, and he plans to get the second dose of the shot after the prescribed 90-day waiting period.

But Mr. Jones, the Houston architect, remains unconvinced, even after suffering what he describes as a “horrible” experience with COVID.

“It’s something I’m still thinking about,” he says of the vaccine. “But I can’t imagine that there wouldn’t be some sort of side effects from something that was developed so fast and had not gone through 4 or 5 years of vetting or trials. So that kind of just leaves doubt in my mind.

“And it’s just so weird that something so personal has become so public -- like people’s medical decisions now are on the front page of The New York Times. When did we think something like that would ever happen?”

The quick results of his treatment were so “remarkable” that he’d recommend it to anyone without hesitation, he says.

“If my story can help people be willing to seek out this infusion and take it early on in their COVID experience, I think it would not only save lives and keep people out of our hospitals and not overwhelm our hospital systems,” he says.

Dr. Huang agrees that the IV therapy is a great “fallback option” for people who’ve been infected, who have weakened immune systems, or can’t receive the vaccine for other health reasons. But for most people, he argues, the vaccine is the best way to go. That’s why Houston Methodist advises the shot for every patient like Mr. Jones, who’s been treated for COVID.

“Getting the vaccine is the way to go for the vast number of people,” he says.

Frederick Thurmond, MD, who oversees COVID-related care at Titus Regional Medical Center, believes it will take more than just doctors’ recommendations to move some patients to get the vaccine. The only thing that will motivate some will be contracting COVID, or knowing someone who does, he says.

“It’s clear that at least here in Texas, I swear man, you tell people they need to do something, and they just say, ‘Well, then I’m NOT going to do it,’” he says. “But once you’ve got COVID, the game becomes a whole lot more serious. And I think most people in the U.S. know someone who’s died from COVID at this point.”

Dr. Thurmond says that for some patients, stubborn resistance to legitimate medical advice persists -- on the vaccine and even treatment -- even after infection.

“We have seen more than one person avoid any medical care whatsoever after they knew they had COVID,” he says. “They languish in private and eventually come to the emergency room extremely sick and doing things with little to no medical value -- such as taking a friend’s hydroxychloroquine, random antibiotics, a horse de-worming dose of ivermectin, and gargling with Betadine and even bleach.”

But most of his patients who have the IV therapy take his advice to get the vaccine afterward.

“The only way to end the pandemic is to vaccinate everybody,” he says.

Dr. Adalja agrees.

“The monoclonal antibodies work, they are great drugs, so I think it is appropriate to praise them,” says Dr. Adalja, who’s given them to his own patients. “But it’s not appropriate to use them as an alternative to vaccination or to think, you know, don’t worry about the getting the vaccine because if you get infected and get the monoclonal antibodies to get through this -- that’s not the way to approach it.

He also worries about what he calls “dark-age mentalities” that have fueled the anti-vaccine movement, which has sought to heighten fears of modern medicine and doctors.

“The anti-vaccine movement has really capitalized on COVID-19, and it’s really a much more virulent form of the anti-vaccine movement than what we’ve seen with measles and other diseases in the past,” he notes. “And I think it’s going to be very difficult to contend with in the future, because no one thought we’d be battling the anti-vaccine movement this late in the pandemic.”

The biggest takeaway?

“When it comes to an infectious disease, prevention is always much better than treatment,” Dr. Adalja says. “If you don’t even need to get to the treatment stage because you prevent people from getting infected, that’s the goal.”

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

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Houston architect Lanson Jones is one of the nearly 80 million Americans who refuse to get a COVID-19 vaccine, arguing the shots are experimental, were rushed to market, may cause side effects, and aren’t all fully approved by federal officials.

But when he contracted COVID in September, he didn’t hesitate to seek treatment with monoclonal antibodies -- a year-old, laboratory-created therapy no less experimental than the vaccines that is not fully approved by the FDA and can also cause rare side effects.

“I haven’t done the shot because I hear a lot -- a lot -- of information about what are some of the effects of these vaccines and how it’s really not being reported, and I just felt I didn’t want to put something in me that has some question,” says Mr. Jones, 65.

“But with this monoclonal antibody treatment, I didn’t hesitate. I had no doubt in my mind -- not even one ounce of doubt about it. Not one person said, ‘Oh, well some people have had a reaction to it.’”

Mr. Jones, who was treated at Houston Methodist Hospital, is one of more than a million Americans who have received antibody IVs after getting the virus.

Those numbers are growing, with the federal government recently taking over distribution of the supplies of the drugs, which are limited in many states.

The treatment has been effective against COVID, in helping patients recover, stay out of the hospital, or die from the illness.

But what doctors and public health experts say is most surprising is that so many of those embracing it are unvaccinated Americans who have refused the shot for reasons that could very well apply to the newly developed and experimental monoclonal antibody therapy, as well.

“I think it’s irrational, quite frankly, if you have to boil it down to one word,” says Howard Huang, MD, who heads up Houston Methodist’s infusion program, which is providing up to 900 doses a week. “It really doesn’t make any sense on multiple levels.”

For one thing, he says, the FDA has just granted full approval for the COVID vaccine produced by Pfizer and BioNTech, upgrading its status from its emergency use authorization (EUA). Many experts expect the FDA to grant similar full approvals to the Moderna vaccine and possibly the Johnson and Johnson shot, which currently have EUA designations.

Many vaccine holdouts have cited the EUA status of the COVID vaccines -- one step shy of full approval -- as a reason they don’t trust the shot. But the antibody treatments have also been granted only EUA approval, which hasn’t stopped vaccine-resistant Americans from seeking them.

“So, they’re refusing an FDA-approved and tested [vaccine], and then they’re seeking something that’s still under an FDA EUA,” says Dr. Huang. “I just don’t get it. I really don’t.”

Amesh Adalja, MD, an emerging infectious diseases specialist with the Johns Hopkins University Center for Health Security, calls it “paradoxical” thinking for vaccine holdouts to refuse a shot that boosts your natural antibodies to prevent COVID, but take an antibody drug to treat it after infection.

“I don’t understand it, I can’t,” he says. “But the pandemic has been politicized and … I think consistency is not something to expect from people who are thinking about this irrationally [and] for people engaging in these conspiracies about the vaccine.

“I do think the fact that people like Joe Rogan and Gov. Abbot and Donald Trump received the monoclonal antibodies does probably play a role in some of the thinking in some of these individuals.”

Terry Scoggin, CEO of Titus Regional Medical Center in Mount Pleasant, Tex., says even the hospital’s doctors have been shocked by the demand for the new therapy among unvaccinated Texans.

“It’s mind-blowing that there’s been such resistance to the vaccine, but that demand for the monoclonal antibodies is so high,” he says, noting only 47% of adults in the region have received at least one dose of the shot. That’s far below CDC estimates that say 75.2% of American adults have received one shot, while 64.7% are fully vaccinated.

“But our doctors believe in the monoclonal antibodies, so it’s a trust factor -- they trust our community physicians,” Mr. Scoggin says. “I’ve never put the two and two together about the fear of the vaccine vs. [lack of fear] of the treatment. But it’s really interesting.”
 

 

 

Treatments effective, costly

Like the COVID vaccines given to nearly 214 million Americans, the antibody treatments taken by more than 1 million in the United States are highly effective and cause only rare (and usually minor) side effects.

Federal health officials say the infusions have helped keep the U.S. death toll -- now about 2,000 per day-- from soaring even higher, even as vaccine hesitancy persists, particularly in Southern states.

The FDA first authorized monoclonal antibody drugs in November 2020 -- just weeks before the vaccines were approved. But their popularity has soared as the Delta variant of the virus that causes COVID-19 has surged in recent months.

Clinical trials show that the drugs can cut COVID-related hospitalization or death in high-risk patients by as much as 70%-80%. They also can prevent infection in healthy people who have been exposed to an infected person, according to research published this month in The New England Journal of Medicine.

Monoclonal antibodies have been used for decades to treat cancer, autoimmune disorders, and other diseases, with the FDA approving nearly 100 such treatments since 1994.

