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News and Views that Matter to Pediatricians
The leading independent newspaper covering news and commentary in pediatrics.
If you give a mouse a genetically engineered bitcoin wallet
The world’s most valuable mouse
You’ve heard of Mighty Mouse. Now say hello to the world’s newest mouse superhero, Crypto-Mouse! After being bitten by a radioactive cryptocurrency investor, Crypto-Mouse can tap directly into the power of the blockchain itself, allowing it to perform incredible, death-defying feats of strength!
We’re going to stop right there before Crypto-Mouse gains entry into the Marvel cinematic universe. Let’s rewind to the beginning, because that’s precisely where this crazy scheme is at. In late January, a new decentralized autonomous organization, BitMouseDAO, launched to enormous … -ly little fanfare, according to Vice. Two investors as of Jan. 31. But what they lack in money they make up for in sheer ambition.
BitMouseDAO’s $100 million dollar idea is to genetically engineer mice to carry bitcoin, the first cryptocurrency and one of the most valuable. This isn’t as crazy an idea as it sounds since DNA can be modified to store information, potentially even bitcoin information. Their plan is to create a private bitcoin wallet, which will be stored in the mouse DNA, and purchase online bitcoin to store in this wallet.
BitMouseDAO, being a “collection of artists,” plans to partner with a lab to translate its private key into a specific DNA sequence to be encoded into the mice during fertilization; or, if that doesn’t work, inject them with a harmless virus that carries the key.
Since these are artists, their ultimate plan is to use their bitcoin mice to make NFTs (scratch that off your cryptocurrency bingo card) and auction them off to people. Or, as Vice put it, BitMouseDAO essentially plans to send preserved dead mice to people. Artistic dead mice! Artistic dead mice worth millions! Maybe. Even BitMouseDAO admits bitcoin could be worthless by the time the project gets off the ground.
If this all sounds completely insane, that’s because it is. But it also sounds crazy enough to work. Now, if you’ll excuse us, we’re off to write a screenplay about a scrappy group of high-tech thieves who steal a group of genetically altered bitcoin mice to sell for millions, only to keep them as their adorable pets. Trust us Hollywood, it’ll make millions!
Alcoholic monkeys vs. the future of feces
Which is more important, the journey or the destination? Science is all about the destination, yes? Solving the problem, saving a life, expanding horizons. That’s science. Or is it? The scientific method is a process, so does that make it a journey?
For us, today’s journey begins at the University of Iowa, where investigators are trying to reduce alcohol consumption. A worthy goal, and they seem to have made some progress by targeting a liver hormone called fibroblast growth factor 21 (FGF21). But we’re more interested in the process right now, so bring on the alcoholic monkeys. And no, that’s not a death metal/reggae fusion band. Should be, though.
“The vervet monkey population is [composed] of alcohol avoiders, moderate alcohol drinkers, and a group of heavy drinkers,” Matthew Potthoff, PhD, and associates wrote in Cell Metabolism. When this particular bunch of heavy-drinking vervets were given FGF21, they consumed 50% less alcohol than did vehicle-treated controls, so mission accomplished.
Maybe it could be a breakfast cereal. Who wouldn’t enjoy a bowl of alcoholic monkeys in the morning?
And after breakfast, you might be ready for a digitized bowel movement, courtesy of researchers at University of California, San Diego. They’re studying ulcerative colitis (UC) by examining the gut microbiome, and their “most useful biological sample is patient stool,” according to a written statement from the university.
“Once we had all the technology to digitize the stool, the question was, is this going to tell us what’s happening in these patients? The answer turned out to be yes,” co-senior author Rob Knight, PhD, said in the statement. “Digitizing fecal material is the future.” The road to UC treatment, in other words, is paved with digital stool.
About 40% of the UC patients had elevated protease levels, and their high-protease feces were then transplanted into germ-free mice, which subsequently developed colitis and were successfully treated with protease inhibitors. And that is our final destination.
As our revered founder and mentor, Josephine Lotmevich, used to say, an alcoholic monkey in the hand is worth a number 2 in the bush.
Raise a glass to delinquency
You wouldn’t think that a glass of water could lead to a life of crime, but a recent study suggests just that.
Children exposed to lead in their drinking water during their early years had a 21% higher risk of delinquency after the age of 14 years and a 38% higher risk of having a record for a serious complaint, Jackie MacDonald Gibson and associates said in a statement on Eurekalert.
Data for the study came from Wake County, N.C., which includes rural areas, wealthy exurban developments, and predominantly Black communities. The investigators compared the blood lead levels for children tested between 1998 and 2011 with juvenile delinquency reports of the same children from the N.C. Department of Public Safety.
The main culprit, they found, was well water. Blood lead levels were 11% higher in the children whose water came from private wells, compared with children using community water. About 13% of U.S. households rely on private wells, which are not regulated under the Safe Drinking Water Act, for their water supply.
The researchers said there is an urgent need for better drinking-water solutions in communities that rely on well water, whether it be through subsidized home filtration or infrastructure redevelopment.
An earlier study had estimated that preventing just one child from entering the adult criminal justice system would save $1.3 to $1.5 million in 1997 dollars. That’s about $2.2 to $2.5 million dollars today!
If you do the math, it’s not hard to see what’s cheaper (and healthier) in the long run.
A ‘dirty’ scam
Another one? This is just getting sad. You’ve probably heard of muds and clays being good for the skin and maybe you’ve gone to a spa and sat in a mud bath, but would you believe it if someone told you that mud can cure all your ailments? No? Neither would we. Senatorial candidate Beto O’Rourke was definitely someone who brought this strange treatment to light, but it seems like this is something that has been going on for years, even before the pandemic.
A company called Black Oxygen Organics (BOO) was selling “magic dirt” for $110 per 4-ounce package. It claimed the dirt was high in fulvic acid and humic acid, which are good for many things. They were, however, literally getting this mud from bogs with landfills nearby, Mel magazine reported.
That doesn’t sound appealing at all, but wait, there’s more. People were eating, drinking, bathing, and feeding their families this sludge in hopes that they would be cured of their ailments. A lot of people jumped aboard the magic dirt train when the pandemic arose, but it quickly became clear that this mud was not as helpful as BOO claimed it to be.
“We began to receive inquiries and calls on our website with people having problems and issues. Ultimately, we sent the products out for independent testing, and then when that came back and showed that there were toxic heavy metals [lead, arsenic, and cadmium among them] at an unsafe level, that’s when we knew we had to act,” Atlanta-based attorney Matt Wetherington, who filed a federal lawsuit against BOO, told Mel.
After a very complicated series of events involving an expose by NBC, product recalls, extortion claims, and grassroots activism, BOO was shut down by both the Canadian and U.S. governments.
As always, please listen only to health care professionals when you wish to use natural remedies for illnesses and ailments.
The world’s most valuable mouse
You’ve heard of Mighty Mouse. Now say hello to the world’s newest mouse superhero, Crypto-Mouse! After being bitten by a radioactive cryptocurrency investor, Crypto-Mouse can tap directly into the power of the blockchain itself, allowing it to perform incredible, death-defying feats of strength!
We’re going to stop right there before Crypto-Mouse gains entry into the Marvel cinematic universe. Let’s rewind to the beginning, because that’s precisely where this crazy scheme is at. In late January, a new decentralized autonomous organization, BitMouseDAO, launched to enormous … -ly little fanfare, according to Vice. Two investors as of Jan. 31. But what they lack in money they make up for in sheer ambition.
BitMouseDAO’s $100 million dollar idea is to genetically engineer mice to carry bitcoin, the first cryptocurrency and one of the most valuable. This isn’t as crazy an idea as it sounds since DNA can be modified to store information, potentially even bitcoin information. Their plan is to create a private bitcoin wallet, which will be stored in the mouse DNA, and purchase online bitcoin to store in this wallet.
BitMouseDAO, being a “collection of artists,” plans to partner with a lab to translate its private key into a specific DNA sequence to be encoded into the mice during fertilization; or, if that doesn’t work, inject them with a harmless virus that carries the key.
Since these are artists, their ultimate plan is to use their bitcoin mice to make NFTs (scratch that off your cryptocurrency bingo card) and auction them off to people. Or, as Vice put it, BitMouseDAO essentially plans to send preserved dead mice to people. Artistic dead mice! Artistic dead mice worth millions! Maybe. Even BitMouseDAO admits bitcoin could be worthless by the time the project gets off the ground.
If this all sounds completely insane, that’s because it is. But it also sounds crazy enough to work. Now, if you’ll excuse us, we’re off to write a screenplay about a scrappy group of high-tech thieves who steal a group of genetically altered bitcoin mice to sell for millions, only to keep them as their adorable pets. Trust us Hollywood, it’ll make millions!
Alcoholic monkeys vs. the future of feces
Which is more important, the journey or the destination? Science is all about the destination, yes? Solving the problem, saving a life, expanding horizons. That’s science. Or is it? The scientific method is a process, so does that make it a journey?
For us, today’s journey begins at the University of Iowa, where investigators are trying to reduce alcohol consumption. A worthy goal, and they seem to have made some progress by targeting a liver hormone called fibroblast growth factor 21 (FGF21). But we’re more interested in the process right now, so bring on the alcoholic monkeys. And no, that’s not a death metal/reggae fusion band. Should be, though.
“The vervet monkey population is [composed] of alcohol avoiders, moderate alcohol drinkers, and a group of heavy drinkers,” Matthew Potthoff, PhD, and associates wrote in Cell Metabolism. When this particular bunch of heavy-drinking vervets were given FGF21, they consumed 50% less alcohol than did vehicle-treated controls, so mission accomplished.
Maybe it could be a breakfast cereal. Who wouldn’t enjoy a bowl of alcoholic monkeys in the morning?
And after breakfast, you might be ready for a digitized bowel movement, courtesy of researchers at University of California, San Diego. They’re studying ulcerative colitis (UC) by examining the gut microbiome, and their “most useful biological sample is patient stool,” according to a written statement from the university.
“Once we had all the technology to digitize the stool, the question was, is this going to tell us what’s happening in these patients? The answer turned out to be yes,” co-senior author Rob Knight, PhD, said in the statement. “Digitizing fecal material is the future.” The road to UC treatment, in other words, is paved with digital stool.
About 40% of the UC patients had elevated protease levels, and their high-protease feces were then transplanted into germ-free mice, which subsequently developed colitis and were successfully treated with protease inhibitors. And that is our final destination.
As our revered founder and mentor, Josephine Lotmevich, used to say, an alcoholic monkey in the hand is worth a number 2 in the bush.
Raise a glass to delinquency
You wouldn’t think that a glass of water could lead to a life of crime, but a recent study suggests just that.
Children exposed to lead in their drinking water during their early years had a 21% higher risk of delinquency after the age of 14 years and a 38% higher risk of having a record for a serious complaint, Jackie MacDonald Gibson and associates said in a statement on Eurekalert.
Data for the study came from Wake County, N.C., which includes rural areas, wealthy exurban developments, and predominantly Black communities. The investigators compared the blood lead levels for children tested between 1998 and 2011 with juvenile delinquency reports of the same children from the N.C. Department of Public Safety.
The main culprit, they found, was well water. Blood lead levels were 11% higher in the children whose water came from private wells, compared with children using community water. About 13% of U.S. households rely on private wells, which are not regulated under the Safe Drinking Water Act, for their water supply.
The researchers said there is an urgent need for better drinking-water solutions in communities that rely on well water, whether it be through subsidized home filtration or infrastructure redevelopment.
An earlier study had estimated that preventing just one child from entering the adult criminal justice system would save $1.3 to $1.5 million in 1997 dollars. That’s about $2.2 to $2.5 million dollars today!
If you do the math, it’s not hard to see what’s cheaper (and healthier) in the long run.
A ‘dirty’ scam
Another one? This is just getting sad. You’ve probably heard of muds and clays being good for the skin and maybe you’ve gone to a spa and sat in a mud bath, but would you believe it if someone told you that mud can cure all your ailments? No? Neither would we. Senatorial candidate Beto O’Rourke was definitely someone who brought this strange treatment to light, but it seems like this is something that has been going on for years, even before the pandemic.
A company called Black Oxygen Organics (BOO) was selling “magic dirt” for $110 per 4-ounce package. It claimed the dirt was high in fulvic acid and humic acid, which are good for many things. They were, however, literally getting this mud from bogs with landfills nearby, Mel magazine reported.
That doesn’t sound appealing at all, but wait, there’s more. People were eating, drinking, bathing, and feeding their families this sludge in hopes that they would be cured of their ailments. A lot of people jumped aboard the magic dirt train when the pandemic arose, but it quickly became clear that this mud was not as helpful as BOO claimed it to be.
“We began to receive inquiries and calls on our website with people having problems and issues. Ultimately, we sent the products out for independent testing, and then when that came back and showed that there were toxic heavy metals [lead, arsenic, and cadmium among them] at an unsafe level, that’s when we knew we had to act,” Atlanta-based attorney Matt Wetherington, who filed a federal lawsuit against BOO, told Mel.
After a very complicated series of events involving an expose by NBC, product recalls, extortion claims, and grassroots activism, BOO was shut down by both the Canadian and U.S. governments.
As always, please listen only to health care professionals when you wish to use natural remedies for illnesses and ailments.
The world’s most valuable mouse
You’ve heard of Mighty Mouse. Now say hello to the world’s newest mouse superhero, Crypto-Mouse! After being bitten by a radioactive cryptocurrency investor, Crypto-Mouse can tap directly into the power of the blockchain itself, allowing it to perform incredible, death-defying feats of strength!
We’re going to stop right there before Crypto-Mouse gains entry into the Marvel cinematic universe. Let’s rewind to the beginning, because that’s precisely where this crazy scheme is at. In late January, a new decentralized autonomous organization, BitMouseDAO, launched to enormous … -ly little fanfare, according to Vice. Two investors as of Jan. 31. But what they lack in money they make up for in sheer ambition.
BitMouseDAO’s $100 million dollar idea is to genetically engineer mice to carry bitcoin, the first cryptocurrency and one of the most valuable. This isn’t as crazy an idea as it sounds since DNA can be modified to store information, potentially even bitcoin information. Their plan is to create a private bitcoin wallet, which will be stored in the mouse DNA, and purchase online bitcoin to store in this wallet.
BitMouseDAO, being a “collection of artists,” plans to partner with a lab to translate its private key into a specific DNA sequence to be encoded into the mice during fertilization; or, if that doesn’t work, inject them with a harmless virus that carries the key.
Since these are artists, their ultimate plan is to use their bitcoin mice to make NFTs (scratch that off your cryptocurrency bingo card) and auction them off to people. Or, as Vice put it, BitMouseDAO essentially plans to send preserved dead mice to people. Artistic dead mice! Artistic dead mice worth millions! Maybe. Even BitMouseDAO admits bitcoin could be worthless by the time the project gets off the ground.
If this all sounds completely insane, that’s because it is. But it also sounds crazy enough to work. Now, if you’ll excuse us, we’re off to write a screenplay about a scrappy group of high-tech thieves who steal a group of genetically altered bitcoin mice to sell for millions, only to keep them as their adorable pets. Trust us Hollywood, it’ll make millions!
Alcoholic monkeys vs. the future of feces
Which is more important, the journey or the destination? Science is all about the destination, yes? Solving the problem, saving a life, expanding horizons. That’s science. Or is it? The scientific method is a process, so does that make it a journey?
For us, today’s journey begins at the University of Iowa, where investigators are trying to reduce alcohol consumption. A worthy goal, and they seem to have made some progress by targeting a liver hormone called fibroblast growth factor 21 (FGF21). But we’re more interested in the process right now, so bring on the alcoholic monkeys. And no, that’s not a death metal/reggae fusion band. Should be, though.
“The vervet monkey population is [composed] of alcohol avoiders, moderate alcohol drinkers, and a group of heavy drinkers,” Matthew Potthoff, PhD, and associates wrote in Cell Metabolism. When this particular bunch of heavy-drinking vervets were given FGF21, they consumed 50% less alcohol than did vehicle-treated controls, so mission accomplished.
Maybe it could be a breakfast cereal. Who wouldn’t enjoy a bowl of alcoholic monkeys in the morning?
And after breakfast, you might be ready for a digitized bowel movement, courtesy of researchers at University of California, San Diego. They’re studying ulcerative colitis (UC) by examining the gut microbiome, and their “most useful biological sample is patient stool,” according to a written statement from the university.
“Once we had all the technology to digitize the stool, the question was, is this going to tell us what’s happening in these patients? The answer turned out to be yes,” co-senior author Rob Knight, PhD, said in the statement. “Digitizing fecal material is the future.” The road to UC treatment, in other words, is paved with digital stool.
About 40% of the UC patients had elevated protease levels, and their high-protease feces were then transplanted into germ-free mice, which subsequently developed colitis and were successfully treated with protease inhibitors. And that is our final destination.
As our revered founder and mentor, Josephine Lotmevich, used to say, an alcoholic monkey in the hand is worth a number 2 in the bush.
Raise a glass to delinquency
You wouldn’t think that a glass of water could lead to a life of crime, but a recent study suggests just that.
Children exposed to lead in their drinking water during their early years had a 21% higher risk of delinquency after the age of 14 years and a 38% higher risk of having a record for a serious complaint, Jackie MacDonald Gibson and associates said in a statement on Eurekalert.
Data for the study came from Wake County, N.C., which includes rural areas, wealthy exurban developments, and predominantly Black communities. The investigators compared the blood lead levels for children tested between 1998 and 2011 with juvenile delinquency reports of the same children from the N.C. Department of Public Safety.
