A significant number of teenage blood donors already have low iron stores before they donate blood, and approximately 15% of males and one-third of females may be iron depleted 1 year after a red blood cell donation, according to a study published online in Pediatrics.

copyrightSaipg/iStockphoto

“Our findings ... support the strong encouragement of postdonation low-dose iron supplements, at least in teenagers with already low or borderline iron stores,” said Ralph R. Vassallo, MD and colleagues. An increased interdonation interval for teenage blood donors may need to be considered. Dr. Vassallo is executive vice president and chief medical and scientific officer at Vitalant, a community blood service provider based in Scottsdale, Ariz., that collects approximately 14% of the U.S. blood supply.
 

Data from a safety initiative

Iron deficiency may erode exercise performance, lead to pica, and have subtle cognitive effects. Iron that is lost during blood donation may be difficult to replace on an average Western diet, the researchers said. Knowledge of the time course of iron recovery is limited, and recent studies have found high rates of mild iron depletion or absent stores in teenage blood donors.

As a safety initiative, Vitalant began serum ferritin testing of predonation specimens from successful donations by 16- to 18-year-old donors to identify iron deficiency. The researchers defined inadequate iron stores as ferritin values less than 20 ng/mL in female donors and less than 30 ng/mL in male donors.

While whole-blood donors generally were deferred from red blood cell donation for 56 days and double red blood cell donors were deferred from any donation for 112 days, teenagers found to have low ferritin were deferred longer: 12 months for females and 6 months for males. Teenagers with low ferritin also were counseled by letter to take low-dose (18-28 mg) iron for 60 days.

Vitalant began conducting serum ferritin tests on Dec. 19, 2016, and the researchers analyzed data that were available through Dec. 31, 2018. The study included data from teen donors aged 16-18 years from 24 states.

In all, 125,384 teenagers donated whole blood or double red blood cells at least once, and 39% of females and 12% of males had a low-index ferritin value. The researchers focused on 30,806 teenagers (24.6%) who returned and successfully donated again within 25 months. In this cohort, 11% of female donors and 10% of male donors had a low-index ferritin value.

Twelve months after the first whole-blood donation, 80%-90% of males and 60%-70% of females had adequate iron stores. These proportions were about 10% lower for double red blood cell donors.

Among whole-blood donors, the percentage of donors with adequate iron stores at a follow-up donation “is highly dependent on index ferritin,” Dr. Vassallo and colleagues reported. For 90% of donors to have adequate iron stores within 3-9 months of index donation, index ferritin values had to be at least 47 ng/mL for males and 53 ng/mL for females, according to their analysis.

“At least 12 months are required for a sizeable proportion to reach next-donation ferritin values indicative of adequate iron stores,” the researchers said. “However, donor sex, donation type, first-time versus repeat status, and ferritin level at index were significant determinants of iron stores at the follow-up donation.”

“The enthusiasm of altruistic, highly motivated young donors makes large high school and college blood drives efficient and productive,” but these donors may be at increased risk for donation-related iron depletion, they said.

The estimated intervals needed to replenish iron stores represent best-case scenarios, the authors noted. The cohort did not include individuals deferred for low hemoglobin, likely due to iron deficiency, and these donors probably require more time to replenish iron stores.

The data suggest that health care providers should consider blood donation as a possible cause of low hemoglobin, Dr. Vassallo and colleagues said. Before prescribing higher doses of iron, however, physicians should assess a patient’s risk for other causes of iron deficiency such as gastrointestinal blood loss or celiac disease.
 

Shift collection efforts away from teenagers?

Vitalant’s findings “are of considerable value to other organizations collecting blood from teenagers,” Alan E. Mast, MD, PhD, said in an accompanying editorial. Dr. Mast is medical director and senior investigator at Versiti Blood Research Institute and associate professor of cell biology, neurobiology, and anatomy at Medical College of Wisconsin in Milwaukee. “The data presented confirm the high baseline level of iron deficiency in teenagers and its increase after blood donation. Pediatricians should be aware of the large number of teenagers donating blood in the United States, consider routinely asking about blood donation during routine physical examinations, and perform appropriate laboratory screening and treatment of iron deficiency.”

High school blood drives are a cost-effective way to collect blood, and stricter regulations on the collection of blood from teenagers may “have a detrimental effect on the blood supply,” Dr. Mast said. Nevertheless, “efforts should be made to reverse the trend of increasing collections from teenagers with increased emphasis on collection from adults.”

AABB (previously known as the American Association of Blood Banks), an organization of professionals who practice transfusion medicine, recommended in 2017 that blood collection agencies limit donors aged 16-18 years to one whole-blood donation per year, dispense iron supplements, or perform ferritin testing to advise donors about further steps, Dr. Mast noted.

“In the absence of other interventions, 1 year should be the minimum interdonation interval for teenagers,” said Dr. Mast. “If ferritin testing is performed, teenagers with ferritin levels [greater than] 50 ng/mL at index donation could perhaps donate twice per year.”

Dr. Vassallo has received payment from Fresenius Kabi and HemaStrat for scientific advisory board membership. Dr. Mast receives research funding from Novo Nordisk and has received honoraria for serving on Novo Nordisk advisory boards. He received no external funding for his commentary.

jremaly@mdedge.com

SOURCE: Vassallo RR et al. Pediatrics. 2020 Jun 5. doi: 10.1542/peds.2019-3316.

A significant number of teenage blood donors already have low iron stores before they donate blood, and approximately 15% of males and one-third of females may be iron depleted 1 year after a red blood cell donation, according to a study published online in Pediatrics.

copyrightSaipg/iStockphoto

“Our findings ... support the strong encouragement of postdonation low-dose iron supplements, at least in teenagers with already low or borderline iron stores,” said Ralph R. Vassallo, MD and colleagues. An increased interdonation interval for teenage blood donors may need to be considered. Dr. Vassallo is executive vice president and chief medical and scientific officer at Vitalant, a community blood service provider based in Scottsdale, Ariz., that collects approximately 14% of the U.S. blood supply.
 

Data from a safety initiative

Iron deficiency may erode exercise performance, lead to pica, and have subtle cognitive effects. Iron that is lost during blood donation may be difficult to replace on an average Western diet, the researchers said. Knowledge of the time course of iron recovery is limited, and recent studies have found high rates of mild iron depletion or absent stores in teenage blood donors.

As a safety initiative, Vitalant began serum ferritin testing of predonation specimens from successful donations by 16- to 18-year-old donors to identify iron deficiency. The researchers defined inadequate iron stores as ferritin values less than 20 ng/mL in female donors and less than 30 ng/mL in male donors.

While whole-blood donors generally were deferred from red blood cell donation for 56 days and double red blood cell donors were deferred from any donation for 112 days, teenagers found to have low ferritin were deferred longer: 12 months for females and 6 months for males. Teenagers with low ferritin also were counseled by letter to take low-dose (18-28 mg) iron for 60 days.

Vitalant began conducting serum ferritin tests on Dec. 19, 2016, and the researchers analyzed data that were available through Dec. 31, 2018. The study included data from teen donors aged 16-18 years from 24 states.

In all, 125,384 teenagers donated whole blood or double red blood cells at least once, and 39% of females and 12% of males had a low-index ferritin value. The researchers focused on 30,806 teenagers (24.6%) who returned and successfully donated again within 25 months. In this cohort, 11% of female donors and 10% of male donors had a low-index ferritin value.

Twelve months after the first whole-blood donation, 80%-90% of males and 60%-70% of females had adequate iron stores. These proportions were about 10% lower for double red blood cell donors.

Among whole-blood donors, the percentage of donors with adequate iron stores at a follow-up donation “is highly dependent on index ferritin,” Dr. Vassallo and colleagues reported. For 90% of donors to have adequate iron stores within 3-9 months of index donation, index ferritin values had to be at least 47 ng/mL for males and 53 ng/mL for females, according to their analysis.

“At least 12 months are required for a sizeable proportion to reach next-donation ferritin values indicative of adequate iron stores,” the researchers said. “However, donor sex, donation type, first-time versus repeat status, and ferritin level at index were significant determinants of iron stores at the follow-up donation.”

“The enthusiasm of altruistic, highly motivated young donors makes large high school and college blood drives efficient and productive,” but these donors may be at increased risk for donation-related iron depletion, they said.

The estimated intervals needed to replenish iron stores represent best-case scenarios, the authors noted. The cohort did not include individuals deferred for low hemoglobin, likely due to iron deficiency, and these donors probably require more time to replenish iron stores.

The data suggest that health care providers should consider blood donation as a possible cause of low hemoglobin, Dr. Vassallo and colleagues said. Before prescribing higher doses of iron, however, physicians should assess a patient’s risk for other causes of iron deficiency such as gastrointestinal blood loss or celiac disease.
 

Shift collection efforts away from teenagers?

Vitalant’s findings “are of considerable value to other organizations collecting blood from teenagers,” Alan E. Mast, MD, PhD, said in an accompanying editorial. Dr. Mast is medical director and senior investigator at Versiti Blood Research Institute and associate professor of cell biology, neurobiology, and anatomy at Medical College of Wisconsin in Milwaukee. “The data presented confirm the high baseline level of iron deficiency in teenagers and its increase after blood donation. Pediatricians should be aware of the large number of teenagers donating blood in the United States, consider routinely asking about blood donation during routine physical examinations, and perform appropriate laboratory screening and treatment of iron deficiency.”

High school blood drives are a cost-effective way to collect blood, and stricter regulations on the collection of blood from teenagers may “have a detrimental effect on the blood supply,” Dr. Mast said. Nevertheless, “efforts should be made to reverse the trend of increasing collections from teenagers with increased emphasis on collection from adults.”

AABB (previously known as the American Association of Blood Banks), an organization of professionals who practice transfusion medicine, recommended in 2017 that blood collection agencies limit donors aged 16-18 years to one whole-blood donation per year, dispense iron supplements, or perform ferritin testing to advise donors about further steps, Dr. Mast noted.

“In the absence of other interventions, 1 year should be the minimum interdonation interval for teenagers,” said Dr. Mast. “If ferritin testing is performed, teenagers with ferritin levels [greater than] 50 ng/mL at index donation could perhaps donate twice per year.”

Dr. Vassallo has received payment from Fresenius Kabi and HemaStrat for scientific advisory board membership. Dr. Mast receives research funding from Novo Nordisk and has received honoraria for serving on Novo Nordisk advisory boards. He received no external funding for his commentary.

jremaly@mdedge.com

SOURCE: Vassallo RR et al. Pediatrics. 2020 Jun 5. doi: 10.1542/peds.2019-3316.

A significant number of teenage blood donors already have low iron stores before they donate blood, and approximately 15% of males and one-third of females may be iron depleted 1 year after a red blood cell donation, according to a study published online in Pediatrics.

copyrightSaipg/iStockphoto

“Our findings ... support the strong encouragement of postdonation low-dose iron supplements, at least in teenagers with already low or borderline iron stores,” said Ralph R. Vassallo, MD and colleagues. An increased interdonation interval for teenage blood donors may need to be considered. Dr. Vassallo is executive vice president and chief medical and scientific officer at Vitalant, a community blood service provider based in Scottsdale, Ariz., that collects approximately 14% of the U.S. blood supply.
 

Data from a safety initiative

Iron deficiency may erode exercise performance, lead to pica, and have subtle cognitive effects. Iron that is lost during blood donation may be difficult to replace on an average Western diet, the researchers said. Knowledge of the time course of iron recovery is limited, and recent studies have found high rates of mild iron depletion or absent stores in teenage blood donors.

As a safety initiative, Vitalant began serum ferritin testing of predonation specimens from successful donations by 16- to 18-year-old donors to identify iron deficiency. The researchers defined inadequate iron stores as ferritin values less than 20 ng/mL in female donors and less than 30 ng/mL in male donors.

While whole-blood donors generally were deferred from red blood cell donation for 56 days and double red blood cell donors were deferred from any donation for 112 days, teenagers found to have low ferritin were deferred longer: 12 months for females and 6 months for males. Teenagers with low ferritin also were counseled by letter to take low-dose (18-28 mg) iron for 60 days.

Vitalant began conducting serum ferritin tests on Dec. 19, 2016, and the researchers analyzed data that were available through Dec. 31, 2018. The study included data from teen donors aged 16-18 years from 24 states.

In all, 125,384 teenagers donated whole blood or double red blood cells at least once, and 39% of females and 12% of males had a low-index ferritin value. The researchers focused on 30,806 teenagers (24.6%) who returned and successfully donated again within 25 months. In this cohort, 11% of female donors and 10% of male donors had a low-index ferritin value.

Twelve months after the first whole-blood donation, 80%-90% of males and 60%-70% of females had adequate iron stores. These proportions were about 10% lower for double red blood cell donors.

Among whole-blood donors, the percentage of donors with adequate iron stores at a follow-up donation “is highly dependent on index ferritin,” Dr. Vassallo and colleagues reported. For 90% of donors to have adequate iron stores within 3-9 months of index donation, index ferritin values had to be at least 47 ng/mL for males and 53 ng/mL for females, according to their analysis.

“At least 12 months are required for a sizeable proportion to reach next-donation ferritin values indicative of adequate iron stores,” the researchers said. “However, donor sex, donation type, first-time versus repeat status, and ferritin level at index were significant determinants of iron stores at the follow-up donation.”

“The enthusiasm of altruistic, highly motivated young donors makes large high school and college blood drives efficient and productive,” but these donors may be at increased risk for donation-related iron depletion, they said.

The estimated intervals needed to replenish iron stores represent best-case scenarios, the authors noted. The cohort did not include individuals deferred for low hemoglobin, likely due to iron deficiency, and these donors probably require more time to replenish iron stores.

The data suggest that health care providers should consider blood donation as a possible cause of low hemoglobin, Dr. Vassallo and colleagues said. Before prescribing higher doses of iron, however, physicians should assess a patient’s risk for other causes of iron deficiency such as gastrointestinal blood loss or celiac disease.
 

Shift collection efforts away from teenagers?

Vitalant’s findings “are of considerable value to other organizations collecting blood from teenagers,” Alan E. Mast, MD, PhD, said in an accompanying editorial. Dr. Mast is medical director and senior investigator at Versiti Blood Research Institute and associate professor of cell biology, neurobiology, and anatomy at Medical College of Wisconsin in Milwaukee. “The data presented confirm the high baseline level of iron deficiency in teenagers and its increase after blood donation. Pediatricians should be aware of the large number of teenagers donating blood in the United States, consider routinely asking about blood donation during routine physical examinations, and perform appropriate laboratory screening and treatment of iron deficiency.”

High school blood drives are a cost-effective way to collect blood, and stricter regulations on the collection of blood from teenagers may “have a detrimental effect on the blood supply,” Dr. Mast said. Nevertheless, “efforts should be made to reverse the trend of increasing collections from teenagers with increased emphasis on collection from adults.”

AABB (previously known as the American Association of Blood Banks), an organization of professionals who practice transfusion medicine, recommended in 2017 that blood collection agencies limit donors aged 16-18 years to one whole-blood donation per year, dispense iron supplements, or perform ferritin testing to advise donors about further steps, Dr. Mast noted.

“In the absence of other interventions, 1 year should be the minimum interdonation interval for teenagers,” said Dr. Mast. “If ferritin testing is performed, teenagers with ferritin levels [greater than] 50 ng/mL at index donation could perhaps donate twice per year.”

Dr. Vassallo has received payment from Fresenius Kabi and HemaStrat for scientific advisory board membership. Dr. Mast receives research funding from Novo Nordisk and has received honoraria for serving on Novo Nordisk advisory boards. He received no external funding for his commentary.

jremaly@mdedge.com

SOURCE: Vassallo RR et al. Pediatrics. 2020 Jun 5. doi: 10.1542/peds.2019-3316.

“Hey there—just checking on you and letting you know I’m thinking of you.”

