COVID-19 Updates

As of January 10, 2021, a reported 4,041,396 first doses of Moderna’s COVID-19 vaccine had been administered in the US. Reports of 1,266 (0.03%) adverse effects (AEs) after receipt of the vaccine were submitted to the Vaccine Adverse Event Reporting System (VAERS), according to researchers from the Centers for Disease Control and Prevention (CDC) COVID-19 Response Team and Food and Drug Administration in a Morbidity and Mortality Weekly Report early release.

The researchers screened VAERS reports that described suspected severe allergic reactions and anaphylaxis and collected information from medical records and outreach to healthcare facilities, providers, and recipients. They identified 108 reports for further review as possible severe allergic reaction, including anaphylaxis, a rare vaccination reaction. Ten cases were determined to be anaphylaxis—or a rate of 2.5 cases per million vaccine doses administered. Nine of the cases were people with a documented history of allergies or allergic reactions; 5 had a history of anaphylaxis.

The median interval from vaccine receipt to symptom onset was 7.5 minutes. Eight people had follow-up information available; all had recovered or were discharged. Of the case reports that were determined not to be anaphylaxis, 47 were assessed as nonanaphylactic allergic reactions and 47 were considered nonallergic adverse events. Four cases lacked enough information to be determined.

Based on those preliminary findings, it appears anaphylaxis is rare after the Moderna vaccination, but the researchers note that comparisons with other non–COVID-19 vaccines are constrained due to the limited information available this early in the vaccination program. They did cite an analysis of the Pfizer-BioNTech COVID-19 vaccine, also an mRNA vaccine, which estimated an initial rate of 11.1 cases per million doses after the first shot.

The researchers found a “strong female predominance” of anaphylaxis for both vaccines. All 10 anaphylaxis cases reported with the Moderna vaccine were in women. However, during the analytic period, 61% of first doses were given to women, vs 36% to men. Similarly, two thirds of first doses of the Pfizer-BioNTech vaccine were administered to women, and women were more affected.

Postvaccine COVID-19 Infections

But patients shouldn’t be too hasty to assume that symptoms after the vaccination are vaccine related, researchers at Israel’s Sheba Medical Center warn. The mere availability of a vaccine may lead to a certain laxity of precautions and a consequent rise in COVID-19 cases. “Thus, almost every physical complaint after vaccination poses a true diagnostic dilemma,” they point out, “as to whether an adverse reaction or a new COVID-19 infection is the cause.”

They studied 4,081 healthcare workers given the Pfizer-BioNTech vaccine. Of the vaccinated healthcare workers, 22 (0.54%) later had laboratory-confirmed COVID-19. Thirteen were tested because they had symptoms, usually an influenza-like illness that included fever, chills, cough, headache, myalgia, and sore throat. The median time between the first dose of vaccine and first symptoms was 3.5 days (one HCW had symptoms before immunization).

The vaccine, BNT162b2, is not likely to protect against clinical disease during the first days after receipt of the first dose, the researchers say. Efficacy was 52% a week after the first dose and positive COVID-19 cases were described among vaccinees even early after the second dose.

Clinicians should have a high level of suspicion of reported symptoms, the researchers advise, and avoid dismissing complaints as vaccine related until true infection is ruled out and the vaccine recipient is tested.

As of January 10, 2021, a reported 4,041,396 first doses of Moderna’s COVID-19 vaccine had been administered in the US. Reports of 1,266 (0.03%) adverse effects (AEs) after receipt of the vaccine were submitted to the Vaccine Adverse Event Reporting System (VAERS), according to researchers from the Centers for Disease Control and Prevention (CDC) COVID-19 Response Team and Food and Drug Administration in a Morbidity and Mortality Weekly Report early release.

The researchers screened VAERS reports that described suspected severe allergic reactions and anaphylaxis and collected information from medical records and outreach to healthcare facilities, providers, and recipients. They identified 108 reports for further review as possible severe allergic reaction, including anaphylaxis, a rare vaccination reaction. Ten cases were determined to be anaphylaxis—or a rate of 2.5 cases per million vaccine doses administered. Nine of the cases were people with a documented history of allergies or allergic reactions; 5 had a history of anaphylaxis.

The median interval from vaccine receipt to symptom onset was 7.5 minutes. Eight people had follow-up information available; all had recovered or were discharged. Of the case reports that were determined not to be anaphylaxis, 47 were assessed as nonanaphylactic allergic reactions and 47 were considered nonallergic adverse events. Four cases lacked enough information to be determined.

Based on those preliminary findings, it appears anaphylaxis is rare after the Moderna vaccination, but the researchers note that comparisons with other non–COVID-19 vaccines are constrained due to the limited information available this early in the vaccination program. They did cite an analysis of the Pfizer-BioNTech COVID-19 vaccine, also an mRNA vaccine, which estimated an initial rate of 11.1 cases per million doses after the first shot.

The researchers found a “strong female predominance” of anaphylaxis for both vaccines. All 10 anaphylaxis cases reported with the Moderna vaccine were in women. However, during the analytic period, 61% of first doses were given to women, vs 36% to men. Similarly, two thirds of first doses of the Pfizer-BioNTech vaccine were administered to women, and women were more affected.

Postvaccine COVID-19 Infections

But patients shouldn’t be too hasty to assume that symptoms after the vaccination are vaccine related, researchers at Israel’s Sheba Medical Center warn. The mere availability of a vaccine may lead to a certain laxity of precautions and a consequent rise in COVID-19 cases. “Thus, almost every physical complaint after vaccination poses a true diagnostic dilemma,” they point out, “as to whether an adverse reaction or a new COVID-19 infection is the cause.”

They studied 4,081 healthcare workers given the Pfizer-BioNTech vaccine. Of the vaccinated healthcare workers, 22 (0.54%) later had laboratory-confirmed COVID-19. Thirteen were tested because they had symptoms, usually an influenza-like illness that included fever, chills, cough, headache, myalgia, and sore throat. The median time between the first dose of vaccine and first symptoms was 3.5 days (one HCW had symptoms before immunization).

The vaccine, BNT162b2, is not likely to protect against clinical disease during the first days after receipt of the first dose, the researchers say. Efficacy was 52% a week after the first dose and positive COVID-19 cases were described among vaccinees even early after the second dose.

Clinicians should have a high level of suspicion of reported symptoms, the researchers advise, and avoid dismissing complaints as vaccine related until true infection is ruled out and the vaccine recipient is tested.

As of January 10, 2021, a reported 4,041,396 first doses of Moderna’s COVID-19 vaccine had been administered in the US. Reports of 1,266 (0.03%) adverse effects (AEs) after receipt of the vaccine were submitted to the Vaccine Adverse Event Reporting System (VAERS), according to researchers from the Centers for Disease Control and Prevention (CDC) COVID-19 Response Team and Food and Drug Administration in a Morbidity and Mortality Weekly Report early release.

The researchers screened VAERS reports that described suspected severe allergic reactions and anaphylaxis and collected information from medical records and outreach to healthcare facilities, providers, and recipients. They identified 108 reports for further review as possible severe allergic reaction, including anaphylaxis, a rare vaccination reaction. Ten cases were determined to be anaphylaxis—or a rate of 2.5 cases per million vaccine doses administered. Nine of the cases were people with a documented history of allergies or allergic reactions; 5 had a history of anaphylaxis.

The median interval from vaccine receipt to symptom onset was 7.5 minutes. Eight people had follow-up information available; all had recovered or were discharged. Of the case reports that were determined not to be anaphylaxis, 47 were assessed as nonanaphylactic allergic reactions and 47 were considered nonallergic adverse events. Four cases lacked enough information to be determined.

Based on those preliminary findings, it appears anaphylaxis is rare after the Moderna vaccination, but the researchers note that comparisons with other non–COVID-19 vaccines are constrained due to the limited information available this early in the vaccination program. They did cite an analysis of the Pfizer-BioNTech COVID-19 vaccine, also an mRNA vaccine, which estimated an initial rate of 11.1 cases per million doses after the first shot.

The researchers found a “strong female predominance” of anaphylaxis for both vaccines. All 10 anaphylaxis cases reported with the Moderna vaccine were in women. However, during the analytic period, 61% of first doses were given to women, vs 36% to men. Similarly, two thirds of first doses of the Pfizer-BioNTech vaccine were administered to women, and women were more affected.

Postvaccine COVID-19 Infections

But patients shouldn’t be too hasty to assume that symptoms after the vaccination are vaccine related, researchers at Israel’s Sheba Medical Center warn. The mere availability of a vaccine may lead to a certain laxity of precautions and a consequent rise in COVID-19 cases. “Thus, almost every physical complaint after vaccination poses a true diagnostic dilemma,” they point out, “as to whether an adverse reaction or a new COVID-19 infection is the cause.”

They studied 4,081 healthcare workers given the Pfizer-BioNTech vaccine. Of the vaccinated healthcare workers, 22 (0.54%) later had laboratory-confirmed COVID-19. Thirteen were tested because they had symptoms, usually an influenza-like illness that included fever, chills, cough, headache, myalgia, and sore throat. The median time between the first dose of vaccine and first symptoms was 3.5 days (one HCW had symptoms before immunization).

The vaccine, BNT162b2, is not likely to protect against clinical disease during the first days after receipt of the first dose, the researchers say. Efficacy was 52% a week after the first dose and positive COVID-19 cases were described among vaccinees even early after the second dose.

Clinicians should have a high level of suspicion of reported symptoms, the researchers advise, and avoid dismissing complaints as vaccine related until true infection is ruled out and the vaccine recipient is tested.

COVID-19 did not discriminate when it came to the impact it imposed on our hospitalist community. As the nomenclature moves away from the negative connotations of ‘burnout’ to ‘wellbeing,’ the pandemic has taught us something important about being intentional about our personal health: we must secure our own oxygen masks before helping others.

In February 2020, the Society of Hospital Medicine’s Wellbeing Taskforce efforts quickly changed focus from addressing general wellbeing, to wellbeing during COVID-19. Our Taskforce was commissioned by SHM’s Board with a new charge: Address immediate and ongoing needs of well-being and resiliency support for hospitalists during the COVID-19 pandemic. In this essay, I will discuss how our SHM Wellbeing Taskforce approached the overall topic of wellbeing for hospitalists during the COVID-19 pandemic, including some of our Taskforce group experiences.

The Taskforce started with a framework to aide in cultivating open and authentic conversations within hospital medicine groups. Creating spaces for honest sharing around how providers are doing is a crucial first step to reducing stigma, building mutual support within a group, and elevating issues of wellbeing to the level where structural change can take place. The Taskforce established two objectives for normalizing and mitigating stressors we face as hospitalists during the COVID-19 pandemic:

• Provide a framework for hospitalists to take their own emotional pulse
• Provide an approach to reduce stigma of hospitalists who are suffering from pandemic stress

While a more typical approach to fix stress and burnout is using formal institutional interventions, we used the value and insight provided by SHM’s 7 Drivers of Burnout in Hospital Medicine to help guide the creation of SHM resources in addressing the severe emotional strain being felt across the country by hospitalists. The 7 Drivers support the idea that the social role peers and hospital leaders can make a crucial difference in mitigating stress and burnout. Two examples of social support come to mind from the Wellbeing Taskforce experience:

• Participate in your meetings. One example comes from a member of our group who had underestimated the “healing power” that our group meetings had provided to his psyche. The simple act of participating in our Taskforce meeting and being in the presence of our group had provided such a positive impact that he was better able to face the “death and misery” in his unit with a smile on his face.
• Share what is stressful. The second example of social support comes from an hour of Zoom-based facilitation meetings between the SHM’s Wellbeing Taskforce members and Chapter Leaders in late October. During our Taskforce debrief after the meeting, we came to realize the enormous burden of grief our peers were carrying as one hospitalist had lost a group colleague the previous week due to suicide. Our member who led this meeting was moved – as were we – at how this had impacted his small team, and he was reminded he was not alone.

To form meaningful relationships that foster support, there needs to be a space where people can safely come together at times that initially might feel awkward. After taking steps toward your peers, these conversations can become normalized and contribute to meaningful relationships, providing the opportunity for healthy exchanges on vulnerable topics like emotional and psychological wellbeing. A printable guide for this specific purpose (“HM COVID-19 Check-In Guide for Self and Peers”) was designed to help hospitalists move into safe and supportive conversations with each other. While it is difficult to place a value on the importance these types of conversations have on individual wellbeing, it is known that the quality of a positive work environment where people feel supported can moderate stress, morale, and depression. In other words, hospitalist groups can positively contribute to their social environment during stressful times by sharing meaningful and difficult experiences with one another.

Second, the Taskforce created a social media campaign to provide a public social space for sharing hospitalists’ COVID-19 experiences. We believed that sharing collective experiences with the theme of #YouAreNotAlone and a complementary social media campaign, SHM Cares, on SHM’s social media channels, would further connect the national hospitalist community and provide a different communication pathway to decrease a sense of isolation. This idea came from the second social support idea mentioned earlier to share what is stressful with others in a safe space. We understood that some hospitalists would be more comfortable sharing publicly their comments, photos, and videos in achieving a sense of hospitalist unity.

Using our shared experiences, we identified three pillars for the final structure of the HM COVID-19 Check-In Guide for Self and Peers:

• Pillar 1. Recognize your issues. Recall our oxygen mask metaphor and this is what we mean by recognizing symptoms of new stressors (e.g., sleeplessness, irritability, forgetfulness).
• Pillar 2. Know what to say. A simple open-ended question about how the other person is working through the pandemic is an easy way to start a connection. We learned from a mental health perspective that it is unlikely that you could say anything to make a situation worse by offering a listening ear.
• Pillar 3. Check in with others. Listen to others without trying to fix the person or the situation. When appropriate, offer humorous reflections without diminishing the problem. Be a partner and commit to check in regularly with the other person.

