MDedge Neurology

Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.

If the request is approved, the broader use of Pfizer boosters would be a step toward President Biden’s goal of boosters for all adults. He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.

This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.

However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.

The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.

The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.

The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
 

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

Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.

If the request is approved, the broader use of Pfizer boosters would be a step toward President Biden’s goal of boosters for all adults. He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.

This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.

However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.

The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.

The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.

The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
 

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

Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.

If the request is approved, the broader use of Pfizer boosters would be a step toward President Biden’s goal of boosters for all adults. He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.

This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.

However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.

The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.

The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.

The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
 

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

Should doctors seeking healthcare disclose that they are a doctor? 

The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”

She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”

The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.

“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.” 

“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.

“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”

Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:

“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.

Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”

“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.

Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.

For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”

@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”

Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”

Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.

“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.

Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”

Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”

Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.

“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.

To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.

Still others offered suggestions on how to broach the subject more directly when presenting as a patient:

‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.

@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”

A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.

“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.

Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”

That’s typically a sign that the Tweet is relatable for a lot of people, she said.

“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.

The debate begs the question: Is there a duty or ethical reason to disclose?

“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”

If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.

“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”

Knowing how to share the information is another story.

“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”

“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested. 

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

Should doctors seeking healthcare disclose that they are a doctor? 

The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”

She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”

The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.

“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.” 

“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.

“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”

Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:

“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.

Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”

“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.

Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.

For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”

@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”

Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”

Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.

“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.

Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”

Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”

Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.

“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.

To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.

Still others offered suggestions on how to broach the subject more directly when presenting as a patient:

‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.

@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”

A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.

“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.

Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”

That’s typically a sign that the Tweet is relatable for a lot of people, she said.

“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.

The debate begs the question: Is there a duty or ethical reason to disclose?

“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”

If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.

“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”

Knowing how to share the information is another story.

“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”

“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested. 

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

Should doctors seeking healthcare disclose that they are a doctor? 

The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”

She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”

The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.

“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.” 

“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.

“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”

Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:

“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.

Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”

“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.

Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.

For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”

@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”

Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”

Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.

“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.

Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”

Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”

Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.

“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.

To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.

Still others offered suggestions on how to broach the subject more directly when presenting as a patient:

‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.

@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”

A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.

“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.

Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”

That’s typically a sign that the Tweet is relatable for a lot of people, she said.

“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.

The debate begs the question: Is there a duty or ethical reason to disclose?

“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”

If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.

“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”

Knowing how to share the information is another story.

“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”

“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested. 

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

A weekend, for most of us in solo practice, doesn’t really signify time off from work. It just means we’re not seeing patients at the office.

There’s always business stuff to do like payroll and paying bills, records to review, the never-ending forms for a million things, and all the other stuff there never seems to be enough time to do on weekdays.

This weekend I started attacking the pile after dinner on Friday and found myself done by Saturday afternoon, which is rare. Usually I spend the better part of a weekend at my desk.

And then, unexpectedly faced with an empty desk, I found myself wondering what to do next.

Boredom is one of the odder human conditions. I have no idea if any other animal experiences it. Certainly, at least for us, there are more ways to entertain ourselves now than there ever have been – TV, Netflix, phone games, TikTok, books, just to name a few.

But do we always have to be entertained? Many great scientists have said that world-changing ideas have come to them when they weren’t working, such as while showering or riding to work. Leo Szilard was crossing a London street in 1933 when he suddenly saw how a nuclear chain reaction would be self-sustaining once initiated. Fortunately he wasn’t hit by a car in the process.

But I’m not Szilard. So I rationalized a reason not to exercise and sat on the couch with a book.

The remarkable human brain doesn’t shut down easily. With nothing else to do, most mammals tend do doze off. But not us. Our brains are always on, trying to think of the next goal, the next move, the next whatever.

Having nothing to do sounds like a great idea, until you have nothing to do. It may be fine for a few days, but after a while you realize there’s only so long you can stare at the waves or mountains before your mind turns back to “what’s next.” Many patients tell me how retirement sounded good until they got there and then found themselves volunteering or taking new jobs just to keep busy.

This isn’t a bad thing. Being bored is probably constructive. Without realizing it we use it to form new ideas and start new plans.

Maybe this is why we are where we are. The mind that keeps working is a powerful tool, driving us forward in all walks of life. Perhaps it’s this feature that pushed the development of intelligence further and led us to form civilizations.

It’s how we keep moving forward.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

A weekend, for most of us in solo practice, doesn’t really signify time off from work. It just means we’re not seeing patients at the office.

There’s always business stuff to do like payroll and paying bills, records to review, the never-ending forms for a million things, and all the other stuff there never seems to be enough time to do on weekdays.

This weekend I started attacking the pile after dinner on Friday and found myself done by Saturday afternoon, which is rare. Usually I spend the better part of a weekend at my desk.

And then, unexpectedly faced with an empty desk, I found myself wondering what to do next.

Boredom is one of the odder human conditions. I have no idea if any other animal experiences it. Certainly, at least for us, there are more ways to entertain ourselves now than there ever have been – TV, Netflix, phone games, TikTok, books, just to name a few.

But do we always have to be entertained? Many great scientists have said that world-changing ideas have come to them when they weren’t working, such as while showering or riding to work. Leo Szilard was crossing a London street in 1933 when he suddenly saw how a nuclear chain reaction would be self-sustaining once initiated. Fortunately he wasn’t hit by a car in the process.

But I’m not Szilard. So I rationalized a reason not to exercise and sat on the couch with a book.

The remarkable human brain doesn’t shut down easily. With nothing else to do, most mammals tend do doze off. But not us. Our brains are always on, trying to think of the next goal, the next move, the next whatever.

Having nothing to do sounds like a great idea, until you have nothing to do. It may be fine for a few days, but after a while you realize there’s only so long you can stare at the waves or mountains before your mind turns back to “what’s next.” Many patients tell me how retirement sounded good until they got there and then found themselves volunteering or taking new jobs just to keep busy.

This isn’t a bad thing. Being bored is probably constructive. Without realizing it we use it to form new ideas and start new plans.

Maybe this is why we are where we are. The mind that keeps working is a powerful tool, driving us forward in all walks of life. Perhaps it’s this feature that pushed the development of intelligence further and led us to form civilizations.

It’s how we keep moving forward.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

A weekend, for most of us in solo practice, doesn’t really signify time off from work. It just means we’re not seeing patients at the office.

There’s always business stuff to do like payroll and paying bills, records to review, the never-ending forms for a million things, and all the other stuff there never seems to be enough time to do on weekdays.

This weekend I started attacking the pile after dinner on Friday and found myself done by Saturday afternoon, which is rare. Usually I spend the better part of a weekend at my desk.

And then, unexpectedly faced with an empty desk, I found myself wondering what to do next.

Boredom is one of the odder human conditions. I have no idea if any other animal experiences it. Certainly, at least for us, there are more ways to entertain ourselves now than there ever have been – TV, Netflix, phone games, TikTok, books, just to name a few.

But do we always have to be entertained? Many great scientists have said that world-changing ideas have come to them when they weren’t working, such as while showering or riding to work. Leo Szilard was crossing a London street in 1933 when he suddenly saw how a nuclear chain reaction would be self-sustaining once initiated. Fortunately he wasn’t hit by a car in the process.

But I’m not Szilard. So I rationalized a reason not to exercise and sat on the couch with a book.

The remarkable human brain doesn’t shut down easily. With nothing else to do, most mammals tend do doze off. But not us. Our brains are always on, trying to think of the next goal, the next move, the next whatever.

Having nothing to do sounds like a great idea, until you have nothing to do. It may be fine for a few days, but after a while you realize there’s only so long you can stare at the waves or mountains before your mind turns back to “what’s next.” Many patients tell me how retirement sounded good until they got there and then found themselves volunteering or taking new jobs just to keep busy.

This isn’t a bad thing. Being bored is probably constructive. Without realizing it we use it to form new ideas and start new plans.

Maybe this is why we are where we are. The mind that keeps working is a powerful tool, driving us forward in all walks of life. Perhaps it’s this feature that pushed the development of intelligence further and led us to form civilizations.

It’s how we keep moving forward.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The anticipated biennial peak in acute flaccid myelitis cases did not occur in 2020, possibly because of “nonpharmaceutical interventions implemented during the COVID-19 pandemic,” suggested researchers at the Centers for Disease Control and Prevention.

Acute flaccid myelitis (AFM) is an uncommon but serious complication of some viral infections, including West Nile virus and nonpolio enteroviruses. It is “characterized by sudden onset of limb weakness and lesions in the gray matter of the spinal cord,” they said, and more than 90% of cases occur in young children.

Cases of AFM, which can lead to respiratory insufficiency and permanent paralysis, spiked during the late summer and early fall in 2014, 2016, and 2018 and were expected to do so again in 2020, Sarah Kidd, MD, and associates at the division of viral diseases at the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta, said in the Morbidity and Mortality Weekly Report.

Monthly peaks in those previous years – each occurring in September – reached 51 cases in 2014, 43 cases in 2016, and 88 cases in 2018, but in 2020 there was only 1 case reported in September, with a high of 4 coming in May, CDC data show. The total number of cases for 2020 (32) was, in fact, lower than in 2019, when 47 were reported.

The investigators’ main objective was to see if there were any differences between the 2018 and 2019-2020 cases. Reports from state health departments to the CDC showed that, in 2019-2020, “patients were older; more likely to have lower limb involvement; and less likely to have upper limb involvement, prodromal illness, [cerebrospinal fluid] pleocytosis, or specimens that tested positive for EV [enterovirus]-D68” than patients from 2018, Dr. Kidd and associates said.

Mask wearing and reduced in-school attendance may have decreased circulation of EV-D68 – the enterovirus type most often detected in the stool and respiratory specimens of AFM patients – as was seen with other respiratory viruses, such as influenza and respiratory syncytial virus, in 2020. Previous studies have suggested that EV-D68 drives the increases in cases during peak years, the researchers noted.

