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Bad breath? Mouthwash is out. Yogurt is in.
Leave the mouthwash. Take the yogurt
Most of us have experienced some sort of bad breath. It’s common in the morning right after waking up, but it also may be a sign for underlying medical issues like dental problems or acid reflux. Wherever it comes from, we always want to get rid of it. A recent meta-analysis in BMJ Open may have found the answer in some common foods.
For those with halitosis, the basic problem is that the bacteria in their mouths are not happy about where they are. The researchers looked at 130 studies and found seven that suggested fermented food has some effect in combating bad breath.
Now when we say fermented food, we’re not talking about that science project waiting to happen in the back of the refrigerator. Think yogurt, sourdough bread, or miso soup. Anything that contains probiotic bacteria.
Matthew J. Messina, DDS, assistant professor of dentistry at Ohio State University, who was not involved with the study, told Healthline that “the whole idea behind probiotics is [bacteria replacement]. Supplant the ‘bad guys’ with the ‘good guys,’ then we’ll end up with a better result.” Essentially balancing the scales in your mouth.
It may not be a long-term solution, Dr. Messina said, but the short-term data are positive. So if you experience bad breath from time to time, try a little bowl of yogurt instead of chewing gum. If nothing else, the bacteria in your mouth will thank you.
You can talk the silly talk, but can you walk the silly walk?
The Ministry of Silly Walks sketch from Monty Python is an enduring comedy classic, and one of surprising relevance for doctors. After all, this isn’t the first time a study has analyzed the unusual strides of Mr. Putey and Mr. Teabag.
The BMJ Christmas edition truly is the gift that keeps on giving. For this plunge into the Flying Circus, the study authors recruited a small group of fairly average adults and had them walk normally around a track for 5 minutes, monitoring their oxygen intake and energy expenditure. After that, the study participants imitated Mr. Putey’s walk and then Mr. Teabag’s.
In the sketch, Mr. Teabag notes that Mr. Putey’s walk is “not particularly silly,” which is borne out in the research. When imitating Mr. Putey’s walk, oxygen intake and energy expenditure were barely higher than a normal walk, not enough to achieve a meaningful difference. Hopefully he’ll get that government grant to further develop his silly walk, because right now Mr. Putey’s walk simply doesn’t cut it.
Mr. Teabag’s walk is a different story and the very image of inefficiency. Oxygen intake was 2.5 times higher than during the normal walk, and energy expenditure was noticeably higher (8 kcal in men and 5.2 kcal in women). In fact, the walk was so inefficient and its effect so drastic it actually reached the level of vigorous exercise. Thanks to this, the study authors noted that just 11 minutes a day of walking like Mr. Teabag would be enough to reach the general goal of 75 minutes of vigorous exercise per week. Boosting that to 12-19 minutes would increase daily energy expenditure by 100 kcal.
The study authors wrote, “Had an initiative to promote inefficient movement been adopted in the early 1970s, we might now be living among a healthier society. Efforts to promote higher energy – and perhaps more joyful – walking should ensure inclusivity and inefficiency for all.” We think they just advocated for a real-life Ministry of Silly Walks. Well, there have been worse ideas. Just look at Twitter.
When efficient gut microbes go bad
With the latest news from the Ministry of Silly Walks, is it time for humans to embrace all things inefficient? Maybe.
Turns out that individuals with more efficient digestive systems – those that extract more energy from the fuel supplied to them by the busy mouths above – tend to gain more weight than those with less efficient guts, even when they eat the same food, according to a recent study published in Microbiome.
The researchers took a look at the composition of gut microbes in a group of 85 volunteers and found that about 40% had microbiomes dominated by Bacteroides bacteria, which are more effective at extracting nutrients from food. That group also weighed 10% more on average, amounting to an extra 9 kg.
In a rather blatant demonstration of efficiency, the investigators also measured the speed of the participants’ digestion, as they had hypothesized that those with the longest digestive travel times would be the ones who harvested the most nutrition from their food. That was not the case.
The study subjects with the most efficient gut bacteria “also have the fastest passage through the gastrointestinal system, which has given us something to think about,” senior author Henrik Roager of the University of Copenhagen said in a written statement.
You know what gives us something to think about? Stool energy density and intestinal transit time and faecal bacterial cell counts, that’s what. Ick. Sometimes science is gross.
Here’s another thought, though: Seeing faecal instead of fecal is kind of funny to our American eyes, but adding that extra letter is also inefficient, which could mean that it’s good. So, in the spirit of embracing the inefficient as a new year begins, we’re resolving to wrap our editorial arms around faecal and the faeces it represents. Well, not literally, of course. More like we’re embracing the spirit of faeces.
Leave the mouthwash. Take the yogurt
Most of us have experienced some sort of bad breath. It’s common in the morning right after waking up, but it also may be a sign for underlying medical issues like dental problems or acid reflux. Wherever it comes from, we always want to get rid of it. A recent meta-analysis in BMJ Open may have found the answer in some common foods.
For those with halitosis, the basic problem is that the bacteria in their mouths are not happy about where they are. The researchers looked at 130 studies and found seven that suggested fermented food has some effect in combating bad breath.
Now when we say fermented food, we’re not talking about that science project waiting to happen in the back of the refrigerator. Think yogurt, sourdough bread, or miso soup. Anything that contains probiotic bacteria.
Matthew J. Messina, DDS, assistant professor of dentistry at Ohio State University, who was not involved with the study, told Healthline that “the whole idea behind probiotics is [bacteria replacement]. Supplant the ‘bad guys’ with the ‘good guys,’ then we’ll end up with a better result.” Essentially balancing the scales in your mouth.
It may not be a long-term solution, Dr. Messina said, but the short-term data are positive. So if you experience bad breath from time to time, try a little bowl of yogurt instead of chewing gum. If nothing else, the bacteria in your mouth will thank you.
You can talk the silly talk, but can you walk the silly walk?
The Ministry of Silly Walks sketch from Monty Python is an enduring comedy classic, and one of surprising relevance for doctors. After all, this isn’t the first time a study has analyzed the unusual strides of Mr. Putey and Mr. Teabag.
The BMJ Christmas edition truly is the gift that keeps on giving. For this plunge into the Flying Circus, the study authors recruited a small group of fairly average adults and had them walk normally around a track for 5 minutes, monitoring their oxygen intake and energy expenditure. After that, the study participants imitated Mr. Putey’s walk and then Mr. Teabag’s.
In the sketch, Mr. Teabag notes that Mr. Putey’s walk is “not particularly silly,” which is borne out in the research. When imitating Mr. Putey’s walk, oxygen intake and energy expenditure were barely higher than a normal walk, not enough to achieve a meaningful difference. Hopefully he’ll get that government grant to further develop his silly walk, because right now Mr. Putey’s walk simply doesn’t cut it.
Mr. Teabag’s walk is a different story and the very image of inefficiency. Oxygen intake was 2.5 times higher than during the normal walk, and energy expenditure was noticeably higher (8 kcal in men and 5.2 kcal in women). In fact, the walk was so inefficient and its effect so drastic it actually reached the level of vigorous exercise. Thanks to this, the study authors noted that just 11 minutes a day of walking like Mr. Teabag would be enough to reach the general goal of 75 minutes of vigorous exercise per week. Boosting that to 12-19 minutes would increase daily energy expenditure by 100 kcal.
The study authors wrote, “Had an initiative to promote inefficient movement been adopted in the early 1970s, we might now be living among a healthier society. Efforts to promote higher energy – and perhaps more joyful – walking should ensure inclusivity and inefficiency for all.” We think they just advocated for a real-life Ministry of Silly Walks. Well, there have been worse ideas. Just look at Twitter.
When efficient gut microbes go bad
With the latest news from the Ministry of Silly Walks, is it time for humans to embrace all things inefficient? Maybe.
Turns out that individuals with more efficient digestive systems – those that extract more energy from the fuel supplied to them by the busy mouths above – tend to gain more weight than those with less efficient guts, even when they eat the same food, according to a recent study published in Microbiome.
The researchers took a look at the composition of gut microbes in a group of 85 volunteers and found that about 40% had microbiomes dominated by Bacteroides bacteria, which are more effective at extracting nutrients from food. That group also weighed 10% more on average, amounting to an extra 9 kg.
In a rather blatant demonstration of efficiency, the investigators also measured the speed of the participants’ digestion, as they had hypothesized that those with the longest digestive travel times would be the ones who harvested the most nutrition from their food. That was not the case.
The study subjects with the most efficient gut bacteria “also have the fastest passage through the gastrointestinal system, which has given us something to think about,” senior author Henrik Roager of the University of Copenhagen said in a written statement.
You know what gives us something to think about? Stool energy density and intestinal transit time and faecal bacterial cell counts, that’s what. Ick. Sometimes science is gross.
Here’s another thought, though: Seeing faecal instead of fecal is kind of funny to our American eyes, but adding that extra letter is also inefficient, which could mean that it’s good. So, in the spirit of embracing the inefficient as a new year begins, we’re resolving to wrap our editorial arms around faecal and the faeces it represents. Well, not literally, of course. More like we’re embracing the spirit of faeces.
Leave the mouthwash. Take the yogurt
Most of us have experienced some sort of bad breath. It’s common in the morning right after waking up, but it also may be a sign for underlying medical issues like dental problems or acid reflux. Wherever it comes from, we always want to get rid of it. A recent meta-analysis in BMJ Open may have found the answer in some common foods.
For those with halitosis, the basic problem is that the bacteria in their mouths are not happy about where they are. The researchers looked at 130 studies and found seven that suggested fermented food has some effect in combating bad breath.
Now when we say fermented food, we’re not talking about that science project waiting to happen in the back of the refrigerator. Think yogurt, sourdough bread, or miso soup. Anything that contains probiotic bacteria.
Matthew J. Messina, DDS, assistant professor of dentistry at Ohio State University, who was not involved with the study, told Healthline that “the whole idea behind probiotics is [bacteria replacement]. Supplant the ‘bad guys’ with the ‘good guys,’ then we’ll end up with a better result.” Essentially balancing the scales in your mouth.
It may not be a long-term solution, Dr. Messina said, but the short-term data are positive. So if you experience bad breath from time to time, try a little bowl of yogurt instead of chewing gum. If nothing else, the bacteria in your mouth will thank you.
You can talk the silly talk, but can you walk the silly walk?
The Ministry of Silly Walks sketch from Monty Python is an enduring comedy classic, and one of surprising relevance for doctors. After all, this isn’t the first time a study has analyzed the unusual strides of Mr. Putey and Mr. Teabag.
The BMJ Christmas edition truly is the gift that keeps on giving. For this plunge into the Flying Circus, the study authors recruited a small group of fairly average adults and had them walk normally around a track for 5 minutes, monitoring their oxygen intake and energy expenditure. After that, the study participants imitated Mr. Putey’s walk and then Mr. Teabag’s.
In the sketch, Mr. Teabag notes that Mr. Putey’s walk is “not particularly silly,” which is borne out in the research. When imitating Mr. Putey’s walk, oxygen intake and energy expenditure were barely higher than a normal walk, not enough to achieve a meaningful difference. Hopefully he’ll get that government grant to further develop his silly walk, because right now Mr. Putey’s walk simply doesn’t cut it.
Mr. Teabag’s walk is a different story and the very image of inefficiency. Oxygen intake was 2.5 times higher than during the normal walk, and energy expenditure was noticeably higher (8 kcal in men and 5.2 kcal in women). In fact, the walk was so inefficient and its effect so drastic it actually reached the level of vigorous exercise. Thanks to this, the study authors noted that just 11 minutes a day of walking like Mr. Teabag would be enough to reach the general goal of 75 minutes of vigorous exercise per week. Boosting that to 12-19 minutes would increase daily energy expenditure by 100 kcal.
The study authors wrote, “Had an initiative to promote inefficient movement been adopted in the early 1970s, we might now be living among a healthier society. Efforts to promote higher energy – and perhaps more joyful – walking should ensure inclusivity and inefficiency for all.” We think they just advocated for a real-life Ministry of Silly Walks. Well, there have been worse ideas. Just look at Twitter.
When efficient gut microbes go bad
With the latest news from the Ministry of Silly Walks, is it time for humans to embrace all things inefficient? Maybe.
Turns out that individuals with more efficient digestive systems – those that extract more energy from the fuel supplied to them by the busy mouths above – tend to gain more weight than those with less efficient guts, even when they eat the same food, according to a recent study published in Microbiome.
The researchers took a look at the composition of gut microbes in a group of 85 volunteers and found that about 40% had microbiomes dominated by Bacteroides bacteria, which are more effective at extracting nutrients from food. That group also weighed 10% more on average, amounting to an extra 9 kg.
In a rather blatant demonstration of efficiency, the investigators also measured the speed of the participants’ digestion, as they had hypothesized that those with the longest digestive travel times would be the ones who harvested the most nutrition from their food. That was not the case.
The study subjects with the most efficient gut bacteria “also have the fastest passage through the gastrointestinal system, which has given us something to think about,” senior author Henrik Roager of the University of Copenhagen said in a written statement.
You know what gives us something to think about? Stool energy density and intestinal transit time and faecal bacterial cell counts, that’s what. Ick. Sometimes science is gross.
Here’s another thought, though: Seeing faecal instead of fecal is kind of funny to our American eyes, but adding that extra letter is also inefficient, which could mean that it’s good. So, in the spirit of embracing the inefficient as a new year begins, we’re resolving to wrap our editorial arms around faecal and the faeces it represents. Well, not literally, of course. More like we’re embracing the spirit of faeces.
Medicare pay cuts partly averted in massive budget bill
Congress averted bigger reductions in Medicare’s future payments for clinicians in its massive, year-end spending bill, but physicians will still see a 2% cut in a key payment variable in 2023.
The bill also authorizes new policies regarding accelerated drug approvals and substance use disorder treatment.
The House voted 225-201 to clear a wide-ranging legislative package, known as an omnibus, for President Joe Biden’s signature. The Senate voted 68-29 to approve the measure.
Clinicians had been facing as much as 8.5% in cuts to certain factors that set their Medicare payment. The American Medical Association credited an advocacy campaign it joined with more than 150 organizations with fending off the much-feared reimbursement cuts. The 2% trim for 2023 will decline to 1.25% for 2024.
These reductions will hit as many clinicians face the toll on rising costs for running their practices, as , the AMA said.
