Damian McNamara

The number of Americans aged 60 years and older who report receiving shingles vaccination had risen steadily since 2008 and has leveled off during the past few years, new data from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics reveal.

The proportion of people in this age group who were vaccinated rose from 6.7% in 2008 to 34.5% in 2018, for example.

“The take-home message of our report is that, among adults aged 60 and over, shingles vaccination has increased since 2008. However, disparities in receipt of this vaccination still remain,” Emily Terlizzi, MPH, told Medscape Medical News.

The report was published online July 9 in NCHS Data Brief.
 

Similar rates for men and women

Rates of people who reported receiving at least one vaccination with Zostavax (Merck) or Shingrix (GlaxoSmithKline) varied by factors that included Hispanic origin, education, and family income. An unexpected finding was that rates did not vary significantly between men and women.

“One finding that I would say surprised me was that, although the percentage who had ever received a shingles vaccine among women aged 60 and over was higher than that among men in this age group, this difference was not statistically significant,” said Ms. Terlizzi, a health statistician in the Data Analysis and Quality Assurance Branch, Division of Health Interview Statistics, the CDC National Center for Health Statistics. In 2018, for example, 35.4% of women and 33.5% of men reported ever receiving a shingles vaccine.

The similarity of rates was less of a surprise to Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York, who was not affiliated with the report. “In my anecdotal experience, I don’t see a preponderance of one sex getting shingles more than another. It’s pretty evenly distributed,” he said in an interview.

Ms. Terlizzi and coauthor Lindsey I. Black, MPH, say their findings align with prior research. However, they noted: “Our report uses more recent data from a large, nationally representative data source to update these estimates and describe these disparities.” Data come from results of the annual National Health Interview Survey of households nationwide.
 

Multiple factors explain vaccination differences

Non-Hispanic White adults were more likely to report receiving the vaccine than were Hispanic and non-Hispanic Black survey respondents. Non-Hispanic White adults were about twice as likely to report vaccination – 38.6% – compared with 19.5% of Hispanic adults and 18.8% of non-Hispanic Black adults.

The disparity in vaccination by race was “disappointing news,” Kenneth E. Schmader, MD, said in an interview.

“The health disparity with regard to lower vaccination rates in Hispanic and non-Hispanic Black populations is reported with other vaccines as well and points to the need for better efforts to vaccinate Hispanic and non-Hispanic Black populations,” added Dr. Schmader, a professor of medicine at Duke University in Durham, N.C.

On a positive note, “It was good to see increasing use of shingles vaccination over time, given how devastating zoster can be in older adults and the fact that the vaccines are effective,” said Dr. Schmader, who also serves on the working groups for the Herpes Zoster, Influenza and General Adult Immunization Guidelines for the CDC Advisory Committee on Immunization Practices (ACIP).

Self-reports of receiving vaccination increased in association with higher education and family income levels. For example, 39.9% of respondents who had more than a high school diploma or GED (General Educational Development) reported receiving the shingles vaccine. In contrast, only 21.2% of people with lower educational attainment reported receiving a vaccine.

In terms of income, 20.4% of poor adults reported being vaccinated, compared with 38.4% of adults who were not poor.

The investigators also evaluated the data by geographic region. They found that rates of vaccinations varied from 26.3% in the East South Central part of the United States (which includes Tennessee, Kentucky, and Alabama) to 42.8% in the West North Central region (which includes the Dakotas, Minnesota, and Nebraska).
 

Clinical and research considerations

For most of the decade evaluated in the study, ACIP recommended vaccination against shingles for Americans aged 60 years and older. The current findings, therefore, do not account for ACIP’s expanding its recommendations in 2017 to include adults aged 50 years and older.

Zostavax is expected to be discontinued this year. It was the only shingles vaccine available before the approval of Shingrix in 2018. The shift to a single product could alter vaccination patterns further.

Ms. Terlizzi plans to continue monitoring trends to “see what changes occur in the next few years,” she said.
 

Compliance a concern

Data on vaccination rates for shingles are important given the large proportion of the population at risk, Dr. Horovitz said. “People over age 50 who have had chickenpox have a one third chance over their lifetimes to get shingles. That is a lot of people.”

Multiple factors could be contributing to the fact that vaccination rates have hovered around 34% in recent years, he said. “Whenever you see variations in vaccination rates, you have to think about cultural differences and questions about differences in access, accessibility, and attitudes. Attitudes toward vaccines vary widely – from people who don’t believe in vaccination to people who are eager to take vaccinations.

“I don’t know how to dissect all that out of these data,” he added.

Compliance with recommendations also contributes to vaccination rates, Dr. Horovitz said. The fact that in about 10% of people, a flulike syndrome develops the day after being vaccinated with Shingrix can cause some to postpone or rethink immunization, he added. In addition, Shingrix requires two shots. “People have to come back, and that always sets up an issue with recalling someone.”

Marketplace shortages of the Shingrix vaccine could also contribute to lower vaccination rates. However, Dr. Horovitz said that, in his practice, availability was only a problem during the first year after approval in 2017.

On a related note, manufacturer GlaxoSmithKline announced that a decrease in vaccination demand during the COVID-19 pandemic has allowed the supply to catch up. Shingrix no longer qualifies for the CDC’s shortages list, according to a July 9 report.

Ms. Terlizzi, Dr. Horovitz, and Dr. Schmader have disclosed no relevant financial relationships.

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

The number of Americans aged 60 years and older who report receiving shingles vaccination had risen steadily since 2008 and has leveled off during the past few years, new data from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics reveal.

The proportion of people in this age group who were vaccinated rose from 6.7% in 2008 to 34.5% in 2018, for example.

“The take-home message of our report is that, among adults aged 60 and over, shingles vaccination has increased since 2008. However, disparities in receipt of this vaccination still remain,” Emily Terlizzi, MPH, told Medscape Medical News.

The report was published online July 9 in NCHS Data Brief.
 

Similar rates for men and women

Rates of people who reported receiving at least one vaccination with Zostavax (Merck) or Shingrix (GlaxoSmithKline) varied by factors that included Hispanic origin, education, and family income. An unexpected finding was that rates did not vary significantly between men and women.

“One finding that I would say surprised me was that, although the percentage who had ever received a shingles vaccine among women aged 60 and over was higher than that among men in this age group, this difference was not statistically significant,” said Ms. Terlizzi, a health statistician in the Data Analysis and Quality Assurance Branch, Division of Health Interview Statistics, the CDC National Center for Health Statistics. In 2018, for example, 35.4% of women and 33.5% of men reported ever receiving a shingles vaccine.

The similarity of rates was less of a surprise to Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York, who was not affiliated with the report. “In my anecdotal experience, I don’t see a preponderance of one sex getting shingles more than another. It’s pretty evenly distributed,” he said in an interview.

Ms. Terlizzi and coauthor Lindsey I. Black, MPH, say their findings align with prior research. However, they noted: “Our report uses more recent data from a large, nationally representative data source to update these estimates and describe these disparities.” Data come from results of the annual National Health Interview Survey of households nationwide.
 

Multiple factors explain vaccination differences

Non-Hispanic White adults were more likely to report receiving the vaccine than were Hispanic and non-Hispanic Black survey respondents. Non-Hispanic White adults were about twice as likely to report vaccination – 38.6% – compared with 19.5% of Hispanic adults and 18.8% of non-Hispanic Black adults.

The disparity in vaccination by race was “disappointing news,” Kenneth E. Schmader, MD, said in an interview.

“The health disparity with regard to lower vaccination rates in Hispanic and non-Hispanic Black populations is reported with other vaccines as well and points to the need for better efforts to vaccinate Hispanic and non-Hispanic Black populations,” added Dr. Schmader, a professor of medicine at Duke University in Durham, N.C.

On a positive note, “It was good to see increasing use of shingles vaccination over time, given how devastating zoster can be in older adults and the fact that the vaccines are effective,” said Dr. Schmader, who also serves on the working groups for the Herpes Zoster, Influenza and General Adult Immunization Guidelines for the CDC Advisory Committee on Immunization Practices (ACIP).

Self-reports of receiving vaccination increased in association with higher education and family income levels. For example, 39.9% of respondents who had more than a high school diploma or GED (General Educational Development) reported receiving the shingles vaccine. In contrast, only 21.2% of people with lower educational attainment reported receiving a vaccine.

In terms of income, 20.4% of poor adults reported being vaccinated, compared with 38.4% of adults who were not poor.

The investigators also evaluated the data by geographic region. They found that rates of vaccinations varied from 26.3% in the East South Central part of the United States (which includes Tennessee, Kentucky, and Alabama) to 42.8% in the West North Central region (which includes the Dakotas, Minnesota, and Nebraska).
 

Clinical and research considerations

For most of the decade evaluated in the study, ACIP recommended vaccination against shingles for Americans aged 60 years and older. The current findings, therefore, do not account for ACIP’s expanding its recommendations in 2017 to include adults aged 50 years and older.

Zostavax is expected to be discontinued this year. It was the only shingles vaccine available before the approval of Shingrix in 2018. The shift to a single product could alter vaccination patterns further.

Ms. Terlizzi plans to continue monitoring trends to “see what changes occur in the next few years,” she said.
 

Compliance a concern

Data on vaccination rates for shingles are important given the large proportion of the population at risk, Dr. Horovitz said. “People over age 50 who have had chickenpox have a one third chance over their lifetimes to get shingles. That is a lot of people.”

Multiple factors could be contributing to the fact that vaccination rates have hovered around 34% in recent years, he said. “Whenever you see variations in vaccination rates, you have to think about cultural differences and questions about differences in access, accessibility, and attitudes. Attitudes toward vaccines vary widely – from people who don’t believe in vaccination to people who are eager to take vaccinations.

“I don’t know how to dissect all that out of these data,” he added.

Compliance with recommendations also contributes to vaccination rates, Dr. Horovitz said. The fact that in about 10% of people, a flulike syndrome develops the day after being vaccinated with Shingrix can cause some to postpone or rethink immunization, he added. In addition, Shingrix requires two shots. “People have to come back, and that always sets up an issue with recalling someone.”

Marketplace shortages of the Shingrix vaccine could also contribute to lower vaccination rates. However, Dr. Horovitz said that, in his practice, availability was only a problem during the first year after approval in 2017.

On a related note, manufacturer GlaxoSmithKline announced that a decrease in vaccination demand during the COVID-19 pandemic has allowed the supply to catch up. Shingrix no longer qualifies for the CDC’s shortages list, according to a July 9 report.

Ms. Terlizzi, Dr. Horovitz, and Dr. Schmader have disclosed no relevant financial relationships.

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

The number of Americans aged 60 years and older who report receiving shingles vaccination had risen steadily since 2008 and has leveled off during the past few years, new data from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics reveal.

The proportion of people in this age group who were vaccinated rose from 6.7% in 2008 to 34.5% in 2018, for example.

“The take-home message of our report is that, among adults aged 60 and over, shingles vaccination has increased since 2008. However, disparities in receipt of this vaccination still remain,” Emily Terlizzi, MPH, told Medscape Medical News.

The report was published online July 9 in NCHS Data Brief.
 

Similar rates for men and women

Rates of people who reported receiving at least one vaccination with Zostavax (Merck) or Shingrix (GlaxoSmithKline) varied by factors that included Hispanic origin, education, and family income. An unexpected finding was that rates did not vary significantly between men and women.

“One finding that I would say surprised me was that, although the percentage who had ever received a shingles vaccine among women aged 60 and over was higher than that among men in this age group, this difference was not statistically significant,” said Ms. Terlizzi, a health statistician in the Data Analysis and Quality Assurance Branch, Division of Health Interview Statistics, the CDC National Center for Health Statistics. In 2018, for example, 35.4% of women and 33.5% of men reported ever receiving a shingles vaccine.

The similarity of rates was less of a surprise to Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York, who was not affiliated with the report. “In my anecdotal experience, I don’t see a preponderance of one sex getting shingles more than another. It’s pretty evenly distributed,” he said in an interview.

Ms. Terlizzi and coauthor Lindsey I. Black, MPH, say their findings align with prior research. However, they noted: “Our report uses more recent data from a large, nationally representative data source to update these estimates and describe these disparities.” Data come from results of the annual National Health Interview Survey of households nationwide.
 

Multiple factors explain vaccination differences

Non-Hispanic White adults were more likely to report receiving the vaccine than were Hispanic and non-Hispanic Black survey respondents. Non-Hispanic White adults were about twice as likely to report vaccination – 38.6% – compared with 19.5% of Hispanic adults and 18.8% of non-Hispanic Black adults.

The disparity in vaccination by race was “disappointing news,” Kenneth E. Schmader, MD, said in an interview.

“The health disparity with regard to lower vaccination rates in Hispanic and non-Hispanic Black populations is reported with other vaccines as well and points to the need for better efforts to vaccinate Hispanic and non-Hispanic Black populations,” added Dr. Schmader, a professor of medicine at Duke University in Durham, N.C.

On a positive note, “It was good to see increasing use of shingles vaccination over time, given how devastating zoster can be in older adults and the fact that the vaccines are effective,” said Dr. Schmader, who also serves on the working groups for the Herpes Zoster, Influenza and General Adult Immunization Guidelines for the CDC Advisory Committee on Immunization Practices (ACIP).