The absence of such an increase “in 2020 reflects a deviation from the previously observed biennial pattern, and it is unclear when the next increase in AFM should be expected. Clinicians should continue to maintain vigilance and suspect AFM in any child with acute flaccid limb weakness, particularly in the setting of recent febrile or respiratory illness,” they wrote.
 

[email protected]

The anticipated biennial peak in acute flaccid myelitis cases did not occur in 2020, possibly because of “nonpharmaceutical interventions implemented during the COVID-19 pandemic,” suggested researchers at the Centers for Disease Control and Prevention.

Acute flaccid myelitis (AFM) is an uncommon but serious complication of some viral infections, including West Nile virus and nonpolio enteroviruses. It is “characterized by sudden onset of limb weakness and lesions in the gray matter of the spinal cord,” they said, and more than 90% of cases occur in young children.

Cases of AFM, which can lead to respiratory insufficiency and permanent paralysis, spiked during the late summer and early fall in 2014, 2016, and 2018 and were expected to do so again in 2020, Sarah Kidd, MD, and associates at the division of viral diseases at the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta, said in the Morbidity and Mortality Weekly Report.

Monthly peaks in those previous years – each occurring in September – reached 51 cases in 2014, 43 cases in 2016, and 88 cases in 2018, but in 2020 there was only 1 case reported in September, with a high of 4 coming in May, CDC data show. The total number of cases for 2020 (32) was, in fact, lower than in 2019, when 47 were reported.

The investigators’ main objective was to see if there were any differences between the 2018 and 2019-2020 cases. Reports from state health departments to the CDC showed that, in 2019-2020, “patients were older; more likely to have lower limb involvement; and less likely to have upper limb involvement, prodromal illness, [cerebrospinal fluid] pleocytosis, or specimens that tested positive for EV [enterovirus]-D68” than patients from 2018, Dr. Kidd and associates said.

Mask wearing and reduced in-school attendance may have decreased circulation of EV-D68 – the enterovirus type most often detected in the stool and respiratory specimens of AFM patients – as was seen with other respiratory viruses, such as influenza and respiratory syncytial virus, in 2020. Previous studies have suggested that EV-D68 drives the increases in cases during peak years, the researchers noted.

The absence of such an increase “in 2020 reflects a deviation from the previously observed biennial pattern, and it is unclear when the next increase in AFM should be expected. Clinicians should continue to maintain vigilance and suspect AFM in any child with acute flaccid limb weakness, particularly in the setting of recent febrile or respiratory illness,” they wrote.
 

[email protected]

The anticipated biennial peak in acute flaccid myelitis cases did not occur in 2020, possibly because of “nonpharmaceutical interventions implemented during the COVID-19 pandemic,” suggested researchers at the Centers for Disease Control and Prevention.

Acute flaccid myelitis (AFM) is an uncommon but serious complication of some viral infections, including West Nile virus and nonpolio enteroviruses. It is “characterized by sudden onset of limb weakness and lesions in the gray matter of the spinal cord,” they said, and more than 90% of cases occur in young children.

Cases of AFM, which can lead to respiratory insufficiency and permanent paralysis, spiked during the late summer and early fall in 2014, 2016, and 2018 and were expected to do so again in 2020, Sarah Kidd, MD, and associates at the division of viral diseases at the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta, said in the Morbidity and Mortality Weekly Report.

Monthly peaks in those previous years – each occurring in September – reached 51 cases in 2014, 43 cases in 2016, and 88 cases in 2018, but in 2020 there was only 1 case reported in September, with a high of 4 coming in May, CDC data show. The total number of cases for 2020 (32) was, in fact, lower than in 2019, when 47 were reported.

The investigators’ main objective was to see if there were any differences between the 2018 and 2019-2020 cases. Reports from state health departments to the CDC showed that, in 2019-2020, “patients were older; more likely to have lower limb involvement; and less likely to have upper limb involvement, prodromal illness, [cerebrospinal fluid] pleocytosis, or specimens that tested positive for EV [enterovirus]-D68” than patients from 2018, Dr. Kidd and associates said.

Mask wearing and reduced in-school attendance may have decreased circulation of EV-D68 – the enterovirus type most often detected in the stool and respiratory specimens of AFM patients – as was seen with other respiratory viruses, such as influenza and respiratory syncytial virus, in 2020. Previous studies have suggested that EV-D68 drives the increases in cases during peak years, the researchers noted.

The absence of such an increase “in 2020 reflects a deviation from the previously observed biennial pattern, and it is unclear when the next increase in AFM should be expected. Clinicians should continue to maintain vigilance and suspect AFM in any child with acute flaccid limb weakness, particularly in the setting of recent febrile or respiratory illness,” they wrote.
 

[email protected]

The effectiveness of COVID-19 vaccines produced by Pfizer/BioNTech, Moderna, and Johnson & Johnson dropped dramatically as the Delta variant swept the United States, a study of almost 800,000 veterans found.

The study, published in the journal Science ., says the three vaccines offered about the same protection against the virus in March, when the Delta variant was first detected in the United States, but that changed 6 months later.

The Moderna two-dose vaccine went from being 89% effective in March to 58% effective in September, according to a story about the study in theLos Angeles Times.

Meanwhile, the Pfizer/BioNTech vaccine went from being 87% effective to 45% effective over the same time period.

The Johnson & Johnson vaccine showed the biggest drop -- from 86% effectiveness to 13% over those 6 months.

“In summary, although vaccination remains protective against SARS-CoV-2 infection, protection waned as the Delta variant emerged in the U.S., and this decline did not differ by age,” the study said.

The three vaccines also lost effectiveness in the ability to protect against death in veterans 65 and over after only 3 months, the Los Angeles Times reported.

Compared to unvaccinated veterans in that age group, veterans who got the Moderna vaccine and had a breakthrough case were 76% less likely to die of COVID-19 by July.

The protection was 70% for Pfizer/BioNTech vaccine recipients and 52% for J&J vaccine recipients for the same age group, compared to unvaccinated veterans, according to the newspaper.

For veterans under 65, the protectiveness against a fatal case of COVID was 84% for Pfizer/BioNTech recipients, 82% for Moderna recipients, and 73% for J&J recipients, compared to unvaccinated veterans in that age group.

The study confirms the need for booster vaccines and protective measures such as vaccine passports, vaccine mandates, masking, hand-washing, and social distancing, the researchers said.

Of the veterans studied, about 500,000 were vaccinated and 300,000 were not. Researchers noted that the study population had 6 times as many men as women. About 48% of the study group was 65 or older, 29% was 50-64, while 24% was under 50.

Researchers from the Public Health Institute in Oakland, the Veterans Affairs Medical Center in San Francisco, and the University of Texas Health Science Center conducted the study.

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

The effectiveness of COVID-19 vaccines produced by Pfizer/BioNTech, Moderna, and Johnson & Johnson dropped dramatically as the Delta variant swept the United States, a study of almost 800,000 veterans found.

The study, published in the journal Science ., says the three vaccines offered about the same protection against the virus in March, when the Delta variant was first detected in the United States, but that changed 6 months later.

The Moderna two-dose vaccine went from being 89% effective in March to 58% effective in September, according to a story about the study in theLos Angeles Times.

Meanwhile, the Pfizer/BioNTech vaccine went from being 87% effective to 45% effective over the same time period.

The Johnson & Johnson vaccine showed the biggest drop -- from 86% effectiveness to 13% over those 6 months.

“In summary, although vaccination remains protective against SARS-CoV-2 infection, protection waned as the Delta variant emerged in the U.S., and this decline did not differ by age,” the study said.

The three vaccines also lost effectiveness in the ability to protect against death in veterans 65 and over after only 3 months, the Los Angeles Times reported.

Compared to unvaccinated veterans in that age group, veterans who got the Moderna vaccine and had a breakthrough case were 76% less likely to die of COVID-19 by July.

The protection was 70% for Pfizer/BioNTech vaccine recipients and 52% for J&J vaccine recipients for the same age group, compared to unvaccinated veterans, according to the newspaper.

For veterans under 65, the protectiveness against a fatal case of COVID was 84% for Pfizer/BioNTech recipients, 82% for Moderna recipients, and 73% for J&J recipients, compared to unvaccinated veterans in that age group.

The study confirms the need for booster vaccines and protective measures such as vaccine passports, vaccine mandates, masking, hand-washing, and social distancing, the researchers said.

Of the veterans studied, about 500,000 were vaccinated and 300,000 were not. Researchers noted that the study population had 6 times as many men as women. About 48% of the study group was 65 or older, 29% was 50-64, while 24% was under 50.

Researchers from the Public Health Institute in Oakland, the Veterans Affairs Medical Center in San Francisco, and the University of Texas Health Science Center conducted the study.

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

The effectiveness of COVID-19 vaccines produced by Pfizer/BioNTech, Moderna, and Johnson & Johnson dropped dramatically as the Delta variant swept the United States, a study of almost 800,000 veterans found.

The study, published in the journal Science ., says the three vaccines offered about the same protection against the virus in March, when the Delta variant was first detected in the United States, but that changed 6 months later.

The Moderna two-dose vaccine went from being 89% effective in March to 58% effective in September, according to a story about the study in theLos Angeles Times.

Meanwhile, the Pfizer/BioNTech vaccine went from being 87% effective to 45% effective over the same time period.

The Johnson & Johnson vaccine showed the biggest drop -- from 86% effectiveness to 13% over those 6 months.

“In summary, although vaccination remains protective against SARS-CoV-2 infection, protection waned as the Delta variant emerged in the U.S., and this decline did not differ by age,” the study said.

The three vaccines also lost effectiveness in the ability to protect against death in veterans 65 and over after only 3 months, the Los Angeles Times reported.

Compared to unvaccinated veterans in that age group, veterans who got the Moderna vaccine and had a breakthrough case were 76% less likely to die of COVID-19 by July.