“Congress must immediately begin the work of long-overdue Medicare physician payment reform that will lead to the program stability that beneficiaries and physicians need,” AMA President Jack Resneck, MD, said in a statement.
While the omnibus bill blocks 6.5% of Medicare payment cuts originally slated to take effect in 2023, it still puts “untenable strain” on primary care clinicians, said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians, in a statement.
“However, we’re pleased to see several provisions that will improve access to care, including bolstering mental health services, extending telehealth, and expanding Medicaid and CHIP coverage,” Dr. Iroku-Malize added.
New health care policies in omnibus
Lawmakers adopted many health care policy changes in the omnibus package, which contained 12 overdue spending bills for fiscal year 2023. (Much of the federal government has been funded through stop-gap measures since this budget year began on Oct. 1.) The final measure runs to more than 4,100 pages in PDF form.
House Energy and Commerce Chairman Frank Pallone Jr. (D-NJ) said the health care provisions will:
- Expand patient access to opioid addiction treatment by making it easier for clinicians to dispense buprenorphine for opioid use disorder maintenance or detoxification treatment
- Require health care providers to complete a training requirement on identifying and treating patients with substance use disorders
- Guarantee 12 months of continuous Medicaid coverage for 40 million children
- Provide 2 years of additional Children’s Health Insurance Program (CHIP) funding
- Permanently extend the option for states to offer 12 months of Medicaid coverage to new mothers
- Continue Medicare’s expanded access to telehealth by extending COVID-19 telehealth flexibilities through Dec. 31, 2024.
FDA’s accelerated approval
The omnibus also will shorten the period of uncertainty patients and clinicians face with medicines cleared under the accelerated approval pathway.
The Food and Drug Administration uses accelerated approvals to give conditional clearances to medicines for fatal and serious conditions based on limited evidence signaling a potential benefit. Companies are expected to continue research needed to prove whether promising signals, such as stemming tumor growth, benefits patients.
Concerns have mounted when companies delay confirmatory trials or try to maintain accelerated approvals for drugs that fail those trials.
Mr. Pallone said the omnibus contains provisions that:
- Require the FDA to specify conditions for required post-approval studies
- Authorize the FDA to require post-approval studies to be underway at the time of approval or within a specified time period following approval.
- Clarify and streamline current FDA authority to withdraw approvals when sponsors fail to conduct studies with due diligence.
Reshma Ramachandran, MD, MPP, MHS, who serves as the chair of the Doctors for America’s FDA Task Force, told this news organization that she was pleased to see these provisions pass. She had been disappointed they were not included earlier this year in the latest Prescription Drug User Fee Act reauthorization.
The provisions in the omnibus make “clear what steps the FDA can take to remove an unproven drug off the market should manufacturers fail to complete these studies or demonstrate meaningful clinical benefit,” Dr. Ramachandran wrote in an email.
Dr. Ramachandran said she hopes lawmakers build on these steps in the future. She suggested Congress add a mandate to require drug labels to clearly state when the FDA is still waiting for evidence needed to confirm benefits of medicines cleared by accelerated approval.
“Nevertheless, Congress in including and, hopefully, passing these reforms has made it clear that drug companies need to provide meaningful evidence that their accelerated approval drugs work in patients and FDA can take action to protect patients should this not occur,” Dr. Ramachandran wrote.
A version of this article first appeared on Medscape.com.
Congress averted bigger reductions in Medicare’s future payments for clinicians in its massive, year-end spending bill, but physicians will still see a 2% cut in a key payment variable in 2023.
The bill also authorizes new policies regarding accelerated drug approvals and substance use disorder treatment.
The House voted 225-201 to clear a wide-ranging legislative package, known as an omnibus, for President Joe Biden’s signature. The Senate voted 68-29 to approve the measure.
Clinicians had been facing as much as 8.5% in cuts to certain factors that set their Medicare payment. The American Medical Association credited an advocacy campaign it joined with more than 150 organizations with fending off the much-feared reimbursement cuts. The 2% trim for 2023 will decline to 1.25% for 2024.
These reductions will hit as many clinicians face the toll on rising costs for running their practices, as , the AMA said.
“Congress must immediately begin the work of long-overdue Medicare physician payment reform that will lead to the program stability that beneficiaries and physicians need,” AMA President Jack Resneck, MD, said in a statement.
While the omnibus bill blocks 6.5% of Medicare payment cuts originally slated to take effect in 2023, it still puts “untenable strain” on primary care clinicians, said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians, in a statement.
“However, we’re pleased to see several provisions that will improve access to care, including bolstering mental health services, extending telehealth, and expanding Medicaid and CHIP coverage,” Dr. Iroku-Malize added.
New health care policies in omnibus
Lawmakers adopted many health care policy changes in the omnibus package, which contained 12 overdue spending bills for fiscal year 2023. (Much of the federal government has been funded through stop-gap measures since this budget year began on Oct. 1.) The final measure runs to more than 4,100 pages in PDF form.
House Energy and Commerce Chairman Frank Pallone Jr. (D-NJ) said the health care provisions will:
- Expand patient access to opioid addiction treatment by making it easier for clinicians to dispense buprenorphine for opioid use disorder maintenance or detoxification treatment
- Require health care providers to complete a training requirement on identifying and treating patients with substance use disorders
- Guarantee 12 months of continuous Medicaid coverage for 40 million children
- Provide 2 years of additional Children’s Health Insurance Program (CHIP) funding
- Permanently extend the option for states to offer 12 months of Medicaid coverage to new mothers
- Continue Medicare’s expanded access to telehealth by extending COVID-19 telehealth flexibilities through Dec. 31, 2024.
FDA’s accelerated approval
The omnibus also will shorten the period of uncertainty patients and clinicians face with medicines cleared under the accelerated approval pathway.
The Food and Drug Administration uses accelerated approvals to give conditional clearances to medicines for fatal and serious conditions based on limited evidence signaling a potential benefit. Companies are expected to continue research needed to prove whether promising signals, such as stemming tumor growth, benefits patients.
Concerns have mounted when companies delay confirmatory trials or try to maintain accelerated approvals for drugs that fail those trials.
Mr. Pallone said the omnibus contains provisions that:
- Require the FDA to specify conditions for required post-approval studies
- Authorize the FDA to require post-approval studies to be underway at the time of approval or within a specified time period following approval.
- Clarify and streamline current FDA authority to withdraw approvals when sponsors fail to conduct studies with due diligence.
Reshma Ramachandran, MD, MPP, MHS, who serves as the chair of the Doctors for America’s FDA Task Force, told this news organization that she was pleased to see these provisions pass. She had been disappointed they were not included earlier this year in the latest Prescription Drug User Fee Act reauthorization.
The provisions in the omnibus make “clear what steps the FDA can take to remove an unproven drug off the market should manufacturers fail to complete these studies or demonstrate meaningful clinical benefit,” Dr. Ramachandran wrote in an email.
Dr. Ramachandran said she hopes lawmakers build on these steps in the future. She suggested Congress add a mandate to require drug labels to clearly state when the FDA is still waiting for evidence needed to confirm benefits of medicines cleared by accelerated approval.
“Nevertheless, Congress in including and, hopefully, passing these reforms has made it clear that drug companies need to provide meaningful evidence that their accelerated approval drugs work in patients and FDA can take action to protect patients should this not occur,” Dr. Ramachandran wrote.
A version of this article first appeared on Medscape.com.
Congress averted bigger reductions in Medicare’s future payments for clinicians in its massive, year-end spending bill, but physicians will still see a 2% cut in a key payment variable in 2023.
The bill also authorizes new policies regarding accelerated drug approvals and substance use disorder treatment.
The House voted 225-201 to clear a wide-ranging legislative package, known as an omnibus, for President Joe Biden’s signature. The Senate voted 68-29 to approve the measure.
Clinicians had been facing as much as 8.5% in cuts to certain factors that set their Medicare payment. The American Medical Association credited an advocacy campaign it joined with more than 150 organizations with fending off the much-feared reimbursement cuts. The 2% trim for 2023 will decline to 1.25% for 2024.
These reductions will hit as many clinicians face the toll on rising costs for running their practices, as , the AMA said.
“Congress must immediately begin the work of long-overdue Medicare physician payment reform that will lead to the program stability that beneficiaries and physicians need,” AMA President Jack Resneck, MD, said in a statement.
While the omnibus bill blocks 6.5% of Medicare payment cuts originally slated to take effect in 2023, it still puts “untenable strain” on primary care clinicians, said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians, in a statement.
“However, we’re pleased to see several provisions that will improve access to care, including bolstering mental health services, extending telehealth, and expanding Medicaid and CHIP coverage,” Dr. Iroku-Malize added.
New health care policies in omnibus
Lawmakers adopted many health care policy changes in the omnibus package, which contained 12 overdue spending bills for fiscal year 2023. (Much of the federal government has been funded through stop-gap measures since this budget year began on Oct. 1.) The final measure runs to more than 4,100 pages in PDF form.
House Energy and Commerce Chairman Frank Pallone Jr. (D-NJ) said the health care provisions will:
- Expand patient access to opioid addiction treatment by making it easier for clinicians to dispense buprenorphine for opioid use disorder maintenance or detoxification treatment
- Require health care providers to complete a training requirement on identifying and treating patients with substance use disorders
- Guarantee 12 months of continuous Medicaid coverage for 40 million children
- Provide 2 years of additional Children’s Health Insurance Program (CHIP) funding
- Permanently extend the option for states to offer 12 months of Medicaid coverage to new mothers
- Continue Medicare’s expanded access to telehealth by extending COVID-19 telehealth flexibilities through Dec. 31, 2024.
FDA’s accelerated approval
The omnibus also will shorten the period of uncertainty patients and clinicians face with medicines cleared under the accelerated approval pathway.
The Food and Drug Administration uses accelerated approvals to give conditional clearances to medicines for fatal and serious conditions based on limited evidence signaling a potential benefit. Companies are expected to continue research needed to prove whether promising signals, such as stemming tumor growth, benefits patients.
Concerns have mounted when companies delay confirmatory trials or try to maintain accelerated approvals for drugs that fail those trials.
Mr. Pallone said the omnibus contains provisions that:
- Require the FDA to specify conditions for required post-approval studies
- Authorize the FDA to require post-approval studies to be underway at the time of approval or within a specified time period following approval.
- Clarify and streamline current FDA authority to withdraw approvals when sponsors fail to conduct studies with due diligence.
Reshma Ramachandran, MD, MPP, MHS, who serves as the chair of the Doctors for America’s FDA Task Force, told this news organization that she was pleased to see these provisions pass. She had been disappointed they were not included earlier this year in the latest Prescription Drug User Fee Act reauthorization.
The provisions in the omnibus make “clear what steps the FDA can take to remove an unproven drug off the market should manufacturers fail to complete these studies or demonstrate meaningful clinical benefit,” Dr. Ramachandran wrote in an email.
Dr. Ramachandran said she hopes lawmakers build on these steps in the future. She suggested Congress add a mandate to require drug labels to clearly state when the FDA is still waiting for evidence needed to confirm benefits of medicines cleared by accelerated approval.
“Nevertheless, Congress in including and, hopefully, passing these reforms has made it clear that drug companies need to provide meaningful evidence that their accelerated approval drugs work in patients and FDA can take action to protect patients should this not occur,” Dr. Ramachandran wrote.
A version of this article first appeared on Medscape.com.
MD-researcher keeps her eyes on the prize
As a toddler undergoing treatment at McMaster Children’s Hospital in Hamilton, Ont., Caroline Diorio, MD, couldn’t grasp what the nice doctors scurrying in and out of her room were doing. She just knew they were taking care of her.
Dr. Diorio had pediatric immune thrombocytopenia (ITP), a type of platelet disorder in which the immune system attacks blood platelets for usually unknown reasons.
“I remember very much how worried my parents were,” recalled Dr. Diorio, now a hematologist-oncologist at Children’s Hospital of Philadelphia. “And I remember how the tone of the doctor’s voice and the way the doctors communicated provided so much reassurance to my parents.”
Dr. Diorio’s ITP resolved within a few years, but her experience left a lasting impression.
“From that moment on, I don’t remember a time that I didn’t want to be a doctor,” she said. “I had these really formative experiences with doctors who were so lovely, and I thought, ‘I want to do that.’ ”
Though she considered other specialties in medical school at the University of Toronto, Dr. Diorio kept feeling drawn back to pediatric oncology and hematology.
“I have always loved the commitment that parents have to their kids and the team approach that exists,” she said. “Hematology/oncology allowed me to take care of really sick kids but also have this long-term relationship with them and their parents, which I really value and love.”
Dr. Diorio even completed her residency at McMaster alongside one of the same physicians who had cared for her as a child, Ronald Duncan Barr, MD. “It sort of all came full circle,” she said.
For B-cell ALL and several other blood cancers, an effective option is CAR T-cell therapy, in which physicians collect T-cells from the patient, re-engineer the T cells in the lab so they recognize the proteins expressed on the surface of cancerous cells – called blasts – and then introduce the modified T-cells back into the patient. Once infused, the re-engineered T-cells attack the blasts with the tell-tale proteins.
But with T-ALL, T-cells themselves are infected with cancer, so autologous CAR T-cell therapy is not currently an option, and no allogeneic CAR T-cell therapies have been approved. Dr. Diorio is part of a cutting-edge research team led by David T. Teachey, MD, striving for breakthroughs. “She’s a brilliant clinician, extremely smart and hard-working, exceptional work ethic, great interaction with patients and families with a great bedside manner,” Dr. Teachey said of Dr. Diorio. “She’s just a superstar all around.”
Dr. Teachey first piqued Dr. Diorio’s interest in researching innovative T-ALL therapies when she arrived at CHOP as a hematology/oncology fellow in 2018 and pursued a master of science degree in translational research under his tutelage at the University of Pennsylvania. Then, for a time, the COVID-19 pandemic shut down most research.
“Caroline pivoted and was at the front line, collecting samples and helping with research on SARS-CoV-2 very early in the pandemic,” Dr. Teachey said. “She was able to then pivot back, taking the skills she learned from that work in the pandemic and applying it to what she was doing in the CAR T-cell space and T-ALL.”
Extraordinary gains in pediatric cancer over the past several decades mean that more than 80% of children diagnosed with cancer today will become long-term survivors. “The 20% of the time that we don’t get the result we want is obviously devastating,” Dr. Diorio said. “However, that’s incredibly motivating to try to make better treatments.”