“I know words don’t suffice right now. You are in my thoughts.”

“If there’s any way that I can be of support or if there’s something you need, just let me know.”

The texts and emails have come in waves. Pinging into my already distracted headspace when, like them, I’m supposed to be focused on a Zoom or WebEx department meeting. These somber reminders underscore what I have known for years but struggled to describe with each new “justice for” hashtag accompanying the name of the latest unarmed Black person to die. This is grief.

With every headline in prior years, as Black Americans we have usually found solace in our collective fellowship of suffering. Social media timelines become flooded with our own amen choirs and outrage along with words of comfort and inspiration. We remind ourselves of the prior atrocities survived by our people. And like them, we vow to rally; clinging to one other and praying to make it to shore. Though intermittently joined by a smattering of allies, our suffering has mostly been a private, repetitive mourning.

The year 2020 ushered in a new decade along with the novel SARS-CoV2 (COVID-19) global pandemic. In addition to the thousands of lives that have been lost in the United States alone, COVID-19 brought with it a disruption of life in ways never seen by most generations. Schools and businesses were closed to mitigate spread. Mandatory shelter-in-place orders coupled with physical distancing recommendations limited human interactions and cancelled everything from hospital visitations to graduations, intergenerational family gatherings, conferences, and weddings.¹ As the data expanded, it quickly became apparent that minorities, particularly Black Americans, shouldered a disproportionate burden of COVID-19.² Known health disparities were amplified.

While caring for our patients as Black physicians in the time of coronavirus, silently we mourned again. The connection and trust once found through racial concordance was now masked figuratively and literally by personal protective equipment (PPE). We ignored the sting of intimations that the staggering numbers of African Americans hospitalized and dying from COVID-19 could be explained by lack of discipline or, worse, genetic differences by race. Years of disenfranchisement and missed economic opportunities forced large numbers of our patients and loved ones out on the front lines to do essential jobs—but without the celebratory cheers or fanfare enjoyed by others. Frantic phone calls from family and acquaintances interrupted our quiet drives home from emotionally grueling shifts in the hospital—each conversation serving as our personal evidence of COVID-19 and her ruthless ravage of the Black community. Add to this trying to serve as cultural bridges between the complexities of medical distrust and patient advocacy along with wrestling with our own vulnerability as potential COVID-19 patients, these have been overwhelming times to say the least.

Then came the acute decompensation of the chronic racism we’d always known in the form of three recent killings of more unarmed African Americans. On March 13, 2020, 26-year-old Breonna Taylor was shot after police forcibly entered her home after midnight on a “no knock” warrant.³ The story was buried in the news of COVID-19—but we knew. Later we’d learn that 26-year-old Ahmaud Arbery was shot and killed by armed neighbors while running through a Brunswick, Georgia, neighborhood. His death on February 23, 2020, initially yielded no criminal charges.⁴ Then, on May 25, 2020, George Floyd, a 46-year-old father arrested for suspected use of a counterfeit $20 bill, died after a law enforcement official kneeled with his full body weight upon Floyd’s neck for over 8 minutes.⁵ The deaths of Arbery and Floyd were captured by cell phone cameras which, aided by social media, quickly reached the eyes of the entire world.

At first, it seemed plausible that this would be like it always has been. A Black mother would stand before a podium filled with multiple microphones crying out in anguish. She would be flanked by community leaders and attorneys demanding justice. Hashtags would be formed. Our people would stand up or kneel down in solidarity—holding fast to our historic resilience. Evanescent allies would appear with signs on lawns and held high over heads. A few weeks would pass by and things would go back to normal. Black people would be left with what always remains: heads bowed and praying at dinner tables petitioning a higher power for protection followed by reaffirmations of what, if anything, could be done to keep our own mamas away from that podium. We’ve learned to treat the grief of racism as endemic to us alone, knowing that it has been a pandemic all along.

The intersection of the crisis of the COVID-19 pandemic, complete with its social isolation and inordinate impact on minorities, and the acuity of the grief felt by the most recent events of abject racism have coalesced to form what feels like a pivotal point in the arc of justice. Like the bloated, disfigured face of lynched teenager Emmett Till lying lifeless in an open casket for the entire world to see in 1955,⁶ footage of these recent deaths typify a level of inhumanity that makes it too hard to turn away or carry on in indifference. The acute-on-chronic grief of racism felt by African Americans has risen into a tsunami, washing open the eyes of privileged persons belonging to all races, ethnicities, faiths, socioeconomic backgrounds, political views, and ages. The bulging neck veins, crackles, and thumping gallop rhythm of our hidden grief has declared itself: The rest of the world now knows that we can’t breathe.

Our moral outrage is pushing us to do something. Marches and demonstrations have occurred in nearly every major city. For those historically disenfranchised and let down by our societal contract, grief has, at times, met rage. Though we all feel an urgency, when we try to imagine ways to dismantle racism in the US it seems insurmountable. But as hospitalists and leaders, we will face black patients, colleagues, and neighbors navigating the pain of this exhausting collective trauma. While we won’t have all the answers immediately, we recognize the peculiar intersection between the COVID-19 crisis and the tipping point of grief felt by Black people with the recent deaths of Ahmaud Arbery, Breonna Taylor, and George Floyd, and it urges us to try.

Where can we start?

This is a time of deep sorrow for Black people. Recognizing it as such is an empathic place to begin. Everyone steers through grief differently, but a few things always hold true:

• Listen more than you talk—even if it’s uncomfortable. This isn’t a time to render opinions or draw suffering comparisons.
• Timely support is always appreciated. Leaders should feel the urgency to speak up early and often. Formal letters from leadership on behalf of organizations may feel like an echo chamber but they are worth the effort. Delays can be misunderstood as indifference and make the pain worse.
• The ministry of presence does not have to be physical. Those awkward text messages and emails create psychological safety in your organization and reduce loneliness. They also afford space to those who are still processing emotions and would prefer not to talk.
• Don’t place an expectation on the grieving to guide you through ways to help them heal. Though well-meaning, it can be overwhelming. This is particularly true in these current times.
• When in doubt, remember that support is a verb. Ultimately, sustained action or inaction will make your position clearer than any text message or email. Be sensitive to the unique intricacy of chronicity and missed opportunity when talking about racism.

Along with the pain we all feel from the impact of COVID-19, this is the time to recognize that your African American colleagues, patients, and friends have been navigating another tenacious and far more destructive pandemic at the same time. It is acute. It is chronic. It is acute-on-chronic. Perhaps 2020 will also be remembered for the opportunity it presented for the centuries old scourge of racism to no longer be our transparent cross to bear alone. Unlike COVID-19, this pandemic of racism is not “unprecedented.” We have been here before. It’s time we all grieve—and act—together.

“Hey there—just checking on you and letting you know I’m thinking of you.”

“I know words don’t suffice right now. You are in my thoughts.”

“If there’s any way that I can be of support or if there’s something you need, just let me know.”

The texts and emails have come in waves. Pinging into my already distracted headspace when, like them, I’m supposed to be focused on a Zoom or WebEx department meeting. These somber reminders underscore what I have known for years but struggled to describe with each new “justice for” hashtag accompanying the name of the latest unarmed Black person to die. This is grief.

With every headline in prior years, as Black Americans we have usually found solace in our collective fellowship of suffering. Social media timelines become flooded with our own amen choirs and outrage along with words of comfort and inspiration. We remind ourselves of the prior atrocities survived by our people. And like them, we vow to rally; clinging to one other and praying to make it to shore. Though intermittently joined by a smattering of allies, our suffering has mostly been a private, repetitive mourning.

The year 2020 ushered in a new decade along with the novel SARS-CoV2 (COVID-19) global pandemic. In addition to the thousands of lives that have been lost in the United States alone, COVID-19 brought with it a disruption of life in ways never seen by most generations. Schools and businesses were closed to mitigate spread. Mandatory shelter-in-place orders coupled with physical distancing recommendations limited human interactions and cancelled everything from hospital visitations to graduations, intergenerational family gatherings, conferences, and weddings.¹ As the data expanded, it quickly became apparent that minorities, particularly Black Americans, shouldered a disproportionate burden of COVID-19.² Known health disparities were amplified.

While caring for our patients as Black physicians in the time of coronavirus, silently we mourned again. The connection and trust once found through racial concordance was now masked figuratively and literally by personal protective equipment (PPE). We ignored the sting of intimations that the staggering numbers of African Americans hospitalized and dying from COVID-19 could be explained by lack of discipline or, worse, genetic differences by race. Years of disenfranchisement and missed economic opportunities forced large numbers of our patients and loved ones out on the front lines to do essential jobs—but without the celebratory cheers or fanfare enjoyed by others. Frantic phone calls from family and acquaintances interrupted our quiet drives home from emotionally grueling shifts in the hospital—each conversation serving as our personal evidence of COVID-19 and her ruthless ravage of the Black community. Add to this trying to serve as cultural bridges between the complexities of medical distrust and patient advocacy along with wrestling with our own vulnerability as potential COVID-19 patients, these have been overwhelming times to say the least.

Then came the acute decompensation of the chronic racism we’d always known in the form of three recent killings of more unarmed African Americans. On March 13, 2020, 26-year-old Breonna Taylor was shot after police forcibly entered her home after midnight on a “no knock” warrant.³ The story was buried in the news of COVID-19—but we knew. Later we’d learn that 26-year-old Ahmaud Arbery was shot and killed by armed neighbors while running through a Brunswick, Georgia, neighborhood. His death on February 23, 2020, initially yielded no criminal charges.⁴ Then, on May 25, 2020, George Floyd, a 46-year-old father arrested for suspected use of a counterfeit $20 bill, died after a law enforcement official kneeled with his full body weight upon Floyd’s neck for over 8 minutes.⁵ The deaths of Arbery and Floyd were captured by cell phone cameras which, aided by social media, quickly reached the eyes of the entire world.

At first, it seemed plausible that this would be like it always has been. A Black mother would stand before a podium filled with multiple microphones crying out in anguish. She would be flanked by community leaders and attorneys demanding justice. Hashtags would be formed. Our people would stand up or kneel down in solidarity—holding fast to our historic resilience. Evanescent allies would appear with signs on lawns and held high over heads. A few weeks would pass by and things would go back to normal. Black people would be left with what always remains: heads bowed and praying at dinner tables petitioning a higher power for protection followed by reaffirmations of what, if anything, could be done to keep our own mamas away from that podium. We’ve learned to treat the grief of racism as endemic to us alone, knowing that it has been a pandemic all along.

The intersection of the crisis of the COVID-19 pandemic, complete with its social isolation and inordinate impact on minorities, and the acuity of the grief felt by the most recent events of abject racism have coalesced to form what feels like a pivotal point in the arc of justice. Like the bloated, disfigured face of lynched teenager Emmett Till lying lifeless in an open casket for the entire world to see in 1955,⁶ footage of these recent deaths typify a level of inhumanity that makes it too hard to turn away or carry on in indifference. The acute-on-chronic grief of racism felt by African Americans has risen into a tsunami, washing open the eyes of privileged persons belonging to all races, ethnicities, faiths, socioeconomic backgrounds, political views, and ages. The bulging neck veins, crackles, and thumping gallop rhythm of our hidden grief has declared itself: The rest of the world now knows that we can’t breathe.

Our moral outrage is pushing us to do something. Marches and demonstrations have occurred in nearly every major city. For those historically disenfranchised and let down by our societal contract, grief has, at times, met rage. Though we all feel an urgency, when we try to imagine ways to dismantle racism in the US it seems insurmountable. But as hospitalists and leaders, we will face black patients, colleagues, and neighbors navigating the pain of this exhausting collective trauma. While we won’t have all the answers immediately, we recognize the peculiar intersection between the COVID-19 crisis and the tipping point of grief felt by Black people with the recent deaths of Ahmaud Arbery, Breonna Taylor, and George Floyd, and it urges us to try.

Where can we start?

This is a time of deep sorrow for Black people. Recognizing it as such is an empathic place to begin. Everyone steers through grief differently, but a few things always hold true:

• Listen more than you talk—even if it’s uncomfortable. This isn’t a time to render opinions or draw suffering comparisons.
• Timely support is always appreciated. Leaders should feel the urgency to speak up early and often. Formal letters from leadership on behalf of organizations may feel like an echo chamber but they are worth the effort. Delays can be misunderstood as indifference and make the pain worse.
• The ministry of presence does not have to be physical. Those awkward text messages and emails create psychological safety in your organization and reduce loneliness. They also afford space to those who are still processing emotions and would prefer not to talk.
• Don’t place an expectation on the grieving to guide you through ways to help them heal. Though well-meaning, it can be overwhelming. This is particularly true in these current times.
• When in doubt, remember that support is a verb. Ultimately, sustained action or inaction will make your position clearer than any text message or email. Be sensitive to the unique intricacy of chronicity and missed opportunity when talking about racism.

Along with the pain we all feel from the impact of COVID-19, this is the time to recognize that your African American colleagues, patients, and friends have been navigating another tenacious and far more destructive pandemic at the same time. It is acute. It is chronic. It is acute-on-chronic. Perhaps 2020 will also be remembered for the opportunity it presented for the centuries old scourge of racism to no longer be our transparent cross to bear alone. Unlike COVID-19, this pandemic of racism is not “unprecedented.” We have been here before. It’s time we all grieve—and act—together.

“Hey there—just checking on you and letting you know I’m thinking of you.”

“I know words don’t suffice right now. You are in my thoughts.”

“If there’s any way that I can be of support or if there’s something you need, just let me know.”

The texts and emails have come in waves. Pinging into my already distracted headspace when, like them, I’m supposed to be focused on a Zoom or WebEx department meeting. These somber reminders underscore what I have known for years but struggled to describe with each new “justice for” hashtag accompanying the name of the latest unarmed Black person to die. This is grief.

With every headline in prior years, as Black Americans we have usually found solace in our collective fellowship of suffering. Social media timelines become flooded with our own amen choirs and outrage along with words of comfort and inspiration. We remind ourselves of the prior atrocities survived by our people. And like them, we vow to rally; clinging to one other and praying to make it to shore. Though intermittently joined by a smattering of allies, our suffering has mostly been a private, repetitive mourning.

The year 2020 ushered in a new decade along with the novel SARS-CoV2 (COVID-19) global pandemic. In addition to the thousands of lives that have been lost in the United States alone, COVID-19 brought with it a disruption of life in ways never seen by most generations. Schools and businesses were closed to mitigate spread. Mandatory shelter-in-place orders coupled with physical distancing recommendations limited human interactions and cancelled everything from hospital visitations to graduations, intergenerational family gatherings, conferences, and weddings.¹ As the data expanded, it quickly became apparent that minorities, particularly Black Americans, shouldered a disproportionate burden of COVID-19.² Known health disparities were amplified.

While caring for our patients as Black physicians in the time of coronavirus, silently we mourned again. The connection and trust once found through racial concordance was now masked figuratively and literally by personal protective equipment (PPE). We ignored the sting of intimations that the staggering numbers of African Americans hospitalized and dying from COVID-19 could be explained by lack of discipline or, worse, genetic differences by race. Years of disenfranchisement and missed economic opportunities forced large numbers of our patients and loved ones out on the front lines to do essential jobs—but without the celebratory cheers or fanfare enjoyed by others. Frantic phone calls from family and acquaintances interrupted our quiet drives home from emotionally grueling shifts in the hospital—each conversation serving as our personal evidence of COVID-19 and her ruthless ravage of the Black community. Add to this trying to serve as cultural bridges between the complexities of medical distrust and patient advocacy along with wrestling with our own vulnerability as potential COVID-19 patients, these have been overwhelming times to say the least.

