Infectious Diseases

Adolescents and adults younger than age 21 who develop myocarditis after mRNA COVID-19 vaccination frequently have abnormal findings on cardiac MRI (cMRI) but most have a mild clinical course with rapid resolution of symptoms, a new study concludes.

• Most patients were male (90.6%), White (66.2%) and with a median age of 15.8 years.
• Suspected myocarditis occurred in 136 patients (97.8%) following mRNA vaccine, with 131 (94.2%) following the Pfizer-BioNTech vaccine; 128 cases (91.4%) occurred after the second dose.
• Symptoms started a median of 2 days (range 0 to 22 days) following vaccination administration.
• Chest pain was the most common symptom (99.3%), with fever present in 30.9% of patients and shortness of breath in 27.3%.
• Patients were treated with nonsteroidal anti-inflammatory drugs (81.3%), intravenous immunoglobulin (21.6%), glucocorticoids (21.6%), colchicine (7.9%) or no anti-inflammatory therapies (8.6%).
• Twenty-six patients (18.7%) were admitted to the intensive care unit; 2 received inotropic/vasoactive support; none required extracorporeal membrane oxygenation or died.
• Median time spent in the hospital was 2 days.
• A total of 111 patients had elevated troponin I (8.12 ng/mL) and 28 had elevated troponin T (0.61 ng/mL).
• More than two-thirds (69.8%) had abnormal electrocardiograms and/or arrhythmias (7 with nonsustained ventricular tachycardia).
• Twenty-six patients (18.7%) had left ventricular ejection fraction (LVEF) less than 55% on echocardiogram; LVEF had returned to normal in the 25 who returned for follow-up.
• 75 of 97 patients (77.3%) who underwent cMRI at a median of 5 days from symptom onset had abnormal findings; 74 (76.3%) had late gadolinium enhancement, 54 (55.7%) had myocardial edema, and 49 (50.5%) met Lake Louise criteria for myocarditis.

“These data suggest that most cases of suspected COVID-19 vaccine–related myocarditis in people younger than 21 are mild and resolve quickly,” corresponding author Dongngan Truong, MD, Division of Pediatric Cardiology, University of Utah and Primary Children’s Hospital, Salt Lake City, said in a statement.

“We were very happy to see that type of recovery. However, we are awaiting further studies to better understand the long-term outcomes of patients who have had COVID-19 vaccination-related myocarditis. We also need to study the risk factors and mechanisms for this rare complication,” Dr. Truong added.

Dr. Lloyd-Jones said these findings support the AHA’s position that COVID-19 vaccines are “safe, highly effective, and fundamental to saving lives, protecting our families and communities against COVID-19, and ending the pandemic.”

The study received no funding. Dr. Truong consults for Pfizer on vaccine-associated myocarditis. A complete list of author disclosures is available with the original article.

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

Adolescents and adults younger than age 21 who develop myocarditis after mRNA COVID-19 vaccination frequently have abnormal findings on cardiac MRI (cMRI) but most have a mild clinical course with rapid resolution of symptoms, a new study concludes.

• Most patients were male (90.6%), White (66.2%) and with a median age of 15.8 years.
• Suspected myocarditis occurred in 136 patients (97.8%) following mRNA vaccine, with 131 (94.2%) following the Pfizer-BioNTech vaccine; 128 cases (91.4%) occurred after the second dose.
• Symptoms started a median of 2 days (range 0 to 22 days) following vaccination administration.
• Chest pain was the most common symptom (99.3%), with fever present in 30.9% of patients and shortness of breath in 27.3%.
• Patients were treated with nonsteroidal anti-inflammatory drugs (81.3%), intravenous immunoglobulin (21.6%), glucocorticoids (21.6%), colchicine (7.9%) or no anti-inflammatory therapies (8.6%).
• Twenty-six patients (18.7%) were admitted to the intensive care unit; 2 received inotropic/vasoactive support; none required extracorporeal membrane oxygenation or died.
• Median time spent in the hospital was 2 days.
• A total of 111 patients had elevated troponin I (8.12 ng/mL) and 28 had elevated troponin T (0.61 ng/mL).
• More than two-thirds (69.8%) had abnormal electrocardiograms and/or arrhythmias (7 with nonsustained ventricular tachycardia).
• Twenty-six patients (18.7%) had left ventricular ejection fraction (LVEF) less than 55% on echocardiogram; LVEF had returned to normal in the 25 who returned for follow-up.
• 75 of 97 patients (77.3%) who underwent cMRI at a median of 5 days from symptom onset had abnormal findings; 74 (76.3%) had late gadolinium enhancement, 54 (55.7%) had myocardial edema, and 49 (50.5%) met Lake Louise criteria for myocarditis.

“These data suggest that most cases of suspected COVID-19 vaccine–related myocarditis in people younger than 21 are mild and resolve quickly,” corresponding author Dongngan Truong, MD, Division of Pediatric Cardiology, University of Utah and Primary Children’s Hospital, Salt Lake City, said in a statement.

“We were very happy to see that type of recovery. However, we are awaiting further studies to better understand the long-term outcomes of patients who have had COVID-19 vaccination-related myocarditis. We also need to study the risk factors and mechanisms for this rare complication,” Dr. Truong added.

Dr. Lloyd-Jones said these findings support the AHA’s position that COVID-19 vaccines are “safe, highly effective, and fundamental to saving lives, protecting our families and communities against COVID-19, and ending the pandemic.”

The study received no funding. Dr. Truong consults for Pfizer on vaccine-associated myocarditis. A complete list of author disclosures is available with the original article.

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

Adolescents and adults younger than age 21 who develop myocarditis after mRNA COVID-19 vaccination frequently have abnormal findings on cardiac MRI (cMRI) but most have a mild clinical course with rapid resolution of symptoms, a new study concludes.

• Most patients were male (90.6%), White (66.2%) and with a median age of 15.8 years.
• Suspected myocarditis occurred in 136 patients (97.8%) following mRNA vaccine, with 131 (94.2%) following the Pfizer-BioNTech vaccine; 128 cases (91.4%) occurred after the second dose.
• Symptoms started a median of 2 days (range 0 to 22 days) following vaccination administration.
• Chest pain was the most common symptom (99.3%), with fever present in 30.9% of patients and shortness of breath in 27.3%.
• Patients were treated with nonsteroidal anti-inflammatory drugs (81.3%), intravenous immunoglobulin (21.6%), glucocorticoids (21.6%), colchicine (7.9%) or no anti-inflammatory therapies (8.6%).
• Twenty-six patients (18.7%) were admitted to the intensive care unit; 2 received inotropic/vasoactive support; none required extracorporeal membrane oxygenation or died.
• Median time spent in the hospital was 2 days.
• A total of 111 patients had elevated troponin I (8.12 ng/mL) and 28 had elevated troponin T (0.61 ng/mL).
• More than two-thirds (69.8%) had abnormal electrocardiograms and/or arrhythmias (7 with nonsustained ventricular tachycardia).
• Twenty-six patients (18.7%) had left ventricular ejection fraction (LVEF) less than 55% on echocardiogram; LVEF had returned to normal in the 25 who returned for follow-up.
• 75 of 97 patients (77.3%) who underwent cMRI at a median of 5 days from symptom onset had abnormal findings; 74 (76.3%) had late gadolinium enhancement, 54 (55.7%) had myocardial edema, and 49 (50.5%) met Lake Louise criteria for myocarditis.

“These data suggest that most cases of suspected COVID-19 vaccine–related myocarditis in people younger than 21 are mild and resolve quickly,” corresponding author Dongngan Truong, MD, Division of Pediatric Cardiology, University of Utah and Primary Children’s Hospital, Salt Lake City, said in a statement.

“We were very happy to see that type of recovery. However, we are awaiting further studies to better understand the long-term outcomes of patients who have had COVID-19 vaccination-related myocarditis. We also need to study the risk factors and mechanisms for this rare complication,” Dr. Truong added.

Dr. Lloyd-Jones said these findings support the AHA’s position that COVID-19 vaccines are “safe, highly effective, and fundamental to saving lives, protecting our families and communities against COVID-19, and ending the pandemic.”

The study received no funding. Dr. Truong consults for Pfizer on vaccine-associated myocarditis. A complete list of author disclosures is available with the original article.

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

An abstract and poster presentation questioning the safety of mRNA-based COVID-19 vaccines, embraced by some and lambasted by others, has drawn an “expression of concern” from the American Heart Association, along with a bid for correction.

The abstract in question concludes that COVID vaccines “dramatically increase” levels of certain inflammatory biomarkers, and therefore, the 5-year risk of acute coronary syndromes (ACS), based on pre- and post-vaccination results of an obscure blood panel called the PULS Cardiac Test (GD Biosciences). The findings were presented at the AHA’s 2021 Scientific Sessionsas, an uncontrolled observational study of 566 patients in a preventive cardiology practice.

Some on social media have seized on the abstract as evidence of serious potential harm from the two available mRNA-based SARS-CoV-2 vaccines, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna). But others contend that the study’s described design and findings are specious and its conclusions overstated.

They also point to the notoriety of its one listed author, Steven R. Gundry, MD, who promotes his diet books and supplements as well as fringe, highly criticized theories about diet and disease on several websites, including drgundry.com. Dr. Gundry has not responded to requests for an interview.

Dr. Gundry’s abstract from the AHA Scientific Sessions 2021, available on the meeting’s program planner, was marked with an “expression of concern” by the AHA that is to stand “until a suitable correction is published, to indicate that the abstract in its current version may not be reliable.”

The expression of concern statement, also published online Nov. 24 in Circulation, says “potential errors in the abstract” were brought to the attention of the meeting planners. “Specifically, there are several typographical errors, there is no data in the abstract regarding myocardial T-cell infiltration, there are no statistical analyses for significance provided, and the author is not clear that only anecdotal data was used.”

The biomarker elevations on which the abstract’s conclusions are based included hepatocyte growth factor, “which serves as a marker for chemotaxis of T-cells into epithelium and cardiac tissue,” it states.

“The expression of concern about the abstract will remain in place until a correction is accepted and published” in Circulation, AHA spokesperson Suzanne Grant told this news organization by email.

“The specific data needed will be up to the abstract author to determine and supply,” she said, noting that Dr. Gundry “has been in communication with the journal throughout this process.”

Submitting researchers “must always attest to the validity of the abstract,” Ms. Grant said. “Abstracts are then curated by independent review panels, blinded to the identities of the abstract authors, and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting.”

Regarding the AHA’s system for vetting abstracts vying for acceptance to the scientific sessions, she said it is not primarily intended to “evaluate scientific validity” and that the organization is “currently reviewing its existing abstract submission processes.”

A recent Reuters report reviews the controversy and provides links to criticisms of the study on social media.

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

An abstract and poster presentation questioning the safety of mRNA-based COVID-19 vaccines, embraced by some and lambasted by others, has drawn an “expression of concern” from the American Heart Association, along with a bid for correction.

The abstract in question concludes that COVID vaccines “dramatically increase” levels of certain inflammatory biomarkers, and therefore, the 5-year risk of acute coronary syndromes (ACS), based on pre- and post-vaccination results of an obscure blood panel called the PULS Cardiac Test (GD Biosciences). The findings were presented at the AHA’s 2021 Scientific Sessionsas, an uncontrolled observational study of 566 patients in a preventive cardiology practice.

Some on social media have seized on the abstract as evidence of serious potential harm from the two available mRNA-based SARS-CoV-2 vaccines, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna). But others contend that the study’s described design and findings are specious and its conclusions overstated.

They also point to the notoriety of its one listed author, Steven R. Gundry, MD, who promotes his diet books and supplements as well as fringe, highly criticized theories about diet and disease on several websites, including drgundry.com. Dr. Gundry has not responded to requests for an interview.

Dr. Gundry’s abstract from the AHA Scientific Sessions 2021, available on the meeting’s program planner, was marked with an “expression of concern” by the AHA that is to stand “until a suitable correction is published, to indicate that the abstract in its current version may not be reliable.”

The expression of concern statement, also published online Nov. 24 in Circulation, says “potential errors in the abstract” were brought to the attention of the meeting planners. “Specifically, there are several typographical errors, there is no data in the abstract regarding myocardial T-cell infiltration, there are no statistical analyses for significance provided, and the author is not clear that only anecdotal data was used.”

The biomarker elevations on which the abstract’s conclusions are based included hepatocyte growth factor, “which serves as a marker for chemotaxis of T-cells into epithelium and cardiac tissue,” it states.

“The expression of concern about the abstract will remain in place until a correction is accepted and published” in Circulation, AHA spokesperson Suzanne Grant told this news organization by email.

“The specific data needed will be up to the abstract author to determine and supply,” she said, noting that Dr. Gundry “has been in communication with the journal throughout this process.”

Submitting researchers “must always attest to the validity of the abstract,” Ms. Grant said. “Abstracts are then curated by independent review panels, blinded to the identities of the abstract authors, and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting.”

Regarding the AHA’s system for vetting abstracts vying for acceptance to the scientific sessions, she said it is not primarily intended to “evaluate scientific validity” and that the organization is “currently reviewing its existing abstract submission processes.”

A recent Reuters report reviews the controversy and provides links to criticisms of the study on social media.

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

An abstract and poster presentation questioning the safety of mRNA-based COVID-19 vaccines, embraced by some and lambasted by others, has drawn an “expression of concern” from the American Heart Association, along with a bid for correction.

The abstract in question concludes that COVID vaccines “dramatically increase” levels of certain inflammatory biomarkers, and therefore, the 5-year risk of acute coronary syndromes (ACS), based on pre- and post-vaccination results of an obscure blood panel called the PULS Cardiac Test (GD Biosciences). The findings were presented at the AHA’s 2021 Scientific Sessionsas, an uncontrolled observational study of 566 patients in a preventive cardiology practice.

Some on social media have seized on the abstract as evidence of serious potential harm from the two available mRNA-based SARS-CoV-2 vaccines, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna). But others contend that the study’s described design and findings are specious and its conclusions overstated.

