Cardiology News

Doctors’ opinions about whether to treat women with osteoporosis with hormone therapy vary. Guidelines by medical societies including those of the American College of Physicians, on the other hand, generally do not recommend it as a first line therapy for the disease, at least in part due to the risks associated with taking it.

This type of hormone therapy (HT) can be given as estrogen or a combination of hormones including estrogen. The physicians interviewed for this piece who prescribe HT for osteoporosis suggest the benefits outweigh the downsides to its use for some of their patients. But such doctors may be a minority group, suggests Michael R. McClung, MD, founding director of the Oregon Osteoporosis Center, Portland.

According to Dr. McClung, HT is now rarely prescribed as treatment – as opposed to prevention – for osteoporosis in the absence of additional benefits such as reducing vasomotor symptoms.

Researchers’ findings on HT use in women with osteoporosis are complex. While HT is approved for menopausal prevention of osteoporosis, it is not indicated as a treatment for the disease by the Food and Drug Administration. See the prescribing information for Premarin tablets, which contain a mixture of estrogen hormones, for an example of the FDA’s indications and usage for the type of HT addressed in this article.
 

Women’s Health Initiative findings

The Women’s Health Initiative (WHI) hormone therapy trials showed that HT reduces the incidence of all osteoporosis-related fractures in postmenopausal women, even those at low risk of fracture, but osteoporosis-related fractures was not a study endpoint. These trials also revealed that HT was associated with increased risks of cardiovascular and cerebrovascular events, an increased risk of breast cancer, and other adverse health outcomes.

The release of the interim results of the WHI trials in 2002 led to a fair amount of fear and confusion about the use of HT after menopause. After the WHI findings were published, estrogen use dropped dramatically, but for everything, including for vasomotor symptoms and the prevention and treatment of osteoporosis.

Prior to the WHI study, it was very common for hormone therapy to be prescribed as women neared or entered menopause, said Risa Kagan MD, clinical professor of obstetrics, gynecology, and reproductive sciences, University of California, San Francisco.

“When a woman turned 50, that was one of the first things we did – was to put her on hormone therapy. All that changed with the WHI, but now we are coming full circle,” noted Dr. Kagan, who currently prescribes HT as first line treatment for osteoporosis to some women.
 

Hormone therapy’s complex history

HT’s ability to reduce bone loss in postmenopausal women is well-documented in many papers, including one published March 8, 2018, in Osteoporosis International, by Dr. Kagan and colleagues. This reduced bone loss has been shown to significantly reduce fractures in patients with low bone mass and osteoporosis.

While a growing number of therapies are now available to treat osteoporosis, HT was traditionally viewed as a standard method of preventing fractures in this population. It was also widely used to prevent other types of symptoms associated with the menopause, such as hot flashes, night sweats, and sleep disturbances, and multiple observational studies had demonstrated that its use appeared to reduce the incidence of cardiovascular disease (CVD) in symptomatic menopausal women who initiated HT in early menopause.

Even though the WHI studies were the largest randomized trials ever performed in postmenopausal women, they had notable limitations, according to Dr. Kagan.

“The women were older – the average age was 63 years,” she said. “And they only investigated one route and one dose of estrogen.”

Since then, many different formulations and routes of administration with more favorable safety profiles than what was used in the WHI have become available.

It’s both scientifically and clinically unsound to extrapolate the unfavorable risk-benefit profile of HT seen in the WHI trials to all women regardless of age, HT dosage or formulation, or the length of time they’re on it, she added.
 

Today’s use of HT in women with osteoporosis

Re-analyses and follow-up studies from the WHI trials, along with data from other studies, have suggested that the benefit-risk profiles of HT are affected by a variety of factors. These include the timing of use in relation to menopause and chronological age and the type of hormone regimen.

“Clinically, many advocate for [hormone therapy] use, especially in the newer younger postmenopausal women to prevent bone loss, but also in younger women who are diagnosed with osteoporosis and then as they get older transition to more bone specific agents,” noted Dr. Kagan.

“Some advocate preserving bone mass and preventing osteoporosis and even treating the younger newly postmenopausal women who have no contraindications with hormone therapy initially, and then gradually transitioning them to a bone specific agent as they get older and at risk for fracture.

“If a woman is already fractured and/or has very low bone density with no other obvious secondary metabolic reason, we also often advocate anabolic agents for 1-2 years then consider estrogen for maintenance – again, if [there is] no contraindication to using HT,” she added.

Thus, an individualized approach is recommended to determine a woman’s risk-benefit ratio of HT use based on the absolute risk of adverse effects, Dr. Kagan noted.

“Transdermal and low/ultra-low doses of HT, have a favorable risk profile, and are effective in preserving bone mineral density and bone quality in many women,” she said.

According to Dr. McClung, HT “is most often used for treatment in women in whom hormone therapy was begun for hot flashes and then, when osteoporosis was found later, was simply continued.

“Society guidelines are cautious about recommending hormone therapy for osteoporosis treatment since estrogen is not approved for treatment, despite the clear fracture protection benefit observed in the WHI study,” he said. “Since [women in the WHI trials] were not recruited as having osteoporosis, those results do not meet the FDA requirement for treatment approval, namely the reduction in fracture risk in patients with osteoporosis. However, knowing what we know about the salutary skeletal effects of estrogen, many of us do use them in our patients with osteoporosis – although not prescribed for that purpose.”
 

Additional scenarios when doctors may advise HT

“I often recommend – and I think colleagues do as well – that women with recent menopause and menopausal symptoms who also have low bone mineral density or even scores showing osteoporosis see their gynecologist to discuss HT for a few years, perhaps until age 60 if no contraindications, and if it is well tolerated,” said Ethel S. Siris, MD, professor of medicine at Columbia University Medical Center in New York.

“Once they stop it we can then give one of our other bone drugs, but it delays the need to start them since on adequate estrogen the bone density should remain stable while they take it,” added Dr. Siris, an endocrinologist and internist, and director of the Toni Stabile Osteoporosis Center in New York. “They may need a bisphosphonate or another bone drug to further protect them from bone loss and future fracture [after stopping HT].”

Victor L. Roberts, MD, founder of Endocrine Associates of Florida, Lake Mary, pointed out that women now have many options for treatment of osteoporosis.

“If a woman is in early menopause and is having other symptoms, then estrogen is warranted,” he said. “If she has osteoporosis, then it’s a bonus.”

“We have better agents that are bone specific,” for a patient who presents with osteoporosis and no other symptoms, he said.

“If a woman is intolerant of alendronate or other similar drugs, or chooses not to have an injectable, then estrogen or a SERM [selective estrogen receptor modulator] would be an option.”

Dr. Roberts added that HT would be more of a niche drug.

“It has a role and documented benefit and works,” he said. “There is good scientific data for the use of estrogen.”

Dr. Kagan is a consultant for Pfizer, Therapeutics MD, Amgen, on the Medical and Scientific Advisory Board of American Bone Health. The other  experts interviewed for this piece reported no conflicts.

Doctors’ opinions about whether to treat women with osteoporosis with hormone therapy vary. Guidelines by medical societies including those of the American College of Physicians, on the other hand, generally do not recommend it as a first line therapy for the disease, at least in part due to the risks associated with taking it.

This type of hormone therapy (HT) can be given as estrogen or a combination of hormones including estrogen. The physicians interviewed for this piece who prescribe HT for osteoporosis suggest the benefits outweigh the downsides to its use for some of their patients. But such doctors may be a minority group, suggests Michael R. McClung, MD, founding director of the Oregon Osteoporosis Center, Portland.

According to Dr. McClung, HT is now rarely prescribed as treatment – as opposed to prevention – for osteoporosis in the absence of additional benefits such as reducing vasomotor symptoms.

Researchers’ findings on HT use in women with osteoporosis are complex. While HT is approved for menopausal prevention of osteoporosis, it is not indicated as a treatment for the disease by the Food and Drug Administration. See the prescribing information for Premarin tablets, which contain a mixture of estrogen hormones, for an example of the FDA’s indications and usage for the type of HT addressed in this article.
 

Women’s Health Initiative findings

The Women’s Health Initiative (WHI) hormone therapy trials showed that HT reduces the incidence of all osteoporosis-related fractures in postmenopausal women, even those at low risk of fracture, but osteoporosis-related fractures was not a study endpoint. These trials also revealed that HT was associated with increased risks of cardiovascular and cerebrovascular events, an increased risk of breast cancer, and other adverse health outcomes.

The release of the interim results of the WHI trials in 2002 led to a fair amount of fear and confusion about the use of HT after menopause. After the WHI findings were published, estrogen use dropped dramatically, but for everything, including for vasomotor symptoms and the prevention and treatment of osteoporosis.

Prior to the WHI study, it was very common for hormone therapy to be prescribed as women neared or entered menopause, said Risa Kagan MD, clinical professor of obstetrics, gynecology, and reproductive sciences, University of California, San Francisco.

“When a woman turned 50, that was one of the first things we did – was to put her on hormone therapy. All that changed with the WHI, but now we are coming full circle,” noted Dr. Kagan, who currently prescribes HT as first line treatment for osteoporosis to some women.
 

Hormone therapy’s complex history

HT’s ability to reduce bone loss in postmenopausal women is well-documented in many papers, including one published March 8, 2018, in Osteoporosis International, by Dr. Kagan and colleagues. This reduced bone loss has been shown to significantly reduce fractures in patients with low bone mass and osteoporosis.

While a growing number of therapies are now available to treat osteoporosis, HT was traditionally viewed as a standard method of preventing fractures in this population. It was also widely used to prevent other types of symptoms associated with the menopause, such as hot flashes, night sweats, and sleep disturbances, and multiple observational studies had demonstrated that its use appeared to reduce the incidence of cardiovascular disease (CVD) in symptomatic menopausal women who initiated HT in early menopause.

Even though the WHI studies were the largest randomized trials ever performed in postmenopausal women, they had notable limitations, according to Dr. Kagan.

“The women were older – the average age was 63 years,” she said. “And they only investigated one route and one dose of estrogen.”

Since then, many different formulations and routes of administration with more favorable safety profiles than what was used in the WHI have become available.

It’s both scientifically and clinically unsound to extrapolate the unfavorable risk-benefit profile of HT seen in the WHI trials to all women regardless of age, HT dosage or formulation, or the length of time they’re on it, she added.
 

Today’s use of HT in women with osteoporosis

Re-analyses and follow-up studies from the WHI trials, along with data from other studies, have suggested that the benefit-risk profiles of HT are affected by a variety of factors. These include the timing of use in relation to menopause and chronological age and the type of hormone regimen.

“Clinically, many advocate for [hormone therapy] use, especially in the newer younger postmenopausal women to prevent bone loss, but also in younger women who are diagnosed with osteoporosis and then as they get older transition to more bone specific agents,” noted Dr. Kagan.

“Some advocate preserving bone mass and preventing osteoporosis and even treating the younger newly postmenopausal women who have no contraindications with hormone therapy initially, and then gradually transitioning them to a bone specific agent as they get older and at risk for fracture.

“If a woman is already fractured and/or has very low bone density with no other obvious secondary metabolic reason, we also often advocate anabolic agents for 1-2 years then consider estrogen for maintenance – again, if [there is] no contraindication to using HT,” she added.

Thus, an individualized approach is recommended to determine a woman’s risk-benefit ratio of HT use based on the absolute risk of adverse effects, Dr. Kagan noted.

“Transdermal and low/ultra-low doses of HT, have a favorable risk profile, and are effective in preserving bone mineral density and bone quality in many women,” she said.

According to Dr. McClung, HT “is most often used for treatment in women in whom hormone therapy was begun for hot flashes and then, when osteoporosis was found later, was simply continued.

“Society guidelines are cautious about recommending hormone therapy for osteoporosis treatment since estrogen is not approved for treatment, despite the clear fracture protection benefit observed in the WHI study,” he said. “Since [women in the WHI trials] were not recruited as having osteoporosis, those results do not meet the FDA requirement for treatment approval, namely the reduction in fracture risk in patients with osteoporosis. However, knowing what we know about the salutary skeletal effects of estrogen, many of us do use them in our patients with osteoporosis – although not prescribed for that purpose.”
 

Additional scenarios when doctors may advise HT

“I often recommend – and I think colleagues do as well – that women with recent menopause and menopausal symptoms who also have low bone mineral density or even scores showing osteoporosis see their gynecologist to discuss HT for a few years, perhaps until age 60 if no contraindications, and if it is well tolerated,” said Ethel S. Siris, MD, professor of medicine at Columbia University Medical Center in New York.

“Once they stop it we can then give one of our other bone drugs, but it delays the need to start them since on adequate estrogen the bone density should remain stable while they take it,” added Dr. Siris, an endocrinologist and internist, and director of the Toni Stabile Osteoporosis Center in New York. “They may need a bisphosphonate or another bone drug to further protect them from bone loss and future fracture [after stopping HT].”

Victor L. Roberts, MD, founder of Endocrine Associates of Florida, Lake Mary, pointed out that women now have many options for treatment of osteoporosis.

“If a woman is in early menopause and is having other symptoms, then estrogen is warranted,” he said. “If she has osteoporosis, then it’s a bonus.”

“We have better agents that are bone specific,” for a patient who presents with osteoporosis and no other symptoms, he said.

“If a woman is intolerant of alendronate or other similar drugs, or chooses not to have an injectable, then estrogen or a SERM [selective estrogen receptor modulator] would be an option.”

Dr. Roberts added that HT would be more of a niche drug.

“It has a role and documented benefit and works,” he said. “There is good scientific data for the use of estrogen.”

Dr. Kagan is a consultant for Pfizer, Therapeutics MD, Amgen, on the Medical and Scientific Advisory Board of American Bone Health. The other  experts interviewed for this piece reported no conflicts.

Doctors’ opinions about whether to treat women with osteoporosis with hormone therapy vary. Guidelines by medical societies including those of the American College of Physicians, on the other hand, generally do not recommend it as a first line therapy for the disease, at least in part due to the risks associated with taking it.

This type of hormone therapy (HT) can be given as estrogen or a combination of hormones including estrogen. The physicians interviewed for this piece who prescribe HT for osteoporosis suggest the benefits outweigh the downsides to its use for some of their patients. But such doctors may be a minority group, suggests Michael R. McClung, MD, founding director of the Oregon Osteoporosis Center, Portland.

According to Dr. McClung, HT is now rarely prescribed as treatment – as opposed to prevention – for osteoporosis in the absence of additional benefits such as reducing vasomotor symptoms.

Researchers’ findings on HT use in women with osteoporosis are complex. While HT is approved for menopausal prevention of osteoporosis, it is not indicated as a treatment for the disease by the Food and Drug Administration. See the prescribing information for Premarin tablets, which contain a mixture of estrogen hormones, for an example of the FDA’s indications and usage for the type of HT addressed in this article.
 

Women’s Health Initiative findings

The Women’s Health Initiative (WHI) hormone therapy trials showed that HT reduces the incidence of all osteoporosis-related fractures in postmenopausal women, even those at low risk of fracture, but osteoporosis-related fractures was not a study endpoint. These trials also revealed that HT was associated with increased risks of cardiovascular and cerebrovascular events, an increased risk of breast cancer, and other adverse health outcomes.

The release of the interim results of the WHI trials in 2002 led to a fair amount of fear and confusion about the use of HT after menopause. After the WHI findings were published, estrogen use dropped dramatically, but for everything, including for vasomotor symptoms and the prevention and treatment of osteoporosis.

Prior to the WHI study, it was very common for hormone therapy to be prescribed as women neared or entered menopause, said Risa Kagan MD, clinical professor of obstetrics, gynecology, and reproductive sciences, University of California, San Francisco.

“When a woman turned 50, that was one of the first things we did – was to put her on hormone therapy. All that changed with the WHI, but now we are coming full circle,” noted Dr. Kagan, who currently prescribes HT as first line treatment for osteoporosis to some women.
 

Hormone therapy’s complex history

HT’s ability to reduce bone loss in postmenopausal women is well-documented in many papers, including one published March 8, 2018, in Osteoporosis International, by Dr. Kagan and colleagues. This reduced bone loss has been shown to significantly reduce fractures in patients with low bone mass and osteoporosis.

While a growing number of therapies are now available to treat osteoporosis, HT was traditionally viewed as a standard method of preventing fractures in this population. It was also widely used to prevent other types of symptoms associated with the menopause, such as hot flashes, night sweats, and sleep disturbances, and multiple observational studies had demonstrated that its use appeared to reduce the incidence of cardiovascular disease (CVD) in symptomatic menopausal women who initiated HT in early menopause.

Even though the WHI studies were the largest randomized trials ever performed in postmenopausal women, they had notable limitations, according to Dr. Kagan.

“The women were older – the average age was 63 years,” she said. “And they only investigated one route and one dose of estrogen.”

Since then, many different formulations and routes of administration with more favorable safety profiles than what was used in the WHI have become available.

It’s both scientifically and clinically unsound to extrapolate the unfavorable risk-benefit profile of HT seen in the WHI trials to all women regardless of age, HT dosage or formulation, or the length of time they’re on it, she added.
 

Today’s use of HT in women with osteoporosis

Re-analyses and follow-up studies from the WHI trials, along with data from other studies, have suggested that the benefit-risk profiles of HT are affected by a variety of factors. These include the timing of use in relation to menopause and chronological age and the type of hormone regimen.

“Clinically, many advocate for [hormone therapy] use, especially in the newer younger postmenopausal women to prevent bone loss, but also in younger women who are diagnosed with osteoporosis and then as they get older transition to more bone specific agents,” noted Dr. Kagan.

“Some advocate preserving bone mass and preventing osteoporosis and even treating the younger newly postmenopausal women who have no contraindications with hormone therapy initially, and then gradually transitioning them to a bone specific agent as they get older and at risk for fracture.

“If a woman is already fractured and/or has very low bone density with no other obvious secondary metabolic reason, we also often advocate anabolic agents for 1-2 years then consider estrogen for maintenance – again, if [there is] no contraindication to using HT,” she added.

Thus, an individualized approach is recommended to determine a woman’s risk-benefit ratio of HT use based on the absolute risk of adverse effects, Dr. Kagan noted.

“Transdermal and low/ultra-low doses of HT, have a favorable risk profile, and are effective in preserving bone mineral density and bone quality in many women,” she said.

According to Dr. McClung, HT “is most often used for treatment in women in whom hormone therapy was begun for hot flashes and then, when osteoporosis was found later, was simply continued.

“Society guidelines are cautious about recommending hormone therapy for osteoporosis treatment since estrogen is not approved for treatment, despite the clear fracture protection benefit observed in the WHI study,” he said. “Since [women in the WHI trials] were not recruited as having osteoporosis, those results do not meet the FDA requirement for treatment approval, namely the reduction in fracture risk in patients with osteoporosis. However, knowing what we know about the salutary skeletal effects of estrogen, many of us do use them in our patients with osteoporosis – although not prescribed for that purpose.”
 

Additional scenarios when doctors may advise HT

“I often recommend – and I think colleagues do as well – that women with recent menopause and menopausal symptoms who also have low bone mineral density or even scores showing osteoporosis see their gynecologist to discuss HT for a few years, perhaps until age 60 if no contraindications, and if it is well tolerated,” said Ethel S. Siris, MD, professor of medicine at Columbia University Medical Center in New York.

“Once they stop it we can then give one of our other bone drugs, but it delays the need to start them since on adequate estrogen the bone density should remain stable while they take it,” added Dr. Siris, an endocrinologist and internist, and director of the Toni Stabile Osteoporosis Center in New York. “They may need a bisphosphonate or another bone drug to further protect them from bone loss and future fracture [after stopping HT].”

Victor L. Roberts, MD, founder of Endocrine Associates of Florida, Lake Mary, pointed out that women now have many options for treatment of osteoporosis.

