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Stroke endovascular therapy: The more you do, the better you do
HONOLULU – The well-documented link between higher procedure volumes and better procedure efficacy also applies to endovascular thrombectomy for acute ischemic stroke.
in analysis of data from two different U.S. sources: the National Inpatient Sample (NIS) and the state of Florida, Sunil A. Sheth, MD, said at the International Stroke Conference sponsored by the American Heart Association.
The finding raises questions about how to best triage patients with an acute ischemic stroke, suggesting that, in at least some situations, patients might be better served being taken to a higher-volume center even if it’s not the closest, noted Dr. Sheth, The results also suggest that the findings in the trials proving the value of EST run primarily at large, tertiary care, referral centers might not be generalizable to all centers that start an endovascular program.
The study looked at data collected during 2006-2016 in Florida and during 2012-2016 in the NIS, and found that in both databases the rate of EST procedures performed showed steadily increasing use over time, with a sharp increase in the number of centers performing EST in 2015. Each of the two data sets also showed that better discharge outcomes occurred in patients treated at centers with the highest procedural volumes.
In the nationwide NIS data, for every 10 additional patients a center treated with EST annually, the incidence of a “good” hospital-discharge outcome (defined as either discharge home or to an acute rehabilitation hospital) rose by 30%, compared with lower-volume centers in a multivariate regression analysis, a statistically significant relationship, said Dr. Sheth, a neurologist at the University of Texas, Houston. This volume-outcome relationship held fairly constant through volumes up to about 50 EST cases annually. “The more the better,” he observed.
“The data suggest that EST outcomes are not always the same,” but right now most emergency medical service systems do not take EST case volume into account when deciding where to take an acute stroke patient, Dr. Sheth said in an interview. But he cautioned against an oversimplified focus on just EST case volume.
A link between volume and better outcomes “is easy to understand and not surprising. We see this relationship for a variety of procedures. The data suggest we need to consider procedure volumes. But volume is only part of makes for good outcomes; it’s not the only factor,” he stressed.
Dr. Sheth and his associates used data collected by the Florida Agency for Health Care Administration on 3,890 acute ischemic stroke patients treated with EST at 56 Florida hospitals and on 42,505 such patients in the NIS database treated at 2,260 U.S. hospitals. During the 11-year period for Florida data collection, the number of centers performing EST in the state rose steadily at an average rate of about four new centers per year. Although the number of EST procedures done also rose sharply, in general over time a higher percentage of patients underwent treatment at lower-volume centers. Similar patterns existed in the national data. The Florida data showed a statistically significant 10% improvement in good discharge outcomes for every 10 additional EST patients a center treated a year, consistent with the NIS data.
Concurrently with Dr. Sheth’s report, the results also appeared in an article published online (Stroke. 2019 Feb 6. doi: 10.1161/STROKEAHA.118.023967).
Dr. Sheth reported no disclosures.
SOURCE: Sheth SA et al. ISC 2019, Abstract 002.
The idea that when centers perform more of a procedure, such as endovascular thrombectomy for acute ischemic stroke, they more often do it better is intuitively plausible, which helps makes these findings believable. It’s also a relationship we’ve already seen for other types of endovascular therapies. What this study did not address were other factors beyond case volume also might also make important contributions to outcome, such as the speed of treatment delivery.
Volume thresholds for endovascular stroke programs will come eventually, but for the time being our focus should be on insuring wide access to endovascular treatment.
Bruce Ovbiagele, MD, a neurologist and chief of staff for the San Francisco Veteran Affairs Health Care System, made these comments in an interview. He reported no disclosures.
The idea that when centers perform more of a procedure, such as endovascular thrombectomy for acute ischemic stroke, they more often do it better is intuitively plausible, which helps makes these findings believable. It’s also a relationship we’ve already seen for other types of endovascular therapies. What this study did not address were other factors beyond case volume also might also make important contributions to outcome, such as the speed of treatment delivery.
Volume thresholds for endovascular stroke programs will come eventually, but for the time being our focus should be on insuring wide access to endovascular treatment.
Bruce Ovbiagele, MD, a neurologist and chief of staff for the San Francisco Veteran Affairs Health Care System, made these comments in an interview. He reported no disclosures.
The idea that when centers perform more of a procedure, such as endovascular thrombectomy for acute ischemic stroke, they more often do it better is intuitively plausible, which helps makes these findings believable. It’s also a relationship we’ve already seen for other types of endovascular therapies. What this study did not address were other factors beyond case volume also might also make important contributions to outcome, such as the speed of treatment delivery.
Volume thresholds for endovascular stroke programs will come eventually, but for the time being our focus should be on insuring wide access to endovascular treatment.
Bruce Ovbiagele, MD, a neurologist and chief of staff for the San Francisco Veteran Affairs Health Care System, made these comments in an interview. He reported no disclosures.
HONOLULU – The well-documented link between higher procedure volumes and better procedure efficacy also applies to endovascular thrombectomy for acute ischemic stroke.
in analysis of data from two different U.S. sources: the National Inpatient Sample (NIS) and the state of Florida, Sunil A. Sheth, MD, said at the International Stroke Conference sponsored by the American Heart Association.
The finding raises questions about how to best triage patients with an acute ischemic stroke, suggesting that, in at least some situations, patients might be better served being taken to a higher-volume center even if it’s not the closest, noted Dr. Sheth, The results also suggest that the findings in the trials proving the value of EST run primarily at large, tertiary care, referral centers might not be generalizable to all centers that start an endovascular program.
The study looked at data collected during 2006-2016 in Florida and during 2012-2016 in the NIS, and found that in both databases the rate of EST procedures performed showed steadily increasing use over time, with a sharp increase in the number of centers performing EST in 2015. Each of the two data sets also showed that better discharge outcomes occurred in patients treated at centers with the highest procedural volumes.
In the nationwide NIS data, for every 10 additional patients a center treated with EST annually, the incidence of a “good” hospital-discharge outcome (defined as either discharge home or to an acute rehabilitation hospital) rose by 30%, compared with lower-volume centers in a multivariate regression analysis, a statistically significant relationship, said Dr. Sheth, a neurologist at the University of Texas, Houston. This volume-outcome relationship held fairly constant through volumes up to about 50 EST cases annually. “The more the better,” he observed.
“The data suggest that EST outcomes are not always the same,” but right now most emergency medical service systems do not take EST case volume into account when deciding where to take an acute stroke patient, Dr. Sheth said in an interview. But he cautioned against an oversimplified focus on just EST case volume.
A link between volume and better outcomes “is easy to understand and not surprising. We see this relationship for a variety of procedures. The data suggest we need to consider procedure volumes. But volume is only part of makes for good outcomes; it’s not the only factor,” he stressed.
Dr. Sheth and his associates used data collected by the Florida Agency for Health Care Administration on 3,890 acute ischemic stroke patients treated with EST at 56 Florida hospitals and on 42,505 such patients in the NIS database treated at 2,260 U.S. hospitals. During the 11-year period for Florida data collection, the number of centers performing EST in the state rose steadily at an average rate of about four new centers per year. Although the number of EST procedures done also rose sharply, in general over time a higher percentage of patients underwent treatment at lower-volume centers. Similar patterns existed in the national data. The Florida data showed a statistically significant 10% improvement in good discharge outcomes for every 10 additional EST patients a center treated a year, consistent with the NIS data.
Concurrently with Dr. Sheth’s report, the results also appeared in an article published online (Stroke. 2019 Feb 6. doi: 10.1161/STROKEAHA.118.023967).
Dr. Sheth reported no disclosures.
SOURCE: Sheth SA et al. ISC 2019, Abstract 002.
HONOLULU – The well-documented link between higher procedure volumes and better procedure efficacy also applies to endovascular thrombectomy for acute ischemic stroke.
in analysis of data from two different U.S. sources: the National Inpatient Sample (NIS) and the state of Florida, Sunil A. Sheth, MD, said at the International Stroke Conference sponsored by the American Heart Association.
The finding raises questions about how to best triage patients with an acute ischemic stroke, suggesting that, in at least some situations, patients might be better served being taken to a higher-volume center even if it’s not the closest, noted Dr. Sheth, The results also suggest that the findings in the trials proving the value of EST run primarily at large, tertiary care, referral centers might not be generalizable to all centers that start an endovascular program.
The study looked at data collected during 2006-2016 in Florida and during 2012-2016 in the NIS, and found that in both databases the rate of EST procedures performed showed steadily increasing use over time, with a sharp increase in the number of centers performing EST in 2015. Each of the two data sets also showed that better discharge outcomes occurred in patients treated at centers with the highest procedural volumes.
In the nationwide NIS data, for every 10 additional patients a center treated with EST annually, the incidence of a “good” hospital-discharge outcome (defined as either discharge home or to an acute rehabilitation hospital) rose by 30%, compared with lower-volume centers in a multivariate regression analysis, a statistically significant relationship, said Dr. Sheth, a neurologist at the University of Texas, Houston. This volume-outcome relationship held fairly constant through volumes up to about 50 EST cases annually. “The more the better,” he observed.
“The data suggest that EST outcomes are not always the same,” but right now most emergency medical service systems do not take EST case volume into account when deciding where to take an acute stroke patient, Dr. Sheth said in an interview. But he cautioned against an oversimplified focus on just EST case volume.
A link between volume and better outcomes “is easy to understand and not surprising. We see this relationship for a variety of procedures. The data suggest we need to consider procedure volumes. But volume is only part of makes for good outcomes; it’s not the only factor,” he stressed.
Dr. Sheth and his associates used data collected by the Florida Agency for Health Care Administration on 3,890 acute ischemic stroke patients treated with EST at 56 Florida hospitals and on 42,505 such patients in the NIS database treated at 2,260 U.S. hospitals. During the 11-year period for Florida data collection, the number of centers performing EST in the state rose steadily at an average rate of about four new centers per year. Although the number of EST procedures done also rose sharply, in general over time a higher percentage of patients underwent treatment at lower-volume centers. Similar patterns existed in the national data. The Florida data showed a statistically significant 10% improvement in good discharge outcomes for every 10 additional EST patients a center treated a year, consistent with the NIS data.
Concurrently with Dr. Sheth’s report, the results also appeared in an article published online (Stroke. 2019 Feb 6. doi: 10.1161/STROKEAHA.118.023967).
Dr. Sheth reported no disclosures.
SOURCE: Sheth SA et al. ISC 2019, Abstract 002.
REPORTING FROM ISC 2019
The size of the baby boomers’ hepatitis C problem
Baby boomers account for more than 74% of chronic hepatitis C virus cases. Noncardiac surgery has a 7% covert stroke rate in the elderly. Enterovirus in at-risk children is associated with later celiac disease. And why you shouldn’t fear spironolactone, isotretinoin, or oral contraceptives for acne.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
Baby boomers account for more than 74% of chronic hepatitis C virus cases. Noncardiac surgery has a 7% covert stroke rate in the elderly. Enterovirus in at-risk children is associated with later celiac disease. And why you shouldn’t fear spironolactone, isotretinoin, or oral contraceptives for acne.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
Baby boomers account for more than 74% of chronic hepatitis C virus cases. Noncardiac surgery has a 7% covert stroke rate in the elderly. Enterovirus in at-risk children is associated with later celiac disease. And why you shouldn’t fear spironolactone, isotretinoin, or oral contraceptives for acne.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
Health spending: Boomers will spike costs, but growing uninsured will soften their impact
Spending on health care is projected to rise at a faster-than-average rate throughout the next decade, according to the Office of the Actuary at the Centers for Medicare & Medicaid Services.