Cultivating human connections outside of your immediate peer group can be valuable and offer additional perspective to stressful situations. For instance, one of my roles as a hospitalist administrator has been offering support by regularly listening as my physicians ‘talk out’ their day confidentially for as long as they needed. Offering open conversation in a safe and confidential way can have a healing effect. As one of my former hospitalists used to say, if issues are not addressed, they will “ooze out somewhere else.”

The HM COVID-19 Check-In Guide for Self and Peers and the SHM Cares social media campaign was the result of the Taskforce’s collective observations to help others normalize the feeling that ‘it’s OK not to be OK.’ Using the pandemic as context, the 7 Drivers of Hospitalist Burnout reminded us that the increased burnout issues we face will require continued attention past the pandemic. The value in cultivating human connections has never been more important. The SHM Wellbeing Taskforce is committed to provide continued resources. Checking in with others and listening to peers are all part of a personal wellbeing and resilience strategy. On behalf of the SHM Wellbeing Taskforce, we hope the information in this article will highlight the importance of continued attention to personal wellbeing during and after the pandemic.

Dr. Robinson received her PhD in organizational learning, performance and change from Colorado State University in 2019. Her dissertation topic was exploring hospitalist burnout, engagement, and social support. She is administrative director of inpatient medicine at St. Mary’s Medical Center in Grand Junction, Colo., a part of SCL Health. She has volunteered in numerous SHM committees, and currently serves on the SHM Wellbeing Taskforce.

COVID-19 did not discriminate when it came to the impact it imposed on our hospitalist community. As the nomenclature moves away from the negative connotations of ‘burnout’ to ‘wellbeing,’ the pandemic has taught us something important about being intentional about our personal health: we must secure our own oxygen masks before helping others.

In February 2020, the Society of Hospital Medicine’s Wellbeing Taskforce efforts quickly changed focus from addressing general wellbeing, to wellbeing during COVID-19. Our Taskforce was commissioned by SHM’s Board with a new charge: Address immediate and ongoing needs of well-being and resiliency support for hospitalists during the COVID-19 pandemic. In this essay, I will discuss how our SHM Wellbeing Taskforce approached the overall topic of wellbeing for hospitalists during the COVID-19 pandemic, including some of our Taskforce group experiences.

The Taskforce started with a framework to aide in cultivating open and authentic conversations within hospital medicine groups. Creating spaces for honest sharing around how providers are doing is a crucial first step to reducing stigma, building mutual support within a group, and elevating issues of wellbeing to the level where structural change can take place. The Taskforce established two objectives for normalizing and mitigating stressors we face as hospitalists during the COVID-19 pandemic:

• Provide a framework for hospitalists to take their own emotional pulse
• Provide an approach to reduce stigma of hospitalists who are suffering from pandemic stress

While a more typical approach to fix stress and burnout is using formal institutional interventions, we used the value and insight provided by SHM’s 7 Drivers of Burnout in Hospital Medicine to help guide the creation of SHM resources in addressing the severe emotional strain being felt across the country by hospitalists. The 7 Drivers support the idea that the social role peers and hospital leaders can make a crucial difference in mitigating stress and burnout. Two examples of social support come to mind from the Wellbeing Taskforce experience:

• Participate in your meetings. One example comes from a member of our group who had underestimated the “healing power” that our group meetings had provided to his psyche. The simple act of participating in our Taskforce meeting and being in the presence of our group had provided such a positive impact that he was better able to face the “death and misery” in his unit with a smile on his face.
• Share what is stressful. The second example of social support comes from an hour of Zoom-based facilitation meetings between the SHM’s Wellbeing Taskforce members and Chapter Leaders in late October. During our Taskforce debrief after the meeting, we came to realize the enormous burden of grief our peers were carrying as one hospitalist had lost a group colleague the previous week due to suicide. Our member who led this meeting was moved – as were we – at how this had impacted his small team, and he was reminded he was not alone.

To form meaningful relationships that foster support, there needs to be a space where people can safely come together at times that initially might feel awkward. After taking steps toward your peers, these conversations can become normalized and contribute to meaningful relationships, providing the opportunity for healthy exchanges on vulnerable topics like emotional and psychological wellbeing. A printable guide for this specific purpose (“HM COVID-19 Check-In Guide for Self and Peers”) was designed to help hospitalists move into safe and supportive conversations with each other. While it is difficult to place a value on the importance these types of conversations have on individual wellbeing, it is known that the quality of a positive work environment where people feel supported can moderate stress, morale, and depression. In other words, hospitalist groups can positively contribute to their social environment during stressful times by sharing meaningful and difficult experiences with one another.

Second, the Taskforce created a social media campaign to provide a public social space for sharing hospitalists’ COVID-19 experiences. We believed that sharing collective experiences with the theme of #YouAreNotAlone and a complementary social media campaign, SHM Cares, on SHM’s social media channels, would further connect the national hospitalist community and provide a different communication pathway to decrease a sense of isolation. This idea came from the second social support idea mentioned earlier to share what is stressful with others in a safe space. We understood that some hospitalists would be more comfortable sharing publicly their comments, photos, and videos in achieving a sense of hospitalist unity.

Using our shared experiences, we identified three pillars for the final structure of the HM COVID-19 Check-In Guide for Self and Peers:

• Pillar 1. Recognize your issues. Recall our oxygen mask metaphor and this is what we mean by recognizing symptoms of new stressors (e.g., sleeplessness, irritability, forgetfulness).
• Pillar 2. Know what to say. A simple open-ended question about how the other person is working through the pandemic is an easy way to start a connection. We learned from a mental health perspective that it is unlikely that you could say anything to make a situation worse by offering a listening ear.
• Pillar 3. Check in with others. Listen to others without trying to fix the person or the situation. When appropriate, offer humorous reflections without diminishing the problem. Be a partner and commit to check in regularly with the other person.

Cultivating human connections outside of your immediate peer group can be valuable and offer additional perspective to stressful situations. For instance, one of my roles as a hospitalist administrator has been offering support by regularly listening as my physicians ‘talk out’ their day confidentially for as long as they needed. Offering open conversation in a safe and confidential way can have a healing effect. As one of my former hospitalists used to say, if issues are not addressed, they will “ooze out somewhere else.”

The HM COVID-19 Check-In Guide for Self and Peers and the SHM Cares social media campaign was the result of the Taskforce’s collective observations to help others normalize the feeling that ‘it’s OK not to be OK.’ Using the pandemic as context, the 7 Drivers of Hospitalist Burnout reminded us that the increased burnout issues we face will require continued attention past the pandemic. The value in cultivating human connections has never been more important. The SHM Wellbeing Taskforce is committed to provide continued resources. Checking in with others and listening to peers are all part of a personal wellbeing and resilience strategy. On behalf of the SHM Wellbeing Taskforce, we hope the information in this article will highlight the importance of continued attention to personal wellbeing during and after the pandemic.

Dr. Robinson received her PhD in organizational learning, performance and change from Colorado State University in 2019. Her dissertation topic was exploring hospitalist burnout, engagement, and social support. She is administrative director of inpatient medicine at St. Mary’s Medical Center in Grand Junction, Colo., a part of SCL Health. She has volunteered in numerous SHM committees, and currently serves on the SHM Wellbeing Taskforce.

COVID-19 did not discriminate when it came to the impact it imposed on our hospitalist community. As the nomenclature moves away from the negative connotations of ‘burnout’ to ‘wellbeing,’ the pandemic has taught us something important about being intentional about our personal health: we must secure our own oxygen masks before helping others.

In February 2020, the Society of Hospital Medicine’s Wellbeing Taskforce efforts quickly changed focus from addressing general wellbeing, to wellbeing during COVID-19. Our Taskforce was commissioned by SHM’s Board with a new charge: Address immediate and ongoing needs of well-being and resiliency support for hospitalists during the COVID-19 pandemic. In this essay, I will discuss how our SHM Wellbeing Taskforce approached the overall topic of wellbeing for hospitalists during the COVID-19 pandemic, including some of our Taskforce group experiences.

The Taskforce started with a framework to aide in cultivating open and authentic conversations within hospital medicine groups. Creating spaces for honest sharing around how providers are doing is a crucial first step to reducing stigma, building mutual support within a group, and elevating issues of wellbeing to the level where structural change can take place. The Taskforce established two objectives for normalizing and mitigating stressors we face as hospitalists during the COVID-19 pandemic:

• Provide a framework for hospitalists to take their own emotional pulse
• Provide an approach to reduce stigma of hospitalists who are suffering from pandemic stress

While a more typical approach to fix stress and burnout is using formal institutional interventions, we used the value and insight provided by SHM’s 7 Drivers of Burnout in Hospital Medicine to help guide the creation of SHM resources in addressing the severe emotional strain being felt across the country by hospitalists. The 7 Drivers support the idea that the social role peers and hospital leaders can make a crucial difference in mitigating stress and burnout. Two examples of social support come to mind from the Wellbeing Taskforce experience:

• Participate in your meetings. One example comes from a member of our group who had underestimated the “healing power” that our group meetings had provided to his psyche. The simple act of participating in our Taskforce meeting and being in the presence of our group had provided such a positive impact that he was better able to face the “death and misery” in his unit with a smile on his face.
• Share what is stressful. The second example of social support comes from an hour of Zoom-based facilitation meetings between the SHM’s Wellbeing Taskforce members and Chapter Leaders in late October. During our Taskforce debrief after the meeting, we came to realize the enormous burden of grief our peers were carrying as one hospitalist had lost a group colleague the previous week due to suicide. Our member who led this meeting was moved – as were we – at how this had impacted his small team, and he was reminded he was not alone.

To form meaningful relationships that foster support, there needs to be a space where people can safely come together at times that initially might feel awkward. After taking steps toward your peers, these conversations can become normalized and contribute to meaningful relationships, providing the opportunity for healthy exchanges on vulnerable topics like emotional and psychological wellbeing. A printable guide for this specific purpose (“HM COVID-19 Check-In Guide for Self and Peers”) was designed to help hospitalists move into safe and supportive conversations with each other. While it is difficult to place a value on the importance these types of conversations have on individual wellbeing, it is known that the quality of a positive work environment where people feel supported can moderate stress, morale, and depression. In other words, hospitalist groups can positively contribute to their social environment during stressful times by sharing meaningful and difficult experiences with one another.

Second, the Taskforce created a social media campaign to provide a public social space for sharing hospitalists’ COVID-19 experiences. We believed that sharing collective experiences with the theme of #YouAreNotAlone and a complementary social media campaign, SHM Cares, on SHM’s social media channels, would further connect the national hospitalist community and provide a different communication pathway to decrease a sense of isolation. This idea came from the second social support idea mentioned earlier to share what is stressful with others in a safe space. We understood that some hospitalists would be more comfortable sharing publicly their comments, photos, and videos in achieving a sense of hospitalist unity.

Using our shared experiences, we identified three pillars for the final structure of the HM COVID-19 Check-In Guide for Self and Peers:

• Pillar 1. Recognize your issues. Recall our oxygen mask metaphor and this is what we mean by recognizing symptoms of new stressors (e.g., sleeplessness, irritability, forgetfulness).
• Pillar 2. Know what to say. A simple open-ended question about how the other person is working through the pandemic is an easy way to start a connection. We learned from a mental health perspective that it is unlikely that you could say anything to make a situation worse by offering a listening ear.
• Pillar 3. Check in with others. Listen to others without trying to fix the person or the situation. When appropriate, offer humorous reflections without diminishing the problem. Be a partner and commit to check in regularly with the other person.

Cultivating human connections outside of your immediate peer group can be valuable and offer additional perspective to stressful situations. For instance, one of my roles as a hospitalist administrator has been offering support by regularly listening as my physicians ‘talk out’ their day confidentially for as long as they needed. Offering open conversation in a safe and confidential way can have a healing effect. As one of my former hospitalists used to say, if issues are not addressed, they will “ooze out somewhere else.”

The HM COVID-19 Check-In Guide for Self and Peers and the SHM Cares social media campaign was the result of the Taskforce’s collective observations to help others normalize the feeling that ‘it’s OK not to be OK.’ Using the pandemic as context, the 7 Drivers of Hospitalist Burnout reminded us that the increased burnout issues we face will require continued attention past the pandemic. The value in cultivating human connections has never been more important. The SHM Wellbeing Taskforce is committed to provide continued resources. Checking in with others and listening to peers are all part of a personal wellbeing and resilience strategy. On behalf of the SHM Wellbeing Taskforce, we hope the information in this article will highlight the importance of continued attention to personal wellbeing during and after the pandemic.

Dr. Robinson received her PhD in organizational learning, performance and change from Colorado State University in 2019. Her dissertation topic was exploring hospitalist burnout, engagement, and social support. She is administrative director of inpatient medicine at St. Mary’s Medical Center in Grand Junction, Colo., a part of SCL Health. She has volunteered in numerous SHM committees, and currently serves on the SHM Wellbeing Taskforce.

Monoclonal antibodies (mAbs) to treat COVID-19 are in ample supply, but scant evidence on their effectiveness, paltry reimbursement, and a lack of a planned infrastructure to administer them has led to major underutilization of these potentially useful therapies, according to a new report from The National Academies of Sciences, Engineering, and Medicine.

The 35-page report described missed opportunities to work with states and hospitals to establish trust with clinicians and patients and to set up an infusion infrastructure to funnel patients to sites. Though the therapies still need more study, they should be an option for the right patient at the right time, said the National Academies experts in their report, Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.

“No potentially eligible patient should be left uninformed, and no eligible patient should be denied access, if there are doses available and the patient and doctor agree it is a reasonable course,” they concluded. The report also noted that underuse, and in particular underuse by members of vulnerable and underserved communities “raises concerns about exacerbating already dramatic health disparities.”

The federal government has spent $375 million on Eli Lilly’s bamlanivimab and $450 million on Regeneron’s casirivimab plus imdevimab cocktail, and agreed last month to spend as much as $2.6 billion more on up to 1.25 million additional doses.