The main culprit, they found, was well water. Blood lead levels were 11% higher in the children whose water came from private wells, compared with children using community water. About 13% of U.S. households rely on private wells, which are not regulated under the Safe Drinking Water Act, for their water supply.
The researchers said there is an urgent need for better drinking-water solutions in communities that rely on well water, whether it be through subsidized home filtration or infrastructure redevelopment.
An earlier study had estimated that preventing just one child from entering the adult criminal justice system would save $1.3 to $1.5 million in 1997 dollars. That’s about $2.2 to $2.5 million dollars today!
If you do the math, it’s not hard to see what’s cheaper (and healthier) in the long run.
A ‘dirty’ scam
Another one? This is just getting sad. You’ve probably heard of muds and clays being good for the skin and maybe you’ve gone to a spa and sat in a mud bath, but would you believe it if someone told you that mud can cure all your ailments? No? Neither would we. Senatorial candidate Beto O’Rourke was definitely someone who brought this strange treatment to light, but it seems like this is something that has been going on for years, even before the pandemic.
A company called Black Oxygen Organics (BOO) was selling “magic dirt” for $110 per 4-ounce package. It claimed the dirt was high in fulvic acid and humic acid, which are good for many things. They were, however, literally getting this mud from bogs with landfills nearby, Mel magazine reported.
That doesn’t sound appealing at all, but wait, there’s more. People were eating, drinking, bathing, and feeding their families this sludge in hopes that they would be cured of their ailments. A lot of people jumped aboard the magic dirt train when the pandemic arose, but it quickly became clear that this mud was not as helpful as BOO claimed it to be.
“We began to receive inquiries and calls on our website with people having problems and issues. Ultimately, we sent the products out for independent testing, and then when that came back and showed that there were toxic heavy metals [lead, arsenic, and cadmium among them] at an unsafe level, that’s when we knew we had to act,” Atlanta-based attorney Matt Wetherington, who filed a federal lawsuit against BOO, told Mel.
After a very complicated series of events involving an expose by NBC, product recalls, extortion claims, and grassroots activism, BOO was shut down by both the Canadian and U.S. governments.
As always, please listen only to health care professionals when you wish to use natural remedies for illnesses and ailments.
CLL patients ‘cured’: 10 years post infusion, CAR T cells persist
“We can now conclude that CAR T cells can actually cure patients with leukemia based on these results,” said senior author Carl H. June, MD, in a press briefing on the study published in Nature.
“The major finding from this paper is that, 10 years down the road, you can find these [CAR T] cells,” Dr. June, director of the Center for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, added. “The cells have evolved, and that was a big surprise ... but they are still able to kill leukemia cells 10 years after infusion.”
CAR T-cell therapy, in which patients’ own T cells are removed, reprogrammed in a lab to recognize and attack cancer cells, and then infused back into the patients, has transformed treatment of various blood cancers and shows often-remarkable results in achieving remissions.
While the treatment has become a routine therapy for certain leukemias, long-term results on the fate and function of the cells over time has been highly anticipated.
In the first published observations of a 10-year follow-up of patients treated with CAR T cells, Dr. June and colleagues described the findings for two patients, both with CLL, who back in 2010 were among the first to be treated with this groundbreaking therapy at the University of Pennsylvania.
A decade later, the CAR T cells are found to have remained detectable in both patients, who achieved complete remission in their first year of treatment, and both have sustained that remission.
Notably, the cells have evolved over the years – from initially being dominated by killer T cells to being dominated primarily by proliferative CD4-positive CAR T cells – with one of the patients exclusively having CD4-positive cells at year 9.3.
“The killer T cells did the initial heavy lifting of eliminating the tumor, “ first author J. Joseph Melenhorst, PhD, said in an interview.
“Once their job was done, those cells went down to very low levels, but the CD4-positive population persisted,” said Dr. Melenhorst, who established the lab at the University of Pennsylvania to follow patients treated with CAR T-cell therapy. “[This] delayed phase of immune response against cancer is a novel insight, and we were surprised to see it.”
Dr. Melenhorst noted that the clonal makeup of the CD4-positive cells importantly stabilized and became dominated by a small number of clones, suggesting further sustainability.
When one of the two patients, Doug Olson, who participated in the press conference, donated his cells back to the center after 9.3 years, the researchers found that his cells were still capable of destroying leukemia cells in the lab.
“Ten years [post infusion], we can’t find any of the leukemia cells and we still have the CAR T cells that are on patrol and on surveillance for residual leukemia,” Dr. June said.
One challenge of the otherwise desirable elimination of leukemia cells is that some aspects of sustaining CAR T-cell activity become problematic.
“The aspect of how the remission is maintained [is] very hard to study in a patient when there is no leukemia at all,” Dr. June explained. “It could be the last cell was gone within 3 weeks [of treatment], or it could be that the [cancer cells] are coming up like whack-a-moles, and they are killed because these CAR T cells are on patrol.”
Sadly, the other CLL patient, Bill Ludwig, who was first to receive the CAR T-cell treatment, died in 2021 from COVID-19.
Effects in other blood diseases similar?
CAR T-cell therapy is currently approved in the United States for several blood cancers, and whether similar long-term patterns of the cells may be observed in other patient and cancer types remains to be seen, Dr. Melenhorst said.
“I think in CLL we will see something similar, but in other diseases, we have yet to learn,” he said. “It may depend on issues including which domain has been engineered into the CAR.”
While the prospect of some patients being “cured” is exciting, responses to the therapy have generally been mixed. In CLL, for instance, full remissions have been observed to be maintained in about a quarter of patients, with higher rates observed in some lymphomas and pediatric ALL patients, Dr. Melenhorst explained.
The effects of CAR T-cell therapy in solid cancers have so far been more disappointing, with no research centers reproducing the kinds of results that have been seen with blood cancers.
“There appear to be a number of reasons, including that the [solid] tumor is more complex, and these solid cancers have ways to evade the immune system that need to be overcome,” Dr. June explained.
And despite the more encouraging findings in blood cancers, even with those, “the biggest disappointment is that CAR T-cell therapy doesn’t work all the time. It doesn’t work in every patient,” coauthor David Porter, MD, the University of Pennsylvania oncologist who treated the two patients, said in the press briefing.
“I think the importance of the Nature study is that we are starting to learn the mechanisms of why and how this works, so that we can start to get at how to make it work for more people,” Dr. Porter added. “But what we do see is that, when it works, it really is beyond what we expected 10 or 11 years ago.”
Speaking in the press briefing, Mr. Olson described how several weeks after his treatment in 2010, he became very ill with what has become known as the common, short-term side effect of cytokine release syndrome.
However, after Mr. Olson recovered a few days later, Dr. Porter gave him the remarkable news that “we cannot find a single cancer cell. You appear completely free of CLL.”
Mr. Olson reported that he has since lived a “full life,” kept working, and has even run some half-marathons.
Dr. June confided that the current 10-year results far exceed the team’s early expectations for CAR T-cell therapy. “After Doug [initially] signed his informed consent document for this, we thought that the cells would all be gone within a month or 2. The fact that they have survived for 10 years was a major surprise – and a happy one at that.”
Dr. June, Dr. Melenhorst, and Dr. Porter reported holding patents related to CAR T-cell manufacturing and biomarker discovery.
“We can now conclude that CAR T cells can actually cure patients with leukemia based on these results,” said senior author Carl H. June, MD, in a press briefing on the study published in Nature.
“The major finding from this paper is that, 10 years down the road, you can find these [CAR T] cells,” Dr. June, director of the Center for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, added. “The cells have evolved, and that was a big surprise ... but they are still able to kill leukemia cells 10 years after infusion.”
CAR T-cell therapy, in which patients’ own T cells are removed, reprogrammed in a lab to recognize and attack cancer cells, and then infused back into the patients, has transformed treatment of various blood cancers and shows often-remarkable results in achieving remissions.
While the treatment has become a routine therapy for certain leukemias, long-term results on the fate and function of the cells over time has been highly anticipated.
In the first published observations of a 10-year follow-up of patients treated with CAR T cells, Dr. June and colleagues described the findings for two patients, both with CLL, who back in 2010 were among the first to be treated with this groundbreaking therapy at the University of Pennsylvania.
A decade later, the CAR T cells are found to have remained detectable in both patients, who achieved complete remission in their first year of treatment, and both have sustained that remission.
Notably, the cells have evolved over the years – from initially being dominated by killer T cells to being dominated primarily by proliferative CD4-positive CAR T cells – with one of the patients exclusively having CD4-positive cells at year 9.3.
“The killer T cells did the initial heavy lifting of eliminating the tumor, “ first author J. Joseph Melenhorst, PhD, said in an interview.
“Once their job was done, those cells went down to very low levels, but the CD4-positive population persisted,” said Dr. Melenhorst, who established the lab at the University of Pennsylvania to follow patients treated with CAR T-cell therapy. “[This] delayed phase of immune response against cancer is a novel insight, and we were surprised to see it.”
Dr. Melenhorst noted that the clonal makeup of the CD4-positive cells importantly stabilized and became dominated by a small number of clones, suggesting further sustainability.
When one of the two patients, Doug Olson, who participated in the press conference, donated his cells back to the center after 9.3 years, the researchers found that his cells were still capable of destroying leukemia cells in the lab.
“Ten years [post infusion], we can’t find any of the leukemia cells and we still have the CAR T cells that are on patrol and on surveillance for residual leukemia,” Dr. June said.
One challenge of the otherwise desirable elimination of leukemia cells is that some aspects of sustaining CAR T-cell activity become problematic.
“The aspect of how the remission is maintained [is] very hard to study in a patient when there is no leukemia at all,” Dr. June explained. “It could be the last cell was gone within 3 weeks [of treatment], or it could be that the [cancer cells] are coming up like whack-a-moles, and they are killed because these CAR T cells are on patrol.”
Sadly, the other CLL patient, Bill Ludwig, who was first to receive the CAR T-cell treatment, died in 2021 from COVID-19.
Effects in other blood diseases similar?
CAR T-cell therapy is currently approved in the United States for several blood cancers, and whether similar long-term patterns of the cells may be observed in other patient and cancer types remains to be seen, Dr. Melenhorst said.
“I think in CLL we will see something similar, but in other diseases, we have yet to learn,” he said. “It may depend on issues including which domain has been engineered into the CAR.”
While the prospect of some patients being “cured” is exciting, responses to the therapy have generally been mixed. In CLL, for instance, full remissions have been observed to be maintained in about a quarter of patients, with higher rates observed in some lymphomas and pediatric ALL patients, Dr. Melenhorst explained.
The effects of CAR T-cell therapy in solid cancers have so far been more disappointing, with no research centers reproducing the kinds of results that have been seen with blood cancers.
“There appear to be a number of reasons, including that the [solid] tumor is more complex, and these solid cancers have ways to evade the immune system that need to be overcome,” Dr. June explained.
And despite the more encouraging findings in blood cancers, even with those, “the biggest disappointment is that CAR T-cell therapy doesn’t work all the time. It doesn’t work in every patient,” coauthor David Porter, MD, the University of Pennsylvania oncologist who treated the two patients, said in the press briefing.
“I think the importance of the Nature study is that we are starting to learn the mechanisms of why and how this works, so that we can start to get at how to make it work for more people,” Dr. Porter added. “But what we do see is that, when it works, it really is beyond what we expected 10 or 11 years ago.”
Speaking in the press briefing, Mr. Olson described how several weeks after his treatment in 2010, he became very ill with what has become known as the common, short-term side effect of cytokine release syndrome.
However, after Mr. Olson recovered a few days later, Dr. Porter gave him the remarkable news that “we cannot find a single cancer cell. You appear completely free of CLL.”
Mr. Olson reported that he has since lived a “full life,” kept working, and has even run some half-marathons.
Dr. June confided that the current 10-year results far exceed the team’s early expectations for CAR T-cell therapy. “After Doug [initially] signed his informed consent document for this, we thought that the cells would all be gone within a month or 2. The fact that they have survived for 10 years was a major surprise – and a happy one at that.”
Dr. June, Dr. Melenhorst, and Dr. Porter reported holding patents related to CAR T-cell manufacturing and biomarker discovery.
“We can now conclude that CAR T cells can actually cure patients with leukemia based on these results,” said senior author Carl H. June, MD, in a press briefing on the study published in Nature.
“The major finding from this paper is that, 10 years down the road, you can find these [CAR T] cells,” Dr. June, director of the Center for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, added. “The cells have evolved, and that was a big surprise ... but they are still able to kill leukemia cells 10 years after infusion.”
CAR T-cell therapy, in which patients’ own T cells are removed, reprogrammed in a lab to recognize and attack cancer cells, and then infused back into the patients, has transformed treatment of various blood cancers and shows often-remarkable results in achieving remissions.
While the treatment has become a routine therapy for certain leukemias, long-term results on the fate and function of the cells over time has been highly anticipated.
In the first published observations of a 10-year follow-up of patients treated with CAR T cells, Dr. June and colleagues described the findings for two patients, both with CLL, who back in 2010 were among the first to be treated with this groundbreaking therapy at the University of Pennsylvania.
A decade later, the CAR T cells are found to have remained detectable in both patients, who achieved complete remission in their first year of treatment, and both have sustained that remission.
Notably, the cells have evolved over the years – from initially being dominated by killer T cells to being dominated primarily by proliferative CD4-positive CAR T cells – with one of the patients exclusively having CD4-positive cells at year 9.3.
“The killer T cells did the initial heavy lifting of eliminating the tumor, “ first author J. Joseph Melenhorst, PhD, said in an interview.
“Once their job was done, those cells went down to very low levels, but the CD4-positive population persisted,” said Dr. Melenhorst, who established the lab at the University of Pennsylvania to follow patients treated with CAR T-cell therapy. “[This] delayed phase of immune response against cancer is a novel insight, and we were surprised to see it.”
Dr. Melenhorst noted that the clonal makeup of the CD4-positive cells importantly stabilized and became dominated by a small number of clones, suggesting further sustainability.
When one of the two patients, Doug Olson, who participated in the press conference, donated his cells back to the center after 9.3 years, the researchers found that his cells were still capable of destroying leukemia cells in the lab.
“Ten years [post infusion], we can’t find any of the leukemia cells and we still have the CAR T cells that are on patrol and on surveillance for residual leukemia,” Dr. June said.
One challenge of the otherwise desirable elimination of leukemia cells is that some aspects of sustaining CAR T-cell activity become problematic.
“The aspect of how the remission is maintained [is] very hard to study in a patient when there is no leukemia at all,” Dr. June explained. “It could be the last cell was gone within 3 weeks [of treatment], or it could be that the [cancer cells] are coming up like whack-a-moles, and they are killed because these CAR T cells are on patrol.”
Sadly, the other CLL patient, Bill Ludwig, who was first to receive the CAR T-cell treatment, died in 2021 from COVID-19.
Effects in other blood diseases similar?
CAR T-cell therapy is currently approved in the United States for several blood cancers, and whether similar long-term patterns of the cells may be observed in other patient and cancer types remains to be seen, Dr. Melenhorst said.
“I think in CLL we will see something similar, but in other diseases, we have yet to learn,” he said. “It may depend on issues including which domain has been engineered into the CAR.”
While the prospect of some patients being “cured” is exciting, responses to the therapy have generally been mixed. In CLL, for instance, full remissions have been observed to be maintained in about a quarter of patients, with higher rates observed in some lymphomas and pediatric ALL patients, Dr. Melenhorst explained.
The effects of CAR T-cell therapy in solid cancers have so far been more disappointing, with no research centers reproducing the kinds of results that have been seen with blood cancers.
“There appear to be a number of reasons, including that the [solid] tumor is more complex, and these solid cancers have ways to evade the immune system that need to be overcome,” Dr. June explained.
And despite the more encouraging findings in blood cancers, even with those, “the biggest disappointment is that CAR T-cell therapy doesn’t work all the time. It doesn’t work in every patient,” coauthor David Porter, MD, the University of Pennsylvania oncologist who treated the two patients, said in the press briefing.
“I think the importance of the Nature study is that we are starting to learn the mechanisms of why and how this works, so that we can start to get at how to make it work for more people,” Dr. Porter added. “But what we do see is that, when it works, it really is beyond what we expected 10 or 11 years ago.”
Speaking in the press briefing, Mr. Olson described how several weeks after his treatment in 2010, he became very ill with what has become known as the common, short-term side effect of cytokine release syndrome.
However, after Mr. Olson recovered a few days later, Dr. Porter gave him the remarkable news that “we cannot find a single cancer cell. You appear completely free of CLL.”
Mr. Olson reported that he has since lived a “full life,” kept working, and has even run some half-marathons.
Dr. June confided that the current 10-year results far exceed the team’s early expectations for CAR T-cell therapy. “After Doug [initially] signed his informed consent document for this, we thought that the cells would all be gone within a month or 2. The fact that they have survived for 10 years was a major surprise – and a happy one at that.”
Dr. June, Dr. Melenhorst, and Dr. Porter reported holding patents related to CAR T-cell manufacturing and biomarker discovery.
FROM NATURE
10 things not to do in a medical board hearing
A Florida doctor told his patient her test result would be available in 3-4 days. When the patient didn’t hear back, she called the practice several times, but she didn’t receive a return call. So she filed a complaint against the doctor with the medical board.
When the board investigator interviewed the doctor, the physician said he wasn’t aware the patient had called. But his staff said otherwise. Because the doctor had not been truthful, the board sent him a letter of guidance and required him to attend a training program in ethics.
