Rheumatology News

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.

Mladenovic/iStock/Getty Images

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.

Michael Blann/DigitalVision

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.

ChrisChrisW/Getty Images

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.

Mladenovic/iStock/Getty Images

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.

Michael Blann/DigitalVision

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.

ChrisChrisW/Getty Images

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.

Mladenovic/iStock/Getty Images

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.

Michael Blann/DigitalVision

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.

ChrisChrisW/Getty Images

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.

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 Congress has not included inflation-based payment adjustments in Medicare’s physician payment rule, 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 Congress has not included inflation-based payment adjustments in Medicare’s physician payment rule, 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 Congress has not included inflation-based payment adjustments in Medicare’s physician payment rule, 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.

Problematic alcohol use by physicians appears to be increasing, new research shows. 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.

Problematic alcohol use by physicians appears to be increasing, new research shows. 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.

Problematic alcohol use by physicians appears to be increasing, new research shows. 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.

Emergencies happen anywhere, anytime, and sometimes physicians find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a new series telling these stories.
 

I live on the Maumee River in Ohio, about 50 yards from the water. I had an early quit time and came home to meet my wife for lunch. Afterward, I went up to my barn across the main road to tinker around. It was a nice day out, so my wife had opened some windows. Suddenly, she heard screaming from the river. It did not sound like fun.

She ran down to the river’s edge and saw a dad and three boys struggling in the water. She phoned me screaming: “They’re drowning! They’re drowning!” I jumped in my truck and drove up our driveway through the yard right down to the river.

My wife was on the phone with 911 at that point, and I could see them about 75-100 yards out. The dad had two of the boys clinging around his neck. They were going under the water and coming up and going under again. The other boy was just floating nearby, face down, motionless.

I threw my shoes and scrubs off and started to walk towards the water. My wife screamed at me, “You’re not going in there!” I said, “I’m not going to stand here and watch this. It’s not going to happen.”

I’m not a kid anymore, but I was a high school swimmer, and to this day I work out all the time. I felt like I had to try something. So, I went in the water despite my wife yelling and I swam towards them.

What happens when you get in that deep water is that you panic. You can’t hear anyone because of the rapids, and your instinct is to swim back towards where you went in, which is against the current. Unless you’re a very strong swimmer, you’re just wasting your time, swimming in place.

But these guys weren’t trying to go anywhere. Dad was just trying to stay up and keep the boys alive. He was in about 10 feet of water. What they didn’t see or just didn’t know: About 20 yards upstream from that deep water is a little island.

When I got to them, I yelled at the dad to move towards the island, “Go backwards! Go back!” I flipped the boy over who wasn’t moving. He was the oldest of the three, around 10 or 11 years old. When I turned him over, he was blue and wasn’t breathing. I put my fingers on his neck and didn’t feel a pulse.

So, I’m treading water, holding him. I put an arm behind his back and started doing chest compressions on him. I probably did a dozen to 15 compressions – nothing. I thought, I’ve got to get some air in this kid. So, I gave him two deep breaths and then started doing compressions again. I know ACLS and CPR training would say we don’t do that anymore. But I couldn’t just sit there and give up. Shortly after that, he coughed out a large amount of water and started breathing.

The dad and the other two boys had made it to the island. So, I started moving towards it with the boy. It was a few minutes before he regained consciousness. Of course, he was unaware of what had happened. He started to scream, because here’s this strange man holding him. But he was breathing. That’s all I cared about.

When we got to the island, I saw that my neighbor downstream had launched his canoe. He’s a retired gentleman who lives next to me, a very physically fit man. He started rolling as hard as he could towards us, against the stream. I kind of gave him a thumbs up, like, “we’re safe now. We’re standing.” We loaded the kids and the dad in the canoe and made it back against the stream to the parking lot where they went in.

All this took probably 10 or 15 minutes, and by then the paramedics were there. Life Flight had been dispatched up by my barn where there’s room to land. So, they drove up there in the ambulance. The boy I revived was flown to the hospital. The others went in the ambulance.

I know all the ED docs, so I talked to somebody later who, with permission from the family, said they were all doing fine. They were getting x-rays on the boy’s lungs. And then I heard the dad and two boys were released that night. The other boy I worked on was observed overnight and discharged the following morning.

Four or 5 days later, I heard from their pediatrician, who also had permission to share. He sent me a very nice note through Epic that he had seen the boys. Besides some mental trauma, they were all healthy and doing fine.

The family lives in the area and the kids go to school 5 miles from my house. So, the following weekend they came over. It was Father’s Day, which was kind of cool. They brought me some flowers and candy and a card the boys had drawn to thank me.

I learned that the dad had brought the boys to the fishing site. They were horsing around in knee deep water. One of the boys walked off a little way and didn’t realize there was a drop off. He went in, and of course the dad went after him, and the other two followed.

I said to the parents: “Look, things like this happen for a reason. People like your son are saved and go on in this world because they’ve got special things to do. I can’t wait to see what kind of man he becomes.”

Two or 3 months later, it was football season, and I got at a message from the dad saying their son was playing football on Saturday at the school. He wondered if I could drop by. So, I kind of snuck over and watched, but I didn’t go say hi. There’s trauma there, and I didn’t want them to have to relive that.

I’m very fortunate that I exercise every day and I know how to do CPR and swim. And thank God the boy was floating when I got to him, or I never would’ve found him. The Maumee River is known as the “muddy Maumee.” You can’t see anything under the water.

Depending on the time of year, the river can be almost dry or overflowing into the parking lot with the current rushing hard. If it had been like that, I wouldn’t have considered going in. And they wouldn’t they have been there in the first place. They’d have been a mile downstream.

I took a risk. I could have gone out there and had the dad and two other kids jump on top of me. Then we all would have been in trouble. But like I told my wife, I couldn’t stand there and watch it. I’m just not that person.

I think it was also about being a dad myself and having grandkids now. Doctor or no doctor, I felt like I was in reasonably good shape and I had to go in there to help. This dad was trying his butt off, but three little kids is too many. You can’t do that by yourself. They were not going to make it.

I go to the hospital and I save lives as part of my job, and I don’t even come home and talk about it. But this is a whole different thing. Being able to save someone’s life when put in this situation is very gratifying. It’s a tremendous feeling. There’s a reason that young man is here today, and I’ll be watching for great things from him.

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

Daniel Cassavar, MD, is a cardiologist with ProMedica in Perrysburg, Ohio.