Some 785,000 doses of the two therapeutics have been produced and about a half million have been distributed to states. But about three quarters have gone unused. The U.S. Department of Health & Human Services has launched an online treatment locater to try to spur interest in the therapies.

But the federal government hasn’t addressed some of the basic barriers to use of the monoclonals, said the National Academies experts.

“Lack of awareness, interest, and confidence in COVID-19 mAb therapies among patients and providers are major issues,” they said in the report. Patients who have tested positive might not want to travel to an infusion site, while others might not have access to health care or only seek such treatments when it’s too late. Some who are eligible might not have the time, resources, or transportation to go to a site and sit through a 2-hour treatment.

In addition, “the supply and availability of infusion centers and personnel was identified as a greater constraint than the supply of COVID-19 mAbs,” said the report.
 

Cost a big impediment

While the federal government has covered the cost of the therapies, hospitals and patients inevitably incur related costs.

“The fragmented payment system in the United States has not provided adequate support to cover the spectrum of costs associated with COVID-19 mAb therapies,” said the report. That is compounded by chronic underfunding and restrictions on federally qualified health centers for community health, the report said.

Patients may have to pay for testing, office visits, follow-up appointments, transportation to and from the infusion site, and potentially a copay for the administration of the drug.

While Medicare pays hospitals $309 per infusion, that might not be enough, especially if a hospital or other site had to build out a new infusion center, the report shows. For clinicians, the administrative payment under Medicare Part B does “not cover the total practice cost to furnish infusion services, resulting in a substantial cost-reimbursement disparity,” the report states.

In addition, there are no specific codes for observing patients during the 2-hour procedure.

“The established Medicare payment rate for furnishing COVID-19 mAb therapies does not cover the cost associated with coordinating care for those patients, nor does it justify the risk and opportunity costs associated with investing in infrastructure modifications to safely integrate COVID-19 patients into existing facilities or building temporary infusion capacity,” the report concluded.
 

More data needed

The U.S. Food and Drug Administration issued emergency-use authorizations (EUAs) for the two monoclonal therapies based on phase 2 trial data, and that leaves a lot of uncertainty, noted the National Academies.

In trials, both therapies reduced COVID-19-related hospitalizations and emergency room visits within 28 days after treatment among patients at high risk of progression, compared with those who received placebo.

But clinicians aren’t certain about who should use the monoclonals, said the report. The underuse has in turn led to trouble collecting data – either through ongoing trials or in starting new trials.

The National Academies recommended allocating the monoclonal antibodies in a way that would give rise to better data collection to inform clinicians. Payers could support the development of a core data platform or registry, or Medicare could develop pilot trials, said the report.

Lilly and UnitedHealth Group are collaborating on a study in high-risk Medicare patients, according to Reuters. Patients who test positive will be given bamlanivimab at home.

“Building infusion capacity and developing the evidence base about the impact of COVID-19 mAbs on clinical outcomes other than hospitalization, including mortality, are the most promising strategies for increasing effective utilization moving forward,” stated the National Academies report.

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

Monoclonal antibodies (mAbs) to treat COVID-19 are in ample supply, but scant evidence on their effectiveness, paltry reimbursement, and a lack of a planned infrastructure to administer them has led to major underutilization of these potentially useful therapies, according to a new report from The National Academies of Sciences, Engineering, and Medicine.

The 35-page report described missed opportunities to work with states and hospitals to establish trust with clinicians and patients and to set up an infusion infrastructure to funnel patients to sites. Though the therapies still need more study, they should be an option for the right patient at the right time, said the National Academies experts in their report, Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.

“No potentially eligible patient should be left uninformed, and no eligible patient should be denied access, if there are doses available and the patient and doctor agree it is a reasonable course,” they concluded. The report also noted that underuse, and in particular underuse by members of vulnerable and underserved communities “raises concerns about exacerbating already dramatic health disparities.”

The federal government has spent $375 million on Eli Lilly’s bamlanivimab and $450 million on Regeneron’s casirivimab plus imdevimab cocktail, and agreed last month to spend as much as $2.6 billion more on up to 1.25 million additional doses.

Some 785,000 doses of the two therapeutics have been produced and about a half million have been distributed to states. But about three quarters have gone unused. The U.S. Department of Health & Human Services has launched an online treatment locater to try to spur interest in the therapies.

But the federal government hasn’t addressed some of the basic barriers to use of the monoclonals, said the National Academies experts.

“Lack of awareness, interest, and confidence in COVID-19 mAb therapies among patients and providers are major issues,” they said in the report. Patients who have tested positive might not want to travel to an infusion site, while others might not have access to health care or only seek such treatments when it’s too late. Some who are eligible might not have the time, resources, or transportation to go to a site and sit through a 2-hour treatment.

In addition, “the supply and availability of infusion centers and personnel was identified as a greater constraint than the supply of COVID-19 mAbs,” said the report.
 

Cost a big impediment

While the federal government has covered the cost of the therapies, hospitals and patients inevitably incur related costs.

“The fragmented payment system in the United States has not provided adequate support to cover the spectrum of costs associated with COVID-19 mAb therapies,” said the report. That is compounded by chronic underfunding and restrictions on federally qualified health centers for community health, the report said.

Patients may have to pay for testing, office visits, follow-up appointments, transportation to and from the infusion site, and potentially a copay for the administration of the drug.

While Medicare pays hospitals $309 per infusion, that might not be enough, especially if a hospital or other site had to build out a new infusion center, the report shows. For clinicians, the administrative payment under Medicare Part B does “not cover the total practice cost to furnish infusion services, resulting in a substantial cost-reimbursement disparity,” the report states.

In addition, there are no specific codes for observing patients during the 2-hour procedure.

“The established Medicare payment rate for furnishing COVID-19 mAb therapies does not cover the cost associated with coordinating care for those patients, nor does it justify the risk and opportunity costs associated with investing in infrastructure modifications to safely integrate COVID-19 patients into existing facilities or building temporary infusion capacity,” the report concluded.
 

More data needed

The U.S. Food and Drug Administration issued emergency-use authorizations (EUAs) for the two monoclonal therapies based on phase 2 trial data, and that leaves a lot of uncertainty, noted the National Academies.

In trials, both therapies reduced COVID-19-related hospitalizations and emergency room visits within 28 days after treatment among patients at high risk of progression, compared with those who received placebo.

But clinicians aren’t certain about who should use the monoclonals, said the report. The underuse has in turn led to trouble collecting data – either through ongoing trials or in starting new trials.

The National Academies recommended allocating the monoclonal antibodies in a way that would give rise to better data collection to inform clinicians. Payers could support the development of a core data platform or registry, or Medicare could develop pilot trials, said the report.

Lilly and UnitedHealth Group are collaborating on a study in high-risk Medicare patients, according to Reuters. Patients who test positive will be given bamlanivimab at home.

“Building infusion capacity and developing the evidence base about the impact of COVID-19 mAbs on clinical outcomes other than hospitalization, including mortality, are the most promising strategies for increasing effective utilization moving forward,” stated the National Academies report.

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

Monoclonal antibodies (mAbs) to treat COVID-19 are in ample supply, but scant evidence on their effectiveness, paltry reimbursement, and a lack of a planned infrastructure to administer them has led to major underutilization of these potentially useful therapies, according to a new report from The National Academies of Sciences, Engineering, and Medicine.

The 35-page report described missed opportunities to work with states and hospitals to establish trust with clinicians and patients and to set up an infusion infrastructure to funnel patients to sites. Though the therapies still need more study, they should be an option for the right patient at the right time, said the National Academies experts in their report, Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.

“No potentially eligible patient should be left uninformed, and no eligible patient should be denied access, if there are doses available and the patient and doctor agree it is a reasonable course,” they concluded. The report also noted that underuse, and in particular underuse by members of vulnerable and underserved communities “raises concerns about exacerbating already dramatic health disparities.”

The federal government has spent $375 million on Eli Lilly’s bamlanivimab and $450 million on Regeneron’s casirivimab plus imdevimab cocktail, and agreed last month to spend as much as $2.6 billion more on up to 1.25 million additional doses.

Some 785,000 doses of the two therapeutics have been produced and about a half million have been distributed to states. But about three quarters have gone unused. The U.S. Department of Health & Human Services has launched an online treatment locater to try to spur interest in the therapies.

But the federal government hasn’t addressed some of the basic barriers to use of the monoclonals, said the National Academies experts.

“Lack of awareness, interest, and confidence in COVID-19 mAb therapies among patients and providers are major issues,” they said in the report. Patients who have tested positive might not want to travel to an infusion site, while others might not have access to health care or only seek such treatments when it’s too late. Some who are eligible might not have the time, resources, or transportation to go to a site and sit through a 2-hour treatment.

In addition, “the supply and availability of infusion centers and personnel was identified as a greater constraint than the supply of COVID-19 mAbs,” said the report.
 

Cost a big impediment

While the federal government has covered the cost of the therapies, hospitals and patients inevitably incur related costs.

“The fragmented payment system in the United States has not provided adequate support to cover the spectrum of costs associated with COVID-19 mAb therapies,” said the report. That is compounded by chronic underfunding and restrictions on federally qualified health centers for community health, the report said.

Patients may have to pay for testing, office visits, follow-up appointments, transportation to and from the infusion site, and potentially a copay for the administration of the drug.

While Medicare pays hospitals $309 per infusion, that might not be enough, especially if a hospital or other site had to build out a new infusion center, the report shows. For clinicians, the administrative payment under Medicare Part B does “not cover the total practice cost to furnish infusion services, resulting in a substantial cost-reimbursement disparity,” the report states.

In addition, there are no specific codes for observing patients during the 2-hour procedure.

“The established Medicare payment rate for furnishing COVID-19 mAb therapies does not cover the cost associated with coordinating care for those patients, nor does it justify the risk and opportunity costs associated with investing in infrastructure modifications to safely integrate COVID-19 patients into existing facilities or building temporary infusion capacity,” the report concluded.
 

More data needed

The U.S. Food and Drug Administration issued emergency-use authorizations (EUAs) for the two monoclonal therapies based on phase 2 trial data, and that leaves a lot of uncertainty, noted the National Academies.

In trials, both therapies reduced COVID-19-related hospitalizations and emergency room visits within 28 days after treatment among patients at high risk of progression, compared with those who received placebo.

But clinicians aren’t certain about who should use the monoclonals, said the report. The underuse has in turn led to trouble collecting data – either through ongoing trials or in starting new trials.

The National Academies recommended allocating the monoclonal antibodies in a way that would give rise to better data collection to inform clinicians. Payers could support the development of a core data platform or registry, or Medicare could develop pilot trials, said the report.

Lilly and UnitedHealth Group are collaborating on a study in high-risk Medicare patients, according to Reuters. Patients who test positive will be given bamlanivimab at home.

“Building infusion capacity and developing the evidence base about the impact of COVID-19 mAbs on clinical outcomes other than hospitalization, including mortality, are the most promising strategies for increasing effective utilization moving forward,” stated the National Academies report.

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

People with rheumatic and musculoskeletal diseases (RMDs) who contract the SARS-CoV-2 virus appear more likely to die from COVID-19 if their rheumatologic condition is not being well controlled at the time of their infection.

New data from the COVID-19 Global Rheumatology Alliance (GRA) physician registry reported in Annals of the Rheumatic Diseases have found that the odds of dying from COVID-19 were 87% higher in individuals recorded as having moderate to high disease activity versus those reported to be in remission or having low disease activity.

“I think this really highlights the importance of continuing to appropriately, and actively, treat our patients, and the importance of controlling their disease,” Pedro Machado, MD, PhD, said in an interview. Dr. Machado, an associate professor in rheumatology and muscle diseases at University College London and a consultant rheumatologist at several U.K. hospitals, has been involved in the GRA physician registry from the start, and sits on the GRA steering committee.

Alongside higher disease activity, several other important factors were found to be associated with increased odds of dying from COVID-19 – older age, male gender, and the presence of one or more comorbidities, such as hypertension combined with cardiovascular disease or chronic lung disease.

These demographic and disease-based factors have been linked to an increased risk for COVID-19–related hospitalization before, both in people with RMDs and in the general population, but the latest GRA physician registry data now take that a step further, and link them also to an increased risk for death, together with several other factors more specific to RMDs.
 

Logging COVID-19 rheumatologic cases

Since the start of the global pandemic, the potential effects that SARS-CoV-2 infection might have on people with RMDs in particular has concerned the rheumatology community. The main worries being that, either because of the underlying RMD itself or to its treatment, there may be immunoregulatory deficits or other risk factors that would make individuals more susceptible to not only infection but also to developing more severe COVID-19 than the general population.

These concerns led to the rapid formation of the GRA and the COVID-19 GRA physician registry in March 2020 to collect and analyze data on adults with rheumatic disease and confirmed or presumptive COVID-19. Entries into the registry are made by or under the direction of rheumatologists, and this is a voluntary process.

“This population cannot ever be entirely representative of the population of patients with rheumatic diseases,” Dr. Machado acknowledged. There will be selection and other biases that affect the reported data. That said, it’s the largest database of reported COVID-19 cases in adult rheumatology patients across the world, with more than 9,000 cases so far included from multiple registries, including those based in Europe and North and South America. Data from one of these – the French RMD cohort – have also recently been published in Annals of the Rheumatic Diseases, showing much the same findings but on a national level.

Hospitalization was the focus of a previous report because “you need large sample sizes” to look at endpoints that occur less frequently. When the first analysis was done, there were around 600 cases from 40 countries in the registry with sufficient data that could be used. Now, with a greater number of recorded cases, factors influencing the risk for death could be examined.

Death rate and risk factors found

Data on 3,729 COVID-19 cases in people with RMDs were included in the current analysis, all recorded in the first few months of the registry being open and up until July 1, 2020. In all, 390 (10.5%) of people died. While this is “clearly higher” than reported in the general population in most countries, the analysis was not designed to calculate a precise estimate.