Then came the acute decompensation of the chronic racism we’d always known in the form of three recent killings of more unarmed African Americans. On March 13, 2020, 26-year-old Breonna Taylor was shot after police forcibly entered her home after midnight on a “no knock” warrant.³ The story was buried in the news of COVID-19—but we knew. Later we’d learn that 26-year-old Ahmaud Arbery was shot and killed by armed neighbors while running through a Brunswick, Georgia, neighborhood. His death on February 23, 2020, initially yielded no criminal charges.⁴ Then, on May 25, 2020, George Floyd, a 46-year-old father arrested for suspected use of a counterfeit $20 bill, died after a law enforcement official kneeled with his full body weight upon Floyd’s neck for over 8 minutes.⁵ The deaths of Arbery and Floyd were captured by cell phone cameras which, aided by social media, quickly reached the eyes of the entire world.

At first, it seemed plausible that this would be like it always has been. A Black mother would stand before a podium filled with multiple microphones crying out in anguish. She would be flanked by community leaders and attorneys demanding justice. Hashtags would be formed. Our people would stand up or kneel down in solidarity—holding fast to our historic resilience. Evanescent allies would appear with signs on lawns and held high over heads. A few weeks would pass by and things would go back to normal. Black people would be left with what always remains: heads bowed and praying at dinner tables petitioning a higher power for protection followed by reaffirmations of what, if anything, could be done to keep our own mamas away from that podium. We’ve learned to treat the grief of racism as endemic to us alone, knowing that it has been a pandemic all along.

The intersection of the crisis of the COVID-19 pandemic, complete with its social isolation and inordinate impact on minorities, and the acuity of the grief felt by the most recent events of abject racism have coalesced to form what feels like a pivotal point in the arc of justice. Like the bloated, disfigured face of lynched teenager Emmett Till lying lifeless in an open casket for the entire world to see in 1955,⁶ footage of these recent deaths typify a level of inhumanity that makes it too hard to turn away or carry on in indifference. The acute-on-chronic grief of racism felt by African Americans has risen into a tsunami, washing open the eyes of privileged persons belonging to all races, ethnicities, faiths, socioeconomic backgrounds, political views, and ages. The bulging neck veins, crackles, and thumping gallop rhythm of our hidden grief has declared itself: The rest of the world now knows that we can’t breathe.

Our moral outrage is pushing us to do something. Marches and demonstrations have occurred in nearly every major city. For those historically disenfranchised and let down by our societal contract, grief has, at times, met rage. Though we all feel an urgency, when we try to imagine ways to dismantle racism in the US it seems insurmountable. But as hospitalists and leaders, we will face black patients, colleagues, and neighbors navigating the pain of this exhausting collective trauma. While we won’t have all the answers immediately, we recognize the peculiar intersection between the COVID-19 crisis and the tipping point of grief felt by Black people with the recent deaths of Ahmaud Arbery, Breonna Taylor, and George Floyd, and it urges us to try.

Where can we start?

This is a time of deep sorrow for Black people. Recognizing it as such is an empathic place to begin. Everyone steers through grief differently, but a few things always hold true:

• Listen more than you talk—even if it’s uncomfortable. This isn’t a time to render opinions or draw suffering comparisons.
• Timely support is always appreciated. Leaders should feel the urgency to speak up early and often. Formal letters from leadership on behalf of organizations may feel like an echo chamber but they are worth the effort. Delays can be misunderstood as indifference and make the pain worse.
• The ministry of presence does not have to be physical. Those awkward text messages and emails create psychological safety in your organization and reduce loneliness. They also afford space to those who are still processing emotions and would prefer not to talk.
• Don’t place an expectation on the grieving to guide you through ways to help them heal. Though well-meaning, it can be overwhelming. This is particularly true in these current times.
• When in doubt, remember that support is a verb. Ultimately, sustained action or inaction will make your position clearer than any text message or email. Be sensitive to the unique intricacy of chronicity and missed opportunity when talking about racism.

Along with the pain we all feel from the impact of COVID-19, this is the time to recognize that your African American colleagues, patients, and friends have been navigating another tenacious and far more destructive pandemic at the same time. It is acute. It is chronic. It is acute-on-chronic. Perhaps 2020 will also be remembered for the opportunity it presented for the centuries old scourge of racism to no longer be our transparent cross to bear alone. Unlike COVID-19, this pandemic of racism is not “unprecedented.” We have been here before. It’s time we all grieve—and act—together.

Click here to read the supplement.

Author

1. Apte RS, Chen DS, Ferrara N. VEGF in signaling and disease: beyond discovery and development. Cell. 2019;176(6):1248-1264.

Click here to read the supplement.

Author

1. Apte RS, Chen DS, Ferrara N. VEGF in signaling and disease: beyond discovery and development. Cell. 2019;176(6):1248-1264.

Click here to read the supplement.

Author

1. Apte RS, Chen DS, Ferrara N. VEGF in signaling and disease: beyond discovery and development. Cell. 2019;176(6):1248-1264.

The Lancet announced today that it has retracted a highly cited study that suggested hydroxychloroquine may cause more harm than benefit in patients with COVID-19. Hours later, the New England Journal of Medicine announced that it had retracted a second article by some of the same authors, also on heart disease and COVID-19.

The Lancet article, titled “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: A multinational registry analysis” was originally published online May 22. The NEJM article, “Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19” was initially published May 1.

Three authors of the Lancet article, Mandeep R. Mehra, MD, Frank Ruschitzka, MD, and Amit N. Patel, MD, wrote in a letter that the action came after concerns were raised about the integrity of the data, and about how the analysis was conducted by Chicago-based Surgisphere Corp and study coauthor Sapan Desai, MD, Surgisphere’s founder and CEO.

The authors asked for an independent third-party review of Surgisphere to evaluate the integrity of the trial elements and to replicate the analyses in the article.

“Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis, as such transfer would violate client agreements and confidentiality requirements,” the authors wrote.

Therefore, reviewers were not able to conduct the review and notified the authors they would withdraw from the peer-review process.

The Lancet said in a statement: “The Lancet takes issues of scientific integrity extremely seriously, and there are many outstanding questions about Surgisphere and the data that were allegedly included in this study. Following guidelines from the Committee on Publication Ethics and International Committee of Medical Journal Editors, institutional reviews of Surgisphere’s research collaborations are urgently needed.”

The authors wrote, “We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted.

“We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic. We deeply apologize to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.”

In a similar, if briefer, note, the authors requested that the New England Journal of Medicine retract the earlier article as well. The retraction notice on the website reads: “Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article, ‘Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.’ We therefore request that the article be retracted. We apologize to the editors and to readers of the Journal for the difficulties that this has caused.”

Both journals had already published “Expression of Concern” notices about the articles. The expression of concern followed an open letter, endorsed by more than 200 scientists, ethicists, and clinicians and posted on May 28, questioning the data and ethics of the study.

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






 

The Lancet announced today that it has retracted a highly cited study that suggested hydroxychloroquine may cause more harm than benefit in patients with COVID-19. Hours later, the New England Journal of Medicine announced that it had retracted a second article by some of the same authors, also on heart disease and COVID-19.

The Lancet article, titled “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: A multinational registry analysis” was originally published online May 22. The NEJM article, “Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19” was initially published May 1.

Three authors of the Lancet article, Mandeep R. Mehra, MD, Frank Ruschitzka, MD, and Amit N. Patel, MD, wrote in a letter that the action came after concerns were raised about the integrity of the data, and about how the analysis was conducted by Chicago-based Surgisphere Corp and study coauthor Sapan Desai, MD, Surgisphere’s founder and CEO.

The authors asked for an independent third-party review of Surgisphere to evaluate the integrity of the trial elements and to replicate the analyses in the article.

“Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis, as such transfer would violate client agreements and confidentiality requirements,” the authors wrote.

Therefore, reviewers were not able to conduct the review and notified the authors they would withdraw from the peer-review process.

The Lancet said in a statement: “The Lancet takes issues of scientific integrity extremely seriously, and there are many outstanding questions about Surgisphere and the data that were allegedly included in this study. Following guidelines from the Committee on Publication Ethics and International Committee of Medical Journal Editors, institutional reviews of Surgisphere’s research collaborations are urgently needed.”

The authors wrote, “We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted.

“We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic. We deeply apologize to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.”

In a similar, if briefer, note, the authors requested that the New England Journal of Medicine retract the earlier article as well. The retraction notice on the website reads: “Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article, ‘Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.’ We therefore request that the article be retracted. We apologize to the editors and to readers of the Journal for the difficulties that this has caused.”

Both journals had already published “Expression of Concern” notices about the articles. The expression of concern followed an open letter, endorsed by more than 200 scientists, ethicists, and clinicians and posted on May 28, questioning the data and ethics of the study.

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






 

The Lancet announced today that it has retracted a highly cited study that suggested hydroxychloroquine may cause more harm than benefit in patients with COVID-19. Hours later, the New England Journal of Medicine announced that it had retracted a second article by some of the same authors, also on heart disease and COVID-19.

The Lancet article, titled “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: A multinational registry analysis” was originally published online May 22. The NEJM article, “Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19” was initially published May 1.

Three authors of the Lancet article, Mandeep R. Mehra, MD, Frank Ruschitzka, MD, and Amit N. Patel, MD, wrote in a letter that the action came after concerns were raised about the integrity of the data, and about how the analysis was conducted by Chicago-based Surgisphere Corp and study coauthor Sapan Desai, MD, Surgisphere’s founder and CEO.

The authors asked for an independent third-party review of Surgisphere to evaluate the integrity of the trial elements and to replicate the analyses in the article.

“Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis, as such transfer would violate client agreements and confidentiality requirements,” the authors wrote.

Therefore, reviewers were not able to conduct the review and notified the authors they would withdraw from the peer-review process.

The Lancet said in a statement: “The Lancet takes issues of scientific integrity extremely seriously, and there are many outstanding questions about Surgisphere and the data that were allegedly included in this study. Following guidelines from the Committee on Publication Ethics and International Committee of Medical Journal Editors, institutional reviews of Surgisphere’s research collaborations are urgently needed.”

The authors wrote, “We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted.

“We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic. We deeply apologize to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.”

In a similar, if briefer, note, the authors requested that the New England Journal of Medicine retract the earlier article as well. The retraction notice on the website reads: “Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article, ‘Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.’ We therefore request that the article be retracted. We apologize to the editors and to readers of the Journal for the difficulties that this has caused.”

Both journals had already published “Expression of Concern” notices about the articles. The expression of concern followed an open letter, endorsed by more than 200 scientists, ethicists, and clinicians and posted on May 28, questioning the data and ethics of the study.

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






 

Wearing a mask at home, even when everyone is feeling fine, might reduce the risk of frontline healthcare workers transmitting SARS-CoV-2 infection to their families, a recent study from China suggests. But the benefits might not outweigh the costs, according to several physicians interviewed.

“My gut reaction is that home mask use for healthcare workers would place an inordinately high burden on those healthcare workers and their families,” said Jeanne Noble, MD, an emergency care physician at the University of California, San Francisco. “Wearing a mask for a 10-hour shift already represents significant physical discomfort, causing sores across the nose and behind the ears. The emotional toll of the physical distance that comes with mask use, with limited facial expression, is also quite real.”

The suggested benefit of home mask use comes from research published online May 28 in BMJ Global Health. To assess predictors of household transmission of SARS-CoV-2 infection, Yu Wang, MD, of the Beijing Center for Disease Prevention and Control and colleagues conducted a retrospective study of 124 families in Beijing in which there was a confirmed case of COVID-19 as of February 21. The researchers surveyed family members by telephone about household hygiene and behaviors during the pandemic to examine risk factors for transmission.

During the 2 weeks following onset of the primary case, secondary transmission occurred in 41 families. Overall, 77 of 335 family members developed COVID-19.

A multivariable logistic regression analysis found that in households in which family members wore masks at home before the first person became ill, there was less likelihood of transmission of disease to a family member, compared with families in which no one wore a mask prior to illness onset.

“Facemasks were 79% effective and disinfection was 77% effective in preventing transmission,” the researchers report, “whilst close frequent contact in the household increased the risk of transmission 18 times, and diarrhea in the index patient increased the risk by four times.

However, wearing masks after symptom onset was not protective, according to the analysis. The findings support “universal face mask use, and also provides guidance on risk reduction for families living with someone in quarantine or isolation, and families of health workers, who may face ongoing risk,” the authors write.

Still, other precautions may be more important, experts say.

“I think by far the best way for healthcare professionals to protect their families is to carefully employ appropriate infection prevention measures at work,” said Mark E. Rupp, MD, chief of the Division of Infectious Diseases at Nebraska Medical Center in Omaha. “The combination of administrative interventions, engineering improvements, and personal protective equipment is very effective in preventing SARS-CoV-2 acquisition in the workplace.”

Many physicians already wear masks at home, and this study “only reemphasized the importance of doing so,” said Raghavendra Tirupathi, MD, medical director of Keystone Infectious Diseases in Chambersburg, Pennsylvania, who recently reviewed studies about masks and COVID-19.

Home mask use provides “one more layer of protection that might help mitigate the risk of transmission to family members,” Tirupathi said. But it does not obviate the need to follow other preventive measures, such as social distancing and proper hygiene.

But Rupp, whose advice on how healthcare workers can protect their families was recently highlighted by the American Medical Association, isn’t convinced. He said he won’t be adding home mask use to his list of recommendations. “It would be intrusive, cumbersome, and impractical to wear a mask in the home setting,” Rupp said in an interview.

However, when out in the community, all family members must protect one another by practicing social distancing, wearing masks, and practicing proper hand hygiene. “I also think that it is a good idea to have some masks on hand in case anyone does develop symptoms in the household and to wear them if a family member falls ill ― at least until testing can confirm COVID-19,” Rupp said. “If a family member does fall ill, masks for the ill person as well as the well persons would be indicated along with other home quarantine measures.”

For her part, Noble, who has provided guidance about proper mask use, said that targeted use of masks at home, such as around older visiting relatives or other more vulnerable family members, may be more realistic than continuous in-home use.

When a household member becomes ill, recommendations for preventing disease spread include having a sick family member sleep in a separate bedroom, using a separate bathroom, and wearing a mask when within 6 feet of other household members. They also should avoid sharing meals. “For a household member who is a medical provider, to follow these self-isolation precautions while at home for months on end would have a significant emotional toll,” Noble said in an email. “With no end in sight for the pandemic, perpetual mask use in both the private and public sphere strikes me as overwhelming ― I write this near the end of my 10-hour shift wearing both an N95 and surgical mask and counting the minutes before I can take them off!”

A limitation of the study was its reliance on telephone interviews, which are subject to recall bias, the authors note.

The study was funded by the Beijing Science and Technology Planning Project. The researchers have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Wearing a mask at home, even when everyone is feeling fine, might reduce the risk of frontline healthcare workers transmitting SARS-CoV-2 infection to their families, a recent study from China suggests. But the benefits might not outweigh the costs, according to several physicians interviewed.

“My gut reaction is that home mask use for healthcare workers would place an inordinately high burden on those healthcare workers and their families,” said Jeanne Noble, MD, an emergency care physician at the University of California, San Francisco. “Wearing a mask for a 10-hour shift already represents significant physical discomfort, causing sores across the nose and behind the ears. The emotional toll of the physical distance that comes with mask use, with limited facial expression, is also quite real.”

The suggested benefit of home mask use comes from research published online May 28 in BMJ Global Health. To assess predictors of household transmission of SARS-CoV-2 infection, Yu Wang, MD, of the Beijing Center for Disease Prevention and Control and colleagues conducted a retrospective study of 124 families in Beijing in which there was a confirmed case of COVID-19 as of February 21. The researchers surveyed family members by telephone about household hygiene and behaviors during the pandemic to examine risk factors for transmission.

During the 2 weeks following onset of the primary case, secondary transmission occurred in 41 families. Overall, 77 of 335 family members developed COVID-19.