Emergencies happen anywhere, anytime, and sometimes physicians find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a new series telling these stories.
 

I live on the Maumee River in Ohio, about 50 yards from the water. I had an early quit time and came home to meet my wife for lunch. Afterward, I went up to my barn across the main road to tinker around. It was a nice day out, so my wife had opened some windows. Suddenly, she heard screaming from the river. It did not sound like fun.

She ran down to the river’s edge and saw a dad and three boys struggling in the water. She phoned me screaming: “They’re drowning! They’re drowning!” I jumped in my truck and drove up our driveway through the yard right down to the river.

My wife was on the phone with 911 at that point, and I could see them about 75-100 yards out. The dad had two of the boys clinging around his neck. They were going under the water and coming up and going under again. The other boy was just floating nearby, face down, motionless.

I threw my shoes and scrubs off and started to walk towards the water. My wife screamed at me, “You’re not going in there!” I said, “I’m not going to stand here and watch this. It’s not going to happen.”

I’m not a kid anymore, but I was a high school swimmer, and to this day I work out all the time. I felt like I had to try something. So, I went in the water despite my wife yelling and I swam towards them.

What happens when you get in that deep water is that you panic. You can’t hear anyone because of the rapids, and your instinct is to swim back towards where you went in, which is against the current. Unless you’re a very strong swimmer, you’re just wasting your time, swimming in place.

But these guys weren’t trying to go anywhere. Dad was just trying to stay up and keep the boys alive. He was in about 10 feet of water. What they didn’t see or just didn’t know: About 20 yards upstream from that deep water is a little island.

When I got to them, I yelled at the dad to move towards the island, “Go backwards! Go back!” I flipped the boy over who wasn’t moving. He was the oldest of the three, around 10 or 11 years old. When I turned him over, he was blue and wasn’t breathing. I put my fingers on his neck and didn’t feel a pulse.

So, I’m treading water, holding him. I put an arm behind his back and started doing chest compressions on him. I probably did a dozen to 15 compressions – nothing. I thought, I’ve got to get some air in this kid. So, I gave him two deep breaths and then started doing compressions again. I know ACLS and CPR training would say we don’t do that anymore. But I couldn’t just sit there and give up. Shortly after that, he coughed out a large amount of water and started breathing.

The dad and the other two boys had made it to the island. So, I started moving towards it with the boy. It was a few minutes before he regained consciousness. Of course, he was unaware of what had happened. He started to scream, because here’s this strange man holding him. But he was breathing. That’s all I cared about.

When we got to the island, I saw that my neighbor downstream had launched his canoe. He’s a retired gentleman who lives next to me, a very physically fit man. He started rolling as hard as he could towards us, against the stream. I kind of gave him a thumbs up, like, “we’re safe now. We’re standing.” We loaded the kids and the dad in the canoe and made it back against the stream to the parking lot where they went in.

All this took probably 10 or 15 minutes, and by then the paramedics were there. Life Flight had been dispatched up by my barn where there’s room to land. So, they drove up there in the ambulance. The boy I revived was flown to the hospital. The others went in the ambulance.

I know all the ED docs, so I talked to somebody later who, with permission from the family, said they were all doing fine. They were getting x-rays on the boy’s lungs. And then I heard the dad and two boys were released that night. The other boy I worked on was observed overnight and discharged the following morning.

Four or 5 days later, I heard from their pediatrician, who also had permission to share. He sent me a very nice note through Epic that he had seen the boys. Besides some mental trauma, they were all healthy and doing fine.

The family lives in the area and the kids go to school 5 miles from my house. So, the following weekend they came over. It was Father’s Day, which was kind of cool. They brought me some flowers and candy and a card the boys had drawn to thank me.

I learned that the dad had brought the boys to the fishing site. They were horsing around in knee deep water. One of the boys walked off a little way and didn’t realize there was a drop off. He went in, and of course the dad went after him, and the other two followed.

I said to the parents: “Look, things like this happen for a reason. People like your son are saved and go on in this world because they’ve got special things to do. I can’t wait to see what kind of man he becomes.”

Two or 3 months later, it was football season, and I got at a message from the dad saying their son was playing football on Saturday at the school. He wondered if I could drop by. So, I kind of snuck over and watched, but I didn’t go say hi. There’s trauma there, and I didn’t want them to have to relive that.

I’m very fortunate that I exercise every day and I know how to do CPR and swim. And thank God the boy was floating when I got to him, or I never would’ve found him. The Maumee River is known as the “muddy Maumee.” You can’t see anything under the water.

Depending on the time of year, the river can be almost dry or overflowing into the parking lot with the current rushing hard. If it had been like that, I wouldn’t have considered going in. And they wouldn’t they have been there in the first place. They’d have been a mile downstream.

I took a risk. I could have gone out there and had the dad and two other kids jump on top of me. Then we all would have been in trouble. But like I told my wife, I couldn’t stand there and watch it. I’m just not that person.

I think it was also about being a dad myself and having grandkids now. Doctor or no doctor, I felt like I was in reasonably good shape and I had to go in there to help. This dad was trying his butt off, but three little kids is too many. You can’t do that by yourself. They were not going to make it.

I go to the hospital and I save lives as part of my job, and I don’t even come home and talk about it. But this is a whole different thing. Being able to save someone’s life when put in this situation is very gratifying. It’s a tremendous feeling. There’s a reason that young man is here today, and I’ll be watching for great things from him.

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

Daniel Cassavar, MD, is a cardiologist with ProMedica in Perrysburg, Ohio.

Emergencies happen anywhere, anytime, and sometimes physicians find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a new series telling these stories.
 

I live on the Maumee River in Ohio, about 50 yards from the water. I had an early quit time and came home to meet my wife for lunch. Afterward, I went up to my barn across the main road to tinker around. It was a nice day out, so my wife had opened some windows. Suddenly, she heard screaming from the river. It did not sound like fun.

She ran down to the river’s edge and saw a dad and three boys struggling in the water. She phoned me screaming: “They’re drowning! They’re drowning!” I jumped in my truck and drove up our driveway through the yard right down to the river.

My wife was on the phone with 911 at that point, and I could see them about 75-100 yards out. The dad had two of the boys clinging around his neck. They were going under the water and coming up and going under again. The other boy was just floating nearby, face down, motionless.

I threw my shoes and scrubs off and started to walk towards the water. My wife screamed at me, “You’re not going in there!” I said, “I’m not going to stand here and watch this. It’s not going to happen.”