“It should not be taken as an estimate of the overall death rate among patients with rheumatic diseases and COVID-19,” Dr. Machado and coauthors have been keen to point out.

“Age is always the biggest risk factor,” Dr. Machado explained. “There’s always a gradient: the older the patient, the worse the outcome.”

Indeed, there was a threefold increased risk for death among those aged 66-75 years versus those who were 65 years or younger (odds ratio, 3.00), and a sixfold increased risk for patients older than 75, compared with the younger age group (OR, 6.18).

Having both hypertension and cardiovascular disease was associated with an OR of 1.89, and coexisting chronic lung disease also significantly increased the chances of dying from COVID-19 (OR, 1.68).

Being of male sex was associated with a 46% increased risk for death from COVID-19 versus being of female sex.

The risk for COVID-19 death also rose with the use of corticosteroids. Compared with no steroid use, there was a 69% increased risk for with death at doses of 10 mg or more prednisolone equivalent per day.

“The finding about moderate to high doses of steroids being associated with a worse outcome is consistent with the first report; it was the same for hospitalization,” Dr. Machado observed.

The general consensus on steroid use in the COVID-19 setting is that they should be continued as needed, but at the lowest possible dose, as outlined in provisional recommendations set out by the recently renamed European Alliance of Associations for Rheumatology.

The GRA physician registry findings provide further support for this, suggesting that disease control should be optimized with disease-modifying antirheumatic drugs, ideally without increasing the dose of steroids.

Surprise over sulfasalazine risk

“Taking all medications into account – such as methotrexate, leflunomide, hydroxychloroquine, [tumor necrosis factor] blockers, interleukin-6 blockers, and [Janus kinase] inhibitors – it is quite reassuring because we did not see an association with worse outcome with those drugs overall,” Dr. Machado said.

However, treatment with rituximab (OR, 4.0), sulfasalazine (OR, 3.6), and immunosuppressive agents such as azathioprine, cyclophosphamide, cyclosporine, mycophenolate, or tacrolimus (OR, 2.2), were associated with higher odds of dying from COVID-19 when compared with treatment with methotrexate alone.

The findings for rituximab and immunosuppressant use were perhaps not unexpected, but the possible association between sulfasalazine and COVID-19 death was “a bit intriguing,” Dr. Machado observed. “Sulfasalazine is believed to have low immunosuppressive effect.”

This warrants further investigation, but there are likely a range of confounding factors at play. One could be that people considered to be at higher risk may have been more often prescribed sulfasalazine because it was thought to be less immunosuppressive. Another might be because people taking sulfasalazine were more likely to be smokers, and they were also not advised to protect themselves from exposure to the virus (shielding) during the first wave of the pandemic, at least not in the United Kingdom.
 

Rituximab caution and vaccination

“Rituximab is a concern,” Dr. Machado acknowledged. “It is a concern that rheumatologists are now aware of and they are addressing, but then it’s a concern for a very specific subgroup of patients.”

While rheumatologists are, and will continue to prescribe it, there will be even more careful consideration over when, in whom, and how to use it during, and possibly even after, the pandemic.

“COVID is here to stay, it will become endemic, and it’s going to be part of our lives like the flu virus is,” Dr. Machado predicted.

Then there is the issue on vaccinating people against COVID-19, should those on rituximab still receive it? The answer is a yes, but, as with other vaccinations it’s all about the timing of when the vaccination is given.

Societies such as the British Society for Rheumatology have already begun to include guidance on this, recommending one of the available COVID-19 vaccines is given at least a month before the next or first dose of rituximab is due. As rituximab is given every few months, with doses sometimes spaced as much as 9 months or even a year apart, this should not be too much of a problem, but it is “better to have the vaccine first,” Dr. Machado said.
 

Has COVID-19 care improved in RMDs?

In separate research published in The Lancet Rheumatology, April Jorge, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and associates found that the risks of severe COVID-19 outcomes have improved over time, although they still “remain substantial.”

Dr. Jorge and colleagues looked at temporal trends in COVID-19 outcomes in patients with RMDs over the course of the first 6 months of the pandemic in 2020, using data from a large, multicenter, electronic health record network (TriNetX).

They formed two patient cohorts – a late (diagnosed from April 20 to July 20) and an early (diagnosed from January 20 to April 20) cohort – to see if outcomes had improved and discovered lower relative risks among patients in the late cohort for hospitalization (0.67), admission to the ICU (0.56), mechanical ventilation (0.39), acute kidney injury (0.66), renal replacement (0.53), and death (0.39).

“These results are encouraging,” but it’s difficult to match these different populations of patients, Dr. Machado said. “There are always factors that you cannot match for” and were not included in the U.S. analysis.

While there are important caveats in how the analysis was performed and thus in interpreting these data, they do “suggest that one of the reasons why outcomes have improved is because we have become better at treating these patients,” Dr. Machado added.

“Our treatment has improved, and our capacity to treat the complications has improved. We understand better how the disease behaves – we know that they can have thromboembolic complications that we can manage, and we are now able to manage ventilation issues better.”

Moreover, Dr. Machado said that, not only were clinicians more aware of what they should or should not do, there were treatments that were being used routinely or in some cases based on recent clinical trial results. “I think we are indeed treating these patients better.”

The COVID-19 GRA physician registry is financially supported by the American College of Rheumatology and EULAR. Dr. Machado had no relevant conflicts of interest.

People with rheumatic and musculoskeletal diseases (RMDs) who contract the SARS-CoV-2 virus appear more likely to die from COVID-19 if their rheumatologic condition is not being well controlled at the time of their infection.

New data from the COVID-19 Global Rheumatology Alliance (GRA) physician registry reported in Annals of the Rheumatic Diseases have found that the odds of dying from COVID-19 were 87% higher in individuals recorded as having moderate to high disease activity versus those reported to be in remission or having low disease activity.

“I think this really highlights the importance of continuing to appropriately, and actively, treat our patients, and the importance of controlling their disease,” Pedro Machado, MD, PhD, said in an interview. Dr. Machado, an associate professor in rheumatology and muscle diseases at University College London and a consultant rheumatologist at several U.K. hospitals, has been involved in the GRA physician registry from the start, and sits on the GRA steering committee.

Alongside higher disease activity, several other important factors were found to be associated with increased odds of dying from COVID-19 – older age, male gender, and the presence of one or more comorbidities, such as hypertension combined with cardiovascular disease or chronic lung disease.

These demographic and disease-based factors have been linked to an increased risk for COVID-19–related hospitalization before, both in people with RMDs and in the general population, but the latest GRA physician registry data now take that a step further, and link them also to an increased risk for death, together with several other factors more specific to RMDs.
 

Logging COVID-19 rheumatologic cases

Since the start of the global pandemic, the potential effects that SARS-CoV-2 infection might have on people with RMDs in particular has concerned the rheumatology community. The main worries being that, either because of the underlying RMD itself or to its treatment, there may be immunoregulatory deficits or other risk factors that would make individuals more susceptible to not only infection but also to developing more severe COVID-19 than the general population.

These concerns led to the rapid formation of the GRA and the COVID-19 GRA physician registry in March 2020 to collect and analyze data on adults with rheumatic disease and confirmed or presumptive COVID-19. Entries into the registry are made by or under the direction of rheumatologists, and this is a voluntary process.

“This population cannot ever be entirely representative of the population of patients with rheumatic diseases,” Dr. Machado acknowledged. There will be selection and other biases that affect the reported data. That said, it’s the largest database of reported COVID-19 cases in adult rheumatology patients across the world, with more than 9,000 cases so far included from multiple registries, including those based in Europe and North and South America. Data from one of these – the French RMD cohort – have also recently been published in Annals of the Rheumatic Diseases, showing much the same findings but on a national level.

Hospitalization was the focus of a previous report because “you need large sample sizes” to look at endpoints that occur less frequently. When the first analysis was done, there were around 600 cases from 40 countries in the registry with sufficient data that could be used. Now, with a greater number of recorded cases, factors influencing the risk for death could be examined.

Death rate and risk factors found

Data on 3,729 COVID-19 cases in people with RMDs were included in the current analysis, all recorded in the first few months of the registry being open and up until July 1, 2020. In all, 390 (10.5%) of people died. While this is “clearly higher” than reported in the general population in most countries, the analysis was not designed to calculate a precise estimate.

“It should not be taken as an estimate of the overall death rate among patients with rheumatic diseases and COVID-19,” Dr. Machado and coauthors have been keen to point out.

“Age is always the biggest risk factor,” Dr. Machado explained. “There’s always a gradient: the older the patient, the worse the outcome.”

Indeed, there was a threefold increased risk for death among those aged 66-75 years versus those who were 65 years or younger (odds ratio, 3.00), and a sixfold increased risk for patients older than 75, compared with the younger age group (OR, 6.18).

Having both hypertension and cardiovascular disease was associated with an OR of 1.89, and coexisting chronic lung disease also significantly increased the chances of dying from COVID-19 (OR, 1.68).

Being of male sex was associated with a 46% increased risk for death from COVID-19 versus being of female sex.

The risk for COVID-19 death also rose with the use of corticosteroids. Compared with no steroid use, there was a 69% increased risk for with death at doses of 10 mg or more prednisolone equivalent per day.

“The finding about moderate to high doses of steroids being associated with a worse outcome is consistent with the first report; it was the same for hospitalization,” Dr. Machado observed.

The general consensus on steroid use in the COVID-19 setting is that they should be continued as needed, but at the lowest possible dose, as outlined in provisional recommendations set out by the recently renamed European Alliance of Associations for Rheumatology.

The GRA physician registry findings provide further support for this, suggesting that disease control should be optimized with disease-modifying antirheumatic drugs, ideally without increasing the dose of steroids.

Surprise over sulfasalazine risk

“Taking all medications into account – such as methotrexate, leflunomide, hydroxychloroquine, [tumor necrosis factor] blockers, interleukin-6 blockers, and [Janus kinase] inhibitors – it is quite reassuring because we did not see an association with worse outcome with those drugs overall,” Dr. Machado said.

However, treatment with rituximab (OR, 4.0), sulfasalazine (OR, 3.6), and immunosuppressive agents such as azathioprine, cyclophosphamide, cyclosporine, mycophenolate, or tacrolimus (OR, 2.2), were associated with higher odds of dying from COVID-19 when compared with treatment with methotrexate alone.

The findings for rituximab and immunosuppressant use were perhaps not unexpected, but the possible association between sulfasalazine and COVID-19 death was “a bit intriguing,” Dr. Machado observed. “Sulfasalazine is believed to have low immunosuppressive effect.”

This warrants further investigation, but there are likely a range of confounding factors at play. One could be that people considered to be at higher risk may have been more often prescribed sulfasalazine because it was thought to be less immunosuppressive. Another might be because people taking sulfasalazine were more likely to be smokers, and they were also not advised to protect themselves from exposure to the virus (shielding) during the first wave of the pandemic, at least not in the United Kingdom.
 

Rituximab caution and vaccination

“Rituximab is a concern,” Dr. Machado acknowledged. “It is a concern that rheumatologists are now aware of and they are addressing, but then it’s a concern for a very specific subgroup of patients.”

While rheumatologists are, and will continue to prescribe it, there will be even more careful consideration over when, in whom, and how to use it during, and possibly even after, the pandemic.

“COVID is here to stay, it will become endemic, and it’s going to be part of our lives like the flu virus is,” Dr. Machado predicted.

Then there is the issue on vaccinating people against COVID-19, should those on rituximab still receive it? The answer is a yes, but, as with other vaccinations it’s all about the timing of when the vaccination is given.

Societies such as the British Society for Rheumatology have already begun to include guidance on this, recommending one of the available COVID-19 vaccines is given at least a month before the next or first dose of rituximab is due. As rituximab is given every few months, with doses sometimes spaced as much as 9 months or even a year apart, this should not be too much of a problem, but it is “better to have the vaccine first,” Dr. Machado said.
 

Has COVID-19 care improved in RMDs?

In separate research published in The Lancet Rheumatology, April Jorge, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and associates found that the risks of severe COVID-19 outcomes have improved over time, although they still “remain substantial.”

Dr. Jorge and colleagues looked at temporal trends in COVID-19 outcomes in patients with RMDs over the course of the first 6 months of the pandemic in 2020, using data from a large, multicenter, electronic health record network (TriNetX).

They formed two patient cohorts – a late (diagnosed from April 20 to July 20) and an early (diagnosed from January 20 to April 20) cohort – to see if outcomes had improved and discovered lower relative risks among patients in the late cohort for hospitalization (0.67), admission to the ICU (0.56), mechanical ventilation (0.39), acute kidney injury (0.66), renal replacement (0.53), and death (0.39).

“These results are encouraging,” but it’s difficult to match these different populations of patients, Dr. Machado said. “There are always factors that you cannot match for” and were not included in the U.S. analysis.

While there are important caveats in how the analysis was performed and thus in interpreting these data, they do “suggest that one of the reasons why outcomes have improved is because we have become better at treating these patients,” Dr. Machado added.

“Our treatment has improved, and our capacity to treat the complications has improved. We understand better how the disease behaves – we know that they can have thromboembolic complications that we can manage, and we are now able to manage ventilation issues better.”

Moreover, Dr. Machado said that, not only were clinicians more aware of what they should or should not do, there were treatments that were being used routinely or in some cases based on recent clinical trial results. “I think we are indeed treating these patients better.”

The COVID-19 GRA physician registry is financially supported by the American College of Rheumatology and EULAR. Dr. Machado had no relevant conflicts of interest.

People with rheumatic and musculoskeletal diseases (RMDs) who contract the SARS-CoV-2 virus appear more likely to die from COVID-19 if their rheumatologic condition is not being well controlled at the time of their infection.

New data from the COVID-19 Global Rheumatology Alliance (GRA) physician registry reported in Annals of the Rheumatic Diseases have found that the odds of dying from COVID-19 were 87% higher in individuals recorded as having moderate to high disease activity versus those reported to be in remission or having low disease activity.