A multivariable logistic regression analysis found that in households in which family members wore masks at home before the first person became ill, there was less likelihood of transmission of disease to a family member, compared with families in which no one wore a mask prior to illness onset.

“Facemasks were 79% effective and disinfection was 77% effective in preventing transmission,” the researchers report, “whilst close frequent contact in the household increased the risk of transmission 18 times, and diarrhea in the index patient increased the risk by four times.

However, wearing masks after symptom onset was not protective, according to the analysis. The findings support “universal face mask use, and also provides guidance on risk reduction for families living with someone in quarantine or isolation, and families of health workers, who may face ongoing risk,” the authors write.

Still, other precautions may be more important, experts say.

“I think by far the best way for healthcare professionals to protect their families is to carefully employ appropriate infection prevention measures at work,” said Mark E. Rupp, MD, chief of the Division of Infectious Diseases at Nebraska Medical Center in Omaha. “The combination of administrative interventions, engineering improvements, and personal protective equipment is very effective in preventing SARS-CoV-2 acquisition in the workplace.”

Many physicians already wear masks at home, and this study “only reemphasized the importance of doing so,” said Raghavendra Tirupathi, MD, medical director of Keystone Infectious Diseases in Chambersburg, Pennsylvania, who recently reviewed studies about masks and COVID-19.

Home mask use provides “one more layer of protection that might help mitigate the risk of transmission to family members,” Tirupathi said. But it does not obviate the need to follow other preventive measures, such as social distancing and proper hygiene.

But Rupp, whose advice on how healthcare workers can protect their families was recently highlighted by the American Medical Association, isn’t convinced. He said he won’t be adding home mask use to his list of recommendations. “It would be intrusive, cumbersome, and impractical to wear a mask in the home setting,” Rupp said in an interview.

However, when out in the community, all family members must protect one another by practicing social distancing, wearing masks, and practicing proper hand hygiene. “I also think that it is a good idea to have some masks on hand in case anyone does develop symptoms in the household and to wear them if a family member falls ill ― at least until testing can confirm COVID-19,” Rupp said. “If a family member does fall ill, masks for the ill person as well as the well persons would be indicated along with other home quarantine measures.”

For her part, Noble, who has provided guidance about proper mask use, said that targeted use of masks at home, such as around older visiting relatives or other more vulnerable family members, may be more realistic than continuous in-home use.

When a household member becomes ill, recommendations for preventing disease spread include having a sick family member sleep in a separate bedroom, using a separate bathroom, and wearing a mask when within 6 feet of other household members. They also should avoid sharing meals. “For a household member who is a medical provider, to follow these self-isolation precautions while at home for months on end would have a significant emotional toll,” Noble said in an email. “With no end in sight for the pandemic, perpetual mask use in both the private and public sphere strikes me as overwhelming ― I write this near the end of my 10-hour shift wearing both an N95 and surgical mask and counting the minutes before I can take them off!”

A limitation of the study was its reliance on telephone interviews, which are subject to recall bias, the authors note.

The study was funded by the Beijing Science and Technology Planning Project. The researchers have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Wearing a mask at home, even when everyone is feeling fine, might reduce the risk of frontline healthcare workers transmitting SARS-CoV-2 infection to their families, a recent study from China suggests. But the benefits might not outweigh the costs, according to several physicians interviewed.

“My gut reaction is that home mask use for healthcare workers would place an inordinately high burden on those healthcare workers and their families,” said Jeanne Noble, MD, an emergency care physician at the University of California, San Francisco. “Wearing a mask for a 10-hour shift already represents significant physical discomfort, causing sores across the nose and behind the ears. The emotional toll of the physical distance that comes with mask use, with limited facial expression, is also quite real.”

The suggested benefit of home mask use comes from research published online May 28 in BMJ Global Health. To assess predictors of household transmission of SARS-CoV-2 infection, Yu Wang, MD, of the Beijing Center for Disease Prevention and Control and colleagues conducted a retrospective study of 124 families in Beijing in which there was a confirmed case of COVID-19 as of February 21. The researchers surveyed family members by telephone about household hygiene and behaviors during the pandemic to examine risk factors for transmission.

During the 2 weeks following onset of the primary case, secondary transmission occurred in 41 families. Overall, 77 of 335 family members developed COVID-19.

A multivariable logistic regression analysis found that in households in which family members wore masks at home before the first person became ill, there was less likelihood of transmission of disease to a family member, compared with families in which no one wore a mask prior to illness onset.

“Facemasks were 79% effective and disinfection was 77% effective in preventing transmission,” the researchers report, “whilst close frequent contact in the household increased the risk of transmission 18 times, and diarrhea in the index patient increased the risk by four times.

However, wearing masks after symptom onset was not protective, according to the analysis. The findings support “universal face mask use, and also provides guidance on risk reduction for families living with someone in quarantine or isolation, and families of health workers, who may face ongoing risk,” the authors write.

Still, other precautions may be more important, experts say.

“I think by far the best way for healthcare professionals to protect their families is to carefully employ appropriate infection prevention measures at work,” said Mark E. Rupp, MD, chief of the Division of Infectious Diseases at Nebraska Medical Center in Omaha. “The combination of administrative interventions, engineering improvements, and personal protective equipment is very effective in preventing SARS-CoV-2 acquisition in the workplace.”

Many physicians already wear masks at home, and this study “only reemphasized the importance of doing so,” said Raghavendra Tirupathi, MD, medical director of Keystone Infectious Diseases in Chambersburg, Pennsylvania, who recently reviewed studies about masks and COVID-19.

Home mask use provides “one more layer of protection that might help mitigate the risk of transmission to family members,” Tirupathi said. But it does not obviate the need to follow other preventive measures, such as social distancing and proper hygiene.

But Rupp, whose advice on how healthcare workers can protect their families was recently highlighted by the American Medical Association, isn’t convinced. He said he won’t be adding home mask use to his list of recommendations. “It would be intrusive, cumbersome, and impractical to wear a mask in the home setting,” Rupp said in an interview.

However, when out in the community, all family members must protect one another by practicing social distancing, wearing masks, and practicing proper hand hygiene. “I also think that it is a good idea to have some masks on hand in case anyone does develop symptoms in the household and to wear them if a family member falls ill ― at least until testing can confirm COVID-19,” Rupp said. “If a family member does fall ill, masks for the ill person as well as the well persons would be indicated along with other home quarantine measures.”

For her part, Noble, who has provided guidance about proper mask use, said that targeted use of masks at home, such as around older visiting relatives or other more vulnerable family members, may be more realistic than continuous in-home use.

When a household member becomes ill, recommendations for preventing disease spread include having a sick family member sleep in a separate bedroom, using a separate bathroom, and wearing a mask when within 6 feet of other household members. They also should avoid sharing meals. “For a household member who is a medical provider, to follow these self-isolation precautions while at home for months on end would have a significant emotional toll,” Noble said in an email. “With no end in sight for the pandemic, perpetual mask use in both the private and public sphere strikes me as overwhelming ― I write this near the end of my 10-hour shift wearing both an N95 and surgical mask and counting the minutes before I can take them off!”

A limitation of the study was its reliance on telephone interviews, which are subject to recall bias, the authors note.

The study was funded by the Beijing Science and Technology Planning Project. The researchers have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

More fatalities in heart transplant patients with COVID-19

COVID-19 infection appears to be associated with a high risk for mortality in heart transplant recipients. The conclusion is based on a case series with 28 patients with a confirmed diagnosis of COVID-19 who received a heart transplant during March and April 2020. There was a case-fatality rate of 25%, according to the study published in JAMA Cardiology. “The high case fatality in our case series should alert physicians to the vulnerability of heart transplant recipients during the COVID-19 pandemic,” senior author Nir Uriel, MD, professor of medicine at Columbia University, New York, said in an interview. “These patients require extra precautions to prevent the development of infection.” Read more.

High costs for type 1 diabetes patients: It’s not just insulin

For privately insured individuals with type 1 diabetes in the United States, out-of-pocket costs for insulin are typically lower than for other diabetes-related supplies. But overall out-of-pocket costs – taking into account everything that is needed to manage diabetes – are still very high. Two separate research letters recently published in JAMA Internal Medicine examined some of the drivers behind these high costs. The first research letter examined all costs for privately insured patients with type 1 diabetes, finding a mean out-of-pocket spend of approximately $2,500 a year. “Policymakers should improve the affordability of all care for type 1 diabetes,” said the lead author of the first research letter, Kao-Ping Chua, MD, PhD, of the department of pediatrics, University of Michigan, Ann Arbor. Read more.

Most rheumatology drugs don’t up COVID-19 hospitalizations

The vast majority of patients with rheumatic and musculoskeletal diseases who contract COVID-19 recover from the virus, regardless of which medication they receive for their rheumatic condition, new international research suggests. Researchers looked at 600 COVID-19 patients from 40 countries, and found that those taking TNF inhibitors for their rheumatic disease were less likely to be hospitalized for COVID-19. Treatment with more than 10 mg of prednisone daily – considered a moderate to high dose – was associated with a higher probability of hospitalization, however. “These results provide, for the first time, information about the outcome of COVID-19 in patients with rheumatic and musculoskeletal diseases,” said study investigator Pedro Machado, MD, PhD, from University College London. “They should provide some reassurance to patients and healthcare providers.” Read more.

A bumpy virtual #ASCO20

Some prominent oncologists gave up on the virtual meeting of the American Society of Clinical Oncology after facing technical problems with online sessions. Despite those glitches, dozens of virtual meeting attendees praised the online effort, which was assembled in just a few months, and called out virtues such as the quick availability of video transcripts as well as the obvious benefits of low cost, zero travel, and overall convenience. But one sentiment was nearly universal: there’s nothing like the real thing. This year’s meeting, which involved 40,000-plus attendees, was shortened to 3 days and limited to scientific presentations because of the COVID-19 pandemic. Education sessions will be held online August 8-10. Read more.

Parenting special needs children: An unlikely model

As families adjust to daily life during a pandemic, the parents of special needs children may be able to offer them some lessons. The chronic struggles of many special needs parents – from staying home often to taking on roles in which they have not been trained – strongly resemble the challenges facing most families in the COVID-19 pandemic, according to Migdalia Miranda Sotir, MD, a psychiatrist in private practice in Wheaton, Ill. “Parents may take on active roles supplementing their developmentally delayed children with educational experiences or therapeutic modalities in their own homes given that the needs might be too great to just rely on the school or therapy time,” she writes on MDedge. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

More fatalities in heart transplant patients with COVID-19

COVID-19 infection appears to be associated with a high risk for mortality in heart transplant recipients. The conclusion is based on a case series with 28 patients with a confirmed diagnosis of COVID-19 who received a heart transplant during March and April 2020. There was a case-fatality rate of 25%, according to the study published in JAMA Cardiology. “The high case fatality in our case series should alert physicians to the vulnerability of heart transplant recipients during the COVID-19 pandemic,” senior author Nir Uriel, MD, professor of medicine at Columbia University, New York, said in an interview. “These patients require extra precautions to prevent the development of infection.” Read more.

High costs for type 1 diabetes patients: It’s not just insulin

For privately insured individuals with type 1 diabetes in the United States, out-of-pocket costs for insulin are typically lower than for other diabetes-related supplies. But overall out-of-pocket costs – taking into account everything that is needed to manage diabetes – are still very high. Two separate research letters recently published in JAMA Internal Medicine examined some of the drivers behind these high costs. The first research letter examined all costs for privately insured patients with type 1 diabetes, finding a mean out-of-pocket spend of approximately $2,500 a year. “Policymakers should improve the affordability of all care for type 1 diabetes,” said the lead author of the first research letter, Kao-Ping Chua, MD, PhD, of the department of pediatrics, University of Michigan, Ann Arbor. Read more.

Most rheumatology drugs don’t up COVID-19 hospitalizations

The vast majority of patients with rheumatic and musculoskeletal diseases who contract COVID-19 recover from the virus, regardless of which medication they receive for their rheumatic condition, new international research suggests. Researchers looked at 600 COVID-19 patients from 40 countries, and found that those taking TNF inhibitors for their rheumatic disease were less likely to be hospitalized for COVID-19. Treatment with more than 10 mg of prednisone daily – considered a moderate to high dose – was associated with a higher probability of hospitalization, however. “These results provide, for the first time, information about the outcome of COVID-19 in patients with rheumatic and musculoskeletal diseases,” said study investigator Pedro Machado, MD, PhD, from University College London. “They should provide some reassurance to patients and healthcare providers.” Read more.

A bumpy virtual #ASCO20

Some prominent oncologists gave up on the virtual meeting of the American Society of Clinical Oncology after facing technical problems with online sessions. Despite those glitches, dozens of virtual meeting attendees praised the online effort, which was assembled in just a few months, and called out virtues such as the quick availability of video transcripts as well as the obvious benefits of low cost, zero travel, and overall convenience. But one sentiment was nearly universal: there’s nothing like the real thing. This year’s meeting, which involved 40,000-plus attendees, was shortened to 3 days and limited to scientific presentations because of the COVID-19 pandemic. Education sessions will be held online August 8-10. Read more.

Parenting special needs children: An unlikely model

As families adjust to daily life during a pandemic, the parents of special needs children may be able to offer them some lessons. The chronic struggles of many special needs parents – from staying home often to taking on roles in which they have not been trained – strongly resemble the challenges facing most families in the COVID-19 pandemic, according to Migdalia Miranda Sotir, MD, a psychiatrist in private practice in Wheaton, Ill. “Parents may take on active roles supplementing their developmentally delayed children with educational experiences or therapeutic modalities in their own homes given that the needs might be too great to just rely on the school or therapy time,” she writes on MDedge. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

More fatalities in heart transplant patients with COVID-19

COVID-19 infection appears to be associated with a high risk for mortality in heart transplant recipients. The conclusion is based on a case series with 28 patients with a confirmed diagnosis of COVID-19 who received a heart transplant during March and April 2020. There was a case-fatality rate of 25%, according to the study published in JAMA Cardiology. “The high case fatality in our case series should alert physicians to the vulnerability of heart transplant recipients during the COVID-19 pandemic,” senior author Nir Uriel, MD, professor of medicine at Columbia University, New York, said in an interview. “These patients require extra precautions to prevent the development of infection.” Read more.

High costs for type 1 diabetes patients: It’s not just insulin

For privately insured individuals with type 1 diabetes in the United States, out-of-pocket costs for insulin are typically lower than for other diabetes-related supplies. But overall out-of-pocket costs – taking into account everything that is needed to manage diabetes – are still very high. Two separate research letters recently published in JAMA Internal Medicine examined some of the drivers behind these high costs. The first research letter examined all costs for privately insured patients with type 1 diabetes, finding a mean out-of-pocket spend of approximately $2,500 a year. “Policymakers should improve the affordability of all care for type 1 diabetes,” said the lead author of the first research letter, Kao-Ping Chua, MD, PhD, of the department of pediatrics, University of Michigan, Ann Arbor. Read more.

Most rheumatology drugs don’t up COVID-19 hospitalizations

The vast majority of patients with rheumatic and musculoskeletal diseases who contract COVID-19 recover from the virus, regardless of which medication they receive for their rheumatic condition, new international research suggests. Researchers looked at 600 COVID-19 patients from 40 countries, and found that those taking TNF inhibitors for their rheumatic disease were less likely to be hospitalized for COVID-19. Treatment with more than 10 mg of prednisone daily – considered a moderate to high dose – was associated with a higher probability of hospitalization, however. “These results provide, for the first time, information about the outcome of COVID-19 in patients with rheumatic and musculoskeletal diseases,” said study investigator Pedro Machado, MD, PhD, from University College London. “They should provide some reassurance to patients and healthcare providers.” Read more.