Her current focus is finding a way to use CAR T-cell therapy in children with T-ALL. About 85% of children with T-ALL do well with standard first-line treatments of chemotherapy, but the 15% who relapse or have chemo-refractory disease have a far lower survival rate – less than 30%, Dr. Diorio said.
The problem with autologous CAR T-cell therapy in T-ALL is twofold: It’s difficult to sort out healthy T cells from the cancerous T cells, and the target current re-engineered T-cells go after is on healthy cells, too.
“What happens is a problem called fratricide – basically the CAR T-cells are killing their brothers,” she said. So Dr. Diorio and her colleagues are trying to modify CAR T-cell strategies to target different markers. One target they’re investigating is CD7, but using CRISPR to gene-edit out CD7 from healthy cells requires making two cuts in the DNA.
“Any time you break DNA, you have to repair it, and any time you repair it, there’s a chance of making a mistake,” Dr. Diorio said. So she used a different technique, cytosine-based editing, which requires only one cut. “You put in what you want, and it’s much more precise and less error-prone.” Cytosine-based editing also preserves T cells’ vitality; too many cuts impair T-cell growth, but that doesn’t happen with cytosine-based editing. In August of 2022, Dr. Diorio published a study demonstrating this technique while the team has continued looking for other targets that show up on cancer cells but not on healthy T-cells.
“I’m not invested in one particular strategy,” Dr. Diorio said. “I’m invested in finding a strategy that works for the maximum number of patients.”
That pragmatic approach may be why Dr. Teachey describes her as an out-of-the-box thinker.
“She brings novel ideas to the table, and not everybody who’s a physician-scientist has that ability to really think about taking things in the bench to the bedside and then back again,” Dr. Teachey said. “It’s knowing what questions are important to ask for our patients and how to study those and the research base, so that you can improve treatments for kids with leukemia.”
Their research looks promising so far. Clinical trials are in development for the CD7-targeted CAR T, and they’re collaborating with others on clinical trials for CAR-T targeting another protein, CD38. In the midst of it all, Dr. Diorio remains focused on her patients.
“It’s really a privilege to see the incredible grace people have in these very difficult circumstances,” Dr. Diorio said. “I find it really motivating to try to make things easier for people, and I try to spend every day looking for better treatments so people don’t have to go through that.”
Dr. Diorio has no disclosures. Dr. Teachey has served on the advisory boards of BEAM, Jazz, Janssen, and Sobi and has received research funding from BEAM, Jazz, Servier, and Neoimmune Tech. He has multiple patents pending on CAR-T therapy.
As a toddler undergoing treatment at McMaster Children’s Hospital in Hamilton, Ont., Caroline Diorio, MD, couldn’t grasp what the nice doctors scurrying in and out of her room were doing. She just knew they were taking care of her.
Dr. Diorio had pediatric immune thrombocytopenia (ITP), a type of platelet disorder in which the immune system attacks blood platelets for usually unknown reasons.
“I remember very much how worried my parents were,” recalled Dr. Diorio, now a hematologist-oncologist at Children’s Hospital of Philadelphia. “And I remember how the tone of the doctor’s voice and the way the doctors communicated provided so much reassurance to my parents.”
Dr. Diorio’s ITP resolved within a few years, but her experience left a lasting impression.
“From that moment on, I don’t remember a time that I didn’t want to be a doctor,” she said. “I had these really formative experiences with doctors who were so lovely, and I thought, ‘I want to do that.’ ”
Though she considered other specialties in medical school at the University of Toronto, Dr. Diorio kept feeling drawn back to pediatric oncology and hematology.
“I have always loved the commitment that parents have to their kids and the team approach that exists,” she said. “Hematology/oncology allowed me to take care of really sick kids but also have this long-term relationship with them and their parents, which I really value and love.”
Dr. Diorio even completed her residency at McMaster alongside one of the same physicians who had cared for her as a child, Ronald Duncan Barr, MD. “It sort of all came full circle,” she said.
For B-cell ALL and several other blood cancers, an effective option is CAR T-cell therapy, in which physicians collect T-cells from the patient, re-engineer the T cells in the lab so they recognize the proteins expressed on the surface of cancerous cells – called blasts – and then introduce the modified T-cells back into the patient. Once infused, the re-engineered T-cells attack the blasts with the tell-tale proteins.
But with T-ALL, T-cells themselves are infected with cancer, so autologous CAR T-cell therapy is not currently an option, and no allogeneic CAR T-cell therapies have been approved. Dr. Diorio is part of a cutting-edge research team led by David T. Teachey, MD, striving for breakthroughs. “She’s a brilliant clinician, extremely smart and hard-working, exceptional work ethic, great interaction with patients and families with a great bedside manner,” Dr. Teachey said of Dr. Diorio. “She’s just a superstar all around.”
Dr. Teachey first piqued Dr. Diorio’s interest in researching innovative T-ALL therapies when she arrived at CHOP as a hematology/oncology fellow in 2018 and pursued a master of science degree in translational research under his tutelage at the University of Pennsylvania. Then, for a time, the COVID-19 pandemic shut down most research.
“Caroline pivoted and was at the front line, collecting samples and helping with research on SARS-CoV-2 very early in the pandemic,” Dr. Teachey said. “She was able to then pivot back, taking the skills she learned from that work in the pandemic and applying it to what she was doing in the CAR T-cell space and T-ALL.”
Extraordinary gains in pediatric cancer over the past several decades mean that more than 80% of children diagnosed with cancer today will become long-term survivors. “The 20% of the time that we don’t get the result we want is obviously devastating,” Dr. Diorio said. “However, that’s incredibly motivating to try to make better treatments.”
Her current focus is finding a way to use CAR T-cell therapy in children with T-ALL. About 85% of children with T-ALL do well with standard first-line treatments of chemotherapy, but the 15% who relapse or have chemo-refractory disease have a far lower survival rate – less than 30%, Dr. Diorio said.
The problem with autologous CAR T-cell therapy in T-ALL is twofold: It’s difficult to sort out healthy T cells from the cancerous T cells, and the target current re-engineered T-cells go after is on healthy cells, too.
“What happens is a problem called fratricide – basically the CAR T-cells are killing their brothers,” she said. So Dr. Diorio and her colleagues are trying to modify CAR T-cell strategies to target different markers. One target they’re investigating is CD7, but using CRISPR to gene-edit out CD7 from healthy cells requires making two cuts in the DNA.
“Any time you break DNA, you have to repair it, and any time you repair it, there’s a chance of making a mistake,” Dr. Diorio said. So she used a different technique, cytosine-based editing, which requires only one cut. “You put in what you want, and it’s much more precise and less error-prone.” Cytosine-based editing also preserves T cells’ vitality; too many cuts impair T-cell growth, but that doesn’t happen with cytosine-based editing. In August of 2022, Dr. Diorio published a study demonstrating this technique while the team has continued looking for other targets that show up on cancer cells but not on healthy T-cells.
“I’m not invested in one particular strategy,” Dr. Diorio said. “I’m invested in finding a strategy that works for the maximum number of patients.”
That pragmatic approach may be why Dr. Teachey describes her as an out-of-the-box thinker.
“She brings novel ideas to the table, and not everybody who’s a physician-scientist has that ability to really think about taking things in the bench to the bedside and then back again,” Dr. Teachey said. “It’s knowing what questions are important to ask for our patients and how to study those and the research base, so that you can improve treatments for kids with leukemia.”
Their research looks promising so far. Clinical trials are in development for the CD7-targeted CAR T, and they’re collaborating with others on clinical trials for CAR-T targeting another protein, CD38. In the midst of it all, Dr. Diorio remains focused on her patients.
“It’s really a privilege to see the incredible grace people have in these very difficult circumstances,” Dr. Diorio said. “I find it really motivating to try to make things easier for people, and I try to spend every day looking for better treatments so people don’t have to go through that.”
Dr. Diorio has no disclosures. Dr. Teachey has served on the advisory boards of BEAM, Jazz, Janssen, and Sobi and has received research funding from BEAM, Jazz, Servier, and Neoimmune Tech. He has multiple patents pending on CAR-T therapy.
As a toddler undergoing treatment at McMaster Children’s Hospital in Hamilton, Ont., Caroline Diorio, MD, couldn’t grasp what the nice doctors scurrying in and out of her room were doing. She just knew they were taking care of her.
Dr. Diorio had pediatric immune thrombocytopenia (ITP), a type of platelet disorder in which the immune system attacks blood platelets for usually unknown reasons.
“I remember very much how worried my parents were,” recalled Dr. Diorio, now a hematologist-oncologist at Children’s Hospital of Philadelphia. “And I remember how the tone of the doctor’s voice and the way the doctors communicated provided so much reassurance to my parents.”
Dr. Diorio’s ITP resolved within a few years, but her experience left a lasting impression.
“From that moment on, I don’t remember a time that I didn’t want to be a doctor,” she said. “I had these really formative experiences with doctors who were so lovely, and I thought, ‘I want to do that.’ ”
Though she considered other specialties in medical school at the University of Toronto, Dr. Diorio kept feeling drawn back to pediatric oncology and hematology.
“I have always loved the commitment that parents have to their kids and the team approach that exists,” she said. “Hematology/oncology allowed me to take care of really sick kids but also have this long-term relationship with them and their parents, which I really value and love.”
Dr. Diorio even completed her residency at McMaster alongside one of the same physicians who had cared for her as a child, Ronald Duncan Barr, MD. “It sort of all came full circle,” she said.
For B-cell ALL and several other blood cancers, an effective option is CAR T-cell therapy, in which physicians collect T-cells from the patient, re-engineer the T cells in the lab so they recognize the proteins expressed on the surface of cancerous cells – called blasts – and then introduce the modified T-cells back into the patient. Once infused, the re-engineered T-cells attack the blasts with the tell-tale proteins.
But with T-ALL, T-cells themselves are infected with cancer, so autologous CAR T-cell therapy is not currently an option, and no allogeneic CAR T-cell therapies have been approved. Dr. Diorio is part of a cutting-edge research team led by David T. Teachey, MD, striving for breakthroughs. “She’s a brilliant clinician, extremely smart and hard-working, exceptional work ethic, great interaction with patients and families with a great bedside manner,” Dr. Teachey said of Dr. Diorio. “She’s just a superstar all around.”
Dr. Teachey first piqued Dr. Diorio’s interest in researching innovative T-ALL therapies when she arrived at CHOP as a hematology/oncology fellow in 2018 and pursued a master of science degree in translational research under his tutelage at the University of Pennsylvania. Then, for a time, the COVID-19 pandemic shut down most research.
“Caroline pivoted and was at the front line, collecting samples and helping with research on SARS-CoV-2 very early in the pandemic,” Dr. Teachey said. “She was able to then pivot back, taking the skills she learned from that work in the pandemic and applying it to what she was doing in the CAR T-cell space and T-ALL.”
Extraordinary gains in pediatric cancer over the past several decades mean that more than 80% of children diagnosed with cancer today will become long-term survivors. “The 20% of the time that we don’t get the result we want is obviously devastating,” Dr. Diorio said. “However, that’s incredibly motivating to try to make better treatments.”
Her current focus is finding a way to use CAR T-cell therapy in children with T-ALL. About 85% of children with T-ALL do well with standard first-line treatments of chemotherapy, but the 15% who relapse or have chemo-refractory disease have a far lower survival rate – less than 30%, Dr. Diorio said.
The problem with autologous CAR T-cell therapy in T-ALL is twofold: It’s difficult to sort out healthy T cells from the cancerous T cells, and the target current re-engineered T-cells go after is on healthy cells, too.
“What happens is a problem called fratricide – basically the CAR T-cells are killing their brothers,” she said. So Dr. Diorio and her colleagues are trying to modify CAR T-cell strategies to target different markers. One target they’re investigating is CD7, but using CRISPR to gene-edit out CD7 from healthy cells requires making two cuts in the DNA.
“Any time you break DNA, you have to repair it, and any time you repair it, there’s a chance of making a mistake,” Dr. Diorio said. So she used a different technique, cytosine-based editing, which requires only one cut. “You put in what you want, and it’s much more precise and less error-prone.” Cytosine-based editing also preserves T cells’ vitality; too many cuts impair T-cell growth, but that doesn’t happen with cytosine-based editing. In August of 2022, Dr. Diorio published a study demonstrating this technique while the team has continued looking for other targets that show up on cancer cells but not on healthy T-cells.
“I’m not invested in one particular strategy,” Dr. Diorio said. “I’m invested in finding a strategy that works for the maximum number of patients.”
That pragmatic approach may be why Dr. Teachey describes her as an out-of-the-box thinker.
“She brings novel ideas to the table, and not everybody who’s a physician-scientist has that ability to really think about taking things in the bench to the bedside and then back again,” Dr. Teachey said. “It’s knowing what questions are important to ask for our patients and how to study those and the research base, so that you can improve treatments for kids with leukemia.”
Their research looks promising so far. Clinical trials are in development for the CD7-targeted CAR T, and they’re collaborating with others on clinical trials for CAR-T targeting another protein, CD38. In the midst of it all, Dr. Diorio remains focused on her patients.
“It’s really a privilege to see the incredible grace people have in these very difficult circumstances,” Dr. Diorio said. “I find it really motivating to try to make things easier for people, and I try to spend every day looking for better treatments so people don’t have to go through that.”
Dr. Diorio has no disclosures. Dr. Teachey has served on the advisory boards of BEAM, Jazz, Janssen, and Sobi and has received research funding from BEAM, Jazz, Servier, and Neoimmune Tech. He has multiple patents pending on CAR-T therapy.
COVID isolated people. Long COVID makes it worse
A year ago in December, mapping specialist Whitney Tyshynski, 35, was working out 5 days a week with a personal trainer near her home in Alberta, Canada, doing 5k trail runs, lifting heavy weights, and feeling good. Then, in January she got COVID-19. The symptoms never went away.
Nowadays, Ms. Tyshynski needs a walker to retrieve her mail, a half-block trip she can’t make without fear of fainting. Because she gets dizzy when she drives, she rarely goes anywhere in her car. Going for a dog walk with a friend means sitting in a car and watching the friend and the dogs in an open field. And since fainting at Costco during the summer, she’s afraid to shop by herself.
Because she lives alone and her closest relatives are an hour and a half away, Ms. Tyshynski is dependent on friends. But she’s reluctant to lean on them because they already have trouble understanding how debilitating her lingering symptoms can be.
“I’ve had people pretty much insinuate that I’m lazy,” she says.
