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Evolving Treatment Options for Generalized Myasthenia Gravis
Myasthenia gravis (MG) is an autoimmune disease leading to muscle weakness and fatigue. Medical therapy for MG has traditionally focused on treatments to alleviate symptoms, but a range of new therapies are improving outcomes.
Dr Raghav Govindarajan, from HSHS Medical Group in O'Fallon, Illinois, reports on therapeutic advances for patients with MG presented at the American Academy of Neurology 2022 annual meeting.
First, Dr Govindarajan discusses interim results from the ADAPT+ study, an ongoing 3-year extension of ADAPT that evaluated the long-term safety, tolerability, and efficacy of efgartigimod.
Next, he highlights CHAMPION MG, an open-label extension trial that looked at the long-term efficacy and safety profile of ravulizumab in adults with anti-acetylcholine receptor antibody–positive generalized MG.
Dr Govindarajan concludes by reviewing a phase 2 study on nipocalimab, a monoclonal antibody that targets the IgG binding site on FcRn with high affinity, therefore reducing serum levels of total IgG and pathogenic IgG autoantibodies — the underlying cause of MG. This study evaluated efficacy data including myasthenia gravis activities of daily living score evaluated efficacy data including myasthenia gravis activities of daily living.
--
Raghav Govindarajan, MD, Staff neurologist, Stroke Director, HSHS Medical Group-St Elizabeth, O'Fallon, Illinois
Serve(d) as a speaker or a member of a speakers bureau for: Alexion
Received research grant from: Alexion
Received income in an amount equal to or greater than $250 from: Alexion
Myasthenia gravis (MG) is an autoimmune disease leading to muscle weakness and fatigue. Medical therapy for MG has traditionally focused on treatments to alleviate symptoms, but a range of new therapies are improving outcomes.
Dr Raghav Govindarajan, from HSHS Medical Group in O'Fallon, Illinois, reports on therapeutic advances for patients with MG presented at the American Academy of Neurology 2022 annual meeting.
First, Dr Govindarajan discusses interim results from the ADAPT+ study, an ongoing 3-year extension of ADAPT that evaluated the long-term safety, tolerability, and efficacy of efgartigimod.
Next, he highlights CHAMPION MG, an open-label extension trial that looked at the long-term efficacy and safety profile of ravulizumab in adults with anti-acetylcholine receptor antibody–positive generalized MG.
Dr Govindarajan concludes by reviewing a phase 2 study on nipocalimab, a monoclonal antibody that targets the IgG binding site on FcRn with high affinity, therefore reducing serum levels of total IgG and pathogenic IgG autoantibodies — the underlying cause of MG. This study evaluated efficacy data including myasthenia gravis activities of daily living score evaluated efficacy data including myasthenia gravis activities of daily living.
--
Raghav Govindarajan, MD, Staff neurologist, Stroke Director, HSHS Medical Group-St Elizabeth, O'Fallon, Illinois
Serve(d) as a speaker or a member of a speakers bureau for: Alexion
Received research grant from: Alexion
Received income in an amount equal to or greater than $250 from: Alexion
Myasthenia gravis (MG) is an autoimmune disease leading to muscle weakness and fatigue. Medical therapy for MG has traditionally focused on treatments to alleviate symptoms, but a range of new therapies are improving outcomes.
Dr Raghav Govindarajan, from HSHS Medical Group in O'Fallon, Illinois, reports on therapeutic advances for patients with MG presented at the American Academy of Neurology 2022 annual meeting.
First, Dr Govindarajan discusses interim results from the ADAPT+ study, an ongoing 3-year extension of ADAPT that evaluated the long-term safety, tolerability, and efficacy of efgartigimod.
Next, he highlights CHAMPION MG, an open-label extension trial that looked at the long-term efficacy and safety profile of ravulizumab in adults with anti-acetylcholine receptor antibody–positive generalized MG.
Dr Govindarajan concludes by reviewing a phase 2 study on nipocalimab, a monoclonal antibody that targets the IgG binding site on FcRn with high affinity, therefore reducing serum levels of total IgG and pathogenic IgG autoantibodies — the underlying cause of MG. This study evaluated efficacy data including myasthenia gravis activities of daily living score evaluated efficacy data including myasthenia gravis activities of daily living.
--
Raghav Govindarajan, MD, Staff neurologist, Stroke Director, HSHS Medical Group-St Elizabeth, O'Fallon, Illinois
Serve(d) as a speaker or a member of a speakers bureau for: Alexion
Received research grant from: Alexion
Received income in an amount equal to or greater than $250 from: Alexion
Access to certified stroke centers divided by race, income
Hospitals in low-income and rural areas of the United States are much less likely to adopt stroke certification than hospitals in high-income and urban communities, a new study shows.
Further, other results showed that, after adjustment for population and hospital size, access to stroke-certified hospitals is significantly lower in Black, racially segregated communities.
The study was published online in JAMA Neurology.
Noting that stroke-certified hospitals provide higher-quality stroke care, the authors, led by Yu-Chu Shen, PhD, Naval Postgraduate School, Monterey, Calif., conclude that: “Our findings suggest that structural inequities in stroke care may be an important consideration in eliminating stroke disparities for vulnerable populations.”
In an audio interview on the JAMA Neurology website, senior author Renee Y. Hsia, MD, University of California, San Francisco, said: “Our findings show there are clear disparities in which communities are getting access to stroke certified hospitals.”
She called for more help for hospitals in underserved areas to obtain stroke certification.
Dr. Hsia explained that hospitals can seek certification at their own expense and that although stroke care is expensive, it is also lucrative in terms of reimbursement. So it tends to be the private for-profit hospitals that seek these certifications. “If you are a county hospital on a really tight budget, you’re not going to have the extra cash on hand to be applying for stroke certification,” she commented.
This can result in an increase in hospitals with stroke certification – but not in the areas that need it the most.
Dr. Hsia points out that this has happened in cardiac care. One study showed a 44% increase in hospitals providing percutaneous coronary intervention over a 10-year period, but the percentage of the population that had better access increased by less than 1%.
“In general, in the United States we have a mentality that ‘more is better,’ and because there is no government regulation in health care, any time a hospital applies for these specialized services we just generally think that’s a good thing. But this might not always be the case,” Dr. Hsia noted. “We have a very market-based approach, and this doesn’t lead to equity. It leads to profit maximization, and that is not synonymous with what’s good for patients or populations.”
She suggested that in future the process of certification should include some consideration of how it will affect population-based equity.
“Rather than rubber stamping an application just because hospitals have certain resources, we need to ask what the benefit is of providing this service,” Dr. Hsia said. “Does this community really need it? If not, maybe we should invest these resources into helping a hospital in a community that needs it more.”
Dr. Hsia explained that she and her colleagues conducted their study to investigate whether there were structural issues that might be contributing to disparities in stroke care.
“We like to think emergency stroke care is equitable. Anyone can call 911 or go the emergency room. But, actually, there is a big disparity on who receives what type of care,” she said. “We know Black patients are less likely to receive thrombolytics and mechanical thrombectomy compared to White patents. And wealthy patients are more likely to receive thrombectomy compared to patients from the poorest zip codes.”
She said there is a tendency to think this is a result of some sort of bias on the part of health care professionals. “We wanted to look deep down in the system and whether the built environment of health care supply and geographic distribution of services contributed to access and treatment inequities.”
The study combined a dataset of hospital stroke certification from all general acute nonfederal hospitals in the continental United States from January 2009 to December 2019. National, hospital, and census data were used to identify historically underserved communities by racial and ethnic composition, income distribution, and rurality.
A total of 4,984 hospitals were assessed. Results showed that over the 11-year study period, the number of hospitals with stroke certification grew from 961 (19%) to 1,763 (36%).
Without controlling for population and hospital size, hospitals in predominantly Black, racially segregated areas were 1.67-fold more likely to adopt stroke care of any level than those in predominantly non-Black, racially segregated areas (hazard ratio, 1.67; 95% confidence interval, 1.41-1.97).
However, after adjustment for population and hospital size, the likelihood of adopting stroke care among hospitals serving Black, racially segregated communities was significantly lower than among those serving non-Black, racially segregated communities (HR, 0.74; 95% CI, 0.62-0.89).
“In other words, on a per-capita basis, a hospital serving a predominantly Black, racially segregated community was 26% less likely to adopt stroke certification of any level than a hospital in a predominantly non-Black, racially segregated community,” the authors state.
In terms of socioeconomic factors, hospitals serving low-income, economically integrated (HR, 0.23) and low-income, economically segregated (HR, 0.29) areas were far less likely to adopt any level of stroke care certification than hospitals serving high-income areas, regardless of income segregation.
Rural hospitals were also much less likely to adopt any level of stroke care than urban hospitals (HR, 0.10).
“Our results suggest that it might be necessary to incentivize hospitals operating in underserved communities to seek stroke certification or to entice hospitals with higher propensity to adopt stroke care to operate in such communities so access at the per-patient level becomes more equitable,” the authors say.
This project was supported by the Pilot Project Award from the National Bureau of Economic Research Center for Aging and Health Research, funded by the National Institute on Aging and by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Shen and Dr. Hsia have received grants from the National Institute of Aging and the National Heart, Lung, and Blood Institute.
A version of this article first appeared on Medscape.com.
Hospitals in low-income and rural areas of the United States are much less likely to adopt stroke certification than hospitals in high-income and urban communities, a new study shows.
Further, other results showed that, after adjustment for population and hospital size, access to stroke-certified hospitals is significantly lower in Black, racially segregated communities.
The study was published online in JAMA Neurology.
Noting that stroke-certified hospitals provide higher-quality stroke care, the authors, led by Yu-Chu Shen, PhD, Naval Postgraduate School, Monterey, Calif., conclude that: “Our findings suggest that structural inequities in stroke care may be an important consideration in eliminating stroke disparities for vulnerable populations.”
In an audio interview on the JAMA Neurology website, senior author Renee Y. Hsia, MD, University of California, San Francisco, said: “Our findings show there are clear disparities in which communities are getting access to stroke certified hospitals.”
She called for more help for hospitals in underserved areas to obtain stroke certification.
Dr. Hsia explained that hospitals can seek certification at their own expense and that although stroke care is expensive, it is also lucrative in terms of reimbursement. So it tends to be the private for-profit hospitals that seek these certifications. “If you are a county hospital on a really tight budget, you’re not going to have the extra cash on hand to be applying for stroke certification,” she commented.
This can result in an increase in hospitals with stroke certification – but not in the areas that need it the most.
Dr. Hsia points out that this has happened in cardiac care. One study showed a 44% increase in hospitals providing percutaneous coronary intervention over a 10-year period, but the percentage of the population that had better access increased by less than 1%.
“In general, in the United States we have a mentality that ‘more is better,’ and because there is no government regulation in health care, any time a hospital applies for these specialized services we just generally think that’s a good thing. But this might not always be the case,” Dr. Hsia noted. “We have a very market-based approach, and this doesn’t lead to equity. It leads to profit maximization, and that is not synonymous with what’s good for patients or populations.”
She suggested that in future the process of certification should include some consideration of how it will affect population-based equity.
“Rather than rubber stamping an application just because hospitals have certain resources, we need to ask what the benefit is of providing this service,” Dr. Hsia said. “Does this community really need it? If not, maybe we should invest these resources into helping a hospital in a community that needs it more.”
Dr. Hsia explained that she and her colleagues conducted their study to investigate whether there were structural issues that might be contributing to disparities in stroke care.
“We like to think emergency stroke care is equitable. Anyone can call 911 or go the emergency room. But, actually, there is a big disparity on who receives what type of care,” she said. “We know Black patients are less likely to receive thrombolytics and mechanical thrombectomy compared to White patents. And wealthy patients are more likely to receive thrombectomy compared to patients from the poorest zip codes.”
She said there is a tendency to think this is a result of some sort of bias on the part of health care professionals. “We wanted to look deep down in the system and whether the built environment of health care supply and geographic distribution of services contributed to access and treatment inequities.”
The study combined a dataset of hospital stroke certification from all general acute nonfederal hospitals in the continental United States from January 2009 to December 2019. National, hospital, and census data were used to identify historically underserved communities by racial and ethnic composition, income distribution, and rurality.
A total of 4,984 hospitals were assessed. Results showed that over the 11-year study period, the number of hospitals with stroke certification grew from 961 (19%) to 1,763 (36%).
Without controlling for population and hospital size, hospitals in predominantly Black, racially segregated areas were 1.67-fold more likely to adopt stroke care of any level than those in predominantly non-Black, racially segregated areas (hazard ratio, 1.67; 95% confidence interval, 1.41-1.97).
However, after adjustment for population and hospital size, the likelihood of adopting stroke care among hospitals serving Black, racially segregated communities was significantly lower than among those serving non-Black, racially segregated communities (HR, 0.74; 95% CI, 0.62-0.89).
“In other words, on a per-capita basis, a hospital serving a predominantly Black, racially segregated community was 26% less likely to adopt stroke certification of any level than a hospital in a predominantly non-Black, racially segregated community,” the authors state.
In terms of socioeconomic factors, hospitals serving low-income, economically integrated (HR, 0.23) and low-income, economically segregated (HR, 0.29) areas were far less likely to adopt any level of stroke care certification than hospitals serving high-income areas, regardless of income segregation.
Rural hospitals were also much less likely to adopt any level of stroke care than urban hospitals (HR, 0.10).
“Our results suggest that it might be necessary to incentivize hospitals operating in underserved communities to seek stroke certification or to entice hospitals with higher propensity to adopt stroke care to operate in such communities so access at the per-patient level becomes more equitable,” the authors say.
This project was supported by the Pilot Project Award from the National Bureau of Economic Research Center for Aging and Health Research, funded by the National Institute on Aging and by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Shen and Dr. Hsia have received grants from the National Institute of Aging and the National Heart, Lung, and Blood Institute.