I’m not a kid anymore, but I was a high school swimmer, and to this day I work out all the time. I felt like I had to try something. So, I went in the water despite my wife yelling and I swam towards them.

What happens when you get in that deep water is that you panic. You can’t hear anyone because of the rapids, and your instinct is to swim back towards where you went in, which is against the current. Unless you’re a very strong swimmer, you’re just wasting your time, swimming in place.

But these guys weren’t trying to go anywhere. Dad was just trying to stay up and keep the boys alive. He was in about 10 feet of water. What they didn’t see or just didn’t know: About 20 yards upstream from that deep water is a little island.

When I got to them, I yelled at the dad to move towards the island, “Go backwards! Go back!” I flipped the boy over who wasn’t moving. He was the oldest of the three, around 10 or 11 years old. When I turned him over, he was blue and wasn’t breathing. I put my fingers on his neck and didn’t feel a pulse.

So, I’m treading water, holding him. I put an arm behind his back and started doing chest compressions on him. I probably did a dozen to 15 compressions – nothing. I thought, I’ve got to get some air in this kid. So, I gave him two deep breaths and then started doing compressions again. I know ACLS and CPR training would say we don’t do that anymore. But I couldn’t just sit there and give up. Shortly after that, he coughed out a large amount of water and started breathing.

The dad and the other two boys had made it to the island. So, I started moving towards it with the boy. It was a few minutes before he regained consciousness. Of course, he was unaware of what had happened. He started to scream, because here’s this strange man holding him. But he was breathing. That’s all I cared about.

When we got to the island, I saw that my neighbor downstream had launched his canoe. He’s a retired gentleman who lives next to me, a very physically fit man. He started rolling as hard as he could towards us, against the stream. I kind of gave him a thumbs up, like, “we’re safe now. We’re standing.” We loaded the kids and the dad in the canoe and made it back against the stream to the parking lot where they went in.

All this took probably 10 or 15 minutes, and by then the paramedics were there. Life Flight had been dispatched up by my barn where there’s room to land. So, they drove up there in the ambulance. The boy I revived was flown to the hospital. The others went in the ambulance.

I know all the ED docs, so I talked to somebody later who, with permission from the family, said they were all doing fine. They were getting x-rays on the boy’s lungs. And then I heard the dad and two boys were released that night. The other boy I worked on was observed overnight and discharged the following morning.

Four or 5 days later, I heard from their pediatrician, who also had permission to share. He sent me a very nice note through Epic that he had seen the boys. Besides some mental trauma, they were all healthy and doing fine.

The family lives in the area and the kids go to school 5 miles from my house. So, the following weekend they came over. It was Father’s Day, which was kind of cool. They brought me some flowers and candy and a card the boys had drawn to thank me.

I learned that the dad had brought the boys to the fishing site. They were horsing around in knee deep water. One of the boys walked off a little way and didn’t realize there was a drop off. He went in, and of course the dad went after him, and the other two followed.

I said to the parents: “Look, things like this happen for a reason. People like your son are saved and go on in this world because they’ve got special things to do. I can’t wait to see what kind of man he becomes.”

Two or 3 months later, it was football season, and I got at a message from the dad saying their son was playing football on Saturday at the school. He wondered if I could drop by. So, I kind of snuck over and watched, but I didn’t go say hi. There’s trauma there, and I didn’t want them to have to relive that.

I’m very fortunate that I exercise every day and I know how to do CPR and swim. And thank God the boy was floating when I got to him, or I never would’ve found him. The Maumee River is known as the “muddy Maumee.” You can’t see anything under the water.

Depending on the time of year, the river can be almost dry or overflowing into the parking lot with the current rushing hard. If it had been like that, I wouldn’t have considered going in. And they wouldn’t they have been there in the first place. They’d have been a mile downstream.

I took a risk. I could have gone out there and had the dad and two other kids jump on top of me. Then we all would have been in trouble. But like I told my wife, I couldn’t stand there and watch it. I’m just not that person.

I think it was also about being a dad myself and having grandkids now. Doctor or no doctor, I felt like I was in reasonably good shape and I had to go in there to help. This dad was trying his butt off, but three little kids is too many. You can’t do that by yourself. They were not going to make it.

I go to the hospital and I save lives as part of my job, and I don’t even come home and talk about it. But this is a whole different thing. Being able to save someone’s life when put in this situation is very gratifying. It’s a tremendous feeling. There’s a reason that young man is here today, and I’ll be watching for great things from him.

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

Daniel Cassavar, MD, is a cardiologist with ProMedica in Perrysburg, Ohio.

A new study provides more evidence that endocarditis associated with drug use is a significant and growing health concern, and further demonstrates that this risk has been exacerbated by the COVID-19 pandemic.

The rate of infective endocarditis among individuals in the United States with opioid or cocaine use disorder increased in the 11-year period 2011 to 2022, with the steepest increase logged during the COVID-19 pandemic (2021-2022), according to the study.

A diagnosis of COVID-19 more than doubled the risk for a new diagnosis of endocarditis in patients with either cocaine (hazard ratio, 2.24) or opioid use disorder (HR, 2.23).

“Our data suggests that, in addition to the major social disruption from the pandemic, including disrupted access to health care, COVID-19 infection itself is a significant risk factor for new diagnosis of endocarditis in drug using populations,” authors Nora Volkow, MD, director of the National Institute on Drug Abuse, and colleagues wrote.

“Drug-using populations, particularly those who use cocaine or opioids, have some of the highest risk for endocarditis, and here we show that having a COVID-19 diagnoses further increases this risk,” they added.

The study was published online in Molecular Psychiatry.

The researchers analyzed electronic health record data collected from January 2011 to August 2022 for more than 109 million people across the United States, including more than 736,000 with an opioid use disorder and more than 379,000 with a cocaine use disorder.

In 2011, there were 4 cases of endocarditis per day for every 1 million people with opioid use disorder. By 2022, the rate had increased to 30 cases per day per 1 million people with opioid use disorder.

For people with cocaine use disorder, cases of endocarditis increased from 5 per 1 million in 2011 to 23 per 1 million in 2022.

Among individuals with cocaine or opioid use disorder, the risk of being hospitalized within 180 days following a diagnosis of endocarditis was higher in those with than without COVID-19 (67.5% vs. 58.7%; HR, 1.21). 

The risk of dying within 180 days following new diagnosis of endocarditis was also higher in those with than without COVID-19 (9.2% vs. 8%; HR, 1.16).