“Overall, national health spending is projected to grow at 5.5% per year, on average, for 2018-27,” wrote Andrea Sisko, economist in the Office of the Actuary, and colleagues (Health Aff. 2019 Feb 20. doi: 10.1377/hlthaff.2018.05499). “This is faster than the average growth rate experienced following the last recession (3.9% for 2008-2013) and the more recent period inclusive of the Affordable Care Act’s major coverage expansions (5.3% for 2014-16).”
Medicare is projected to see the fastest growth in spending at 7.4% per year “as the shift of the Baby Boom generation into the program continues to result in robust growth in enrollment,” according to the authors.
Private payers should see a corollary slower growth in spending (4.8% per year) over the same period, while Medicaid spending is projected at 5.5% per year.
Faster growth in Medicare spending is expected to come from higher spending on prescription drugs and hospital services, as well as higher fee-for-service payment updates.
Spending increases are projected to be mitigated somewhat by the end of the ACA penalty for not having insurance – which is projected to add 1.3 million people this year to the ranks of the uninsured, according to the report.
Half of the overall growth in health care spending is attributable to rising prices in personal health care prices, on average, Ms. Sisko and colleagues wrote. “Growth in use and intensity is expected to account for just under one-third of the average annual personal health care spending growth, with population growth and the changing age-sex mix of the population accounting for the remainder.”
For those with private insurance, out-of-pocket spending is projected to accelerate to a 3.6% growth rate in 2018 from 2.6% in 2017 “a rate that is consistent with faster income growth as well as with the higher average deductibles for employer-based private health insurance enrollees in 2018 compared to 2017,” the authors note.
“Growth in out-of-pocket spending, which is also primarily influenced by economic factors, is expected to be similar to that of private health insurance spending in 2020-27, at 5%,” they add.
Prescription drug spending also is expected to grow.
“Following growth of just 0.4% in 2017, prescription drug spending is expected to have grown 3.3% in 2018 but still be among the slowest-growing health care sectors,” according to the authors. “Higher utilization growth is anticipated, compared to the relatively low growth in 2016 and 2017, partially driven by an increase in the number of new drug introductions.”
Growth in prescription drug spending is expected to accelerate further to 4.6% in 2019, based on growth in utilization and a “modest increase in drug price growth.”
Starting in 2020, that growth rate is projected to increase, on average, by 6.1% per year, based on the expectation that employers and insurers will lower barriers to maintenance medications for chronic conditions.
In 2019, growth in spending for physician clinical services is projected to accelerate to 5.4% from 4.9% in 2018.
“An acceleration in Medicaid spending growth is the primary factor contributing to the trend, which is in part associated with program’s expansion by additional states,” the authors note.
From 2020 to 2027, growth in spending on physician and clinical services is expected to average 5.4% per year, driven in part by price growth for these services.
“Underlying this acceleration are projected rising costs related to the provision of care,” the report said. “In particular, wages are expected to increase as a result of the supply of physicians not being able to meet expected increases in demand for care connected with the aging population. Furthermore, some of the productivity gains that have been achieved through the use of lower-cost providers as a substitute for physician care within physician practices may be less pronounced in the future, because of limitations such as licensing restrictions on the scope of care that may be provided by nonphysician providers.”
SOURCE: Sisko A et al. Health Aff. 2019 Feb 20. doi: 10.1377/hlthaff.2018.05499.
Spending on health care is projected to rise at a faster-than-average rate throughout the next decade, according to the Office of the Actuary at the Centers for Medicare & Medicaid Services.
“Overall, national health spending is projected to grow at 5.5% per year, on average, for 2018-27,” wrote Andrea Sisko, economist in the Office of the Actuary, and colleagues (Health Aff. 2019 Feb 20. doi: 10.1377/hlthaff.2018.05499). “This is faster than the average growth rate experienced following the last recession (3.9% for 2008-2013) and the more recent period inclusive of the Affordable Care Act’s major coverage expansions (5.3% for 2014-16).”
Medicare is projected to see the fastest growth in spending at 7.4% per year “as the shift of the Baby Boom generation into the program continues to result in robust growth in enrollment,” according to the authors.
Private payers should see a corollary slower growth in spending (4.8% per year) over the same period, while Medicaid spending is projected at 5.5% per year.
Faster growth in Medicare spending is expected to come from higher spending on prescription drugs and hospital services, as well as higher fee-for-service payment updates.
Spending increases are projected to be mitigated somewhat by the end of the ACA penalty for not having insurance – which is projected to add 1.3 million people this year to the ranks of the uninsured, according to the report.
Half of the overall growth in health care spending is attributable to rising prices in personal health care prices, on average, Ms. Sisko and colleagues wrote. “Growth in use and intensity is expected to account for just under one-third of the average annual personal health care spending growth, with population growth and the changing age-sex mix of the population accounting for the remainder.”
For those with private insurance, out-of-pocket spending is projected to accelerate to a 3.6% growth rate in 2018 from 2.6% in 2017 “a rate that is consistent with faster income growth as well as with the higher average deductibles for employer-based private health insurance enrollees in 2018 compared to 2017,” the authors note.
“Growth in out-of-pocket spending, which is also primarily influenced by economic factors, is expected to be similar to that of private health insurance spending in 2020-27, at 5%,” they add.
Prescription drug spending also is expected to grow.
“Following growth of just 0.4% in 2017, prescription drug spending is expected to have grown 3.3% in 2018 but still be among the slowest-growing health care sectors,” according to the authors. “Higher utilization growth is anticipated, compared to the relatively low growth in 2016 and 2017, partially driven by an increase in the number of new drug introductions.”
Growth in prescription drug spending is expected to accelerate further to 4.6% in 2019, based on growth in utilization and a “modest increase in drug price growth.”
Starting in 2020, that growth rate is projected to increase, on average, by 6.1% per year, based on the expectation that employers and insurers will lower barriers to maintenance medications for chronic conditions.
In 2019, growth in spending for physician clinical services is projected to accelerate to 5.4% from 4.9% in 2018.
“An acceleration in Medicaid spending growth is the primary factor contributing to the trend, which is in part associated with program’s expansion by additional states,” the authors note.
From 2020 to 2027, growth in spending on physician and clinical services is expected to average 5.4% per year, driven in part by price growth for these services.
“Underlying this acceleration are projected rising costs related to the provision of care,” the report said. “In particular, wages are expected to increase as a result of the supply of physicians not being able to meet expected increases in demand for care connected with the aging population. Furthermore, some of the productivity gains that have been achieved through the use of lower-cost providers as a substitute for physician care within physician practices may be less pronounced in the future, because of limitations such as licensing restrictions on the scope of care that may be provided by nonphysician providers.”
SOURCE: Sisko A et al. Health Aff. 2019 Feb 20. doi: 10.1377/hlthaff.2018.05499.
Spending on health care is projected to rise at a faster-than-average rate throughout the next decade, according to the Office of the Actuary at the Centers for Medicare & Medicaid Services.
“Overall, national health spending is projected to grow at 5.5% per year, on average, for 2018-27,” wrote Andrea Sisko, economist in the Office of the Actuary, and colleagues (Health Aff. 2019 Feb 20. doi: 10.1377/hlthaff.2018.05499). “This is faster than the average growth rate experienced following the last recession (3.9% for 2008-2013) and the more recent period inclusive of the Affordable Care Act’s major coverage expansions (5.3% for 2014-16).”
Medicare is projected to see the fastest growth in spending at 7.4% per year “as the shift of the Baby Boom generation into the program continues to result in robust growth in enrollment,” according to the authors.
Private payers should see a corollary slower growth in spending (4.8% per year) over the same period, while Medicaid spending is projected at 5.5% per year.
Faster growth in Medicare spending is expected to come from higher spending on prescription drugs and hospital services, as well as higher fee-for-service payment updates.
Spending increases are projected to be mitigated somewhat by the end of the ACA penalty for not having insurance – which is projected to add 1.3 million people this year to the ranks of the uninsured, according to the report.
Half of the overall growth in health care spending is attributable to rising prices in personal health care prices, on average, Ms. Sisko and colleagues wrote. “Growth in use and intensity is expected to account for just under one-third of the average annual personal health care spending growth, with population growth and the changing age-sex mix of the population accounting for the remainder.”
For those with private insurance, out-of-pocket spending is projected to accelerate to a 3.6% growth rate in 2018 from 2.6% in 2017 “a rate that is consistent with faster income growth as well as with the higher average deductibles for employer-based private health insurance enrollees in 2018 compared to 2017,” the authors note.
“Growth in out-of-pocket spending, which is also primarily influenced by economic factors, is expected to be similar to that of private health insurance spending in 2020-27, at 5%,” they add.
Prescription drug spending also is expected to grow.
“Following growth of just 0.4% in 2017, prescription drug spending is expected to have grown 3.3% in 2018 but still be among the slowest-growing health care sectors,” according to the authors. “Higher utilization growth is anticipated, compared to the relatively low growth in 2016 and 2017, partially driven by an increase in the number of new drug introductions.”
Growth in prescription drug spending is expected to accelerate further to 4.6% in 2019, based on growth in utilization and a “modest increase in drug price growth.”
Starting in 2020, that growth rate is projected to increase, on average, by 6.1% per year, based on the expectation that employers and insurers will lower barriers to maintenance medications for chronic conditions.
In 2019, growth in spending for physician clinical services is projected to accelerate to 5.4% from 4.9% in 2018.
“An acceleration in Medicaid spending growth is the primary factor contributing to the trend, which is in part associated with program’s expansion by additional states,” the authors note.
From 2020 to 2027, growth in spending on physician and clinical services is expected to average 5.4% per year, driven in part by price growth for these services.
“Underlying this acceleration are projected rising costs related to the provision of care,” the report said. “In particular, wages are expected to increase as a result of the supply of physicians not being able to meet expected increases in demand for care connected with the aging population. Furthermore, some of the productivity gains that have been achieved through the use of lower-cost providers as a substitute for physician care within physician practices may be less pronounced in the future, because of limitations such as licensing restrictions on the scope of care that may be provided by nonphysician providers.”
SOURCE: Sisko A et al. Health Aff. 2019 Feb 20. doi: 10.1377/hlthaff.2018.05499.
FROM HEALTH AFFAIRS
Diagnostic metal rod, eyeball extramission, fungal foot fetish
Doctor, (fake) doctor, gimme the news
Florida Man strikes again, and this time he’s a faux MD.
Onelio Hipolit-Gonzalez was charged with a felony for impersonating a doctor who promised patients he could easily diagnose their diabetes, cancer, multiple sclerosis, Parkinson’s, and pretty much any other malady … with a metal rod. The “doctor” would have patients hold on to a metal rod connected to a beeping machine (these are the scientific terms, of course), and then he would gravely diagnose them with a variety of ailments that he could cure for the low, low price of $2,000.
If you’re curious how he treated patients, fear not. This intrepid medical professional took the ingenious measure of drawing a patient’s blood and simply injecting it back inside them. Bada-bing, instant cure! Honestly, medical school these days is really overrated. Just learn to properly use a syringe, and you should be good to go. Just make sure not to attempt to treat/con any undercover cops.
Step away from the stinky socks
In another edition of “Humans: What Won’t They Do?” a Chinese man has developed a severe lung infection from prolonged, voluntary inhalation of his sweaty socks.
Take a moment to gag if you need it.
The man reportedly would finish his daily walk home from work with a deep, relaxing session of smelling his socks. Somewhat unsurprisingly, he developed a fungal infection and had to be hospitalized.