Self-reports of receiving vaccination increased in association with higher education and family income levels. For example, 39.9% of respondents who had more than a high school diploma or GED (General Educational Development) reported receiving the shingles vaccine. In contrast, only 21.2% of people with lower educational attainment reported receiving a vaccine.

In terms of income, 20.4% of poor adults reported being vaccinated, compared with 38.4% of adults who were not poor.

The investigators also evaluated the data by geographic region. They found that rates of vaccinations varied from 26.3% in the East South Central part of the United States (which includes Tennessee, Kentucky, and Alabama) to 42.8% in the West North Central region (which includes the Dakotas, Minnesota, and Nebraska).
 

Clinical and research considerations

For most of the decade evaluated in the study, ACIP recommended vaccination against shingles for Americans aged 60 years and older. The current findings, therefore, do not account for ACIP’s expanding its recommendations in 2017 to include adults aged 50 years and older.

Zostavax is expected to be discontinued this year. It was the only shingles vaccine available before the approval of Shingrix in 2018. The shift to a single product could alter vaccination patterns further.

Ms. Terlizzi plans to continue monitoring trends to “see what changes occur in the next few years,” she said.
 

Compliance a concern

Data on vaccination rates for shingles are important given the large proportion of the population at risk, Dr. Horovitz said. “People over age 50 who have had chickenpox have a one third chance over their lifetimes to get shingles. That is a lot of people.”

Multiple factors could be contributing to the fact that vaccination rates have hovered around 34% in recent years, he said. “Whenever you see variations in vaccination rates, you have to think about cultural differences and questions about differences in access, accessibility, and attitudes. Attitudes toward vaccines vary widely – from people who don’t believe in vaccination to people who are eager to take vaccinations.

“I don’t know how to dissect all that out of these data,” he added.

Compliance with recommendations also contributes to vaccination rates, Dr. Horovitz said. The fact that in about 10% of people, a flulike syndrome develops the day after being vaccinated with Shingrix can cause some to postpone or rethink immunization, he added. In addition, Shingrix requires two shots. “People have to come back, and that always sets up an issue with recalling someone.”

Marketplace shortages of the Shingrix vaccine could also contribute to lower vaccination rates. However, Dr. Horovitz said that, in his practice, availability was only a problem during the first year after approval in 2017.

On a related note, manufacturer GlaxoSmithKline announced that a decrease in vaccination demand during the COVID-19 pandemic has allowed the supply to catch up. Shingrix no longer qualifies for the CDC’s shortages list, according to a July 9 report.

Ms. Terlizzi, Dr. Horovitz, and Dr. Schmader have disclosed no relevant financial relationships.

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

The Food and Drug Administration has approved Inqovi (decitabine and cedazuridine tablets, Astex Pharmaceuticals) to treat adults with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). The agency’s action gives physicians and patients a new treatment option – an oral-formulation MDS and CMML medication that can be taken at home.

Approval of the tablets could obviate the need for some patients to come to healthcare settings for intravenous therapy, a consideration that goes beyond patient convenience. “The FDA remains committed to providing additional treatments to patients during the coronavirus pandemic. In this case, the FDA is making available an oral outpatient treatment option that can reduce the need for frequent visits to health care facilities,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, stated in a news release.

“At this critical time, we continue to focus on providing options to patients with cancer, including regimens that can be taken at home,” added Dr. Pazdur, who is also acting director of the office of oncologic diseases in the FDA’s Center for Drug Evaluation and Research.

Inqovi received an Orphan Drug designation and a Priority Review from the agency.

The FDA based the new formulation approval on clinical trials that showed patients taking Inqovi had similar drug concentrations, compared with others receiving intravenous decitabine.

The two therapies also had similar safety profiles. Fatigue, constipation, hemorrhage, muscle pain, mucositis, arthralgia, nausea, and fever with low white blood cell count were common side effects reported in people taking Inqovi. The agency noted that Inqovi can cause fetal harm, and that both male and female patients of reproductive age are advised to use effective contraception.

In the clinical trials, approximately half of the patients formerly dependent on transfusions no longer required them during an 8-week period.

Inqovi is taken as one tablet by mouth once daily for 5 consecutive days of each 28-day cycle.

The Food and Drug Administration has approved Inqovi (decitabine and cedazuridine tablets, Astex Pharmaceuticals) to treat adults with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). The agency’s action gives physicians and patients a new treatment option – an oral-formulation MDS and CMML medication that can be taken at home.

Approval of the tablets could obviate the need for some patients to come to healthcare settings for intravenous therapy, a consideration that goes beyond patient convenience. “The FDA remains committed to providing additional treatments to patients during the coronavirus pandemic. In this case, the FDA is making available an oral outpatient treatment option that can reduce the need for frequent visits to health care facilities,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, stated in a news release.

“At this critical time, we continue to focus on providing options to patients with cancer, including regimens that can be taken at home,” added Dr. Pazdur, who is also acting director of the office of oncologic diseases in the FDA’s Center for Drug Evaluation and Research.

Inqovi received an Orphan Drug designation and a Priority Review from the agency.

The FDA based the new formulation approval on clinical trials that showed patients taking Inqovi had similar drug concentrations, compared with others receiving intravenous decitabine.

The two therapies also had similar safety profiles. Fatigue, constipation, hemorrhage, muscle pain, mucositis, arthralgia, nausea, and fever with low white blood cell count were common side effects reported in people taking Inqovi. The agency noted that Inqovi can cause fetal harm, and that both male and female patients of reproductive age are advised to use effective contraception.

In the clinical trials, approximately half of the patients formerly dependent on transfusions no longer required them during an 8-week period.

Inqovi is taken as one tablet by mouth once daily for 5 consecutive days of each 28-day cycle.

The Food and Drug Administration has approved Inqovi (decitabine and cedazuridine tablets, Astex Pharmaceuticals) to treat adults with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). The agency’s action gives physicians and patients a new treatment option – an oral-formulation MDS and CMML medication that can be taken at home.

Approval of the tablets could obviate the need for some patients to come to healthcare settings for intravenous therapy, a consideration that goes beyond patient convenience. “The FDA remains committed to providing additional treatments to patients during the coronavirus pandemic. In this case, the FDA is making available an oral outpatient treatment option that can reduce the need for frequent visits to health care facilities,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, stated in a news release.

“At this critical time, we continue to focus on providing options to patients with cancer, including regimens that can be taken at home,” added Dr. Pazdur, who is also acting director of the office of oncologic diseases in the FDA’s Center for Drug Evaluation and Research.

Inqovi received an Orphan Drug designation and a Priority Review from the agency.

The FDA based the new formulation approval on clinical trials that showed patients taking Inqovi had similar drug concentrations, compared with others receiving intravenous decitabine.

The two therapies also had similar safety profiles. Fatigue, constipation, hemorrhage, muscle pain, mucositis, arthralgia, nausea, and fever with low white blood cell count were common side effects reported in people taking Inqovi. The agency noted that Inqovi can cause fetal harm, and that both male and female patients of reproductive age are advised to use effective contraception.

In the clinical trials, approximately half of the patients formerly dependent on transfusions no longer required them during an 8-week period.

Inqovi is taken as one tablet by mouth once daily for 5 consecutive days of each 28-day cycle.

The World Health Organization is preparing a scientific brief to address the continually emerging evidence on transmission of COVID-19 and plans to release its guidance “in the coming days.”

WHO will likely address airborne transmission of the virus after a commentary from almost 240 multidisciplinary scientists raised the alarm that virus particles could remain airborne longer that previously appreciated, particularly in poorly ventilated indoor spaces.

“Airborne route of infection transmission is significant, but so far completely undermined, and not recognized by the decision makers and bodies responsible for infection control,” lead commentary author Lidia Morawska, PhD, told Medscape Medical News.

“This means that no control measures are taken to mitigate airborne transmission and, as a consequence, people are infected and can die,” said Morawska, director of the International Laboratory for Air Quality and Health at Queensland University of Technology in Brisbane, Australia. “We wanted to bring this to the attention of the world to prevent this from happening.”

The commentary was published July 6 in Clinical Infectious Diseases.

WHO leaders defended their progress in announcing any changes regarding how COVID-19 can be transmitted during a virtual press briefing today. They have collaborated since April with some of the scientists who coauthored the commentary, for example, said Maria Van Kerkhove, PhD, WHO technical lead on COVID-19.

“We have been working on a scientific brief ... to consolidate knowledge around transmission,” she added.

One focus will be on how masks protect healthcare workers. “We are also looking at the possible role of airborne transmission in other settings,” Van Kerkhove said. “We will be releasing our brief in the coming days.”

“We acknowledge there is emerging evidence in this field,” Benedetta Allegranzi, MD, WHO technical lead on COVID-19, said during the briefing from Geneva. “Therefore, we believe we have to be open to this evidence and its implications.”

WHO participated in an international research meeting last week that addressed means for controlling modes of COVID-19 transmission, Allegranzi said. “Our group and others really highlighted importance of research on different modes of transmission, including droplets of different sizes and their relative importance,” she said. Another aim was determining the dose of the virus required for airborne transmission.

“These fields of research are really growing but not definitive. More evidence needs to be gathered and evaluated,” she explained.

In the meantime, Allegranzi said, “the possibility of airborne transmission in public settings – especially closed, poorly ventilated settings – cannot be ruled out.”

Morawska said the evidence already exists. “A continuous surprise is that it takes the world such a long time to accept this, while this has such solid scientific foundation.” As an example, she cited an April report she coauthored in the journal Environment International. She and colleagues call for “national authorities to acknowledge the reality that the virus spreads through air and recommend that adequate control measures be implemented to prevent further spread of the SARS-CoV-2 virus, in particularly removal of the virus-laden droplets from indoor air by ventilation.”

The take-home message from the commentary, Morawska said, is a call to action. The authors state there is a need “to provide sufficient and effective ventilation (supply clean outdoor air, minimize recirculating air) particularly in public buildings, workplace environments, schools, hospitals, and aged care homes.”

WHO Chief Scientist Soumya Swaminathan, MD, explained why the organization remains cautious about making premature pronouncements regarding airborne transmission. “Any guidance we put out has implications for billions of people around the world, so we want to be as careful as possible,” she said during the press briefing. “We have to consider the weight of the evidence.”

“We are constantly looking for information on how we can do better,” Swaminathan added. WHO officials are reviewing hundreds of scientific reports every day, she said, and not all are of good quality. For this reason, she and other scientists at WHO perform a “living systematic review” – updating the consensus of evidence on a weekly basis.  

“This process on COVID-19 will, I am sure, continue for the weeks and months to come,” she added.

This article first appeared on Medscape.com.

The World Health Organization is preparing a scientific brief to address the continually emerging evidence on transmission of COVID-19 and plans to release its guidance “in the coming days.”

WHO will likely address airborne transmission of the virus after a commentary from almost 240 multidisciplinary scientists raised the alarm that virus particles could remain airborne longer that previously appreciated, particularly in poorly ventilated indoor spaces.

“Airborne route of infection transmission is significant, but so far completely undermined, and not recognized by the decision makers and bodies responsible for infection control,” lead commentary author Lidia Morawska, PhD, told Medscape Medical News.

“This means that no control measures are taken to mitigate airborne transmission and, as a consequence, people are infected and can die,” said Morawska, director of the International Laboratory for Air Quality and Health at Queensland University of Technology in Brisbane, Australia. “We wanted to bring this to the attention of the world to prevent this from happening.”

The commentary was published July 6 in Clinical Infectious Diseases.

WHO leaders defended their progress in announcing any changes regarding how COVID-19 can be transmitted during a virtual press briefing today. They have collaborated since April with some of the scientists who coauthored the commentary, for example, said Maria Van Kerkhove, PhD, WHO technical lead on COVID-19.

“We have been working on a scientific brief ... to consolidate knowledge around transmission,” she added.

One focus will be on how masks protect healthcare workers. “We are also looking at the possible role of airborne transmission in other settings,” Van Kerkhove said. “We will be releasing our brief in the coming days.”

“We acknowledge there is emerging evidence in this field,” Benedetta Allegranzi, MD, WHO technical lead on COVID-19, said during the briefing from Geneva. “Therefore, we believe we have to be open to this evidence and its implications.”

WHO participated in an international research meeting last week that addressed means for controlling modes of COVID-19 transmission, Allegranzi said. “Our group and others really highlighted importance of research on different modes of transmission, including droplets of different sizes and their relative importance,” she said. Another aim was determining the dose of the virus required for airborne transmission.

“These fields of research are really growing but not definitive. More evidence needs to be gathered and evaluated,” she explained.

In the meantime, Allegranzi said, “the possibility of airborne transmission in public settings – especially closed, poorly ventilated settings – cannot be ruled out.”

Morawska said the evidence already exists. “A continuous surprise is that it takes the world such a long time to accept this, while this has such solid scientific foundation.” As an example, she cited an April report she coauthored in the journal Environment International. She and colleagues call for “national authorities to acknowledge the reality that the virus spreads through air and recommend that adequate control measures be implemented to prevent further spread of the SARS-CoV-2 virus, in particularly removal of the virus-laden droplets from indoor air by ventilation.”