A bumpy virtual #ASCO20

Some prominent oncologists gave up on the virtual meeting of the American Society of Clinical Oncology after facing technical problems with online sessions. Despite those glitches, dozens of virtual meeting attendees praised the online effort, which was assembled in just a few months, and called out virtues such as the quick availability of video transcripts as well as the obvious benefits of low cost, zero travel, and overall convenience. But one sentiment was nearly universal: there’s nothing like the real thing. This year’s meeting, which involved 40,000-plus attendees, was shortened to 3 days and limited to scientific presentations because of the COVID-19 pandemic. Education sessions will be held online August 8-10. Read more.

Parenting special needs children: An unlikely model

As families adjust to daily life during a pandemic, the parents of special needs children may be able to offer them some lessons. The chronic struggles of many special needs parents – from staying home often to taking on roles in which they have not been trained – strongly resemble the challenges facing most families in the COVID-19 pandemic, according to Migdalia Miranda Sotir, MD, a psychiatrist in private practice in Wheaton, Ill. “Parents may take on active roles supplementing their developmentally delayed children with educational experiences or therapeutic modalities in their own homes given that the needs might be too great to just rely on the school or therapy time,” she writes on MDedge. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Exposure to maternal antenatal corticosteroid treatment is significantly associated with mental and behavioral disorders in children, compared with nonexposure, according to a Finnish population-based study published in JAMA. The findings may lead to changes in clinical practice, particularly for infants who may be born full term.

After adjustment for variables such as maternal age, smoking during pregnancy, any lifetime mental disorder diagnosis, and gestational age at birth, exposure to maternal antenatal corticosteroid treatment was significantly associated with mental and behavioral disorders in children, compared with nonexposure, with a hazard ratio of 1.33. Among children born at term, the adjusted hazard ratio was 1.47. Among preterm children, the hazard ratio was not significant.

“Although benefits of this therapy outweigh risks in the most vulnerable infants, this may not be true for all infants,” wrote Sara B. DeMauro, MD, an attending neonatologist and program director of the neonatal follow-up program at Children’s Hospital of Philadelphia, in an editorial also published in JAMA. “Recommendations to administer this therapy to broader populations of pregnant women may need to be reexamined until sufficient safety data, particularly among more mature infants, are available.”

Corticosteroid treatment to accelerate fetal maturation is standard care before 34 weeks’ gestation when there is a likelihood of delivery within 7 days, and studies have found that providing this therapy reduces the risk for respiratory problems when administered beyond 34 weeks. In 2016, updates to U.S. guidelines allowed for the use of corticosteroid treatment between 34 weeks and 36 weeks 6 days when women are at risk for preterm delivery within 7 days and have not received a previous course of antenatal corticosteroids.

The data from Finland indicate that “a significant number of very preterm children who might have benefited from this treatment did not receive it,” Dr. DeMauro wrote. At the same time, “45% of steroid-exposed infants were delivered at term. In these infants, minor short-term benefit may have been outweighed by significant longer-term risks. These data elucidate both the continuing struggle to accurately predict preterm birth and the incomplete uptake of an effective therapy that is beneficial when administered to the correct patients.”
 

Pause expanded use?

“Since the recommendations came out to expand the use of corticosteroids for preterm labor up until 37 weeks gestational age, my practice has incorporated these guidelines,” said Santina Wheat, MD, assistant professor of family and community medicine at Northwestern University in Chicago. “We have incorporated the guidelines though with the understanding that the benefits outweigh the risk. This article indicates that we may have been wrong in that understanding.” Although the association does not establish that the treatment causes mental and behavioral disorders, it “raises the question of whether we should halt this practice until additional information can be gathered,” noted Dr. Wheat, who also serves on the editorial advisory board of Family Practice News.

When administered before delivery of a very premature infant, corticosteroid therapy accelerates fetal lung maturation and helps prevent neonatal mortality, respiratory distress syndrome, and brain injury. Investigators demonstrated the benefits of antenatal corticosteroids in 1972, and the treatment – “one of the most important advances in perinatal care” – became widely used in the 1990s, Dr. DeMauro said.

To examine whether treatment exposure is associated with a risk of childhood mental and behavioral disorders and whether the risk is similar in infants born at term and preterm, Katri Räikkönen, PhD, a researcher at the University of Helsinki, and colleagues conducted a population-based retrospective study of more than 670,000 children.

The researchers identified all singleton pregnancies ending in a live birth in Finland during Jan. 1, 2006–Dec.31, 2017. In addition, they identified all consecutive maternal sibling pairs born at term, including sibling pairs discordant for maternal antenatal corticosteroid treatment exposure and sibling pairs concordant for treatment exposure or nonexposure. The investigators identified diagnoses of childhood mental and behavioral disorders using the Finnish Care Register for Health Care using ICD-10 codes on hospital inpatient and outpatient treatments by physicians in specialized medical care.
 

A range of disorders

In all, 670,097 infants with a median follow-up duration of 5.8 years were included in the analysis, and 14,868 (2.22%) were exposed to antenatal corticosteroids. Of the treatment-exposed children, about 45% were born at term. Of the nonexposed children, approximately 97% were born at term. Cumulative incidence rates for any mental and behavioral disorder were significantly higher for treatment-exposed children, compared with nonexposed children, in the entire cohort (12.01% vs. 6.45%; P less than .001) and in term-born children (8.89% vs. 6.31%; P less than .001).

In preterm children, the incidence rate of any mental and behavioral disorder was significantly higher among those with treatment exposure (14.59% vs. 10.71%; P less than .001). Associations persisted when the investigators focused on 241,621 sibling pairs, “suggesting that unmeasured familial confounding did not explain these associations,” the authors said.

“[In] the entire cohort and term-born children, treatment exposure ... was significantly associated with psychological development disorders; attention-deficit/hyperactivity or conduct disorders; mixed disorders of conduct and emotions, emotional disorders, disorders of social functioning or tic disorders; other behavioral or emotional disorders; and sleep disorders,” Dr. Räikkönen and colleagues reported. Among preterm-born, treatment-exposed children, the adjusted hazard ratio was significantly lower for intellectual disability and higher for sleep disorders.

Dr. DeMauro noted potential confounders in this observational study, including abnormal pregnancy events that lead clinicians to administer steroids. Such events “predispose the exposed children to adverse cognitive outcomes,” suggests some research. “Alternately, after a pregnancy at high risk for preterm delivery, families may perceive their children as vulnerable and therefore may be more likely to seek care and earlier diagnosis of mental or behavioral disorders,” Dr. DeMauro said.

The study was funded by the Academy of Finland, European Commission, Foundation for Pediatric Research, the Signe and Ane Gyllenberg Foundation, the Novo Nordisk Foundation, the Sigrid Juselius Foundation, and the Juho Vainio Foundation. The investigators and Dr. DeMauro had no conflict of interest disclosures.

jremaly@mdedge.com

SOURCE: Räikkönen K et al. JAMA. 2020;323(19):1924-33. doi: 10.1001/jama.2020.3937.

Exposure to maternal antenatal corticosteroid treatment is significantly associated with mental and behavioral disorders in children, compared with nonexposure, according to a Finnish population-based study published in JAMA. The findings may lead to changes in clinical practice, particularly for infants who may be born full term.

After adjustment for variables such as maternal age, smoking during pregnancy, any lifetime mental disorder diagnosis, and gestational age at birth, exposure to maternal antenatal corticosteroid treatment was significantly associated with mental and behavioral disorders in children, compared with nonexposure, with a hazard ratio of 1.33. Among children born at term, the adjusted hazard ratio was 1.47. Among preterm children, the hazard ratio was not significant.

“Although benefits of this therapy outweigh risks in the most vulnerable infants, this may not be true for all infants,” wrote Sara B. DeMauro, MD, an attending neonatologist and program director of the neonatal follow-up program at Children’s Hospital of Philadelphia, in an editorial also published in JAMA. “Recommendations to administer this therapy to broader populations of pregnant women may need to be reexamined until sufficient safety data, particularly among more mature infants, are available.”

Corticosteroid treatment to accelerate fetal maturation is standard care before 34 weeks’ gestation when there is a likelihood of delivery within 7 days, and studies have found that providing this therapy reduces the risk for respiratory problems when administered beyond 34 weeks. In 2016, updates to U.S. guidelines allowed for the use of corticosteroid treatment between 34 weeks and 36 weeks 6 days when women are at risk for preterm delivery within 7 days and have not received a previous course of antenatal corticosteroids.

The data from Finland indicate that “a significant number of very preterm children who might have benefited from this treatment did not receive it,” Dr. DeMauro wrote. At the same time, “45% of steroid-exposed infants were delivered at term. In these infants, minor short-term benefit may have been outweighed by significant longer-term risks. These data elucidate both the continuing struggle to accurately predict preterm birth and the incomplete uptake of an effective therapy that is beneficial when administered to the correct patients.”
 

Pause expanded use?

“Since the recommendations came out to expand the use of corticosteroids for preterm labor up until 37 weeks gestational age, my practice has incorporated these guidelines,” said Santina Wheat, MD, assistant professor of family and community medicine at Northwestern University in Chicago. “We have incorporated the guidelines though with the understanding that the benefits outweigh the risk. This article indicates that we may have been wrong in that understanding.” Although the association does not establish that the treatment causes mental and behavioral disorders, it “raises the question of whether we should halt this practice until additional information can be gathered,” noted Dr. Wheat, who also serves on the editorial advisory board of Family Practice News.

When administered before delivery of a very premature infant, corticosteroid therapy accelerates fetal lung maturation and helps prevent neonatal mortality, respiratory distress syndrome, and brain injury. Investigators demonstrated the benefits of antenatal corticosteroids in 1972, and the treatment – “one of the most important advances in perinatal care” – became widely used in the 1990s, Dr. DeMauro said.

To examine whether treatment exposure is associated with a risk of childhood mental and behavioral disorders and whether the risk is similar in infants born at term and preterm, Katri Räikkönen, PhD, a researcher at the University of Helsinki, and colleagues conducted a population-based retrospective study of more than 670,000 children.

The researchers identified all singleton pregnancies ending in a live birth in Finland during Jan. 1, 2006–Dec.31, 2017. In addition, they identified all consecutive maternal sibling pairs born at term, including sibling pairs discordant for maternal antenatal corticosteroid treatment exposure and sibling pairs concordant for treatment exposure or nonexposure. The investigators identified diagnoses of childhood mental and behavioral disorders using the Finnish Care Register for Health Care using ICD-10 codes on hospital inpatient and outpatient treatments by physicians in specialized medical care.
 

A range of disorders

In all, 670,097 infants with a median follow-up duration of 5.8 years were included in the analysis, and 14,868 (2.22%) were exposed to antenatal corticosteroids. Of the treatment-exposed children, about 45% were born at term. Of the nonexposed children, approximately 97% were born at term. Cumulative incidence rates for any mental and behavioral disorder were significantly higher for treatment-exposed children, compared with nonexposed children, in the entire cohort (12.01% vs. 6.45%; P less than .001) and in term-born children (8.89% vs. 6.31%; P less than .001).

In preterm children, the incidence rate of any mental and behavioral disorder was significantly higher among those with treatment exposure (14.59% vs. 10.71%; P less than .001). Associations persisted when the investigators focused on 241,621 sibling pairs, “suggesting that unmeasured familial confounding did not explain these associations,” the authors said.

“[In] the entire cohort and term-born children, treatment exposure ... was significantly associated with psychological development disorders; attention-deficit/hyperactivity or conduct disorders; mixed disorders of conduct and emotions, emotional disorders, disorders of social functioning or tic disorders; other behavioral or emotional disorders; and sleep disorders,” Dr. Räikkönen and colleagues reported. Among preterm-born, treatment-exposed children, the adjusted hazard ratio was significantly lower for intellectual disability and higher for sleep disorders.

Dr. DeMauro noted potential confounders in this observational study, including abnormal pregnancy events that lead clinicians to administer steroids. Such events “predispose the exposed children to adverse cognitive outcomes,” suggests some research. “Alternately, after a pregnancy at high risk for preterm delivery, families may perceive their children as vulnerable and therefore may be more likely to seek care and earlier diagnosis of mental or behavioral disorders,” Dr. DeMauro said.

The study was funded by the Academy of Finland, European Commission, Foundation for Pediatric Research, the Signe and Ane Gyllenberg Foundation, the Novo Nordisk Foundation, the Sigrid Juselius Foundation, and the Juho Vainio Foundation. The investigators and Dr. DeMauro had no conflict of interest disclosures.

jremaly@mdedge.com

SOURCE: Räikkönen K et al. JAMA. 2020;323(19):1924-33. doi: 10.1001/jama.2020.3937.

Exposure to maternal antenatal corticosteroid treatment is significantly associated with mental and behavioral disorders in children, compared with nonexposure, according to a Finnish population-based study published in JAMA. The findings may lead to changes in clinical practice, particularly for infants who may be born full term.

After adjustment for variables such as maternal age, smoking during pregnancy, any lifetime mental disorder diagnosis, and gestational age at birth, exposure to maternal antenatal corticosteroid treatment was significantly associated with mental and behavioral disorders in children, compared with nonexposure, with a hazard ratio of 1.33. Among children born at term, the adjusted hazard ratio was 1.47. Among preterm children, the hazard ratio was not significant.

“Although benefits of this therapy outweigh risks in the most vulnerable infants, this may not be true for all infants,” wrote Sara B. DeMauro, MD, an attending neonatologist and program director of the neonatal follow-up program at Children’s Hospital of Philadelphia, in an editorial also published in JAMA. “Recommendations to administer this therapy to broader populations of pregnant women may need to be reexamined until sufficient safety data, particularly among more mature infants, are available.”

Corticosteroid treatment to accelerate fetal maturation is standard care before 34 weeks’ gestation when there is a likelihood of delivery within 7 days, and studies have found that providing this therapy reduces the risk for respiratory problems when administered beyond 34 weeks. In 2016, updates to U.S. guidelines allowed for the use of corticosteroid treatment between 34 weeks and 36 weeks 6 days when women are at risk for preterm delivery within 7 days and have not received a previous course of antenatal corticosteroids.

The data from Finland indicate that “a significant number of very preterm children who might have benefited from this treatment did not receive it,” Dr. DeMauro wrote. At the same time, “45% of steroid-exposed infants were delivered at term. In these infants, minor short-term benefit may have been outweighed by significant longer-term risks. These data elucidate both the continuing struggle to accurately predict preterm birth and the incomplete uptake of an effective therapy that is beneficial when administered to the correct patients.”
 

Pause expanded use?

“Since the recommendations came out to expand the use of corticosteroids for preterm labor up until 37 weeks gestational age, my practice has incorporated these guidelines,” said Santina Wheat, MD, assistant professor of family and community medicine at Northwestern University in Chicago. “We have incorporated the guidelines though with the understanding that the benefits outweigh the risk. This article indicates that we may have been wrong in that understanding.” Although the association does not establish that the treatment causes mental and behavioral disorders, it “raises the question of whether we should halt this practice until additional information can be gathered,” noted Dr. Wheat, who also serves on the editorial advisory board of Family Practice News.

When administered before delivery of a very premature infant, corticosteroid therapy accelerates fetal lung maturation and helps prevent neonatal mortality, respiratory distress syndrome, and brain injury. Investigators demonstrated the benefits of antenatal corticosteroids in 1972, and the treatment – “one of the most important advances in perinatal care” – became widely used in the 1990s, Dr. DeMauro said.

To examine whether treatment exposure is associated with a risk of childhood mental and behavioral disorders and whether the risk is similar in infants born at term and preterm, Katri Räikkönen, PhD, a researcher at the University of Helsinki, and colleagues conducted a population-based retrospective study of more than 670,000 children.

The researchers identified all singleton pregnancies ending in a live birth in Finland during Jan. 1, 2006–Dec.31, 2017. In addition, they identified all consecutive maternal sibling pairs born at term, including sibling pairs discordant for maternal antenatal corticosteroid treatment exposure and sibling pairs concordant for treatment exposure or nonexposure. The investigators identified diagnoses of childhood mental and behavioral disorders using the Finnish Care Register for Health Care using ICD-10 codes on hospital inpatient and outpatient treatments by physicians in specialized medical care.
 