His doctor, perhaps in an effort to spare his feelings, conceded that the infection could be attributed to his weakened immune system from looking after his child. Sock-smelling weirdo, or just a good dad? Let’s just hope he doesn’t pass on this … unorthodox hobby to his offspring.
Turn down your eye beams
Do you remember the recent LOTME about a company selling tissues that have already been used by a sick person? Good news! This next item has nothing to do with that.
More good news! Belief in extramission – the ability to emit an invisible energy from the eyes – is down to about 5% among Americans after being greater than 50% at the turn of the century. The bad news? Belief in extramission is about 5% among Americans, according to investigators at Princeton (N.J.) University.
It’s not really a superhero thing, though. The researchers shared an explanation common among the extramission believers: “Light enters the eye, and there is a reflector piece inside the eye. The reflector reflects the light back out and hits the object, allowing the eye to see it.”
Now, we’d like to discount this whole eye-beam business, we really would, but there may be an exception that proves the rule. Ever had a staring contest with a cat? There’s got to be some sort of freaky power going on there.
The world’s worst superpower
Have you ever wondered what it would be like to live in the beginning of a science fiction novel? Well, worry no more – a group of researchers at the Georgia Institute of Technology and Emory University has you covered!
Okay, we’re pretty sure that the nanoparticles they’ve come up with won’t turn you into the Borg, but they will make your urine glow. Specifically, when injected into the bodies of people who’ve recently undergone transplants, they can help identify when an organ is failing.
The particles are tiny (duh), but they’re big enough that they won’t accumulate in normal, native tissue. However, they are small enough that, when a transplanted organ is being attacked by the body, the nanoparticles will end up getting through the kidneys and into urine. The particles are fluorescent and glow under near-infrared light.
The nanoparticles are aimed at replacing biopsies, as they are more predictive and less invasive. Also, who wouldn’t want to claim they’ve been enhanced by nanotechnology? Resistance is futile, after all.
Doctor, (fake) doctor, gimme the news
Florida Man strikes again, and this time he’s a faux MD.
Onelio Hipolit-Gonzalez was charged with a felony for impersonating a doctor who promised patients he could easily diagnose their diabetes, cancer, multiple sclerosis, Parkinson’s, and pretty much any other malady … with a metal rod. The “doctor” would have patients hold on to a metal rod connected to a beeping machine (these are the scientific terms, of course), and then he would gravely diagnose them with a variety of ailments that he could cure for the low, low price of $2,000.
If you’re curious how he treated patients, fear not. This intrepid medical professional took the ingenious measure of drawing a patient’s blood and simply injecting it back inside them. Bada-bing, instant cure! Honestly, medical school these days is really overrated. Just learn to properly use a syringe, and you should be good to go. Just make sure not to attempt to treat/con any undercover cops.
Step away from the stinky socks
In another edition of “Humans: What Won’t They Do?” a Chinese man has developed a severe lung infection from prolonged, voluntary inhalation of his sweaty socks.
Take a moment to gag if you need it.
The man reportedly would finish his daily walk home from work with a deep, relaxing session of smelling his socks. Somewhat unsurprisingly, he developed a fungal infection and had to be hospitalized.
His doctor, perhaps in an effort to spare his feelings, conceded that the infection could be attributed to his weakened immune system from looking after his child. Sock-smelling weirdo, or just a good dad? Let’s just hope he doesn’t pass on this … unorthodox hobby to his offspring.
Turn down your eye beams
Do you remember the recent LOTME about a company selling tissues that have already been used by a sick person? Good news! This next item has nothing to do with that.
More good news! Belief in extramission – the ability to emit an invisible energy from the eyes – is down to about 5% among Americans after being greater than 50% at the turn of the century. The bad news? Belief in extramission is about 5% among Americans, according to investigators at Princeton (N.J.) University.
It’s not really a superhero thing, though. The researchers shared an explanation common among the extramission believers: “Light enters the eye, and there is a reflector piece inside the eye. The reflector reflects the light back out and hits the object, allowing the eye to see it.”
Now, we’d like to discount this whole eye-beam business, we really would, but there may be an exception that proves the rule. Ever had a staring contest with a cat? There’s got to be some sort of freaky power going on there.
The world’s worst superpower
Have you ever wondered what it would be like to live in the beginning of a science fiction novel? Well, worry no more – a group of researchers at the Georgia Institute of Technology and Emory University has you covered!
Okay, we’re pretty sure that the nanoparticles they’ve come up with won’t turn you into the Borg, but they will make your urine glow. Specifically, when injected into the bodies of people who’ve recently undergone transplants, they can help identify when an organ is failing.
The particles are tiny (duh), but they’re big enough that they won’t accumulate in normal, native tissue. However, they are small enough that, when a transplanted organ is being attacked by the body, the nanoparticles will end up getting through the kidneys and into urine. The particles are fluorescent and glow under near-infrared light.
The nanoparticles are aimed at replacing biopsies, as they are more predictive and less invasive. Also, who wouldn’t want to claim they’ve been enhanced by nanotechnology? Resistance is futile, after all.
Doctor, (fake) doctor, gimme the news
Florida Man strikes again, and this time he’s a faux MD.
Onelio Hipolit-Gonzalez was charged with a felony for impersonating a doctor who promised patients he could easily diagnose their diabetes, cancer, multiple sclerosis, Parkinson’s, and pretty much any other malady … with a metal rod. The “doctor” would have patients hold on to a metal rod connected to a beeping machine (these are the scientific terms, of course), and then he would gravely diagnose them with a variety of ailments that he could cure for the low, low price of $2,000.
If you’re curious how he treated patients, fear not. This intrepid medical professional took the ingenious measure of drawing a patient’s blood and simply injecting it back inside them. Bada-bing, instant cure! Honestly, medical school these days is really overrated. Just learn to properly use a syringe, and you should be good to go. Just make sure not to attempt to treat/con any undercover cops.
Step away from the stinky socks
In another edition of “Humans: What Won’t They Do?” a Chinese man has developed a severe lung infection from prolonged, voluntary inhalation of his sweaty socks.
Take a moment to gag if you need it.
The man reportedly would finish his daily walk home from work with a deep, relaxing session of smelling his socks. Somewhat unsurprisingly, he developed a fungal infection and had to be hospitalized.
His doctor, perhaps in an effort to spare his feelings, conceded that the infection could be attributed to his weakened immune system from looking after his child. Sock-smelling weirdo, or just a good dad? Let’s just hope he doesn’t pass on this … unorthodox hobby to his offspring.
Turn down your eye beams
Do you remember the recent LOTME about a company selling tissues that have already been used by a sick person? Good news! This next item has nothing to do with that.
More good news! Belief in extramission – the ability to emit an invisible energy from the eyes – is down to about 5% among Americans after being greater than 50% at the turn of the century. The bad news? Belief in extramission is about 5% among Americans, according to investigators at Princeton (N.J.) University.
It’s not really a superhero thing, though. The researchers shared an explanation common among the extramission believers: “Light enters the eye, and there is a reflector piece inside the eye. The reflector reflects the light back out and hits the object, allowing the eye to see it.”
Now, we’d like to discount this whole eye-beam business, we really would, but there may be an exception that proves the rule. Ever had a staring contest with a cat? There’s got to be some sort of freaky power going on there.
The world’s worst superpower
Have you ever wondered what it would be like to live in the beginning of a science fiction novel? Well, worry no more – a group of researchers at the Georgia Institute of Technology and Emory University has you covered!
Okay, we’re pretty sure that the nanoparticles they’ve come up with won’t turn you into the Borg, but they will make your urine glow. Specifically, when injected into the bodies of people who’ve recently undergone transplants, they can help identify when an organ is failing.
The particles are tiny (duh), but they’re big enough that they won’t accumulate in normal, native tissue. However, they are small enough that, when a transplanted organ is being attacked by the body, the nanoparticles will end up getting through the kidneys and into urine. The particles are fluorescent and glow under near-infrared light.
The nanoparticles are aimed at replacing biopsies, as they are more predictive and less invasive. Also, who wouldn’t want to claim they’ve been enhanced by nanotechnology? Resistance is futile, after all.
Complementary and alternative medicine
Question: Which one of the following statements regarding complementary and alternative medicine (CAM) is correct?
A. CAM practitioners are just as likely as medical doctors to be sued.
B. Damages arising out of the use of CAM may be compensable if there is clear and convincing evidence of substandard care, and the plaintiff can prove legal causation.
C. An acupuncturist who treats an asthmatic patient will be sued if he/she fails to refer the patient to a medical specialist.
D. Obtaining informed consent after discussing all therapeutic options and material risks is especially important for those who practice CAM.
E. It is not a valid defense that the patient had fully and willingly assumed the risk of treatment.
Answer: D. Compared with medical doctors, non-MD practitioners of CAM pay lower malpractice insurance premiums, as they are much less likely to be sued, and patient injuries are usually less severe.
CAM covers a broad range of healing philosophies, approaches, and therapies that are typically outside mainstream Western medicine. It comprises modalities such as chiropractic, acupuncture, massage therapy, naturopathic medicine, nutritional therapy, and others.
More than half of the U.S. population uses some form of CAM, which is widely perceived as a natural and effective means of promoting overall well being in addition to treating a specific illness. The scope of practice for CAM providers is defined and limited by state rather than federal statutes, and enforced by regulatory bodies.
CAM treatments are generally noninvasive, and there are fewer than 50 indemnity insurers in the country for chiropractors, massage therapists, and acupuncturists, underwriting some 5% of the total medical malpractice insurance market.
In the event of an injury, damages are recoverable if there is a preponderance of evidence to indicate substandard care. “Clear and convincing” is a higher evidentiary level of legal proof, and it is not required in a negligence action. Whether an acupuncturist will be sued successfully for treating an asthmatic patient will depend on many factors, for example, whether it is an acceptable CAM practice in the jurisdiction, whether there is any statutory restriction on such treatment, whether there was a failure of a timely referral, etc.
Finally, assumption of risk is a valid defense in a negligence tort action under some circumstances.
For a negligence claim to prevail, the plaintiff must establish breach of duty, i.e., that the defendant deviated from the standard of care ordinarily exercised by a similarly situated practitioner. In addition to falling below that level of skill, practitioners may also be sued for having failed to refer to a medical doctor, for practicing outside the scope of CAM, or for venturing into traditional Western medical practice.
In one instance, a plaintiff alleged that he was led to believe that chiropractic manipulation would help his diabetes. The court found in favor of the plaintiff and awarded damages.1 In another, the plaintiff successfully sued a chiropractor for failing to take x-rays and refer to a medical doctor. The court held that the defendant fell below the standard of care, as the state licensing board required physician referral when the problem extended beyond the limits of chiropractic practice.2
However, an injured party does not always prevail. In Miyamoto v. Lazo, the plaintiff claimed that Dr. Lazo, a chiropractor, negligently treated his injuries from a car accident.3 The patient was taking Coumadin and developed a hematoma in his left shoulder following chiropractic treatment. This was complicated by neuropathy in his left hand when the hematoma expanded and required surgical drainage.
The jury, however, found Dr. Lazo not liable, because of evidence that a hematoma could spontaneously arise in someone on an anticoagulant.
Injured patients have also filed lawsuits against other CAM practitioners. Allegations against acupuncturists have included cases of pneumothorax, wrongful death in an adolescent girl with asthma, and burns from a heat lamp.4 And in Wallman v. Kelley,a plaintiff developed liver damage and filed negligence and breach of implied warranty claims against a seller of Chinese herbal medicine.5 The court held that the defendant was not liable, as the plaintiff failed to prove causation or give timely notice of suit.