A version of this article first appeared on Medscape.com.
Hospitals in low-income and rural areas of the United States are much less likely to adopt stroke certification than hospitals in high-income and urban communities, a new study shows.
Further, other results showed that, after adjustment for population and hospital size, access to stroke-certified hospitals is significantly lower in Black, racially segregated communities.
The study was published online in JAMA Neurology.
Noting that stroke-certified hospitals provide higher-quality stroke care, the authors, led by Yu-Chu Shen, PhD, Naval Postgraduate School, Monterey, Calif., conclude that: “Our findings suggest that structural inequities in stroke care may be an important consideration in eliminating stroke disparities for vulnerable populations.”
In an audio interview on the JAMA Neurology website, senior author Renee Y. Hsia, MD, University of California, San Francisco, said: “Our findings show there are clear disparities in which communities are getting access to stroke certified hospitals.”
She called for more help for hospitals in underserved areas to obtain stroke certification.
Dr. Hsia explained that hospitals can seek certification at their own expense and that although stroke care is expensive, it is also lucrative in terms of reimbursement. So it tends to be the private for-profit hospitals that seek these certifications. “If you are a county hospital on a really tight budget, you’re not going to have the extra cash on hand to be applying for stroke certification,” she commented.
This can result in an increase in hospitals with stroke certification – but not in the areas that need it the most.
Dr. Hsia points out that this has happened in cardiac care. One study showed a 44% increase in hospitals providing percutaneous coronary intervention over a 10-year period, but the percentage of the population that had better access increased by less than 1%.
“In general, in the United States we have a mentality that ‘more is better,’ and because there is no government regulation in health care, any time a hospital applies for these specialized services we just generally think that’s a good thing. But this might not always be the case,” Dr. Hsia noted. “We have a very market-based approach, and this doesn’t lead to equity. It leads to profit maximization, and that is not synonymous with what’s good for patients or populations.”
She suggested that in future the process of certification should include some consideration of how it will affect population-based equity.
“Rather than rubber stamping an application just because hospitals have certain resources, we need to ask what the benefit is of providing this service,” Dr. Hsia said. “Does this community really need it? If not, maybe we should invest these resources into helping a hospital in a community that needs it more.”
Dr. Hsia explained that she and her colleagues conducted their study to investigate whether there were structural issues that might be contributing to disparities in stroke care.
“We like to think emergency stroke care is equitable. Anyone can call 911 or go the emergency room. But, actually, there is a big disparity on who receives what type of care,” she said. “We know Black patients are less likely to receive thrombolytics and mechanical thrombectomy compared to White patents. And wealthy patients are more likely to receive thrombectomy compared to patients from the poorest zip codes.”
She said there is a tendency to think this is a result of some sort of bias on the part of health care professionals. “We wanted to look deep down in the system and whether the built environment of health care supply and geographic distribution of services contributed to access and treatment inequities.”
The study combined a dataset of hospital stroke certification from all general acute nonfederal hospitals in the continental United States from January 2009 to December 2019. National, hospital, and census data were used to identify historically underserved communities by racial and ethnic composition, income distribution, and rurality.
A total of 4,984 hospitals were assessed. Results showed that over the 11-year study period, the number of hospitals with stroke certification grew from 961 (19%) to 1,763 (36%).
Without controlling for population and hospital size, hospitals in predominantly Black, racially segregated areas were 1.67-fold more likely to adopt stroke care of any level than those in predominantly non-Black, racially segregated areas (hazard ratio, 1.67; 95% confidence interval, 1.41-1.97).
However, after adjustment for population and hospital size, the likelihood of adopting stroke care among hospitals serving Black, racially segregated communities was significantly lower than among those serving non-Black, racially segregated communities (HR, 0.74; 95% CI, 0.62-0.89).
“In other words, on a per-capita basis, a hospital serving a predominantly Black, racially segregated community was 26% less likely to adopt stroke certification of any level than a hospital in a predominantly non-Black, racially segregated community,” the authors state.
In terms of socioeconomic factors, hospitals serving low-income, economically integrated (HR, 0.23) and low-income, economically segregated (HR, 0.29) areas were far less likely to adopt any level of stroke care certification than hospitals serving high-income areas, regardless of income segregation.
Rural hospitals were also much less likely to adopt any level of stroke care than urban hospitals (HR, 0.10).
“Our results suggest that it might be necessary to incentivize hospitals operating in underserved communities to seek stroke certification or to entice hospitals with higher propensity to adopt stroke care to operate in such communities so access at the per-patient level becomes more equitable,” the authors say.
This project was supported by the Pilot Project Award from the National Bureau of Economic Research Center for Aging and Health Research, funded by the National Institute on Aging and by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Shen and Dr. Hsia have received grants from the National Institute of Aging and the National Heart, Lung, and Blood Institute.
A version of this article first appeared on Medscape.com.
Hard habit to break
“I love practicing medicine.”
The speaker was one of my patients. A distinguished, friendly, gentleman in his mid-to-late 70s, here to see me for a minor problem. He still practices medicine part time.
Since his neurologic issue was simple, we spent a fair amount of the time chatting. We’d both seen changes in medicine over time, he more than I, obviously.
Some good, some bad. Fancier toys, better drugs, more paperwork (even if it’s not all on paper anymore).
But we both still like what we do, and have no plans to give it up anytime soon.
Some doctors end up hating their jobs and leave the field. I understand that, and I don’t blame them. It’s not an easy one.
But I still enjoy the job. I look forward to seeing patients each day, turning over their cases, trying to figure them out, and doing what I can to help people.
I see that it is similar with attorneys. Maybe it’s part of the time and commitment you put into getting to a job that makes it hard to walk away as you get older. Or maybe (probably more likely) it’s some intrinsic part of the personality that drove you to get there.
I’m roughly two-thirds of the way through my career, but still don’t have any plans to close down. Granted, that’s practical – I have kids in college, a mortgage, and office overhead. My colleague across the desk can stop practicing whenever he wants, but gets satisfaction, validation, and enjoyment from doing the same job. At this point in his life that’s more important than the money.
I hope to someday feel that same way. I don’t want to always work the 80-90 hours a week I do now, but I can’t imagine not doing this, either.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
“I love practicing medicine.”
The speaker was one of my patients. A distinguished, friendly, gentleman in his mid-to-late 70s, here to see me for a minor problem. He still practices medicine part time.
Since his neurologic issue was simple, we spent a fair amount of the time chatting. We’d both seen changes in medicine over time, he more than I, obviously.
Some good, some bad. Fancier toys, better drugs, more paperwork (even if it’s not all on paper anymore).
But we both still like what we do, and have no plans to give it up anytime soon.
Some doctors end up hating their jobs and leave the field. I understand that, and I don’t blame them. It’s not an easy one.
But I still enjoy the job. I look forward to seeing patients each day, turning over their cases, trying to figure them out, and doing what I can to help people.
I see that it is similar with attorneys. Maybe it’s part of the time and commitment you put into getting to a job that makes it hard to walk away as you get older. Or maybe (probably more likely) it’s some intrinsic part of the personality that drove you to get there.
I’m roughly two-thirds of the way through my career, but still don’t have any plans to close down. Granted, that’s practical – I have kids in college, a mortgage, and office overhead. My colleague across the desk can stop practicing whenever he wants, but gets satisfaction, validation, and enjoyment from doing the same job. At this point in his life that’s more important than the money.
I hope to someday feel that same way. I don’t want to always work the 80-90 hours a week I do now, but I can’t imagine not doing this, either.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
“I love practicing medicine.”
The speaker was one of my patients. A distinguished, friendly, gentleman in his mid-to-late 70s, here to see me for a minor problem. He still practices medicine part time.
Since his neurologic issue was simple, we spent a fair amount of the time chatting. We’d both seen changes in medicine over time, he more than I, obviously.
Some good, some bad. Fancier toys, better drugs, more paperwork (even if it’s not all on paper anymore).
But we both still like what we do, and have no plans to give it up anytime soon.
Some doctors end up hating their jobs and leave the field. I understand that, and I don’t blame them. It’s not an easy one.
But I still enjoy the job. I look forward to seeing patients each day, turning over their cases, trying to figure them out, and doing what I can to help people.
I see that it is similar with attorneys. Maybe it’s part of the time and commitment you put into getting to a job that makes it hard to walk away as you get older. Or maybe (probably more likely) it’s some intrinsic part of the personality that drove you to get there.
I’m roughly two-thirds of the way through my career, but still don’t have any plans to close down. Granted, that’s practical – I have kids in college, a mortgage, and office overhead. My colleague across the desk can stop practicing whenever he wants, but gets satisfaction, validation, and enjoyment from doing the same job. At this point in his life that’s more important than the money.
I hope to someday feel that same way. I don’t want to always work the 80-90 hours a week I do now, but I can’t imagine not doing this, either.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Bored? Change the world or read a book
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), legal cases 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.
So 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.
Boredom is one of the odder human conditions. Certainly, there are more ways to waste time 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 other mammals tend to doze off. But not us. It’s 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.”
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’re here. 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.
Perhaps it’s the real reason 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), legal cases 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.
So 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.
Boredom is one of the odder human conditions. Certainly, there are more ways to waste time 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 other mammals tend to doze off. But not us. It’s 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.”
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’re here. 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.
Perhaps it’s the real reason 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), legal cases 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.
So 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.
Boredom is one of the odder human conditions. Certainly, there are more ways to waste time 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 other mammals tend to doze off. But not us. It’s 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.”
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’re here. 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.
Perhaps it’s the real reason we keep moving forward.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
PTSD may accelerate cognitive decline over time
, new research suggests.
In an analysis of more than 12,000 middle-aged women who had experienced at least one trauma in their lives, those with PTSD symptoms showed an approximately twofold faster decline in cognition during follow-up compared with those who did not have PTSD symptoms.
These associations were not fully explained by other known cognition-related factors such as depression, the researchers noted.
“PTSD may increase the risk of dementia by accelerating cognitive decline at midlife,” coinvestigator Jiaxuan Liu, a doctoral candidate at Harvard TH Chan School of Public Health, Boston, said in an interview.
“Our findings may suggest the value of earlier cognitive screening among individuals with PTSD and the importance of PTSD prevention and treatment across the lifespan,” she added.
The results were published online in JAMA Network Open.
Vital public health issue
“Cognitive decline at midlife and older is of vital public health interest,” Ms. Liu said. “It is a risk factor for a variety of poor health outcomes and strongly predicts Alzheimer’s disease and other dementias.
Although PTSD has been linked to lower cognitive function and dementia incidence, it has not been known whether it is associated with decline in cognitive function, she added.
“In addition, both PTSD and dementia are more common in women than men, so it’s important to understand a possible link,” Ms. Liu said.
Because no large-scale study had examined whether PTSD is associated with cognitive decline in women, the current researchers examined PTSD symptoms and their association with repeated measures of cognitive function among a large civilian trauma-exposed cohort of women aged 50-70 years at study baseline.
Participants were drawn from the Nurses’ Health Study II, a longitudinal study of a cohort of 116,429 U.S. female nurses who were between 25 and 42 years old at enrollment in 1989. Participants completed biennial questionnaires, with follow-up on an ongoing basis.
The current analysis included 12,270 trauma-exposed women (mean age at baseline, 61.1 years) who completed assessments every 1 or 12 months for up to 24 months after baseline. The mean follow-up time was 0.9 years.
In the study population, 95.9% were non-Hispanic White, 1.3% were Hispanic, 1% were Asian, 0.6% were Black, and 1.2% were classified as “other.”
Higher depression scores
Lifetime trauma exposure and PTSD symptoms were assessed from March 1, 2008, to Feb. 28, 2010, using the Short Screening Scale for DSM-IV PTSD.
In total, 67% of the participants reported experiencing PTSD symptoms. The women were divided into four groups, on the basis of symptom number: no PTSD symptoms (n = 4,052), one to three PTSD symptoms (n = 5,058), four to five PTSD symptoms (n = 2,018), and six to seven PTSD symptoms (n = 1,052).
The Cogstate Brief Battery, a validated and self-administered online cognitive assessment, was completed by participants between Oct. 3, 2014, and July 30, 2019. The researchers measured cognitive function with two composite scores: psychomotor speed and attention, and learning and working memory.
Covariates potentially associated with cognitive decline included demographic, educational, and behavior-related health factors such as body mass index, physical activity, cigarette smoking, diet quality, and alcohol consumption.
The researchers conducted secondary analyses that adjusted for symptoms and history of depression as well as the consequences of potential practice effects of taking the test multiple times.
Behavior-related health factors “did not substantially differ by PTSD symptom level,” the investigators noted. However, compared with women who did not have PTSD symptoms, those who had such symptoms had higher depressive symptom scores and higher rates of clinician-diagnosed depression.
Both cognitive composite scores improved through the follow-up period, “likely because of practice effects,” the researchers wrote. But after adjusting for practice effects, they found a decline over time in both composite scores.
Dose-related trajectories
Results showed that having more PTSD symptoms was associated with dose-related poorer cognitive trajectories.
After adjustment for demographic characteristics, women with the highest symptom level (six to seven symptoms) had a significantly worse rate of change in both composite domains of learning and working memory (beta = −0.08 SD/y; 95% confidence interval [CI], −0.11 to −0.04 SD/y; P < .001) and of psychomotor speed and attention (beta = −0.05 SD/y; 95% CI, −0.09 to −0.01 SD/y; P = .02) compared with women with no PTSD symptoms.
Women with four to five PTSD symptoms showed a worse rate of change in learning and working memory compared with those who had no symptoms, but not in psychomotor speed and attention. Women with one to three PTSD symptoms had cognitive scores similar to those of women without PTSD symptoms.
