CHEST Physician

While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay.

“We remain confident that the benefits of vaccination far exceed the very unusual risks,” the leadership of the AHA/ASA said in a statement issued June 12.

“The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,” they point out.

Late last week, the Centers for Disease Control and Prevention alerted health care providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna.

The CDC is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

These cases may occur more often in males than females and more frequently after the second dose than the first dose of either mRNA vaccine. Symptoms typically occur in the 3 days after administration.

“The CDC’s ongoing investigation into cases of suspected myocarditis reflects a strong and steadfast commitment to transparency and the importance of scientific rigor on all fronts. We applaud the CDC’s unwavering efforts to lead our nation’s scientific and public health efforts, including ensuring the continued safety of the COVID-19 vaccines,” the AHA/ASA states.

They emphasize that vaccinations should continue, and say it’s important to consider the details of the suspected myocarditis cases being investigated by the CDC.

As of June 11, more than 306 million doses of COVID-19 vaccines have been administered in the United States (since Dec. 14, 2020) and nearly 43% of Americans – more than 142 million people – are now fully vaccinated.

According to the June 10 CDC VAERS report detailing adverse events through May 31:

• 789 cases of suspected myocarditis have been reported, with 475 involving people younger than 30 years; 79 cases reported were in patients 16 or 17 years old.
• The vast majority (81%) of the 270 patients younger than 30 years who were discharged from care after suspected myocarditis related to COVID-19 vaccination have recovered fully; the remaining 19% of patients report ongoing symptoms or complete data are missing.
• 196 cases of suspected myocarditis after a COVID-19 vaccine were reported in young adults 18 to 24 years of age, which is higher than expected for this age group.

As of May 31, only about 9% of the COVID-19 vaccine doses administered were to people 16 to 24 years of age, which is why this “higher-than-normal rate of possible myocarditis cases” warrants investigation, the AHA/ASA says.

They note that these suspected myocarditis cases were reported to VAERS because of their proximity to COVID-19 vaccine administration.

It remains to be determined which cases meet the clinical criteria for a diagnosis of myocarditis and whether they have any direct connection to the COVID-19 vaccine, the AHA/ASA says.

They urge all health care professionals to be aware of “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation.

They advise asking patients who present with symptoms related to these conditions about the timing of recent COVID vaccinations, as needed, to confirm the diagnosis and provide appropriate treatment quickly.

The AHA will be at the CDC’s June 18 meeting to review the latest evidence on cases of suspected myocarditis after the COVID-19 vaccine, the statement adds.

The statement notes that it reflects the views of the AHA/ASA and its scientific leadership, including current president Mitchel S.V. Elkind, MD, PhD; immediate past-president Robert A. Harrington, MD; president-elect Donald M. Lloyd-Jones, MD; AHA/ASA chief science and medical officer Mariell Jessup, MD; and chief medical officer for prevention Eduardo Sanchez, MD, MPH.

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

While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay.

“We remain confident that the benefits of vaccination far exceed the very unusual risks,” the leadership of the AHA/ASA said in a statement issued June 12.

“The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,” they point out.

Late last week, the Centers for Disease Control and Prevention alerted health care providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna.

The CDC is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

These cases may occur more often in males than females and more frequently after the second dose than the first dose of either mRNA vaccine. Symptoms typically occur in the 3 days after administration.

“The CDC’s ongoing investigation into cases of suspected myocarditis reflects a strong and steadfast commitment to transparency and the importance of scientific rigor on all fronts. We applaud the CDC’s unwavering efforts to lead our nation’s scientific and public health efforts, including ensuring the continued safety of the COVID-19 vaccines,” the AHA/ASA states.

They emphasize that vaccinations should continue, and say it’s important to consider the details of the suspected myocarditis cases being investigated by the CDC.

As of June 11, more than 306 million doses of COVID-19 vaccines have been administered in the United States (since Dec. 14, 2020) and nearly 43% of Americans – more than 142 million people – are now fully vaccinated.

According to the June 10 CDC VAERS report detailing adverse events through May 31:

• 789 cases of suspected myocarditis have been reported, with 475 involving people younger than 30 years; 79 cases reported were in patients 16 or 17 years old.
• The vast majority (81%) of the 270 patients younger than 30 years who were discharged from care after suspected myocarditis related to COVID-19 vaccination have recovered fully; the remaining 19% of patients report ongoing symptoms or complete data are missing.
• 196 cases of suspected myocarditis after a COVID-19 vaccine were reported in young adults 18 to 24 years of age, which is higher than expected for this age group.

As of May 31, only about 9% of the COVID-19 vaccine doses administered were to people 16 to 24 years of age, which is why this “higher-than-normal rate of possible myocarditis cases” warrants investigation, the AHA/ASA says.

They note that these suspected myocarditis cases were reported to VAERS because of their proximity to COVID-19 vaccine administration.

It remains to be determined which cases meet the clinical criteria for a diagnosis of myocarditis and whether they have any direct connection to the COVID-19 vaccine, the AHA/ASA says.

They urge all health care professionals to be aware of “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation.

They advise asking patients who present with symptoms related to these conditions about the timing of recent COVID vaccinations, as needed, to confirm the diagnosis and provide appropriate treatment quickly.

The AHA will be at the CDC’s June 18 meeting to review the latest evidence on cases of suspected myocarditis after the COVID-19 vaccine, the statement adds.

The statement notes that it reflects the views of the AHA/ASA and its scientific leadership, including current president Mitchel S.V. Elkind, MD, PhD; immediate past-president Robert A. Harrington, MD; president-elect Donald M. Lloyd-Jones, MD; AHA/ASA chief science and medical officer Mariell Jessup, MD; and chief medical officer for prevention Eduardo Sanchez, MD, MPH.

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

While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay.

“We remain confident that the benefits of vaccination far exceed the very unusual risks,” the leadership of the AHA/ASA said in a statement issued June 12.

“The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,” they point out.

Late last week, the Centers for Disease Control and Prevention alerted health care providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna.

The CDC is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

These cases may occur more often in males than females and more frequently after the second dose than the first dose of either mRNA vaccine. Symptoms typically occur in the 3 days after administration.

“The CDC’s ongoing investigation into cases of suspected myocarditis reflects a strong and steadfast commitment to transparency and the importance of scientific rigor on all fronts. We applaud the CDC’s unwavering efforts to lead our nation’s scientific and public health efforts, including ensuring the continued safety of the COVID-19 vaccines,” the AHA/ASA states.

They emphasize that vaccinations should continue, and say it’s important to consider the details of the suspected myocarditis cases being investigated by the CDC.

As of June 11, more than 306 million doses of COVID-19 vaccines have been administered in the United States (since Dec. 14, 2020) and nearly 43% of Americans – more than 142 million people – are now fully vaccinated.

According to the June 10 CDC VAERS report detailing adverse events through May 31:

• 789 cases of suspected myocarditis have been reported, with 475 involving people younger than 30 years; 79 cases reported were in patients 16 or 17 years old.
• The vast majority (81%) of the 270 patients younger than 30 years who were discharged from care after suspected myocarditis related to COVID-19 vaccination have recovered fully; the remaining 19% of patients report ongoing symptoms or complete data are missing.
• 196 cases of suspected myocarditis after a COVID-19 vaccine were reported in young adults 18 to 24 years of age, which is higher than expected for this age group.

As of May 31, only about 9% of the COVID-19 vaccine doses administered were to people 16 to 24 years of age, which is why this “higher-than-normal rate of possible myocarditis cases” warrants investigation, the AHA/ASA says.

They note that these suspected myocarditis cases were reported to VAERS because of their proximity to COVID-19 vaccine administration.

It remains to be determined which cases meet the clinical criteria for a diagnosis of myocarditis and whether they have any direct connection to the COVID-19 vaccine, the AHA/ASA says.

They urge all health care professionals to be aware of “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation.

They advise asking patients who present with symptoms related to these conditions about the timing of recent COVID vaccinations, as needed, to confirm the diagnosis and provide appropriate treatment quickly.

The AHA will be at the CDC’s June 18 meeting to review the latest evidence on cases of suspected myocarditis after the COVID-19 vaccine, the statement adds.

The statement notes that it reflects the views of the AHA/ASA and its scientific leadership, including current president Mitchel S.V. Elkind, MD, PhD; immediate past-president Robert A. Harrington, MD; president-elect Donald M. Lloyd-Jones, MD; AHA/ASA chief science and medical officer Mariell Jessup, MD; and chief medical officer for prevention Eduardo Sanchez, MD, MPH.

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

A report by the American Medical Association’s medical education advisory body points to systemic racism or other systems of oppression as causing a lack of representation, exclusion, and marginalization in medical education and medicine.

The report received overwhelming support at the House of Delegates, the AMA’s legislative policy making body, during an online meeting held June 13.

The Council on Medical Education’s report recommends that the AMA acknowledge the harm caused by the Flexner Report, which was issued in 1910 and has since shaped medical education. The Flexner Report caused harm not only to historically Black medical schools, but also to physician workforce diversity and to the clinical outcomes of minority and marginalized patients, according to the medical education advisory body.

The council also recommended conducting a study on medical education with a focus on health equity and racial justice, improving diversity among healthcare workers, and fixing inequitable outcomes from minorities and marginalized patient populations.

The report comes on the heels of the resignation of JAMA editor-in-chief Howard Bauchner, MD, and another high-ranking editor following a February podcast on systemic racism in medicine. The AMA has since released a strategic plan addressing racism and health inequity that has divided membership.
 

Flexner Report’s effect on physician diversity

The Council on Medical Education’s report observed that as a result of the Flexner Report’s recommendations, 89 medical schools, including 5 of the 7 existing medical schools training Black physicians, were closed because they didn’t meet the report’s standards. In addition, the report created a limited role for Black physicians while “hint[ing] that Black physicians possessed less potential and ability than their White counterparts,” read the Council’s report.

In addition to consigning the role of the Black physician to “educating the [Black] race to know and to practice fundamental hygienic principles,” the Flexner Report also observed that “a well-taught negro sanitarian will be immensely useful,” per the Council’s report.

The impact of the closure of medical schools training Black physicians was dramatic. According to the Council’s report, in 1964, 93% of medical students in the United States were men and 97% of those students were non-Hispanic White.

Today, 56% of physicians identify as White, 17% as Asian, 6% as Hispanic, and 5% as Black or African American, per the Association of American Medical Colleges; nearly 14% of active physicians didn’t report their race in the survey. By means of contrast, the U.S. population in 2019 was 60% White, 19% Latino/Hispanic, 13% Black or African American, and 6% Asian American, according to the Brookings Institute.

Abraham Flexner, who wrote the Flexner Report, is often referred to as the “father of modern medical education,” according to the AAMC. In November, the AAMC observed that the Flexner Report contained racist and sexist ideas and that his work contributed to the closure of historically Black medical schools. Both statements were included in AAMC’s announcement about the removal of Flexner’s name from its most prestigious award. As of January, the award is now called the AAMC Award for Excellence in Medical Education.
 

Pathway programs can increase diversity

Pathway programs, which leverage targeted milestones along the journey to becoming a physician in order to increase diversity, were an area of focus in the council’s report. These programs “can exert a meaningful, positive effect on student outcomes and increase diversity across various levels of educational settings,” according to its report.

Centers of Excellence, which provides grants for mentorship and training programs, is one of many pathway programs. During the 2018-2019 academic year, Centers of Excellence supported more than 1,300 trainees – 99% of them were underrepresented minorities and 64% came from financially or educationally disadvantaged backgrounds. In 2006, federal funding was cut to these programs and the number of Centers of Excellence fell.

Still, the report cites the passage of federal funding in 2020 of $50 million for public institutions of higher education that train physicians; educational institutions in states with a projected primary care shortage in 2025 are given priority in the grant-funding process.
 

AMA council’s report garners support from delegates

Delegates voiced overwhelming support of the council’s report during the June 13 meeting. Lou Edje, MD, a Perrysburgh, Ohio–based family physician, voiced strong support for the council’s report, in particular its recommendations that recognize the harm caused by the Flexner Report. Dr. Edje observed that the Flexner Report, with its elimination of five of seven Black medical schools, “[set] back admissions of Black students into medicine by 50 years.”

“Empathy is what we are called to have as physicians. I implore you to simply substitute your ethnicity into these quotes to help understand the historic need for health equity in medicine today. This CME report is part of the antidote to Flexner. We support [it] fully,” concluded Dr. Edje, who spoke for the Great Lakes States Coalition of the AMA.

Rohan Khazanchi, a medical student at the University of Nebraska, Omaha, and a member of the council, said, “Our broad attempt with this report was twofold: to fill gaps in AMA policy with evidence-based recommendations which could improve diversity in our health workforce and, second, to enhance our organization’s vision for truth, reconciliation, and healing to redress the historic marginalization of minoritized physicians in medicine.”

According to an AMA spokesperson, the House of Delegates will vote on this and other policies this week, after which the policies are considered final.

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

A report by the American Medical Association’s medical education advisory body points to systemic racism or other systems of oppression as causing a lack of representation, exclusion, and marginalization in medical education and medicine.

The report received overwhelming support at the House of Delegates, the AMA’s legislative policy making body, during an online meeting held June 13.

The Council on Medical Education’s report recommends that the AMA acknowledge the harm caused by the Flexner Report, which was issued in 1910 and has since shaped medical education. The Flexner Report caused harm not only to historically Black medical schools, but also to physician workforce diversity and to the clinical outcomes of minority and marginalized patients, according to the medical education advisory body.

The council also recommended conducting a study on medical education with a focus on health equity and racial justice, improving diversity among healthcare workers, and fixing inequitable outcomes from minorities and marginalized patient populations.

The report comes on the heels of the resignation of JAMA editor-in-chief Howard Bauchner, MD, and another high-ranking editor following a February podcast on systemic racism in medicine. The AMA has since released a strategic plan addressing racism and health inequity that has divided membership.
 

Flexner Report’s effect on physician diversity

The Council on Medical Education’s report observed that as a result of the Flexner Report’s recommendations, 89 medical schools, including 5 of the 7 existing medical schools training Black physicians, were closed because they didn’t meet the report’s standards. In addition, the report created a limited role for Black physicians while “hint[ing] that Black physicians possessed less potential and ability than their White counterparts,” read the Council’s report.

In addition to consigning the role of the Black physician to “educating the [Black] race to know and to practice fundamental hygienic principles,” the Flexner Report also observed that “a well-taught negro sanitarian will be immensely useful,” per the Council’s report.

The impact of the closure of medical schools training Black physicians was dramatic. According to the Council’s report, in 1964, 93% of medical students in the United States were men and 97% of those students were non-Hispanic White.

Today, 56% of physicians identify as White, 17% as Asian, 6% as Hispanic, and 5% as Black or African American, per the Association of American Medical Colleges; nearly 14% of active physicians didn’t report their race in the survey. By means of contrast, the U.S. population in 2019 was 60% White, 19% Latino/Hispanic, 13% Black or African American, and 6% Asian American, according to the Brookings Institute.

Abraham Flexner, who wrote the Flexner Report, is often referred to as the “father of modern medical education,” according to the AAMC. In November, the AAMC observed that the Flexner Report contained racist and sexist ideas and that his work contributed to the closure of historically Black medical schools. Both statements were included in AAMC’s announcement about the removal of Flexner’s name from its most prestigious award. As of January, the award is now called the AAMC Award for Excellence in Medical Education.
 

Pathway programs can increase diversity

Pathway programs, which leverage targeted milestones along the journey to becoming a physician in order to increase diversity, were an area of focus in the council’s report. These programs “can exert a meaningful, positive effect on student outcomes and increase diversity across various levels of educational settings,” according to its report.

Centers of Excellence, which provides grants for mentorship and training programs, is one of many pathway programs. During the 2018-2019 academic year, Centers of Excellence supported more than 1,300 trainees – 99% of them were underrepresented minorities and 64% came from financially or educationally disadvantaged backgrounds. In 2006, federal funding was cut to these programs and the number of Centers of Excellence fell.

Still, the report cites the passage of federal funding in 2020 of $50 million for public institutions of higher education that train physicians; educational institutions in states with a projected primary care shortage in 2025 are given priority in the grant-funding process.
 

AMA council’s report garners support from delegates

Delegates voiced overwhelming support of the council’s report during the June 13 meeting. Lou Edje, MD, a Perrysburgh, Ohio–based family physician, voiced strong support for the council’s report, in particular its recommendations that recognize the harm caused by the Flexner Report. Dr. Edje observed that the Flexner Report, with its elimination of five of seven Black medical schools, “[set] back admissions of Black students into medicine by 50 years.”

“Empathy is what we are called to have as physicians. I implore you to simply substitute your ethnicity into these quotes to help understand the historic need for health equity in medicine today. This CME report is part of the antidote to Flexner. We support [it] fully,” concluded Dr. Edje, who spoke for the Great Lakes States Coalition of the AMA.

Rohan Khazanchi, a medical student at the University of Nebraska, Omaha, and a member of the council, said, “Our broad attempt with this report was twofold: to fill gaps in AMA policy with evidence-based recommendations which could improve diversity in our health workforce and, second, to enhance our organization’s vision for truth, reconciliation, and healing to redress the historic marginalization of minoritized physicians in medicine.”