A range of disorders

In all, 670,097 infants with a median follow-up duration of 5.8 years were included in the analysis, and 14,868 (2.22%) were exposed to antenatal corticosteroids. Of the treatment-exposed children, about 45% were born at term. Of the nonexposed children, approximately 97% were born at term. Cumulative incidence rates for any mental and behavioral disorder were significantly higher for treatment-exposed children, compared with nonexposed children, in the entire cohort (12.01% vs. 6.45%; P less than .001) and in term-born children (8.89% vs. 6.31%; P less than .001).

In preterm children, the incidence rate of any mental and behavioral disorder was significantly higher among those with treatment exposure (14.59% vs. 10.71%; P less than .001). Associations persisted when the investigators focused on 241,621 sibling pairs, “suggesting that unmeasured familial confounding did not explain these associations,” the authors said.

“[In] the entire cohort and term-born children, treatment exposure ... was significantly associated with psychological development disorders; attention-deficit/hyperactivity or conduct disorders; mixed disorders of conduct and emotions, emotional disorders, disorders of social functioning or tic disorders; other behavioral or emotional disorders; and sleep disorders,” Dr. Räikkönen and colleagues reported. Among preterm-born, treatment-exposed children, the adjusted hazard ratio was significantly lower for intellectual disability and higher for sleep disorders.

Dr. DeMauro noted potential confounders in this observational study, including abnormal pregnancy events that lead clinicians to administer steroids. Such events “predispose the exposed children to adverse cognitive outcomes,” suggests some research. “Alternately, after a pregnancy at high risk for preterm delivery, families may perceive their children as vulnerable and therefore may be more likely to seek care and earlier diagnosis of mental or behavioral disorders,” Dr. DeMauro said.

The study was funded by the Academy of Finland, European Commission, Foundation for Pediatric Research, the Signe and Ane Gyllenberg Foundation, the Novo Nordisk Foundation, the Sigrid Juselius Foundation, and the Juho Vainio Foundation. The investigators and Dr. DeMauro had no conflict of interest disclosures.

jremaly@mdedge.com

SOURCE: Räikkönen K et al. JAMA. 2020;323(19):1924-33. doi: 10.1001/jama.2020.3937.

The vast majority of patients with rheumatic and musculoskeletal diseases who contract COVID-19 recover from the virus, regardless of which medication they receive for their rheumatic condition, new international research suggests.

“These results provide, for the first time, information about the outcome of COVID-19 in patients with rheumatic and musculoskeletal diseases,” said study investigator Pedro Machado, MD, PhD, from University College London. “They should provide some reassurance to patients and healthcare providers.”

Machado and his colleagues looked at 600 COVID-19 patients from 40 countries, and found that those taking TNF inhibitors for their rheumatic disease were less likely to be hospitalized for COVID-19. However, treatment with more than 10 mg of prednisone daily — considered a moderate to high dose — was associated with a higher probability of hospitalization.

In addition, hospitalization was not associated with biologics; JAK inhibitors; conventional disease-modifying antirheumatic drugs (DMARDs), such as methotrexate; antimalarials, such as hydroxychloroquine; or nonsteroidal anti-inflammatory drugs (NSAIDs) — either alone or in combination with other biologics, such as TNF-alpha inhibitors.

The findings were presented at the virtual European League Against Rheumatism (EULAR) 2020 Congress and were published online in Annals of the Rheumatic Diseases.

“Initially, there was a huge concern that these drugs could affect the outcome of patients getting COVID-19, but what this is showing is that probably these drugs do not increase their risk of severe outcome,” Machado, who is chair of the EULAR standing committee on epidemiology and health services research, told Medscape Medical News.

As of June 1, 1061 patients from 28 participating countries had been entered into the EULAR COVID-19 database, which was launched as part of the international Global Rheumatology Alliance registry. Patient data are categorized by factors such as top rheumatology diagnosis, comorbidities, top-five COVID-19 symptoms, and DMARD therapy at the time of virus infection. Anonymized data will be shared with an international register based in the United States.

Machado’s team combined data from the EULAR and Global Rheumatology Alliance COVID-19 registries from March 24 to April 20. They looked at patient factors — such as age, sex, smoking status, rheumatic diagnosis, comorbidities, and rheumatic therapies — to examine the association of rheumatic therapies with hospitalization rates and COVID-19 disease course.

Of the 277 patients (46%) in the study cohort who required hospitalization, 55 (9%) died. But this finding shouldn’t be viewed as the true rate of hospitalization or death in patients with rheumatic disease and COVID-19, said Gerd Burmester, MD, from Charité–University Medicine Berlin.

“There’s tremendous bias in terms of more serious cases of COVID-19 being reported to the registries,” he explained, “because the mild cases won’t even show up at their rheumatologist’s office.”

“This can skew the idea that COVID-19 is much more dangerous to rheumatic patients than to the regular population,” Burmester told Medscape Medical News. “It scares the patients, obviously, but we believe this is not justified.”

It’s still unclear whether rituximab use raises the risk for severe COVID-19, he said. “It appears to be the only biologic for which the jury is still out,” he said.

“Anti-TNFs and anti-IL-6 drugs may even be beneficial, although we don’t have robust data,” he added.

The study can only highlight associations between rheumatic drugs and COVID-19 outcomes. “We cannot say there is a causal relationship between the findings,” Machado said.

Longer-term data, when available, should illuminate “more granular” aspects of COVID-19 outcomes in rheumatic patients, including their risks of requiring ventilation or developing a cytokine storm, he noted.

Burmester and Machado agree that research needs to continue as the pandemic rages on. But so far, “there are no data suggesting that, if you’re on a targeted, dedicated immunomodulator, your risk is higher to have a worse course of COVID-19 than the general population,” Burmester said.

“We simply didn’t know that when the pandemic started, and some patients even discontinued their drugs out of this fear,” he added. “It’s more reassuring than we originally thought.”

This article first appeared on Medscape.com.

The vast majority of patients with rheumatic and musculoskeletal diseases who contract COVID-19 recover from the virus, regardless of which medication they receive for their rheumatic condition, new international research suggests.

“These results provide, for the first time, information about the outcome of COVID-19 in patients with rheumatic and musculoskeletal diseases,” said study investigator Pedro Machado, MD, PhD, from University College London. “They should provide some reassurance to patients and healthcare providers.”

Machado and his colleagues looked at 600 COVID-19 patients from 40 countries, and found that those taking TNF inhibitors for their rheumatic disease were less likely to be hospitalized for COVID-19. However, treatment with more than 10 mg of prednisone daily — considered a moderate to high dose — was associated with a higher probability of hospitalization.

In addition, hospitalization was not associated with biologics; JAK inhibitors; conventional disease-modifying antirheumatic drugs (DMARDs), such as methotrexate; antimalarials, such as hydroxychloroquine; or nonsteroidal anti-inflammatory drugs (NSAIDs) — either alone or in combination with other biologics, such as TNF-alpha inhibitors.

The findings were presented at the virtual European League Against Rheumatism (EULAR) 2020 Congress and were published online in Annals of the Rheumatic Diseases.

“Initially, there was a huge concern that these drugs could affect the outcome of patients getting COVID-19, but what this is showing is that probably these drugs do not increase their risk of severe outcome,” Machado, who is chair of the EULAR standing committee on epidemiology and health services research, told Medscape Medical News.

As of June 1, 1061 patients from 28 participating countries had been entered into the EULAR COVID-19 database, which was launched as part of the international Global Rheumatology Alliance registry. Patient data are categorized by factors such as top rheumatology diagnosis, comorbidities, top-five COVID-19 symptoms, and DMARD therapy at the time of virus infection. Anonymized data will be shared with an international register based in the United States.

Machado’s team combined data from the EULAR and Global Rheumatology Alliance COVID-19 registries from March 24 to April 20. They looked at patient factors — such as age, sex, smoking status, rheumatic diagnosis, comorbidities, and rheumatic therapies — to examine the association of rheumatic therapies with hospitalization rates and COVID-19 disease course.

Of the 277 patients (46%) in the study cohort who required hospitalization, 55 (9%) died. But this finding shouldn’t be viewed as the true rate of hospitalization or death in patients with rheumatic disease and COVID-19, said Gerd Burmester, MD, from Charité–University Medicine Berlin.

“There’s tremendous bias in terms of more serious cases of COVID-19 being reported to the registries,” he explained, “because the mild cases won’t even show up at their rheumatologist’s office.”

“This can skew the idea that COVID-19 is much more dangerous to rheumatic patients than to the regular population,” Burmester told Medscape Medical News. “It scares the patients, obviously, but we believe this is not justified.”

It’s still unclear whether rituximab use raises the risk for severe COVID-19, he said. “It appears to be the only biologic for which the jury is still out,” he said.

“Anti-TNFs and anti-IL-6 drugs may even be beneficial, although we don’t have robust data,” he added.

The study can only highlight associations between rheumatic drugs and COVID-19 outcomes. “We cannot say there is a causal relationship between the findings,” Machado said.

Longer-term data, when available, should illuminate “more granular” aspects of COVID-19 outcomes in rheumatic patients, including their risks of requiring ventilation or developing a cytokine storm, he noted.

Burmester and Machado agree that research needs to continue as the pandemic rages on. But so far, “there are no data suggesting that, if you’re on a targeted, dedicated immunomodulator, your risk is higher to have a worse course of COVID-19 than the general population,” Burmester said.

“We simply didn’t know that when the pandemic started, and some patients even discontinued their drugs out of this fear,” he added. “It’s more reassuring than we originally thought.”

This article first appeared on Medscape.com.

The vast majority of patients with rheumatic and musculoskeletal diseases who contract COVID-19 recover from the virus, regardless of which medication they receive for their rheumatic condition, new international research suggests.

“These results provide, for the first time, information about the outcome of COVID-19 in patients with rheumatic and musculoskeletal diseases,” said study investigator Pedro Machado, MD, PhD, from University College London. “They should provide some reassurance to patients and healthcare providers.”

Machado and his colleagues looked at 600 COVID-19 patients from 40 countries, and found that those taking TNF inhibitors for their rheumatic disease were less likely to be hospitalized for COVID-19. However, treatment with more than 10 mg of prednisone daily — considered a moderate to high dose — was associated with a higher probability of hospitalization.

In addition, hospitalization was not associated with biologics; JAK inhibitors; conventional disease-modifying antirheumatic drugs (DMARDs), such as methotrexate; antimalarials, such as hydroxychloroquine; or nonsteroidal anti-inflammatory drugs (NSAIDs) — either alone or in combination with other biologics, such as TNF-alpha inhibitors.

The findings were presented at the virtual European League Against Rheumatism (EULAR) 2020 Congress and were published online in Annals of the Rheumatic Diseases.

“Initially, there was a huge concern that these drugs could affect the outcome of patients getting COVID-19, but what this is showing is that probably these drugs do not increase their risk of severe outcome,” Machado, who is chair of the EULAR standing committee on epidemiology and health services research, told Medscape Medical News.

As of June 1, 1061 patients from 28 participating countries had been entered into the EULAR COVID-19 database, which was launched as part of the international Global Rheumatology Alliance registry. Patient data are categorized by factors such as top rheumatology diagnosis, comorbidities, top-five COVID-19 symptoms, and DMARD therapy at the time of virus infection. Anonymized data will be shared with an international register based in the United States.

Machado’s team combined data from the EULAR and Global Rheumatology Alliance COVID-19 registries from March 24 to April 20. They looked at patient factors — such as age, sex, smoking status, rheumatic diagnosis, comorbidities, and rheumatic therapies — to examine the association of rheumatic therapies with hospitalization rates and COVID-19 disease course.

Of the 277 patients (46%) in the study cohort who required hospitalization, 55 (9%) died. But this finding shouldn’t be viewed as the true rate of hospitalization or death in patients with rheumatic disease and COVID-19, said Gerd Burmester, MD, from Charité–University Medicine Berlin.

“There’s tremendous bias in terms of more serious cases of COVID-19 being reported to the registries,” he explained, “because the mild cases won’t even show up at their rheumatologist’s office.”

“This can skew the idea that COVID-19 is much more dangerous to rheumatic patients than to the regular population,” Burmester told Medscape Medical News. “It scares the patients, obviously, but we believe this is not justified.”

It’s still unclear whether rituximab use raises the risk for severe COVID-19, he said. “It appears to be the only biologic for which the jury is still out,” he said.

“Anti-TNFs and anti-IL-6 drugs may even be beneficial, although we don’t have robust data,” he added.

The study can only highlight associations between rheumatic drugs and COVID-19 outcomes. “We cannot say there is a causal relationship between the findings,” Machado said.

Longer-term data, when available, should illuminate “more granular” aspects of COVID-19 outcomes in rheumatic patients, including their risks of requiring ventilation or developing a cytokine storm, he noted.

Burmester and Machado agree that research needs to continue as the pandemic rages on. But so far, “there are no data suggesting that, if you’re on a targeted, dedicated immunomodulator, your risk is higher to have a worse course of COVID-19 than the general population,” Burmester said.

“We simply didn’t know that when the pandemic started, and some patients even discontinued their drugs out of this fear,” he added. “It’s more reassuring than we originally thought.”

This article first appeared on Medscape.com.

CYBERSPACE – Hope Rugo, MD, was one of the would-be attendees of the American Society of Clinical Oncology annual meeting who could not access the online event on its first day, Friday, May 29.

“Such a shame – virtual ASCO is nonexistent,” tweeted Rugo, who is from the University of California, San Francisco.

The breast cancer specialist tried for more than hour before finally gaining entry in the late morning.

Not everyone was as successful.

That same day, Arjun Balar, MD, of NYU Langone Health in New York announced on Twitter that he’d quit for the day. “I give up @ASCO. Time for a cocktail.”

Don Dizon, MD, of Brown University in Providence, Rhode Island, tried repeatedly to join the meeting as a live broadcast, using his desktop and laptop computers as well as an iPad. Nothing worked. Limited to seeing data and discussions “after the fact,” Dizon looked to next year, tweeting hopefully: “... fingers crossed for an inperson #ASCO21.”

ASCO did not respond to a request for further information about the technical difficulties of the meeting’s first day.

This year’s meeting, which involved 40,000-plus attendees, was shortened to 3 days and limited to scientific presentations because of the COVID-19 pandemic. Education sessions will be held online August 8-10.

Despite those technical glitches, dozens of virtual meeting attendees praised the online effort, which was assembled in just a few months, and called out virtues such as the quick availability of video transcripts as well as the obvious benefits of low cost, zero travel, and overall convenience. But one sentiment was nearly universal: there’s nothing like the real thing.

At the same time, a Medscape Oncology online meeting poll indicated that nearly half (48%) of the 335 respondents said “no,” they do not envision themselves in person at the real thing in Chicago in 2021. About one fifth (21%) said, “yes, if there is a vaccine.” Roughly 15% said “yes,” and another 15% said “not sure right now.”

What did oncologists miss most with virtual ASCO?

Many said face-to-face (F2F) interactions. Collaboration, networking, and catching up with old friends were some of the stock F2F moments cited as losses.

Others described more idiosyncratic disappointments, including Riyaz Shah, MD, of the Kent Oncology Centre in the UK, who dismissed a future with exclusively virtual meetings.

He tweeted: “Not sustainable. We need to meet F2F. Oncology is an odd one. Exposed to human distress daily (if not hourly). [Very] few people understand what we do, fewer would do it. There aren’t many people we can talk to. I love chewing the cud with my colleagues who are close friends.”