Medical doctors are increasingly incorporating CAM into their practices, so they must adhere to CAM standards in addition to their own medical standards.
In Charell v. Gonzalez, a cancer patient refused conventional treatment by oncologists and opted instead for nutritional therapy by a physician.6 Her cancer metastasized, and she alleged negligence and failure to warn of risks. The jury found the physician 51% liable for departure from standard of care and lack of informed consent. The plaintiff was found to be 49% at fault for choosing to ignore the recommendations of her oncologists.
Even if it’s the patient’s choice, physicians must still exercise due care when implementing therapy.
In Gonzalez v. New York State Department of Health, Dr. Gonzales was charged with gross negligence and incompetence after he used nutritional therapies to treat six patients with incurable cancer who had failed or rejected conventional treatment.7
The hearing committee found that he missed signs of disease progression and failed to perform adequate assessments, testing, and follow-up evaluations. The court held that a patient’s consent to or even insistence upon a certain treatment does not relieve the physician from the obligation of treating the patient with the usual standard of care.
In general, a physician may employ several legal defenses to avert liability following an adverse event.
One defense is to assert the “respectable minority” standard of care, if it can be shown that a respectable minority in the medical community also accepts the treatment in question.
A second defense is assumption of risk. In Schneider v. Revici, a physician delivered nutritional (selenium and dietary restrictions) and other nonsurgical treatment for breast cancer after the patient refused conventional treatments offered by other physicians.8 The patient signed a detailed consent form releasing the physician from liability and acknowledging that the defendant’s treatments lacked Food and Drug Administration approval, and that no results could be guaranteed.
The cancer spread, and the patient sued for common law fraud, medical malpractice, and lack of informed consent. The court of appeals held that assumption of risk is a complete defense to malpractice. The same court also held in another case that a patient’s failure to sign a consent form did not preclude the jury from considering the assumption of risk defense.
A third defense, rarely successful, is to invoke “clinical innovation” when CAM is used to alleviate a desperate situation, for example, if the patient is terminal or has failed conventional therapy. The defendant-physician may plead involvement in a clinical trial study, or show that the unorthodox treatment is based on extensive personal experience or some newly discovered developments in the field.
When discussing CAM, the physician should first fully inform the patient about conventional treatments and their limitations. Next, the physician should explain why the “novel” rather than the recognized conventional therapy is being considered. Finally, whether the physician intends to carry out CAM therapy or refer to another practitioner, the patient must be warned about the potential risks associated with such therapy.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is modified from a chapter in the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk.” It is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Wengel v. Herfert, 473 N.W.2d 741 (1991).
2. Salazar v. Ehmann, 505 P.2d 387 (1972).
3. Miyamoto v. Lum and Lazo, 84 P.3d 509 (2004).
4. Rosenberg v. Jing Jiang, 153 A.D.3d 744 (2017).
5. Wallman v. Kelley, 976 P.2d 330 (1998).
6. Charell v. Gonzales, 673 N.Y.S. 2d 685 (1998).
7. Gonzales v. NYS DOH, 232 A.D.2d 886 (1996).
8. Schneider v. Revici, 817 F. 2d 987 (1987).
Question: Which one of the following statements regarding complementary and alternative medicine (CAM) is correct?
A. CAM practitioners are just as likely as medical doctors to be sued.
B. Damages arising out of the use of CAM may be compensable if there is clear and convincing evidence of substandard care, and the plaintiff can prove legal causation.
C. An acupuncturist who treats an asthmatic patient will be sued if he/she fails to refer the patient to a medical specialist.
D. Obtaining informed consent after discussing all therapeutic options and material risks is especially important for those who practice CAM.
E. It is not a valid defense that the patient had fully and willingly assumed the risk of treatment.
Answer: D. Compared with medical doctors, non-MD practitioners of CAM pay lower malpractice insurance premiums, as they are much less likely to be sued, and patient injuries are usually less severe.
CAM covers a broad range of healing philosophies, approaches, and therapies that are typically outside mainstream Western medicine. It comprises modalities such as chiropractic, acupuncture, massage therapy, naturopathic medicine, nutritional therapy, and others.
More than half of the U.S. population uses some form of CAM, which is widely perceived as a natural and effective means of promoting overall well being in addition to treating a specific illness. The scope of practice for CAM providers is defined and limited by state rather than federal statutes, and enforced by regulatory bodies.
CAM treatments are generally noninvasive, and there are fewer than 50 indemnity insurers in the country for chiropractors, massage therapists, and acupuncturists, underwriting some 5% of the total medical malpractice insurance market.
In the event of an injury, damages are recoverable if there is a preponderance of evidence to indicate substandard care. “Clear and convincing” is a higher evidentiary level of legal proof, and it is not required in a negligence action. Whether an acupuncturist will be sued successfully for treating an asthmatic patient will depend on many factors, for example, whether it is an acceptable CAM practice in the jurisdiction, whether there is any statutory restriction on such treatment, whether there was a failure of a timely referral, etc.
Finally, assumption of risk is a valid defense in a negligence tort action under some circumstances.
For a negligence claim to prevail, the plaintiff must establish breach of duty, i.e., that the defendant deviated from the standard of care ordinarily exercised by a similarly situated practitioner. In addition to falling below that level of skill, practitioners may also be sued for having failed to refer to a medical doctor, for practicing outside the scope of CAM, or for venturing into traditional Western medical practice.
In one instance, a plaintiff alleged that he was led to believe that chiropractic manipulation would help his diabetes. The court found in favor of the plaintiff and awarded damages.1 In another, the plaintiff successfully sued a chiropractor for failing to take x-rays and refer to a medical doctor. The court held that the defendant fell below the standard of care, as the state licensing board required physician referral when the problem extended beyond the limits of chiropractic practice.2
However, an injured party does not always prevail. In Miyamoto v. Lazo, the plaintiff claimed that Dr. Lazo, a chiropractor, negligently treated his injuries from a car accident.3 The patient was taking Coumadin and developed a hematoma in his left shoulder following chiropractic treatment. This was complicated by neuropathy in his left hand when the hematoma expanded and required surgical drainage.
The jury, however, found Dr. Lazo not liable, because of evidence that a hematoma could spontaneously arise in someone on an anticoagulant.
Injured patients have also filed lawsuits against other CAM practitioners. Allegations against acupuncturists have included cases of pneumothorax, wrongful death in an adolescent girl with asthma, and burns from a heat lamp.4 And in Wallman v. Kelley,a plaintiff developed liver damage and filed negligence and breach of implied warranty claims against a seller of Chinese herbal medicine.5 The court held that the defendant was not liable, as the plaintiff failed to prove causation or give timely notice of suit.
Medical doctors are increasingly incorporating CAM into their practices, so they must adhere to CAM standards in addition to their own medical standards.
In Charell v. Gonzalez, a cancer patient refused conventional treatment by oncologists and opted instead for nutritional therapy by a physician.6 Her cancer metastasized, and she alleged negligence and failure to warn of risks. The jury found the physician 51% liable for departure from standard of care and lack of informed consent. The plaintiff was found to be 49% at fault for choosing to ignore the recommendations of her oncologists.
Even if it’s the patient’s choice, physicians must still exercise due care when implementing therapy.
In Gonzalez v. New York State Department of Health, Dr. Gonzales was charged with gross negligence and incompetence after he used nutritional therapies to treat six patients with incurable cancer who had failed or rejected conventional treatment.7
The hearing committee found that he missed signs of disease progression and failed to perform adequate assessments, testing, and follow-up evaluations. The court held that a patient’s consent to or even insistence upon a certain treatment does not relieve the physician from the obligation of treating the patient with the usual standard of care.
In general, a physician may employ several legal defenses to avert liability following an adverse event.
One defense is to assert the “respectable minority” standard of care, if it can be shown that a respectable minority in the medical community also accepts the treatment in question.
A second defense is assumption of risk. In Schneider v. Revici, a physician delivered nutritional (selenium and dietary restrictions) and other nonsurgical treatment for breast cancer after the patient refused conventional treatments offered by other physicians.8 The patient signed a detailed consent form releasing the physician from liability and acknowledging that the defendant’s treatments lacked Food and Drug Administration approval, and that no results could be guaranteed.
The cancer spread, and the patient sued for common law fraud, medical malpractice, and lack of informed consent. The court of appeals held that assumption of risk is a complete defense to malpractice. The same court also held in another case that a patient’s failure to sign a consent form did not preclude the jury from considering the assumption of risk defense.
A third defense, rarely successful, is to invoke “clinical innovation” when CAM is used to alleviate a desperate situation, for example, if the patient is terminal or has failed conventional therapy. The defendant-physician may plead involvement in a clinical trial study, or show that the unorthodox treatment is based on extensive personal experience or some newly discovered developments in the field.
When discussing CAM, the physician should first fully inform the patient about conventional treatments and their limitations. Next, the physician should explain why the “novel” rather than the recognized conventional therapy is being considered. Finally, whether the physician intends to carry out CAM therapy or refer to another practitioner, the patient must be warned about the potential risks associated with such therapy.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is modified from a chapter in the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk.” It is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Wengel v. Herfert, 473 N.W.2d 741 (1991).
2. Salazar v. Ehmann, 505 P.2d 387 (1972).
3. Miyamoto v. Lum and Lazo, 84 P.3d 509 (2004).
4. Rosenberg v. Jing Jiang, 153 A.D.3d 744 (2017).
5. Wallman v. Kelley, 976 P.2d 330 (1998).
6. Charell v. Gonzales, 673 N.Y.S. 2d 685 (1998).
7. Gonzales v. NYS DOH, 232 A.D.2d 886 (1996).
8. Schneider v. Revici, 817 F. 2d 987 (1987).
Question: Which one of the following statements regarding complementary and alternative medicine (CAM) is correct?
A. CAM practitioners are just as likely as medical doctors to be sued.
B. Damages arising out of the use of CAM may be compensable if there is clear and convincing evidence of substandard care, and the plaintiff can prove legal causation.
C. An acupuncturist who treats an asthmatic patient will be sued if he/she fails to refer the patient to a medical specialist.
D. Obtaining informed consent after discussing all therapeutic options and material risks is especially important for those who practice CAM.
E. It is not a valid defense that the patient had fully and willingly assumed the risk of treatment.
Answer: D. Compared with medical doctors, non-MD practitioners of CAM pay lower malpractice insurance premiums, as they are much less likely to be sued, and patient injuries are usually less severe.
CAM covers a broad range of healing philosophies, approaches, and therapies that are typically outside mainstream Western medicine. It comprises modalities such as chiropractic, acupuncture, massage therapy, naturopathic medicine, nutritional therapy, and others.
More than half of the U.S. population uses some form of CAM, which is widely perceived as a natural and effective means of promoting overall well being in addition to treating a specific illness. The scope of practice for CAM providers is defined and limited by state rather than federal statutes, and enforced by regulatory bodies.
CAM treatments are generally noninvasive, and there are fewer than 50 indemnity insurers in the country for chiropractors, massage therapists, and acupuncturists, underwriting some 5% of the total medical malpractice insurance market.
In the event of an injury, damages are recoverable if there is a preponderance of evidence to indicate substandard care. “Clear and convincing” is a higher evidentiary level of legal proof, and it is not required in a negligence action. Whether an acupuncturist will be sued successfully for treating an asthmatic patient will depend on many factors, for example, whether it is an acceptable CAM practice in the jurisdiction, whether there is any statutory restriction on such treatment, whether there was a failure of a timely referral, etc.