According to an AMA spokesperson, the House of Delegates will vote on this and other policies this week, after which the policies are considered final.

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

A report by the American Medical Association’s medical education advisory body points to systemic racism or other systems of oppression as causing a lack of representation, exclusion, and marginalization in medical education and medicine.

The report received overwhelming support at the House of Delegates, the AMA’s legislative policy making body, during an online meeting held June 13.

The Council on Medical Education’s report recommends that the AMA acknowledge the harm caused by the Flexner Report, which was issued in 1910 and has since shaped medical education. The Flexner Report caused harm not only to historically Black medical schools, but also to physician workforce diversity and to the clinical outcomes of minority and marginalized patients, according to the medical education advisory body.

The council also recommended conducting a study on medical education with a focus on health equity and racial justice, improving diversity among healthcare workers, and fixing inequitable outcomes from minorities and marginalized patient populations.

The report comes on the heels of the resignation of JAMA editor-in-chief Howard Bauchner, MD, and another high-ranking editor following a February podcast on systemic racism in medicine. The AMA has since released a strategic plan addressing racism and health inequity that has divided membership.
 

Flexner Report’s effect on physician diversity

The Council on Medical Education’s report observed that as a result of the Flexner Report’s recommendations, 89 medical schools, including 5 of the 7 existing medical schools training Black physicians, were closed because they didn’t meet the report’s standards. In addition, the report created a limited role for Black physicians while “hint[ing] that Black physicians possessed less potential and ability than their White counterparts,” read the Council’s report.

In addition to consigning the role of the Black physician to “educating the [Black] race to know and to practice fundamental hygienic principles,” the Flexner Report also observed that “a well-taught negro sanitarian will be immensely useful,” per the Council’s report.

The impact of the closure of medical schools training Black physicians was dramatic. According to the Council’s report, in 1964, 93% of medical students in the United States were men and 97% of those students were non-Hispanic White.

Today, 56% of physicians identify as White, 17% as Asian, 6% as Hispanic, and 5% as Black or African American, per the Association of American Medical Colleges; nearly 14% of active physicians didn’t report their race in the survey. By means of contrast, the U.S. population in 2019 was 60% White, 19% Latino/Hispanic, 13% Black or African American, and 6% Asian American, according to the Brookings Institute.

Abraham Flexner, who wrote the Flexner Report, is often referred to as the “father of modern medical education,” according to the AAMC. In November, the AAMC observed that the Flexner Report contained racist and sexist ideas and that his work contributed to the closure of historically Black medical schools. Both statements were included in AAMC’s announcement about the removal of Flexner’s name from its most prestigious award. As of January, the award is now called the AAMC Award for Excellence in Medical Education.
 

Pathway programs can increase diversity

Pathway programs, which leverage targeted milestones along the journey to becoming a physician in order to increase diversity, were an area of focus in the council’s report. These programs “can exert a meaningful, positive effect on student outcomes and increase diversity across various levels of educational settings,” according to its report.

Centers of Excellence, which provides grants for mentorship and training programs, is one of many pathway programs. During the 2018-2019 academic year, Centers of Excellence supported more than 1,300 trainees – 99% of them were underrepresented minorities and 64% came from financially or educationally disadvantaged backgrounds. In 2006, federal funding was cut to these programs and the number of Centers of Excellence fell.

Still, the report cites the passage of federal funding in 2020 of $50 million for public institutions of higher education that train physicians; educational institutions in states with a projected primary care shortage in 2025 are given priority in the grant-funding process.
 

AMA council’s report garners support from delegates

Delegates voiced overwhelming support of the council’s report during the June 13 meeting. Lou Edje, MD, a Perrysburgh, Ohio–based family physician, voiced strong support for the council’s report, in particular its recommendations that recognize the harm caused by the Flexner Report. Dr. Edje observed that the Flexner Report, with its elimination of five of seven Black medical schools, “[set] back admissions of Black students into medicine by 50 years.”

“Empathy is what we are called to have as physicians. I implore you to simply substitute your ethnicity into these quotes to help understand the historic need for health equity in medicine today. This CME report is part of the antidote to Flexner. We support [it] fully,” concluded Dr. Edje, who spoke for the Great Lakes States Coalition of the AMA.

Rohan Khazanchi, a medical student at the University of Nebraska, Omaha, and a member of the council, said, “Our broad attempt with this report was twofold: to fill gaps in AMA policy with evidence-based recommendations which could improve diversity in our health workforce and, second, to enhance our organization’s vision for truth, reconciliation, and healing to redress the historic marginalization of minoritized physicians in medicine.”

According to an AMA spokesperson, the House of Delegates will vote on this and other policies this week, after which the policies are considered final.

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

Quantitative assessment of the extent of interstitial lung disease in patients with systemic sclerosis and levels of certain proteins in bronchoalveolar lavage samples have potential for predicting mortality and disease progression, according to two analyses of data from the Scleroderma Lung Study I and II.

The analyses, presented at the annual European Congress of Rheumatology, aim to improve current prognostic abilities in patients with systemic sclerosis–interstitial lung disease (SSc-ILD). Although forced vital capacity is commonly used as a biomarker for survival in many SSc-ILD trials, other factors can affect FVC, such as respiratory muscle weakness and skin fibrosis. Further, FVC correlates poorly with patient-reported outcomes, explained first author Elizabeth Volkmann, MD, director of the scleroderma program at the University of California, Los Angeles, and the founder and codirector of the UCLA connective tissue disease–related interstitial lung disease program.

Dr. Volkmann presented two studies that investigated the potential of radiographic and protein biomarkers for predicting mortality and identifying patients at risk for ILD progression. The biomarkers may also help to identify patients who would benefit most from immunosuppressive therapy.

The first study found that tracking the quantitative extent of ILD (QILD) over time with high-resolution CT (HRCT) predicted poorer outcomes and could therefore act as a surrogate endpoint for mortality among patients with SSc-ILD. The other study identified associations between specific proteins from bronchoalveolar lavage (BAL) and the likelihood of ILD progression, although some associations were treatment dependent.

Jacob M. van Laar, MD, PhD, professor of rheumatology at the University Medical Center Utrecht (the Netherlands), who was not involved in the study, found the results intriguing and noted the importance of further validation in research before these biomarkers are considered for clinical use.

“It would be wonderful if we can tailor therapy based on BAL biomarkers in the future, as clinicians often struggle to decide on selection, timing, and duration of immunosuppressive treatment,” Dr. van Laar told this news organization. “This has become even more relevant with the introduction of new drugs such as nintedanib.”
 

Extent of ILD progression as a surrogate for mortality

Scleroderma Lung Study I involved 158 patients with SSc-ILD who were randomly assigned to receive either cyclophosphamide or placebo for 12 months. Scleroderma Lung Study II included 142 patients with SSc-ILD who were randomly assigned to receive either mycophenolate for 24 months or cyclophosphamide for 12 months followed by placebo for 12 months.

The researchers calculated QILD in the whole lung at baseline, at 12 months in the first trial, and at 24 months in the second trial. However, only 82 participants from the first trial and 90 participants from the second trial underwent HRCT. Demographic and disease characteristics were similar between the two groups on follow-up scans.

Follow-up continued for 12 years for patients in the first trial and 8 years in the second. The researchers compared survival rates between the 41% of participants from the first study and 31% of participants from the second study who had poorer QILD scores (at least a 2% increase) with the participants who had stable or improved scores (less than 2% increase).

Participants from both trials had significantly poorer long-term survival if their QILD scores had increased by at least 2% at follow-up (P = .01 for I; P = .019 for II). The association was no longer significant after adjustment for baseline FVC, age, and modified Rodnan skin score in the first trial (hazard ratio, 1.98; P = .089), but it remained significant for participants of the second trial (HR, 3.86; P = .014).

“Data from two independent trial cohorts demonstrated that radiographic progression of SSc-ILD at 1 and 2 years is associated with worse long-term survival,” Dr. Volkmann told attendees.

However, FVC did not significantly predict risk of mortality in either trial.

“To me, the most striking finding from the first study was that change in QILD performed better as a predictor of survival than change in FVC,” Dr. van Laar said in an interview. “This indicates QILD is fit for purpose and worth including in future clinical trials.”

Limitations of the study included lack of HRCT for all participants in the trials and the difference in timing (1 year and 2 years) of HRCT assessment between the two trials. The greater hazard ratio for worsened QILD in the second trial may suggest that assessment at 2 years provides more reliable data as a biomarker, Dr. Volkmann said.

“QILD may represent a better proxy for how a patient feels, functions, and survives than FVC,” she said.
 

Treatment-dependent biomarkers for worsening lung fibrosis

In the second study, the researchers looked for any associations between changes in the radiographic extent of SSc-ILD and 68 proteins from BAL.

“Being able to risk-stratify patients with interstitial lung disease at the time of diagnosis and predict which patients are likely to have a stable versus progressive disease course is critical for making important treatment decisions for these patients,” Dr. Volkmann told attendees.

The second study she presented involved Scleroderma Lung Study I. Of the 158 participants, 144 underwent a bronchoscopy, yielding BAL protein samples from 103 participants. The researchers determined the extent of radiographic fibrosis in the whole lung with quantitative imaging analysis of HRCT of the chest at baseline and 12 months.

Although the researchers identified several statistically significant associations between certain proteins and changes in radiographic fibrosis, “baseline protein levels were differentially associated with the course of ILD based on treatment status,” she told attendees.

For example, increased levels of the following proteins were linked to poor radiographic fibrosis scores for patients who received placebo:

• Granulocyte-macrophage colony-stimulating factor
• Interleukin-1
• Monocyte chemoattractant protein–3
• Chemokine ligand–5
• Transforming growth factor–beta
• Hepatocyte growth factor
• Stem cell factor
• IL-4
• TGF-alpha

Yet increases in these proteins predicted improvement in radiographic fibrosis in patients who had taken cyclophosphamide.

Independently of treatment, the researchers also identified an association between higher levels of fractalkine and poorer radiographic fibrosis scores and between higher IL-7 levels and improved radiographic fibrosis scores.

After adjusting for treatment arm and baseline severity of ILD, significant associations remained between change in radiographic fibrosis score and IL-1, MCP-3, surfactant protein C, IL-7 and CCL-5 levels.

“Biomarker discovery is really central to our ability to risk stratify patients with SSc-ILD,” Dr. Volkmann told attendees. “Understanding how biomarkers predict outcomes in treated and untreated patients may improve personalized medicine to patients with SSc-ILD and could also reveal novel treatment targets.”

Dr. van Laar said in an interview that this study’s biggest strength lay in its large sample size and in the comprehensiveness of the biomarkers studied.

“The findings are interesting from a research perspective and potentially relevant for clinical practice, but the utility of measuring biomarkers in BAL should be further studied for predictive value on clinical endpoints,” Dr. van Laar said. “BAL is an invasive procedure [that] is not routinely done.”

The research was funded by the National Institutes of Health. Dr. Volkmann has consulted for Boehringer Ingelheim and received grant funding from Corbus, Forbius, and Kadmon. Dr. van Laar has received grant funding or personal fees from Arthrogen, Arxx Therapeutics, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Gesynta, Leadiant, Merck Sharp & Dohme, Roche, Sanofi, and Thermofisher.

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

Quantitative assessment of the extent of interstitial lung disease in patients with systemic sclerosis and levels of certain proteins in bronchoalveolar lavage samples have potential for predicting mortality and disease progression, according to two analyses of data from the Scleroderma Lung Study I and II.

The analyses, presented at the annual European Congress of Rheumatology, aim to improve current prognostic abilities in patients with systemic sclerosis–interstitial lung disease (SSc-ILD). Although forced vital capacity is commonly used as a biomarker for survival in many SSc-ILD trials, other factors can affect FVC, such as respiratory muscle weakness and skin fibrosis. Further, FVC correlates poorly with patient-reported outcomes, explained first author Elizabeth Volkmann, MD, director of the scleroderma program at the University of California, Los Angeles, and the founder and codirector of the UCLA connective tissue disease–related interstitial lung disease program.

Dr. Volkmann presented two studies that investigated the potential of radiographic and protein biomarkers for predicting mortality and identifying patients at risk for ILD progression. The biomarkers may also help to identify patients who would benefit most from immunosuppressive therapy.

The first study found that tracking the quantitative extent of ILD (QILD) over time with high-resolution CT (HRCT) predicted poorer outcomes and could therefore act as a surrogate endpoint for mortality among patients with SSc-ILD. The other study identified associations between specific proteins from bronchoalveolar lavage (BAL) and the likelihood of ILD progression, although some associations were treatment dependent.

Jacob M. van Laar, MD, PhD, professor of rheumatology at the University Medical Center Utrecht (the Netherlands), who was not involved in the study, found the results intriguing and noted the importance of further validation in research before these biomarkers are considered for clinical use.

“It would be wonderful if we can tailor therapy based on BAL biomarkers in the future, as clinicians often struggle to decide on selection, timing, and duration of immunosuppressive treatment,” Dr. van Laar told this news organization. “This has become even more relevant with the introduction of new drugs such as nintedanib.”
 

Extent of ILD progression as a surrogate for mortality

Scleroderma Lung Study I involved 158 patients with SSc-ILD who were randomly assigned to receive either cyclophosphamide or placebo for 12 months. Scleroderma Lung Study II included 142 patients with SSc-ILD who were randomly assigned to receive either mycophenolate for 24 months or cyclophosphamide for 12 months followed by placebo for 12 months.

The researchers calculated QILD in the whole lung at baseline, at 12 months in the first trial, and at 24 months in the second trial. However, only 82 participants from the first trial and 90 participants from the second trial underwent HRCT. Demographic and disease characteristics were similar between the two groups on follow-up scans.

Follow-up continued for 12 years for patients in the first trial and 8 years in the second. The researchers compared survival rates between the 41% of participants from the first study and 31% of participants from the second study who had poorer QILD scores (at least a 2% increase) with the participants who had stable or improved scores (less than 2% increase).

Participants from both trials had significantly poorer long-term survival if their QILD scores had increased by at least 2% at follow-up (P = .01 for I; P = .019 for II). The association was no longer significant after adjustment for baseline FVC, age, and modified Rodnan skin score in the first trial (hazard ratio, 1.98; P = .089), but it remained significant for participants of the second trial (HR, 3.86; P = .014).

“Data from two independent trial cohorts demonstrated that radiographic progression of SSc-ILD at 1 and 2 years is associated with worse long-term survival,” Dr. Volkmann told attendees.

However, FVC did not significantly predict risk of mortality in either trial.

“To me, the most striking finding from the first study was that change in QILD performed better as a predictor of survival than change in FVC,” Dr. van Laar said in an interview. “This indicates QILD is fit for purpose and worth including in future clinical trials.”

Limitations of the study included lack of HRCT for all participants in the trials and the difference in timing (1 year and 2 years) of HRCT assessment between the two trials. The greater hazard ratio for worsened QILD in the second trial may suggest that assessment at 2 years provides more reliable data as a biomarker, Dr. Volkmann said.

“QILD may represent a better proxy for how a patient feels, functions, and survives than FVC,” she said.
 

Treatment-dependent biomarkers for worsening lung fibrosis

In the second study, the researchers looked for any associations between changes in the radiographic extent of SSc-ILD and 68 proteins from BAL.

“Being able to risk-stratify patients with interstitial lung disease at the time of diagnosis and predict which patients are likely to have a stable versus progressive disease course is critical for making important treatment decisions for these patients,” Dr. Volkmann told attendees.

The second study she presented involved Scleroderma Lung Study I. Of the 158 participants, 144 underwent a bronchoscopy, yielding BAL protein samples from 103 participants. The researchers determined the extent of radiographic fibrosis in the whole lung with quantitative imaging analysis of HRCT of the chest at baseline and 12 months.

Although the researchers identified several statistically significant associations between certain proteins and changes in radiographic fibrosis, “baseline protein levels were differentially associated with the course of ILD based on treatment status,” she told attendees.

For example, increased levels of the following proteins were linked to poor radiographic fibrosis scores for patients who received placebo:

• Granulocyte-macrophage colony-stimulating factor
• Interleukin-1
• Monocyte chemoattractant protein–3
• Chemokine ligand–5
• Transforming growth factor–beta
• Hepatocyte growth factor
• Stem cell factor
• IL-4
• TGF-alpha

Yet increases in these proteins predicted improvement in radiographic fibrosis in patients who had taken cyclophosphamide.

Independently of treatment, the researchers also identified an association between higher levels of fractalkine and poorer radiographic fibrosis scores and between higher IL-7 levels and improved radiographic fibrosis scores.

After adjusting for treatment arm and baseline severity of ILD, significant associations remained between change in radiographic fibrosis score and IL-1, MCP-3, surfactant protein C, IL-7 and CCL-5 levels.

“Biomarker discovery is really central to our ability to risk stratify patients with SSc-ILD,” Dr. Volkmann told attendees. “Understanding how biomarkers predict outcomes in treated and untreated patients may improve personalized medicine to patients with SSc-ILD and could also reveal novel treatment targets.”

Dr. van Laar said in an interview that this study’s biggest strength lay in its large sample size and in the comprehensiveness of the biomarkers studied.