The study also showed that Black and Hispanic individuals had a lower risk for COVID-19-associated endocarditis than non-Hispanic White individuals, which is consistent with a higher prevalence of injection drug use in non-Hispanic White populations, compared with Black or Hispanic populations, the researchers pointed out.

Dr. Volkow and colleagues said their findings highlight the need to screen drug users for endocarditis and link them to infectious disease and addiction treatment if they contract COVID-19.

“People with substance use disorder already face major impediments to proper health care due to lack of access and stigma,” Dr. Volkow said in a news release. 

“Proven techniques like syringe service programs, which help people avoid infection from reused or shared injection equipment, can help prevent this often fatal and costly condition,” Dr. Volkow added.

The authors said it will also be important to determine exactly how SARS-CoV-2 viral infection exacerbates the risk for endocarditis in drug users.

Support for the study was provided by the National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute Case Comprehensive Cancer Center. The authors reported no relevant financial relationships.

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

A new study provides more evidence that endocarditis associated with drug use is a significant and growing health concern, and further demonstrates that this risk has been exacerbated by the COVID-19 pandemic.

The rate of infective endocarditis among individuals in the United States with opioid or cocaine use disorder increased in the 11-year period 2011 to 2022, with the steepest increase logged during the COVID-19 pandemic (2021-2022), according to the study.

A diagnosis of COVID-19 more than doubled the risk for a new diagnosis of endocarditis in patients with either cocaine (hazard ratio, 2.24) or opioid use disorder (HR, 2.23).

“Our data suggests that, in addition to the major social disruption from the pandemic, including disrupted access to health care, COVID-19 infection itself is a significant risk factor for new diagnosis of endocarditis in drug using populations,” authors Nora Volkow, MD, director of the National Institute on Drug Abuse, and colleagues wrote.

“Drug-using populations, particularly those who use cocaine or opioids, have some of the highest risk for endocarditis, and here we show that having a COVID-19 diagnoses further increases this risk,” they added.

The study was published online in Molecular Psychiatry.

The researchers analyzed electronic health record data collected from January 2011 to August 2022 for more than 109 million people across the United States, including more than 736,000 with an opioid use disorder and more than 379,000 with a cocaine use disorder.

In 2011, there were 4 cases of endocarditis per day for every 1 million people with opioid use disorder. By 2022, the rate had increased to 30 cases per day per 1 million people with opioid use disorder.

For people with cocaine use disorder, cases of endocarditis increased from 5 per 1 million in 2011 to 23 per 1 million in 2022.

Among individuals with cocaine or opioid use disorder, the risk of being hospitalized within 180 days following a diagnosis of endocarditis was higher in those with than without COVID-19 (67.5% vs. 58.7%; HR, 1.21). 

The risk of dying within 180 days following new diagnosis of endocarditis was also higher in those with than without COVID-19 (9.2% vs. 8%; HR, 1.16).

The study also showed that Black and Hispanic individuals had a lower risk for COVID-19-associated endocarditis than non-Hispanic White individuals, which is consistent with a higher prevalence of injection drug use in non-Hispanic White populations, compared with Black or Hispanic populations, the researchers pointed out.

Dr. Volkow and colleagues said their findings highlight the need to screen drug users for endocarditis and link them to infectious disease and addiction treatment if they contract COVID-19.

“People with substance use disorder already face major impediments to proper health care due to lack of access and stigma,” Dr. Volkow said in a news release. 

“Proven techniques like syringe service programs, which help people avoid infection from reused or shared injection equipment, can help prevent this often fatal and costly condition,” Dr. Volkow added.

The authors said it will also be important to determine exactly how SARS-CoV-2 viral infection exacerbates the risk for endocarditis in drug users.

Support for the study was provided by the National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute Case Comprehensive Cancer Center. The authors reported no relevant financial relationships.

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

A new study provides more evidence that endocarditis associated with drug use is a significant and growing health concern, and further demonstrates that this risk has been exacerbated by the COVID-19 pandemic.

The rate of infective endocarditis among individuals in the United States with opioid or cocaine use disorder increased in the 11-year period 2011 to 2022, with the steepest increase logged during the COVID-19 pandemic (2021-2022), according to the study.

A diagnosis of COVID-19 more than doubled the risk for a new diagnosis of endocarditis in patients with either cocaine (hazard ratio, 2.24) or opioid use disorder (HR, 2.23).

“Our data suggests that, in addition to the major social disruption from the pandemic, including disrupted access to health care, COVID-19 infection itself is a significant risk factor for new diagnosis of endocarditis in drug using populations,” authors Nora Volkow, MD, director of the National Institute on Drug Abuse, and colleagues wrote.

“Drug-using populations, particularly those who use cocaine or opioids, have some of the highest risk for endocarditis, and here we show that having a COVID-19 diagnoses further increases this risk,” they added.

The study was published online in Molecular Psychiatry.

The researchers analyzed electronic health record data collected from January 2011 to August 2022 for more than 109 million people across the United States, including more than 736,000 with an opioid use disorder and more than 379,000 with a cocaine use disorder.

In 2011, there were 4 cases of endocarditis per day for every 1 million people with opioid use disorder. By 2022, the rate had increased to 30 cases per day per 1 million people with opioid use disorder.

For people with cocaine use disorder, cases of endocarditis increased from 5 per 1 million in 2011 to 23 per 1 million in 2022.

Among individuals with cocaine or opioid use disorder, the risk of being hospitalized within 180 days following a diagnosis of endocarditis was higher in those with than without COVID-19 (67.5% vs. 58.7%; HR, 1.21). 

The risk of dying within 180 days following new diagnosis of endocarditis was also higher in those with than without COVID-19 (9.2% vs. 8%; HR, 1.16).

The study also showed that Black and Hispanic individuals had a lower risk for COVID-19-associated endocarditis than non-Hispanic White individuals, which is consistent with a higher prevalence of injection drug use in non-Hispanic White populations, compared with Black or Hispanic populations, the researchers pointed out.

Dr. Volkow and colleagues said their findings highlight the need to screen drug users for endocarditis and link them to infectious disease and addiction treatment if they contract COVID-19.

“People with substance use disorder already face major impediments to proper health care due to lack of access and stigma,” Dr. Volkow said in a news release. 

“Proven techniques like syringe service programs, which help people avoid infection from reused or shared injection equipment, can help prevent this often fatal and costly condition,” Dr. Volkow added.

The authors said it will also be important to determine exactly how SARS-CoV-2 viral infection exacerbates the risk for endocarditis in drug users.