Notably, the associations of PTSD with cognitive change remained evident after additional adjustment for behavioral factors and health conditions – and were only “partially attenuated but still evident” after further adjustment for practice effects and comorbid depression, the investigators wrote.
“We thought PTSD might be associated with worse cognitive decline through health behaviors like smoking and alcohol drinking and higher risk of other health conditions like hypertension and depression,” Ms. Liu said.
However, those factors did not account for the current study’s findings, she noted.
“We could not determine why women with PTSD had faster cognitive decline than those without PTSD,” she said.
Ms. Liu suggested that PTSD “may have effects on the brain, such as altering brain structures and affecting brain immune function.” However, more research is needed “to investigate these mechanisms that might underlie the association we found between PTSD and cognitive decline,” she said.
Neurotoxic effect
In a comment, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said, “It is well known that stress is neurotoxic, and PTSD is a particularly serious form of stress.”
Dr. Fillit, clinical professor of geriatric medicine and palliative care, medicine, and neuroscience at Mount Sinai Hospital, New York, was not involved with the study.
“We tend to think of PTSD in postacute settings, such as soldiers returning from war,” he said. “This study contributes to our understanding of the long-term effects of PTSD on cognitive decline, measured objectively over time”
Dr. Fillit noted that an important implication is that, by increasing the risk for cognitive decline, PTSD also increases risk for Alzheimer’s disease. This leads to the “main take-home, which is that PTSD is a risk factor not only for cognitive decline but also for Alzheimer’s and related dementias,” he said.
However, this opens a potential therapeutic approach, Dr. Fillit added.
Because cortisol and other stress hormones drive the stress response, finding ways to block the neurotoxic effects of these hormones “might be a target to prevent cognitive decline and decrease Alzheimer’s disease risk,” he said.
The study was supported by grants from the National Institute of Mental Health and the National Institutes of Health. Ms. Liu and Dr. Fillit report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In an analysis of more than 12,000 middle-aged women who had experienced at least one trauma in their lives, those with PTSD symptoms showed an approximately twofold faster decline in cognition during follow-up compared with those who did not have PTSD symptoms.
These associations were not fully explained by other known cognition-related factors such as depression, the researchers noted.
“PTSD may increase the risk of dementia by accelerating cognitive decline at midlife,” coinvestigator Jiaxuan Liu, a doctoral candidate at Harvard TH Chan School of Public Health, Boston, said in an interview.
“Our findings may suggest the value of earlier cognitive screening among individuals with PTSD and the importance of PTSD prevention and treatment across the lifespan,” she added.
The results were published online in JAMA Network Open.
Vital public health issue
“Cognitive decline at midlife and older is of vital public health interest,” Ms. Liu said. “It is a risk factor for a variety of poor health outcomes and strongly predicts Alzheimer’s disease and other dementias.
Although PTSD has been linked to lower cognitive function and dementia incidence, it has not been known whether it is associated with decline in cognitive function, she added.
“In addition, both PTSD and dementia are more common in women than men, so it’s important to understand a possible link,” Ms. Liu said.
Because no large-scale study had examined whether PTSD is associated with cognitive decline in women, the current researchers examined PTSD symptoms and their association with repeated measures of cognitive function among a large civilian trauma-exposed cohort of women aged 50-70 years at study baseline.
Participants were drawn from the Nurses’ Health Study II, a longitudinal study of a cohort of 116,429 U.S. female nurses who were between 25 and 42 years old at enrollment in 1989. Participants completed biennial questionnaires, with follow-up on an ongoing basis.
The current analysis included 12,270 trauma-exposed women (mean age at baseline, 61.1 years) who completed assessments every 1 or 12 months for up to 24 months after baseline. The mean follow-up time was 0.9 years.
In the study population, 95.9% were non-Hispanic White, 1.3% were Hispanic, 1% were Asian, 0.6% were Black, and 1.2% were classified as “other.”
Higher depression scores
Lifetime trauma exposure and PTSD symptoms were assessed from March 1, 2008, to Feb. 28, 2010, using the Short Screening Scale for DSM-IV PTSD.
In total, 67% of the participants reported experiencing PTSD symptoms. The women were divided into four groups, on the basis of symptom number: no PTSD symptoms (n = 4,052), one to three PTSD symptoms (n = 5,058), four to five PTSD symptoms (n = 2,018), and six to seven PTSD symptoms (n = 1,052).
The Cogstate Brief Battery, a validated and self-administered online cognitive assessment, was completed by participants between Oct. 3, 2014, and July 30, 2019. The researchers measured cognitive function with two composite scores: psychomotor speed and attention, and learning and working memory.
Covariates potentially associated with cognitive decline included demographic, educational, and behavior-related health factors such as body mass index, physical activity, cigarette smoking, diet quality, and alcohol consumption.
The researchers conducted secondary analyses that adjusted for symptoms and history of depression as well as the consequences of potential practice effects of taking the test multiple times.
Behavior-related health factors “did not substantially differ by PTSD symptom level,” the investigators noted. However, compared with women who did not have PTSD symptoms, those who had such symptoms had higher depressive symptom scores and higher rates of clinician-diagnosed depression.
Both cognitive composite scores improved through the follow-up period, “likely because of practice effects,” the researchers wrote. But after adjusting for practice effects, they found a decline over time in both composite scores.
Dose-related trajectories
Results showed that having more PTSD symptoms was associated with dose-related poorer cognitive trajectories.
After adjustment for demographic characteristics, women with the highest symptom level (six to seven symptoms) had a significantly worse rate of change in both composite domains of learning and working memory (beta = −0.08 SD/y; 95% confidence interval [CI], −0.11 to −0.04 SD/y; P < .001) and of psychomotor speed and attention (beta = −0.05 SD/y; 95% CI, −0.09 to −0.01 SD/y; P = .02) compared with women with no PTSD symptoms.
Women with four to five PTSD symptoms showed a worse rate of change in learning and working memory compared with those who had no symptoms, but not in psychomotor speed and attention. Women with one to three PTSD symptoms had cognitive scores similar to those of women without PTSD symptoms.
Notably, the associations of PTSD with cognitive change remained evident after additional adjustment for behavioral factors and health conditions – and were only “partially attenuated but still evident” after further adjustment for practice effects and comorbid depression, the investigators wrote.
“We thought PTSD might be associated with worse cognitive decline through health behaviors like smoking and alcohol drinking and higher risk of other health conditions like hypertension and depression,” Ms. Liu said.
However, those factors did not account for the current study’s findings, she noted.
“We could not determine why women with PTSD had faster cognitive decline than those without PTSD,” she said.
Ms. Liu suggested that PTSD “may have effects on the brain, such as altering brain structures and affecting brain immune function.” However, more research is needed “to investigate these mechanisms that might underlie the association we found between PTSD and cognitive decline,” she said.
Neurotoxic effect
In a comment, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said, “It is well known that stress is neurotoxic, and PTSD is a particularly serious form of stress.”
Dr. Fillit, clinical professor of geriatric medicine and palliative care, medicine, and neuroscience at Mount Sinai Hospital, New York, was not involved with the study.
“We tend to think of PTSD in postacute settings, such as soldiers returning from war,” he said. “This study contributes to our understanding of the long-term effects of PTSD on cognitive decline, measured objectively over time”
Dr. Fillit noted that an important implication is that, by increasing the risk for cognitive decline, PTSD also increases risk for Alzheimer’s disease. This leads to the “main take-home, which is that PTSD is a risk factor not only for cognitive decline but also for Alzheimer’s and related dementias,” he said.
However, this opens a potential therapeutic approach, Dr. Fillit added.
Because cortisol and other stress hormones drive the stress response, finding ways to block the neurotoxic effects of these hormones “might be a target to prevent cognitive decline and decrease Alzheimer’s disease risk,” he said.
The study was supported by grants from the National Institute of Mental Health and the National Institutes of Health. Ms. Liu and Dr. Fillit report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In an analysis of more than 12,000 middle-aged women who had experienced at least one trauma in their lives, those with PTSD symptoms showed an approximately twofold faster decline in cognition during follow-up compared with those who did not have PTSD symptoms.
These associations were not fully explained by other known cognition-related factors such as depression, the researchers noted.
“PTSD may increase the risk of dementia by accelerating cognitive decline at midlife,” coinvestigator Jiaxuan Liu, a doctoral candidate at Harvard TH Chan School of Public Health, Boston, said in an interview.
“Our findings may suggest the value of earlier cognitive screening among individuals with PTSD and the importance of PTSD prevention and treatment across the lifespan,” she added.
The results were published online in JAMA Network Open.
Vital public health issue
“Cognitive decline at midlife and older is of vital public health interest,” Ms. Liu said. “It is a risk factor for a variety of poor health outcomes and strongly predicts Alzheimer’s disease and other dementias.
Although PTSD has been linked to lower cognitive function and dementia incidence, it has not been known whether it is associated with decline in cognitive function, she added.
“In addition, both PTSD and dementia are more common in women than men, so it’s important to understand a possible link,” Ms. Liu said.
Because no large-scale study had examined whether PTSD is associated with cognitive decline in women, the current researchers examined PTSD symptoms and their association with repeated measures of cognitive function among a large civilian trauma-exposed cohort of women aged 50-70 years at study baseline.
Participants were drawn from the Nurses’ Health Study II, a longitudinal study of a cohort of 116,429 U.S. female nurses who were between 25 and 42 years old at enrollment in 1989. Participants completed biennial questionnaires, with follow-up on an ongoing basis.
The current analysis included 12,270 trauma-exposed women (mean age at baseline, 61.1 years) who completed assessments every 1 or 12 months for up to 24 months after baseline. The mean follow-up time was 0.9 years.
In the study population, 95.9% were non-Hispanic White, 1.3% were Hispanic, 1% were Asian, 0.6% were Black, and 1.2% were classified as “other.”
Higher depression scores
Lifetime trauma exposure and PTSD symptoms were assessed from March 1, 2008, to Feb. 28, 2010, using the Short Screening Scale for DSM-IV PTSD.
In total, 67% of the participants reported experiencing PTSD symptoms. The women were divided into four groups, on the basis of symptom number: no PTSD symptoms (n = 4,052), one to three PTSD symptoms (n = 5,058), four to five PTSD symptoms (n = 2,018), and six to seven PTSD symptoms (n = 1,052).
The Cogstate Brief Battery, a validated and self-administered online cognitive assessment, was completed by participants between Oct. 3, 2014, and July 30, 2019. The researchers measured cognitive function with two composite scores: psychomotor speed and attention, and learning and working memory.
Covariates potentially associated with cognitive decline included demographic, educational, and behavior-related health factors such as body mass index, physical activity, cigarette smoking, diet quality, and alcohol consumption.
The researchers conducted secondary analyses that adjusted for symptoms and history of depression as well as the consequences of potential practice effects of taking the test multiple times.
Behavior-related health factors “did not substantially differ by PTSD symptom level,” the investigators noted. However, compared with women who did not have PTSD symptoms, those who had such symptoms had higher depressive symptom scores and higher rates of clinician-diagnosed depression.
Both cognitive composite scores improved through the follow-up period, “likely because of practice effects,” the researchers wrote. But after adjusting for practice effects, they found a decline over time in both composite scores.
Dose-related trajectories
Results showed that having more PTSD symptoms was associated with dose-related poorer cognitive trajectories.
After adjustment for demographic characteristics, women with the highest symptom level (six to seven symptoms) had a significantly worse rate of change in both composite domains of learning and working memory (beta = −0.08 SD/y; 95% confidence interval [CI], −0.11 to −0.04 SD/y; P < .001) and of psychomotor speed and attention (beta = −0.05 SD/y; 95% CI, −0.09 to −0.01 SD/y; P = .02) compared with women with no PTSD symptoms.
Women with four to five PTSD symptoms showed a worse rate of change in learning and working memory compared with those who had no symptoms, but not in psychomotor speed and attention. Women with one to three PTSD symptoms had cognitive scores similar to those of women without PTSD symptoms.
Notably, the associations of PTSD with cognitive change remained evident after additional adjustment for behavioral factors and health conditions – and were only “partially attenuated but still evident” after further adjustment for practice effects and comorbid depression, the investigators wrote.
“We thought PTSD might be associated with worse cognitive decline through health behaviors like smoking and alcohol drinking and higher risk of other health conditions like hypertension and depression,” Ms. Liu said.
However, those factors did not account for the current study’s findings, she noted.
“We could not determine why women with PTSD had faster cognitive decline than those without PTSD,” she said.
Ms. Liu suggested that PTSD “may have effects on the brain, such as altering brain structures and affecting brain immune function.” However, more research is needed “to investigate these mechanisms that might underlie the association we found between PTSD and cognitive decline,” she said.
Neurotoxic effect
In a comment, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said, “It is well known that stress is neurotoxic, and PTSD is a particularly serious form of stress.”
Dr. Fillit, clinical professor of geriatric medicine and palliative care, medicine, and neuroscience at Mount Sinai Hospital, New York, was not involved with the study.
“We tend to think of PTSD in postacute settings, such as soldiers returning from war,” he said. “This study contributes to our understanding of the long-term effects of PTSD on cognitive decline, measured objectively over time”
Dr. Fillit noted that an important implication is that, by increasing the risk for cognitive decline, PTSD also increases risk for Alzheimer’s disease. This leads to the “main take-home, which is that PTSD is a risk factor not only for cognitive decline but also for Alzheimer’s and related dementias,” he said.
However, this opens a potential therapeutic approach, Dr. Fillit added.
Because cortisol and other stress hormones drive the stress response, finding ways to block the neurotoxic effects of these hormones “might be a target to prevent cognitive decline and decrease Alzheimer’s disease risk,” he said.