“I think this really highlights the importance of continuing to appropriately, and actively, treat our patients, and the importance of controlling their disease,” Pedro Machado, MD, PhD, said in an interview. Dr. Machado, an associate professor in rheumatology and muscle diseases at University College London and a consultant rheumatologist at several U.K. hospitals, has been involved in the GRA physician registry from the start, and sits on the GRA steering committee.

Alongside higher disease activity, several other important factors were found to be associated with increased odds of dying from COVID-19 – older age, male gender, and the presence of one or more comorbidities, such as hypertension combined with cardiovascular disease or chronic lung disease.

These demographic and disease-based factors have been linked to an increased risk for COVID-19–related hospitalization before, both in people with RMDs and in the general population, but the latest GRA physician registry data now take that a step further, and link them also to an increased risk for death, together with several other factors more specific to RMDs.
 

Logging COVID-19 rheumatologic cases

Since the start of the global pandemic, the potential effects that SARS-CoV-2 infection might have on people with RMDs in particular has concerned the rheumatology community. The main worries being that, either because of the underlying RMD itself or to its treatment, there may be immunoregulatory deficits or other risk factors that would make individuals more susceptible to not only infection but also to developing more severe COVID-19 than the general population.

These concerns led to the rapid formation of the GRA and the COVID-19 GRA physician registry in March 2020 to collect and analyze data on adults with rheumatic disease and confirmed or presumptive COVID-19. Entries into the registry are made by or under the direction of rheumatologists, and this is a voluntary process.

“This population cannot ever be entirely representative of the population of patients with rheumatic diseases,” Dr. Machado acknowledged. There will be selection and other biases that affect the reported data. That said, it’s the largest database of reported COVID-19 cases in adult rheumatology patients across the world, with more than 9,000 cases so far included from multiple registries, including those based in Europe and North and South America. Data from one of these – the French RMD cohort – have also recently been published in Annals of the Rheumatic Diseases, showing much the same findings but on a national level.

Hospitalization was the focus of a previous report because “you need large sample sizes” to look at endpoints that occur less frequently. When the first analysis was done, there were around 600 cases from 40 countries in the registry with sufficient data that could be used. Now, with a greater number of recorded cases, factors influencing the risk for death could be examined.

Death rate and risk factors found

Data on 3,729 COVID-19 cases in people with RMDs were included in the current analysis, all recorded in the first few months of the registry being open and up until July 1, 2020. In all, 390 (10.5%) of people died. While this is “clearly higher” than reported in the general population in most countries, the analysis was not designed to calculate a precise estimate.

“It should not be taken as an estimate of the overall death rate among patients with rheumatic diseases and COVID-19,” Dr. Machado and coauthors have been keen to point out.

“Age is always the biggest risk factor,” Dr. Machado explained. “There’s always a gradient: the older the patient, the worse the outcome.”

Indeed, there was a threefold increased risk for death among those aged 66-75 years versus those who were 65 years or younger (odds ratio, 3.00), and a sixfold increased risk for patients older than 75, compared with the younger age group (OR, 6.18).

Having both hypertension and cardiovascular disease was associated with an OR of 1.89, and coexisting chronic lung disease also significantly increased the chances of dying from COVID-19 (OR, 1.68).

Being of male sex was associated with a 46% increased risk for death from COVID-19 versus being of female sex.

The risk for COVID-19 death also rose with the use of corticosteroids. Compared with no steroid use, there was a 69% increased risk for with death at doses of 10 mg or more prednisolone equivalent per day.

“The finding about moderate to high doses of steroids being associated with a worse outcome is consistent with the first report; it was the same for hospitalization,” Dr. Machado observed.

The general consensus on steroid use in the COVID-19 setting is that they should be continued as needed, but at the lowest possible dose, as outlined in provisional recommendations set out by the recently renamed European Alliance of Associations for Rheumatology.

The GRA physician registry findings provide further support for this, suggesting that disease control should be optimized with disease-modifying antirheumatic drugs, ideally without increasing the dose of steroids.

Surprise over sulfasalazine risk

“Taking all medications into account – such as methotrexate, leflunomide, hydroxychloroquine, [tumor necrosis factor] blockers, interleukin-6 blockers, and [Janus kinase] inhibitors – it is quite reassuring because we did not see an association with worse outcome with those drugs overall,” Dr. Machado said.

However, treatment with rituximab (OR, 4.0), sulfasalazine (OR, 3.6), and immunosuppressive agents such as azathioprine, cyclophosphamide, cyclosporine, mycophenolate, or tacrolimus (OR, 2.2), were associated with higher odds of dying from COVID-19 when compared with treatment with methotrexate alone.

The findings for rituximab and immunosuppressant use were perhaps not unexpected, but the possible association between sulfasalazine and COVID-19 death was “a bit intriguing,” Dr. Machado observed. “Sulfasalazine is believed to have low immunosuppressive effect.”

This warrants further investigation, but there are likely a range of confounding factors at play. One could be that people considered to be at higher risk may have been more often prescribed sulfasalazine because it was thought to be less immunosuppressive. Another might be because people taking sulfasalazine were more likely to be smokers, and they were also not advised to protect themselves from exposure to the virus (shielding) during the first wave of the pandemic, at least not in the United Kingdom.
 

Rituximab caution and vaccination

“Rituximab is a concern,” Dr. Machado acknowledged. “It is a concern that rheumatologists are now aware of and they are addressing, but then it’s a concern for a very specific subgroup of patients.”

While rheumatologists are, and will continue to prescribe it, there will be even more careful consideration over when, in whom, and how to use it during, and possibly even after, the pandemic.

“COVID is here to stay, it will become endemic, and it’s going to be part of our lives like the flu virus is,” Dr. Machado predicted.

Then there is the issue on vaccinating people against COVID-19, should those on rituximab still receive it? The answer is a yes, but, as with other vaccinations it’s all about the timing of when the vaccination is given.

Societies such as the British Society for Rheumatology have already begun to include guidance on this, recommending one of the available COVID-19 vaccines is given at least a month before the next or first dose of rituximab is due. As rituximab is given every few months, with doses sometimes spaced as much as 9 months or even a year apart, this should not be too much of a problem, but it is “better to have the vaccine first,” Dr. Machado said.
 

Has COVID-19 care improved in RMDs?

In separate research published in The Lancet Rheumatology, April Jorge, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and associates found that the risks of severe COVID-19 outcomes have improved over time, although they still “remain substantial.”

Dr. Jorge and colleagues looked at temporal trends in COVID-19 outcomes in patients with RMDs over the course of the first 6 months of the pandemic in 2020, using data from a large, multicenter, electronic health record network (TriNetX).

They formed two patient cohorts – a late (diagnosed from April 20 to July 20) and an early (diagnosed from January 20 to April 20) cohort – to see if outcomes had improved and discovered lower relative risks among patients in the late cohort for hospitalization (0.67), admission to the ICU (0.56), mechanical ventilation (0.39), acute kidney injury (0.66), renal replacement (0.53), and death (0.39).

“These results are encouraging,” but it’s difficult to match these different populations of patients, Dr. Machado said. “There are always factors that you cannot match for” and were not included in the U.S. analysis.

While there are important caveats in how the analysis was performed and thus in interpreting these data, they do “suggest that one of the reasons why outcomes have improved is because we have become better at treating these patients,” Dr. Machado added.

“Our treatment has improved, and our capacity to treat the complications has improved. We understand better how the disease behaves – we know that they can have thromboembolic complications that we can manage, and we are now able to manage ventilation issues better.”

Moreover, Dr. Machado said that, not only were clinicians more aware of what they should or should not do, there were treatments that were being used routinely or in some cases based on recent clinical trial results. “I think we are indeed treating these patients better.”

The COVID-19 GRA physician registry is financially supported by the American College of Rheumatology and EULAR. Dr. Machado had no relevant conflicts of interest.

When many people across the country, not to mention in public office, believe that the world is run by a group of Satanic pedophiles that includes top Democrats and Hollywood elites, and that former President Trump is leading a secret mission to bring these evildoers to justice, one can’t help but ask if they’re at least to some degree mentally impaired.

Conspiracy theories are often received with psychiatric connotations; associated with paranoid plan-hatchers, and nonbelieving outsiders. But whereas theories such as QAnon strain credibility for many people, we would argue that they are likely not the product of psychosis or mental illness; nor do conspiracy theories in general represent delusions.

For one thing, surveys have consistently revealed that about 50% of the population believes in at least one conspiracy theory. Furthermore, there are several substantive differences between conspiracy theory beliefs and delusions.

Some researchers consider conspiracy theories to be “a subset of false beliefs,” but  most scholars, ourselves included, do not prejudge their validity or veracity. Real-life conspiracies, such as the CIA’s MK-Ultra program, have clearly occurred throughout history.

Our central contention is that belief in conspiracy theories is distinct from psychosis, and more closely resembles extreme but subculturally sanctioned religious or political beliefs. However, the line between believing in conspiracies and being delusional becomes blurred when the believer becomes part of the conspiracy theory and feels compelled to act on the belief as part of a personal mission.

Take Edgar Maddison Welch, a 28-year-old man who firmly believed the so-called “Pizzagate” conspiracy theory – the baseless claim that Hillary Clinton and Democratic elites were running a child sex-trafficking ring out of a Washington, DC, pizzeria. Seeing himself a potential savior of children, Mr. Welch drove 350 miles to the pizza shop from his home in North Carolina in December 2016 and fired three shots from an AR-15 style rifle into a locked closet door, ultimately surrendering to police. However, on questioning he quickly conceded, “The intel on this wasn’t 100%.”

Who believes in conspiracy theories?

Given that half the population believes in at least one conspiracy theory, it should come as little surprise that there is no reliable “profile” for believers. Although some studies have suggested associations with low education, right-wing political orientation, and certain personality traits like subclinical paranoia and schizotypy, such findings have been inconsistent and may vary across specific conspiracy theory. Associations between conspiracy belief and paranoia suggest overlap within a “conspiratorial mindset,” with recent evidence that “distrust of officialdom” is a key mediator between believing in conspiracies and political ideology.

Other quantitative “cognitive quirks” reported in those who believe in conspiracies are a need for certainty and control, a need for uniqueness, illusory pattern perception, and lack of analytical thinking. It’s unclear which of these factors may represent universal cognitive explanations for conspiratorial beliefs, vs. those that might be related to specific beliefs, such as the need for certainty during times of crisis and societal upheaval, when conspiracy theories tend to flourish.

Much of the research on conspiracy theory belief is based on the questionable premise that it’s best understood at the level of the individual’s psychopathology, or the “deficit model,” as it’s called. One of us (JMP) has instead proposed a two-component model that includes social and informational contexts. The first component – epistemic mistrust – involves mistrusting conventional, “authoritative” knowledge. The second involves biased information processing and exposure to misinformation, often transmitted by word of mouth, or through social networks. With this model, believing in conspiracy theories could be conceived as involving “delusion-like beliefs,” but not frank psychosis or full-blown delusions, as one might see, for example, in schizophrenia.

Indeed, many of the cognitive characteristics associated with conspiracy theory belief are universal, continuously distributed traits, varying in quantity, rather than all-or-none variables or distinct symptoms of mental illness.

Essentially, delusions are fixed, false, usually unshared beliefs, often based on subjective “inner” experience. (One rare exception is the so-called folie à deux, in which two people appear to “share” the same delusion; however, psychiatrists have long debated whether both individuals should be considered truly delusional). The delusion’s content is often “self-referential”; i.e., focused primarily on the believer.

In contrast, conspiracy theories are usually, but not necessarily, false. They are typically shared beliefs that don’t explicitly or directly involve the believer, and are based on evidence that one finds “out there,” such as on the Internet. This speaks to the highly communal nature of so many conspiracy theories – networks of like-minded individuals reinforcing one another’s beliefs in a particular socio-cultural context.
 

Conspiracy theory belief, COVID-19, and medical intervention

As for medical conspiracy theories, none have flourished recently more so than those involving the COVID-19 pandemic. As a recent editorial by Stein and colleagues noted, “Some conspiratorial claims include assertions that COVID‐19 is a hoax; arguments that the virus was created artificially and spread on purpose as a bioweapon; or allegations that governments are using the emergency situation to pursue their antidemocratic goals. … Other conspiracies argued that people in power are taking advantage of the pandemic as a plan to inject microchip quantum-dot spy software and monitor people.”

Stein and colleagues make the important point that a “key difference between COVID‐19 and the 1918 flu pandemic ... is that [now] a highly interconnected world, to a great extent on social media, is setting the stage for distributing information and misinformation about COVID‐19.”

Consider the following composite vignette: Mr. A is a 70-year-old retiree with a history of COPD who has been advised by his PCP to get vaccinated against COVID-19. He is extremely reluctant to do so, fearing that “the vaccine is going to change my DNA” and “might even give me COVID.” He has heard from friends on social media that vaccine developers “faked the results” and are “in cahoots with the federal government.” Mr. A has heard “experts” declare the vaccines safe, but does not trust them. Mr. A has no psychiatric or substance abuse history, and there are no cognitive, perceptual, or other abnormalities in Mr. A’s mental status exam.

Mr. A’s beliefs qualify as a “conspiracy theory,” but probably represent widely held misconceptions about COVID-19 vaccines, as well as widespread mistrust of pharmaceutical companies and the federal government. Based on the information provided, there is no basis for concluding that Mr. A is psychotic or delusional. His beliefs appear to be the result of “epistemic mistrust” of authoritative informational accounts, biased information processing, and exposure to misinformation.

How should the physician manage and care for patients like Mr. A? Absent frank delusions, there is no role for antipsychotic medication, though for extremely anxious patients, a time-limited course of an antianxiety agent may sometimes be warranted. In addition to providing accurate medical information to the patient, the physician should avoid arguing, or trying to “talk the patient out of” his or her belief. Instead, the focus should be on sustaining and strengthening the physician-patient alliance, establishing an atmosphere of respect and safety, clarifying differences in trusted sources of medical information, and allowing the patient time to process the physician’s recommendations.

