MDedge Pediatrics

Marcus Welby, MD, was a fictitious hometown doctor featured in a TV drama with the same name that was shown on ABC from 1969 to 1976. Played by actor Robert Young, Dr. Welby treated his patients through their bouts with breast cancer, impotence, and Alzheimer’s disease.

Dr. Welby likely wouldn’t recognize the practice of medicine today, where nearly three quarters (73.9%) of physicians are employed by hospitals, health systems, or corporate entities, according to a recent report sponsored by the Physicians Advocacy Institute and prepared by consulting firm Avalere Health.

“COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we’ve seen in recent years, and these trends continued to accelerate in 2021,” Kelly Kenney, chief executive officer of Physicians Advocacy Institute, said in an announcement. “This study underscores the fact that physicians across the nation are facing severe burnout and strain. The pressures of the pandemic forced many independent physicians to make difficult decisions to sell their practices, health insurers, or other corporate entities.”

Corporate entities are defined in the report as health insurers, private equity firms, and umbrella corporate entities that own multiple physician practices.

“The pandemic has been just brutal ... for nurses and physicians who are caring for patients,” Ms. Kenney told this news organization. “Between the financial stress that the pandemic certainly had on practices, because they certainly had little revenue for a while, and then also we know that the stress that physicians have felt mentally, you can’t overstate that.”

More than half of physician practices owned by hospitals, corporate entities

The Physicians Advocacy Institute has tracked changes in physician employment consistently since 2012, said Ms. Kenney. In 2012, 25% of physicians were employed; that has jumped to nearly 74%, which means the past decade has brought a world of change to the nation’s physicians.

“These are essentially small-business people ... and they were primarily trained to care for patients,” said Ms. Kenney, referring to physicians in independent practice. Still, she understands why physicians would seek employment in the face of “the crushing kind of pressure of having to deal with 20 different payers, pay overhead, and keep the lights on [at the practice].”

According to the report, 108,700 physicians left independent practice to enter employment with hospitals or other corporate entities in the 3-year period that ended in 2021. Seventy-six percent of that shift to employed status among physicians has occurred since the start of the COVID-19 pandemic in March 2020.

From a regional perspective, the report found continued growth among employed physicians across all U.S. regions in the last half of 2020. Hospital- or corporate-owned physician practices increased between 28% and 44%, while the percentage of hospital- or corporate-employed physicians increased between 13% and 24%.

Eighty percent of physicians in the Midwest are employed by hospitals or corporations, which leads the rest of the country, per the report. That’s followed by the Northeast, the West, and the South. Overall, the number of physicians working for such entities increased in all regions.

The report revealed that physician employment by corporations such as health insurers and venture capital firms grew from 92,400 in January 2019 to 142,900 in January 2022.

Hospitals and corporate entities acquired 36,200 physician practices (representing 38% growth) between 2019 and 2021, and the majority of these moves occurred since the pandemic’s start, according to the report.

Value-based care, venture capital firms driving change

Ms. Kenney pointed to value-based care as driving much of this activity by hospitals. “We all embrace [value-based payment], because we need to get a handle on cost, and we want better quality [but] those trends tend to favor integrated systems and systems that can handle a lot of risk and populations of patients.”

Still, the moves by private equity firms and health insurers in this space is relatively new, said Ms. Kenney, who added that her organization started tracking this trend 3 years ago. She pointed to a “marked acceleration” in the trend toward employing physicians and the sale of practices in the 18 months following the pandemic’s start; nonhospital corporate entities drove that steep increase, she said.

Ms. Kenney calls for further study and “guardrails” to respond to “that force in the health care system,” referring to the acquisition of practices by entities such as private equity firms. “Are these big [health care] systems going to continue to see patients in underserved areas, rural areas, and Medicaid patients if it doesn’t make sense financially to do so?

“That’s what we’re teeing up with this research,” added Ms. Kenney. “We are providing information that starts some conversations around what we might want to think about in terms of policies to ensure that we don’t impact patients’ access to care.”

The Physicians Advocacy Institute represents more than 170,000 physicians and medical students. Avalere Health used the IQVIA OneKey database for the report. The researchers studied the 3-year period from Jan. 1, 2019, to Jan. 1, 2022.

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

Marcus Welby, MD, was a fictitious hometown doctor featured in a TV drama with the same name that was shown on ABC from 1969 to 1976. Played by actor Robert Young, Dr. Welby treated his patients through their bouts with breast cancer, impotence, and Alzheimer’s disease.

Dr. Welby likely wouldn’t recognize the practice of medicine today, where nearly three quarters (73.9%) of physicians are employed by hospitals, health systems, or corporate entities, according to a recent report sponsored by the Physicians Advocacy Institute and prepared by consulting firm Avalere Health.

“COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we’ve seen in recent years, and these trends continued to accelerate in 2021,” Kelly Kenney, chief executive officer of Physicians Advocacy Institute, said in an announcement. “This study underscores the fact that physicians across the nation are facing severe burnout and strain. The pressures of the pandemic forced many independent physicians to make difficult decisions to sell their practices, health insurers, or other corporate entities.”

Corporate entities are defined in the report as health insurers, private equity firms, and umbrella corporate entities that own multiple physician practices.

“The pandemic has been just brutal ... for nurses and physicians who are caring for patients,” Ms. Kenney told this news organization. “Between the financial stress that the pandemic certainly had on practices, because they certainly had little revenue for a while, and then also we know that the stress that physicians have felt mentally, you can’t overstate that.”

More than half of physician practices owned by hospitals, corporate entities

The Physicians Advocacy Institute has tracked changes in physician employment consistently since 2012, said Ms. Kenney. In 2012, 25% of physicians were employed; that has jumped to nearly 74%, which means the past decade has brought a world of change to the nation’s physicians.

“These are essentially small-business people ... and they were primarily trained to care for patients,” said Ms. Kenney, referring to physicians in independent practice. Still, she understands why physicians would seek employment in the face of “the crushing kind of pressure of having to deal with 20 different payers, pay overhead, and keep the lights on [at the practice].”

According to the report, 108,700 physicians left independent practice to enter employment with hospitals or other corporate entities in the 3-year period that ended in 2021. Seventy-six percent of that shift to employed status among physicians has occurred since the start of the COVID-19 pandemic in March 2020.

From a regional perspective, the report found continued growth among employed physicians across all U.S. regions in the last half of 2020. Hospital- or corporate-owned physician practices increased between 28% and 44%, while the percentage of hospital- or corporate-employed physicians increased between 13% and 24%.

Eighty percent of physicians in the Midwest are employed by hospitals or corporations, which leads the rest of the country, per the report. That’s followed by the Northeast, the West, and the South. Overall, the number of physicians working for such entities increased in all regions.

The report revealed that physician employment by corporations such as health insurers and venture capital firms grew from 92,400 in January 2019 to 142,900 in January 2022.

Hospitals and corporate entities acquired 36,200 physician practices (representing 38% growth) between 2019 and 2021, and the majority of these moves occurred since the pandemic’s start, according to the report.

Value-based care, venture capital firms driving change

Ms. Kenney pointed to value-based care as driving much of this activity by hospitals. “We all embrace [value-based payment], because we need to get a handle on cost, and we want better quality [but] those trends tend to favor integrated systems and systems that can handle a lot of risk and populations of patients.”

Still, the moves by private equity firms and health insurers in this space is relatively new, said Ms. Kenney, who added that her organization started tracking this trend 3 years ago. She pointed to a “marked acceleration” in the trend toward employing physicians and the sale of practices in the 18 months following the pandemic’s start; nonhospital corporate entities drove that steep increase, she said.

Ms. Kenney calls for further study and “guardrails” to respond to “that force in the health care system,” referring to the acquisition of practices by entities such as private equity firms. “Are these big [health care] systems going to continue to see patients in underserved areas, rural areas, and Medicaid patients if it doesn’t make sense financially to do so?

“That’s what we’re teeing up with this research,” added Ms. Kenney. “We are providing information that starts some conversations around what we might want to think about in terms of policies to ensure that we don’t impact patients’ access to care.”

The Physicians Advocacy Institute represents more than 170,000 physicians and medical students. Avalere Health used the IQVIA OneKey database for the report. The researchers studied the 3-year period from Jan. 1, 2019, to Jan. 1, 2022.

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

Marcus Welby, MD, was a fictitious hometown doctor featured in a TV drama with the same name that was shown on ABC from 1969 to 1976. Played by actor Robert Young, Dr. Welby treated his patients through their bouts with breast cancer, impotence, and Alzheimer’s disease.

Dr. Welby likely wouldn’t recognize the practice of medicine today, where nearly three quarters (73.9%) of physicians are employed by hospitals, health systems, or corporate entities, according to a recent report sponsored by the Physicians Advocacy Institute and prepared by consulting firm Avalere Health.

“COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we’ve seen in recent years, and these trends continued to accelerate in 2021,” Kelly Kenney, chief executive officer of Physicians Advocacy Institute, said in an announcement. “This study underscores the fact that physicians across the nation are facing severe burnout and strain. The pressures of the pandemic forced many independent physicians to make difficult decisions to sell their practices, health insurers, or other corporate entities.”

Corporate entities are defined in the report as health insurers, private equity firms, and umbrella corporate entities that own multiple physician practices.

“The pandemic has been just brutal ... for nurses and physicians who are caring for patients,” Ms. Kenney told this news organization. “Between the financial stress that the pandemic certainly had on practices, because they certainly had little revenue for a while, and then also we know that the stress that physicians have felt mentally, you can’t overstate that.”

More than half of physician practices owned by hospitals, corporate entities

The Physicians Advocacy Institute has tracked changes in physician employment consistently since 2012, said Ms. Kenney. In 2012, 25% of physicians were employed; that has jumped to nearly 74%, which means the past decade has brought a world of change to the nation’s physicians.

“These are essentially small-business people ... and they were primarily trained to care for patients,” said Ms. Kenney, referring to physicians in independent practice. Still, she understands why physicians would seek employment in the face of “the crushing kind of pressure of having to deal with 20 different payers, pay overhead, and keep the lights on [at the practice].”

According to the report, 108,700 physicians left independent practice to enter employment with hospitals or other corporate entities in the 3-year period that ended in 2021. Seventy-six percent of that shift to employed status among physicians has occurred since the start of the COVID-19 pandemic in March 2020.

From a regional perspective, the report found continued growth among employed physicians across all U.S. regions in the last half of 2020. Hospital- or corporate-owned physician practices increased between 28% and 44%, while the percentage of hospital- or corporate-employed physicians increased between 13% and 24%.

Eighty percent of physicians in the Midwest are employed by hospitals or corporations, which leads the rest of the country, per the report. That’s followed by the Northeast, the West, and the South. Overall, the number of physicians working for such entities increased in all regions.

The report revealed that physician employment by corporations such as health insurers and venture capital firms grew from 92,400 in January 2019 to 142,900 in January 2022.

Hospitals and corporate entities acquired 36,200 physician practices (representing 38% growth) between 2019 and 2021, and the majority of these moves occurred since the pandemic’s start, according to the report.

Value-based care, venture capital firms driving change

Ms. Kenney pointed to value-based care as driving much of this activity by hospitals. “We all embrace [value-based payment], because we need to get a handle on cost, and we want better quality [but] those trends tend to favor integrated systems and systems that can handle a lot of risk and populations of patients.”

Still, the moves by private equity firms and health insurers in this space is relatively new, said Ms. Kenney, who added that her organization started tracking this trend 3 years ago. She pointed to a “marked acceleration” in the trend toward employing physicians and the sale of practices in the 18 months following the pandemic’s start; nonhospital corporate entities drove that steep increase, she said.

Ms. Kenney calls for further study and “guardrails” to respond to “that force in the health care system,” referring to the acquisition of practices by entities such as private equity firms. “Are these big [health care] systems going to continue to see patients in underserved areas, rural areas, and Medicaid patients if it doesn’t make sense financially to do so?

“That’s what we’re teeing up with this research,” added Ms. Kenney. “We are providing information that starts some conversations around what we might want to think about in terms of policies to ensure that we don’t impact patients’ access to care.”