“The findings are interesting from a research perspective and potentially relevant for clinical practice, but the utility of measuring biomarkers in BAL should be further studied for predictive value on clinical endpoints,” Dr. van Laar said. “BAL is an invasive procedure [that] is not routinely done.”

The research was funded by the National Institutes of Health. Dr. Volkmann has consulted for Boehringer Ingelheim and received grant funding from Corbus, Forbius, and Kadmon. Dr. van Laar has received grant funding or personal fees from Arthrogen, Arxx Therapeutics, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Gesynta, Leadiant, Merck Sharp & Dohme, Roche, Sanofi, and Thermofisher.

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

Quantitative assessment of the extent of interstitial lung disease in patients with systemic sclerosis and levels of certain proteins in bronchoalveolar lavage samples have potential for predicting mortality and disease progression, according to two analyses of data from the Scleroderma Lung Study I and II.

The analyses, presented at the annual European Congress of Rheumatology, aim to improve current prognostic abilities in patients with systemic sclerosis–interstitial lung disease (SSc-ILD). Although forced vital capacity is commonly used as a biomarker for survival in many SSc-ILD trials, other factors can affect FVC, such as respiratory muscle weakness and skin fibrosis. Further, FVC correlates poorly with patient-reported outcomes, explained first author Elizabeth Volkmann, MD, director of the scleroderma program at the University of California, Los Angeles, and the founder and codirector of the UCLA connective tissue disease–related interstitial lung disease program.

Dr. Volkmann presented two studies that investigated the potential of radiographic and protein biomarkers for predicting mortality and identifying patients at risk for ILD progression. The biomarkers may also help to identify patients who would benefit most from immunosuppressive therapy.

The first study found that tracking the quantitative extent of ILD (QILD) over time with high-resolution CT (HRCT) predicted poorer outcomes and could therefore act as a surrogate endpoint for mortality among patients with SSc-ILD. The other study identified associations between specific proteins from bronchoalveolar lavage (BAL) and the likelihood of ILD progression, although some associations were treatment dependent.

Jacob M. van Laar, MD, PhD, professor of rheumatology at the University Medical Center Utrecht (the Netherlands), who was not involved in the study, found the results intriguing and noted the importance of further validation in research before these biomarkers are considered for clinical use.

“It would be wonderful if we can tailor therapy based on BAL biomarkers in the future, as clinicians often struggle to decide on selection, timing, and duration of immunosuppressive treatment,” Dr. van Laar told this news organization. “This has become even more relevant with the introduction of new drugs such as nintedanib.”
 

Extent of ILD progression as a surrogate for mortality

Scleroderma Lung Study I involved 158 patients with SSc-ILD who were randomly assigned to receive either cyclophosphamide or placebo for 12 months. Scleroderma Lung Study II included 142 patients with SSc-ILD who were randomly assigned to receive either mycophenolate for 24 months or cyclophosphamide for 12 months followed by placebo for 12 months.

The researchers calculated QILD in the whole lung at baseline, at 12 months in the first trial, and at 24 months in the second trial. However, only 82 participants from the first trial and 90 participants from the second trial underwent HRCT. Demographic and disease characteristics were similar between the two groups on follow-up scans.

Follow-up continued for 12 years for patients in the first trial and 8 years in the second. The researchers compared survival rates between the 41% of participants from the first study and 31% of participants from the second study who had poorer QILD scores (at least a 2% increase) with the participants who had stable or improved scores (less than 2% increase).

Participants from both trials had significantly poorer long-term survival if their QILD scores had increased by at least 2% at follow-up (P = .01 for I; P = .019 for II). The association was no longer significant after adjustment for baseline FVC, age, and modified Rodnan skin score in the first trial (hazard ratio, 1.98; P = .089), but it remained significant for participants of the second trial (HR, 3.86; P = .014).

“Data from two independent trial cohorts demonstrated that radiographic progression of SSc-ILD at 1 and 2 years is associated with worse long-term survival,” Dr. Volkmann told attendees.

However, FVC did not significantly predict risk of mortality in either trial.

“To me, the most striking finding from the first study was that change in QILD performed better as a predictor of survival than change in FVC,” Dr. van Laar said in an interview. “This indicates QILD is fit for purpose and worth including in future clinical trials.”

Limitations of the study included lack of HRCT for all participants in the trials and the difference in timing (1 year and 2 years) of HRCT assessment between the two trials. The greater hazard ratio for worsened QILD in the second trial may suggest that assessment at 2 years provides more reliable data as a biomarker, Dr. Volkmann said.

“QILD may represent a better proxy for how a patient feels, functions, and survives than FVC,” she said.
 

Treatment-dependent biomarkers for worsening lung fibrosis

In the second study, the researchers looked for any associations between changes in the radiographic extent of SSc-ILD and 68 proteins from BAL.

“Being able to risk-stratify patients with interstitial lung disease at the time of diagnosis and predict which patients are likely to have a stable versus progressive disease course is critical for making important treatment decisions for these patients,” Dr. Volkmann told attendees.

The second study she presented involved Scleroderma Lung Study I. Of the 158 participants, 144 underwent a bronchoscopy, yielding BAL protein samples from 103 participants. The researchers determined the extent of radiographic fibrosis in the whole lung with quantitative imaging analysis of HRCT of the chest at baseline and 12 months.

Although the researchers identified several statistically significant associations between certain proteins and changes in radiographic fibrosis, “baseline protein levels were differentially associated with the course of ILD based on treatment status,” she told attendees.

For example, increased levels of the following proteins were linked to poor radiographic fibrosis scores for patients who received placebo:

• Granulocyte-macrophage colony-stimulating factor
• Interleukin-1
• Monocyte chemoattractant protein–3
• Chemokine ligand–5
• Transforming growth factor–beta
• Hepatocyte growth factor
• Stem cell factor
• IL-4
• TGF-alpha

Yet increases in these proteins predicted improvement in radiographic fibrosis in patients who had taken cyclophosphamide.

Independently of treatment, the researchers also identified an association between higher levels of fractalkine and poorer radiographic fibrosis scores and between higher IL-7 levels and improved radiographic fibrosis scores.

After adjusting for treatment arm and baseline severity of ILD, significant associations remained between change in radiographic fibrosis score and IL-1, MCP-3, surfactant protein C, IL-7 and CCL-5 levels.

“Biomarker discovery is really central to our ability to risk stratify patients with SSc-ILD,” Dr. Volkmann told attendees. “Understanding how biomarkers predict outcomes in treated and untreated patients may improve personalized medicine to patients with SSc-ILD and could also reveal novel treatment targets.”

Dr. van Laar said in an interview that this study’s biggest strength lay in its large sample size and in the comprehensiveness of the biomarkers studied.

“The findings are interesting from a research perspective and potentially relevant for clinical practice, but the utility of measuring biomarkers in BAL should be further studied for predictive value on clinical endpoints,” Dr. van Laar said. “BAL is an invasive procedure [that] is not routinely done.”

The research was funded by the National Institutes of Health. Dr. Volkmann has consulted for Boehringer Ingelheim and received grant funding from Corbus, Forbius, and Kadmon. Dr. van Laar has received grant funding or personal fees from Arthrogen, Arxx Therapeutics, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Gesynta, Leadiant, Merck Sharp & Dohme, Roche, Sanofi, and Thermofisher.

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

Even as the number of new COVID-19 cases continues to drop, the United States reached the 4-million mark for infected children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of children with COVID-19 was 4,008,572 as of June 10 after just under 14,500 new cases were reported over the preceding week. That weekly total, the lowest since June of 2020, comes from 49 states (excluding N.Y.), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.

Children represent 14.1% of all COVID-19 cases since the beginning of the pandemic, while the corresponding figure for the week ending June 10 was 19.0%. That weekly proportion of cases among children had been rising pretty steadily through the winter and early spring, but the situation has become much more volatile over the last month, the AAP/CHA data show.

Use of the Pfizer-BioNTech vaccine in children aged 16-17 years, of course, didn’t begin until April, and the vaccine wasn’t authorized for children aged 12-15 years until mid-May. The Moderna and Johnson & Johnson vaccines have not received such authorization yet, but Moderna is in the process of seeking an emergency-use recommendation from the Food and Drug Administration.

In the younger group of children who are currently eligible, completion of the vaccine regimen took a big jump in the week ending June 14, according to the Centers for Disease Control and Prevention. The cumulative share of those aged 12-15 years who had received a second dose jumped from 4.1% on June 7 to 11.4% on June 14, with comparable numbers for 16- and 17-year-olds coming in at 26.4% and 29.1%.

Activity over just the last 14 days, however, shows a slight decrease in children aged 12-15 getting a first dose: For just the 2 weeks ending June 7, 17.9% of all children in the age group initiated a first dose, but for the 14 days ending June 14, only 17.1% of the age group did so, the CDC said on its COVID Data Tracker site.

For children aged 16-17 years – of whom less than 30% have reached full vaccination – activity seems to have stagnated: 4.8% of all 16- to 17-year-olds initiated a first vaccination during the 14 days ending June 7, compared with 4.7% who did so during the 14 days ending June 14, the CDC reported.

Older age groups with higher completion rates are still producing greater vaccine initiation. As of June 14, those aged 25-39 years had a completion rate of 41.9% and 24.0% of the age group had received a first dose in the previous 2 weeks, while 61.4% of those aged 50-64 were fully vaccinated, and 18.0% had gotten their first dose, the CDC data indicate.

[email protected]

Even as the number of new COVID-19 cases continues to drop, the United States reached the 4-million mark for infected children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of children with COVID-19 was 4,008,572 as of June 10 after just under 14,500 new cases were reported over the preceding week. That weekly total, the lowest since June of 2020, comes from 49 states (excluding N.Y.), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.

Children represent 14.1% of all COVID-19 cases since the beginning of the pandemic, while the corresponding figure for the week ending June 10 was 19.0%. That weekly proportion of cases among children had been rising pretty steadily through the winter and early spring, but the situation has become much more volatile over the last month, the AAP/CHA data show.

Use of the Pfizer-BioNTech vaccine in children aged 16-17 years, of course, didn’t begin until April, and the vaccine wasn’t authorized for children aged 12-15 years until mid-May. The Moderna and Johnson & Johnson vaccines have not received such authorization yet, but Moderna is in the process of seeking an emergency-use recommendation from the Food and Drug Administration.

In the younger group of children who are currently eligible, completion of the vaccine regimen took a big jump in the week ending June 14, according to the Centers for Disease Control and Prevention. The cumulative share of those aged 12-15 years who had received a second dose jumped from 4.1% on June 7 to 11.4% on June 14, with comparable numbers for 16- and 17-year-olds coming in at 26.4% and 29.1%.

Activity over just the last 14 days, however, shows a slight decrease in children aged 12-15 getting a first dose: For just the 2 weeks ending June 7, 17.9% of all children in the age group initiated a first dose, but for the 14 days ending June 14, only 17.1% of the age group did so, the CDC said on its COVID Data Tracker site.

For children aged 16-17 years – of whom less than 30% have reached full vaccination – activity seems to have stagnated: 4.8% of all 16- to 17-year-olds initiated a first vaccination during the 14 days ending June 7, compared with 4.7% who did so during the 14 days ending June 14, the CDC reported.

Older age groups with higher completion rates are still producing greater vaccine initiation. As of June 14, those aged 25-39 years had a completion rate of 41.9% and 24.0% of the age group had received a first dose in the previous 2 weeks, while 61.4% of those aged 50-64 were fully vaccinated, and 18.0% had gotten their first dose, the CDC data indicate.

[email protected]

Even as the number of new COVID-19 cases continues to drop, the United States reached the 4-million mark for infected children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of children with COVID-19 was 4,008,572 as of June 10 after just under 14,500 new cases were reported over the preceding week. That weekly total, the lowest since June of 2020, comes from 49 states (excluding N.Y.), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.

Children represent 14.1% of all COVID-19 cases since the beginning of the pandemic, while the corresponding figure for the week ending June 10 was 19.0%. That weekly proportion of cases among children had been rising pretty steadily through the winter and early spring, but the situation has become much more volatile over the last month, the AAP/CHA data show.

Use of the Pfizer-BioNTech vaccine in children aged 16-17 years, of course, didn’t begin until April, and the vaccine wasn’t authorized for children aged 12-15 years until mid-May. The Moderna and Johnson & Johnson vaccines have not received such authorization yet, but Moderna is in the process of seeking an emergency-use recommendation from the Food and Drug Administration.

In the younger group of children who are currently eligible, completion of the vaccine regimen took a big jump in the week ending June 14, according to the Centers for Disease Control and Prevention. The cumulative share of those aged 12-15 years who had received a second dose jumped from 4.1% on June 7 to 11.4% on June 14, with comparable numbers for 16- and 17-year-olds coming in at 26.4% and 29.1%.

Activity over just the last 14 days, however, shows a slight decrease in children aged 12-15 getting a first dose: For just the 2 weeks ending June 7, 17.9% of all children in the age group initiated a first dose, but for the 14 days ending June 14, only 17.1% of the age group did so, the CDC said on its COVID Data Tracker site.

For children aged 16-17 years – of whom less than 30% have reached full vaccination – activity seems to have stagnated: 4.8% of all 16- to 17-year-olds initiated a first vaccination during the 14 days ending June 7, compared with 4.7% who did so during the 14 days ending June 14, the CDC reported.

Older age groups with higher completion rates are still producing greater vaccine initiation. As of June 14, those aged 25-39 years had a completion rate of 41.9% and 24.0% of the age group had received a first dose in the previous 2 weeks, while 61.4% of those aged 50-64 were fully vaccinated, and 18.0% had gotten their first dose, the CDC data indicate.

[email protected]

For physicians who are just starting out or thinking about moving, the “Land of 10,000 Lakes” could be the land of opportunity, according to a recent Medscape analysis.

In a ranking of the 50 states, Minnesota “claimed top marks for livability, low incidence of adverse actions against doctors, and the performance of its health system,” Shelly Reese wrote in Medscape’s “Best & Worst Places to Practice 2021.”

Minnesota is below average where it’s good to be below average – share of physicians reporting burnout and/or depression – but above average in the share of physicians who say they’re “very happy” outside of work, Medscape said in the annual report.

Second on this year’s list is Wisconsin, which benefits from low levels of malpractice payouts and adverse actions and a high level of livability. Third place went to Washington (called the most livable state in the country by U.S. News and World Report), fourth to Colorado (physicians happy at and outside of work, high retention rate for residents), and fifth to Utah (low crime rate, high quality of life), Medscape said.

At the bottom of the list for 2021 is West Virginia, where physicians “may confront a bevy of challenges” in the form of low livability, a high rate of adverse actions, and relatively high malpractice payouts, Ms. Reese noted in the report.

State number 49 is Louisiana, where livability is low, malpractice payouts are high, and more than half of physicians say that they’re burned out and/or depressed. New Mexico is 48th (very high rate of adverse actions, poor resident retention), Nevada is 47th (low marks for avoidable hospital use and disparity in care), and Rhode Island is 46th (high malpractice payouts, low physician compensation), Medscape said.

Continuing with the group-of-five theme, America’s three most populous states finished in the top half of the ranking – California 16th, Texas 11th, and Florida 21st – but New York and Pennsylvania, numbers four and five by population size, did not.

The rankings are based on states’ performance in 10 different measures, three of which were sourced from Medscape surveys – happiness at work, happiness outside of work, and burnout/depression – and seven from other organizations: adverse actions against physicians, malpractice payouts, compensation (adjusted for cost of living), overall health, health system performance, overall livability, resident retention.
 

[email protected]

For physicians who are just starting out or thinking about moving, the “Land of 10,000 Lakes” could be the land of opportunity, according to a recent Medscape analysis.

In a ranking of the 50 states, Minnesota “claimed top marks for livability, low incidence of adverse actions against doctors, and the performance of its health system,” Shelly Reese wrote in Medscape’s “Best & Worst Places to Practice 2021.”

Minnesota is below average where it’s good to be below average – share of physicians reporting burnout and/or depression – but above average in the share of physicians who say they’re “very happy” outside of work, Medscape said in the annual report.

Second on this year’s list is Wisconsin, which benefits from low levels of malpractice payouts and adverse actions and a high level of livability. Third place went to Washington (called the most livable state in the country by U.S. News and World Report), fourth to Colorado (physicians happy at and outside of work, high retention rate for residents), and fifth to Utah (low crime rate, high quality of life), Medscape said.

At the bottom of the list for 2021 is West Virginia, where physicians “may confront a bevy of challenges” in the form of low livability, a high rate of adverse actions, and relatively high malpractice payouts, Ms. Reese noted in the report.

State number 49 is Louisiana, where livability is low, malpractice payouts are high, and more than half of physicians say that they’re burned out and/or depressed. New Mexico is 48th (very high rate of adverse actions, poor resident retention), Nevada is 47th (low marks for avoidable hospital use and disparity in care), and Rhode Island is 46th (high malpractice payouts, low physician compensation), Medscape said.

Continuing with the group-of-five theme, America’s three most populous states finished in the top half of the ranking – California 16th, Texas 11th, and Florida 21st – but New York and Pennsylvania, numbers four and five by population size, did not.