“If a woman is in early menopause and is having other symptoms, then estrogen is warranted,” he said. “If she has osteoporosis, then it’s a bonus.”

“We have better agents that are bone specific,” for a patient who presents with osteoporosis and no other symptoms, he said.

“If a woman is intolerant of alendronate or other similar drugs, or chooses not to have an injectable, then estrogen or a SERM [selective estrogen receptor modulator] would be an option.”

Dr. Roberts added that HT would be more of a niche drug.

“It has a role and documented benefit and works,” he said. “There is good scientific data for the use of estrogen.”

Dr. Kagan is a consultant for Pfizer, Therapeutics MD, Amgen, on the Medical and Scientific Advisory Board of American Bone Health. The other  experts interviewed for this piece reported no conflicts.

The American College of Cardiology has issued an expert consensus clinical guidance document for the evaluation and management of adults with key cardiovascular consequences of COVID-19.

The document makes recommendations on how to evaluate and manage COVID-associated myocarditis and long COVID and gives advice on resumption of exercise following COVID-19 infection.

The clinical guidance was published online March 16 in the Journal of the American College of Cardiology.

AlexLMX/Getty Images

“The best means to diagnose and treat myocarditis and long COVID following SARS-CoV-2 infection continues to evolve,” said Ty Gluckman, MD, MHA, cochair of the expert consensus decision pathway. “This document attempts to provide key recommendations for how to evaluate and manage adults with these conditions, including guidance for safe return to play for both competitive and noncompetitive athletes.”

The authors of the guidance note that COVID-19 can be associated with various abnormalities in cardiac testing and a wide range of cardiovascular complications. For some patients, cardiac symptoms such as chest pain, shortness of breath, fatigue, and palpitations persist, lasting months after the initial illness, and evidence of myocardial injury has also been observed in both symptomatic and asymptomatic individuals, as well as after receipt of the COVID-19 mRNA vaccine. 

“For clinicians treating these individuals, a growing number of questions exist related to evaluation and management of these conditions, as well as safe resumption of physical activity,” they say. This report is intended to provide practical guidance on these issues.
 

Myocarditis

The report states that myocarditis has been recognized as a rare but serious complication of SARS-CoV-2 infection as well as COVID-19 mRNA vaccination.

It defines myocarditis as: 1.cardiac symptoms such as chest pain, dyspnea, palpitations, or syncope; 2. elevated cardiac troponin; and 3. abnormal electrocardiographic, echocardiographic, cardiac MRI, and/or histopathologic findings on biopsy.

The document makes the following recommendations in regard to COVID-related myocarditis:

When there is increased suspicion for cardiac involvement with COVID-19, initial testing should consist of an ECG, measurement of cardiac troponin, and an echocardiogram. Cardiology consultation is recommended for those with a rising cardiac troponin and/or echocardiographic abnormalities. Cardiac MRI is recommended in hemodynamically stable patients with suspected myocarditis.

Hospitalization is recommended for patients with definite myocarditis, ideally at an advanced heart failure center. Patients with fulminant myocarditis should be managed at centers with an expertise in advanced heart failure, mechanical circulatory support, and other advanced therapies.

Patients with myocarditis and COVID-19 pneumonia (with an ongoing need for supplemental oxygen) should be treated with corticosteroids. For patients with suspected pericardial involvement, treatment with NSAIDs, colchicine, and/or prednisone is reasonable. Intravenous corticosteroids may be considered in those with suspected or confirmed COVID-19 myocarditis with hemodynamic compromise or MIS-A (multisystem inflammatory syndrome in adults). Empiric use of corticosteroids may also be considered in those with biopsy evidence of severe myocardial infiltrates or fulminant myocarditis, balanced against infection risk.

As appropriate, guideline-directed medical therapy for heart failure should be initiated and continued after discharge.

The document notes that myocarditis following COVID-19 mRNA vaccination is rare, with highest rates seen in young males after the second vaccine dose. As of May 22, 2021, the U.S. Vaccine Adverse Event Reporting System noted rates of 40.6 cases per million after the second vaccine dose among male individuals aged 12-29 years and 2.4 cases per million among male individuals aged 30 and older. Corresponding rates in female individuals were 4.2 and 1 cases per million, respectively.

But the report says that COVID-19 vaccination is associated with “a very favorable benefit-to-risk ratio” for all age and sex groups evaluated thus far.

In general, vaccine-associated myocarditis should be diagnosed, categorized, and treated in a manner analogous to myocarditis following SARS-CoV-2 infection, the guidance advises.
 

Long COVID

The document refers to long COVID as postacute sequelae of SARS-CoV-2 infection (PASC), and reports that this condition is experienced by up to 10%-30% of infected individuals. It is defined by a constellation of new, returning, or persistent health problems experienced by individuals 4 or more weeks after COVID-19 infection.

Although individuals with this condition may experience wide-ranging symptoms, the symptoms that draw increased attention to the cardiovascular system include tachycardia, exercise intolerance, chest pain, and shortness of breath.

Nicole Bhave, MD, cochair of the expert consensus decision pathway, says: “There appears to be a ‘downward spiral’ for long-COVID patients. Fatigue and decreased exercise capacity lead to diminished activity and bed rest, in turn leading to worsening symptoms and decreased quality of life.” She adds that “the writing committee recommends a basic cardiopulmonary evaluation performed up front to determine if further specialty care and formalized medical therapy is needed for these patients.”

The authors propose two terms to better understand potential etiologies for those with cardiovascular symptoms:

PASC-CVD, or PASC-cardiovascular disease, refers to a broad group of cardiovascular conditions (including myocarditis) that manifest at least 4 weeks after COVID-19 infection.

PASC-CVS, or PASC-cardiovascular syndrome, includes a wide range of cardiovascular symptoms without objective evidence of cardiovascular disease following standard diagnostic testing.

The document makes the following recommendations for the management of PASC-CVD and PASC-CVS.

For patients with cardiovascular symptoms and suspected PASC, the authors suggest that a reasonable initial testing approach includes basic laboratory testing, including cardiac troponin, an ECG, an echocardiogram, an ambulatory rhythm monitor, chest imaging, and/or pulmonary function tests.

Cardiology consultation is recommended for patients with PASC who have abnormal cardiac test results, known cardiovascular disease with new or worsening symptoms, documented cardiac complications during SARS-CoV-2 infection, and/or persistent cardiopulmonary symptoms that are not otherwise explained.

Recumbent or semirecumbent exercise (for example, rowing, swimming, or cycling) is recommended initially for PASC-CVS patients with tachycardia, exercise/orthostatic intolerance, and/or deconditioning, with transition to upright exercise as orthostatic intolerance improves. Exercise duration should also be short (5-10 minutes/day) initially, with gradual increases as functional capacity improves.

Salt and fluid loading represent nonpharmacologic interventions that may provide symptomatic relief for patients with tachycardia, palpitations, and/or orthostatic hypotension.

Beta-blockers, nondihydropyridine calcium-channel blockers, ivabradine, fludrocortisone, and midodrine may be used empirically as well.
 

Return to play for athletes

The authors note that concerns about possible cardiac injury after COVID-19 fueled early apprehension regarding the safety of competitive sports for athletes recovering from the infection.

But they say that subsequent data from large registries have demonstrated an overall low prevalence of clinical myocarditis, without a rise in the rate of adverse cardiac events. Based on this, updated guidance is provided with a practical, evidence-based framework to guide resumption of athletics and intense exercise training.

They make the following recommendations:

• For athletes recovering from COVID-19 with ongoing cardiopulmonary symptoms (chest pain, shortness of breath, palpitations, lightheadedness) or those requiring hospitalization with increased suspicion for cardiac involvement, further evaluation with triad testing – an ECG, measurement of cardiac troponin, and an echocardiogram – should be performed.
• For those with abnormal test results, further evaluation with cardiac MRI should be considered. Individuals diagnosed with clinical myocarditis should abstain from exercise for 3-6 months.
• Cardiac testing is not recommended for asymptomatic individuals following COVID-19 infection. Individuals should abstain from training for 3 days to ensure that symptoms do not develop.
• For those with mild or moderate noncardiopulmonary symptoms (fever, lethargy, muscle aches), training may resume after symptom resolution.
• For those with remote infection (≥3 months) without ongoing cardiopulmonary symptoms, a gradual increase in exercise is recommended without the need for cardiac testing.

Based on the low prevalence of myocarditis observed in competitive athletes with COVID-19, the authors note that these recommendations can be reasonably applied to high-school athletes (aged 14 and older) along with adult recreational exercise enthusiasts.

Future study is needed, however, to better understand how long cardiac abnormalities persist following COVID-19 infection and the role of exercise training in long COVID.

The authors conclude that the current guidance is intended to help clinicians understand not only when testing may be warranted, but also when it is not.

“Given that it reflects the current state of knowledge through early 2022, it is anticipated that recommendations will change over time as our understanding evolves,” they say.

The 2022 ACC Expert Consensus Decision Pathway on Cardiovascular Sequelae of COVID-19: Myocarditis, Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), and Return to Play will be discussed in a session at the American College of Cardiology’s annual scientific session meeting in Washington in April.

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

The American College of Cardiology has issued an expert consensus clinical guidance document for the evaluation and management of adults with key cardiovascular consequences of COVID-19.

The document makes recommendations on how to evaluate and manage COVID-associated myocarditis and long COVID and gives advice on resumption of exercise following COVID-19 infection.

The clinical guidance was published online March 16 in the Journal of the American College of Cardiology.

AlexLMX/Getty Images

“The best means to diagnose and treat myocarditis and long COVID following SARS-CoV-2 infection continues to evolve,” said Ty Gluckman, MD, MHA, cochair of the expert consensus decision pathway. “This document attempts to provide key recommendations for how to evaluate and manage adults with these conditions, including guidance for safe return to play for both competitive and noncompetitive athletes.”

The authors of the guidance note that COVID-19 can be associated with various abnormalities in cardiac testing and a wide range of cardiovascular complications. For some patients, cardiac symptoms such as chest pain, shortness of breath, fatigue, and palpitations persist, lasting months after the initial illness, and evidence of myocardial injury has also been observed in both symptomatic and asymptomatic individuals, as well as after receipt of the COVID-19 mRNA vaccine. 

“For clinicians treating these individuals, a growing number of questions exist related to evaluation and management of these conditions, as well as safe resumption of physical activity,” they say. This report is intended to provide practical guidance on these issues.
 

Myocarditis

The report states that myocarditis has been recognized as a rare but serious complication of SARS-CoV-2 infection as well as COVID-19 mRNA vaccination.

It defines myocarditis as: 1.cardiac symptoms such as chest pain, dyspnea, palpitations, or syncope; 2. elevated cardiac troponin; and 3. abnormal electrocardiographic, echocardiographic, cardiac MRI, and/or histopathologic findings on biopsy.

The document makes the following recommendations in regard to COVID-related myocarditis:

When there is increased suspicion for cardiac involvement with COVID-19, initial testing should consist of an ECG, measurement of cardiac troponin, and an echocardiogram. Cardiology consultation is recommended for those with a rising cardiac troponin and/or echocardiographic abnormalities. Cardiac MRI is recommended in hemodynamically stable patients with suspected myocarditis.

Hospitalization is recommended for patients with definite myocarditis, ideally at an advanced heart failure center. Patients with fulminant myocarditis should be managed at centers with an expertise in advanced heart failure, mechanical circulatory support, and other advanced therapies.

Patients with myocarditis and COVID-19 pneumonia (with an ongoing need for supplemental oxygen) should be treated with corticosteroids. For patients with suspected pericardial involvement, treatment with NSAIDs, colchicine, and/or prednisone is reasonable. Intravenous corticosteroids may be considered in those with suspected or confirmed COVID-19 myocarditis with hemodynamic compromise or MIS-A (multisystem inflammatory syndrome in adults). Empiric use of corticosteroids may also be considered in those with biopsy evidence of severe myocardial infiltrates or fulminant myocarditis, balanced against infection risk.

As appropriate, guideline-directed medical therapy for heart failure should be initiated and continued after discharge.

The document notes that myocarditis following COVID-19 mRNA vaccination is rare, with highest rates seen in young males after the second vaccine dose. As of May 22, 2021, the U.S. Vaccine Adverse Event Reporting System noted rates of 40.6 cases per million after the second vaccine dose among male individuals aged 12-29 years and 2.4 cases per million among male individuals aged 30 and older. Corresponding rates in female individuals were 4.2 and 1 cases per million, respectively.

But the report says that COVID-19 vaccination is associated with “a very favorable benefit-to-risk ratio” for all age and sex groups evaluated thus far.

In general, vaccine-associated myocarditis should be diagnosed, categorized, and treated in a manner analogous to myocarditis following SARS-CoV-2 infection, the guidance advises.
 

Long COVID

The document refers to long COVID as postacute sequelae of SARS-CoV-2 infection (PASC), and reports that this condition is experienced by up to 10%-30% of infected individuals. It is defined by a constellation of new, returning, or persistent health problems experienced by individuals 4 or more weeks after COVID-19 infection.

Although individuals with this condition may experience wide-ranging symptoms, the symptoms that draw increased attention to the cardiovascular system include tachycardia, exercise intolerance, chest pain, and shortness of breath.

Nicole Bhave, MD, cochair of the expert consensus decision pathway, says: “There appears to be a ‘downward spiral’ for long-COVID patients. Fatigue and decreased exercise capacity lead to diminished activity and bed rest, in turn leading to worsening symptoms and decreased quality of life.” She adds that “the writing committee recommends a basic cardiopulmonary evaluation performed up front to determine if further specialty care and formalized medical therapy is needed for these patients.”

The authors propose two terms to better understand potential etiologies for those with cardiovascular symptoms:

PASC-CVD, or PASC-cardiovascular disease, refers to a broad group of cardiovascular conditions (including myocarditis) that manifest at least 4 weeks after COVID-19 infection.

PASC-CVS, or PASC-cardiovascular syndrome, includes a wide range of cardiovascular symptoms without objective evidence of cardiovascular disease following standard diagnostic testing.

The document makes the following recommendations for the management of PASC-CVD and PASC-CVS.

For patients with cardiovascular symptoms and suspected PASC, the authors suggest that a reasonable initial testing approach includes basic laboratory testing, including cardiac troponin, an ECG, an echocardiogram, an ambulatory rhythm monitor, chest imaging, and/or pulmonary function tests.

Cardiology consultation is recommended for patients with PASC who have abnormal cardiac test results, known cardiovascular disease with new or worsening symptoms, documented cardiac complications during SARS-CoV-2 infection, and/or persistent cardiopulmonary symptoms that are not otherwise explained.

Recumbent or semirecumbent exercise (for example, rowing, swimming, or cycling) is recommended initially for PASC-CVS patients with tachycardia, exercise/orthostatic intolerance, and/or deconditioning, with transition to upright exercise as orthostatic intolerance improves. Exercise duration should also be short (5-10 minutes/day) initially, with gradual increases as functional capacity improves.

Salt and fluid loading represent nonpharmacologic interventions that may provide symptomatic relief for patients with tachycardia, palpitations, and/or orthostatic hypotension.

Beta-blockers, nondihydropyridine calcium-channel blockers, ivabradine, fludrocortisone, and midodrine may be used empirically as well.
 

Return to play for athletes

The authors note that concerns about possible cardiac injury after COVID-19 fueled early apprehension regarding the safety of competitive sports for athletes recovering from the infection.

But they say that subsequent data from large registries have demonstrated an overall low prevalence of clinical myocarditis, without a rise in the rate of adverse cardiac events. Based on this, updated guidance is provided with a practical, evidence-based framework to guide resumption of athletics and intense exercise training.

They make the following recommendations:

• For athletes recovering from COVID-19 with ongoing cardiopulmonary symptoms (chest pain, shortness of breath, palpitations, lightheadedness) or those requiring hospitalization with increased suspicion for cardiac involvement, further evaluation with triad testing – an ECG, measurement of cardiac troponin, and an echocardiogram – should be performed.
• For those with abnormal test results, further evaluation with cardiac MRI should be considered. Individuals diagnosed with clinical myocarditis should abstain from exercise for 3-6 months.
• Cardiac testing is not recommended for asymptomatic individuals following COVID-19 infection. Individuals should abstain from training for 3 days to ensure that symptoms do not develop.
• For those with mild or moderate noncardiopulmonary symptoms (fever, lethargy, muscle aches), training may resume after symptom resolution.
• For those with remote infection (≥3 months) without ongoing cardiopulmonary symptoms, a gradual increase in exercise is recommended without the need for cardiac testing.

Based on the low prevalence of myocarditis observed in competitive athletes with COVID-19, the authors note that these recommendations can be reasonably applied to high-school athletes (aged 14 and older) along with adult recreational exercise enthusiasts.

Future study is needed, however, to better understand how long cardiac abnormalities persist following COVID-19 infection and the role of exercise training in long COVID.

The authors conclude that the current guidance is intended to help clinicians understand not only when testing may be warranted, but also when it is not.

“Given that it reflects the current state of knowledge through early 2022, it is anticipated that recommendations will change over time as our understanding evolves,” they say.

The 2022 ACC Expert Consensus Decision Pathway on Cardiovascular Sequelae of COVID-19: Myocarditis, Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), and Return to Play will be discussed in a session at the American College of Cardiology’s annual scientific session meeting in Washington in April.

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

The American College of Cardiology has issued an expert consensus clinical guidance document for the evaluation and management of adults with key cardiovascular consequences of COVID-19.

The document makes recommendations on how to evaluate and manage COVID-associated myocarditis and long COVID and gives advice on resumption of exercise following COVID-19 infection.

The clinical guidance was published online March 16 in the Journal of the American College of Cardiology.

AlexLMX/Getty Images

“The best means to diagnose and treat myocarditis and long COVID following SARS-CoV-2 infection continues to evolve,” said Ty Gluckman, MD, MHA, cochair of the expert consensus decision pathway. “This document attempts to provide key recommendations for how to evaluate and manage adults with these conditions, including guidance for safe return to play for both competitive and noncompetitive athletes.”

The authors of the guidance note that COVID-19 can be associated with various abnormalities in cardiac testing and a wide range of cardiovascular complications. For some patients, cardiac symptoms such as chest pain, shortness of breath, fatigue, and palpitations persist, lasting months after the initial illness, and evidence of myocardial injury has also been observed in both symptomatic and asymptomatic individuals, as well as after receipt of the COVID-19 mRNA vaccine. 

“For clinicians treating these individuals, a growing number of questions exist related to evaluation and management of these conditions, as well as safe resumption of physical activity,” they say. This report is intended to provide practical guidance on these issues.
 

Myocarditis

The report states that myocarditis has been recognized as a rare but serious complication of SARS-CoV-2 infection as well as COVID-19 mRNA vaccination.

It defines myocarditis as: 1.cardiac symptoms such as chest pain, dyspnea, palpitations, or syncope; 2. elevated cardiac troponin; and 3. abnormal electrocardiographic, echocardiographic, cardiac MRI, and/or histopathologic findings on biopsy.

The document makes the following recommendations in regard to COVID-related myocarditis:

When there is increased suspicion for cardiac involvement with COVID-19, initial testing should consist of an ECG, measurement of cardiac troponin, and an echocardiogram. Cardiology consultation is recommended for those with a rising cardiac troponin and/or echocardiographic abnormalities. Cardiac MRI is recommended in hemodynamically stable patients with suspected myocarditis.

Hospitalization is recommended for patients with definite myocarditis, ideally at an advanced heart failure center. Patients with fulminant myocarditis should be managed at centers with an expertise in advanced heart failure, mechanical circulatory support, and other advanced therapies.