The FDA has granted EUA approvals to four antibody treatments for COVID-19.

A two-antibody drug combination from Regeneron -- containing casirivimab and imdevimab -- has been shown to reduce the risk of hospitalization and death by 70% in people infected with COVID. Sotrovimab, made by GlaxoSmithKline and Vir, has had similar results.

The FDA approved a third treatment -- Eli Lilly’s combination of bamlanivimab and etesevimab -- in 2020, but the agency recommended against its use earlier this year after it proved ineffective against the Delta variant. The combination came back on the market in late August, but only in states where fewer than 5% of COVID infections are from strains, such as Delta, that are resistant to the treatment.

In June, the FDA authorized a fourth drug combination, Genentech’s tocilizumab, for people already hospitalized with COVID. But it is only moderately effective against the disease.

Lab-made monoclonal antibodies mimic the antibodies the body makes to fight viruses and illnesses. They work by targeting the spike protein on the surface of the virus. COVID vaccines work by priming the body’s immune system to recognize this very same spike protein and block it from entering your body’s cells, preventing infection.

Antibody treatments are given as an IV to treat an infection but can also be given as shots into the belly for people who have been exposed to the virus but have not yet been sickened by it, Dr. Huang says.

Timing is critical, he says, noting antibodies are most effective when given in the first few days after symptoms emerge.
 

Demands, concerns on the rise

Orders for monoclonal antibodies have skyrocketed in recent weeks -- to 168,000 doses per week in late August, up from 27,000 in July. The Biden administration, which has been covering the cost of the treatment for most patients, took over its distribution as well this week.

But experts foresee potential problems as patient demand increases.

Federal officials have already warned states of potential shortages ahead. Only about 2.4 million monoclonal antibody doses have been shipped nationally so far, less than half of which have been administered.

More supplies are on the way, with the federal government recently buying another 1.8 million doses for delivery in the months ahead. But for now, some hospitals are uncertain of supplies and are already struggling to meet the demand for the treatments.

Seven Southern states account for 70% of orders: Texas, Alabama, Florida, Mississippi, Tennessee, Georgia, and Louisiana. Those states have among the nation’s lowest vaccine rates and highest infection numbers.

Florida officials said the state’s latest weekly allotment left clinics 41,000 doses short of what they need. Tennessee has begun limiting treatments for unvaccinated patients to give priority to those most at risk of dying from COVID. And in Texas, elective surgeries have been postponed to make room for COVID-19 patients at some hospitals, as operating room nurses have been enlisted to give IVs.

Some strong proponents of monoclonal antibody treatments have been frustrated by Republican governors who are scrambling to push and deliver them, while opposing vaccine and mask mandates.

Raising vaccination rates, scientists say, would make the antibody treatments unnecessary in many cases.

Experts also note the drugs are far more costly than the vaccines -- with a price tag of about $2,100 for each IV, compared to $20-$40 for the shot.

“When you’re talking about just the cost to society as a whole -- turning down a [vaccine] that costs a couple dozen dollars for therapies that cost thousands of dollars -- it just doesn’t make any sense,” says Dr. Huang.

“And the tragedy is that a lot of these infections right now are preventable. It’s not like the pre-vaccine days, when we didn’t have anything better. And for these people, it’s just hard to justify that line of thinking. And so, the challenge is changing people’s minds. And that’s really been the difficult thing.”

In addition, the treatments take 90 minutes to administer, taxing health care workers in hard-hit states that have been slammed by the influx of patients.

Beyond these issues, Dr. Huang cites other public health costs of people choosing treatment over vaccination. The vaccine protects others because it limits transmission of the virus. By contrast, a single antibody IV helps only that patient and does not keep people from infecting others or becoming reinfected, requiring another IV.

“Getting the vaccine helps people beyond yourself; it helps the community, too,” he notes. “There’s just a strong argument for getting the vaccine. I obviously have a very biased opinion, but I would hope I have more of a scientific or expert opinion, but that doesn’t seem to matter these days.”
 

 

 

Vaccine resistance still remains for some

Seth Thurman, an IT technician from Mount Pleasant, Tex., acknowledges he was hesitant to get the vaccine at first because he felt it was fast-tracked, “experimental,” might cause unknown side effects, was developed quickly, and was being pushed by government officials.

“I shared the same sentiments as a lot of other people [as] some of the reasons why I might have been hesitant in the beginning to get the vaccine, says Mr. Thurman, 47. “A lot of people don’t trust what’s out there, maybe what the government is pushing, so I was taking a wait-and-see approach.”

In August, he relented and received the first of the two-shot Moderna vaccine. But several weeks later, he developed COVID and took his doctor’s advice to receive antibody therapy at Titus Regional Medical Center.

The results were almost immediate.

“I noticed within just a few hours of getting that infusion I was feeling better,” he says. “And by the next day, I was feeling great. No more temperature and no cough and no loss of taste and smell. And today, I’m 100%.”

Having had COVID convinced him of the importance of getting the vaccine, and he plans to get the second dose of the shot after the prescribed 90-day waiting period.

But Mr. Jones, the Houston architect, remains unconvinced, even after suffering what he describes as a “horrible” experience with COVID.

“It’s something I’m still thinking about,” he says of the vaccine. “But I can’t imagine that there wouldn’t be some sort of side effects from something that was developed so fast and had not gone through 4 or 5 years of vetting or trials. So that kind of just leaves doubt in my mind.

“And it’s just so weird that something so personal has become so public -- like people’s medical decisions now are on the front page of The New York Times. When did we think something like that would ever happen?”

The quick results of his treatment were so “remarkable” that he’d recommend it to anyone without hesitation, he says.

“If my story can help people be willing to seek out this infusion and take it early on in their COVID experience, I think it would not only save lives and keep people out of our hospitals and not overwhelm our hospital systems,” he says.

Dr. Huang agrees that the IV therapy is a great “fallback option” for people who’ve been infected, who have weakened immune systems, or can’t receive the vaccine for other health reasons. But for most people, he argues, the vaccine is the best way to go. That’s why Houston Methodist advises the shot for every patient like Mr. Jones, who’s been treated for COVID.

“Getting the vaccine is the way to go for the vast number of people,” he says.

Frederick Thurmond, MD, who oversees COVID-related care at Titus Regional Medical Center, believes it will take more than just doctors’ recommendations to move some patients to get the vaccine. The only thing that will motivate some will be contracting COVID, or knowing someone who does, he says.

“It’s clear that at least here in Texas, I swear man, you tell people they need to do something, and they just say, ‘Well, then I’m NOT going to do it,’” he says. “But once you’ve got COVID, the game becomes a whole lot more serious. And I think most people in the U.S. know someone who’s died from COVID at this point.”

Dr. Thurmond says that for some patients, stubborn resistance to legitimate medical advice persists -- on the vaccine and even treatment -- even after infection.

“We have seen more than one person avoid any medical care whatsoever after they knew they had COVID,” he says. “They languish in private and eventually come to the emergency room extremely sick and doing things with little to no medical value -- such as taking a friend’s hydroxychloroquine, random antibiotics, a horse de-worming dose of ivermectin, and gargling with Betadine and even bleach.”

But most of his patients who have the IV therapy take his advice to get the vaccine afterward.

“The only way to end the pandemic is to vaccinate everybody,” he says.

Dr. Adalja agrees.

“The monoclonal antibodies work, they are great drugs, so I think it is appropriate to praise them,” says Dr. Adalja, who’s given them to his own patients. “But it’s not appropriate to use them as an alternative to vaccination or to think, you know, don’t worry about the getting the vaccine because if you get infected and get the monoclonal antibodies to get through this -- that’s not the way to approach it.

He also worries about what he calls “dark-age mentalities” that have fueled the anti-vaccine movement, which has sought to heighten fears of modern medicine and doctors.