Support for the study was provided by the National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute Case Comprehensive Cancer Center. The authors reported no relevant financial relationships.

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

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.

PxHere

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.

Vassiliy Vassilenko/thinkstockphotos.com

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?

Gio_tto/Thinkstock

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.

PxHere

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.

Vassiliy Vassilenko/thinkstockphotos.com

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?

Gio_tto/Thinkstock

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.

PxHere

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.

Vassiliy Vassilenko/thinkstockphotos.com

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?

Gio_tto/Thinkstock

A re-evaluation of cardiovascular risk management guidelines intended for use by rheumatologists may be warranted based on findings from a recently published population-based study of the risks for 12 different cardiovascular disease outcomes in patients with autoimmune diseases.

“The notion that patients with rheumatic diseases are at increased risk of developing cardiovascular diseases has been ongoing for many years,” Nathalie Conrad, PhD, and coauthors wrote in a viewpoint article in Annals of the Rheumatic Diseases.

This has “sparked much debate concerning whether and when to initiate cardiovascular prevention therapies,” they said.

Dr. Conrad was first author on the population-based study published in The Lancet in August 2022 that used linked primary and secondary care records from datasets in the U.K. Clinical Practice Research Datalink involving individuals who were recently diagnosed with any of 19 different autoimmune diseases during an 18-year period stretching from 2000 to 2017 but free of cardiovascular disease until at least 12 months after incident autoimmune disease. “Every single autoimmune disorder we looked at was associated with increased cardiovascular risk,” Dr. Conrad, of the department of public health and primary care at Catholic University Leuven (Belgium), said in an interview.

Not only was the risk for cardiovascular disease increased for people with rheumatic diseases by an average of 68%, compared with people without rheumatic diseases, but also the whole spectrum of cardiovascular disorders was seen.

“We saw increases in thromboembolic diseases, degenerative heart diseases, and heart inflammation,” Dr. Conrad said.
 

Large datasets examined

The idea for the epidemiologic study came from mounting evidence for cardiovascular disease risk among people with autoimmune diseases but not enough to support the design of specific prevention measures.

Dr. Conrad’s Lancet study examined electronic health records of 446,449 individuals with autoimmune diseases and matched them to 2,102,830 individuals without autoimmune disease. This included 160,217 individuals with seven rheumatic diseases: rheumatoid arthritis, polymyalgia rheumatica, vasculitis, systemic lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis, and systemic sclerosis.

In addition to looking for any evidence of cardiovascular disease, Dr. Conrad and coauthors looked at 12 specific outcomes: atherosclerotic diseases, peripheral arterial disease, stroke or transient ischemic attack, heart failure, valve disorders, thromboembolic disease, atrial fibrillation or flutter, conduction system disease, supraventricular arrhythmias, aortic aneurysm, myocarditis and pericarditis, and infective endocarditis.
 

CV risk in rheumatic diseases

As might be expected, “greater magnitudes of risk” were seen for individuals with systemic lupus erythematosus and systemic sclerosis than for people in the general population, with the chances of cardiovascular disease being two to four times higher. But what perhaps wasn’t expected was that all rheumatic diseases carried an increased risk for heart or vascular-related problems.

Furthermore, the increased risk could not solely be accounted for by the presence of traditional risk factors, such as blood pressure, smoking, or obesity.

“The background here is that any context of systemic inflammation would be predicted to lead to an increased vascular risk,” Iain McInnes, MD, PhD, professor of medicine and rheumatology at the University of Glasgow, said in an interview. Dr. McInnes was a coauthor of the viewpoint article in Annals of the Rheumatic Diseases.

“The implication is that there may well be increased vascular risk across the whole range of immune-mediated inflammatory diseases,” he added. “We should not, however, infer the magnitude of risk will be the same for each disease.”

What is more intriguing, Dr. McInnes said, is that “we don’t know yet whether there’s one final common pathway that leads to the blood vessel being damaged or whether different diseases might contribute different pathways.”

He added: “A question for the future is to see what are those mechanisms that drive risk across different diseases? And the reason that matters, of course, is that we might want to think about the effectiveness of different therapeutic interventions.”
 

Determining cardiovascular risk

Dr. Conrad and associates in their viewpoint article suggested that an update to the European Alliance of Associations for Rheumatology guidelines for cardiovascular risk management of rheumatic and musculoskeletal diseases (RMDs) could tailor cardiovascular risk scores to certain diseases.

They suggested that the guidelines could consider a risk multiplier of 2.5 for systemic sclerosis, 2.0 for lupus, and 1.5 for any other rheumatic disease.

“We argue that [EULAR] recommendations should consider this new evidence of poorer cardiovascular health in numerous RMDs and envisage cardiovascular screening and associated prevention measures,” Dr. Conrad said.

While they recognize that risk multipliers aren’t perfect, “they are the best available option until personalized risk prediction tools are developed specifically for patients with RMDs.”
 

Addressing cardiovascular risk

As a former president of EULAR, Dr. McInnes was keen to point out that “EULAR’s recommendations are evidence based and are rigorously built on [standard operating procedures] that work and have stood the test of time. I’m quite sure that the members of relevant EULAR task forces will be looking at these data, but they’ll be looking at the whole range of literature to see whether change is necessary.”

Good-quality inflammatory disease control will certainly contribute to reducing vascular risk, “but we should not make the assumption that it will be sufficient,” he cautioned. “We still have to be very careful in addressing so called conventional risk factors, but in particular thinking about obesity and cardiometabolic syndrome to be sure that when those are present, that we detect them and we treat them appropriately.”

As to who is best placed to manage a patient’s cardiovascular risk profile, Dr. McInnes said: “I think the rheumatologist has a responsibility to make sure that as much of the patient’s disease spectrum is being treated as possible.”

“As a rheumatologist, I would like to know that those elements of a patient’s disease presentation are being addressed,” whether that is by a primary care physician, cardiologist, diabetologist, or other specialist involved in the optimal management of the patient.

Dr. Conrad acknowledged receiving support from the European Union’s Horizon 2020 Program, the European Society for Cardiology, and grant funding paid to her institution from the Belgian-based Research Foundation Flounders. She also acknowledged receipt of royalties in regard to the intellectual property of a home-monitoring system for heart failure paid to Oxford University Innovation. Dr. McInnes acknowledged financial relationships with many pharmaceutical companies.

*This article was updated 12/30/2022.