Patients with myocarditis and COVID-19 pneumonia (with an ongoing need for supplemental oxygen) should be treated with corticosteroids. For patients with suspected pericardial involvement, treatment with NSAIDs, colchicine, and/or prednisone is reasonable. Intravenous corticosteroids may be considered in those with suspected or confirmed COVID-19 myocarditis with hemodynamic compromise or MIS-A (multisystem inflammatory syndrome in adults). Empiric use of corticosteroids may also be considered in those with biopsy evidence of severe myocardial infiltrates or fulminant myocarditis, balanced against infection risk.

As appropriate, guideline-directed medical therapy for heart failure should be initiated and continued after discharge.

The document notes that myocarditis following COVID-19 mRNA vaccination is rare, with highest rates seen in young males after the second vaccine dose. As of May 22, 2021, the U.S. Vaccine Adverse Event Reporting System noted rates of 40.6 cases per million after the second vaccine dose among male individuals aged 12-29 years and 2.4 cases per million among male individuals aged 30 and older. Corresponding rates in female individuals were 4.2 and 1 cases per million, respectively.

But the report says that COVID-19 vaccination is associated with “a very favorable benefit-to-risk ratio” for all age and sex groups evaluated thus far.

In general, vaccine-associated myocarditis should be diagnosed, categorized, and treated in a manner analogous to myocarditis following SARS-CoV-2 infection, the guidance advises.
 

Long COVID

The document refers to long COVID as postacute sequelae of SARS-CoV-2 infection (PASC), and reports that this condition is experienced by up to 10%-30% of infected individuals. It is defined by a constellation of new, returning, or persistent health problems experienced by individuals 4 or more weeks after COVID-19 infection.

Although individuals with this condition may experience wide-ranging symptoms, the symptoms that draw increased attention to the cardiovascular system include tachycardia, exercise intolerance, chest pain, and shortness of breath.

Nicole Bhave, MD, cochair of the expert consensus decision pathway, says: “There appears to be a ‘downward spiral’ for long-COVID patients. Fatigue and decreased exercise capacity lead to diminished activity and bed rest, in turn leading to worsening symptoms and decreased quality of life.” She adds that “the writing committee recommends a basic cardiopulmonary evaluation performed up front to determine if further specialty care and formalized medical therapy is needed for these patients.”

The authors propose two terms to better understand potential etiologies for those with cardiovascular symptoms:

PASC-CVD, or PASC-cardiovascular disease, refers to a broad group of cardiovascular conditions (including myocarditis) that manifest at least 4 weeks after COVID-19 infection.

PASC-CVS, or PASC-cardiovascular syndrome, includes a wide range of cardiovascular symptoms without objective evidence of cardiovascular disease following standard diagnostic testing.

The document makes the following recommendations for the management of PASC-CVD and PASC-CVS.

For patients with cardiovascular symptoms and suspected PASC, the authors suggest that a reasonable initial testing approach includes basic laboratory testing, including cardiac troponin, an ECG, an echocardiogram, an ambulatory rhythm monitor, chest imaging, and/or pulmonary function tests.

Cardiology consultation is recommended for patients with PASC who have abnormal cardiac test results, known cardiovascular disease with new or worsening symptoms, documented cardiac complications during SARS-CoV-2 infection, and/or persistent cardiopulmonary symptoms that are not otherwise explained.

Recumbent or semirecumbent exercise (for example, rowing, swimming, or cycling) is recommended initially for PASC-CVS patients with tachycardia, exercise/orthostatic intolerance, and/or deconditioning, with transition to upright exercise as orthostatic intolerance improves. Exercise duration should also be short (5-10 minutes/day) initially, with gradual increases as functional capacity improves.

Salt and fluid loading represent nonpharmacologic interventions that may provide symptomatic relief for patients with tachycardia, palpitations, and/or orthostatic hypotension.

Beta-blockers, nondihydropyridine calcium-channel blockers, ivabradine, fludrocortisone, and midodrine may be used empirically as well.
 

Return to play for athletes

The authors note that concerns about possible cardiac injury after COVID-19 fueled early apprehension regarding the safety of competitive sports for athletes recovering from the infection.

But they say that subsequent data from large registries have demonstrated an overall low prevalence of clinical myocarditis, without a rise in the rate of adverse cardiac events. Based on this, updated guidance is provided with a practical, evidence-based framework to guide resumption of athletics and intense exercise training.

They make the following recommendations:

• For athletes recovering from COVID-19 with ongoing cardiopulmonary symptoms (chest pain, shortness of breath, palpitations, lightheadedness) or those requiring hospitalization with increased suspicion for cardiac involvement, further evaluation with triad testing – an ECG, measurement of cardiac troponin, and an echocardiogram – should be performed.
• For those with abnormal test results, further evaluation with cardiac MRI should be considered. Individuals diagnosed with clinical myocarditis should abstain from exercise for 3-6 months.
• Cardiac testing is not recommended for asymptomatic individuals following COVID-19 infection. Individuals should abstain from training for 3 days to ensure that symptoms do not develop.
• For those with mild or moderate noncardiopulmonary symptoms (fever, lethargy, muscle aches), training may resume after symptom resolution.
• For those with remote infection (≥3 months) without ongoing cardiopulmonary symptoms, a gradual increase in exercise is recommended without the need for cardiac testing.

Based on the low prevalence of myocarditis observed in competitive athletes with COVID-19, the authors note that these recommendations can be reasonably applied to high-school athletes (aged 14 and older) along with adult recreational exercise enthusiasts.

Future study is needed, however, to better understand how long cardiac abnormalities persist following COVID-19 infection and the role of exercise training in long COVID.

The authors conclude that the current guidance is intended to help clinicians understand not only when testing may be warranted, but also when it is not.

“Given that it reflects the current state of knowledge through early 2022, it is anticipated that recommendations will change over time as our understanding evolves,” they say.

The 2022 ACC Expert Consensus Decision Pathway on Cardiovascular Sequelae of COVID-19: Myocarditis, Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), and Return to Play will be discussed in a session at the American College of Cardiology’s annual scientific session meeting in Washington in April.

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

The oncologist’s new best friend

We know that dogs have very sensitive noses. They can track criminals and missing persons and sniff out drugs and bombs. They can even detect cancer cells … after months of training.

And then there are ants.

Erik Karits/Pixabay

Cancer cells produce volatile organic compounds (VOCs), which can be sniffed out by dogs and other animals with sufficiently sophisticated olfactory senses. A group of French investigators decided to find out if Formica fusca is such an animal.

First, they placed breast cancer cells and healthy cells in a petri dish. The sample of cancer cells, however, included a sugary treat. “Over successive trials, the ants got quicker and quicker at finding the treat, indicating that they had learned to recognize the VOCs produced by the cancerous cells, using these as a beacon to guide their way to the sugary delight,” according to IFL Science.

When the researchers removed the treat, the ants still went straight for the cancer cells. Then they removed the healthy cells and substituted another type of breast cancer cell, with just one type getting the treat. They went for the cancer cells with the treat, “indicating that they were capable of distinguishing between the different cancer types based on the unique pattern of VOCs emitted by each one,” IFL Science explained.

It’s just another chapter in the eternal struggle between dogs and ants. Dogs need months of training to learn to detect cancer cells; ants can do it in 30 minutes. Over the course of a dog’s training, Fido eats more food than 10,000 ants combined. (Okay, we’re guessing here, but it’s got to be a pretty big number, right?)

Then there’s the warm and fuzzy factor. Just look at that picture. Who wouldn’t want a cutie like that curling up in the bed next to you?
 

Console War II: Battle of the Twitter users

Video games can be a lot of fun, provided you’re not playing something like Rock Simulator. Or Surgeon Simulator. Or Surgeon Simulator 2. Yes, those are all real games. But calling yourself a video gamer invites a certain negative connotation, and nowhere can that be better exemplified than the increasingly ridiculous console war.

Comstock/Thinkstock

For those who don’t know their video game history, back in the early 90s Nintendo and Sega were the main video game console makers. Nintendo had Mario, Sega had Sonic, and everyone had an opinion on which was best. With Sega now but a shell of its former self and Nintendo viewed as too “casual” for the true gaming connoisseur, today’s battle pits Playstation against Xbox, and fans of both consoles spend their time trying to one-up each other in increasingly silly online arguments.

That brings us nicely to a Twitter user named “Shreeveera,” who is very vocal about his love of Playstation and hatred of the Xbox. Importantly, for LOTME purposes, Shreeveera identified himself as a doctor on his profile, and in the middle of an argument, Xbox enthusiasts called his credentials into question.

At this point, most people would recognize that there are very few noteworthy console-exclusive video games in today’s world and that any argument about consoles essentially comes down to which console design you like or which company you find less distasteful, and they would step away from the Twitter argument. Shreeveera is not most people, and he decided the next logical move was to post a video of himself and an anesthetized patient about to undergo a laparoscopic cholecystectomy.

This move did prove that he was indeed a doctor, but the ethics of posting such a video with a patient in the room is a bit dubious at best. Since Shreeveera also listed the hospital he worked at, numerous Twitter users review bombed the hospital with one-star reviews. Shreeveera’s fate is unknown, but he did take down the video and removed “doctor by profession” from his profile. He also made a second video asking Twitter to stop trying to ruin his life. We’re sure that’ll go well. Twitter is known for being completely fair and reasonable.
 

Use your words to gain power

We live in the age of the emoji. The use of emojis in texts and emails is basically the new shorthand. It’s a fun and easy way to chat with people close to us, but a new study shows that it doesn’t help in a business setting. In fact, it may do a little damage.

Gordon Johnson/Pixabay

The use of images such as emojis in communication or logos can make a person seem less powerful than someone who opts for written words, according to Elinor Amit, PhD, of Tel Aviv University and associates.

Participants in their study were asked to imagine shopping with a person wearing a T-shirt. Half were then shown the logo of the Red Sox baseball team and half saw the words “Red Sox.” In another scenario, they were asked to imagine attending a retreat of a company called Lotus. Then half were shown an employee wearing a shirt with an image of lotus flower and half saw the verbal logo “Lotus.” In both scenarios, the individuals wearing shirts with images were seen as less powerful than the people who wore shirts with words on them.

Why is that? In a Eurekalert statement, Dr. Amit said that “visual messages are often interpreted as a signal for desire for social proximity.” In a world with COVID-19, that could give anyone pause.

That desire for more social proximity, in turn, equals a suggested loss of power because research shows that people who want to be around other people more are less powerful than people who don’t.

With the reduced social proximity we have these days, we may want to keep things cool and lighthearted, especially in work emails with people who we’ve never met. It may be, however, that using your words to say thank you in the multitude of emails you respond to on a regular basis is better than that thumbs-up emoji. Nobody will think less of you.
 

Should Daylight Savings Time still be a thing?

This past week, we just experienced the spring-forward portion of Daylight Savings Time, which took an hour of sleep away from us all. Some of us may still be struggling to find our footing with the time change, but at least it’s still sunny out at 7 pm. For those who don’t really see the point of changing the clocks twice a year, there are actually some good reasons to do so.

mohamed hassan/PxHere

Sen. Marco Rubio, sponsor of a bill to make the time change permanent, put it simply: “If we can get this passed, we don’t have to do this stupidity anymore.” Message received, apparently, since the measure just passed unanimously in the Senate.

It’s not clear if President Biden will approve it, though, because there’s a lot that comes into play: economic needs, seasonal depression, and safety.

“I know this is not the most important issue confronting America, but it’s one of those issues where there’s a lot of agreement,” Sen. Rubio said.

Not total agreement, though. The National Association of Convenience Stores is opposed to the bill, and Reuters noted that one witness at a recent hearing said the time change “is like living in the wrong time zone for almost eight months out of the year.”

Many people, however, seem to be leaning toward the permanent spring-forward as it gives businesses a longer window to provide entertainment in the evenings and kids are able to play outside longer after school.

Honestly, we’re leaning toward whichever one can reduce seasonal depression.

The oncologist’s new best friend

We know that dogs have very sensitive noses. They can track criminals and missing persons and sniff out drugs and bombs. They can even detect cancer cells … after months of training.

And then there are ants.

Erik Karits/Pixabay

Cancer cells produce volatile organic compounds (VOCs), which can be sniffed out by dogs and other animals with sufficiently sophisticated olfactory senses. A group of French investigators decided to find out if Formica fusca is such an animal.

First, they placed breast cancer cells and healthy cells in a petri dish. The sample of cancer cells, however, included a sugary treat. “Over successive trials, the ants got quicker and quicker at finding the treat, indicating that they had learned to recognize the VOCs produced by the cancerous cells, using these as a beacon to guide their way to the sugary delight,” according to IFL Science.

When the researchers removed the treat, the ants still went straight for the cancer cells. Then they removed the healthy cells and substituted another type of breast cancer cell, with just one type getting the treat. They went for the cancer cells with the treat, “indicating that they were capable of distinguishing between the different cancer types based on the unique pattern of VOCs emitted by each one,” IFL Science explained.

It’s just another chapter in the eternal struggle between dogs and ants. Dogs need months of training to learn to detect cancer cells; ants can do it in 30 minutes. Over the course of a dog’s training, Fido eats more food than 10,000 ants combined. (Okay, we’re guessing here, but it’s got to be a pretty big number, right?)

Then there’s the warm and fuzzy factor. Just look at that picture. Who wouldn’t want a cutie like that curling up in the bed next to you?
 

Console War II: Battle of the Twitter users

Video games can be a lot of fun, provided you’re not playing something like Rock Simulator. Or Surgeon Simulator. Or Surgeon Simulator 2. Yes, those are all real games. But calling yourself a video gamer invites a certain negative connotation, and nowhere can that be better exemplified than the increasingly ridiculous console war.

Comstock/Thinkstock

For those who don’t know their video game history, back in the early 90s Nintendo and Sega were the main video game console makers. Nintendo had Mario, Sega had Sonic, and everyone had an opinion on which was best. With Sega now but a shell of its former self and Nintendo viewed as too “casual” for the true gaming connoisseur, today’s battle pits Playstation against Xbox, and fans of both consoles spend their time trying to one-up each other in increasingly silly online arguments.

That brings us nicely to a Twitter user named “Shreeveera,” who is very vocal about his love of Playstation and hatred of the Xbox. Importantly, for LOTME purposes, Shreeveera identified himself as a doctor on his profile, and in the middle of an argument, Xbox enthusiasts called his credentials into question.

At this point, most people would recognize that there are very few noteworthy console-exclusive video games in today’s world and that any argument about consoles essentially comes down to which console design you like or which company you find less distasteful, and they would step away from the Twitter argument. Shreeveera is not most people, and he decided the next logical move was to post a video of himself and an anesthetized patient about to undergo a laparoscopic cholecystectomy.

This move did prove that he was indeed a doctor, but the ethics of posting such a video with a patient in the room is a bit dubious at best. Since Shreeveera also listed the hospital he worked at, numerous Twitter users review bombed the hospital with one-star reviews. Shreeveera’s fate is unknown, but he did take down the video and removed “doctor by profession” from his profile. He also made a second video asking Twitter to stop trying to ruin his life. We’re sure that’ll go well. Twitter is known for being completely fair and reasonable.
 

Use your words to gain power

We live in the age of the emoji. The use of emojis in texts and emails is basically the new shorthand. It’s a fun and easy way to chat with people close to us, but a new study shows that it doesn’t help in a business setting. In fact, it may do a little damage.

Gordon Johnson/Pixabay

The use of images such as emojis in communication or logos can make a person seem less powerful than someone who opts for written words, according to Elinor Amit, PhD, of Tel Aviv University and associates.

Participants in their study were asked to imagine shopping with a person wearing a T-shirt. Half were then shown the logo of the Red Sox baseball team and half saw the words “Red Sox.” In another scenario, they were asked to imagine attending a retreat of a company called Lotus. Then half were shown an employee wearing a shirt with an image of lotus flower and half saw the verbal logo “Lotus.” In both scenarios, the individuals wearing shirts with images were seen as less powerful than the people who wore shirts with words on them.

Why is that? In a Eurekalert statement, Dr. Amit said that “visual messages are often interpreted as a signal for desire for social proximity.” In a world with COVID-19, that could give anyone pause.

That desire for more social proximity, in turn, equals a suggested loss of power because research shows that people who want to be around other people more are less powerful than people who don’t.

With the reduced social proximity we have these days, we may want to keep things cool and lighthearted, especially in work emails with people who we’ve never met. It may be, however, that using your words to say thank you in the multitude of emails you respond to on a regular basis is better than that thumbs-up emoji. Nobody will think less of you.
 

Should Daylight Savings Time still be a thing?

This past week, we just experienced the spring-forward portion of Daylight Savings Time, which took an hour of sleep away from us all. Some of us may still be struggling to find our footing with the time change, but at least it’s still sunny out at 7 pm. For those who don’t really see the point of changing the clocks twice a year, there are actually some good reasons to do so.

mohamed hassan/PxHere

Sen. Marco Rubio, sponsor of a bill to make the time change permanent, put it simply: “If we can get this passed, we don’t have to do this stupidity anymore.” Message received, apparently, since the measure just passed unanimously in the Senate.

It’s not clear if President Biden will approve it, though, because there’s a lot that comes into play: economic needs, seasonal depression, and safety.

“I know this is not the most important issue confronting America, but it’s one of those issues where there’s a lot of agreement,” Sen. Rubio said.

Not total agreement, though. The National Association of Convenience Stores is opposed to the bill, and Reuters noted that one witness at a recent hearing said the time change “is like living in the wrong time zone for almost eight months out of the year.”

Many people, however, seem to be leaning toward the permanent spring-forward as it gives businesses a longer window to provide entertainment in the evenings and kids are able to play outside longer after school.

Honestly, we’re leaning toward whichever one can reduce seasonal depression.

The oncologist’s new best friend

We know that dogs have very sensitive noses. They can track criminals and missing persons and sniff out drugs and bombs. They can even detect cancer cells … after months of training.

And then there are ants.

Erik Karits/Pixabay

Cancer cells produce volatile organic compounds (VOCs), which can be sniffed out by dogs and other animals with sufficiently sophisticated olfactory senses. A group of French investigators decided to find out if Formica fusca is such an animal.

First, they placed breast cancer cells and healthy cells in a petri dish. The sample of cancer cells, however, included a sugary treat. “Over successive trials, the ants got quicker and quicker at finding the treat, indicating that they had learned to recognize the VOCs produced by the cancerous cells, using these as a beacon to guide their way to the sugary delight,” according to IFL Science.

When the researchers removed the treat, the ants still went straight for the cancer cells. Then they removed the healthy cells and substituted another type of breast cancer cell, with just one type getting the treat. They went for the cancer cells with the treat, “indicating that they were capable of distinguishing between the different cancer types based on the unique pattern of VOCs emitted by each one,” IFL Science explained.

It’s just another chapter in the eternal struggle between dogs and ants. Dogs need months of training to learn to detect cancer cells; ants can do it in 30 minutes. Over the course of a dog’s training, Fido eats more food than 10,000 ants combined. (Okay, we’re guessing here, but it’s got to be a pretty big number, right?)

Then there’s the warm and fuzzy factor. Just look at that picture. Who wouldn’t want a cutie like that curling up in the bed next to you?
 

Console War II: Battle of the Twitter users

Video games can be a lot of fun, provided you’re not playing something like Rock Simulator. Or Surgeon Simulator. Or Surgeon Simulator 2. Yes, those are all real games. But calling yourself a video gamer invites a certain negative connotation, and nowhere can that be better exemplified than the increasingly ridiculous console war.

Comstock/Thinkstock

For those who don’t know their video game history, back in the early 90s Nintendo and Sega were the main video game console makers. Nintendo had Mario, Sega had Sonic, and everyone had an opinion on which was best. With Sega now but a shell of its former self and Nintendo viewed as too “casual” for the true gaming connoisseur, today’s battle pits Playstation against Xbox, and fans of both consoles spend their time trying to one-up each other in increasingly silly online arguments.