They also point to the notoriety of its one listed author, Steven R. Gundry, MD, who promotes his diet books and supplements as well as fringe, highly criticized theories about diet and disease on several websites, including drgundry.com. Dr. Gundry has not responded to requests for an interview.

Dr. Gundry’s abstract from the AHA Scientific Sessions 2021, available on the meeting’s program planner, was marked with an “expression of concern” by the AHA that is to stand “until a suitable correction is published, to indicate that the abstract in its current version may not be reliable.”

The expression of concern statement, also published online Nov. 24 in Circulation, says “potential errors in the abstract” were brought to the attention of the meeting planners. “Specifically, there are several typographical errors, there is no data in the abstract regarding myocardial T-cell infiltration, there are no statistical analyses for significance provided, and the author is not clear that only anecdotal data was used.”

The biomarker elevations on which the abstract’s conclusions are based included hepatocyte growth factor, “which serves as a marker for chemotaxis of T-cells into epithelium and cardiac tissue,” it states.

“The expression of concern about the abstract will remain in place until a correction is accepted and published” in Circulation, AHA spokesperson Suzanne Grant told this news organization by email.

“The specific data needed will be up to the abstract author to determine and supply,” she said, noting that Dr. Gundry “has been in communication with the journal throughout this process.”

Submitting researchers “must always attest to the validity of the abstract,” Ms. Grant said. “Abstracts are then curated by independent review panels, blinded to the identities of the abstract authors, and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting.”

Regarding the AHA’s system for vetting abstracts vying for acceptance to the scientific sessions, she said it is not primarily intended to “evaluate scientific validity” and that the organization is “currently reviewing its existing abstract submission processes.”

A recent Reuters report reviews the controversy and provides links to criticisms of the study on social media.

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

The intention to vaccinate children against COVID-19 was lower among vaccine-hesitant parents when compared with parents who were willing to or had already received the COVID vaccine, a new survey finds.

“Parental vaccine hesitancy is a major issue for schools resuming in-person instruction, potentially requiring regular testing, strict mask wearing, and physical distancing for safe operation,” wrote lead author Madhura S. Rane, PhD, from the City University of New York in New York City, and colleagues in their paper, published online in JAMA Pediatrics.

The survey was conducted in June 2021 of 1,162 parents with children ranging in age from 2 to 17 years. The majority of parents (74.4%) were already vaccinated/vaccine-willing ,while 25.6% were vaccine hesitant. The study cohort, including both 1,652 children and their parents, was part of the nationwide CHASING COVID.

Vaccinated parents overall were more willing to vaccinate or had already vaccinated their eligible children when compared with vaccine-hesitant parents: 64.9% vs. 8.3% for children 2-4 years of age; 77.6% vs. 12.1% for children 5-11 years of age; 81.3% vs. 13.9% for children 12-15 years of age; and 86.4% vs. 12.7% for children 16-17 years of age; P < .001.

The researchers found greater hesitancy among Black and Hispanic parents, compared with parents who were non-Hispanic White, women, younger, and did not have a college education. Parents of children who were currently attending school remotely or only partially, were found to be more willing to vaccinate their children when compared to parents of children who were attending school fully in person.

The authors also found that parents who knew someone who had died of COVID-19 or had experienced a prior COVID-19 infection, were more willing to vaccinate their children.

Hesitance in vaccinated parents

Interestingly, 10% of COVID-vaccinated parents said they were still hesitant to vaccinate their kids because of concern for long-term adverse effects of the vaccine.

“These data point out that vaccine concerns may exist even among vaccinated or vaccine-favorable parents, so we should ask any parent who has not vaccinated their child whether we can discuss their concerns and perhaps move their opinions,” said William T. Basco Jr, MD, MS, a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics.

In an interview, when asked whether recent approval of the vaccine for children aged 5-11 will likely aid in overcoming parental hesitancy, Dr. Basco replied: “Absolutely. As more children get the vaccine and people know a neighbor or nephew or cousin, etc., who received the vaccine and did fine, it will engender greater comfort and allow parents to feel better about having their own child receive the vaccine.”

Advice for clinicians from outside expert

“We can always start by asking parents if we can help them understand the vaccine and the need for it. The tidal wave of disinformation is huge, but we can, on a daily basis, offer to help families navigate this decision,” concluded Dr. Basco, who was not involved with the new paper.

Funding for this study was provided through grants from the National Institute of Allergy and Infectious Diseases, the CUNY Institute of Implementation Science in Population Health, and the COVID-19 Grant Program of the CUNY Graduate School of Public Health and Health Policy. The authors and Dr. Basco have disclosed no relevant financial relationships.

The intention to vaccinate children against COVID-19 was lower among vaccine-hesitant parents when compared with parents who were willing to or had already received the COVID vaccine, a new survey finds.

“Parental vaccine hesitancy is a major issue for schools resuming in-person instruction, potentially requiring regular testing, strict mask wearing, and physical distancing for safe operation,” wrote lead author Madhura S. Rane, PhD, from the City University of New York in New York City, and colleagues in their paper, published online in JAMA Pediatrics.

The survey was conducted in June 2021 of 1,162 parents with children ranging in age from 2 to 17 years. The majority of parents (74.4%) were already vaccinated/vaccine-willing ,while 25.6% were vaccine hesitant. The study cohort, including both 1,652 children and their parents, was part of the nationwide CHASING COVID.

Vaccinated parents overall were more willing to vaccinate or had already vaccinated their eligible children when compared with vaccine-hesitant parents: 64.9% vs. 8.3% for children 2-4 years of age; 77.6% vs. 12.1% for children 5-11 years of age; 81.3% vs. 13.9% for children 12-15 years of age; and 86.4% vs. 12.7% for children 16-17 years of age; P < .001.

The researchers found greater hesitancy among Black and Hispanic parents, compared with parents who were non-Hispanic White, women, younger, and did not have a college education. Parents of children who were currently attending school remotely or only partially, were found to be more willing to vaccinate their children when compared to parents of children who were attending school fully in person.

The authors also found that parents who knew someone who had died of COVID-19 or had experienced a prior COVID-19 infection, were more willing to vaccinate their children.

Hesitance in vaccinated parents

Interestingly, 10% of COVID-vaccinated parents said they were still hesitant to vaccinate their kids because of concern for long-term adverse effects of the vaccine.

“These data point out that vaccine concerns may exist even among vaccinated or vaccine-favorable parents, so we should ask any parent who has not vaccinated their child whether we can discuss their concerns and perhaps move their opinions,” said William T. Basco Jr, MD, MS, a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics.

In an interview, when asked whether recent approval of the vaccine for children aged 5-11 will likely aid in overcoming parental hesitancy, Dr. Basco replied: “Absolutely. As more children get the vaccine and people know a neighbor or nephew or cousin, etc., who received the vaccine and did fine, it will engender greater comfort and allow parents to feel better about having their own child receive the vaccine.”

Advice for clinicians from outside expert

“We can always start by asking parents if we can help them understand the vaccine and the need for it. The tidal wave of disinformation is huge, but we can, on a daily basis, offer to help families navigate this decision,” concluded Dr. Basco, who was not involved with the new paper.

Funding for this study was provided through grants from the National Institute of Allergy and Infectious Diseases, the CUNY Institute of Implementation Science in Population Health, and the COVID-19 Grant Program of the CUNY Graduate School of Public Health and Health Policy. The authors and Dr. Basco have disclosed no relevant financial relationships.

The intention to vaccinate children against COVID-19 was lower among vaccine-hesitant parents when compared with parents who were willing to or had already received the COVID vaccine, a new survey finds.

“Parental vaccine hesitancy is a major issue for schools resuming in-person instruction, potentially requiring regular testing, strict mask wearing, and physical distancing for safe operation,” wrote lead author Madhura S. Rane, PhD, from the City University of New York in New York City, and colleagues in their paper, published online in JAMA Pediatrics.

The survey was conducted in June 2021 of 1,162 parents with children ranging in age from 2 to 17 years. The majority of parents (74.4%) were already vaccinated/vaccine-willing ,while 25.6% were vaccine hesitant. The study cohort, including both 1,652 children and their parents, was part of the nationwide CHASING COVID.

Vaccinated parents overall were more willing to vaccinate or had already vaccinated their eligible children when compared with vaccine-hesitant parents: 64.9% vs. 8.3% for children 2-4 years of age; 77.6% vs. 12.1% for children 5-11 years of age; 81.3% vs. 13.9% for children 12-15 years of age; and 86.4% vs. 12.7% for children 16-17 years of age; P < .001.

The researchers found greater hesitancy among Black and Hispanic parents, compared with parents who were non-Hispanic White, women, younger, and did not have a college education. Parents of children who were currently attending school remotely or only partially, were found to be more willing to vaccinate their children when compared to parents of children who were attending school fully in person.

The authors also found that parents who knew someone who had died of COVID-19 or had experienced a prior COVID-19 infection, were more willing to vaccinate their children.

Hesitance in vaccinated parents

Interestingly, 10% of COVID-vaccinated parents said they were still hesitant to vaccinate their kids because of concern for long-term adverse effects of the vaccine.

“These data point out that vaccine concerns may exist even among vaccinated or vaccine-favorable parents, so we should ask any parent who has not vaccinated their child whether we can discuss their concerns and perhaps move their opinions,” said William T. Basco Jr, MD, MS, a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics.

In an interview, when asked whether recent approval of the vaccine for children aged 5-11 will likely aid in overcoming parental hesitancy, Dr. Basco replied: “Absolutely. As more children get the vaccine and people know a neighbor or nephew or cousin, etc., who received the vaccine and did fine, it will engender greater comfort and allow parents to feel better about having their own child receive the vaccine.”

Advice for clinicians from outside expert

“We can always start by asking parents if we can help them understand the vaccine and the need for it. The tidal wave of disinformation is huge, but we can, on a daily basis, offer to help families navigate this decision,” concluded Dr. Basco, who was not involved with the new paper.

Funding for this study was provided through grants from the National Institute of Allergy and Infectious Diseases, the CUNY Institute of Implementation Science in Population Health, and the COVID-19 Grant Program of the CUNY Graduate School of Public Health and Health Policy. The authors and Dr. Basco have disclosed no relevant financial relationships.

Total COVID-19 cases in children surpassed the 7-million mark as new cases rose slightly after the previous week’s decline, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The 133,000 new cases reported for the week ending Dec. 2 mark the 17th consecutive week that the count has exceeded 100,000 and brought the cumulative national count to 7.03 million since the start of the pandemic, the AAP and CHA said in their weekly COVID-19 report. New cases had dropped the previous week after 3 straight weeks of increases since late October.

The Centers for Disease Control and Prevention puts the total number of child COVID-19 cases at 6.2 million, but both estimates are based on all-age totals – 40 million for the CDC and 41 million for the AAP/CHA – that are well short of the CDC’s latest cumulative figure, which is now just over 49 million, so the actual figures are undoubtedly higher.

Meanwhile, the 1-month anniversary of 5- to 11-year-olds’ vaccine eligibility brought many completions: 923,000 received their second dose during the week ending Dec. 6, compared with 405,000 the previous week. About 16.9% (4.9 million) of children aged 5-11 have gotten at least one dose of the COVID-19 vaccine thus far, of whom almost 1.5 million children (5.1% of the age group) are now fully vaccinated, the CDC said on its COVID-19 Data Tracker.

The pace of vaccinations, however, is much lower for older children. Weekly numbers for all COVID-19 vaccinations, both first and second doses, dropped from 84,000 (Nov. 23-29) to 70,000 (Nov. 30 to Dec. 6), for those aged 12-17 years. In that group, 61.6% have received at least one dose and 51.8% are fully vaccinated, the CDC said.

The pace of vaccinations varies for younger children as well, when geography is considered. The AAP analyzed the CDC’s data and found that 42% of all 5- to 11-year-olds in Vermont had received at least one dose as of Dec. 1, followed by Massachusetts (33%), Maine (30%), and Rhode Island (28%). At the other end of the vaccination scale are Alabama, Louisiana, Mississippi, and West Virginia, all with 4%, the AAP reported.

As the United States puts 7 million children infected with COVID-19 in its rear view mirror, another milestone is looming ahead: The CDC’s current count of deaths in children is 974.

[email protected]

Total COVID-19 cases in children surpassed the 7-million mark as new cases rose slightly after the previous week’s decline, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The 133,000 new cases reported for the week ending Dec. 2 mark the 17th consecutive week that the count has exceeded 100,000 and brought the cumulative national count to 7.03 million since the start of the pandemic, the AAP and CHA said in their weekly COVID-19 report. New cases had dropped the previous week after 3 straight weeks of increases since late October.

The Centers for Disease Control and Prevention puts the total number of child COVID-19 cases at 6.2 million, but both estimates are based on all-age totals – 40 million for the CDC and 41 million for the AAP/CHA – that are well short of the CDC’s latest cumulative figure, which is now just over 49 million, so the actual figures are undoubtedly higher.

Meanwhile, the 1-month anniversary of 5- to 11-year-olds’ vaccine eligibility brought many completions: 923,000 received their second dose during the week ending Dec. 6, compared with 405,000 the previous week. About 16.9% (4.9 million) of children aged 5-11 have gotten at least one dose of the COVID-19 vaccine thus far, of whom almost 1.5 million children (5.1% of the age group) are now fully vaccinated, the CDC said on its COVID-19 Data Tracker.

The pace of vaccinations, however, is much lower for older children. Weekly numbers for all COVID-19 vaccinations, both first and second doses, dropped from 84,000 (Nov. 23-29) to 70,000 (Nov. 30 to Dec. 6), for those aged 12-17 years. In that group, 61.6% have received at least one dose and 51.8% are fully vaccinated, the CDC said.

The pace of vaccinations varies for younger children as well, when geography is considered. The AAP analyzed the CDC’s data and found that 42% of all 5- to 11-year-olds in Vermont had received at least one dose as of Dec. 1, followed by Massachusetts (33%), Maine (30%), and Rhode Island (28%). At the other end of the vaccination scale are Alabama, Louisiana, Mississippi, and West Virginia, all with 4%, the AAP reported.