“The anti-vaccine movement has really capitalized on COVID-19, and it’s really a much more virulent form of the anti-vaccine movement than what we’ve seen with measles and other diseases in the past,” he notes. “And I think it’s going to be very difficult to contend with in the future, because no one thought we’d be battling the anti-vaccine movement this late in the pandemic.”

The biggest takeaway?

“When it comes to an infectious disease, prevention is always much better than treatment,” Dr. Adalja says. “If you don’t even need to get to the treatment stage because you prevent people from getting infected, that’s the goal.”

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

Houston architect Lanson Jones is one of the nearly 80 million Americans who refuse to get a COVID-19 vaccine, arguing the shots are experimental, were rushed to market, may cause side effects, and aren’t all fully approved by federal officials.

But when he contracted COVID in September, he didn’t hesitate to seek treatment with monoclonal antibodies -- a year-old, laboratory-created therapy no less experimental than the vaccines that is not fully approved by the FDA and can also cause rare side effects.

“I haven’t done the shot because I hear a lot -- a lot -- of information about what are some of the effects of these vaccines and how it’s really not being reported, and I just felt I didn’t want to put something in me that has some question,” says Mr. Jones, 65.

“But with this monoclonal antibody treatment, I didn’t hesitate. I had no doubt in my mind -- not even one ounce of doubt about it. Not one person said, ‘Oh, well some people have had a reaction to it.’”

Mr. Jones, who was treated at Houston Methodist Hospital, is one of more than a million Americans who have received antibody IVs after getting the virus.

Those numbers are growing, with the federal government recently taking over distribution of the supplies of the drugs, which are limited in many states.

The treatment has been effective against COVID, in helping patients recover, stay out of the hospital, or die from the illness.

But what doctors and public health experts say is most surprising is that so many of those embracing it are unvaccinated Americans who have refused the shot for reasons that could very well apply to the newly developed and experimental monoclonal antibody therapy, as well.

“I think it’s irrational, quite frankly, if you have to boil it down to one word,” says Howard Huang, MD, who heads up Houston Methodist’s infusion program, which is providing up to 900 doses a week. “It really doesn’t make any sense on multiple levels.”

For one thing, he says, the FDA has just granted full approval for the COVID vaccine produced by Pfizer and BioNTech, upgrading its status from its emergency use authorization (EUA). Many experts expect the FDA to grant similar full approvals to the Moderna vaccine and possibly the Johnson and Johnson shot, which currently have EUA designations.

Many vaccine holdouts have cited the EUA status of the COVID vaccines -- one step shy of full approval -- as a reason they don’t trust the shot. But the antibody treatments have also been granted only EUA approval, which hasn’t stopped vaccine-resistant Americans from seeking them.

“So, they’re refusing an FDA-approved and tested [vaccine], and then they’re seeking something that’s still under an FDA EUA,” says Dr. Huang. “I just don’t get it. I really don’t.”

Amesh Adalja, MD, an emerging infectious diseases specialist with the Johns Hopkins University Center for Health Security, calls it “paradoxical” thinking for vaccine holdouts to refuse a shot that boosts your natural antibodies to prevent COVID, but take an antibody drug to treat it after infection.

“I don’t understand it, I can’t,” he says. “But the pandemic has been politicized and … I think consistency is not something to expect from people who are thinking about this irrationally [and] for people engaging in these conspiracies about the vaccine.

“I do think the fact that people like Joe Rogan and Gov. Abbot and Donald Trump received the monoclonal antibodies does probably play a role in some of the thinking in some of these individuals.”

Terry Scoggin, CEO of Titus Regional Medical Center in Mount Pleasant, Tex., says even the hospital’s doctors have been shocked by the demand for the new therapy among unvaccinated Texans.

“It’s mind-blowing that there’s been such resistance to the vaccine, but that demand for the monoclonal antibodies is so high,” he says, noting only 47% of adults in the region have received at least one dose of the shot. That’s far below CDC estimates that say 75.2% of American adults have received one shot, while 64.7% are fully vaccinated.

“But our doctors believe in the monoclonal antibodies, so it’s a trust factor -- they trust our community physicians,” Mr. Scoggin says. “I’ve never put the two and two together about the fear of the vaccine vs. [lack of fear] of the treatment. But it’s really interesting.”
 

 

 

Treatments effective, costly

Like the COVID vaccines given to nearly 214 million Americans, the antibody treatments taken by more than 1 million in the United States are highly effective and cause only rare (and usually minor) side effects.

Federal health officials say the infusions have helped keep the U.S. death toll -- now about 2,000 per day-- from soaring even higher, even as vaccine hesitancy persists, particularly in Southern states.

The FDA first authorized monoclonal antibody drugs in November 2020 -- just weeks before the vaccines were approved. But their popularity has soared as the Delta variant of the virus that causes COVID-19 has surged in recent months.

Clinical trials show that the drugs can cut COVID-related hospitalization or death in high-risk patients by as much as 70%-80%. They also can prevent infection in healthy people who have been exposed to an infected person, according to research published this month in The New England Journal of Medicine.

Monoclonal antibodies have been used for decades to treat cancer, autoimmune disorders, and other diseases, with the FDA approving nearly 100 such treatments since 1994.

The FDA has granted EUA approvals to four antibody treatments for COVID-19.

A two-antibody drug combination from Regeneron -- containing casirivimab and imdevimab -- has been shown to reduce the risk of hospitalization and death by 70% in people infected with COVID. Sotrovimab, made by GlaxoSmithKline and Vir, has had similar results.

The FDA approved a third treatment -- Eli Lilly’s combination of bamlanivimab and etesevimab -- in 2020, but the agency recommended against its use earlier this year after it proved ineffective against the Delta variant. The combination came back on the market in late August, but only in states where fewer than 5% of COVID infections are from strains, such as Delta, that are resistant to the treatment.

In June, the FDA authorized a fourth drug combination, Genentech’s tocilizumab, for people already hospitalized with COVID. But it is only moderately effective against the disease.

Lab-made monoclonal antibodies mimic the antibodies the body makes to fight viruses and illnesses. They work by targeting the spike protein on the surface of the virus. COVID vaccines work by priming the body’s immune system to recognize this very same spike protein and block it from entering your body’s cells, preventing infection.

Antibody treatments are given as an IV to treat an infection but can also be given as shots into the belly for people who have been exposed to the virus but have not yet been sickened by it, Dr. Huang says.

Timing is critical, he says, noting antibodies are most effective when given in the first few days after symptoms emerge.
 

Demands, concerns on the rise

Orders for monoclonal antibodies have skyrocketed in recent weeks -- to 168,000 doses per week in late August, up from 27,000 in July. The Biden administration, which has been covering the cost of the treatment for most patients, took over its distribution as well this week.

But experts foresee potential problems as patient demand increases.

Federal officials have already warned states of potential shortages ahead. Only about 2.4 million monoclonal antibody doses have been shipped nationally so far, less than half of which have been administered.

More supplies are on the way, with the federal government recently buying another 1.8 million doses for delivery in the months ahead. But for now, some hospitals are uncertain of supplies and are already struggling to meet the demand for the treatments.

Seven Southern states account for 70% of orders: Texas, Alabama, Florida, Mississippi, Tennessee, Georgia, and Louisiana. Those states have among the nation’s lowest vaccine rates and highest infection numbers.

Florida officials said the state’s latest weekly allotment left clinics 41,000 doses short of what they need. Tennessee has begun limiting treatments for unvaccinated patients to give priority to those most at risk of dying from COVID. And in Texas, elective surgeries have been postponed to make room for COVID-19 patients at some hospitals, as operating room nurses have been enlisted to give IVs.

Some strong proponents of monoclonal antibody treatments have been frustrated by Republican governors who are scrambling to push and deliver them, while opposing vaccine and mask mandates.

Raising vaccination rates, scientists say, would make the antibody treatments unnecessary in many cases.

Experts also note the drugs are far more costly than the vaccines -- with a price tag of about $2,100 for each IV, compared to $20-$40 for the shot.