The protection was 70% for Pfizer/BioNTech vaccine recipients and 52% for J&J vaccine recipients for the same age group, compared to unvaccinated veterans, according to the newspaper.

For veterans under 65, the protectiveness against a fatal case of COVID was 84% for Pfizer/BioNTech recipients, 82% for Moderna recipients, and 73% for J&J recipients, compared to unvaccinated veterans in that age group.

The study confirms the need for booster vaccines and protective measures such as vaccine passports, vaccine mandates, masking, hand-washing, and social distancing, the researchers said.

Of the veterans studied, about 500,000 were vaccinated and 300,000 were not. Researchers noted that the study population had 6 times as many men as women. About 48% of the study group was 65 or older, 29% was 50-64, while 24% was under 50.

Researchers from the Public Health Institute in Oakland, the Veterans Affairs Medical Center in San Francisco, and the University of Texas Health Science Center conducted the study.

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

Naila Makhani, MD completed medical school training at the University of British Columbia (Vancouver, Canada). This was followed by a residency in child neurology and fellowship in MS and other demyelinating diseases at the University of Toronto and The Hospital for Sick Children (Toronto, Canada). Concurrent with fellowship training, Dr. Makhani obtained a Masters’ degree in public health from Harvard University. Dr. Makhani is the Director of the Pediatric MS Program at Yale and the lead investigator of a multi-center international study examining outcomes following the radiologically isolated syndrome in children.

Q1. Could you please provide an overview of Radiologically Isolated Syndrome ?

A1. Radiologically Isolated Syndrome (RIS) was first described in adults in 2009. Since then it has also been increasingly recognized and diagnosed in children. RIS is diagnosed after an MRI of the brain that the patient has sought for reasons other than suspected multiple sclerosis-- for instance, for evaluation of head trauma or headache. However, unexpectedly or incidentally, the patient’s MRI shows the typical findings that we see in multiple sclerosis, even in the absence of any typical clinical symptoms. RIS is generally considered a rare syndrome.

Q2. You created Yale Medicine’s Pediatric Multiple Sclerosis program which advocates for the eradication of MS. What  criteria defines a rare disease? Does RIS meet these criteria? And if so, how?

A2. The criteria for a rare disease vary, depending on the reference. In the US, a rare disease is defined as a condition that affects fewer than 200,000 people, in total, across the country.  By contrast, in Europe, a disease is considered rare if it affects fewer than one in every 2,000 people within the country’s population.

In the case of RIS, especially in children, we suspect that this is a rare condition, but we don't know for sure, as there have been very few population-based studies. There is one large study that was conducted in Europe that found one case of RIS among approximately 5,000 otherwise healthy children, who were between 7 and 14 years of age.  I think that's our best estimate of the overall prevalence of RIS in children. Using that finding, it likely would qualify as a rare condition, although, as I said, we really don't know for sure, as the prevalence may vary among different populations or age groups.

Q3. How do you investigate and manage RIS in children? What are some of the challenges?  

A3. For children with radiologically isolated syndrome, we usually undertake a comprehensive workup. This includes a detailed clinical neurological exam to ensure that there are no abnormalities that would, for instance, suggest a misdiagnosis of multiple sclerosis or an alternative diagnosis. In addition to the brain MRI, we usually obtain an MRI of the spinal cord to determine whether there is any spinal cord involvement. We also obtain blood tests. We often analyze spinal fluid as well, primarily to exclude other alternative processes that may explain the  MRI findings. A key challenge in this field is that there are currently no formal guidelines for the investigation and management of children with RIS. Collaborations within the pediatric MS community are needed to develop such consensus approaches to standardize care.

Q4. What are the most significant risk factors that indicate children with RIS could one day develop multiple sclerosis?

A4.This is an area of active research within our group. So far, we've found that approximately 42% of children with RIS develop multiple sclerosis in the future; on average, two years following their first abnormal MRI. Therefore, this is a high-risk group for developing  multiple sclerosis in the future. Thus far, we've determined that in children with RIS, it is the presence of abnormal spinal cord imaging and an abnormality in spinal fluid – namely, the presence of oligoclonal bands – that are likely the predictors of whether these children could develop MS in the future. a child’s possible development 

Q5. Based on your recent studies, are there data in children highlighting the potential for higher prevalence  in one population over another?

A5. Thus far, population-based studies assessing RIS, especially in children, have been rare and thus far have not identified particular subgroups with increased prevalence. We do know that the prevalence of multiple sclerosis varies across different age groups and across gender. Whether such associations are also present for RIS is an area of active research.

Naila Makhani, MD completed medical school training at the University of British Columbia (Vancouver, Canada). This was followed by a residency in child neurology and fellowship in MS and other demyelinating diseases at the University of Toronto and The Hospital for Sick Children (Toronto, Canada). Concurrent with fellowship training, Dr. Makhani obtained a Masters’ degree in public health from Harvard University. Dr. Makhani is the Director of the Pediatric MS Program at Yale and the lead investigator of a multi-center international study examining outcomes following the radiologically isolated syndrome in children.

Q1. Could you please provide an overview of Radiologically Isolated Syndrome ?

A1. Radiologically Isolated Syndrome (RIS) was first described in adults in 2009. Since then it has also been increasingly recognized and diagnosed in children. RIS is diagnosed after an MRI of the brain that the patient has sought for reasons other than suspected multiple sclerosis-- for instance, for evaluation of head trauma or headache. However, unexpectedly or incidentally, the patient’s MRI shows the typical findings that we see in multiple sclerosis, even in the absence of any typical clinical symptoms. RIS is generally considered a rare syndrome.

Q2. You created Yale Medicine’s Pediatric Multiple Sclerosis program which advocates for the eradication of MS. What  criteria defines a rare disease? Does RIS meet these criteria? And if so, how?

A2. The criteria for a rare disease vary, depending on the reference. In the US, a rare disease is defined as a condition that affects fewer than 200,000 people, in total, across the country.  By contrast, in Europe, a disease is considered rare if it affects fewer than one in every 2,000 people within the country’s population.

In the case of RIS, especially in children, we suspect that this is a rare condition, but we don't know for sure, as there have been very few population-based studies. There is one large study that was conducted in Europe that found one case of RIS among approximately 5,000 otherwise healthy children, who were between 7 and 14 years of age.  I think that's our best estimate of the overall prevalence of RIS in children. Using that finding, it likely would qualify as a rare condition, although, as I said, we really don't know for sure, as the prevalence may vary among different populations or age groups.

Q3. How do you investigate and manage RIS in children? What are some of the challenges?  

A3. For children with radiologically isolated syndrome, we usually undertake a comprehensive workup. This includes a detailed clinical neurological exam to ensure that there are no abnormalities that would, for instance, suggest a misdiagnosis of multiple sclerosis or an alternative diagnosis. In addition to the brain MRI, we usually obtain an MRI of the spinal cord to determine whether there is any spinal cord involvement. We also obtain blood tests. We often analyze spinal fluid as well, primarily to exclude other alternative processes that may explain the  MRI findings. A key challenge in this field is that there are currently no formal guidelines for the investigation and management of children with RIS. Collaborations within the pediatric MS community are needed to develop such consensus approaches to standardize care.

Q4. What are the most significant risk factors that indicate children with RIS could one day develop multiple sclerosis?

A4.This is an area of active research within our group. So far, we've found that approximately 42% of children with RIS develop multiple sclerosis in the future; on average, two years following their first abnormal MRI. Therefore, this is a high-risk group for developing  multiple sclerosis in the future. Thus far, we've determined that in children with RIS, it is the presence of abnormal spinal cord imaging and an abnormality in spinal fluid – namely, the presence of oligoclonal bands – that are likely the predictors of whether these children could develop MS in the future. a child’s possible development 

Q5. Based on your recent studies, are there data in children highlighting the potential for higher prevalence  in one population over another?

A5. Thus far, population-based studies assessing RIS, especially in children, have been rare and thus far have not identified particular subgroups with increased prevalence. We do know that the prevalence of multiple sclerosis varies across different age groups and across gender. Whether such associations are also present for RIS is an area of active research.

Naila Makhani, MD completed medical school training at the University of British Columbia (Vancouver, Canada). This was followed by a residency in child neurology and fellowship in MS and other demyelinating diseases at the University of Toronto and The Hospital for Sick Children (Toronto, Canada). Concurrent with fellowship training, Dr. Makhani obtained a Masters’ degree in public health from Harvard University. Dr. Makhani is the Director of the Pediatric MS Program at Yale and the lead investigator of a multi-center international study examining outcomes following the radiologically isolated syndrome in children.

Q1. Could you please provide an overview of Radiologically Isolated Syndrome ?

A1. Radiologically Isolated Syndrome (RIS) was first described in adults in 2009. Since then it has also been increasingly recognized and diagnosed in children. RIS is diagnosed after an MRI of the brain that the patient has sought for reasons other than suspected multiple sclerosis-- for instance, for evaluation of head trauma or headache. However, unexpectedly or incidentally, the patient’s MRI shows the typical findings that we see in multiple sclerosis, even in the absence of any typical clinical symptoms. RIS is generally considered a rare syndrome.

Q2. You created Yale Medicine’s Pediatric Multiple Sclerosis program which advocates for the eradication of MS. What  criteria defines a rare disease? Does RIS meet these criteria? And if so, how?

A2. The criteria for a rare disease vary, depending on the reference. In the US, a rare disease is defined as a condition that affects fewer than 200,000 people, in total, across the country.  By contrast, in Europe, a disease is considered rare if it affects fewer than one in every 2,000 people within the country’s population.

In the case of RIS, especially in children, we suspect that this is a rare condition, but we don't know for sure, as there have been very few population-based studies. There is one large study that was conducted in Europe that found one case of RIS among approximately 5,000 otherwise healthy children, who were between 7 and 14 years of age.  I think that's our best estimate of the overall prevalence of RIS in children. Using that finding, it likely would qualify as a rare condition, although, as I said, we really don't know for sure, as the prevalence may vary among different populations or age groups.