The study was supported by grants from the National Institute of Mental Health and the National Institutes of Health. Ms. Liu and Dr. Fillit report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
New AHA checklist: Only one in five adults has optimal heart health
About 80% of American adults have low to moderate cardiovascular (CV) health based on the American Heart Association checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health.
With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist.
“The new metric of sleep duration reflects the latest research findings: Sleep impacts overall health, and people who have healthier sleep patterns manage health factors such as weight, blood pressure, or risk for type 2 diabetes more effectively,” AHA President Donald M. Lloyd-Jones, MD, said in a news release.
“In addition, advances in ways to measure sleep, such as with wearable devices, now offer people the ability to reliably and routinely monitor their sleep habits at home,” said Dr. Lloyd-Jones, chair of the department of preventive medicine at Northwestern University in Chicago.
The AHA Presidential Advisory – Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health – was published online in the journal Circulation.
A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.
Overall, the results show that CV health of the U.S. population is “suboptimal, and we see important differences across age and sociodemographic groups,” Dr. Lloyd-Jones said.
Refining Life’s Simple 7
The AHA first defined the seven metrics for optimal CV health in 2010. After 12 years and more than 2,400 scientific papers on the topic, new discoveries in CV health and ways to measure it provided an opportunity to revisit each health component in more detail and provide updates as needed, the AHA explains.
“We felt it was the right time to conduct a comprehensive review of the latest research to refine the existing metrics and consider any new metrics that add value to assessing cardiovascular health for all people,” Dr. Lloyd-Jones said.
Four of the original metrics have been redefined for consistency with newer clinical guidelines or compatibility with new measurement tools, and the scoring system can now also be applied to anyone ages 2 and older. Here is a snapshot of Life’s Essential 8 metrics, including updates.
1. Diet (updated)
The tool includes a new guide to assess diet quality for adults and children at the individual and population level. At the population level, dietary assessment is based on daily intake of elements in the Dietary Approaches to Stop Hypertension (DASH) eating pattern. For individuals, the Mediterranean Eating Pattern for Americans (MEPA) is used to assess and monitor cardiovascular health.
2. Physical activity (no changes)
Physical activity continues to be measured by the total number of minutes of moderate or vigorous physical activity per week, as defined by the U.S. Physical Activity Guidelines for Americans (2nd edition). The optimal level is 150 minutes (2.5 hours) of moderate physical activity or more per week or 75 minutes per week of vigorous-intensity physical activity for adults; 420 minutes (7 hours) or more per week for children ages 6 and older; and age-specific modifications for younger children.
3. Nicotine exposure (updated)
Use of inhaled nicotine-delivery systems, which includes e-cigarettes or vaping devices, has been added since the previous metric monitored only traditional, combustible cigarettes. This reflects use by adults and youth and their implications on long-term health. Second-hand smoke exposure for children and adults has also been added.
4. Sleep duration (new)
Sleep duration is associated with CV health. Measured by average hours of sleep per night, the ideal level is 7-9 hours daily for adults. Ideal daily sleep ranges for children are 10-16 hours per 24 hours for ages 5 and younger; 9-12 hours for ages 6-12 years; and 8-10 hours for ages 13-18 years.
5. Body mass index (no changes)
The AHA acknowledges that body mass index (BMI) is an imperfect metric. Yet, because it’s easily calculated and widely available, BMI continues as a “reasonable” gauge to assess weight categories that may lead to health problems. BMI of 18.5-24.9 is associated with the highest levels of CV health. The AHA notes that BMI ranges and the subsequent health risks associated with them may differ among people from diverse racial or ethnic backgrounds or ancestry. This aligns with the World Health Organization recommendations to adjust BMI ranges for people of Asian or Pacific Islander ancestry because recent evidence indicates their risk of conditions such as CVD or type 2 diabetes is higher at a lower BMI.
6. Blood lipids (updated)
The metric for blood lipids (cholesterol and triglycerides) is updated to use non-HDL cholesterol as the preferred number to monitor, rather than total cholesterol. This shift is made because non-HDL cholesterol can be measured without fasting beforehand (thereby increasing its availability at any time of day and implementation at more appointments) and reliably calculated among all people.
7. Blood glucose (updated)
This metric is expanded to include the option of hemoglobin A1c readings or blood glucose levels for people with or without type 1 or 2 diabetes or prediabetes.
8. Blood pressure (no changes)
Blood pressure criteria remain unchanged from 2017 guidance that established levels less than 120/80 mm Hg as optimal, and defined hypertension as 130-139 mm Hg systolic pressure or 80-89 mm Hg diastolic pressure.
‘Concerning’ new data
Results of the first study using Life’s Essential 8 show that the overall CV health of the U.S. population is “well below ideal,” with 80% of adults scoring at a low or moderate level, the researchers report.
Data for the analysis came from 2013-2018 U.S. National Health and Nutrition Examination surveys (NHANES) of more than 13,500 adults aged 20-79 years and nearly 9,900 children aged 2-19 years. Among the key findings:
- The average CV health score based on Life’s Essential 8 was 64.7 for adults and 65.5 for children – in the moderate range on the 0-100 scale.
- Only 0.45% of adults had a perfect score of 100; 20% had high CV health (score of 80 or higher), 63% moderate (score of 50-79), and 18% had low CV health (score of less than 50).
- Adult women had higher average CV health scores (67) compared with men (62.5).
- In general, adults scored lowest in the areas of diet, physical activity, and BMI.
- CV health scores were generally lower at older ages.
- Non-Hispanic Asian Americans had a higher average CV health score than other racial/ethnic groups. Non-Hispanic Whites had the second highest average CV health score, followed, in order, by Hispanic (other than Mexican), Mexican, and non-Hispanic Blacks.
- Children’s diet scores were low, at an average of 40.6.
- Adult sociodemographic groups varied notably in CV health scores for diet, nicotine exposure, blood glucose, and blood pressure.
“These data represent the first look at the cardiovascular health of the U.S. population using the AHA’s new Life’s Essential 8 scoring algorithm,” Dr. Lloyd-Jones said.
“Life’s Essential 8 is a major step forward in our ability to identify when cardiovascular health can be preserved and when it is suboptimal. It should energize efforts to improve cardiovascular health for all people and at every life stage,” Dr. Lloyd-Jones added.
“Analyses like this can help policymakers, communities, clinicians, and the public to understand the opportunities to intervene to improve and maintain optimal cardiovascular health across the life course,” he said.
This research had no commercial funding. The authors have no reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
About 80% of American adults have low to moderate cardiovascular (CV) health based on the American Heart Association checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health.
With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist.
“The new metric of sleep duration reflects the latest research findings: Sleep impacts overall health, and people who have healthier sleep patterns manage health factors such as weight, blood pressure, or risk for type 2 diabetes more effectively,” AHA President Donald M. Lloyd-Jones, MD, said in a news release.
“In addition, advances in ways to measure sleep, such as with wearable devices, now offer people the ability to reliably and routinely monitor their sleep habits at home,” said Dr. Lloyd-Jones, chair of the department of preventive medicine at Northwestern University in Chicago.
The AHA Presidential Advisory – Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health – was published online in the journal Circulation.
A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.
Overall, the results show that CV health of the U.S. population is “suboptimal, and we see important differences across age and sociodemographic groups,” Dr. Lloyd-Jones said.
Refining Life’s Simple 7
The AHA first defined the seven metrics for optimal CV health in 2010. After 12 years and more than 2,400 scientific papers on the topic, new discoveries in CV health and ways to measure it provided an opportunity to revisit each health component in more detail and provide updates as needed, the AHA explains.
“We felt it was the right time to conduct a comprehensive review of the latest research to refine the existing metrics and consider any new metrics that add value to assessing cardiovascular health for all people,” Dr. Lloyd-Jones said.
Four of the original metrics have been redefined for consistency with newer clinical guidelines or compatibility with new measurement tools, and the scoring system can now also be applied to anyone ages 2 and older. Here is a snapshot of Life’s Essential 8 metrics, including updates.
1. Diet (updated)
The tool includes a new guide to assess diet quality for adults and children at the individual and population level. At the population level, dietary assessment is based on daily intake of elements in the Dietary Approaches to Stop Hypertension (DASH) eating pattern. For individuals, the Mediterranean Eating Pattern for Americans (MEPA) is used to assess and monitor cardiovascular health.
2. Physical activity (no changes)
Physical activity continues to be measured by the total number of minutes of moderate or vigorous physical activity per week, as defined by the U.S. Physical Activity Guidelines for Americans (2nd edition). The optimal level is 150 minutes (2.5 hours) of moderate physical activity or more per week or 75 minutes per week of vigorous-intensity physical activity for adults; 420 minutes (7 hours) or more per week for children ages 6 and older; and age-specific modifications for younger children.
3. Nicotine exposure (updated)
Use of inhaled nicotine-delivery systems, which includes e-cigarettes or vaping devices, has been added since the previous metric monitored only traditional, combustible cigarettes. This reflects use by adults and youth and their implications on long-term health. Second-hand smoke exposure for children and adults has also been added.
4. Sleep duration (new)
Sleep duration is associated with CV health. Measured by average hours of sleep per night, the ideal level is 7-9 hours daily for adults. Ideal daily sleep ranges for children are 10-16 hours per 24 hours for ages 5 and younger; 9-12 hours for ages 6-12 years; and 8-10 hours for ages 13-18 years.
5. Body mass index (no changes)
The AHA acknowledges that body mass index (BMI) is an imperfect metric. Yet, because it’s easily calculated and widely available, BMI continues as a “reasonable” gauge to assess weight categories that may lead to health problems. BMI of 18.5-24.9 is associated with the highest levels of CV health. The AHA notes that BMI ranges and the subsequent health risks associated with them may differ among people from diverse racial or ethnic backgrounds or ancestry. This aligns with the World Health Organization recommendations to adjust BMI ranges for people of Asian or Pacific Islander ancestry because recent evidence indicates their risk of conditions such as CVD or type 2 diabetes is higher at a lower BMI.
6. Blood lipids (updated)
The metric for blood lipids (cholesterol and triglycerides) is updated to use non-HDL cholesterol as the preferred number to monitor, rather than total cholesterol. This shift is made because non-HDL cholesterol can be measured without fasting beforehand (thereby increasing its availability at any time of day and implementation at more appointments) and reliably calculated among all people.
7. Blood glucose (updated)
This metric is expanded to include the option of hemoglobin A1c readings or blood glucose levels for people with or without type 1 or 2 diabetes or prediabetes.
8. Blood pressure (no changes)
Blood pressure criteria remain unchanged from 2017 guidance that established levels less than 120/80 mm Hg as optimal, and defined hypertension as 130-139 mm Hg systolic pressure or 80-89 mm Hg diastolic pressure.
‘Concerning’ new data
Results of the first study using Life’s Essential 8 show that the overall CV health of the U.S. population is “well below ideal,” with 80% of adults scoring at a low or moderate level, the researchers report.
Data for the analysis came from 2013-2018 U.S. National Health and Nutrition Examination surveys (NHANES) of more than 13,500 adults aged 20-79 years and nearly 9,900 children aged 2-19 years. Among the key findings:
- The average CV health score based on Life’s Essential 8 was 64.7 for adults and 65.5 for children – in the moderate range on the 0-100 scale.
- Only 0.45% of adults had a perfect score of 100; 20% had high CV health (score of 80 or higher), 63% moderate (score of 50-79), and 18% had low CV health (score of less than 50).
- Adult women had higher average CV health scores (67) compared with men (62.5).
- In general, adults scored lowest in the areas of diet, physical activity, and BMI.
- CV health scores were generally lower at older ages.
- Non-Hispanic Asian Americans had a higher average CV health score than other racial/ethnic groups. Non-Hispanic Whites had the second highest average CV health score, followed, in order, by Hispanic (other than Mexican), Mexican, and non-Hispanic Blacks.
- Children’s diet scores were low, at an average of 40.6.
- Adult sociodemographic groups varied notably in CV health scores for diet, nicotine exposure, blood glucose, and blood pressure.
“These data represent the first look at the cardiovascular health of the U.S. population using the AHA’s new Life’s Essential 8 scoring algorithm,” Dr. Lloyd-Jones said.
“Life’s Essential 8 is a major step forward in our ability to identify when cardiovascular health can be preserved and when it is suboptimal. It should energize efforts to improve cardiovascular health for all people and at every life stage,” Dr. Lloyd-Jones added.
“Analyses like this can help policymakers, communities, clinicians, and the public to understand the opportunities to intervene to improve and maintain optimal cardiovascular health across the life course,” he said.
This research had no commercial funding. The authors have no reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
About 80% of American adults have low to moderate cardiovascular (CV) health based on the American Heart Association checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health.
With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist.
“The new metric of sleep duration reflects the latest research findings: Sleep impacts overall health, and people who have healthier sleep patterns manage health factors such as weight, blood pressure, or risk for type 2 diabetes more effectively,” AHA President Donald M. Lloyd-Jones, MD, said in a news release.
“In addition, advances in ways to measure sleep, such as with wearable devices, now offer people the ability to reliably and routinely monitor their sleep habits at home,” said Dr. Lloyd-Jones, chair of the department of preventive medicine at Northwestern University in Chicago.
The AHA Presidential Advisory – Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health – was published online in the journal Circulation.
A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.
Overall, the results show that CV health of the U.S. population is “suboptimal, and we see important differences across age and sociodemographic groups,” Dr. Lloyd-Jones said.
Refining Life’s Simple 7
The AHA first defined the seven metrics for optimal CV health in 2010. After 12 years and more than 2,400 scientific papers on the topic, new discoveries in CV health and ways to measure it provided an opportunity to revisit each health component in more detail and provide updates as needed, the AHA explains.