Miami attorney William J. Spratt Jr., who supplied this anecdote about a former client, said that
The following are some common mistakes that physicians make when dealing with a board complaint.
1. Not responding to the complaint
The complaint you get from the board – which often comes with a subpoena and a response deadline – usually asks for medical records pertinent to the case.
You can’t disregard the board’s letter, said Doug Brocker, an attorney handling board actions in Raleigh, N.C. “It’s amazing to me that some people just ignore a board complaint. Sometimes it’s because the doctor is just burnt out, which may have gotten the doctor into trouble in the first place.”
If you do not respond to a subpoena, “the board can file a court order holding you in contempt and start taking action on your license,” said Jeff Segal, MD, a neurosurgeon and attorney in Greensboro, N.C. Dr. Segal is CEO of Medical Justice Services, which protects physicians’ reputations associated with malpractice suits and board actions. “Not responding is not much different from agreeing to all of the charges.”
2. Not recognizing the seriousness of the complaint
“The biggest mistake is not taking a complaint seriously,” said Linda Stimmel, an attorney at Wilson Elser in Dallas. “Physicians who get a complaint often fire off a brief response stating that the complaint has no merit, without offering any evidence.”
According to Ms. Stimmel, “it’s really important to back up your assertions, such as using excerpts from the medical record, citations of peer-reviewed articles, or a letter of support from a colleague.”
“Weigh your answers carefully, because lack of accuracy will complicate your case,” Mr. Brocker said. “Consult the medical record rather than rely on your memory.”
“Present your version of events, in your own words, because that’s almost always better than the board’s version,” said Dr. Segal.
Even if there was a bad clinical outcome, Dr. Segal said you might point out that the patient was at high risk, or you could show that your clinical outcomes are better than the national average.
3. Thinking the board is on your side
You may be lulled into a false sense of security because the physicians on the medical board are your peers, but they can be as tough as any medical malpractice judge, said William P. Sullivan, DO, an emergency physician and attorney in Frankfort, Ill.
As per the National Practitioner Data Bank, physicians are three to four times more likely to incur an adverse board action than make a malpractice payout, Dr. Sullivan said.
Also, although a malpractice lawsuit rarely involves more than a monetary payment, a board action, like a monitoring plan, can restrict your ability to practice medicine. In fact, any kind of board action against you can make it harder to find employment.
4. Not being honest or forthcoming
“Lying to the board is the fastest way to turn what would have been a minor infraction into putting your license at risk,” Mr. Brocker said. This can happen when doctors update a medical record to support their version of events.
As per Dr. Sullivan, another way to put your license at risk is to withhold adverse information, which the board can detect by obtaining your application for hospital privileges or for licensure to another state, in which you revealed the adverse information.
Dr. Sullivan also advised against claiming you “always” take a certain precautionary measure. “In reality, we doctors don’t always do what we would like to have done. By saying you always do it when you didn’t, you appear less than truthful to the board, and boards have a hard time with that.”
Similarly, “when doctors don’t want to recognize that they could have handled things better, they tend to dance around the issue,” Mr. Brocker said. “This does not sit well with the board.” Insisting that you did everything right when it’s obvious that you didn’t can lead to harsher sanctions. “The board wants to make sure doctors recognize their mistakes and are willing to learn from them.”
5. Providing too much information
You may think that providing a great deal of information strengthens your case, but it can actually weaken it, Mr. Brocker said. Irrelevant information makes your response hard to follow, and it may contain evidence that could prompt another line of inquiry.
“Less is more,” Dr. Segal advised. “Present a coherent argument and keep to the most salient points.” Being concise is also good advice if your complaint proceeds to the board and you have to present your case.
Dr. Segal said the board will stop paying attention to long-winded presentations. He tells his clients to imagine the board is watching a movie. “If your presentation is tedious or hard to follow, you will lose them.”
6. Trying to contact the complainant
Complaints are kept anonymous, but in many cases, the doctor has an idea who the complainant was and may try to contact that person. “It’s natural to wonder why a patient would file a complaint against you,” Mr. Brocker said, but if you reach out to the patient to ask why, “it could look like you’re trying to persuade the patient to drop the complaint.”
Doctors who are involved in a practice breakup or a divorce can be victims of false and malicious complaints, but Beth Y. Collis, a partner at the law firm of Dinsmore & Shohl in Columbus, said boards are onto this tactic and usually reject these complaints.
The doctor may be tempted to sue the complainant, but Mr. Brocker said this won’t stop the complaint and could strengthen it. “Most statements to the medical board are protected from defamation lawsuits, and any lawsuit could appear to be intimidation.”
7. Simply signing a consent agreement
A small minority of complaints may result in the board taking action against the doctor. Typically, this involves getting the doctor to sign a consent agreement stating that he or she agrees with the board’s decision and its remedy, such as continuing education, a fine, or being placed under another doctor’s supervision.
“When the board sends you a consent agreement, it’s usually about something fairly minor,” Ms. Collis said. “You can make a counteroffer and see if they accept that. But once you enter into the agreement, you waive any right to appeal the board’s decision.”
8. Not hiring an attorney
Although some doctors manage to deal with a board complaint on their own, many will need to get an attorney, Mr. Brocker said. “An experienced attorney can help you navigate the board’s process.”
Clients often look for attorneys at the end of the process, when formal charges have already been filed, Mr. Brocker said. At that point, “it’s harder to get things moving in the right direction. You can’t unring the bell.”
Even if you don’t think you need an attorney throughout the case, “it helps to get advice from an attorney at the beginning,” Dr. Segal said. Doctors may think they can’t afford an attorney, but many malpractice carriers pay attorneys’ fees in medical board investigations.
Mr. Brocker advised finding an attorney who is familiar with licensing boards. “Malpractice attorneys may think they can deal with medical boards, but boards are quite different.” For example, “malpractice cases involve an adversarial approach, but licensing boards normally require working collaboratively.”
9. Not requesting a hearing
When the board takes action against you, it can be tempting to just accept the allegations and move on with your life, but it may be possible to undo the action, Dr. Sullivan said. “The board still has to prove its allegations, and it may not have a strong case against you.”
In some states, the medical board has to meet a very high standard of proof, Dr. Sullivan said. In Illinois, for example, the board must show “clear and convincing evidence,” while a malpractice plaintiff must only prove that it’s “more likely than not” that a physician violated the standard of care.
A hearing can especially help doctors facing harsh sanctions for minor offenses. For example, in a case handled by the law firm of Ray & Bishop in Newport Beach, Calif., a doctor who was stopped by police while driving home after having wine at a family gathering was found to have a blood alcohol level of 0.11%. Noting that the physician was on call at the time, the Medical Board of California decided to give him 5 years of probation.
Ray & Bishop asked for a judicial hearing to contest the decision. At the hearing, the physician noted that other physicians were also available to take call that night, and an expert stated that the doctor was not an alcohol abuser. The judge ruled that the board’s action was unduly harsh, and the physician received a public reprimand with no further penalties.
10. Getting upset with board officials
A board investigator may show up at your office uninvited and ask you to answer some questions, but you aren’t required to answer then and there, said Ms. Collis.
In fact, she noted, it’s never a good idea to let investigators into your office. “They can walk around, look through your records, and find more things to investigate.” For this reason, Ms. Collis makes it a point to schedule meetings with investigators at her office.
When you have to interact with board officials, such as during hearings, expressing anger is a mistake. “Some board members may raise their voices and make untrue assertions about your medical care,” Dr. Sullivan said. “You may wish you could respond in kind, but that will not help you.” Instead, calmly provide studies or guidelines supporting the care you provided.
Taking board investigators to task is also a mistake, Mr. Brocker pointed out. In his words, “investigators have to follow the rules. Getting mad at them will only make your case more difficult. Even if you believe the complaint against you is totally without merit, the process needs to run its course.”
A version of this article first appeared on Medscape.com.
A Florida doctor told his patient her test result would be available in 3-4 days. When the patient didn’t hear back, she called the practice several times, but she didn’t receive a return call. So she filed a complaint against the doctor with the medical board.
When the board investigator interviewed the doctor, the physician said he wasn’t aware the patient had called. But his staff said otherwise. Because the doctor had not been truthful, the board sent him a letter of guidance and required him to attend a training program in ethics.
Miami attorney William J. Spratt Jr., who supplied this anecdote about a former client, said that
The following are some common mistakes that physicians make when dealing with a board complaint.
1. Not responding to the complaint
The complaint you get from the board – which often comes with a subpoena and a response deadline – usually asks for medical records pertinent to the case.
You can’t disregard the board’s letter, said Doug Brocker, an attorney handling board actions in Raleigh, N.C. “It’s amazing to me that some people just ignore a board complaint. Sometimes it’s because the doctor is just burnt out, which may have gotten the doctor into trouble in the first place.”
If you do not respond to a subpoena, “the board can file a court order holding you in contempt and start taking action on your license,” said Jeff Segal, MD, a neurosurgeon and attorney in Greensboro, N.C. Dr. Segal is CEO of Medical Justice Services, which protects physicians’ reputations associated with malpractice suits and board actions. “Not responding is not much different from agreeing to all of the charges.”
2. Not recognizing the seriousness of the complaint
“The biggest mistake is not taking a complaint seriously,” said Linda Stimmel, an attorney at Wilson Elser in Dallas. “Physicians who get a complaint often fire off a brief response stating that the complaint has no merit, without offering any evidence.”
According to Ms. Stimmel, “it’s really important to back up your assertions, such as using excerpts from the medical record, citations of peer-reviewed articles, or a letter of support from a colleague.”
“Weigh your answers carefully, because lack of accuracy will complicate your case,” Mr. Brocker said. “Consult the medical record rather than rely on your memory.”
“Present your version of events, in your own words, because that’s almost always better than the board’s version,” said Dr. Segal.
Even if there was a bad clinical outcome, Dr. Segal said you might point out that the patient was at high risk, or you could show that your clinical outcomes are better than the national average.
3. Thinking the board is on your side
You may be lulled into a false sense of security because the physicians on the medical board are your peers, but they can be as tough as any medical malpractice judge, said William P. Sullivan, DO, an emergency physician and attorney in Frankfort, Ill.
As per the National Practitioner Data Bank, physicians are three to four times more likely to incur an adverse board action than make a malpractice payout, Dr. Sullivan said.
Also, although a malpractice lawsuit rarely involves more than a monetary payment, a board action, like a monitoring plan, can restrict your ability to practice medicine. In fact, any kind of board action against you can make it harder to find employment.
4. Not being honest or forthcoming
“Lying to the board is the fastest way to turn what would have been a minor infraction into putting your license at risk,” Mr. Brocker said. This can happen when doctors update a medical record to support their version of events.
As per Dr. Sullivan, another way to put your license at risk is to withhold adverse information, which the board can detect by obtaining your application for hospital privileges or for licensure to another state, in which you revealed the adverse information.
Dr. Sullivan also advised against claiming you “always” take a certain precautionary measure. “In reality, we doctors don’t always do what we would like to have done. By saying you always do it when you didn’t, you appear less than truthful to the board, and boards have a hard time with that.”
Similarly, “when doctors don’t want to recognize that they could have handled things better, they tend to dance around the issue,” Mr. Brocker said. “This does not sit well with the board.” Insisting that you did everything right when it’s obvious that you didn’t can lead to harsher sanctions. “The board wants to make sure doctors recognize their mistakes and are willing to learn from them.”
5. Providing too much information
You may think that providing a great deal of information strengthens your case, but it can actually weaken it, Mr. Brocker said. Irrelevant information makes your response hard to follow, and it may contain evidence that could prompt another line of inquiry.
“Less is more,” Dr. Segal advised. “Present a coherent argument and keep to the most salient points.” Being concise is also good advice if your complaint proceeds to the board and you have to present your case.
Dr. Segal said the board will stop paying attention to long-winded presentations. He tells his clients to imagine the board is watching a movie. “If your presentation is tedious or hard to follow, you will lose them.”
6. Trying to contact the complainant
Complaints are kept anonymous, but in many cases, the doctor has an idea who the complainant was and may try to contact that person. “It’s natural to wonder why a patient would file a complaint against you,” Mr. Brocker said, but if you reach out to the patient to ask why, “it could look like you’re trying to persuade the patient to drop the complaint.”
Doctors who are involved in a practice breakup or a divorce can be victims of false and malicious complaints, but Beth Y. Collis, a partner at the law firm of Dinsmore & Shohl in Columbus, said boards are onto this tactic and usually reject these complaints.
The doctor may be tempted to sue the complainant, but Mr. Brocker said this won’t stop the complaint and could strengthen it. “Most statements to the medical board are protected from defamation lawsuits, and any lawsuit could appear to be intimidation.”
7. Simply signing a consent agreement
A small minority of complaints may result in the board taking action against the doctor. Typically, this involves getting the doctor to sign a consent agreement stating that he or she agrees with the board’s decision and its remedy, such as continuing education, a fine, or being placed under another doctor’s supervision.
“When the board sends you a consent agreement, it’s usually about something fairly minor,” Ms. Collis said. “You can make a counteroffer and see if they accept that. But once you enter into the agreement, you waive any right to appeal the board’s decision.”
8. Not hiring an attorney
Although some doctors manage to deal with a board complaint on their own, many will need to get an attorney, Mr. Brocker said. “An experienced attorney can help you navigate the board’s process.”
Clients often look for attorneys at the end of the process, when formal charges have already been filed, Mr. Brocker said. At that point, “it’s harder to get things moving in the right direction. You can’t unring the bell.”
Even if you don’t think you need an attorney throughout the case, “it helps to get advice from an attorney at the beginning,” Dr. Segal said. Doctors may think they can’t afford an attorney, but many malpractice carriers pay attorneys’ fees in medical board investigations.
Mr. Brocker advised finding an attorney who is familiar with licensing boards. “Malpractice attorneys may think they can deal with medical boards, but boards are quite different.” For example, “malpractice cases involve an adversarial approach, but licensing boards normally require working collaboratively.”
9. Not requesting a hearing
When the board takes action against you, it can be tempting to just accept the allegations and move on with your life, but it may be possible to undo the action, Dr. Sullivan said. “The board still has to prove its allegations, and it may not have a strong case against you.”
In some states, the medical board has to meet a very high standard of proof, Dr. Sullivan said. In Illinois, for example, the board must show “clear and convincing evidence,” while a malpractice plaintiff must only prove that it’s “more likely than not” that a physician violated the standard of care.
A hearing can especially help doctors facing harsh sanctions for minor offenses. For example, in a case handled by the law firm of Ray & Bishop in Newport Beach, Calif., a doctor who was stopped by police while driving home after having wine at a family gathering was found to have a blood alcohol level of 0.11%. Noting that the physician was on call at the time, the Medical Board of California decided to give him 5 years of probation.
Ray & Bishop asked for a judicial hearing to contest the decision. At the hearing, the physician noted that other physicians were also available to take call that night, and an expert stated that the doctor was not an alcohol abuser. The judge ruled that the board’s action was unduly harsh, and the physician received a public reprimand with no further penalties.
10. Getting upset with board officials
A board investigator may show up at your office uninvited and ask you to answer some questions, but you aren’t required to answer then and there, said Ms. Collis.
In fact, she noted, it’s never a good idea to let investigators into your office. “They can walk around, look through your records, and find more things to investigate.” For this reason, Ms. Collis makes it a point to schedule meetings with investigators at her office.
When you have to interact with board officials, such as during hearings, expressing anger is a mistake. “Some board members may raise their voices and make untrue assertions about your medical care,” Dr. Sullivan said. “You may wish you could respond in kind, but that will not help you.” Instead, calmly provide studies or guidelines supporting the care you provided.
Taking board investigators to task is also a mistake, Mr. Brocker pointed out. In his words, “investigators have to follow the rules. Getting mad at them will only make your case more difficult. Even if you believe the complaint against you is totally without merit, the process needs to run its course.”
A version of this article first appeared on Medscape.com.
A Florida doctor told his patient her test result would be available in 3-4 days. When the patient didn’t hear back, she called the practice several times, but she didn’t receive a return call. So she filed a complaint against the doctor with the medical board.
When the board investigator interviewed the doctor, the physician said he wasn’t aware the patient had called. But his staff said otherwise. Because the doctor had not been truthful, the board sent him a letter of guidance and required him to attend a training program in ethics.
Miami attorney William J. Spratt Jr., who supplied this anecdote about a former client, said that
The following are some common mistakes that physicians make when dealing with a board complaint.
1. Not responding to the complaint
The complaint you get from the board – which often comes with a subpoena and a response deadline – usually asks for medical records pertinent to the case.
You can’t disregard the board’s letter, said Doug Brocker, an attorney handling board actions in Raleigh, N.C. “It’s amazing to me that some people just ignore a board complaint. Sometimes it’s because the doctor is just burnt out, which may have gotten the doctor into trouble in the first place.”
If you do not respond to a subpoena, “the board can file a court order holding you in contempt and start taking action on your license,” said Jeff Segal, MD, a neurosurgeon and attorney in Greensboro, N.C. Dr. Segal is CEO of Medical Justice Services, which protects physicians’ reputations associated with malpractice suits and board actions. “Not responding is not much different from agreeing to all of the charges.”
2. Not recognizing the seriousness of the complaint
“The biggest mistake is not taking a complaint seriously,” said Linda Stimmel, an attorney at Wilson Elser in Dallas. “Physicians who get a complaint often fire off a brief response stating that the complaint has no merit, without offering any evidence.”
According to Ms. Stimmel, “it’s really important to back up your assertions, such as using excerpts from the medical record, citations of peer-reviewed articles, or a letter of support from a colleague.”