Q3. How do you investigate and manage RIS in children? What are some of the challenges?  

A3. For children with radiologically isolated syndrome, we usually undertake a comprehensive workup. This includes a detailed clinical neurological exam to ensure that there are no abnormalities that would, for instance, suggest a misdiagnosis of multiple sclerosis or an alternative diagnosis. In addition to the brain MRI, we usually obtain an MRI of the spinal cord to determine whether there is any spinal cord involvement. We also obtain blood tests. We often analyze spinal fluid as well, primarily to exclude other alternative processes that may explain the  MRI findings. A key challenge in this field is that there are currently no formal guidelines for the investigation and management of children with RIS. Collaborations within the pediatric MS community are needed to develop such consensus approaches to standardize care.

Q4. What are the most significant risk factors that indicate children with RIS could one day develop multiple sclerosis?

A4.This is an area of active research within our group. So far, we've found that approximately 42% of children with RIS develop multiple sclerosis in the future; on average, two years following their first abnormal MRI. Therefore, this is a high-risk group for developing  multiple sclerosis in the future. Thus far, we've determined that in children with RIS, it is the presence of abnormal spinal cord imaging and an abnormality in spinal fluid – namely, the presence of oligoclonal bands – that are likely the predictors of whether these children could develop MS in the future. a child’s possible development 

Q5. Based on your recent studies, are there data in children highlighting the potential for higher prevalence  in one population over another?

A5. Thus far, population-based studies assessing RIS, especially in children, have been rare and thus far have not identified particular subgroups with increased prevalence. We do know that the prevalence of multiple sclerosis varies across different age groups and across gender. Whether such associations are also present for RIS is an area of active research.

Naila Makhani, MD completed medical school training at the University of British Columbia (Vancouver, Canada). This was followed by a residency in child neurology and fellowship in MS and other demyelinating diseases at the University of Toronto and The Hospital for Sick Children (Toronto, Canada). Concurrent with fellowship training, Dr. Makhani obtained a Masters’ degree in public health from Harvard University. Dr. Makhani is the Director of the Pediatric MS Program at Yale and the lead investigator of a multi-center international study examining outcomes following the radiologically isolated syndrome in children.

Q1. Could you please provide an overview of Radiologically Isolated Syndrome ?

A1. Radiologically Isolated Syndrome (RIS) was first described in adults in 2009. Since then it has also been increasingly recognized and diagnosed in children. RIS is diagnosed after an MRI of the brain that the patient has sought for reasons other than suspected multiple sclerosis-- for instance, for evaluation of head trauma or headache. However, unexpectedly or incidentally, the patient’s MRI shows the typical findings that we see in multiple sclerosis, even in the absence of any typical clinical symptoms. RIS is generally considered a rare syndrome.

Q2. You created Yale Medicine’s Pediatric Multiple Sclerosis program which advocates for the eradication of MS. What  criteria defines a rare disease? Does RIS meet these criteria? And if so, how?

A2. The criteria for a rare disease vary, depending on the reference. In the US, a rare disease is defined as a condition that affects fewer than 200,000 people, in total, across the country.  By contrast, in Europe, a disease is considered rare if it affects fewer than one in every 2,000 people within the country’s population.

In the case of RIS, especially in children, we suspect that this is a rare condition, but we don't know for sure, as there have been very few population-based studies. There is one large study that was conducted in Europe that found one case of RIS among approximately 5,000 otherwise healthy children, who were between 7 and 14 years of age.  I think that's our best estimate of the overall prevalence of RIS in children. Using that finding, it likely would qualify as a rare condition, although, as I said, we really don't know for sure, as the prevalence may vary among different populations or age groups.

Q3. How do you investigate and manage RIS in children? What are some of the challenges?  

A3. For children with radiologically isolated syndrome, we usually undertake a comprehensive workup. This includes a detailed clinical neurological exam to ensure that there are no abnormalities that would, for instance, suggest a misdiagnosis of multiple sclerosis or an alternative diagnosis. In addition to the brain MRI, we usually obtain an MRI of the spinal cord to determine whether there is any spinal cord involvement. We also obtain blood tests. We often analyze spinal fluid as well, primarily to exclude other alternative processes that may explain the  MRI findings. A key challenge in this field is that there are currently no formal guidelines for the investigation and management of children with RIS. Collaborations within the pediatric MS community are needed to develop such consensus approaches to standardize care.

Q4. What are the most significant risk factors that indicate children with RIS could one day develop multiple sclerosis?

A4.This is an area of active research within our group. So far, we've found that approximately 42% of children with RIS develop multiple sclerosis in the future; on average, two years following their first abnormal MRI. Therefore, this is a high-risk group for developing  multiple sclerosis in the future. Thus far, we've determined that in children with RIS, it is the presence of abnormal spinal cord imaging and an abnormality in spinal fluid – namely, the presence of oligoclonal bands – that are likely the predictors of whether these children could develop MS in the future. a child’s possible development 

Q5. Based on your recent studies, are there data in children highlighting the potential for higher prevalence  in one population over another?

A5. Thus far, population-based studies assessing RIS, especially in children, have been rare and thus far have not identified particular subgroups with increased prevalence. We do know that the prevalence of multiple sclerosis varies across different age groups and across gender. Whether such associations are also present for RIS is an area of active research.

Naila Makhani, MD completed medical school training at the University of British Columbia (Vancouver, Canada). This was followed by a residency in child neurology and fellowship in MS and other demyelinating diseases at the University of Toronto and The Hospital for Sick Children (Toronto, Canada). Concurrent with fellowship training, Dr. Makhani obtained a Masters’ degree in public health from Harvard University. Dr. Makhani is the Director of the Pediatric MS Program at Yale and the lead investigator of a multi-center international study examining outcomes following the radiologically isolated syndrome in children.

Q1. Could you please provide an overview of Radiologically Isolated Syndrome ?

A1. Radiologically Isolated Syndrome (RIS) was first described in adults in 2009. Since then it has also been increasingly recognized and diagnosed in children. RIS is diagnosed after an MRI of the brain that the patient has sought for reasons other than suspected multiple sclerosis-- for instance, for evaluation of head trauma or headache. However, unexpectedly or incidentally, the patient’s MRI shows the typical findings that we see in multiple sclerosis, even in the absence of any typical clinical symptoms. RIS is generally considered a rare syndrome.

Q2. You created Yale Medicine’s Pediatric Multiple Sclerosis program which advocates for the eradication of MS. What  criteria defines a rare disease? Does RIS meet these criteria? And if so, how?

A2. The criteria for a rare disease vary, depending on the reference. In the US, a rare disease is defined as a condition that affects fewer than 200,000 people, in total, across the country.  By contrast, in Europe, a disease is considered rare if it affects fewer than one in every 2,000 people within the country’s population.

In the case of RIS, especially in children, we suspect that this is a rare condition, but we don't know for sure, as there have been very few population-based studies. There is one large study that was conducted in Europe that found one case of RIS among approximately 5,000 otherwise healthy children, who were between 7 and 14 years of age.  I think that's our best estimate of the overall prevalence of RIS in children. Using that finding, it likely would qualify as a rare condition, although, as I said, we really don't know for sure, as the prevalence may vary among different populations or age groups.

Q3. How do you investigate and manage RIS in children? What are some of the challenges?  

A3. For children with radiologically isolated syndrome, we usually undertake a comprehensive workup. This includes a detailed clinical neurological exam to ensure that there are no abnormalities that would, for instance, suggest a misdiagnosis of multiple sclerosis or an alternative diagnosis. In addition to the brain MRI, we usually obtain an MRI of the spinal cord to determine whether there is any spinal cord involvement. We also obtain blood tests. We often analyze spinal fluid as well, primarily to exclude other alternative processes that may explain the  MRI findings. A key challenge in this field is that there are currently no formal guidelines for the investigation and management of children with RIS. Collaborations within the pediatric MS community are needed to develop such consensus approaches to standardize care.

Q4. What are the most significant risk factors that indicate children with RIS could one day develop multiple sclerosis?

A4.This is an area of active research within our group. So far, we've found that approximately 42% of children with RIS develop multiple sclerosis in the future; on average, two years following their first abnormal MRI. Therefore, this is a high-risk group for developing  multiple sclerosis in the future. Thus far, we've determined that in children with RIS, it is the presence of abnormal spinal cord imaging and an abnormality in spinal fluid – namely, the presence of oligoclonal bands – that are likely the predictors of whether these children could develop MS in the future. a child’s possible development 

Q5. Based on your recent studies, are there data in children highlighting the potential for higher prevalence  in one population over another?

A5. Thus far, population-based studies assessing RIS, especially in children, have been rare and thus far have not identified particular subgroups with increased prevalence. We do know that the prevalence of multiple sclerosis varies across different age groups and across gender. Whether such associations are also present for RIS is an area of active research.

Naila Makhani, MD completed medical school training at the University of British Columbia (Vancouver, Canada). This was followed by a residency in child neurology and fellowship in MS and other demyelinating diseases at the University of Toronto and The Hospital for Sick Children (Toronto, Canada). Concurrent with fellowship training, Dr. Makhani obtained a Masters’ degree in public health from Harvard University. Dr. Makhani is the Director of the Pediatric MS Program at Yale and the lead investigator of a multi-center international study examining outcomes following the radiologically isolated syndrome in children.

Q1. Could you please provide an overview of Radiologically Isolated Syndrome ?

A1. Radiologically Isolated Syndrome (RIS) was first described in adults in 2009. Since then it has also been increasingly recognized and diagnosed in children. RIS is diagnosed after an MRI of the brain that the patient has sought for reasons other than suspected multiple sclerosis-- for instance, for evaluation of head trauma or headache. However, unexpectedly or incidentally, the patient’s MRI shows the typical findings that we see in multiple sclerosis, even in the absence of any typical clinical symptoms. RIS is generally considered a rare syndrome.