As the United States puts 7 million children infected with COVID-19 in its rear view mirror, another milestone is looming ahead: The CDC’s current count of deaths in children is 974.

[email protected]

Total COVID-19 cases in children surpassed the 7-million mark as new cases rose slightly after the previous week’s decline, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The 133,000 new cases reported for the week ending Dec. 2 mark the 17th consecutive week that the count has exceeded 100,000 and brought the cumulative national count to 7.03 million since the start of the pandemic, the AAP and CHA said in their weekly COVID-19 report. New cases had dropped the previous week after 3 straight weeks of increases since late October.

The Centers for Disease Control and Prevention puts the total number of child COVID-19 cases at 6.2 million, but both estimates are based on all-age totals – 40 million for the CDC and 41 million for the AAP/CHA – that are well short of the CDC’s latest cumulative figure, which is now just over 49 million, so the actual figures are undoubtedly higher.

Meanwhile, the 1-month anniversary of 5- to 11-year-olds’ vaccine eligibility brought many completions: 923,000 received their second dose during the week ending Dec. 6, compared with 405,000 the previous week. About 16.9% (4.9 million) of children aged 5-11 have gotten at least one dose of the COVID-19 vaccine thus far, of whom almost 1.5 million children (5.1% of the age group) are now fully vaccinated, the CDC said on its COVID-19 Data Tracker.

The pace of vaccinations, however, is much lower for older children. Weekly numbers for all COVID-19 vaccinations, both first and second doses, dropped from 84,000 (Nov. 23-29) to 70,000 (Nov. 30 to Dec. 6), for those aged 12-17 years. In that group, 61.6% have received at least one dose and 51.8% are fully vaccinated, the CDC said.

The pace of vaccinations varies for younger children as well, when geography is considered. The AAP analyzed the CDC’s data and found that 42% of all 5- to 11-year-olds in Vermont had received at least one dose as of Dec. 1, followed by Massachusetts (33%), Maine (30%), and Rhode Island (28%). At the other end of the vaccination scale are Alabama, Louisiana, Mississippi, and West Virginia, all with 4%, the AAP reported.

As the United States puts 7 million children infected with COVID-19 in its rear view mirror, another milestone is looming ahead: The CDC’s current count of deaths in children is 974.

[email protected]

A new survey from the National Foundation for Infectious Diseases shows that, despite the recommendation that patients who have chronic illnesses receive annual flu vaccines, only 45% of these patients do get them. People with chronic diseases are at increased risk for serious flu-related complications, including hospitalization and death.

MarianVejcik/Getty Images

The survey looked at physicians’ practices toward flu vaccination and communication between health care providers (HCP) and their adult patients with chronic health conditions.

Overall, less than a third of HCPs (31%) said they recommend annual flu vaccination to all of their patients with chronic health conditions. There were some surprising differences between subspecialists. For example, 72% of patients with a heart problem who saw a cardiologist said that physician recommended the flu vaccine. The recommendation rate dropped to 32% of lung patients seeing a pulmonary physician and only 10% of people with diabetes who saw an endocrinologist.

There is quite a large gap between what physicians and patients say about their interactions. Fully 77% of HCPs who recommend annual flu vaccination say they tell patients when they are at higher risk of complications from influenza. Yet only 48% of patients say they have been given such information.

Although it is critically important information for patients to learn, their risk of influenza is often missing from the discussion. For example, patients with heart disease are six times more likely to have a heart attack within 7 days of flu infection. People with diabetes are six times more likely to be hospitalized from flu and three times more likely to die. Similarly, those with asthma or chronic obstructive pulmonary disorder are at a much higher risk of complications.

One problem is that more than half of specialist physicians who do not offer flu vaccinations report that it is because they believe that immunizations are the responsibility of the primary care physician. Yet only 65% of patients with one of these chronic illnesses report seeing their primary care physician at least annually.

Much of the disparity between the patient’s perception of what they were told and the physician’s is “how the ‘recommendation’ is actually made,” William Schaffner, MD, NFID’s medical director and professor of medicine at Vanderbilt University, Nashville, Tenn., told this news organization. Dr. Schaffner offered the following example: At the end of the visit, the doctor might say: “It’s that time of the year again – you want to think about getting your flu shot.”

“The doctor thinks they’ve recommended that, but the doctor really has opened the door for you to think about it and leave [yourself] unvaccinated.”

Dr. Schaffner’s alternative? Tell the patient: “‘You’ll get your flu vaccine on the way out. Tom or Sally will give it to you.’ That’s a very different kind of recommendation. And it’s a much greater assurance of providing the vaccine.”

Another major problem, Dr. Schaffner said, is that many specialists “don’t think of vaccination as something that’s included with their routine care” even though they do direct much of the patient’s care. He said that physicians should be more “directive” in their care and that immunizations should be better integrated into routine practice.

Jody Lanard, MD, a retired risk communication consultant who spent many years working with the World Health Organization on disease outbreak communications, said in an interview that this disconnect between physician and patient reports “was really jarring. And it’s actionable!”

She offered several practical suggestions. For one, she said, “the messaging to the specialists has to be very, very empathic. We know you’re already overburdened. And here we’re asking you to do something that you think of as somebody else’s job.” But if your patient gets flu, then your job as the cardiologist or endocrinologist will become more complicated and time-consuming. So getting the patients vaccinated will be a good investment and will make your job easier.

Because of the disparity in patient and physician reports, Dr. Lanard suggested implementing a “feedback mechanism where they [the health care providers] give out the prescription, and then the office calls [the patient] to see if they’ve gotten the shot or not. Because that way it will help correct the mismatch between them thinking that they told the patient and the patient not hearing it.”

Asked about why there might be a big gap between what physicians report they said and what patients heard, Dr. Lanard explained that “physicians often communicate in [a manner] sort of like a checklist. And the patients are focused on one or two things that are high in their minds. And the physician was mentioning some things that are on a separate topic that are not on a patient’s list and it goes right past them.”

Dr. Lanard recommended brief storytelling instead of checklists. For example: “I’ve been treating your diabetes for 10 years. During this last flu season, several of my diabetic patients had a really hard time when they caught the flu. So now I’m trying harder to remember to remind you to get your flu shots.”

She urged HCPs to “make it more personal ... but it can still be scripted in advance as part of something that [you’re] remembering to do during the check.” She added that their professional associations may be able to send them suggested language they can adapt.

Finally, Dr. Lanard cautioned about vaccine myths. “The word myth is so insulting. It’s basically a word that sends the signal that you’re an idiot.”

She advised specialists to avoid the word “myth,” which will make the person defensive. Instead, say something like, “A lot of people, even some of my own family members, think the flu vaccine gives you the flu. ... But it doesn’t. And then you go into the reality.”

Dr. Lanard suggested that specialists implement the follow-up calls and close the feedback loop, saying: “If they did the survey a few years later, I bet that gap would narrow.”

Dr. Schaffner and Dr. Lanard disclosed no relevant financial relationships.

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

A new survey from the National Foundation for Infectious Diseases shows that, despite the recommendation that patients who have chronic illnesses receive annual flu vaccines, only 45% of these patients do get them. People with chronic diseases are at increased risk for serious flu-related complications, including hospitalization and death.

MarianVejcik/Getty Images

The survey looked at physicians’ practices toward flu vaccination and communication between health care providers (HCP) and their adult patients with chronic health conditions.

Overall, less than a third of HCPs (31%) said they recommend annual flu vaccination to all of their patients with chronic health conditions. There were some surprising differences between subspecialists. For example, 72% of patients with a heart problem who saw a cardiologist said that physician recommended the flu vaccine. The recommendation rate dropped to 32% of lung patients seeing a pulmonary physician and only 10% of people with diabetes who saw an endocrinologist.

There is quite a large gap between what physicians and patients say about their interactions. Fully 77% of HCPs who recommend annual flu vaccination say they tell patients when they are at higher risk of complications from influenza. Yet only 48% of patients say they have been given such information.

Although it is critically important information for patients to learn, their risk of influenza is often missing from the discussion. For example, patients with heart disease are six times more likely to have a heart attack within 7 days of flu infection. People with diabetes are six times more likely to be hospitalized from flu and three times more likely to die. Similarly, those with asthma or chronic obstructive pulmonary disorder are at a much higher risk of complications.

One problem is that more than half of specialist physicians who do not offer flu vaccinations report that it is because they believe that immunizations are the responsibility of the primary care physician. Yet only 65% of patients with one of these chronic illnesses report seeing their primary care physician at least annually.

Much of the disparity between the patient’s perception of what they were told and the physician’s is “how the ‘recommendation’ is actually made,” William Schaffner, MD, NFID’s medical director and professor of medicine at Vanderbilt University, Nashville, Tenn., told this news organization. Dr. Schaffner offered the following example: At the end of the visit, the doctor might say: “It’s that time of the year again – you want to think about getting your flu shot.”

“The doctor thinks they’ve recommended that, but the doctor really has opened the door for you to think about it and leave [yourself] unvaccinated.”

Dr. Schaffner’s alternative? Tell the patient: “‘You’ll get your flu vaccine on the way out. Tom or Sally will give it to you.’ That’s a very different kind of recommendation. And it’s a much greater assurance of providing the vaccine.”

Another major problem, Dr. Schaffner said, is that many specialists “don’t think of vaccination as something that’s included with their routine care” even though they do direct much of the patient’s care. He said that physicians should be more “directive” in their care and that immunizations should be better integrated into routine practice.

Jody Lanard, MD, a retired risk communication consultant who spent many years working with the World Health Organization on disease outbreak communications, said in an interview that this disconnect between physician and patient reports “was really jarring. And it’s actionable!”

She offered several practical suggestions. For one, she said, “the messaging to the specialists has to be very, very empathic. We know you’re already overburdened. And here we’re asking you to do something that you think of as somebody else’s job.” But if your patient gets flu, then your job as the cardiologist or endocrinologist will become more complicated and time-consuming. So getting the patients vaccinated will be a good investment and will make your job easier.

Because of the disparity in patient and physician reports, Dr. Lanard suggested implementing a “feedback mechanism where they [the health care providers] give out the prescription, and then the office calls [the patient] to see if they’ve gotten the shot or not. Because that way it will help correct the mismatch between them thinking that they told the patient and the patient not hearing it.”

Asked about why there might be a big gap between what physicians report they said and what patients heard, Dr. Lanard explained that “physicians often communicate in [a manner] sort of like a checklist. And the patients are focused on one or two things that are high in their minds. And the physician was mentioning some things that are on a separate topic that are not on a patient’s list and it goes right past them.”

Dr. Lanard recommended brief storytelling instead of checklists. For example: “I’ve been treating your diabetes for 10 years. During this last flu season, several of my diabetic patients had a really hard time when they caught the flu. So now I’m trying harder to remember to remind you to get your flu shots.”

She urged HCPs to “make it more personal ... but it can still be scripted in advance as part of something that [you’re] remembering to do during the check.” She added that their professional associations may be able to send them suggested language they can adapt.

Finally, Dr. Lanard cautioned about vaccine myths. “The word myth is so insulting. It’s basically a word that sends the signal that you’re an idiot.”

She advised specialists to avoid the word “myth,” which will make the person defensive. Instead, say something like, “A lot of people, even some of my own family members, think the flu vaccine gives you the flu. ... But it doesn’t. And then you go into the reality.”

Dr. Lanard suggested that specialists implement the follow-up calls and close the feedback loop, saying: “If they did the survey a few years later, I bet that gap would narrow.”

Dr. Schaffner and Dr. Lanard disclosed no relevant financial relationships.

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

A new survey from the National Foundation for Infectious Diseases shows that, despite the recommendation that patients who have chronic illnesses receive annual flu vaccines, only 45% of these patients do get them. People with chronic diseases are at increased risk for serious flu-related complications, including hospitalization and death.

MarianVejcik/Getty Images

The survey looked at physicians’ practices toward flu vaccination and communication between health care providers (HCP) and their adult patients with chronic health conditions.

Overall, less than a third of HCPs (31%) said they recommend annual flu vaccination to all of their patients with chronic health conditions. There were some surprising differences between subspecialists. For example, 72% of patients with a heart problem who saw a cardiologist said that physician recommended the flu vaccine. The recommendation rate dropped to 32% of lung patients seeing a pulmonary physician and only 10% of people with diabetes who saw an endocrinologist.

There is quite a large gap between what physicians and patients say about their interactions. Fully 77% of HCPs who recommend annual flu vaccination say they tell patients when they are at higher risk of complications from influenza. Yet only 48% of patients say they have been given such information.

Although it is critically important information for patients to learn, their risk of influenza is often missing from the discussion. For example, patients with heart disease are six times more likely to have a heart attack within 7 days of flu infection. People with diabetes are six times more likely to be hospitalized from flu and three times more likely to die. Similarly, those with asthma or chronic obstructive pulmonary disorder are at a much higher risk of complications.

One problem is that more than half of specialist physicians who do not offer flu vaccinations report that it is because they believe that immunizations are the responsibility of the primary care physician. Yet only 65% of patients with one of these chronic illnesses report seeing their primary care physician at least annually.

Much of the disparity between the patient’s perception of what they were told and the physician’s is “how the ‘recommendation’ is actually made,” William Schaffner, MD, NFID’s medical director and professor of medicine at Vanderbilt University, Nashville, Tenn., told this news organization. Dr. Schaffner offered the following example: At the end of the visit, the doctor might say: “It’s that time of the year again – you want to think about getting your flu shot.”

“The doctor thinks they’ve recommended that, but the doctor really has opened the door for you to think about it and leave [yourself] unvaccinated.”

Dr. Schaffner’s alternative? Tell the patient: “‘You’ll get your flu vaccine on the way out. Tom or Sally will give it to you.’ That’s a very different kind of recommendation. And it’s a much greater assurance of providing the vaccine.”