There’s no question that COVID-19 cut people off from one another. But for those like Ms. Tyshynski who have long COVID, that disconnect has never ended. that the condition is real.
At worst, as Ms. Tyshynski has discovered, people don’t take it seriously and accuse those who have it of exaggerating their health woes. In that way, long COVID can be as isolating as the original illness.
“Isolation in long COVID comes in various forms and it’s not primarily just that physical isolation,” says Yochai Re’em, MD, a psychiatrist in private practice in New York who has experienced long COVID and blogs about the condition for Psychology Today. “A different yet equally challenging type of isolation is the emotional isolation, where you need more emotional support, connection with other people who can appreciate what it is you are going through without putting their own needs and desires onto you – and that can be hard to find.”
It’s hard to find in part because of what Dr. Re’em sees as a collective belief that anyone who feels bad should be able to get better by exercising, researching, or going to a doctor.
“Society thinks you need to take some kind of action and usually that’s a physical action,” he says. “And that attitude is tremendously problematic in this illness because of the postexertional malaise that people experience: When people exert themselves, their symptoms get worse. And so the action that people take can’t be that traditional action that we’re used to taking in our society.”
Long COVID patients often have their feelings invalidated not just by friends, loved ones, and extended family, but by health care providers. That can heighten feelings of isolation, particularly for people who live alone, says Jordan Anderson, DO, a neuropsychiatrist and assistant professor of psychiatry at Oregon Health & Science University in Portland.
The first patients Dr. Anderson saw as part of OHSU’s long COVID program contracted the virus in February 2020. Because the program addresses both the physical and mental health components of the condition, Dr. Anderson has seen a lot of people whose emotional challenges are similar to those Ms. Tyshynski faces.
“I think there’s a lack of understanding that leads to people just not necessarily taking it seriously,” he says. “Plus, the symptoms of long COVID do wax and wane. They’re not static. So people can be feeling pretty good one day and be feeling terrible the next. There’s some predictability to it, but it’s not absolutely predictable. It can be difficult for people to understand.”
Both Dr. Anderson and Dr. Re’em stress that long COVID patients need to prioritize their own energy regardless of what they’re being told by those who don’t understand the illness. Dr. Anderson offers to speak to his patients’ spouses to educate them about the realities of the condition because, he says, “any kind of lack of awareness or understanding in a family member or close support could potentially isolate the person struggling with long COVID.”
Depending on how open-minded and motivated a friend or relative is, they might develop more empathy with time and education, Dr. Re’em says. But for others, dealing with a confusing, unfamiliar chronic illness can be overwhelming and provoke anxiety.
“The hopelessness is too much for them to sit with, so instead they say things like ‘just push through it,’ or ‘just do X, Y, and Z,’ because psychologically it’s too much for them to take on that burden,” he says.
The good news is that there are plenty of web-based support groups for people with long COVID, including Body Politic (which Dr. Re’em is affiliated with), Survivor Corps, and on Facebook. “The patient community with this illness is tremendous, absolutely tremendous,” Dr. Re’em says. “Those people can be found and they can support each other.”
Some long COVID clinics run groups, as do individual practitioners such as Dr. Re’em, although those can be challenging to join. For instance, Dr. Re’em’s are only for New York state residents.
The key to finding a group is to be patient, because finding the right one takes time and energy.
“There are support groups that exist, but they are not as prevalent as I would like them to be,” Dr. Anderson says.
OHSU had an educational support group run by a social worker affiliated with the long COVID hub, but when the social worker left the program, the program was put on hold.
There’s a psychotherapy group operating out of the psychiatry department, but the patients are recruited exclusively from Dr. Anderson’s clinic and access is limited.
“The services exist, but I think that generally they’re sparse and pretty geographically dependent,” Dr. Anderson says. “I think you’d probably more likely be able to find something like this in a city or an area that has an academic institution or a place with a lot of resources rather than out in a rural community.”
Ms. Tyshynski opted not to join a group for fear it would increase the depression and anxiety that she had even before developing long COVID. When she and her family joined a cancer support group when her father was ill, she found it more depressing than helpful. Where she has found support is from the cofounder of the animal rescue society where she volunteers, a woman who has had long COVID for more than 2 years and has been a source of comfort and advice.
It’s one of the rare reminders Ms. Tyshynski has that even though she may live alone, she’s not completely alone. “Other people are going through this, too,” she says. “It helps to remember that.”
A version of this article first appeared on WebMD.com.
A year ago in December, mapping specialist Whitney Tyshynski, 35, was working out 5 days a week with a personal trainer near her home in Alberta, Canada, doing 5k trail runs, lifting heavy weights, and feeling good. Then, in January she got COVID-19. The symptoms never went away.
Nowadays, Ms. Tyshynski needs a walker to retrieve her mail, a half-block trip she can’t make without fear of fainting. Because she gets dizzy when she drives, she rarely goes anywhere in her car. Going for a dog walk with a friend means sitting in a car and watching the friend and the dogs in an open field. And since fainting at Costco during the summer, she’s afraid to shop by herself.
Because she lives alone and her closest relatives are an hour and a half away, Ms. Tyshynski is dependent on friends. But she’s reluctant to lean on them because they already have trouble understanding how debilitating her lingering symptoms can be.
“I’ve had people pretty much insinuate that I’m lazy,” she says.
There’s no question that COVID-19 cut people off from one another. But for those like Ms. Tyshynski who have long COVID, that disconnect has never ended. that the condition is real.
At worst, as Ms. Tyshynski has discovered, people don’t take it seriously and accuse those who have it of exaggerating their health woes. In that way, long COVID can be as isolating as the original illness.
“Isolation in long COVID comes in various forms and it’s not primarily just that physical isolation,” says Yochai Re’em, MD, a psychiatrist in private practice in New York who has experienced long COVID and blogs about the condition for Psychology Today. “A different yet equally challenging type of isolation is the emotional isolation, where you need more emotional support, connection with other people who can appreciate what it is you are going through without putting their own needs and desires onto you – and that can be hard to find.”
It’s hard to find in part because of what Dr. Re’em sees as a collective belief that anyone who feels bad should be able to get better by exercising, researching, or going to a doctor.
“Society thinks you need to take some kind of action and usually that’s a physical action,” he says. “And that attitude is tremendously problematic in this illness because of the postexertional malaise that people experience: When people exert themselves, their symptoms get worse. And so the action that people take can’t be that traditional action that we’re used to taking in our society.”
Long COVID patients often have their feelings invalidated not just by friends, loved ones, and extended family, but by health care providers. That can heighten feelings of isolation, particularly for people who live alone, says Jordan Anderson, DO, a neuropsychiatrist and assistant professor of psychiatry at Oregon Health & Science University in Portland.
The first patients Dr. Anderson saw as part of OHSU’s long COVID program contracted the virus in February 2020. Because the program addresses both the physical and mental health components of the condition, Dr. Anderson has seen a lot of people whose emotional challenges are similar to those Ms. Tyshynski faces.
“I think there’s a lack of understanding that leads to people just not necessarily taking it seriously,” he says. “Plus, the symptoms of long COVID do wax and wane. They’re not static. So people can be feeling pretty good one day and be feeling terrible the next. There’s some predictability to it, but it’s not absolutely predictable. It can be difficult for people to understand.”
Both Dr. Anderson and Dr. Re’em stress that long COVID patients need to prioritize their own energy regardless of what they’re being told by those who don’t understand the illness. Dr. Anderson offers to speak to his patients’ spouses to educate them about the realities of the condition because, he says, “any kind of lack of awareness or understanding in a family member or close support could potentially isolate the person struggling with long COVID.”
Depending on how open-minded and motivated a friend or relative is, they might develop more empathy with time and education, Dr. Re’em says. But for others, dealing with a confusing, unfamiliar chronic illness can be overwhelming and provoke anxiety.
“The hopelessness is too much for them to sit with, so instead they say things like ‘just push through it,’ or ‘just do X, Y, and Z,’ because psychologically it’s too much for them to take on that burden,” he says.
The good news is that there are plenty of web-based support groups for people with long COVID, including Body Politic (which Dr. Re’em is affiliated with), Survivor Corps, and on Facebook. “The patient community with this illness is tremendous, absolutely tremendous,” Dr. Re’em says. “Those people can be found and they can support each other.”
Some long COVID clinics run groups, as do individual practitioners such as Dr. Re’em, although those can be challenging to join. For instance, Dr. Re’em’s are only for New York state residents.
The key to finding a group is to be patient, because finding the right one takes time and energy.
“There are support groups that exist, but they are not as prevalent as I would like them to be,” Dr. Anderson says.
OHSU had an educational support group run by a social worker affiliated with the long COVID hub, but when the social worker left the program, the program was put on hold.
There’s a psychotherapy group operating out of the psychiatry department, but the patients are recruited exclusively from Dr. Anderson’s clinic and access is limited.
“The services exist, but I think that generally they’re sparse and pretty geographically dependent,” Dr. Anderson says. “I think you’d probably more likely be able to find something like this in a city or an area that has an academic institution or a place with a lot of resources rather than out in a rural community.”
Ms. Tyshynski opted not to join a group for fear it would increase the depression and anxiety that she had even before developing long COVID. When she and her family joined a cancer support group when her father was ill, she found it more depressing than helpful. Where she has found support is from the cofounder of the animal rescue society where she volunteers, a woman who has had long COVID for more than 2 years and has been a source of comfort and advice.
It’s one of the rare reminders Ms. Tyshynski has that even though she may live alone, she’s not completely alone. “Other people are going through this, too,” she says. “It helps to remember that.”
A version of this article first appeared on WebMD.com.
A year ago in December, mapping specialist Whitney Tyshynski, 35, was working out 5 days a week with a personal trainer near her home in Alberta, Canada, doing 5k trail runs, lifting heavy weights, and feeling good. Then, in January she got COVID-19. The symptoms never went away.
Nowadays, Ms. Tyshynski needs a walker to retrieve her mail, a half-block trip she can’t make without fear of fainting. Because she gets dizzy when she drives, she rarely goes anywhere in her car. Going for a dog walk with a friend means sitting in a car and watching the friend and the dogs in an open field. And since fainting at Costco during the summer, she’s afraid to shop by herself.
Because she lives alone and her closest relatives are an hour and a half away, Ms. Tyshynski is dependent on friends. But she’s reluctant to lean on them because they already have trouble understanding how debilitating her lingering symptoms can be.
“I’ve had people pretty much insinuate that I’m lazy,” she says.
There’s no question that COVID-19 cut people off from one another. But for those like Ms. Tyshynski who have long COVID, that disconnect has never ended. that the condition is real.
At worst, as Ms. Tyshynski has discovered, people don’t take it seriously and accuse those who have it of exaggerating their health woes. In that way, long COVID can be as isolating as the original illness.
“Isolation in long COVID comes in various forms and it’s not primarily just that physical isolation,” says Yochai Re’em, MD, a psychiatrist in private practice in New York who has experienced long COVID and blogs about the condition for Psychology Today. “A different yet equally challenging type of isolation is the emotional isolation, where you need more emotional support, connection with other people who can appreciate what it is you are going through without putting their own needs and desires onto you – and that can be hard to find.”
It’s hard to find in part because of what Dr. Re’em sees as a collective belief that anyone who feels bad should be able to get better by exercising, researching, or going to a doctor.
“Society thinks you need to take some kind of action and usually that’s a physical action,” he says. “And that attitude is tremendously problematic in this illness because of the postexertional malaise that people experience: When people exert themselves, their symptoms get worse. And so the action that people take can’t be that traditional action that we’re used to taking in our society.”
Long COVID patients often have their feelings invalidated not just by friends, loved ones, and extended family, but by health care providers. That can heighten feelings of isolation, particularly for people who live alone, says Jordan Anderson, DO, a neuropsychiatrist and assistant professor of psychiatry at Oregon Health & Science University in Portland.
The first patients Dr. Anderson saw as part of OHSU’s long COVID program contracted the virus in February 2020. Because the program addresses both the physical and mental health components of the condition, Dr. Anderson has seen a lot of people whose emotional challenges are similar to those Ms. Tyshynski faces.
“I think there’s a lack of understanding that leads to people just not necessarily taking it seriously,” he says. “Plus, the symptoms of long COVID do wax and wane. They’re not static. So people can be feeling pretty good one day and be feeling terrible the next. There’s some predictability to it, but it’s not absolutely predictable. It can be difficult for people to understand.”
Both Dr. Anderson and Dr. Re’em stress that long COVID patients need to prioritize their own energy regardless of what they’re being told by those who don’t understand the illness. Dr. Anderson offers to speak to his patients’ spouses to educate them about the realities of the condition because, he says, “any kind of lack of awareness or understanding in a family member or close support could potentially isolate the person struggling with long COVID.”
Depending on how open-minded and motivated a friend or relative is, they might develop more empathy with time and education, Dr. Re’em says. But for others, dealing with a confusing, unfamiliar chronic illness can be overwhelming and provoke anxiety.
“The hopelessness is too much for them to sit with, so instead they say things like ‘just push through it,’ or ‘just do X, Y, and Z,’ because psychologically it’s too much for them to take on that burden,” he says.
The good news is that there are plenty of web-based support groups for people with long COVID, including Body Politic (which Dr. Re’em is affiliated with), Survivor Corps, and on Facebook. “The patient community with this illness is tremendous, absolutely tremendous,” Dr. Re’em says. “Those people can be found and they can support each other.”
Some long COVID clinics run groups, as do individual practitioners such as Dr. Re’em, although those can be challenging to join. For instance, Dr. Re’em’s are only for New York state residents.
The key to finding a group is to be patient, because finding the right one takes time and energy.
“There are support groups that exist, but they are not as prevalent as I would like them to be,” Dr. Anderson says.
OHSU had an educational support group run by a social worker affiliated with the long COVID hub, but when the social worker left the program, the program was put on hold.
There’s a psychotherapy group operating out of the psychiatry department, but the patients are recruited exclusively from Dr. Anderson’s clinic and access is limited.
“The services exist, but I think that generally they’re sparse and pretty geographically dependent,” Dr. Anderson says. “I think you’d probably more likely be able to find something like this in a city or an area that has an academic institution or a place with a lot of resources rather than out in a rural community.”
Ms. Tyshynski opted not to join a group for fear it would increase the depression and anxiety that she had even before developing long COVID. When she and her family joined a cancer support group when her father was ill, she found it more depressing than helpful. Where she has found support is from the cofounder of the animal rescue society where she volunteers, a woman who has had long COVID for more than 2 years and has been a source of comfort and advice.