Q2. You created Yale Medicine’s Pediatric Multiple Sclerosis program which advocates for the eradication of MS. What  criteria defines a rare disease? Does RIS meet these criteria? And if so, how?

A2. The criteria for a rare disease vary, depending on the reference. In the US, a rare disease is defined as a condition that affects fewer than 200,000 people, in total, across the country.  By contrast, in Europe, a disease is considered rare if it affects fewer than one in every 2,000 people within the country’s population.

In the case of RIS, especially in children, we suspect that this is a rare condition, but we don't know for sure, as there have been very few population-based studies. There is one large study that was conducted in Europe that found one case of RIS among approximately 5,000 otherwise healthy children, who were between 7 and 14 years of age.  I think that's our best estimate of the overall prevalence of RIS in children. Using that finding, it likely would qualify as a rare condition, although, as I said, we really don't know for sure, as the prevalence may vary among different populations or age groups.

Q3. How do you investigate and manage RIS in children? What are some of the challenges?  

A3. For children with radiologically isolated syndrome, we usually undertake a comprehensive workup. This includes a detailed clinical neurological exam to ensure that there are no abnormalities that would, for instance, suggest a misdiagnosis of multiple sclerosis or an alternative diagnosis. In addition to the brain MRI, we usually obtain an MRI of the spinal cord to determine whether there is any spinal cord involvement. We also obtain blood tests. We often analyze spinal fluid as well, primarily to exclude other alternative processes that may explain the  MRI findings. A key challenge in this field is that there are currently no formal guidelines for the investigation and management of children with RIS. Collaborations within the pediatric MS community are needed to develop such consensus approaches to standardize care.

Q4. What are the most significant risk factors that indicate children with RIS could one day develop multiple sclerosis?

A4.This is an area of active research within our group. So far, we've found that approximately 42% of children with RIS develop multiple sclerosis in the future; on average, two years following their first abnormal MRI. Therefore, this is a high-risk group for developing  multiple sclerosis in the future. Thus far, we've determined that in children with RIS, it is the presence of abnormal spinal cord imaging and an abnormality in spinal fluid – namely, the presence of oligoclonal bands – that are likely the predictors of whether these children could develop MS in the future. a child’s possible development 

Q5. Based on your recent studies, are there data in children highlighting the potential for higher prevalence  in one population over another?

A5. Thus far, population-based studies assessing RIS, especially in children, have been rare and thus far have not identified particular subgroups with increased prevalence. We do know that the prevalence of multiple sclerosis varies across different age groups and across gender. Whether such associations are also present for RIS is an area of active research.

For those of us who cannot sit in the sun and fish all day, the next best thing for preventing autoimmune diseases may be supplementation with vitamin D and fish oil-derived omega-3 fatty acids, results of a large prospective randomized trial suggest.

Ziga Plahutar

Among nearly 26,000 adults enrolled in a randomized trial designed primarily to study the effects of vitamin D and omega-3 supplementation on incident cancer and cardiovascular disease, 5 years of vitamin D supplementation was associated with a 22% reduction in risk for confirmed autoimmune diseases, and 5 years of omega-3 fatty acid supplementation was associated with an 18% reduction in confirmed and probable incident autoimmune diseases, reported Karen H. Costenbader, MD, MPH, of Brigham & Women’s Hospital in Boston.

“The clinical importance of these results is very high, given that these are nontoxic, well-tolerated supplements, and that there are no other known effective therapies to reduce the incidence of autoimmune diseases,” she said during the virtual annual meeting of the American College of Rheumatology.

“People do have to take the supplements a long time to start to see the reduction in risk, especially for vitamin D, but they make biological sense, and autoimmune diseases develop slowly over time, so taking it today isn’t going to reduce risk of developing something tomorrow,” Dr. Costenbader said in an interview.

“These supplements have other health benefits. Obviously, fish oil is anti-inflammatory, and vitamin D is good for osteoporosis prevention, especially in our patients who take glucocorticoids. People who are otherwise healthy and have a family history of autoimmune disease might also consider starting to take these supplements,” she said.

After watching her presentation, session co-moderator Gregg Silverman, MD, from the NYU Langone School of Medicine in New York, who was not involved in the study, commented “I’m going to [nutrition store] GNC to get some vitamins.”

When asked for comment, the other session moderator, Tracy Frech, MD, of Vanderbilt University, Nashville, said, “I think Dr. Costenbader’s work is very important and her presentation excellent. My current practice is replacement of vitamin D in all autoimmune disease patients with low levels and per bone health guidelines. Additionally, I discuss omega-3 supplementation with Sjögren’s [syndrome] patients as a consideration.”

Evidence base

Dr. Costenbader noted that in a 2013 observational study from France, vitamin D derived through ultraviolet (UV) light exposure was associated with a lower risk for incident Crohn’s disease but not ulcerative colitis, and in two analyses of data in 2014 from the Nurses’ Health Study, both high plasma levels of 25-OH vitamin D and geographic residence in areas of high UV exposure were associated with a decreased incidence of rheumatoid arthritis (RA).

Other observational studies have supported omega-3 fatty acids for their anti-inflammatory properties, including a 2005 Danish prospective cohort study showing a lower risk for RA in participants who reported higher levels of fatty fish intake. In a separate study conducted in 2017, healthy volunteers with higher omega-3 fatty acid/total lipid proportions in red blood cell membranes had a lower prevalence of anti-cyclic citrullinated peptide (anti-CCP) antibodies and rheumatoid factor and a lower incidence of progression to inflammatory arthritis, she said.

Ancillary study

Despite the evidence, however, there have been no prospective randomized trials to test the effects of either vitamin D or omega-3 fatty acid supplementation on the incidence of autoimmune disease over time.

To rectify this, Dr. Costenbader and colleagues piggybacked an ancillary study onto the Vitamin D and Omega-3 Trial (VITAL), which had primary outcomes of cancer and cardiovascular disease incidence.

A total of 25,871 participants were enrolled, including 12,786 men aged 50 and older, and 13,085 women aged 55 and older.

The study had a 2 x 2 factorial design, with patients randomly assigned to vitamin D 2,000 IU/day or placebo, and then further randomized to either 1 g/day omega-3 fatty acids or placebo in both the vitamin D and placebo primary randomization arms.

At baseline 16,956 participants were assayed for 25-OH vitamin D and plasma omega 3 index, the ratio of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) to total fatty acids. Participants self-reported baseline and all incident autoimmune diseases annually, with the reports confirmed by medical record review and disease criteria whenever possible.

Results

At 5 years of follow-up, confirmed incident autoimmune diseases had occurred in 123 patients in the active vitamin D group, compared with 155 in the placebo vitamin D group, translating into a hazard ratio (HR) for vitamin D of 0.78 (P = .045).

In the active omega-3 arm, 130 participants developed an autoimmune disease, compared with 148 in the placebo omega-3 arm, which translated into a nonsignificant HR of 0.85.

There was no statistical interaction between the two supplements. The investigators did observe an interaction between vitamin D and body mass index, with the effect stronger among participants with low BMI (P = .02). There also was an interaction between omega-3 fatty acids with a family history of autoimmune disease (P = .03).

In multivariate analysis adjusted for age, sex, race, and other supplement arm, vitamin D alone was associated with an HR for incident autoimmune disease of 0.68 (P = .02), omega-3 alone was associated with a nonsignificant HR of 0.74, and the combination was associated with an HR of 0.69 (P = .03).

Dr. Costenbader and colleagues acknowledged that the study was limited by the lack of a high-risk or nutritionally-deficient population, where the effects of supplementation might be larger; the restriction of the sample to older adults; and to the difficulty of confirming incident autoimmune thyroid disease from patient reports.

Cheryl Koehn, an arthritis patient advocate from Vancouver, Canada, who was not involved in the study, commented in the “chat” section of the presentation that her rheumatologist “has recommended vitamin D for years now. Says basically everyone north of Boston is vitamin D deficient. I take 1,000 IU per day. Been taking it for years.” Ms. Koehn is the founder and president of Arthritis Consumer Experts, a website that provides education to those with arthritis.

“Agreed. I tell every patient to take vitamin D supplement,” commented Fatma Dedeoglu, MD, a rheumatologist at Boston Children’s Hospital.



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

For those of us who cannot sit in the sun and fish all day, the next best thing for preventing autoimmune diseases may be supplementation with vitamin D and fish oil-derived omega-3 fatty acids, results of a large prospective randomized trial suggest.

Ziga Plahutar

Among nearly 26,000 adults enrolled in a randomized trial designed primarily to study the effects of vitamin D and omega-3 supplementation on incident cancer and cardiovascular disease, 5 years of vitamin D supplementation was associated with a 22% reduction in risk for confirmed autoimmune diseases, and 5 years of omega-3 fatty acid supplementation was associated with an 18% reduction in confirmed and probable incident autoimmune diseases, reported Karen H. Costenbader, MD, MPH, of Brigham & Women’s Hospital in Boston.

“The clinical importance of these results is very high, given that these are nontoxic, well-tolerated supplements, and that there are no other known effective therapies to reduce the incidence of autoimmune diseases,” she said during the virtual annual meeting of the American College of Rheumatology.

“People do have to take the supplements a long time to start to see the reduction in risk, especially for vitamin D, but they make biological sense, and autoimmune diseases develop slowly over time, so taking it today isn’t going to reduce risk of developing something tomorrow,” Dr. Costenbader said in an interview.

“These supplements have other health benefits. Obviously, fish oil is anti-inflammatory, and vitamin D is good for osteoporosis prevention, especially in our patients who take glucocorticoids. People who are otherwise healthy and have a family history of autoimmune disease might also consider starting to take these supplements,” she said.

After watching her presentation, session co-moderator Gregg Silverman, MD, from the NYU Langone School of Medicine in New York, who was not involved in the study, commented “I’m going to [nutrition store] GNC to get some vitamins.”