“Weigh your answers carefully, because lack of accuracy will complicate your case,” Mr. Brocker said. “Consult the medical record rather than rely on your memory.”
“Present your version of events, in your own words, because that’s almost always better than the board’s version,” said Dr. Segal.
Even if there was a bad clinical outcome, Dr. Segal said you might point out that the patient was at high risk, or you could show that your clinical outcomes are better than the national average.
3. Thinking the board is on your side
You may be lulled into a false sense of security because the physicians on the medical board are your peers, but they can be as tough as any medical malpractice judge, said William P. Sullivan, DO, an emergency physician and attorney in Frankfort, Ill.
As per the National Practitioner Data Bank, physicians are three to four times more likely to incur an adverse board action than make a malpractice payout, Dr. Sullivan said.
Also, although a malpractice lawsuit rarely involves more than a monetary payment, a board action, like a monitoring plan, can restrict your ability to practice medicine. In fact, any kind of board action against you can make it harder to find employment.
4. Not being honest or forthcoming
“Lying to the board is the fastest way to turn what would have been a minor infraction into putting your license at risk,” Mr. Brocker said. This can happen when doctors update a medical record to support their version of events.
As per Dr. Sullivan, another way to put your license at risk is to withhold adverse information, which the board can detect by obtaining your application for hospital privileges or for licensure to another state, in which you revealed the adverse information.
Dr. Sullivan also advised against claiming you “always” take a certain precautionary measure. “In reality, we doctors don’t always do what we would like to have done. By saying you always do it when you didn’t, you appear less than truthful to the board, and boards have a hard time with that.”
Similarly, “when doctors don’t want to recognize that they could have handled things better, they tend to dance around the issue,” Mr. Brocker said. “This does not sit well with the board.” Insisting that you did everything right when it’s obvious that you didn’t can lead to harsher sanctions. “The board wants to make sure doctors recognize their mistakes and are willing to learn from them.”
5. Providing too much information
You may think that providing a great deal of information strengthens your case, but it can actually weaken it, Mr. Brocker said. Irrelevant information makes your response hard to follow, and it may contain evidence that could prompt another line of inquiry.
“Less is more,” Dr. Segal advised. “Present a coherent argument and keep to the most salient points.” Being concise is also good advice if your complaint proceeds to the board and you have to present your case.
Dr. Segal said the board will stop paying attention to long-winded presentations. He tells his clients to imagine the board is watching a movie. “If your presentation is tedious or hard to follow, you will lose them.”
6. Trying to contact the complainant
Complaints are kept anonymous, but in many cases, the doctor has an idea who the complainant was and may try to contact that person. “It’s natural to wonder why a patient would file a complaint against you,” Mr. Brocker said, but if you reach out to the patient to ask why, “it could look like you’re trying to persuade the patient to drop the complaint.”
Doctors who are involved in a practice breakup or a divorce can be victims of false and malicious complaints, but Beth Y. Collis, a partner at the law firm of Dinsmore & Shohl in Columbus, said boards are onto this tactic and usually reject these complaints.
The doctor may be tempted to sue the complainant, but Mr. Brocker said this won’t stop the complaint and could strengthen it. “Most statements to the medical board are protected from defamation lawsuits, and any lawsuit could appear to be intimidation.”
7. Simply signing a consent agreement
A small minority of complaints may result in the board taking action against the doctor. Typically, this involves getting the doctor to sign a consent agreement stating that he or she agrees with the board’s decision and its remedy, such as continuing education, a fine, or being placed under another doctor’s supervision.
“When the board sends you a consent agreement, it’s usually about something fairly minor,” Ms. Collis said. “You can make a counteroffer and see if they accept that. But once you enter into the agreement, you waive any right to appeal the board’s decision.”
8. Not hiring an attorney
Although some doctors manage to deal with a board complaint on their own, many will need to get an attorney, Mr. Brocker said. “An experienced attorney can help you navigate the board’s process.”
Clients often look for attorneys at the end of the process, when formal charges have already been filed, Mr. Brocker said. At that point, “it’s harder to get things moving in the right direction. You can’t unring the bell.”
Even if you don’t think you need an attorney throughout the case, “it helps to get advice from an attorney at the beginning,” Dr. Segal said. Doctors may think they can’t afford an attorney, but many malpractice carriers pay attorneys’ fees in medical board investigations.
Mr. Brocker advised finding an attorney who is familiar with licensing boards. “Malpractice attorneys may think they can deal with medical boards, but boards are quite different.” For example, “malpractice cases involve an adversarial approach, but licensing boards normally require working collaboratively.”
9. Not requesting a hearing
When the board takes action against you, it can be tempting to just accept the allegations and move on with your life, but it may be possible to undo the action, Dr. Sullivan said. “The board still has to prove its allegations, and it may not have a strong case against you.”
In some states, the medical board has to meet a very high standard of proof, Dr. Sullivan said. In Illinois, for example, the board must show “clear and convincing evidence,” while a malpractice plaintiff must only prove that it’s “more likely than not” that a physician violated the standard of care.
A hearing can especially help doctors facing harsh sanctions for minor offenses. For example, in a case handled by the law firm of Ray & Bishop in Newport Beach, Calif., a doctor who was stopped by police while driving home after having wine at a family gathering was found to have a blood alcohol level of 0.11%. Noting that the physician was on call at the time, the Medical Board of California decided to give him 5 years of probation.
Ray & Bishop asked for a judicial hearing to contest the decision. At the hearing, the physician noted that other physicians were also available to take call that night, and an expert stated that the doctor was not an alcohol abuser. The judge ruled that the board’s action was unduly harsh, and the physician received a public reprimand with no further penalties.
10. Getting upset with board officials
A board investigator may show up at your office uninvited and ask you to answer some questions, but you aren’t required to answer then and there, said Ms. Collis.
In fact, she noted, it’s never a good idea to let investigators into your office. “They can walk around, look through your records, and find more things to investigate.” For this reason, Ms. Collis makes it a point to schedule meetings with investigators at her office.
When you have to interact with board officials, such as during hearings, expressing anger is a mistake. “Some board members may raise their voices and make untrue assertions about your medical care,” Dr. Sullivan said. “You may wish you could respond in kind, but that will not help you.” Instead, calmly provide studies or guidelines supporting the care you provided.
Taking board investigators to task is also a mistake, Mr. Brocker pointed out. In his words, “investigators have to follow the rules. Getting mad at them will only make your case more difficult. Even if you believe the complaint against you is totally without merit, the process needs to run its course.”
A version of this article first appeared on Medscape.com.
Open-label placebo improves symptoms in pediatric IBS and functional abdominal pain
A spoonful of sugar helps the medicine go down – but what if the sugar is the medicine?
Nearly three in four children with irritable bowel syndrome (IBS) or unexplained abdominal pain reported at least a 30% improvement in discomfort after taking a regimen of sugar water they knew had no medicinal properties.
The findings, published online in JAMA Pediatrics on Jan. 31, 2022, also revealed that participants used significantly less rescue medications when taking the so-called “open-label placebo.” The magnitude of the effect was enough to meet one of the criteria from the Food and Drug Administration to approve drugs to treat IBS, which affects between 10% and 15% of U.S. children.
Although open-label placebo is not ready for clinical use, IBS expert Miranda van Tilburg, PhD, said she is “glad we have evidence” of a strong response in this patient population and that the results “may make clinicians rethink how they introduce treatments.
“By emphasizing their belief that a treatment may work, clinicians can harness the placebo effect,” Dr. van Tilburg, professor of medicine and vice chair of research at Marshall University, Huntington, W.Va., told this news organization.
Study leader Samuel Nurko, MD, MPH, the director of the functional abdominal pain program at Harvard Medical School, Boston, said placebo-controlled trials in patients with IBS and functional abdominal pain consistently show a “very high placebo response.” The question his group set out to answer, he said, was: “Can we get the pain symptoms of these children better by giving them placebo with no deception?”
Between 2015 and 2018, Dr. Nurko and colleagues randomly assigned 30 children and adolescents, aged 8-18 years, with IBS or functional abdominal pain to receive either an open-label inert liquid placebo – consisting of 85% sucrose, citric acid, purified water, and the preservative methyl paraben – twice daily for 3 weeks followed by 3 weeks with no placebo, or to follow the reverse sequence. Roughly half (53%) of the children had functional abdominal pain, and 47% had IBS as defined by Rome III criteria.
Researchers at the three participating clinical sites followed a standardized protocol for explaining the nature of placebo (“like sugar pills without medication”), telling participants that adults with conditions like theirs often benefit from placebo when they receive it as part of blinded, randomized clinical trials. Participants in the study were allowed to use hyoscyamine, an anticholinergic medication, as rescue treatment during the trial.
Dr. Nurko’s team reported that patients had a mean pain score of 39.9 on a 100-point visual analogue scale during the open-label placebo phase of the trial and a mean score of 45 during the control period. That difference was statistically significant (P = .03).
Participants took an average of two hyoscyamine pills during the placebo phase, compared with 3.8 pills during the 3-week period when they did not receive placebo (P < .001).
Nearly three-fourths (73.3%) of children in the study reported that open-label placebo improved their pain by over 30%, thus meeting one of the FDA’s criteria for clinical evaluation of drugs for IBS. Half said the placebo liquid cut their pain by more than 50%.
Dr. Nurko said the findings highlight the need to address “mind-body connections” in the management of gut-brain disorders. Like Dr. van Tilburg, he cautioned that open-label placebo “is not ready for widespread use. Placebo is complicated, and we need to understand the mechanism” underlying its efficacy.
“The idea is eventually we will be able to sort out the exact mechanism and harness it for clinical practice,” he added.
However, Dr. van Tilburg expressed that using placebo therapy to treat children and adolescents with these conditions could send the message that “the pain is not real or all in their heads. Children with chronic pain encounter a lot of stigma, and this kind of treatment may increase the feeling of not being believed. We should be careful to avoid this.”
The study was funded by the National Institutes of Health, the Swiss National Science Foundation, the Schwartz family fund, the Foundation for the Science of the Therapeutic Relationship, and the Morgan Family Foundation.
A version of this article first appeared on Medscape.com.
A spoonful of sugar helps the medicine go down – but what if the sugar is the medicine?
Nearly three in four children with irritable bowel syndrome (IBS) or unexplained abdominal pain reported at least a 30% improvement in discomfort after taking a regimen of sugar water they knew had no medicinal properties.
The findings, published online in JAMA Pediatrics on Jan. 31, 2022, also revealed that participants used significantly less rescue medications when taking the so-called “open-label placebo.” The magnitude of the effect was enough to meet one of the criteria from the Food and Drug Administration to approve drugs to treat IBS, which affects between 10% and 15% of U.S. children.
Although open-label placebo is not ready for clinical use, IBS expert Miranda van Tilburg, PhD, said she is “glad we have evidence” of a strong response in this patient population and that the results “may make clinicians rethink how they introduce treatments.
“By emphasizing their belief that a treatment may work, clinicians can harness the placebo effect,” Dr. van Tilburg, professor of medicine and vice chair of research at Marshall University, Huntington, W.Va., told this news organization.
Study leader Samuel Nurko, MD, MPH, the director of the functional abdominal pain program at Harvard Medical School, Boston, said placebo-controlled trials in patients with IBS and functional abdominal pain consistently show a “very high placebo response.” The question his group set out to answer, he said, was: “Can we get the pain symptoms of these children better by giving them placebo with no deception?”
Between 2015 and 2018, Dr. Nurko and colleagues randomly assigned 30 children and adolescents, aged 8-18 years, with IBS or functional abdominal pain to receive either an open-label inert liquid placebo – consisting of 85% sucrose, citric acid, purified water, and the preservative methyl paraben – twice daily for 3 weeks followed by 3 weeks with no placebo, or to follow the reverse sequence. Roughly half (53%) of the children had functional abdominal pain, and 47% had IBS as defined by Rome III criteria.
Researchers at the three participating clinical sites followed a standardized protocol for explaining the nature of placebo (“like sugar pills without medication”), telling participants that adults with conditions like theirs often benefit from placebo when they receive it as part of blinded, randomized clinical trials. Participants in the study were allowed to use hyoscyamine, an anticholinergic medication, as rescue treatment during the trial.
Dr. Nurko’s team reported that patients had a mean pain score of 39.9 on a 100-point visual analogue scale during the open-label placebo phase of the trial and a mean score of 45 during the control period. That difference was statistically significant (P = .03).
Participants took an average of two hyoscyamine pills during the placebo phase, compared with 3.8 pills during the 3-week period when they did not receive placebo (P < .001).
Nearly three-fourths (73.3%) of children in the study reported that open-label placebo improved their pain by over 30%, thus meeting one of the FDA’s criteria for clinical evaluation of drugs for IBS. Half said the placebo liquid cut their pain by more than 50%.
Dr. Nurko said the findings highlight the need to address “mind-body connections” in the management of gut-brain disorders. Like Dr. van Tilburg, he cautioned that open-label placebo “is not ready for widespread use. Placebo is complicated, and we need to understand the mechanism” underlying its efficacy.
“The idea is eventually we will be able to sort out the exact mechanism and harness it for clinical practice,” he added.
However, Dr. van Tilburg expressed that using placebo therapy to treat children and adolescents with these conditions could send the message that “the pain is not real or all in their heads. Children with chronic pain encounter a lot of stigma, and this kind of treatment may increase the feeling of not being believed. We should be careful to avoid this.”
The study was funded by the National Institutes of Health, the Swiss National Science Foundation, the Schwartz family fund, the Foundation for the Science of the Therapeutic Relationship, and the Morgan Family Foundation.
A version of this article first appeared on Medscape.com.
A spoonful of sugar helps the medicine go down – but what if the sugar is the medicine?
Nearly three in four children with irritable bowel syndrome (IBS) or unexplained abdominal pain reported at least a 30% improvement in discomfort after taking a regimen of sugar water they knew had no medicinal properties.
The findings, published online in JAMA Pediatrics on Jan. 31, 2022, also revealed that participants used significantly less rescue medications when taking the so-called “open-label placebo.” The magnitude of the effect was enough to meet one of the criteria from the Food and Drug Administration to approve drugs to treat IBS, which affects between 10% and 15% of U.S. children.
Although open-label placebo is not ready for clinical use, IBS expert Miranda van Tilburg, PhD, said she is “glad we have evidence” of a strong response in this patient population and that the results “may make clinicians rethink how they introduce treatments.
“By emphasizing their belief that a treatment may work, clinicians can harness the placebo effect,” Dr. van Tilburg, professor of medicine and vice chair of research at Marshall University, Huntington, W.Va., told this news organization.
Study leader Samuel Nurko, MD, MPH, the director of the functional abdominal pain program at Harvard Medical School, Boston, said placebo-controlled trials in patients with IBS and functional abdominal pain consistently show a “very high placebo response.” The question his group set out to answer, he said, was: “Can we get the pain symptoms of these children better by giving them placebo with no deception?”
Between 2015 and 2018, Dr. Nurko and colleagues randomly assigned 30 children and adolescents, aged 8-18 years, with IBS or functional abdominal pain to receive either an open-label inert liquid placebo – consisting of 85% sucrose, citric acid, purified water, and the preservative methyl paraben – twice daily for 3 weeks followed by 3 weeks with no placebo, or to follow the reverse sequence. Roughly half (53%) of the children had functional abdominal pain, and 47% had IBS as defined by Rome III criteria.
Researchers at the three participating clinical sites followed a standardized protocol for explaining the nature of placebo (“like sugar pills without medication”), telling participants that adults with conditions like theirs often benefit from placebo when they receive it as part of blinded, randomized clinical trials. Participants in the study were allowed to use hyoscyamine, an anticholinergic medication, as rescue treatment during the trial.
Dr. Nurko’s team reported that patients had a mean pain score of 39.9 on a 100-point visual analogue scale during the open-label placebo phase of the trial and a mean score of 45 during the control period. That difference was statistically significant (P = .03).
Participants took an average of two hyoscyamine pills during the placebo phase, compared with 3.8 pills during the 3-week period when they did not receive placebo (P < .001).
Nearly three-fourths (73.3%) of children in the study reported that open-label placebo improved their pain by over 30%, thus meeting one of the FDA’s criteria for clinical evaluation of drugs for IBS. Half said the placebo liquid cut their pain by more than 50%.
Dr. Nurko said the findings highlight the need to address “mind-body connections” in the management of gut-brain disorders. Like Dr. van Tilburg, he cautioned that open-label placebo “is not ready for widespread use. Placebo is complicated, and we need to understand the mechanism” underlying its efficacy.
“The idea is eventually we will be able to sort out the exact mechanism and harness it for clinical practice,” he added.
However, Dr. van Tilburg expressed that using placebo therapy to treat children and adolescents with these conditions could send the message that “the pain is not real or all in their heads. Children with chronic pain encounter a lot of stigma, and this kind of treatment may increase the feeling of not being believed. We should be careful to avoid this.”
The study was funded by the National Institutes of Health, the Swiss National Science Foundation, the Schwartz family fund, the Foundation for the Science of the Therapeutic Relationship, and the Morgan Family Foundation.
A version of this article first appeared on Medscape.com.
FROM JAMA PEDIATRICS
Childhood trauma may influence vaccine hesitancy
, data published Feb. 1 suggest.
The findings by Mark A. Bellis, DSc, College of Human Sciences, Bangor (Wales) University, and colleagues were published online in BMJ Open.
The results are especially significant, the authors say, because of the prevalence of adverse childhood experiences (ACEs) globally, with proportions of people having multiple traumas in some countries at 10% or more of the population.