That brings us nicely to a Twitter user named “Shreeveera,” who is very vocal about his love of Playstation and hatred of the Xbox. Importantly, for LOTME purposes, Shreeveera identified himself as a doctor on his profile, and in the middle of an argument, Xbox enthusiasts called his credentials into question.

At this point, most people would recognize that there are very few noteworthy console-exclusive video games in today’s world and that any argument about consoles essentially comes down to which console design you like or which company you find less distasteful, and they would step away from the Twitter argument. Shreeveera is not most people, and he decided the next logical move was to post a video of himself and an anesthetized patient about to undergo a laparoscopic cholecystectomy.

This move did prove that he was indeed a doctor, but the ethics of posting such a video with a patient in the room is a bit dubious at best. Since Shreeveera also listed the hospital he worked at, numerous Twitter users review bombed the hospital with one-star reviews. Shreeveera’s fate is unknown, but he did take down the video and removed “doctor by profession” from his profile. He also made a second video asking Twitter to stop trying to ruin his life. We’re sure that’ll go well. Twitter is known for being completely fair and reasonable.
 

Use your words to gain power

We live in the age of the emoji. The use of emojis in texts and emails is basically the new shorthand. It’s a fun and easy way to chat with people close to us, but a new study shows that it doesn’t help in a business setting. In fact, it may do a little damage.

Gordon Johnson/Pixabay

The use of images such as emojis in communication or logos can make a person seem less powerful than someone who opts for written words, according to Elinor Amit, PhD, of Tel Aviv University and associates.

Participants in their study were asked to imagine shopping with a person wearing a T-shirt. Half were then shown the logo of the Red Sox baseball team and half saw the words “Red Sox.” In another scenario, they were asked to imagine attending a retreat of a company called Lotus. Then half were shown an employee wearing a shirt with an image of lotus flower and half saw the verbal logo “Lotus.” In both scenarios, the individuals wearing shirts with images were seen as less powerful than the people who wore shirts with words on them.

Why is that? In a Eurekalert statement, Dr. Amit said that “visual messages are often interpreted as a signal for desire for social proximity.” In a world with COVID-19, that could give anyone pause.

That desire for more social proximity, in turn, equals a suggested loss of power because research shows that people who want to be around other people more are less powerful than people who don’t.

With the reduced social proximity we have these days, we may want to keep things cool and lighthearted, especially in work emails with people who we’ve never met. It may be, however, that using your words to say thank you in the multitude of emails you respond to on a regular basis is better than that thumbs-up emoji. Nobody will think less of you.
 

Should Daylight Savings Time still be a thing?

This past week, we just experienced the spring-forward portion of Daylight Savings Time, which took an hour of sleep away from us all. Some of us may still be struggling to find our footing with the time change, but at least it’s still sunny out at 7 pm. For those who don’t really see the point of changing the clocks twice a year, there are actually some good reasons to do so.

mohamed hassan/PxHere

Sen. Marco Rubio, sponsor of a bill to make the time change permanent, put it simply: “If we can get this passed, we don’t have to do this stupidity anymore.” Message received, apparently, since the measure just passed unanimously in the Senate.

It’s not clear if President Biden will approve it, though, because there’s a lot that comes into play: economic needs, seasonal depression, and safety.

“I know this is not the most important issue confronting America, but it’s one of those issues where there’s a lot of agreement,” Sen. Rubio said.

Not total agreement, though. The National Association of Convenience Stores is opposed to the bill, and Reuters noted that one witness at a recent hearing said the time change “is like living in the wrong time zone for almost eight months out of the year.”

Many people, however, seem to be leaning toward the permanent spring-forward as it gives businesses a longer window to provide entertainment in the evenings and kids are able to play outside longer after school.

Honestly, we’re leaning toward whichever one can reduce seasonal depression.

A year of high-intensity interval training seemed to benefit obese middle-aged adults at a high risk of heart failure, but omega-3 fatty acid supplementation didn’t have any effect on cardiac biomarkers measured in a small, single-center, prospective study.

“One year of HIIT training reduces adiposity but had no consistent effect on myocardial triglyceride content or visceral adiposity,” wrote lead author Christopher M. Hearon Jr., PhD, and colleagues in JACC: Heart Failure. “However, long-duration HIIT improves fitness and induces favorable cardiac remodeling.” Omega-3 supplementation, however, had “no independent or additive effect.” Dr. Hearon is an instructor of applied clinical research at University of Texas Southwestern Medical Center in Dallas.

Investigators there and at the Institute for Exercise and Environmental Medicine at Texas Health Presbyterian Hospital Dallas studied 80 patients aged 40-55 years classified as high risk for HF and obese, randomizing them to a year of high-intensity interval training (HIIT) with supplementation of either 1.6 g omega-3 FA or placebo daily; or to a control group split between supplementation or placebo. Fifty-six patients completed the 1-year study, with a compliance rate of 90% in the HIIT group and 92% in those assigned omega-3 FA supplementation.

Carl J. “Chip” Lavie, MD, of the John Ochsner Heart and Vascular Institute in New Orleans, commented that, although the study was “extremely well done from an excellent research group,” it was limited by its small population and relatively short follow-up. Future research should evaluate HIIT and moderate exercise on clinical events over a longer term as well as different doses of omega-3 “There is tremendous potential for omega-3 in heart failure prevention and treatment.”
 

HIIT boosts exercise capacity, more

In the study, the HIIT group showed improvement in a number of cardiac markers: around a 22% improvement in exercise capacity as measured by absolute peak and relative peak oxygen uptake (VO₂), even without significant weight loss. They improved an average of 0.43 L/min (0.32-0.53; P < .0001) and 4.46 mL/kg per minute (3.18-5.56; ^P < .0001), respectively.

The researchers attributed the increase in peak VO₂ to an increase in peak cardiac output averaging 2.15 L/min (95% confidence interval, 0.90-3.39; P = .001) and stroke volume averaging 9.46 mL (95% CI, 0.65-18.27; P = .04). A year of exercise training also resulted in changes in cardiac remodeling, including increases in left ventricle mass and LV end diastolic volume, averaging 9.4 g (95% CI, 4.36-14.44; P < .001) and 12.33 mL (95% CI, 5.61-19.05; P < .001), respectively.  

The study also found that neither intervention had any appreciable impact on body weight, body mass index, body surface area or lean mass, or markers of arterial or local carotid stiffness. The exercise group had a modest decrease in fat mass, averaging 2.63 kg (95% CI,–4.81 to –0.46; P = .02), but without any effect from omega-3 supplementation.

The study acknowledged that high-dose omega-3 supplements have been found to lower triglyceride levels in people with severe hypertriglyceridemia, and hypothesized that HIIT alone or with omega-3 supplementation would improve fitness and biomarkers in people with stage A HF. “Contrary to our hypothesis, we found that one year of n-3FA [omega-3 FA] supplementation had no detectable effect on any parameter related to cardiopulmonary fitness, cardiovascular remodeling/stiffness, visceral adiposity, or myocardial triglyceride content,” Dr. Hearon and colleagues wrote.

The study “shows that obese middle-aged patients with heart failure with preserved ejection fraction [HFpEF] can markedly improve their fitness with HIIT and, generally, fitness is one of the strongest if not the strongest predictor of prognosis and survival,” said Dr. Lavie.

“Studies are needed on exercise that improves fitness in both HF with reduced ejection fraction and HFpEF, but especially HFpEF,” he said.

The study received funding from the American Heart Association Strategically Focused Research Network. Dr. Hearon and coauthors have no relevant disclosures. Dr. Lavie is a speaker and consultant for PAI Health, the Global Organization for EPA and DHA Omega-3s and DSM Nutritional Products.
 

A year of high-intensity interval training seemed to benefit obese middle-aged adults at a high risk of heart failure, but omega-3 fatty acid supplementation didn’t have any effect on cardiac biomarkers measured in a small, single-center, prospective study.

“One year of HIIT training reduces adiposity but had no consistent effect on myocardial triglyceride content or visceral adiposity,” wrote lead author Christopher M. Hearon Jr., PhD, and colleagues in JACC: Heart Failure. “However, long-duration HIIT improves fitness and induces favorable cardiac remodeling.” Omega-3 supplementation, however, had “no independent or additive effect.” Dr. Hearon is an instructor of applied clinical research at University of Texas Southwestern Medical Center in Dallas.

Investigators there and at the Institute for Exercise and Environmental Medicine at Texas Health Presbyterian Hospital Dallas studied 80 patients aged 40-55 years classified as high risk for HF and obese, randomizing them to a year of high-intensity interval training (HIIT) with supplementation of either 1.6 g omega-3 FA or placebo daily; or to a control group split between supplementation or placebo. Fifty-six patients completed the 1-year study, with a compliance rate of 90% in the HIIT group and 92% in those assigned omega-3 FA supplementation.

Carl J. “Chip” Lavie, MD, of the John Ochsner Heart and Vascular Institute in New Orleans, commented that, although the study was “extremely well done from an excellent research group,” it was limited by its small population and relatively short follow-up. Future research should evaluate HIIT and moderate exercise on clinical events over a longer term as well as different doses of omega-3 “There is tremendous potential for omega-3 in heart failure prevention and treatment.”
 

HIIT boosts exercise capacity, more

In the study, the HIIT group showed improvement in a number of cardiac markers: around a 22% improvement in exercise capacity as measured by absolute peak and relative peak oxygen uptake (VO₂), even without significant weight loss. They improved an average of 0.43 L/min (0.32-0.53; P < .0001) and 4.46 mL/kg per minute (3.18-5.56; ^P < .0001), respectively.

The researchers attributed the increase in peak VO₂ to an increase in peak cardiac output averaging 2.15 L/min (95% confidence interval, 0.90-3.39; P = .001) and stroke volume averaging 9.46 mL (95% CI, 0.65-18.27; P = .04). A year of exercise training also resulted in changes in cardiac remodeling, including increases in left ventricle mass and LV end diastolic volume, averaging 9.4 g (95% CI, 4.36-14.44; P < .001) and 12.33 mL (95% CI, 5.61-19.05; P < .001), respectively.  

The study also found that neither intervention had any appreciable impact on body weight, body mass index, body surface area or lean mass, or markers of arterial or local carotid stiffness. The exercise group had a modest decrease in fat mass, averaging 2.63 kg (95% CI,–4.81 to –0.46; P = .02), but without any effect from omega-3 supplementation.

The study acknowledged that high-dose omega-3 supplements have been found to lower triglyceride levels in people with severe hypertriglyceridemia, and hypothesized that HIIT alone or with omega-3 supplementation would improve fitness and biomarkers in people with stage A HF. “Contrary to our hypothesis, we found that one year of n-3FA [omega-3 FA] supplementation had no detectable effect on any parameter related to cardiopulmonary fitness, cardiovascular remodeling/stiffness, visceral adiposity, or myocardial triglyceride content,” Dr. Hearon and colleagues wrote.

The study “shows that obese middle-aged patients with heart failure with preserved ejection fraction [HFpEF] can markedly improve their fitness with HIIT and, generally, fitness is one of the strongest if not the strongest predictor of prognosis and survival,” said Dr. Lavie.

“Studies are needed on exercise that improves fitness in both HF with reduced ejection fraction and HFpEF, but especially HFpEF,” he said.

The study received funding from the American Heart Association Strategically Focused Research Network. Dr. Hearon and coauthors have no relevant disclosures. Dr. Lavie is a speaker and consultant for PAI Health, the Global Organization for EPA and DHA Omega-3s and DSM Nutritional Products.
 

A year of high-intensity interval training seemed to benefit obese middle-aged adults at a high risk of heart failure, but omega-3 fatty acid supplementation didn’t have any effect on cardiac biomarkers measured in a small, single-center, prospective study.

“One year of HIIT training reduces adiposity but had no consistent effect on myocardial triglyceride content or visceral adiposity,” wrote lead author Christopher M. Hearon Jr., PhD, and colleagues in JACC: Heart Failure. “However, long-duration HIIT improves fitness and induces favorable cardiac remodeling.” Omega-3 supplementation, however, had “no independent or additive effect.” Dr. Hearon is an instructor of applied clinical research at University of Texas Southwestern Medical Center in Dallas.

Investigators there and at the Institute for Exercise and Environmental Medicine at Texas Health Presbyterian Hospital Dallas studied 80 patients aged 40-55 years classified as high risk for HF and obese, randomizing them to a year of high-intensity interval training (HIIT) with supplementation of either 1.6 g omega-3 FA or placebo daily; or to a control group split between supplementation or placebo. Fifty-six patients completed the 1-year study, with a compliance rate of 90% in the HIIT group and 92% in those assigned omega-3 FA supplementation.

Carl J. “Chip” Lavie, MD, of the John Ochsner Heart and Vascular Institute in New Orleans, commented that, although the study was “extremely well done from an excellent research group,” it was limited by its small population and relatively short follow-up. Future research should evaluate HIIT and moderate exercise on clinical events over a longer term as well as different doses of omega-3 “There is tremendous potential for omega-3 in heart failure prevention and treatment.”
 

HIIT boosts exercise capacity, more

In the study, the HIIT group showed improvement in a number of cardiac markers: around a 22% improvement in exercise capacity as measured by absolute peak and relative peak oxygen uptake (VO₂), even without significant weight loss. They improved an average of 0.43 L/min (0.32-0.53; P < .0001) and 4.46 mL/kg per minute (3.18-5.56; ^P < .0001), respectively.

The researchers attributed the increase in peak VO₂ to an increase in peak cardiac output averaging 2.15 L/min (95% confidence interval, 0.90-3.39; P = .001) and stroke volume averaging 9.46 mL (95% CI, 0.65-18.27; P = .04). A year of exercise training also resulted in changes in cardiac remodeling, including increases in left ventricle mass and LV end diastolic volume, averaging 9.4 g (95% CI, 4.36-14.44; P < .001) and 12.33 mL (95% CI, 5.61-19.05; P < .001), respectively.  

The study also found that neither intervention had any appreciable impact on body weight, body mass index, body surface area or lean mass, or markers of arterial or local carotid stiffness. The exercise group had a modest decrease in fat mass, averaging 2.63 kg (95% CI,–4.81 to –0.46; P = .02), but without any effect from omega-3 supplementation.

The study acknowledged that high-dose omega-3 supplements have been found to lower triglyceride levels in people with severe hypertriglyceridemia, and hypothesized that HIIT alone or with omega-3 supplementation would improve fitness and biomarkers in people with stage A HF. “Contrary to our hypothesis, we found that one year of n-3FA [omega-3 FA] supplementation had no detectable effect on any parameter related to cardiopulmonary fitness, cardiovascular remodeling/stiffness, visceral adiposity, or myocardial triglyceride content,” Dr. Hearon and colleagues wrote.

The study “shows that obese middle-aged patients with heart failure with preserved ejection fraction [HFpEF] can markedly improve their fitness with HIIT and, generally, fitness is one of the strongest if not the strongest predictor of prognosis and survival,” said Dr. Lavie.

“Studies are needed on exercise that improves fitness in both HF with reduced ejection fraction and HFpEF, but especially HFpEF,” he said.

The study received funding from the American Heart Association Strategically Focused Research Network. Dr. Hearon and coauthors have no relevant disclosures. Dr. Lavie is a speaker and consultant for PAI Health, the Global Organization for EPA and DHA Omega-3s and DSM Nutritional Products.
 

A survey of 323 women cardiologists who were working while they were pregnant showed that nearly 75% experienced discriminatory maternity-leave practices, some of which were likely violations of the Family and Medical Leave Act (FMLA).

More than 40% saw their salaries decreased during their year of pregnancy, 38% were required to perform extra service or call before taking maternity leave, exposing them to occupational hazards such as radiation, and 40% experienced a pregnancy complication, significantly higher than the general population and other medical specialties.

Additionally, of those who performed extra service or call, 18% were placed on bedrest before delivery, compared with 7.4% who did not perform extra service or call.

More than half of respondents reported that pregnancy negatively impacted their careers, and 42.4% said they experienced pressure to return to work and a delay in promotions, both illegal practices under the FMLA.

The survey is published in the Journal of the American College of Cardiology.

“Childbearing is difficult for women in cardiology with more than double the rate of gestational complications of the U.S. population, frequent income loss out of proportion to reduced productivity, and for nearly half, has an adverse impact on their career,” lead author Martha Gulati, MD, University of Arizona, Phoenix, said in a statement.

“While many professions struggle to create environments supportive of pregnancy and child-rearing, the prevalence of illegal behavior in cardiology is quite high and presents substantial legal risk for employers,” Dr. Gulati added.

C. Noel Bairey Merz, MD, professor of cardiology at Cedars-Sinai Smidt Heart Institute, Los Angeles, and a coauthor of the survey, told this news organization that it’s not surprising that such a situation exists, even “in this day and age.”

“I’m not surprised as a woman in cardiology myself. I was told by my training director that if I took off more than my allowed sick leave when I had my first and second children, I would have to repeat the year of training, so not surprised at all. I hear this from colleagues all the time,” Dr. Bairey Merz said.

The exchange left her feeling fearful for her career.

“Who wants to repeat a year? It pushes you back from a career standpoint, financially, everything. It also made me angry. I had a colleague who busted his leg in a motorcycle accident. He was unable to do any procedures for 16 weeks, and he didn’t have to repeat the year,” she pointed out.

The challenge that pregnancy represents is frequently cited by women as a deterrent for applying for a cardiology fellowship, Laxmi S. Mehta, MD, Ohio State University, Columbus, and colleagues wrote in an accompanying editorial.

The findings from the survey “reveal restrictive maternity leave data in a profession that has historically and currently continues to have a diversity problem,” they wrote.

“Maternity and pregnancy issues are a thing in cardiology,” Dr. Mehta said in an interview. “It’s one of the reasons why women get deterred from going into the field. It makes it challenging to choose cardiology if you perceive that the culture is negative, that it’s hard to be pregnant, or to bear children, or to take care of them post partum. It is problematic and it should not be occurring now.”

Leadership that condones such restrictive policies or even promotes them through ignorance and inaction needs to be held accountable, she added.

“We need to move forward from this negativity and make it more warm and welcoming to have families, whether you are a trainee or a practicing cardiologist, male or female. We need transparent and consistent parental leave policies and things like lactation support when a woman returns to work. That is a big issue,” Dr. Mehta said.

Having cardiovascular leaders champion the cause of adequate maternity and paternity leave are crucial to creating a newer, inclusive environment in cardiology.

As an example, Dr. Mehta recounted her own experience when she was in training 17 years ago.

“When I interviewed for a cardiology fellowship, one of the female program directors asked me if I was planning to have children, because if I did, the other fellows wouldn’t like it if they had to cover for me,” she said. “I ended up doing my fellowship where the chief of cardiology encouraged me to have children. He said: ‘Have your children during training, we will support you.’ And he did. I still had to do all of the call make-up and that stuff, but I worked in a supportive environment, and it made all the difference.”

“It’s about allyship,” she added. “You will have some people who are supportive and some who are not, but when you have the chief supporting you, you have a strong ally.”

The researchers suggest that one strategy is to temporarily replace cardiologists on maternity leave with locums, or “deepen the bench of coverage for clinical work, as is done for other absences. Given the expanding coverage of parental and family medical leaves, and awareness of these issues nationally, the need for this is likely to become less of an exception and more the rule.”

For example, nine states and Washington, D.C. now provide paid parental leave, they wrote, “and there is pending legislation in others.”

Dr. Bairey Merz and Dr. Mehta reported no relevant financial relationships.

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

A survey of 323 women cardiologists who were working while they were pregnant showed that nearly 75% experienced discriminatory maternity-leave practices, some of which were likely violations of the Family and Medical Leave Act (FMLA).