When asked for comment, the other session moderator, Tracy Frech, MD, of Vanderbilt University, Nashville, said, “I think Dr. Costenbader’s work is very important and her presentation excellent. My current practice is replacement of vitamin D in all autoimmune disease patients with low levels and per bone health guidelines. Additionally, I discuss omega-3 supplementation with Sjögren’s [syndrome] patients as a consideration.”

Evidence base

Dr. Costenbader noted that in a 2013 observational study from France, vitamin D derived through ultraviolet (UV) light exposure was associated with a lower risk for incident Crohn’s disease but not ulcerative colitis, and in two analyses of data in 2014 from the Nurses’ Health Study, both high plasma levels of 25-OH vitamin D and geographic residence in areas of high UV exposure were associated with a decreased incidence of rheumatoid arthritis (RA).

Other observational studies have supported omega-3 fatty acids for their anti-inflammatory properties, including a 2005 Danish prospective cohort study showing a lower risk for RA in participants who reported higher levels of fatty fish intake. In a separate study conducted in 2017, healthy volunteers with higher omega-3 fatty acid/total lipid proportions in red blood cell membranes had a lower prevalence of anti-cyclic citrullinated peptide (anti-CCP) antibodies and rheumatoid factor and a lower incidence of progression to inflammatory arthritis, she said.

Ancillary study

Despite the evidence, however, there have been no prospective randomized trials to test the effects of either vitamin D or omega-3 fatty acid supplementation on the incidence of autoimmune disease over time.

To rectify this, Dr. Costenbader and colleagues piggybacked an ancillary study onto the Vitamin D and Omega-3 Trial (VITAL), which had primary outcomes of cancer and cardiovascular disease incidence.

A total of 25,871 participants were enrolled, including 12,786 men aged 50 and older, and 13,085 women aged 55 and older.

The study had a 2 x 2 factorial design, with patients randomly assigned to vitamin D 2,000 IU/day or placebo, and then further randomized to either 1 g/day omega-3 fatty acids or placebo in both the vitamin D and placebo primary randomization arms.

At baseline 16,956 participants were assayed for 25-OH vitamin D and plasma omega 3 index, the ratio of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) to total fatty acids. Participants self-reported baseline and all incident autoimmune diseases annually, with the reports confirmed by medical record review and disease criteria whenever possible.

Results

At 5 years of follow-up, confirmed incident autoimmune diseases had occurred in 123 patients in the active vitamin D group, compared with 155 in the placebo vitamin D group, translating into a hazard ratio (HR) for vitamin D of 0.78 (P = .045).

In the active omega-3 arm, 130 participants developed an autoimmune disease, compared with 148 in the placebo omega-3 arm, which translated into a nonsignificant HR of 0.85.

There was no statistical interaction between the two supplements. The investigators did observe an interaction between vitamin D and body mass index, with the effect stronger among participants with low BMI (P = .02). There also was an interaction between omega-3 fatty acids with a family history of autoimmune disease (P = .03).

In multivariate analysis adjusted for age, sex, race, and other supplement arm, vitamin D alone was associated with an HR for incident autoimmune disease of 0.68 (P = .02), omega-3 alone was associated with a nonsignificant HR of 0.74, and the combination was associated with an HR of 0.69 (P = .03).

Dr. Costenbader and colleagues acknowledged that the study was limited by the lack of a high-risk or nutritionally-deficient population, where the effects of supplementation might be larger; the restriction of the sample to older adults; and to the difficulty of confirming incident autoimmune thyroid disease from patient reports.

Cheryl Koehn, an arthritis patient advocate from Vancouver, Canada, who was not involved in the study, commented in the “chat” section of the presentation that her rheumatologist “has recommended vitamin D for years now. Says basically everyone north of Boston is vitamin D deficient. I take 1,000 IU per day. Been taking it for years.” Ms. Koehn is the founder and president of Arthritis Consumer Experts, a website that provides education to those with arthritis.

“Agreed. I tell every patient to take vitamin D supplement,” commented Fatma Dedeoglu, MD, a rheumatologist at Boston Children’s Hospital.



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

For those of us who cannot sit in the sun and fish all day, the next best thing for preventing autoimmune diseases may be supplementation with vitamin D and fish oil-derived omega-3 fatty acids, results of a large prospective randomized trial suggest.

Ziga Plahutar

Among nearly 26,000 adults enrolled in a randomized trial designed primarily to study the effects of vitamin D and omega-3 supplementation on incident cancer and cardiovascular disease, 5 years of vitamin D supplementation was associated with a 22% reduction in risk for confirmed autoimmune diseases, and 5 years of omega-3 fatty acid supplementation was associated with an 18% reduction in confirmed and probable incident autoimmune diseases, reported Karen H. Costenbader, MD, MPH, of Brigham & Women’s Hospital in Boston.

“The clinical importance of these results is very high, given that these are nontoxic, well-tolerated supplements, and that there are no other known effective therapies to reduce the incidence of autoimmune diseases,” she said during the virtual annual meeting of the American College of Rheumatology.

“People do have to take the supplements a long time to start to see the reduction in risk, especially for vitamin D, but they make biological sense, and autoimmune diseases develop slowly over time, so taking it today isn’t going to reduce risk of developing something tomorrow,” Dr. Costenbader said in an interview.

“These supplements have other health benefits. Obviously, fish oil is anti-inflammatory, and vitamin D is good for osteoporosis prevention, especially in our patients who take glucocorticoids. People who are otherwise healthy and have a family history of autoimmune disease might also consider starting to take these supplements,” she said.

After watching her presentation, session co-moderator Gregg Silverman, MD, from the NYU Langone School of Medicine in New York, who was not involved in the study, commented “I’m going to [nutrition store] GNC to get some vitamins.”

When asked for comment, the other session moderator, Tracy Frech, MD, of Vanderbilt University, Nashville, said, “I think Dr. Costenbader’s work is very important and her presentation excellent. My current practice is replacement of vitamin D in all autoimmune disease patients with low levels and per bone health guidelines. Additionally, I discuss omega-3 supplementation with Sjögren’s [syndrome] patients as a consideration.”

Evidence base

Dr. Costenbader noted that in a 2013 observational study from France, vitamin D derived through ultraviolet (UV) light exposure was associated with a lower risk for incident Crohn’s disease but not ulcerative colitis, and in two analyses of data in 2014 from the Nurses’ Health Study, both high plasma levels of 25-OH vitamin D and geographic residence in areas of high UV exposure were associated with a decreased incidence of rheumatoid arthritis (RA).

Other observational studies have supported omega-3 fatty acids for their anti-inflammatory properties, including a 2005 Danish prospective cohort study showing a lower risk for RA in participants who reported higher levels of fatty fish intake. In a separate study conducted in 2017, healthy volunteers with higher omega-3 fatty acid/total lipid proportions in red blood cell membranes had a lower prevalence of anti-cyclic citrullinated peptide (anti-CCP) antibodies and rheumatoid factor and a lower incidence of progression to inflammatory arthritis, she said.

Ancillary study

Despite the evidence, however, there have been no prospective randomized trials to test the effects of either vitamin D or omega-3 fatty acid supplementation on the incidence of autoimmune disease over time.

To rectify this, Dr. Costenbader and colleagues piggybacked an ancillary study onto the Vitamin D and Omega-3 Trial (VITAL), which had primary outcomes of cancer and cardiovascular disease incidence.

A total of 25,871 participants were enrolled, including 12,786 men aged 50 and older, and 13,085 women aged 55 and older.

The study had a 2 x 2 factorial design, with patients randomly assigned to vitamin D 2,000 IU/day or placebo, and then further randomized to either 1 g/day omega-3 fatty acids or placebo in both the vitamin D and placebo primary randomization arms.

At baseline 16,956 participants were assayed for 25-OH vitamin D and plasma omega 3 index, the ratio of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) to total fatty acids. Participants self-reported baseline and all incident autoimmune diseases annually, with the reports confirmed by medical record review and disease criteria whenever possible.

Results

At 5 years of follow-up, confirmed incident autoimmune diseases had occurred in 123 patients in the active vitamin D group, compared with 155 in the placebo vitamin D group, translating into a hazard ratio (HR) for vitamin D of 0.78 (P = .045).

In the active omega-3 arm, 130 participants developed an autoimmune disease, compared with 148 in the placebo omega-3 arm, which translated into a nonsignificant HR of 0.85.

There was no statistical interaction between the two supplements. The investigators did observe an interaction between vitamin D and body mass index, with the effect stronger among participants with low BMI (P = .02). There also was an interaction between omega-3 fatty acids with a family history of autoimmune disease (P = .03).

In multivariate analysis adjusted for age, sex, race, and other supplement arm, vitamin D alone was associated with an HR for incident autoimmune disease of 0.68 (P = .02), omega-3 alone was associated with a nonsignificant HR of 0.74, and the combination was associated with an HR of 0.69 (P = .03).

Dr. Costenbader and colleagues acknowledged that the study was limited by the lack of a high-risk or nutritionally-deficient population, where the effects of supplementation might be larger; the restriction of the sample to older adults; and to the difficulty of confirming incident autoimmune thyroid disease from patient reports.

Cheryl Koehn, an arthritis patient advocate from Vancouver, Canada, who was not involved in the study, commented in the “chat” section of the presentation that her rheumatologist “has recommended vitamin D for years now. Says basically everyone north of Boston is vitamin D deficient. I take 1,000 IU per day. Been taking it for years.” Ms. Koehn is the founder and president of Arthritis Consumer Experts, a website that provides education to those with arthritis.

“Agreed. I tell every patient to take vitamin D supplement,” commented Fatma Dedeoglu, MD, a rheumatologist at Boston Children’s Hospital.



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

Certain antihypertensive medications, particularly diuretics, are linked to lower Alzheimer’s disease neuropathology and other brain disease processes, new research shows.

Investigators found that use of any antihypertensive was associated with an 18% decrease in Alzheimer’s disease neuropathology, a 22% decrease in Lewy bodies, and a 40% decrease in TAR DNA-binding protein 43 (TDP-43), a protein relevant to several neurodegenerative diseases. Diuretics in particular appear to be driving the association.