“When you’re talking about just the cost to society as a whole -- turning down a [vaccine] that costs a couple dozen dollars for therapies that cost thousands of dollars -- it just doesn’t make any sense,” says Dr. Huang.

“And the tragedy is that a lot of these infections right now are preventable. It’s not like the pre-vaccine days, when we didn’t have anything better. And for these people, it’s just hard to justify that line of thinking. And so, the challenge is changing people’s minds. And that’s really been the difficult thing.”

In addition, the treatments take 90 minutes to administer, taxing health care workers in hard-hit states that have been slammed by the influx of patients.

Beyond these issues, Dr. Huang cites other public health costs of people choosing treatment over vaccination. The vaccine protects others because it limits transmission of the virus. By contrast, a single antibody IV helps only that patient and does not keep people from infecting others or becoming reinfected, requiring another IV.

“Getting the vaccine helps people beyond yourself; it helps the community, too,” he notes. “There’s just a strong argument for getting the vaccine. I obviously have a very biased opinion, but I would hope I have more of a scientific or expert opinion, but that doesn’t seem to matter these days.”
 

 

 

Vaccine resistance still remains for some

Seth Thurman, an IT technician from Mount Pleasant, Tex., acknowledges he was hesitant to get the vaccine at first because he felt it was fast-tracked, “experimental,” might cause unknown side effects, was developed quickly, and was being pushed by government officials.

“I shared the same sentiments as a lot of other people [as] some of the reasons why I might have been hesitant in the beginning to get the vaccine, says Mr. Thurman, 47. “A lot of people don’t trust what’s out there, maybe what the government is pushing, so I was taking a wait-and-see approach.”

In August, he relented and received the first of the two-shot Moderna vaccine. But several weeks later, he developed COVID and took his doctor’s advice to receive antibody therapy at Titus Regional Medical Center.

The results were almost immediate.

“I noticed within just a few hours of getting that infusion I was feeling better,” he says. “And by the next day, I was feeling great. No more temperature and no cough and no loss of taste and smell. And today, I’m 100%.”

Having had COVID convinced him of the importance of getting the vaccine, and he plans to get the second dose of the shot after the prescribed 90-day waiting period.

But Mr. Jones, the Houston architect, remains unconvinced, even after suffering what he describes as a “horrible” experience with COVID.

“It’s something I’m still thinking about,” he says of the vaccine. “But I can’t imagine that there wouldn’t be some sort of side effects from something that was developed so fast and had not gone through 4 or 5 years of vetting or trials. So that kind of just leaves doubt in my mind.

“And it’s just so weird that something so personal has become so public -- like people’s medical decisions now are on the front page of The New York Times. When did we think something like that would ever happen?”

The quick results of his treatment were so “remarkable” that he’d recommend it to anyone without hesitation, he says.

“If my story can help people be willing to seek out this infusion and take it early on in their COVID experience, I think it would not only save lives and keep people out of our hospitals and not overwhelm our hospital systems,” he says.

Dr. Huang agrees that the IV therapy is a great “fallback option” for people who’ve been infected, who have weakened immune systems, or can’t receive the vaccine for other health reasons. But for most people, he argues, the vaccine is the best way to go. That’s why Houston Methodist advises the shot for every patient like Mr. Jones, who’s been treated for COVID.

“Getting the vaccine is the way to go for the vast number of people,” he says.

Frederick Thurmond, MD, who oversees COVID-related care at Titus Regional Medical Center, believes it will take more than just doctors’ recommendations to move some patients to get the vaccine. The only thing that will motivate some will be contracting COVID, or knowing someone who does, he says.

“It’s clear that at least here in Texas, I swear man, you tell people they need to do something, and they just say, ‘Well, then I’m NOT going to do it,’” he says. “But once you’ve got COVID, the game becomes a whole lot more serious. And I think most people in the U.S. know someone who’s died from COVID at this point.”

Dr. Thurmond says that for some patients, stubborn resistance to legitimate medical advice persists -- on the vaccine and even treatment -- even after infection.

“We have seen more than one person avoid any medical care whatsoever after they knew they had COVID,” he says. “They languish in private and eventually come to the emergency room extremely sick and doing things with little to no medical value -- such as taking a friend’s hydroxychloroquine, random antibiotics, a horse de-worming dose of ivermectin, and gargling with Betadine and even bleach.”

But most of his patients who have the IV therapy take his advice to get the vaccine afterward.

“The only way to end the pandemic is to vaccinate everybody,” he says.

Dr. Adalja agrees.

“The monoclonal antibodies work, they are great drugs, so I think it is appropriate to praise them,” says Dr. Adalja, who’s given them to his own patients. “But it’s not appropriate to use them as an alternative to vaccination or to think, you know, don’t worry about the getting the vaccine because if you get infected and get the monoclonal antibodies to get through this -- that’s not the way to approach it.

He also worries about what he calls “dark-age mentalities” that have fueled the anti-vaccine movement, which has sought to heighten fears of modern medicine and doctors.

“The anti-vaccine movement has really capitalized on COVID-19, and it’s really a much more virulent form of the anti-vaccine movement than what we’ve seen with measles and other diseases in the past,” he notes. “And I think it’s going to be very difficult to contend with in the future, because no one thought we’d be battling the anti-vaccine movement this late in the pandemic.”

The biggest takeaway?

“When it comes to an infectious disease, prevention is always much better than treatment,” Dr. Adalja says. “If you don’t even need to get to the treatment stage because you prevent people from getting infected, that’s the goal.”

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

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As COVID resurges, vaccinated Americans rage against holdouts

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Thu, 08/26/2021 - 15:43

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.

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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.

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Biden victory: What it means for COVID, health care

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Thu, 08/26/2021 - 15:56

Joe Biden’s victory sets the stage for health care to become a high-profile priority of his presidency.

The former vice president has sketched out a big health agenda: ramping up the federal response to COVID-19, boosting the Affordable Care Act, creating a new “public option” to cover uninsured Americans, and expanding Medicare and Medicaid.

But the president-elect’s long to-do list on health is likely to face significant roadblocks in Congress and the courts, experts say.

For instance, Biden’s ambitious proposals on COVID-19 -- including his recent call for a national mask mandate -- could be waylaid by legal challenges and run into political hurdles on Capitol Hill, where he may face a divided Congress.

Joseph Antos, PhD, a health policy expert with the conservative American Enterprise Institute, predicts Biden will encounter the same type of congressional “gridlock situation” that President Barack Obama ran into during his second term.

“We have a situation that has been like this for a very, very long time -- lack of cooperation, lack of recognition that either party is capable of rising above their own electoral views to deal with problems that the country actually has.”

Antos also suggests that Biden may also face enormous political pressure to address the economic fallout from the coronavirus, including record unemployment and business closures, before anything else.

“I think it’s really going to be efforts that are intended to promote economic development and promote the economy,” he says.

In addition, Biden’s plans to expand Obamacare might face a new challenge from the Supreme Court in the year ahead. This month, the high court will take up a new case seeking to overturn the law.

Even so, experts say Biden’s plans on COVID-19 and expanding health care are likely to define his tenure in the White House as a central focus of his presidency.

“Health care will be at the very top of the list of the president’s priorities,” says Sabrina Corlette, JD, co-director of the Center on Health Insurance Reforms at Georgetown University’s McCourt School of Public Policy. “I do think, however, that the administration is going to be very preoccupied with the response to COVID-19 and the economic fallout … particularly in the first year.”

Here’s a closer look at what we can expect from a Biden presidency.

COVID-19: Federalizing response efforts

Biden will move to federalize the response to COVID-19. He has said he will take back major responsibilities from the states -- such as setting national policies on mask wearing, social distancing, and the reopening of schools and businesses, based on CDC guidance. In the days leading up to the election, Biden called for a national mask mandate, after waffling on the issue throughout the summer.

He has said he will let public health science drive political policy. Biden is also planning to create his own task force to advise officials during the transition on managing the new surge in COVID-19 cases, vaccine safety and protecting at-risk populations, Politico reported this week. He received a virtual briefing on the pandemic from a panel of experts as he awaited the election’s outcome.