“We felt it was the right time to conduct a comprehensive review of the latest research to refine the existing metrics and consider any new metrics that add value to assessing cardiovascular health for all people,” Dr. Lloyd-Jones said.
Four of the original metrics have been redefined for consistency with newer clinical guidelines or compatibility with new measurement tools, and the scoring system can now also be applied to anyone ages 2 and older. Here is a snapshot of Life’s Essential 8 metrics, including updates.
1. Diet (updated)
The tool includes a new guide to assess diet quality for adults and children at the individual and population level. At the population level, dietary assessment is based on daily intake of elements in the Dietary Approaches to Stop Hypertension (DASH) eating pattern. For individuals, the Mediterranean Eating Pattern for Americans (MEPA) is used to assess and monitor cardiovascular health.
2. Physical activity (no changes)
Physical activity continues to be measured by the total number of minutes of moderate or vigorous physical activity per week, as defined by the U.S. Physical Activity Guidelines for Americans (2nd edition). The optimal level is 150 minutes (2.5 hours) of moderate physical activity or more per week or 75 minutes per week of vigorous-intensity physical activity for adults; 420 minutes (7 hours) or more per week for children ages 6 and older; and age-specific modifications for younger children.
3. Nicotine exposure (updated)
Use of inhaled nicotine-delivery systems, which includes e-cigarettes or vaping devices, has been added since the previous metric monitored only traditional, combustible cigarettes. This reflects use by adults and youth and their implications on long-term health. Second-hand smoke exposure for children and adults has also been added.
4. Sleep duration (new)
Sleep duration is associated with CV health. Measured by average hours of sleep per night, the ideal level is 7-9 hours daily for adults. Ideal daily sleep ranges for children are 10-16 hours per 24 hours for ages 5 and younger; 9-12 hours for ages 6-12 years; and 8-10 hours for ages 13-18 years.
5. Body mass index (no changes)
The AHA acknowledges that body mass index (BMI) is an imperfect metric. Yet, because it’s easily calculated and widely available, BMI continues as a “reasonable” gauge to assess weight categories that may lead to health problems. BMI of 18.5-24.9 is associated with the highest levels of CV health. The AHA notes that BMI ranges and the subsequent health risks associated with them may differ among people from diverse racial or ethnic backgrounds or ancestry. This aligns with the World Health Organization recommendations to adjust BMI ranges for people of Asian or Pacific Islander ancestry because recent evidence indicates their risk of conditions such as CVD or type 2 diabetes is higher at a lower BMI.
6. Blood lipids (updated)
The metric for blood lipids (cholesterol and triglycerides) is updated to use non-HDL cholesterol as the preferred number to monitor, rather than total cholesterol. This shift is made because non-HDL cholesterol can be measured without fasting beforehand (thereby increasing its availability at any time of day and implementation at more appointments) and reliably calculated among all people.
7. Blood glucose (updated)
This metric is expanded to include the option of hemoglobin A1c readings or blood glucose levels for people with or without type 1 or 2 diabetes or prediabetes.
8. Blood pressure (no changes)
Blood pressure criteria remain unchanged from 2017 guidance that established levels less than 120/80 mm Hg as optimal, and defined hypertension as 130-139 mm Hg systolic pressure or 80-89 mm Hg diastolic pressure.
‘Concerning’ new data
Results of the first study using Life’s Essential 8 show that the overall CV health of the U.S. population is “well below ideal,” with 80% of adults scoring at a low or moderate level, the researchers report.
Data for the analysis came from 2013-2018 U.S. National Health and Nutrition Examination surveys (NHANES) of more than 13,500 adults aged 20-79 years and nearly 9,900 children aged 2-19 years. Among the key findings:
- The average CV health score based on Life’s Essential 8 was 64.7 for adults and 65.5 for children – in the moderate range on the 0-100 scale.
- Only 0.45% of adults had a perfect score of 100; 20% had high CV health (score of 80 or higher), 63% moderate (score of 50-79), and 18% had low CV health (score of less than 50).
- Adult women had higher average CV health scores (67) compared with men (62.5).
- In general, adults scored lowest in the areas of diet, physical activity, and BMI.
- CV health scores were generally lower at older ages.
- Non-Hispanic Asian Americans had a higher average CV health score than other racial/ethnic groups. Non-Hispanic Whites had the second highest average CV health score, followed, in order, by Hispanic (other than Mexican), Mexican, and non-Hispanic Blacks.
- Children’s diet scores were low, at an average of 40.6.
- Adult sociodemographic groups varied notably in CV health scores for diet, nicotine exposure, blood glucose, and blood pressure.
“These data represent the first look at the cardiovascular health of the U.S. population using the AHA’s new Life’s Essential 8 scoring algorithm,” Dr. Lloyd-Jones said.
“Life’s Essential 8 is a major step forward in our ability to identify when cardiovascular health can be preserved and when it is suboptimal. It should energize efforts to improve cardiovascular health for all people and at every life stage,” Dr. Lloyd-Jones added.
“Analyses like this can help policymakers, communities, clinicians, and the public to understand the opportunities to intervene to improve and maintain optimal cardiovascular health across the life course,” he said.
This research had no commercial funding. The authors have no reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION
Doctors still overprescribing fluoroquinolones despite risks
When Amy Moser had a simple urinary tract infection in her late 20s, her doctor prescribed Cipro, a powerful antibiotic used to treat anthrax and some of the most fearsome bacterial infections.
Nearly 2 weeks after she finished her treatment, her left kneecap dislocated while she was trying on a swimsuit at a retail store. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, followed by three Achilles tendon tears.
“That’s when I fell apart,” says Ms. Moser, a Phoenix health blogger and book author. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”
Ms. Moser’s doctors had no answer for what was causing her injuries, all of which required surgical fixes. A married mother of three, she was otherwise healthy and fit. So, after her third Achilles tear, she turned to the FDA’s website for answers. There, she found many warnings about side effects of Cipro, Levaquin, and other so-called fluoroquinolones, including risks for tendon and ligament injuries.
“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’ ” she recalls.
Her search led to FDA warnings and articles about the possibility of tendon and ligament ruptures with fluroquinolones.
“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list ... and I realized that I’d just been prescribed that before everything started,” she says.
That was 12 years ago. Since then, the FDA has issued more warnings about fluoroquinolone risks. In that time, Ms. Moser, now 40, has had more than 30 surgeries to correct tendon ruptures and injuries, including a double-knee replacement this year.
“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated, and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”
Ms. Moser’s is hardly an isolated case. Since the 1980s, more than 60,000 patients have reported hundreds of thousands of serious events linked to fluoroquinolones to the FDA, including 6,575 reports of deaths.
The most common side effects were tendon rupture, as well as neurological and psychiatric symptoms. But experts estimate only 1%-10% of such events are reported to the FDA. That suggests that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy, Columbia.
Yet despite the many patient reports and FDA warnings on dangerous side effects, better treated with less risky antibiotics.
“There probably is overprescription by primary care doctors for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious disease specialist and senior scholar with the Johns Hopkins Center for Health Security.
“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors ... but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
FDA warnings on fluoroquinolones
Fluoroquinolones are a class of broad-spectrum antibiotics used for decades to treat certain bacterial infections.
FDA-approved fluoroquinolones include ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic versions of these brand-name medicines are also on the market, making them among the most prescribed antibiotics in the U.S.
Over the past 2 decades, a wide range of physical and mental health side effects have been tied to fluoroquinolones. As a result of these “adverse event reports” and research published in medical literature, the FDA has required an escalating series of warnings and safety labeling changes for doctors who prescribe these drugs.
- In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an increased risk of tendinitis and tendon rupture in patients prescribed these meds.
- In 2011, the agency required the warning label to include risks of worsening symptoms for those with myasthenia gravis, a chronic autoimmune disease that causes muscle weakness, vision problems, and speech problems.
- In 2013, regulators required updated labels noting the potential for irreversible peripheral neuropathy (serious nerve damage).
- In 2016, the FDA issued its strongest warning against the use of such antibiotics for simple bacterial infections – such as uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system ... outweighs the benefits for patients.”
- And in 2018, regulators required safety labeling changes to include warnings about the risks of aortic aneurysm – a life-threatening enlargement of the main vessel that delivers blood to the body – as well as mental health side effects and serious blood sugar disturbances.
But FDA regulators have stopped short of barring fluoroquinolone use in the treatment of bacterial infections, citing the benefits for certain conditions.
“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”
In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.
“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. ... Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”
Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.
Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.
“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Ms. Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.
As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.
“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”
Ms. Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.
Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.
As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.
“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’
“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
Should guidelines be stronger?
So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Dr. Adalja and other experts say several things are at work.
For one thing, Dr. Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.
“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”
But Dr. Adalja says the overprescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.
“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”
That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.
“Any time a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’ ”
What you can do
Ms. Brummert and Ms. Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.
Ms. Moser has published a book on her experiences, “The Magnificent Story of a Lame Author,” and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.
“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.
Ms. Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.
“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”
The upshot for patients?
- the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
- If you believe you’ve been harmed by fluoroquinolones, MedWatch website to report your experiences.
Ms. Brummert also advises patients to ask 12 critical questions of any doctor who wants to prescribe a fluoroquinolone, including the following listed on her website:
- For what condition is this medication prescribed, and is there another drug specific to my condition?
- What are the risks associated with this medication, and do the benefits outweigh them?
- Will this medication interact with my other drugs and/or other health conditions?
- What are the “boxed” warnings for this medication, and where can I report adverse events?
“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’ ”
Ms. Moser agrees that you have to be your own patient advocate and not simply take a doctor’s advice on any medical issue without having a deeper conversation.
“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.”
“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”
A version of this article first appeared on WebMD.com.
When Amy Moser had a simple urinary tract infection in her late 20s, her doctor prescribed Cipro, a powerful antibiotic used to treat anthrax and some of the most fearsome bacterial infections.
Nearly 2 weeks after she finished her treatment, her left kneecap dislocated while she was trying on a swimsuit at a retail store. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, followed by three Achilles tendon tears.
“That’s when I fell apart,” says Ms. Moser, a Phoenix health blogger and book author. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”
Ms. Moser’s doctors had no answer for what was causing her injuries, all of which required surgical fixes. A married mother of three, she was otherwise healthy and fit. So, after her third Achilles tear, she turned to the FDA’s website for answers. There, she found many warnings about side effects of Cipro, Levaquin, and other so-called fluoroquinolones, including risks for tendon and ligament injuries.
“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’ ” she recalls.
Her search led to FDA warnings and articles about the possibility of tendon and ligament ruptures with fluroquinolones.
“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list ... and I realized that I’d just been prescribed that before everything started,” she says.
That was 12 years ago. Since then, the FDA has issued more warnings about fluoroquinolone risks. In that time, Ms. Moser, now 40, has had more than 30 surgeries to correct tendon ruptures and injuries, including a double-knee replacement this year.
“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated, and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”
Ms. Moser’s is hardly an isolated case. Since the 1980s, more than 60,000 patients have reported hundreds of thousands of serious events linked to fluoroquinolones to the FDA, including 6,575 reports of deaths.
The most common side effects were tendon rupture, as well as neurological and psychiatric symptoms. But experts estimate only 1%-10% of such events are reported to the FDA. That suggests that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy, Columbia.
Yet despite the many patient reports and FDA warnings on dangerous side effects, better treated with less risky antibiotics.
“There probably is overprescription by primary care doctors for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious disease specialist and senior scholar with the Johns Hopkins Center for Health Security.
“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors ... but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
FDA warnings on fluoroquinolones
Fluoroquinolones are a class of broad-spectrum antibiotics used for decades to treat certain bacterial infections.
FDA-approved fluoroquinolones include ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic versions of these brand-name medicines are also on the market, making them among the most prescribed antibiotics in the U.S.
Over the past 2 decades, a wide range of physical and mental health side effects have been tied to fluoroquinolones. As a result of these “adverse event reports” and research published in medical literature, the FDA has required an escalating series of warnings and safety labeling changes for doctors who prescribe these drugs.
- In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an increased risk of tendinitis and tendon rupture in patients prescribed these meds.
- In 2011, the agency required the warning label to include risks of worsening symptoms for those with myasthenia gravis, a chronic autoimmune disease that causes muscle weakness, vision problems, and speech problems.
- In 2013, regulators required updated labels noting the potential for irreversible peripheral neuropathy (serious nerve damage).
- In 2016, the FDA issued its strongest warning against the use of such antibiotics for simple bacterial infections – such as uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system ... outweighs the benefits for patients.”
- And in 2018, regulators required safety labeling changes to include warnings about the risks of aortic aneurysm – a life-threatening enlargement of the main vessel that delivers blood to the body – as well as mental health side effects and serious blood sugar disturbances.
But FDA regulators have stopped short of barring fluoroquinolone use in the treatment of bacterial infections, citing the benefits for certain conditions.
“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”
In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.
“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. ... Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”
Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.
Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.
“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Ms. Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.
As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.
“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”
Ms. Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.
Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.
As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.
“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’
“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
Should guidelines be stronger?
So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Dr. Adalja and other experts say several things are at work.
For one thing, Dr. Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.
“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”
But Dr. Adalja says the overprescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.
“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”
That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.
“Any time a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’ ”
What you can do
Ms. Brummert and Ms. Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.
Ms. Moser has published a book on her experiences, “The Magnificent Story of a Lame Author,” and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.
“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.
Ms. Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.
“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”
The upshot for patients?
- the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
- If you believe you’ve been harmed by fluoroquinolones, MedWatch website to report your experiences.
Ms. Brummert also advises patients to ask 12 critical questions of any doctor who wants to prescribe a fluoroquinolone, including the following listed on her website:
- For what condition is this medication prescribed, and is there another drug specific to my condition?
- What are the risks associated with this medication, and do the benefits outweigh them?
- Will this medication interact with my other drugs and/or other health conditions?