Another major problem, Dr. Schaffner said, is that many specialists “don’t think of vaccination as something that’s included with their routine care” even though they do direct much of the patient’s care. He said that physicians should be more “directive” in their care and that immunizations should be better integrated into routine practice.

Jody Lanard, MD, a retired risk communication consultant who spent many years working with the World Health Organization on disease outbreak communications, said in an interview that this disconnect between physician and patient reports “was really jarring. And it’s actionable!”

She offered several practical suggestions. For one, she said, “the messaging to the specialists has to be very, very empathic. We know you’re already overburdened. And here we’re asking you to do something that you think of as somebody else’s job.” But if your patient gets flu, then your job as the cardiologist or endocrinologist will become more complicated and time-consuming. So getting the patients vaccinated will be a good investment and will make your job easier.

Because of the disparity in patient and physician reports, Dr. Lanard suggested implementing a “feedback mechanism where they [the health care providers] give out the prescription, and then the office calls [the patient] to see if they’ve gotten the shot or not. Because that way it will help correct the mismatch between them thinking that they told the patient and the patient not hearing it.”

Asked about why there might be a big gap between what physicians report they said and what patients heard, Dr. Lanard explained that “physicians often communicate in [a manner] sort of like a checklist. And the patients are focused on one or two things that are high in their minds. And the physician was mentioning some things that are on a separate topic that are not on a patient’s list and it goes right past them.”

Dr. Lanard recommended brief storytelling instead of checklists. For example: “I’ve been treating your diabetes for 10 years. During this last flu season, several of my diabetic patients had a really hard time when they caught the flu. So now I’m trying harder to remember to remind you to get your flu shots.”

She urged HCPs to “make it more personal ... but it can still be scripted in advance as part of something that [you’re] remembering to do during the check.” She added that their professional associations may be able to send them suggested language they can adapt.

Finally, Dr. Lanard cautioned about vaccine myths. “The word myth is so insulting. It’s basically a word that sends the signal that you’re an idiot.”

She advised specialists to avoid the word “myth,” which will make the person defensive. Instead, say something like, “A lot of people, even some of my own family members, think the flu vaccine gives you the flu. ... But it doesn’t. And then you go into the reality.”

Dr. Lanard suggested that specialists implement the follow-up calls and close the feedback loop, saying: “If they did the survey a few years later, I bet that gap would narrow.”

Dr. Schaffner and Dr. Lanard disclosed no relevant financial relationships.

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

Background: Recurrent cellulitis is a common condition in patients with lower-extremity edema. Although some clinicians recommend compression garments as a preventative treatment, there are no data evaluating their efficacy for this purpose.

Dr. Herscher is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: Recurrent cellulitis is a common condition in patients with lower-extremity edema. Although some clinicians recommend compression garments as a preventative treatment, there are no data evaluating their efficacy for this purpose.

Dr. Herscher is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: Recurrent cellulitis is a common condition in patients with lower-extremity edema. Although some clinicians recommend compression garments as a preventative treatment, there are no data evaluating their efficacy for this purpose.

Dr. Herscher is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Decades before becoming the go-to authority in the United States on the COVID-19 global pandemic, Anthony S. Fauci, MD, found himself witnessing the earliest perplexing cases of what would become another devastating global pandemic – HIV/AIDS. And while extraordinary advances have transformed treatment and prevention, glaring treatment gaps and challenges remain after 40 years.

“I certainly remember those initial MMWRs [the Morbidity and Mortality Weekly Reports] in the summer of 1981 that introduced us to what would turn out to be the most extraordinary and devastating pandemic of an infectious disease up until that time in the modern era,” said Dr. Fauci when addressing the 2021 United States Conference on HIV/AIDS.

“Now, 40 years into it, we are still in the middle of a global pandemic despite the fact that there have been extraordinary advances,” said Dr. Fauci, who is director of the National Institute of Allergy and Infectious Diseases and chief medical advisor to the President of the United States.

Specifically, it was on June 5, 1981, that the Centers for Disease Control and Prevention issued its fateful report on the first five cases of what would soon become known as Acquired Immune Deficiency Syndrome.

By 2020, the 5 cases had grown to 79.3 million HIV infections since the start of the HIV/AIDS pandemic, claiming 36.3 million lives, according to the NAIDS Global AIDS update, Dr. Fauci reported.

At the end of 2020, there were 1.5 million new infections, as many as 37.7 million people living with HIV, and 680,000 deaths, according to the report.

The fact that so many people are living with HIV – and not dying from it – is largely attributable to “breathtaking” advances in treatment, Dr. Fauci said, underscoring the fact that there are now 13 single-tablet, once-daily, antiretroviral (ART) regimens approved in the United States to replace the multidrug cocktail that has long been necessary with HIV treatment.

“I can remember when the combination therapies were first made available, we were giving patients literally dozens of pills of different types each day, but that is no longer the case,” Dr. Fauci said.

“We can say, without hyperbole, that highly effective antiretroviral therapy for HIV is indeed one of the most important biomedical research advances of our era.”

Furthermore, HIV prevention using pre-exposure prophylaxis (PrEP), when used optimally and consistently, has further transformed the HIV landscape with 99% efficacy in preventing sexual HIV acquisition.
 

Troubling treatment gaps

Despite the advances, disparities and challenges are abundant, Dr. Fauci said.

Notably, the majority of those infected globally – 65% – are concentrated among key populations, including gay men and other men who have sex with men (23%), clients of sex workers (20%), sex workers (11%), people who inject drugs (9%), and transgender people (2%), according to the Joint United Nations Programme on HIV/AIDS.

According to UNAIDS, among the 37.7 million people living with HIV at the end of 2020, 27.5 million were being treated with life-saving ART, leaving a gap of 10.2 million people with HIV who are not receiving the treatment, Dr. Fauci pointed out.

And of those who do receive treatment, retention is suboptimal, with only about 65% of patients in low- and middle-income countries being retained in care at 48 months following ART initiation.

Dr. Fauci underscored encouraging developments that could address some of those problems, notably long-acting ART therapies that, in requiring administration only every 6 months or so, could negate the need for adherence to daily ART therapy.

Likewise, long-acting PrEP provided intermittently over longer periods could prevent transmission.

“We’re looking at [long-acting PrEP] with a great deal of enthusiasm as providing protection with longer durations between doses to get people to essentially have close to 99% protection against HIV acquisition,” Dr. Fauci said.

While several efforts to develop vaccines for HIV in long-term clinical trials have had disappointing results, Dr. Fauci says he stops short of calling them failures.

“We don’t consider the trials to be failures because, in fact, they tell us the way we need to go – which direction,” he said.

“In fact, COVID-19 itself has given us new enthusiasm about the use of vaccine platforms such as mRNA that are now being applied in the vaccine quest for HIV,” Dr. Fauci noted.

Ultimately, “we must steadily and steadfastly move forward to address critical research gaps and unanswered questions [regarding HIV],” Dr. Fauci said. “The scientific advances have been breathtaking and it is up to us to [achieve] greater scientific advances, but also to translate them into something that can be implemented.”

USCHA Executive Director Paul Kawata, MD, commented that he shares Dr. Fauci’s optimism — and his concerns.

“NMAC [formerly the National Minority AIDS Council, which runs USCHA] is very excited about the science,” he said in an interview. “Our ability to make treatment easier should be a pathway to success.”

“Our concern is that we need more implementation science to know if long-acting ART will be used by the communities hardest hit by HIV,” he said.

Dr. Kawata noted that NMAC agrees that vaccine trial “failures” can offer important lessons, “but we are getting impatient,” he said. “Back in the 80s, Secretary Margret Heckler said we would have a vaccine in 5 years.”

Furthermore, ongoing racial disparities, left unaddressed, will hold back meaningful progress in the fight against HIV, he noted. “We are always hopeful, [but] the reality is that race and racism play an outsized role in health outcome in America. Unless we address these inequalities, we will never end HIV.”

NMAC receives funding from Gilead, Viiv, Merck, and Janssen.

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

Decades before becoming the go-to authority in the United States on the COVID-19 global pandemic, Anthony S. Fauci, MD, found himself witnessing the earliest perplexing cases of what would become another devastating global pandemic – HIV/AIDS. And while extraordinary advances have transformed treatment and prevention, glaring treatment gaps and challenges remain after 40 years.

“I certainly remember those initial MMWRs [the Morbidity and Mortality Weekly Reports] in the summer of 1981 that introduced us to what would turn out to be the most extraordinary and devastating pandemic of an infectious disease up until that time in the modern era,” said Dr. Fauci when addressing the 2021 United States Conference on HIV/AIDS.

“Now, 40 years into it, we are still in the middle of a global pandemic despite the fact that there have been extraordinary advances,” said Dr. Fauci, who is director of the National Institute of Allergy and Infectious Diseases and chief medical advisor to the President of the United States.

Specifically, it was on June 5, 1981, that the Centers for Disease Control and Prevention issued its fateful report on the first five cases of what would soon become known as Acquired Immune Deficiency Syndrome.

By 2020, the 5 cases had grown to 79.3 million HIV infections since the start of the HIV/AIDS pandemic, claiming 36.3 million lives, according to the NAIDS Global AIDS update, Dr. Fauci reported.

At the end of 2020, there were 1.5 million new infections, as many as 37.7 million people living with HIV, and 680,000 deaths, according to the report.

The fact that so many people are living with HIV – and not dying from it – is largely attributable to “breathtaking” advances in treatment, Dr. Fauci said, underscoring the fact that there are now 13 single-tablet, once-daily, antiretroviral (ART) regimens approved in the United States to replace the multidrug cocktail that has long been necessary with HIV treatment.

“I can remember when the combination therapies were first made available, we were giving patients literally dozens of pills of different types each day, but that is no longer the case,” Dr. Fauci said.

“We can say, without hyperbole, that highly effective antiretroviral therapy for HIV is indeed one of the most important biomedical research advances of our era.”

Furthermore, HIV prevention using pre-exposure prophylaxis (PrEP), when used optimally and consistently, has further transformed the HIV landscape with 99% efficacy in preventing sexual HIV acquisition.
 

Troubling treatment gaps

Despite the advances, disparities and challenges are abundant, Dr. Fauci said.

Notably, the majority of those infected globally – 65% – are concentrated among key populations, including gay men and other men who have sex with men (23%), clients of sex workers (20%), sex workers (11%), people who inject drugs (9%), and transgender people (2%), according to the Joint United Nations Programme on HIV/AIDS.

According to UNAIDS, among the 37.7 million people living with HIV at the end of 2020, 27.5 million were being treated with life-saving ART, leaving a gap of 10.2 million people with HIV who are not receiving the treatment, Dr. Fauci pointed out.

And of those who do receive treatment, retention is suboptimal, with only about 65% of patients in low- and middle-income countries being retained in care at 48 months following ART initiation.

Dr. Fauci underscored encouraging developments that could address some of those problems, notably long-acting ART therapies that, in requiring administration only every 6 months or so, could negate the need for adherence to daily ART therapy.

Likewise, long-acting PrEP provided intermittently over longer periods could prevent transmission.

“We’re looking at [long-acting PrEP] with a great deal of enthusiasm as providing protection with longer durations between doses to get people to essentially have close to 99% protection against HIV acquisition,” Dr. Fauci said.

While several efforts to develop vaccines for HIV in long-term clinical trials have had disappointing results, Dr. Fauci says he stops short of calling them failures.

“We don’t consider the trials to be failures because, in fact, they tell us the way we need to go – which direction,” he said.

“In fact, COVID-19 itself has given us new enthusiasm about the use of vaccine platforms such as mRNA that are now being applied in the vaccine quest for HIV,” Dr. Fauci noted.

Ultimately, “we must steadily and steadfastly move forward to address critical research gaps and unanswered questions [regarding HIV],” Dr. Fauci said. “The scientific advances have been breathtaking and it is up to us to [achieve] greater scientific advances, but also to translate them into something that can be implemented.”

USCHA Executive Director Paul Kawata, MD, commented that he shares Dr. Fauci’s optimism — and his concerns.

“NMAC [formerly the National Minority AIDS Council, which runs USCHA] is very excited about the science,” he said in an interview. “Our ability to make treatment easier should be a pathway to success.”

“Our concern is that we need more implementation science to know if long-acting ART will be used by the communities hardest hit by HIV,” he said.

Dr. Kawata noted that NMAC agrees that vaccine trial “failures” can offer important lessons, “but we are getting impatient,” he said. “Back in the 80s, Secretary Margret Heckler said we would have a vaccine in 5 years.”

Furthermore, ongoing racial disparities, left unaddressed, will hold back meaningful progress in the fight against HIV, he noted. “We are always hopeful, [but] the reality is that race and racism play an outsized role in health outcome in America. Unless we address these inequalities, we will never end HIV.”

NMAC receives funding from Gilead, Viiv, Merck, and Janssen.

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

Decades before becoming the go-to authority in the United States on the COVID-19 global pandemic, Anthony S. Fauci, MD, found himself witnessing the earliest perplexing cases of what would become another devastating global pandemic – HIV/AIDS. And while extraordinary advances have transformed treatment and prevention, glaring treatment gaps and challenges remain after 40 years.

“I certainly remember those initial MMWRs [the Morbidity and Mortality Weekly Reports] in the summer of 1981 that introduced us to what would turn out to be the most extraordinary and devastating pandemic of an infectious disease up until that time in the modern era,” said Dr. Fauci when addressing the 2021 United States Conference on HIV/AIDS.

“Now, 40 years into it, we are still in the middle of a global pandemic despite the fact that there have been extraordinary advances,” said Dr. Fauci, who is director of the National Institute of Allergy and Infectious Diseases and chief medical advisor to the President of the United States.

Specifically, it was on June 5, 1981, that the Centers for Disease Control and Prevention issued its fateful report on the first five cases of what would soon become known as Acquired Immune Deficiency Syndrome.

By 2020, the 5 cases had grown to 79.3 million HIV infections since the start of the HIV/AIDS pandemic, claiming 36.3 million lives, according to the NAIDS Global AIDS update, Dr. Fauci reported.