The rankings are based on states’ performance in 10 different measures, three of which were sourced from Medscape surveys – happiness at work, happiness outside of work, and burnout/depression – and seven from other organizations: adverse actions against physicians, malpractice payouts, compensation (adjusted for cost of living), overall health, health system performance, overall livability, resident retention.
 

[email protected]

For physicians who are just starting out or thinking about moving, the “Land of 10,000 Lakes” could be the land of opportunity, according to a recent Medscape analysis.

In a ranking of the 50 states, Minnesota “claimed top marks for livability, low incidence of adverse actions against doctors, and the performance of its health system,” Shelly Reese wrote in Medscape’s “Best & Worst Places to Practice 2021.”

Minnesota is below average where it’s good to be below average – share of physicians reporting burnout and/or depression – but above average in the share of physicians who say they’re “very happy” outside of work, Medscape said in the annual report.

Second on this year’s list is Wisconsin, which benefits from low levels of malpractice payouts and adverse actions and a high level of livability. Third place went to Washington (called the most livable state in the country by U.S. News and World Report), fourth to Colorado (physicians happy at and outside of work, high retention rate for residents), and fifth to Utah (low crime rate, high quality of life), Medscape said.

At the bottom of the list for 2021 is West Virginia, where physicians “may confront a bevy of challenges” in the form of low livability, a high rate of adverse actions, and relatively high malpractice payouts, Ms. Reese noted in the report.

State number 49 is Louisiana, where livability is low, malpractice payouts are high, and more than half of physicians say that they’re burned out and/or depressed. New Mexico is 48th (very high rate of adverse actions, poor resident retention), Nevada is 47th (low marks for avoidable hospital use and disparity in care), and Rhode Island is 46th (high malpractice payouts, low physician compensation), Medscape said.

Continuing with the group-of-five theme, America’s three most populous states finished in the top half of the ranking – California 16th, Texas 11th, and Florida 21st – but New York and Pennsylvania, numbers four and five by population size, did not.

The rankings are based on states’ performance in 10 different measures, three of which were sourced from Medscape surveys – happiness at work, happiness outside of work, and burnout/depression – and seven from other organizations: adverse actions against physicians, malpractice payouts, compensation (adjusted for cost of living), overall health, health system performance, overall livability, resident retention.
 

[email protected]

A third dose of a COVID-19 vaccine can boost antibody levels in people who previously received a solid organ transplant and had an unsatisfactory response to their first two mRNA shots, according to data from a newly published 30-patient case series.

All of those with low titers before the third dose had high titers after receiving the additional shot, but only about 33% of those with negative initial responses had detectable antibodies after the third dose, according to the paper, published in Annals of Internal Medicine.

Researchers at Johns Hopkins, Baltimore, who keep a COVID-19 vaccine registry, perform antibody tests on all registry subjects and inform them of their results. Registry participants were asked to inform the research team if they received a third dose, and, the research team tracked the immune responses of those who did.

The participants in this case series had low antibody levels and received a third dose of the vaccine on their own between March 20 and May 10 of 2021.
 

Third dose results

In this cases series – thought to be the first to look at third vaccine shots in this type of patient group – all six of those who had low antibody titers before the third dose had high-positive titers after the third dose.

Of the 24 individuals who had negative antibody titers before the third dose, just 6 had high titers after the third dose.

Two of the participants had low-positive titers, and 16 were negative.

“Several of those boosted very nicely into ranges seen, using these assays, in healthy persons,” said William Werbel, MD, a fellow in infectious disease at Johns Hopkins Medicine, Baltimore, who helped lead the study. Those with negative levels, even if they responded, tended to have lower titers, he said.

“The benefits at least from an antibody perspective were not the same for everybody and so this is obviously something that needs to be considered when thinking about selecting patients” for a COVID-19 prevention strategy, he said.

Reactions to the vaccine were low to moderate, such as some arm pain and fatigue.

“Showing that something is safe in that special, vulnerable population is important,” Dr. Werbel said. “We’re all wanting to make sure that we’re doing no harm.”

Dr. Werbel noted that there was no pattern in the small series based on the organ transplanted or in the vaccines used. As their third shot, 15 of the patients received the Johnson & Johnson vaccine; 9 received Moderna; and 6 received Pfizer-BioNTech.
 

Welcome news, but larger studies needed

“To think that a third dose could confer protection for a significant number of people is of course extremely welcome news,” said Christian Larsen, MD, DPhil, professor of surgery in the transplantation division at Emory University, Atlanta, who was not involved in the study. “It’s the easiest conceivable next intervention.”

He added, “We just want studies to confirm that – larger studies.”

Dr. Werbel stressed the importance of looking at third doses in these patients in a more controlled fashion in a randomized trial, to more carefully monitor safety and how patients fare when starting with one type of vaccine and switching to another, for example.

Richard Wender, MD, chair of family medicine and community health at the University of Pennsylvania, Philadelphia, said the findings are a reminder that there is still a lot that is unknown about COVID-19 and vaccination.

“We still don’t know who will or will not benefit from a third dose,” he said. “And our knowledge is evolving.  For example, a recent study suggested that people with previous infection and who are vaccinated may have better and longer protection than people with vaccination alone. We’re still learning.”

He added that specialists, not primary care clinicians, should be relied upon to respond to this emerging vaccination data. Primary care doctors are very busy in other ways – such as in getting children caught up on vaccinations and helping adults return to managing their chronic diseases, Dr. Wender noted.

“Their focus needs to be on helping to overcome hesitancy, mistrust, lack of information, or antivaccination sentiment to help more people feel comfortable being vaccinated – this is a lot of work and needs constant focus. In short, primary care clinicians need to focus chiefly on the unvaccinated,” he said.

“Monitoring immunization recommendations for unique at-risk populations should be the chief responsibility of teams providing subspecialty care, [such as for] transplant patients, people with chronic kidney disease, cancer patients, and people with other chronic illnesses.  This will allow primary care clinicians to tackle their many complex jobs.”
 

Possible solutions for those with low antibody responses

Dr. Larsen said that those with ongoing low antibody responses might still have other immune responses, such as a T-cell response. Such patients also could consider changing their vaccine type, he said.

“At the more significant intervention level, there may be circumstances where one could change the immunosuppressive drugs in a controlled way that might allow a better response,” suggested Dr. Larsen. “That’s obviously going to be something that requires a lot more thought and careful study.”

Dr. Werbel said that other options might need to be considered for those having no response following a third dose. One possibility is trying a vaccine with an adjuvant, such as the Novavax version, which might be more widely available soon.

“If you’re given a third dose of a very immunogenic vaccine – something that should work – and you just have no antibody development, it seems relatively unlikely that doing the same thing again is going to help you from that perspective, and for all we know might expose you to more risk,” Dr. Werbel noted.
 

Participant details

None of the 30 patients were thought to have ever had COVID-19. On average, patients had received their transplant 4.5 years before their original vaccination. In 25 patients, maintenance immunosuppression included tacrolimus or cyclosporine along with mycophenolate. Corticosteroids were also used for 24 patients, sirolimus was used for one patient, and belatacept was used for another patient.

Fifty-seven percent of patients had received the Pfizer/BioNTech vaccine originally, and 43% the Moderna vaccine. Most of the patients were kidney recipients, with two heart, three liver, one lung, one pancreas and one kidney-pancreas.

Dr. Werbel, Dr. Wender, and Dr. Larsen reported no relevant disclosures.

A third dose of a COVID-19 vaccine can boost antibody levels in people who previously received a solid organ transplant and had an unsatisfactory response to their first two mRNA shots, according to data from a newly published 30-patient case series.

All of those with low titers before the third dose had high titers after receiving the additional shot, but only about 33% of those with negative initial responses had detectable antibodies after the third dose, according to the paper, published in Annals of Internal Medicine.

Researchers at Johns Hopkins, Baltimore, who keep a COVID-19 vaccine registry, perform antibody tests on all registry subjects and inform them of their results. Registry participants were asked to inform the research team if they received a third dose, and, the research team tracked the immune responses of those who did.

The participants in this case series had low antibody levels and received a third dose of the vaccine on their own between March 20 and May 10 of 2021.
 

Third dose results

In this cases series – thought to be the first to look at third vaccine shots in this type of patient group – all six of those who had low antibody titers before the third dose had high-positive titers after the third dose.

Of the 24 individuals who had negative antibody titers before the third dose, just 6 had high titers after the third dose.

Two of the participants had low-positive titers, and 16 were negative.

“Several of those boosted very nicely into ranges seen, using these assays, in healthy persons,” said William Werbel, MD, a fellow in infectious disease at Johns Hopkins Medicine, Baltimore, who helped lead the study. Those with negative levels, even if they responded, tended to have lower titers, he said.

“The benefits at least from an antibody perspective were not the same for everybody and so this is obviously something that needs to be considered when thinking about selecting patients” for a COVID-19 prevention strategy, he said.

Reactions to the vaccine were low to moderate, such as some arm pain and fatigue.

“Showing that something is safe in that special, vulnerable population is important,” Dr. Werbel said. “We’re all wanting to make sure that we’re doing no harm.”

Dr. Werbel noted that there was no pattern in the small series based on the organ transplanted or in the vaccines used. As their third shot, 15 of the patients received the Johnson & Johnson vaccine; 9 received Moderna; and 6 received Pfizer-BioNTech.
 

Welcome news, but larger studies needed

“To think that a third dose could confer protection for a significant number of people is of course extremely welcome news,” said Christian Larsen, MD, DPhil, professor of surgery in the transplantation division at Emory University, Atlanta, who was not involved in the study. “It’s the easiest conceivable next intervention.”

He added, “We just want studies to confirm that – larger studies.”

Dr. Werbel stressed the importance of looking at third doses in these patients in a more controlled fashion in a randomized trial, to more carefully monitor safety and how patients fare when starting with one type of vaccine and switching to another, for example.

Richard Wender, MD, chair of family medicine and community health at the University of Pennsylvania, Philadelphia, said the findings are a reminder that there is still a lot that is unknown about COVID-19 and vaccination.

“We still don’t know who will or will not benefit from a third dose,” he said. “And our knowledge is evolving.  For example, a recent study suggested that people with previous infection and who are vaccinated may have better and longer protection than people with vaccination alone. We’re still learning.”

He added that specialists, not primary care clinicians, should be relied upon to respond to this emerging vaccination data. Primary care doctors are very busy in other ways – such as in getting children caught up on vaccinations and helping adults return to managing their chronic diseases, Dr. Wender noted.

“Their focus needs to be on helping to overcome hesitancy, mistrust, lack of information, or antivaccination sentiment to help more people feel comfortable being vaccinated – this is a lot of work and needs constant focus. In short, primary care clinicians need to focus chiefly on the unvaccinated,” he said.

“Monitoring immunization recommendations for unique at-risk populations should be the chief responsibility of teams providing subspecialty care, [such as for] transplant patients, people with chronic kidney disease, cancer patients, and people with other chronic illnesses.  This will allow primary care clinicians to tackle their many complex jobs.”
 

Possible solutions for those with low antibody responses

Dr. Larsen said that those with ongoing low antibody responses might still have other immune responses, such as a T-cell response. Such patients also could consider changing their vaccine type, he said.

“At the more significant intervention level, there may be circumstances where one could change the immunosuppressive drugs in a controlled way that might allow a better response,” suggested Dr. Larsen. “That’s obviously going to be something that requires a lot more thought and careful study.”

Dr. Werbel said that other options might need to be considered for those having no response following a third dose. One possibility is trying a vaccine with an adjuvant, such as the Novavax version, which might be more widely available soon.

“If you’re given a third dose of a very immunogenic vaccine – something that should work – and you just have no antibody development, it seems relatively unlikely that doing the same thing again is going to help you from that perspective, and for all we know might expose you to more risk,” Dr. Werbel noted.
 

Participant details

None of the 30 patients were thought to have ever had COVID-19. On average, patients had received their transplant 4.5 years before their original vaccination. In 25 patients, maintenance immunosuppression included tacrolimus or cyclosporine along with mycophenolate. Corticosteroids were also used for 24 patients, sirolimus was used for one patient, and belatacept was used for another patient.

Fifty-seven percent of patients had received the Pfizer/BioNTech vaccine originally, and 43% the Moderna vaccine. Most of the patients were kidney recipients, with two heart, three liver, one lung, one pancreas and one kidney-pancreas.

Dr. Werbel, Dr. Wender, and Dr. Larsen reported no relevant disclosures.

A third dose of a COVID-19 vaccine can boost antibody levels in people who previously received a solid organ transplant and had an unsatisfactory response to their first two mRNA shots, according to data from a newly published 30-patient case series.

All of those with low titers before the third dose had high titers after receiving the additional shot, but only about 33% of those with negative initial responses had detectable antibodies after the third dose, according to the paper, published in Annals of Internal Medicine.

Researchers at Johns Hopkins, Baltimore, who keep a COVID-19 vaccine registry, perform antibody tests on all registry subjects and inform them of their results. Registry participants were asked to inform the research team if they received a third dose, and, the research team tracked the immune responses of those who did.

The participants in this case series had low antibody levels and received a third dose of the vaccine on their own between March 20 and May 10 of 2021.
 

Third dose results

In this cases series – thought to be the first to look at third vaccine shots in this type of patient group – all six of those who had low antibody titers before the third dose had high-positive titers after the third dose.

Of the 24 individuals who had negative antibody titers before the third dose, just 6 had high titers after the third dose.

Two of the participants had low-positive titers, and 16 were negative.

“Several of those boosted very nicely into ranges seen, using these assays, in healthy persons,” said William Werbel, MD, a fellow in infectious disease at Johns Hopkins Medicine, Baltimore, who helped lead the study. Those with negative levels, even if they responded, tended to have lower titers, he said.

“The benefits at least from an antibody perspective were not the same for everybody and so this is obviously something that needs to be considered when thinking about selecting patients” for a COVID-19 prevention strategy, he said.

Reactions to the vaccine were low to moderate, such as some arm pain and fatigue.

“Showing that something is safe in that special, vulnerable population is important,” Dr. Werbel said. “We’re all wanting to make sure that we’re doing no harm.”

Dr. Werbel noted that there was no pattern in the small series based on the organ transplanted or in the vaccines used. As their third shot, 15 of the patients received the Johnson & Johnson vaccine; 9 received Moderna; and 6 received Pfizer-BioNTech.
 

Welcome news, but larger studies needed

“To think that a third dose could confer protection for a significant number of people is of course extremely welcome news,” said Christian Larsen, MD, DPhil, professor of surgery in the transplantation division at Emory University, Atlanta, who was not involved in the study. “It’s the easiest conceivable next intervention.”

He added, “We just want studies to confirm that – larger studies.”

Dr. Werbel stressed the importance of looking at third doses in these patients in a more controlled fashion in a randomized trial, to more carefully monitor safety and how patients fare when starting with one type of vaccine and switching to another, for example.

Richard Wender, MD, chair of family medicine and community health at the University of Pennsylvania, Philadelphia, said the findings are a reminder that there is still a lot that is unknown about COVID-19 and vaccination.

“We still don’t know who will or will not benefit from a third dose,” he said. “And our knowledge is evolving.  For example, a recent study suggested that people with previous infection and who are vaccinated may have better and longer protection than people with vaccination alone. We’re still learning.”

He added that specialists, not primary care clinicians, should be relied upon to respond to this emerging vaccination data. Primary care doctors are very busy in other ways – such as in getting children caught up on vaccinations and helping adults return to managing their chronic diseases, Dr. Wender noted.

“Their focus needs to be on helping to overcome hesitancy, mistrust, lack of information, or antivaccination sentiment to help more people feel comfortable being vaccinated – this is a lot of work and needs constant focus. In short, primary care clinicians need to focus chiefly on the unvaccinated,” he said.

“Monitoring immunization recommendations for unique at-risk populations should be the chief responsibility of teams providing subspecialty care, [such as for] transplant patients, people with chronic kidney disease, cancer patients, and people with other chronic illnesses.  This will allow primary care clinicians to tackle their many complex jobs.”
 

Possible solutions for those with low antibody responses

Dr. Larsen said that those with ongoing low antibody responses might still have other immune responses, such as a T-cell response. Such patients also could consider changing their vaccine type, he said.

“At the more significant intervention level, there may be circumstances where one could change the immunosuppressive drugs in a controlled way that might allow a better response,” suggested Dr. Larsen. “That’s obviously going to be something that requires a lot more thought and careful study.”

Dr. Werbel said that other options might need to be considered for those having no response following a third dose. One possibility is trying a vaccine with an adjuvant, such as the Novavax version, which might be more widely available soon.

“If you’re given a third dose of a very immunogenic vaccine – something that should work – and you just have no antibody development, it seems relatively unlikely that doing the same thing again is going to help you from that perspective, and for all we know might expose you to more risk,” Dr. Werbel noted.
 

Participant details

None of the 30 patients were thought to have ever had COVID-19. On average, patients had received their transplant 4.5 years before their original vaccination. In 25 patients, maintenance immunosuppression included tacrolimus or cyclosporine along with mycophenolate. Corticosteroids were also used for 24 patients, sirolimus was used for one patient, and belatacept was used for another patient.

Fifty-seven percent of patients had received the Pfizer/BioNTech vaccine originally, and 43% the Moderna vaccine. Most of the patients were kidney recipients, with two heart, three liver, one lung, one pancreas and one kidney-pancreas.