- What are the “boxed” warnings for this medication, and where can I report adverse events?
“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’ ”
Ms. Moser agrees that you have to be your own patient advocate and not simply take a doctor’s advice on any medical issue without having a deeper conversation.
“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.”
“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”
A version of this article first appeared on WebMD.com.
When Amy Moser had a simple urinary tract infection in her late 20s, her doctor prescribed Cipro, a powerful antibiotic used to treat anthrax and some of the most fearsome bacterial infections.
Nearly 2 weeks after she finished her treatment, her left kneecap dislocated while she was trying on a swimsuit at a retail store. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, followed by three Achilles tendon tears.
“That’s when I fell apart,” says Ms. Moser, a Phoenix health blogger and book author. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”
Ms. Moser’s doctors had no answer for what was causing her injuries, all of which required surgical fixes. A married mother of three, she was otherwise healthy and fit. So, after her third Achilles tear, she turned to the FDA’s website for answers. There, she found many warnings about side effects of Cipro, Levaquin, and other so-called fluoroquinolones, including risks for tendon and ligament injuries.
“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’ ” she recalls.
Her search led to FDA warnings and articles about the possibility of tendon and ligament ruptures with fluroquinolones.
“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list ... and I realized that I’d just been prescribed that before everything started,” she says.
That was 12 years ago. Since then, the FDA has issued more warnings about fluoroquinolone risks. In that time, Ms. Moser, now 40, has had more than 30 surgeries to correct tendon ruptures and injuries, including a double-knee replacement this year.
“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated, and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”
Ms. Moser’s is hardly an isolated case. Since the 1980s, more than 60,000 patients have reported hundreds of thousands of serious events linked to fluoroquinolones to the FDA, including 6,575 reports of deaths.
The most common side effects were tendon rupture, as well as neurological and psychiatric symptoms. But experts estimate only 1%-10% of such events are reported to the FDA. That suggests that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy, Columbia.
Yet despite the many patient reports and FDA warnings on dangerous side effects, better treated with less risky antibiotics.
“There probably is overprescription by primary care doctors for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious disease specialist and senior scholar with the Johns Hopkins Center for Health Security.
“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors ... but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
FDA warnings on fluoroquinolones
Fluoroquinolones are a class of broad-spectrum antibiotics used for decades to treat certain bacterial infections.
FDA-approved fluoroquinolones include ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic versions of these brand-name medicines are also on the market, making them among the most prescribed antibiotics in the U.S.
Over the past 2 decades, a wide range of physical and mental health side effects have been tied to fluoroquinolones. As a result of these “adverse event reports” and research published in medical literature, the FDA has required an escalating series of warnings and safety labeling changes for doctors who prescribe these drugs.
- In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an increased risk of tendinitis and tendon rupture in patients prescribed these meds.
- In 2011, the agency required the warning label to include risks of worsening symptoms for those with myasthenia gravis, a chronic autoimmune disease that causes muscle weakness, vision problems, and speech problems.
- In 2013, regulators required updated labels noting the potential for irreversible peripheral neuropathy (serious nerve damage).
- In 2016, the FDA issued its strongest warning against the use of such antibiotics for simple bacterial infections – such as uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system ... outweighs the benefits for patients.”
- And in 2018, regulators required safety labeling changes to include warnings about the risks of aortic aneurysm – a life-threatening enlargement of the main vessel that delivers blood to the body – as well as mental health side effects and serious blood sugar disturbances.
But FDA regulators have stopped short of barring fluoroquinolone use in the treatment of bacterial infections, citing the benefits for certain conditions.
“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”
In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.
“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. ... Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”
Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.
Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.
“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Ms. Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.
As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.
“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”
Ms. Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.
Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.
As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.
“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’
“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
Should guidelines be stronger?
So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Dr. Adalja and other experts say several things are at work.
For one thing, Dr. Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.
“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”
But Dr. Adalja says the overprescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.
“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”
That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.
“Any time a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’ ”
What you can do
Ms. Brummert and Ms. Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.
Ms. Moser has published a book on her experiences, “The Magnificent Story of a Lame Author,” and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.
“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.
Ms. Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.
“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”
The upshot for patients?
- the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
- If you believe you’ve been harmed by fluoroquinolones, MedWatch website to report your experiences.
Ms. Brummert also advises patients to ask 12 critical questions of any doctor who wants to prescribe a fluoroquinolone, including the following listed on her website:
- For what condition is this medication prescribed, and is there another drug specific to my condition?
- What are the risks associated with this medication, and do the benefits outweigh them?
- Will this medication interact with my other drugs and/or other health conditions?
- What are the “boxed” warnings for this medication, and where can I report adverse events?
“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’ ”
Ms. Moser agrees that you have to be your own patient advocate and not simply take a doctor’s advice on any medical issue without having a deeper conversation.
“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.”
“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”
A version of this article first appeared on WebMD.com.
Scientists find brain mechanism behind age-related memory loss
Scientists at Johns Hopkins University have identified a mechanism in the brain behind age-related memory loss, expanding our knowledge of the inner workings of the aging brain and possibly opening the door to new Alzheimer’s treatments.
The researchers looked at the hippocampus, a part of the brain thought to store long-term memories.
Neurons there are responsible for a pair of memory functions – called pattern separation and pattern completion – that work together in young, healthy brains. These functions can swing out of balance with age, impacting memory.
The Johns Hopkins team may have discovered what causes this imbalance. Their findings – reported in a paper in the journal Current Biology – may not only help us improve dementia treatments, but even prevent or delay a loss of thinking skills in the first place, the researchers say.
Pattern separation vs. pattern completion
To understand how the hippocampus changes with age, the researchers looked at rats’ brains. In rats and in humans, pattern separation and pattern completion are present, controlled by neurons in the hippocampus.
As the name suggests, pattern completion is when you take a few details or fragments of information – a few notes of music, or the start of a famous movie quote – and your brain retrieves the full memory. Pattern separation, on the other hand, is being able to tell similar observations or experiences apart (like two visits to the same restaurant) to be stored as separate memories.
These functions occur along a gradient across a tiny region called CA3. That gradient, the study found, disappears with aging, said lead study author Hey-Kyoung Lee, PhD, an assistant research scientist at the university’s Zanvyl Krieger Mind/Brain Institute. “The main consequence of the loss,” Dr. Lee said, “is that pattern completion becomes more dominant in rats as they age.”
What’s happening in the brain
Neurons responsible for pattern completion occupy the “distal” end of CA3, while those in charge of pattern separation reside at the “proximal” end. Dr. Lee said prior studies had not examined the proximal and distal regions separately, as she and her team did in this study.
What was surprising, said Dr. Lee, “was that hyperactivity in aging was observed toward the proximal CA3 region, not the expected distal region.” Contrary to their expectations, that hyperactivity did not enhance function in that area but rather dampened it. Hence: “There is diminished pattern separation and augmented pattern completion,” she said.
– they may recall a certain restaurant they’d been to but not be able to separate what happened during one visit versus another.
Why do some older adults stay sharp?
That memory impairment does not happen to everyone, and it doesn’t happen to all rats either. In fact, the researchers found that some older rats performed spatial-learning tasks as well as young rats did – even though their brains were already beginning to favor pattern completion.
If we can better understand why this happens, we may uncover new therapies for age-related memory loss, Dr. Lee said.
Coauthor Michela Gallagher’s team previously demonstrated that the anti-epilepsy drug levetiracetam improves memory performance by reducing hyperactivity in the hippocampus.
The extra detail this study adds may allow scientists to better aim such drugs in the future, Dr. Lee speculated. “It would give us better control of where we could possibly target the deficits we see.”
A version of this article first appeared on WebMD.com.
Scientists at Johns Hopkins University have identified a mechanism in the brain behind age-related memory loss, expanding our knowledge of the inner workings of the aging brain and possibly opening the door to new Alzheimer’s treatments.
The researchers looked at the hippocampus, a part of the brain thought to store long-term memories.
Neurons there are responsible for a pair of memory functions – called pattern separation and pattern completion – that work together in young, healthy brains. These functions can swing out of balance with age, impacting memory.
The Johns Hopkins team may have discovered what causes this imbalance. Their findings – reported in a paper in the journal Current Biology – may not only help us improve dementia treatments, but even prevent or delay a loss of thinking skills in the first place, the researchers say.
Pattern separation vs. pattern completion
To understand how the hippocampus changes with age, the researchers looked at rats’ brains. In rats and in humans, pattern separation and pattern completion are present, controlled by neurons in the hippocampus.
As the name suggests, pattern completion is when you take a few details or fragments of information – a few notes of music, or the start of a famous movie quote – and your brain retrieves the full memory. Pattern separation, on the other hand, is being able to tell similar observations or experiences apart (like two visits to the same restaurant) to be stored as separate memories.
These functions occur along a gradient across a tiny region called CA3. That gradient, the study found, disappears with aging, said lead study author Hey-Kyoung Lee, PhD, an assistant research scientist at the university’s Zanvyl Krieger Mind/Brain Institute. “The main consequence of the loss,” Dr. Lee said, “is that pattern completion becomes more dominant in rats as they age.”
What’s happening in the brain
Neurons responsible for pattern completion occupy the “distal” end of CA3, while those in charge of pattern separation reside at the “proximal” end. Dr. Lee said prior studies had not examined the proximal and distal regions separately, as she and her team did in this study.
What was surprising, said Dr. Lee, “was that hyperactivity in aging was observed toward the proximal CA3 region, not the expected distal region.” Contrary to their expectations, that hyperactivity did not enhance function in that area but rather dampened it. Hence: “There is diminished pattern separation and augmented pattern completion,” she said.
– they may recall a certain restaurant they’d been to but not be able to separate what happened during one visit versus another.
Why do some older adults stay sharp?
That memory impairment does not happen to everyone, and it doesn’t happen to all rats either. In fact, the researchers found that some older rats performed spatial-learning tasks as well as young rats did – even though their brains were already beginning to favor pattern completion.
If we can better understand why this happens, we may uncover new therapies for age-related memory loss, Dr. Lee said.
Coauthor Michela Gallagher’s team previously demonstrated that the anti-epilepsy drug levetiracetam improves memory performance by reducing hyperactivity in the hippocampus.
The extra detail this study adds may allow scientists to better aim such drugs in the future, Dr. Lee speculated. “It would give us better control of where we could possibly target the deficits we see.”
A version of this article first appeared on WebMD.com.
Scientists at Johns Hopkins University have identified a mechanism in the brain behind age-related memory loss, expanding our knowledge of the inner workings of the aging brain and possibly opening the door to new Alzheimer’s treatments.
The researchers looked at the hippocampus, a part of the brain thought to store long-term memories.
Neurons there are responsible for a pair of memory functions – called pattern separation and pattern completion – that work together in young, healthy brains. These functions can swing out of balance with age, impacting memory.
The Johns Hopkins team may have discovered what causes this imbalance. Their findings – reported in a paper in the journal Current Biology – may not only help us improve dementia treatments, but even prevent or delay a loss of thinking skills in the first place, the researchers say.
Pattern separation vs. pattern completion
To understand how the hippocampus changes with age, the researchers looked at rats’ brains. In rats and in humans, pattern separation and pattern completion are present, controlled by neurons in the hippocampus.
As the name suggests, pattern completion is when you take a few details or fragments of information – a few notes of music, or the start of a famous movie quote – and your brain retrieves the full memory. Pattern separation, on the other hand, is being able to tell similar observations or experiences apart (like two visits to the same restaurant) to be stored as separate memories.
These functions occur along a gradient across a tiny region called CA3. That gradient, the study found, disappears with aging, said lead study author Hey-Kyoung Lee, PhD, an assistant research scientist at the university’s Zanvyl Krieger Mind/Brain Institute. “The main consequence of the loss,” Dr. Lee said, “is that pattern completion becomes more dominant in rats as they age.”
What’s happening in the brain
Neurons responsible for pattern completion occupy the “distal” end of CA3, while those in charge of pattern separation reside at the “proximal” end. Dr. Lee said prior studies had not examined the proximal and distal regions separately, as she and her team did in this study.
What was surprising, said Dr. Lee, “was that hyperactivity in aging was observed toward the proximal CA3 region, not the expected distal region.” Contrary to their expectations, that hyperactivity did not enhance function in that area but rather dampened it. Hence: “There is diminished pattern separation and augmented pattern completion,” she said.
– they may recall a certain restaurant they’d been to but not be able to separate what happened during one visit versus another.
Why do some older adults stay sharp?
That memory impairment does not happen to everyone, and it doesn’t happen to all rats either. In fact, the researchers found that some older rats performed spatial-learning tasks as well as young rats did – even though their brains were already beginning to favor pattern completion.
If we can better understand why this happens, we may uncover new therapies for age-related memory loss, Dr. Lee said.
Coauthor Michela Gallagher’s team previously demonstrated that the anti-epilepsy drug levetiracetam improves memory performance by reducing hyperactivity in the hippocampus.
The extra detail this study adds may allow scientists to better aim such drugs in the future, Dr. Lee speculated. “It would give us better control of where we could possibly target the deficits we see.”
A version of this article first appeared on WebMD.com.
FROM CURRENT BIOLOGY
Can bone density scans help predict dementia risk?
, new research suggests.
In an analysis of more than 900 study participants, women in their 70s with more advanced abdominal aortic calcification (AAC) seen on lateral spine images during dual-energy x-ray absorptiometry (DXA) had a two- to fourfold higher risk for late-life dementia than those with low AAC.
This finding was independent of cardiovascular risk factors and apolipoprotein E (APOE ) genotype.
“While these results are exciting, we now need to undertake further large screening studies in older men and women using this approach to show that the findings are generalizable to older men and can identify people with greater cognitive decline,” coinvestigator Marc Sim, PhD, Edith Cowan University, Joondalup, Australia, said in an interview.