At the end of 2020, there were 1.5 million new infections, as many as 37.7 million people living with HIV, and 680,000 deaths, according to the report.

The fact that so many people are living with HIV – and not dying from it – is largely attributable to “breathtaking” advances in treatment, Dr. Fauci said, underscoring the fact that there are now 13 single-tablet, once-daily, antiretroviral (ART) regimens approved in the United States to replace the multidrug cocktail that has long been necessary with HIV treatment.

“I can remember when the combination therapies were first made available, we were giving patients literally dozens of pills of different types each day, but that is no longer the case,” Dr. Fauci said.

“We can say, without hyperbole, that highly effective antiretroviral therapy for HIV is indeed one of the most important biomedical research advances of our era.”

Furthermore, HIV prevention using pre-exposure prophylaxis (PrEP), when used optimally and consistently, has further transformed the HIV landscape with 99% efficacy in preventing sexual HIV acquisition.
 

Troubling treatment gaps

Despite the advances, disparities and challenges are abundant, Dr. Fauci said.

Notably, the majority of those infected globally – 65% – are concentrated among key populations, including gay men and other men who have sex with men (23%), clients of sex workers (20%), sex workers (11%), people who inject drugs (9%), and transgender people (2%), according to the Joint United Nations Programme on HIV/AIDS.

According to UNAIDS, among the 37.7 million people living with HIV at the end of 2020, 27.5 million were being treated with life-saving ART, leaving a gap of 10.2 million people with HIV who are not receiving the treatment, Dr. Fauci pointed out.

And of those who do receive treatment, retention is suboptimal, with only about 65% of patients in low- and middle-income countries being retained in care at 48 months following ART initiation.

Dr. Fauci underscored encouraging developments that could address some of those problems, notably long-acting ART therapies that, in requiring administration only every 6 months or so, could negate the need for adherence to daily ART therapy.

Likewise, long-acting PrEP provided intermittently over longer periods could prevent transmission.

“We’re looking at [long-acting PrEP] with a great deal of enthusiasm as providing protection with longer durations between doses to get people to essentially have close to 99% protection against HIV acquisition,” Dr. Fauci said.

While several efforts to develop vaccines for HIV in long-term clinical trials have had disappointing results, Dr. Fauci says he stops short of calling them failures.

“We don’t consider the trials to be failures because, in fact, they tell us the way we need to go – which direction,” he said.

“In fact, COVID-19 itself has given us new enthusiasm about the use of vaccine platforms such as mRNA that are now being applied in the vaccine quest for HIV,” Dr. Fauci noted.

Ultimately, “we must steadily and steadfastly move forward to address critical research gaps and unanswered questions [regarding HIV],” Dr. Fauci said. “The scientific advances have been breathtaking and it is up to us to [achieve] greater scientific advances, but also to translate them into something that can be implemented.”

USCHA Executive Director Paul Kawata, MD, commented that he shares Dr. Fauci’s optimism — and his concerns.

“NMAC [formerly the National Minority AIDS Council, which runs USCHA] is very excited about the science,” he said in an interview. “Our ability to make treatment easier should be a pathway to success.”

“Our concern is that we need more implementation science to know if long-acting ART will be used by the communities hardest hit by HIV,” he said.

Dr. Kawata noted that NMAC agrees that vaccine trial “failures” can offer important lessons, “but we are getting impatient,” he said. “Back in the 80s, Secretary Margret Heckler said we would have a vaccine in 5 years.”

Furthermore, ongoing racial disparities, left unaddressed, will hold back meaningful progress in the fight against HIV, he noted. “We are always hopeful, [but] the reality is that race and racism play an outsized role in health outcome in America. Unless we address these inequalities, we will never end HIV.”

NMAC receives funding from Gilead, Viiv, Merck, and Janssen.

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

Although the universal use of masks by both health care professionals and the general public now appears routine, widely differing recommendations were distributed by different health organizations early in the pandemic. In April 2020, the World Health Organization (WHO) stated that there was no evidence that healthy individuals wearing a medical mask in the community prevented COVID-19 infection.¹ However, these recommendations must be placed in the context of a national shortage of personal protective equipment early in the pandemic. The WHO guidance released on June 5, 2020, recommended continuous use of masks for health care workers in the clinical setting.² Additional recommendations included mask replacement when wet, soiled, or damaged, and when the wearer touched the mask. The WHO also recommended mask usage by those with underlying medical comorbidities and those living in high population–density areas and in settings where physical distancing was not possible.²

The Centers for Disease Control and Prevention (CDC) officially recommended the use of face coverings for the general public to prevent COVID-19 transmission on April 3, 2020.³ The CDC highlighted that masks should not be worn by children younger than 2 years; individuals with respiratory compromise; and patients who are unconscious, incapacitated, or unable to remove a mask without assistance.⁴ Medical masks and respirators were only recommended for health care workers. Importantly, masks with valves/vents were not recommended, as respiratory droplets can be emitted, defeating the purpose of source control.⁴ New York State mandated mask usage in public places starting on April 15, 2020.

These recommendations were based on the hypothesis that COVID-19 transmission occurs primarily via droplets and contact. In reality, SARS-CoV-2 transmission more likely occurs in a continuum from larger droplets to miniscule aerosols expelled from an infected person when talking, coughing, or sneezing.^5,6 It should be noted that there was a formal suggestion of the potential for airborne transmission of SARS-CoV-2 by the CDC in a statement on September 18, 2020, that was subsequently retracted 3 days later.^7,8 The CDC, reversing their prior recommendations, updated their guidance on October 5, 2020, endorsing prior reports that SARS-CoV-2 can be spread through aerosol transmission.⁸

Mask usage helps prevent viral spread by all individuals, especially those who are presymptomatic and asymptomatic. Presymptomatic individuals account for approximately 40% to 60% of transmissions, and asymptomatic individuals account for approximately 4% to 30% of infections by some models, which suggest these individuals are the drivers of the pandemic, more so than symptomatic individuals.^9-15 Additionally, masking also may in effect reduce the amount of SARS-CoV-2 to which individuals are being exposed in the community.¹⁴ Universal masking is a relatively low-cost, low-risk intervention that may provide moderate benefit to the individual but substantial benefit to communities at large.^10-13 Universal masking in other countries also has clearly demonstrated major benefits during the pandemic. Implementation of universal masking in Taiwan resulted in only approximately 440 COVID-19 cases and less than 10 deaths, despite a population of 23 million.¹⁶ South Korea, having experience with Middle East respiratory syndrome, also was able to quickly institute a mask policy for its citizens, resulting in approximately 94% compliance.¹⁷ Moreover, several mathematical models have shown that even imperfect use of masks on a population level can prevent disease transmission and should be instituted.¹⁸

Given the importance and potential benefits of mask usage, we investigated compliance and proper utilization of facial masks in New York City (NYC), once the epicenter of the pandemic in the United States. New York City and the rest of New York State experienced more than 1.13 million and 1.46 million cases of COVID-19, respectively, as of early November 2021.¹⁹ Nationwide, NYC had the greatest absolute death count of more than 34,634 and the greatest rate of death per 100,000 individuals of 412. In contrast, New York State, excluding NYC, had an absolute death count of more than 21,646 and a death rate per 100,000 individuals of 195 as of early November 2021.¹⁹ Now entering 20 months since the first case of COVID-19 in NYC, it continues to be vital for facial mask protocols to be emphasized as part of a comprehensive infection prevention protocol, especially in light of continued vaccine resistance, to help stall continued spread of SARS-CoV-2.²⁰

We seek to show that despite months of policies for universal masking in NYC, there is still considerable mask noncompliance by the general public in health care settings where the use of masks is particularly imperative. We conducted an observational study investigating proper use of face masks of adults entering the main entrance of 4 hospitals located in NYC.

Methods

We observed mask usage in adults entering 4 hospitals in September 2020 (postsurge in NYC and prior to the availability of COVID-19 vaccinations). Hospitals were chosen to represent several types of health care delivery systems available in the United States and included a city, state, federal, and private hospital. Data collection was completed during peak traffic hours (8:00 am to 12:00 pm) on a weekday and continued until a total of 100 unique patients were observed at each site. Each hospital entrance was barricaded, and hospital staff were stationed at these entry points to take each individual’s temperature, screen for symptoms and exposure risk, verify patients’ appointments, and ensure proper mask wearing (in optimal circumstances). Data collectors (J.L. and N.M.) were stationed just past the barricade of each hospital’s entrance and observed those who entered. Individuals were not approached about the study, demographics, or the use and/or views about usage of facial masks. Children and hospital employees were excluded from data collection, with the exception of 1 hospital with a dedicated employee entrance where employees were observed for mask compliance. Except for vented/valved masks or makeshift masks fashioned out of scarfs, bandanas, or similar materials, the type of mask an individual wore was not distinguished (medical masks, cotton masks, or respirator-type masks were not differentiated).

Mask usage was observed and classified into several categories: correctly fitting mask over the nose and mouth, no face mask, mask usage with nose exposed, mask usage with mouth exposed, mask usage with both nose and mouth exposed (ie, mask on the chin/neck area), loosely fitting mask, vented/valved mask, or other form of face covering (eg, bandana, scarf).

Results

We observed a consistent rate of mask compliance between 72% and 85%, with an average of 78% of the 600 individuals observed wearing correctly fitting masks across the 4 hospitals included in this study (Table). The employee entrance included in this study had the highest compliance rate of 85%. An overall low rate of complete mask noncompliance was observed, with only 9 individuals (1.5%) in the entire study not wearing any mask. The federal hospital had the highest rate of mask noncompliance. We also observed a low rate of nose and mouth exposure, with 1.8% of individuals wearing a mask with the nose and mouth exposed (ie, mask tucked under the chin). No individuals were observed with the mouth exposed but with the nose covered by a mask. Additionally, only 3 individuals (0.5%) wore a mask with a vent/valve. The most common way that masks were worn incorrectly was with the nose exposed, accounting for 9.5% of individuals observed. Overall, only 9 individuals (1.5%) wore a nontraditional face covering, with a bandana being the most commonly observed makeshift mask.

Signage regarding the requirement to wear masks and to social distance was universally instituted at all hospital entry points (both inside and outside the hospital) in this study. However, there were no illustrations demonstrating correct and incorrect forms of mask usage. All signage merely displayed a graphic of a facial mask noting the requirement to wear a mask prior to entering the building. Hospital staff also had face masks available for patients who failed to bring a mask or who wore an inappropriate mask (ie, vented/valved masks).

Comment

Mask Effectiveness—Masks reduce the spread of SARS-CoV-2 by preventing both droplets and potentially virus-bearing aerosols.^6,21,22 It has been demonstrated that well-fitted cotton homemade masks and medical masks provide the most effective method of reducing droplet dispersion. Loosely fitted masks as well as bandana-style facial coverings minimally reduce small aerosolized droplets, and an uncovered mouth and nose can disperse particles at a distance much greater than 6 feet.²²

Mask Compliance—We report an overall high compliance rate with mask wearing among individuals visiting a hospital; however, compliance was still imperfect. Overall, 78% of observed individuals wore a correctly fitting mask when entering a hospital, even with hospital staff positioned at entry points to ensure proper mask usage. With all the resources available at health care centers, we anticipated a much higher compliance rate for correctly fitting masks at hospital entrances. We hypothesize that given only 78% of individuals showed proper mask compliance in a setting with enforcement by health care personnel, the mask compliance rate in the larger community is likely much lower. It is imperative to enforce continued mask compliance in medical centers and other public areas given notable vaccine noncompliance in certain parts of the country.

Tools to Prevent Disease Transmission—Mask usage by the general public in NYC helped in its response to the COVID-19 pandemic. Yang et al²³ demonstrated through mathematical modeling that mask usage in NYC was associated with a 6.6% reduction in transmission overall and a 20% decrease in transmission for individuals 65 years and older during the first month of the universal mask policy going into effect. The authors extrapolated these data during the NYC reopening and found that universal masking reduced transmission by approximately 9% to 11%, accounting for the increase in hours spent outside home quarantine. The authors also hypothesized that if universal masking was as effective in its reduction of transmission for everyone in NYC as it was for older adults, the potential reduction in transmission of SARS-CoV-2 could be as high as 28% to 32%.²³

Temperature checks at entrance barricades were standard protocol during the observation period. Although the main purpose of this study was to investigate compliance with and proper use of facial masks in a health care setting, it should be mentioned that, although temperature checks were being done on almost every person entering a hospital, the uniformity and practicality of this intervention has not been backed by substantial evidence. Although many nontouch thermometers are intended to capture a forehead temperature for the most accurate reading, the authors will share that in their observation, medical personnel screening individuals at hospital entrances were observed checking temperatures at any easily accessible body part, such as the forearm, hand, or neck. Furthermore, it has been reported that only approximately 40% of individuals with COVID-19 present with a fever.²⁴ Many hospitals, including the 4 that were included in this investigation, have formal protocols for patients presenting with a fever, especially those presenting to an ambulatory center. Patients are usually instructed to call ahead if they have a fever, and a decision regarding next steps will be discussed with a health care provider. In addition, 1 meta-analysis on the symptoms of COVID-19 suggested that approximately 12% of infected patients are asymptomatic, likely a conservative estimate.²⁵ Although we do not suggest that hospitals stop temperature checks, consistent temperature checks in anatomic locations intended for the specific thermometer used must be employed. Alternatively, a thermographic camera system that could detect heat signatures may be a way to screen faster, only necessitating that those above a threshold be assessed further.