The take-home message from the commentary, Morawska said, is a call to action. The authors state there is a need “to provide sufficient and effective ventilation (supply clean outdoor air, minimize recirculating air) particularly in public buildings, workplace environments, schools, hospitals, and aged care homes.”

WHO Chief Scientist Soumya Swaminathan, MD, explained why the organization remains cautious about making premature pronouncements regarding airborne transmission. “Any guidance we put out has implications for billions of people around the world, so we want to be as careful as possible,” she said during the press briefing. “We have to consider the weight of the evidence.”

“We are constantly looking for information on how we can do better,” Swaminathan added. WHO officials are reviewing hundreds of scientific reports every day, she said, and not all are of good quality. For this reason, she and other scientists at WHO perform a “living systematic review” – updating the consensus of evidence on a weekly basis.  

“This process on COVID-19 will, I am sure, continue for the weeks and months to come,” she added.

This article first appeared on Medscape.com.

The World Health Organization is preparing a scientific brief to address the continually emerging evidence on transmission of COVID-19 and plans to release its guidance “in the coming days.”

WHO will likely address airborne transmission of the virus after a commentary from almost 240 multidisciplinary scientists raised the alarm that virus particles could remain airborne longer that previously appreciated, particularly in poorly ventilated indoor spaces.

“Airborne route of infection transmission is significant, but so far completely undermined, and not recognized by the decision makers and bodies responsible for infection control,” lead commentary author Lidia Morawska, PhD, told Medscape Medical News.

“This means that no control measures are taken to mitigate airborne transmission and, as a consequence, people are infected and can die,” said Morawska, director of the International Laboratory for Air Quality and Health at Queensland University of Technology in Brisbane, Australia. “We wanted to bring this to the attention of the world to prevent this from happening.”

The commentary was published July 6 in Clinical Infectious Diseases.

WHO leaders defended their progress in announcing any changes regarding how COVID-19 can be transmitted during a virtual press briefing today. They have collaborated since April with some of the scientists who coauthored the commentary, for example, said Maria Van Kerkhove, PhD, WHO technical lead on COVID-19.

“We have been working on a scientific brief ... to consolidate knowledge around transmission,” she added.

One focus will be on how masks protect healthcare workers. “We are also looking at the possible role of airborne transmission in other settings,” Van Kerkhove said. “We will be releasing our brief in the coming days.”

“We acknowledge there is emerging evidence in this field,” Benedetta Allegranzi, MD, WHO technical lead on COVID-19, said during the briefing from Geneva. “Therefore, we believe we have to be open to this evidence and its implications.”

WHO participated in an international research meeting last week that addressed means for controlling modes of COVID-19 transmission, Allegranzi said. “Our group and others really highlighted importance of research on different modes of transmission, including droplets of different sizes and their relative importance,” she said. Another aim was determining the dose of the virus required for airborne transmission.

“These fields of research are really growing but not definitive. More evidence needs to be gathered and evaluated,” she explained.

In the meantime, Allegranzi said, “the possibility of airborne transmission in public settings – especially closed, poorly ventilated settings – cannot be ruled out.”

Morawska said the evidence already exists. “A continuous surprise is that it takes the world such a long time to accept this, while this has such solid scientific foundation.” As an example, she cited an April report she coauthored in the journal Environment International. She and colleagues call for “national authorities to acknowledge the reality that the virus spreads through air and recommend that adequate control measures be implemented to prevent further spread of the SARS-CoV-2 virus, in particularly removal of the virus-laden droplets from indoor air by ventilation.”

The take-home message from the commentary, Morawska said, is a call to action. The authors state there is a need “to provide sufficient and effective ventilation (supply clean outdoor air, minimize recirculating air) particularly in public buildings, workplace environments, schools, hospitals, and aged care homes.”

WHO Chief Scientist Soumya Swaminathan, MD, explained why the organization remains cautious about making premature pronouncements regarding airborne transmission. “Any guidance we put out has implications for billions of people around the world, so we want to be as careful as possible,” she said during the press briefing. “We have to consider the weight of the evidence.”

“We are constantly looking for information on how we can do better,” Swaminathan added. WHO officials are reviewing hundreds of scientific reports every day, she said, and not all are of good quality. For this reason, she and other scientists at WHO perform a “living systematic review” – updating the consensus of evidence on a weekly basis.  

“This process on COVID-19 will, I am sure, continue for the weeks and months to come,” she added.

This article first appeared on Medscape.com.

The Food and Administration has approved a new indication for the PD-L1 inhibitor avelumab.

Physicians can now prescribe avelumab (Bavencio) as maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed after first-line platinum-containing chemotherapy.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The new indication adds to avelumab use in other patient populations, including people with locally advanced or metastatic UC who experience disease progression during or following platinum-containing chemotherapy. The FDA also previously approved avelumab for patients who experienced UC progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The FDA first approved marketing of avelumab in 2017. Other uses include treatment of metastatic Merkel cell carcinoma and first-line treatment of advanced renal cell carcinoma in combination with axitinib.

The new maintenance therapy indication for avelumab is based on efficacy demonstrated in the JAVELIN Bladder 100 trial. Results from this trial were presented as part of the American Society of Clinical Oncology virtual scientific program.

Investigators randomly assigned 700 patients with unresectable, locally advanced or metastatic UC to intravenous avelumab and best supportive care or best supportive care alone. All participants had UC that had not progressed after first-line platinum-containing chemotherapy.

The median overall survival was 21.4 months in the avelumab arm and 14.3 months in the best supportive care–alone arm (hazard ratio, 0.69; 95% confidence interval, 0.56-0.86). This difference was statistically significant (P = .001).

Avelumab also was associated with significantly longer overall survival in the 51% of participants with PD-L1–positive tumors (hazard ratio, 0.56; 95% confidence interval, 0.40-0.79; P < .001).

Results from the JAVELIN Bladder 100 trial allowed the FDA to convert an initial accelerated approval of avelumab to a regular approval.

Fatigue, musculoskeletal pain, urinary tract infection, and rash were the most common adverse events reported in 20% or more of trial participants. In all, 28% of patients experienced serious adverse events, and one patient died from sepsis during the trial.

Recommended avelumab dosing is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progresses or toxicity becomes unacceptable.

See the full prescribing information for more details.

The Food and Administration has approved a new indication for the PD-L1 inhibitor avelumab.

Physicians can now prescribe avelumab (Bavencio) as maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed after first-line platinum-containing chemotherapy.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The new indication adds to avelumab use in other patient populations, including people with locally advanced or metastatic UC who experience disease progression during or following platinum-containing chemotherapy. The FDA also previously approved avelumab for patients who experienced UC progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The FDA first approved marketing of avelumab in 2017. Other uses include treatment of metastatic Merkel cell carcinoma and first-line treatment of advanced renal cell carcinoma in combination with axitinib.

The new maintenance therapy indication for avelumab is based on efficacy demonstrated in the JAVELIN Bladder 100 trial. Results from this trial were presented as part of the American Society of Clinical Oncology virtual scientific program.

Investigators randomly assigned 700 patients with unresectable, locally advanced or metastatic UC to intravenous avelumab and best supportive care or best supportive care alone. All participants had UC that had not progressed after first-line platinum-containing chemotherapy.

The median overall survival was 21.4 months in the avelumab arm and 14.3 months in the best supportive care–alone arm (hazard ratio, 0.69; 95% confidence interval, 0.56-0.86). This difference was statistically significant (P = .001).

Avelumab also was associated with significantly longer overall survival in the 51% of participants with PD-L1–positive tumors (hazard ratio, 0.56; 95% confidence interval, 0.40-0.79; P < .001).

Results from the JAVELIN Bladder 100 trial allowed the FDA to convert an initial accelerated approval of avelumab to a regular approval.

Fatigue, musculoskeletal pain, urinary tract infection, and rash were the most common adverse events reported in 20% or more of trial participants. In all, 28% of patients experienced serious adverse events, and one patient died from sepsis during the trial.

Recommended avelumab dosing is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progresses or toxicity becomes unacceptable.

See the full prescribing information for more details.

The Food and Administration has approved a new indication for the PD-L1 inhibitor avelumab.

Physicians can now prescribe avelumab (Bavencio) as maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed after first-line platinum-containing chemotherapy.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The new indication adds to avelumab use in other patient populations, including people with locally advanced or metastatic UC who experience disease progression during or following platinum-containing chemotherapy. The FDA also previously approved avelumab for patients who experienced UC progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The FDA first approved marketing of avelumab in 2017. Other uses include treatment of metastatic Merkel cell carcinoma and first-line treatment of advanced renal cell carcinoma in combination with axitinib.

The new maintenance therapy indication for avelumab is based on efficacy demonstrated in the JAVELIN Bladder 100 trial. Results from this trial were presented as part of the American Society of Clinical Oncology virtual scientific program.

Investigators randomly assigned 700 patients with unresectable, locally advanced or metastatic UC to intravenous avelumab and best supportive care or best supportive care alone. All participants had UC that had not progressed after first-line platinum-containing chemotherapy.

The median overall survival was 21.4 months in the avelumab arm and 14.3 months in the best supportive care–alone arm (hazard ratio, 0.69; 95% confidence interval, 0.56-0.86). This difference was statistically significant (P = .001).

Avelumab also was associated with significantly longer overall survival in the 51% of participants with PD-L1–positive tumors (hazard ratio, 0.56; 95% confidence interval, 0.40-0.79; P < .001).

Results from the JAVELIN Bladder 100 trial allowed the FDA to convert an initial accelerated approval of avelumab to a regular approval.

Fatigue, musculoskeletal pain, urinary tract infection, and rash were the most common adverse events reported in 20% or more of trial participants. In all, 28% of patients experienced serious adverse events, and one patient died from sepsis during the trial.

Recommended avelumab dosing is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progresses or toxicity becomes unacceptable.

See the full prescribing information for more details.

The Food and Drug Administration recently announced two new types of cancer that can be treated by the anti–PD-1 antibody pembrolizumab.

The new indications expand the use of pembrolizumab (Keytruda) to include treatment of patients with unresectable or metastatic tumor mutational burden–high (TMB-H) solid tumors as well as patients with cutaneous squamous cell carcinoma (cSCC). The FDA announced the new indications just 8 days apart, on June 16 and June 24.

In addition, on June 29, the FDA approved a third new indication for pembrolizumab, this time as first-line treatment for patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer.



The new approvals add to a wide range of oncology indications for which pembrolizumab can be used.

Accelerated approval to treat solid tumors

The FDA granted accelerated approval for pembrolizumab to treat children and adults with unresectable or metastatic TMB-H solid tumors that progressed after previous treatment or in instances where there are no satisfactory alternative treatment options.

The tumor mutational burden must be confirmed by an FDA-approved test. To that end, the FDA approved the FoundationOneCDx assay, which is designed to help physicians determine which patients meet the threshold for TMB-H malignancies (10 or more mutations per megabase).

The efficacy of pembrolizumab in TMB-H solid tumors was investigated in 10 cohorts from the multicenter, open-label KEYNOTE-158 trial. Participants received 200 mg of pembrolizumab intravenously every 3 weeks until their disease progressed or they experienced unacceptable toxicity.

Within this population, 102 patients had tumors that met the TMB-H definition. In this group, the overall response rate was 29%, including a 25% partial response rate and a 4% complete response rate.

The median duration of response was not reached, but 57% of participants experienced a response lasting 12 months or longer, and 50% had a response lasting 24 months or longer.

The most common adverse events associated with pembrolizumab in this trial were fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain. Pembrolizumab is associated with immune-mediated side effects, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and skin adverse reactions, the FDA noted.

Safety and efficacy of pembrolizumab in pediatric patients with TMB-H central nervous system cancers have not been established.
 

New option for recurrent or metastatic cSCC

Physicians treating patients with cSCC that is not curable by surgery or radiation now have pembrolizumab to consider as another treatment option.

The cSCC approval is based on results of the multicenter, open-label KEYNOTE-629 trial. The dosage regimen was 200 mg of pembrolizumab intravenously every 3 weeks until cancer progressed, unacceptable toxicity arose, or 24 months of treatment were completed.

The objective response rate was 34%, and the median duration of response was not reached.

Adverse events were similar to those occurring in patients who received pembrolizumab as a single agent in other clinical trials, the FDA noted.

The Food and Drug Administration recently announced two new types of cancer that can be treated by the anti–PD-1 antibody pembrolizumab.

The new indications expand the use of pembrolizumab (Keytruda) to include treatment of patients with unresectable or metastatic tumor mutational burden–high (TMB-H) solid tumors as well as patients with cutaneous squamous cell carcinoma (cSCC). The FDA announced the new indications just 8 days apart, on June 16 and June 24.

In addition, on June 29, the FDA approved a third new indication for pembrolizumab, this time as first-line treatment for patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer.



The new approvals add to a wide range of oncology indications for which pembrolizumab can be used.

Accelerated approval to treat solid tumors

The FDA granted accelerated approval for pembrolizumab to treat children and adults with unresectable or metastatic TMB-H solid tumors that progressed after previous treatment or in instances where there are no satisfactory alternative treatment options.