The Physicians Advocacy Institute represents more than 170,000 physicians and medical students. Avalere Health used the IQVIA OneKey database for the report. The researchers studied the 3-year period from Jan. 1, 2019, to Jan. 1, 2022.

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

Approximately two-thirds of pediatric acute care concerns managed in telemedicine visits required no additional visits or follow-up, based on data from more than 600 visits.

The increase in use of telemedicine during the first year of the COVID-19 pandemic enabled access to care and connection to doctors for many pediatric patients, said Kristina Kissiova, MD, of Children’s National Health System, Washington, and colleagues. Some advantages of telemedicine include enhanced medical homes, reduced health care costs, and less crowding and wait time for patients in offices and emergency departments; however, the optimal use of telemedicine for acute primary care has not been examined, they said.

In a study presented at the annual meeting of the Pediatric Academic Societies, the researchers conducted a retrospective chart review of 638 acute care telemedicine visits conducted by 21 health care providers at a single practice in Washington in October 2020 and November 2020. Approximately half of the patients were male, 65% were white, and 89% had commercial insurance. The most common age group was 6-12 years (23%), followed by 2-3 years (16%), 3-6 years (15%), and 12-18 years (14%).

The primary outcome was the number and nature of visits completed via telemedicine without the need for referral or a subsequent in-person visit. Telemedicine visits for well-child checks and follow-up visits were excluded.

Overall, 60% of the visits (384 of 638) were completed over telemedicine with no need for additional visits or referrals. The most common acute complaints were upper respiratory infections, dermatologic issues, gastrointestinal issues, COVID-19 related issues, and fever (18.7%, 16.3%, 12.9%, 11.9%, and 10.3%, respectively).

Of these, dermatologic and GI concerns were most often completed via telemedicine (93.3% and 81.7%, respectively), while upper respiratory tract infections and fever issues were the least likely to be completed via telemedicine (22.7% and 13.6%), mainly because of the need to report for in-person COVID-19 testing, the researchers said.

Among other less common chief complaints, 100% of breathing concerns, behavior/mental health concerns, and head trauma or falls were addressed via telemedicine without additional referrals or follow-up visits. In addition, 90.9% of urgent care or emergency department follow-ups, 88.9% of ear concerns, and 87.5% of eye concerns were completely resolved via telemedicine visits.

Overall, 3% of patients who were not referred after a telemedicine visit presented in person for worsening symptoms. Of these who were referred after a telemedicine visit, 90% were seen in person within 48 hours.

The study findings were limited by the inclusion of data from only a single center. However, “These early findings provide insight into the utility of telehealth in the primary care setting for a broad array of urgent concerns,” the researchers concluded.
 

Pandemic propelled telemedicine to improve patient care

The widespread adoption of telemedicine in primary care has been a beneficial side effect of the COVID-19 pandemic, said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“Toward the end of World War II and in the push to form the United Nations, Winston Churchill was credited with the saying, ‘Never let a good crisis go to waste,’” said Dr. Joos, who was not connected with the study.

“As awful as this pandemic has been, it has propelled health care delivery at an unprecedented pace into the digital age,” he noted.

The current study is important because it highlights the number of complaints that can be successfully resolved through telemedicine, offering patients and families quicker access and more options for care, Dr. Joos said.

“I feel that giving patients and families an open choice for either telemedicine or in-person visits improves the likelihood that the issue will be resolved efficiently and satisfactorily with fewer visits,” he added.

Approximately two-thirds of pediatric acute care concerns managed in telemedicine visits required no additional visits or follow-up, based on data from more than 600 visits.

The increase in use of telemedicine during the first year of the COVID-19 pandemic enabled access to care and connection to doctors for many pediatric patients, said Kristina Kissiova, MD, of Children’s National Health System, Washington, and colleagues. Some advantages of telemedicine include enhanced medical homes, reduced health care costs, and less crowding and wait time for patients in offices and emergency departments; however, the optimal use of telemedicine for acute primary care has not been examined, they said.

In a study presented at the annual meeting of the Pediatric Academic Societies, the researchers conducted a retrospective chart review of 638 acute care telemedicine visits conducted by 21 health care providers at a single practice in Washington in October 2020 and November 2020. Approximately half of the patients were male, 65% were white, and 89% had commercial insurance. The most common age group was 6-12 years (23%), followed by 2-3 years (16%), 3-6 years (15%), and 12-18 years (14%).

The primary outcome was the number and nature of visits completed via telemedicine without the need for referral or a subsequent in-person visit. Telemedicine visits for well-child checks and follow-up visits were excluded.

Overall, 60% of the visits (384 of 638) were completed over telemedicine with no need for additional visits or referrals. The most common acute complaints were upper respiratory infections, dermatologic issues, gastrointestinal issues, COVID-19 related issues, and fever (18.7%, 16.3%, 12.9%, 11.9%, and 10.3%, respectively).

Of these, dermatologic and GI concerns were most often completed via telemedicine (93.3% and 81.7%, respectively), while upper respiratory tract infections and fever issues were the least likely to be completed via telemedicine (22.7% and 13.6%), mainly because of the need to report for in-person COVID-19 testing, the researchers said.

Among other less common chief complaints, 100% of breathing concerns, behavior/mental health concerns, and head trauma or falls were addressed via telemedicine without additional referrals or follow-up visits. In addition, 90.9% of urgent care or emergency department follow-ups, 88.9% of ear concerns, and 87.5% of eye concerns were completely resolved via telemedicine visits.

Overall, 3% of patients who were not referred after a telemedicine visit presented in person for worsening symptoms. Of these who were referred after a telemedicine visit, 90% were seen in person within 48 hours.

The study findings were limited by the inclusion of data from only a single center. However, “These early findings provide insight into the utility of telehealth in the primary care setting for a broad array of urgent concerns,” the researchers concluded.
 

Pandemic propelled telemedicine to improve patient care

The widespread adoption of telemedicine in primary care has been a beneficial side effect of the COVID-19 pandemic, said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“Toward the end of World War II and in the push to form the United Nations, Winston Churchill was credited with the saying, ‘Never let a good crisis go to waste,’” said Dr. Joos, who was not connected with the study.

“As awful as this pandemic has been, it has propelled health care delivery at an unprecedented pace into the digital age,” he noted.

The current study is important because it highlights the number of complaints that can be successfully resolved through telemedicine, offering patients and families quicker access and more options for care, Dr. Joos said.

“I feel that giving patients and families an open choice for either telemedicine or in-person visits improves the likelihood that the issue will be resolved efficiently and satisfactorily with fewer visits,” he added.

Approximately two-thirds of pediatric acute care concerns managed in telemedicine visits required no additional visits or follow-up, based on data from more than 600 visits.

The increase in use of telemedicine during the first year of the COVID-19 pandemic enabled access to care and connection to doctors for many pediatric patients, said Kristina Kissiova, MD, of Children’s National Health System, Washington, and colleagues. Some advantages of telemedicine include enhanced medical homes, reduced health care costs, and less crowding and wait time for patients in offices and emergency departments; however, the optimal use of telemedicine for acute primary care has not been examined, they said.

In a study presented at the annual meeting of the Pediatric Academic Societies, the researchers conducted a retrospective chart review of 638 acute care telemedicine visits conducted by 21 health care providers at a single practice in Washington in October 2020 and November 2020. Approximately half of the patients were male, 65% were white, and 89% had commercial insurance. The most common age group was 6-12 years (23%), followed by 2-3 years (16%), 3-6 years (15%), and 12-18 years (14%).

The primary outcome was the number and nature of visits completed via telemedicine without the need for referral or a subsequent in-person visit. Telemedicine visits for well-child checks and follow-up visits were excluded.

Overall, 60% of the visits (384 of 638) were completed over telemedicine with no need for additional visits or referrals. The most common acute complaints were upper respiratory infections, dermatologic issues, gastrointestinal issues, COVID-19 related issues, and fever (18.7%, 16.3%, 12.9%, 11.9%, and 10.3%, respectively).

Of these, dermatologic and GI concerns were most often completed via telemedicine (93.3% and 81.7%, respectively), while upper respiratory tract infections and fever issues were the least likely to be completed via telemedicine (22.7% and 13.6%), mainly because of the need to report for in-person COVID-19 testing, the researchers said.

Among other less common chief complaints, 100% of breathing concerns, behavior/mental health concerns, and head trauma or falls were addressed via telemedicine without additional referrals or follow-up visits. In addition, 90.9% of urgent care or emergency department follow-ups, 88.9% of ear concerns, and 87.5% of eye concerns were completely resolved via telemedicine visits.

Overall, 3% of patients who were not referred after a telemedicine visit presented in person for worsening symptoms. Of these who were referred after a telemedicine visit, 90% were seen in person within 48 hours.

The study findings were limited by the inclusion of data from only a single center. However, “These early findings provide insight into the utility of telehealth in the primary care setting for a broad array of urgent concerns,” the researchers concluded.
 

Pandemic propelled telemedicine to improve patient care

The widespread adoption of telemedicine in primary care has been a beneficial side effect of the COVID-19 pandemic, said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“Toward the end of World War II and in the push to form the United Nations, Winston Churchill was credited with the saying, ‘Never let a good crisis go to waste,’” said Dr. Joos, who was not connected with the study.

“As awful as this pandemic has been, it has propelled health care delivery at an unprecedented pace into the digital age,” he noted.

The current study is important because it highlights the number of complaints that can be successfully resolved through telemedicine, offering patients and families quicker access and more options for care, Dr. Joos said.

“I feel that giving patients and families an open choice for either telemedicine or in-person visits improves the likelihood that the issue will be resolved efficiently and satisfactorily with fewer visits,” he added.

One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.

The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.

The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.

By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.

The study was published online in JAMA Cardiology.

The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.

For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.

“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.

“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.

“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.

After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.

The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.

Risk higher with vaccination than infection?

For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.

Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.

Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.

“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”

The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.

“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.

The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.

“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.

Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions. 

But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.

Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.

What to advise patients?

In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.

They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.

They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.

“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.

But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.

The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.

“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.

Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.

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

One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.

The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.

The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.

By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.

The study was published online in JAMA Cardiology.

The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.

For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.

“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.

“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.

“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.

After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.

The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.

Risk higher with vaccination than infection?

For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.

Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.

Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.

“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”

The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.

“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.

The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.

“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.

Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions. 

But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.

Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.

What to advise patients?

In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.

They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.

They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.

“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.

But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.

The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.

“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.

Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.

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

One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.

The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.

The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.

By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.

The study was published online in JAMA Cardiology.

The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.

For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.

“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.

“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.

“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.

After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.

The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.

Risk higher with vaccination than infection?

For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.

Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.

Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.

“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”

The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.

“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.

The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.

“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.

Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions. 

But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.

Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.

What to advise patients?

In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.

They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.

They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.

“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.

But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.

The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.

“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.

Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.

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

“Texas investigates parents of transgender teen.” “Court did not force dad to allow chemical castration of son.” Headlines such as these are becoming more common as transgender adolescents and young adults, as well as their families, continue to come under attack from state and local governments. In the 2021 state legislative sessions, more than 100 anti-trans bills were filed across 35 state legislatures. Texas alone saw 13 anti-trans bills, covering everything from sports participation to criminalization of best-practice medical care.¹ Many of these bills are introduced under the guise of “protecting” these adolescents and young adults but are detrimental to their health. They also contain descriptions of gender-affirming care that do not reflect the evidence-based standards of care followed by clinicians across the country. Below is scientifically accurate information on gender-affirming care.
 

Gender identity development

Trajectories of gender identity are diverse. In a large sample of transgender adults (n = 27,715), 10% started to realize they were transgender at age 5 or younger, 16% between ages 6 and 10, 28% between 11 and 15, 29% between 16 and 20, and 18% at age 21 or older.² In childhood, cross-gender play and preferences are a normal part of gender expression and many gender-nonconforming children will go on to identify with the sex they were assigned at birth (labeled cisgender). However, some children explicitly identify with a gender different than the sex they were assigned at birth (labeled transgender). Children who are consistent, insistent, and persistent in this identity appear likely to remain so into adolescence and adulthood. It is important to note that there is no evidence that discouraging gender nonconformity decreases the likelihood that a child will identify as transgender. In fact, this practice is no longer considered ethical, as it can have damaging effects on self-esteem and mental health. In addition, not all transgender people are noticeably gender nonconforming in childhood and that lack of childhood gender nonconformity does not invalidate someone’s transgender identity.