More than 40% saw their salaries decreased during their year of pregnancy, 38% were required to perform extra service or call before taking maternity leave, exposing them to occupational hazards such as radiation, and 40% experienced a pregnancy complication, significantly higher than the general population and other medical specialties.

Additionally, of those who performed extra service or call, 18% were placed on bedrest before delivery, compared with 7.4% who did not perform extra service or call.

More than half of respondents reported that pregnancy negatively impacted their careers, and 42.4% said they experienced pressure to return to work and a delay in promotions, both illegal practices under the FMLA.

The survey is published in the Journal of the American College of Cardiology.

“Childbearing is difficult for women in cardiology with more than double the rate of gestational complications of the U.S. population, frequent income loss out of proportion to reduced productivity, and for nearly half, has an adverse impact on their career,” lead author Martha Gulati, MD, University of Arizona, Phoenix, said in a statement.

“While many professions struggle to create environments supportive of pregnancy and child-rearing, the prevalence of illegal behavior in cardiology is quite high and presents substantial legal risk for employers,” Dr. Gulati added.

C. Noel Bairey Merz, MD, professor of cardiology at Cedars-Sinai Smidt Heart Institute, Los Angeles, and a coauthor of the survey, told this news organization that it’s not surprising that such a situation exists, even “in this day and age.”

“I’m not surprised as a woman in cardiology myself. I was told by my training director that if I took off more than my allowed sick leave when I had my first and second children, I would have to repeat the year of training, so not surprised at all. I hear this from colleagues all the time,” Dr. Bairey Merz said.

The exchange left her feeling fearful for her career.

“Who wants to repeat a year? It pushes you back from a career standpoint, financially, everything. It also made me angry. I had a colleague who busted his leg in a motorcycle accident. He was unable to do any procedures for 16 weeks, and he didn’t have to repeat the year,” she pointed out.

The challenge that pregnancy represents is frequently cited by women as a deterrent for applying for a cardiology fellowship, Laxmi S. Mehta, MD, Ohio State University, Columbus, and colleagues wrote in an accompanying editorial.

The findings from the survey “reveal restrictive maternity leave data in a profession that has historically and currently continues to have a diversity problem,” they wrote.

“Maternity and pregnancy issues are a thing in cardiology,” Dr. Mehta said in an interview. “It’s one of the reasons why women get deterred from going into the field. It makes it challenging to choose cardiology if you perceive that the culture is negative, that it’s hard to be pregnant, or to bear children, or to take care of them post partum. It is problematic and it should not be occurring now.”

Leadership that condones such restrictive policies or even promotes them through ignorance and inaction needs to be held accountable, she added.

“We need to move forward from this negativity and make it more warm and welcoming to have families, whether you are a trainee or a practicing cardiologist, male or female. We need transparent and consistent parental leave policies and things like lactation support when a woman returns to work. That is a big issue,” Dr. Mehta said.

Having cardiovascular leaders champion the cause of adequate maternity and paternity leave are crucial to creating a newer, inclusive environment in cardiology.

As an example, Dr. Mehta recounted her own experience when she was in training 17 years ago.

“When I interviewed for a cardiology fellowship, one of the female program directors asked me if I was planning to have children, because if I did, the other fellows wouldn’t like it if they had to cover for me,” she said. “I ended up doing my fellowship where the chief of cardiology encouraged me to have children. He said: ‘Have your children during training, we will support you.’ And he did. I still had to do all of the call make-up and that stuff, but I worked in a supportive environment, and it made all the difference.”

“It’s about allyship,” she added. “You will have some people who are supportive and some who are not, but when you have the chief supporting you, you have a strong ally.”

The researchers suggest that one strategy is to temporarily replace cardiologists on maternity leave with locums, or “deepen the bench of coverage for clinical work, as is done for other absences. Given the expanding coverage of parental and family medical leaves, and awareness of these issues nationally, the need for this is likely to become less of an exception and more the rule.”

For example, nine states and Washington, D.C. now provide paid parental leave, they wrote, “and there is pending legislation in others.”

Dr. Bairey Merz and Dr. Mehta reported no relevant financial relationships.

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

A survey of 323 women cardiologists who were working while they were pregnant showed that nearly 75% experienced discriminatory maternity-leave practices, some of which were likely violations of the Family and Medical Leave Act (FMLA).

More than 40% saw their salaries decreased during their year of pregnancy, 38% were required to perform extra service or call before taking maternity leave, exposing them to occupational hazards such as radiation, and 40% experienced a pregnancy complication, significantly higher than the general population and other medical specialties.

Additionally, of those who performed extra service or call, 18% were placed on bedrest before delivery, compared with 7.4% who did not perform extra service or call.

More than half of respondents reported that pregnancy negatively impacted their careers, and 42.4% said they experienced pressure to return to work and a delay in promotions, both illegal practices under the FMLA.

The survey is published in the Journal of the American College of Cardiology.

“Childbearing is difficult for women in cardiology with more than double the rate of gestational complications of the U.S. population, frequent income loss out of proportion to reduced productivity, and for nearly half, has an adverse impact on their career,” lead author Martha Gulati, MD, University of Arizona, Phoenix, said in a statement.

“While many professions struggle to create environments supportive of pregnancy and child-rearing, the prevalence of illegal behavior in cardiology is quite high and presents substantial legal risk for employers,” Dr. Gulati added.

C. Noel Bairey Merz, MD, professor of cardiology at Cedars-Sinai Smidt Heart Institute, Los Angeles, and a coauthor of the survey, told this news organization that it’s not surprising that such a situation exists, even “in this day and age.”

“I’m not surprised as a woman in cardiology myself. I was told by my training director that if I took off more than my allowed sick leave when I had my first and second children, I would have to repeat the year of training, so not surprised at all. I hear this from colleagues all the time,” Dr. Bairey Merz said.

The exchange left her feeling fearful for her career.

“Who wants to repeat a year? It pushes you back from a career standpoint, financially, everything. It also made me angry. I had a colleague who busted his leg in a motorcycle accident. He was unable to do any procedures for 16 weeks, and he didn’t have to repeat the year,” she pointed out.

The challenge that pregnancy represents is frequently cited by women as a deterrent for applying for a cardiology fellowship, Laxmi S. Mehta, MD, Ohio State University, Columbus, and colleagues wrote in an accompanying editorial.

The findings from the survey “reveal restrictive maternity leave data in a profession that has historically and currently continues to have a diversity problem,” they wrote.

“Maternity and pregnancy issues are a thing in cardiology,” Dr. Mehta said in an interview. “It’s one of the reasons why women get deterred from going into the field. It makes it challenging to choose cardiology if you perceive that the culture is negative, that it’s hard to be pregnant, or to bear children, or to take care of them post partum. It is problematic and it should not be occurring now.”

Leadership that condones such restrictive policies or even promotes them through ignorance and inaction needs to be held accountable, she added.

“We need to move forward from this negativity and make it more warm and welcoming to have families, whether you are a trainee or a practicing cardiologist, male or female. We need transparent and consistent parental leave policies and things like lactation support when a woman returns to work. That is a big issue,” Dr. Mehta said.

Having cardiovascular leaders champion the cause of adequate maternity and paternity leave are crucial to creating a newer, inclusive environment in cardiology.

As an example, Dr. Mehta recounted her own experience when she was in training 17 years ago.

“When I interviewed for a cardiology fellowship, one of the female program directors asked me if I was planning to have children, because if I did, the other fellows wouldn’t like it if they had to cover for me,” she said. “I ended up doing my fellowship where the chief of cardiology encouraged me to have children. He said: ‘Have your children during training, we will support you.’ And he did. I still had to do all of the call make-up and that stuff, but I worked in a supportive environment, and it made all the difference.”

“It’s about allyship,” she added. “You will have some people who are supportive and some who are not, but when you have the chief supporting you, you have a strong ally.”

The researchers suggest that one strategy is to temporarily replace cardiologists on maternity leave with locums, or “deepen the bench of coverage for clinical work, as is done for other absences. Given the expanding coverage of parental and family medical leaves, and awareness of these issues nationally, the need for this is likely to become less of an exception and more the rule.”

For example, nine states and Washington, D.C. now provide paid parental leave, they wrote, “and there is pending legislation in others.”

Dr. Bairey Merz and Dr. Mehta reported no relevant financial relationships.

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

More than half of research on homeopathic remedies is unpublished or unregistered, according to a new analysis.

Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.

The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.

The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.

The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.

“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.

Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.

According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.

Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
 

Study methods and findings

The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.

The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.

To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.

They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.

The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.

The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
 

Proceed with caution before recommending use of homeopathic remedies, says expert

Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.

The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.

“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”

Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.

Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.

“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.

At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.

“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.

Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.

“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”

The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.

More than half of research on homeopathic remedies is unpublished or unregistered, according to a new analysis.

Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.

The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.

The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.

The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.

“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.

Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.

According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.

Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
 

Study methods and findings

The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.

The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.

To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.

They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.

The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.

The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
 

Proceed with caution before recommending use of homeopathic remedies, says expert

Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.

The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.

“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”

Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.

Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.

“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.

At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.

“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.

Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.

“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”

The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.

More than half of research on homeopathic remedies is unpublished or unregistered, according to a new analysis.

Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.

The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.

The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.

The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.

“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.

Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.

According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.

Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
 

Study methods and findings

The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.

The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.

To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.

They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.

The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.

The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
 

Proceed with caution before recommending use of homeopathic remedies, says expert

Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.

The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.

“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”

Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.

Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.

“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.

At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.

“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.

Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.

“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”

The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.

Severe food insecurity was associated with metabolic syndrome and unfavorable cardiometabolic markers in Hispanic/Latino youth, researchers report.

The findings, published March 16 in Pediatrics, highlight the need to investigate interventions that address food insecurity among Hispanic/Latino youth, a segment of the U.S. population at high risk of cardiometabolic complications.

“Among Hispanic/Latino youth, no study, to our knowledge has evaluated food insecurity’s role in metabolic syndrome and metabolic syndrome–relevant cardiometabolic markers in this population,” lead author Luis E. Maldonado, PhD, of the University of North Carolina at Chapel Hill, and colleagues explained.

The researchers conducted a cross-sectional study to evaluate the associations between lower household and child food security and metabolic syndrome, as well as clinically measured cardiometabolic markers, including fasting plasma glucose, waist circumference, triglycerides, systolic and diastolic blood pressure, and high-density lipoprotein cholesterol (HDL-C).

Household food security (high, marginal, low, very low) and child food security (high, marginal, low/very low) measures were evaluated separately, and were adjusted for participant age, sex, site, parental education, and poverty-income ratio.

Data were obtained from the Hispanic Community Children’s Health Study/Study of Latino Youth, a study of offspring of adults enrolled in the Hispanic Community Health Survey/Study of Latinos.
 

Results

The study cohort included 1,325 Hispanic/Latino youth aged 8-16 years. For both household food security and child food security, youth in the lowest food security category had significantly lower HDL-C compared with youth with high food security (household food security, –3.17; 95% confidence interval, –5.65 to –0.70; child food security, –1.81; 95% CI, –3.54 to –0.09).

In addition, low/very low compared with high child food security was associated with higher triglycerides (beta, 8.68; 95% CI, 1.75-15.61), higher fasting plasma glucose (beta, 1.37; 95% CI, 0.08-2.65), and metabolic syndrome composite variable expected log counts (beta, 2.12; 95% CI, 0.02-0.45).

Furthermore, the researchers found statistically significant interactions between each of the two food security measures and receipt of any food assistance in the previous year in models of triglycerides (P for interactions: household food security, .03 and child food security, .005) and HDL-C (P for interactions: household food security, .01 and child food security, .04).

After evaluating the effect of parental place of birth, they found a statistically significant association for triglycerides only (P for interactions: household food security, .05 and child food security, .008).

“Our study is among the first to document adverse associations between household and child food security measures with a metabolic syndrome score variable and several metabolic syndrome–relevant cardiometabolic markers among US Hispanic/Latino youth,” the researchers wrote.

The researchers acknowledged that the cross-sectional nature of the study was a key limitation; thus, causality could not be inferred.

“In the future, we plan to conduct more qualitative work to better understand how Hispanic/Latino families respond to food insecurity, which may identify the factors that shape their response,” study author Sandra S. Albrecht, PhD, of Columbia University, New York, NY, said in an interview.
 

Recommendations for pediatricians

Food insecurity researcher Yankun Wang, PhD candidate at Indiana University, Bloomington, commented: “I would recommend pediatricians pay more attention to children from low-income households since they are more likely to have mental and physical health issues due to food insecurity.

“It can be very helpful if pediatricians could help families obtain SNAP benefits, enroll youth in the school breakfast and lunch programs, and promote nutrition education in schools,” Mr. Wang added.

This study was supported by grant funding from the National Heart, Lung, and Blood Institute. The authors reported no relevant disclosures.

Severe food insecurity was associated with metabolic syndrome and unfavorable cardiometabolic markers in Hispanic/Latino youth, researchers report.

The findings, published March 16 in Pediatrics, highlight the need to investigate interventions that address food insecurity among Hispanic/Latino youth, a segment of the U.S. population at high risk of cardiometabolic complications.

“Among Hispanic/Latino youth, no study, to our knowledge has evaluated food insecurity’s role in metabolic syndrome and metabolic syndrome–relevant cardiometabolic markers in this population,” lead author Luis E. Maldonado, PhD, of the University of North Carolina at Chapel Hill, and colleagues explained.

The researchers conducted a cross-sectional study to evaluate the associations between lower household and child food security and metabolic syndrome, as well as clinically measured cardiometabolic markers, including fasting plasma glucose, waist circumference, triglycerides, systolic and diastolic blood pressure, and high-density lipoprotein cholesterol (HDL-C).

Household food security (high, marginal, low, very low) and child food security (high, marginal, low/very low) measures were evaluated separately, and were adjusted for participant age, sex, site, parental education, and poverty-income ratio.

Data were obtained from the Hispanic Community Children’s Health Study/Study of Latino Youth, a study of offspring of adults enrolled in the Hispanic Community Health Survey/Study of Latinos.
 

Results

The study cohort included 1,325 Hispanic/Latino youth aged 8-16 years. For both household food security and child food security, youth in the lowest food security category had significantly lower HDL-C compared with youth with high food security (household food security, –3.17; 95% confidence interval, –5.65 to –0.70; child food security, –1.81; 95% CI, –3.54 to –0.09).

In addition, low/very low compared with high child food security was associated with higher triglycerides (beta, 8.68; 95% CI, 1.75-15.61), higher fasting plasma glucose (beta, 1.37; 95% CI, 0.08-2.65), and metabolic syndrome composite variable expected log counts (beta, 2.12; 95% CI, 0.02-0.45).

Furthermore, the researchers found statistically significant interactions between each of the two food security measures and receipt of any food assistance in the previous year in models of triglycerides (P for interactions: household food security, .03 and child food security, .005) and HDL-C (P for interactions: household food security, .01 and child food security, .04).

After evaluating the effect of parental place of birth, they found a statistically significant association for triglycerides only (P for interactions: household food security, .05 and child food security, .008).

“Our study is among the first to document adverse associations between household and child food security measures with a metabolic syndrome score variable and several metabolic syndrome–relevant cardiometabolic markers among US Hispanic/Latino youth,” the researchers wrote.

The researchers acknowledged that the cross-sectional nature of the study was a key limitation; thus, causality could not be inferred.

“In the future, we plan to conduct more qualitative work to better understand how Hispanic/Latino families respond to food insecurity, which may identify the factors that shape their response,” study author Sandra S. Albrecht, PhD, of Columbia University, New York, NY, said in an interview.
 

Recommendations for pediatricians

Food insecurity researcher Yankun Wang, PhD candidate at Indiana University, Bloomington, commented: “I would recommend pediatricians pay more attention to children from low-income households since they are more likely to have mental and physical health issues due to food insecurity.

“It can be very helpful if pediatricians could help families obtain SNAP benefits, enroll youth in the school breakfast and lunch programs, and promote nutrition education in schools,” Mr. Wang added.

This study was supported by grant funding from the National Heart, Lung, and Blood Institute. The authors reported no relevant disclosures.

Severe food insecurity was associated with metabolic syndrome and unfavorable cardiometabolic markers in Hispanic/Latino youth, researchers report.

The findings, published March 16 in Pediatrics, highlight the need to investigate interventions that address food insecurity among Hispanic/Latino youth, a segment of the U.S. population at high risk of cardiometabolic complications.

“Among Hispanic/Latino youth, no study, to our knowledge has evaluated food insecurity’s role in metabolic syndrome and metabolic syndrome–relevant cardiometabolic markers in this population,” lead author Luis E. Maldonado, PhD, of the University of North Carolina at Chapel Hill, and colleagues explained.

The researchers conducted a cross-sectional study to evaluate the associations between lower household and child food security and metabolic syndrome, as well as clinically measured cardiometabolic markers, including fasting plasma glucose, waist circumference, triglycerides, systolic and diastolic blood pressure, and high-density lipoprotein cholesterol (HDL-C).

Household food security (high, marginal, low, very low) and child food security (high, marginal, low/very low) measures were evaluated separately, and were adjusted for participant age, sex, site, parental education, and poverty-income ratio.

Data were obtained from the Hispanic Community Children’s Health Study/Study of Latino Youth, a study of offspring of adults enrolled in the Hispanic Community Health Survey/Study of Latinos.
 

Results

The study cohort included 1,325 Hispanic/Latino youth aged 8-16 years. For both household food security and child food security, youth in the lowest food security category had significantly lower HDL-C compared with youth with high food security (household food security, –3.17; 95% confidence interval, –5.65 to –0.70; child food security, –1.81; 95% CI, –3.54 to –0.09).

In addition, low/very low compared with high child food security was associated with higher triglycerides (beta, 8.68; 95% CI, 1.75-15.61), higher fasting plasma glucose (beta, 1.37; 95% CI, 0.08-2.65), and metabolic syndrome composite variable expected log counts (beta, 2.12; 95% CI, 0.02-0.45).

Furthermore, the researchers found statistically significant interactions between each of the two food security measures and receipt of any food assistance in the previous year in models of triglycerides (P for interactions: household food security, .03 and child food security, .005) and HDL-C (P for interactions: household food security, .01 and child food security, .04).

After evaluating the effect of parental place of birth, they found a statistically significant association for triglycerides only (P for interactions: household food security, .05 and child food security, .008).

“Our study is among the first to document adverse associations between household and child food security measures with a metabolic syndrome score variable and several metabolic syndrome–relevant cardiometabolic markers among US Hispanic/Latino youth,” the researchers wrote.

The researchers acknowledged that the cross-sectional nature of the study was a key limitation; thus, causality could not be inferred.

“In the future, we plan to conduct more qualitative work to better understand how Hispanic/Latino families respond to food insecurity, which may identify the factors that shape their response,” study author Sandra S. Albrecht, PhD, of Columbia University, New York, NY, said in an interview.
 

Recommendations for pediatricians

Food insecurity researcher Yankun Wang, PhD candidate at Indiana University, Bloomington, commented: “I would recommend pediatricians pay more attention to children from low-income households since they are more likely to have mental and physical health issues due to food insecurity.

“It can be very helpful if pediatricians could help families obtain SNAP benefits, enroll youth in the school breakfast and lunch programs, and promote nutrition education in schools,” Mr. Wang added.

This study was supported by grant funding from the National Heart, Lung, and Blood Institute. The authors reported no relevant disclosures.

The American Academy of Neurology (AAN) has released new expert guidance on palliative care for patients with stroke, dementia, Parkinson’s disease, and other neurologic disorders.

Palliative care includes much more than hospice services, lead author of the new position statement Lynne P. Taylor, MD, University of Washington, Seattle, and a fellow of the AAN, said in a press release.

“Neurologists provide palliative care to people living with life-altering neurologic illnesses not just at the end of life but throughout the course of a disease, improving their lives with symptom control,” Dr. Taylor added.