The tumor mutational burden must be confirmed by an FDA-approved test. To that end, the FDA approved the FoundationOneCDx assay, which is designed to help physicians determine which patients meet the threshold for TMB-H malignancies (10 or more mutations per megabase).

The efficacy of pembrolizumab in TMB-H solid tumors was investigated in 10 cohorts from the multicenter, open-label KEYNOTE-158 trial. Participants received 200 mg of pembrolizumab intravenously every 3 weeks until their disease progressed or they experienced unacceptable toxicity.

Within this population, 102 patients had tumors that met the TMB-H definition. In this group, the overall response rate was 29%, including a 25% partial response rate and a 4% complete response rate.

The median duration of response was not reached, but 57% of participants experienced a response lasting 12 months or longer, and 50% had a response lasting 24 months or longer.

The most common adverse events associated with pembrolizumab in this trial were fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain. Pembrolizumab is associated with immune-mediated side effects, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and skin adverse reactions, the FDA noted.

Safety and efficacy of pembrolizumab in pediatric patients with TMB-H central nervous system cancers have not been established.
 

New option for recurrent or metastatic cSCC

Physicians treating patients with cSCC that is not curable by surgery or radiation now have pembrolizumab to consider as another treatment option.

The cSCC approval is based on results of the multicenter, open-label KEYNOTE-629 trial. The dosage regimen was 200 mg of pembrolizumab intravenously every 3 weeks until cancer progressed, unacceptable toxicity arose, or 24 months of treatment were completed.

The objective response rate was 34%, and the median duration of response was not reached.

Adverse events were similar to those occurring in patients who received pembrolizumab as a single agent in other clinical trials, the FDA noted.

The Food and Drug Administration recently announced two new types of cancer that can be treated by the anti–PD-1 antibody pembrolizumab.

The new indications expand the use of pembrolizumab (Keytruda) to include treatment of patients with unresectable or metastatic tumor mutational burden–high (TMB-H) solid tumors as well as patients with cutaneous squamous cell carcinoma (cSCC). The FDA announced the new indications just 8 days apart, on June 16 and June 24.

In addition, on June 29, the FDA approved a third new indication for pembrolizumab, this time as first-line treatment for patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer.



The new approvals add to a wide range of oncology indications for which pembrolizumab can be used.

Accelerated approval to treat solid tumors

The FDA granted accelerated approval for pembrolizumab to treat children and adults with unresectable or metastatic TMB-H solid tumors that progressed after previous treatment or in instances where there are no satisfactory alternative treatment options.

The tumor mutational burden must be confirmed by an FDA-approved test. To that end, the FDA approved the FoundationOneCDx assay, which is designed to help physicians determine which patients meet the threshold for TMB-H malignancies (10 or more mutations per megabase).

The efficacy of pembrolizumab in TMB-H solid tumors was investigated in 10 cohorts from the multicenter, open-label KEYNOTE-158 trial. Participants received 200 mg of pembrolizumab intravenously every 3 weeks until their disease progressed or they experienced unacceptable toxicity.

Within this population, 102 patients had tumors that met the TMB-H definition. In this group, the overall response rate was 29%, including a 25% partial response rate and a 4% complete response rate.

The median duration of response was not reached, but 57% of participants experienced a response lasting 12 months or longer, and 50% had a response lasting 24 months or longer.

The most common adverse events associated with pembrolizumab in this trial were fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain. Pembrolizumab is associated with immune-mediated side effects, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and skin adverse reactions, the FDA noted.

Safety and efficacy of pembrolizumab in pediatric patients with TMB-H central nervous system cancers have not been established.
 

New option for recurrent or metastatic cSCC

Physicians treating patients with cSCC that is not curable by surgery or radiation now have pembrolizumab to consider as another treatment option.

The cSCC approval is based on results of the multicenter, open-label KEYNOTE-629 trial. The dosage regimen was 200 mg of pembrolizumab intravenously every 3 weeks until cancer progressed, unacceptable toxicity arose, or 24 months of treatment were completed.

The objective response rate was 34%, and the median duration of response was not reached.

Adverse events were similar to those occurring in patients who received pembrolizumab as a single agent in other clinical trials, the FDA noted.

An expected surge in the number of people seeking colonoscopy after the peak of the COVID-19 pandemic passes could cause physicians to rethink patient prioritization, could create a strain on endoscopy capacity, and might raise the specter of detecting colorectal cancer in more patients at a later stage of disease.

Furthermore, months of delay in diagnosis of colorectal cancer (CRC) could shorten survival, although more data is needed, according to expert analysis from a gastroenterologist, a medical oncologist, and a colorectal surgeon.

“It has been a big decrease in the number of colonoscopies performed at our hospital in Alicante, Spain,” Rodrigo Jover Martinez, MD, PhD, said during a COVID-19 and Digestive Health webinar presented by United European Gastroenterology (UEG). He estimated colonoscopy procedures are down 60%-90%, and the number of CRC surgeries has dropped by 60%. “As you know, the COVID-19 pandemic is hitting Europe hard.”

When patients do return, “the backlog will be huge ... in already exhausted endoscopy units,” predicted Dr. Martinez, a gastroenterologist at Hospital General Universitario in Alicante.
 

Multiple risks

Not knowing which patients with CRC will develop severe COVID-19 infection is another challenge, Bartomeu Massuti, MD, of the medical oncology service at the Hospital General Universitario de Alicante, said during the webinar.

Caution is warranted because “we know cancer patients have an increased risk of infection.” However, he added, most evidence supports an elevated risk for bacterial infections, not viral infections.

Therefore, physicians must continue to balance the risks associated with potential COVID-19 exposure against the risks associated with postponed treatment, Dr. Massuti said. “The goal of oncology care is to try to maintain the preplanned treatment and follow-up. We need mainly to avoid stopping or delaying treatment ... because we will lose efficacy in oncology disease outcomes.”

Imran Aslam, MD, PhD, a colorectal surgeon who moderated and presented during the webinar, agreed: “By delaying the treatment, we might do harm to our patients.”

Dr. Aslam cited data about clinical costs of delaying CRC surgery. A 2019 population-based study in PLOS ONE evaluated different times from diagnosis to treatment. The researchers found a delay of more than 150 days “significantly reduced survival, even during stage I, II, and III disease,” he said. The stage I hazard ratio was 2.66, compared with a reference HR of 1.00 for 90 days or fewer. They also reported elevated risk for people with stage II CRC (HR, 2.80), stage III CRC (HR, 2.70), and stage IV CRC (HR, 1.36).

“This could become more and more abysmal if the pandemic continues,” added Dr. Aslam, consultant colorectal surgeon at University Hospitals of Coventry and Warwickshire, England.
 

Prioritizing patients

Restarting endoscopy with prioritization strategies and increasing patient capacity are possible solutions. Dr. Martinez suggested a four-quadrant matrix in which physicians place patients into “now,” “next,” “delayed,” or “never” categories based on clinical indicators. The priority 1 “now” patients, for example, will be those with suspected CRC based on physical examination, imaging results, and/or an abnormal fecal immunochemical test result.

He suggested, furthermore, that more widespread CRC screening can resume once “endoscopy units have been alleviated of priority 1, symptomatic patients.”

Dr. Massuti concurred with Dr. Martinez’s call to prioritize patients carefully. He suggested a green, yellow, and red classification system based on treatment priority recommendations from the European Society for Medical Oncology. The green group, for example, should receive priority for intervention based on a condition that is immediately clinically unstable or life threatening.

“The main goal is to preserve the continuum of care,” he added.

Another concern – although data are limited – is that treatment might also increase risk of mortality among cancer patients with COVID-19, according to a cohort study of nearly 1,000 such patients reported May 2020 in The Lancet. Dr. Massuti, who was not affiliated with the research, noted that 12% of the patients had GI tumors. In addition to increased risk associated with male sex (odds ratio, 1.63), cytotoxic cancer treatment in the prior 4 weeks increased risk (OR, 1.47), as did surgery in the same time frame (OR, 1.52).

“This means patients on treatment have an increased risk of mortality,” Dr. Massuti said.
 

Moving forward

Implementing telehealth information and communication technologies will continue to grow in importance, Dr. Massuti said. Dr. Aslam noted that video consultation with patients before surgery is already replacing face-to-face interaction, and most follow-up care at his hospital is now done by telephone.

Postoperative care is just as essential in the COVID-19 era, if not more so. “We need to be very vigilant to manage postoperative complications – any symptoms of pyrexia or sepsis, or any sign of COVID,” Dr. Aslam said, including postoperative fever. “If there is any doubt, do a chest CT scan.”

Dr. Aslam predicted the time to perform endoscopy or surgery for each patient will be longer, “so the number of patients done in 1 day will be less than 4 months ago.” In addition, elective surgery patients at his institution undergo COVID-19 testing twice, 3 days apart, prior to intervention.

“This disease will continue in the community for a while, so we have to continue what we’ve done well, like social distancing,” Dr. Aslam said. “We’ve gone through a storm and we are awaiting a tsunami. That tsunami of patients will overwhelm us in the coming months.”

Dr. Martinez, Dr. Massuti, and Dr. Aslam had no relevant disclosures.

An expected surge in the number of people seeking colonoscopy after the peak of the COVID-19 pandemic passes could cause physicians to rethink patient prioritization, could create a strain on endoscopy capacity, and might raise the specter of detecting colorectal cancer in more patients at a later stage of disease.

Furthermore, months of delay in diagnosis of colorectal cancer (CRC) could shorten survival, although more data is needed, according to expert analysis from a gastroenterologist, a medical oncologist, and a colorectal surgeon.

“It has been a big decrease in the number of colonoscopies performed at our hospital in Alicante, Spain,” Rodrigo Jover Martinez, MD, PhD, said during a COVID-19 and Digestive Health webinar presented by United European Gastroenterology (UEG). He estimated colonoscopy procedures are down 60%-90%, and the number of CRC surgeries has dropped by 60%. “As you know, the COVID-19 pandemic is hitting Europe hard.”

When patients do return, “the backlog will be huge ... in already exhausted endoscopy units,” predicted Dr. Martinez, a gastroenterologist at Hospital General Universitario in Alicante.
 

Multiple risks

Not knowing which patients with CRC will develop severe COVID-19 infection is another challenge, Bartomeu Massuti, MD, of the medical oncology service at the Hospital General Universitario de Alicante, said during the webinar.

Caution is warranted because “we know cancer patients have an increased risk of infection.” However, he added, most evidence supports an elevated risk for bacterial infections, not viral infections.

Therefore, physicians must continue to balance the risks associated with potential COVID-19 exposure against the risks associated with postponed treatment, Dr. Massuti said. “The goal of oncology care is to try to maintain the preplanned treatment and follow-up. We need mainly to avoid stopping or delaying treatment ... because we will lose efficacy in oncology disease outcomes.”

Imran Aslam, MD, PhD, a colorectal surgeon who moderated and presented during the webinar, agreed: “By delaying the treatment, we might do harm to our patients.”

Dr. Aslam cited data about clinical costs of delaying CRC surgery. A 2019 population-based study in PLOS ONE evaluated different times from diagnosis to treatment. The researchers found a delay of more than 150 days “significantly reduced survival, even during stage I, II, and III disease,” he said. The stage I hazard ratio was 2.66, compared with a reference HR of 1.00 for 90 days or fewer. They also reported elevated risk for people with stage II CRC (HR, 2.80), stage III CRC (HR, 2.70), and stage IV CRC (HR, 1.36).

“This could become more and more abysmal if the pandemic continues,” added Dr. Aslam, consultant colorectal surgeon at University Hospitals of Coventry and Warwickshire, England.
 

Prioritizing patients

Restarting endoscopy with prioritization strategies and increasing patient capacity are possible solutions. Dr. Martinez suggested a four-quadrant matrix in which physicians place patients into “now,” “next,” “delayed,” or “never” categories based on clinical indicators. The priority 1 “now” patients, for example, will be those with suspected CRC based on physical examination, imaging results, and/or an abnormal fecal immunochemical test result.

He suggested, furthermore, that more widespread CRC screening can resume once “endoscopy units have been alleviated of priority 1, symptomatic patients.”

Dr. Massuti concurred with Dr. Martinez’s call to prioritize patients carefully. He suggested a green, yellow, and red classification system based on treatment priority recommendations from the European Society for Medical Oncology. The green group, for example, should receive priority for intervention based on a condition that is immediately clinically unstable or life threatening.

“The main goal is to preserve the continuum of care,” he added.

Another concern – although data are limited – is that treatment might also increase risk of mortality among cancer patients with COVID-19, according to a cohort study of nearly 1,000 such patients reported May 2020 in The Lancet. Dr. Massuti, who was not affiliated with the research, noted that 12% of the patients had GI tumors. In addition to increased risk associated with male sex (odds ratio, 1.63), cytotoxic cancer treatment in the prior 4 weeks increased risk (OR, 1.47), as did surgery in the same time frame (OR, 1.52).

“This means patients on treatment have an increased risk of mortality,” Dr. Massuti said.
 

Moving forward

Implementing telehealth information and communication technologies will continue to grow in importance, Dr. Massuti said. Dr. Aslam noted that video consultation with patients before surgery is already replacing face-to-face interaction, and most follow-up care at his hospital is now done by telephone.