It’s one of the rare reminders Ms. Tyshynski has that even though she may live alone, she’s not completely alone. “Other people are going through this, too,” she says. “It helps to remember that.”
A version of this article first appeared on WebMD.com.
Problematic alcohol use on the rise among physicians?
However, good data on exactly how common this is and on salient risk factors are lacking.
In a systematic literature review, investigators found the prevalence of self-reported problematic alcohol use varied widely, but could affect up to one third of physicians.
However, all studies were survey-based and self-reported, and definitions of problematic alcohol use were mixed, with inconsistent reporting on differences across sex, age, physician specialty, and career stage.
“Key epidemiologic information of the prevalence of problematic alcohol use in physicians and associated risk factors are unknown, hampering the ability to identify high-risk individuals for targeted interventions,” Manish Sood, MD, University of Ottawa, and colleagues wrote.
The findings were published online in JAMA Network Open.
Serious concern
The researchers noted that physicians are at a higher risk for burnout and mental health conditions, including depression and anxiety, than the general population, which could contribute to problematic drinking.
Problematic drinking among physicians poses a “serious concern” to their health and ability to provide care, the investigators wrote. Understanding the extent and characteristics of the issue is important to guide interventions.
To better characterize problematic drinking among physicians, the investigators reviewed 31 studies from 2006 to 2020 involving 51,680 residents, fellows, or staff physicians in 17 countries.
In the studies, problematic alcohol use was measured by a validated tool: the Alcohol Use Disorders Identification Test, AUDIT Version C (AUDIT-C), or the Cut down, Annoyed, Guilty, and Eye-opener (CAGE) questionnaire.
“Problematic alcohol use” included hazardous, potentially hazardous, risky, at-risk, harmful, problematic, or heavy drinking or alcohol use, as well as alcohol misuse, alcohol dependence, and alcohol use more than low-risk guidelines and alcohol use disorder.
Results showed problematic alcohol use “varied widely” regardless of measurement method used. The rate was 0%-34% with AUDIT, 9%-35% with AUDIT-C, and 4%-22% with CAGE.
The data also showed an increase in reported problematic alcohol use over time, rising from 16.3% between 2006 and 2010 to 26.8% between 2017 and 2020.
True prevalence unknown
“It remains unknown whether this increase is indeed accurate or whether it is due to increased transparency by physicians in self-reporting problematic alcohol use because of a changing culture of medicine,” the investigators wrote.
The data suggest that problematic alcohol use is more common in male than female physicians; but no firm conclusions can be drawn from the data on how problematic alcohol use varies based on physician age, sex, specialty, and career stage, the researchers noted.
True prevalence of problematic alcohol use among physicians remains unknown – and identifying this type of behavior is difficult, they pointed out.
They added that physicians with problematic use may be “high functioning,” making identifying potential impairment a challenge. Also, societal stigma and fear of reprisal from professional colleges for reporting or seeking care for problematic alcohol use may encourage physicians with alcohol problems to keep their problems hidden.
The researchers noted that future population-based studies with longitudinal designs or using health administrative data could help identify the prevalence of and salient risk factors for problematic alcohol use in physicians.
The study was supported by the Canadian Medical Association. The authors reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
However, good data on exactly how common this is and on salient risk factors are lacking.
In a systematic literature review, investigators found the prevalence of self-reported problematic alcohol use varied widely, but could affect up to one third of physicians.
However, all studies were survey-based and self-reported, and definitions of problematic alcohol use were mixed, with inconsistent reporting on differences across sex, age, physician specialty, and career stage.
“Key epidemiologic information of the prevalence of problematic alcohol use in physicians and associated risk factors are unknown, hampering the ability to identify high-risk individuals for targeted interventions,” Manish Sood, MD, University of Ottawa, and colleagues wrote.
The findings were published online in JAMA Network Open.
Serious concern
The researchers noted that physicians are at a higher risk for burnout and mental health conditions, including depression and anxiety, than the general population, which could contribute to problematic drinking.
Problematic drinking among physicians poses a “serious concern” to their health and ability to provide care, the investigators wrote. Understanding the extent and characteristics of the issue is important to guide interventions.
To better characterize problematic drinking among physicians, the investigators reviewed 31 studies from 2006 to 2020 involving 51,680 residents, fellows, or staff physicians in 17 countries.
In the studies, problematic alcohol use was measured by a validated tool: the Alcohol Use Disorders Identification Test, AUDIT Version C (AUDIT-C), or the Cut down, Annoyed, Guilty, and Eye-opener (CAGE) questionnaire.
“Problematic alcohol use” included hazardous, potentially hazardous, risky, at-risk, harmful, problematic, or heavy drinking or alcohol use, as well as alcohol misuse, alcohol dependence, and alcohol use more than low-risk guidelines and alcohol use disorder.
Results showed problematic alcohol use “varied widely” regardless of measurement method used. The rate was 0%-34% with AUDIT, 9%-35% with AUDIT-C, and 4%-22% with CAGE.
The data also showed an increase in reported problematic alcohol use over time, rising from 16.3% between 2006 and 2010 to 26.8% between 2017 and 2020.
True prevalence unknown
“It remains unknown whether this increase is indeed accurate or whether it is due to increased transparency by physicians in self-reporting problematic alcohol use because of a changing culture of medicine,” the investigators wrote.
The data suggest that problematic alcohol use is more common in male than female physicians; but no firm conclusions can be drawn from the data on how problematic alcohol use varies based on physician age, sex, specialty, and career stage, the researchers noted.
True prevalence of problematic alcohol use among physicians remains unknown – and identifying this type of behavior is difficult, they pointed out.
They added that physicians with problematic use may be “high functioning,” making identifying potential impairment a challenge. Also, societal stigma and fear of reprisal from professional colleges for reporting or seeking care for problematic alcohol use may encourage physicians with alcohol problems to keep their problems hidden.
The researchers noted that future population-based studies with longitudinal designs or using health administrative data could help identify the prevalence of and salient risk factors for problematic alcohol use in physicians.
The study was supported by the Canadian Medical Association. The authors reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
However, good data on exactly how common this is and on salient risk factors are lacking.
In a systematic literature review, investigators found the prevalence of self-reported problematic alcohol use varied widely, but could affect up to one third of physicians.
However, all studies were survey-based and self-reported, and definitions of problematic alcohol use were mixed, with inconsistent reporting on differences across sex, age, physician specialty, and career stage.
“Key epidemiologic information of the prevalence of problematic alcohol use in physicians and associated risk factors are unknown, hampering the ability to identify high-risk individuals for targeted interventions,” Manish Sood, MD, University of Ottawa, and colleagues wrote.
The findings were published online in JAMA Network Open.
Serious concern
The researchers noted that physicians are at a higher risk for burnout and mental health conditions, including depression and anxiety, than the general population, which could contribute to problematic drinking.
Problematic drinking among physicians poses a “serious concern” to their health and ability to provide care, the investigators wrote. Understanding the extent and characteristics of the issue is important to guide interventions.
To better characterize problematic drinking among physicians, the investigators reviewed 31 studies from 2006 to 2020 involving 51,680 residents, fellows, or staff physicians in 17 countries.
In the studies, problematic alcohol use was measured by a validated tool: the Alcohol Use Disorders Identification Test, AUDIT Version C (AUDIT-C), or the Cut down, Annoyed, Guilty, and Eye-opener (CAGE) questionnaire.
“Problematic alcohol use” included hazardous, potentially hazardous, risky, at-risk, harmful, problematic, or heavy drinking or alcohol use, as well as alcohol misuse, alcohol dependence, and alcohol use more than low-risk guidelines and alcohol use disorder.
Results showed problematic alcohol use “varied widely” regardless of measurement method used. The rate was 0%-34% with AUDIT, 9%-35% with AUDIT-C, and 4%-22% with CAGE.
The data also showed an increase in reported problematic alcohol use over time, rising from 16.3% between 2006 and 2010 to 26.8% between 2017 and 2020.
True prevalence unknown
“It remains unknown whether this increase is indeed accurate or whether it is due to increased transparency by physicians in self-reporting problematic alcohol use because of a changing culture of medicine,” the investigators wrote.
The data suggest that problematic alcohol use is more common in male than female physicians; but no firm conclusions can be drawn from the data on how problematic alcohol use varies based on physician age, sex, specialty, and career stage, the researchers noted.
True prevalence of problematic alcohol use among physicians remains unknown – and identifying this type of behavior is difficult, they pointed out.
They added that physicians with problematic use may be “high functioning,” making identifying potential impairment a challenge. Also, societal stigma and fear of reprisal from professional colleges for reporting or seeking care for problematic alcohol use may encourage physicians with alcohol problems to keep their problems hidden.
The researchers noted that future population-based studies with longitudinal designs or using health administrative data could help identify the prevalence of and salient risk factors for problematic alcohol use in physicians.
The study was supported by the Canadian Medical Association. The authors reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Alzheimer’s Association to CMS: Ditch restraints on amyloid drugs
In a letter addressed to CMS administrator Chiquita Brooks-LaSure, MPP, the association has asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved anti-amyloid monoclonal antibodies.
The CMS coverage restrictions for anti-amyloid drugs were finalized in April on the basis of data available at the time.
Since then, new data from the CLARITY AD trial “clearly demonstrate a meaningful clinical benefit” from the investigational anti-amyloid agent lecanemab (Eisai/Biogen), Robert Egge, chief public policy officer for the Alzheimer’s Association, told this news organization.
The CLARITY AD results were published in the New England Journal of Medicine. Lecanemab is currently under accelerated review at the FDA.
The Alzheimer’s Association’s letter to the CMS includes a joint statement signed by more than 200 AD researchers and experts. All agree that the lecanemab results represent “significant new evidence” that necessitates reconsidering the restrictions on anti-amyloid agents.
“CMS has said it would look at new evidence, and now that evidence is here. We believe CMS recognizes this evidence for lecanemab is stronger than that for many treatments Medicare routinely covers,” Mr. Egge said.
‘No time to waste’
“With the timing of accelerated approvals for both lecanemab and donanemab in the next few months, the Alzheimer’s Association wants to ensure, if approved, that patients can access these treatments,” Mr. Egge noted.
“Because revisions to National Coverage Determinations can be a lengthy process, CMS needs to act quickly to minimize delays. People living with Alzheimer’s disease don’t have time to waste,” he added.
The Alzheimer’s Association estimates that every day, more than 2,000 individuals aged 65 or older may transition from mild dementia due to AD to a more advanced stage of the disease in which they may no longer be eligible for lecanemab and the other anti-amyloid agents currently being tested.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and incoming chief executive officer for the Alzheimer’s Association, noted in a news release.
“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike said.
A version of this article first appeared on Medscape.com.
In a letter addressed to CMS administrator Chiquita Brooks-LaSure, MPP, the association has asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved anti-amyloid monoclonal antibodies.
The CMS coverage restrictions for anti-amyloid drugs were finalized in April on the basis of data available at the time.
Since then, new data from the CLARITY AD trial “clearly demonstrate a meaningful clinical benefit” from the investigational anti-amyloid agent lecanemab (Eisai/Biogen), Robert Egge, chief public policy officer for the Alzheimer’s Association, told this news organization.
The CLARITY AD results were published in the New England Journal of Medicine. Lecanemab is currently under accelerated review at the FDA.
The Alzheimer’s Association’s letter to the CMS includes a joint statement signed by more than 200 AD researchers and experts. All agree that the lecanemab results represent “significant new evidence” that necessitates reconsidering the restrictions on anti-amyloid agents.
“CMS has said it would look at new evidence, and now that evidence is here. We believe CMS recognizes this evidence for lecanemab is stronger than that for many treatments Medicare routinely covers,” Mr. Egge said.
‘No time to waste’
“With the timing of accelerated approvals for both lecanemab and donanemab in the next few months, the Alzheimer’s Association wants to ensure, if approved, that patients can access these treatments,” Mr. Egge noted.
“Because revisions to National Coverage Determinations can be a lengthy process, CMS needs to act quickly to minimize delays. People living with Alzheimer’s disease don’t have time to waste,” he added.
The Alzheimer’s Association estimates that every day, more than 2,000 individuals aged 65 or older may transition from mild dementia due to AD to a more advanced stage of the disease in which they may no longer be eligible for lecanemab and the other anti-amyloid agents currently being tested.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and incoming chief executive officer for the Alzheimer’s Association, noted in a news release.
“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike said.
A version of this article first appeared on Medscape.com.
In a letter addressed to CMS administrator Chiquita Brooks-LaSure, MPP, the association has asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved anti-amyloid monoclonal antibodies.
The CMS coverage restrictions for anti-amyloid drugs were finalized in April on the basis of data available at the time.
Since then, new data from the CLARITY AD trial “clearly demonstrate a meaningful clinical benefit” from the investigational anti-amyloid agent lecanemab (Eisai/Biogen), Robert Egge, chief public policy officer for the Alzheimer’s Association, told this news organization.
The CLARITY AD results were published in the New England Journal of Medicine. Lecanemab is currently under accelerated review at the FDA.
The Alzheimer’s Association’s letter to the CMS includes a joint statement signed by more than 200 AD researchers and experts. All agree that the lecanemab results represent “significant new evidence” that necessitates reconsidering the restrictions on anti-amyloid agents.
“CMS has said it would look at new evidence, and now that evidence is here. We believe CMS recognizes this evidence for lecanemab is stronger than that for many treatments Medicare routinely covers,” Mr. Egge said.
‘No time to waste’
“With the timing of accelerated approvals for both lecanemab and donanemab in the next few months, the Alzheimer’s Association wants to ensure, if approved, that patients can access these treatments,” Mr. Egge noted.
“Because revisions to National Coverage Determinations can be a lengthy process, CMS needs to act quickly to minimize delays. People living with Alzheimer’s disease don’t have time to waste,” he added.
The Alzheimer’s Association estimates that every day, more than 2,000 individuals aged 65 or older may transition from mild dementia due to AD to a more advanced stage of the disease in which they may no longer be eligible for lecanemab and the other anti-amyloid agents currently being tested.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and incoming chief executive officer for the Alzheimer’s Association, noted in a news release.
“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike said.
A version of this article first appeared on Medscape.com.
All the National Health Service wants for Christmas is tea and biscuits
Three cups of tea, two biscuit packs, and a Christmas study from the BMJ
Warning: The following content may contain excessive Britishness. Continue at your own risk.