The authors wrote that hesitancy or refusal to get the vaccine increased with the number of traumas reported.
For example, hesitancy was three times higher among people who had experienced four or more types of childhood trauma than among those who did not report any traumatic events.
Dr. Bellis told this news organization that though their work suggests that higher levels of ACEs are linked with higher vaccine hesitancy, it is by no means the only reason people choose not to get vaccinated.
However, he said, the association they found may have key messages for clinicians.
“For clinicians, simply being trauma informed can help,” Dr. Bellis said. “Understanding how such childhood adversity can affect people may help them when discussing vaccines, and in understanding resistance to what is a complex medical issue and one that requires considerable trust. What can appear routine to a clinician may be a difficult leap of faith especially for those who have poorer experiences of trusting even within family settings.”
More trauma, less trust
The authors used responses to a nationally representative telephone survey of adults in Wales taken between December 2020 and March 2021, when COVID-19 restrictions were in force. Out of 6,763 people contacted, 2,285 met all criteria and answered all the questions and were included in the final analysis.
The survey asked about nine types of ACEs before the age of 18, including: parental separation; physical, verbal, and sexual abuse; exposure to domestic violence; and living with a household member who has mental illness, misuses alcohol and/or drugs, or who was incarcerated.
It also included personal details and long-term health information.
About half of the respondents said they hadn’t experienced any childhood trauma. Of those who did, one in five said they had experienced one type, 17% reported two to three types, and 10% reported four or more.
According to the authors, prevalence of ACEs reported was consistent with other comparable population surveys, including those conducted face to face.
They also investigated measures of trust and preference for different health regulations.
People with more ACEs were more likely to have low trust in National Health Service COVID-19 information.
“Other sociodemographics and a history of either chronic disease or COVID-19 infection were not significantly associated with low trust,” the authors pointed out.
People reporting higher ACEs also were more likely to report that they felt they were unfairly restricted by the government. People with four or more ACEs were twice as likely than were those with no ACEs to say they felt unfairly restricted and wanted rules such as mandatory masking to stop.
People with four or more types of trauma were almost twice as likely to ignore the restrictions as were those who hadn’t experienced any – 38% versus 21% – to ignore the restrictions, even after the researchers accounted for associations with sociodemographic factors and previous COVID-19 infection or a history of long-term conditions.
“Clinicians can be a powerful voice to counter more alarmist or even conspiratorial messages that might otherwise resonate with those who find trust difficult,” Dr. Bellis said.
He said that the effect of childhood adversity needs to be considered at all levels in health systems. Overarching public health strategists should include ways to earn trust to counter resistance in some of the most vulnerable communities where ACEs can be higher.
It will also be important in the short-term to “provide reassurance, build community champions, and understand the low base from which trust needs to be built,” he said.
Loss of control
“Past traumatic experiences can predispose someone to avoid things that remind them of that trauma. This avoidance protects them from re-experiencing the negative symptoms and behaviors that come with it. Whether this results into hesitancy of something that would benefit their health is not well known,” Consuelo Cagande, MD, senior associate program director and fellowship adviser in the department of child and adolescent psychiatry and behavioral sciences, Children’s Hospital of Philadelphia, told this news organization.
She pointed out a limitation the authors mention that is common when using ACEs as a measure linking to future negative behaviors – that people self-report them and may misremember or misreport them.
Another limitation is the potential for self-selection bias, as participation level was 36.4%, though the authors noted that is not unusual for unsolicited telephone surveys.
Dr. Cagande said that fearing loss of control may be another factor at play in having to follow restrictions, such as quarantining and masking, social distancing, or mandated vaccinations.
She said it’s important to understand a person’s reason for hesitancy to vaccines and work with the person with the help of the community, to help them trust and feel safe.
Young adults of particular concern
The 18- to 29-year-old age group is of particular concern, Dr. Bellis said.
The researchers estimated the likely rates of vaccine hesitancy according to childhood trauma and age, and the numbers ranged from around 3.5% among those aged 70 and older with no experience of childhood adversity to 38% among 18- to 29-year-olds who had experienced four or more types of childhood trauma.
“Childhood adversity can be an especially raw issue in this group,” he explained. “Some have already been obliged to sacrifice substantial proportions of their teenage lives and some will have suffered greater exposure to adverse childhood experiences as a result of being isolated during the pandemic, sometimes in difficult home environments. Our results suggest that this age group and especially those with high levels of ACEs are some of the most likely to be vaccine hesitant.”
This work was supported by Public Health Wales. The study authors and Dr. Cagande reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, data published Feb. 1 suggest.
The findings by Mark A. Bellis, DSc, College of Human Sciences, Bangor (Wales) University, and colleagues were published online in BMJ Open.
The results are especially significant, the authors say, because of the prevalence of adverse childhood experiences (ACEs) globally, with proportions of people having multiple traumas in some countries at 10% or more of the population.
The authors wrote that hesitancy or refusal to get the vaccine increased with the number of traumas reported.
For example, hesitancy was three times higher among people who had experienced four or more types of childhood trauma than among those who did not report any traumatic events.
Dr. Bellis told this news organization that though their work suggests that higher levels of ACEs are linked with higher vaccine hesitancy, it is by no means the only reason people choose not to get vaccinated.
However, he said, the association they found may have key messages for clinicians.
“For clinicians, simply being trauma informed can help,” Dr. Bellis said. “Understanding how such childhood adversity can affect people may help them when discussing vaccines, and in understanding resistance to what is a complex medical issue and one that requires considerable trust. What can appear routine to a clinician may be a difficult leap of faith especially for those who have poorer experiences of trusting even within family settings.”
More trauma, less trust
The authors used responses to a nationally representative telephone survey of adults in Wales taken between December 2020 and March 2021, when COVID-19 restrictions were in force. Out of 6,763 people contacted, 2,285 met all criteria and answered all the questions and were included in the final analysis.
The survey asked about nine types of ACEs before the age of 18, including: parental separation; physical, verbal, and sexual abuse; exposure to domestic violence; and living with a household member who has mental illness, misuses alcohol and/or drugs, or who was incarcerated.
It also included personal details and long-term health information.
About half of the respondents said they hadn’t experienced any childhood trauma. Of those who did, one in five said they had experienced one type, 17% reported two to three types, and 10% reported four or more.
According to the authors, prevalence of ACEs reported was consistent with other comparable population surveys, including those conducted face to face.
They also investigated measures of trust and preference for different health regulations.
People with more ACEs were more likely to have low trust in National Health Service COVID-19 information.
“Other sociodemographics and a history of either chronic disease or COVID-19 infection were not significantly associated with low trust,” the authors pointed out.
People reporting higher ACEs also were more likely to report that they felt they were unfairly restricted by the government. People with four or more ACEs were twice as likely than were those with no ACEs to say they felt unfairly restricted and wanted rules such as mandatory masking to stop.
People with four or more types of trauma were almost twice as likely to ignore the restrictions as were those who hadn’t experienced any – 38% versus 21% – to ignore the restrictions, even after the researchers accounted for associations with sociodemographic factors and previous COVID-19 infection or a history of long-term conditions.
“Clinicians can be a powerful voice to counter more alarmist or even conspiratorial messages that might otherwise resonate with those who find trust difficult,” Dr. Bellis said.
He said that the effect of childhood adversity needs to be considered at all levels in health systems. Overarching public health strategists should include ways to earn trust to counter resistance in some of the most vulnerable communities where ACEs can be higher.
It will also be important in the short-term to “provide reassurance, build community champions, and understand the low base from which trust needs to be built,” he said.
Loss of control
“Past traumatic experiences can predispose someone to avoid things that remind them of that trauma. This avoidance protects them from re-experiencing the negative symptoms and behaviors that come with it. Whether this results into hesitancy of something that would benefit their health is not well known,” Consuelo Cagande, MD, senior associate program director and fellowship adviser in the department of child and adolescent psychiatry and behavioral sciences, Children’s Hospital of Philadelphia, told this news organization.
She pointed out a limitation the authors mention that is common when using ACEs as a measure linking to future negative behaviors – that people self-report them and may misremember or misreport them.
Another limitation is the potential for self-selection bias, as participation level was 36.4%, though the authors noted that is not unusual for unsolicited telephone surveys.
Dr. Cagande said that fearing loss of control may be another factor at play in having to follow restrictions, such as quarantining and masking, social distancing, or mandated vaccinations.
She said it’s important to understand a person’s reason for hesitancy to vaccines and work with the person with the help of the community, to help them trust and feel safe.
Young adults of particular concern
The 18- to 29-year-old age group is of particular concern, Dr. Bellis said.
The researchers estimated the likely rates of vaccine hesitancy according to childhood trauma and age, and the numbers ranged from around 3.5% among those aged 70 and older with no experience of childhood adversity to 38% among 18- to 29-year-olds who had experienced four or more types of childhood trauma.
“Childhood adversity can be an especially raw issue in this group,” he explained. “Some have already been obliged to sacrifice substantial proportions of their teenage lives and some will have suffered greater exposure to adverse childhood experiences as a result of being isolated during the pandemic, sometimes in difficult home environments. Our results suggest that this age group and especially those with high levels of ACEs are some of the most likely to be vaccine hesitant.”
This work was supported by Public Health Wales. The study authors and Dr. Cagande reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, data published Feb. 1 suggest.
The findings by Mark A. Bellis, DSc, College of Human Sciences, Bangor (Wales) University, and colleagues were published online in BMJ Open.
The results are especially significant, the authors say, because of the prevalence of adverse childhood experiences (ACEs) globally, with proportions of people having multiple traumas in some countries at 10% or more of the population.
The authors wrote that hesitancy or refusal to get the vaccine increased with the number of traumas reported.
For example, hesitancy was three times higher among people who had experienced four or more types of childhood trauma than among those who did not report any traumatic events.
Dr. Bellis told this news organization that though their work suggests that higher levels of ACEs are linked with higher vaccine hesitancy, it is by no means the only reason people choose not to get vaccinated.
However, he said, the association they found may have key messages for clinicians.
“For clinicians, simply being trauma informed can help,” Dr. Bellis said. “Understanding how such childhood adversity can affect people may help them when discussing vaccines, and in understanding resistance to what is a complex medical issue and one that requires considerable trust. What can appear routine to a clinician may be a difficult leap of faith especially for those who have poorer experiences of trusting even within family settings.”
More trauma, less trust
The authors used responses to a nationally representative telephone survey of adults in Wales taken between December 2020 and March 2021, when COVID-19 restrictions were in force. Out of 6,763 people contacted, 2,285 met all criteria and answered all the questions and were included in the final analysis.
The survey asked about nine types of ACEs before the age of 18, including: parental separation; physical, verbal, and sexual abuse; exposure to domestic violence; and living with a household member who has mental illness, misuses alcohol and/or drugs, or who was incarcerated.
It also included personal details and long-term health information.
About half of the respondents said they hadn’t experienced any childhood trauma. Of those who did, one in five said they had experienced one type, 17% reported two to three types, and 10% reported four or more.
According to the authors, prevalence of ACEs reported was consistent with other comparable population surveys, including those conducted face to face.
They also investigated measures of trust and preference for different health regulations.
People with more ACEs were more likely to have low trust in National Health Service COVID-19 information.
“Other sociodemographics and a history of either chronic disease or COVID-19 infection were not significantly associated with low trust,” the authors pointed out.
People reporting higher ACEs also were more likely to report that they felt they were unfairly restricted by the government. People with four or more ACEs were twice as likely than were those with no ACEs to say they felt unfairly restricted and wanted rules such as mandatory masking to stop.
People with four or more types of trauma were almost twice as likely to ignore the restrictions as were those who hadn’t experienced any – 38% versus 21% – to ignore the restrictions, even after the researchers accounted for associations with sociodemographic factors and previous COVID-19 infection or a history of long-term conditions.
“Clinicians can be a powerful voice to counter more alarmist or even conspiratorial messages that might otherwise resonate with those who find trust difficult,” Dr. Bellis said.
He said that the effect of childhood adversity needs to be considered at all levels in health systems. Overarching public health strategists should include ways to earn trust to counter resistance in some of the most vulnerable communities where ACEs can be higher.
It will also be important in the short-term to “provide reassurance, build community champions, and understand the low base from which trust needs to be built,” he said.
Loss of control
“Past traumatic experiences can predispose someone to avoid things that remind them of that trauma. This avoidance protects them from re-experiencing the negative symptoms and behaviors that come with it. Whether this results into hesitancy of something that would benefit their health is not well known,” Consuelo Cagande, MD, senior associate program director and fellowship adviser in the department of child and adolescent psychiatry and behavioral sciences, Children’s Hospital of Philadelphia, told this news organization.
She pointed out a limitation the authors mention that is common when using ACEs as a measure linking to future negative behaviors – that people self-report them and may misremember or misreport them.
Another limitation is the potential for self-selection bias, as participation level was 36.4%, though the authors noted that is not unusual for unsolicited telephone surveys.
Dr. Cagande said that fearing loss of control may be another factor at play in having to follow restrictions, such as quarantining and masking, social distancing, or mandated vaccinations.
She said it’s important to understand a person’s reason for hesitancy to vaccines and work with the person with the help of the community, to help them trust and feel safe.
Young adults of particular concern
The 18- to 29-year-old age group is of particular concern, Dr. Bellis said.
The researchers estimated the likely rates of vaccine hesitancy according to childhood trauma and age, and the numbers ranged from around 3.5% among those aged 70 and older with no experience of childhood adversity to 38% among 18- to 29-year-olds who had experienced four or more types of childhood trauma.
“Childhood adversity can be an especially raw issue in this group,” he explained. “Some have already been obliged to sacrifice substantial proportions of their teenage lives and some will have suffered greater exposure to adverse childhood experiences as a result of being isolated during the pandemic, sometimes in difficult home environments. Our results suggest that this age group and especially those with high levels of ACEs are some of the most likely to be vaccine hesitant.”
This work was supported by Public Health Wales. The study authors and Dr. Cagande reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM BMJ OPEN
What docs don’t know about the Disabilities Act can hurt them and patients
Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School and a disability researcher at Massachusetts General Hospital, both in Boston, has used a wheelchair for more than 30 years because of multiple sclerosis. When she visits her primary care doctor, she doesn’t get weighed because the scales are not wheelchair accessible.
This failure to weigh her and other patients in wheelchairs could lead to serious medical problems. Weight is used to monitor a person’s overall health and prenatal health and to determine accurate doses for medications such as some chemotherapies, said Dr. Iezzoni.
In another situation, a man who used a wheelchair said that his primary care doctor never got him out of it for a complete physical exam. The patient later developed lymphoma, which first appeared in his groin. The doctor should have accommodated his disability and used a height-adjustable exam table or a portable lift to transfer him onto the table.
When physicians don’t provide access to medical care that patients with disabilities need, they put themselves at greater risk of lawsuits, fines, and settlements.
Yet, a new study in Health Affairs suggests that a large percentage of doctors are not fully aware of what they are legally required to do.
Under federal nondiscrimination laws (Americans With Disabilities Act, American Rehabilitation Act, and ADA Amendments Act), medical practices must provide equal access to people with disabilities, accommodate their disability-related needs, and not refuse them medical services because of their disabilities, say disability experts.
Where doctors go wrong with disability laws
What doctors don’t know about providing reasonable accommodations makes them vulnerable to lawsuits, which worries more than two-thirds of the 714 outpatient doctors surveyed.
Not only are they required to provide reasonable accommodations, but they also have to pay for them, the researchers said. One-fifth of the surveyed doctors said they didn’t know that practice owners have to pay.
More than one practice has made patients pay for services needed for their disability, such as sign language interpreters – the patients later complained this violated the ADA to enforcement agencies.
Doctors also don’t know that they have to collaborate with patients to determine what reasonable accommodations they need – over two-thirds of those surveyed said they didn’t know it was a joint responsibility, the study found.
When doctors fail to accommodate patients’ disability needs, they engage in discrimination and violate the ADA, says Elizabeth Pendo, JD, a coauthor of the study and the Joseph J. Simeone Professor of Law at Saint Louis University.
The Department of Justice has investigated several patient complaints of alleged disability discrimination recently and resolved the disputes with agreements and small fines in some cases. “The goal is not to get large financial settlements but to work with practices to get the correct procedures in place to be compliant,” said Ms. Pendo.
Physicians would be wise to check out whether their practices are as accessible as they think. Even if there’s a ramp to the office building, the parking lot may not have a van-accessible space or enough handicapped parking signs, or the exam room may be too narrow for a wheelchair to navigate.
These practices violated the ADA and agreed to make changes:
- Hamden, Conn., has two buildings that patients with physical disabilities couldn’t easily enter. The physician owners agreed to change the buildings’ entrances and access routes and add features to make it easier to use examination rooms and restrooms and the check-in and check-out areas.
- Seven medical offices in Riverside, Calif., failed to communicate effectively with deaf and hard-of-hearing patients. They should have had a qualified sign language interpreter, an assistive listening device, or another appropriate aid or service available to a deaf patient and her family. Instead, the office relied on a video remote interpretation system that often failed to work. The agreement requires the clinic to provide those aids and services to patients and their companions who are deaf or hard of hearing, advertise their availability, assess each patient who is deaf or hard of hearing to determine the best aids and services for their needs, and pay $5,000 in compensation to the complainant and a $1,000 civil penalty to the United States.