Gender-affirming care

For youth who identify as transgender, all steps in transition prior to puberty are social. This includes steps like changing hairstyles or clothing and using a different (affirmed) name and/or pronouns. This time period allows youth to explore their gender identity and expression. In one large study of 10,000 LGBTQ youth, among youth who reported “all or most people” used their affirmed pronoun, 12% reported a history of suicide attempt.³ In comparison, among those who reported that “no one” used their affirmed pronoun, the suicide attempt rate was 28%. Further, 14% of youth who reported that they were able to make changes in their clothing and appearance reported a past suicide attempt in comparison to 26% of those who were not able to. Many of these youth also are under the care of mental health professionals during this time.

Outcomes

At least 13 studies have documented an improvement in gender dysphoria and/or mental health for adolescents and young adults after beginning gender affirming medical care.⁵ A recent study by Turban et al. showed that access to gender affirming hormones during adolescence or early adulthood was associated with decreased odds of past month suicidal ideation than for those who did not have access to gender-affirming hormones.⁶ Tordoff et al. found that receipt of gender-affirming care, including medications, led to a 60% decrease in depressive symptoms and a 73% decrease in suicidality.⁷ One other question that often arises is whether youth who undergo medical treatment for their transition regret their transition or retransition back to the sex they were assigned at birth. In a large study at a gender clinic in the United Kingdom, they found a regret rate of only 0.47% (16 of 3,398 adolescents aged 13-20).⁸ This is similar to other studies that have also found low rates of regret. Regret is often due to lack of acceptance in society rather than lack of transgender identity.

The care of gender diverse youth takes place on a spectrum, including options that do not include medical treatment. By supporting youth where they are on their gender journey, there is a significant reduction in adverse mental health outcomes. Gender-affirming hormonal treatment is individualized and a thorough multidisciplinary evaluation and informed consent are obtained prior to initiation. There are careful, nuanced discussions with patients and their families to individualize care based on individual goals. By following established evidence-based standards of care, physicians can support their gender-diverse patients throughout their gender journey. Just like other medical treatments, procedures, or surgeries, gender-affirming care should be undertaken in the context of the sacred patient-physician relationship.
 

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas.

References

1. Equality Texas. Legislative Bill Tracker.

2. James SE et al. The Report of the 2015 U.S. Transgender Survey. 2016. Washington, DC: National Center for Transgender Equality.

3. The Trevor Project. 2020. National Survey on LGBTQ Mental Health.

4. Lopez X et al. Curr Opin Pediatrics. 2017;29(4):475-80.

5. Turban J. The evidence for trans youth gender-affirming medical care. Psychology Today. 2022 Jan 24.

6. Turban J et al. Access to gender-affirming hormones during adolescence and mental health outcomes among transgender adults. PLOS ONE. 2022;17(1).

7. Tordoff DM et al. Mental health outcomes in transgender and nonbinary youths receiving gender-affirming care. JAMA Network Open. 2022;5(2).

8. Davies S et al. Detransition rates in a national UK gender identity clinic. Inside Matters. On Law, Ethics, and Religion. 2019 Apr 11.

“Texas investigates parents of transgender teen.” “Court did not force dad to allow chemical castration of son.” Headlines such as these are becoming more common as transgender adolescents and young adults, as well as their families, continue to come under attack from state and local governments. In the 2021 state legislative sessions, more than 100 anti-trans bills were filed across 35 state legislatures. Texas alone saw 13 anti-trans bills, covering everything from sports participation to criminalization of best-practice medical care.¹ Many of these bills are introduced under the guise of “protecting” these adolescents and young adults but are detrimental to their health. They also contain descriptions of gender-affirming care that do not reflect the evidence-based standards of care followed by clinicians across the country. Below is scientifically accurate information on gender-affirming care.
 

Gender identity development

Trajectories of gender identity are diverse. In a large sample of transgender adults (n = 27,715), 10% started to realize they were transgender at age 5 or younger, 16% between ages 6 and 10, 28% between 11 and 15, 29% between 16 and 20, and 18% at age 21 or older.² In childhood, cross-gender play and preferences are a normal part of gender expression and many gender-nonconforming children will go on to identify with the sex they were assigned at birth (labeled cisgender). However, some children explicitly identify with a gender different than the sex they were assigned at birth (labeled transgender). Children who are consistent, insistent, and persistent in this identity appear likely to remain so into adolescence and adulthood. It is important to note that there is no evidence that discouraging gender nonconformity decreases the likelihood that a child will identify as transgender. In fact, this practice is no longer considered ethical, as it can have damaging effects on self-esteem and mental health. In addition, not all transgender people are noticeably gender nonconforming in childhood and that lack of childhood gender nonconformity does not invalidate someone’s transgender identity.

Gender-affirming care

For youth who identify as transgender, all steps in transition prior to puberty are social. This includes steps like changing hairstyles or clothing and using a different (affirmed) name and/or pronouns. This time period allows youth to explore their gender identity and expression. In one large study of 10,000 LGBTQ youth, among youth who reported “all or most people” used their affirmed pronoun, 12% reported a history of suicide attempt.³ In comparison, among those who reported that “no one” used their affirmed pronoun, the suicide attempt rate was 28%. Further, 14% of youth who reported that they were able to make changes in their clothing and appearance reported a past suicide attempt in comparison to 26% of those who were not able to. Many of these youth also are under the care of mental health professionals during this time.

Outcomes

At least 13 studies have documented an improvement in gender dysphoria and/or mental health for adolescents and young adults after beginning gender affirming medical care.⁵ A recent study by Turban et al. showed that access to gender affirming hormones during adolescence or early adulthood was associated with decreased odds of past month suicidal ideation than for those who did not have access to gender-affirming hormones.⁶ Tordoff et al. found that receipt of gender-affirming care, including medications, led to a 60% decrease in depressive symptoms and a 73% decrease in suicidality.⁷ One other question that often arises is whether youth who undergo medical treatment for their transition regret their transition or retransition back to the sex they were assigned at birth. In a large study at a gender clinic in the United Kingdom, they found a regret rate of only 0.47% (16 of 3,398 adolescents aged 13-20).⁸ This is similar to other studies that have also found low rates of regret. Regret is often due to lack of acceptance in society rather than lack of transgender identity.

The care of gender diverse youth takes place on a spectrum, including options that do not include medical treatment. By supporting youth where they are on their gender journey, there is a significant reduction in adverse mental health outcomes. Gender-affirming hormonal treatment is individualized and a thorough multidisciplinary evaluation and informed consent are obtained prior to initiation. There are careful, nuanced discussions with patients and their families to individualize care based on individual goals. By following established evidence-based standards of care, physicians can support their gender-diverse patients throughout their gender journey. Just like other medical treatments, procedures, or surgeries, gender-affirming care should be undertaken in the context of the sacred patient-physician relationship.
 

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas.

References

1. Equality Texas. Legislative Bill Tracker.

2. James SE et al. The Report of the 2015 U.S. Transgender Survey. 2016. Washington, DC: National Center for Transgender Equality.

3. The Trevor Project. 2020. National Survey on LGBTQ Mental Health.

4. Lopez X et al. Curr Opin Pediatrics. 2017;29(4):475-80.

5. Turban J. The evidence for trans youth gender-affirming medical care. Psychology Today. 2022 Jan 24.

6. Turban J et al. Access to gender-affirming hormones during adolescence and mental health outcomes among transgender adults. PLOS ONE. 2022;17(1).

7. Tordoff DM et al. Mental health outcomes in transgender and nonbinary youths receiving gender-affirming care. JAMA Network Open. 2022;5(2).

8. Davies S et al. Detransition rates in a national UK gender identity clinic. Inside Matters. On Law, Ethics, and Religion. 2019 Apr 11.

“Texas investigates parents of transgender teen.” “Court did not force dad to allow chemical castration of son.” Headlines such as these are becoming more common as transgender adolescents and young adults, as well as their families, continue to come under attack from state and local governments. In the 2021 state legislative sessions, more than 100 anti-trans bills were filed across 35 state legislatures. Texas alone saw 13 anti-trans bills, covering everything from sports participation to criminalization of best-practice medical care.¹ Many of these bills are introduced under the guise of “protecting” these adolescents and young adults but are detrimental to their health. They also contain descriptions of gender-affirming care that do not reflect the evidence-based standards of care followed by clinicians across the country. Below is scientifically accurate information on gender-affirming care.
 

Gender identity development

Trajectories of gender identity are diverse. In a large sample of transgender adults (n = 27,715), 10% started to realize they were transgender at age 5 or younger, 16% between ages 6 and 10, 28% between 11 and 15, 29% between 16 and 20, and 18% at age 21 or older.² In childhood, cross-gender play and preferences are a normal part of gender expression and many gender-nonconforming children will go on to identify with the sex they were assigned at birth (labeled cisgender). However, some children explicitly identify with a gender different than the sex they were assigned at birth (labeled transgender). Children who are consistent, insistent, and persistent in this identity appear likely to remain so into adolescence and adulthood. It is important to note that there is no evidence that discouraging gender nonconformity decreases the likelihood that a child will identify as transgender. In fact, this practice is no longer considered ethical, as it can have damaging effects on self-esteem and mental health. In addition, not all transgender people are noticeably gender nonconforming in childhood and that lack of childhood gender nonconformity does not invalidate someone’s transgender identity.

Gender-affirming care

For youth who identify as transgender, all steps in transition prior to puberty are social. This includes steps like changing hairstyles or clothing and using a different (affirmed) name and/or pronouns. This time period allows youth to explore their gender identity and expression. In one large study of 10,000 LGBTQ youth, among youth who reported “all or most people” used their affirmed pronoun, 12% reported a history of suicide attempt.³ In comparison, among those who reported that “no one” used their affirmed pronoun, the suicide attempt rate was 28%. Further, 14% of youth who reported that they were able to make changes in their clothing and appearance reported a past suicide attempt in comparison to 26% of those who were not able to. Many of these youth also are under the care of mental health professionals during this time.

Outcomes

At least 13 studies have documented an improvement in gender dysphoria and/or mental health for adolescents and young adults after beginning gender affirming medical care.⁵ A recent study by Turban et al. showed that access to gender affirming hormones during adolescence or early adulthood was associated with decreased odds of past month suicidal ideation than for those who did not have access to gender-affirming hormones.⁶ Tordoff et al. found that receipt of gender-affirming care, including medications, led to a 60% decrease in depressive symptoms and a 73% decrease in suicidality.⁷ One other question that often arises is whether youth who undergo medical treatment for their transition regret their transition or retransition back to the sex they were assigned at birth. In a large study at a gender clinic in the United Kingdom, they found a regret rate of only 0.47% (16 of 3,398 adolescents aged 13-20).⁸ This is similar to other studies that have also found low rates of regret. Regret is often due to lack of acceptance in society rather than lack of transgender identity.

The care of gender diverse youth takes place on a spectrum, including options that do not include medical treatment. By supporting youth where they are on their gender journey, there is a significant reduction in adverse mental health outcomes. Gender-affirming hormonal treatment is individualized and a thorough multidisciplinary evaluation and informed consent are obtained prior to initiation. There are careful, nuanced discussions with patients and their families to individualize care based on individual goals. By following established evidence-based standards of care, physicians can support their gender-diverse patients throughout their gender journey. Just like other medical treatments, procedures, or surgeries, gender-affirming care should be undertaken in the context of the sacred patient-physician relationship.
 

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas.

References

1. Equality Texas. Legislative Bill Tracker.

2. James SE et al. The Report of the 2015 U.S. Transgender Survey. 2016. Washington, DC: National Center for Transgender Equality.