One-to-one engagement with health care providers has proved effective in reducing vaccine hesitancy and correcting misinformation. For patients with less fixed conspiracy theory beliefs, it may sometimes be helpful to gently offer alternative hypotheses to the patient’s conspiracy theory, using elements of cognitive-behavioral therapy (CBT). For example, a physician might ask, “Is it possible that the online source you read was mistaken about the vaccine changing your DNA?” while reminding patients that – contrary to popular belief – mRNA vaccines have been in development against cancer for several decades.

Challenging beliefs collaboratively and acknowledging areas of uncertainty, rather than confronting or arguing about false beliefs, can foster trust between physician and patient and, at the very least, open a dialogue regarding potential exposure to medical misinformation. “Inoculation” strategies that present and then dispel misinformation before patients become aware of it are among the best supported strategies for mitigating conspiracy theory belief. Ideally, physicians and health care systems should maintain an ongoing “inventory” of medical misinformation circulating online and “beat it to the punch” with reliable information.

Finally, because believing in conspiracy theories is often associated with a sense of uncertainty, and feeling that one’s life is “out of control,” medical interventions can be framed as ways of regaining control and appealing to patients’ values; for example, saying, “By getting the vaccine, you’ll be more likely to stay in good health, protect your family, and do all the things you want to do.”
 

Dr. Pies is professor of psychiatry and a lecturer on bioethics and humanities at State University of New York, Syracuse. Dr. Pierre is a health sciences clinical professor in the department of psychiatry and biobehavioral sciences at the University of California, Los Angeles. A version of this article first appeared on Medscape.com.

When many people across the country, not to mention in public office, believe that the world is run by a group of Satanic pedophiles that includes top Democrats and Hollywood elites, and that former President Trump is leading a secret mission to bring these evildoers to justice, one can’t help but ask if they’re at least to some degree mentally impaired.

Conspiracy theories are often received with psychiatric connotations; associated with paranoid plan-hatchers, and nonbelieving outsiders. But whereas theories such as QAnon strain credibility for many people, we would argue that they are likely not the product of psychosis or mental illness; nor do conspiracy theories in general represent delusions.

For one thing, surveys have consistently revealed that about 50% of the population believes in at least one conspiracy theory. Furthermore, there are several substantive differences between conspiracy theory beliefs and delusions.

Some researchers consider conspiracy theories to be “a subset of false beliefs,” but  most scholars, ourselves included, do not prejudge their validity or veracity. Real-life conspiracies, such as the CIA’s MK-Ultra program, have clearly occurred throughout history.

Our central contention is that belief in conspiracy theories is distinct from psychosis, and more closely resembles extreme but subculturally sanctioned religious or political beliefs. However, the line between believing in conspiracies and being delusional becomes blurred when the believer becomes part of the conspiracy theory and feels compelled to act on the belief as part of a personal mission.

Take Edgar Maddison Welch, a 28-year-old man who firmly believed the so-called “Pizzagate” conspiracy theory – the baseless claim that Hillary Clinton and Democratic elites were running a child sex-trafficking ring out of a Washington, DC, pizzeria. Seeing himself a potential savior of children, Mr. Welch drove 350 miles to the pizza shop from his home in North Carolina in December 2016 and fired three shots from an AR-15 style rifle into a locked closet door, ultimately surrendering to police. However, on questioning he quickly conceded, “The intel on this wasn’t 100%.”

Who believes in conspiracy theories?

Given that half the population believes in at least one conspiracy theory, it should come as little surprise that there is no reliable “profile” for believers. Although some studies have suggested associations with low education, right-wing political orientation, and certain personality traits like subclinical paranoia and schizotypy, such findings have been inconsistent and may vary across specific conspiracy theory. Associations between conspiracy belief and paranoia suggest overlap within a “conspiratorial mindset,” with recent evidence that “distrust of officialdom” is a key mediator between believing in conspiracies and political ideology.

Other quantitative “cognitive quirks” reported in those who believe in conspiracies are a need for certainty and control, a need for uniqueness, illusory pattern perception, and lack of analytical thinking. It’s unclear which of these factors may represent universal cognitive explanations for conspiratorial beliefs, vs. those that might be related to specific beliefs, such as the need for certainty during times of crisis and societal upheaval, when conspiracy theories tend to flourish.

Much of the research on conspiracy theory belief is based on the questionable premise that it’s best understood at the level of the individual’s psychopathology, or the “deficit model,” as it’s called. One of us (JMP) has instead proposed a two-component model that includes social and informational contexts. The first component – epistemic mistrust – involves mistrusting conventional, “authoritative” knowledge. The second involves biased information processing and exposure to misinformation, often transmitted by word of mouth, or through social networks. With this model, believing in conspiracy theories could be conceived as involving “delusion-like beliefs,” but not frank psychosis or full-blown delusions, as one might see, for example, in schizophrenia.

Indeed, many of the cognitive characteristics associated with conspiracy theory belief are universal, continuously distributed traits, varying in quantity, rather than all-or-none variables or distinct symptoms of mental illness.

Essentially, delusions are fixed, false, usually unshared beliefs, often based on subjective “inner” experience. (One rare exception is the so-called folie à deux, in which two people appear to “share” the same delusion; however, psychiatrists have long debated whether both individuals should be considered truly delusional). The delusion’s content is often “self-referential”; i.e., focused primarily on the believer.

In contrast, conspiracy theories are usually, but not necessarily, false. They are typically shared beliefs that don’t explicitly or directly involve the believer, and are based on evidence that one finds “out there,” such as on the Internet. This speaks to the highly communal nature of so many conspiracy theories – networks of like-minded individuals reinforcing one another’s beliefs in a particular socio-cultural context.
 

Conspiracy theory belief, COVID-19, and medical intervention

As for medical conspiracy theories, none have flourished recently more so than those involving the COVID-19 pandemic. As a recent editorial by Stein and colleagues noted, “Some conspiratorial claims include assertions that COVID‐19 is a hoax; arguments that the virus was created artificially and spread on purpose as a bioweapon; or allegations that governments are using the emergency situation to pursue their antidemocratic goals. … Other conspiracies argued that people in power are taking advantage of the pandemic as a plan to inject microchip quantum-dot spy software and monitor people.”

Stein and colleagues make the important point that a “key difference between COVID‐19 and the 1918 flu pandemic ... is that [now] a highly interconnected world, to a great extent on social media, is setting the stage for distributing information and misinformation about COVID‐19.”

Consider the following composite vignette: Mr. A is a 70-year-old retiree with a history of COPD who has been advised by his PCP to get vaccinated against COVID-19. He is extremely reluctant to do so, fearing that “the vaccine is going to change my DNA” and “might even give me COVID.” He has heard from friends on social media that vaccine developers “faked the results” and are “in cahoots with the federal government.” Mr. A has heard “experts” declare the vaccines safe, but does not trust them. Mr. A has no psychiatric or substance abuse history, and there are no cognitive, perceptual, or other abnormalities in Mr. A’s mental status exam.

Mr. A’s beliefs qualify as a “conspiracy theory,” but probably represent widely held misconceptions about COVID-19 vaccines, as well as widespread mistrust of pharmaceutical companies and the federal government. Based on the information provided, there is no basis for concluding that Mr. A is psychotic or delusional. His beliefs appear to be the result of “epistemic mistrust” of authoritative informational accounts, biased information processing, and exposure to misinformation.

How should the physician manage and care for patients like Mr. A? Absent frank delusions, there is no role for antipsychotic medication, though for extremely anxious patients, a time-limited course of an antianxiety agent may sometimes be warranted. In addition to providing accurate medical information to the patient, the physician should avoid arguing, or trying to “talk the patient out of” his or her belief. Instead, the focus should be on sustaining and strengthening the physician-patient alliance, establishing an atmosphere of respect and safety, clarifying differences in trusted sources of medical information, and allowing the patient time to process the physician’s recommendations.

One-to-one engagement with health care providers has proved effective in reducing vaccine hesitancy and correcting misinformation. For patients with less fixed conspiracy theory beliefs, it may sometimes be helpful to gently offer alternative hypotheses to the patient’s conspiracy theory, using elements of cognitive-behavioral therapy (CBT). For example, a physician might ask, “Is it possible that the online source you read was mistaken about the vaccine changing your DNA?” while reminding patients that – contrary to popular belief – mRNA vaccines have been in development against cancer for several decades.

Challenging beliefs collaboratively and acknowledging areas of uncertainty, rather than confronting or arguing about false beliefs, can foster trust between physician and patient and, at the very least, open a dialogue regarding potential exposure to medical misinformation. “Inoculation” strategies that present and then dispel misinformation before patients become aware of it are among the best supported strategies for mitigating conspiracy theory belief. Ideally, physicians and health care systems should maintain an ongoing “inventory” of medical misinformation circulating online and “beat it to the punch” with reliable information.

Finally, because believing in conspiracy theories is often associated with a sense of uncertainty, and feeling that one’s life is “out of control,” medical interventions can be framed as ways of regaining control and appealing to patients’ values; for example, saying, “By getting the vaccine, you’ll be more likely to stay in good health, protect your family, and do all the things you want to do.”
 

Dr. Pies is professor of psychiatry and a lecturer on bioethics and humanities at State University of New York, Syracuse. Dr. Pierre is a health sciences clinical professor in the department of psychiatry and biobehavioral sciences at the University of California, Los Angeles. A version of this article first appeared on Medscape.com.

When many people across the country, not to mention in public office, believe that the world is run by a group of Satanic pedophiles that includes top Democrats and Hollywood elites, and that former President Trump is leading a secret mission to bring these evildoers to justice, one can’t help but ask if they’re at least to some degree mentally impaired.

Conspiracy theories are often received with psychiatric connotations; associated with paranoid plan-hatchers, and nonbelieving outsiders. But whereas theories such as QAnon strain credibility for many people, we would argue that they are likely not the product of psychosis or mental illness; nor do conspiracy theories in general represent delusions.

For one thing, surveys have consistently revealed that about 50% of the population believes in at least one conspiracy theory. Furthermore, there are several substantive differences between conspiracy theory beliefs and delusions.

Some researchers consider conspiracy theories to be “a subset of false beliefs,” but  most scholars, ourselves included, do not prejudge their validity or veracity. Real-life conspiracies, such as the CIA’s MK-Ultra program, have clearly occurred throughout history.

Our central contention is that belief in conspiracy theories is distinct from psychosis, and more closely resembles extreme but subculturally sanctioned religious or political beliefs. However, the line between believing in conspiracies and being delusional becomes blurred when the believer becomes part of the conspiracy theory and feels compelled to act on the belief as part of a personal mission.

Take Edgar Maddison Welch, a 28-year-old man who firmly believed the so-called “Pizzagate” conspiracy theory – the baseless claim that Hillary Clinton and Democratic elites were running a child sex-trafficking ring out of a Washington, DC, pizzeria. Seeing himself a potential savior of children, Mr. Welch drove 350 miles to the pizza shop from his home in North Carolina in December 2016 and fired three shots from an AR-15 style rifle into a locked closet door, ultimately surrendering to police. However, on questioning he quickly conceded, “The intel on this wasn’t 100%.”

Who believes in conspiracy theories?

Given that half the population believes in at least one conspiracy theory, it should come as little surprise that there is no reliable “profile” for believers. Although some studies have suggested associations with low education, right-wing political orientation, and certain personality traits like subclinical paranoia and schizotypy, such findings have been inconsistent and may vary across specific conspiracy theory. Associations between conspiracy belief and paranoia suggest overlap within a “conspiratorial mindset,” with recent evidence that “distrust of officialdom” is a key mediator between believing in conspiracies and political ideology.

Other quantitative “cognitive quirks” reported in those who believe in conspiracies are a need for certainty and control, a need for uniqueness, illusory pattern perception, and lack of analytical thinking. It’s unclear which of these factors may represent universal cognitive explanations for conspiratorial beliefs, vs. those that might be related to specific beliefs, such as the need for certainty during times of crisis and societal upheaval, when conspiracy theories tend to flourish.

Much of the research on conspiracy theory belief is based on the questionable premise that it’s best understood at the level of the individual’s psychopathology, or the “deficit model,” as it’s called. One of us (JMP) has instead proposed a two-component model that includes social and informational contexts. The first component – epistemic mistrust – involves mistrusting conventional, “authoritative” knowledge. The second involves biased information processing and exposure to misinformation, often transmitted by word of mouth, or through social networks. With this model, believing in conspiracy theories could be conceived as involving “delusion-like beliefs,” but not frank psychosis or full-blown delusions, as one might see, for example, in schizophrenia.

Indeed, many of the cognitive characteristics associated with conspiracy theory belief are universal, continuously distributed traits, varying in quantity, rather than all-or-none variables or distinct symptoms of mental illness.

Essentially, delusions are fixed, false, usually unshared beliefs, often based on subjective “inner” experience. (One rare exception is the so-called folie à deux, in which two people appear to “share” the same delusion; however, psychiatrists have long debated whether both individuals should be considered truly delusional). The delusion’s content is often “self-referential”; i.e., focused primarily on the believer.

In contrast, conspiracy theories are usually, but not necessarily, false. They are typically shared beliefs that don’t explicitly or directly involve the believer, and are based on evidence that one finds “out there,” such as on the Internet. This speaks to the highly communal nature of so many conspiracy theories – networks of like-minded individuals reinforcing one another’s beliefs in a particular socio-cultural context.
 

Conspiracy theory belief, COVID-19, and medical intervention

As for medical conspiracy theories, none have flourished recently more so than those involving the COVID-19 pandemic. As a recent editorial by Stein and colleagues noted, “Some conspiratorial claims include assertions that COVID‐19 is a hoax; arguments that the virus was created artificially and spread on purpose as a bioweapon; or allegations that governments are using the emergency situation to pursue their antidemocratic goals. … Other conspiracies argued that people in power are taking advantage of the pandemic as a plan to inject microchip quantum-dot spy software and monitor people.”