Postoperative care is just as essential in the COVID-19 era, if not more so. “We need to be very vigilant to manage postoperative complications – any symptoms of pyrexia or sepsis, or any sign of COVID,” Dr. Aslam said, including postoperative fever. “If there is any doubt, do a chest CT scan.”

Dr. Aslam predicted the time to perform endoscopy or surgery for each patient will be longer, “so the number of patients done in 1 day will be less than 4 months ago.” In addition, elective surgery patients at his institution undergo COVID-19 testing twice, 3 days apart, prior to intervention.

“This disease will continue in the community for a while, so we have to continue what we’ve done well, like social distancing,” Dr. Aslam said. “We’ve gone through a storm and we are awaiting a tsunami. That tsunami of patients will overwhelm us in the coming months.”

Dr. Martinez, Dr. Massuti, and Dr. Aslam had no relevant disclosures.

An expected surge in the number of people seeking colonoscopy after the peak of the COVID-19 pandemic passes could cause physicians to rethink patient prioritization, could create a strain on endoscopy capacity, and might raise the specter of detecting colorectal cancer in more patients at a later stage of disease.

Furthermore, months of delay in diagnosis of colorectal cancer (CRC) could shorten survival, although more data is needed, according to expert analysis from a gastroenterologist, a medical oncologist, and a colorectal surgeon.

“It has been a big decrease in the number of colonoscopies performed at our hospital in Alicante, Spain,” Rodrigo Jover Martinez, MD, PhD, said during a COVID-19 and Digestive Health webinar presented by United European Gastroenterology (UEG). He estimated colonoscopy procedures are down 60%-90%, and the number of CRC surgeries has dropped by 60%. “As you know, the COVID-19 pandemic is hitting Europe hard.”

When patients do return, “the backlog will be huge ... in already exhausted endoscopy units,” predicted Dr. Martinez, a gastroenterologist at Hospital General Universitario in Alicante.
 

Multiple risks

Not knowing which patients with CRC will develop severe COVID-19 infection is another challenge, Bartomeu Massuti, MD, of the medical oncology service at the Hospital General Universitario de Alicante, said during the webinar.

Caution is warranted because “we know cancer patients have an increased risk of infection.” However, he added, most evidence supports an elevated risk for bacterial infections, not viral infections.

Therefore, physicians must continue to balance the risks associated with potential COVID-19 exposure against the risks associated with postponed treatment, Dr. Massuti said. “The goal of oncology care is to try to maintain the preplanned treatment and follow-up. We need mainly to avoid stopping or delaying treatment ... because we will lose efficacy in oncology disease outcomes.”

Imran Aslam, MD, PhD, a colorectal surgeon who moderated and presented during the webinar, agreed: “By delaying the treatment, we might do harm to our patients.”

Dr. Aslam cited data about clinical costs of delaying CRC surgery. A 2019 population-based study in PLOS ONE evaluated different times from diagnosis to treatment. The researchers found a delay of more than 150 days “significantly reduced survival, even during stage I, II, and III disease,” he said. The stage I hazard ratio was 2.66, compared with a reference HR of 1.00 for 90 days or fewer. They also reported elevated risk for people with stage II CRC (HR, 2.80), stage III CRC (HR, 2.70), and stage IV CRC (HR, 1.36).

“This could become more and more abysmal if the pandemic continues,” added Dr. Aslam, consultant colorectal surgeon at University Hospitals of Coventry and Warwickshire, England.
 

Prioritizing patients

Restarting endoscopy with prioritization strategies and increasing patient capacity are possible solutions. Dr. Martinez suggested a four-quadrant matrix in which physicians place patients into “now,” “next,” “delayed,” or “never” categories based on clinical indicators. The priority 1 “now” patients, for example, will be those with suspected CRC based on physical examination, imaging results, and/or an abnormal fecal immunochemical test result.

He suggested, furthermore, that more widespread CRC screening can resume once “endoscopy units have been alleviated of priority 1, symptomatic patients.”

Dr. Massuti concurred with Dr. Martinez’s call to prioritize patients carefully. He suggested a green, yellow, and red classification system based on treatment priority recommendations from the European Society for Medical Oncology. The green group, for example, should receive priority for intervention based on a condition that is immediately clinically unstable or life threatening.

“The main goal is to preserve the continuum of care,” he added.

Another concern – although data are limited – is that treatment might also increase risk of mortality among cancer patients with COVID-19, according to a cohort study of nearly 1,000 such patients reported May 2020 in The Lancet. Dr. Massuti, who was not affiliated with the research, noted that 12% of the patients had GI tumors. In addition to increased risk associated with male sex (odds ratio, 1.63), cytotoxic cancer treatment in the prior 4 weeks increased risk (OR, 1.47), as did surgery in the same time frame (OR, 1.52).

“This means patients on treatment have an increased risk of mortality,” Dr. Massuti said.
 

Moving forward

Implementing telehealth information and communication technologies will continue to grow in importance, Dr. Massuti said. Dr. Aslam noted that video consultation with patients before surgery is already replacing face-to-face interaction, and most follow-up care at his hospital is now done by telephone.

Postoperative care is just as essential in the COVID-19 era, if not more so. “We need to be very vigilant to manage postoperative complications – any symptoms of pyrexia or sepsis, or any sign of COVID,” Dr. Aslam said, including postoperative fever. “If there is any doubt, do a chest CT scan.”

Dr. Aslam predicted the time to perform endoscopy or surgery for each patient will be longer, “so the number of patients done in 1 day will be less than 4 months ago.” In addition, elective surgery patients at his institution undergo COVID-19 testing twice, 3 days apart, prior to intervention.

“This disease will continue in the community for a while, so we have to continue what we’ve done well, like social distancing,” Dr. Aslam said. “We’ve gone through a storm and we are awaiting a tsunami. That tsunami of patients will overwhelm us in the coming months.”

Dr. Martinez, Dr. Massuti, and Dr. Aslam had no relevant disclosures.

The U.S. Food and Drug Administration revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.

The FDA also warned today that the use of hydroxychloroquine or chloroquine may have a potential drug interaction with the investigational antiviral drug remdesivir that limits its effectiveness against COVID-19.

Remdesivir was granted emergency use authorization by the FDA on May 1.

“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a news release.
 

Controversy over hydroxychloroquine

Even with such federal permission, since late March the use of these two agents has been mired in controversy.

President Donald J. Trump promoted the use of hydroxychloroquine and chloroquine to treat Americans with COVID-19, while scientific studies raised questions about their safety and effectiveness. Recent research, for example, pointed to elevated cardiovascular risks, as reported by Medscape Medical News.

The FDA acknowledged this recent evidence. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The full suspension of the EUA follows a warning the agency issued on April 24. The FDA’s Safety Communication cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” based on a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, MD, acting director of CDER, noted in the FDA statement.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.

The FDA also warned today that the use of hydroxychloroquine or chloroquine may have a potential drug interaction with the investigational antiviral drug remdesivir that limits its effectiveness against COVID-19.

Remdesivir was granted emergency use authorization by the FDA on May 1.

“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a news release.
 

Controversy over hydroxychloroquine

Even with such federal permission, since late March the use of these two agents has been mired in controversy.

President Donald J. Trump promoted the use of hydroxychloroquine and chloroquine to treat Americans with COVID-19, while scientific studies raised questions about their safety and effectiveness. Recent research, for example, pointed to elevated cardiovascular risks, as reported by Medscape Medical News.

The FDA acknowledged this recent evidence. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The full suspension of the EUA follows a warning the agency issued on April 24. The FDA’s Safety Communication cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” based on a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, MD, acting director of CDER, noted in the FDA statement.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.

The FDA also warned today that the use of hydroxychloroquine or chloroquine may have a potential drug interaction with the investigational antiviral drug remdesivir that limits its effectiveness against COVID-19.

Remdesivir was granted emergency use authorization by the FDA on May 1.

“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a news release.
 

Controversy over hydroxychloroquine

Even with such federal permission, since late March the use of these two agents has been mired in controversy.

President Donald J. Trump promoted the use of hydroxychloroquine and chloroquine to treat Americans with COVID-19, while scientific studies raised questions about their safety and effectiveness. Recent research, for example, pointed to elevated cardiovascular risks, as reported by Medscape Medical News.

The FDA acknowledged this recent evidence. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The full suspension of the EUA follows a warning the agency issued on April 24. The FDA’s Safety Communication cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” based on a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, MD, acting director of CDER, noted in the FDA statement.

This article first appeared on Medscape.com.

An expected surge in the number of people seeking colonoscopy after the peak of the COVID-19 pandemic passes could cause physicians to rethink patient prioritization, could create a strain on endoscopy capacity, and might raise the specter of detecting colorectal cancer in more patients at a later stage of disease.

Furthermore, months of delay in diagnosis of colorectal cancer (CRC) could shorten survival, although more data is needed, according to expert analysis from a gastroenterologist, a medical oncologist, and a colorectal surgeon.

“It has been a big decrease in the number of colonoscopies performed at our hospital in Alicante, Spain,” Rodrigo Jover Martinez, MD, PhD, said during a COVID-19 and Digestive Health webinar presented by United European Gastroenterology (UEG). He estimated colonoscopy procedures are down 60%-90%, and the number of CRC surgeries has dropped by 60%. “As you know, the COVID-19 pandemic is hitting Europe hard.”

When patients do return, “the backlog will be huge ... in already exhausted endoscopy units,” predicted Dr. Martinez, a gastroenterologist at Hospital General Universitario in Alicante.
 

Multiple risks

Not knowing which patients with CRC will develop severe COVID-19 infection is another challenge, Bartomeu Massuti, MD, of the medical oncology service at the Hospital General Universitario de Alicante, said during the webinar.

Caution is warranted because “we know cancer patients have an increased risk of infection.” However, he added, most evidence supports an elevated risk for bacterial infections, not viral infections.

Therefore, physicians must continue to balance the risks associated with potential COVID-19 exposure against the risks associated with postponed treatment, Dr. Massuti said. “The goal of oncology care is to try to maintain the preplanned treatment and follow-up. We need mainly to avoid stopping or delaying treatment ... because we will lose efficacy in oncology disease outcomes.”

Imran Aslam, MD, PhD, a colorectal surgeon who moderated and presented during the webinar, agreed: “By delaying the treatment, we might do harm to our patients.”

Dr. Aslam cited data about clinical costs of delaying CRC surgery. A 2019 population-based study in PLOS ONE evaluated different times from diagnosis to treatment. The researchers found a delay of more than 150 days “significantly reduced survival, even during stage I, II, and III disease,” he said. The stage I hazard ratio was 2.66, compared with a reference HR of 1.00 for 90 days or fewer. They also reported elevated risk for people with stage II CRC (HR, 2.80), stage III CRC (HR, 2.70), and stage IV CRC (HR, 1.36).

“This could become more and more abysmal if the pandemic continues,” added Dr. Aslam, consultant colorectal surgeon at University Hospitals of Coventry and Warwickshire, England.
 

Prioritizing patients

Restarting endoscopy with prioritization strategies and increasing patient capacity are possible solutions. Dr. Martinez suggested a four-quadrant matrix in which physicians place patients into “now,” “next,” “delayed,” or “never” categories based on clinical indicators. The priority 1 “now” patients, for example, will be those with suspected CRC based on physical examination, imaging results, and/or an abnormal fecal immunochemical test result.

He suggested, furthermore, that more widespread CRC screening can resume once “endoscopy units have been alleviated of priority 1, symptomatic patients.”

Dr. Massuti concurred with Dr. Martinez’s call to prioritize patients carefully. He suggested a green, yellow, and red classification system based on treatment priority recommendations from the European Society for Medical Oncology. The green group, for example, should receive priority for intervention based on a condition that is immediately clinically unstable or life threatening.

“The main goal is to preserve the continuum of care,” he added.

Another concern – although data are limited – is that treatment might also increase risk of mortality among cancer patients with COVID-19, according to a cohort study of nearly 1,000 such patients reported May 2020 in The Lancet. Dr. Massuti, who was not affiliated with the research, noted that 12% of the patients had GI tumors. In addition to increased risk associated with male sex (odds ratio, 1.63), cytotoxic cancer treatment in the prior 4 weeks increased risk (OR, 1.47), as did surgery in the same time frame (OR, 1.52).

“This means patients on treatment have an increased risk of mortality,” Dr. Massuti said.
 

Moving forward

Implementing telehealth information and communication technologies will continue to grow in importance, Dr. Massuti said. Dr. Aslam noted that video consultation with patients before surgery is already replacing face-to-face interaction, and most follow-up care at his hospital is now done by telephone.

Postoperative care is just as essential in the COVID-19 era, if not more so. “We need to be very vigilant to manage postoperative complications – any symptoms of pyrexia or sepsis, or any sign of COVID,” Dr. Aslam said, including postoperative fever. “If there is any doubt, do a chest CT scan.”

Dr. Aslam predicted the time to perform endoscopy or surgery for each patient will be longer, “so the number of patients done in 1 day will be less than 4 months ago.” In addition, elective surgery patients at his institution undergo COVID-19 testing twice, 3 days apart, prior to intervention.

“This disease will continue in the community for a while, so we have to continue what we’ve done well, like social distancing,” Dr. Aslam said. “We’ve gone through a storm and we are awaiting a tsunami. That tsunami of patients will overwhelm us in the coming months.”