A re-evaluation of cardiovascular risk management guidelines intended for use by rheumatologists may be warranted based on findings from a recently published population-based study of the risks for 12 different cardiovascular disease outcomes in patients with autoimmune diseases.

“The notion that patients with rheumatic diseases are at increased risk of developing cardiovascular diseases has been ongoing for many years,” Nathalie Conrad, PhD, and coauthors wrote in a viewpoint article in Annals of the Rheumatic Diseases.

This has “sparked much debate concerning whether and when to initiate cardiovascular prevention therapies,” they said.

Dr. Conrad was first author on the population-based study published in The Lancet in August 2022 that used linked primary and secondary care records from datasets in the U.K. Clinical Practice Research Datalink involving individuals who were recently diagnosed with any of 19 different autoimmune diseases during an 18-year period stretching from 2000 to 2017 but free of cardiovascular disease until at least 12 months after incident autoimmune disease. “Every single autoimmune disorder we looked at was associated with increased cardiovascular risk,” Dr. Conrad, of the department of public health and primary care at Catholic University Leuven (Belgium), said in an interview.

Not only was the risk for cardiovascular disease increased for people with rheumatic diseases by an average of 68%, compared with people without rheumatic diseases, but also the whole spectrum of cardiovascular disorders was seen.

“We saw increases in thromboembolic diseases, degenerative heart diseases, and heart inflammation,” Dr. Conrad said.
 

Large datasets examined

The idea for the epidemiologic study came from mounting evidence for cardiovascular disease risk among people with autoimmune diseases but not enough to support the design of specific prevention measures.

Dr. Conrad’s Lancet study examined electronic health records of 446,449 individuals with autoimmune diseases and matched them to 2,102,830 individuals without autoimmune disease. This included 160,217 individuals with seven rheumatic diseases: rheumatoid arthritis, polymyalgia rheumatica, vasculitis, systemic lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis, and systemic sclerosis.

In addition to looking for any evidence of cardiovascular disease, Dr. Conrad and coauthors looked at 12 specific outcomes: atherosclerotic diseases, peripheral arterial disease, stroke or transient ischemic attack, heart failure, valve disorders, thromboembolic disease, atrial fibrillation or flutter, conduction system disease, supraventricular arrhythmias, aortic aneurysm, myocarditis and pericarditis, and infective endocarditis.
 

CV risk in rheumatic diseases

As might be expected, “greater magnitudes of risk” were seen for individuals with systemic lupus erythematosus and systemic sclerosis than for people in the general population, with the chances of cardiovascular disease being two to four times higher. But what perhaps wasn’t expected was that all rheumatic diseases carried an increased risk for heart or vascular-related problems.

Furthermore, the increased risk could not solely be accounted for by the presence of traditional risk factors, such as blood pressure, smoking, or obesity.

“The background here is that any context of systemic inflammation would be predicted to lead to an increased vascular risk,” Iain McInnes, MD, PhD, professor of medicine and rheumatology at the University of Glasgow, said in an interview. Dr. McInnes was a coauthor of the viewpoint article in Annals of the Rheumatic Diseases.

“The implication is that there may well be increased vascular risk across the whole range of immune-mediated inflammatory diseases,” he added. “We should not, however, infer the magnitude of risk will be the same for each disease.”

What is more intriguing, Dr. McInnes said, is that “we don’t know yet whether there’s one final common pathway that leads to the blood vessel being damaged or whether different diseases might contribute different pathways.”

He added: “A question for the future is to see what are those mechanisms that drive risk across different diseases? And the reason that matters, of course, is that we might want to think about the effectiveness of different therapeutic interventions.”
 

Determining cardiovascular risk

Dr. Conrad and associates in their viewpoint article suggested that an update to the European Alliance of Associations for Rheumatology guidelines for cardiovascular risk management of rheumatic and musculoskeletal diseases (RMDs) could tailor cardiovascular risk scores to certain diseases.

They suggested that the guidelines could consider a risk multiplier of 2.5 for systemic sclerosis, 2.0 for lupus, and 1.5 for any other rheumatic disease.

“We argue that [EULAR] recommendations should consider this new evidence of poorer cardiovascular health in numerous RMDs and envisage cardiovascular screening and associated prevention measures,” Dr. Conrad said.

While they recognize that risk multipliers aren’t perfect, “they are the best available option until personalized risk prediction tools are developed specifically for patients with RMDs.”
 

Addressing cardiovascular risk

As a former president of EULAR, Dr. McInnes was keen to point out that “EULAR’s recommendations are evidence based and are rigorously built on [standard operating procedures] that work and have stood the test of time. I’m quite sure that the members of relevant EULAR task forces will be looking at these data, but they’ll be looking at the whole range of literature to see whether change is necessary.”

Good-quality inflammatory disease control will certainly contribute to reducing vascular risk, “but we should not make the assumption that it will be sufficient,” he cautioned. “We still have to be very careful in addressing so called conventional risk factors, but in particular thinking about obesity and cardiometabolic syndrome to be sure that when those are present, that we detect them and we treat them appropriately.”

As to who is best placed to manage a patient’s cardiovascular risk profile, Dr. McInnes said: “I think the rheumatologist has a responsibility to make sure that as much of the patient’s disease spectrum is being treated as possible.”

“As a rheumatologist, I would like to know that those elements of a patient’s disease presentation are being addressed,” whether that is by a primary care physician, cardiologist, diabetologist, or other specialist involved in the optimal management of the patient.

Dr. Conrad acknowledged receiving support from the European Union’s Horizon 2020 Program, the European Society for Cardiology, and grant funding paid to her institution from the Belgian-based Research Foundation Flounders. She also acknowledged receipt of royalties in regard to the intellectual property of a home-monitoring system for heart failure paid to Oxford University Innovation. Dr. McInnes acknowledged financial relationships with many pharmaceutical companies.

*This article was updated 12/30/2022.

A re-evaluation of cardiovascular risk management guidelines intended for use by rheumatologists may be warranted based on findings from a recently published population-based study of the risks for 12 different cardiovascular disease outcomes in patients with autoimmune diseases.

“The notion that patients with rheumatic diseases are at increased risk of developing cardiovascular diseases has been ongoing for many years,” Nathalie Conrad, PhD, and coauthors wrote in a viewpoint article in Annals of the Rheumatic Diseases.

This has “sparked much debate concerning whether and when to initiate cardiovascular prevention therapies,” they said.