Although diuretics might be a better option for preventing brain neuropathology, it’s too early to make firm recommendations solely on the basis of these results as to what blood pressure–lowering agent to prescribe a particular patient, said study investigator Ahmad Sajjadi, MD, assistant professor of neurology, University of California, Irvine.

“This is early stages and preliminary results,” said Dr. Sajjadi, “but it’s food for thought.”

The findings were presented at the 2021 annual meeting of the American Neurological Association.
 

Autopsy data

The study included 3,315 individuals who had donated their brains to research. The National Alzheimer’s Coordinating Center maintains a database that includes data from 32 Alzheimer’s disease research centers in the United States. Participants in the study must have visited one of these centers within 4 years of death. Each person whose brain was included in the study underwent two or more BP measurements on at least 50% of visits.

The mean age at death was 81.7 years, and the mean time between last visit and death was 13.1 months. About 44.4% of participants were women, 57.0% had at least a college degree, and 84.7% had cognitive impairment.

Researchers defined hypertension as systolic BP of at least 130 mm Hg, diastolic BP of at least 80 mm Hg, mean arterial pressure of at least 100 mm Hg, and pulse pressure of at least 60 mm Hg.

Antihypertensive medications that were evaluated included antiadrenergic agents, ACE inhibitors, angiotensin II receptor blockers, beta blockers, calcium channel blockers, diuretics, vasodilators, and combination therapies.

The investigators assessed the number of neuropathologies. In addition to Alzheimer’s disease neuropathology, which included amyloid-beta, tau, Lewy bodies, and TDP-43, they also assessed for atherosclerosis, arteriolosclerosis, cerebral amyloid angiopathy, frontotemporal lobar degeneration, and hippocampal sclerosis.

Results showed that use of any antihypertensive was associated with a lower likelihood of Alzheimer’s disease neuropathology (odds ratio, 0.822), Lewy bodies (OR, 0.786), and TDP 43 (OR, 0.597). Use of antihypertensives was also associated with increased odds of atherosclerosis (OR, 1.217) (all P < .5.)

The study showed that hypertensive systolic BP was associated with higher odds of Alzheimer’s disease neuropathology (OR, 1.28; P < .5).

Differences by drug type

Results differed in accordance with antihypertensive class. Angiotensin II receptor blockers decreased the odds of Alzheimer’s disease neuropathology by 40% (OR, 0.60; P < .5). Diuretics decreased the odds of Alzheimer’s disease by 36% (OR, 0.64; P < .001) and of hippocampal sclerosis by 32% (OR, 0.68; P < .5).

“We see diuretics are a main driver, especially for lower odds of Alzheimer’s disease and lower odds of hippocampal sclerosis,” said lead author Hanna L. Nguyen, a first-year medical student at the University of California, Irvine.

The results indicate that it is the medications, not BP levels, that account for these associations, she added.

One potential mechanism linking antihypertensives to brain pathology is that with these agents, BP is maintained in the target zone. Blood pressure that’s too high can damage blood vessels, whereas BP that’s too low may result in less than adequate perfusion, said Ms. Nguyen.

These medications may also alter pathways leading to degeneration and could, for example, affect the apo E mechanism of Alzheimer’s disease, she added.

The researchers plan to conduct subset analyses using apo E genetic status and age of death.

Although this is a “massive database,” it has limitations. For example, said Dr. Sajjadi, it does not reveal when patients started taking BP medication, how long they had been taking it, or why.

“We don’t know the exact the reason they were taking these medications. Was it just hypertension, or did they also have heart disease, stroke, a kidney problem, or was there another explanation,” he said.

Following the study presentation, session comoderator Krish Sathian, MBBS, PhD, professor of neurology, neural, and behavioral sciences, and psychology and director of the Neuroscience Institute, Penn State University, Hershey, called this work “fascinating. It provides a lot of data that really touches on everyday practice,” inasmuch as clinicians often prescribe antihypertensive medications and see patients with these kinds of brain disorders.

The investigators and Dr. Sathian reported no relevant financial relationships.

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

Certain antihypertensive medications, particularly diuretics, are linked to lower Alzheimer’s disease neuropathology and other brain disease processes, new research shows.

Investigators found that use of any antihypertensive was associated with an 18% decrease in Alzheimer’s disease neuropathology, a 22% decrease in Lewy bodies, and a 40% decrease in TAR DNA-binding protein 43 (TDP-43), a protein relevant to several neurodegenerative diseases. Diuretics in particular appear to be driving the association.

Although diuretics might be a better option for preventing brain neuropathology, it’s too early to make firm recommendations solely on the basis of these results as to what blood pressure–lowering agent to prescribe a particular patient, said study investigator Ahmad Sajjadi, MD, assistant professor of neurology, University of California, Irvine.

“This is early stages and preliminary results,” said Dr. Sajjadi, “but it’s food for thought.”

The findings were presented at the 2021 annual meeting of the American Neurological Association.
 

Autopsy data

The study included 3,315 individuals who had donated their brains to research. The National Alzheimer’s Coordinating Center maintains a database that includes data from 32 Alzheimer’s disease research centers in the United States. Participants in the study must have visited one of these centers within 4 years of death. Each person whose brain was included in the study underwent two or more BP measurements on at least 50% of visits.

The mean age at death was 81.7 years, and the mean time between last visit and death was 13.1 months. About 44.4% of participants were women, 57.0% had at least a college degree, and 84.7% had cognitive impairment.

Researchers defined hypertension as systolic BP of at least 130 mm Hg, diastolic BP of at least 80 mm Hg, mean arterial pressure of at least 100 mm Hg, and pulse pressure of at least 60 mm Hg.

Antihypertensive medications that were evaluated included antiadrenergic agents, ACE inhibitors, angiotensin II receptor blockers, beta blockers, calcium channel blockers, diuretics, vasodilators, and combination therapies.

The investigators assessed the number of neuropathologies. In addition to Alzheimer’s disease neuropathology, which included amyloid-beta, tau, Lewy bodies, and TDP-43, they also assessed for atherosclerosis, arteriolosclerosis, cerebral amyloid angiopathy, frontotemporal lobar degeneration, and hippocampal sclerosis.

Results showed that use of any antihypertensive was associated with a lower likelihood of Alzheimer’s disease neuropathology (odds ratio, 0.822), Lewy bodies (OR, 0.786), and TDP 43 (OR, 0.597). Use of antihypertensives was also associated with increased odds of atherosclerosis (OR, 1.217) (all P < .5.)

The study showed that hypertensive systolic BP was associated with higher odds of Alzheimer’s disease neuropathology (OR, 1.28; P < .5).

Differences by drug type

Results differed in accordance with antihypertensive class. Angiotensin II receptor blockers decreased the odds of Alzheimer’s disease neuropathology by 40% (OR, 0.60; P < .5). Diuretics decreased the odds of Alzheimer’s disease by 36% (OR, 0.64; P < .001) and of hippocampal sclerosis by 32% (OR, 0.68; P < .5).

“We see diuretics are a main driver, especially for lower odds of Alzheimer’s disease and lower odds of hippocampal sclerosis,” said lead author Hanna L. Nguyen, a first-year medical student at the University of California, Irvine.

The results indicate that it is the medications, not BP levels, that account for these associations, she added.

One potential mechanism linking antihypertensives to brain pathology is that with these agents, BP is maintained in the target zone. Blood pressure that’s too high can damage blood vessels, whereas BP that’s too low may result in less than adequate perfusion, said Ms. Nguyen.

These medications may also alter pathways leading to degeneration and could, for example, affect the apo E mechanism of Alzheimer’s disease, she added.

The researchers plan to conduct subset analyses using apo E genetic status and age of death.

Although this is a “massive database,” it has limitations. For example, said Dr. Sajjadi, it does not reveal when patients started taking BP medication, how long they had been taking it, or why.

“We don’t know the exact the reason they were taking these medications. Was it just hypertension, or did they also have heart disease, stroke, a kidney problem, or was there another explanation,” he said.

Following the study presentation, session comoderator Krish Sathian, MBBS, PhD, professor of neurology, neural, and behavioral sciences, and psychology and director of the Neuroscience Institute, Penn State University, Hershey, called this work “fascinating. It provides a lot of data that really touches on everyday practice,” inasmuch as clinicians often prescribe antihypertensive medications and see patients with these kinds of brain disorders.

The investigators and Dr. Sathian reported no relevant financial relationships.

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

Certain antihypertensive medications, particularly diuretics, are linked to lower Alzheimer’s disease neuropathology and other brain disease processes, new research shows.

Investigators found that use of any antihypertensive was associated with an 18% decrease in Alzheimer’s disease neuropathology, a 22% decrease in Lewy bodies, and a 40% decrease in TAR DNA-binding protein 43 (TDP-43), a protein relevant to several neurodegenerative diseases. Diuretics in particular appear to be driving the association.

Although diuretics might be a better option for preventing brain neuropathology, it’s too early to make firm recommendations solely on the basis of these results as to what blood pressure–lowering agent to prescribe a particular patient, said study investigator Ahmad Sajjadi, MD, assistant professor of neurology, University of California, Irvine.

“This is early stages and preliminary results,” said Dr. Sajjadi, “but it’s food for thought.”

The findings were presented at the 2021 annual meeting of the American Neurological Association.
 

Autopsy data

The study included 3,315 individuals who had donated their brains to research. The National Alzheimer’s Coordinating Center maintains a database that includes data from 32 Alzheimer’s disease research centers in the United States. Participants in the study must have visited one of these centers within 4 years of death. Each person whose brain was included in the study underwent two or more BP measurements on at least 50% of visits.

The mean age at death was 81.7 years, and the mean time between last visit and death was 13.1 months. About 44.4% of participants were women, 57.0% had at least a college degree, and 84.7% had cognitive impairment.