Dr. Werbel, Dr. Wender, and Dr. Larsen reported no relevant disclosures.

A federal judge in Texas has dismissed a lawsuit from 117 Houston Methodist Hospital workers who refused to get a COVID-19 vaccine and said it was illegal to require them to do so.

In the ruling issued June 12, U.S. District Judge Lynn Hughes upheld the hospital’s policy and said the vaccination requirement didn’t break any federal laws.

“This is not coercion,” Judge Hughes wrote in the ruling.

“Methodist is trying to do their business of saving lives without giving them the COVID-19 virus,” he wrote. “It is a choice made to keep staff, patients, and their families safer.”

In April, the Houston Methodist Hospital system announced a policy that required employees to be vaccinated by June 7 or request an exemption. After the deadline, 178 of 26,000 employees refused to get inoculated and were placed on suspension without pay. The employees said the vaccine was unsafe and “experimental.” In his ruling, Judge Hughes said their claim was false and irrelevant.

“Texas law only protects employees from being terminated for refusing to commit an act carrying criminal penalties to the worker,” he wrote. “Receiving a COVID-19 vaccination is not an illegal act, and it carries no criminal penalties.”

He denounced the “press-release style of the complaint” and the comparison of the hospital’s vaccine policy to forced experimentation by the Nazis against Jewish people during the Holocaust.

“Equating the injection requirement to medical experimentation in concentration camps is reprehensible,” he wrote. “Nazi doctors conducted medical experiments on victims that caused pain, mutilation, permanent disability, and in many cases, death.”

Judge Hughes also said that employees can “freely choose” to accept or refuse a COVID-19 vaccine. If they refuse, they “simply need to work somewhere else,” he wrote.

“If a worker refuses an assignment, changed office, earlier start time, or other directive, he may be properly fired,” Judge Hughes said. “Every employment includes limits on the worker’s behavior in exchange for his remuneration. This is all part of the bargain.”

The ruling could set a precedent for similar COVID-19 vaccine lawsuits across the country, NPR reported. Houston Methodist was one of the first hospitals to require staff to be vaccinated. After the ruling on June 12, the hospital system wrote in a statement that it was “pleased and reassured” that Judge Hughes dismissed a “frivolous lawsuit.”

The hospital system will begin to terminate the 178 employees who were suspended if they don’t get a vaccine by June 21.

Jennifer Bridges, a nurse who has led the campaign against the vaccine policy, said she and the other plaintiffs will appeal the decision, according to KHOU.

“We’re OK with this decision. We are appealing. This will be taken all the way to the Supreme Court,” she told the news station. “This is far from over. This is literally only the beginning.”

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

A federal judge in Texas has dismissed a lawsuit from 117 Houston Methodist Hospital workers who refused to get a COVID-19 vaccine and said it was illegal to require them to do so.

In the ruling issued June 12, U.S. District Judge Lynn Hughes upheld the hospital’s policy and said the vaccination requirement didn’t break any federal laws.

“This is not coercion,” Judge Hughes wrote in the ruling.

“Methodist is trying to do their business of saving lives without giving them the COVID-19 virus,” he wrote. “It is a choice made to keep staff, patients, and their families safer.”

In April, the Houston Methodist Hospital system announced a policy that required employees to be vaccinated by June 7 or request an exemption. After the deadline, 178 of 26,000 employees refused to get inoculated and were placed on suspension without pay. The employees said the vaccine was unsafe and “experimental.” In his ruling, Judge Hughes said their claim was false and irrelevant.

“Texas law only protects employees from being terminated for refusing to commit an act carrying criminal penalties to the worker,” he wrote. “Receiving a COVID-19 vaccination is not an illegal act, and it carries no criminal penalties.”

He denounced the “press-release style of the complaint” and the comparison of the hospital’s vaccine policy to forced experimentation by the Nazis against Jewish people during the Holocaust.

“Equating the injection requirement to medical experimentation in concentration camps is reprehensible,” he wrote. “Nazi doctors conducted medical experiments on victims that caused pain, mutilation, permanent disability, and in many cases, death.”

Judge Hughes also said that employees can “freely choose” to accept or refuse a COVID-19 vaccine. If they refuse, they “simply need to work somewhere else,” he wrote.

“If a worker refuses an assignment, changed office, earlier start time, or other directive, he may be properly fired,” Judge Hughes said. “Every employment includes limits on the worker’s behavior in exchange for his remuneration. This is all part of the bargain.”

The ruling could set a precedent for similar COVID-19 vaccine lawsuits across the country, NPR reported. Houston Methodist was one of the first hospitals to require staff to be vaccinated. After the ruling on June 12, the hospital system wrote in a statement that it was “pleased and reassured” that Judge Hughes dismissed a “frivolous lawsuit.”

The hospital system will begin to terminate the 178 employees who were suspended if they don’t get a vaccine by June 21.

Jennifer Bridges, a nurse who has led the campaign against the vaccine policy, said she and the other plaintiffs will appeal the decision, according to KHOU.

“We’re OK with this decision. We are appealing. This will be taken all the way to the Supreme Court,” she told the news station. “This is far from over. This is literally only the beginning.”

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

A federal judge in Texas has dismissed a lawsuit from 117 Houston Methodist Hospital workers who refused to get a COVID-19 vaccine and said it was illegal to require them to do so.

In the ruling issued June 12, U.S. District Judge Lynn Hughes upheld the hospital’s policy and said the vaccination requirement didn’t break any federal laws.

“This is not coercion,” Judge Hughes wrote in the ruling.

“Methodist is trying to do their business of saving lives without giving them the COVID-19 virus,” he wrote. “It is a choice made to keep staff, patients, and their families safer.”

In April, the Houston Methodist Hospital system announced a policy that required employees to be vaccinated by June 7 or request an exemption. After the deadline, 178 of 26,000 employees refused to get inoculated and were placed on suspension without pay. The employees said the vaccine was unsafe and “experimental.” In his ruling, Judge Hughes said their claim was false and irrelevant.

“Texas law only protects employees from being terminated for refusing to commit an act carrying criminal penalties to the worker,” he wrote. “Receiving a COVID-19 vaccination is not an illegal act, and it carries no criminal penalties.”

He denounced the “press-release style of the complaint” and the comparison of the hospital’s vaccine policy to forced experimentation by the Nazis against Jewish people during the Holocaust.

“Equating the injection requirement to medical experimentation in concentration camps is reprehensible,” he wrote. “Nazi doctors conducted medical experiments on victims that caused pain, mutilation, permanent disability, and in many cases, death.”

Judge Hughes also said that employees can “freely choose” to accept or refuse a COVID-19 vaccine. If they refuse, they “simply need to work somewhere else,” he wrote.

“If a worker refuses an assignment, changed office, earlier start time, or other directive, he may be properly fired,” Judge Hughes said. “Every employment includes limits on the worker’s behavior in exchange for his remuneration. This is all part of the bargain.”

The ruling could set a precedent for similar COVID-19 vaccine lawsuits across the country, NPR reported. Houston Methodist was one of the first hospitals to require staff to be vaccinated. After the ruling on June 12, the hospital system wrote in a statement that it was “pleased and reassured” that Judge Hughes dismissed a “frivolous lawsuit.”

The hospital system will begin to terminate the 178 employees who were suspended if they don’t get a vaccine by June 21.

Jennifer Bridges, a nurse who has led the campaign against the vaccine policy, said she and the other plaintiffs will appeal the decision, according to KHOU.

“We’re OK with this decision. We are appealing. This will be taken all the way to the Supreme Court,” she told the news station. “This is far from over. This is literally only the beginning.”

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

In 2008, the U.S. Department of Labor (DOL) paid for Tony Adams, a 48-year-old coal miner, to have a chest x-ray. His doctor found stage I black lung disease. Yet Mr. Adams’ claim for medical benefits was denied. This was because the insurance group that represented his employer hired a different – more credentialed – doctor as its medical expert. That doctor said he saw no such evidence. The judge ruled in favor of the mining company on the basis of the latter’s “expertise.”

Before he died 5 years later, at age 53, Mr. Adams went through this process again. In fact, he did it four more times. Each time, his doctor found evidence of black lung, but the company’s medical expert did not. He died without receiving benefits. Among the causes of death listed on his autopsy were cardiopulmonary arrest and coal worker’s pneumoconiosis (CWP): black lung.

Since his death in 2013, two judges have awarded Mr. Adams’ benefits to his widow, Linda. Both times, the mining company appealed the decision, most recently in December 2020. She’s not giving up. “Two weeks before he died, he told me, ‘I’m going to die of black lung,’ ” Linda recalled. “‘But I don’t want you to give up on black lung. There are too many people screwing these miners out of what they deserve.’”

There has long been suspicion among miners and their advocates that doctors used by coal companies to fight claims like Mr. Adams’ are in the pocket of “Big Coal.” At the very least, some say these physicians are swayed by their client’s preference when reading a coal miner’s chest x-ray. A recent study published in Annals of the American Thoracic Society provides empirical evidence that these doctors’ conflict of interest – namely, that parties representing coal companies hired them – appears to influence their medical opinion.
 

Proof of a ‘broken system’

The Annals study examined 63,780 radiograph classifications made by 264 physicians – all certified as B-readers, a certification by the National Institute for Occupational Safety and Health (NIOSH) for physicians who demonstrate proficiency in classifying radiographs of pneumoconiosis. The results showed that doctors hired by miners identified black lung 49% of the time; those hired by coal companies identified black lung only 15% of the time.

The study also found that B-readers contracted by employers read results differently for different clients. The same doctors were significantly less likely to say a miner’s lungs were negative for CWP when they were hired by the DOL (77.2%) than when they were hired by a coal company or its insurers (90.2%).

The bias does appear to work both ways: B-readers hired by miners and miners’ attorneys were more likely to find evidence of black lung when they worked with plaintiffs. However, a much higher number of doctors appeared to be biased in favor of the companies. “There were 3X more B-readers providing 8X more classifications among those affiliated with employers compared to those affiliated with miners,” the study concluded.

The authors suggest that one reason for this was the difference in pay. Some company-hired doctors made as much as $750 per reading, about 10 times what miner-hired doctors were paid.

“We knew [about the potential bias] from our work over the decades taking care of these guys,” said Robert A. Cohen, MD, a pulmonologist and the study’s senior author. “But then you see it with P values that are incredibly statistically significant ...”

The study finally put numbers to a problem that many working with black lung claims had always assumed. Those within the system are accustomed to seeing names of the same doctors on documents and reports, with little to no overlap between those hired by the defense and the plaintiffs.

“The vast majority of the time, we know what a report will say based on the doctor’s name,” said Evan Smith, JD, advocacy director at AppalReD Legal Aid, in Prestonsburg, Ky.. It is far more surprising, he said, when a defense-hired doctor agrees with a miner-hired doctor.

Over the years, Katherine DePonte, MD, a radiologist and B-reader in West Virginia, has often seen an “almost textbook appearance” of CWP, only to later learn that “another radiologist read it as negative.” She explained, “They would use some other term, like ‘old granulomatous disease.’”

Employer-hired doctors often do acknowledge the same lung damage on the radiograph as miner-hired docs; they simply don’t attribute it to coal dust. Common “alternative diagnoses” include chronic obstructive pulmonary disease or histoplasmosis. “I know a number don’t believe this disease of coal worker pneumoconiosis exists [at all],” Dr. DePonte said.

What’s inarguable is that, even as coal mining in Appalachia is on the decline, black lung disease is on the rise. NIOSH now estimates that it affects over 20% of long-term (25+ years) coal workers in central Appalachia. That’s the highest prevalence in a quarter of a century.

Mr. Smith said that at its most basic level, these doctors’ conflicts of interest “lead to people who have the disease that these benefits are for, having them denied.” People like Tony Adams. Whether the doctors involved are complicit or just conservative, critics say they have become a fixture of a broken system.
 

Financial bias or difference of opinion?

Broken system or not, evidence suggests that the problem can’t be blamed solely on medical experts. Dr. DePonte primarily reads for the DOL and miners. “Not that I necessarily chose that,” she said. “You get pigeonholed.”

Some say that the bias demonstrated by the Annals study is at least partially driven by the litigation process itself. It is an adversarial system. As such, attorneys on both sides are naturally inclined to seek out doctors who will best support their clients’ cases. Doctors with a legitimately conservative perspective on what constitutes black lung are more sought after by the coal companies’ attorneys.

“It can often be impossible to tell whether the money is driving a change in the behavior or if the behavior is causing them to be sought out,” said Matt McCoy, PhD, a medical ethicist who specializes in conflicts of interest at the University of Pennsylvania, Philadelphia.

Although some believe that certain doctors are driven purely by financial incentive and offer a specific reading to secure repeat business, B-readers can end up working exclusively for companies because of other reasons. Wes Addington, JD, an attorney at the Appalachian Citizens’ Law Center, Whitesburg, Ky., said some doctors appear to have an authentically different – often antiquated – view of the disease.

Perhaps the most extreme example is Paul Wheeler, MD, a highly credentialed Johns Hopkins radiologist who was exposed for false medical testimony in Chris Hamby’s 2013 Pulitzer Prize reporting. In 1,500 readings, Dr. Wheeler never diagnosed a single case of severe black lung. And yet, Dr. Cohen, Mr. Addington, Mr. Smith, and other experts all agree that Dr. Wheeler appeared to wholeheartedly believe that his view of black lung was accurate. That made him a valuable asset to mining companies.

Since Dr. Wheeler’s exposure, there has been a greater sense of accountability among B-readers, said John Cline, JD, a West Virginia–based attorney who represents miners with federal black lung claims. “Radiologists were thinking, ‘Somebody could be watching me.’ Even if they thought they were doing this in the shadows, it made people more cautious,” he said.

The data used in the Annals study predate Mr. Hamby’s investigation, going back to 2000. Thus, it is possible that, as Mr. Cline argues, things may be different now. However, Lee S. Friedman, PhD, associate professor at the University of Illinois at Chicago, who is the lead author of the study, remains skeptical.

“While the Wheeler case might have dampened some physicians [who were] completely skewing their readings always negative, I think it’s premature or incorrect” to say it resolved the issue, he said. “Did they all change their behavior the morning after? It doesn’t seem likely, given the evidence of financial conflicts of interest and behavior that’s been demonstrated.”
 

Skewing the evidence?

Mr. Hamby’s 2013 reporting also revealed that even when company-hired doctors did diagnose CWP, law firms were burying those readings. In 2016, the DOL attempted to stop this practice. The agency made suppression of written evidence illegal – emphasis on written.

Law firms can’t hide positive reports, but they can prevent them. Dr. Cohen explained that now, “a doctor on the phone says, ‘I will read this as positive.’ Then the company says, ‘No, thank you,’ we will send you a check.”

This practice was confirmed by Kim Adcock, MD, a retired radiologist and B-reader in Littleton, Colo., who primarily reads for 26 law firms. Some of his clients want a report no matter how he reads the radiograph. However, some want him to call them first if he’s going to read the radiograph as positive. Dr. Adcock said this practice skews the dataset to make company-hired docs appear to read more negatively than they actually do.

Because the dataset used in the study is from the Federal Black Lung Program (FBLP), it includes only readings that made it to court. Dr. Adcock said he reads approximately 2,000 radiographs a year, although only a few of his readings appeared in the study’s dataset, according to a search by Dr. Friedman. This difference is likely because the study evaluated only readings between 2000 and 2013, the year Dr. Adcock started B-reading.

“I think it’s important to get a message that, to a certain extent, contravenes this paper. Yes, we should have some reservations about the conclusions,” Dr. Adcock explained. “There are people out there attempting to do the best job they could do.”

Law firms shopping for the reading they want and censoring the ones they don’t might alter the FBLP data, but experts say that doesn’t change the underlying problem. “In any case like this, where you’re looking at individuals going up against corporations,” Dr. McCoy said, “[corporations] are able to marshal their resources and hire more officials in a way claimants can’t, and that’s a baseline concern here.”
 

Battling bias

Admitting bias is notoriously difficult; thus, it isn’t surprising that many doctors involved refuse to believe they are influenced by money, incentives, or other biases. Dr. DePonte said she’s not swayed by money, nor does she actively take a pro-miner stance. She views herself as more of an advocate for accuracy. However, she did say that it has traditionally been far more difficult for miners to prove their cases, a problem that has improved with new regulations in recent years.

In Colorado, Dr. Adcock’s approach is to stay as far removed from the litigation process as possible. He said he has limited understanding of how his reports are used or how claims are filed and awarded. He leans heavily on his initial – almost instantaneous – impression of a chest x-ray.

Dr. DePonte and Dr. Adcock were both hired as experts on Tony Adams’ case. In 2008, Dr. DePonte read his chest x-ray as positive for early-stage black lung (1/0). Dr. Adcock also read two of Adams’ four chest x-rays, one in 2009 and the other in 2013. He read them as negative. When asked about the case, which autopsy confirmed as black lung, Dr. Adcock explained that positive histopathology doesn’t mean the radiograph reading was wrong, only that the disease didn’t show on that radiograph. He said his “highest ambition” is to be “an objective finder of fact” and that he trusts the process to work out the truth.