Finally, assumption of risk is a valid defense in a negligence tort action under some circumstances.
For a negligence claim to prevail, the plaintiff must establish breach of duty, i.e., that the defendant deviated from the standard of care ordinarily exercised by a similarly situated practitioner. In addition to falling below that level of skill, practitioners may also be sued for having failed to refer to a medical doctor, for practicing outside the scope of CAM, or for venturing into traditional Western medical practice.
In one instance, a plaintiff alleged that he was led to believe that chiropractic manipulation would help his diabetes. The court found in favor of the plaintiff and awarded damages.1 In another, the plaintiff successfully sued a chiropractor for failing to take x-rays and refer to a medical doctor. The court held that the defendant fell below the standard of care, as the state licensing board required physician referral when the problem extended beyond the limits of chiropractic practice.2
However, an injured party does not always prevail. In Miyamoto v. Lazo, the plaintiff claimed that Dr. Lazo, a chiropractor, negligently treated his injuries from a car accident.3 The patient was taking Coumadin and developed a hematoma in his left shoulder following chiropractic treatment. This was complicated by neuropathy in his left hand when the hematoma expanded and required surgical drainage.
The jury, however, found Dr. Lazo not liable, because of evidence that a hematoma could spontaneously arise in someone on an anticoagulant.
Injured patients have also filed lawsuits against other CAM practitioners. Allegations against acupuncturists have included cases of pneumothorax, wrongful death in an adolescent girl with asthma, and burns from a heat lamp.4 And in Wallman v. Kelley,a plaintiff developed liver damage and filed negligence and breach of implied warranty claims against a seller of Chinese herbal medicine.5 The court held that the defendant was not liable, as the plaintiff failed to prove causation or give timely notice of suit.
Medical doctors are increasingly incorporating CAM into their practices, so they must adhere to CAM standards in addition to their own medical standards.
In Charell v. Gonzalez, a cancer patient refused conventional treatment by oncologists and opted instead for nutritional therapy by a physician.6 Her cancer metastasized, and she alleged negligence and failure to warn of risks. The jury found the physician 51% liable for departure from standard of care and lack of informed consent. The plaintiff was found to be 49% at fault for choosing to ignore the recommendations of her oncologists.
Even if it’s the patient’s choice, physicians must still exercise due care when implementing therapy.
In Gonzalez v. New York State Department of Health, Dr. Gonzales was charged with gross negligence and incompetence after he used nutritional therapies to treat six patients with incurable cancer who had failed or rejected conventional treatment.7
The hearing committee found that he missed signs of disease progression and failed to perform adequate assessments, testing, and follow-up evaluations. The court held that a patient’s consent to or even insistence upon a certain treatment does not relieve the physician from the obligation of treating the patient with the usual standard of care.
In general, a physician may employ several legal defenses to avert liability following an adverse event.
One defense is to assert the “respectable minority” standard of care, if it can be shown that a respectable minority in the medical community also accepts the treatment in question.
A second defense is assumption of risk. In Schneider v. Revici, a physician delivered nutritional (selenium and dietary restrictions) and other nonsurgical treatment for breast cancer after the patient refused conventional treatments offered by other physicians.8 The patient signed a detailed consent form releasing the physician from liability and acknowledging that the defendant’s treatments lacked Food and Drug Administration approval, and that no results could be guaranteed.
The cancer spread, and the patient sued for common law fraud, medical malpractice, and lack of informed consent. The court of appeals held that assumption of risk is a complete defense to malpractice. The same court also held in another case that a patient’s failure to sign a consent form did not preclude the jury from considering the assumption of risk defense.
A third defense, rarely successful, is to invoke “clinical innovation” when CAM is used to alleviate a desperate situation, for example, if the patient is terminal or has failed conventional therapy. The defendant-physician may plead involvement in a clinical trial study, or show that the unorthodox treatment is based on extensive personal experience or some newly discovered developments in the field.
When discussing CAM, the physician should first fully inform the patient about conventional treatments and their limitations. Next, the physician should explain why the “novel” rather than the recognized conventional therapy is being considered. Finally, whether the physician intends to carry out CAM therapy or refer to another practitioner, the patient must be warned about the potential risks associated with such therapy.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is modified from a chapter in the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk.” It is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Wengel v. Herfert, 473 N.W.2d 741 (1991).
2. Salazar v. Ehmann, 505 P.2d 387 (1972).
3. Miyamoto v. Lum and Lazo, 84 P.3d 509 (2004).
4. Rosenberg v. Jing Jiang, 153 A.D.3d 744 (2017).
5. Wallman v. Kelley, 976 P.2d 330 (1998).
6. Charell v. Gonzales, 673 N.Y.S. 2d 685 (1998).
7. Gonzales v. NYS DOH, 232 A.D.2d 886 (1996).
8. Schneider v. Revici, 817 F. 2d 987 (1987).
Dr. Lisa Christopher-Stine: Polymyositis? It’s more likely something else
“When someone refers you [a patient with suspected] polymyositis, I want you to do a checklist in your head and say, ‘Have I thought about these five things?’ ” Dr. Christopher-Stine, director of the Johns Hopkins Myositis Center, Baltimore, said at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
The five most common diagnoses in patients labeled as having polymyositis are immune-mediated necrotizing myopathy (IMNM), overlap with other rheumatologic conditions, antisynthetase syndrome, inclusion body myositis (IBM), and muscular dystrophy, she explained.
“You may say, ‘look, it’s all what you call it,’ but I think we need to be a little bit more careful in what we call it,” she said.
IMNM
Patients with IMNM present with clinical symptoms similar to those seen in polymyositis and dermatomyositis – mainly proximal muscle weakness.
However, there are some important differences, both clinically and histologically, Dr. Christopher-Stine said.
“Look for higher [creatine kinase (CK)] levels,” she said. “In the thousands, usually multiple thousands ... like 5,000, 10,000, 2,000 ... that’s when you’re thinking about a necrotizing phenotype before you even look at the biopsy.”
CK levels will usually be under 30,000 U/L in IMNM, she noted, adding that data increasingly suggest that the extensive muscle necrosis in IMNM explains the elevated CK levels versus those seen in other myopathies.
Myalgias also tend to be more prominent in IMNM than in polymyositis.
“These folks hurt,” she said, noting that IMNM patients tend to have more extensive muscle atrophy and functional disability. “Many will be wheelchair bound within 9 months of diagnosis; it’s not subtle.”
The most important tool for making an IMNM diagnosis is muscle biopsy; look for prominent myocyte necrosis and a relative paucity of lymphocytes, she advised.
Overlap
Sometimes patients with polymyositis also have other rheumatologic conditions that shouldn’t be overlooked, therefore “overlap is its own category,” she said.
“In our experience, the most common overlap is scleroderma,” she noted, adding that the scleroderma is often, but not always, subtle, and that there may be overlapping autoantibodies.
Overt sclerodactyly is rarely seen, although a small amount may be present, but significant Raynaud’s phenomenon is common in these patients, and tiny telangiectasias across the neck are a tell-tale sign.
“Why does that matter? It’s not an esoteric argument; those are the folks that go on to have pulmonary hypertension,” she said. “They can have the same [interstitial lung disease] and all of the other internal scleroderma manifestations.”
Think about overlap and “look close phenotypically and with antibodies,” she advised.
There is also “the typical RA seropositive overlap,” she said, but lupus only rarely overlaps with myositis.
“However, the next diagnosis on the list – antisynthetase syndrome – can be a forme fruste where you first see a seronegative RA-like picture, and it’s important to think about that as well,” she said.
Antisynthetase syndrome
In patients referred for polymyositis, it’s also important to evaluate for antisynthetase syndrome, Dr. Christopher-Stine said.
The arthritis seen in the extramuscular phenotype of the syndrome is rarely deforming, but despite what many physicians were taught, “it absolutely can be erosive,” she said.
In fact, 40% of people with this syndrome present with an isolated forme fruste seronegative rheumatoid arthritis, she said.
Roughening and desquamation of the skin on the radial surface of fingers or palms – a sign known as mechanic’s hands – that doesn’t have another identifiable cause suggests this diagnosis in patients with this type of arthritis, as does interstitial lung disease and Raynaud’s phenomenon.
The Raynaud’s can be “fairly significant in the sense that it is bothersome,” but it usually doesn’t lead to ulceration or digital necrosis.
This is different from what is seen with the scleroderma phenotype, she said, adding that “if you’re starting to see gangrene and digital loss, think of something else.”
IBM
IBM is “probably the No. 1 most-missed diagnosis” among patients referred for what is initially believed to be polymyositis, Dr. Christopher-Stine said.
“I used to think that this was missed at entry, that everybody [with IBM] had all of these criteria and that rheumatologists really didn’t understand this phenotype ... but some people morph into this,” she said, explaining that they often start out looking like they have polymyositis with proximal muscle weakness.
“They may even initially respond to steroids. And then they get this phenotype,” she said.
Older men are more likely to present with the phenotype from the beginning; women, in her experience, tend to present with what appears to be polymyositis, and then develop the phenotype over time, she noted.
An IBM diagnosis requires age over 30 years, but most patients are over 50, she said.
“This is the only one of the myopathies that is preferential to men,” she added, noting that it affects men twice as often as it does women.
The syndrome is characterized by proximal strength loss and muscle atrophy. Also, a finding that a patient’s knee extensors are weaker than their hip flexors is “a fantastic bedside sign” differentiating IBM from polymyositis, she said.
That’s not to say IBM patients don’t have hip flexor weakness, but their knee extensors usually are “considerably weaker by a grade strength or more” versus their hip flexors, she explained.
“It’s a very easy bedside test. In typical other myopathies we have this, but the knee extensors aren’t that weak in general, or they’re not as weak as the hip flexors,” she added.
Another sign is distal strength loss, particularly in the forearm and finger flexors.
“I was taught to have them make a fist; don’t have them make a fist,” she said, explaining that this recruits intrinsic muscles which basically allows cheating that may mask weakness.
Instead, ask them to flex just their distal interphalangeal joints by making a claw and using the fingers to pull against your fingers, she suggested.
Mixed myopathic and neuropathic features on electromyography also indicate IBM, she said.
Muscle biopsy may be helpful, but inclusions are seen in less than one-third of IBM patients.
“At times, we have had to biopsy three times to see them at all, and some people never show them, so you have to rely on your clinical acumen if you don’t see them,” she said.
Also, keep in mind that these patients are often labeled as having treatment-resistant polymyositis.
“Please, when somebody refers to you somebody that’s treatment resistant, that may be the case, but I want you to think maybe they’re treatment resistant because they don’t have that disease.”
Muscular dystrophy
Some cases of myositis mimic certain types of muscular dystrophy, Dr. Christopher-Stine said, providing a checklist of muscular dystrophies that can look “clinically completely indistinguishable from a typical inflammatory myopathy,” and should therefore be considered in these patients.
The checklist includes Duchenne’s manifesting carrier, limb girdle muscular dystrophy type 2b, myotonic dystrophy (usually type 2), and facioscapulohumeral muscular dystrophy.
Dr. Christopher-Stine reported having intellectual property interest in a novel Inova Diagnostics autoantibody assay detection for anti-HMGCR. She was also the safety officer for the JBT-101 Trial sponsored by Corbus and funded by the National Institutes of Health.