Researchers defined hypertension as systolic BP of at least 130 mm Hg, diastolic BP of at least 80 mm Hg, mean arterial pressure of at least 100 mm Hg, and pulse pressure of at least 60 mm Hg.

Antihypertensive medications that were evaluated included antiadrenergic agents, ACE inhibitors, angiotensin II receptor blockers, beta blockers, calcium channel blockers, diuretics, vasodilators, and combination therapies.

The investigators assessed the number of neuropathologies. In addition to Alzheimer’s disease neuropathology, which included amyloid-beta, tau, Lewy bodies, and TDP-43, they also assessed for atherosclerosis, arteriolosclerosis, cerebral amyloid angiopathy, frontotemporal lobar degeneration, and hippocampal sclerosis.

Results showed that use of any antihypertensive was associated with a lower likelihood of Alzheimer’s disease neuropathology (odds ratio, 0.822), Lewy bodies (OR, 0.786), and TDP 43 (OR, 0.597). Use of antihypertensives was also associated with increased odds of atherosclerosis (OR, 1.217) (all P < .5.)

The study showed that hypertensive systolic BP was associated with higher odds of Alzheimer’s disease neuropathology (OR, 1.28; P < .5).

Differences by drug type

Results differed in accordance with antihypertensive class. Angiotensin II receptor blockers decreased the odds of Alzheimer’s disease neuropathology by 40% (OR, 0.60; P < .5). Diuretics decreased the odds of Alzheimer’s disease by 36% (OR, 0.64; P < .001) and of hippocampal sclerosis by 32% (OR, 0.68; P < .5).

“We see diuretics are a main driver, especially for lower odds of Alzheimer’s disease and lower odds of hippocampal sclerosis,” said lead author Hanna L. Nguyen, a first-year medical student at the University of California, Irvine.

The results indicate that it is the medications, not BP levels, that account for these associations, she added.

One potential mechanism linking antihypertensives to brain pathology is that with these agents, BP is maintained in the target zone. Blood pressure that’s too high can damage blood vessels, whereas BP that’s too low may result in less than adequate perfusion, said Ms. Nguyen.

These medications may also alter pathways leading to degeneration and could, for example, affect the apo E mechanism of Alzheimer’s disease, she added.

The researchers plan to conduct subset analyses using apo E genetic status and age of death.

Although this is a “massive database,” it has limitations. For example, said Dr. Sajjadi, it does not reveal when patients started taking BP medication, how long they had been taking it, or why.

“We don’t know the exact the reason they were taking these medications. Was it just hypertension, or did they also have heart disease, stroke, a kidney problem, or was there another explanation,” he said.

Following the study presentation, session comoderator Krish Sathian, MBBS, PhD, professor of neurology, neural, and behavioral sciences, and psychology and director of the Neuroscience Institute, Penn State University, Hershey, called this work “fascinating. It provides a lot of data that really touches on everyday practice,” inasmuch as clinicians often prescribe antihypertensive medications and see patients with these kinds of brain disorders.

The investigators and Dr. Sathian reported no relevant financial relationships.

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

An experimental antiviral pill appears to work very well at keeping people who are at high risk of severe COVID-19 from being admitted to the hospital and dying, according to the drug’s maker, Pfizer.

The drug -- called Paxlovid -- was 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who were at high risk of severe complications. The company says it plans to ask the FDA to authorize the drug for emergency use.

The medication appears to work so well that Pfizer has stopped enrollment in the trial of the drug, which works by blocking an enzyme called a protease that the new coronavirus needs to make more copies of itself.

Stopping a clinical trial is a rare action that’s typically taken when a therapy appears to be very effective or clearly dangerous. In both those cases, it’s considered unethical to continue a clinical trial where people are randomly assigned either an active drug or a placebo, when safer or more effective options are available to them.

In this case, the company said in a news release that the move was recommended by an independent panel of advisers who are overseeing the trial, called a data safety monitoring committee, and done in consultation with the FDA.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, PhD, Pfizer chairman and chief executive officer. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In a randomized clinical trial that included more than 1,900 patients who tested positive for COVID-19 and were at risk for having severe complications for their infections, those who received Paxlovid within 3 days of the start of their symptoms were 89% less likely to be hospitalized than those who got a placebo pill -- three patients out of 389 who got the drug were hospitalized, compared with 27 out of 385 who got the placebo. Among patients who got the drug within 5 days of the start of their symptoms, six out of 607 were hospitalized within 28 days, compared to 41 out of 612 who got the placebo.

There were no deaths over the course of a month in patients who took Paxlovid, but 10 deaths in the group that got the placebo.

The news comes on the heels of an announcement in October by the drug company Merck that its experimental antiviral pill, molnupiravir, reduced the risk of hospitalization or death by 50% in patients with mild to moderate COVID, compared to a placebo.

The United Kingdom became the first country to authorize the use of molnupiravir, which is brand-named Lagevrio.

Stephen Griffin, PhD, an associate professor of medicine at the University of Leeds, hailed the success of both new antiviral pills.

“They both demonstrate that, with appropriate investment, the development of bespoke direct-acting antiviral drugs targeting SARS-CoV2 was eminently feasible and has ultimately proven far more successful than repurposing other drugs with questionable antiviral effects,” said Dr. Griffin, who was not involved in the development of either drug.

“The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection, and is also a vital element for the care of clinically vulnerable people who may be unable to either receive or respond to vaccines,” he said.

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

An experimental antiviral pill appears to work very well at keeping people who are at high risk of severe COVID-19 from being admitted to the hospital and dying, according to the drug’s maker, Pfizer.

The drug -- called Paxlovid -- was 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who were at high risk of severe complications. The company says it plans to ask the FDA to authorize the drug for emergency use.

The medication appears to work so well that Pfizer has stopped enrollment in the trial of the drug, which works by blocking an enzyme called a protease that the new coronavirus needs to make more copies of itself.

Stopping a clinical trial is a rare action that’s typically taken when a therapy appears to be very effective or clearly dangerous. In both those cases, it’s considered unethical to continue a clinical trial where people are randomly assigned either an active drug or a placebo, when safer or more effective options are available to them.

In this case, the company said in a news release that the move was recommended by an independent panel of advisers who are overseeing the trial, called a data safety monitoring committee, and done in consultation with the FDA.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, PhD, Pfizer chairman and chief executive officer. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In a randomized clinical trial that included more than 1,900 patients who tested positive for COVID-19 and were at risk for having severe complications for their infections, those who received Paxlovid within 3 days of the start of their symptoms were 89% less likely to be hospitalized than those who got a placebo pill -- three patients out of 389 who got the drug were hospitalized, compared with 27 out of 385 who got the placebo. Among patients who got the drug within 5 days of the start of their symptoms, six out of 607 were hospitalized within 28 days, compared to 41 out of 612 who got the placebo.

There were no deaths over the course of a month in patients who took Paxlovid, but 10 deaths in the group that got the placebo.

The news comes on the heels of an announcement in October by the drug company Merck that its experimental antiviral pill, molnupiravir, reduced the risk of hospitalization or death by 50% in patients with mild to moderate COVID, compared to a placebo.

The United Kingdom became the first country to authorize the use of molnupiravir, which is brand-named Lagevrio.

Stephen Griffin, PhD, an associate professor of medicine at the University of Leeds, hailed the success of both new antiviral pills.

“They both demonstrate that, with appropriate investment, the development of bespoke direct-acting antiviral drugs targeting SARS-CoV2 was eminently feasible and has ultimately proven far more successful than repurposing other drugs with questionable antiviral effects,” said Dr. Griffin, who was not involved in the development of either drug.

“The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection, and is also a vital element for the care of clinically vulnerable people who may be unable to either receive or respond to vaccines,” he said.

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

An experimental antiviral pill appears to work very well at keeping people who are at high risk of severe COVID-19 from being admitted to the hospital and dying, according to the drug’s maker, Pfizer.

The drug -- called Paxlovid -- was 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who were at high risk of severe complications. The company says it plans to ask the FDA to authorize the drug for emergency use.

The medication appears to work so well that Pfizer has stopped enrollment in the trial of the drug, which works by blocking an enzyme called a protease that the new coronavirus needs to make more copies of itself.

Stopping a clinical trial is a rare action that’s typically taken when a therapy appears to be very effective or clearly dangerous. In both those cases, it’s considered unethical to continue a clinical trial where people are randomly assigned either an active drug or a placebo, when safer or more effective options are available to them.

In this case, the company said in a news release that the move was recommended by an independent panel of advisers who are overseeing the trial, called a data safety monitoring committee, and done in consultation with the FDA.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, PhD, Pfizer chairman and chief executive officer. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In a randomized clinical trial that included more than 1,900 patients who tested positive for COVID-19 and were at risk for having severe complications for their infections, those who received Paxlovid within 3 days of the start of their symptoms were 89% less likely to be hospitalized than those who got a placebo pill -- three patients out of 389 who got the drug were hospitalized, compared with 27 out of 385 who got the placebo. Among patients who got the drug within 5 days of the start of their symptoms, six out of 607 were hospitalized within 28 days, compared to 41 out of 612 who got the placebo.

There were no deaths over the course of a month in patients who took Paxlovid, but 10 deaths in the group that got the placebo.

The news comes on the heels of an announcement in October by the drug company Merck that its experimental antiviral pill, molnupiravir, reduced the risk of hospitalization or death by 50% in patients with mild to moderate COVID, compared to a placebo.

The United Kingdom became the first country to authorize the use of molnupiravir, which is brand-named Lagevrio.

Stephen Griffin, PhD, an associate professor of medicine at the University of Leeds, hailed the success of both new antiviral pills.

“They both demonstrate that, with appropriate investment, the development of bespoke direct-acting antiviral drugs targeting SARS-CoV2 was eminently feasible and has ultimately proven far more successful than repurposing other drugs with questionable antiviral effects,” said Dr. Griffin, who was not involved in the development of either drug.

“The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection, and is also a vital element for the care of clinically vulnerable people who may be unable to either receive or respond to vaccines,” he said.

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