“I think we will no longer have this confused and contradictory public messaging,” Corlette says, “but I also think there will be humility and the recognition that the evidence is evolving -- that we don’t have all the answers, but we’re learning as we go.”

But national mandates on masks and social distancing will be challenging to enforce, experts say. They are also likely to face pushback from business interests, opposition from public officials in GOP-led states, and even legal challenges.

 

 


Biden’s ability to work with Congress -- or not -- may determine whether he is able to implement some of the key components of his coronavirus action plan, which includes:

 

  • Providing free COVID-19 testing for all Americans
  • Hiring 100,000 contact tracers
  • Eliminating out-of-pocket expenses for coronavirus treatment
  • Delivering “sufficient” PPE for essential workers
  • Supporting science-backed vaccines and medical treatments being developed
  • Requiring the reopening of businesses, workplaces, and schools only after “sufficient” reductions in community transmission -- under evidence-based protocols put forward by the CDC
  • Giving emergency paid leave for workers dislocated by the pandemic and more financial aid for workers, families, and small businesses
  • Shoring up safeguards to protect at-risk Americans, including older people
  • Boosting pay for health care workers on the front lines

Biden has not detailed how he would pay for many of these, beyond promising to force wealthy Americans to “pay their fair share” of taxes to help. He has proposed a tax increase on Americans making more than $400,000 a year, which would require congressional approval.

Antos says he expects Biden’s proposed COVID-19 action plan to be virtually the same as Trump’s in two areas: efforts to develop a vaccine and antiviral treatments.

The administration has spent some $225 million on COVID-19 testing efforts, with a particular focus on rural areas.

Trump launched Operation Warp Speed to fast-track a vaccine. As part of that, the federal government has contracted with six drug companies, spending nearly $11 billion. The operation aims to provide at least 300 million doses of a coronavirus vaccine by January 2021.

Antos would like to see “a more sophisticated approach to social distancing” from the president-elect that takes into account the different challenges facing Americans depending on their income, work situation, and other factors during the pandemic.

“There are a lot of people in this country where working from home is fine and their jobs are secure,” he notes. “It’s the person who used to work at a restaurant that closed, it’s the line worker at a factory that has severely cut back its hours. It’s basically lower-middle-class people, low-income people, middle-class people, and it’s not the elite.

“And the policies have not given enough consideration to the fact that their circumstances and their tradeoffs would differ from the tradeoffs of somebody who doesn’t have anything to worry about economically.

“So, what we need is a more supple policy [that] will give people the information they need and give them the financial support that they also need … so they can make good decisions for themselves and their families. And we basically haven’t done that.”

Obamacare on the blocks?

The Supreme Court’s decision to take up another case seeking to overturn the Affordable Care Act could hand Biden’s health agenda a major setback -- and put the medical care for millions of Americans in jeopardy.

On Nov. 10, the high court will hear oral arguments on a lawsuit that would strike down all of Obamacare. A decision is not expected until next year.

The court has previously upheld the 2010 law, which Biden helped usher through Congress as vice president. But the addition of right-leaning Supreme Court Justice Amy Coney Barrett to the bench last month gives the court a clear conservative majority that could mean the end of Obamacare, legal experts say.

Republicans have opposed the law since its passage, but they have been unable to muster the votes to repeal it, or to pass an alternative

Antos, from the American Enterprise Institute, notes conservatives believe the law has increased costs for health care and insurance over the past decade, in part because of its protections for Americans with preexisting conditions and requiring insurers to provide comprehensive “gold-plated” policies.

“It’s driven up costs, offers plans that are not very strong, put high-risk folks into the same [insurance pool], which has increased costs for everyone, the employer mandate … these are all the reasons,” he says.

The Supreme Court isn’t expected to deliver a decision on the Affordable Care Act before the middle of next year. But the uncertainty will likely push back Biden’s proposals to expand on the law.

 

 


Overturning Obamacare would have huge impacts on millions of Americans:

 

  • As many as 133 million Americans -- roughly half the U.S. population -- with preexisting conditions could find it harder, if not impossible, to find affordable health insurance. That figure does not include Americans infected with COVID-19.
  • About 165 million who require expensive treatments -- for cancer and other conditions -- would no longer be protected from huge costs for care by federal caps on out-of-pocket expenditures the Affordable Care Act requires.
  • An estimated 21 million who now buy insurance through the Obamacare Marketplaces could lose their coverage.
  • Another 12 million on Medicaid could find themselves without insurance.
  • At least 2 million young adults ages 26 and under, now on their parents’ health policies, could be kicked off.
  • Millions of people who use Medicare could face higher costs.
  • Federal subsidies for lower-income Americans to buy policies would disappear.

Throughout the campaign, Biden repeatedly stressed the need to preserve the law’s provision barring insurance companies from refusing coverage for Americans with preexisting conditions, such as diabetes, cancer, and heart disease. It also outlaws charging higher premiums on the basis of health status, age, or gender.

Biden has also pledged to bolster the law as president.

He has proposed a variety of add-ons to the Affordable Care Act he says will “insure more than an estimated 97% of Americans,” according to the Biden campaign site.

Biden’s proposals include offering larger federal subsidies to help low- and middle-income Americans pay for policies purchased through Obamacare insurance Marketplaces.

The boldest of Biden’s proposals is the creation of a “public option” for insurance -- a Medicare-like program that small businesses and individuals could choose if they do not have coverage, cannot afford it, or don’t like their employer-based coverage.

It would also automatically enroll millions of uninsured Americans living in the 14 states that have not expanded Medicaid, which covers low-income people.

But such a plan would require congressional approval -- including a “super majority” of 60 Senate votes to block a likely GOP filibuster. That will be a significant challenge Biden will have to overcome, with Congress so evenly divided.

The White House would also have to defeat heavy lobbying from some of the most influential industry interest groups in Washington, Corlette says.

“I’m not even confident they would get all the Democrat votes,” she says.

“So, it’s a going to be an uphill battle to get a public option passed.”

Taken together, Biden’s plans for expanding Obamacare are projected to cost $750 billion over 10 years. He has said much of that financing would come from increasing taxes on the wealthy.

That means it would likely require congressional approval, which Antos suggests is unlikely given the polarization on Capitol Hill.

Medicare, Medicaid, and drug costs

Biden has called for a host of reforms targeting Medicare, Medicaid, and rising drug costs.

On Medicare, which primarily covers seniors 65 and older, Biden has proposed lowering the eligibility age from 65 to 60. That could extend Medicare to up to 20 million more Americans.

On Medicaid, the health care safety net for low-income and disabled Americans, the president-elect supports increased federal funding to states during the current economic crisis, and potentially beyond.

Medicare is likely to become a key focus of the new administration, in light of the pressures the pandemic is placing on Medicare funding.

In April, Medicare’s trustees said that the Part A trust fund for the program, which pays for hospital and inpatient care, could start to run dry in 2026.

But those projections did not include the impact of COVID-19. Some economists have since projected that Medicare Part A could become insolvent as early as 2022.

Medicare Part B, which pays for doctor and outpatient costs, is funded by general tax funding and beneficiary insurance premiums, so it is not in danger of drying up.

Adding to those pressures is an executive order Trump signed in August temporarily deferring payroll taxes, a primary funding vehicle for Medicare and Social Security.

Under these taxes, employees pay 6.2% of their earnings (on annual income up to $137,700) toward Social Security and 1.45% for Medicare taxes each pay period. Employers pay the same rate per paycheck, adding up to a combined 12.4% Social Security tax and 2.9% Medicare tax.

Biden has said he would reverse the tax cut when he takes office.

But to get a handle on Medicare and Medicaid funding issues, he is likely to need congressional support. Corlette and other experts say that could be a challenge while the nation remains in the grip of the coronavirus pandemic.

In addition to his Medicare and Medicaid reforms, Biden has proposed several plans to lower drug prices, a subset of rising health care and insurance costs.