Dr. Martinez, Dr. Massuti, and Dr. Aslam had no relevant disclosures.

An expected surge in the number of people seeking colonoscopy after the peak of the COVID-19 pandemic passes could cause physicians to rethink patient prioritization, could create a strain on endoscopy capacity, and might raise the specter of detecting colorectal cancer in more patients at a later stage of disease.

Furthermore, months of delay in diagnosis of colorectal cancer (CRC) could shorten survival, although more data is needed, according to expert analysis from a gastroenterologist, a medical oncologist, and a colorectal surgeon.

“It has been a big decrease in the number of colonoscopies performed at our hospital in Alicante, Spain,” Rodrigo Jover Martinez, MD, PhD, said during a COVID-19 and Digestive Health webinar presented by United European Gastroenterology (UEG). He estimated colonoscopy procedures are down 60%-90%, and the number of CRC surgeries has dropped by 60%. “As you know, the COVID-19 pandemic is hitting Europe hard.”

When patients do return, “the backlog will be huge ... in already exhausted endoscopy units,” predicted Dr. Martinez, a gastroenterologist at Hospital General Universitario in Alicante.
 

Multiple risks

Not knowing which patients with CRC will develop severe COVID-19 infection is another challenge, Bartomeu Massuti, MD, of the medical oncology service at the Hospital General Universitario de Alicante, said during the webinar.

Caution is warranted because “we know cancer patients have an increased risk of infection.” However, he added, most evidence supports an elevated risk for bacterial infections, not viral infections.

Therefore, physicians must continue to balance the risks associated with potential COVID-19 exposure against the risks associated with postponed treatment, Dr. Massuti said. “The goal of oncology care is to try to maintain the preplanned treatment and follow-up. We need mainly to avoid stopping or delaying treatment ... because we will lose efficacy in oncology disease outcomes.”

Imran Aslam, MD, PhD, a colorectal surgeon who moderated and presented during the webinar, agreed: “By delaying the treatment, we might do harm to our patients.”

Dr. Aslam cited data about clinical costs of delaying CRC surgery. A 2019 population-based study in PLOS ONE evaluated different times from diagnosis to treatment. The researchers found a delay of more than 150 days “significantly reduced survival, even during stage I, II, and III disease,” he said. The stage I hazard ratio was 2.66, compared with a reference HR of 1.00 for 90 days or fewer. They also reported elevated risk for people with stage II CRC (HR, 2.80), stage III CRC (HR, 2.70), and stage IV CRC (HR, 1.36).

“This could become more and more abysmal if the pandemic continues,” added Dr. Aslam, consultant colorectal surgeon at University Hospitals of Coventry and Warwickshire, England.
 

Prioritizing patients

Restarting endoscopy with prioritization strategies and increasing patient capacity are possible solutions. Dr. Martinez suggested a four-quadrant matrix in which physicians place patients into “now,” “next,” “delayed,” or “never” categories based on clinical indicators. The priority 1 “now” patients, for example, will be those with suspected CRC based on physical examination, imaging results, and/or an abnormal fecal immunochemical test result.

He suggested, furthermore, that more widespread CRC screening can resume once “endoscopy units have been alleviated of priority 1, symptomatic patients.”

Dr. Massuti concurred with Dr. Martinez’s call to prioritize patients carefully. He suggested a green, yellow, and red classification system based on treatment priority recommendations from the European Society for Medical Oncology. The green group, for example, should receive priority for intervention based on a condition that is immediately clinically unstable or life threatening.

“The main goal is to preserve the continuum of care,” he added.

Another concern – although data are limited – is that treatment might also increase risk of mortality among cancer patients with COVID-19, according to a cohort study of nearly 1,000 such patients reported May 2020 in The Lancet. Dr. Massuti, who was not affiliated with the research, noted that 12% of the patients had GI tumors. In addition to increased risk associated with male sex (odds ratio, 1.63), cytotoxic cancer treatment in the prior 4 weeks increased risk (OR, 1.47), as did surgery in the same time frame (OR, 1.52).

“This means patients on treatment have an increased risk of mortality,” Dr. Massuti said.
 

Moving forward

Implementing telehealth information and communication technologies will continue to grow in importance, Dr. Massuti said. Dr. Aslam noted that video consultation with patients before surgery is already replacing face-to-face interaction, and most follow-up care at his hospital is now done by telephone.

Postoperative care is just as essential in the COVID-19 era, if not more so. “We need to be very vigilant to manage postoperative complications – any symptoms of pyrexia or sepsis, or any sign of COVID,” Dr. Aslam said, including postoperative fever. “If there is any doubt, do a chest CT scan.”

Dr. Aslam predicted the time to perform endoscopy or surgery for each patient will be longer, “so the number of patients done in 1 day will be less than 4 months ago.” In addition, elective surgery patients at his institution undergo COVID-19 testing twice, 3 days apart, prior to intervention.

“This disease will continue in the community for a while, so we have to continue what we’ve done well, like social distancing,” Dr. Aslam said. “We’ve gone through a storm and we are awaiting a tsunami. That tsunami of patients will overwhelm us in the coming months.”

Dr. Martinez, Dr. Massuti, and Dr. Aslam had no relevant disclosures.

An expected surge in the number of people seeking colonoscopy after the peak of the COVID-19 pandemic passes could cause physicians to rethink patient prioritization, could create a strain on endoscopy capacity, and might raise the specter of detecting colorectal cancer in more patients at a later stage of disease.

Furthermore, months of delay in diagnosis of colorectal cancer (CRC) could shorten survival, although more data is needed, according to expert analysis from a gastroenterologist, a medical oncologist, and a colorectal surgeon.

“It has been a big decrease in the number of colonoscopies performed at our hospital in Alicante, Spain,” Rodrigo Jover Martinez, MD, PhD, said during a COVID-19 and Digestive Health webinar presented by United European Gastroenterology (UEG). He estimated colonoscopy procedures are down 60%-90%, and the number of CRC surgeries has dropped by 60%. “As you know, the COVID-19 pandemic is hitting Europe hard.”

When patients do return, “the backlog will be huge ... in already exhausted endoscopy units,” predicted Dr. Martinez, a gastroenterologist at Hospital General Universitario in Alicante.
 

Multiple risks

Not knowing which patients with CRC will develop severe COVID-19 infection is another challenge, Bartomeu Massuti, MD, of the medical oncology service at the Hospital General Universitario de Alicante, said during the webinar.

Caution is warranted because “we know cancer patients have an increased risk of infection.” However, he added, most evidence supports an elevated risk for bacterial infections, not viral infections.

Therefore, physicians must continue to balance the risks associated with potential COVID-19 exposure against the risks associated with postponed treatment, Dr. Massuti said. “The goal of oncology care is to try to maintain the preplanned treatment and follow-up. We need mainly to avoid stopping or delaying treatment ... because we will lose efficacy in oncology disease outcomes.”

Imran Aslam, MD, PhD, a colorectal surgeon who moderated and presented during the webinar, agreed: “By delaying the treatment, we might do harm to our patients.”

Dr. Aslam cited data about clinical costs of delaying CRC surgery. A 2019 population-based study in PLOS ONE evaluated different times from diagnosis to treatment. The researchers found a delay of more than 150 days “significantly reduced survival, even during stage I, II, and III disease,” he said. The stage I hazard ratio was 2.66, compared with a reference HR of 1.00 for 90 days or fewer. They also reported elevated risk for people with stage II CRC (HR, 2.80), stage III CRC (HR, 2.70), and stage IV CRC (HR, 1.36).

“This could become more and more abysmal if the pandemic continues,” added Dr. Aslam, consultant colorectal surgeon at University Hospitals of Coventry and Warwickshire, England.
 

Prioritizing patients

Restarting endoscopy with prioritization strategies and increasing patient capacity are possible solutions. Dr. Martinez suggested a four-quadrant matrix in which physicians place patients into “now,” “next,” “delayed,” or “never” categories based on clinical indicators. The priority 1 “now” patients, for example, will be those with suspected CRC based on physical examination, imaging results, and/or an abnormal fecal immunochemical test result.

He suggested, furthermore, that more widespread CRC screening can resume once “endoscopy units have been alleviated of priority 1, symptomatic patients.”

Dr. Massuti concurred with Dr. Martinez’s call to prioritize patients carefully. He suggested a green, yellow, and red classification system based on treatment priority recommendations from the European Society for Medical Oncology. The green group, for example, should receive priority for intervention based on a condition that is immediately clinically unstable or life threatening.

“The main goal is to preserve the continuum of care,” he added.

Another concern – although data are limited – is that treatment might also increase risk of mortality among cancer patients with COVID-19, according to a cohort study of nearly 1,000 such patients reported May 2020 in The Lancet. Dr. Massuti, who was not affiliated with the research, noted that 12% of the patients had GI tumors. In addition to increased risk associated with male sex (odds ratio, 1.63), cytotoxic cancer treatment in the prior 4 weeks increased risk (OR, 1.47), as did surgery in the same time frame (OR, 1.52).

“This means patients on treatment have an increased risk of mortality,” Dr. Massuti said.
 

Moving forward

Implementing telehealth information and communication technologies will continue to grow in importance, Dr. Massuti said. Dr. Aslam noted that video consultation with patients before surgery is already replacing face-to-face interaction, and most follow-up care at his hospital is now done by telephone.

Postoperative care is just as essential in the COVID-19 era, if not more so. “We need to be very vigilant to manage postoperative complications – any symptoms of pyrexia or sepsis, or any sign of COVID,” Dr. Aslam said, including postoperative fever. “If there is any doubt, do a chest CT scan.”

Dr. Aslam predicted the time to perform endoscopy or surgery for each patient will be longer, “so the number of patients done in 1 day will be less than 4 months ago.” In addition, elective surgery patients at his institution undergo COVID-19 testing twice, 3 days apart, prior to intervention.

“This disease will continue in the community for a while, so we have to continue what we’ve done well, like social distancing,” Dr. Aslam said. “We’ve gone through a storm and we are awaiting a tsunami. That tsunami of patients will overwhelm us in the coming months.”

Dr. Martinez, Dr. Massuti, and Dr. Aslam had no relevant disclosures.

Second only to the American Society of Clinical Oncology, the volunteer leaders of the American College of Rheumatology with ties to industry received the highest median payment amounts, a new cross-sectional study reveals.

Total research payments exceeded $54 million to ASCO leaders and $20 million to ACR leaders, for example. The investigators identified the 10 most common and costly conditions in the United States – including heart disease, trauma-related disorders, mental disorders, and others. They then used a new national database to explore the financial relationships between pharmaceutical and device manufacturers and the leaders of “influential U.S. professional medical associations active across these disease areas.” Steven Echard, executive vice president of the American College of Rheumatology, responded to the study findings, published in the BMJ. “We require our leaders to tell us about any payments they receive as part of their professional and personal activities that may pose actual or potential conflicts, post this information transparently to our website, and adjust what projects and initiatives they can participate in to avoid any undue influence,” he said in an interview.

“Many of the disclosures included in the study were due to individuals participating in research projects to move the needle forward in the care of rheumatology patients,” he added.

There remains an ongoing debate about how close the relationships should be between medical associations and industry, wrote lead author Ray Moynihan, PhD, assistant professor in the Institute for Evidence-Based Healthcare at Bond University, Gold Coast, Australia, and colleagues.
 

Majority report relationship with industry

Dr. Moynihan and associates conducted the first study to evaluate these relationships in such detail. Using the U.S. government’s Open Payments database, established in 2013, they assessed research payments and general payments for consultancy, royalties, and hospitality. The study included the current year of board membership, as well as the 4 years prior and 1 year after membership.

Overall, out of 293 physician association leaders, 235 or 80% had a financial relationship. None of the associations in the study featured a leadership free of financial ties.

Payments totaled almost $130 million, including nearly $25 million in general payments, almost $105 million for research, and about half a million in other payments. The research payments went primarily to institutions with leaders named as principal investigators, they noted.

“The most common misperception [in the BMJ study] is that all the funding identified represents personal payments to the individuals,” Mr. Echard said. “Because research dollars are included, almost 80% of the payments referenced in the article – sometimes more – go to individuals’ academic institutions.” These funds cover overhead, lab materials, protected time for said research, research assistant salaries, and other expenses.

“We have other board of director members who have no industry relationships at all,” he added.
 

Part of business model

“Faculty members are expected to bring in funding to support research, so most academic institutions receive industry funding, and it’s considered part of their business model,” Mr. Echard said. “For this reason, we generally do not consider these payments the same as being on advisory boards, speakers bureaus, or going to dinners, etc.”

The median total amounts linked to individual leaders varied between associations. For example, the median amount was $518,000 for ASCO leaders, as previously reported by Medscape Medical News.

Volunteer leaders for the ACR received a median $251,000. Not all ACR board of director members receive funding in this range, Mr. Echard said. “We have board of director members who work at academic institutions that can receive funding that high due to their participation in research studies, particularly when looking over a 4-year period prior to their leadership role, as the study did.”

At the lower end, median total payments were $404 for leaders of the American College of Physicians and $212 for those of the American Psychiatric Association.