- Springfield, Mass., refused to provide full joint replacements to two patients being treated with buprenorphine, a medication used to treat opioid use disorder. Rather than accommodate the patients, the surgeons referred them elsewhere because they were uncomfortable with the postoperative pain management protocol for patients prescribed buprenorphine. “The Americans With Disabilities Act protects health care access for people under medical treatment for opioid use disorder,” said Acting U.S. Attorney Nathaniel R. Mendell. “Health care providers must comply with the ADA, even when doing so is inconvenient or makes them uncomfortable.” The agreement requires the practice to adopt a nondiscrimination policy, provide training on the ADA and opioid use disorder, and pay two complainants $15,000 each for pain and suffering.
The DOJ has filed civil lawsuits against medical practices when they failed to resolve the allegations. Recent cases include an ophthalmology practice with 24 facilities in Arizona that refused to help transfer patients in wheelchairs to surgery tables for eye surgery and required them to pay for transfer support services and two obstetricians-gynecologists in Bakersfield, Calif., who refused to provide routine medical care to a patient because of her HIV status.
What doctors should know
Many people tend to think of a person with a disability as being in a wheelchair. But the ADA has a very broad definition of disability, which includes any physical or mental impairment that substantially limits any major life activity, said Ms. Pendo.
“It was amended in 2008 to clarify that the definition includes people with chronic diseases such as diabetes and cancer, cognitive and neurological disorders, substance abuse disorders, vision and hearing loss, and learning and other disabilities,” she said.
That means that doctors have to accommodate many types of disabilities, which can be challenging. The ADA only specifies that fixed structures need to be accessible, such as parking lots, driveways, and buildings, said Dr. Iezzoni.
When it comes to “reasonable accommodations,” doctors should decide that on a case-by-case basis, she said.
“We can say based on our study that 71% of doctors don’t know the right way to think about the accommodations – they don’t know they need to talk to patients so they can explain to them exactly what they need to accommodate their disability,” said Dr. Iezzoni.
Doctors are also required to provide effective communication for patients with sensory or cognitive disabilities, which can depend on the severity, said Ms. Pendo. Is the person deaf or hard of hearing, blind or partially sighted – is the dementia mild or severe?
“The requirement is there, but what that looks like will vary by patient. That’s what’s challenging,” said Ms. Pendo.
Dr. Iezzoni recommends that doctor’s offices ask patients whether they need special help or individual assistance when they make appointments and enter their responses in their records. She also suggests that patients be asked at follow-up appointments whether they still need the same help or not.
“Disabilities can change over time – a person with bad arthritis may need help getting onto an exam table, but later get a knee or hip replacement that is effective and no longer need that help,” said Dr. Iezzoni.
Benefits outweigh costs
Physicians have made progress in meeting the ADA’s physical accessibility requirements, said Dr. Iezzoni. “The literature suggests that doctors have done a good job at fixing the structural barriers people with mobility issues face, such as ramps and bathrooms.”
However, there are exceptions in rural older buildings which can be harder to retrofit for wheelchair accessibility, she said. “I recall interviewing a rural doctor several years ago who said that he knew his patients well and when a patient visits with mobility problems, he goes down and carries the patient up the steps to his office. My response was that is not respectful of the patient or safe for the patient or you. That doctor has since changed the location of his practice,” said Dr. Iezzoni.
Some doctors may resist paying for accessible medical equipment because of cost, but she said the benefits are worth it. These include preventing staff injuries when they transfer patients and being used by patients with temporary disabilities and aging people with bad knees, backs, hearing and sight. In addition, businesses may be eligible for federal and state tax credits.
Dr. Iezzoni recently visited her doctor where they finally got height-adjustable exam tables. “I asked the assistant, who really likes these tables? She said it’s the elderly ladies of short stature – the table is lowered and they sit down and get on it.”
But, Dr. Iezonni’s main message to doctors is that patients with disabilities deserve equal quality of care. “Just because we have a disability doesn’t mean we should get worse care than other people. It’s a matter of professionalism that doctors should want to give the same quality care to all their patients.”
A version of this article first appeared on Medscape.com.
Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School and a disability researcher at Massachusetts General Hospital, both in Boston, has used a wheelchair for more than 30 years because of multiple sclerosis. When she visits her primary care doctor, she doesn’t get weighed because the scales are not wheelchair accessible.
This failure to weigh her and other patients in wheelchairs could lead to serious medical problems. Weight is used to monitor a person’s overall health and prenatal health and to determine accurate doses for medications such as some chemotherapies, said Dr. Iezzoni.
In another situation, a man who used a wheelchair said that his primary care doctor never got him out of it for a complete physical exam. The patient later developed lymphoma, which first appeared in his groin. The doctor should have accommodated his disability and used a height-adjustable exam table or a portable lift to transfer him onto the table.
When physicians don’t provide access to medical care that patients with disabilities need, they put themselves at greater risk of lawsuits, fines, and settlements.
Yet, a new study in Health Affairs suggests that a large percentage of doctors are not fully aware of what they are legally required to do.
Under federal nondiscrimination laws (Americans With Disabilities Act, American Rehabilitation Act, and ADA Amendments Act), medical practices must provide equal access to people with disabilities, accommodate their disability-related needs, and not refuse them medical services because of their disabilities, say disability experts.
Where doctors go wrong with disability laws
What doctors don’t know about providing reasonable accommodations makes them vulnerable to lawsuits, which worries more than two-thirds of the 714 outpatient doctors surveyed.
Not only are they required to provide reasonable accommodations, but they also have to pay for them, the researchers said. One-fifth of the surveyed doctors said they didn’t know that practice owners have to pay.
More than one practice has made patients pay for services needed for their disability, such as sign language interpreters – the patients later complained this violated the ADA to enforcement agencies.
Doctors also don’t know that they have to collaborate with patients to determine what reasonable accommodations they need – over two-thirds of those surveyed said they didn’t know it was a joint responsibility, the study found.
When doctors fail to accommodate patients’ disability needs, they engage in discrimination and violate the ADA, says Elizabeth Pendo, JD, a coauthor of the study and the Joseph J. Simeone Professor of Law at Saint Louis University.
The Department of Justice has investigated several patient complaints of alleged disability discrimination recently and resolved the disputes with agreements and small fines in some cases. “The goal is not to get large financial settlements but to work with practices to get the correct procedures in place to be compliant,” said Ms. Pendo.
Physicians would be wise to check out whether their practices are as accessible as they think. Even if there’s a ramp to the office building, the parking lot may not have a van-accessible space or enough handicapped parking signs, or the exam room may be too narrow for a wheelchair to navigate.
These practices violated the ADA and agreed to make changes:
- Hamden, Conn., has two buildings that patients with physical disabilities couldn’t easily enter. The physician owners agreed to change the buildings’ entrances and access routes and add features to make it easier to use examination rooms and restrooms and the check-in and check-out areas.
- Seven medical offices in Riverside, Calif., failed to communicate effectively with deaf and hard-of-hearing patients. They should have had a qualified sign language interpreter, an assistive listening device, or another appropriate aid or service available to a deaf patient and her family. Instead, the office relied on a video remote interpretation system that often failed to work. The agreement requires the clinic to provide those aids and services to patients and their companions who are deaf or hard of hearing, advertise their availability, assess each patient who is deaf or hard of hearing to determine the best aids and services for their needs, and pay $5,000 in compensation to the complainant and a $1,000 civil penalty to the United States.
- Springfield, Mass., refused to provide full joint replacements to two patients being treated with buprenorphine, a medication used to treat opioid use disorder. Rather than accommodate the patients, the surgeons referred them elsewhere because they were uncomfortable with the postoperative pain management protocol for patients prescribed buprenorphine. “The Americans With Disabilities Act protects health care access for people under medical treatment for opioid use disorder,” said Acting U.S. Attorney Nathaniel R. Mendell. “Health care providers must comply with the ADA, even when doing so is inconvenient or makes them uncomfortable.” The agreement requires the practice to adopt a nondiscrimination policy, provide training on the ADA and opioid use disorder, and pay two complainants $15,000 each for pain and suffering.
The DOJ has filed civil lawsuits against medical practices when they failed to resolve the allegations. Recent cases include an ophthalmology practice with 24 facilities in Arizona that refused to help transfer patients in wheelchairs to surgery tables for eye surgery and required them to pay for transfer support services and two obstetricians-gynecologists in Bakersfield, Calif., who refused to provide routine medical care to a patient because of her HIV status.
What doctors should know
Many people tend to think of a person with a disability as being in a wheelchair. But the ADA has a very broad definition of disability, which includes any physical or mental impairment that substantially limits any major life activity, said Ms. Pendo.
“It was amended in 2008 to clarify that the definition includes people with chronic diseases such as diabetes and cancer, cognitive and neurological disorders, substance abuse disorders, vision and hearing loss, and learning and other disabilities,” she said.
That means that doctors have to accommodate many types of disabilities, which can be challenging. The ADA only specifies that fixed structures need to be accessible, such as parking lots, driveways, and buildings, said Dr. Iezzoni.
When it comes to “reasonable accommodations,” doctors should decide that on a case-by-case basis, she said.
“We can say based on our study that 71% of doctors don’t know the right way to think about the accommodations – they don’t know they need to talk to patients so they can explain to them exactly what they need to accommodate their disability,” said Dr. Iezzoni.
Doctors are also required to provide effective communication for patients with sensory or cognitive disabilities, which can depend on the severity, said Ms. Pendo. Is the person deaf or hard of hearing, blind or partially sighted – is the dementia mild or severe?
“The requirement is there, but what that looks like will vary by patient. That’s what’s challenging,” said Ms. Pendo.
Dr. Iezzoni recommends that doctor’s offices ask patients whether they need special help or individual assistance when they make appointments and enter their responses in their records. She also suggests that patients be asked at follow-up appointments whether they still need the same help or not.
“Disabilities can change over time – a person with bad arthritis may need help getting onto an exam table, but later get a knee or hip replacement that is effective and no longer need that help,” said Dr. Iezzoni.
Benefits outweigh costs
Physicians have made progress in meeting the ADA’s physical accessibility requirements, said Dr. Iezzoni. “The literature suggests that doctors have done a good job at fixing the structural barriers people with mobility issues face, such as ramps and bathrooms.”
However, there are exceptions in rural older buildings which can be harder to retrofit for wheelchair accessibility, she said. “I recall interviewing a rural doctor several years ago who said that he knew his patients well and when a patient visits with mobility problems, he goes down and carries the patient up the steps to his office. My response was that is not respectful of the patient or safe for the patient or you. That doctor has since changed the location of his practice,” said Dr. Iezzoni.
Some doctors may resist paying for accessible medical equipment because of cost, but she said the benefits are worth it. These include preventing staff injuries when they transfer patients and being used by patients with temporary disabilities and aging people with bad knees, backs, hearing and sight. In addition, businesses may be eligible for federal and state tax credits.
Dr. Iezzoni recently visited her doctor where they finally got height-adjustable exam tables. “I asked the assistant, who really likes these tables? She said it’s the elderly ladies of short stature – the table is lowered and they sit down and get on it.”
But, Dr. Iezonni’s main message to doctors is that patients with disabilities deserve equal quality of care. “Just because we have a disability doesn’t mean we should get worse care than other people. It’s a matter of professionalism that doctors should want to give the same quality care to all their patients.”
A version of this article first appeared on Medscape.com.
Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School and a disability researcher at Massachusetts General Hospital, both in Boston, has used a wheelchair for more than 30 years because of multiple sclerosis. When she visits her primary care doctor, she doesn’t get weighed because the scales are not wheelchair accessible.
This failure to weigh her and other patients in wheelchairs could lead to serious medical problems. Weight is used to monitor a person’s overall health and prenatal health and to determine accurate doses for medications such as some chemotherapies, said Dr. Iezzoni.
In another situation, a man who used a wheelchair said that his primary care doctor never got him out of it for a complete physical exam. The patient later developed lymphoma, which first appeared in his groin. The doctor should have accommodated his disability and used a height-adjustable exam table or a portable lift to transfer him onto the table.
When physicians don’t provide access to medical care that patients with disabilities need, they put themselves at greater risk of lawsuits, fines, and settlements.
Yet, a new study in Health Affairs suggests that a large percentage of doctors are not fully aware of what they are legally required to do.
Under federal nondiscrimination laws (Americans With Disabilities Act, American Rehabilitation Act, and ADA Amendments Act), medical practices must provide equal access to people with disabilities, accommodate their disability-related needs, and not refuse them medical services because of their disabilities, say disability experts.
Where doctors go wrong with disability laws
What doctors don’t know about providing reasonable accommodations makes them vulnerable to lawsuits, which worries more than two-thirds of the 714 outpatient doctors surveyed.
Not only are they required to provide reasonable accommodations, but they also have to pay for them, the researchers said. One-fifth of the surveyed doctors said they didn’t know that practice owners have to pay.
More than one practice has made patients pay for services needed for their disability, such as sign language interpreters – the patients later complained this violated the ADA to enforcement agencies.
Doctors also don’t know that they have to collaborate with patients to determine what reasonable accommodations they need – over two-thirds of those surveyed said they didn’t know it was a joint responsibility, the study found.
When doctors fail to accommodate patients’ disability needs, they engage in discrimination and violate the ADA, says Elizabeth Pendo, JD, a coauthor of the study and the Joseph J. Simeone Professor of Law at Saint Louis University.
The Department of Justice has investigated several patient complaints of alleged disability discrimination recently and resolved the disputes with agreements and small fines in some cases. “The goal is not to get large financial settlements but to work with practices to get the correct procedures in place to be compliant,” said Ms. Pendo.
Physicians would be wise to check out whether their practices are as accessible as they think. Even if there’s a ramp to the office building, the parking lot may not have a van-accessible space or enough handicapped parking signs, or the exam room may be too narrow for a wheelchair to navigate.
These practices violated the ADA and agreed to make changes:
- Hamden, Conn., has two buildings that patients with physical disabilities couldn’t easily enter. The physician owners agreed to change the buildings’ entrances and access routes and add features to make it easier to use examination rooms and restrooms and the check-in and check-out areas.
- Seven medical offices in Riverside, Calif., failed to communicate effectively with deaf and hard-of-hearing patients. They should have had a qualified sign language interpreter, an assistive listening device, or another appropriate aid or service available to a deaf patient and her family. Instead, the office relied on a video remote interpretation system that often failed to work. The agreement requires the clinic to provide those aids and services to patients and their companions who are deaf or hard of hearing, advertise their availability, assess each patient who is deaf or hard of hearing to determine the best aids and services for their needs, and pay $5,000 in compensation to the complainant and a $1,000 civil penalty to the United States.
- Springfield, Mass., refused to provide full joint replacements to two patients being treated with buprenorphine, a medication used to treat opioid use disorder. Rather than accommodate the patients, the surgeons referred them elsewhere because they were uncomfortable with the postoperative pain management protocol for patients prescribed buprenorphine. “The Americans With Disabilities Act protects health care access for people under medical treatment for opioid use disorder,” said Acting U.S. Attorney Nathaniel R. Mendell. “Health care providers must comply with the ADA, even when doing so is inconvenient or makes them uncomfortable.” The agreement requires the practice to adopt a nondiscrimination policy, provide training on the ADA and opioid use disorder, and pay two complainants $15,000 each for pain and suffering.
The DOJ has filed civil lawsuits against medical practices when they failed to resolve the allegations. Recent cases include an ophthalmology practice with 24 facilities in Arizona that refused to help transfer patients in wheelchairs to surgery tables for eye surgery and required them to pay for transfer support services and two obstetricians-gynecologists in Bakersfield, Calif., who refused to provide routine medical care to a patient because of her HIV status.
What doctors should know
Many people tend to think of a person with a disability as being in a wheelchair. But the ADA has a very broad definition of disability, which includes any physical or mental impairment that substantially limits any major life activity, said Ms. Pendo.
“It was amended in 2008 to clarify that the definition includes people with chronic diseases such as diabetes and cancer, cognitive and neurological disorders, substance abuse disorders, vision and hearing loss, and learning and other disabilities,” she said.
That means that doctors have to accommodate many types of disabilities, which can be challenging. The ADA only specifies that fixed structures need to be accessible, such as parking lots, driveways, and buildings, said Dr. Iezzoni.
When it comes to “reasonable accommodations,” doctors should decide that on a case-by-case basis, she said.
“We can say based on our study that 71% of doctors don’t know the right way to think about the accommodations – they don’t know they need to talk to patients so they can explain to them exactly what they need to accommodate their disability,” said Dr. Iezzoni.
Doctors are also required to provide effective communication for patients with sensory or cognitive disabilities, which can depend on the severity, said Ms. Pendo. Is the person deaf or hard of hearing, blind or partially sighted – is the dementia mild or severe?
“The requirement is there, but what that looks like will vary by patient. That’s what’s challenging,” said Ms. Pendo.
Dr. Iezzoni recommends that doctor’s offices ask patients whether they need special help or individual assistance when they make appointments and enter their responses in their records. She also suggests that patients be asked at follow-up appointments whether they still need the same help or not.
“Disabilities can change over time – a person with bad arthritis may need help getting onto an exam table, but later get a knee or hip replacement that is effective and no longer need that help,” said Dr. Iezzoni.
Benefits outweigh costs
Physicians have made progress in meeting the ADA’s physical accessibility requirements, said Dr. Iezzoni. “The literature suggests that doctors have done a good job at fixing the structural barriers people with mobility issues face, such as ramps and bathrooms.”
However, there are exceptions in rural older buildings which can be harder to retrofit for wheelchair accessibility, she said. “I recall interviewing a rural doctor several years ago who said that he knew his patients well and when a patient visits with mobility problems, he goes down and carries the patient up the steps to his office. My response was that is not respectful of the patient or safe for the patient or you. That doctor has since changed the location of his practice,” said Dr. Iezzoni.