The virtual meeting inspired more social media engagement, but fewer oncologists participated, according to data from social media analytics firm Symplur. This year, 1K users identified as oncologists generated 17.75K tweets. In 2019, 1.3K oncologists put out 15.2K tweets.

Virtual meeting ‘like homework’

George Sledge, MD, of Stanford University, California, asked his 1700 Twitter followers to discuss the virtual ASCO experience, including the spotty functionality of presenter videos (a con) and eating dinner between talks (a pro).

One of his criticisms struck a nerve – that the online meeting was “like homework.”

“ ‘Feels like homework’ is the best expression I [have] read so far!” tweeted Gustavo Gössling, MD, from the Kaplan Oncology Institute in Porto Alegre, Brazil.

Yes, it feels “like studying alone,” agreed Stanford’s Lidia Schapira, MD, in a tweet.

“It’s incredibly boring – let’s bring back F2F next year,” tweeted Ioannis Gounaris, MD, Merck Group, Cambridge, UK, in response to Sledge’s request.

Sledge joined many others in saying that, ultimately, the future should include – and will demand – both virtual and in-person meetings.

What will happen with ASCO next year?

Medscape Medical News asked some virtual attendees whether they envisioned going in person to the ASCO meeting next year in Chicago.

“Counting on it,” said Harold Burstein, MD, PhD, Dana-Farber Cancer Institute, Boston. “But I also recognize that it fully depends on what happens between now and then. Vaccines. Safety of travel. Safety of large, indoor, crowded spaces.”

Despite acknowledging the uncertainty of how things will “play out,” Burstein advised: “Put it on your calendar and make reservations, and make sure the reservations are fully refundable.”

Ahmad Tarhini, MD, from the Moffitt Cancer Center in Tampa, Florida, sounded similarly optimistic: “Hopefully we will have a vaccine by then. I expect the ASCO annual meeting will happen in person in 2021.”

Moffitt colleague Michelle Echevarria Colon, MD, said, “I could see myself attending ... in Chicago in 2021.” And she added: “I think we’ll get to a point where it could happen.”

Others were uncertain.

Ishwaria Subbiah, MD, University of Texas MD Anderson Cancer Center, Houston, said: “If someone told us 6 months ago that our ‘new normal’ would be in this near-total virtual existence, most of us would not have believed them. So it is hard to imagine what our reality will be in a year from now at ASCO 2021.”

Jack West, MD, from City of Hope Comprehensive Cancer Center in Duarte, California, thinks the meeting will be changed for a long time, even if 2021 is a live event.

“While I think that there MIGHT be a live conference, I think it will be many years, if ever, before we see it return to its prior magnitude,” he wrote in an email, echoing remarks previously made by other healthcare professionals about medical meetings in any post–COVID-19 world.

A year from now, said West, “I strongly suspect that we will still be contending with risk of exposure” and that means clinician attendees might, in turn, expose their cancer patients back home.

Despite his wistful “fingers crossed” tweet during ASCO 2020, Brown’s Dizon also recently commented on Medscape that “I wonder whether I will ever sit in a crowded auditorium at an ASCO annual meeting again.”

Sagar Sardesai, MBBS, Ohio State Comprehensive Cancer Center, Columbus, responded: “Unless we have a vaccine that is successful or we can demonstrate enough herd immunity in the United States, I can’t imagine that such large gatherings are a real possibility. We need to protect our vulnerable populations.”

City of Hope’s Cary Presant, MD, acknowledged he is one of those vulnerable people. “In 2021, if the environment is safe for oncologists of my age, I will be in Chicago,” he said. “But with COVID-19 still a threat, I might have to attend only virtually.”
 

“This year was special”

On social media, MD Anderson’s Vivek Subbiah, MD, did not speculate about next year’s meeting but observed the uniqueness of the current moment.

He tweeted: “The last 8 years of @asco are a blur in my memory. This year #ASCO was special, and I’m sure we will all remember where we were for this year’s meeting.”

Other oncologists praised the accessibility of the virtual meeting.

“The power of a virtual meeting is it creates an unlimited number of seats at the oncology research table. Anyone globally can be involved and that is really special,” said Suneel Kamath, MD, Cleveland Clinic, Ohio.

“Virtual ASCO levels the playing field for oncologists everywhere,” says Bishal Gyawali, MD, PhD, from Queen’s University, Kingston, Canada. In a Medscape Commentary, he notes that  “attending a typical ASCO meeting is astonishingly cost-prohibitive, especially for colleagues from low- and middle-income countries ... now everybody has the same access to the meeting.”

ASCO made the best out of a bad situation with the expanded virtual meeting, suggested David Henry, MD, Pennsylvania Hospital, Philadelphia, host of MDEdge’s Blood and Cancer podcast, part of the Medscape Professional Network. In an interview with ASCO president Skip Burris, MD, before the meeting, Henry said: “Making lemonade out of lemons. It’ll give us something new and different. What an amazing turn of events.”

With additional reporting by Zosia Chustecka , Liz Neporent, Neil Osterweil, and Jennifer Smith. This article first appeared on Medscape.com.

CYBERSPACE – Hope Rugo, MD, was one of the would-be attendees of the American Society of Clinical Oncology annual meeting who could not access the online event on its first day, Friday, May 29.

“Such a shame – virtual ASCO is nonexistent,” tweeted Rugo, who is from the University of California, San Francisco.

The breast cancer specialist tried for more than hour before finally gaining entry in the late morning.

Not everyone was as successful.

That same day, Arjun Balar, MD, of NYU Langone Health in New York announced on Twitter that he’d quit for the day. “I give up @ASCO. Time for a cocktail.”

Don Dizon, MD, of Brown University in Providence, Rhode Island, tried repeatedly to join the meeting as a live broadcast, using his desktop and laptop computers as well as an iPad. Nothing worked. Limited to seeing data and discussions “after the fact,” Dizon looked to next year, tweeting hopefully: “... fingers crossed for an inperson #ASCO21.”

ASCO did not respond to a request for further information about the technical difficulties of the meeting’s first day.

This year’s meeting, which involved 40,000-plus attendees, was shortened to 3 days and limited to scientific presentations because of the COVID-19 pandemic. Education sessions will be held online August 8-10.

Despite those technical glitches, dozens of virtual meeting attendees praised the online effort, which was assembled in just a few months, and called out virtues such as the quick availability of video transcripts as well as the obvious benefits of low cost, zero travel, and overall convenience. But one sentiment was nearly universal: there’s nothing like the real thing.

At the same time, a Medscape Oncology online meeting poll indicated that nearly half (48%) of the 335 respondents said “no,” they do not envision themselves in person at the real thing in Chicago in 2021. About one fifth (21%) said, “yes, if there is a vaccine.” Roughly 15% said “yes,” and another 15% said “not sure right now.”

What did oncologists miss most with virtual ASCO?

Many said face-to-face (F2F) interactions. Collaboration, networking, and catching up with old friends were some of the stock F2F moments cited as losses.

Others described more idiosyncratic disappointments, including Riyaz Shah, MD, of the Kent Oncology Centre in the UK, who dismissed a future with exclusively virtual meetings.

He tweeted: “Not sustainable. We need to meet F2F. Oncology is an odd one. Exposed to human distress daily (if not hourly). [Very] few people understand what we do, fewer would do it. There aren’t many people we can talk to. I love chewing the cud with my colleagues who are close friends.”

The virtual meeting inspired more social media engagement, but fewer oncologists participated, according to data from social media analytics firm Symplur. This year, 1K users identified as oncologists generated 17.75K tweets. In 2019, 1.3K oncologists put out 15.2K tweets.

Virtual meeting ‘like homework’

George Sledge, MD, of Stanford University, California, asked his 1700 Twitter followers to discuss the virtual ASCO experience, including the spotty functionality of presenter videos (a con) and eating dinner between talks (a pro).

One of his criticisms struck a nerve – that the online meeting was “like homework.”

“ ‘Feels like homework’ is the best expression I [have] read so far!” tweeted Gustavo Gössling, MD, from the Kaplan Oncology Institute in Porto Alegre, Brazil.

Yes, it feels “like studying alone,” agreed Stanford’s Lidia Schapira, MD, in a tweet.

“It’s incredibly boring – let’s bring back F2F next year,” tweeted Ioannis Gounaris, MD, Merck Group, Cambridge, UK, in response to Sledge’s request.

Sledge joined many others in saying that, ultimately, the future should include – and will demand – both virtual and in-person meetings.

What will happen with ASCO next year?

Medscape Medical News asked some virtual attendees whether they envisioned going in person to the ASCO meeting next year in Chicago.

“Counting on it,” said Harold Burstein, MD, PhD, Dana-Farber Cancer Institute, Boston. “But I also recognize that it fully depends on what happens between now and then. Vaccines. Safety of travel. Safety of large, indoor, crowded spaces.”

Despite acknowledging the uncertainty of how things will “play out,” Burstein advised: “Put it on your calendar and make reservations, and make sure the reservations are fully refundable.”

Ahmad Tarhini, MD, from the Moffitt Cancer Center in Tampa, Florida, sounded similarly optimistic: “Hopefully we will have a vaccine by then. I expect the ASCO annual meeting will happen in person in 2021.”

Moffitt colleague Michelle Echevarria Colon, MD, said, “I could see myself attending ... in Chicago in 2021.” And she added: “I think we’ll get to a point where it could happen.”

Others were uncertain.

Ishwaria Subbiah, MD, University of Texas MD Anderson Cancer Center, Houston, said: “If someone told us 6 months ago that our ‘new normal’ would be in this near-total virtual existence, most of us would not have believed them. So it is hard to imagine what our reality will be in a year from now at ASCO 2021.”

Jack West, MD, from City of Hope Comprehensive Cancer Center in Duarte, California, thinks the meeting will be changed for a long time, even if 2021 is a live event.

“While I think that there MIGHT be a live conference, I think it will be many years, if ever, before we see it return to its prior magnitude,” he wrote in an email, echoing remarks previously made by other healthcare professionals about medical meetings in any post–COVID-19 world.

A year from now, said West, “I strongly suspect that we will still be contending with risk of exposure” and that means clinician attendees might, in turn, expose their cancer patients back home.

Despite his wistful “fingers crossed” tweet during ASCO 2020, Brown’s Dizon also recently commented on Medscape that “I wonder whether I will ever sit in a crowded auditorium at an ASCO annual meeting again.”

Sagar Sardesai, MBBS, Ohio State Comprehensive Cancer Center, Columbus, responded: “Unless we have a vaccine that is successful or we can demonstrate enough herd immunity in the United States, I can’t imagine that such large gatherings are a real possibility. We need to protect our vulnerable populations.”

City of Hope’s Cary Presant, MD, acknowledged he is one of those vulnerable people. “In 2021, if the environment is safe for oncologists of my age, I will be in Chicago,” he said. “But with COVID-19 still a threat, I might have to attend only virtually.”
 

“This year was special”

On social media, MD Anderson’s Vivek Subbiah, MD, did not speculate about next year’s meeting but observed the uniqueness of the current moment.

He tweeted: “The last 8 years of @asco are a blur in my memory. This year #ASCO was special, and I’m sure we will all remember where we were for this year’s meeting.”

Other oncologists praised the accessibility of the virtual meeting.

“The power of a virtual meeting is it creates an unlimited number of seats at the oncology research table. Anyone globally can be involved and that is really special,” said Suneel Kamath, MD, Cleveland Clinic, Ohio.

“Virtual ASCO levels the playing field for oncologists everywhere,” says Bishal Gyawali, MD, PhD, from Queen’s University, Kingston, Canada. In a Medscape Commentary, he notes that  “attending a typical ASCO meeting is astonishingly cost-prohibitive, especially for colleagues from low- and middle-income countries ... now everybody has the same access to the meeting.”

ASCO made the best out of a bad situation with the expanded virtual meeting, suggested David Henry, MD, Pennsylvania Hospital, Philadelphia, host of MDEdge’s Blood and Cancer podcast, part of the Medscape Professional Network. In an interview with ASCO president Skip Burris, MD, before the meeting, Henry said: “Making lemonade out of lemons. It’ll give us something new and different. What an amazing turn of events.”

With additional reporting by Zosia Chustecka , Liz Neporent, Neil Osterweil, and Jennifer Smith. This article first appeared on Medscape.com.

CYBERSPACE – Hope Rugo, MD, was one of the would-be attendees of the American Society of Clinical Oncology annual meeting who could not access the online event on its first day, Friday, May 29.

“Such a shame – virtual ASCO is nonexistent,” tweeted Rugo, who is from the University of California, San Francisco.

The breast cancer specialist tried for more than hour before finally gaining entry in the late morning.

Not everyone was as successful.

That same day, Arjun Balar, MD, of NYU Langone Health in New York announced on Twitter that he’d quit for the day. “I give up @ASCO. Time for a cocktail.”

Don Dizon, MD, of Brown University in Providence, Rhode Island, tried repeatedly to join the meeting as a live broadcast, using his desktop and laptop computers as well as an iPad. Nothing worked. Limited to seeing data and discussions “after the fact,” Dizon looked to next year, tweeting hopefully: “... fingers crossed for an inperson #ASCO21.”

ASCO did not respond to a request for further information about the technical difficulties of the meeting’s first day.

This year’s meeting, which involved 40,000-plus attendees, was shortened to 3 days and limited to scientific presentations because of the COVID-19 pandemic. Education sessions will be held online August 8-10.

Despite those technical glitches, dozens of virtual meeting attendees praised the online effort, which was assembled in just a few months, and called out virtues such as the quick availability of video transcripts as well as the obvious benefits of low cost, zero travel, and overall convenience. But one sentiment was nearly universal: there’s nothing like the real thing.

At the same time, a Medscape Oncology online meeting poll indicated that nearly half (48%) of the 335 respondents said “no,” they do not envision themselves in person at the real thing in Chicago in 2021. About one fifth (21%) said, “yes, if there is a vaccine.” Roughly 15% said “yes,” and another 15% said “not sure right now.”

What did oncologists miss most with virtual ASCO?

Many said face-to-face (F2F) interactions. Collaboration, networking, and catching up with old friends were some of the stock F2F moments cited as losses.

Others described more idiosyncratic disappointments, including Riyaz Shah, MD, of the Kent Oncology Centre in the UK, who dismissed a future with exclusively virtual meetings.

He tweeted: “Not sustainable. We need to meet F2F. Oncology is an odd one. Exposed to human distress daily (if not hourly). [Very] few people understand what we do, fewer would do it. There aren’t many people we can talk to. I love chewing the cud with my colleagues who are close friends.”

The virtual meeting inspired more social media engagement, but fewer oncologists participated, according to data from social media analytics firm Symplur. This year, 1K users identified as oncologists generated 17.75K tweets. In 2019, 1.3K oncologists put out 15.2K tweets.

Virtual meeting ‘like homework’

George Sledge, MD, of Stanford University, California, asked his 1700 Twitter followers to discuss the virtual ASCO experience, including the spotty functionality of presenter videos (a con) and eating dinner between talks (a pro).

One of his criticisms struck a nerve – that the online meeting was “like homework.”

“ ‘Feels like homework’ is the best expression I [have] read so far!” tweeted Gustavo Gössling, MD, from the Kaplan Oncology Institute in Porto Alegre, Brazil.

Yes, it feels “like studying alone,” agreed Stanford’s Lidia Schapira, MD, in a tweet.

“It’s incredibly boring – let’s bring back F2F next year,” tweeted Ioannis Gounaris, MD, Merck Group, Cambridge, UK, in response to Sledge’s request.

Sledge joined many others in saying that, ultimately, the future should include – and will demand – both virtual and in-person meetings.

What will happen with ASCO next year?

Medscape Medical News asked some virtual attendees whether they envisioned going in person to the ASCO meeting next year in Chicago.

“Counting on it,” said Harold Burstein, MD, PhD, Dana-Farber Cancer Institute, Boston. “But I also recognize that it fully depends on what happens between now and then. Vaccines. Safety of travel. Safety of large, indoor, crowded spaces.”