U.S. spending on prescription drugs has increased nearly 42% over the past decade -- from $253.1 billion in 2010 to $358.7 billion in 2020 (projected) -- according to the Centers for Medicare & Medicaid Services.

In 2020, retail prices for 460 commonly prescribed drugs have spiked an average of 5.2%, according to new analysis by 3 Axis Advisors, a health research firm.

That’s more than double the projected rate of inflation.

To control drug costs, Biden supports legislation approved by the Democratic-led House of Representatives last year that would empower Medicare to negotiate drug prices with drug companies, as private insurers do.

Federal law now bars Medicare from negotiating prices on behalf of the 67.7 million Americans who use it. Drug companies and many GOP leaders argue that the current law is necessary to allow them to spend more on research and development of new medications.

In addition, Biden supports the idea of lifting bans on importing drugs from foreign countries with lower costs.

He also backs creating an independent review board to set price caps for new medications with no competitors; making high-quality generics more available; ending tax breaks for drug company advertising; and limiting their leeway in raising prices.

All of these proposals would likely require congressional approval and could face legal challenges in the courts.

This article first appeared on WebMD.com.

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Joe Biden’s victory sets the stage for health care to become a high-profile priority of his presidency.

The former vice president has sketched out a big health agenda: ramping up the federal response to COVID-19, boosting the Affordable Care Act, creating a new “public option” to cover uninsured Americans, and expanding Medicare and Medicaid.

But the president-elect’s long to-do list on health is likely to face significant roadblocks in Congress and the courts, experts say.

For instance, Biden’s ambitious proposals on COVID-19 -- including his recent call for a national mask mandate -- could be waylaid by legal challenges and run into political hurdles on Capitol Hill, where he may face a divided Congress.

Joseph Antos, PhD, a health policy expert with the conservative American Enterprise Institute, predicts Biden will encounter the same type of congressional “gridlock situation” that President Barack Obama ran into during his second term.

“We have a situation that has been like this for a very, very long time -- lack of cooperation, lack of recognition that either party is capable of rising above their own electoral views to deal with problems that the country actually has.”

Antos also suggests that Biden may also face enormous political pressure to address the economic fallout from the coronavirus, including record unemployment and business closures, before anything else.

“I think it’s really going to be efforts that are intended to promote economic development and promote the economy,” he says.

In addition, Biden’s plans to expand Obamacare might face a new challenge from the Supreme Court in the year ahead. This month, the high court will take up a new case seeking to overturn the law.

Even so, experts say Biden’s plans on COVID-19 and expanding health care are likely to define his tenure in the White House as a central focus of his presidency.

“Health care will be at the very top of the list of the president’s priorities,” says Sabrina Corlette, JD, co-director of the Center on Health Insurance Reforms at Georgetown University’s McCourt School of Public Policy. “I do think, however, that the administration is going to be very preoccupied with the response to COVID-19 and the economic fallout … particularly in the first year.”

Here’s a closer look at what we can expect from a Biden presidency.

COVID-19: Federalizing response efforts

Biden will move to federalize the response to COVID-19. He has said he will take back major responsibilities from the states -- such as setting national policies on mask wearing, social distancing, and the reopening of schools and businesses, based on CDC guidance. In the days leading up to the election, Biden called for a national mask mandate, after waffling on the issue throughout the summer.

He has said he will let public health science drive political policy. Biden is also planning to create his own task force to advise officials during the transition on managing the new surge in COVID-19 cases, vaccine safety and protecting at-risk populations, Politico reported this week. He received a virtual briefing on the pandemic from a panel of experts as he awaited the election’s outcome.

“I think we will no longer have this confused and contradictory public messaging,” Corlette says, “but I also think there will be humility and the recognition that the evidence is evolving -- that we don’t have all the answers, but we’re learning as we go.”

But national mandates on masks and social distancing will be challenging to enforce, experts say. They are also likely to face pushback from business interests, opposition from public officials in GOP-led states, and even legal challenges.

 

 


Biden’s ability to work with Congress -- or not -- may determine whether he is able to implement some of the key components of his coronavirus action plan, which includes:

 

  • Providing free COVID-19 testing for all Americans
  • Hiring 100,000 contact tracers
  • Eliminating out-of-pocket expenses for coronavirus treatment
  • Delivering “sufficient” PPE for essential workers
  • Supporting science-backed vaccines and medical treatments being developed
  • Requiring the reopening of businesses, workplaces, and schools only after “sufficient” reductions in community transmission -- under evidence-based protocols put forward by the CDC
  • Giving emergency paid leave for workers dislocated by the pandemic and more financial aid for workers, families, and small businesses
  • Shoring up safeguards to protect at-risk Americans, including older people
  • Boosting pay for health care workers on the front lines

Biden has not detailed how he would pay for many of these, beyond promising to force wealthy Americans to “pay their fair share” of taxes to help. He has proposed a tax increase on Americans making more than $400,000 a year, which would require congressional approval.

Antos says he expects Biden’s proposed COVID-19 action plan to be virtually the same as Trump’s in two areas: efforts to develop a vaccine and antiviral treatments.

The administration has spent some $225 million on COVID-19 testing efforts, with a particular focus on rural areas.

Trump launched Operation Warp Speed to fast-track a vaccine. As part of that, the federal government has contracted with six drug companies, spending nearly $11 billion. The operation aims to provide at least 300 million doses of a coronavirus vaccine by January 2021.

Antos would like to see “a more sophisticated approach to social distancing” from the president-elect that takes into account the different challenges facing Americans depending on their income, work situation, and other factors during the pandemic.

“There are a lot of people in this country where working from home is fine and their jobs are secure,” he notes. “It’s the person who used to work at a restaurant that closed, it’s the line worker at a factory that has severely cut back its hours. It’s basically lower-middle-class people, low-income people, middle-class people, and it’s not the elite.

“And the policies have not given enough consideration to the fact that their circumstances and their tradeoffs would differ from the tradeoffs of somebody who doesn’t have anything to worry about economically.

“So, what we need is a more supple policy [that] will give people the information they need and give them the financial support that they also need … so they can make good decisions for themselves and their families. And we basically haven’t done that.”

Obamacare on the blocks?

The Supreme Court’s decision to take up another case seeking to overturn the Affordable Care Act could hand Biden’s health agenda a major setback -- and put the medical care for millions of Americans in jeopardy.

On Nov. 10, the high court will hear oral arguments on a lawsuit that would strike down all of Obamacare. A decision is not expected until next year.

The court has previously upheld the 2010 law, which Biden helped usher through Congress as vice president. But the addition of right-leaning Supreme Court Justice Amy Coney Barrett to the bench last month gives the court a clear conservative majority that could mean the end of Obamacare, legal experts say.

Republicans have opposed the law since its passage, but they have been unable to muster the votes to repeal it, or to pass an alternative

Antos, from the American Enterprise Institute, notes conservatives believe the law has increased costs for health care and insurance over the past decade, in part because of its protections for Americans with preexisting conditions and requiring insurers to provide comprehensive “gold-plated” policies.

“It’s driven up costs, offers plans that are not very strong, put high-risk folks into the same [insurance pool], which has increased costs for everyone, the employer mandate … these are all the reasons,” he says.

The Supreme Court isn’t expected to deliver a decision on the Affordable Care Act before the middle of next year. But the uncertainty will likely push back Biden’s proposals to expand on the law.

 

 


Overturning Obamacare would have huge impacts on millions of Americans:

 

  • As many as 133 million Americans -- roughly half the U.S. population -- with preexisting conditions could find it harder, if not impossible, to find affordable health insurance. That figure does not include Americans infected with COVID-19.
  • About 165 million who require expensive treatments -- for cancer and other conditions -- would no longer be protected from huge costs for care by federal caps on out-of-pocket expenditures the Affordable Care Act requires.
  • An estimated 21 million who now buy insurance through the Obamacare Marketplaces could lose their coverage.
  • Another 12 million on Medicaid could find themselves without insurance.
  • At least 2 million young adults ages 26 and under, now on their parents’ health policies, could be kicked off.
  • Millions of people who use Medicare could face higher costs.
  • Federal subsidies for lower-income Americans to buy policies would disappear.