That process didn’t work in time for Tony Adams. Dr. Friedman argues that people who provide expert testimony have an ethical responsibility to know how their testimony is being used; to do otherwise, he says, is “willful ignorance.” Still, the Annals study authors, along with Dr. DePonte, Mr. Cline, and West Virginia attorney Sam Petsonk, say that the process is getting fairer, thanks to new policies developed over the past 5 years by the DOL.

“The DOL has worked very hard to reconcile the final award rate (around 30%) with the incidence of disease in the population (between 20% and 25%),” Mr. Petsonk said. Although the study calls into question the integrity of the system and the doctors within it, it’s critical for miners to know that the system is working and that they can get benefits, he explained. Many fear that cynicism about the system drives miners away and causes them to resort to Social Security or long-term disability.
 

Fixing what’s broken

The Annals study’s authors propose some solutions to the problems they quantified. The first is a sort of “super panel” that collectively evaluates readings. Although a completely unbiased panel would be nice, such impartiality is likely unsustainable, Mr. Smith said. He believes that over time, the panel would become vulnerable to politics and would work in favor of the companies.

Even without a panel, a method to provide greater transparency could be a great start, some suggest. The DOL could make the entire FBLP database public and analyze it annually. The authors also propose a flat fee for readings. Even now, Dr. Adcock said he doesn’t make anywhere close to the upper limit of $750 per readings. “My understanding is around $125 is a pretty characteristic fee [for reading a chest x-ray],” he elaborated. “Everyone I’ve had a conversation with is within 25 bucks [of that].”

That said, Dr. Adcock is not currently listed among the heavy readers who appear in the data used for the study; it’s possible that his experience is not representative. Some readers who were included in that dataset read more than 10 times the average number of classifications per reader – the average was 242 classifications – and read 95% of chest x-rays as negative, according to Dr. Friedman. This news organization obtained the names of two doctors whose readings were 95% negative on a high volume of cases. Neither agreed to an interview.

It’s possible that if the dataset had included readings from more recent years, Dr. Adcock would have appeared more frequently, given his personal estimates. That’s why the study authors recommend that the DOL conduct this kind of analysis annually in order to get an accurate picture of who is contributing to these cases, in what way, and how often. By doing so, readers who appear biased could be identified and addressed with more regularity, Dr. Friedman said.

Even if the rate were more consistent and the data were more frequently analyzed, the very nature of the adversarial system will put any potential solution at risk. “I’m not sure there’s a foolproof system that can be devised that can’t be corrupted in time,” Mr. Cline said.
 

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

In 2008, the U.S. Department of Labor (DOL) paid for Tony Adams, a 48-year-old coal miner, to have a chest x-ray. His doctor found stage I black lung disease. Yet Mr. Adams’ claim for medical benefits was denied. This was because the insurance group that represented his employer hired a different – more credentialed – doctor as its medical expert. That doctor said he saw no such evidence. The judge ruled in favor of the mining company on the basis of the latter’s “expertise.”

Before he died 5 years later, at age 53, Mr. Adams went through this process again. In fact, he did it four more times. Each time, his doctor found evidence of black lung, but the company’s medical expert did not. He died without receiving benefits. Among the causes of death listed on his autopsy were cardiopulmonary arrest and coal worker’s pneumoconiosis (CWP): black lung.

Since his death in 2013, two judges have awarded Mr. Adams’ benefits to his widow, Linda. Both times, the mining company appealed the decision, most recently in December 2020. She’s not giving up. “Two weeks before he died, he told me, ‘I’m going to die of black lung,’ ” Linda recalled. “‘But I don’t want you to give up on black lung. There are too many people screwing these miners out of what they deserve.’”

There has long been suspicion among miners and their advocates that doctors used by coal companies to fight claims like Mr. Adams’ are in the pocket of “Big Coal.” At the very least, some say these physicians are swayed by their client’s preference when reading a coal miner’s chest x-ray. A recent study published in Annals of the American Thoracic Society provides empirical evidence that these doctors’ conflict of interest – namely, that parties representing coal companies hired them – appears to influence their medical opinion.
 

Proof of a ‘broken system’

The Annals study examined 63,780 radiograph classifications made by 264 physicians – all certified as B-readers, a certification by the National Institute for Occupational Safety and Health (NIOSH) for physicians who demonstrate proficiency in classifying radiographs of pneumoconiosis. The results showed that doctors hired by miners identified black lung 49% of the time; those hired by coal companies identified black lung only 15% of the time.

The study also found that B-readers contracted by employers read results differently for different clients. The same doctors were significantly less likely to say a miner’s lungs were negative for CWP when they were hired by the DOL (77.2%) than when they were hired by a coal company or its insurers (90.2%).

The bias does appear to work both ways: B-readers hired by miners and miners’ attorneys were more likely to find evidence of black lung when they worked with plaintiffs. However, a much higher number of doctors appeared to be biased in favor of the companies. “There were 3X more B-readers providing 8X more classifications among those affiliated with employers compared to those affiliated with miners,” the study concluded.

The authors suggest that one reason for this was the difference in pay. Some company-hired doctors made as much as $750 per reading, about 10 times what miner-hired doctors were paid.

“We knew [about the potential bias] from our work over the decades taking care of these guys,” said Robert A. Cohen, MD, a pulmonologist and the study’s senior author. “But then you see it with P values that are incredibly statistically significant ...”

The study finally put numbers to a problem that many working with black lung claims had always assumed. Those within the system are accustomed to seeing names of the same doctors on documents and reports, with little to no overlap between those hired by the defense and the plaintiffs.

“The vast majority of the time, we know what a report will say based on the doctor’s name,” said Evan Smith, JD, advocacy director at AppalReD Legal Aid, in Prestonsburg, Ky.. It is far more surprising, he said, when a defense-hired doctor agrees with a miner-hired doctor.

Over the years, Katherine DePonte, MD, a radiologist and B-reader in West Virginia, has often seen an “almost textbook appearance” of CWP, only to later learn that “another radiologist read it as negative.” She explained, “They would use some other term, like ‘old granulomatous disease.’”

Employer-hired doctors often do acknowledge the same lung damage on the radiograph as miner-hired docs; they simply don’t attribute it to coal dust. Common “alternative diagnoses” include chronic obstructive pulmonary disease or histoplasmosis. “I know a number don’t believe this disease of coal worker pneumoconiosis exists [at all],” Dr. DePonte said.

What’s inarguable is that, even as coal mining in Appalachia is on the decline, black lung disease is on the rise. NIOSH now estimates that it affects over 20% of long-term (25+ years) coal workers in central Appalachia. That’s the highest prevalence in a quarter of a century.

Mr. Smith said that at its most basic level, these doctors’ conflicts of interest “lead to people who have the disease that these benefits are for, having them denied.” People like Tony Adams. Whether the doctors involved are complicit or just conservative, critics say they have become a fixture of a broken system.
 

Financial bias or difference of opinion?

Broken system or not, evidence suggests that the problem can’t be blamed solely on medical experts. Dr. DePonte primarily reads for the DOL and miners. “Not that I necessarily chose that,” she said. “You get pigeonholed.”

Some say that the bias demonstrated by the Annals study is at least partially driven by the litigation process itself. It is an adversarial system. As such, attorneys on both sides are naturally inclined to seek out doctors who will best support their clients’ cases. Doctors with a legitimately conservative perspective on what constitutes black lung are more sought after by the coal companies’ attorneys.

“It can often be impossible to tell whether the money is driving a change in the behavior or if the behavior is causing them to be sought out,” said Matt McCoy, PhD, a medical ethicist who specializes in conflicts of interest at the University of Pennsylvania, Philadelphia.

Although some believe that certain doctors are driven purely by financial incentive and offer a specific reading to secure repeat business, B-readers can end up working exclusively for companies because of other reasons. Wes Addington, JD, an attorney at the Appalachian Citizens’ Law Center, Whitesburg, Ky., said some doctors appear to have an authentically different – often antiquated – view of the disease.

Perhaps the most extreme example is Paul Wheeler, MD, a highly credentialed Johns Hopkins radiologist who was exposed for false medical testimony in Chris Hamby’s 2013 Pulitzer Prize reporting. In 1,500 readings, Dr. Wheeler never diagnosed a single case of severe black lung. And yet, Dr. Cohen, Mr. Addington, Mr. Smith, and other experts all agree that Dr. Wheeler appeared to wholeheartedly believe that his view of black lung was accurate. That made him a valuable asset to mining companies.

Since Dr. Wheeler’s exposure, there has been a greater sense of accountability among B-readers, said John Cline, JD, a West Virginia–based attorney who represents miners with federal black lung claims. “Radiologists were thinking, ‘Somebody could be watching me.’ Even if they thought they were doing this in the shadows, it made people more cautious,” he said.

The data used in the Annals study predate Mr. Hamby’s investigation, going back to 2000. Thus, it is possible that, as Mr. Cline argues, things may be different now. However, Lee S. Friedman, PhD, associate professor at the University of Illinois at Chicago, who is the lead author of the study, remains skeptical.

“While the Wheeler case might have dampened some physicians [who were] completely skewing their readings always negative, I think it’s premature or incorrect” to say it resolved the issue, he said. “Did they all change their behavior the morning after? It doesn’t seem likely, given the evidence of financial conflicts of interest and behavior that’s been demonstrated.”
 

Skewing the evidence?

Mr. Hamby’s 2013 reporting also revealed that even when company-hired doctors did diagnose CWP, law firms were burying those readings. In 2016, the DOL attempted to stop this practice. The agency made suppression of written evidence illegal – emphasis on written.

Law firms can’t hide positive reports, but they can prevent them. Dr. Cohen explained that now, “a doctor on the phone says, ‘I will read this as positive.’ Then the company says, ‘No, thank you,’ we will send you a check.”

This practice was confirmed by Kim Adcock, MD, a retired radiologist and B-reader in Littleton, Colo., who primarily reads for 26 law firms. Some of his clients want a report no matter how he reads the radiograph. However, some want him to call them first if he’s going to read the radiograph as positive. Dr. Adcock said this practice skews the dataset to make company-hired docs appear to read more negatively than they actually do.

Because the dataset used in the study is from the Federal Black Lung Program (FBLP), it includes only readings that made it to court. Dr. Adcock said he reads approximately 2,000 radiographs a year, although only a few of his readings appeared in the study’s dataset, according to a search by Dr. Friedman. This difference is likely because the study evaluated only readings between 2000 and 2013, the year Dr. Adcock started B-reading.

“I think it’s important to get a message that, to a certain extent, contravenes this paper. Yes, we should have some reservations about the conclusions,” Dr. Adcock explained. “There are people out there attempting to do the best job they could do.”

Law firms shopping for the reading they want and censoring the ones they don’t might alter the FBLP data, but experts say that doesn’t change the underlying problem. “In any case like this, where you’re looking at individuals going up against corporations,” Dr. McCoy said, “[corporations] are able to marshal their resources and hire more officials in a way claimants can’t, and that’s a baseline concern here.”
 

Battling bias

Admitting bias is notoriously difficult; thus, it isn’t surprising that many doctors involved refuse to believe they are influenced by money, incentives, or other biases. Dr. DePonte said she’s not swayed by money, nor does she actively take a pro-miner stance. She views herself as more of an advocate for accuracy. However, she did say that it has traditionally been far more difficult for miners to prove their cases, a problem that has improved with new regulations in recent years.

In Colorado, Dr. Adcock’s approach is to stay as far removed from the litigation process as possible. He said he has limited understanding of how his reports are used or how claims are filed and awarded. He leans heavily on his initial – almost instantaneous – impression of a chest x-ray.

Dr. DePonte and Dr. Adcock were both hired as experts on Tony Adams’ case. In 2008, Dr. DePonte read his chest x-ray as positive for early-stage black lung (1/0). Dr. Adcock also read two of Adams’ four chest x-rays, one in 2009 and the other in 2013. He read them as negative. When asked about the case, which autopsy confirmed as black lung, Dr. Adcock explained that positive histopathology doesn’t mean the radiograph reading was wrong, only that the disease didn’t show on that radiograph. He said his “highest ambition” is to be “an objective finder of fact” and that he trusts the process to work out the truth.

That process didn’t work in time for Tony Adams. Dr. Friedman argues that people who provide expert testimony have an ethical responsibility to know how their testimony is being used; to do otherwise, he says, is “willful ignorance.” Still, the Annals study authors, along with Dr. DePonte, Mr. Cline, and West Virginia attorney Sam Petsonk, say that the process is getting fairer, thanks to new policies developed over the past 5 years by the DOL.

“The DOL has worked very hard to reconcile the final award rate (around 30%) with the incidence of disease in the population (between 20% and 25%),” Mr. Petsonk said. Although the study calls into question the integrity of the system and the doctors within it, it’s critical for miners to know that the system is working and that they can get benefits, he explained. Many fear that cynicism about the system drives miners away and causes them to resort to Social Security or long-term disability.
 

Fixing what’s broken

The Annals study’s authors propose some solutions to the problems they quantified. The first is a sort of “super panel” that collectively evaluates readings. Although a completely unbiased panel would be nice, such impartiality is likely unsustainable, Mr. Smith said. He believes that over time, the panel would become vulnerable to politics and would work in favor of the companies.

Even without a panel, a method to provide greater transparency could be a great start, some suggest. The DOL could make the entire FBLP database public and analyze it annually. The authors also propose a flat fee for readings. Even now, Dr. Adcock said he doesn’t make anywhere close to the upper limit of $750 per readings. “My understanding is around $125 is a pretty characteristic fee [for reading a chest x-ray],” he elaborated. “Everyone I’ve had a conversation with is within 25 bucks [of that].”

That said, Dr. Adcock is not currently listed among the heavy readers who appear in the data used for the study; it’s possible that his experience is not representative. Some readers who were included in that dataset read more than 10 times the average number of classifications per reader – the average was 242 classifications – and read 95% of chest x-rays as negative, according to Dr. Friedman. This news organization obtained the names of two doctors whose readings were 95% negative on a high volume of cases. Neither agreed to an interview.

It’s possible that if the dataset had included readings from more recent years, Dr. Adcock would have appeared more frequently, given his personal estimates. That’s why the study authors recommend that the DOL conduct this kind of analysis annually in order to get an accurate picture of who is contributing to these cases, in what way, and how often. By doing so, readers who appear biased could be identified and addressed with more regularity, Dr. Friedman said.

Even if the rate were more consistent and the data were more frequently analyzed, the very nature of the adversarial system will put any potential solution at risk. “I’m not sure there’s a foolproof system that can be devised that can’t be corrupted in time,” Mr. Cline said.
 

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

In 2008, the U.S. Department of Labor (DOL) paid for Tony Adams, a 48-year-old coal miner, to have a chest x-ray. His doctor found stage I black lung disease. Yet Mr. Adams’ claim for medical benefits was denied. This was because the insurance group that represented his employer hired a different – more credentialed – doctor as its medical expert. That doctor said he saw no such evidence. The judge ruled in favor of the mining company on the basis of the latter’s “expertise.”

Before he died 5 years later, at age 53, Mr. Adams went through this process again. In fact, he did it four more times. Each time, his doctor found evidence of black lung, but the company’s medical expert did not. He died without receiving benefits. Among the causes of death listed on his autopsy were cardiopulmonary arrest and coal worker’s pneumoconiosis (CWP): black lung.

Since his death in 2013, two judges have awarded Mr. Adams’ benefits to his widow, Linda. Both times, the mining company appealed the decision, most recently in December 2020. She’s not giving up. “Two weeks before he died, he told me, ‘I’m going to die of black lung,’ ” Linda recalled. “‘But I don’t want you to give up on black lung. There are too many people screwing these miners out of what they deserve.’”

There has long been suspicion among miners and their advocates that doctors used by coal companies to fight claims like Mr. Adams’ are in the pocket of “Big Coal.” At the very least, some say these physicians are swayed by their client’s preference when reading a coal miner’s chest x-ray. A recent study published in Annals of the American Thoracic Society provides empirical evidence that these doctors’ conflict of interest – namely, that parties representing coal companies hired them – appears to influence their medical opinion.
 

Proof of a ‘broken system’

The Annals study examined 63,780 radiograph classifications made by 264 physicians – all certified as B-readers, a certification by the National Institute for Occupational Safety and Health (NIOSH) for physicians who demonstrate proficiency in classifying radiographs of pneumoconiosis. The results showed that doctors hired by miners identified black lung 49% of the time; those hired by coal companies identified black lung only 15% of the time.

The study also found that B-readers contracted by employers read results differently for different clients. The same doctors were significantly less likely to say a miner’s lungs were negative for CWP when they were hired by the DOL (77.2%) than when they were hired by a coal company or its insurers (90.2%).

The bias does appear to work both ways: B-readers hired by miners and miners’ attorneys were more likely to find evidence of black lung when they worked with plaintiffs. However, a much higher number of doctors appeared to be biased in favor of the companies. “There were 3X more B-readers providing 8X more classifications among those affiliated with employers compared to those affiliated with miners,” the study concluded.

The authors suggest that one reason for this was the difference in pay. Some company-hired doctors made as much as $750 per reading, about 10 times what miner-hired doctors were paid.

“We knew [about the potential bias] from our work over the decades taking care of these guys,” said Robert A. Cohen, MD, a pulmonologist and the study’s senior author. “But then you see it with P values that are incredibly statistically significant ...”