The position paper, developed by a joint committee of the AAN, American Neurological Association, and Child Neurology Society, was published online March 8 in Neurology.
 

Guidance across the lifespan

The new paper, an update of previous position statements, includes palliative care guidance for different neurologic disorders across the lifespan. For example, neuropalliative care for neonates deserves “extra consideration,” because one-third of pediatric deaths occur during the neonatal period, most often in the neonatal intensive care unit, and after withdrawal of life-sustaining interventions, the authors note.

For older children, neuropalliative care consultation benefits families trying to maximize the quality of the remainder of their child’s life. Decisionmaking must consider the child’s cognitive abilities, the diagnosis, the perceived level of suffering, parental values, and the family’s understanding of the prognosis, the authors note.

They note that discussions about prognosis are often difficult but critical. Previous research “supports that patients desire prognostic information even when prognosis is uncertain and appreciate when their physicians disclose the presence of that uncertainty,” the authors note.

Also important is engaging in shared decisionmaking with patients and families. “This approach requires the physician to elicit a patient’s goals, make recommendations based on whether medical treatments are likely to achieve those goals, and work with patients and families to finalize a treatment plan,” according to the new guidance.
 

Ethical considerations

When treatments are physiologically futile, clinicians need to explain why interventions that may cause harm and have no benefit are not offered.

The authors cite cardiopulmonary resuscitation in the setting of cardiac arrest from irreversible herniation as an example of futility in the context of neurologic disease.

When life-prolonging care is no longer an option, clinicians have an obligation to shift the focus of care to preserving quality of life and comfort as much as possible, they add.

Hospices, which provide comfort-focused medical care as well as psychosocial and spiritual support, are reserved for patients believed to be in the last 6 months of their life if their disease follows the expected course.

The investigators also broached ethical considerations for individual neurologic conditions. Concerns for disorders of consciousness include misdiagnosis or inaccurate prognostication, and serial examinations are needed to re-evaluate levels of cognition, psychological state, decisionmaking capacity, and disease trajectory.

In patients with locked-in syndrome, a state of irreversible paralysis, often with respiratory and vocal paralysis, consciousness may range from a chronic minimally conscious state to intact cognition.

Without careful examination, patients with preserved consciousness may be mistaken as having a disorder of consciousness and risk their decisional capacity being ignored, the researchers note.

These patients may need assistance from speech pathologists to identify techniques to enhance communication, such as careful “yes/no” questioning, communication boards, or advanced eye-gaze technology, they add.
 

Stroke, dementia, Parkinson’s guidance

For stroke, the guidance suggests neurologists encourage patients with retained decisionmaking capacity to complete advance care planning given the risk of recurrent stroke and loss of capacity in the future.

For dementia, a proper and timely diagnosis can help patients and their families prepare for the consequences of cognitive dysfunction and loss of autonomy while respecting their identified values, the authors write.

They note that for Parkinson’s disease, which is marked by slow functional and cognitive decline, neurologists must aim to anticipate and treat symptoms, address psychosocial and spiritual distress and caregiver burden, and engage patients and families in advance care planning before onset of cognitive impairment.

For patients with amyotrophic lateral sclerosis (ALS) and related disorders, clinicians should aim to document goals and treatment preferences prior to extreme weakness and aphonia.

It is also important to anticipate patient preferences for future disability-specific decisions, such as those related to feeding tubes and mechanical ventilation, and to identify the patient’s minimal acceptable outcome from these life-sustaining interventions.

On the topic of withdrawal of treatment, the paper notes that competent patients have the right to refuse life-prolonging therapies, including artificial nutrition, hydration, mechanical ventilation, and antibiotics. If physicians have a moral objection to removing life-support systems, they are obligated to transfer the care of the patient to another physician, the authors add.

Once a decision is made to forgo life-sustaining treatment, physicians should minimize subsequent suffering. The investigators note most symptoms at the end of life can be managed without sedation.

In broaching the “gap” in neurology training programs, the statement referred to a survey of 49 neurology residency programs. Results showed that 42% of respondents reported being dissatisfied with their palliative care education.
 

Well-timed update

Kate T. Brizzi, MD, a Boston neurologist with experience in hospice and palliative care, said the updated position statement is “well-timed” as neuropalliative care has evolved dramatically over the last decade.

“In the last several years, I’ve witnessed a significant increase in trainee interest in the field, and there is growing recognition of how a palliative care approach can improve patient care and hopefully outcomes,” said Dr. Brizzi.

She praised the authors for doing “an excellent job” in highlighting the ethical challenges facing the neurology provider, particularly as it relates to prognostication in an uncertain setting.

Dr. Brizzi noted communication tools that help facilitate discussions around shared decisionmaking “have enhanced our ability to meet the palliative care needs of our patients and can be incorporated by any provider.”

However, she added that the paper only briefly comments on the role of the neurologist in “lawful physician-hastened death.”

“I anticipate that this will be an area of further discussion in the neurology and palliative care community in the future, as requests for hastened death are frequently encountered from patients with serious neurologic illness,” she said.

Dr. Brizzi also noted the importance of understanding the reasons behind the request – and addressing patient worries related to end-of-life care, which can frequently help alleviate distress.

There was no targeted funding for this paper. Coauthor Salvador Cruz-Flores, MD, department of neurology, Texas Tech University Center, El Paso, reported participation on member adjudication committees for clinical trials for Novo Nordisk, Sunovion, and Galapagos. The remaining authors have disclosed no relevant financial relationships.

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

The American Academy of Neurology (AAN) has released new expert guidance on palliative care for patients with stroke, dementia, Parkinson’s disease, and other neurologic disorders.

Palliative care includes much more than hospice services, lead author of the new position statement Lynne P. Taylor, MD, University of Washington, Seattle, and a fellow of the AAN, said in a press release.

“Neurologists provide palliative care to people living with life-altering neurologic illnesses not just at the end of life but throughout the course of a disease, improving their lives with symptom control,” Dr. Taylor added.

The position paper, developed by a joint committee of the AAN, American Neurological Association, and Child Neurology Society, was published online March 8 in Neurology.
 

Guidance across the lifespan

The new paper, an update of previous position statements, includes palliative care guidance for different neurologic disorders across the lifespan. For example, neuropalliative care for neonates deserves “extra consideration,” because one-third of pediatric deaths occur during the neonatal period, most often in the neonatal intensive care unit, and after withdrawal of life-sustaining interventions, the authors note.

For older children, neuropalliative care consultation benefits families trying to maximize the quality of the remainder of their child’s life. Decisionmaking must consider the child’s cognitive abilities, the diagnosis, the perceived level of suffering, parental values, and the family’s understanding of the prognosis, the authors note.

They note that discussions about prognosis are often difficult but critical. Previous research “supports that patients desire prognostic information even when prognosis is uncertain and appreciate when their physicians disclose the presence of that uncertainty,” the authors note.

Also important is engaging in shared decisionmaking with patients and families. “This approach requires the physician to elicit a patient’s goals, make recommendations based on whether medical treatments are likely to achieve those goals, and work with patients and families to finalize a treatment plan,” according to the new guidance.
 

Ethical considerations

When treatments are physiologically futile, clinicians need to explain why interventions that may cause harm and have no benefit are not offered.

The authors cite cardiopulmonary resuscitation in the setting of cardiac arrest from irreversible herniation as an example of futility in the context of neurologic disease.

When life-prolonging care is no longer an option, clinicians have an obligation to shift the focus of care to preserving quality of life and comfort as much as possible, they add.

Hospices, which provide comfort-focused medical care as well as psychosocial and spiritual support, are reserved for patients believed to be in the last 6 months of their life if their disease follows the expected course.

The investigators also broached ethical considerations for individual neurologic conditions. Concerns for disorders of consciousness include misdiagnosis or inaccurate prognostication, and serial examinations are needed to re-evaluate levels of cognition, psychological state, decisionmaking capacity, and disease trajectory.

In patients with locked-in syndrome, a state of irreversible paralysis, often with respiratory and vocal paralysis, consciousness may range from a chronic minimally conscious state to intact cognition.

Without careful examination, patients with preserved consciousness may be mistaken as having a disorder of consciousness and risk their decisional capacity being ignored, the researchers note.

These patients may need assistance from speech pathologists to identify techniques to enhance communication, such as careful “yes/no” questioning, communication boards, or advanced eye-gaze technology, they add.
 

Stroke, dementia, Parkinson’s guidance

For stroke, the guidance suggests neurologists encourage patients with retained decisionmaking capacity to complete advance care planning given the risk of recurrent stroke and loss of capacity in the future.

For dementia, a proper and timely diagnosis can help patients and their families prepare for the consequences of cognitive dysfunction and loss of autonomy while respecting their identified values, the authors write.

They note that for Parkinson’s disease, which is marked by slow functional and cognitive decline, neurologists must aim to anticipate and treat symptoms, address psychosocial and spiritual distress and caregiver burden, and engage patients and families in advance care planning before onset of cognitive impairment.

For patients with amyotrophic lateral sclerosis (ALS) and related disorders, clinicians should aim to document goals and treatment preferences prior to extreme weakness and aphonia.

It is also important to anticipate patient preferences for future disability-specific decisions, such as those related to feeding tubes and mechanical ventilation, and to identify the patient’s minimal acceptable outcome from these life-sustaining interventions.

On the topic of withdrawal of treatment, the paper notes that competent patients have the right to refuse life-prolonging therapies, including artificial nutrition, hydration, mechanical ventilation, and antibiotics. If physicians have a moral objection to removing life-support systems, they are obligated to transfer the care of the patient to another physician, the authors add.

Once a decision is made to forgo life-sustaining treatment, physicians should minimize subsequent suffering. The investigators note most symptoms at the end of life can be managed without sedation.

In broaching the “gap” in neurology training programs, the statement referred to a survey of 49 neurology residency programs. Results showed that 42% of respondents reported being dissatisfied with their palliative care education.
 

Well-timed update

Kate T. Brizzi, MD, a Boston neurologist with experience in hospice and palliative care, said the updated position statement is “well-timed” as neuropalliative care has evolved dramatically over the last decade.

“In the last several years, I’ve witnessed a significant increase in trainee interest in the field, and there is growing recognition of how a palliative care approach can improve patient care and hopefully outcomes,” said Dr. Brizzi.

She praised the authors for doing “an excellent job” in highlighting the ethical challenges facing the neurology provider, particularly as it relates to prognostication in an uncertain setting.

Dr. Brizzi noted communication tools that help facilitate discussions around shared decisionmaking “have enhanced our ability to meet the palliative care needs of our patients and can be incorporated by any provider.”

However, she added that the paper only briefly comments on the role of the neurologist in “lawful physician-hastened death.”

“I anticipate that this will be an area of further discussion in the neurology and palliative care community in the future, as requests for hastened death are frequently encountered from patients with serious neurologic illness,” she said.

Dr. Brizzi also noted the importance of understanding the reasons behind the request – and addressing patient worries related to end-of-life care, which can frequently help alleviate distress.

There was no targeted funding for this paper. Coauthor Salvador Cruz-Flores, MD, department of neurology, Texas Tech University Center, El Paso, reported participation on member adjudication committees for clinical trials for Novo Nordisk, Sunovion, and Galapagos. The remaining authors have disclosed no relevant financial relationships.

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

The American Academy of Neurology (AAN) has released new expert guidance on palliative care for patients with stroke, dementia, Parkinson’s disease, and other neurologic disorders.

Palliative care includes much more than hospice services, lead author of the new position statement Lynne P. Taylor, MD, University of Washington, Seattle, and a fellow of the AAN, said in a press release.

“Neurologists provide palliative care to people living with life-altering neurologic illnesses not just at the end of life but throughout the course of a disease, improving their lives with symptom control,” Dr. Taylor added.

The position paper, developed by a joint committee of the AAN, American Neurological Association, and Child Neurology Society, was published online March 8 in Neurology.
 

Guidance across the lifespan

The new paper, an update of previous position statements, includes palliative care guidance for different neurologic disorders across the lifespan. For example, neuropalliative care for neonates deserves “extra consideration,” because one-third of pediatric deaths occur during the neonatal period, most often in the neonatal intensive care unit, and after withdrawal of life-sustaining interventions, the authors note.

For older children, neuropalliative care consultation benefits families trying to maximize the quality of the remainder of their child’s life. Decisionmaking must consider the child’s cognitive abilities, the diagnosis, the perceived level of suffering, parental values, and the family’s understanding of the prognosis, the authors note.

They note that discussions about prognosis are often difficult but critical. Previous research “supports that patients desire prognostic information even when prognosis is uncertain and appreciate when their physicians disclose the presence of that uncertainty,” the authors note.

Also important is engaging in shared decisionmaking with patients and families. “This approach requires the physician to elicit a patient’s goals, make recommendations based on whether medical treatments are likely to achieve those goals, and work with patients and families to finalize a treatment plan,” according to the new guidance.
 

Ethical considerations

When treatments are physiologically futile, clinicians need to explain why interventions that may cause harm and have no benefit are not offered.

The authors cite cardiopulmonary resuscitation in the setting of cardiac arrest from irreversible herniation as an example of futility in the context of neurologic disease.

When life-prolonging care is no longer an option, clinicians have an obligation to shift the focus of care to preserving quality of life and comfort as much as possible, they add.

Hospices, which provide comfort-focused medical care as well as psychosocial and spiritual support, are reserved for patients believed to be in the last 6 months of their life if their disease follows the expected course.

The investigators also broached ethical considerations for individual neurologic conditions. Concerns for disorders of consciousness include misdiagnosis or inaccurate prognostication, and serial examinations are needed to re-evaluate levels of cognition, psychological state, decisionmaking capacity, and disease trajectory.

In patients with locked-in syndrome, a state of irreversible paralysis, often with respiratory and vocal paralysis, consciousness may range from a chronic minimally conscious state to intact cognition.

Without careful examination, patients with preserved consciousness may be mistaken as having a disorder of consciousness and risk their decisional capacity being ignored, the researchers note.

These patients may need assistance from speech pathologists to identify techniques to enhance communication, such as careful “yes/no” questioning, communication boards, or advanced eye-gaze technology, they add.
 

Stroke, dementia, Parkinson’s guidance

For stroke, the guidance suggests neurologists encourage patients with retained decisionmaking capacity to complete advance care planning given the risk of recurrent stroke and loss of capacity in the future.

For dementia, a proper and timely diagnosis can help patients and their families prepare for the consequences of cognitive dysfunction and loss of autonomy while respecting their identified values, the authors write.

They note that for Parkinson’s disease, which is marked by slow functional and cognitive decline, neurologists must aim to anticipate and treat symptoms, address psychosocial and spiritual distress and caregiver burden, and engage patients and families in advance care planning before onset of cognitive impairment.

For patients with amyotrophic lateral sclerosis (ALS) and related disorders, clinicians should aim to document goals and treatment preferences prior to extreme weakness and aphonia.

It is also important to anticipate patient preferences for future disability-specific decisions, such as those related to feeding tubes and mechanical ventilation, and to identify the patient’s minimal acceptable outcome from these life-sustaining interventions.

On the topic of withdrawal of treatment, the paper notes that competent patients have the right to refuse life-prolonging therapies, including artificial nutrition, hydration, mechanical ventilation, and antibiotics. If physicians have a moral objection to removing life-support systems, they are obligated to transfer the care of the patient to another physician, the authors add.

Once a decision is made to forgo life-sustaining treatment, physicians should minimize subsequent suffering. The investigators note most symptoms at the end of life can be managed without sedation.

In broaching the “gap” in neurology training programs, the statement referred to a survey of 49 neurology residency programs. Results showed that 42% of respondents reported being dissatisfied with their palliative care education.
 

Well-timed update

Kate T. Brizzi, MD, a Boston neurologist with experience in hospice and palliative care, said the updated position statement is “well-timed” as neuropalliative care has evolved dramatically over the last decade.

“In the last several years, I’ve witnessed a significant increase in trainee interest in the field, and there is growing recognition of how a palliative care approach can improve patient care and hopefully outcomes,” said Dr. Brizzi.

She praised the authors for doing “an excellent job” in highlighting the ethical challenges facing the neurology provider, particularly as it relates to prognostication in an uncertain setting.

Dr. Brizzi noted communication tools that help facilitate discussions around shared decisionmaking “have enhanced our ability to meet the palliative care needs of our patients and can be incorporated by any provider.”

However, she added that the paper only briefly comments on the role of the neurologist in “lawful physician-hastened death.”

“I anticipate that this will be an area of further discussion in the neurology and palliative care community in the future, as requests for hastened death are frequently encountered from patients with serious neurologic illness,” she said.

Dr. Brizzi also noted the importance of understanding the reasons behind the request – and addressing patient worries related to end-of-life care, which can frequently help alleviate distress.

There was no targeted funding for this paper. Coauthor Salvador Cruz-Flores, MD, department of neurology, Texas Tech University Center, El Paso, reported participation on member adjudication committees for clinical trials for Novo Nordisk, Sunovion, and Galapagos. The remaining authors have disclosed no relevant financial relationships.

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

My previous column on practice valuation prompted a number of questions on the mechanics of selling a private practice. As usual, I cannot hope to cover this complex topic comprehensively in only 750 words, but here are the basics.

A generation ago, the sale of a medical practice was much like the sale of any other business: A retiring physician would sell his or her practice to a young doctor and the practice would continue on as before. Occasionally, that still happens, but changes in the business of medicine – most significantly the growth of managed care – have had a big impact on the way medical practices are bought and sold.

For one thing, there are far fewer solo practitioners these days, and polls indicate that most young physicians intend to continue that trend. The buyer of a medical practice today is more likely to be an institution, such as a hospital, an HMO, or a large practice group, rather than an individual.

For another, because the rules governing such sales have become so numbingly complex, the services of expert (and expensive) third parties are essential.

While these issues may complicate matters, there is still a market for the sale of medical practices. However, you must do everything possible to ensure you identify the best possible buyer and structure the best deal.

The first hurdle is the accurate valuation of your practice, which was covered in some detail in my last column. Briefly, for the protection of both parties, it is important that the appraisal be done by an experienced and neutral financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation be supplied to support the conclusions reached.

Keep in mind that the valuation will not necessarily equal the purchase price; other factors may need to be considered before a final price can be agreed upon. Keep in mind, too, that there may be legal constraints on the purchase price. For example, if the buyer is a nonprofit corporation such as a hospital or HMO, by law it cannot pay in excess of fair market value for the practice – which may rule out any valuation of “good will.” In some states, the purchase of private practices by hospitals is prohibited altogether – so you might need to consider a long-term lease rather than a sale.

Once a value has been agreed upon, you must consider how the transaction will be structured. The most popular structures include purchase of assets, purchase of corporate stock, and merger.

Many buyers prefer to purchase assets, because it allows them to pick and choose only those items that have value to them. This can leave you with a bunch of “odd lot” assets to dispose of. But depending on the circumstances, an asset sale may still be to your advantage.

Sellers typically prefer to sell stock, because it allows them to sell their entire practice, which is often worth more than the sum of its parts, and often provides tax advantages.

The third option, merger, continues to grow in popularity and is a column subject in itself, and I will address it separately next month.

Tax issues must always be considered. Most private practices are corporations, and the sale of corporate stock will result in a long-term capital gain that will be taxed – currently at 15%-20%. As the saying goes, it’s not what you earn, it’s what you keep. So it may benefit you to accept a slightly lower price if the sale can be structured to provide significantly lower tax treatment. However, any gain that does not qualify as a long-term capital gain will be taxed as regular income – currently in the 32%-37% percent range – plus a Social Security tax of about 15%.

Payment in installments is a popular way to defer taxes, since they are incurred on each installment as it is paid; but such payments may be mistaken by the IRS for payments for referrals, which is illegal. And there is always the problem of making certain all payments are eventually made.