3. The Trevor Project. 2020. National Survey on LGBTQ Mental Health.

4. Lopez X et al. Curr Opin Pediatrics. 2017;29(4):475-80.

5. Turban J. The evidence for trans youth gender-affirming medical care. Psychology Today. 2022 Jan 24.

6. Turban J et al. Access to gender-affirming hormones during adolescence and mental health outcomes among transgender adults. PLOS ONE. 2022;17(1).

7. Tordoff DM et al. Mental health outcomes in transgender and nonbinary youths receiving gender-affirming care. JAMA Network Open. 2022;5(2).

8. Davies S et al. Detransition rates in a national UK gender identity clinic. Inside Matters. On Law, Ethics, and Religion. 2019 Apr 11.

More than 50% of obese adolescents met criteria for depression, which also was associated with several components of metabolic syndrome, based on data from 160 individuals.

Previous research shows that the metabolic consequences of obesity are worsened with the coexistence of depression in adults, but a similar relationship in obese adolescents has not been explored, according to Nisha Gupta, a medical student at the University of Texas Health Science Center, Houston, and colleagues.

“This relationship is explained by an overactive stress response and adoption of unhealthy lifestyle habits,” both of which increased during the COVID-19 pandemic, the researchers noted in their abstract.

In a study presented at the Pediatric Academic Societies annual meeting, the researchers reviewed data from 160 obese adolescents seen at a pediatric weight management clinic between July 1, 2018, and Dec. 3, 2021. The data included anthropometric, clinical, and laboratory information. Depression was assessed using the Patient Health Questionnaire–9 (PHQ-9). The goal of the study was to compare the prevalence of metabolic syndrome components in obese youth with and without diagnosed depression.

Overall, 46% of the patients had PHQ-9 scores less than 5, which was defined as no clinically significant depression. A total of 26% had current or prior diagnoses of depression, and 25% met the criteria for moderate to severe depression, with PHQ-9 scores of 10 or higher. Notably, 18% of individuals with no prior history of depression met criteria for moderate to severe depression, the researchers wrote.

Teens who reported daytime fatigue or trouble sleeping, and those who reported eating out seven or more times a week had higher scores than those without these reports.

In laboratory analyses, higher PHQ-9 scores were significantly associated with increasing weight, body mass index, body fat percentage, diastolic blood pressure, and fasting blood insulin (P < .02 for all).

The study findings were limited by the relatively small sample size, the researchers noted. However, the results suggest that depression is common, but often underdiagnosed in obese adolescents, and depression screening should be part of obesity management.
 

Study highlights need to screen

The current study is important because of the overall increase in obesity in the United States, which extends to children and teens, Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.

“With skyrocketing rates of obesity among children and teens over the last decades, we are seeing more ‘adult’ diseases seep into the younger ages, including type 2 diabetes, high blood pressure and now, depression,” he said.

“The results are a wake-up call for the need for better system-wide prevention and management of obesity in adolescents and the importance of screening and managing depression in obese teenagers,” he emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

More than 50% of obese adolescents met criteria for depression, which also was associated with several components of metabolic syndrome, based on data from 160 individuals.

Previous research shows that the metabolic consequences of obesity are worsened with the coexistence of depression in adults, but a similar relationship in obese adolescents has not been explored, according to Nisha Gupta, a medical student at the University of Texas Health Science Center, Houston, and colleagues.

“This relationship is explained by an overactive stress response and adoption of unhealthy lifestyle habits,” both of which increased during the COVID-19 pandemic, the researchers noted in their abstract.

In a study presented at the Pediatric Academic Societies annual meeting, the researchers reviewed data from 160 obese adolescents seen at a pediatric weight management clinic between July 1, 2018, and Dec. 3, 2021. The data included anthropometric, clinical, and laboratory information. Depression was assessed using the Patient Health Questionnaire–9 (PHQ-9). The goal of the study was to compare the prevalence of metabolic syndrome components in obese youth with and without diagnosed depression.

Overall, 46% of the patients had PHQ-9 scores less than 5, which was defined as no clinically significant depression. A total of 26% had current or prior diagnoses of depression, and 25% met the criteria for moderate to severe depression, with PHQ-9 scores of 10 or higher. Notably, 18% of individuals with no prior history of depression met criteria for moderate to severe depression, the researchers wrote.

Teens who reported daytime fatigue or trouble sleeping, and those who reported eating out seven or more times a week had higher scores than those without these reports.

In laboratory analyses, higher PHQ-9 scores were significantly associated with increasing weight, body mass index, body fat percentage, diastolic blood pressure, and fasting blood insulin (P < .02 for all).

The study findings were limited by the relatively small sample size, the researchers noted. However, the results suggest that depression is common, but often underdiagnosed in obese adolescents, and depression screening should be part of obesity management.
 

Study highlights need to screen

The current study is important because of the overall increase in obesity in the United States, which extends to children and teens, Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.

“With skyrocketing rates of obesity among children and teens over the last decades, we are seeing more ‘adult’ diseases seep into the younger ages, including type 2 diabetes, high blood pressure and now, depression,” he said.

“The results are a wake-up call for the need for better system-wide prevention and management of obesity in adolescents and the importance of screening and managing depression in obese teenagers,” he emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

More than 50% of obese adolescents met criteria for depression, which also was associated with several components of metabolic syndrome, based on data from 160 individuals.

Previous research shows that the metabolic consequences of obesity are worsened with the coexistence of depression in adults, but a similar relationship in obese adolescents has not been explored, according to Nisha Gupta, a medical student at the University of Texas Health Science Center, Houston, and colleagues.

“This relationship is explained by an overactive stress response and adoption of unhealthy lifestyle habits,” both of which increased during the COVID-19 pandemic, the researchers noted in their abstract.

In a study presented at the Pediatric Academic Societies annual meeting, the researchers reviewed data from 160 obese adolescents seen at a pediatric weight management clinic between July 1, 2018, and Dec. 3, 2021. The data included anthropometric, clinical, and laboratory information. Depression was assessed using the Patient Health Questionnaire–9 (PHQ-9). The goal of the study was to compare the prevalence of metabolic syndrome components in obese youth with and without diagnosed depression.

Overall, 46% of the patients had PHQ-9 scores less than 5, which was defined as no clinically significant depression. A total of 26% had current or prior diagnoses of depression, and 25% met the criteria for moderate to severe depression, with PHQ-9 scores of 10 or higher. Notably, 18% of individuals with no prior history of depression met criteria for moderate to severe depression, the researchers wrote.

Teens who reported daytime fatigue or trouble sleeping, and those who reported eating out seven or more times a week had higher scores than those without these reports.

In laboratory analyses, higher PHQ-9 scores were significantly associated with increasing weight, body mass index, body fat percentage, diastolic blood pressure, and fasting blood insulin (P < .02 for all).

The study findings were limited by the relatively small sample size, the researchers noted. However, the results suggest that depression is common, but often underdiagnosed in obese adolescents, and depression screening should be part of obesity management.
 

Study highlights need to screen

The current study is important because of the overall increase in obesity in the United States, which extends to children and teens, Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.

“With skyrocketing rates of obesity among children and teens over the last decades, we are seeing more ‘adult’ diseases seep into the younger ages, including type 2 diabetes, high blood pressure and now, depression,” he said.

“The results are a wake-up call for the need for better system-wide prevention and management of obesity in adolescents and the importance of screening and managing depression in obese teenagers,” he emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Gun violence has become the leading killer of youth in the United States, rising by nearly 30% between 2019 and 2020.

In 2020, 4,357 children aged 1-19, or approximately 6 in 100,000, died from a gun-related injury, the researchers reported, modestly exceeding the number for auto accidents (3,913) and greatly exceeding deaths caused by suffocation (1,411) or drowning (966).

To observers of gun violence in this country, the grim statistical marker has been all but inevitable. Gunshots were the second-leading cause of death in 2016 among children aged 1-19, the researchers reported. But sharp rises in such fatalities since then, especially in 2020 as the COVID-19 pandemic began, pushed the death toll above all other causes among Americans in this age group.

Guns accounted for more than 45,000 deaths among all age groups in 2020, also a record, according to the U.S. Centers for Disease Control and Prevention.

Although gun deaths rose across nearly every racial and ethnic group, the increase was greatest among Black children. In this group, firearms accounted for more than 15 deaths per 100,000 children in 2020 – up from about 12 such deaths in 2019.

Homicide was the leading cause of gun deaths, followed by suicide and then accidental shootings, although the reason for some deaths could not be determined, according to the researchers.

The researchers reported their findings in the New England Journal of Medicine.

Gun deaths among children are preventable, both researchers and advocates said.

“There are ways to reduce injuries without banning guns,” said Jason Goldstick, PhD, a statistician at the University of Michigan, Ann Arbor, who led the study.

Dr. Goldstick pointed to significant investments in car vehicle safety as a model for policy makers to follow today for making gun injuries less frequent and deadly.

“More people drive today than in the 1970s, and motor vehicle–related injury rates are much lower,” Dr. Goldstick said. Innovations like seatbelt laws and changes in how cars are built have made them less deadly during a crash. Similar innovations are possible in how guns are managed.

More than 4.6 million U.S. children live in homes with unsecured firearms, according to Shannon Watts of the advocacy organization Moms Demand Action. “Securely storing firearms unloaded, locked and separate from ammunition is a simple yet lifesaving action that all gun owners should follow – and lawmakers should require,” she said in a statement to this news organization.

“The effects of gun violence ripple far beyond the child who was struck by a bullet,” said Sarah Burd-Sharps, the senior director of research for the advocacy organization Everytown for Gun Safety. Children might grieve their friends who are now lost or worry that they will be next.

The data in this study aren’t surprising, Ms. Burd-Sharps said, given the large number of homes in which guns are unsecured and the sharp rise in gun sales during the pandemic. On average one child per day in the United States accesses an unsecured gun that ends up injuring or killing themself or someone else.

“Gun owners want to be responsible. These deaths are really preventable,” Ms. Burd-Sharps said. In addition to securing ammunition and firearms separately, she recommended wider use of biometric guns that can only be used by someone with a specific fingerprint. If a young person got ahold of such a gun, even if it was loaded, they couldn’t use it.

The researchers reported no relevant financial conflicts of interest.

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

Gun violence has become the leading killer of youth in the United States, rising by nearly 30% between 2019 and 2020.

In 2020, 4,357 children aged 1-19, or approximately 6 in 100,000, died from a gun-related injury, the researchers reported, modestly exceeding the number for auto accidents (3,913) and greatly exceeding deaths caused by suffocation (1,411) or drowning (966).

To observers of gun violence in this country, the grim statistical marker has been all but inevitable. Gunshots were the second-leading cause of death in 2016 among children aged 1-19, the researchers reported. But sharp rises in such fatalities since then, especially in 2020 as the COVID-19 pandemic began, pushed the death toll above all other causes among Americans in this age group.

Guns accounted for more than 45,000 deaths among all age groups in 2020, also a record, according to the U.S. Centers for Disease Control and Prevention.

Although gun deaths rose across nearly every racial and ethnic group, the increase was greatest among Black children. In this group, firearms accounted for more than 15 deaths per 100,000 children in 2020 – up from about 12 such deaths in 2019.

Homicide was the leading cause of gun deaths, followed by suicide and then accidental shootings, although the reason for some deaths could not be determined, according to the researchers.

The researchers reported their findings in the New England Journal of Medicine.

Gun deaths among children are preventable, both researchers and advocates said.

“There are ways to reduce injuries without banning guns,” said Jason Goldstick, PhD, a statistician at the University of Michigan, Ann Arbor, who led the study.

Dr. Goldstick pointed to significant investments in car vehicle safety as a model for policy makers to follow today for making gun injuries less frequent and deadly.

“More people drive today than in the 1970s, and motor vehicle–related injury rates are much lower,” Dr. Goldstick said. Innovations like seatbelt laws and changes in how cars are built have made them less deadly during a crash. Similar innovations are possible in how guns are managed.