The study finally put numbers to a problem that many working with black lung claims had always assumed. Those within the system are accustomed to seeing names of the same doctors on documents and reports, with little to no overlap between those hired by the defense and the plaintiffs.

“The vast majority of the time, we know what a report will say based on the doctor’s name,” said Evan Smith, JD, advocacy director at AppalReD Legal Aid, in Prestonsburg, Ky.. It is far more surprising, he said, when a defense-hired doctor agrees with a miner-hired doctor.

Over the years, Katherine DePonte, MD, a radiologist and B-reader in West Virginia, has often seen an “almost textbook appearance” of CWP, only to later learn that “another radiologist read it as negative.” She explained, “They would use some other term, like ‘old granulomatous disease.’”

Employer-hired doctors often do acknowledge the same lung damage on the radiograph as miner-hired docs; they simply don’t attribute it to coal dust. Common “alternative diagnoses” include chronic obstructive pulmonary disease or histoplasmosis. “I know a number don’t believe this disease of coal worker pneumoconiosis exists [at all],” Dr. DePonte said.

What’s inarguable is that, even as coal mining in Appalachia is on the decline, black lung disease is on the rise. NIOSH now estimates that it affects over 20% of long-term (25+ years) coal workers in central Appalachia. That’s the highest prevalence in a quarter of a century.

Mr. Smith said that at its most basic level, these doctors’ conflicts of interest “lead to people who have the disease that these benefits are for, having them denied.” People like Tony Adams. Whether the doctors involved are complicit or just conservative, critics say they have become a fixture of a broken system.
 

Financial bias or difference of opinion?

Broken system or not, evidence suggests that the problem can’t be blamed solely on medical experts. Dr. DePonte primarily reads for the DOL and miners. “Not that I necessarily chose that,” she said. “You get pigeonholed.”

Some say that the bias demonstrated by the Annals study is at least partially driven by the litigation process itself. It is an adversarial system. As such, attorneys on both sides are naturally inclined to seek out doctors who will best support their clients’ cases. Doctors with a legitimately conservative perspective on what constitutes black lung are more sought after by the coal companies’ attorneys.

“It can often be impossible to tell whether the money is driving a change in the behavior or if the behavior is causing them to be sought out,” said Matt McCoy, PhD, a medical ethicist who specializes in conflicts of interest at the University of Pennsylvania, Philadelphia.

Although some believe that certain doctors are driven purely by financial incentive and offer a specific reading to secure repeat business, B-readers can end up working exclusively for companies because of other reasons. Wes Addington, JD, an attorney at the Appalachian Citizens’ Law Center, Whitesburg, Ky., said some doctors appear to have an authentically different – often antiquated – view of the disease.

Perhaps the most extreme example is Paul Wheeler, MD, a highly credentialed Johns Hopkins radiologist who was exposed for false medical testimony in Chris Hamby’s 2013 Pulitzer Prize reporting. In 1,500 readings, Dr. Wheeler never diagnosed a single case of severe black lung. And yet, Dr. Cohen, Mr. Addington, Mr. Smith, and other experts all agree that Dr. Wheeler appeared to wholeheartedly believe that his view of black lung was accurate. That made him a valuable asset to mining companies.

Since Dr. Wheeler’s exposure, there has been a greater sense of accountability among B-readers, said John Cline, JD, a West Virginia–based attorney who represents miners with federal black lung claims. “Radiologists were thinking, ‘Somebody could be watching me.’ Even if they thought they were doing this in the shadows, it made people more cautious,” he said.

The data used in the Annals study predate Mr. Hamby’s investigation, going back to 2000. Thus, it is possible that, as Mr. Cline argues, things may be different now. However, Lee S. Friedman, PhD, associate professor at the University of Illinois at Chicago, who is the lead author of the study, remains skeptical.

“While the Wheeler case might have dampened some physicians [who were] completely skewing their readings always negative, I think it’s premature or incorrect” to say it resolved the issue, he said. “Did they all change their behavior the morning after? It doesn’t seem likely, given the evidence of financial conflicts of interest and behavior that’s been demonstrated.”
 

Skewing the evidence?

Mr. Hamby’s 2013 reporting also revealed that even when company-hired doctors did diagnose CWP, law firms were burying those readings. In 2016, the DOL attempted to stop this practice. The agency made suppression of written evidence illegal – emphasis on written.

Law firms can’t hide positive reports, but they can prevent them. Dr. Cohen explained that now, “a doctor on the phone says, ‘I will read this as positive.’ Then the company says, ‘No, thank you,’ we will send you a check.”

This practice was confirmed by Kim Adcock, MD, a retired radiologist and B-reader in Littleton, Colo., who primarily reads for 26 law firms. Some of his clients want a report no matter how he reads the radiograph. However, some want him to call them first if he’s going to read the radiograph as positive. Dr. Adcock said this practice skews the dataset to make company-hired docs appear to read more negatively than they actually do.

Because the dataset used in the study is from the Federal Black Lung Program (FBLP), it includes only readings that made it to court. Dr. Adcock said he reads approximately 2,000 radiographs a year, although only a few of his readings appeared in the study’s dataset, according to a search by Dr. Friedman. This difference is likely because the study evaluated only readings between 2000 and 2013, the year Dr. Adcock started B-reading.

“I think it’s important to get a message that, to a certain extent, contravenes this paper. Yes, we should have some reservations about the conclusions,” Dr. Adcock explained. “There are people out there attempting to do the best job they could do.”

Law firms shopping for the reading they want and censoring the ones they don’t might alter the FBLP data, but experts say that doesn’t change the underlying problem. “In any case like this, where you’re looking at individuals going up against corporations,” Dr. McCoy said, “[corporations] are able to marshal their resources and hire more officials in a way claimants can’t, and that’s a baseline concern here.”
 

Battling bias

Admitting bias is notoriously difficult; thus, it isn’t surprising that many doctors involved refuse to believe they are influenced by money, incentives, or other biases. Dr. DePonte said she’s not swayed by money, nor does she actively take a pro-miner stance. She views herself as more of an advocate for accuracy. However, she did say that it has traditionally been far more difficult for miners to prove their cases, a problem that has improved with new regulations in recent years.

In Colorado, Dr. Adcock’s approach is to stay as far removed from the litigation process as possible. He said he has limited understanding of how his reports are used or how claims are filed and awarded. He leans heavily on his initial – almost instantaneous – impression of a chest x-ray.

Dr. DePonte and Dr. Adcock were both hired as experts on Tony Adams’ case. In 2008, Dr. DePonte read his chest x-ray as positive for early-stage black lung (1/0). Dr. Adcock also read two of Adams’ four chest x-rays, one in 2009 and the other in 2013. He read them as negative. When asked about the case, which autopsy confirmed as black lung, Dr. Adcock explained that positive histopathology doesn’t mean the radiograph reading was wrong, only that the disease didn’t show on that radiograph. He said his “highest ambition” is to be “an objective finder of fact” and that he trusts the process to work out the truth.

That process didn’t work in time for Tony Adams. Dr. Friedman argues that people who provide expert testimony have an ethical responsibility to know how their testimony is being used; to do otherwise, he says, is “willful ignorance.” Still, the Annals study authors, along with Dr. DePonte, Mr. Cline, and West Virginia attorney Sam Petsonk, say that the process is getting fairer, thanks to new policies developed over the past 5 years by the DOL.

“The DOL has worked very hard to reconcile the final award rate (around 30%) with the incidence of disease in the population (between 20% and 25%),” Mr. Petsonk said. Although the study calls into question the integrity of the system and the doctors within it, it’s critical for miners to know that the system is working and that they can get benefits, he explained. Many fear that cynicism about the system drives miners away and causes them to resort to Social Security or long-term disability.
 

Fixing what’s broken

The Annals study’s authors propose some solutions to the problems they quantified. The first is a sort of “super panel” that collectively evaluates readings. Although a completely unbiased panel would be nice, such impartiality is likely unsustainable, Mr. Smith said. He believes that over time, the panel would become vulnerable to politics and would work in favor of the companies.

Even without a panel, a method to provide greater transparency could be a great start, some suggest. The DOL could make the entire FBLP database public and analyze it annually. The authors also propose a flat fee for readings. Even now, Dr. Adcock said he doesn’t make anywhere close to the upper limit of $750 per readings. “My understanding is around $125 is a pretty characteristic fee [for reading a chest x-ray],” he elaborated. “Everyone I’ve had a conversation with is within 25 bucks [of that].”

That said, Dr. Adcock is not currently listed among the heavy readers who appear in the data used for the study; it’s possible that his experience is not representative. Some readers who were included in that dataset read more than 10 times the average number of classifications per reader – the average was 242 classifications – and read 95% of chest x-rays as negative, according to Dr. Friedman. This news organization obtained the names of two doctors whose readings were 95% negative on a high volume of cases. Neither agreed to an interview.

It’s possible that if the dataset had included readings from more recent years, Dr. Adcock would have appeared more frequently, given his personal estimates. That’s why the study authors recommend that the DOL conduct this kind of analysis annually in order to get an accurate picture of who is contributing to these cases, in what way, and how often. By doing so, readers who appear biased could be identified and addressed with more regularity, Dr. Friedman said.

Even if the rate were more consistent and the data were more frequently analyzed, the very nature of the adversarial system will put any potential solution at risk. “I’m not sure there’s a foolproof system that can be devised that can’t be corrupted in time,” Mr. Cline said.
 

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

The U.S. Occupational Safety and Health Administration issued its long-awaited Emergency Temporary Standard (ETS) for COVID-19 June 10, surprising many by including only health care workers in the new emergency workplace safety rules.

“The ETS is an overdue step toward protecting health care workers, especially those working in long-term care facilities and home health care who are at greatly increased risk of infection,” said George Washington University, Washington, professor and former Obama administration Assistant Secretary of Labor David Michaels, PhD, MPH. “OSHA’s failure to issue a COVID-specific standard in other high-risk industries, like meat and poultry processing, corrections, homeless shelters, and retail establishments is disappointing. If exposure is not controlled in these workplaces, they will continue to be important drivers of infections.”

With the new regulations in place, about 10.3 million health care workers at hospitals, nursing homes, and assisted living facilities, as well as emergency responders and home health care workers, should be guaranteed protection standards that replace former guidance.

The new protections include supplying personal protective equipment and ensuring proper usage (for example, mandatory seal checks on respirators); screening everyone who enters the facility for COVID-19; ensuring proper ventilation; and establishing physical distancing requirements (6 feet) for unvaccinated workers. It also requires employers to give workers time off for vaccination. An antiretaliation clause could shield workers who complain about unsafe conditions.

“The science tells us that health care workers, particularly those who come into regular contact with the virus, are most at risk at this point in the pandemic,” Labor Secretary Marty Walsh said on a press call. “So following an extensive review of the science and data, OSHA determined that a health care–specific safety requirement will make the biggest impact.”

But questions remain, said James Brudney, JD, a professor at Fordham Law School in New York and former chief counsel of the U.S. Senate Subcommittee on Labor. The standard doesn’t amplify or address existing rules regarding a right to refuse unsafe work, for example, so employees may still feel they are risking their jobs to complain, despite the antiretaliation clause.

And although vaccinated employees don’t have to adhere to the same distancing and masking standards in many instances, the standard doesn’t spell out how employers should determine their workers’ vaccination status – instead leaving that determination to employers through their own policies and procedures. (California’s state OSHA office rules specify the mechanism for documentation of vaccination.)

The Trump administration did not issue an ETS, saying OSHA’s general duty clause sufficed. President Joe Biden took the opposite approach, calling for an investigation into an ETS on his first day in office. But the process took months longer than promised.

“I know it’s been a long time coming,” Mr. Walsh acknowledged. “Our health care workers from the very beginning have been put at risk.

While health care unions had asked for mandated safety standards sooner, National Nurses United, the country’s largest labor union for registered nurses, still welcomed the rules.

“An ETS is a major step toward requiring accountability for hospitals who consistently put their budget goals and profits over our health and safety,” Zenei Triunfo-Cortez, RN, one of NNU’s three presidents, said in a statement June 9 anticipating the publication of the rules.

The rules do not apply to retail pharmacies, ambulatory care settings that screen nonemployees for COVID-19, or certain other settings in which all employees are vaccinated and people with suspected or confirmed COVID-19 cannot enter.

The agency said it will work with states that have already issued local regulations, including two states that issued temporary standards of their own, Virginia and California.

Employers will have 2 weeks to comply with most of the regulations after they’re published in the Federal Register. The standards will expire in 6 months but could then become permanent, as Virginia’s did in January.

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

The U.S. Occupational Safety and Health Administration issued its long-awaited Emergency Temporary Standard (ETS) for COVID-19 June 10, surprising many by including only health care workers in the new emergency workplace safety rules.

“The ETS is an overdue step toward protecting health care workers, especially those working in long-term care facilities and home health care who are at greatly increased risk of infection,” said George Washington University, Washington, professor and former Obama administration Assistant Secretary of Labor David Michaels, PhD, MPH. “OSHA’s failure to issue a COVID-specific standard in other high-risk industries, like meat and poultry processing, corrections, homeless shelters, and retail establishments is disappointing. If exposure is not controlled in these workplaces, they will continue to be important drivers of infections.”

With the new regulations in place, about 10.3 million health care workers at hospitals, nursing homes, and assisted living facilities, as well as emergency responders and home health care workers, should be guaranteed protection standards that replace former guidance.

The new protections include supplying personal protective equipment and ensuring proper usage (for example, mandatory seal checks on respirators); screening everyone who enters the facility for COVID-19; ensuring proper ventilation; and establishing physical distancing requirements (6 feet) for unvaccinated workers. It also requires employers to give workers time off for vaccination. An antiretaliation clause could shield workers who complain about unsafe conditions.

“The science tells us that health care workers, particularly those who come into regular contact with the virus, are most at risk at this point in the pandemic,” Labor Secretary Marty Walsh said on a press call. “So following an extensive review of the science and data, OSHA determined that a health care–specific safety requirement will make the biggest impact.”

But questions remain, said James Brudney, JD, a professor at Fordham Law School in New York and former chief counsel of the U.S. Senate Subcommittee on Labor. The standard doesn’t amplify or address existing rules regarding a right to refuse unsafe work, for example, so employees may still feel they are risking their jobs to complain, despite the antiretaliation clause.

And although vaccinated employees don’t have to adhere to the same distancing and masking standards in many instances, the standard doesn’t spell out how employers should determine their workers’ vaccination status – instead leaving that determination to employers through their own policies and procedures. (California’s state OSHA office rules specify the mechanism for documentation of vaccination.)

The Trump administration did not issue an ETS, saying OSHA’s general duty clause sufficed. President Joe Biden took the opposite approach, calling for an investigation into an ETS on his first day in office. But the process took months longer than promised.

“I know it’s been a long time coming,” Mr. Walsh acknowledged. “Our health care workers from the very beginning have been put at risk.

While health care unions had asked for mandated safety standards sooner, National Nurses United, the country’s largest labor union for registered nurses, still welcomed the rules.

“An ETS is a major step toward requiring accountability for hospitals who consistently put their budget goals and profits over our health and safety,” Zenei Triunfo-Cortez, RN, one of NNU’s three presidents, said in a statement June 9 anticipating the publication of the rules.

The rules do not apply to retail pharmacies, ambulatory care settings that screen nonemployees for COVID-19, or certain other settings in which all employees are vaccinated and people with suspected or confirmed COVID-19 cannot enter.

The agency said it will work with states that have already issued local regulations, including two states that issued temporary standards of their own, Virginia and California.

Employers will have 2 weeks to comply with most of the regulations after they’re published in the Federal Register. The standards will expire in 6 months but could then become permanent, as Virginia’s did in January.

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

The U.S. Occupational Safety and Health Administration issued its long-awaited Emergency Temporary Standard (ETS) for COVID-19 June 10, surprising many by including only health care workers in the new emergency workplace safety rules.

“The ETS is an overdue step toward protecting health care workers, especially those working in long-term care facilities and home health care who are at greatly increased risk of infection,” said George Washington University, Washington, professor and former Obama administration Assistant Secretary of Labor David Michaels, PhD, MPH. “OSHA’s failure to issue a COVID-specific standard in other high-risk industries, like meat and poultry processing, corrections, homeless shelters, and retail establishments is disappointing. If exposure is not controlled in these workplaces, they will continue to be important drivers of infections.”

With the new regulations in place, about 10.3 million health care workers at hospitals, nursing homes, and assisted living facilities, as well as emergency responders and home health care workers, should be guaranteed protection standards that replace former guidance.

The new protections include supplying personal protective equipment and ensuring proper usage (for example, mandatory seal checks on respirators); screening everyone who enters the facility for COVID-19; ensuring proper ventilation; and establishing physical distancing requirements (6 feet) for unvaccinated workers. It also requires employers to give workers time off for vaccination. An antiretaliation clause could shield workers who complain about unsafe conditions.

“The science tells us that health care workers, particularly those who come into regular contact with the virus, are most at risk at this point in the pandemic,” Labor Secretary Marty Walsh said on a press call. “So following an extensive review of the science and data, OSHA determined that a health care–specific safety requirement will make the biggest impact.”