You may wish to continue working at the practice as an employee for an agreed-upon period of time, and this is often to the buyer’s advantage as well. Transitioning to new ownership in stages often maximizes the value of the business by improving patient retention, and allows patients to become accustomed to the transition. However, care must be taken, with the aid of good legal advice, to structure such an arrangement in a way that minimizes concerns of fraud and abuse.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

My previous column on practice valuation prompted a number of questions on the mechanics of selling a private practice. As usual, I cannot hope to cover this complex topic comprehensively in only 750 words, but here are the basics.

A generation ago, the sale of a medical practice was much like the sale of any other business: A retiring physician would sell his or her practice to a young doctor and the practice would continue on as before. Occasionally, that still happens, but changes in the business of medicine – most significantly the growth of managed care – have had a big impact on the way medical practices are bought and sold.

For one thing, there are far fewer solo practitioners these days, and polls indicate that most young physicians intend to continue that trend. The buyer of a medical practice today is more likely to be an institution, such as a hospital, an HMO, or a large practice group, rather than an individual.

For another, because the rules governing such sales have become so numbingly complex, the services of expert (and expensive) third parties are essential.

While these issues may complicate matters, there is still a market for the sale of medical practices. However, you must do everything possible to ensure you identify the best possible buyer and structure the best deal.

The first hurdle is the accurate valuation of your practice, which was covered in some detail in my last column. Briefly, for the protection of both parties, it is important that the appraisal be done by an experienced and neutral financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation be supplied to support the conclusions reached.

Keep in mind that the valuation will not necessarily equal the purchase price; other factors may need to be considered before a final price can be agreed upon. Keep in mind, too, that there may be legal constraints on the purchase price. For example, if the buyer is a nonprofit corporation such as a hospital or HMO, by law it cannot pay in excess of fair market value for the practice – which may rule out any valuation of “good will.” In some states, the purchase of private practices by hospitals is prohibited altogether – so you might need to consider a long-term lease rather than a sale.

Once a value has been agreed upon, you must consider how the transaction will be structured. The most popular structures include purchase of assets, purchase of corporate stock, and merger.

Many buyers prefer to purchase assets, because it allows them to pick and choose only those items that have value to them. This can leave you with a bunch of “odd lot” assets to dispose of. But depending on the circumstances, an asset sale may still be to your advantage.

Sellers typically prefer to sell stock, because it allows them to sell their entire practice, which is often worth more than the sum of its parts, and often provides tax advantages.

The third option, merger, continues to grow in popularity and is a column subject in itself, and I will address it separately next month.

Tax issues must always be considered. Most private practices are corporations, and the sale of corporate stock will result in a long-term capital gain that will be taxed – currently at 15%-20%. As the saying goes, it’s not what you earn, it’s what you keep. So it may benefit you to accept a slightly lower price if the sale can be structured to provide significantly lower tax treatment. However, any gain that does not qualify as a long-term capital gain will be taxed as regular income – currently in the 32%-37% percent range – plus a Social Security tax of about 15%.

Payment in installments is a popular way to defer taxes, since they are incurred on each installment as it is paid; but such payments may be mistaken by the IRS for payments for referrals, which is illegal. And there is always the problem of making certain all payments are eventually made.

You may wish to continue working at the practice as an employee for an agreed-upon period of time, and this is often to the buyer’s advantage as well. Transitioning to new ownership in stages often maximizes the value of the business by improving patient retention, and allows patients to become accustomed to the transition. However, care must be taken, with the aid of good legal advice, to structure such an arrangement in a way that minimizes concerns of fraud and abuse.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

My previous column on practice valuation prompted a number of questions on the mechanics of selling a private practice. As usual, I cannot hope to cover this complex topic comprehensively in only 750 words, but here are the basics.

A generation ago, the sale of a medical practice was much like the sale of any other business: A retiring physician would sell his or her practice to a young doctor and the practice would continue on as before. Occasionally, that still happens, but changes in the business of medicine – most significantly the growth of managed care – have had a big impact on the way medical practices are bought and sold.

For one thing, there are far fewer solo practitioners these days, and polls indicate that most young physicians intend to continue that trend. The buyer of a medical practice today is more likely to be an institution, such as a hospital, an HMO, or a large practice group, rather than an individual.

For another, because the rules governing such sales have become so numbingly complex, the services of expert (and expensive) third parties are essential.

While these issues may complicate matters, there is still a market for the sale of medical practices. However, you must do everything possible to ensure you identify the best possible buyer and structure the best deal.

The first hurdle is the accurate valuation of your practice, which was covered in some detail in my last column. Briefly, for the protection of both parties, it is important that the appraisal be done by an experienced and neutral financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation be supplied to support the conclusions reached.

Keep in mind that the valuation will not necessarily equal the purchase price; other factors may need to be considered before a final price can be agreed upon. Keep in mind, too, that there may be legal constraints on the purchase price. For example, if the buyer is a nonprofit corporation such as a hospital or HMO, by law it cannot pay in excess of fair market value for the practice – which may rule out any valuation of “good will.” In some states, the purchase of private practices by hospitals is prohibited altogether – so you might need to consider a long-term lease rather than a sale.

Once a value has been agreed upon, you must consider how the transaction will be structured. The most popular structures include purchase of assets, purchase of corporate stock, and merger.

Many buyers prefer to purchase assets, because it allows them to pick and choose only those items that have value to them. This can leave you with a bunch of “odd lot” assets to dispose of. But depending on the circumstances, an asset sale may still be to your advantage.

Sellers typically prefer to sell stock, because it allows them to sell their entire practice, which is often worth more than the sum of its parts, and often provides tax advantages.

The third option, merger, continues to grow in popularity and is a column subject in itself, and I will address it separately next month.

Tax issues must always be considered. Most private practices are corporations, and the sale of corporate stock will result in a long-term capital gain that will be taxed – currently at 15%-20%. As the saying goes, it’s not what you earn, it’s what you keep. So it may benefit you to accept a slightly lower price if the sale can be structured to provide significantly lower tax treatment. However, any gain that does not qualify as a long-term capital gain will be taxed as regular income – currently in the 32%-37% percent range – plus a Social Security tax of about 15%.

Payment in installments is a popular way to defer taxes, since they are incurred on each installment as it is paid; but such payments may be mistaken by the IRS for payments for referrals, which is illegal. And there is always the problem of making certain all payments are eventually made.

You may wish to continue working at the practice as an employee for an agreed-upon period of time, and this is often to the buyer’s advantage as well. Transitioning to new ownership in stages often maximizes the value of the business by improving patient retention, and allows patients to become accustomed to the transition. However, care must be taken, with the aid of good legal advice, to structure such an arrangement in a way that minimizes concerns of fraud and abuse.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Editor’s note: This is the second in a two-part series commemorating the 100-year anniversary of the first use of insulin in humans. Part 1 of this series examined the rivalry behind the discovery and use of insulin.

One hundred years ago, teenager Leonard Thompson was the first patient with type 1 diabetes to be successfully treated with insulin, granting him a reprieve from what was a certain death sentence at the time.

Since then, research has gathered pace. In the century since insulin’s discovery and first use, recombinant DNA technology has allowed for the engineering of the insulin molecule, providing numerous short- and long-acting analog versions. At the same time, technological leaps in automated insulin delivery and monitoring of blood glucose ensure more time with glucose in range and fewer life-threatening complications for those with type 1 diabetes fortunate enough to have access to the technology. 

In spite of these advancements, there is still scope for further evolution of disease management, with the holy grail being the transplant of stem cell–derived islet cells capable of making insulin, ideally encased in some kind of protective device so that immunosuppression is not required.

Indeed, it is not unreasonable to “hope that type 1 diabetes will be a curable disease in the next 100 years,” said Elizabeth Stephens, MD, an endocrinologist who has type 1 diabetes and practices in Portland, Ore.
 

Type 1 diabetes: The past 100 years

The epidemiology of type 1 diabetes has shifted considerably since 1922. A century ago, given that average life expectancy in the United States was around 54 years, it was pretty much the only type of diabetes that doctors encountered. “There was some type 2 diabetes about in heavier people, but the focus was on type 1 diabetes,” noted Dr. Stephens.

Originally called juvenile diabetes because it was thought to only occur in children, “now 50% of people are diagnosed with type 1 diabetes ... over [the age of] 20,” explained Dr. Stephens.

In the United States, around 1.4 million adults 20 years and older, and 187,000 children younger than 20, have the disease, according to data from the National Diabetes Statistics Report 2020 by the Centers for Disease Control and Prevention. This total represents an increase of nearly 30% from 2017.

Over the years, theories as to the cause, or trigger, for type 1 diabetes “have included cow’s milk and [viral] infections,” said Dr. Stephens. “Most likely, there’s a genetic predisposition and some type of exposure, which creates the perfect storm to trigger disease.”

There are hints that COVID-19 might be precipitating type 1 diabetes in some people. Recently, the CDC found SARS-CoV-2 infection was associated with an increased risk for diabetes (all types) among youth, but not other acute respiratory infections. And two further studies from different parts of the world have recently identified an increase in the incidence of type 1 diabetes in children since the COVID-19 pandemic began, but the reasons remain unclear.

The global CoviDiab registry has also been established to collect data on patients with COVID-19–related diabetes.

The million-dollar question: Is COVID-19 itself is propagating type 1 diabetes or unmasking a predisposition to the disease sooner? The latter might be associated with a lower type 1 diabetes rate in the future, said Partha Kar, MBBS, OBE, national specialty advisor, diabetes, for National Health Service England.

“Right now, we don’t know the answer. Whichever way you look at it, it is likely there will be a rise in cases, and in countries where insulin is not freely available, healthcare systems need to have supply ready because insulin is lifesaving in type 1 diabetes,” Dr. Kar emphasized.
 

CGMs and automated insulin delivery: A ‘godsend’

A huge change has also been seen, most notably in the past 15 to 20 years, in the technological advancements that can help those with type 1 diabetes live an easier life.

Continuous glucose monitors (CGMs) and automated ways of delivering insulin, such as smart pens and insulin pumps, have made the daily life of a person with type 1 diabetes in the Western world considerably more comfortable.

CGMs provide a constant stream of data to an app, often wirelessly in sync with the insulin pump. However, on a global level, they are only available to a lucky few.

In England, pending National Institute for Health and Care Excellence) approval, any CGM should be available to all eligible patients with type 1 diabetes within the NHS from April 2022, Dr. Kar pointed out. In the United States, CGMs are often unaffordable and access is mostly dependent on a person’s health insurance.

Kersten Hall, PhD, a scientist and U.K.-based medical historian who recently wrote a book, “Insulin, the Crooked Timber” (Oxford, England: Oxford University Press, 2022) uncovering the lesser-known story behind the discovery of insulin, was diagnosed with adult-onset type 1 diabetes at the age of 41. Dr. Hall had always found the finger-prick blood glucose test to be a chore but now has a CGM. 

“It’s a total game changer for me: a godsend. I can’t sing its praises enough,” he said. “All it involves is the swipe of the phone and this provides a reading which tells me if my glucose is too low, so I eat something, or too high, so I might [go for] a run.”
 

Brewing insulin at scale

As described by Dr. Hall in his book, the journey from treating Mr. Thompson in 1922 to treating the masses began when biochemist James Collip, MD, PhD, discovered a means of purifying the animal pancreas extracts used to treat the teenager.

But production at scale presented a further challenge. This was overcome in 1924 when Eli Lilly drew on a technique used in the beer brewing process – where pH guides bitterness – to purify and manufacture large amounts of insulin.

By 1936, a range of slower-acting cattle and pig-derived insulins, the first produced by Novo Nordisk Pharmaceuticals, were developed.

However, it took 8,000 lb (approximately 3,600 kg) of pancreas glands from 23,500 animals to make 1 lb (0.5 kg) of insulin, so a more efficient process was badly needed.

Dr. Hall, who is a molecular biologist as well as an author, explains that the use of recombinant DNA technology to produce human insulin, as done by Genentech in the late 70s, was a key development in the story of modern insulin products. Genentech then provided synthetic human insulin for Eli Lilly to conduct clinical trials.

Human insulin most closely resembles porcine insulin structure and function, differing by only one amino acid, while human insulin differs from bovine insulin by three amino acid residues. This synthetic human insulin eliminated the allergies that the animal-derived products sometimes caused.

In the early 1980s, Eli Lilly produced Humulin, the first biosynthetic (made in Escherichia coli, hence the term, “bio”) human insulin.

This technology eventually “allowed for the alteration of specific amino acids in the sequence of the insulin protein to make insulin analogs [synthetic versions grown in E. coli and genetically altered for various properties] that act faster, or more slowly, than normal human insulin. By using the slow- and fast-acting insulins in combination, a patient can control their blood sugar levels with a much greater degree of finesse and precision,” Dr. Hall explained.

Today, a whole range of insulins are available, including ultra–rapid-acting, short-acting, intermediate-acting, long-acting, ultra–long-acting, and even inhaled insulin, although the latter is expensive, has been associated with side effects, and is less commonly used, according to Dr. Stephens.

Oral insulin formulations are even in the early stages of development, with candidate drugs by Generex and from the Oralis project.

“With insulin therapy, we try to reproduce the normal physiology of the healthy body and pancreas,” Dr. Stephens explained.

Insulin analogs are only made by three companies (Eli Lilly, Novo Nordisk, and Sanofi), and they are generally much more expensive than nonanalog human insulin. In the United Kingdom through the NHS, they cost twice as much.

In the United States today, one of the biggest barriers to proper care of type 1 diabetes is the cost of insulin, which can limit access. With the market controlled by these three large companies, the average cost of a unit of insulin in the United States, according to RAND research, was $98.17 in January 2021, compared with $7.52 in the United Kingdom and $12.00 in Canada. 

Several U.S. states have enacted legislation capping insulin copayments to at, or under, $100 a month. But the federal Build Back Better Framework Act – which would cap copayments for insulin at $35 – currently hangs in the balance.

Alongside these moves, in 2020 the Food and Drug Administration approved the first interchangeable biosimilar insulin for type 1 diabetes (and insulin-dependent type 2 diabetes) in children and adults, called Semglee (Mylan Pharmaceuticals). 

Biosimilars (essentially generic versions of branded insulins) are expected to be less expensive than branded analogs, but the indications so far are that they will only be around 20% cheaper.

“I totally fail to understand how the richest country in the world still has a debate about price caps, and we are looking at biosimilar markets to change the debate. This makes no sense to me at all,” stressed Dr. Kar. “For lifesaving drugs, they should be funded by the state.”

Insulin also remains unaffordable for many in numerous low- and middle-income countries, where most patients pay out-of-pocket for medicines. Globally, there are estimated to be around 30 million people who need insulin but cannot afford it.

How near to a cure in the coming decades?

Looking ahead to the coming years, if not the next 100, Dr. Stephens highlighted two important aspects of care.

First, the use of a CGM device in combination with an insulin pump (also known as a closed-loop system or artificial pancreas), where the CGM effectively tells the insulin pump how much insulin to automatically dispense, should revolutionize care.

A number of such closed-loop systems have recently been approved in both the United States, including systems from Medtronic and Omnipod, and Europe.

“I wear one of these and it’s been a life changer for me, but it doesn’t suit everyone because the technology can be cumbersome, but with time, hopefully things will become smaller and more accurate in insulin delivery,” Dr. Stephens added.

The second advance of interest is the development and transplantation of cells that produce insulin.

Dr. Stephens explained that someone living with type 1 diabetes has a lot to think about, not least, doing the math related to insulin requirement. “If we just had cells from a pancreas that could be transplanted and would do that for us, then it would be a total game changer.”

To date, Vertex Pharmaceuticals has successfully treated one patient – who had lived with type 1 diabetes for about 40 years and had recurrent episodes of severe hypoglycemia – with an infusion of stem cell–derived differentiated islet cells into his liver. The procedure resulted in near reversal of type 1 diabetes, with his insulin dose reduced from 34 to 3 units, and his hemoglobin A1c falling from 8.6% to 7.2%.

And although the patient, Brian Shelton, still needs to take immunosuppressive agents to prevent rejection of the stem cell–derived islets, “it’s a whole new life,” he recently told the New York Times.  

Another company called ViaCyte is also working on a similar approach.

Whether this is a cure for type 1 diabetes is still debatable, said Anne Peters, MD, of the University of Southern California, Los Angeles. “Is it true? In a word, no. But we are part of the way there, which is much closer than we were 6 months ago.”

There are also ongoing clinical trials of therapeutic interventions to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes. The most advanced is the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio), which was rejected by the FDA in July 2021, but has since been refiled. The company expects to hear from the agency by the end of March 2022 as to whether the resubmission has been accepted.
 

Diabetes specialist nurses/educators keep it human

Dr. Hall said he concurs with the late eminent U.K. diabetes specialist Robert Tattersall’s observation on what he considers one of the most important advances in the management and treatment of type 1 diabetes: the human touch.

Referring to Dr. Tattersall’s book, “Diabetes: A Biography,” Dr. Hall quoted: “If asked what innovation had made the most difference to their lives in the 1980s, patients with type 1 diabetes in England would unhesitatingly have chosen not human insulin, but the spread of diabetes specialist nurses ... these people (mainly women) did more in the last two decades of the 20th century to improve the standard of diabetes care than any other innovation or drug.”

In the United States, diabetes specialist nurses were called diabetes educators until recently, when the name changed to certified diabetes care and education specialist.

“Above all, they have humanized the service and given the patient a say in the otherwise unequal relationship with all-powerful doctors,” concluded Dr. Hall, again quoting Dr. Tattersall.

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

Editor’s note: This is the second in a two-part series commemorating the 100-year anniversary of the first use of insulin in humans. Part 1 of this series examined the rivalry behind the discovery and use of insulin.

One hundred years ago, teenager Leonard Thompson was the first patient with type 1 diabetes to be successfully treated with insulin, granting him a reprieve from what was a certain death sentence at the time.

Since then, research has gathered pace. In the century since insulin’s discovery and first use, recombinant DNA technology has allowed for the engineering of the insulin molecule, providing numerous short- and long-acting analog versions. At the same time, technological leaps in automated insulin delivery and monitoring of blood glucose ensure more time with glucose in range and fewer life-threatening complications for those with type 1 diabetes fortunate enough to have access to the technology. 

In spite of these advancements, there is still scope for further evolution of disease management, with the holy grail being the transplant of stem cell–derived islet cells capable of making insulin, ideally encased in some kind of protective device so that immunosuppression is not required.

Indeed, it is not unreasonable to “hope that type 1 diabetes will be a curable disease in the next 100 years,” said Elizabeth Stephens, MD, an endocrinologist who has type 1 diabetes and practices in Portland, Ore.
 

Type 1 diabetes: The past 100 years

The epidemiology of type 1 diabetes has shifted considerably since 1922. A century ago, given that average life expectancy in the United States was around 54 years, it was pretty much the only type of diabetes that doctors encountered. “There was some type 2 diabetes about in heavier people, but the focus was on type 1 diabetes,” noted Dr. Stephens.

Originally called juvenile diabetes because it was thought to only occur in children, “now 50% of people are diagnosed with type 1 diabetes ... over [the age of] 20,” explained Dr. Stephens.

In the United States, around 1.4 million adults 20 years and older, and 187,000 children younger than 20, have the disease, according to data from the National Diabetes Statistics Report 2020 by the Centers for Disease Control and Prevention. This total represents an increase of nearly 30% from 2017.

Over the years, theories as to the cause, or trigger, for type 1 diabetes “have included cow’s milk and [viral] infections,” said Dr. Stephens. “Most likely, there’s a genetic predisposition and some type of exposure, which creates the perfect storm to trigger disease.”