More than 4.6 million U.S. children live in homes with unsecured firearms, according to Shannon Watts of the advocacy organization Moms Demand Action. “Securely storing firearms unloaded, locked and separate from ammunition is a simple yet lifesaving action that all gun owners should follow – and lawmakers should require,” she said in a statement to this news organization.

“The effects of gun violence ripple far beyond the child who was struck by a bullet,” said Sarah Burd-Sharps, the senior director of research for the advocacy organization Everytown for Gun Safety. Children might grieve their friends who are now lost or worry that they will be next.

The data in this study aren’t surprising, Ms. Burd-Sharps said, given the large number of homes in which guns are unsecured and the sharp rise in gun sales during the pandemic. On average one child per day in the United States accesses an unsecured gun that ends up injuring or killing themself or someone else.

“Gun owners want to be responsible. These deaths are really preventable,” Ms. Burd-Sharps said. In addition to securing ammunition and firearms separately, she recommended wider use of biometric guns that can only be used by someone with a specific fingerprint. If a young person got ahold of such a gun, even if it was loaded, they couldn’t use it.

The researchers reported no relevant financial conflicts of interest.

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

Gun violence has become the leading killer of youth in the United States, rising by nearly 30% between 2019 and 2020.

In 2020, 4,357 children aged 1-19, or approximately 6 in 100,000, died from a gun-related injury, the researchers reported, modestly exceeding the number for auto accidents (3,913) and greatly exceeding deaths caused by suffocation (1,411) or drowning (966).

To observers of gun violence in this country, the grim statistical marker has been all but inevitable. Gunshots were the second-leading cause of death in 2016 among children aged 1-19, the researchers reported. But sharp rises in such fatalities since then, especially in 2020 as the COVID-19 pandemic began, pushed the death toll above all other causes among Americans in this age group.

Guns accounted for more than 45,000 deaths among all age groups in 2020, also a record, according to the U.S. Centers for Disease Control and Prevention.

Although gun deaths rose across nearly every racial and ethnic group, the increase was greatest among Black children. In this group, firearms accounted for more than 15 deaths per 100,000 children in 2020 – up from about 12 such deaths in 2019.

Homicide was the leading cause of gun deaths, followed by suicide and then accidental shootings, although the reason for some deaths could not be determined, according to the researchers.

The researchers reported their findings in the New England Journal of Medicine.

Gun deaths among children are preventable, both researchers and advocates said.

“There are ways to reduce injuries without banning guns,” said Jason Goldstick, PhD, a statistician at the University of Michigan, Ann Arbor, who led the study.

Dr. Goldstick pointed to significant investments in car vehicle safety as a model for policy makers to follow today for making gun injuries less frequent and deadly.

“More people drive today than in the 1970s, and motor vehicle–related injury rates are much lower,” Dr. Goldstick said. Innovations like seatbelt laws and changes in how cars are built have made them less deadly during a crash. Similar innovations are possible in how guns are managed.

More than 4.6 million U.S. children live in homes with unsecured firearms, according to Shannon Watts of the advocacy organization Moms Demand Action. “Securely storing firearms unloaded, locked and separate from ammunition is a simple yet lifesaving action that all gun owners should follow – and lawmakers should require,” she said in a statement to this news organization.

“The effects of gun violence ripple far beyond the child who was struck by a bullet,” said Sarah Burd-Sharps, the senior director of research for the advocacy organization Everytown for Gun Safety. Children might grieve their friends who are now lost or worry that they will be next.

The data in this study aren’t surprising, Ms. Burd-Sharps said, given the large number of homes in which guns are unsecured and the sharp rise in gun sales during the pandemic. On average one child per day in the United States accesses an unsecured gun that ends up injuring or killing themself or someone else.

“Gun owners want to be responsible. These deaths are really preventable,” Ms. Burd-Sharps said. In addition to securing ammunition and firearms separately, she recommended wider use of biometric guns that can only be used by someone with a specific fingerprint. If a young person got ahold of such a gun, even if it was loaded, they couldn’t use it.

The researchers reported no relevant financial conflicts of interest.

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

Even within the first year of implementation, the Research to Accelerate Cures and Equity (RACE) for Children Act has made an impact.

“In the year prior to RACE implementation, there were no approvals of therapeutics that required pediatric studies,” said Brittany Avin McKelvey, PhD, science policy analyst with Friends of Cancer Research and a childhood cancer survivor. “Within the first year of implementation, almost half of approved therapeutics required pediatric study.”

The legislation was passed by Congress in 2017 and took effect in August 2020. It requires that therapeutics that are approved for adult cancers be tested in pediatric cancers if those drugs are directed at molecular targets relevant for pediatric cancers.

The RACE Act also requires testing of therapeutics that are given an orphan drug designation. Such drugs were previously exempt from pediatric trials.

Dr. McKelvey presented the new findings at the annual meeting of the American Association for Cancer Research.

To evaluate the impact of the RACE Act during the first year of its implementation, her team assessed all the new cancer drugs approved between August 2019 and August 2021.

Nineteen drugs were identified; 63.2% were approved in the year before the RACE Act took effect, and 36.8% were approved after its implementation. The team suspects that the coronavirus pandemic may have contributed to the lower number of post-RACE approvals.

The researchers found that prior to implementation of the RACE Act, none of the approved adult cancer therapeutics were required to be studied in pediatric populations. But more than 90% of those had molecular targets that would have required that they be studied in pediatric cancers had the RACE Act been in place. The majority of these drugs were exempt because of their designation as orphan drugs.

In the post-RACE group, however, 42.9% of approved drugs are required to be studied in pediatric cancers. One example is infigratinib (Truseltiq), a drug for adult cholangiocarcinoma that targets the protein fibroblast growth factor receptor 2 (FGFR2). Truseltiq is an orphan drug – and thus would have been exempt prior to the RACE Act – but it will now be studied in pediatric patients with advanced or metastatic tumors harboring alterations in FGFR2.

“I find these results encouraging, but it is still very early,” said John Maris, MD, an attending physician and professor of pediatrics at the Children’s Hospital of Philadelphia, who was not involved in the study. “This is only 1 year into implementation, and this legislation will be around for a long time.”

In an interview, Dr. McKelvey noted that although a handful of clinical trials for pediatric cancers have been launched since implementation of RACE, many drugs are still being waived for pediatric study even when a relevant mechanism of action is present – largely because the extremely low incidence of many childhood cancers makes it impractical or, in some cases, impossible to conduct such studies. “This highlights the need for additional opportunities to help facilitate and encourage robust pediatric studies,” she said.

The main limitation of the study is that it examined data 1 year after the implementation of the RACE Act; further analysis is needed to determine the full extent of its impact, Dr. McKelvey said. “The true measure of success will be determined by whether increased pediatric studies actually translate to label expansions for pediatric patient populations and access to these therapies.”

The study was supported by funding from Friends of Cancer Research.

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

Even within the first year of implementation, the Research to Accelerate Cures and Equity (RACE) for Children Act has made an impact.

“In the year prior to RACE implementation, there were no approvals of therapeutics that required pediatric studies,” said Brittany Avin McKelvey, PhD, science policy analyst with Friends of Cancer Research and a childhood cancer survivor. “Within the first year of implementation, almost half of approved therapeutics required pediatric study.”

The legislation was passed by Congress in 2017 and took effect in August 2020. It requires that therapeutics that are approved for adult cancers be tested in pediatric cancers if those drugs are directed at molecular targets relevant for pediatric cancers.

The RACE Act also requires testing of therapeutics that are given an orphan drug designation. Such drugs were previously exempt from pediatric trials.

Dr. McKelvey presented the new findings at the annual meeting of the American Association for Cancer Research.

To evaluate the impact of the RACE Act during the first year of its implementation, her team assessed all the new cancer drugs approved between August 2019 and August 2021.

Nineteen drugs were identified; 63.2% were approved in the year before the RACE Act took effect, and 36.8% were approved after its implementation. The team suspects that the coronavirus pandemic may have contributed to the lower number of post-RACE approvals.

The researchers found that prior to implementation of the RACE Act, none of the approved adult cancer therapeutics were required to be studied in pediatric populations. But more than 90% of those had molecular targets that would have required that they be studied in pediatric cancers had the RACE Act been in place. The majority of these drugs were exempt because of their designation as orphan drugs.

In the post-RACE group, however, 42.9% of approved drugs are required to be studied in pediatric cancers. One example is infigratinib (Truseltiq), a drug for adult cholangiocarcinoma that targets the protein fibroblast growth factor receptor 2 (FGFR2). Truseltiq is an orphan drug – and thus would have been exempt prior to the RACE Act – but it will now be studied in pediatric patients with advanced or metastatic tumors harboring alterations in FGFR2.

“I find these results encouraging, but it is still very early,” said John Maris, MD, an attending physician and professor of pediatrics at the Children’s Hospital of Philadelphia, who was not involved in the study. “This is only 1 year into implementation, and this legislation will be around for a long time.”

In an interview, Dr. McKelvey noted that although a handful of clinical trials for pediatric cancers have been launched since implementation of RACE, many drugs are still being waived for pediatric study even when a relevant mechanism of action is present – largely because the extremely low incidence of many childhood cancers makes it impractical or, in some cases, impossible to conduct such studies. “This highlights the need for additional opportunities to help facilitate and encourage robust pediatric studies,” she said.

The main limitation of the study is that it examined data 1 year after the implementation of the RACE Act; further analysis is needed to determine the full extent of its impact, Dr. McKelvey said. “The true measure of success will be determined by whether increased pediatric studies actually translate to label expansions for pediatric patient populations and access to these therapies.”

The study was supported by funding from Friends of Cancer Research.

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

Even within the first year of implementation, the Research to Accelerate Cures and Equity (RACE) for Children Act has made an impact.

“In the year prior to RACE implementation, there were no approvals of therapeutics that required pediatric studies,” said Brittany Avin McKelvey, PhD, science policy analyst with Friends of Cancer Research and a childhood cancer survivor. “Within the first year of implementation, almost half of approved therapeutics required pediatric study.”

The legislation was passed by Congress in 2017 and took effect in August 2020. It requires that therapeutics that are approved for adult cancers be tested in pediatric cancers if those drugs are directed at molecular targets relevant for pediatric cancers.

The RACE Act also requires testing of therapeutics that are given an orphan drug designation. Such drugs were previously exempt from pediatric trials.

Dr. McKelvey presented the new findings at the annual meeting of the American Association for Cancer Research.

To evaluate the impact of the RACE Act during the first year of its implementation, her team assessed all the new cancer drugs approved between August 2019 and August 2021.

Nineteen drugs were identified; 63.2% were approved in the year before the RACE Act took effect, and 36.8% were approved after its implementation. The team suspects that the coronavirus pandemic may have contributed to the lower number of post-RACE approvals.

The researchers found that prior to implementation of the RACE Act, none of the approved adult cancer therapeutics were required to be studied in pediatric populations. But more than 90% of those had molecular targets that would have required that they be studied in pediatric cancers had the RACE Act been in place. The majority of these drugs were exempt because of their designation as orphan drugs.

In the post-RACE group, however, 42.9% of approved drugs are required to be studied in pediatric cancers. One example is infigratinib (Truseltiq), a drug for adult cholangiocarcinoma that targets the protein fibroblast growth factor receptor 2 (FGFR2). Truseltiq is an orphan drug – and thus would have been exempt prior to the RACE Act – but it will now be studied in pediatric patients with advanced or metastatic tumors harboring alterations in FGFR2.

“I find these results encouraging, but it is still very early,” said John Maris, MD, an attending physician and professor of pediatrics at the Children’s Hospital of Philadelphia, who was not involved in the study. “This is only 1 year into implementation, and this legislation will be around for a long time.”

In an interview, Dr. McKelvey noted that although a handful of clinical trials for pediatric cancers have been launched since implementation of RACE, many drugs are still being waived for pediatric study even when a relevant mechanism of action is present – largely because the extremely low incidence of many childhood cancers makes it impractical or, in some cases, impossible to conduct such studies. “This highlights the need for additional opportunities to help facilitate and encourage robust pediatric studies,” she said.