The results of this study suggest that much greater effort is being placed on these temperature checks than on other equally important components of the entrance health assessment. This initial encounter at hospital entrances should serve as an opportunity for education on proper choice and use of masks with clear instructions that masks should not be removed unless directed by a health care provider and in a designated area, such as an examination room. The COVID-19 pandemic in the United States is likely the first time an individual is wearing these types of masks. Reiterating when and how often a mask should be changed (eg, when wet or soiled), how a soiled mask is not an effective mask, how a used mask should be discarded, ways to prevent self-contamination (ie, proper donning and doffing), and the importance of other infection-prevention behaviors—hand hygiene; social distancing; avoidance of touching the eyes, nose, and mouth with unwashed hands; and regular disinfecting of surfaces—should be practiced.^11,26-29 Extended use and reuse of masks also can result in transmission of infection.³⁰

Throughout the pandemic, our personal experience is that some patients often overtly refuse to wear a mask, citing underlying respiratory issues. The implications of patients not wearing a mask in a medical office and endangering other patients and staff are beyond the scope of this analysis. We will, however, comment briefly on the evidence behind this common concern. Matuschek et al³¹ found substantial adverse changes in respiratory rate, oxygen saturation, and CO₂ levels in patients with severe chronic obstructive pulmonary disease who were wearing N95 respirators during a 6-minute walk test. Another study by Chan et al³² showed that nonmedical masks in healthy older adults in the community setting had no impact on oxygen saturation. Ultimately, the most effective mask a patient can wear is a mask that will be worn consistently.³²

Populations With Limited Access to Masks—The COVID-19 pandemic disproportionately impacted disadvantaged populations, both in socioeconomic status and minority status. A disproportionate number of COVID-19 hospitalizations and deaths occurred in lower-income and minority populations.¹⁰ In fact, Lamb et al³³ reported that NYC neighborhoods with a larger proportion of uninsured individuals with limited access to health care and overall lower socioeconomic status had a higher rate of SARS-CoV-2 positivity. A retrospective study in Louisiana showed that Black individuals accounted for 77% of hospitalizations and 71% of deaths due to COVID-19 in a population where only 31% of individuals identified as Black.¹⁰ Chu et al⁶ even asserted that policies should be put into place to address equity issues for populations with limited access to masks. We agree that policies should be put into action to ensure that individuals lacking the means to obtain appropriate masks or unable to obtain an adequate supply of masks be provided this new necessity. It has been calculated that the impact of masks in reducing virus transmission would be greatest if mask availability to disadvantaged populations is ensured.¹⁸ We support a plan for masks to be covered by government-sponsored health plans.

Study Limitations—Several limitations exist in our study that should be discussed. Although the data collectors observed a large number of individuals, each hospital entrance was only observed for 1 half-day morning session. There may be variations in the number of people wearing a mask at different times of day and different days of the week with fluctuations in hospital traffic. Although data were collected at a variety of hospitals representing the diverse health care delivery models available in the United States, the NYC hospitals included in this study may have different resources available for infection-prevention strategies than hospitals across the country, given NYC’s unique population density and demographics.

Study Strengths—The generalizability of the study should be recognized. Data were collected by all major health care delivery models available in the United States—private, state, city, and federal hospital systems. This study can be easily replicated in other health care delivery systems to further investigate potential gaps in mask usage and infection prevention. Repeating this study in areas where a large portion of the population does not believe in the virus also will likely show lower levels of mask use.

Conclusion

As the country grapples with vaccine hesitancy and with the new variants of SARS-CoV-2, continued universal masking is still imperative. The effectiveness of universal masking has been demonstrated, and with the combination of vaccinations, we can be assured that the world will continue to emerge from the pandemic.

Although the universal use of masks by both health care professionals and the general public now appears routine, widely differing recommendations were distributed by different health organizations early in the pandemic. In April 2020, the World Health Organization (WHO) stated that there was no evidence that healthy individuals wearing a medical mask in the community prevented COVID-19 infection.¹ However, these recommendations must be placed in the context of a national shortage of personal protective equipment early in the pandemic. The WHO guidance released on June 5, 2020, recommended continuous use of masks for health care workers in the clinical setting.² Additional recommendations included mask replacement when wet, soiled, or damaged, and when the wearer touched the mask. The WHO also recommended mask usage by those with underlying medical comorbidities and those living in high population–density areas and in settings where physical distancing was not possible.²

The Centers for Disease Control and Prevention (CDC) officially recommended the use of face coverings for the general public to prevent COVID-19 transmission on April 3, 2020.³ The CDC highlighted that masks should not be worn by children younger than 2 years; individuals with respiratory compromise; and patients who are unconscious, incapacitated, or unable to remove a mask without assistance.⁴ Medical masks and respirators were only recommended for health care workers. Importantly, masks with valves/vents were not recommended, as respiratory droplets can be emitted, defeating the purpose of source control.⁴ New York State mandated mask usage in public places starting on April 15, 2020.

These recommendations were based on the hypothesis that COVID-19 transmission occurs primarily via droplets and contact. In reality, SARS-CoV-2 transmission more likely occurs in a continuum from larger droplets to miniscule aerosols expelled from an infected person when talking, coughing, or sneezing.^5,6 It should be noted that there was a formal suggestion of the potential for airborne transmission of SARS-CoV-2 by the CDC in a statement on September 18, 2020, that was subsequently retracted 3 days later.^7,8 The CDC, reversing their prior recommendations, updated their guidance on October 5, 2020, endorsing prior reports that SARS-CoV-2 can be spread through aerosol transmission.⁸

Mask usage helps prevent viral spread by all individuals, especially those who are presymptomatic and asymptomatic. Presymptomatic individuals account for approximately 40% to 60% of transmissions, and asymptomatic individuals account for approximately 4% to 30% of infections by some models, which suggest these individuals are the drivers of the pandemic, more so than symptomatic individuals.^9-15 Additionally, masking also may in effect reduce the amount of SARS-CoV-2 to which individuals are being exposed in the community.¹⁴ Universal masking is a relatively low-cost, low-risk intervention that may provide moderate benefit to the individual but substantial benefit to communities at large.^10-13 Universal masking in other countries also has clearly demonstrated major benefits during the pandemic. Implementation of universal masking in Taiwan resulted in only approximately 440 COVID-19 cases and less than 10 deaths, despite a population of 23 million.¹⁶ South Korea, having experience with Middle East respiratory syndrome, also was able to quickly institute a mask policy for its citizens, resulting in approximately 94% compliance.¹⁷ Moreover, several mathematical models have shown that even imperfect use of masks on a population level can prevent disease transmission and should be instituted.¹⁸

Given the importance and potential benefits of mask usage, we investigated compliance and proper utilization of facial masks in New York City (NYC), once the epicenter of the pandemic in the United States. New York City and the rest of New York State experienced more than 1.13 million and 1.46 million cases of COVID-19, respectively, as of early November 2021.¹⁹ Nationwide, NYC had the greatest absolute death count of more than 34,634 and the greatest rate of death per 100,000 individuals of 412. In contrast, New York State, excluding NYC, had an absolute death count of more than 21,646 and a death rate per 100,000 individuals of 195 as of early November 2021.¹⁹ Now entering 20 months since the first case of COVID-19 in NYC, it continues to be vital for facial mask protocols to be emphasized as part of a comprehensive infection prevention protocol, especially in light of continued vaccine resistance, to help stall continued spread of SARS-CoV-2.²⁰

We seek to show that despite months of policies for universal masking in NYC, there is still considerable mask noncompliance by the general public in health care settings where the use of masks is particularly imperative. We conducted an observational study investigating proper use of face masks of adults entering the main entrance of 4 hospitals located in NYC.

Methods

We observed mask usage in adults entering 4 hospitals in September 2020 (postsurge in NYC and prior to the availability of COVID-19 vaccinations). Hospitals were chosen to represent several types of health care delivery systems available in the United States and included a city, state, federal, and private hospital. Data collection was completed during peak traffic hours (8:00 am to 12:00 pm) on a weekday and continued until a total of 100 unique patients were observed at each site. Each hospital entrance was barricaded, and hospital staff were stationed at these entry points to take each individual’s temperature, screen for symptoms and exposure risk, verify patients’ appointments, and ensure proper mask wearing (in optimal circumstances). Data collectors (J.L. and N.M.) were stationed just past the barricade of each hospital’s entrance and observed those who entered. Individuals were not approached about the study, demographics, or the use and/or views about usage of facial masks. Children and hospital employees were excluded from data collection, with the exception of 1 hospital with a dedicated employee entrance where employees were observed for mask compliance. Except for vented/valved masks or makeshift masks fashioned out of scarfs, bandanas, or similar materials, the type of mask an individual wore was not distinguished (medical masks, cotton masks, or respirator-type masks were not differentiated).

Mask usage was observed and classified into several categories: correctly fitting mask over the nose and mouth, no face mask, mask usage with nose exposed, mask usage with mouth exposed, mask usage with both nose and mouth exposed (ie, mask on the chin/neck area), loosely fitting mask, vented/valved mask, or other form of face covering (eg, bandana, scarf).

Results

We observed a consistent rate of mask compliance between 72% and 85%, with an average of 78% of the 600 individuals observed wearing correctly fitting masks across the 4 hospitals included in this study (Table). The employee entrance included in this study had the highest compliance rate of 85%. An overall low rate of complete mask noncompliance was observed, with only 9 individuals (1.5%) in the entire study not wearing any mask. The federal hospital had the highest rate of mask noncompliance. We also observed a low rate of nose and mouth exposure, with 1.8% of individuals wearing a mask with the nose and mouth exposed (ie, mask tucked under the chin). No individuals were observed with the mouth exposed but with the nose covered by a mask. Additionally, only 3 individuals (0.5%) wore a mask with a vent/valve. The most common way that masks were worn incorrectly was with the nose exposed, accounting for 9.5% of individuals observed. Overall, only 9 individuals (1.5%) wore a nontraditional face covering, with a bandana being the most commonly observed makeshift mask.

Signage regarding the requirement to wear masks and to social distance was universally instituted at all hospital entry points (both inside and outside the hospital) in this study. However, there were no illustrations demonstrating correct and incorrect forms of mask usage. All signage merely displayed a graphic of a facial mask noting the requirement to wear a mask prior to entering the building. Hospital staff also had face masks available for patients who failed to bring a mask or who wore an inappropriate mask (ie, vented/valved masks).

Comment

Mask Effectiveness—Masks reduce the spread of SARS-CoV-2 by preventing both droplets and potentially virus-bearing aerosols.^6,21,22 It has been demonstrated that well-fitted cotton homemade masks and medical masks provide the most effective method of reducing droplet dispersion. Loosely fitted masks as well as bandana-style facial coverings minimally reduce small aerosolized droplets, and an uncovered mouth and nose can disperse particles at a distance much greater than 6 feet.²²

Mask Compliance—We report an overall high compliance rate with mask wearing among individuals visiting a hospital; however, compliance was still imperfect. Overall, 78% of observed individuals wore a correctly fitting mask when entering a hospital, even with hospital staff positioned at entry points to ensure proper mask usage. With all the resources available at health care centers, we anticipated a much higher compliance rate for correctly fitting masks at hospital entrances. We hypothesize that given only 78% of individuals showed proper mask compliance in a setting with enforcement by health care personnel, the mask compliance rate in the larger community is likely much lower. It is imperative to enforce continued mask compliance in medical centers and other public areas given notable vaccine noncompliance in certain parts of the country.

Tools to Prevent Disease Transmission—Mask usage by the general public in NYC helped in its response to the COVID-19 pandemic. Yang et al²³ demonstrated through mathematical modeling that mask usage in NYC was associated with a 6.6% reduction in transmission overall and a 20% decrease in transmission for individuals 65 years and older during the first month of the universal mask policy going into effect. The authors extrapolated these data during the NYC reopening and found that universal masking reduced transmission by approximately 9% to 11%, accounting for the increase in hours spent outside home quarantine. The authors also hypothesized that if universal masking was as effective in its reduction of transmission for everyone in NYC as it was for older adults, the potential reduction in transmission of SARS-CoV-2 could be as high as 28% to 32%.²³

Temperature checks at entrance barricades were standard protocol during the observation period. Although the main purpose of this study was to investigate compliance with and proper use of facial masks in a health care setting, it should be mentioned that, although temperature checks were being done on almost every person entering a hospital, the uniformity and practicality of this intervention has not been backed by substantial evidence. Although many nontouch thermometers are intended to capture a forehead temperature for the most accurate reading, the authors will share that in their observation, medical personnel screening individuals at hospital entrances were observed checking temperatures at any easily accessible body part, such as the forearm, hand, or neck. Furthermore, it has been reported that only approximately 40% of individuals with COVID-19 present with a fever.²⁴ Many hospitals, including the 4 that were included in this investigation, have formal protocols for patients presenting with a fever, especially those presenting to an ambulatory center. Patients are usually instructed to call ahead if they have a fever, and a decision regarding next steps will be discussed with a health care provider. In addition, 1 meta-analysis on the symptoms of COVID-19 suggested that approximately 12% of infected patients are asymptomatic, likely a conservative estimate.²⁵ Although we do not suggest that hospitals stop temperature checks, consistent temperature checks in anatomic locations intended for the specific thermometer used must be employed. Alternatively, a thermographic camera system that could detect heat signatures may be a way to screen faster, only necessitating that those above a threshold be assessed further.