“When someone refers you [a patient with suspected] polymyositis, I want you to do a checklist in your head and say, ‘Have I thought about these five things?’ ” Dr. Christopher-Stine, director of the Johns Hopkins Myositis Center, Baltimore, said at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
The five most common diagnoses in patients labeled as having polymyositis are immune-mediated necrotizing myopathy (IMNM), overlap with other rheumatologic conditions, antisynthetase syndrome, inclusion body myositis (IBM), and muscular dystrophy, she explained.
“You may say, ‘look, it’s all what you call it,’ but I think we need to be a little bit more careful in what we call it,” she said.
IMNM
Patients with IMNM present with clinical symptoms similar to those seen in polymyositis and dermatomyositis – mainly proximal muscle weakness.
However, there are some important differences, both clinically and histologically, Dr. Christopher-Stine said.
“Look for higher [creatine kinase (CK)] levels,” she said. “In the thousands, usually multiple thousands ... like 5,000, 10,000, 2,000 ... that’s when you’re thinking about a necrotizing phenotype before you even look at the biopsy.”
CK levels will usually be under 30,000 U/L in IMNM, she noted, adding that data increasingly suggest that the extensive muscle necrosis in IMNM explains the elevated CK levels versus those seen in other myopathies.
Myalgias also tend to be more prominent in IMNM than in polymyositis.
“These folks hurt,” she said, noting that IMNM patients tend to have more extensive muscle atrophy and functional disability. “Many will be wheelchair bound within 9 months of diagnosis; it’s not subtle.”
The most important tool for making an IMNM diagnosis is muscle biopsy; look for prominent myocyte necrosis and a relative paucity of lymphocytes, she advised.
Overlap
Sometimes patients with polymyositis also have other rheumatologic conditions that shouldn’t be overlooked, therefore “overlap is its own category,” she said.
“In our experience, the most common overlap is scleroderma,” she noted, adding that the scleroderma is often, but not always, subtle, and that there may be overlapping autoantibodies.
Overt sclerodactyly is rarely seen, although a small amount may be present, but significant Raynaud’s phenomenon is common in these patients, and tiny telangiectasias across the neck are a tell-tale sign.
“Why does that matter? It’s not an esoteric argument; those are the folks that go on to have pulmonary hypertension,” she said. “They can have the same [interstitial lung disease] and all of the other internal scleroderma manifestations.”
Think about overlap and “look close phenotypically and with antibodies,” she advised.
There is also “the typical RA seropositive overlap,” she said, but lupus only rarely overlaps with myositis.
“However, the next diagnosis on the list – antisynthetase syndrome – can be a forme fruste where you first see a seronegative RA-like picture, and it’s important to think about that as well,” she said.
Antisynthetase syndrome
In patients referred for polymyositis, it’s also important to evaluate for antisynthetase syndrome, Dr. Christopher-Stine said.
The arthritis seen in the extramuscular phenotype of the syndrome is rarely deforming, but despite what many physicians were taught, “it absolutely can be erosive,” she said.
In fact, 40% of people with this syndrome present with an isolated forme fruste seronegative rheumatoid arthritis, she said.
Roughening and desquamation of the skin on the radial surface of fingers or palms – a sign known as mechanic’s hands – that doesn’t have another identifiable cause suggests this diagnosis in patients with this type of arthritis, as does interstitial lung disease and Raynaud’s phenomenon.
The Raynaud’s can be “fairly significant in the sense that it is bothersome,” but it usually doesn’t lead to ulceration or digital necrosis.
This is different from what is seen with the scleroderma phenotype, she said, adding that “if you’re starting to see gangrene and digital loss, think of something else.”
IBM
IBM is “probably the No. 1 most-missed diagnosis” among patients referred for what is initially believed to be polymyositis, Dr. Christopher-Stine said.
“I used to think that this was missed at entry, that everybody [with IBM] had all of these criteria and that rheumatologists really didn’t understand this phenotype ... but some people morph into this,” she said, explaining that they often start out looking like they have polymyositis with proximal muscle weakness.
“They may even initially respond to steroids. And then they get this phenotype,” she said.
Older men are more likely to present with the phenotype from the beginning; women, in her experience, tend to present with what appears to be polymyositis, and then develop the phenotype over time, she noted.
An IBM diagnosis requires age over 30 years, but most patients are over 50, she said.
“This is the only one of the myopathies that is preferential to men,” she added, noting that it affects men twice as often as it does women.
The syndrome is characterized by proximal strength loss and muscle atrophy. Also, a finding that a patient’s knee extensors are weaker than their hip flexors is “a fantastic bedside sign” differentiating IBM from polymyositis, she said.
That’s not to say IBM patients don’t have hip flexor weakness, but their knee extensors usually are “considerably weaker by a grade strength or more” versus their hip flexors, she explained.
“It’s a very easy bedside test. In typical other myopathies we have this, but the knee extensors aren’t that weak in general, or they’re not as weak as the hip flexors,” she added.
Another sign is distal strength loss, particularly in the forearm and finger flexors.
“I was taught to have them make a fist; don’t have them make a fist,” she said, explaining that this recruits intrinsic muscles which basically allows cheating that may mask weakness.
Instead, ask them to flex just their distal interphalangeal joints by making a claw and using the fingers to pull against your fingers, she suggested.
Mixed myopathic and neuropathic features on electromyography also indicate IBM, she said.
Muscle biopsy may be helpful, but inclusions are seen in less than one-third of IBM patients.
“At times, we have had to biopsy three times to see them at all, and some people never show them, so you have to rely on your clinical acumen if you don’t see them,” she said.
Also, keep in mind that these patients are often labeled as having treatment-resistant polymyositis.
“Please, when somebody refers to you somebody that’s treatment resistant, that may be the case, but I want you to think maybe they’re treatment resistant because they don’t have that disease.”
Muscular dystrophy
Some cases of myositis mimic certain types of muscular dystrophy, Dr. Christopher-Stine said, providing a checklist of muscular dystrophies that can look “clinically completely indistinguishable from a typical inflammatory myopathy,” and should therefore be considered in these patients.
The checklist includes Duchenne’s manifesting carrier, limb girdle muscular dystrophy type 2b, myotonic dystrophy (usually type 2), and facioscapulohumeral muscular dystrophy.
Dr. Christopher-Stine reported having intellectual property interest in a novel Inova Diagnostics autoantibody assay detection for anti-HMGCR. She was also the safety officer for the JBT-101 Trial sponsored by Corbus and funded by the National Institutes of Health.
“When someone refers you [a patient with suspected] polymyositis, I want you to do a checklist in your head and say, ‘Have I thought about these five things?’ ” Dr. Christopher-Stine, director of the Johns Hopkins Myositis Center, Baltimore, said at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
The five most common diagnoses in patients labeled as having polymyositis are immune-mediated necrotizing myopathy (IMNM), overlap with other rheumatologic conditions, antisynthetase syndrome, inclusion body myositis (IBM), and muscular dystrophy, she explained.
“You may say, ‘look, it’s all what you call it,’ but I think we need to be a little bit more careful in what we call it,” she said.
IMNM
Patients with IMNM present with clinical symptoms similar to those seen in polymyositis and dermatomyositis – mainly proximal muscle weakness.
However, there are some important differences, both clinically and histologically, Dr. Christopher-Stine said.
“Look for higher [creatine kinase (CK)] levels,” she said. “In the thousands, usually multiple thousands ... like 5,000, 10,000, 2,000 ... that’s when you’re thinking about a necrotizing phenotype before you even look at the biopsy.”
CK levels will usually be under 30,000 U/L in IMNM, she noted, adding that data increasingly suggest that the extensive muscle necrosis in IMNM explains the elevated CK levels versus those seen in other myopathies.
Myalgias also tend to be more prominent in IMNM than in polymyositis.
“These folks hurt,” she said, noting that IMNM patients tend to have more extensive muscle atrophy and functional disability. “Many will be wheelchair bound within 9 months of diagnosis; it’s not subtle.”
The most important tool for making an IMNM diagnosis is muscle biopsy; look for prominent myocyte necrosis and a relative paucity of lymphocytes, she advised.
Overlap
Sometimes patients with polymyositis also have other rheumatologic conditions that shouldn’t be overlooked, therefore “overlap is its own category,” she said.
“In our experience, the most common overlap is scleroderma,” she noted, adding that the scleroderma is often, but not always, subtle, and that there may be overlapping autoantibodies.
Overt sclerodactyly is rarely seen, although a small amount may be present, but significant Raynaud’s phenomenon is common in these patients, and tiny telangiectasias across the neck are a tell-tale sign.
“Why does that matter? It’s not an esoteric argument; those are the folks that go on to have pulmonary hypertension,” she said. “They can have the same [interstitial lung disease] and all of the other internal scleroderma manifestations.”
Think about overlap and “look close phenotypically and with antibodies,” she advised.
There is also “the typical RA seropositive overlap,” she said, but lupus only rarely overlaps with myositis.
“However, the next diagnosis on the list – antisynthetase syndrome – can be a forme fruste where you first see a seronegative RA-like picture, and it’s important to think about that as well,” she said.
Antisynthetase syndrome
In patients referred for polymyositis, it’s also important to evaluate for antisynthetase syndrome, Dr. Christopher-Stine said.
The arthritis seen in the extramuscular phenotype of the syndrome is rarely deforming, but despite what many physicians were taught, “it absolutely can be erosive,” she said.
In fact, 40% of people with this syndrome present with an isolated forme fruste seronegative rheumatoid arthritis, she said.
Roughening and desquamation of the skin on the radial surface of fingers or palms – a sign known as mechanic’s hands – that doesn’t have another identifiable cause suggests this diagnosis in patients with this type of arthritis, as does interstitial lung disease and Raynaud’s phenomenon.
The Raynaud’s can be “fairly significant in the sense that it is bothersome,” but it usually doesn’t lead to ulceration or digital necrosis.
This is different from what is seen with the scleroderma phenotype, she said, adding that “if you’re starting to see gangrene and digital loss, think of something else.”
IBM
IBM is “probably the No. 1 most-missed diagnosis” among patients referred for what is initially believed to be polymyositis, Dr. Christopher-Stine said.
“I used to think that this was missed at entry, that everybody [with IBM] had all of these criteria and that rheumatologists really didn’t understand this phenotype ... but some people morph into this,” she said, explaining that they often start out looking like they have polymyositis with proximal muscle weakness.
“They may even initially respond to steroids. And then they get this phenotype,” she said.
Older men are more likely to present with the phenotype from the beginning; women, in her experience, tend to present with what appears to be polymyositis, and then develop the phenotype over time, she noted.
An IBM diagnosis requires age over 30 years, but most patients are over 50, she said.
“This is the only one of the myopathies that is preferential to men,” she added, noting that it affects men twice as often as it does women.
The syndrome is characterized by proximal strength loss and muscle atrophy. Also, a finding that a patient’s knee extensors are weaker than their hip flexors is “a fantastic bedside sign” differentiating IBM from polymyositis, she said.
That’s not to say IBM patients don’t have hip flexor weakness, but their knee extensors usually are “considerably weaker by a grade strength or more” versus their hip flexors, she explained.
“It’s a very easy bedside test. In typical other myopathies we have this, but the knee extensors aren’t that weak in general, or they’re not as weak as the hip flexors,” she added.
Another sign is distal strength loss, particularly in the forearm and finger flexors.
“I was taught to have them make a fist; don’t have them make a fist,” she said, explaining that this recruits intrinsic muscles which basically allows cheating that may mask weakness.
Instead, ask them to flex just their distal interphalangeal joints by making a claw and using the fingers to pull against your fingers, she suggested.
Mixed myopathic and neuropathic features on electromyography also indicate IBM, she said.