The main limitation of the study is that it examined data 1 year after the implementation of the RACE Act; further analysis is needed to determine the full extent of its impact, Dr. McKelvey said. “The true measure of success will be determined by whether increased pediatric studies actually translate to label expansions for pediatric patient populations and access to these therapies.”

The study was supported by funding from Friends of Cancer Research.

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

In their heyday, drug reps had big expense budgets and would wine and dine physicians, golf with them, and give gifts to their potential physician clients.

But in 2002, pressure from Congress and increased scrutiny from the American Medical Association prompted the Pharmaceutical Research and Manufacturers of America to adopt a set of voluntary ethical codes to regulate the gifts given to physicians. Now, physicians must report even small gifts or meals to the National Practitioner Data Bank.

Before the restrictions, physician/pharmaceutical rep relationships relied on face-to-face meetings. These included lunches with a limited budget or sharing a cup of coffee during a morning visit to a practice. The parties got to know each other, which led to trust and long-term relationships.

During the COVID-19 pandemic, everything changed. “It was culture shock for us,” admitted Craig F, a career pharmaceutical rep. “We didn’t know what we were going to do.”

The pharmaceutical industry pivoted and quickly got up to speed with Zoom, Microsoft Teams, and the like. “We began by reaching out to doctors via email and cell phones to set up virtual meetings,” Craig said. “Most of the doctors were working from home, doing telehealth whenever possible. For new sales reps, this was particularly difficult, because they couldn’t visit offices and get to know doctors.”

Many physicians didn’t want to devote time to Zoom meetings with pharma reps. “We worked around their schedules, and sometimes this even looked like Sunday calls,” he said.

As vaccination levels increased and medical offices began to reopen, so too did some of the old-school, face-to-face pharma rep/doctor meetings. But most proceeded with caution. “Some pharmaceutical companies didn’t put reps back into the field until the fall of 2020,” said Craig. “If we weren’t welcome in an office, we didn’t push it.”

Once much of the population was vaccinated, the thaw began in earnest, although the drug reps continued to tread cautiously, mask up, and respect the wishes of physicians. Today, Craig estimated that about two-thirds of his appointments are in person.

Still, it’s unlikely that the drug rep–supplied “free staff lunch” will ever regain its former popularity. Medical office staff are still keeping distance, owing to COVID; office schedules may be more crowded and may not allow the time; and many physicians are still nervous about having to report “gifts” or “paid lunches” from pharma. A new paradigm has emerged in the physician/pharma rep relationship, and it’s unlikely things will ever be the same.
 

The post-COVID paradigm shift

The pandemic put a dent in the pharma rep/doctor relationship, said Suzy Jackson, managing director of life sciences at Accenture and an author of The “New” Rules of Healthcare Provider Engagement . “COVID started moving power away from reps because they lost the ability to simply wander into a building and have a conversation with a health care provider. We’re seeing the pandemic evolve the meeting model into a hybrid in-person and virtual.”

“Many doctors are operating in a slower fashion because they’re balancing a hybrid model with patients, as well,” said Craig. “Some of my visits now involve talking to nurses or front-office staff, not getting in to see the doctors.”

The push from some doctors to see reps virtually as opposed to in person is a challenge for the pharma companies. “We get more done in person, so virtual is not our favorite way to do business,” said Craig. “But we’re thankful for any time we can get with doctors, so when they ask to do virtual, we agree.”

Still, the Accenture survey offered good news for pharma reps: Only 4% of respondents didn’t want to continue with in-person meetings at all. “I think of this as a positive,” Ms. Jackson said. “It shows that physicians value these relationships, if they’re done in the right way.”

But a survey by Boston Consulting Group confirms that virtual visits are likely to continue. BCG’s Doctors’ Changing Expectations of Pharma Are Here to Stay revealed that three-quarters of respondent physicians prefer to maintain or increase the amount of virtual engagements with pharma reps after becoming accustomed to the practice during the pandemic.

Under these changing scenarios, said Ms. Jackson, pharma reps have to think about more meaningful ways to engage with doctors.

“I feel that doctors are more crunched for time now, managing hybrid environments,” Craig said. “They have less time and want more patient-specific information that leads to fewer calls back to their offices.”

More physicians now value webinars, virtual training, and speaker programs. Virtual channels, the survey found, “give physicians access to the information they need in an easy and convenient manner.”

Still, physicians have noted that the survey indicated that email communications from pharma reps had increased. Often, physicians found the useful information buried in irrelevant “clutter.”
 

Restrictions on drug reps became tighter

In the 20 years since the guidelines came into existence, PhRMA has continued to strengthen the codes. In 2009, PhRMA issued new recommendations surrounding noneducational gifts and placed a cap of $100 for meals, drug samples, and other items. In 2022, they added layers to the code that focus on speaker programs. For instance, while companies can provide “modest” meals to attendees as an incidental courtesy, pharma reps can no longer pay for or provide alcohol in conjunction with these programs.

The rules vary from state to state. In Minnesota, for instance, gifts from pharma companies cannot exceed $50 per year. Some institutions – such as the Cleveland Clinic – have even stricter rules. “When we have conventions, we put up signage reminding doctors from the strictest states that they can’t even accept a cup of coffee from a rep,” said Craig.

However, COVID hasn’t completely changed doctor/pharma relationships. In Ms. Jackson’s words, “In spite of the shift to a more hybrid model, this is a very human relationship yielding real human results.”

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

In their heyday, drug reps had big expense budgets and would wine and dine physicians, golf with them, and give gifts to their potential physician clients.

But in 2002, pressure from Congress and increased scrutiny from the American Medical Association prompted the Pharmaceutical Research and Manufacturers of America to adopt a set of voluntary ethical codes to regulate the gifts given to physicians. Now, physicians must report even small gifts or meals to the National Practitioner Data Bank.

Before the restrictions, physician/pharmaceutical rep relationships relied on face-to-face meetings. These included lunches with a limited budget or sharing a cup of coffee during a morning visit to a practice. The parties got to know each other, which led to trust and long-term relationships.

During the COVID-19 pandemic, everything changed. “It was culture shock for us,” admitted Craig F, a career pharmaceutical rep. “We didn’t know what we were going to do.”

The pharmaceutical industry pivoted and quickly got up to speed with Zoom, Microsoft Teams, and the like. “We began by reaching out to doctors via email and cell phones to set up virtual meetings,” Craig said. “Most of the doctors were working from home, doing telehealth whenever possible. For new sales reps, this was particularly difficult, because they couldn’t visit offices and get to know doctors.”

Many physicians didn’t want to devote time to Zoom meetings with pharma reps. “We worked around their schedules, and sometimes this even looked like Sunday calls,” he said.

As vaccination levels increased and medical offices began to reopen, so too did some of the old-school, face-to-face pharma rep/doctor meetings. But most proceeded with caution. “Some pharmaceutical companies didn’t put reps back into the field until the fall of 2020,” said Craig. “If we weren’t welcome in an office, we didn’t push it.”

Once much of the population was vaccinated, the thaw began in earnest, although the drug reps continued to tread cautiously, mask up, and respect the wishes of physicians. Today, Craig estimated that about two-thirds of his appointments are in person.

Still, it’s unlikely that the drug rep–supplied “free staff lunch” will ever regain its former popularity. Medical office staff are still keeping distance, owing to COVID; office schedules may be more crowded and may not allow the time; and many physicians are still nervous about having to report “gifts” or “paid lunches” from pharma. A new paradigm has emerged in the physician/pharma rep relationship, and it’s unlikely things will ever be the same.
 

The post-COVID paradigm shift

The pandemic put a dent in the pharma rep/doctor relationship, said Suzy Jackson, managing director of life sciences at Accenture and an author of The “New” Rules of Healthcare Provider Engagement . “COVID started moving power away from reps because they lost the ability to simply wander into a building and have a conversation with a health care provider. We’re seeing the pandemic evolve the meeting model into a hybrid in-person and virtual.”

“Many doctors are operating in a slower fashion because they’re balancing a hybrid model with patients, as well,” said Craig. “Some of my visits now involve talking to nurses or front-office staff, not getting in to see the doctors.”

The push from some doctors to see reps virtually as opposed to in person is a challenge for the pharma companies. “We get more done in person, so virtual is not our favorite way to do business,” said Craig. “But we’re thankful for any time we can get with doctors, so when they ask to do virtual, we agree.”

Still, the Accenture survey offered good news for pharma reps: Only 4% of respondents didn’t want to continue with in-person meetings at all. “I think of this as a positive,” Ms. Jackson said. “It shows that physicians value these relationships, if they’re done in the right way.”

But a survey by Boston Consulting Group confirms that virtual visits are likely to continue. BCG’s Doctors’ Changing Expectations of Pharma Are Here to Stay revealed that three-quarters of respondent physicians prefer to maintain or increase the amount of virtual engagements with pharma reps after becoming accustomed to the practice during the pandemic.

Under these changing scenarios, said Ms. Jackson, pharma reps have to think about more meaningful ways to engage with doctors.

“I feel that doctors are more crunched for time now, managing hybrid environments,” Craig said. “They have less time and want more patient-specific information that leads to fewer calls back to their offices.”

More physicians now value webinars, virtual training, and speaker programs. Virtual channels, the survey found, “give physicians access to the information they need in an easy and convenient manner.”

Still, physicians have noted that the survey indicated that email communications from pharma reps had increased. Often, physicians found the useful information buried in irrelevant “clutter.”
 

Restrictions on drug reps became tighter

In the 20 years since the guidelines came into existence, PhRMA has continued to strengthen the codes. In 2009, PhRMA issued new recommendations surrounding noneducational gifts and placed a cap of $100 for meals, drug samples, and other items. In 2022, they added layers to the code that focus on speaker programs. For instance, while companies can provide “modest” meals to attendees as an incidental courtesy, pharma reps can no longer pay for or provide alcohol in conjunction with these programs.

The rules vary from state to state. In Minnesota, for instance, gifts from pharma companies cannot exceed $50 per year. Some institutions – such as the Cleveland Clinic – have even stricter rules. “When we have conventions, we put up signage reminding doctors from the strictest states that they can’t even accept a cup of coffee from a rep,” said Craig.

However, COVID hasn’t completely changed doctor/pharma relationships. In Ms. Jackson’s words, “In spite of the shift to a more hybrid model, this is a very human relationship yielding real human results.”

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

In their heyday, drug reps had big expense budgets and would wine and dine physicians, golf with them, and give gifts to their potential physician clients.

But in 2002, pressure from Congress and increased scrutiny from the American Medical Association prompted the Pharmaceutical Research and Manufacturers of America to adopt a set of voluntary ethical codes to regulate the gifts given to physicians. Now, physicians must report even small gifts or meals to the National Practitioner Data Bank.

Before the restrictions, physician/pharmaceutical rep relationships relied on face-to-face meetings. These included lunches with a limited budget or sharing a cup of coffee during a morning visit to a practice. The parties got to know each other, which led to trust and long-term relationships.

During the COVID-19 pandemic, everything changed. “It was culture shock for us,” admitted Craig F, a career pharmaceutical rep. “We didn’t know what we were going to do.”

The pharmaceutical industry pivoted and quickly got up to speed with Zoom, Microsoft Teams, and the like. “We began by reaching out to doctors via email and cell phones to set up virtual meetings,” Craig said. “Most of the doctors were working from home, doing telehealth whenever possible. For new sales reps, this was particularly difficult, because they couldn’t visit offices and get to know doctors.”

Many physicians didn’t want to devote time to Zoom meetings with pharma reps. “We worked around their schedules, and sometimes this even looked like Sunday calls,” he said.

As vaccination levels increased and medical offices began to reopen, so too did some of the old-school, face-to-face pharma rep/doctor meetings. But most proceeded with caution. “Some pharmaceutical companies didn’t put reps back into the field until the fall of 2020,” said Craig. “If we weren’t welcome in an office, we didn’t push it.”

Once much of the population was vaccinated, the thaw began in earnest, although the drug reps continued to tread cautiously, mask up, and respect the wishes of physicians. Today, Craig estimated that about two-thirds of his appointments are in person.