Some doctors may resist paying for accessible medical equipment because of cost, but she said the benefits are worth it. These include preventing staff injuries when they transfer patients and being used by patients with temporary disabilities and aging people with bad knees, backs, hearing and sight. In addition, businesses may be eligible for federal and state tax credits.
Dr. Iezzoni recently visited her doctor where they finally got height-adjustable exam tables. “I asked the assistant, who really likes these tables? She said it’s the elderly ladies of short stature – the table is lowered and they sit down and get on it.”
But, Dr. Iezonni’s main message to doctors is that patients with disabilities deserve equal quality of care. “Just because we have a disability doesn’t mean we should get worse care than other people. It’s a matter of professionalism that doctors should want to give the same quality care to all their patients.”
A version of this article first appeared on Medscape.com.
Children and COVID-19: The Omicron tide may have turned
The Omicron-fueled surge appears to have peaked as new cases of COVID-19 in U.S. children dropped for the first time since late November 2021, dipping back below the 1 million mark for the week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of cases in children was up to 11.4 million as of Jan. 27, with children representing 18.6% of all cases reported since the pandemic started, the AAP and CHA said in their weekly COVID-19 report.
As children remain the largest reservoir of unvaccinated Americans, their share of the COVID case load continues to rise quickly. Just 2 weeks ago, children made up 17.8% of the cumulative number of cases, and at the end of December it was 17.4%, the AAP/CHA data show.
The latest data from the Centers for Disease Control and Prevention show that trends for admissions and emergency department visits reflect the decline in new cases. New admissions of children aged 0-17 years with diagnosed COVID-19 peaked at 1.25 per 100,000 population on Jan. 15 and were down to 0.95 per 100,000 on Jan. 29.
Daily ED visits for COVID-19, measured as a percentage of all ED visits, peaked at 13.9% on Jan. 14 for children aged 0-11 years and on Jan. 9 for both 12- to 15-year-olds (14.1%) and 16- to 17-year-olds (13.8%). By Jan. 28, the rates were down to 5.6% (0-11), 3.1% (12-15), and 3.3% (16-17), the CDC reported based on data from the National Syndromic Surveillance Program.
Trends involving more severe illness support observations that Omicron is milder than earlier variants. Children hospitalized with COVID-19 were less likely to be admitted to an intensive care unit over the last 2 months than during the Delta surge in the late summer and early fall or during the winter of 2020-2021, the CDC said based on data from the BD Insights Research Database, which includes 229,000 patients and 267 hospitals.
Those data show that the highest monthly rate occurred early on, in May of 2020, when 27.8% of children with COVID-19 ended up in the ICU. The rates for December 2021 and January 2022, by comparison, were 11.0% and 11.3%, respectively, the CDC said.
Vaccination lags in younger children
As reports surface about Pfizer-BioNTech filing an emergency use request to extend vaccine coverage to children aged 6 months to 5 years, it does appear that prevention efforts could use the proverbial shot in the arm.
As of Jan. 30, just 30.4% of children aged 5-11 have received at least one dose of the COVID-19 vaccine, and only 21.6% are fully vaccinated. At a comparable point in their timeline – just short of 3 months after approval – the respective numbers for children aged 12-15 were about 42% and 31%, CDC data show.
In the younger group, both initial doses and completions rose slightly in the first 2 weeks of January but then dropped in each of the last 2 weeks. There was a more significant surge in interest among the 12- to 17-year-olds in mid-January, but the last full week of the month brought declines of more than 50% in both measures, according to a separate AAP analysis.
The Omicron-fueled surge appears to have peaked as new cases of COVID-19 in U.S. children dropped for the first time since late November 2021, dipping back below the 1 million mark for the week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of cases in children was up to 11.4 million as of Jan. 27, with children representing 18.6% of all cases reported since the pandemic started, the AAP and CHA said in their weekly COVID-19 report.
As children remain the largest reservoir of unvaccinated Americans, their share of the COVID case load continues to rise quickly. Just 2 weeks ago, children made up 17.8% of the cumulative number of cases, and at the end of December it was 17.4%, the AAP/CHA data show.
The latest data from the Centers for Disease Control and Prevention show that trends for admissions and emergency department visits reflect the decline in new cases. New admissions of children aged 0-17 years with diagnosed COVID-19 peaked at 1.25 per 100,000 population on Jan. 15 and were down to 0.95 per 100,000 on Jan. 29.
Daily ED visits for COVID-19, measured as a percentage of all ED visits, peaked at 13.9% on Jan. 14 for children aged 0-11 years and on Jan. 9 for both 12- to 15-year-olds (14.1%) and 16- to 17-year-olds (13.8%). By Jan. 28, the rates were down to 5.6% (0-11), 3.1% (12-15), and 3.3% (16-17), the CDC reported based on data from the National Syndromic Surveillance Program.
Trends involving more severe illness support observations that Omicron is milder than earlier variants. Children hospitalized with COVID-19 were less likely to be admitted to an intensive care unit over the last 2 months than during the Delta surge in the late summer and early fall or during the winter of 2020-2021, the CDC said based on data from the BD Insights Research Database, which includes 229,000 patients and 267 hospitals.
Those data show that the highest monthly rate occurred early on, in May of 2020, when 27.8% of children with COVID-19 ended up in the ICU. The rates for December 2021 and January 2022, by comparison, were 11.0% and 11.3%, respectively, the CDC said.
Vaccination lags in younger children
As reports surface about Pfizer-BioNTech filing an emergency use request to extend vaccine coverage to children aged 6 months to 5 years, it does appear that prevention efforts could use the proverbial shot in the arm.
As of Jan. 30, just 30.4% of children aged 5-11 have received at least one dose of the COVID-19 vaccine, and only 21.6% are fully vaccinated. At a comparable point in their timeline – just short of 3 months after approval – the respective numbers for children aged 12-15 were about 42% and 31%, CDC data show.
In the younger group, both initial doses and completions rose slightly in the first 2 weeks of January but then dropped in each of the last 2 weeks. There was a more significant surge in interest among the 12- to 17-year-olds in mid-January, but the last full week of the month brought declines of more than 50% in both measures, according to a separate AAP analysis.
The Omicron-fueled surge appears to have peaked as new cases of COVID-19 in U.S. children dropped for the first time since late November 2021, dipping back below the 1 million mark for the week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of cases in children was up to 11.4 million as of Jan. 27, with children representing 18.6% of all cases reported since the pandemic started, the AAP and CHA said in their weekly COVID-19 report.
As children remain the largest reservoir of unvaccinated Americans, their share of the COVID case load continues to rise quickly. Just 2 weeks ago, children made up 17.8% of the cumulative number of cases, and at the end of December it was 17.4%, the AAP/CHA data show.
The latest data from the Centers for Disease Control and Prevention show that trends for admissions and emergency department visits reflect the decline in new cases. New admissions of children aged 0-17 years with diagnosed COVID-19 peaked at 1.25 per 100,000 population on Jan. 15 and were down to 0.95 per 100,000 on Jan. 29.
Daily ED visits for COVID-19, measured as a percentage of all ED visits, peaked at 13.9% on Jan. 14 for children aged 0-11 years and on Jan. 9 for both 12- to 15-year-olds (14.1%) and 16- to 17-year-olds (13.8%). By Jan. 28, the rates were down to 5.6% (0-11), 3.1% (12-15), and 3.3% (16-17), the CDC reported based on data from the National Syndromic Surveillance Program.
Trends involving more severe illness support observations that Omicron is milder than earlier variants. Children hospitalized with COVID-19 were less likely to be admitted to an intensive care unit over the last 2 months than during the Delta surge in the late summer and early fall or during the winter of 2020-2021, the CDC said based on data from the BD Insights Research Database, which includes 229,000 patients and 267 hospitals.
Those data show that the highest monthly rate occurred early on, in May of 2020, when 27.8% of children with COVID-19 ended up in the ICU. The rates for December 2021 and January 2022, by comparison, were 11.0% and 11.3%, respectively, the CDC said.
Vaccination lags in younger children
As reports surface about Pfizer-BioNTech filing an emergency use request to extend vaccine coverage to children aged 6 months to 5 years, it does appear that prevention efforts could use the proverbial shot in the arm.
As of Jan. 30, just 30.4% of children aged 5-11 have received at least one dose of the COVID-19 vaccine, and only 21.6% are fully vaccinated. At a comparable point in their timeline – just short of 3 months after approval – the respective numbers for children aged 12-15 were about 42% and 31%, CDC data show.
In the younger group, both initial doses and completions rose slightly in the first 2 weeks of January but then dropped in each of the last 2 weeks. There was a more significant surge in interest among the 12- to 17-year-olds in mid-January, but the last full week of the month brought declines of more than 50% in both measures, according to a separate AAP analysis.
Omicron subvariant 1.5 times more contagious than Omicron
according to CNBC.
The Statens Serum Institut, which monitors infectious diseases in Denmark, said that BA.2 is more contagious, but it doesn’t appear to increase hospitalizations or reduce how well the vaccine works.
BA.2 overtook BA.1 as the primary variant in Denmark within a few weeks, Troels Lillebaek, director of the institute, told CNBC. The subvariant has five unique mutations on a key part of the spike protein, which is what the coronavirus uses to invade human cells. This often means a higher rate of spreading.
The Omicron subvariant has been detected in at least 29 states in the United States and 56 countries, according to the latest update from Outbreak.info. The United States has detected 188 infections, with the worldwide total nearing 25,000.
Denmark has reported the highest number of cases, followed by the United Kingdom and India. Both Denmark and India have reported that BA.2 now accounts for about half of new COVID-19 cases in those countries.
On Jan. 28, the U.K. Health Security Agency said BA.2 has a “substantial” growth advantage over the original Omicron strain. The subvariant has spread faster in all regions of England where there were enough cases to conduct an analysis, the agency said in a report.
A preliminary evaluation found that BA.2 doesn’t appear to change how well the vaccine works compared to the original Omicron strain, the agency said. A booster dose was 70% effective at preventing symptomatic illness for BA.2, compared with 63% for the original Omicron strain.
The Centers for Disease Control and Prevention also said on Jan. 28 that, although the subvariant has become more common in some countries, it is currently at a low level in the United States and doesn’t appear to be more serious.
“Currently there is no evidence that the BA.2 lineage is more severe than the BA.1 lineage,” Kristen Nordlund, a CDC spokesperson, told CNBC.
The World Health Organization hasn’t labeled BA.2 a “variant of concern” so far but will continue to monitor it. WHO officials have said that new variants will arise as Omicron spreads across the world.
“The next variant of concern will be more fit, and what we mean by that is it will be more transmissible because it will have to overtake what is currently circulating,” Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said during a livestream on Jan. 25.
“The big question is whether or not future variants will be more or less severe,” she said.
A version of this article first appeared on WebMD.com.
according to CNBC.
The Statens Serum Institut, which monitors infectious diseases in Denmark, said that BA.2 is more contagious, but it doesn’t appear to increase hospitalizations or reduce how well the vaccine works.
BA.2 overtook BA.1 as the primary variant in Denmark within a few weeks, Troels Lillebaek, director of the institute, told CNBC. The subvariant has five unique mutations on a key part of the spike protein, which is what the coronavirus uses to invade human cells. This often means a higher rate of spreading.
The Omicron subvariant has been detected in at least 29 states in the United States and 56 countries, according to the latest update from Outbreak.info. The United States has detected 188 infections, with the worldwide total nearing 25,000.
Denmark has reported the highest number of cases, followed by the United Kingdom and India. Both Denmark and India have reported that BA.2 now accounts for about half of new COVID-19 cases in those countries.
On Jan. 28, the U.K. Health Security Agency said BA.2 has a “substantial” growth advantage over the original Omicron strain. The subvariant has spread faster in all regions of England where there were enough cases to conduct an analysis, the agency said in a report.
A preliminary evaluation found that BA.2 doesn’t appear to change how well the vaccine works compared to the original Omicron strain, the agency said. A booster dose was 70% effective at preventing symptomatic illness for BA.2, compared with 63% for the original Omicron strain.
The Centers for Disease Control and Prevention also said on Jan. 28 that, although the subvariant has become more common in some countries, it is currently at a low level in the United States and doesn’t appear to be more serious.
“Currently there is no evidence that the BA.2 lineage is more severe than the BA.1 lineage,” Kristen Nordlund, a CDC spokesperson, told CNBC.
The World Health Organization hasn’t labeled BA.2 a “variant of concern” so far but will continue to monitor it. WHO officials have said that new variants will arise as Omicron spreads across the world.
“The next variant of concern will be more fit, and what we mean by that is it will be more transmissible because it will have to overtake what is currently circulating,” Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said during a livestream on Jan. 25.
“The big question is whether or not future variants will be more or less severe,” she said.
A version of this article first appeared on WebMD.com.
according to CNBC.
The Statens Serum Institut, which monitors infectious diseases in Denmark, said that BA.2 is more contagious, but it doesn’t appear to increase hospitalizations or reduce how well the vaccine works.
BA.2 overtook BA.1 as the primary variant in Denmark within a few weeks, Troels Lillebaek, director of the institute, told CNBC. The subvariant has five unique mutations on a key part of the spike protein, which is what the coronavirus uses to invade human cells. This often means a higher rate of spreading.
The Omicron subvariant has been detected in at least 29 states in the United States and 56 countries, according to the latest update from Outbreak.info. The United States has detected 188 infections, with the worldwide total nearing 25,000.
Denmark has reported the highest number of cases, followed by the United Kingdom and India. Both Denmark and India have reported that BA.2 now accounts for about half of new COVID-19 cases in those countries.
On Jan. 28, the U.K. Health Security Agency said BA.2 has a “substantial” growth advantage over the original Omicron strain. The subvariant has spread faster in all regions of England where there were enough cases to conduct an analysis, the agency said in a report.
A preliminary evaluation found that BA.2 doesn’t appear to change how well the vaccine works compared to the original Omicron strain, the agency said. A booster dose was 70% effective at preventing symptomatic illness for BA.2, compared with 63% for the original Omicron strain.
The Centers for Disease Control and Prevention also said on Jan. 28 that, although the subvariant has become more common in some countries, it is currently at a low level in the United States and doesn’t appear to be more serious.
“Currently there is no evidence that the BA.2 lineage is more severe than the BA.1 lineage,” Kristen Nordlund, a CDC spokesperson, told CNBC.
The World Health Organization hasn’t labeled BA.2 a “variant of concern” so far but will continue to monitor it. WHO officials have said that new variants will arise as Omicron spreads across the world.
“The next variant of concern will be more fit, and what we mean by that is it will be more transmissible because it will have to overtake what is currently circulating,” Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said during a livestream on Jan. 25.
“The big question is whether or not future variants will be more or less severe,” she said.
A version of this article first appeared on WebMD.com.
Pandemic pushed death rates to historic highs
Excess mortality is a way of quantifying the impact of a pandemic, based on overall mortality from nonpandemic periods. Mortality data over long periods of time are not available for many countries, but Switzerland, Sweden, and Spain have accumulated death count data for an uninterrupted period of more than 100 years.
In a study published in the Annals of Internal Medicine, Kaspar Staub, PhD, of the University of Zurich led a team of researchers in reviewing data on monthly excess deaths from all causes for Switzerland, Sweden, and Spain for 2020 to 2021. Dr. Staub and colleagues also compared these numbers to other pandemic and nonpandemic periods since the end of the 19th century. The starting years were 1877 for Switzerland, 1851 for Sweden, and 1908 for Spain.
The researchers collected data for monthly all-cause deaths from the statistical offices of each country and determined excess mortality by comparing these numbers to population size and age structure.
They found that 2020 showed the highest number of excess deaths since 1918, with relative excess of deaths of 12.5% in Switzerland, 8.5% in Sweden, and 17.3 % in Spain.
To put it another way, the number of excess deaths per 100,000 people was 100 for Switzerland, 75 for Sweden, and 155 for Spain.
“Our findings suggest that the pandemic led to the second-largest mortality disaster driven by a viral infection in more than 100 years in the three countries we studied, second only to the 1918 influenza pandemic,” the researchers wrote.
They explained that the excess mortality for the year 1918 was six to seven times higher than the 2020 numbers, but that the 2020 numbers might have been higher without the strong public health interventions taken worldwide to mitigate the impact of the COVID-19 pandemic.
“Early estimates suggest that vaccination prevented approximately 470,000 deaths in persons aged 60 years or older across 33 European countries between December 2019 and November 2021,” they wrote. However, because the COVID-19 pandemic is ongoing, “a more conclusive assessment will have to wait,” they added.
The 2020 numbers also were higher than most mortality rates since 1918, including peak years of previous influenza pandemics that occurred in 1957, 1968, 1977, and, most recently, the swine flu pandemic of 2009 which was caused by a novel strain of the H1N1 influenza virus.
The study findings had some limitations. For example, only three countries were included. Also, monthly death numbers according to sex, age, and cause of death were available only for the past 60 years, and data from years before the 20th century may not be reliable, the researchers said.
The new study does not account for the long-term effects of patients suffering from long COVID, they noted.
Study findings support strong public health response
“With the COVID-19 pandemic ongoing, this study reinforces the historic magnitude of the problem in terms of mortality and could add to the justification for ongoing public health measures such as vaccination drives and vaccine mandates to curb deaths,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.
“The results are surprising because when we view the rapid advancement in medical science over the last few decades, which have led to a decline in mortality from many previously fatal diseases, the scale of excess mortality from COVID-19 seems to have offset many such gains in the past 2 years.”