“This will hopefully open the door to studies of early disease-modifying interventions,” Sim said.
The findings were published online in The Lancet Regional Health – Western Pacific.
AAC and cognition
Late-life dementia occurring after age 80 is increasingly common because of both vascular and nonvascular risk factors.
Two recent studies in middle-aged and older men and women showed that AAC identified on bone densitometry was associated with poorer cognition, suggesting it may be related to cognitive decline and increased dementia risk.
This provided the rationale for the current study, Dr. Sim noted.
The researchers assessed AAC using DXA lateral spine images captured in the late 1990s in a prospective cohort of 958 older women who were participating in an osteoporosis study.
AAC was classified into established low, moderate, and extensive categories. At baseline, all women were aged 70 and older, and 45% had low AAC, 36% had moderate AAC, and 19% had extensive AAC.
Over 14.5 years, 150 women (15.7%) had a late-life hospitalization and/or died.
Improved risk prediction
Results showed that, compared with women who had low AAC, women with moderate and extensive AAC were more likely to experience late-life dementia hospitalization (9.3% low, 15.5% moderate, and 18.3% extensive) and death (2.8%, 8.3%, and 9.4%, respectively).
After multivariable adjustment, women with moderate AAC had a two- and threefold increased relative risk for late-life dementia hospitalization or death, compared with their peers who had low AAC.
Women with extensive AAC had a two- and fourfold increase in the adjusted relative risk for late-life dementia hospitalization or death.
“To our knowledge this is the first time it has been shown that AAC from these scans is related to late-life dementia,” Dr. Sim said.
“We demonstrated that AAC improved risk prediction in addition to cardiovascular risk factors and APOE genotype, a genetic risk factor for Alzheimer’s disease, the major form of dementia,” he added.
Dr. Sim noted “these additional lateral spine images” can be taken at the same time that hip and spine bone density tests are done.
“This provides an opportunity to identify AAC in large numbers of people,” he said.
He cautioned, however, that further studies with detailed dementia-related phenotypes, brain imaging, and measures of cognition are needed to confirm whether AAC will add value to dementia risk prediction.
‘Not surprising’
Commenting on the findings for this article, Claire Sexton, DPhil, senior director of scientific programs and outreach at the Alzheimer’s Association, Chicago, noted that AAC is a marker of atherosclerosis and is associated with vascular health outcomes.
Therefore, it is “not surprising it would be associated with dementia too. There’s been previous research linking atherosclerosis and Alzheimer’s disease,” Dr. Sexton said.
“What’s novel about this research is that it’s looking at AAC specifically, which can be identified through a relatively simple test that is already in widespread use,” she added.
Dr. Sexton noted that “much more research” is now needed in larger, more diverse populations in order to better understand the link between AAC and dementia – and whether bone density testing may be an appropriate dementia-screening tool.
“The good news is vascular conditions like atherosclerosis can be managed through lifestyle changes like eating a healthy diet and getting regular exercise. And research tells us what’s good for the heart is good for the brain,” Dr. Sexton said.
The study was funded by Kidney Health Australia, Healthway Health Promotion Foundation of Western Australia, Sir Charles Gairdner Hospital Research Advisory Committee Grant, and the National Health and Medical Research Council of Australia. Dr. Sim and Dr. Sexton have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In an analysis of more than 900 study participants, women in their 70s with more advanced abdominal aortic calcification (AAC) seen on lateral spine images during dual-energy x-ray absorptiometry (DXA) had a two- to fourfold higher risk for late-life dementia than those with low AAC.
This finding was independent of cardiovascular risk factors and apolipoprotein E (APOE ) genotype.
“While these results are exciting, we now need to undertake further large screening studies in older men and women using this approach to show that the findings are generalizable to older men and can identify people with greater cognitive decline,” coinvestigator Marc Sim, PhD, Edith Cowan University, Joondalup, Australia, said in an interview.
“This will hopefully open the door to studies of early disease-modifying interventions,” Sim said.
The findings were published online in The Lancet Regional Health – Western Pacific.
AAC and cognition
Late-life dementia occurring after age 80 is increasingly common because of both vascular and nonvascular risk factors.
Two recent studies in middle-aged and older men and women showed that AAC identified on bone densitometry was associated with poorer cognition, suggesting it may be related to cognitive decline and increased dementia risk.
This provided the rationale for the current study, Dr. Sim noted.
The researchers assessed AAC using DXA lateral spine images captured in the late 1990s in a prospective cohort of 958 older women who were participating in an osteoporosis study.
AAC was classified into established low, moderate, and extensive categories. At baseline, all women were aged 70 and older, and 45% had low AAC, 36% had moderate AAC, and 19% had extensive AAC.
Over 14.5 years, 150 women (15.7%) had a late-life hospitalization and/or died.
Improved risk prediction
Results showed that, compared with women who had low AAC, women with moderate and extensive AAC were more likely to experience late-life dementia hospitalization (9.3% low, 15.5% moderate, and 18.3% extensive) and death (2.8%, 8.3%, and 9.4%, respectively).
After multivariable adjustment, women with moderate AAC had a two- and threefold increased relative risk for late-life dementia hospitalization or death, compared with their peers who had low AAC.
Women with extensive AAC had a two- and fourfold increase in the adjusted relative risk for late-life dementia hospitalization or death.
“To our knowledge this is the first time it has been shown that AAC from these scans is related to late-life dementia,” Dr. Sim said.
“We demonstrated that AAC improved risk prediction in addition to cardiovascular risk factors and APOE genotype, a genetic risk factor for Alzheimer’s disease, the major form of dementia,” he added.
Dr. Sim noted “these additional lateral spine images” can be taken at the same time that hip and spine bone density tests are done.
“This provides an opportunity to identify AAC in large numbers of people,” he said.
He cautioned, however, that further studies with detailed dementia-related phenotypes, brain imaging, and measures of cognition are needed to confirm whether AAC will add value to dementia risk prediction.
‘Not surprising’
Commenting on the findings for this article, Claire Sexton, DPhil, senior director of scientific programs and outreach at the Alzheimer’s Association, Chicago, noted that AAC is a marker of atherosclerosis and is associated with vascular health outcomes.
Therefore, it is “not surprising it would be associated with dementia too. There’s been previous research linking atherosclerosis and Alzheimer’s disease,” Dr. Sexton said.
“What’s novel about this research is that it’s looking at AAC specifically, which can be identified through a relatively simple test that is already in widespread use,” she added.
Dr. Sexton noted that “much more research” is now needed in larger, more diverse populations in order to better understand the link between AAC and dementia – and whether bone density testing may be an appropriate dementia-screening tool.
“The good news is vascular conditions like atherosclerosis can be managed through lifestyle changes like eating a healthy diet and getting regular exercise. And research tells us what’s good for the heart is good for the brain,” Dr. Sexton said.
The study was funded by Kidney Health Australia, Healthway Health Promotion Foundation of Western Australia, Sir Charles Gairdner Hospital Research Advisory Committee Grant, and the National Health and Medical Research Council of Australia. Dr. Sim and Dr. Sexton have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In an analysis of more than 900 study participants, women in their 70s with more advanced abdominal aortic calcification (AAC) seen on lateral spine images during dual-energy x-ray absorptiometry (DXA) had a two- to fourfold higher risk for late-life dementia than those with low AAC.
This finding was independent of cardiovascular risk factors and apolipoprotein E (APOE ) genotype.
“While these results are exciting, we now need to undertake further large screening studies in older men and women using this approach to show that the findings are generalizable to older men and can identify people with greater cognitive decline,” coinvestigator Marc Sim, PhD, Edith Cowan University, Joondalup, Australia, said in an interview.
“This will hopefully open the door to studies of early disease-modifying interventions,” Sim said.
The findings were published online in The Lancet Regional Health – Western Pacific.
AAC and cognition
Late-life dementia occurring after age 80 is increasingly common because of both vascular and nonvascular risk factors.
Two recent studies in middle-aged and older men and women showed that AAC identified on bone densitometry was associated with poorer cognition, suggesting it may be related to cognitive decline and increased dementia risk.
This provided the rationale for the current study, Dr. Sim noted.
The researchers assessed AAC using DXA lateral spine images captured in the late 1990s in a prospective cohort of 958 older women who were participating in an osteoporosis study.
AAC was classified into established low, moderate, and extensive categories. At baseline, all women were aged 70 and older, and 45% had low AAC, 36% had moderate AAC, and 19% had extensive AAC.
Over 14.5 years, 150 women (15.7%) had a late-life hospitalization and/or died.
Improved risk prediction
Results showed that, compared with women who had low AAC, women with moderate and extensive AAC were more likely to experience late-life dementia hospitalization (9.3% low, 15.5% moderate, and 18.3% extensive) and death (2.8%, 8.3%, and 9.4%, respectively).
After multivariable adjustment, women with moderate AAC had a two- and threefold increased relative risk for late-life dementia hospitalization or death, compared with their peers who had low AAC.
Women with extensive AAC had a two- and fourfold increase in the adjusted relative risk for late-life dementia hospitalization or death.
“To our knowledge this is the first time it has been shown that AAC from these scans is related to late-life dementia,” Dr. Sim said.
“We demonstrated that AAC improved risk prediction in addition to cardiovascular risk factors and APOE genotype, a genetic risk factor for Alzheimer’s disease, the major form of dementia,” he added.
Dr. Sim noted “these additional lateral spine images” can be taken at the same time that hip and spine bone density tests are done.
“This provides an opportunity to identify AAC in large numbers of people,” he said.
He cautioned, however, that further studies with detailed dementia-related phenotypes, brain imaging, and measures of cognition are needed to confirm whether AAC will add value to dementia risk prediction.
‘Not surprising’
Commenting on the findings for this article, Claire Sexton, DPhil, senior director of scientific programs and outreach at the Alzheimer’s Association, Chicago, noted that AAC is a marker of atherosclerosis and is associated with vascular health outcomes.
Therefore, it is “not surprising it would be associated with dementia too. There’s been previous research linking atherosclerosis and Alzheimer’s disease,” Dr. Sexton said.
“What’s novel about this research is that it’s looking at AAC specifically, which can be identified through a relatively simple test that is already in widespread use,” she added.
Dr. Sexton noted that “much more research” is now needed in larger, more diverse populations in order to better understand the link between AAC and dementia – and whether bone density testing may be an appropriate dementia-screening tool.
“The good news is vascular conditions like atherosclerosis can be managed through lifestyle changes like eating a healthy diet and getting regular exercise. And research tells us what’s good for the heart is good for the brain,” Dr. Sexton said.
The study was funded by Kidney Health Australia, Healthway Health Promotion Foundation of Western Australia, Sir Charles Gairdner Hospital Research Advisory Committee Grant, and the National Health and Medical Research Council of Australia. Dr. Sim and Dr. Sexton have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LANCET REGIONAL HEALTH – WESTERN PACIFIC
How much health insurers pay for almost everything is about to go public
perhaps helping answer a question that has long dogged those who buy insurance: Are we getting the best deal we can?
As of July 1, health insurers and self-insured employers must post on websites just about every price they’ve negotiated with providers for health care services, item by item. About the only thing excluded are the prices paid for prescription drugs, except those administered in hospitals or doctors’ offices.
The federally required data release could affect future prices or even how employers contract for health care. Many will see for the first time how well their insurers are doing, compared with others.
The new rules are far broader than those that went into effect in 2021 requiring hospitals to post their negotiated rates for the public to see. Now insurers must post the amounts paid for “every physician in network, every hospital, every surgery center, every nursing facility,” said Jeffrey Leibach, a partner at the consulting firm Guidehouse.
“When you start doing the math, you’re talking trillions of records,” he said. The fines the federal government could impose for noncompliance are also heftier than the penalties that hospitals face.
Federal officials learned from the hospital experience and gave insurers more direction on what was expected, said Mr. Leibach. Insurers or self-insured employers could be fined as much as $100 a day for each violation, for each affected enrollee if they fail to provide the data.
“Get your calculator out: All of a sudden you are in the millions pretty fast,” Mr. Leibach said.
Determined consumers, especially those with high-deductible health plans, may try to dig in right away and use the data to try comparing what they will have to pay at different hospitals, clinics, or doctor offices for specific services.
But each database’s enormous size may mean that most people “will find it very hard to use the data in a nuanced way,” said Katherine Baicker, dean of the University of Chicago Harris School of Public Policy.
At least at first.
Entrepreneurs are expected to quickly translate the information into more user-friendly formats so it can be incorporated into new or existing services that estimate costs for patients. And starting Jan. 1, the rules require insurers to provide online tools that will help people get up-front cost estimates for about 500 so-called “shoppable” services, meaning medical care they can schedule ahead of time.
Once those things happen, “you’ll at least have the options in front of you,” said Chris Severn, CEO of Turquoise Health, an online company that has posted price information made available under the rules for hospitals, although many hospitals have yet to comply.
With the addition of the insurers’ data, sites like his will be able to drill down further into cost variation from one place to another or among insurers.
“If you’re going to get an x-ray, you will be able to see that you can do it for $250 at this hospital, $75 at the imaging center down the road, or your specialist can do it in office for $25,” he said.
Everyone will know everyone else’s business: for example, how much insurers Aetna and Humana pay the same surgery center for a knee replacement.
The requirements stem from the Affordable Care Act and a 2019 executive order by then-President Donald Trump.
“These plans are supposed to be acting on behalf of employers in negotiating good rates, and the little insight we have on that shows it has not happened,” said Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health, an affiliation of employers who offer job-based health benefits to workers. “I do believe the dynamics are going to change.”
Other observers are more circumspect.
“Maybe at best this will reduce the wide variance of prices out there,” said Zack Cooper, director of health policy at the Yale University Institution for Social and Policy Studies, New Haven, Conn. “But it won’t be unleashing a consumer revolution.”