Still, it’s unlikely that the drug rep–supplied “free staff lunch” will ever regain its former popularity. Medical office staff are still keeping distance, owing to COVID; office schedules may be more crowded and may not allow the time; and many physicians are still nervous about having to report “gifts” or “paid lunches” from pharma. A new paradigm has emerged in the physician/pharma rep relationship, and it’s unlikely things will ever be the same.
 

The post-COVID paradigm shift

The pandemic put a dent in the pharma rep/doctor relationship, said Suzy Jackson, managing director of life sciences at Accenture and an author of The “New” Rules of Healthcare Provider Engagement . “COVID started moving power away from reps because they lost the ability to simply wander into a building and have a conversation with a health care provider. We’re seeing the pandemic evolve the meeting model into a hybrid in-person and virtual.”

“Many doctors are operating in a slower fashion because they’re balancing a hybrid model with patients, as well,” said Craig. “Some of my visits now involve talking to nurses or front-office staff, not getting in to see the doctors.”

The push from some doctors to see reps virtually as opposed to in person is a challenge for the pharma companies. “We get more done in person, so virtual is not our favorite way to do business,” said Craig. “But we’re thankful for any time we can get with doctors, so when they ask to do virtual, we agree.”

Still, the Accenture survey offered good news for pharma reps: Only 4% of respondents didn’t want to continue with in-person meetings at all. “I think of this as a positive,” Ms. Jackson said. “It shows that physicians value these relationships, if they’re done in the right way.”

But a survey by Boston Consulting Group confirms that virtual visits are likely to continue. BCG’s Doctors’ Changing Expectations of Pharma Are Here to Stay revealed that three-quarters of respondent physicians prefer to maintain or increase the amount of virtual engagements with pharma reps after becoming accustomed to the practice during the pandemic.

Under these changing scenarios, said Ms. Jackson, pharma reps have to think about more meaningful ways to engage with doctors.

“I feel that doctors are more crunched for time now, managing hybrid environments,” Craig said. “They have less time and want more patient-specific information that leads to fewer calls back to their offices.”

More physicians now value webinars, virtual training, and speaker programs. Virtual channels, the survey found, “give physicians access to the information they need in an easy and convenient manner.”

Still, physicians have noted that the survey indicated that email communications from pharma reps had increased. Often, physicians found the useful information buried in irrelevant “clutter.”
 

Restrictions on drug reps became tighter

In the 20 years since the guidelines came into existence, PhRMA has continued to strengthen the codes. In 2009, PhRMA issued new recommendations surrounding noneducational gifts and placed a cap of $100 for meals, drug samples, and other items. In 2022, they added layers to the code that focus on speaker programs. For instance, while companies can provide “modest” meals to attendees as an incidental courtesy, pharma reps can no longer pay for or provide alcohol in conjunction with these programs.

The rules vary from state to state. In Minnesota, for instance, gifts from pharma companies cannot exceed $50 per year. Some institutions – such as the Cleveland Clinic – have even stricter rules. “When we have conventions, we put up signage reminding doctors from the strictest states that they can’t even accept a cup of coffee from a rep,” said Craig.

However, COVID hasn’t completely changed doctor/pharma relationships. In Ms. Jackson’s words, “In spite of the shift to a more hybrid model, this is a very human relationship yielding real human results.”

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

The force is with Ukraine, always

Of all the things we could want from Star Wars, a lightsaber is at the top of the list. And someone is working on that. But second is probably the iconic X-wing. It was used to blow up the Death Star after all: Who wouldn’t want one?

A real-life star fighter may be outside our technological capabilities, but Dr. Akaki Lekiachvili of Atlanta has done the next best thing and constructed a two-thirds scale model to encourage kids to enter the sciences and, with the advent of the war in Ukraine, raise money for medical supplies to assist doctors in the embattled country. Perhaps unsurprisingly, Dr. Lekiachvili, originally from Georgia (the country, former Soviet republic, and previous target of Russian aggression in 2008), takes a dim view toward the invasion of Ukraine: “Russia is like the Evil Empire and Ukraine the Rebel Alliance.”

Richard Franki/MDedge

It’s been a long road finishing the X-Wing, as Dr. Lekiachvili started the project in 2016 and spent $60,000 on it, posting numerous updates on social media over that time, even attracting the attention of Luke Skywalker himself, actor Mark Hamill. Now that he’s done, he’s brought his model out to the public multiple times, delighting kids and adults alike. It can’t fly, but it has an engine and wheels so it can move, the wings can lock into attack position, the thrusters light up, and the voices of Obi-Wan Kenobi and R2-D2 guide children along as they sit in the cockpit.

Dr. Lekiachvili hopes to auction off his creation to a collector and donate the proceeds to Ukrainian charities, and we’re sure he’ll receive far more than the $60,000 he spent building his masterpiece. Now, if you’ll excuse us, we’re off to raid our bank accounts. We have a Death Star to destroy.
 

I’m a doctor, not a hologram

Telemedicine got a big boost during the early phase of the pandemic when hospitals and medical offices were off limits to anyone without COVID-19, but things have cooled off, telemedically speaking, since then. Well, NASA may have heated them up again. Or maybe it was Starfleet. Hmm, wait a second while we check. … No, it was NASA.

Thomas Pesquet/ESA

The space agency used the Microsoft Hololens Kinect camera and a personal computer with custom software from Aexa Aerospace to “holoport” NASA flight surgeon Josef Schmid up to the International Space Station, where he had a conversation with European Space Agency astronaut Thomas Pesquet, who wore an augmented reality headset that allowed him to see, hear, and interact with a 3D representation of the earthbound medical provider.

“Holoportation has been in use since at least 2016 by Microsoft, but this is the first use in such an extreme and remote environment such as space,” NASA said in a recent written statement, noting that the extreme house call took place on Oct. 8, 2021.

They seem to be forgetting about Star Trek, but we’ll let them slide on that one. Anyway, NASA didn’t share any details of the medical holoconversation – which may have strained the limits of HIPAA’s portability provisions – but Dr. Schmid described it as “a brand-new way of human exploration, where our human entity is able to travel off the planet. Our physical body is not there, but our human entity absolutely is there.”

Boldly doctoring where no doctor has gone before, you might say. You also might notice from the photo that Dr. Schmid went full Trekkie with a genuine Vulcan salute. Live long and prosper, Dr. Schmid. Live long and prosper.
 

Add electricity for umami

Salt makes everything taste better. Unfortunately, excess salt can cause problems for our bodies down the line, starting with high blood pressure and continuing on to heart disease and strokes. So how do we enjoy our deliciously salty foods without putting ourselves at risk? One answer may be electricity.

OpenClipart-Vectors/Pixabay

Researchers at Meiji University in Tokyo partnered with food and beverage maker Kirin to develop a set of electric chopsticks to boost the taste of salt in foods without the extra sodium. According to codeveloper and Meiji University professor Homei Miyashita, the device, worn like a watch with a wire attached to one of the chopsticks, “uses a weak electrical current to transmit sodium ions from food, through the chopsticks, to the mouth where they create a sense of saltines,” Reuters said.

In a country like Japan, where a lot of food is made with heavily sodium-based ingredients like miso and soy sauce, the average adult consumes 10 g of salt a day. That’s twice the recommended amount proposed by the World Health Organization. To not sacrifice bland food for better health, this device, which enhances the saltiness of the food consumed by 1.5 times, offers a fairly easy solution to a big public health crisis.

The chopsticks were tested by giving participants reduced-sodium miso soup. They told the researchers that the food was improved in “richness, sweetness, and overall tastiness,” the Guardian said.

Worried about having something electric in your mouth? Don’t worry. Kirin said in a statement that the electricity is very weak and not enough to affect the body.

The chopsticks are still in a prototype stage, but you may be able to get your pair as soon as next year. Until then, maybe be a little mindful of the salt.
 

Pet poop works in mysterious ways

We usually see it as a burden when our pets poop and pee in the house, but those bodily excretions may be able to tell us something about cancer-causing toxins running rampant in our homes.

PxHere

Those toxins, known as aromatic amines, can be found in tobacco smoke and dyes used in make-up, textiles, and plastics. “Our findings suggest that pets are coming into contact with aromatic amines that leach from products in their household environment,” lead author Sridhar Chinthakindi, PhD, of NYU Langone Health, said in a statement from the university. “As these substances have been tied to bladder, colorectal, and other forms of cancer, our results may help explain why so many dogs and cats develop such diseases.”

Tobacco smoke was not the main source of the aromatic amines found in the poop and urine, but 70% of dogs and 80% of cats had these chemicals in their waste. The researchers looked for 30 types of aromatic amines plus nicotine in the sample and found 8. The chemical concentrations were much higher in cats than in dogs, possibly because of differences in exposure and metabolism between the two species, they suggested.

“If [pets] are getting exposed to toxins in our homes, then we had better take a closer look at our own exposure,” said senior author Kurunthachalam Kannan, PhD, of NYU Langone.

So the next time your pet poops or pees in the house, don’t get mad. Maybe they’re just trying to help you out by supplying some easy-to-collect samples.

The force is with Ukraine, always

Of all the things we could want from Star Wars, a lightsaber is at the top of the list. And someone is working on that. But second is probably the iconic X-wing. It was used to blow up the Death Star after all: Who wouldn’t want one?

A real-life star fighter may be outside our technological capabilities, but Dr. Akaki Lekiachvili of Atlanta has done the next best thing and constructed a two-thirds scale model to encourage kids to enter the sciences and, with the advent of the war in Ukraine, raise money for medical supplies to assist doctors in the embattled country. Perhaps unsurprisingly, Dr. Lekiachvili, originally from Georgia (the country, former Soviet republic, and previous target of Russian aggression in 2008), takes a dim view toward the invasion of Ukraine: “Russia is like the Evil Empire and Ukraine the Rebel Alliance.”

Richard Franki/MDedge

It’s been a long road finishing the X-Wing, as Dr. Lekiachvili started the project in 2016 and spent $60,000 on it, posting numerous updates on social media over that time, even attracting the attention of Luke Skywalker himself, actor Mark Hamill. Now that he’s done, he’s brought his model out to the public multiple times, delighting kids and adults alike. It can’t fly, but it has an engine and wheels so it can move, the wings can lock into attack position, the thrusters light up, and the voices of Obi-Wan Kenobi and R2-D2 guide children along as they sit in the cockpit.

Dr. Lekiachvili hopes to auction off his creation to a collector and donate the proceeds to Ukrainian charities, and we’re sure he’ll receive far more than the $60,000 he spent building his masterpiece. Now, if you’ll excuse us, we’re off to raid our bank accounts. We have a Death Star to destroy.
 

I’m a doctor, not a hologram

Telemedicine got a big boost during the early phase of the pandemic when hospitals and medical offices were off limits to anyone without COVID-19, but things have cooled off, telemedically speaking, since then. Well, NASA may have heated them up again. Or maybe it was Starfleet. Hmm, wait a second while we check. … No, it was NASA.

Thomas Pesquet/ESA

The space agency used the Microsoft Hololens Kinect camera and a personal computer with custom software from Aexa Aerospace to “holoport” NASA flight surgeon Josef Schmid up to the International Space Station, where he had a conversation with European Space Agency astronaut Thomas Pesquet, who wore an augmented reality headset that allowed him to see, hear, and interact with a 3D representation of the earthbound medical provider.

“Holoportation has been in use since at least 2016 by Microsoft, but this is the first use in such an extreme and remote environment such as space,” NASA said in a recent written statement, noting that the extreme house call took place on Oct. 8, 2021.

They seem to be forgetting about Star Trek, but we’ll let them slide on that one. Anyway, NASA didn’t share any details of the medical holoconversation – which may have strained the limits of HIPAA’s portability provisions – but Dr. Schmid described it as “a brand-new way of human exploration, where our human entity is able to travel off the planet. Our physical body is not there, but our human entity absolutely is there.”

Boldly doctoring where no doctor has gone before, you might say. You also might notice from the photo that Dr. Schmid went full Trekkie with a genuine Vulcan salute. Live long and prosper, Dr. Schmid. Live long and prosper.
 