Dr. Conrad was first author on the population-based study published in The Lancet in August 2022 that used linked primary and secondary care records from datasets in the U.K. Clinical Practice Research Datalink involving individuals who were recently diagnosed with any of 19 different autoimmune diseases during an 18-year period stretching from 2000 to 2017 but free of cardiovascular disease until at least 12 months after incident autoimmune disease. “Every single autoimmune disorder we looked at was associated with increased cardiovascular risk,” Dr. Conrad, of the department of public health and primary care at Catholic University Leuven (Belgium), said in an interview.

Not only was the risk for cardiovascular disease increased for people with rheumatic diseases by an average of 68%, compared with people without rheumatic diseases, but also the whole spectrum of cardiovascular disorders was seen.

“We saw increases in thromboembolic diseases, degenerative heart diseases, and heart inflammation,” Dr. Conrad said.
 

Large datasets examined

The idea for the epidemiologic study came from mounting evidence for cardiovascular disease risk among people with autoimmune diseases but not enough to support the design of specific prevention measures.

Dr. Conrad’s Lancet study examined electronic health records of 446,449 individuals with autoimmune diseases and matched them to 2,102,830 individuals without autoimmune disease. This included 160,217 individuals with seven rheumatic diseases: rheumatoid arthritis, polymyalgia rheumatica, vasculitis, systemic lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis, and systemic sclerosis.

In addition to looking for any evidence of cardiovascular disease, Dr. Conrad and coauthors looked at 12 specific outcomes: atherosclerotic diseases, peripheral arterial disease, stroke or transient ischemic attack, heart failure, valve disorders, thromboembolic disease, atrial fibrillation or flutter, conduction system disease, supraventricular arrhythmias, aortic aneurysm, myocarditis and pericarditis, and infective endocarditis.
 

CV risk in rheumatic diseases

As might be expected, “greater magnitudes of risk” were seen for individuals with systemic lupus erythematosus and systemic sclerosis than for people in the general population, with the chances of cardiovascular disease being two to four times higher. But what perhaps wasn’t expected was that all rheumatic diseases carried an increased risk for heart or vascular-related problems.

Furthermore, the increased risk could not solely be accounted for by the presence of traditional risk factors, such as blood pressure, smoking, or obesity.

“The background here is that any context of systemic inflammation would be predicted to lead to an increased vascular risk,” Iain McInnes, MD, PhD, professor of medicine and rheumatology at the University of Glasgow, said in an interview. Dr. McInnes was a coauthor of the viewpoint article in Annals of the Rheumatic Diseases.

“The implication is that there may well be increased vascular risk across the whole range of immune-mediated inflammatory diseases,” he added. “We should not, however, infer the magnitude of risk will be the same for each disease.”

What is more intriguing, Dr. McInnes said, is that “we don’t know yet whether there’s one final common pathway that leads to the blood vessel being damaged or whether different diseases might contribute different pathways.”

He added: “A question for the future is to see what are those mechanisms that drive risk across different diseases? And the reason that matters, of course, is that we might want to think about the effectiveness of different therapeutic interventions.”
 

Determining cardiovascular risk

Dr. Conrad and associates in their viewpoint article suggested that an update to the European Alliance of Associations for Rheumatology guidelines for cardiovascular risk management of rheumatic and musculoskeletal diseases (RMDs) could tailor cardiovascular risk scores to certain diseases.

They suggested that the guidelines could consider a risk multiplier of 2.5 for systemic sclerosis, 2.0 for lupus, and 1.5 for any other rheumatic disease.

“We argue that [EULAR] recommendations should consider this new evidence of poorer cardiovascular health in numerous RMDs and envisage cardiovascular screening and associated prevention measures,” Dr. Conrad said.

While they recognize that risk multipliers aren’t perfect, “they are the best available option until personalized risk prediction tools are developed specifically for patients with RMDs.”
 

Addressing cardiovascular risk

As a former president of EULAR, Dr. McInnes was keen to point out that “EULAR’s recommendations are evidence based and are rigorously built on [standard operating procedures] that work and have stood the test of time. I’m quite sure that the members of relevant EULAR task forces will be looking at these data, but they’ll be looking at the whole range of literature to see whether change is necessary.”

Good-quality inflammatory disease control will certainly contribute to reducing vascular risk, “but we should not make the assumption that it will be sufficient,” he cautioned. “We still have to be very careful in addressing so called conventional risk factors, but in particular thinking about obesity and cardiometabolic syndrome to be sure that when those are present, that we detect them and we treat them appropriately.”

As to who is best placed to manage a patient’s cardiovascular risk profile, Dr. McInnes said: “I think the rheumatologist has a responsibility to make sure that as much of the patient’s disease spectrum is being treated as possible.”

“As a rheumatologist, I would like to know that those elements of a patient’s disease presentation are being addressed,” whether that is by a primary care physician, cardiologist, diabetologist, or other specialist involved in the optimal management of the patient.

Dr. Conrad acknowledged receiving support from the European Union’s Horizon 2020 Program, the European Society for Cardiology, and grant funding paid to her institution from the Belgian-based Research Foundation Flounders. She also acknowledged receipt of royalties in regard to the intellectual property of a home-monitoring system for heart failure paid to Oxford University Innovation. Dr. McInnes acknowledged financial relationships with many pharmaceutical companies.

*This article was updated 12/30/2022.

Corticosteroid (CS) injections may worsen progression of knee osteoarthritis as seen on radiography and whole-knee MRI. Injecting hyaluronic acid (HA) instead, or managing the condition without injections, may better preserve knee structure and cartilage, according to results of two related studies presented at the annual meeting of the Radiological Society of North America.

The findings come nonrandomized, observational cohort studies, leading knee OA experts to call for further study in randomized trial settings. In the meantime, shared decision-making between patients and clinicians is advised on the use of these injections.

For knee OA, most patients seek a noninvasive treatment for symptomatic relief. “At least 10% of these patients undergo local treatment with injectable corticosteroids or hyaluronic acid,” the lead author of one of the studies, Upasana Upadhyay Bharadwaj, MD, research fellow in musculoskeletal radiology at the University of California, San Francisco, said in a video press release.

Researchers in both studies used data and images from the Osteoarthritis Initiative (OAI), a multicenter, longitudinal, observational study of 4,796 U.S. patients aged 45-79 years with knee OA. Participants were enrolled from February 2004 to May 2006.

The OAI maintains a natural history database of information regarding participants’ clinical evaluation data, x-rays, MRI scans, and a biospecimen repository. Data are available to researchers worldwide.
 