Still, the biggest value of the July data release may well be to shed light on how successful insurers have been at negotiating prices. It comes on the heels of research that has shown tremendous variation in what is paid for health care. A recent study by Rand, for example, shows that employers that offer job-based insurance plans paid, on average, 224% more than Medicare for the same services.
Tens of thousands of employers who buy insurance coverage for their workers will get this more-complete pricing picture – and may not like what they see.
“What we’re learning from the hospital data is that insurers are really bad at negotiating,” said Gerard Anderson, a professor in the department of health policy at the Johns Hopkins Bloomberg, Baltimore, citing research that found that negotiated rates for hospital care can be higher than what the facilities accept from patients who are not using insurance and are paying cash.
That could add to the frustration that Ms. Mitchell and others say employers have with the current health insurance system. More might try to contract with providers directly, only using insurance companies for claims processing.
Other employers may bring their insurers back to the bargaining table.
“For the first time, an employer will be able to go to an insurance company and say: ‘You have not negotiated a good-enough deal, and we know that because we can see the same provider has negotiated a better deal with another company,’ ” said James Gelfand, president of the ERISA Industry Committee, a trade group of self-insured employers.
If that happens, he added, “patients will be able to save money.”
That’s not necessarily a given, however.
Because this kind of public release of pricing data hasn’t been tried widely in health care before, how it will affect future spending remains uncertain. If insurers are pushed back to the bargaining table or providers see where they stand relative to their peers, prices could drop. However, some providers could raise their prices if they see they are charging less than their peers.
“Downward pressure may not be a given,” said Kelley Schultz, vice president of commercial policy for AHIP, the industry’s trade lobby.
Ms. Baicker said that, even after the data is out, rates will continue to be heavily influenced by local conditions, such as the size of an insurer or employer – providers often give bigger discounts, for example, to the insurers or self-insured employers that can send them the most patients. The number of hospitals in a region also matters – if an area has only one, for instance, that usually means the facility can demand higher rates.
Another unknown: Will insurers meet the deadline and provide usable data?
Ms. Schultz, at AHIP, said the industry is well on the way, partly because the original deadline was extended by 6 months. She expects insurers to do better than the hospital industry. “We saw a lot of hospitals that just decided not to post files or make them difficult to find,” she said.
So far, more than 300 noncompliant hospitals received warning letters from the government. But they could face fines of $300 a day fines for failing to comply, which is less than what insurers potentially face, although the federal government has recently upped the ante to up to $5,500 a day for the largest facilities.
Even after the pricing data is public, “I don’t think things will change overnight,” said Mr. Leibach. “Patients are still going to make care decisions based on their doctors and referrals, a lot of reasons other than price.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
perhaps helping answer a question that has long dogged those who buy insurance: Are we getting the best deal we can?
As of July 1, health insurers and self-insured employers must post on websites just about every price they’ve negotiated with providers for health care services, item by item. About the only thing excluded are the prices paid for prescription drugs, except those administered in hospitals or doctors’ offices.
The federally required data release could affect future prices or even how employers contract for health care. Many will see for the first time how well their insurers are doing, compared with others.
The new rules are far broader than those that went into effect in 2021 requiring hospitals to post their negotiated rates for the public to see. Now insurers must post the amounts paid for “every physician in network, every hospital, every surgery center, every nursing facility,” said Jeffrey Leibach, a partner at the consulting firm Guidehouse.
“When you start doing the math, you’re talking trillions of records,” he said. The fines the federal government could impose for noncompliance are also heftier than the penalties that hospitals face.
Federal officials learned from the hospital experience and gave insurers more direction on what was expected, said Mr. Leibach. Insurers or self-insured employers could be fined as much as $100 a day for each violation, for each affected enrollee if they fail to provide the data.
“Get your calculator out: All of a sudden you are in the millions pretty fast,” Mr. Leibach said.
Determined consumers, especially those with high-deductible health plans, may try to dig in right away and use the data to try comparing what they will have to pay at different hospitals, clinics, or doctor offices for specific services.
But each database’s enormous size may mean that most people “will find it very hard to use the data in a nuanced way,” said Katherine Baicker, dean of the University of Chicago Harris School of Public Policy.
At least at first.
Entrepreneurs are expected to quickly translate the information into more user-friendly formats so it can be incorporated into new or existing services that estimate costs for patients. And starting Jan. 1, the rules require insurers to provide online tools that will help people get up-front cost estimates for about 500 so-called “shoppable” services, meaning medical care they can schedule ahead of time.
Once those things happen, “you’ll at least have the options in front of you,” said Chris Severn, CEO of Turquoise Health, an online company that has posted price information made available under the rules for hospitals, although many hospitals have yet to comply.
With the addition of the insurers’ data, sites like his will be able to drill down further into cost variation from one place to another or among insurers.
“If you’re going to get an x-ray, you will be able to see that you can do it for $250 at this hospital, $75 at the imaging center down the road, or your specialist can do it in office for $25,” he said.
Everyone will know everyone else’s business: for example, how much insurers Aetna and Humana pay the same surgery center for a knee replacement.
The requirements stem from the Affordable Care Act and a 2019 executive order by then-President Donald Trump.
“These plans are supposed to be acting on behalf of employers in negotiating good rates, and the little insight we have on that shows it has not happened,” said Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health, an affiliation of employers who offer job-based health benefits to workers. “I do believe the dynamics are going to change.”
Other observers are more circumspect.
“Maybe at best this will reduce the wide variance of prices out there,” said Zack Cooper, director of health policy at the Yale University Institution for Social and Policy Studies, New Haven, Conn. “But it won’t be unleashing a consumer revolution.”
Still, the biggest value of the July data release may well be to shed light on how successful insurers have been at negotiating prices. It comes on the heels of research that has shown tremendous variation in what is paid for health care. A recent study by Rand, for example, shows that employers that offer job-based insurance plans paid, on average, 224% more than Medicare for the same services.
Tens of thousands of employers who buy insurance coverage for their workers will get this more-complete pricing picture – and may not like what they see.
“What we’re learning from the hospital data is that insurers are really bad at negotiating,” said Gerard Anderson, a professor in the department of health policy at the Johns Hopkins Bloomberg, Baltimore, citing research that found that negotiated rates for hospital care can be higher than what the facilities accept from patients who are not using insurance and are paying cash.
That could add to the frustration that Ms. Mitchell and others say employers have with the current health insurance system. More might try to contract with providers directly, only using insurance companies for claims processing.
Other employers may bring their insurers back to the bargaining table.
“For the first time, an employer will be able to go to an insurance company and say: ‘You have not negotiated a good-enough deal, and we know that because we can see the same provider has negotiated a better deal with another company,’ ” said James Gelfand, president of the ERISA Industry Committee, a trade group of self-insured employers.
If that happens, he added, “patients will be able to save money.”
That’s not necessarily a given, however.
Because this kind of public release of pricing data hasn’t been tried widely in health care before, how it will affect future spending remains uncertain. If insurers are pushed back to the bargaining table or providers see where they stand relative to their peers, prices could drop. However, some providers could raise their prices if they see they are charging less than their peers.
“Downward pressure may not be a given,” said Kelley Schultz, vice president of commercial policy for AHIP, the industry’s trade lobby.
Ms. Baicker said that, even after the data is out, rates will continue to be heavily influenced by local conditions, such as the size of an insurer or employer – providers often give bigger discounts, for example, to the insurers or self-insured employers that can send them the most patients. The number of hospitals in a region also matters – if an area has only one, for instance, that usually means the facility can demand higher rates.
Another unknown: Will insurers meet the deadline and provide usable data?
Ms. Schultz, at AHIP, said the industry is well on the way, partly because the original deadline was extended by 6 months. She expects insurers to do better than the hospital industry. “We saw a lot of hospitals that just decided not to post files or make them difficult to find,” she said.
So far, more than 300 noncompliant hospitals received warning letters from the government. But they could face fines of $300 a day fines for failing to comply, which is less than what insurers potentially face, although the federal government has recently upped the ante to up to $5,500 a day for the largest facilities.
Even after the pricing data is public, “I don’t think things will change overnight,” said Mr. Leibach. “Patients are still going to make care decisions based on their doctors and referrals, a lot of reasons other than price.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
perhaps helping answer a question that has long dogged those who buy insurance: Are we getting the best deal we can?
As of July 1, health insurers and self-insured employers must post on websites just about every price they’ve negotiated with providers for health care services, item by item. About the only thing excluded are the prices paid for prescription drugs, except those administered in hospitals or doctors’ offices.
The federally required data release could affect future prices or even how employers contract for health care. Many will see for the first time how well their insurers are doing, compared with others.
The new rules are far broader than those that went into effect in 2021 requiring hospitals to post their negotiated rates for the public to see. Now insurers must post the amounts paid for “every physician in network, every hospital, every surgery center, every nursing facility,” said Jeffrey Leibach, a partner at the consulting firm Guidehouse.
“When you start doing the math, you’re talking trillions of records,” he said. The fines the federal government could impose for noncompliance are also heftier than the penalties that hospitals face.
Federal officials learned from the hospital experience and gave insurers more direction on what was expected, said Mr. Leibach. Insurers or self-insured employers could be fined as much as $100 a day for each violation, for each affected enrollee if they fail to provide the data.
“Get your calculator out: All of a sudden you are in the millions pretty fast,” Mr. Leibach said.
Determined consumers, especially those with high-deductible health plans, may try to dig in right away and use the data to try comparing what they will have to pay at different hospitals, clinics, or doctor offices for specific services.
But each database’s enormous size may mean that most people “will find it very hard to use the data in a nuanced way,” said Katherine Baicker, dean of the University of Chicago Harris School of Public Policy.
At least at first.
Entrepreneurs are expected to quickly translate the information into more user-friendly formats so it can be incorporated into new or existing services that estimate costs for patients. And starting Jan. 1, the rules require insurers to provide online tools that will help people get up-front cost estimates for about 500 so-called “shoppable” services, meaning medical care they can schedule ahead of time.
Once those things happen, “you’ll at least have the options in front of you,” said Chris Severn, CEO of Turquoise Health, an online company that has posted price information made available under the rules for hospitals, although many hospitals have yet to comply.
With the addition of the insurers’ data, sites like his will be able to drill down further into cost variation from one place to another or among insurers.
“If you’re going to get an x-ray, you will be able to see that you can do it for $250 at this hospital, $75 at the imaging center down the road, or your specialist can do it in office for $25,” he said.
Everyone will know everyone else’s business: for example, how much insurers Aetna and Humana pay the same surgery center for a knee replacement.
The requirements stem from the Affordable Care Act and a 2019 executive order by then-President Donald Trump.
“These plans are supposed to be acting on behalf of employers in negotiating good rates, and the little insight we have on that shows it has not happened,” said Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health, an affiliation of employers who offer job-based health benefits to workers. “I do believe the dynamics are going to change.”
Other observers are more circumspect.
“Maybe at best this will reduce the wide variance of prices out there,” said Zack Cooper, director of health policy at the Yale University Institution for Social and Policy Studies, New Haven, Conn. “But it won’t be unleashing a consumer revolution.”
Still, the biggest value of the July data release may well be to shed light on how successful insurers have been at negotiating prices. It comes on the heels of research that has shown tremendous variation in what is paid for health care. A recent study by Rand, for example, shows that employers that offer job-based insurance plans paid, on average, 224% more than Medicare for the same services.
Tens of thousands of employers who buy insurance coverage for their workers will get this more-complete pricing picture – and may not like what they see.
“What we’re learning from the hospital data is that insurers are really bad at negotiating,” said Gerard Anderson, a professor in the department of health policy at the Johns Hopkins Bloomberg, Baltimore, citing research that found that negotiated rates for hospital care can be higher than what the facilities accept from patients who are not using insurance and are paying cash.
That could add to the frustration that Ms. Mitchell and others say employers have with the current health insurance system. More might try to contract with providers directly, only using insurance companies for claims processing.
Other employers may bring their insurers back to the bargaining table.
“For the first time, an employer will be able to go to an insurance company and say: ‘You have not negotiated a good-enough deal, and we know that because we can see the same provider has negotiated a better deal with another company,’ ” said James Gelfand, president of the ERISA Industry Committee, a trade group of self-insured employers.
If that happens, he added, “patients will be able to save money.”
That’s not necessarily a given, however.
Because this kind of public release of pricing data hasn’t been tried widely in health care before, how it will affect future spending remains uncertain. If insurers are pushed back to the bargaining table or providers see where they stand relative to their peers, prices could drop. However, some providers could raise their prices if they see they are charging less than their peers.
“Downward pressure may not be a given,” said Kelley Schultz, vice president of commercial policy for AHIP, the industry’s trade lobby.
Ms. Baicker said that, even after the data is out, rates will continue to be heavily influenced by local conditions, such as the size of an insurer or employer – providers often give bigger discounts, for example, to the insurers or self-insured employers that can send them the most patients. The number of hospitals in a region also matters – if an area has only one, for instance, that usually means the facility can demand higher rates.
Another unknown: Will insurers meet the deadline and provide usable data?
Ms. Schultz, at AHIP, said the industry is well on the way, partly because the original deadline was extended by 6 months. She expects insurers to do better than the hospital industry. “We saw a lot of hospitals that just decided not to post files or make them difficult to find,” she said.
So far, more than 300 noncompliant hospitals received warning letters from the government. But they could face fines of $300 a day fines for failing to comply, which is less than what insurers potentially face, although the federal government has recently upped the ante to up to $5,500 a day for the largest facilities.
Even after the pricing data is public, “I don’t think things will change overnight,” said Mr. Leibach. “Patients are still going to make care decisions based on their doctors and referrals, a lot of reasons other than price.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.