Muscle biopsy may be helpful, but inclusions are seen in less than one-third of IBM patients.
“At times, we have had to biopsy three times to see them at all, and some people never show them, so you have to rely on your clinical acumen if you don’t see them,” she said.
Also, keep in mind that these patients are often labeled as having treatment-resistant polymyositis.
“Please, when somebody refers to you somebody that’s treatment resistant, that may be the case, but I want you to think maybe they’re treatment resistant because they don’t have that disease.”
Muscular dystrophy
Some cases of myositis mimic certain types of muscular dystrophy, Dr. Christopher-Stine said, providing a checklist of muscular dystrophies that can look “clinically completely indistinguishable from a typical inflammatory myopathy,” and should therefore be considered in these patients.
The checklist includes Duchenne’s manifesting carrier, limb girdle muscular dystrophy type 2b, myotonic dystrophy (usually type 2), and facioscapulohumeral muscular dystrophy.
Dr. Christopher-Stine reported having intellectual property interest in a novel Inova Diagnostics autoantibody assay detection for anti-HMGCR. She was also the safety officer for the JBT-101 Trial sponsored by Corbus and funded by the National Institutes of Health.
EXPERT ANALYSIS FROM THE WINTER RHEUMATOLOGY SYMPOSIUM
McAneny: Transparency needed for meaningful talk on drug pricing
WASHINGTON – As the rising cost of prescription drugs continues to garner heightened scrutiny from the federal government, one thing is missing from the conversation that would make any solution more effective, according to American Medical Association President Barbara L. McAneny, MD.
“We would like to see transparency from end to end in this pipeline because that is the way we will have the ability to look for savings,” she said in an interview at a national advocacy conference sponsored by the American Medical Association.
“I think we don’t have the information we need to make rational decisions,” she said. “I think the first thing we need to do is to understand the entire pipeline from the basic research that results in a drug’s clinical trials that results in a new drug to the pharmacy benefit managers and all of the ways that they have increased the cost of the drugs all the way to when the patient actually gets it.”
In particular, Dr. McAneny targeted the need for transparency in the role and financial impact pharmacy benefit managers have on the cost of prescription drugs.
“We were told at our state advocacy conference, which we held in January, by an expert who studied pharmacy benefit managers, that 42% of the cost of any drug is attributable to the profits of pharmacy benefit managers,” she said. “To me, that makes me wonder what value do they add that is worth 42% of these exorbitant costs and if they are not adding value, why do we have them in this process?”
She also called on the pharmaceutical manufacturers to be more forthcoming with their financial information regarding marketing and advertising, but she stressed that it needs to be done in a way that does not hinder future development of life-saving therapies.
“We do not want to stifle innovation.” Dr. McAneny said. “As a cancer doctor, I have seen diseases that I used to treat with morphine and sympathy now be diseases that I can treat, where I can restore people to good quality of life and buy them additional years of life because of these drugs. They are amazing and I don’t want to do without them and I want more of them. ... We want to support that research. That is probably worth a lot of the price tag. But how much of that goes to direct-to-consumer advertising? How much of that is the advertising budget? Where can we cut some of this out of the system so that we get the innovation, but we get innovation that all of our patients can afford?”
Another issue that is looming for physicians is a payment rate freeze from 2020-2025 under the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program, which was created under the Medicare Access and CHIP Reauthorization Act (MACRA).
“A 5-year freeze when my expenses do not freeze is a terrifying thing and could be a practice-ending expense for a lot of practices,” Dr. McAneny warned. “I will point out that independent practices, if they sell to a hospital, the cost of care immediately doubles. The amount that is paid for it, not the cost of delivering it. So that is not a great solution. But we also have this increasing practice expense and a flat rate is not going to help practices survive. So I am very concerned.”
Related to the QPP, Dr. McAneny also wants to see the Centers for Medicare & Medicaid Services do more with physician-developed alternative payment models. The Physician-Focused Payment Model Technical Advisory Committee (PTAC) continues to review and evaluate submissions, but to date, the CMS has yet to implement any of the committee’s recommendations.
“I read all of the PTAC submissions that went to CMS. Some of them I thought were a little on the weak side, but there are a lot of them that I thought were really good ideas. I do not know why CMS did not approve them and fund them and let them be tried,” she said, although she did offer an opinion on why the agency has yet to act on any of them.
“I read their paper saying why they didn’t approve [the recommended physician-developed alternative payment models]. It seemed to me they are waiting for one silver bullet that will fix all of health care. I don’t think a silver bullet is going to fix health care. It’s not an issue. It’s a complicated set of issues. You will not have a quick fix.”
WASHINGTON – As the rising cost of prescription drugs continues to garner heightened scrutiny from the federal government, one thing is missing from the conversation that would make any solution more effective, according to American Medical Association President Barbara L. McAneny, MD.
“We would like to see transparency from end to end in this pipeline because that is the way we will have the ability to look for savings,” she said in an interview at a national advocacy conference sponsored by the American Medical Association.
“I think we don’t have the information we need to make rational decisions,” she said. “I think the first thing we need to do is to understand the entire pipeline from the basic research that results in a drug’s clinical trials that results in a new drug to the pharmacy benefit managers and all of the ways that they have increased the cost of the drugs all the way to when the patient actually gets it.”
In particular, Dr. McAneny targeted the need for transparency in the role and financial impact pharmacy benefit managers have on the cost of prescription drugs.
“We were told at our state advocacy conference, which we held in January, by an expert who studied pharmacy benefit managers, that 42% of the cost of any drug is attributable to the profits of pharmacy benefit managers,” she said. “To me, that makes me wonder what value do they add that is worth 42% of these exorbitant costs and if they are not adding value, why do we have them in this process?”
She also called on the pharmaceutical manufacturers to be more forthcoming with their financial information regarding marketing and advertising, but she stressed that it needs to be done in a way that does not hinder future development of life-saving therapies.
“We do not want to stifle innovation.” Dr. McAneny said. “As a cancer doctor, I have seen diseases that I used to treat with morphine and sympathy now be diseases that I can treat, where I can restore people to good quality of life and buy them additional years of life because of these drugs. They are amazing and I don’t want to do without them and I want more of them. ... We want to support that research. That is probably worth a lot of the price tag. But how much of that goes to direct-to-consumer advertising? How much of that is the advertising budget? Where can we cut some of this out of the system so that we get the innovation, but we get innovation that all of our patients can afford?”
Another issue that is looming for physicians is a payment rate freeze from 2020-2025 under the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program, which was created under the Medicare Access and CHIP Reauthorization Act (MACRA).
“A 5-year freeze when my expenses do not freeze is a terrifying thing and could be a practice-ending expense for a lot of practices,” Dr. McAneny warned. “I will point out that independent practices, if they sell to a hospital, the cost of care immediately doubles. The amount that is paid for it, not the cost of delivering it. So that is not a great solution. But we also have this increasing practice expense and a flat rate is not going to help practices survive. So I am very concerned.”
Related to the QPP, Dr. McAneny also wants to see the Centers for Medicare & Medicaid Services do more with physician-developed alternative payment models. The Physician-Focused Payment Model Technical Advisory Committee (PTAC) continues to review and evaluate submissions, but to date, the CMS has yet to implement any of the committee’s recommendations.
“I read all of the PTAC submissions that went to CMS. Some of them I thought were a little on the weak side, but there are a lot of them that I thought were really good ideas. I do not know why CMS did not approve them and fund them and let them be tried,” she said, although she did offer an opinion on why the agency has yet to act on any of them.
“I read their paper saying why they didn’t approve [the recommended physician-developed alternative payment models]. It seemed to me they are waiting for one silver bullet that will fix all of health care. I don’t think a silver bullet is going to fix health care. It’s not an issue. It’s a complicated set of issues. You will not have a quick fix.”
WASHINGTON – As the rising cost of prescription drugs continues to garner heightened scrutiny from the federal government, one thing is missing from the conversation that would make any solution more effective, according to American Medical Association President Barbara L. McAneny, MD.
“We would like to see transparency from end to end in this pipeline because that is the way we will have the ability to look for savings,” she said in an interview at a national advocacy conference sponsored by the American Medical Association.
“I think we don’t have the information we need to make rational decisions,” she said. “I think the first thing we need to do is to understand the entire pipeline from the basic research that results in a drug’s clinical trials that results in a new drug to the pharmacy benefit managers and all of the ways that they have increased the cost of the drugs all the way to when the patient actually gets it.”
In particular, Dr. McAneny targeted the need for transparency in the role and financial impact pharmacy benefit managers have on the cost of prescription drugs.
“We were told at our state advocacy conference, which we held in January, by an expert who studied pharmacy benefit managers, that 42% of the cost of any drug is attributable to the profits of pharmacy benefit managers,” she said. “To me, that makes me wonder what value do they add that is worth 42% of these exorbitant costs and if they are not adding value, why do we have them in this process?”
She also called on the pharmaceutical manufacturers to be more forthcoming with their financial information regarding marketing and advertising, but she stressed that it needs to be done in a way that does not hinder future development of life-saving therapies.
“We do not want to stifle innovation.” Dr. McAneny said. “As a cancer doctor, I have seen diseases that I used to treat with morphine and sympathy now be diseases that I can treat, where I can restore people to good quality of life and buy them additional years of life because of these drugs. They are amazing and I don’t want to do without them and I want more of them. ... We want to support that research. That is probably worth a lot of the price tag. But how much of that goes to direct-to-consumer advertising? How much of that is the advertising budget? Where can we cut some of this out of the system so that we get the innovation, but we get innovation that all of our patients can afford?”
Another issue that is looming for physicians is a payment rate freeze from 2020-2025 under the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program, which was created under the Medicare Access and CHIP Reauthorization Act (MACRA).
“A 5-year freeze when my expenses do not freeze is a terrifying thing and could be a practice-ending expense for a lot of practices,” Dr. McAneny warned. “I will point out that independent practices, if they sell to a hospital, the cost of care immediately doubles. The amount that is paid for it, not the cost of delivering it. So that is not a great solution. But we also have this increasing practice expense and a flat rate is not going to help practices survive. So I am very concerned.”
Related to the QPP, Dr. McAneny also wants to see the Centers for Medicare & Medicaid Services do more with physician-developed alternative payment models. The Physician-Focused Payment Model Technical Advisory Committee (PTAC) continues to review and evaluate submissions, but to date, the CMS has yet to implement any of the committee’s recommendations.
“I read all of the PTAC submissions that went to CMS. Some of them I thought were a little on the weak side, but there are a lot of them that I thought were really good ideas. I do not know why CMS did not approve them and fund them and let them be tried,” she said, although she did offer an opinion on why the agency has yet to act on any of them.
“I read their paper saying why they didn’t approve [the recommended physician-developed alternative payment models]. It seemed to me they are waiting for one silver bullet that will fix all of health care. I don’t think a silver bullet is going to fix health care. It’s not an issue. It’s a complicated set of issues. You will not have a quick fix.”
REPORTING FROM THE AMA NATIONAL ADVOCACY CONFERENCE
A prescription for medicine’s gender inequality
A small study identifies skin microbiome changes after UV exposure. Lower prices drive OTC insulin sales at Walmart. And early intensive treatment of multiple sclerosis may benefit patients.
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A small study identifies skin microbiome changes after UV exposure. Lower prices drive OTC insulin sales at Walmart. And early intensive treatment of multiple sclerosis may benefit patients.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
A small study identifies skin microbiome changes after UV exposure. Lower prices drive OTC insulin sales at Walmart. And early intensive treatment of multiple sclerosis may benefit patients.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
Noncardiac surgery has 7% covert stroke rate in elderly
HONOLULU – Covert strokes are relatively common in elderly patients who undergo noncardiac surgery, with a 7% incidence among a group of prospectively followed but generally unselected patients in a multicenter, international study.