Two studies draw similar conclusions

In one study, Dr. Bharadwaj and colleagues found that HA injections appeared to show decreased knee OA progression in bone marrow lesions.

They investigated 8 patients who received one CS injection, 12 who received one HA injection, and 40 control persons who received neither treatment. Participants were propensity-score matched by age, sex, body mass index (BMI), Kellgren-Lawrence (KL) grade, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Physical Activity Scale for the Elderly (PASE).

The researchers semiquantitatively graded three Tesla MRI scans that had been obtained at baseline, 2 years before the injection, and 2 years after the injection, using whole-organ MRI score (WORMS) for the meniscus, bone marrow lesions, cartilage, joint effusion, and ligaments.

They quantified OA progression using the difference in WORMS between baseline and 2-year follow-up, and they used linear regression models, adjusted for age, sex, BMI, KL grade, WOMAC, and PASE, to identify the link between type of injection and progression of WORMS.

At 2 years, the authors found a significant association between CS injection and postinjection progression of WORMS over 2 years for the knee overall, the lateral meniscus, lateral cartilage, and medial cartilage. There was no significant link between HA injection and postinjection progression of WORMS or between either injection type and progression of pain, as quantified by WOMAC. There was also no significant difference in progression of WORMS over the 2 years prior to injection for CS and HA injections.

“Corticosteroid injections must be administered with caution with respect to long-term effects on osteoarthritis,” Dr. Bharadwaj advised. “Hyaluronic acid injections, on the other hand, may slow down progression of knee osteoarthritis and alleviate long-term effects while offering similar symptomatic relief to corticosteroid injections. Overall, they are perhaps a safer alternative when looking at medium- and long-term disease course of knee osteoarthritis.”

In the second study, lead author Azad Darbandi, MS, a fourth-year medical student at Chicago Medical School, North Chicago, and colleagues found that patients who received CS injections experienced significantly more medial joint space narrowing.

They identified 210 knees with imaging at baseline and at 48 months that received CS injections, and 59 that received HA injections; 6,827 knees served as controls. The investigators matched 50 patients per group on the basis of confounding factors, which included age, sex, BMI, comorbidities, surgery, and semiquantitative imaging outcomes at baseline. They performed ANCOVA testing using 48-month semiquantitative imaging outcomes as dependent variables and confounding variables as covariates.

The researchers analyzed joint space narrowing, KL grade, and tibia/femur medial/lateral compartment osteophyte formation and sclerosis.

At 4 years, the average KL grade in the CS group was 2.79, it was 2.11 in the HA group,;and it was 2.37 in the control group. Intergroup comparisons showed significant differences in KL grade between CS and HA groups and between CS and control groups. Medial compartment joint space narrowing was 1.56 in the CS group, 1.11 in the HA group, and 1.18 in controls. There was a significant difference between the CS and control groups. Other dependent variables were not significant.

“These preliminary results suggest that corticosteroid injections accelerated the radiographic progression of osteoarthritis, specifically medial joint space narrowing and Kellgren-Lawrence grading, whereas hyaluronic acid injections did not,” Mr. Darbandi said in an interview.

“OA radiographic progression does not always correlate with clinical progression, and further research is needed,” he added.

Proper matching of patients at baseline for confounding factors is a strength of the study, Mr. Darbandi said, while the retrospective study design is a weakness.
 

Experts share their perspectives on the preliminary results

Michael M. Kheir, MD, assistant professor of orthopedic surgery at the University of Michigan Health System, who was not involved in the studies, said he would like to see further related research.

“Perhaps steroid injections are not as benign as they once seemed,” he added. “They should be reserved for patients who already have significant arthritis and are seeking temporary relief prior to surgical reconstruction with a joint replacement, or for patients with recalcitrant pain after having already tried HA injections.”

William A. Jiranek, MD, professor and orthopedic surgeon at Duke Health in Morrisville, N.C., who also was not involved in the studies, was not surprised by the findings.

“It is important to do these studies to learn that steroid injections do not come with zero cost,” he said.

“I am pretty sure that a percentage of these patients had no cartilage loss at all,” he added. “We need to understand which OA phenotypes are not at risk of progressive cartilage loss from steroid injections.”

Annunziato (Ned) Amendola, MD, professor and sports medicine orthopedic surgeon at Duke Health in Durham, N.C., who was also not involved in the studies, said he would like to know how injection effectiveness and activity level are related.

“If the injections were effective at relieving pain, and the patients were more active, that may have predisposed to more joint wear,” he said. “It’s like tires that last longer if you don’t abuse them.”
 

Shared decision-making and further research recommended

Amanda E. Nelson, MD, associate professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, said: “The lack of randomization introduces potential biases around why certain therapies (CS injection, HA injection, or neither) were selected over others (such as disease severity, preference, comorbid conditions, other contraindications, etc), thus making interpretation of the findings challenging.

“The causal relationship remains in question, and questions around the efficacy of intra-articular HA in particular, and the ideal settings for intra-articular therapy in general, persist,” noted Dr. Nelson, who was also not involved in the studies. “Thus, shared decision-making between patients and their providers is essential when considering these options.”

C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona and director of the University of Arizona Arthritis Center, both in Tucson, said in an interview that these types of studies are important because CS injections are common treatments for knee OA, they are recommended in treatment guidelines, and other good options are lacking.

But he pointed out that the results of these two studies need to be interpreted with caution and should not be used to decide the course of treatment.

“These data are hypothesis generating. They suggest association, but they do not show causation,” said Dr. Kwoh, who was also not involved in the studies. “Both studies are secondary analyses of data collected from the OAI, which was not specifically designed to answer the questions these studies are posing.

“The OAI was not a treatment study, and participants were seen only once a year or so. They may have had joint injections anytime from only days to around 1 year before their visit, and their levels of activity or pain just prior to or just after their joint injections were not reported,” Dr. Kwoh explained.

The reasons why patients did or did not receive a specific joint injection – including their socioeconomic status, race, access to insurance, and other confounding factors – were not assessed and may have affected the results, he added.

The fact that both studies used the same data and came to the same conclusions gives the conclusions some strength, he said, but “the gold standard to understanding causation would be a randomized, controlled trial.”

Mr. Darbandi’s research received grant support from Boeing, His c-authors, as well as all experts not involved in the studies, reported no relevant financial relationshiips. Dr. Bharadwaj did not provide conflict-of-interest and funding details. Dr. Kwoh reported membership on panels that have developed guidelines for the management of knee OA.