In an accompanying editorial, Jake Checketts, DO, and Matt Vassar, PhD, of the Oklahoma State University Center for Health Sciences, Tulsa, proposed five actions that “could mitigate or even eliminate the overwhelming presence of financial conflicts of interest among medical societies and associations. This would protect these groups from producing biased documents or policies, which in turn would protect all physicians and the patients they treat.”

They made five proposals:

• Each association must take the initiative to evaluate its present conflicts using open payments.
• Associations should alter their recruitment processes to yield balanced and diverse groups of physician leaders largely free from financial conflicts of interest.
• The creation of standards for promoting medical associations that are free from financial conflicts of interest, similar to the framework within the Institute of Medicine’s standards for producing clinical practice guidelines we can trust.
• Greater reliance on the Sunshine Act and open payments in the United States (and elsewhere for countries with similar data) could eliminate the need for the traditional “honor system” of financial self-disclosure, which is ineffective and inaccurate at best.
• All medical associations, guidelines groups, and policy makers provide links from their documents and websites to open payments data for each U.S.-based physician contributor. Such links would make it easier for anyone, including patients, to evaluate any risk of bias.

On a final note, the ACR prohibits key college leaders, including the ACR president, ACR president-elect, foundation president, and others from having direct financial ties to commercial entities in their conflict of interest guidelines.

“We agree that actively managing conflict of interest is important to maintaining the integrity and reputation of an association with the medical community and with the public,” Mr. Echard said. “And all actual, potential, and perceived conflicts of interest should be addressed and managed through a disclosure process.”

Several authors of the study reported receiving grants from the Australian National Health and Medical Research Council. Mr. Echard, Dr. Checketts, and Dr. Vassar had no relevant disclosures.

SOURCE: Moynihan R et al. BMJ. 2020;369:m1505.

Second only to the American Society of Clinical Oncology, the volunteer leaders of the American College of Rheumatology with ties to industry received the highest median payment amounts, a new cross-sectional study reveals.

Total research payments exceeded $54 million to ASCO leaders and $20 million to ACR leaders, for example. The investigators identified the 10 most common and costly conditions in the United States – including heart disease, trauma-related disorders, mental disorders, and others. They then used a new national database to explore the financial relationships between pharmaceutical and device manufacturers and the leaders of “influential U.S. professional medical associations active across these disease areas.” Steven Echard, executive vice president of the American College of Rheumatology, responded to the study findings, published in the BMJ. “We require our leaders to tell us about any payments they receive as part of their professional and personal activities that may pose actual or potential conflicts, post this information transparently to our website, and adjust what projects and initiatives they can participate in to avoid any undue influence,” he said in an interview.

“Many of the disclosures included in the study were due to individuals participating in research projects to move the needle forward in the care of rheumatology patients,” he added.

There remains an ongoing debate about how close the relationships should be between medical associations and industry, wrote lead author Ray Moynihan, PhD, assistant professor in the Institute for Evidence-Based Healthcare at Bond University, Gold Coast, Australia, and colleagues.
 

Majority report relationship with industry

Dr. Moynihan and associates conducted the first study to evaluate these relationships in such detail. Using the U.S. government’s Open Payments database, established in 2013, they assessed research payments and general payments for consultancy, royalties, and hospitality. The study included the current year of board membership, as well as the 4 years prior and 1 year after membership.

Overall, out of 293 physician association leaders, 235 or 80% had a financial relationship. None of the associations in the study featured a leadership free of financial ties.

Payments totaled almost $130 million, including nearly $25 million in general payments, almost $105 million for research, and about half a million in other payments. The research payments went primarily to institutions with leaders named as principal investigators, they noted.

“The most common misperception [in the BMJ study] is that all the funding identified represents personal payments to the individuals,” Mr. Echard said. “Because research dollars are included, almost 80% of the payments referenced in the article – sometimes more – go to individuals’ academic institutions.” These funds cover overhead, lab materials, protected time for said research, research assistant salaries, and other expenses.

“We have other board of director members who have no industry relationships at all,” he added.
 

Part of business model

“Faculty members are expected to bring in funding to support research, so most academic institutions receive industry funding, and it’s considered part of their business model,” Mr. Echard said. “For this reason, we generally do not consider these payments the same as being on advisory boards, speakers bureaus, or going to dinners, etc.”

The median total amounts linked to individual leaders varied between associations. For example, the median amount was $518,000 for ASCO leaders, as previously reported by Medscape Medical News.

Volunteer leaders for the ACR received a median $251,000. Not all ACR board of director members receive funding in this range, Mr. Echard said. “We have board of director members who work at academic institutions that can receive funding that high due to their participation in research studies, particularly when looking over a 4-year period prior to their leadership role, as the study did.”

At the lower end, median total payments were $404 for leaders of the American College of Physicians and $212 for those of the American Psychiatric Association.

In an accompanying editorial, Jake Checketts, DO, and Matt Vassar, PhD, of the Oklahoma State University Center for Health Sciences, Tulsa, proposed five actions that “could mitigate or even eliminate the overwhelming presence of financial conflicts of interest among medical societies and associations. This would protect these groups from producing biased documents or policies, which in turn would protect all physicians and the patients they treat.”

They made five proposals:

• Each association must take the initiative to evaluate its present conflicts using open payments.
• Associations should alter their recruitment processes to yield balanced and diverse groups of physician leaders largely free from financial conflicts of interest.
• The creation of standards for promoting medical associations that are free from financial conflicts of interest, similar to the framework within the Institute of Medicine’s standards for producing clinical practice guidelines we can trust.
• Greater reliance on the Sunshine Act and open payments in the United States (and elsewhere for countries with similar data) could eliminate the need for the traditional “honor system” of financial self-disclosure, which is ineffective and inaccurate at best.
• All medical associations, guidelines groups, and policy makers provide links from their documents and websites to open payments data for each U.S.-based physician contributor. Such links would make it easier for anyone, including patients, to evaluate any risk of bias.

On a final note, the ACR prohibits key college leaders, including the ACR president, ACR president-elect, foundation president, and others from having direct financial ties to commercial entities in their conflict of interest guidelines.

“We agree that actively managing conflict of interest is important to maintaining the integrity and reputation of an association with the medical community and with the public,” Mr. Echard said. “And all actual, potential, and perceived conflicts of interest should be addressed and managed through a disclosure process.”

Several authors of the study reported receiving grants from the Australian National Health and Medical Research Council. Mr. Echard, Dr. Checketts, and Dr. Vassar had no relevant disclosures.

SOURCE: Moynihan R et al. BMJ. 2020;369:m1505.

Second only to the American Society of Clinical Oncology, the volunteer leaders of the American College of Rheumatology with ties to industry received the highest median payment amounts, a new cross-sectional study reveals.

Total research payments exceeded $54 million to ASCO leaders and $20 million to ACR leaders, for example. The investigators identified the 10 most common and costly conditions in the United States – including heart disease, trauma-related disorders, mental disorders, and others. They then used a new national database to explore the financial relationships between pharmaceutical and device manufacturers and the leaders of “influential U.S. professional medical associations active across these disease areas.” Steven Echard, executive vice president of the American College of Rheumatology, responded to the study findings, published in the BMJ. “We require our leaders to tell us about any payments they receive as part of their professional and personal activities that may pose actual or potential conflicts, post this information transparently to our website, and adjust what projects and initiatives they can participate in to avoid any undue influence,” he said in an interview.

“Many of the disclosures included in the study were due to individuals participating in research projects to move the needle forward in the care of rheumatology patients,” he added.

There remains an ongoing debate about how close the relationships should be between medical associations and industry, wrote lead author Ray Moynihan, PhD, assistant professor in the Institute for Evidence-Based Healthcare at Bond University, Gold Coast, Australia, and colleagues.
 

Majority report relationship with industry

Dr. Moynihan and associates conducted the first study to evaluate these relationships in such detail. Using the U.S. government’s Open Payments database, established in 2013, they assessed research payments and general payments for consultancy, royalties, and hospitality. The study included the current year of board membership, as well as the 4 years prior and 1 year after membership.

Overall, out of 293 physician association leaders, 235 or 80% had a financial relationship. None of the associations in the study featured a leadership free of financial ties.

Payments totaled almost $130 million, including nearly $25 million in general payments, almost $105 million for research, and about half a million in other payments. The research payments went primarily to institutions with leaders named as principal investigators, they noted.

“The most common misperception [in the BMJ study] is that all the funding identified represents personal payments to the individuals,” Mr. Echard said. “Because research dollars are included, almost 80% of the payments referenced in the article – sometimes more – go to individuals’ academic institutions.” These funds cover overhead, lab materials, protected time for said research, research assistant salaries, and other expenses.

“We have other board of director members who have no industry relationships at all,” he added.
 

Part of business model

“Faculty members are expected to bring in funding to support research, so most academic institutions receive industry funding, and it’s considered part of their business model,” Mr. Echard said. “For this reason, we generally do not consider these payments the same as being on advisory boards, speakers bureaus, or going to dinners, etc.”

The median total amounts linked to individual leaders varied between associations. For example, the median amount was $518,000 for ASCO leaders, as previously reported by Medscape Medical News.

Volunteer leaders for the ACR received a median $251,000. Not all ACR board of director members receive funding in this range, Mr. Echard said. “We have board of director members who work at academic institutions that can receive funding that high due to their participation in research studies, particularly when looking over a 4-year period prior to their leadership role, as the study did.”

At the lower end, median total payments were $404 for leaders of the American College of Physicians and $212 for those of the American Psychiatric Association.

In an accompanying editorial, Jake Checketts, DO, and Matt Vassar, PhD, of the Oklahoma State University Center for Health Sciences, Tulsa, proposed five actions that “could mitigate or even eliminate the overwhelming presence of financial conflicts of interest among medical societies and associations. This would protect these groups from producing biased documents or policies, which in turn would protect all physicians and the patients they treat.”

They made five proposals:

• Each association must take the initiative to evaluate its present conflicts using open payments.
• Associations should alter their recruitment processes to yield balanced and diverse groups of physician leaders largely free from financial conflicts of interest.
• The creation of standards for promoting medical associations that are free from financial conflicts of interest, similar to the framework within the Institute of Medicine’s standards for producing clinical practice guidelines we can trust.
• Greater reliance on the Sunshine Act and open payments in the United States (and elsewhere for countries with similar data) could eliminate the need for the traditional “honor system” of financial self-disclosure, which is ineffective and inaccurate at best.
• All medical associations, guidelines groups, and policy makers provide links from their documents and websites to open payments data for each U.S.-based physician contributor. Such links would make it easier for anyone, including patients, to evaluate any risk of bias.

On a final note, the ACR prohibits key college leaders, including the ACR president, ACR president-elect, foundation president, and others from having direct financial ties to commercial entities in their conflict of interest guidelines.

“We agree that actively managing conflict of interest is important to maintaining the integrity and reputation of an association with the medical community and with the public,” Mr. Echard said. “And all actual, potential, and perceived conflicts of interest should be addressed and managed through a disclosure process.”

Several authors of the study reported receiving grants from the Australian National Health and Medical Research Council. Mr. Echard, Dr. Checketts, and Dr. Vassar had no relevant disclosures.

SOURCE: Moynihan R et al. BMJ. 2020;369:m1505.

The death of George Floyd and other African Americans spurred the Association of Black Cardiologists, the American Heart Association, and the American College of Cardiology to join forces and issue an urgent letter denouncing recent and ongoing events.

Starting off by acknowledging that these are “difficult and disturbing times,” the presidents of the three societies tied the violence into the bigger public health picture. “Like cardiovascular disease, acts of violence and racism are core causes of psychosocial stress that promote poor well-being and cardiovascular health, especially for communities of color.”

“It’s not just one quick solution, one quick letter. It’s more of an ongoing project to raise awareness and have really defined projects. We want to have goals, tactics, and measurable outcomes. We want to make sure it’s not just a banner on the wall,” Athena Poppas, MD, president of the American College of Cardiology and one of three physicians signing the letter, said in an interview.

The Association of Black Cardiologists drafted the statement and asked the AHA and ACC if they wanted to sign on. “It felt important to join them and follow their lead,” she said. “There is a clear link between psychosocial stress and discrimination and health equity in the communities.”

Interestingly, the ABC and ACC have an existing partnership, one that included creating a “Campaign for the Future” a little more than a year ago. One of the focuses is on reducing health disparities and starting a diversity and inclusion task force that later became a committee. The groups held a joint board of trustees meeting at Morehouse University, Atlanta, in January 2020. Thinking about that time, Dr. Poppas added, “who knew what was about to transpire over the next few months?”

The letter is only one component of an ongoing effort to “find concrete ways to make change, both within the college and within our profession,” added Dr. Poppas, chief of cardiology and professor of medicine at Brown University, Providence, R.I., and director of the Lifespan Cardiovascular Institute of Rhode Island, Miriam Hospitals, and Newport Hospitals. “Thereby, there is good data that you affect health equity in the population as well.”

“We DENOUNCE incidents of racism and violence that continue to ravage our communities,” the society leaders wrote in the letter. “Given that heart disease and stroke are the leading causes of death for communities of color, particularly African Americans who have the lowest life expectancy of all racial/ethnic groups living in the United States, we are extremely disturbed by violent acts that cut to the core of the lives of our community.”