Prior studies of United States mortality data have estimated that excess deaths in the United States in 2020 exceeded the deaths attributed to COVID-19, said Dr. Pal. “The findings of this study could help clinicians in their discussion of the need for COVID-19 prevention measures with their patients” and inform discussions between doctors and patients about prevention strategies, he explained.
“Emphasizing that this pandemic is the second-largest cause of death due to a viral infection in a century could help patients understand the need for public health measures that may be viewed as unprecedented, such as government-imposed lockdowns, contact tracing, mask requirements, restrictions on travel, and vaccine mandates,” Dr. Pal noted. Better understanding of the evidence behind such measures may decrease the public’s resistance to following them, he added.As for additional research, “region-specific analysis of excess deaths may help estimate the impact of COVID-19 better, especially in regions where data reporting may be unreliable.”
Dr. F. Perry Wilson's take on study
“All-cause mortality is a key metric to assess the impact of the pandemic, because each death is treated equally,” said F. Perry Wilson, MD, of Yale University, in an interview. “With this type of analysis, there is no vague definition of a death from COVID or with COVID,” he explained. “A death is a death, and more deaths than expected is, of course, a bad thing. These analyses give a high-level view of the true human cost of the pandemic,” he said.
Dr. Wilson said he was not surprised by the findings. “There have been multiple studies, across multiple countries including the United States, which show similar findings—that observed deaths during this pandemic are substantially higher than expected,” he said. The current study findings are unique in that they compare the current pandemic to death rates in a nearly unbroken chain into the last century using data that only a few countries can provide, he noted.
The mortality data are “quite similar to what we see in the United States, with the exception that Spain was particularly hard-hit in the first COVID-19 wave in April 2020, said Dr. Wilson. By contrast, “the U.S. had substantially more excess deaths in the recent Delta wave, presumably due to lower vaccination uptake,” he added.
The current study is important for clinicians and their patients, said Dr. Wilson. “Data like these can help cut through some of the misinformation, such as the idea that only people who would have died anyway die of COVID, or that COVID is not severe,” he emphasized. “Overall death data are quite clear that far more people, millions more people, died over the last 22 months than could possibly be explained except by a global-level mortality event,” he said.
“One thing this study reminds us of is the value of high-quality data,” said Dr. Wilson. “Few countries have near complete vital statistics records on their entire populations and these can be so crucial to understand the true impact of pandemics and other disasters,” he explained. Of course, mortality data also serve as a reminder “that COVID is a serious disease: a once-in-a-century (we hope) pandemic,” he added.
The current study showed that excess death rates were similar, but not the same, from country to country, Dr. Wilson noted. “Moving forward, we need to learn what factors, from vaccination to social distancing strategies,” saved lives around the world,” he said.
The study was supported by the Foundation for Research in Science and the Humanities at the University of Zurich, the Swiss National Science Foundation, and the U.S. National Institute of Allergy and Infectious Diseases. The researchers, Dr. Pal, and Dr. Wilson had no financial conflicts.
*This article was updated on 2/1/2022.
Excess mortality is a way of quantifying the impact of a pandemic, based on overall mortality from nonpandemic periods. Mortality data over long periods of time are not available for many countries, but Switzerland, Sweden, and Spain have accumulated death count data for an uninterrupted period of more than 100 years.
In a study published in the Annals of Internal Medicine, Kaspar Staub, PhD, of the University of Zurich led a team of researchers in reviewing data on monthly excess deaths from all causes for Switzerland, Sweden, and Spain for 2020 to 2021. Dr. Staub and colleagues also compared these numbers to other pandemic and nonpandemic periods since the end of the 19th century. The starting years were 1877 for Switzerland, 1851 for Sweden, and 1908 for Spain.
The researchers collected data for monthly all-cause deaths from the statistical offices of each country and determined excess mortality by comparing these numbers to population size and age structure.
They found that 2020 showed the highest number of excess deaths since 1918, with relative excess of deaths of 12.5% in Switzerland, 8.5% in Sweden, and 17.3 % in Spain.
To put it another way, the number of excess deaths per 100,000 people was 100 for Switzerland, 75 for Sweden, and 155 for Spain.
“Our findings suggest that the pandemic led to the second-largest mortality disaster driven by a viral infection in more than 100 years in the three countries we studied, second only to the 1918 influenza pandemic,” the researchers wrote.
They explained that the excess mortality for the year 1918 was six to seven times higher than the 2020 numbers, but that the 2020 numbers might have been higher without the strong public health interventions taken worldwide to mitigate the impact of the COVID-19 pandemic.
“Early estimates suggest that vaccination prevented approximately 470,000 deaths in persons aged 60 years or older across 33 European countries between December 2019 and November 2021,” they wrote. However, because the COVID-19 pandemic is ongoing, “a more conclusive assessment will have to wait,” they added.
The 2020 numbers also were higher than most mortality rates since 1918, including peak years of previous influenza pandemics that occurred in 1957, 1968, 1977, and, most recently, the swine flu pandemic of 2009 which was caused by a novel strain of the H1N1 influenza virus.
The study findings had some limitations. For example, only three countries were included. Also, monthly death numbers according to sex, age, and cause of death were available only for the past 60 years, and data from years before the 20th century may not be reliable, the researchers said.
The new study does not account for the long-term effects of patients suffering from long COVID, they noted.
Study findings support strong public health response
“With the COVID-19 pandemic ongoing, this study reinforces the historic magnitude of the problem in terms of mortality and could add to the justification for ongoing public health measures such as vaccination drives and vaccine mandates to curb deaths,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.
“The results are surprising because when we view the rapid advancement in medical science over the last few decades, which have led to a decline in mortality from many previously fatal diseases, the scale of excess mortality from COVID-19 seems to have offset many such gains in the past 2 years.”
Prior studies of United States mortality data have estimated that excess deaths in the United States in 2020 exceeded the deaths attributed to COVID-19, said Dr. Pal. “The findings of this study could help clinicians in their discussion of the need for COVID-19 prevention measures with their patients” and inform discussions between doctors and patients about prevention strategies, he explained.
“Emphasizing that this pandemic is the second-largest cause of death due to a viral infection in a century could help patients understand the need for public health measures that may be viewed as unprecedented, such as government-imposed lockdowns, contact tracing, mask requirements, restrictions on travel, and vaccine mandates,” Dr. Pal noted. Better understanding of the evidence behind such measures may decrease the public’s resistance to following them, he added.As for additional research, “region-specific analysis of excess deaths may help estimate the impact of COVID-19 better, especially in regions where data reporting may be unreliable.”
Dr. F. Perry Wilson's take on study
“All-cause mortality is a key metric to assess the impact of the pandemic, because each death is treated equally,” said F. Perry Wilson, MD, of Yale University, in an interview. “With this type of analysis, there is no vague definition of a death from COVID or with COVID,” he explained. “A death is a death, and more deaths than expected is, of course, a bad thing. These analyses give a high-level view of the true human cost of the pandemic,” he said.
Dr. Wilson said he was not surprised by the findings. “There have been multiple studies, across multiple countries including the United States, which show similar findings—that observed deaths during this pandemic are substantially higher than expected,” he said. The current study findings are unique in that they compare the current pandemic to death rates in a nearly unbroken chain into the last century using data that only a few countries can provide, he noted.
The mortality data are “quite similar to what we see in the United States, with the exception that Spain was particularly hard-hit in the first COVID-19 wave in April 2020, said Dr. Wilson. By contrast, “the U.S. had substantially more excess deaths in the recent Delta wave, presumably due to lower vaccination uptake,” he added.
The current study is important for clinicians and their patients, said Dr. Wilson. “Data like these can help cut through some of the misinformation, such as the idea that only people who would have died anyway die of COVID, or that COVID is not severe,” he emphasized. “Overall death data are quite clear that far more people, millions more people, died over the last 22 months than could possibly be explained except by a global-level mortality event,” he said.
“One thing this study reminds us of is the value of high-quality data,” said Dr. Wilson. “Few countries have near complete vital statistics records on their entire populations and these can be so crucial to understand the true impact of pandemics and other disasters,” he explained. Of course, mortality data also serve as a reminder “that COVID is a serious disease: a once-in-a-century (we hope) pandemic,” he added.
The current study showed that excess death rates were similar, but not the same, from country to country, Dr. Wilson noted. “Moving forward, we need to learn what factors, from vaccination to social distancing strategies,” saved lives around the world,” he said.
The study was supported by the Foundation for Research in Science and the Humanities at the University of Zurich, the Swiss National Science Foundation, and the U.S. National Institute of Allergy and Infectious Diseases. The researchers, Dr. Pal, and Dr. Wilson had no financial conflicts.
*This article was updated on 2/1/2022.
Excess mortality is a way of quantifying the impact of a pandemic, based on overall mortality from nonpandemic periods. Mortality data over long periods of time are not available for many countries, but Switzerland, Sweden, and Spain have accumulated death count data for an uninterrupted period of more than 100 years.
In a study published in the Annals of Internal Medicine, Kaspar Staub, PhD, of the University of Zurich led a team of researchers in reviewing data on monthly excess deaths from all causes for Switzerland, Sweden, and Spain for 2020 to 2021. Dr. Staub and colleagues also compared these numbers to other pandemic and nonpandemic periods since the end of the 19th century. The starting years were 1877 for Switzerland, 1851 for Sweden, and 1908 for Spain.
The researchers collected data for monthly all-cause deaths from the statistical offices of each country and determined excess mortality by comparing these numbers to population size and age structure.
They found that 2020 showed the highest number of excess deaths since 1918, with relative excess of deaths of 12.5% in Switzerland, 8.5% in Sweden, and 17.3 % in Spain.
To put it another way, the number of excess deaths per 100,000 people was 100 for Switzerland, 75 for Sweden, and 155 for Spain.
“Our findings suggest that the pandemic led to the second-largest mortality disaster driven by a viral infection in more than 100 years in the three countries we studied, second only to the 1918 influenza pandemic,” the researchers wrote.
They explained that the excess mortality for the year 1918 was six to seven times higher than the 2020 numbers, but that the 2020 numbers might have been higher without the strong public health interventions taken worldwide to mitigate the impact of the COVID-19 pandemic.
“Early estimates suggest that vaccination prevented approximately 470,000 deaths in persons aged 60 years or older across 33 European countries between December 2019 and November 2021,” they wrote. However, because the COVID-19 pandemic is ongoing, “a more conclusive assessment will have to wait,” they added.
The 2020 numbers also were higher than most mortality rates since 1918, including peak years of previous influenza pandemics that occurred in 1957, 1968, 1977, and, most recently, the swine flu pandemic of 2009 which was caused by a novel strain of the H1N1 influenza virus.
The study findings had some limitations. For example, only three countries were included. Also, monthly death numbers according to sex, age, and cause of death were available only for the past 60 years, and data from years before the 20th century may not be reliable, the researchers said.
The new study does not account for the long-term effects of patients suffering from long COVID, they noted.
Study findings support strong public health response
“With the COVID-19 pandemic ongoing, this study reinforces the historic magnitude of the problem in terms of mortality and could add to the justification for ongoing public health measures such as vaccination drives and vaccine mandates to curb deaths,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.
“The results are surprising because when we view the rapid advancement in medical science over the last few decades, which have led to a decline in mortality from many previously fatal diseases, the scale of excess mortality from COVID-19 seems to have offset many such gains in the past 2 years.”
Prior studies of United States mortality data have estimated that excess deaths in the United States in 2020 exceeded the deaths attributed to COVID-19, said Dr. Pal. “The findings of this study could help clinicians in their discussion of the need for COVID-19 prevention measures with their patients” and inform discussions between doctors and patients about prevention strategies, he explained.
“Emphasizing that this pandemic is the second-largest cause of death due to a viral infection in a century could help patients understand the need for public health measures that may be viewed as unprecedented, such as government-imposed lockdowns, contact tracing, mask requirements, restrictions on travel, and vaccine mandates,” Dr. Pal noted. Better understanding of the evidence behind such measures may decrease the public’s resistance to following them, he added.As for additional research, “region-specific analysis of excess deaths may help estimate the impact of COVID-19 better, especially in regions where data reporting may be unreliable.”
Dr. F. Perry Wilson's take on study
“All-cause mortality is a key metric to assess the impact of the pandemic, because each death is treated equally,” said F. Perry Wilson, MD, of Yale University, in an interview. “With this type of analysis, there is no vague definition of a death from COVID or with COVID,” he explained. “A death is a death, and more deaths than expected is, of course, a bad thing. These analyses give a high-level view of the true human cost of the pandemic,” he said.
Dr. Wilson said he was not surprised by the findings. “There have been multiple studies, across multiple countries including the United States, which show similar findings—that observed deaths during this pandemic are substantially higher than expected,” he said. The current study findings are unique in that they compare the current pandemic to death rates in a nearly unbroken chain into the last century using data that only a few countries can provide, he noted.
The mortality data are “quite similar to what we see in the United States, with the exception that Spain was particularly hard-hit in the first COVID-19 wave in April 2020, said Dr. Wilson. By contrast, “the U.S. had substantially more excess deaths in the recent Delta wave, presumably due to lower vaccination uptake,” he added.
The current study is important for clinicians and their patients, said Dr. Wilson. “Data like these can help cut through some of the misinformation, such as the idea that only people who would have died anyway die of COVID, or that COVID is not severe,” he emphasized. “Overall death data are quite clear that far more people, millions more people, died over the last 22 months than could possibly be explained except by a global-level mortality event,” he said.
“One thing this study reminds us of is the value of high-quality data,” said Dr. Wilson. “Few countries have near complete vital statistics records on their entire populations and these can be so crucial to understand the true impact of pandemics and other disasters,” he explained. Of course, mortality data also serve as a reminder “that COVID is a serious disease: a once-in-a-century (we hope) pandemic,” he added.
The current study showed that excess death rates were similar, but not the same, from country to country, Dr. Wilson noted. “Moving forward, we need to learn what factors, from vaccination to social distancing strategies,” saved lives around the world,” he said.
The study was supported by the Foundation for Research in Science and the Humanities at the University of Zurich, the Swiss National Science Foundation, and the U.S. National Institute of Allergy and Infectious Diseases. The researchers, Dr. Pal, and Dr. Wilson had no financial conflicts.
*This article was updated on 2/1/2022.
FROM ANNALS OF INTERNAL MEDICINE
FDA grants full approval to Moderna COVID-19 vaccine
Moderna announced today that its mRNA COVID-19 vaccine has received full Food and Drug Administration approval for adults 18 years and older.
The move lifts an FDA emergency use authorization for the vaccine, which started Dec. 18, 2020.
The Moderna vaccine also now has a new trade name: Spikevax.
The FDA approval comes a little more than 5 months after the agency granted full approval to the Pfizer/BioNTech COVID-19 vaccine on Aug. 23. At the time, the Pfizer vaccine received the trade name Comirnaty.
The FDA approved the Moderna vaccine based on how well it works and its safety for 6 months after a second dose, including follow-up data from a phase 3 study, Moderna announced this morning through a news release. The FDA also announced the news.
Spikevax is the first Moderna product to be fully licensed in the United States.
The United States joins more than 70 other countries where regulators have approved the vaccine. A total of 807 million doses of Moderna’s COVID-19 vaccine were shipped worldwide in 2021, the company reported.
“The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the U.K., Israel, and other countries, where the adolescent indication is also approved,” Stéphane Bancel, Moderna chief executive officer, said in the release.
A version of this article first appeared on WebMD.com.
Moderna announced today that its mRNA COVID-19 vaccine has received full Food and Drug Administration approval for adults 18 years and older.
The move lifts an FDA emergency use authorization for the vaccine, which started Dec. 18, 2020.
The Moderna vaccine also now has a new trade name: Spikevax.
The FDA approval comes a little more than 5 months after the agency granted full approval to the Pfizer/BioNTech COVID-19 vaccine on Aug. 23. At the time, the Pfizer vaccine received the trade name Comirnaty.
The FDA approved the Moderna vaccine based on how well it works and its safety for 6 months after a second dose, including follow-up data from a phase 3 study, Moderna announced this morning through a news release. The FDA also announced the news.
Spikevax is the first Moderna product to be fully licensed in the United States.
The United States joins more than 70 other countries where regulators have approved the vaccine. A total of 807 million doses of Moderna’s COVID-19 vaccine were shipped worldwide in 2021, the company reported.
“The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the U.K., Israel, and other countries, where the adolescent indication is also approved,” Stéphane Bancel, Moderna chief executive officer, said in the release.
A version of this article first appeared on WebMD.com.
Moderna announced today that its mRNA COVID-19 vaccine has received full Food and Drug Administration approval for adults 18 years and older.
The move lifts an FDA emergency use authorization for the vaccine, which started Dec. 18, 2020.
The Moderna vaccine also now has a new trade name: Spikevax.
The FDA approval comes a little more than 5 months after the agency granted full approval to the Pfizer/BioNTech COVID-19 vaccine on Aug. 23. At the time, the Pfizer vaccine received the trade name Comirnaty.
The FDA approved the Moderna vaccine based on how well it works and its safety for 6 months after a second dose, including follow-up data from a phase 3 study, Moderna announced this morning through a news release. The FDA also announced the news.
Spikevax is the first Moderna product to be fully licensed in the United States.
The United States joins more than 70 other countries where regulators have approved the vaccine. A total of 807 million doses of Moderna’s COVID-19 vaccine were shipped worldwide in 2021, the company reported.
“The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the U.K., Israel, and other countries, where the adolescent indication is also approved,” Stéphane Bancel, Moderna chief executive officer, said in the release.
A version of this article first appeared on WebMD.com.