By definition, these covert strokes were acutely asymptomatic, but showed evidence of clinical effects during the subsequent year. Twelve months after surgery, patients with acute, perioperative covert strokes found by systematic collection of postoperative MRI brain scans had a twofold increased rate of cognitive decline and a greater than twofold increased rate of delirium, compared with the patients who did not have evidence of a covert stroke, Marko Mrkobrada, MD, said at the International Stroke Conference sponsored by the American Heart Association.
The message from these findings is that, when elderly patients exhibit confusion or delirium after noncardiac surgery, their physicians should have a high index of suspicion that a covert stroke may have occurred, Dr. Mrkobrada said in a video interview. It’s possible that typical stroke symptoms do not appear in many of the covert stroke patients because they are masked in the immediate postoperative period, he added.
Right now, the only way to screen for a covert stroke is with a brain MR, a test that generally costs several hundred dollars, which is too expensive for routine screening. Dr. Mrkobrada said that his team hopes further study will identify a biomarker that can flag patients with a covert stroke at a lower cost. For example, colleagues of Dr. Mrkobrada have successfully used high-sensitivity troponin T, a biomarker of myocardial injury, to identify patients who have myocardial injury after noncardiac surgery (MINS; JAMA. 2017 April 25;371[16]:1642-51). Study results also established that treating MINS patients with dabigatran improved their long-term clinical outcomes (Lancet. 2018 June 9;391[10137]:2325-34).
Covert stroke after noncardiac surgery “is the same concept” as MINS, said Dr. Mrkobrada, a researcher at the London Health Sciences Centre in Canada. “We find strokes that do not get picked up after noncardiac surgery just like MIs that are not picked up,” he said. It’s also possible that certain interventions may improve outcomes in patients with covert strokes, just as they have helped MINS patients, he suggested. Potentially helpful interventions could include aspirin, a statin, and improved blood pressure control. A major goal for his research group is finding a biomarker that makes diagnosing covert stroke as easy as using high sensitivity troponin T to diagnose MINS.
The NeuroVISION (Detection and Neurological Impact of Cerebrovascular Events In Noncardiac Surgery Patients: A Cohort EvaluatioN) study enrolled and tested 1,114 people aged 65 years or older scheduled for elective noncardiac surgery anticipated to keep them hospitalized for at least 2 days at any of 12 participating centers in nine countries. Patients underwent cognitive function testing before surgery and had a brain MR scan 2-9 days after surgery, and they were excluded if they developed an overt stroke prior to the scan. Patients underwent a second round of cognitive testing a year after surgery. Patients averaged 73 years old.
The screening MR scans identified covert strokes in 78 of the study subjects (7%). The 1-year cognitive tests showed measurable drops in cognitive function in 42% of those who had experience covert strokes and in 29% of everyone else. Those rates translated to a doubled odds ratio for cognitive decline after covert stroke, compared with people without covert stroke after adjustment for baseline between-group differences, a highly statistically significant between-group difference for the study’s primary endpoint. Delirium occurred 2.2-fold more often in the covert stroke patients after adjustment, and overt strokes during 1-year follow-up were 4.1-fold more common patients who’d experienced a covert stroke, compared with everyone else, after adjustment, Dr. Mrkobrada reported. NeuroVISION is the first large-scale study to assess the incidence and associations of covert strokes after noncardiac surgery, he noted.
SOURCE: Mrkobrada M. ISC 2019, Late-Breaking Abstract LB18.
HONOLULU – Covert strokes are relatively common in elderly patients who undergo noncardiac surgery, with a 7% incidence among a group of prospectively followed but generally unselected patients in a multicenter, international study.
By definition, these covert strokes were acutely asymptomatic, but showed evidence of clinical effects during the subsequent year. Twelve months after surgery, patients with acute, perioperative covert strokes found by systematic collection of postoperative MRI brain scans had a twofold increased rate of cognitive decline and a greater than twofold increased rate of delirium, compared with the patients who did not have evidence of a covert stroke, Marko Mrkobrada, MD, said at the International Stroke Conference sponsored by the American Heart Association.
The message from these findings is that, when elderly patients exhibit confusion or delirium after noncardiac surgery, their physicians should have a high index of suspicion that a covert stroke may have occurred, Dr. Mrkobrada said in a video interview. It’s possible that typical stroke symptoms do not appear in many of the covert stroke patients because they are masked in the immediate postoperative period, he added.
Right now, the only way to screen for a covert stroke is with a brain MR, a test that generally costs several hundred dollars, which is too expensive for routine screening. Dr. Mrkobrada said that his team hopes further study will identify a biomarker that can flag patients with a covert stroke at a lower cost. For example, colleagues of Dr. Mrkobrada have successfully used high-sensitivity troponin T, a biomarker of myocardial injury, to identify patients who have myocardial injury after noncardiac surgery (MINS; JAMA. 2017 April 25;371[16]:1642-51). Study results also established that treating MINS patients with dabigatran improved their long-term clinical outcomes (Lancet. 2018 June 9;391[10137]:2325-34).
Covert stroke after noncardiac surgery “is the same concept” as MINS, said Dr. Mrkobrada, a researcher at the London Health Sciences Centre in Canada. “We find strokes that do not get picked up after noncardiac surgery just like MIs that are not picked up,” he said. It’s also possible that certain interventions may improve outcomes in patients with covert strokes, just as they have helped MINS patients, he suggested. Potentially helpful interventions could include aspirin, a statin, and improved blood pressure control. A major goal for his research group is finding a biomarker that makes diagnosing covert stroke as easy as using high sensitivity troponin T to diagnose MINS.
The NeuroVISION (Detection and Neurological Impact of Cerebrovascular Events In Noncardiac Surgery Patients: A Cohort EvaluatioN) study enrolled and tested 1,114 people aged 65 years or older scheduled for elective noncardiac surgery anticipated to keep them hospitalized for at least 2 days at any of 12 participating centers in nine countries. Patients underwent cognitive function testing before surgery and had a brain MR scan 2-9 days after surgery, and they were excluded if they developed an overt stroke prior to the scan. Patients underwent a second round of cognitive testing a year after surgery. Patients averaged 73 years old.
The screening MR scans identified covert strokes in 78 of the study subjects (7%). The 1-year cognitive tests showed measurable drops in cognitive function in 42% of those who had experience covert strokes and in 29% of everyone else. Those rates translated to a doubled odds ratio for cognitive decline after covert stroke, compared with people without covert stroke after adjustment for baseline between-group differences, a highly statistically significant between-group difference for the study’s primary endpoint. Delirium occurred 2.2-fold more often in the covert stroke patients after adjustment, and overt strokes during 1-year follow-up were 4.1-fold more common patients who’d experienced a covert stroke, compared with everyone else, after adjustment, Dr. Mrkobrada reported. NeuroVISION is the first large-scale study to assess the incidence and associations of covert strokes after noncardiac surgery, he noted.
SOURCE: Mrkobrada M. ISC 2019, Late-Breaking Abstract LB18.
HONOLULU – Covert strokes are relatively common in elderly patients who undergo noncardiac surgery, with a 7% incidence among a group of prospectively followed but generally unselected patients in a multicenter, international study.
By definition, these covert strokes were acutely asymptomatic, but showed evidence of clinical effects during the subsequent year. Twelve months after surgery, patients with acute, perioperative covert strokes found by systematic collection of postoperative MRI brain scans had a twofold increased rate of cognitive decline and a greater than twofold increased rate of delirium, compared with the patients who did not have evidence of a covert stroke, Marko Mrkobrada, MD, said at the International Stroke Conference sponsored by the American Heart Association.
The message from these findings is that, when elderly patients exhibit confusion or delirium after noncardiac surgery, their physicians should have a high index of suspicion that a covert stroke may have occurred, Dr. Mrkobrada said in a video interview. It’s possible that typical stroke symptoms do not appear in many of the covert stroke patients because they are masked in the immediate postoperative period, he added.
Right now, the only way to screen for a covert stroke is with a brain MR, a test that generally costs several hundred dollars, which is too expensive for routine screening. Dr. Mrkobrada said that his team hopes further study will identify a biomarker that can flag patients with a covert stroke at a lower cost. For example, colleagues of Dr. Mrkobrada have successfully used high-sensitivity troponin T, a biomarker of myocardial injury, to identify patients who have myocardial injury after noncardiac surgery (MINS; JAMA. 2017 April 25;371[16]:1642-51). Study results also established that treating MINS patients with dabigatran improved their long-term clinical outcomes (Lancet. 2018 June 9;391[10137]:2325-34).
Covert stroke after noncardiac surgery “is the same concept” as MINS, said Dr. Mrkobrada, a researcher at the London Health Sciences Centre in Canada. “We find strokes that do not get picked up after noncardiac surgery just like MIs that are not picked up,” he said. It’s also possible that certain interventions may improve outcomes in patients with covert strokes, just as they have helped MINS patients, he suggested. Potentially helpful interventions could include aspirin, a statin, and improved blood pressure control. A major goal for his research group is finding a biomarker that makes diagnosing covert stroke as easy as using high sensitivity troponin T to diagnose MINS.
The NeuroVISION (Detection and Neurological Impact of Cerebrovascular Events In Noncardiac Surgery Patients: A Cohort EvaluatioN) study enrolled and tested 1,114 people aged 65 years or older scheduled for elective noncardiac surgery anticipated to keep them hospitalized for at least 2 days at any of 12 participating centers in nine countries. Patients underwent cognitive function testing before surgery and had a brain MR scan 2-9 days after surgery, and they were excluded if they developed an overt stroke prior to the scan. Patients underwent a second round of cognitive testing a year after surgery. Patients averaged 73 years old.
The screening MR scans identified covert strokes in 78 of the study subjects (7%). The 1-year cognitive tests showed measurable drops in cognitive function in 42% of those who had experience covert strokes and in 29% of everyone else. Those rates translated to a doubled odds ratio for cognitive decline after covert stroke, compared with people without covert stroke after adjustment for baseline between-group differences, a highly statistically significant between-group difference for the study’s primary endpoint. Delirium occurred 2.2-fold more often in the covert stroke patients after adjustment, and overt strokes during 1-year follow-up were 4.1-fold more common patients who’d experienced a covert stroke, compared with everyone else, after adjustment, Dr. Mrkobrada reported. NeuroVISION is the first large-scale study to assess the incidence and associations of covert strokes after noncardiac surgery, he noted.
SOURCE: Mrkobrada M. ISC 2019, Late-Breaking Abstract LB18.
REPORTING FROM ISC 2019
Key clinical point:
Major finding: Elderly patients who underwent noncardiac surgery had a 7% incidence of covert stroke.
Study details: NeuroVISION, a prospective, multicenter, observational study with 1,114 patients.
Disclosures: NeuroVISION did not receive commercial funding. Dr. Mrkobrada had no disclosures.
Source: Mrkobrada M. ISC 2019, Late-Breaking Abstract LB18.
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Also today, adherence to statins is lower among younger patients, women, and minorities, the flu season rages on, and how medication-assisted treatment impacts pregnant women with opioid use disorder.
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Apple Podcasts
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Also today, adherence to statins is lower among younger patients, women, and minorities, the flu season rages on, and how medication-assisted treatment impacts pregnant women with opioid use disorder.
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