Throughout the campaign, Biden repeatedly stressed the need to preserve the law’s provision barring insurance companies from refusing coverage for Americans with preexisting conditions, such as diabetes, cancer, and heart disease. It also outlaws charging higher premiums on the basis of health status, age, or gender.

Biden has also pledged to bolster the law as president.

He has proposed a variety of add-ons to the Affordable Care Act he says will “insure more than an estimated 97% of Americans,” according to the Biden campaign site.

Biden’s proposals include offering larger federal subsidies to help low- and middle-income Americans pay for policies purchased through Obamacare insurance Marketplaces.

The boldest of Biden’s proposals is the creation of a “public option” for insurance -- a Medicare-like program that small businesses and individuals could choose if they do not have coverage, cannot afford it, or don’t like their employer-based coverage.

It would also automatically enroll millions of uninsured Americans living in the 14 states that have not expanded Medicaid, which covers low-income people.

But such a plan would require congressional approval -- including a “super majority” of 60 Senate votes to block a likely GOP filibuster. That will be a significant challenge Biden will have to overcome, with Congress so evenly divided.

The White House would also have to defeat heavy lobbying from some of the most influential industry interest groups in Washington, Corlette says.

“I’m not even confident they would get all the Democrat votes,” she says.

“So, it’s a going to be an uphill battle to get a public option passed.”

Taken together, Biden’s plans for expanding Obamacare are projected to cost $750 billion over 10 years. He has said much of that financing would come from increasing taxes on the wealthy.

That means it would likely require congressional approval, which Antos suggests is unlikely given the polarization on Capitol Hill.

Medicare, Medicaid, and drug costs

Biden has called for a host of reforms targeting Medicare, Medicaid, and rising drug costs.

On Medicare, which primarily covers seniors 65 and older, Biden has proposed lowering the eligibility age from 65 to 60. That could extend Medicare to up to 20 million more Americans.

On Medicaid, the health care safety net for low-income and disabled Americans, the president-elect supports increased federal funding to states during the current economic crisis, and potentially beyond.

Medicare is likely to become a key focus of the new administration, in light of the pressures the pandemic is placing on Medicare funding.

In April, Medicare’s trustees said that the Part A trust fund for the program, which pays for hospital and inpatient care, could start to run dry in 2026.

But those projections did not include the impact of COVID-19. Some economists have since projected that Medicare Part A could become insolvent as early as 2022.

Medicare Part B, which pays for doctor and outpatient costs, is funded by general tax funding and beneficiary insurance premiums, so it is not in danger of drying up.

Adding to those pressures is an executive order Trump signed in August temporarily deferring payroll taxes, a primary funding vehicle for Medicare and Social Security.

Under these taxes, employees pay 6.2% of their earnings (on annual income up to $137,700) toward Social Security and 1.45% for Medicare taxes each pay period. Employers pay the same rate per paycheck, adding up to a combined 12.4% Social Security tax and 2.9% Medicare tax.

Biden has said he would reverse the tax cut when he takes office.

But to get a handle on Medicare and Medicaid funding issues, he is likely to need congressional support. Corlette and other experts say that could be a challenge while the nation remains in the grip of the coronavirus pandemic.

In addition to his Medicare and Medicaid reforms, Biden has proposed several plans to lower drug prices, a subset of rising health care and insurance costs.

U.S. spending on prescription drugs has increased nearly 42% over the past decade -- from $253.1 billion in 2010 to $358.7 billion in 2020 (projected) -- according to the Centers for Medicare & Medicaid Services.

In 2020, retail prices for 460 commonly prescribed drugs have spiked an average of 5.2%, according to new analysis by 3 Axis Advisors, a health research firm.

That’s more than double the projected rate of inflation.

To control drug costs, Biden supports legislation approved by the Democratic-led House of Representatives last year that would empower Medicare to negotiate drug prices with drug companies, as private insurers do.

Federal law now bars Medicare from negotiating prices on behalf of the 67.7 million Americans who use it. Drug companies and many GOP leaders argue that the current law is necessary to allow them to spend more on research and development of new medications.

In addition, Biden supports the idea of lifting bans on importing drugs from foreign countries with lower costs.

He also backs creating an independent review board to set price caps for new medications with no competitors; making high-quality generics more available; ending tax breaks for drug company advertising; and limiting their leeway in raising prices.

All of these proposals would likely require congressional approval and could face legal challenges in the courts.

This article first appeared on WebMD.com.

Joe Biden’s victory sets the stage for health care to become a high-profile priority of his presidency.

The former vice president has sketched out a big health agenda: ramping up the federal response to COVID-19, boosting the Affordable Care Act, creating a new “public option” to cover uninsured Americans, and expanding Medicare and Medicaid.

But the president-elect’s long to-do list on health is likely to face significant roadblocks in Congress and the courts, experts say.

For instance, Biden’s ambitious proposals on COVID-19 -- including his recent call for a national mask mandate -- could be waylaid by legal challenges and run into political hurdles on Capitol Hill, where he may face a divided Congress.

Joseph Antos, PhD, a health policy expert with the conservative American Enterprise Institute, predicts Biden will encounter the same type of congressional “gridlock situation” that President Barack Obama ran into during his second term.

“We have a situation that has been like this for a very, very long time -- lack of cooperation, lack of recognition that either party is capable of rising above their own electoral views to deal with problems that the country actually has.”

Antos also suggests that Biden may also face enormous political pressure to address the economic fallout from the coronavirus, including record unemployment and business closures, before anything else.

“I think it’s really going to be efforts that are intended to promote economic development and promote the economy,” he says.

In addition, Biden’s plans to expand Obamacare might face a new challenge from the Supreme Court in the year ahead. This month, the high court will take up a new case seeking to overturn the law.

Even so, experts say Biden’s plans on COVID-19 and expanding health care are likely to define his tenure in the White House as a central focus of his presidency.

“Health care will be at the very top of the list of the president’s priorities,” says Sabrina Corlette, JD, co-director of the Center on Health Insurance Reforms at Georgetown University’s McCourt School of Public Policy. “I do think, however, that the administration is going to be very preoccupied with the response to COVID-19 and the economic fallout … particularly in the first year.”

Here’s a closer look at what we can expect from a Biden presidency.

COVID-19: Federalizing response efforts

Biden will move to federalize the response to COVID-19. He has said he will take back major responsibilities from the states -- such as setting national policies on mask wearing, social distancing, and the reopening of schools and businesses, based on CDC guidance. In the days leading up to the election, Biden called for a national mask mandate, after waffling on the issue throughout the summer.

He has said he will let public health science drive political policy. Biden is also planning to create his own task force to advise officials during the transition on managing the new surge in COVID-19 cases, vaccine safety and protecting at-risk populations, Politico reported this week. He received a virtual briefing on the pandemic from a panel of experts as he awaited the election’s outcome.

“I think we will no longer have this confused and contradictory public messaging,” Corlette says, “but I also think there will be humility and the recognition that the evidence is evolving -- that we don’t have all the answers, but we’re learning as we go.”

But national mandates on masks and social distancing will be challenging to enforce, experts say. They are also likely to face pushback from business interests, opposition from public officials in GOP-led states, and even legal challenges.

 

 


Biden’s ability to work with Congress -- or not -- may determine whether he is able to implement some of the key components of his coronavirus action plan, which includes:

 

  • Providing free COVID-19 testing for all Americans
  • Hiring 100,000 contact tracers
  • Eliminating out-of-pocket expenses for coronavirus treatment
  • Delivering “sufficient” PPE for essential workers
  • Supporting science-backed vaccines and medical treatments being developed
  • Requiring the reopening of businesses, workplaces, and schools only after “sufficient” reductions in community transmission -- under evidence-based protocols put forward by the CDC
  • Giving emergency paid leave for workers dislocated by the pandemic and more financial aid for workers, families, and small businesses
  • Shoring up safeguards to protect at-risk Americans, including older people
  • Boosting pay for health care workers on the front lines

Biden has not detailed how he would pay for many of these, beyond promising to force wealthy Americans to “pay their fair share” of taxes to help. He has proposed a tax increase on Americans making more than $400,000 a year, which would require congressional approval.