It’s no secret that the world economy is in an … interesting spot right now. Belt tightening is occurring around the world despite the holiday season, and hospitals across the pond in Great Britain are no exception.
It was a simple sign that prompted the study, published in the Christmas edition of the BMJ: “Please do not take excessive quantities of these refreshments.” And if we all know one thing, you do not get between Brits and their tea and biscuits. So the researchers behind the study drafted a survey and sent it around to nearly 2,000 British health care workers and asked what they considered to be excessive consumption of work-provided hot drinks and biscuits.
In the hot drinks department (tea and coffee, though we appreciate the two people who voiced a preference for free hot whiskey, if it was available) the survey participants decreed that 3.32 drinks was the maximum before consumption became excessive. That’s pretty close to the actual number of hot drinks respondents drank daily (3.04), so it’s pretty fair to say that British health care workers do a good job of self-limiting.
It’s much the same story with biscuits: Health care workers reported that consuming 2.25 packets of free biscuits would be excessive. Notably, doctors would take more than nondoctors (2.35 vs. 2.14 – typical doctor behavior), and those who had been in their role for less than 2 years would consume nearly 3 packets a day before calling it quits.
The study did not include an official cost analysis, but calculations conducted on a biscuit wrapper (that’s not a joke, by the way) estimated that the combined cost for providing every National Health Service employee with three free drinks and two free biscuit packages a day would be about 160 million pounds a year. Now, that’s a lot of money for tea and biscuits, but, they added, it’s a meager 0.1% of the NHS annual budget. They also noted that most employees consider free hot drinks a more valuable workplace perk than free support for mental health.
In conclusion, the authors wrote, “As a target for cost-saving initiatives, limiting free refreshment consumption is really scraping the biscuit barrel (although some limits on hot whiskey availability may be necessary), and implementing, or continuing, perks that improve staff morale seems justifiable. … Healthcare employers should allow biscuits and hot drinks to be freely available to staff, and they should leave these grateful recipients to judge for themselves what constitutes reasonable consumption.”
Now there’s a Christmas sentiment we can all get behind.
We come not to bury sugar, but to improve it
When we think about sugar, healthy isn’t the first thing that comes to mind. Research also shows that artificial sweeteners, as well as processed foods in general, are bad for your body and brain. People, however, love the stuff. That’s why one of the leading brands in processed foods, Kraft Heinz, partnered with the Wyss Institute for Biologically Inspired Engineering at Harvard to find a way to reduce consumers’ sugar consumption.
The question that Kraft Heinz presented to Wyss was this: How could it reduce the fructose in its products without losing the functionality of regular sugar.
The Wyss team’s approach seems pretty simple: Use a naturally occurring enzyme to convert sugar to fiber. The trick was to add the enzymes into the food so they could convert the sugar to fiber after being consumed. The enzymes also needed to be able to be added to existing food products without changing their existing recipes, Kraft Heinz insisted.
How does it work? The crafted enzyme is encapsulated to remain dormant in the food until exposed to an increased pH level, as is found in the GI tract between the stomach and the intestine. It reduces the amount of sugar absorbed in the bloodstream and creates a healthy prebiotic fiber, the institute explained.
This opens a whole new window for consumers. People with diabetes can enjoy their favorite cookies from time to time, while parents can feel less guilty about their children bathing their chicken nuggets in unholy amounts of ketchup.
New genes, or not new genes? That is the question
… and the police report that no capybaras were harmed in the incident. What a relief. Now Action News 8 brings you Carol Espinosa’s exclusive interview with legendary scientist and zombie, Charles Darwin.
Carol: Thanks, Daryl. Tell us, Prof. Darwin, what have you been up to lately?
Prof. Darwin: Please, Carol, call me Chuck. As always, I’ve got my hands full with the whole evolution thing. The big news right now is a study published in Cell Reports that offers evidence of the continuing evolution of humans. Can I eat your brain now?
Carol: No, Chuck, you may not. So people are still evolving? It sure seems like we’ve reverted to survival of the dumbest.
Chuck Darwin: Good one, Carol, but evolution hasn’t stopped. The investigators used a previously published dataset of functionally relevant new genes to create an ancestral tree comparing humans with other vertebrate species. By tracking the genes across evolution, they found 155 from regions of unique DNA that arose from scratch and not from duplication events in the existing genome. That’s a big deal.
Carol: Anything made from scratch is always better. Everyone knows that. What else can you tell us, Chuck?
Chuck Darwin: So these 155 genes didn’t exist when humans separated from chimpanzees nearly 7 million years ago. Turns out that 44 of them are associated with growth defects in cell cultures and three “have disease-associated DNA markers that point to connections with ailments such as muscular dystrophy, retinitis pigmentosa, and Alazami syndrome.” At least that’s what the investigators said in a written statement. I must say, Carol, that your brain is looking particularly delicious tonight.
Carol: Ironic. For years I’ve been hoping a man would appreciate me for my brain, and now I get this. Back to you, Daryl.
Three cups of tea, two biscuit packs, and a Christmas study from the BMJ
Warning: The following content may contain excessive Britishness. Continue at your own risk.
It’s no secret that the world economy is in an … interesting spot right now. Belt tightening is occurring around the world despite the holiday season, and hospitals across the pond in Great Britain are no exception.
It was a simple sign that prompted the study, published in the Christmas edition of the BMJ: “Please do not take excessive quantities of these refreshments.” And if we all know one thing, you do not get between Brits and their tea and biscuits. So the researchers behind the study drafted a survey and sent it around to nearly 2,000 British health care workers and asked what they considered to be excessive consumption of work-provided hot drinks and biscuits.
In the hot drinks department (tea and coffee, though we appreciate the two people who voiced a preference for free hot whiskey, if it was available) the survey participants decreed that 3.32 drinks was the maximum before consumption became excessive. That’s pretty close to the actual number of hot drinks respondents drank daily (3.04), so it’s pretty fair to say that British health care workers do a good job of self-limiting.
It’s much the same story with biscuits: Health care workers reported that consuming 2.25 packets of free biscuits would be excessive. Notably, doctors would take more than nondoctors (2.35 vs. 2.14 – typical doctor behavior), and those who had been in their role for less than 2 years would consume nearly 3 packets a day before calling it quits.
The study did not include an official cost analysis, but calculations conducted on a biscuit wrapper (that’s not a joke, by the way) estimated that the combined cost for providing every National Health Service employee with three free drinks and two free biscuit packages a day would be about 160 million pounds a year. Now, that’s a lot of money for tea and biscuits, but, they added, it’s a meager 0.1% of the NHS annual budget. They also noted that most employees consider free hot drinks a more valuable workplace perk than free support for mental health.
In conclusion, the authors wrote, “As a target for cost-saving initiatives, limiting free refreshment consumption is really scraping the biscuit barrel (although some limits on hot whiskey availability may be necessary), and implementing, or continuing, perks that improve staff morale seems justifiable. … Healthcare employers should allow biscuits and hot drinks to be freely available to staff, and they should leave these grateful recipients to judge for themselves what constitutes reasonable consumption.”
Now there’s a Christmas sentiment we can all get behind.
We come not to bury sugar, but to improve it
When we think about sugar, healthy isn’t the first thing that comes to mind. Research also shows that artificial sweeteners, as well as processed foods in general, are bad for your body and brain. People, however, love the stuff. That’s why one of the leading brands in processed foods, Kraft Heinz, partnered with the Wyss Institute for Biologically Inspired Engineering at Harvard to find a way to reduce consumers’ sugar consumption.
The question that Kraft Heinz presented to Wyss was this: How could it reduce the fructose in its products without losing the functionality of regular sugar.
The Wyss team’s approach seems pretty simple: Use a naturally occurring enzyme to convert sugar to fiber. The trick was to add the enzymes into the food so they could convert the sugar to fiber after being consumed. The enzymes also needed to be able to be added to existing food products without changing their existing recipes, Kraft Heinz insisted.
How does it work? The crafted enzyme is encapsulated to remain dormant in the food until exposed to an increased pH level, as is found in the GI tract between the stomach and the intestine. It reduces the amount of sugar absorbed in the bloodstream and creates a healthy prebiotic fiber, the institute explained.
This opens a whole new window for consumers. People with diabetes can enjoy their favorite cookies from time to time, while parents can feel less guilty about their children bathing their chicken nuggets in unholy amounts of ketchup.
New genes, or not new genes? That is the question
… and the police report that no capybaras were harmed in the incident. What a relief. Now Action News 8 brings you Carol Espinosa’s exclusive interview with legendary scientist and zombie, Charles Darwin.
Carol: Thanks, Daryl. Tell us, Prof. Darwin, what have you been up to lately?
Prof. Darwin: Please, Carol, call me Chuck. As always, I’ve got my hands full with the whole evolution thing. The big news right now is a study published in Cell Reports that offers evidence of the continuing evolution of humans. Can I eat your brain now?
Carol: No, Chuck, you may not. So people are still evolving? It sure seems like we’ve reverted to survival of the dumbest.
Chuck Darwin: Good one, Carol, but evolution hasn’t stopped. The investigators used a previously published dataset of functionally relevant new genes to create an ancestral tree comparing humans with other vertebrate species. By tracking the genes across evolution, they found 155 from regions of unique DNA that arose from scratch and not from duplication events in the existing genome. That’s a big deal.
Carol: Anything made from scratch is always better. Everyone knows that. What else can you tell us, Chuck?
Chuck Darwin: So these 155 genes didn’t exist when humans separated from chimpanzees nearly 7 million years ago. Turns out that 44 of them are associated with growth defects in cell cultures and three “have disease-associated DNA markers that point to connections with ailments such as muscular dystrophy, retinitis pigmentosa, and Alazami syndrome.” At least that’s what the investigators said in a written statement. I must say, Carol, that your brain is looking particularly delicious tonight.
Carol: Ironic. For years I’ve been hoping a man would appreciate me for my brain, and now I get this. Back to you, Daryl.
Three cups of tea, two biscuit packs, and a Christmas study from the BMJ
Warning: The following content may contain excessive Britishness. Continue at your own risk.
It’s no secret that the world economy is in an … interesting spot right now. Belt tightening is occurring around the world despite the holiday season, and hospitals across the pond in Great Britain are no exception.
It was a simple sign that prompted the study, published in the Christmas edition of the BMJ: “Please do not take excessive quantities of these refreshments.” And if we all know one thing, you do not get between Brits and their tea and biscuits. So the researchers behind the study drafted a survey and sent it around to nearly 2,000 British health care workers and asked what they considered to be excessive consumption of work-provided hot drinks and biscuits.
In the hot drinks department (tea and coffee, though we appreciate the two people who voiced a preference for free hot whiskey, if it was available) the survey participants decreed that 3.32 drinks was the maximum before consumption became excessive. That’s pretty close to the actual number of hot drinks respondents drank daily (3.04), so it’s pretty fair to say that British health care workers do a good job of self-limiting.
It’s much the same story with biscuits: Health care workers reported that consuming 2.25 packets of free biscuits would be excessive. Notably, doctors would take more than nondoctors (2.35 vs. 2.14 – typical doctor behavior), and those who had been in their role for less than 2 years would consume nearly 3 packets a day before calling it quits.
The study did not include an official cost analysis, but calculations conducted on a biscuit wrapper (that’s not a joke, by the way) estimated that the combined cost for providing every National Health Service employee with three free drinks and two free biscuit packages a day would be about 160 million pounds a year. Now, that’s a lot of money for tea and biscuits, but, they added, it’s a meager 0.1% of the NHS annual budget. They also noted that most employees consider free hot drinks a more valuable workplace perk than free support for mental health.
In conclusion, the authors wrote, “As a target for cost-saving initiatives, limiting free refreshment consumption is really scraping the biscuit barrel (although some limits on hot whiskey availability may be necessary), and implementing, or continuing, perks that improve staff morale seems justifiable. … Healthcare employers should allow biscuits and hot drinks to be freely available to staff, and they should leave these grateful recipients to judge for themselves what constitutes reasonable consumption.”
Now there’s a Christmas sentiment we can all get behind.
We come not to bury sugar, but to improve it
When we think about sugar, healthy isn’t the first thing that comes to mind. Research also shows that artificial sweeteners, as well as processed foods in general, are bad for your body and brain. People, however, love the stuff. That’s why one of the leading brands in processed foods, Kraft Heinz, partnered with the Wyss Institute for Biologically Inspired Engineering at Harvard to find a way to reduce consumers’ sugar consumption.
The question that Kraft Heinz presented to Wyss was this: How could it reduce the fructose in its products without losing the functionality of regular sugar.
The Wyss team’s approach seems pretty simple: Use a naturally occurring enzyme to convert sugar to fiber. The trick was to add the enzymes into the food so they could convert the sugar to fiber after being consumed. The enzymes also needed to be able to be added to existing food products without changing their existing recipes, Kraft Heinz insisted.
How does it work? The crafted enzyme is encapsulated to remain dormant in the food until exposed to an increased pH level, as is found in the GI tract between the stomach and the intestine. It reduces the amount of sugar absorbed in the bloodstream and creates a healthy prebiotic fiber, the institute explained.
This opens a whole new window for consumers. People with diabetes can enjoy their favorite cookies from time to time, while parents can feel less guilty about their children bathing their chicken nuggets in unholy amounts of ketchup.
New genes, or not new genes? That is the question
… and the police report that no capybaras were harmed in the incident. What a relief. Now Action News 8 brings you Carol Espinosa’s exclusive interview with legendary scientist and zombie, Charles Darwin.
Carol: Thanks, Daryl. Tell us, Prof. Darwin, what have you been up to lately?
Prof. Darwin: Please, Carol, call me Chuck. As always, I’ve got my hands full with the whole evolution thing. The big news right now is a study published in Cell Reports that offers evidence of the continuing evolution of humans. Can I eat your brain now?
Carol: No, Chuck, you may not. So people are still evolving? It sure seems like we’ve reverted to survival of the dumbest.
Chuck Darwin: Good one, Carol, but evolution hasn’t stopped. The investigators used a previously published dataset of functionally relevant new genes to create an ancestral tree comparing humans with other vertebrate species. By tracking the genes across evolution, they found 155 from regions of unique DNA that arose from scratch and not from duplication events in the existing genome. That’s a big deal.
Carol: Anything made from scratch is always better. Everyone knows that. What else can you tell us, Chuck?