The results of this study suggest that much greater effort is being placed on these temperature checks than on other equally important components of the entrance health assessment. This initial encounter at hospital entrances should serve as an opportunity for education on proper choice and use of masks with clear instructions that masks should not be removed unless directed by a health care provider and in a designated area, such as an examination room. The COVID-19 pandemic in the United States is likely the first time an individual is wearing these types of masks. Reiterating when and how often a mask should be changed (eg, when wet or soiled), how a soiled mask is not an effective mask, how a used mask should be discarded, ways to prevent self-contamination (ie, proper donning and doffing), and the importance of other infection-prevention behaviors—hand hygiene; social distancing; avoidance of touching the eyes, nose, and mouth with unwashed hands; and regular disinfecting of surfaces—should be practiced.^11,26-29 Extended use and reuse of masks also can result in transmission of infection.³⁰

Throughout the pandemic, our personal experience is that some patients often overtly refuse to wear a mask, citing underlying respiratory issues. The implications of patients not wearing a mask in a medical office and endangering other patients and staff are beyond the scope of this analysis. We will, however, comment briefly on the evidence behind this common concern. Matuschek et al³¹ found substantial adverse changes in respiratory rate, oxygen saturation, and CO₂ levels in patients with severe chronic obstructive pulmonary disease who were wearing N95 respirators during a 6-minute walk test. Another study by Chan et al³² showed that nonmedical masks in healthy older adults in the community setting had no impact on oxygen saturation. Ultimately, the most effective mask a patient can wear is a mask that will be worn consistently.³²

Populations With Limited Access to Masks—The COVID-19 pandemic disproportionately impacted disadvantaged populations, both in socioeconomic status and minority status. A disproportionate number of COVID-19 hospitalizations and deaths occurred in lower-income and minority populations.¹⁰ In fact, Lamb et al³³ reported that NYC neighborhoods with a larger proportion of uninsured individuals with limited access to health care and overall lower socioeconomic status had a higher rate of SARS-CoV-2 positivity. A retrospective study in Louisiana showed that Black individuals accounted for 77% of hospitalizations and 71% of deaths due to COVID-19 in a population where only 31% of individuals identified as Black.¹⁰ Chu et al⁶ even asserted that policies should be put into place to address equity issues for populations with limited access to masks. We agree that policies should be put into action to ensure that individuals lacking the means to obtain appropriate masks or unable to obtain an adequate supply of masks be provided this new necessity. It has been calculated that the impact of masks in reducing virus transmission would be greatest if mask availability to disadvantaged populations is ensured.¹⁸ We support a plan for masks to be covered by government-sponsored health plans.

Study Limitations—Several limitations exist in our study that should be discussed. Although the data collectors observed a large number of individuals, each hospital entrance was only observed for 1 half-day morning session. There may be variations in the number of people wearing a mask at different times of day and different days of the week with fluctuations in hospital traffic. Although data were collected at a variety of hospitals representing the diverse health care delivery models available in the United States, the NYC hospitals included in this study may have different resources available for infection-prevention strategies than hospitals across the country, given NYC’s unique population density and demographics.

Study Strengths—The generalizability of the study should be recognized. Data were collected by all major health care delivery models available in the United States—private, state, city, and federal hospital systems. This study can be easily replicated in other health care delivery systems to further investigate potential gaps in mask usage and infection prevention. Repeating this study in areas where a large portion of the population does not believe in the virus also will likely show lower levels of mask use.

Conclusion

As the country grapples with vaccine hesitancy and with the new variants of SARS-CoV-2, continued universal masking is still imperative. The effectiveness of universal masking has been demonstrated, and with the combination of vaccinations, we can be assured that the world will continue to emerge from the pandemic.

Although the universal use of masks by both health care professionals and the general public now appears routine, widely differing recommendations were distributed by different health organizations early in the pandemic. In April 2020, the World Health Organization (WHO) stated that there was no evidence that healthy individuals wearing a medical mask in the community prevented COVID-19 infection.¹ However, these recommendations must be placed in the context of a national shortage of personal protective equipment early in the pandemic. The WHO guidance released on June 5, 2020, recommended continuous use of masks for health care workers in the clinical setting.² Additional recommendations included mask replacement when wet, soiled, or damaged, and when the wearer touched the mask. The WHO also recommended mask usage by those with underlying medical comorbidities and those living in high population–density areas and in settings where physical distancing was not possible.²

The Centers for Disease Control and Prevention (CDC) officially recommended the use of face coverings for the general public to prevent COVID-19 transmission on April 3, 2020.³ The CDC highlighted that masks should not be worn by children younger than 2 years; individuals with respiratory compromise; and patients who are unconscious, incapacitated, or unable to remove a mask without assistance.⁴ Medical masks and respirators were only recommended for health care workers. Importantly, masks with valves/vents were not recommended, as respiratory droplets can be emitted, defeating the purpose of source control.⁴ New York State mandated mask usage in public places starting on April 15, 2020.

These recommendations were based on the hypothesis that COVID-19 transmission occurs primarily via droplets and contact. In reality, SARS-CoV-2 transmission more likely occurs in a continuum from larger droplets to miniscule aerosols expelled from an infected person when talking, coughing, or sneezing.^5,6 It should be noted that there was a formal suggestion of the potential for airborne transmission of SARS-CoV-2 by the CDC in a statement on September 18, 2020, that was subsequently retracted 3 days later.^7,8 The CDC, reversing their prior recommendations, updated their guidance on October 5, 2020, endorsing prior reports that SARS-CoV-2 can be spread through aerosol transmission.⁸

Mask usage helps prevent viral spread by all individuals, especially those who are presymptomatic and asymptomatic. Presymptomatic individuals account for approximately 40% to 60% of transmissions, and asymptomatic individuals account for approximately 4% to 30% of infections by some models, which suggest these individuals are the drivers of the pandemic, more so than symptomatic individuals.^9-15 Additionally, masking also may in effect reduce the amount of SARS-CoV-2 to which individuals are being exposed in the community.¹⁴ Universal masking is a relatively low-cost, low-risk intervention that may provide moderate benefit to the individual but substantial benefit to communities at large.^10-13 Universal masking in other countries also has clearly demonstrated major benefits during the pandemic. Implementation of universal masking in Taiwan resulted in only approximately 440 COVID-19 cases and less than 10 deaths, despite a population of 23 million.¹⁶ South Korea, having experience with Middle East respiratory syndrome, also was able to quickly institute a mask policy for its citizens, resulting in approximately 94% compliance.¹⁷ Moreover, several mathematical models have shown that even imperfect use of masks on a population level can prevent disease transmission and should be instituted.¹⁸

Given the importance and potential benefits of mask usage, we investigated compliance and proper utilization of facial masks in New York City (NYC), once the epicenter of the pandemic in the United States. New York City and the rest of New York State experienced more than 1.13 million and 1.46 million cases of COVID-19, respectively, as of early November 2021.¹⁹ Nationwide, NYC had the greatest absolute death count of more than 34,634 and the greatest rate of death per 100,000 individuals of 412. In contrast, New York State, excluding NYC, had an absolute death count of more than 21,646 and a death rate per 100,000 individuals of 195 as of early November 2021.¹⁹ Now entering 20 months since the first case of COVID-19 in NYC, it continues to be vital for facial mask protocols to be emphasized as part of a comprehensive infection prevention protocol, especially in light of continued vaccine resistance, to help stall continued spread of SARS-CoV-2.²⁰

We seek to show that despite months of policies for universal masking in NYC, there is still considerable mask noncompliance by the general public in health care settings where the use of masks is particularly imperative. We conducted an observational study investigating proper use of face masks of adults entering the main entrance of 4 hospitals located in NYC.

Methods

We observed mask usage in adults entering 4 hospitals in September 2020 (postsurge in NYC and prior to the availability of COVID-19 vaccinations). Hospitals were chosen to represent several types of health care delivery systems available in the United States and included a city, state, federal, and private hospital. Data collection was completed during peak traffic hours (8:00 am to 12:00 pm) on a weekday and continued until a total of 100 unique patients were observed at each site. Each hospital entrance was barricaded, and hospital staff were stationed at these entry points to take each individual’s temperature, screen for symptoms and exposure risk, verify patients’ appointments, and ensure proper mask wearing (in optimal circumstances). Data collectors (J.L. and N.M.) were stationed just past the barricade of each hospital’s entrance and observed those who entered. Individuals were not approached about the study, demographics, or the use and/or views about usage of facial masks. Children and hospital employees were excluded from data collection, with the exception of 1 hospital with a dedicated employee entrance where employees were observed for mask compliance. Except for vented/valved masks or makeshift masks fashioned out of scarfs, bandanas, or similar materials, the type of mask an individual wore was not distinguished (medical masks, cotton masks, or respirator-type masks were not differentiated).

Mask usage was observed and classified into several categories: correctly fitting mask over the nose and mouth, no face mask, mask usage with nose exposed, mask usage with mouth exposed, mask usage with both nose and mouth exposed (ie, mask on the chin/neck area), loosely fitting mask, vented/valved mask, or other form of face covering (eg, bandana, scarf).

Results

We observed a consistent rate of mask compliance between 72% and 85%, with an average of 78% of the 600 individuals observed wearing correctly fitting masks across the 4 hospitals included in this study (Table). The employee entrance included in this study had the highest compliance rate of 85%. An overall low rate of complete mask noncompliance was observed, with only 9 individuals (1.5%) in the entire study not wearing any mask. The federal hospital had the highest rate of mask noncompliance. We also observed a low rate of nose and mouth exposure, with 1.8% of individuals wearing a mask with the nose and mouth exposed (ie, mask tucked under the chin). No individuals were observed with the mouth exposed but with the nose covered by a mask. Additionally, only 3 individuals (0.5%) wore a mask with a vent/valve. The most common way that masks were worn incorrectly was with the nose exposed, accounting for 9.5% of individuals observed. Overall, only 9 individuals (1.5%) wore a nontraditional face covering, with a bandana being the most commonly observed makeshift mask.

Signage regarding the requirement to wear masks and to social distance was universally instituted at all hospital entry points (both inside and outside the hospital) in this study. However, there were no illustrations demonstrating correct and incorrect forms of mask usage. All signage merely displayed a graphic of a facial mask noting the requirement to wear a mask prior to entering the building. Hospital staff also had face masks available for patients who failed to bring a mask or who wore an inappropriate mask (ie, vented/valved masks).

Comment

Mask Effectiveness—Masks reduce the spread of SARS-CoV-2 by preventing both droplets and potentially virus-bearing aerosols.^6,21,22 It has been demonstrated that well-fitted cotton homemade masks and medical masks provide the most effective method of reducing droplet dispersion. Loosely fitted masks as well as bandana-style facial coverings minimally reduce small aerosolized droplets, and an uncovered mouth and nose can disperse particles at a distance much greater than 6 feet.²²

Mask Compliance—We report an overall high compliance rate with mask wearing among individuals visiting a hospital; however, compliance was still imperfect. Overall, 78% of observed individuals wore a correctly fitting mask when entering a hospital, even with hospital staff positioned at entry points to ensure proper mask usage. With all the resources available at health care centers, we anticipated a much higher compliance rate for correctly fitting masks at hospital entrances. We hypothesize that given only 78% of individuals showed proper mask compliance in a setting with enforcement by health care personnel, the mask compliance rate in the larger community is likely much lower. It is imperative to enforce continued mask compliance in medical centers and other public areas given notable vaccine noncompliance in certain parts of the country.

Tools to Prevent Disease Transmission—Mask usage by the general public in NYC helped in its response to the COVID-19 pandemic. Yang et al²³ demonstrated through mathematical modeling that mask usage in NYC was associated with a 6.6% reduction in transmission overall and a 20% decrease in transmission for individuals 65 years and older during the first month of the universal mask policy going into effect. The authors extrapolated these data during the NYC reopening and found that universal masking reduced transmission by approximately 9% to 11%, accounting for the increase in hours spent outside home quarantine. The authors also hypothesized that if universal masking was as effective in its reduction of transmission for everyone in NYC as it was for older adults, the potential reduction in transmission of SARS-CoV-2 could be as high as 28% to 32%.²³

Temperature checks at entrance barricades were standard protocol during the observation period. Although the main purpose of this study was to investigate compliance with and proper use of facial masks in a health care setting, it should be mentioned that, although temperature checks were being done on almost every person entering a hospital, the uniformity and practicality of this intervention has not been backed by substantial evidence. Although many nontouch thermometers are intended to capture a forehead temperature for the most accurate reading, the authors will share that in their observation, medical personnel screening individuals at hospital entrances were observed checking temperatures at any easily accessible body part, such as the forearm, hand, or neck. Furthermore, it has been reported that only approximately 40% of individuals with COVID-19 present with a fever.²⁴ Many hospitals, including the 4 that were included in this investigation, have formal protocols for patients presenting with a fever, especially those presenting to an ambulatory center. Patients are usually instructed to call ahead if they have a fever, and a decision regarding next steps will be discussed with a health care provider. In addition, 1 meta-analysis on the symptoms of COVID-19 suggested that approximately 12% of infected patients are asymptomatic, likely a conservative estimate.²⁵ Although we do not suggest that hospitals stop temperature checks, consistent temperature checks in anatomic locations intended for the specific thermometer used must be employed. Alternatively, a thermographic camera system that could detect heat signatures may be a way to screen faster, only necessitating that those above a threshold be assessed further.

The results of this study suggest that much greater effort is being placed on these temperature checks than on other equally important components of the entrance health assessment. This initial encounter at hospital entrances should serve as an opportunity for education on proper choice and use of masks with clear instructions that masks should not be removed unless directed by a health care provider and in a designated area, such as an examination room. The COVID-19 pandemic in the United States is likely the first time an individual is wearing these types of masks. Reiterating when and how often a mask should be changed (eg, when wet or soiled), how a soiled mask is not an effective mask, how a used mask should be discarded, ways to prevent self-contamination (ie, proper donning and doffing), and the importance of other infection-prevention behaviors—hand hygiene; social distancing; avoidance of touching the eyes, nose, and mouth with unwashed hands; and regular disinfecting of surfaces—should be practiced.^11,26-29 Extended use and reuse of masks also can result in transmission of infection.³⁰

Throughout the pandemic, our personal experience is that some patients often overtly refuse to wear a mask, citing underlying respiratory issues. The implications of patients not wearing a mask in a medical office and endangering other patients and staff are beyond the scope of this analysis. We will, however, comment briefly on the evidence behind this common concern. Matuschek et al³¹ found substantial adverse changes in respiratory rate, oxygen saturation, and CO₂ levels in patients with severe chronic obstructive pulmonary disease who were wearing N95 respirators during a 6-minute walk test. Another study by Chan et al³² showed that nonmedical masks in healthy older adults in the community setting had no impact on oxygen saturation. Ultimately, the most effective mask a patient can wear is a mask that will be worn consistently.³²

Populations With Limited Access to Masks—The COVID-19 pandemic disproportionately impacted disadvantaged populations, both in socioeconomic status and minority status. A disproportionate number of COVID-19 hospitalizations and deaths occurred in lower-income and minority populations.¹⁰ In fact, Lamb et al³³ reported that NYC neighborhoods with a larger proportion of uninsured individuals with limited access to health care and overall lower socioeconomic status had a higher rate of SARS-CoV-2 positivity. A retrospective study in Louisiana showed that Black individuals accounted for 77% of hospitalizations and 71% of deaths due to COVID-19 in a population where only 31% of individuals identified as Black.¹⁰ Chu et al⁶ even asserted that policies should be put into place to address equity issues for populations with limited access to masks. We agree that policies should be put into action to ensure that individuals lacking the means to obtain appropriate masks or unable to obtain an adequate supply of masks be provided this new necessity. It has been calculated that the impact of masks in reducing virus transmission would be greatest if mask availability to disadvantaged populations is ensured.¹⁸ We support a plan for masks to be covered by government-sponsored health plans.