Add electricity for umami

Salt makes everything taste better. Unfortunately, excess salt can cause problems for our bodies down the line, starting with high blood pressure and continuing on to heart disease and strokes. So how do we enjoy our deliciously salty foods without putting ourselves at risk? One answer may be electricity.

OpenClipart-Vectors/Pixabay

Researchers at Meiji University in Tokyo partnered with food and beverage maker Kirin to develop a set of electric chopsticks to boost the taste of salt in foods without the extra sodium. According to codeveloper and Meiji University professor Homei Miyashita, the device, worn like a watch with a wire attached to one of the chopsticks, “uses a weak electrical current to transmit sodium ions from food, through the chopsticks, to the mouth where they create a sense of saltines,” Reuters said.

In a country like Japan, where a lot of food is made with heavily sodium-based ingredients like miso and soy sauce, the average adult consumes 10 g of salt a day. That’s twice the recommended amount proposed by the World Health Organization. To not sacrifice bland food for better health, this device, which enhances the saltiness of the food consumed by 1.5 times, offers a fairly easy solution to a big public health crisis.

The chopsticks were tested by giving participants reduced-sodium miso soup. They told the researchers that the food was improved in “richness, sweetness, and overall tastiness,” the Guardian said.

Worried about having something electric in your mouth? Don’t worry. Kirin said in a statement that the electricity is very weak and not enough to affect the body.

The chopsticks are still in a prototype stage, but you may be able to get your pair as soon as next year. Until then, maybe be a little mindful of the salt.
 

Pet poop works in mysterious ways

We usually see it as a burden when our pets poop and pee in the house, but those bodily excretions may be able to tell us something about cancer-causing toxins running rampant in our homes.

PxHere

Those toxins, known as aromatic amines, can be found in tobacco smoke and dyes used in make-up, textiles, and plastics. “Our findings suggest that pets are coming into contact with aromatic amines that leach from products in their household environment,” lead author Sridhar Chinthakindi, PhD, of NYU Langone Health, said in a statement from the university. “As these substances have been tied to bladder, colorectal, and other forms of cancer, our results may help explain why so many dogs and cats develop such diseases.”

Tobacco smoke was not the main source of the aromatic amines found in the poop and urine, but 70% of dogs and 80% of cats had these chemicals in their waste. The researchers looked for 30 types of aromatic amines plus nicotine in the sample and found 8. The chemical concentrations were much higher in cats than in dogs, possibly because of differences in exposure and metabolism between the two species, they suggested.

“If [pets] are getting exposed to toxins in our homes, then we had better take a closer look at our own exposure,” said senior author Kurunthachalam Kannan, PhD, of NYU Langone.

So the next time your pet poops or pees in the house, don’t get mad. Maybe they’re just trying to help you out by supplying some easy-to-collect samples.

The force is with Ukraine, always

Of all the things we could want from Star Wars, a lightsaber is at the top of the list. And someone is working on that. But second is probably the iconic X-wing. It was used to blow up the Death Star after all: Who wouldn’t want one?

A real-life star fighter may be outside our technological capabilities, but Dr. Akaki Lekiachvili of Atlanta has done the next best thing and constructed a two-thirds scale model to encourage kids to enter the sciences and, with the advent of the war in Ukraine, raise money for medical supplies to assist doctors in the embattled country. Perhaps unsurprisingly, Dr. Lekiachvili, originally from Georgia (the country, former Soviet republic, and previous target of Russian aggression in 2008), takes a dim view toward the invasion of Ukraine: “Russia is like the Evil Empire and Ukraine the Rebel Alliance.”

Richard Franki/MDedge

It’s been a long road finishing the X-Wing, as Dr. Lekiachvili started the project in 2016 and spent $60,000 on it, posting numerous updates on social media over that time, even attracting the attention of Luke Skywalker himself, actor Mark Hamill. Now that he’s done, he’s brought his model out to the public multiple times, delighting kids and adults alike. It can’t fly, but it has an engine and wheels so it can move, the wings can lock into attack position, the thrusters light up, and the voices of Obi-Wan Kenobi and R2-D2 guide children along as they sit in the cockpit.

Dr. Lekiachvili hopes to auction off his creation to a collector and donate the proceeds to Ukrainian charities, and we’re sure he’ll receive far more than the $60,000 he spent building his masterpiece. Now, if you’ll excuse us, we’re off to raid our bank accounts. We have a Death Star to destroy.
 

I’m a doctor, not a hologram

Telemedicine got a big boost during the early phase of the pandemic when hospitals and medical offices were off limits to anyone without COVID-19, but things have cooled off, telemedically speaking, since then. Well, NASA may have heated them up again. Or maybe it was Starfleet. Hmm, wait a second while we check. … No, it was NASA.

Thomas Pesquet/ESA

The space agency used the Microsoft Hololens Kinect camera and a personal computer with custom software from Aexa Aerospace to “holoport” NASA flight surgeon Josef Schmid up to the International Space Station, where he had a conversation with European Space Agency astronaut Thomas Pesquet, who wore an augmented reality headset that allowed him to see, hear, and interact with a 3D representation of the earthbound medical provider.

“Holoportation has been in use since at least 2016 by Microsoft, but this is the first use in such an extreme and remote environment such as space,” NASA said in a recent written statement, noting that the extreme house call took place on Oct. 8, 2021.

They seem to be forgetting about Star Trek, but we’ll let them slide on that one. Anyway, NASA didn’t share any details of the medical holoconversation – which may have strained the limits of HIPAA’s portability provisions – but Dr. Schmid described it as “a brand-new way of human exploration, where our human entity is able to travel off the planet. Our physical body is not there, but our human entity absolutely is there.”

Boldly doctoring where no doctor has gone before, you might say. You also might notice from the photo that Dr. Schmid went full Trekkie with a genuine Vulcan salute. Live long and prosper, Dr. Schmid. Live long and prosper.
 

Add electricity for umami

Salt makes everything taste better. Unfortunately, excess salt can cause problems for our bodies down the line, starting with high blood pressure and continuing on to heart disease and strokes. So how do we enjoy our deliciously salty foods without putting ourselves at risk? One answer may be electricity.

OpenClipart-Vectors/Pixabay

Researchers at Meiji University in Tokyo partnered with food and beverage maker Kirin to develop a set of electric chopsticks to boost the taste of salt in foods without the extra sodium. According to codeveloper and Meiji University professor Homei Miyashita, the device, worn like a watch with a wire attached to one of the chopsticks, “uses a weak electrical current to transmit sodium ions from food, through the chopsticks, to the mouth where they create a sense of saltines,” Reuters said.

In a country like Japan, where a lot of food is made with heavily sodium-based ingredients like miso and soy sauce, the average adult consumes 10 g of salt a day. That’s twice the recommended amount proposed by the World Health Organization. To not sacrifice bland food for better health, this device, which enhances the saltiness of the food consumed by 1.5 times, offers a fairly easy solution to a big public health crisis.

The chopsticks were tested by giving participants reduced-sodium miso soup. They told the researchers that the food was improved in “richness, sweetness, and overall tastiness,” the Guardian said.

Worried about having something electric in your mouth? Don’t worry. Kirin said in a statement that the electricity is very weak and not enough to affect the body.

The chopsticks are still in a prototype stage, but you may be able to get your pair as soon as next year. Until then, maybe be a little mindful of the salt.
 

Pet poop works in mysterious ways

We usually see it as a burden when our pets poop and pee in the house, but those bodily excretions may be able to tell us something about cancer-causing toxins running rampant in our homes.

PxHere

Those toxins, known as aromatic amines, can be found in tobacco smoke and dyes used in make-up, textiles, and plastics. “Our findings suggest that pets are coming into contact with aromatic amines that leach from products in their household environment,” lead author Sridhar Chinthakindi, PhD, of NYU Langone Health, said in a statement from the university. “As these substances have been tied to bladder, colorectal, and other forms of cancer, our results may help explain why so many dogs and cats develop such diseases.”

Tobacco smoke was not the main source of the aromatic amines found in the poop and urine, but 70% of dogs and 80% of cats had these chemicals in their waste. The researchers looked for 30 types of aromatic amines plus nicotine in the sample and found 8. The chemical concentrations were much higher in cats than in dogs, possibly because of differences in exposure and metabolism between the two species, they suggested.

“If [pets] are getting exposed to toxins in our homes, then we had better take a closer look at our own exposure,” said senior author Kurunthachalam Kannan, PhD, of NYU Langone.

So the next time your pet poops or pees in the house, don’t get mad. Maybe they’re just trying to help you out by supplying some easy-to-collect samples.

Just what we need – another tick-borne virus that mimics ehrlichiosis or anaplasmosis and is endemic in the lower Midwest and parts of the Southeast and Atlantic coast of the United States. Yet here it is. Human illness was first reported in northeast Missouri in 2012. It is known to be associated with Lone star ticks, with reservoirs including white tailed deer and several other mammals. 

It has up to a 2-week incubation period. So, living in or having recently traveled to an endemic area is an important historical clue. Most infections present with headache, fever, fatigue, nausea, diarrhea, and/or muscle and joint pain. There may be a nonspecific rash but nothing like the classic Lyme disease or Rocky Mountain spotted fever rashes. The illness may be severe enough to lead to hospitalization, particularly when laboratory tests results, such as leukopenia, thrombocytopenia, and/or elevated liver function studies, raise the specter of other serious illnesses.  

There is no commercial test, so the diagnosis is by serology and/or reverse transcription–polymerase chain reaction by the Centers for Disease Control and Prevention. Clinicians considering the diagnosis should contact their state health department for instructions on sample collection, processing, and shipment.   

The good news is that it appears to be self-limited. There is no specific treatment or vaccine, so management is by supportive treatment.

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

Just what we need – another tick-borne virus that mimics ehrlichiosis or anaplasmosis and is endemic in the lower Midwest and parts of the Southeast and Atlantic coast of the United States. Yet here it is. Human illness was first reported in northeast Missouri in 2012. It is known to be associated with Lone star ticks, with reservoirs including white tailed deer and several other mammals. 

It has up to a 2-week incubation period. So, living in or having recently traveled to an endemic area is an important historical clue. Most infections present with headache, fever, fatigue, nausea, diarrhea, and/or muscle and joint pain. There may be a nonspecific rash but nothing like the classic Lyme disease or Rocky Mountain spotted fever rashes. The illness may be severe enough to lead to hospitalization, particularly when laboratory tests results, such as leukopenia, thrombocytopenia, and/or elevated liver function studies, raise the specter of other serious illnesses.  

There is no commercial test, so the diagnosis is by serology and/or reverse transcription–polymerase chain reaction by the Centers for Disease Control and Prevention. Clinicians considering the diagnosis should contact their state health department for instructions on sample collection, processing, and shipment.   

The good news is that it appears to be self-limited. There is no specific treatment or vaccine, so management is by supportive treatment.

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

Just what we need – another tick-borne virus that mimics ehrlichiosis or anaplasmosis and is endemic in the lower Midwest and parts of the Southeast and Atlantic coast of the United States. Yet here it is. Human illness was first reported in northeast Missouri in 2012. It is known to be associated with Lone star ticks, with reservoirs including white tailed deer and several other mammals. 

It has up to a 2-week incubation period. So, living in or having recently traveled to an endemic area is an important historical clue. Most infections present with headache, fever, fatigue, nausea, diarrhea, and/or muscle and joint pain. There may be a nonspecific rash but nothing like the classic Lyme disease or Rocky Mountain spotted fever rashes. The illness may be severe enough to lead to hospitalization, particularly when laboratory tests results, such as leukopenia, thrombocytopenia, and/or elevated liver function studies, raise the specter of other serious illnesses.  

There is no commercial test, so the diagnosis is by serology and/or reverse transcription–polymerase chain reaction by the Centers for Disease Control and Prevention. Clinicians considering the diagnosis should contact their state health department for instructions on sample collection, processing, and shipment.   

The good news is that it appears to be self-limited. There is no specific treatment or vaccine, so management is by supportive treatment.

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.