Chuck Darwin: So these 155 genes didn’t exist when humans separated from chimpanzees nearly 7 million years ago. Turns out that 44 of them are associated with growth defects in cell cultures and three “have disease-associated DNA markers that point to connections with ailments such as muscular dystrophy, retinitis pigmentosa, and Alazami syndrome.” At least that’s what the investigators said in a written statement. I must say, Carol, that your brain is looking particularly delicious tonight.
Carol: Ironic. For years I’ve been hoping a man would appreciate me for my brain, and now I get this. Back to you, Daryl.
FDA calls for withdrawal of multiple myeloma drug Pepaxto
(melphalan flufenamide), the company announced in a press release.
The drug was granted an accelerated approval by the FDA in February 2021, for use in combination with dexamethasone in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
However, the phase 3 OCEAN study raised concerns about safety, as it showed a higher mortality associated with melphalan flufenamide in the experimental arm, compared with pomalidomide (Pomalyst).
The FDA already flagged this issue in July 2021, issuing a safety alert flagging the increased risk for death observed in the OCEAN trial among patients receiving melphalan flufenamide versus pomalidomide (47.6% vs. 43.4%) and a 5.3-month shorter overall survival.
The issue was also discussed in September 2022 by FDA’s Oncologic Drugs Advisory Committee, which voted 14-to-2 against maintaining the accelerated approval, citing an unfavorable risk/benefit profile.
The company stopped marketing the drug in the United States in October 2021 at the FDA’s request but continued to make it available for patients already undergoing treatment.
However, in March 2022, Oncopeptides rescinded the letter that voluntarily withdrew the agent from market, after further review of overall survival data from the OCEAN trial led the company to reconsider its decision. Notably, marketing efforts were still discontinued while the company worked with the FDA to interpret the data, it stated in the press release.
That review of the data showed that progression-free survival was 42% higher with melphalan flufenamide versus pomalidomide and overall response rates were 32.1% versus 26.5%, respectively.
Now, the FDA has requested that the company withdraw its U.S. marketing authorization.
“We respect FDA’s accelerated approval regulations,” Jakob Lindberg, CEO of Oncopeptides commented in the press release.
However, he also added, “multiple myeloma remains an incurable disease, and the treatment options for patients with triple-class refractory disease will ultimately become exhausted. The OCEAN study demonstrated clinical benefit for multiple myeloma patients, in particular for nontransplanted elderly patients where the unmet medical need remains very high.”
Commercialization of the drug in Europe, under the brand name Pepaxti, is ongoing.
“Pepaxti has a full approval from the European Medicines Agency, EMA, since Aug. 18, 2022, and was approved by the Medicines and Healthcare Products Regulatory Agency, MHRA, in the U.K. on Nov 11, 2022,” the company noted.
A version of this article first appeared on Medscape.com.
(melphalan flufenamide), the company announced in a press release.
The drug was granted an accelerated approval by the FDA in February 2021, for use in combination with dexamethasone in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
However, the phase 3 OCEAN study raised concerns about safety, as it showed a higher mortality associated with melphalan flufenamide in the experimental arm, compared with pomalidomide (Pomalyst).
The FDA already flagged this issue in July 2021, issuing a safety alert flagging the increased risk for death observed in the OCEAN trial among patients receiving melphalan flufenamide versus pomalidomide (47.6% vs. 43.4%) and a 5.3-month shorter overall survival.
The issue was also discussed in September 2022 by FDA’s Oncologic Drugs Advisory Committee, which voted 14-to-2 against maintaining the accelerated approval, citing an unfavorable risk/benefit profile.
The company stopped marketing the drug in the United States in October 2021 at the FDA’s request but continued to make it available for patients already undergoing treatment.
However, in March 2022, Oncopeptides rescinded the letter that voluntarily withdrew the agent from market, after further review of overall survival data from the OCEAN trial led the company to reconsider its decision. Notably, marketing efforts were still discontinued while the company worked with the FDA to interpret the data, it stated in the press release.
That review of the data showed that progression-free survival was 42% higher with melphalan flufenamide versus pomalidomide and overall response rates were 32.1% versus 26.5%, respectively.
Now, the FDA has requested that the company withdraw its U.S. marketing authorization.
“We respect FDA’s accelerated approval regulations,” Jakob Lindberg, CEO of Oncopeptides commented in the press release.
However, he also added, “multiple myeloma remains an incurable disease, and the treatment options for patients with triple-class refractory disease will ultimately become exhausted. The OCEAN study demonstrated clinical benefit for multiple myeloma patients, in particular for nontransplanted elderly patients where the unmet medical need remains very high.”
Commercialization of the drug in Europe, under the brand name Pepaxti, is ongoing.
“Pepaxti has a full approval from the European Medicines Agency, EMA, since Aug. 18, 2022, and was approved by the Medicines and Healthcare Products Regulatory Agency, MHRA, in the U.K. on Nov 11, 2022,” the company noted.
A version of this article first appeared on Medscape.com.
(melphalan flufenamide), the company announced in a press release.
The drug was granted an accelerated approval by the FDA in February 2021, for use in combination with dexamethasone in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
However, the phase 3 OCEAN study raised concerns about safety, as it showed a higher mortality associated with melphalan flufenamide in the experimental arm, compared with pomalidomide (Pomalyst).
The FDA already flagged this issue in July 2021, issuing a safety alert flagging the increased risk for death observed in the OCEAN trial among patients receiving melphalan flufenamide versus pomalidomide (47.6% vs. 43.4%) and a 5.3-month shorter overall survival.
The issue was also discussed in September 2022 by FDA’s Oncologic Drugs Advisory Committee, which voted 14-to-2 against maintaining the accelerated approval, citing an unfavorable risk/benefit profile.
The company stopped marketing the drug in the United States in October 2021 at the FDA’s request but continued to make it available for patients already undergoing treatment.
However, in March 2022, Oncopeptides rescinded the letter that voluntarily withdrew the agent from market, after further review of overall survival data from the OCEAN trial led the company to reconsider its decision. Notably, marketing efforts were still discontinued while the company worked with the FDA to interpret the data, it stated in the press release.
That review of the data showed that progression-free survival was 42% higher with melphalan flufenamide versus pomalidomide and overall response rates were 32.1% versus 26.5%, respectively.
Now, the FDA has requested that the company withdraw its U.S. marketing authorization.
“We respect FDA’s accelerated approval regulations,” Jakob Lindberg, CEO of Oncopeptides commented in the press release.
However, he also added, “multiple myeloma remains an incurable disease, and the treatment options for patients with triple-class refractory disease will ultimately become exhausted. The OCEAN study demonstrated clinical benefit for multiple myeloma patients, in particular for nontransplanted elderly patients where the unmet medical need remains very high.”
Commercialization of the drug in Europe, under the brand name Pepaxti, is ongoing.
“Pepaxti has a full approval from the European Medicines Agency, EMA, since Aug. 18, 2022, and was approved by the Medicines and Healthcare Products Regulatory Agency, MHRA, in the U.K. on Nov 11, 2022,” the company noted.
A version of this article first appeared on Medscape.com.
Cardiac injury caused by COVID-19 less common than thought
The study examined cardiac MRI scans in 31 patients before and after having COVID-19 infection and found no new evidence of myocardial injury in the post-COVID scans relative to the pre-COVID scans.
“To the best of our knowledge this is the first cardiac MRI study to assess myocardial injury pre- and post-COVID-19,” the authors stated.
They say that while this study cannot rule out the possibility of rare events of COVID-19–induced myocardial injury, “the complete absence of de novo late gadolinium enhancement lesions after COVID-19 in this cohort indicates that outside special circumstances, COVID-19–induced myocardial injury may be much less common than suggested by previous studies.”
The study was published online in JACC: Cardiovascular Imaging.
Coauthor Till F. Althoff, MD, Cardiovascular Institute, Clínic–University Hospital Barcelona, said in an interview that previous reports have found a high rate of cardiac lesions in patients undergoing imaging after having had COVID-19 infection.
“In some reports, this has been as high as 80% of patients even though they have not had severe COVID disease. These reports have been interpreted as showing the majority of patients have some COVID-induced cardiac damage, which is an alarming message,” he commented.
However, he pointed out that the patients in these reports did not undergo a cardiac MRI scan before they had COVID-19 so it wasn’t known whether these cardiac lesions were present before infection or not.
To try and gain more accurate information, the current study examined cardiac MRI scans in the same patients before and after they had COVID-19.
The researchers, from an arrhythmia unit, made use of the fact that all their patients have cardiac MRI data, so they used their large registry of patients in whom cardiac MRI had been performed, and cross referenced this to a health care database to identify those patients who had confirmed COVID-19 after they obtaining a cardiac scan at the arrhythmia unit. They then conducted another cardiac MRI scan in the 31 patients identified a median of 5 months after their COVID-19 infection.
“These 31 patients had a cardiac MRI scan pre-COVID and post COVID using exactly the same scanner with identical sequences, so the scans were absolutely comparable,” Dr. Althoff noted.
Of these 31 patients, 7 had been hospitalized at the time of acute presentation with COVID-19, of whom 2 required intensive care. Most patients (29) had been symptomatic, but none reported cardiac symptoms.
Results showed that, on the post–COVID-19 scan, late gadolinium enhancement lesions indicative of residual myocardial injury were encountered in 15 of the 31 patients (48%), which the researchers said is in line with previous reports.
However, intraindividual comparison with the pre–COVID-19 cardiac MRI scans showed all these lesions were preexisting with identical localization, pattern, and transmural distribution, and thus not COVID-19 related.
Quantitative analyses, performed independently, detected no increase in the size of individual lesions nor in the global left ventricular late gadolinium enhancement extent.
Comparison of pre- and post COVID-19 imaging sequences did not show any differences in ventricular functional or structural parameters.
“While this study only has 31 patients, the fact that we are conducting intra-individual comparisons, which rules out bias, means that we don’t need a large number of patients for reliable results,” Dr. Althoff said.
“These types of lesions are normal to see. We know that individuals without cardiac disease have these types of lesions, and they are not necessarily an indication of any specific pathology. I was kind of surprised by the interpretation of previous data, which is why we did the current study,” he added.
Dr. Althoff acknowledged that some cardiac injury may have been seen if much larger numbers of patients had been included. “But I think we can say from this data that COVID-induced cardiac damage is much less of an issue than we may have previously thought,” he added.
He also noted that most of the patients in this study had mild COVID-19, so the results cannot be extrapolated to severe COVID-19 infection.
However, Dr. Althoff pointed out that all the patients already had atrial fibrillation, so would have been at higher risk of cardiac injury from COVID-19.
“These patients had preexisting cardiac risk factors, and thus they would have been more susceptible to both a more severe course of COVID and an increased risk of myocardial damage due to COVID. The fact that we don’t find any myocardial injury due to COVID in this group is even more reassuring. The general population will be at even lower risk,” he commented.
“I think we can say that, in COVID patients who do not have any cardiac symptoms, our study suggests that the incidence of cardiac injury is very low,” Dr. Althoff said.
“Even in patients with severe COVID and myocardial involvement reflected by increased troponin levels, I wouldn’t be sure that they have any residual cardiac injury. While it has been reported that cardiac lesions have been found in such patients, pre-COVID MRI scans were not available so we don’t know if they were there before,” he added.
“We do not know the true incidence of cardiac injury after COVID, but I think we can say from this data that it is definitely not anywhere near the 40%-50% or even greater that some of the previous reports have suggested,” he stated.
Dr. Althoff suggested that, based on these data, some of the recommendations based on previous reports such the need for follow-up cardiac scans and caution about partaking in sports again after COVID-19 infection, are probably not necessary.
“Our data suggest that these concerns are unfounded, and we need to step back a bit and stop alarming patients about the risk of cardiac damage after COVID,” he said. “Yes, if patients have cardiac symptoms during or after COVID infection they should get checked out, but I do not think we need to do a cardiac risk assessment in patients without cardiac symptoms in COVID.”
This work is supported in part by grants from Instituto de Salud Carlos III, the Spanish government, Madrid, and Fundació la Marató de TV3 in Catalonia. Dr. Althoff has received research grants for investigator-initiated trials from Biosense Webster.
A version of this article first appeared on Medscape.com.
The study examined cardiac MRI scans in 31 patients before and after having COVID-19 infection and found no new evidence of myocardial injury in the post-COVID scans relative to the pre-COVID scans.
“To the best of our knowledge this is the first cardiac MRI study to assess myocardial injury pre- and post-COVID-19,” the authors stated.
They say that while this study cannot rule out the possibility of rare events of COVID-19–induced myocardial injury, “the complete absence of de novo late gadolinium enhancement lesions after COVID-19 in this cohort indicates that outside special circumstances, COVID-19–induced myocardial injury may be much less common than suggested by previous studies.”
The study was published online in JACC: Cardiovascular Imaging.
Coauthor Till F. Althoff, MD, Cardiovascular Institute, Clínic–University Hospital Barcelona, said in an interview that previous reports have found a high rate of cardiac lesions in patients undergoing imaging after having had COVID-19 infection.
“In some reports, this has been as high as 80% of patients even though they have not had severe COVID disease. These reports have been interpreted as showing the majority of patients have some COVID-induced cardiac damage, which is an alarming message,” he commented.
However, he pointed out that the patients in these reports did not undergo a cardiac MRI scan before they had COVID-19 so it wasn’t known whether these cardiac lesions were present before infection or not.
To try and gain more accurate information, the current study examined cardiac MRI scans in the same patients before and after they had COVID-19.
The researchers, from an arrhythmia unit, made use of the fact that all their patients have cardiac MRI data, so they used their large registry of patients in whom cardiac MRI had been performed, and cross referenced this to a health care database to identify those patients who had confirmed COVID-19 after they obtaining a cardiac scan at the arrhythmia unit. They then conducted another cardiac MRI scan in the 31 patients identified a median of 5 months after their COVID-19 infection.
“These 31 patients had a cardiac MRI scan pre-COVID and post COVID using exactly the same scanner with identical sequences, so the scans were absolutely comparable,” Dr. Althoff noted.
Of these 31 patients, 7 had been hospitalized at the time of acute presentation with COVID-19, of whom 2 required intensive care. Most patients (29) had been symptomatic, but none reported cardiac symptoms.
Results showed that, on the post–COVID-19 scan, late gadolinium enhancement lesions indicative of residual myocardial injury were encountered in 15 of the 31 patients (48%), which the researchers said is in line with previous reports.