Antos says he expects Biden’s proposed COVID-19 action plan to be virtually the same as Trump’s in two areas: efforts to develop a vaccine and antiviral treatments.

The administration has spent some $225 million on COVID-19 testing efforts, with a particular focus on rural areas.

Trump launched Operation Warp Speed to fast-track a vaccine. As part of that, the federal government has contracted with six drug companies, spending nearly $11 billion. The operation aims to provide at least 300 million doses of a coronavirus vaccine by January 2021.

Antos would like to see “a more sophisticated approach to social distancing” from the president-elect that takes into account the different challenges facing Americans depending on their income, work situation, and other factors during the pandemic.

“There are a lot of people in this country where working from home is fine and their jobs are secure,” he notes. “It’s the person who used to work at a restaurant that closed, it’s the line worker at a factory that has severely cut back its hours. It’s basically lower-middle-class people, low-income people, middle-class people, and it’s not the elite.

“And the policies have not given enough consideration to the fact that their circumstances and their tradeoffs would differ from the tradeoffs of somebody who doesn’t have anything to worry about economically.

“So, what we need is a more supple policy [that] will give people the information they need and give them the financial support that they also need … so they can make good decisions for themselves and their families. And we basically haven’t done that.”

Obamacare on the blocks?

The Supreme Court’s decision to take up another case seeking to overturn the Affordable Care Act could hand Biden’s health agenda a major setback -- and put the medical care for millions of Americans in jeopardy.

On Nov. 10, the high court will hear oral arguments on a lawsuit that would strike down all of Obamacare. A decision is not expected until next year.

The court has previously upheld the 2010 law, which Biden helped usher through Congress as vice president. But the addition of right-leaning Supreme Court Justice Amy Coney Barrett to the bench last month gives the court a clear conservative majority that could mean the end of Obamacare, legal experts say.

Republicans have opposed the law since its passage, but they have been unable to muster the votes to repeal it, or to pass an alternative

Antos, from the American Enterprise Institute, notes conservatives believe the law has increased costs for health care and insurance over the past decade, in part because of its protections for Americans with preexisting conditions and requiring insurers to provide comprehensive “gold-plated” policies.

“It’s driven up costs, offers plans that are not very strong, put high-risk folks into the same [insurance pool], which has increased costs for everyone, the employer mandate … these are all the reasons,” he says.

The Supreme Court isn’t expected to deliver a decision on the Affordable Care Act before the middle of next year. But the uncertainty will likely push back Biden’s proposals to expand on the law.

 

 


Overturning Obamacare would have huge impacts on millions of Americans:

 

  • As many as 133 million Americans -- roughly half the U.S. population -- with preexisting conditions could find it harder, if not impossible, to find affordable health insurance. That figure does not include Americans infected with COVID-19.
  • About 165 million who require expensive treatments -- for cancer and other conditions -- would no longer be protected from huge costs for care by federal caps on out-of-pocket expenditures the Affordable Care Act requires.
  • An estimated 21 million who now buy insurance through the Obamacare Marketplaces could lose their coverage.
  • Another 12 million on Medicaid could find themselves without insurance.
  • At least 2 million young adults ages 26 and under, now on their parents’ health policies, could be kicked off.
  • Millions of people who use Medicare could face higher costs.
  • Federal subsidies for lower-income Americans to buy policies would disappear.

Throughout the campaign, Biden repeatedly stressed the need to preserve the law’s provision barring insurance companies from refusing coverage for Americans with preexisting conditions, such as diabetes, cancer, and heart disease. It also outlaws charging higher premiums on the basis of health status, age, or gender.

Biden has also pledged to bolster the law as president.

He has proposed a variety of add-ons to the Affordable Care Act he says will “insure more than an estimated 97% of Americans,” according to the Biden campaign site.

Biden’s proposals include offering larger federal subsidies to help low- and middle-income Americans pay for policies purchased through Obamacare insurance Marketplaces.

The boldest of Biden’s proposals is the creation of a “public option” for insurance -- a Medicare-like program that small businesses and individuals could choose if they do not have coverage, cannot afford it, or don’t like their employer-based coverage.

It would also automatically enroll millions of uninsured Americans living in the 14 states that have not expanded Medicaid, which covers low-income people.

But such a plan would require congressional approval -- including a “super majority” of 60 Senate votes to block a likely GOP filibuster. That will be a significant challenge Biden will have to overcome, with Congress so evenly divided.

The White House would also have to defeat heavy lobbying from some of the most influential industry interest groups in Washington, Corlette says.

“I’m not even confident they would get all the Democrat votes,” she says.

“So, it’s a going to be an uphill battle to get a public option passed.”

Taken together, Biden’s plans for expanding Obamacare are projected to cost $750 billion over 10 years. He has said much of that financing would come from increasing taxes on the wealthy.

That means it would likely require congressional approval, which Antos suggests is unlikely given the polarization on Capitol Hill.

Medicare, Medicaid, and drug costs

Biden has called for a host of reforms targeting Medicare, Medicaid, and rising drug costs.

On Medicare, which primarily covers seniors 65 and older, Biden has proposed lowering the eligibility age from 65 to 60. That could extend Medicare to up to 20 million more Americans.

On Medicaid, the health care safety net for low-income and disabled Americans, the president-elect supports increased federal funding to states during the current economic crisis, and potentially beyond.

Medicare is likely to become a key focus of the new administration, in light of the pressures the pandemic is placing on Medicare funding.

In April, Medicare’s trustees said that the Part A trust fund for the program, which pays for hospital and inpatient care, could start to run dry in 2026.

But those projections did not include the impact of COVID-19. Some economists have since projected that Medicare Part A could become insolvent as early as 2022.

Medicare Part B, which pays for doctor and outpatient costs, is funded by general tax funding and beneficiary insurance premiums, so it is not in danger of drying up.

Adding to those pressures is an executive order Trump signed in August temporarily deferring payroll taxes, a primary funding vehicle for Medicare and Social Security.

Under these taxes, employees pay 6.2% of their earnings (on annual income up to $137,700) toward Social Security and 1.45% for Medicare taxes each pay period. Employers pay the same rate per paycheck, adding up to a combined 12.4% Social Security tax and 2.9% Medicare tax.

Biden has said he would reverse the tax cut when he takes office.

But to get a handle on Medicare and Medicaid funding issues, he is likely to need congressional support. Corlette and other experts say that could be a challenge while the nation remains in the grip of the coronavirus pandemic.

In addition to his Medicare and Medicaid reforms, Biden has proposed several plans to lower drug prices, a subset of rising health care and insurance costs.

U.S. spending on prescription drugs has increased nearly 42% over the past decade -- from $253.1 billion in 2010 to $358.7 billion in 2020 (projected) -- according to the Centers for Medicare & Medicaid Services.

In 2020, retail prices for 460 commonly prescribed drugs have spiked an average of 5.2%, according to new analysis by 3 Axis Advisors, a health research firm.

That’s more than double the projected rate of inflation.

To control drug costs, Biden supports legislation approved by the Democratic-led House of Representatives last year that would empower Medicare to negotiate drug prices with drug companies, as private insurers do.

Federal law now bars Medicare from negotiating prices on behalf of the 67.7 million Americans who use it. Drug companies and many GOP leaders argue that the current law is necessary to allow them to spend more on research and development of new medications.

In addition, Biden supports the idea of lifting bans on importing drugs from foreign countries with lower costs.

He also backs creating an independent review board to set price caps for new medications with no competitors; making high-quality generics more available; ending tax breaks for drug company advertising; and limiting their leeway in raising prices.

All of these proposals would likely require congressional approval and could face legal challenges in the courts.

This article first appeared on WebMD.com.

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