Study Limitations—Several limitations exist in our study that should be discussed. Although the data collectors observed a large number of individuals, each hospital entrance was only observed for 1 half-day morning session. There may be variations in the number of people wearing a mask at different times of day and different days of the week with fluctuations in hospital traffic. Although data were collected at a variety of hospitals representing the diverse health care delivery models available in the United States, the NYC hospitals included in this study may have different resources available for infection-prevention strategies than hospitals across the country, given NYC’s unique population density and demographics.

Study Strengths—The generalizability of the study should be recognized. Data were collected by all major health care delivery models available in the United States—private, state, city, and federal hospital systems. This study can be easily replicated in other health care delivery systems to further investigate potential gaps in mask usage and infection prevention. Repeating this study in areas where a large portion of the population does not believe in the virus also will likely show lower levels of mask use.

Conclusion

As the country grapples with vaccine hesitancy and with the new variants of SARS-CoV-2, continued universal masking is still imperative. The effectiveness of universal masking has been demonstrated, and with the combination of vaccinations, we can be assured that the world will continue to emerge from the pandemic.

Pityriasis rosea is a papulosquamous eruption that favors the trunk and proximal extremities. It occurs most commonly in adolescents and young adults.¹ The rash typically presents with a solitary lesion, known as a “herald patch,” which is followed by a scaly erythematous eruption along the cleavage lines of the skin. The condition is self-limited and often resolves in 6 to 8 weeks. Recent evidence suggests that viral reactivation of human herpesvirus 6 and human herpesvirus 7 may play a role in the development of skin lesions.² Pityriasis rosea also has been reported following the administration of new medications and vaccinations.^1-3 We report a case of a 30-year-old woman who developed pityriasis rosea 3 days after receiving the second dose of the COVID-19 vaccine.

Case Report

A 30-year-old woman presented to the dermatology office for evaluation of a rash on the trunk and upper extremities that had been present for 5 days. She reported an initial solitary lesion on the left upper back, subsequently followed by the appearance of a mildly pruritic rash on the trunk and upper extremities. The rash first appeared 3 days after she received the second dose of the Pfizer-BioNTech COVID-19 vaccine. She was otherwise asymptomatic after vaccination and denied fever, chills, headache, and myalgia. She denied any rash following her first dose of the COVID-19 vaccine, history of known COVID-19 infection or exposures, or new medications. Notably, the patient worked in health care.

Physical examination revealed a 2-cm, erythematous, thin, scaly plaque over the left side of the upper back (Figure, A). Erythematous, scaly, thin papules of varying sizes were distributed along the cleavage lines of the trunk and upper extremities (Figure, B). No biopsy was performed because of the classic clinical presentation of this self-limited condition and the patient’s history of hypertrophic scarring. No additional laboratory workup was performed. She was prescribed triamcinolone cream 0.1% as needed for pruritus and was reassured about the benign nature of this cutaneous eruption.

Comment

A broad spectrum of cutaneous manifestations has been reported in association with acute COVID-19 infection, including a papulovesicular rash, perniolike eruptions, urticaria, livedo reticularis, and petechiae.⁴ Several cases of pityriasis rosea in association with acute COVID-19 infection also have been reported.⁵ COVID-19 infection has been linked to reactivation of the herpesvirus, which may explain the connection between acute COVID-19 infection and the development of pityriasis rosea.⁶ Pityriasis rosea associated with administration of the COVID-19 vaccine is a rare complication with few reports in the literature.⁷ Similar to our patient, there are reports of pityriasis rosea developing after the second dose of the vaccine, with some patients reporting a reactivation of skin lesions.⁸ There is a paucity of reports describing pityriasis rosea associated with the influenza vaccine, hepatitis B vaccine, and human papillomavirus vaccine.³ In such cases, the onset of skin lesions was thought to be related to vaccine-induced stimulation of the immune system or a component of the vaccine.

Conclusion

We presented a unique case of pityriasis rosea following COVID-19 vaccination. Because additional laboratory workup and a skin biopsy were not performed, we are unable to infer causation. However, the classic clinical presentation, rash development within 3 days of vaccination, and prior reports of vaccine-associated pityriasis rosea strengthen the aforementioned association. We hope this case adds to the growing understanding of the novel COVID-19 vaccine. As more individuals become vaccinated, both clinicians and patients should be aware of this benign cutaneous eruption that can develop following COVID-19 vaccination.

Pityriasis rosea is a papulosquamous eruption that favors the trunk and proximal extremities. It occurs most commonly in adolescents and young adults.¹ The rash typically presents with a solitary lesion, known as a “herald patch,” which is followed by a scaly erythematous eruption along the cleavage lines of the skin. The condition is self-limited and often resolves in 6 to 8 weeks. Recent evidence suggests that viral reactivation of human herpesvirus 6 and human herpesvirus 7 may play a role in the development of skin lesions.² Pityriasis rosea also has been reported following the administration of new medications and vaccinations.^1-3 We report a case of a 30-year-old woman who developed pityriasis rosea 3 days after receiving the second dose of the COVID-19 vaccine.

Case Report

A 30-year-old woman presented to the dermatology office for evaluation of a rash on the trunk and upper extremities that had been present for 5 days. She reported an initial solitary lesion on the left upper back, subsequently followed by the appearance of a mildly pruritic rash on the trunk and upper extremities. The rash first appeared 3 days after she received the second dose of the Pfizer-BioNTech COVID-19 vaccine. She was otherwise asymptomatic after vaccination and denied fever, chills, headache, and myalgia. She denied any rash following her first dose of the COVID-19 vaccine, history of known COVID-19 infection or exposures, or new medications. Notably, the patient worked in health care.

Physical examination revealed a 2-cm, erythematous, thin, scaly plaque over the left side of the upper back (Figure, A). Erythematous, scaly, thin papules of varying sizes were distributed along the cleavage lines of the trunk and upper extremities (Figure, B). No biopsy was performed because of the classic clinical presentation of this self-limited condition and the patient’s history of hypertrophic scarring. No additional laboratory workup was performed. She was prescribed triamcinolone cream 0.1% as needed for pruritus and was reassured about the benign nature of this cutaneous eruption.

Comment

A broad spectrum of cutaneous manifestations has been reported in association with acute COVID-19 infection, including a papulovesicular rash, perniolike eruptions, urticaria, livedo reticularis, and petechiae.⁴ Several cases of pityriasis rosea in association with acute COVID-19 infection also have been reported.⁵ COVID-19 infection has been linked to reactivation of the herpesvirus, which may explain the connection between acute COVID-19 infection and the development of pityriasis rosea.⁶ Pityriasis rosea associated with administration of the COVID-19 vaccine is a rare complication with few reports in the literature.⁷ Similar to our patient, there are reports of pityriasis rosea developing after the second dose of the vaccine, with some patients reporting a reactivation of skin lesions.⁸ There is a paucity of reports describing pityriasis rosea associated with the influenza vaccine, hepatitis B vaccine, and human papillomavirus vaccine.³ In such cases, the onset of skin lesions was thought to be related to vaccine-induced stimulation of the immune system or a component of the vaccine.

Conclusion

We presented a unique case of pityriasis rosea following COVID-19 vaccination. Because additional laboratory workup and a skin biopsy were not performed, we are unable to infer causation. However, the classic clinical presentation, rash development within 3 days of vaccination, and prior reports of vaccine-associated pityriasis rosea strengthen the aforementioned association. We hope this case adds to the growing understanding of the novel COVID-19 vaccine. As more individuals become vaccinated, both clinicians and patients should be aware of this benign cutaneous eruption that can develop following COVID-19 vaccination.

Pityriasis rosea is a papulosquamous eruption that favors the trunk and proximal extremities. It occurs most commonly in adolescents and young adults.¹ The rash typically presents with a solitary lesion, known as a “herald patch,” which is followed by a scaly erythematous eruption along the cleavage lines of the skin. The condition is self-limited and often resolves in 6 to 8 weeks. Recent evidence suggests that viral reactivation of human herpesvirus 6 and human herpesvirus 7 may play a role in the development of skin lesions.² Pityriasis rosea also has been reported following the administration of new medications and vaccinations.^1-3 We report a case of a 30-year-old woman who developed pityriasis rosea 3 days after receiving the second dose of the COVID-19 vaccine.

Case Report

A 30-year-old woman presented to the dermatology office for evaluation of a rash on the trunk and upper extremities that had been present for 5 days. She reported an initial solitary lesion on the left upper back, subsequently followed by the appearance of a mildly pruritic rash on the trunk and upper extremities. The rash first appeared 3 days after she received the second dose of the Pfizer-BioNTech COVID-19 vaccine. She was otherwise asymptomatic after vaccination and denied fever, chills, headache, and myalgia. She denied any rash following her first dose of the COVID-19 vaccine, history of known COVID-19 infection or exposures, or new medications. Notably, the patient worked in health care.

Physical examination revealed a 2-cm, erythematous, thin, scaly plaque over the left side of the upper back (Figure, A). Erythematous, scaly, thin papules of varying sizes were distributed along the cleavage lines of the trunk and upper extremities (Figure, B). No biopsy was performed because of the classic clinical presentation of this self-limited condition and the patient’s history of hypertrophic scarring. No additional laboratory workup was performed. She was prescribed triamcinolone cream 0.1% as needed for pruritus and was reassured about the benign nature of this cutaneous eruption.

Comment

A broad spectrum of cutaneous manifestations has been reported in association with acute COVID-19 infection, including a papulovesicular rash, perniolike eruptions, urticaria, livedo reticularis, and petechiae.⁴ Several cases of pityriasis rosea in association with acute COVID-19 infection also have been reported.⁵ COVID-19 infection has been linked to reactivation of the herpesvirus, which may explain the connection between acute COVID-19 infection and the development of pityriasis rosea.⁶ Pityriasis rosea associated with administration of the COVID-19 vaccine is a rare complication with few reports in the literature.⁷ Similar to our patient, there are reports of pityriasis rosea developing after the second dose of the vaccine, with some patients reporting a reactivation of skin lesions.⁸ There is a paucity of reports describing pityriasis rosea associated with the influenza vaccine, hepatitis B vaccine, and human papillomavirus vaccine.³ In such cases, the onset of skin lesions was thought to be related to vaccine-induced stimulation of the immune system or a component of the vaccine.

Conclusion

We presented a unique case of pityriasis rosea following COVID-19 vaccination. Because additional laboratory workup and a skin biopsy were not performed, we are unable to infer causation. However, the classic clinical presentation, rash development within 3 days of vaccination, and prior reports of vaccine-associated pityriasis rosea strengthen the aforementioned association. We hope this case adds to the growing understanding of the novel COVID-19 vaccine. As more individuals become vaccinated, both clinicians and patients should be aware of this benign cutaneous eruption that can develop following COVID-19 vaccination.

The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.

Kuzma/istockphoto

Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.

The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.

Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. Well-intentioned medical professionals may be tempted to promote the information and products featured on websites that advocate for unproven products and protocols. This can have serious legal consequences.
 

The crux of the issue

This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.

On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:

“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”

 

What are the legal consequences?

Medical malpractice

The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.

The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.

By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.

In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.

In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
 

Professional licensing action

Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.

This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.

In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.

The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.

The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.

Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.

Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.

In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
 

Peer review and affected privileges

Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.

The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
 

Criminal charges

Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.

Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
 

Breach of contract

Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.

Reputation/credibility damage and the attendant consequences

In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.

Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.

In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
 

Violation of the COVID-19 Consumer Protection Act of 2020

For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.

The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.

Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”

After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.

In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
 

Conclusion

It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.

Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.

The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.

Kuzma/istockphoto

Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.

The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.

Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. Well-intentioned medical professionals may be tempted to promote the information and products featured on websites that advocate for unproven products and protocols. This can have serious legal consequences.
 

The crux of the issue

This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.

On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:

“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”

 

What are the legal consequences?

Medical malpractice

The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.

The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.

By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.

In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.

In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
 

Professional licensing action

Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.

This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.

In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.

The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.

The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.

Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.

Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.

In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
 

Peer review and affected privileges

Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.

The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
 

Criminal charges

Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.

Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
 

Breach of contract

Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.

Reputation/credibility damage and the attendant consequences

In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.

Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.

In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
 

Violation of the COVID-19 Consumer Protection Act of 2020

For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.

The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.

Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”

After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.

In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
 

Conclusion

It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.

Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.

The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.

Kuzma/istockphoto

Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.

The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.

Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. Well-intentioned medical professionals may be tempted to promote the information and products featured on websites that advocate for unproven products and protocols. This can have serious legal consequences.
 

The crux of the issue

This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.

On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:

“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”

 

What are the legal consequences?

Medical malpractice

The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.

The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.

By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.

In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.

In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
 

Professional licensing action

Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.

This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.

In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.

The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.

The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.

Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.

Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.

In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
 

Peer review and affected privileges

Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.

The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
 

Criminal charges

Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.

Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
 

Breach of contract

Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.

Reputation/credibility damage and the attendant consequences

In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.

Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.

In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
 

Violation of the COVID-19 Consumer Protection Act of 2020

For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.

The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.

Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”

After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.

In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
 

Conclusion

It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.

Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.