Stein and colleagues make the important point that a “key difference between COVID‐19 and the 1918 flu pandemic ... is that [now] a highly interconnected world, to a great extent on social media, is setting the stage for distributing information and misinformation about COVID‐19.”

Consider the following composite vignette: Mr. A is a 70-year-old retiree with a history of COPD who has been advised by his PCP to get vaccinated against COVID-19. He is extremely reluctant to do so, fearing that “the vaccine is going to change my DNA” and “might even give me COVID.” He has heard from friends on social media that vaccine developers “faked the results” and are “in cahoots with the federal government.” Mr. A has heard “experts” declare the vaccines safe, but does not trust them. Mr. A has no psychiatric or substance abuse history, and there are no cognitive, perceptual, or other abnormalities in Mr. A’s mental status exam.

Mr. A’s beliefs qualify as a “conspiracy theory,” but probably represent widely held misconceptions about COVID-19 vaccines, as well as widespread mistrust of pharmaceutical companies and the federal government. Based on the information provided, there is no basis for concluding that Mr. A is psychotic or delusional. His beliefs appear to be the result of “epistemic mistrust” of authoritative informational accounts, biased information processing, and exposure to misinformation.

How should the physician manage and care for patients like Mr. A? Absent frank delusions, there is no role for antipsychotic medication, though for extremely anxious patients, a time-limited course of an antianxiety agent may sometimes be warranted. In addition to providing accurate medical information to the patient, the physician should avoid arguing, or trying to “talk the patient out of” his or her belief. Instead, the focus should be on sustaining and strengthening the physician-patient alliance, establishing an atmosphere of respect and safety, clarifying differences in trusted sources of medical information, and allowing the patient time to process the physician’s recommendations.

One-to-one engagement with health care providers has proved effective in reducing vaccine hesitancy and correcting misinformation. For patients with less fixed conspiracy theory beliefs, it may sometimes be helpful to gently offer alternative hypotheses to the patient’s conspiracy theory, using elements of cognitive-behavioral therapy (CBT). For example, a physician might ask, “Is it possible that the online source you read was mistaken about the vaccine changing your DNA?” while reminding patients that – contrary to popular belief – mRNA vaccines have been in development against cancer for several decades.

Challenging beliefs collaboratively and acknowledging areas of uncertainty, rather than confronting or arguing about false beliefs, can foster trust between physician and patient and, at the very least, open a dialogue regarding potential exposure to medical misinformation. “Inoculation” strategies that present and then dispel misinformation before patients become aware of it are among the best supported strategies for mitigating conspiracy theory belief. Ideally, physicians and health care systems should maintain an ongoing “inventory” of medical misinformation circulating online and “beat it to the punch” with reliable information.

Finally, because believing in conspiracy theories is often associated with a sense of uncertainty, and feeling that one’s life is “out of control,” medical interventions can be framed as ways of regaining control and appealing to patients’ values; for example, saying, “By getting the vaccine, you’ll be more likely to stay in good health, protect your family, and do all the things you want to do.”
 

Dr. Pies is professor of psychiatry and a lecturer on bioethics and humanities at State University of New York, Syracuse. Dr. Pierre is a health sciences clinical professor in the department of psychiatry and biobehavioral sciences at the University of California, Los Angeles. A version of this article first appeared on Medscape.com.

COVID-19 cases are continuing to fall in the United States, according to the New York Times tracker, though the number of deaths from the disease again neared 4,000 on Feb. 3.

janiecbros/iStock/Getty Images Plus

The United States has averaged 141,146 cases a day in the past week, down 30% from the average 2 weeks ago. For the first time since November 2020, the country is averaging fewer than 150,000 cases a day, according to the tracker.

However, Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, warned that new COVID-19 variants popping up widely could threaten that progress.

“Although we have seen declines in cases and admissions and a recent slowing of deaths, cases remain extraordinarily high, still twice as high as the peak number of cases over the summer. And the continued proliferation of variants, variants that likely have increased transmissibility, that spread more easily, threatens to reverse these recent trends.

“Based on contact tracing of recent variant cases, not wearing masks and participating in in-person social gatherings have contributed to the variants’ spread,” she said at a White House COVID-19 briefing on Feb. 3, 2021.

The number of cases worldwide neared 104 million on Feb. 3 and the U.S. numbers made up 26.4 million of that total.

As of Feb. 4, COVID-19 had killed at least 454,000 people and infected about 26.6 million in the United States since January 2020, according to the Johns Hopkins University tracker.

The Johns Hopkins tracker found that, per capita, North Dakota, South Dakota, and Rhode Island have reported the most cases while New Jersey and New York have recorded the most deaths.

According to the COVID tracking project, hospitalizations for COVID-19 nationwide were down to 91,440 on Feb. 3.

The tracking report noted, “compared to last week, the number of people currently hospitalized with COVID-19 is down by 10% or more in 38 states.”

Even in hard-hit Los Angeles County, infections and case numbers are on the decline, according to the Los Angeles Times. However, officials, warn the numbers remain well above presurge levels. Over the past week, 201 city residents have died every day.

Reuters also reports that Anthony S. Fauci, MD, the government’s top infectious disease expert, said despite some good news in the numbers, Americans should continue to follow social distancing guidelines. He added that double-masking may add protection.

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

COVID-19 cases are continuing to fall in the United States, according to the New York Times tracker, though the number of deaths from the disease again neared 4,000 on Feb. 3.

janiecbros/iStock/Getty Images Plus

The United States has averaged 141,146 cases a day in the past week, down 30% from the average 2 weeks ago. For the first time since November 2020, the country is averaging fewer than 150,000 cases a day, according to the tracker.

However, Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, warned that new COVID-19 variants popping up widely could threaten that progress.

“Although we have seen declines in cases and admissions and a recent slowing of deaths, cases remain extraordinarily high, still twice as high as the peak number of cases over the summer. And the continued proliferation of variants, variants that likely have increased transmissibility, that spread more easily, threatens to reverse these recent trends.

“Based on contact tracing of recent variant cases, not wearing masks and participating in in-person social gatherings have contributed to the variants’ spread,” she said at a White House COVID-19 briefing on Feb. 3, 2021.

The number of cases worldwide neared 104 million on Feb. 3 and the U.S. numbers made up 26.4 million of that total.

As of Feb. 4, COVID-19 had killed at least 454,000 people and infected about 26.6 million in the United States since January 2020, according to the Johns Hopkins University tracker.

The Johns Hopkins tracker found that, per capita, North Dakota, South Dakota, and Rhode Island have reported the most cases while New Jersey and New York have recorded the most deaths.

According to the COVID tracking project, hospitalizations for COVID-19 nationwide were down to 91,440 on Feb. 3.

The tracking report noted, “compared to last week, the number of people currently hospitalized with COVID-19 is down by 10% or more in 38 states.”

Even in hard-hit Los Angeles County, infections and case numbers are on the decline, according to the Los Angeles Times. However, officials, warn the numbers remain well above presurge levels. Over the past week, 201 city residents have died every day.

Reuters also reports that Anthony S. Fauci, MD, the government’s top infectious disease expert, said despite some good news in the numbers, Americans should continue to follow social distancing guidelines. He added that double-masking may add protection.

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

COVID-19 cases are continuing to fall in the United States, according to the New York Times tracker, though the number of deaths from the disease again neared 4,000 on Feb. 3.

janiecbros/iStock/Getty Images Plus

The United States has averaged 141,146 cases a day in the past week, down 30% from the average 2 weeks ago. For the first time since November 2020, the country is averaging fewer than 150,000 cases a day, according to the tracker.

However, Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, warned that new COVID-19 variants popping up widely could threaten that progress.

“Although we have seen declines in cases and admissions and a recent slowing of deaths, cases remain extraordinarily high, still twice as high as the peak number of cases over the summer. And the continued proliferation of variants, variants that likely have increased transmissibility, that spread more easily, threatens to reverse these recent trends.

“Based on contact tracing of recent variant cases, not wearing masks and participating in in-person social gatherings have contributed to the variants’ spread,” she said at a White House COVID-19 briefing on Feb. 3, 2021.

The number of cases worldwide neared 104 million on Feb. 3 and the U.S. numbers made up 26.4 million of that total.

As of Feb. 4, COVID-19 had killed at least 454,000 people and infected about 26.6 million in the United States since January 2020, according to the Johns Hopkins University tracker.

The Johns Hopkins tracker found that, per capita, North Dakota, South Dakota, and Rhode Island have reported the most cases while New Jersey and New York have recorded the most deaths.

According to the COVID tracking project, hospitalizations for COVID-19 nationwide were down to 91,440 on Feb. 3.

The tracking report noted, “compared to last week, the number of people currently hospitalized with COVID-19 is down by 10% or more in 38 states.”

Even in hard-hit Los Angeles County, infections and case numbers are on the decline, according to the Los Angeles Times. However, officials, warn the numbers remain well above presurge levels. Over the past week, 201 city residents have died every day.

Reuters also reports that Anthony S. Fauci, MD, the government’s top infectious disease expert, said despite some good news in the numbers, Americans should continue to follow social distancing guidelines. He added that double-masking may add protection.

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

The antidepressant fluvoxamine shows promise in preventing people infected with coronavirus from developing serious symptoms and having to be hospitalized, according to a nonrandomized study of California racetrack workers.

“What we observed was that of all the patients who received fluvoxamine, none of them had a severe COVID infection that affected their lungs or their respiratory status,” Caline Mattar, MD, told KNBC in Los Angeles. Dr. Mattar is an infectious disease researcher at Washington University in St. Louis who helped conduct the study that was published in Open Forum Infectious Diseases.

Fluvoxamine, which is sold under the brand name Luvox, is a selective serotonin reuptake inhibitor (SSRI) often prescribed for people diagnosed with obsessive-compulsive disorder. It’s been on the market for over a decade.

Two-hundred employees at Golden Gate Fields Racetrack in Berkeley, Calif., tested positive for COVID-19 last November. Track physician David Seftel, MD, offered fluvoxamine to 113 of them, having learned of a previous randomized study of COVID-19 patients that indicated fluvoxamine helped ward off serious illness, Science News said.

The 65 workers who took a 2-week course of the drug didn’t have to be hospitalized, didn’t have serious symptoms, and felt better after 2 weeks, the study said. Six of the 48 workers who turned down fluvoxamine had to be hospitalized, two required intensive care, and one died, the study said.

“Overall, fluvoxamine appears promising as early treatment for COVID-19 to prevent clinical deterioration requiring hospitalization and to prevent possible long haul symptoms persisting beyond 2 weeks,” the study said.

The authors stressed that their findings were “a real world evidence study” necessitated by the urgency of the coronavirus pandemic.

They said their research needed verification from a randomized, controlled trial. Such a study is now being conducted by Washington University and other schools, KNBC said.

The track workers who were infected were predominantly male and Latino, and 30% had chronic medical problems such as diabetes or high blood pressure, Science News said.

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

The antidepressant fluvoxamine shows promise in preventing people infected with coronavirus from developing serious symptoms and having to be hospitalized, according to a nonrandomized study of California racetrack workers.

“What we observed was that of all the patients who received fluvoxamine, none of them had a severe COVID infection that affected their lungs or their respiratory status,” Caline Mattar, MD, told KNBC in Los Angeles. Dr. Mattar is an infectious disease researcher at Washington University in St. Louis who helped conduct the study that was published in Open Forum Infectious Diseases.

Fluvoxamine, which is sold under the brand name Luvox, is a selective serotonin reuptake inhibitor (SSRI) often prescribed for people diagnosed with obsessive-compulsive disorder. It’s been on the market for over a decade.

Two-hundred employees at Golden Gate Fields Racetrack in Berkeley, Calif., tested positive for COVID-19 last November. Track physician David Seftel, MD, offered fluvoxamine to 113 of them, having learned of a previous randomized study of COVID-19 patients that indicated fluvoxamine helped ward off serious illness, Science News said.

The 65 workers who took a 2-week course of the drug didn’t have to be hospitalized, didn’t have serious symptoms, and felt better after 2 weeks, the study said. Six of the 48 workers who turned down fluvoxamine had to be hospitalized, two required intensive care, and one died, the study said.

“Overall, fluvoxamine appears promising as early treatment for COVID-19 to prevent clinical deterioration requiring hospitalization and to prevent possible long haul symptoms persisting beyond 2 weeks,” the study said.

The authors stressed that their findings were “a real world evidence study” necessitated by the urgency of the coronavirus pandemic.

They said their research needed verification from a randomized, controlled trial. Such a study is now being conducted by Washington University and other schools, KNBC said.

The track workers who were infected were predominantly male and Latino, and 30% had chronic medical problems such as diabetes or high blood pressure, Science News said.

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

The antidepressant fluvoxamine shows promise in preventing people infected with coronavirus from developing serious symptoms and having to be hospitalized, according to a nonrandomized study of California racetrack workers.

“What we observed was that of all the patients who received fluvoxamine, none of them had a severe COVID infection that affected their lungs or their respiratory status,” Caline Mattar, MD, told KNBC in Los Angeles. Dr. Mattar is an infectious disease researcher at Washington University in St. Louis who helped conduct the study that was published in Open Forum Infectious Diseases.

Fluvoxamine, which is sold under the brand name Luvox, is a selective serotonin reuptake inhibitor (SSRI) often prescribed for people diagnosed with obsessive-compulsive disorder. It’s been on the market for over a decade.

Two-hundred employees at Golden Gate Fields Racetrack in Berkeley, Calif., tested positive for COVID-19 last November. Track physician David Seftel, MD, offered fluvoxamine to 113 of them, having learned of a previous randomized study of COVID-19 patients that indicated fluvoxamine helped ward off serious illness, Science News said.