However, intraindividual comparison with the pre–COVID-19 cardiac MRI scans showed all these lesions were preexisting with identical localization, pattern, and transmural distribution, and thus not COVID-19 related.
Quantitative analyses, performed independently, detected no increase in the size of individual lesions nor in the global left ventricular late gadolinium enhancement extent.
Comparison of pre- and post COVID-19 imaging sequences did not show any differences in ventricular functional or structural parameters.
“While this study only has 31 patients, the fact that we are conducting intra-individual comparisons, which rules out bias, means that we don’t need a large number of patients for reliable results,” Dr. Althoff said.
“These types of lesions are normal to see. We know that individuals without cardiac disease have these types of lesions, and they are not necessarily an indication of any specific pathology. I was kind of surprised by the interpretation of previous data, which is why we did the current study,” he added.
Dr. Althoff acknowledged that some cardiac injury may have been seen if much larger numbers of patients had been included. “But I think we can say from this data that COVID-induced cardiac damage is much less of an issue than we may have previously thought,” he added.
He also noted that most of the patients in this study had mild COVID-19, so the results cannot be extrapolated to severe COVID-19 infection.
However, Dr. Althoff pointed out that all the patients already had atrial fibrillation, so would have been at higher risk of cardiac injury from COVID-19.
“These patients had preexisting cardiac risk factors, and thus they would have been more susceptible to both a more severe course of COVID and an increased risk of myocardial damage due to COVID. The fact that we don’t find any myocardial injury due to COVID in this group is even more reassuring. The general population will be at even lower risk,” he commented.
“I think we can say that, in COVID patients who do not have any cardiac symptoms, our study suggests that the incidence of cardiac injury is very low,” Dr. Althoff said.
“Even in patients with severe COVID and myocardial involvement reflected by increased troponin levels, I wouldn’t be sure that they have any residual cardiac injury. While it has been reported that cardiac lesions have been found in such patients, pre-COVID MRI scans were not available so we don’t know if they were there before,” he added.
“We do not know the true incidence of cardiac injury after COVID, but I think we can say from this data that it is definitely not anywhere near the 40%-50% or even greater that some of the previous reports have suggested,” he stated.
Dr. Althoff suggested that, based on these data, some of the recommendations based on previous reports such the need for follow-up cardiac scans and caution about partaking in sports again after COVID-19 infection, are probably not necessary.
“Our data suggest that these concerns are unfounded, and we need to step back a bit and stop alarming patients about the risk of cardiac damage after COVID,” he said. “Yes, if patients have cardiac symptoms during or after COVID infection they should get checked out, but I do not think we need to do a cardiac risk assessment in patients without cardiac symptoms in COVID.”
This work is supported in part by grants from Instituto de Salud Carlos III, the Spanish government, Madrid, and Fundació la Marató de TV3 in Catalonia. Dr. Althoff has received research grants for investigator-initiated trials from Biosense Webster.
A version of this article first appeared on Medscape.com.
The study examined cardiac MRI scans in 31 patients before and after having COVID-19 infection and found no new evidence of myocardial injury in the post-COVID scans relative to the pre-COVID scans.
“To the best of our knowledge this is the first cardiac MRI study to assess myocardial injury pre- and post-COVID-19,” the authors stated.
They say that while this study cannot rule out the possibility of rare events of COVID-19–induced myocardial injury, “the complete absence of de novo late gadolinium enhancement lesions after COVID-19 in this cohort indicates that outside special circumstances, COVID-19–induced myocardial injury may be much less common than suggested by previous studies.”
The study was published online in JACC: Cardiovascular Imaging.
Coauthor Till F. Althoff, MD, Cardiovascular Institute, Clínic–University Hospital Barcelona, said in an interview that previous reports have found a high rate of cardiac lesions in patients undergoing imaging after having had COVID-19 infection.
“In some reports, this has been as high as 80% of patients even though they have not had severe COVID disease. These reports have been interpreted as showing the majority of patients have some COVID-induced cardiac damage, which is an alarming message,” he commented.
However, he pointed out that the patients in these reports did not undergo a cardiac MRI scan before they had COVID-19 so it wasn’t known whether these cardiac lesions were present before infection or not.
To try and gain more accurate information, the current study examined cardiac MRI scans in the same patients before and after they had COVID-19.
The researchers, from an arrhythmia unit, made use of the fact that all their patients have cardiac MRI data, so they used their large registry of patients in whom cardiac MRI had been performed, and cross referenced this to a health care database to identify those patients who had confirmed COVID-19 after they obtaining a cardiac scan at the arrhythmia unit. They then conducted another cardiac MRI scan in the 31 patients identified a median of 5 months after their COVID-19 infection.
“These 31 patients had a cardiac MRI scan pre-COVID and post COVID using exactly the same scanner with identical sequences, so the scans were absolutely comparable,” Dr. Althoff noted.
Of these 31 patients, 7 had been hospitalized at the time of acute presentation with COVID-19, of whom 2 required intensive care. Most patients (29) had been symptomatic, but none reported cardiac symptoms.
Results showed that, on the post–COVID-19 scan, late gadolinium enhancement lesions indicative of residual myocardial injury were encountered in 15 of the 31 patients (48%), which the researchers said is in line with previous reports.
However, intraindividual comparison with the pre–COVID-19 cardiac MRI scans showed all these lesions were preexisting with identical localization, pattern, and transmural distribution, and thus not COVID-19 related.
Quantitative analyses, performed independently, detected no increase in the size of individual lesions nor in the global left ventricular late gadolinium enhancement extent.
Comparison of pre- and post COVID-19 imaging sequences did not show any differences in ventricular functional or structural parameters.
“While this study only has 31 patients, the fact that we are conducting intra-individual comparisons, which rules out bias, means that we don’t need a large number of patients for reliable results,” Dr. Althoff said.
“These types of lesions are normal to see. We know that individuals without cardiac disease have these types of lesions, and they are not necessarily an indication of any specific pathology. I was kind of surprised by the interpretation of previous data, which is why we did the current study,” he added.
Dr. Althoff acknowledged that some cardiac injury may have been seen if much larger numbers of patients had been included. “But I think we can say from this data that COVID-induced cardiac damage is much less of an issue than we may have previously thought,” he added.
He also noted that most of the patients in this study had mild COVID-19, so the results cannot be extrapolated to severe COVID-19 infection.
However, Dr. Althoff pointed out that all the patients already had atrial fibrillation, so would have been at higher risk of cardiac injury from COVID-19.
“These patients had preexisting cardiac risk factors, and thus they would have been more susceptible to both a more severe course of COVID and an increased risk of myocardial damage due to COVID. The fact that we don’t find any myocardial injury due to COVID in this group is even more reassuring. The general population will be at even lower risk,” he commented.
“I think we can say that, in COVID patients who do not have any cardiac symptoms, our study suggests that the incidence of cardiac injury is very low,” Dr. Althoff said.
“Even in patients with severe COVID and myocardial involvement reflected by increased troponin levels, I wouldn’t be sure that they have any residual cardiac injury. While it has been reported that cardiac lesions have been found in such patients, pre-COVID MRI scans were not available so we don’t know if they were there before,” he added.
“We do not know the true incidence of cardiac injury after COVID, but I think we can say from this data that it is definitely not anywhere near the 40%-50% or even greater that some of the previous reports have suggested,” he stated.
Dr. Althoff suggested that, based on these data, some of the recommendations based on previous reports such the need for follow-up cardiac scans and caution about partaking in sports again after COVID-19 infection, are probably not necessary.
“Our data suggest that these concerns are unfounded, and we need to step back a bit and stop alarming patients about the risk of cardiac damage after COVID,” he said. “Yes, if patients have cardiac symptoms during or after COVID infection they should get checked out, but I do not think we need to do a cardiac risk assessment in patients without cardiac symptoms in COVID.”
This work is supported in part by grants from Instituto de Salud Carlos III, the Spanish government, Madrid, and Fundació la Marató de TV3 in Catalonia. Dr. Althoff has received research grants for investigator-initiated trials from Biosense Webster.
A version of this article first appeared on Medscape.com.
FROM JACC: CARDIOVASCULAR IMAGING
Indiana cardiologist faces multiple malpractice complaints
alleging he performed unnecessary cardiac procedures that led to physical and emotional harm.
The medical records for one patient, 70-year-old John Pflum, of Noblesville, Ind., show that Edward Harlamert, MD, performed 44 heart catheterizations and inserted at least 41 stents between 2004 and 2013, according to an investigation by WTHR 13News in Indianapolis that was published Dec. 14.
The news outlet asked four cardiologists to review and comment on John Pflum’s medical records.
“There is not a single scenario I can think of where doing this level of stents and angiograms would be justified or make sense. I have never seen this happen in the course of my medical training or my medical career,” Payal Kohli, MD, cardiologist and medical director of Cherry Creek Heart in Denver, told 13News.
Sunil Rao, MD, director of interventional cardiology at NYU Langone Health and president of the Society for Cardiovascular Angioplasty and Interventions, who also reviewed Mr. Pflum’s medical records for 13News, said he’s “never seen a patient who has gotten this many procedures.”
Dr. Rao said that on the basis of what he saw in the records and in the images, there were several deviations from the standard of care.
Two other independent cardiologists who spoke with 13News voiced similar opinions.
Mr. Pflum was “getting cathed almost every month. That’s not how it’s done,” Morton Rinder, MD, an interventional cardiologist at St. Luke’s Hospital near St. Louis, told 13News.
Dr. Rinder has been hired as a medical consultant for the attorneys who filed Mr. Pflum’s malpractice complaint against Dr. Harlamert.
Cardiologists who reviewed the catheterization films for 13News said some of Mr. Pflum’s heart blockages met the 70% threshold to warrant consideration of a stent, while others clearly did not. In-stent restenosis occurred in several of the implanted stents, requiring a second open heart surgery.
In a statement, Dr. Harlamert’s attorneys told 13News that Dr. Harlamert has “always been committed to providing quality care to patients” and that he treated his cardiology patients “based on their unique circumstances, his expertise, and the tools available.
“Because of stringent privacy laws and pending litigation, a response to a local news story is not the proper forum to present a picture of any particular treatment decision, especially when that picture may be incomplete at this time,” the statement reads.
A version of this article first appeared on Medscape.com.
alleging he performed unnecessary cardiac procedures that led to physical and emotional harm.
The medical records for one patient, 70-year-old John Pflum, of Noblesville, Ind., show that Edward Harlamert, MD, performed 44 heart catheterizations and inserted at least 41 stents between 2004 and 2013, according to an investigation by WTHR 13News in Indianapolis that was published Dec. 14.
The news outlet asked four cardiologists to review and comment on John Pflum’s medical records.
“There is not a single scenario I can think of where doing this level of stents and angiograms would be justified or make sense. I have never seen this happen in the course of my medical training or my medical career,” Payal Kohli, MD, cardiologist and medical director of Cherry Creek Heart in Denver, told 13News.
Sunil Rao, MD, director of interventional cardiology at NYU Langone Health and president of the Society for Cardiovascular Angioplasty and Interventions, who also reviewed Mr. Pflum’s medical records for 13News, said he’s “never seen a patient who has gotten this many procedures.”
Dr. Rao said that on the basis of what he saw in the records and in the images, there were several deviations from the standard of care.
Two other independent cardiologists who spoke with 13News voiced similar opinions.
Mr. Pflum was “getting cathed almost every month. That’s not how it’s done,” Morton Rinder, MD, an interventional cardiologist at St. Luke’s Hospital near St. Louis, told 13News.
Dr. Rinder has been hired as a medical consultant for the attorneys who filed Mr. Pflum’s malpractice complaint against Dr. Harlamert.
Cardiologists who reviewed the catheterization films for 13News said some of Mr. Pflum’s heart blockages met the 70% threshold to warrant consideration of a stent, while others clearly did not. In-stent restenosis occurred in several of the implanted stents, requiring a second open heart surgery.
In a statement, Dr. Harlamert’s attorneys told 13News that Dr. Harlamert has “always been committed to providing quality care to patients” and that he treated his cardiology patients “based on their unique circumstances, his expertise, and the tools available.
“Because of stringent privacy laws and pending litigation, a response to a local news story is not the proper forum to present a picture of any particular treatment decision, especially when that picture may be incomplete at this time,” the statement reads.
A version of this article first appeared on Medscape.com.
alleging he performed unnecessary cardiac procedures that led to physical and emotional harm.
The medical records for one patient, 70-year-old John Pflum, of Noblesville, Ind., show that Edward Harlamert, MD, performed 44 heart catheterizations and inserted at least 41 stents between 2004 and 2013, according to an investigation by WTHR 13News in Indianapolis that was published Dec. 14.
The news outlet asked four cardiologists to review and comment on John Pflum’s medical records.
“There is not a single scenario I can think of where doing this level of stents and angiograms would be justified or make sense. I have never seen this happen in the course of my medical training or my medical career,” Payal Kohli, MD, cardiologist and medical director of Cherry Creek Heart in Denver, told 13News.
Sunil Rao, MD, director of interventional cardiology at NYU Langone Health and president of the Society for Cardiovascular Angioplasty and Interventions, who also reviewed Mr. Pflum’s medical records for 13News, said he’s “never seen a patient who has gotten this many procedures.”
Dr. Rao said that on the basis of what he saw in the records and in the images, there were several deviations from the standard of care.
Two other independent cardiologists who spoke with 13News voiced similar opinions.
Mr. Pflum was “getting cathed almost every month. That’s not how it’s done,” Morton Rinder, MD, an interventional cardiologist at St. Luke’s Hospital near St. Louis, told 13News.
Dr. Rinder has been hired as a medical consultant for the attorneys who filed Mr. Pflum’s malpractice complaint against Dr. Harlamert.
Cardiologists who reviewed the catheterization films for 13News said some of Mr. Pflum’s heart blockages met the 70% threshold to warrant consideration of a stent, while others clearly did not. In-stent restenosis occurred in several of the implanted stents, requiring a second open heart surgery.
In a statement, Dr. Harlamert’s attorneys told 13News that Dr. Harlamert has “always been committed to providing quality care to patients” and that he treated his cardiology patients “based on their unique circumstances, his expertise, and the tools available.
“Because of stringent privacy laws and pending litigation, a response to a local news story is not the proper forum to present a picture of any particular treatment decision, especially when that picture may be incomplete at this time,” the statement reads.
A version of this article first appeared on Medscape.com.