But questions remain, said James Brudney, JD, a professor at Fordham Law School in New York and former chief counsel of the U.S. Senate Subcommittee on Labor. The standard doesn’t amplify or address existing rules regarding a right to refuse unsafe work, for example, so employees may still feel they are risking their jobs to complain, despite the antiretaliation clause.

And although vaccinated employees don’t have to adhere to the same distancing and masking standards in many instances, the standard doesn’t spell out how employers should determine their workers’ vaccination status – instead leaving that determination to employers through their own policies and procedures. (California’s state OSHA office rules specify the mechanism for documentation of vaccination.)

The Trump administration did not issue an ETS, saying OSHA’s general duty clause sufficed. President Joe Biden took the opposite approach, calling for an investigation into an ETS on his first day in office. But the process took months longer than promised.

“I know it’s been a long time coming,” Mr. Walsh acknowledged. “Our health care workers from the very beginning have been put at risk.

While health care unions had asked for mandated safety standards sooner, National Nurses United, the country’s largest labor union for registered nurses, still welcomed the rules.

“An ETS is a major step toward requiring accountability for hospitals who consistently put their budget goals and profits over our health and safety,” Zenei Triunfo-Cortez, RN, one of NNU’s three presidents, said in a statement June 9 anticipating the publication of the rules.

The rules do not apply to retail pharmacies, ambulatory care settings that screen nonemployees for COVID-19, or certain other settings in which all employees are vaccinated and people with suspected or confirmed COVID-19 cannot enter.

The agency said it will work with states that have already issued local regulations, including two states that issued temporary standards of their own, Virginia and California.

Employers will have 2 weeks to comply with most of the regulations after they’re published in the Federal Register. The standards will expire in 6 months but could then become permanent, as Virginia’s did in January.

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

Three or more weeks of oral anticoagulation (OAC) sometimes isn’t up to the job of clearing any potentially embolic left atrial (LA) thrombi before procedures like cardioversion or catheter ablation in patients with atrial fibrillation (AF). Such OAC-defiant LA thrombi aren’t common, nor are they rare enough to ignore, suggests a new meta-analysis that might also have identified features that predispose to them.

Such predictors of LA clots that persist despite OAC could potentially guide selective use of transesophageal echocardiography (TEE) instead of more routine policies to either use or not use TEE for thrombus rule-out before rhythm-control procedures, researchers propose.

Their prevalence was about 2.7% among the study’s more than 14,000 patients who received at least 3 weeks of OAC with either vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC) before undergoing TEE.

But OAC-resistant LA thrombi were two- to four-times as common in patients with than without certain features, including AF other than paroxysmal and higher CHADS2 and CHA2DS2-VASc stroke risk-stratification scores.

“TEE imaging in select patients at an elevated risk of LA thrombus, despite anticoagulation status, may be a reasonable approach to minimize the risk of thromboembolic complications following cardioversion or catheter ablation,” propose the study’s authors, led by Antony Lurie, BMSC, Population Health Research Institute, Hamilton, Ont. Their report was published in the June 15 issue of the Journal of the American College of Cardiology.

Guidelines don’t encourage TEE before cardioversion in patients who have been on OAC for at least 3 weeks, the group notes, and policies on TEE use before AF ablation vary widely regardless of anticoagulation status.

The current study suggests that 3 weeks of OAC isn’t enough for a substantial number of patients, who might be put at thromboembolic risk if TEE were to be skipped before rhythm-control procedures.

Conversely, many patients unlikely to have LA thrombi get preprocedure TEE anyway. That can happen “irrespective of how long they’ve been anticoagulated, their pattern of atrial fibrillation, or their stroke risk,” senior author Jorge A. Wong, MD, MPH, Population Health Research Institute and McMaster University, Hamilton, Ont., told this news organization.

But “TEE is an invasive imaging modality, so it is associated with small element of risk.” The current study, Dr. Wong said, points to potential risk-stratification tools clinicians might use to guide more selective TEE screening.

“At sites where TEEs are done all the time for patients undergoing ablation, one could use several of these risk markers to perhaps tailor use of TEE in individuals,” Dr. Wong said. “For example, in people with paroxysmal atrial fibrillation, we found that the risk of left atrial appendage clot was approximately 1% or less.” Screening by TEE might reasonably be avoided in such patients.

“Fortunately, continued oral anticoagulation already yields low peri-procedural stroke rates,” observes an accompanying editorial from Paulus Kirchhof, MD, and Christoph Sinning, MD, from the University Heart & Vascular Center and German Centre of Cardiovascular Research, Hamburg.

“Based on this new analysis of existing data, a risk-based use of TEE imaging in anticoagulated patients could enable further improvement in the safe delivery of rhythm control interventions in patients with AF,” the editorialists agree.

The meta-analysis covered 10 prospective and 25 retrospective studies with a total of 14,653 patients that reported whether LA thrombus was present in patients with AF or atrial flutter (AFL) who underwent TEE after at least 3 weeks of VKA or DOAC therapy. Reports for 30 of the studies identified patients by rhythm-control procedure, and the remaining five didn’t specify TEE indications.

The weighted mean prevalence of LA thrombus at TEE was 2.73% (95% confidence interval, 1.95%-3.80%). The finding was not significantly changed in separate sensitivity analyses, the report says, including one limited to studies with low risk of bias and others excluding patients with valvular AF, interrupted OAC, heparin bridging, or subtherapeutic anticoagulation, respectively.

Patients treated with VKA and DOACs showed similar prevalences of LA thrombi, with means of 2.80% and 3.12%, respectively (P = .674). The prevalence was significantly higher in patients:

• with nonparoxysmal than with paroxysmal AF/AFL (4.81% vs. 1.03%; P < .001)
• undergoing cardioversion than ablation (5.55% vs. 1.65; P < .001)
• with CHA2DS2-VASc scores of at least 3 than with scores of 2 or less (6.31% vs. 1.06%; P < .001).

A limitation of the study, observe Dr. Kirchhof and Dr. Sinning, “is that all patients had a clinical indication for a TEE, which might be a selection bias. When a thrombus was found on TEE, clinical judgment led to postponing of the procedure,” thereby avoiding potential thromboembolism.

“Thus, the paper cannot demonstrate that presence of a thrombus on TEE is related to peri-procedural ischemic stroke,” they write.

The literature puts the risk for stroke or systemic embolism at well under 1% for patients anticoagulated with either VKA or DOACs for at least 3 weeks prior to cardioversion, in contrast to the nearly 3% prevalence of LA appendage thrombus by TEE in the current analysis, Dr. Wong observed.

“So we’re seeing a lot more left atrial appendage thrombus than we would see stroke,” but there wasn’t a way to determine whether that increases the stroke risk, he agreed.Dr. Wong, Dr. Lurie, and the other authors report no relevant conflicts. Dr. Kirchhof discloses receiving partial support “from several drug and device companies active in atrial fibrillation” and to being listed as inventor on two AF-related patents held by the University of Birmingham. Dr. Sinning reports no relevant relationships. 

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

Three or more weeks of oral anticoagulation (OAC) sometimes isn’t up to the job of clearing any potentially embolic left atrial (LA) thrombi before procedures like cardioversion or catheter ablation in patients with atrial fibrillation (AF). Such OAC-defiant LA thrombi aren’t common, nor are they rare enough to ignore, suggests a new meta-analysis that might also have identified features that predispose to them.

Such predictors of LA clots that persist despite OAC could potentially guide selective use of transesophageal echocardiography (TEE) instead of more routine policies to either use or not use TEE for thrombus rule-out before rhythm-control procedures, researchers propose.

Their prevalence was about 2.7% among the study’s more than 14,000 patients who received at least 3 weeks of OAC with either vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC) before undergoing TEE.

But OAC-resistant LA thrombi were two- to four-times as common in patients with than without certain features, including AF other than paroxysmal and higher CHADS2 and CHA2DS2-VASc stroke risk-stratification scores.

“TEE imaging in select patients at an elevated risk of LA thrombus, despite anticoagulation status, may be a reasonable approach to minimize the risk of thromboembolic complications following cardioversion or catheter ablation,” propose the study’s authors, led by Antony Lurie, BMSC, Population Health Research Institute, Hamilton, Ont. Their report was published in the June 15 issue of the Journal of the American College of Cardiology.

Guidelines don’t encourage TEE before cardioversion in patients who have been on OAC for at least 3 weeks, the group notes, and policies on TEE use before AF ablation vary widely regardless of anticoagulation status.

The current study suggests that 3 weeks of OAC isn’t enough for a substantial number of patients, who might be put at thromboembolic risk if TEE were to be skipped before rhythm-control procedures.

Conversely, many patients unlikely to have LA thrombi get preprocedure TEE anyway. That can happen “irrespective of how long they’ve been anticoagulated, their pattern of atrial fibrillation, or their stroke risk,” senior author Jorge A. Wong, MD, MPH, Population Health Research Institute and McMaster University, Hamilton, Ont., told this news organization.

But “TEE is an invasive imaging modality, so it is associated with small element of risk.” The current study, Dr. Wong said, points to potential risk-stratification tools clinicians might use to guide more selective TEE screening.

“At sites where TEEs are done all the time for patients undergoing ablation, one could use several of these risk markers to perhaps tailor use of TEE in individuals,” Dr. Wong said. “For example, in people with paroxysmal atrial fibrillation, we found that the risk of left atrial appendage clot was approximately 1% or less.” Screening by TEE might reasonably be avoided in such patients.

“Fortunately, continued oral anticoagulation already yields low peri-procedural stroke rates,” observes an accompanying editorial from Paulus Kirchhof, MD, and Christoph Sinning, MD, from the University Heart & Vascular Center and German Centre of Cardiovascular Research, Hamburg.

“Based on this new analysis of existing data, a risk-based use of TEE imaging in anticoagulated patients could enable further improvement in the safe delivery of rhythm control interventions in patients with AF,” the editorialists agree.

The meta-analysis covered 10 prospective and 25 retrospective studies with a total of 14,653 patients that reported whether LA thrombus was present in patients with AF or atrial flutter (AFL) who underwent TEE after at least 3 weeks of VKA or DOAC therapy. Reports for 30 of the studies identified patients by rhythm-control procedure, and the remaining five didn’t specify TEE indications.

The weighted mean prevalence of LA thrombus at TEE was 2.73% (95% confidence interval, 1.95%-3.80%). The finding was not significantly changed in separate sensitivity analyses, the report says, including one limited to studies with low risk of bias and others excluding patients with valvular AF, interrupted OAC, heparin bridging, or subtherapeutic anticoagulation, respectively.

Patients treated with VKA and DOACs showed similar prevalences of LA thrombi, with means of 2.80% and 3.12%, respectively (P = .674). The prevalence was significantly higher in patients:

• with nonparoxysmal than with paroxysmal AF/AFL (4.81% vs. 1.03%; P < .001)
• undergoing cardioversion than ablation (5.55% vs. 1.65; P < .001)
• with CHA2DS2-VASc scores of at least 3 than with scores of 2 or less (6.31% vs. 1.06%; P < .001).

A limitation of the study, observe Dr. Kirchhof and Dr. Sinning, “is that all patients had a clinical indication for a TEE, which might be a selection bias. When a thrombus was found on TEE, clinical judgment led to postponing of the procedure,” thereby avoiding potential thromboembolism.

“Thus, the paper cannot demonstrate that presence of a thrombus on TEE is related to peri-procedural ischemic stroke,” they write.

The literature puts the risk for stroke or systemic embolism at well under 1% for patients anticoagulated with either VKA or DOACs for at least 3 weeks prior to cardioversion, in contrast to the nearly 3% prevalence of LA appendage thrombus by TEE in the current analysis, Dr. Wong observed.

“So we’re seeing a lot more left atrial appendage thrombus than we would see stroke,” but there wasn’t a way to determine whether that increases the stroke risk, he agreed.Dr. Wong, Dr. Lurie, and the other authors report no relevant conflicts. Dr. Kirchhof discloses receiving partial support “from several drug and device companies active in atrial fibrillation” and to being listed as inventor on two AF-related patents held by the University of Birmingham. Dr. Sinning reports no relevant relationships. 

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

Three or more weeks of oral anticoagulation (OAC) sometimes isn’t up to the job of clearing any potentially embolic left atrial (LA) thrombi before procedures like cardioversion or catheter ablation in patients with atrial fibrillation (AF). Such OAC-defiant LA thrombi aren’t common, nor are they rare enough to ignore, suggests a new meta-analysis that might also have identified features that predispose to them.

Such predictors of LA clots that persist despite OAC could potentially guide selective use of transesophageal echocardiography (TEE) instead of more routine policies to either use or not use TEE for thrombus rule-out before rhythm-control procedures, researchers propose.

Their prevalence was about 2.7% among the study’s more than 14,000 patients who received at least 3 weeks of OAC with either vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC) before undergoing TEE.

But OAC-resistant LA thrombi were two- to four-times as common in patients with than without certain features, including AF other than paroxysmal and higher CHADS2 and CHA2DS2-VASc stroke risk-stratification scores.

“TEE imaging in select patients at an elevated risk of LA thrombus, despite anticoagulation status, may be a reasonable approach to minimize the risk of thromboembolic complications following cardioversion or catheter ablation,” propose the study’s authors, led by Antony Lurie, BMSC, Population Health Research Institute, Hamilton, Ont. Their report was published in the June 15 issue of the Journal of the American College of Cardiology.

Guidelines don’t encourage TEE before cardioversion in patients who have been on OAC for at least 3 weeks, the group notes, and policies on TEE use before AF ablation vary widely regardless of anticoagulation status.

The current study suggests that 3 weeks of OAC isn’t enough for a substantial number of patients, who might be put at thromboembolic risk if TEE were to be skipped before rhythm-control procedures.

Conversely, many patients unlikely to have LA thrombi get preprocedure TEE anyway. That can happen “irrespective of how long they’ve been anticoagulated, their pattern of atrial fibrillation, or their stroke risk,” senior author Jorge A. Wong, MD, MPH, Population Health Research Institute and McMaster University, Hamilton, Ont., told this news organization.

But “TEE is an invasive imaging modality, so it is associated with small element of risk.” The current study, Dr. Wong said, points to potential risk-stratification tools clinicians might use to guide more selective TEE screening.

“At sites where TEEs are done all the time for patients undergoing ablation, one could use several of these risk markers to perhaps tailor use of TEE in individuals,” Dr. Wong said. “For example, in people with paroxysmal atrial fibrillation, we found that the risk of left atrial appendage clot was approximately 1% or less.” Screening by TEE might reasonably be avoided in such patients.

“Fortunately, continued oral anticoagulation already yields low peri-procedural stroke rates,” observes an accompanying editorial from Paulus Kirchhof, MD, and Christoph Sinning, MD, from the University Heart & Vascular Center and German Centre of Cardiovascular Research, Hamburg.

“Based on this new analysis of existing data, a risk-based use of TEE imaging in anticoagulated patients could enable further improvement in the safe delivery of rhythm control interventions in patients with AF,” the editorialists agree.

The meta-analysis covered 10 prospective and 25 retrospective studies with a total of 14,653 patients that reported whether LA thrombus was present in patients with AF or atrial flutter (AFL) who underwent TEE after at least 3 weeks of VKA or DOAC therapy. Reports for 30 of the studies identified patients by rhythm-control procedure, and the remaining five didn’t specify TEE indications.

The weighted mean prevalence of LA thrombus at TEE was 2.73% (95% confidence interval, 1.95%-3.80%). The finding was not significantly changed in separate sensitivity analyses, the report says, including one limited to studies with low risk of bias and others excluding patients with valvular AF, interrupted OAC, heparin bridging, or subtherapeutic anticoagulation, respectively.

Patients treated with VKA and DOACs showed similar prevalences of LA thrombi, with means of 2.80% and 3.12%, respectively (P = .674). The prevalence was significantly higher in patients:

• with nonparoxysmal than with paroxysmal AF/AFL (4.81% vs. 1.03%; P < .001)
• undergoing cardioversion than ablation (5.55% vs. 1.65; P < .001)
• with CHA2DS2-VASc scores of at least 3 than with scores of 2 or less (6.31% vs. 1.06%; P < .001).

A limitation of the study, observe Dr. Kirchhof and Dr. Sinning, “is that all patients had a clinical indication for a TEE, which might be a selection bias. When a thrombus was found on TEE, clinical judgment led to postponing of the procedure,” thereby avoiding potential thromboembolism.

“Thus, the paper cannot demonstrate that presence of a thrombus on TEE is related to peri-procedural ischemic stroke,” they write.

The literature puts the risk for stroke or systemic embolism at well under 1% for patients anticoagulated with either VKA or DOACs for at least 3 weeks prior to cardioversion, in contrast to the nearly 3% prevalence of LA appendage thrombus by TEE in the current analysis, Dr. Wong observed.

“So we’re seeing a lot more left atrial appendage thrombus than we would see stroke,” but there wasn’t a way to determine whether that increases the stroke risk, he agreed.Dr. Wong, Dr. Lurie, and the other authors report no relevant conflicts. Dr. Kirchhof discloses receiving partial support “from several drug and device companies active in atrial fibrillation” and to being listed as inventor on two AF-related patents held by the University of Birmingham. Dr. Sinning reports no relevant relationships. 

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