Despite acknowledging the uncertainty of how things will “play out,” Burstein advised: “Put it on your calendar and make reservations, and make sure the reservations are fully refundable.”

Ahmad Tarhini, MD, from the Moffitt Cancer Center in Tampa, Florida, sounded similarly optimistic: “Hopefully we will have a vaccine by then. I expect the ASCO annual meeting will happen in person in 2021.”

Moffitt colleague Michelle Echevarria Colon, MD, said, “I could see myself attending ... in Chicago in 2021.” And she added: “I think we’ll get to a point where it could happen.”

Others were uncertain.

Ishwaria Subbiah, MD, University of Texas MD Anderson Cancer Center, Houston, said: “If someone told us 6 months ago that our ‘new normal’ would be in this near-total virtual existence, most of us would not have believed them. So it is hard to imagine what our reality will be in a year from now at ASCO 2021.”

Jack West, MD, from City of Hope Comprehensive Cancer Center in Duarte, California, thinks the meeting will be changed for a long time, even if 2021 is a live event.

“While I think that there MIGHT be a live conference, I think it will be many years, if ever, before we see it return to its prior magnitude,” he wrote in an email, echoing remarks previously made by other healthcare professionals about medical meetings in any post–COVID-19 world.

A year from now, said West, “I strongly suspect that we will still be contending with risk of exposure” and that means clinician attendees might, in turn, expose their cancer patients back home.

Despite his wistful “fingers crossed” tweet during ASCO 2020, Brown’s Dizon also recently commented on Medscape that “I wonder whether I will ever sit in a crowded auditorium at an ASCO annual meeting again.”

Sagar Sardesai, MBBS, Ohio State Comprehensive Cancer Center, Columbus, responded: “Unless we have a vaccine that is successful or we can demonstrate enough herd immunity in the United States, I can’t imagine that such large gatherings are a real possibility. We need to protect our vulnerable populations.”

City of Hope’s Cary Presant, MD, acknowledged he is one of those vulnerable people. “In 2021, if the environment is safe for oncologists of my age, I will be in Chicago,” he said. “But with COVID-19 still a threat, I might have to attend only virtually.”
 

“This year was special”

On social media, MD Anderson’s Vivek Subbiah, MD, did not speculate about next year’s meeting but observed the uniqueness of the current moment.

He tweeted: “The last 8 years of @asco are a blur in my memory. This year #ASCO was special, and I’m sure we will all remember where we were for this year’s meeting.”

Other oncologists praised the accessibility of the virtual meeting.

“The power of a virtual meeting is it creates an unlimited number of seats at the oncology research table. Anyone globally can be involved and that is really special,” said Suneel Kamath, MD, Cleveland Clinic, Ohio.

“Virtual ASCO levels the playing field for oncologists everywhere,” says Bishal Gyawali, MD, PhD, from Queen’s University, Kingston, Canada. In a Medscape Commentary, he notes that  “attending a typical ASCO meeting is astonishingly cost-prohibitive, especially for colleagues from low- and middle-income countries ... now everybody has the same access to the meeting.”

ASCO made the best out of a bad situation with the expanded virtual meeting, suggested David Henry, MD, Pennsylvania Hospital, Philadelphia, host of MDEdge’s Blood and Cancer podcast, part of the Medscape Professional Network. In an interview with ASCO president Skip Burris, MD, before the meeting, Henry said: “Making lemonade out of lemons. It’ll give us something new and different. What an amazing turn of events.”

With additional reporting by Zosia Chustecka , Liz Neporent, Neil Osterweil, and Jennifer Smith. This article first appeared on Medscape.com.

The three oral disease-modifying therapies (DMTs) for multiple sclerosis (MS) approved last year in the United States haven’t made a big splash in the marketplace. So far, it’s more like a ripple, according to a study of neurologists’ prescribing patterns. “The recently approved therapies will initially be niched as later-line options,” predicted Virginia R. Schobel, MSc, nephrology franchise head at Spherix Global Insights, an independent market intelligence firm in Exton, Pa.

At the virtual annual meeting of the Consortium of Multiple Sclerosis Centers, Ms. Schobel presented the results of a retrospective chart audit Spherix conducted in February 2020 of 1,006 patients with MS who were switched to a new DMT by 199 U.S. participating neurologists within the previous 3 months. About 72% of the switchers had relapsing remitting MS (RRMS).
 

Assessing the three new oral DMTs

The purpose of the study was to gain an understanding of the early adoption patterns for the three recently approved oral DMTs: siponimod (Mayzent), cladribine (Mavenclad), and diroximel fumarate (Vumerity).

The first surprise was that only 41% of medication switches to a new DMT among the RRMS group were to oral DMTs; that’s a substantially lower proportion than in prior Spherix chart audits. Instead, the most popular switch was to ocrelizumab (Ocrevus), a monoclonal antibody.

“Things to keep in mind when we see the switch shares for the newer products are just how crowded this market has become and how much Ocrevus has really changed the market,” Ms. Schobel explained in an interview. “Ocrevus has become increasingly dominant in the RRMS segment, so that now there are six oral DMTs competing among themselves for a relatively limited pool of patients.”

Because of grandfathering by the Food and Drug Administration, most of the oral DMTs now share identical indications for clinically isolated syndrome, RRMS, and active secondary progressive MS. Ocrevus, she noted, has the same indications.

Only 1% of MS patients who switched to a different DMT in late 2019 or early 2020 moved to diroximel fumarate. Three percent switched to siponimod, and another 3% switched to cladribine. Switches to the three older, established oral DMTs were collectively five times more common, with 15% of patients moving to dimethyl fumarate (Tecfidera), 11% to fingolimod (Gilenya), and 9% to teriflunomide (Aubagio).

Ms. Schobel said that the three latest oral DMTs offer advantages over the older ones in terms of various combinations of efficacy, dosing schedule, and/or tolerability, which may make them attractive options as first-line therapy. She predicted that, over time as neurologists gain increasing familiarity with these drugs as first line, they will also gradually become more comfortable in turning to them as switch options.

First-time switches to an oral DMT among patients with RRMS were most often made in search of improved efficacy. Neurologists cited this as their main reason for 73% of switches to cladribine and 36% of switches to teriflunomide, with the other oral agents falling at various points in between. A switch to fingolimod was most often driven by a wish for a high-efficacy DMT with once-daily oral dosing. Improved tolerability figured prominently in switches to teriflunomide, and even more so in the relatively few changes to diroximel fumarate.
 

Drug switching in the pandemic era

Ms. Schobel said Spherix has been serially tracking neurologists’ prescribing for MS during the COVID-19 pandemic, which has clearly had an enormous dampening effect on medication switching. In mid-April, neurologists’ switching volume was down by 70%, compared with prepandemic figures. A slow recovery began in May, but by the end of the month prescription-switching volume was still down by 52%.

Of the neurologist prescriptions that are being run for switching thus far during the pandemic, 82% are being done via telemedicine. Therein hangs a tale, since neurology doesn’t readily lend itself to practice by telemedicine. Indeed, neurologists are using telemedicine to a lesser extent than physicians in the other specialties that Spherix monitors, according to Ms. Schobel. “COVID is definitely changing the MS world. Within MS, drug switching is now much more likely to involve a switch to a DMT that doesn’t impact the immune response and is not immunosuppressant, such as an injectable interferon or glatiramer acetate,” she said. “In this COVID world, safety and conservatism may end up trumping the move toward ‘time is brain’ which we’ve been talking so much about in recent years: the importance of getting patients on high-efficacy DMTs from the start in order to give them the best chance for positive outcomes.”

Ms. Schobel noted that Spherix received no industry funding to conduct these studies.

bjancin@mdedge.com

The three oral disease-modifying therapies (DMTs) for multiple sclerosis (MS) approved last year in the United States haven’t made a big splash in the marketplace. So far, it’s more like a ripple, according to a study of neurologists’ prescribing patterns. “The recently approved therapies will initially be niched as later-line options,” predicted Virginia R. Schobel, MSc, nephrology franchise head at Spherix Global Insights, an independent market intelligence firm in Exton, Pa.

At the virtual annual meeting of the Consortium of Multiple Sclerosis Centers, Ms. Schobel presented the results of a retrospective chart audit Spherix conducted in February 2020 of 1,006 patients with MS who were switched to a new DMT by 199 U.S. participating neurologists within the previous 3 months. About 72% of the switchers had relapsing remitting MS (RRMS).
 

Assessing the three new oral DMTs

The purpose of the study was to gain an understanding of the early adoption patterns for the three recently approved oral DMTs: siponimod (Mayzent), cladribine (Mavenclad), and diroximel fumarate (Vumerity).

The first surprise was that only 41% of medication switches to a new DMT among the RRMS group were to oral DMTs; that’s a substantially lower proportion than in prior Spherix chart audits. Instead, the most popular switch was to ocrelizumab (Ocrevus), a monoclonal antibody.

“Things to keep in mind when we see the switch shares for the newer products are just how crowded this market has become and how much Ocrevus has really changed the market,” Ms. Schobel explained in an interview. “Ocrevus has become increasingly dominant in the RRMS segment, so that now there are six oral DMTs competing among themselves for a relatively limited pool of patients.”

Because of grandfathering by the Food and Drug Administration, most of the oral DMTs now share identical indications for clinically isolated syndrome, RRMS, and active secondary progressive MS. Ocrevus, she noted, has the same indications.

Only 1% of MS patients who switched to a different DMT in late 2019 or early 2020 moved to diroximel fumarate. Three percent switched to siponimod, and another 3% switched to cladribine. Switches to the three older, established oral DMTs were collectively five times more common, with 15% of patients moving to dimethyl fumarate (Tecfidera), 11% to fingolimod (Gilenya), and 9% to teriflunomide (Aubagio).

Ms. Schobel said that the three latest oral DMTs offer advantages over the older ones in terms of various combinations of efficacy, dosing schedule, and/or tolerability, which may make them attractive options as first-line therapy. She predicted that, over time as neurologists gain increasing familiarity with these drugs as first line, they will also gradually become more comfortable in turning to them as switch options.

First-time switches to an oral DMT among patients with RRMS were most often made in search of improved efficacy. Neurologists cited this as their main reason for 73% of switches to cladribine and 36% of switches to teriflunomide, with the other oral agents falling at various points in between. A switch to fingolimod was most often driven by a wish for a high-efficacy DMT with once-daily oral dosing. Improved tolerability figured prominently in switches to teriflunomide, and even more so in the relatively few changes to diroximel fumarate.
 

Drug switching in the pandemic era

Ms. Schobel said Spherix has been serially tracking neurologists’ prescribing for MS during the COVID-19 pandemic, which has clearly had an enormous dampening effect on medication switching. In mid-April, neurologists’ switching volume was down by 70%, compared with prepandemic figures. A slow recovery began in May, but by the end of the month prescription-switching volume was still down by 52%.

Of the neurologist prescriptions that are being run for switching thus far during the pandemic, 82% are being done via telemedicine. Therein hangs a tale, since neurology doesn’t readily lend itself to practice by telemedicine. Indeed, neurologists are using telemedicine to a lesser extent than physicians in the other specialties that Spherix monitors, according to Ms. Schobel. “COVID is definitely changing the MS world. Within MS, drug switching is now much more likely to involve a switch to a DMT that doesn’t impact the immune response and is not immunosuppressant, such as an injectable interferon or glatiramer acetate,” she said. “In this COVID world, safety and conservatism may end up trumping the move toward ‘time is brain’ which we’ve been talking so much about in recent years: the importance of getting patients on high-efficacy DMTs from the start in order to give them the best chance for positive outcomes.”

Ms. Schobel noted that Spherix received no industry funding to conduct these studies.

bjancin@mdedge.com

The three oral disease-modifying therapies (DMTs) for multiple sclerosis (MS) approved last year in the United States haven’t made a big splash in the marketplace. So far, it’s more like a ripple, according to a study of neurologists’ prescribing patterns. “The recently approved therapies will initially be niched as later-line options,” predicted Virginia R. Schobel, MSc, nephrology franchise head at Spherix Global Insights, an independent market intelligence firm in Exton, Pa.

At the virtual annual meeting of the Consortium of Multiple Sclerosis Centers, Ms. Schobel presented the results of a retrospective chart audit Spherix conducted in February 2020 of 1,006 patients with MS who were switched to a new DMT by 199 U.S. participating neurologists within the previous 3 months. About 72% of the switchers had relapsing remitting MS (RRMS).
 

Assessing the three new oral DMTs

The purpose of the study was to gain an understanding of the early adoption patterns for the three recently approved oral DMTs: siponimod (Mayzent), cladribine (Mavenclad), and diroximel fumarate (Vumerity).

The first surprise was that only 41% of medication switches to a new DMT among the RRMS group were to oral DMTs; that’s a substantially lower proportion than in prior Spherix chart audits. Instead, the most popular switch was to ocrelizumab (Ocrevus), a monoclonal antibody.

“Things to keep in mind when we see the switch shares for the newer products are just how crowded this market has become and how much Ocrevus has really changed the market,” Ms. Schobel explained in an interview. “Ocrevus has become increasingly dominant in the RRMS segment, so that now there are six oral DMTs competing among themselves for a relatively limited pool of patients.”

Because of grandfathering by the Food and Drug Administration, most of the oral DMTs now share identical indications for clinically isolated syndrome, RRMS, and active secondary progressive MS. Ocrevus, she noted, has the same indications.

Only 1% of MS patients who switched to a different DMT in late 2019 or early 2020 moved to diroximel fumarate. Three percent switched to siponimod, and another 3% switched to cladribine. Switches to the three older, established oral DMTs were collectively five times more common, with 15% of patients moving to dimethyl fumarate (Tecfidera), 11% to fingolimod (Gilenya), and 9% to teriflunomide (Aubagio).

Ms. Schobel said that the three latest oral DMTs offer advantages over the older ones in terms of various combinations of efficacy, dosing schedule, and/or tolerability, which may make them attractive options as first-line therapy. She predicted that, over time as neurologists gain increasing familiarity with these drugs as first line, they will also gradually become more comfortable in turning to them as switch options.

First-time switches to an oral DMT among patients with RRMS were most often made in search of improved efficacy. Neurologists cited this as their main reason for 73% of switches to cladribine and 36% of switches to teriflunomide, with the other oral agents falling at various points in between. A switch to fingolimod was most often driven by a wish for a high-efficacy DMT with once-daily oral dosing. Improved tolerability figured prominently in switches to teriflunomide, and even more so in the relatively few changes to diroximel fumarate.
 

Drug switching in the pandemic era

Ms. Schobel said Spherix has been serially tracking neurologists’ prescribing for MS during the COVID-19 pandemic, which has clearly had an enormous dampening effect on medication switching. In mid-April, neurologists’ switching volume was down by 70%, compared with prepandemic figures. A slow recovery began in May, but by the end of the month prescription-switching volume was still down by 52%.

Of the neurologist prescriptions that are being run for switching thus far during the pandemic, 82% are being done via telemedicine. Therein hangs a tale, since neurology doesn’t readily lend itself to practice by telemedicine. Indeed, neurologists are using telemedicine to a lesser extent than physicians in the other specialties that Spherix monitors, according to Ms. Schobel. “COVID is definitely changing the MS world. Within MS, drug switching is now much more likely to involve a switch to a DMT that doesn’t impact the immune response and is not immunosuppressant, such as an injectable interferon or glatiramer acetate,” she said. “In this COVID world, safety and conservatism may end up trumping the move toward ‘time is brain’ which we’ve been talking so much about in recent years: the importance of getting patients on high-efficacy DMTs from the start in order to give them the best chance for positive outcomes.”

Ms. Schobel noted that Spherix received no industry funding to conduct these studies.

bjancin@mdedge.com