There are hints that COVID-19 might be precipitating type 1 diabetes in some people. Recently, the CDC found SARS-CoV-2 infection was associated with an increased risk for diabetes (all types) among youth, but not other acute respiratory infections. And two further studies from different parts of the world have recently identified an increase in the incidence of type 1 diabetes in children since the COVID-19 pandemic began, but the reasons remain unclear.

The global CoviDiab registry has also been established to collect data on patients with COVID-19–related diabetes.

The million-dollar question: Is COVID-19 itself is propagating type 1 diabetes or unmasking a predisposition to the disease sooner? The latter might be associated with a lower type 1 diabetes rate in the future, said Partha Kar, MBBS, OBE, national specialty advisor, diabetes, for National Health Service England.

“Right now, we don’t know the answer. Whichever way you look at it, it is likely there will be a rise in cases, and in countries where insulin is not freely available, healthcare systems need to have supply ready because insulin is lifesaving in type 1 diabetes,” Dr. Kar emphasized.
 

CGMs and automated insulin delivery: A ‘godsend’

A huge change has also been seen, most notably in the past 15 to 20 years, in the technological advancements that can help those with type 1 diabetes live an easier life.

Continuous glucose monitors (CGMs) and automated ways of delivering insulin, such as smart pens and insulin pumps, have made the daily life of a person with type 1 diabetes in the Western world considerably more comfortable.

CGMs provide a constant stream of data to an app, often wirelessly in sync with the insulin pump. However, on a global level, they are only available to a lucky few.

In England, pending National Institute for Health and Care Excellence) approval, any CGM should be available to all eligible patients with type 1 diabetes within the NHS from April 2022, Dr. Kar pointed out. In the United States, CGMs are often unaffordable and access is mostly dependent on a person’s health insurance.

Kersten Hall, PhD, a scientist and U.K.-based medical historian who recently wrote a book, “Insulin, the Crooked Timber” (Oxford, England: Oxford University Press, 2022) uncovering the lesser-known story behind the discovery of insulin, was diagnosed with adult-onset type 1 diabetes at the age of 41. Dr. Hall had always found the finger-prick blood glucose test to be a chore but now has a CGM. 

“It’s a total game changer for me: a godsend. I can’t sing its praises enough,” he said. “All it involves is the swipe of the phone and this provides a reading which tells me if my glucose is too low, so I eat something, or too high, so I might [go for] a run.”
 

Brewing insulin at scale

As described by Dr. Hall in his book, the journey from treating Mr. Thompson in 1922 to treating the masses began when biochemist James Collip, MD, PhD, discovered a means of purifying the animal pancreas extracts used to treat the teenager.

But production at scale presented a further challenge. This was overcome in 1924 when Eli Lilly drew on a technique used in the beer brewing process – where pH guides bitterness – to purify and manufacture large amounts of insulin.

By 1936, a range of slower-acting cattle and pig-derived insulins, the first produced by Novo Nordisk Pharmaceuticals, were developed.

However, it took 8,000 lb (approximately 3,600 kg) of pancreas glands from 23,500 animals to make 1 lb (0.5 kg) of insulin, so a more efficient process was badly needed.

Dr. Hall, who is a molecular biologist as well as an author, explains that the use of recombinant DNA technology to produce human insulin, as done by Genentech in the late 70s, was a key development in the story of modern insulin products. Genentech then provided synthetic human insulin for Eli Lilly to conduct clinical trials.

Human insulin most closely resembles porcine insulin structure and function, differing by only one amino acid, while human insulin differs from bovine insulin by three amino acid residues. This synthetic human insulin eliminated the allergies that the animal-derived products sometimes caused.

In the early 1980s, Eli Lilly produced Humulin, the first biosynthetic (made in Escherichia coli, hence the term, “bio”) human insulin.

This technology eventually “allowed for the alteration of specific amino acids in the sequence of the insulin protein to make insulin analogs [synthetic versions grown in E. coli and genetically altered for various properties] that act faster, or more slowly, than normal human insulin. By using the slow- and fast-acting insulins in combination, a patient can control their blood sugar levels with a much greater degree of finesse and precision,” Dr. Hall explained.

Today, a whole range of insulins are available, including ultra–rapid-acting, short-acting, intermediate-acting, long-acting, ultra–long-acting, and even inhaled insulin, although the latter is expensive, has been associated with side effects, and is less commonly used, according to Dr. Stephens.

Oral insulin formulations are even in the early stages of development, with candidate drugs by Generex and from the Oralis project.

“With insulin therapy, we try to reproduce the normal physiology of the healthy body and pancreas,” Dr. Stephens explained.

Insulin analogs are only made by three companies (Eli Lilly, Novo Nordisk, and Sanofi), and they are generally much more expensive than nonanalog human insulin. In the United Kingdom through the NHS, they cost twice as much.

In the United States today, one of the biggest barriers to proper care of type 1 diabetes is the cost of insulin, which can limit access. With the market controlled by these three large companies, the average cost of a unit of insulin in the United States, according to RAND research, was $98.17 in January 2021, compared with $7.52 in the United Kingdom and $12.00 in Canada. 

Several U.S. states have enacted legislation capping insulin copayments to at, or under, $100 a month. But the federal Build Back Better Framework Act – which would cap copayments for insulin at $35 – currently hangs in the balance.

Alongside these moves, in 2020 the Food and Drug Administration approved the first interchangeable biosimilar insulin for type 1 diabetes (and insulin-dependent type 2 diabetes) in children and adults, called Semglee (Mylan Pharmaceuticals). 

Biosimilars (essentially generic versions of branded insulins) are expected to be less expensive than branded analogs, but the indications so far are that they will only be around 20% cheaper.

“I totally fail to understand how the richest country in the world still has a debate about price caps, and we are looking at biosimilar markets to change the debate. This makes no sense to me at all,” stressed Dr. Kar. “For lifesaving drugs, they should be funded by the state.”

Insulin also remains unaffordable for many in numerous low- and middle-income countries, where most patients pay out-of-pocket for medicines. Globally, there are estimated to be around 30 million people who need insulin but cannot afford it.

How near to a cure in the coming decades?

Looking ahead to the coming years, if not the next 100, Dr. Stephens highlighted two important aspects of care.

First, the use of a CGM device in combination with an insulin pump (also known as a closed-loop system or artificial pancreas), where the CGM effectively tells the insulin pump how much insulin to automatically dispense, should revolutionize care.

A number of such closed-loop systems have recently been approved in both the United States, including systems from Medtronic and Omnipod, and Europe.

“I wear one of these and it’s been a life changer for me, but it doesn’t suit everyone because the technology can be cumbersome, but with time, hopefully things will become smaller and more accurate in insulin delivery,” Dr. Stephens added.

The second advance of interest is the development and transplantation of cells that produce insulin.

Dr. Stephens explained that someone living with type 1 diabetes has a lot to think about, not least, doing the math related to insulin requirement. “If we just had cells from a pancreas that could be transplanted and would do that for us, then it would be a total game changer.”

To date, Vertex Pharmaceuticals has successfully treated one patient – who had lived with type 1 diabetes for about 40 years and had recurrent episodes of severe hypoglycemia – with an infusion of stem cell–derived differentiated islet cells into his liver. The procedure resulted in near reversal of type 1 diabetes, with his insulin dose reduced from 34 to 3 units, and his hemoglobin A1c falling from 8.6% to 7.2%.

And although the patient, Brian Shelton, still needs to take immunosuppressive agents to prevent rejection of the stem cell–derived islets, “it’s a whole new life,” he recently told the New York Times.  

Another company called ViaCyte is also working on a similar approach.

Whether this is a cure for type 1 diabetes is still debatable, said Anne Peters, MD, of the University of Southern California, Los Angeles. “Is it true? In a word, no. But we are part of the way there, which is much closer than we were 6 months ago.”

There are also ongoing clinical trials of therapeutic interventions to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes. The most advanced is the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio), which was rejected by the FDA in July 2021, but has since been refiled. The company expects to hear from the agency by the end of March 2022 as to whether the resubmission has been accepted.
 

Diabetes specialist nurses/educators keep it human

Dr. Hall said he concurs with the late eminent U.K. diabetes specialist Robert Tattersall’s observation on what he considers one of the most important advances in the management and treatment of type 1 diabetes: the human touch.

Referring to Dr. Tattersall’s book, “Diabetes: A Biography,” Dr. Hall quoted: “If asked what innovation had made the most difference to their lives in the 1980s, patients with type 1 diabetes in England would unhesitatingly have chosen not human insulin, but the spread of diabetes specialist nurses ... these people (mainly women) did more in the last two decades of the 20th century to improve the standard of diabetes care than any other innovation or drug.”

In the United States, diabetes specialist nurses were called diabetes educators until recently, when the name changed to certified diabetes care and education specialist.

“Above all, they have humanized the service and given the patient a say in the otherwise unequal relationship with all-powerful doctors,” concluded Dr. Hall, again quoting Dr. Tattersall.

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

Editor’s note: This is the second in a two-part series commemorating the 100-year anniversary of the first use of insulin in humans. Part 1 of this series examined the rivalry behind the discovery and use of insulin.

One hundred years ago, teenager Leonard Thompson was the first patient with type 1 diabetes to be successfully treated with insulin, granting him a reprieve from what was a certain death sentence at the time.

Since then, research has gathered pace. In the century since insulin’s discovery and first use, recombinant DNA technology has allowed for the engineering of the insulin molecule, providing numerous short- and long-acting analog versions. At the same time, technological leaps in automated insulin delivery and monitoring of blood glucose ensure more time with glucose in range and fewer life-threatening complications for those with type 1 diabetes fortunate enough to have access to the technology. 

In spite of these advancements, there is still scope for further evolution of disease management, with the holy grail being the transplant of stem cell–derived islet cells capable of making insulin, ideally encased in some kind of protective device so that immunosuppression is not required.

Indeed, it is not unreasonable to “hope that type 1 diabetes will be a curable disease in the next 100 years,” said Elizabeth Stephens, MD, an endocrinologist who has type 1 diabetes and practices in Portland, Ore.
 

Type 1 diabetes: The past 100 years

The epidemiology of type 1 diabetes has shifted considerably since 1922. A century ago, given that average life expectancy in the United States was around 54 years, it was pretty much the only type of diabetes that doctors encountered. “There was some type 2 diabetes about in heavier people, but the focus was on type 1 diabetes,” noted Dr. Stephens.

Originally called juvenile diabetes because it was thought to only occur in children, “now 50% of people are diagnosed with type 1 diabetes ... over [the age of] 20,” explained Dr. Stephens.

In the United States, around 1.4 million adults 20 years and older, and 187,000 children younger than 20, have the disease, according to data from the National Diabetes Statistics Report 2020 by the Centers for Disease Control and Prevention. This total represents an increase of nearly 30% from 2017.

Over the years, theories as to the cause, or trigger, for type 1 diabetes “have included cow’s milk and [viral] infections,” said Dr. Stephens. “Most likely, there’s a genetic predisposition and some type of exposure, which creates the perfect storm to trigger disease.”

There are hints that COVID-19 might be precipitating type 1 diabetes in some people. Recently, the CDC found SARS-CoV-2 infection was associated with an increased risk for diabetes (all types) among youth, but not other acute respiratory infections. And two further studies from different parts of the world have recently identified an increase in the incidence of type 1 diabetes in children since the COVID-19 pandemic began, but the reasons remain unclear.

The global CoviDiab registry has also been established to collect data on patients with COVID-19–related diabetes.

The million-dollar question: Is COVID-19 itself is propagating type 1 diabetes or unmasking a predisposition to the disease sooner? The latter might be associated with a lower type 1 diabetes rate in the future, said Partha Kar, MBBS, OBE, national specialty advisor, diabetes, for National Health Service England.

“Right now, we don’t know the answer. Whichever way you look at it, it is likely there will be a rise in cases, and in countries where insulin is not freely available, healthcare systems need to have supply ready because insulin is lifesaving in type 1 diabetes,” Dr. Kar emphasized.
 

CGMs and automated insulin delivery: A ‘godsend’

A huge change has also been seen, most notably in the past 15 to 20 years, in the technological advancements that can help those with type 1 diabetes live an easier life.

Continuous glucose monitors (CGMs) and automated ways of delivering insulin, such as smart pens and insulin pumps, have made the daily life of a person with type 1 diabetes in the Western world considerably more comfortable.

CGMs provide a constant stream of data to an app, often wirelessly in sync with the insulin pump. However, on a global level, they are only available to a lucky few.

In England, pending National Institute for Health and Care Excellence) approval, any CGM should be available to all eligible patients with type 1 diabetes within the NHS from April 2022, Dr. Kar pointed out. In the United States, CGMs are often unaffordable and access is mostly dependent on a person’s health insurance.

Kersten Hall, PhD, a scientist and U.K.-based medical historian who recently wrote a book, “Insulin, the Crooked Timber” (Oxford, England: Oxford University Press, 2022) uncovering the lesser-known story behind the discovery of insulin, was diagnosed with adult-onset type 1 diabetes at the age of 41. Dr. Hall had always found the finger-prick blood glucose test to be a chore but now has a CGM. 

“It’s a total game changer for me: a godsend. I can’t sing its praises enough,” he said. “All it involves is the swipe of the phone and this provides a reading which tells me if my glucose is too low, so I eat something, or too high, so I might [go for] a run.”
 

Brewing insulin at scale

As described by Dr. Hall in his book, the journey from treating Mr. Thompson in 1922 to treating the masses began when biochemist James Collip, MD, PhD, discovered a means of purifying the animal pancreas extracts used to treat the teenager.

But production at scale presented a further challenge. This was overcome in 1924 when Eli Lilly drew on a technique used in the beer brewing process – where pH guides bitterness – to purify and manufacture large amounts of insulin.

By 1936, a range of slower-acting cattle and pig-derived insulins, the first produced by Novo Nordisk Pharmaceuticals, were developed.

However, it took 8,000 lb (approximately 3,600 kg) of pancreas glands from 23,500 animals to make 1 lb (0.5 kg) of insulin, so a more efficient process was badly needed.

Dr. Hall, who is a molecular biologist as well as an author, explains that the use of recombinant DNA technology to produce human insulin, as done by Genentech in the late 70s, was a key development in the story of modern insulin products. Genentech then provided synthetic human insulin for Eli Lilly to conduct clinical trials.

Human insulin most closely resembles porcine insulin structure and function, differing by only one amino acid, while human insulin differs from bovine insulin by three amino acid residues. This synthetic human insulin eliminated the allergies that the animal-derived products sometimes caused.

In the early 1980s, Eli Lilly produced Humulin, the first biosynthetic (made in Escherichia coli, hence the term, “bio”) human insulin.

This technology eventually “allowed for the alteration of specific amino acids in the sequence of the insulin protein to make insulin analogs [synthetic versions grown in E. coli and genetically altered for various properties] that act faster, or more slowly, than normal human insulin. By using the slow- and fast-acting insulins in combination, a patient can control their blood sugar levels with a much greater degree of finesse and precision,” Dr. Hall explained.

Today, a whole range of insulins are available, including ultra–rapid-acting, short-acting, intermediate-acting, long-acting, ultra–long-acting, and even inhaled insulin, although the latter is expensive, has been associated with side effects, and is less commonly used, according to Dr. Stephens.

Oral insulin formulations are even in the early stages of development, with candidate drugs by Generex and from the Oralis project.

“With insulin therapy, we try to reproduce the normal physiology of the healthy body and pancreas,” Dr. Stephens explained.

Insulin analogs are only made by three companies (Eli Lilly, Novo Nordisk, and Sanofi), and they are generally much more expensive than nonanalog human insulin. In the United Kingdom through the NHS, they cost twice as much.

In the United States today, one of the biggest barriers to proper care of type 1 diabetes is the cost of insulin, which can limit access. With the market controlled by these three large companies, the average cost of a unit of insulin in the United States, according to RAND research, was $98.17 in January 2021, compared with $7.52 in the United Kingdom and $12.00 in Canada. 

Several U.S. states have enacted legislation capping insulin copayments to at, or under, $100 a month. But the federal Build Back Better Framework Act – which would cap copayments for insulin at $35 – currently hangs in the balance.

Alongside these moves, in 2020 the Food and Drug Administration approved the first interchangeable biosimilar insulin for type 1 diabetes (and insulin-dependent type 2 diabetes) in children and adults, called Semglee (Mylan Pharmaceuticals). 

Biosimilars (essentially generic versions of branded insulins) are expected to be less expensive than branded analogs, but the indications so far are that they will only be around 20% cheaper.

“I totally fail to understand how the richest country in the world still has a debate about price caps, and we are looking at biosimilar markets to change the debate. This makes no sense to me at all,” stressed Dr. Kar. “For lifesaving drugs, they should be funded by the state.”

Insulin also remains unaffordable for many in numerous low- and middle-income countries, where most patients pay out-of-pocket for medicines. Globally, there are estimated to be around 30 million people who need insulin but cannot afford it.

How near to a cure in the coming decades?

Looking ahead to the coming years, if not the next 100, Dr. Stephens highlighted two important aspects of care.

First, the use of a CGM device in combination with an insulin pump (also known as a closed-loop system or artificial pancreas), where the CGM effectively tells the insulin pump how much insulin to automatically dispense, should revolutionize care.

A number of such closed-loop systems have recently been approved in both the United States, including systems from Medtronic and Omnipod, and Europe.

“I wear one of these and it’s been a life changer for me, but it doesn’t suit everyone because the technology can be cumbersome, but with time, hopefully things will become smaller and more accurate in insulin delivery,” Dr. Stephens added.

The second advance of interest is the development and transplantation of cells that produce insulin.

Dr. Stephens explained that someone living with type 1 diabetes has a lot to think about, not least, doing the math related to insulin requirement. “If we just had cells from a pancreas that could be transplanted and would do that for us, then it would be a total game changer.”

To date, Vertex Pharmaceuticals has successfully treated one patient – who had lived with type 1 diabetes for about 40 years and had recurrent episodes of severe hypoglycemia – with an infusion of stem cell–derived differentiated islet cells into his liver. The procedure resulted in near reversal of type 1 diabetes, with his insulin dose reduced from 34 to 3 units, and his hemoglobin A1c falling from 8.6% to 7.2%.

And although the patient, Brian Shelton, still needs to take immunosuppressive agents to prevent rejection of the stem cell–derived islets, “it’s a whole new life,” he recently told the New York Times.  

Another company called ViaCyte is also working on a similar approach.

Whether this is a cure for type 1 diabetes is still debatable, said Anne Peters, MD, of the University of Southern California, Los Angeles. “Is it true? In a word, no. But we are part of the way there, which is much closer than we were 6 months ago.”

There are also ongoing clinical trials of therapeutic interventions to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes. The most advanced is the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio), which was rejected by the FDA in July 2021, but has since been refiled. The company expects to hear from the agency by the end of March 2022 as to whether the resubmission has been accepted.
 

Diabetes specialist nurses/educators keep it human

Dr. Hall said he concurs with the late eminent U.K. diabetes specialist Robert Tattersall’s observation on what he considers one of the most important advances in the management and treatment of type 1 diabetes: the human touch.

Referring to Dr. Tattersall’s book, “Diabetes: A Biography,” Dr. Hall quoted: “If asked what innovation had made the most difference to their lives in the 1980s, patients with type 1 diabetes in England would unhesitatingly have chosen not human insulin, but the spread of diabetes specialist nurses ... these people (mainly women) did more in the last two decades of the 20th century to improve the standard of diabetes care than any other innovation or drug.”

In the United States, diabetes specialist nurses were called diabetes educators until recently, when the name changed to certified diabetes care and education specialist.

“Above all, they have humanized the service and given the patient a say in the otherwise unequal relationship with all-powerful doctors,” concluded Dr. Hall, again quoting Dr. Tattersall.

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