Other societies released similar statements. For example, the American College of Physicians expressed “grave concern” about recent events and the American Medical Association released a statement entitled “Police brutality must stop.”

A cardiologist speaks out

“Thank you to my organizations, the Association of Black Cardiologists and the American College of Cardiology, for taking a stand,” Travis C. Batts, MD, said in a video statement posted to YouTube on June 2, 2020.

“As an African American male who has sons, brothers, and friends who are also African American, I oftentimes have angst, particularly with my sons. Despite what I do to create an environment that cultivates education and puts them in the right position, there are some people who would stop just at how they look when they approach them,” Dr. Batts said.

“I always have that fear as a father that at some point they may engage with law enforcement – and it may not turn out the way we want it to,” said Dr. Batts, chairman of medical sub-specialties and medical director of the cardiology clinic at Wilford Hall Ambulatory Surgical Center at Lackland Air Force Base, Tex. He also is an associate professor of cardiovascular medicine for the Uniformed Services University of the Health Sciences, Bethesda, Md., and is an adjunct assistant professor at Texas A&M University. He went on in the video to describe how a personal encounter with police years ago changed his life.

The urgent letter from the cardiology societies speaks to health care disparities, Dr. Batts said, “but it doesn’t stop there. It talks about their goals to balance these issues that we see as a pervasive problem in our community.”

The societies point out that George Floyd’s death is not an isolated incident. “Mr. Floyd’s death comes on the heels of other recent incidents caught on camera. In another 2020 incident, Ahmaud Arbery was shot and killed while jogging in his hometown of Brunswick, Ga. Christian Cooper is fortunately alive and well to speak to the Memorial Day incident in New York’s Central Park where he was accused of threatening the life of a woman while bird watching.” They added that “another senseless death involves officers entering the Louisville, Kent., home of emergency medical technician Breonna Taylor.”

Dr. Batts said this portion of the statement was particularly poignant: “We stand and link arms in solidarity with efforts to dismantle systems that maintain excess morbidity and mortality, especially among vulnerable populations and those historically oppressed. Indeed, our collective vast membership, many of whom are at the front lines of clinical health care, has taken an oath to decisively and with kindness, compassion and grace act to relieve suffering related to ‘I can’t breathe’ in order to preserve life.”

A Positive Response

The response to the urgent letter has been “overwhelmingly positive,” Dr. Poppas said. “This isn’t political, per se. This is really about justice, about health equity, and about being moral and conscious human beings. People I hadn’t heard from in years said, ‘thank you for doing this.’ ” The comments on social media were “almost uniformly positive,” she added. “There is always one or two people who feel this isn’t what cardiology is about.”

“Although making a statement is important, so is doing the hard work to make change,” Dr. Poppas said. The goal involves “rolling up our sleeves and spending the time, the money and the energy to make changes – so 5-10 years from now, it looks different.”

In addition to Dr. Poppas, Michelle A. Albert, MD, MPH, president of the Association of Black Cardiologists and Robert A. Harrington, MD, president of the American Heart Association, signed the letter. Dr. Pappas and Dr. Batts had no relevant disclosures.

The death of George Floyd and other African Americans spurred the Association of Black Cardiologists, the American Heart Association, and the American College of Cardiology to join forces and issue an urgent letter denouncing recent and ongoing events.

Starting off by acknowledging that these are “difficult and disturbing times,” the presidents of the three societies tied the violence into the bigger public health picture. “Like cardiovascular disease, acts of violence and racism are core causes of psychosocial stress that promote poor well-being and cardiovascular health, especially for communities of color.”

“It’s not just one quick solution, one quick letter. It’s more of an ongoing project to raise awareness and have really defined projects. We want to have goals, tactics, and measurable outcomes. We want to make sure it’s not just a banner on the wall,” Athena Poppas, MD, president of the American College of Cardiology and one of three physicians signing the letter, said in an interview.

The Association of Black Cardiologists drafted the statement and asked the AHA and ACC if they wanted to sign on. “It felt important to join them and follow their lead,” she said. “There is a clear link between psychosocial stress and discrimination and health equity in the communities.”

Interestingly, the ABC and ACC have an existing partnership, one that included creating a “Campaign for the Future” a little more than a year ago. One of the focuses is on reducing health disparities and starting a diversity and inclusion task force that later became a committee. The groups held a joint board of trustees meeting at Morehouse University, Atlanta, in January 2020. Thinking about that time, Dr. Poppas added, “who knew what was about to transpire over the next few months?”

The letter is only one component of an ongoing effort to “find concrete ways to make change, both within the college and within our profession,” added Dr. Poppas, chief of cardiology and professor of medicine at Brown University, Providence, R.I., and director of the Lifespan Cardiovascular Institute of Rhode Island, Miriam Hospitals, and Newport Hospitals. “Thereby, there is good data that you affect health equity in the population as well.”

“We DENOUNCE incidents of racism and violence that continue to ravage our communities,” the society leaders wrote in the letter. “Given that heart disease and stroke are the leading causes of death for communities of color, particularly African Americans who have the lowest life expectancy of all racial/ethnic groups living in the United States, we are extremely disturbed by violent acts that cut to the core of the lives of our community.”

Other societies released similar statements. For example, the American College of Physicians expressed “grave concern” about recent events and the American Medical Association released a statement entitled “Police brutality must stop.”

A cardiologist speaks out

“Thank you to my organizations, the Association of Black Cardiologists and the American College of Cardiology, for taking a stand,” Travis C. Batts, MD, said in a video statement posted to YouTube on June 2, 2020.

“As an African American male who has sons, brothers, and friends who are also African American, I oftentimes have angst, particularly with my sons. Despite what I do to create an environment that cultivates education and puts them in the right position, there are some people who would stop just at how they look when they approach them,” Dr. Batts said.

“I always have that fear as a father that at some point they may engage with law enforcement – and it may not turn out the way we want it to,” said Dr. Batts, chairman of medical sub-specialties and medical director of the cardiology clinic at Wilford Hall Ambulatory Surgical Center at Lackland Air Force Base, Tex. He also is an associate professor of cardiovascular medicine for the Uniformed Services University of the Health Sciences, Bethesda, Md., and is an adjunct assistant professor at Texas A&M University. He went on in the video to describe how a personal encounter with police years ago changed his life.

The urgent letter from the cardiology societies speaks to health care disparities, Dr. Batts said, “but it doesn’t stop there. It talks about their goals to balance these issues that we see as a pervasive problem in our community.”

The societies point out that George Floyd’s death is not an isolated incident. “Mr. Floyd’s death comes on the heels of other recent incidents caught on camera. In another 2020 incident, Ahmaud Arbery was shot and killed while jogging in his hometown of Brunswick, Ga. Christian Cooper is fortunately alive and well to speak to the Memorial Day incident in New York’s Central Park where he was accused of threatening the life of a woman while bird watching.” They added that “another senseless death involves officers entering the Louisville, Kent., home of emergency medical technician Breonna Taylor.”

Dr. Batts said this portion of the statement was particularly poignant: “We stand and link arms in solidarity with efforts to dismantle systems that maintain excess morbidity and mortality, especially among vulnerable populations and those historically oppressed. Indeed, our collective vast membership, many of whom are at the front lines of clinical health care, has taken an oath to decisively and with kindness, compassion and grace act to relieve suffering related to ‘I can’t breathe’ in order to preserve life.”

A Positive Response

The response to the urgent letter has been “overwhelmingly positive,” Dr. Poppas said. “This isn’t political, per se. This is really about justice, about health equity, and about being moral and conscious human beings. People I hadn’t heard from in years said, ‘thank you for doing this.’ ” The comments on social media were “almost uniformly positive,” she added. “There is always one or two people who feel this isn’t what cardiology is about.”

“Although making a statement is important, so is doing the hard work to make change,” Dr. Poppas said. The goal involves “rolling up our sleeves and spending the time, the money and the energy to make changes – so 5-10 years from now, it looks different.”

In addition to Dr. Poppas, Michelle A. Albert, MD, MPH, president of the Association of Black Cardiologists and Robert A. Harrington, MD, president of the American Heart Association, signed the letter. Dr. Pappas and Dr. Batts had no relevant disclosures.

The death of George Floyd and other African Americans spurred the Association of Black Cardiologists, the American Heart Association, and the American College of Cardiology to join forces and issue an urgent letter denouncing recent and ongoing events.

Starting off by acknowledging that these are “difficult and disturbing times,” the presidents of the three societies tied the violence into the bigger public health picture. “Like cardiovascular disease, acts of violence and racism are core causes of psychosocial stress that promote poor well-being and cardiovascular health, especially for communities of color.”

“It’s not just one quick solution, one quick letter. It’s more of an ongoing project to raise awareness and have really defined projects. We want to have goals, tactics, and measurable outcomes. We want to make sure it’s not just a banner on the wall,” Athena Poppas, MD, president of the American College of Cardiology and one of three physicians signing the letter, said in an interview.

The Association of Black Cardiologists drafted the statement and asked the AHA and ACC if they wanted to sign on. “It felt important to join them and follow their lead,” she said. “There is a clear link between psychosocial stress and discrimination and health equity in the communities.”

Interestingly, the ABC and ACC have an existing partnership, one that included creating a “Campaign for the Future” a little more than a year ago. One of the focuses is on reducing health disparities and starting a diversity and inclusion task force that later became a committee. The groups held a joint board of trustees meeting at Morehouse University, Atlanta, in January 2020. Thinking about that time, Dr. Poppas added, “who knew what was about to transpire over the next few months?”

The letter is only one component of an ongoing effort to “find concrete ways to make change, both within the college and within our profession,” added Dr. Poppas, chief of cardiology and professor of medicine at Brown University, Providence, R.I., and director of the Lifespan Cardiovascular Institute of Rhode Island, Miriam Hospitals, and Newport Hospitals. “Thereby, there is good data that you affect health equity in the population as well.”

“We DENOUNCE incidents of racism and violence that continue to ravage our communities,” the society leaders wrote in the letter. “Given that heart disease and stroke are the leading causes of death for communities of color, particularly African Americans who have the lowest life expectancy of all racial/ethnic groups living in the United States, we are extremely disturbed by violent acts that cut to the core of the lives of our community.”

Other societies released similar statements. For example, the American College of Physicians expressed “grave concern” about recent events and the American Medical Association released a statement entitled “Police brutality must stop.”

A cardiologist speaks out

“Thank you to my organizations, the Association of Black Cardiologists and the American College of Cardiology, for taking a stand,” Travis C. Batts, MD, said in a video statement posted to YouTube on June 2, 2020.

“As an African American male who has sons, brothers, and friends who are also African American, I oftentimes have angst, particularly with my sons. Despite what I do to create an environment that cultivates education and puts them in the right position, there are some people who would stop just at how they look when they approach them,” Dr. Batts said.

“I always have that fear as a father that at some point they may engage with law enforcement – and it may not turn out the way we want it to,” said Dr. Batts, chairman of medical sub-specialties and medical director of the cardiology clinic at Wilford Hall Ambulatory Surgical Center at Lackland Air Force Base, Tex. He also is an associate professor of cardiovascular medicine for the Uniformed Services University of the Health Sciences, Bethesda, Md., and is an adjunct assistant professor at Texas A&M University. He went on in the video to describe how a personal encounter with police years ago changed his life.

The urgent letter from the cardiology societies speaks to health care disparities, Dr. Batts said, “but it doesn’t stop there. It talks about their goals to balance these issues that we see as a pervasive problem in our community.”

The societies point out that George Floyd’s death is not an isolated incident. “Mr. Floyd’s death comes on the heels of other recent incidents caught on camera. In another 2020 incident, Ahmaud Arbery was shot and killed while jogging in his hometown of Brunswick, Ga. Christian Cooper is fortunately alive and well to speak to the Memorial Day incident in New York’s Central Park where he was accused of threatening the life of a woman while bird watching.” They added that “another senseless death involves officers entering the Louisville, Kent., home of emergency medical technician Breonna Taylor.”

Dr. Batts said this portion of the statement was particularly poignant: “We stand and link arms in solidarity with efforts to dismantle systems that maintain excess morbidity and mortality, especially among vulnerable populations and those historically oppressed. Indeed, our collective vast membership, many of whom are at the front lines of clinical health care, has taken an oath to decisively and with kindness, compassion and grace act to relieve suffering related to ‘I can’t breathe’ in order to preserve life.”

A Positive Response

The response to the urgent letter has been “overwhelmingly positive,” Dr. Poppas said. “This isn’t political, per se. This is really about justice, about health equity, and about being moral and conscious human beings. People I hadn’t heard from in years said, ‘thank you for doing this.’ ” The comments on social media were “almost uniformly positive,” she added. “There is always one or two people who feel this isn’t what cardiology is about.”

“Although making a statement is important, so is doing the hard work to make change,” Dr. Poppas said. The goal involves “rolling up our sleeves and spending the time, the money and the energy to make changes – so 5-10 years from now, it looks different.”

In addition to Dr. Poppas, Michelle A. Albert, MD, MPH, president of the Association of Black Cardiologists and Robert A. Harrington, MD, president of the American Heart Association, signed the letter. Dr. Pappas and Dr. Batts had no relevant disclosures.