The 65 workers who took a 2-week course of the drug didn’t have to be hospitalized, didn’t have serious symptoms, and felt better after 2 weeks, the study said. Six of the 48 workers who turned down fluvoxamine had to be hospitalized, two required intensive care, and one died, the study said.

“Overall, fluvoxamine appears promising as early treatment for COVID-19 to prevent clinical deterioration requiring hospitalization and to prevent possible long haul symptoms persisting beyond 2 weeks,” the study said.

The authors stressed that their findings were “a real world evidence study” necessitated by the urgency of the coronavirus pandemic.

They said their research needed verification from a randomized, controlled trial. Such a study is now being conducted by Washington University and other schools, KNBC said.

The track workers who were infected were predominantly male and Latino, and 30% had chronic medical problems such as diabetes or high blood pressure, Science News said.

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

As health care providers work against the clock to administer as many COVID-19 vaccine doses as soon as possible, logistics aren’t the only thing standing in their way.

Misinformation – which has hampered the nation’s coronavirus response – is now hurting vaccination efforts, too.

About one in five Americans say they won’t take a COVID-19 vaccine, according to the Kaiser Family Foundation’s COVID-19 Vaccine Monitor. Even a third of health care workers have voiced their hesitance.

The spread of COVID-19 vaccine misinformation creates “a really powerful parallel pandemic to the real pandemic,” Imran Ahmed, CEO of the Center for Countering Digital Hate, told NPR. The center has tracked the links between vaccine misinformation and vaccine hesitancy during the past year.

The “infodemic” is essentially “working in concert to really undermine our capacity to contain COVID,” Mr. Ahmed said.

To help combat vaccine misinformation and address lingering concerns that people have, corporate, nonprofit, and media leaders, including this news organization, are joining a public service campaign called VaxFacts. Led by HealthGuard, the goal of the campaign is to provide facts and tools to help consumers make informed decisions about vaccines.

Steven Brill, co-CEO of HealthGuard, said credible information that comes from trusted messengers is critical to counter vaccine hesitancy.

“There’s traditionally a lot of skepticism about vaccines. That has really ramped up in the last few years based on campaigns about the measles vaccine. ... And now you have the COVID vaccine, which by everybody’s understanding has been ‘rushed,’ ” Mr. Brill said during an interview on Coronavirus in Context, a video series hosted by John Whyte, MD, chief medical officer for WebMD.

“There may be less understanding of the nature of what rushed really means. It’s still gone through the clinical trials it needs to go through.”

HealthGuard is a browser extension that flags health hoaxes, provides credibility ratings for hundreds of websites, and guides users to sources that offer trusted information. The tool is a new service from NewsGuard, which veteran journalists Mr. Brill and co-CEO Gordon Crovitz created in 2018 to combat misinformation in the news. HealthGuard, which is free for users globally through June, is specifically aimed at informing readers about health myths related to vaccines and COVID-19. It will cost $35 per year after that.

The HealthGuard Coronavirus Tracking Center has flagged nearly 400 websites for publishing misinformation about the coronavirus, including several top myths about COVID-19 vaccines:

• The mRNA vaccines can alter human DNA.
• Vaccines will use microchip surveillance technology.
• COVID-19 vaccines cause infertility.
• The vaccine developed by Oxford University will turn people into monkeys.
• COVID-19 vaccines contain aborted human fetal tissue.

As a partner, this news organization will feature continuing coverage of COVID-19 vaccine misinformation, including articles and videos.

There will be other efforts this year. Google has launched a $3 million fund to back fact-checking organizations to counter vaccine misinformation, and social media platforms are monitoring posts that actively promote disinformation around vaccines.

The United States has distributed nearly 50 million vaccine doses, and states have administered more than 32 million of them, including 5.9 million second doses in the two-shot vaccines, according to the latest CDC update.

To reach herd immunity, about 75%-85% of Americans will need to receive a vaccine, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in December 2020.

Vaccine skepticism has increased in recent years, which has led to a decline in vaccination rates and the highest annual number of measles cases in the United States in more than 25 years, according to the Pew Research Center. In 2019, the World Health Organization named vaccine hesitancy as 1 of 10 threats to global health.

With the COVID-19 vaccines in particular, people have voiced concerns about their safety and how well they work, given their accelerated development, according to Kaiser’s poll. They’re also worried about potential side effects, the perceived role of politics in the development process, and a lack of trust in government. Others don’t trust vaccines in general or believe they may contract COVID-19 from a vaccine, the Kaiser poll found, “suggesting that messages combating particular types of misinformation may be especially important for increasing vaccine confidence.”

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

As health care providers work against the clock to administer as many COVID-19 vaccine doses as soon as possible, logistics aren’t the only thing standing in their way.

Misinformation – which has hampered the nation’s coronavirus response – is now hurting vaccination efforts, too.

About one in five Americans say they won’t take a COVID-19 vaccine, according to the Kaiser Family Foundation’s COVID-19 Vaccine Monitor. Even a third of health care workers have voiced their hesitance.

The spread of COVID-19 vaccine misinformation creates “a really powerful parallel pandemic to the real pandemic,” Imran Ahmed, CEO of the Center for Countering Digital Hate, told NPR. The center has tracked the links between vaccine misinformation and vaccine hesitancy during the past year.

The “infodemic” is essentially “working in concert to really undermine our capacity to contain COVID,” Mr. Ahmed said.

To help combat vaccine misinformation and address lingering concerns that people have, corporate, nonprofit, and media leaders, including this news organization, are joining a public service campaign called VaxFacts. Led by HealthGuard, the goal of the campaign is to provide facts and tools to help consumers make informed decisions about vaccines.

Steven Brill, co-CEO of HealthGuard, said credible information that comes from trusted messengers is critical to counter vaccine hesitancy.

“There’s traditionally a lot of skepticism about vaccines. That has really ramped up in the last few years based on campaigns about the measles vaccine. ... And now you have the COVID vaccine, which by everybody’s understanding has been ‘rushed,’ ” Mr. Brill said during an interview on Coronavirus in Context, a video series hosted by John Whyte, MD, chief medical officer for WebMD.

“There may be less understanding of the nature of what rushed really means. It’s still gone through the clinical trials it needs to go through.”

HealthGuard is a browser extension that flags health hoaxes, provides credibility ratings for hundreds of websites, and guides users to sources that offer trusted information. The tool is a new service from NewsGuard, which veteran journalists Mr. Brill and co-CEO Gordon Crovitz created in 2018 to combat misinformation in the news. HealthGuard, which is free for users globally through June, is specifically aimed at informing readers about health myths related to vaccines and COVID-19. It will cost $35 per year after that.

The HealthGuard Coronavirus Tracking Center has flagged nearly 400 websites for publishing misinformation about the coronavirus, including several top myths about COVID-19 vaccines:

• The mRNA vaccines can alter human DNA.
• Vaccines will use microchip surveillance technology.
• COVID-19 vaccines cause infertility.
• The vaccine developed by Oxford University will turn people into monkeys.
• COVID-19 vaccines contain aborted human fetal tissue.

As a partner, this news organization will feature continuing coverage of COVID-19 vaccine misinformation, including articles and videos.

There will be other efforts this year. Google has launched a $3 million fund to back fact-checking organizations to counter vaccine misinformation, and social media platforms are monitoring posts that actively promote disinformation around vaccines.

The United States has distributed nearly 50 million vaccine doses, and states have administered more than 32 million of them, including 5.9 million second doses in the two-shot vaccines, according to the latest CDC update.

To reach herd immunity, about 75%-85% of Americans will need to receive a vaccine, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in December 2020.

Vaccine skepticism has increased in recent years, which has led to a decline in vaccination rates and the highest annual number of measles cases in the United States in more than 25 years, according to the Pew Research Center. In 2019, the World Health Organization named vaccine hesitancy as 1 of 10 threats to global health.

With the COVID-19 vaccines in particular, people have voiced concerns about their safety and how well they work, given their accelerated development, according to Kaiser’s poll. They’re also worried about potential side effects, the perceived role of politics in the development process, and a lack of trust in government. Others don’t trust vaccines in general or believe they may contract COVID-19 from a vaccine, the Kaiser poll found, “suggesting that messages combating particular types of misinformation may be especially important for increasing vaccine confidence.”

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

As health care providers work against the clock to administer as many COVID-19 vaccine doses as soon as possible, logistics aren’t the only thing standing in their way.

Misinformation – which has hampered the nation’s coronavirus response – is now hurting vaccination efforts, too.

About one in five Americans say they won’t take a COVID-19 vaccine, according to the Kaiser Family Foundation’s COVID-19 Vaccine Monitor. Even a third of health care workers have voiced their hesitance.

The spread of COVID-19 vaccine misinformation creates “a really powerful parallel pandemic to the real pandemic,” Imran Ahmed, CEO of the Center for Countering Digital Hate, told NPR. The center has tracked the links between vaccine misinformation and vaccine hesitancy during the past year.

The “infodemic” is essentially “working in concert to really undermine our capacity to contain COVID,” Mr. Ahmed said.

To help combat vaccine misinformation and address lingering concerns that people have, corporate, nonprofit, and media leaders, including this news organization, are joining a public service campaign called VaxFacts. Led by HealthGuard, the goal of the campaign is to provide facts and tools to help consumers make informed decisions about vaccines.

Steven Brill, co-CEO of HealthGuard, said credible information that comes from trusted messengers is critical to counter vaccine hesitancy.

“There’s traditionally a lot of skepticism about vaccines. That has really ramped up in the last few years based on campaigns about the measles vaccine. ... And now you have the COVID vaccine, which by everybody’s understanding has been ‘rushed,’ ” Mr. Brill said during an interview on Coronavirus in Context, a video series hosted by John Whyte, MD, chief medical officer for WebMD.

“There may be less understanding of the nature of what rushed really means. It’s still gone through the clinical trials it needs to go through.”

HealthGuard is a browser extension that flags health hoaxes, provides credibility ratings for hundreds of websites, and guides users to sources that offer trusted information. The tool is a new service from NewsGuard, which veteran journalists Mr. Brill and co-CEO Gordon Crovitz created in 2018 to combat misinformation in the news. HealthGuard, which is free for users globally through June, is specifically aimed at informing readers about health myths related to vaccines and COVID-19. It will cost $35 per year after that.

The HealthGuard Coronavirus Tracking Center has flagged nearly 400 websites for publishing misinformation about the coronavirus, including several top myths about COVID-19 vaccines:

• The mRNA vaccines can alter human DNA.
• Vaccines will use microchip surveillance technology.
• COVID-19 vaccines cause infertility.
• The vaccine developed by Oxford University will turn people into monkeys.
• COVID-19 vaccines contain aborted human fetal tissue.

As a partner, this news organization will feature continuing coverage of COVID-19 vaccine misinformation, including articles and videos.

There will be other efforts this year. Google has launched a $3 million fund to back fact-checking organizations to counter vaccine misinformation, and social media platforms are monitoring posts that actively promote disinformation around vaccines.

The United States has distributed nearly 50 million vaccine doses, and states have administered more than 32 million of them, including 5.9 million second doses in the two-shot vaccines, according to the latest CDC update.

To reach herd immunity, about 75%-85% of Americans will need to receive a vaccine, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in December 2020.

Vaccine skepticism has increased in recent years, which has led to a decline in vaccination rates and the highest annual number of measles cases in the United States in more than 25 years, according to the Pew Research Center. In 2019, the World Health Organization named vaccine hesitancy as 1 of 10 threats to global health.

With the COVID-19 vaccines in particular, people have voiced concerns about their safety and how well they work, given their accelerated development, according to Kaiser’s poll. They’re also worried about potential side effects, the perceived role of politics in the development process, and a lack of trust in government. Others don’t trust vaccines in general or believe they may contract COVID-19 from a vaccine, the Kaiser poll found, “suggesting that messages combating particular types of misinformation may be especially important for increasing vaccine confidence.”

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

The gout drug colchicine appears to lower the severity of COVID-19, a small new Brazilian study finds, adding to evidence that the familiar medication holds promise as a treatment for hospitalized patients.

Patients who received colchicine in this randomized, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. ... Colchicine was safe and well tolerated,” the study authors wrote in RMD Open. However, deaths were rare in the trial, they added, and it is impossible to “evaluate the capacity of colchicine to avoid admission to ICU and reduce mortality.”

The oral anti-inflammatory colchicine, widely used as treatment in rheumatic disease, was first approved in the United States 60 years ago. Researchers began to explore its potential as a COVID-19 treatment in the early months of the pandemic.

On Jan. 25, an international team of researchers reported in a press release – but not yet a published paper – that the drug seemed to reduce hospitalizations, mechanical ventilation, and deaths in the ColCORONA trial. Earlier, a much-smaller, randomized, open-label, Greek trial linked the drug to reduced time to clinical deterioration and hospital stay.

The Brazilian authors of the new study, led by Maria Isabel Lopes of the University of São Paulo’s Ribeirão Preto Medical School, randomly assigned 75 hospitalized patients with moderate to severe COVID-19 to colchicine or placebo. A total of 72 subjects completed the April-August 2020 trial: 36 received colchicine (typically 0.5 mg three times for 5 days, then 0.5 mg twice daily for 5 days; doses were adjusted in low-weight patients and those with chronic kidney disease). The other 36 received the placebo.

(In the United States, 0.6-mg tablets of generic colchicine cost as little as $1.90 each with free coupons, according to goodrx.com.)

The median age in the groups was similar (55 years); and the placebo group had more women (61% vs. 47% in the colchicine group, P = .34). All 72 patients received the same COVID-19 treatment at the time of the trial: azithromycin, hydroxychloroquine, and unfractionated heparin. Most patients, about two-thirds in both groups, also received methylprednisolone because they needed higher amounts of supplemental oxygen.

Patients in the colchicine group needed supplemental oxygen for less time: Their median time of need was 4.0 days (interquartile range [IQR], 2.0-6.0) vs. 6.5 days (IQR, 4.0-9.0) for the placebo group (P < .001). The median time for hospitalization was also lower at 7.0 days (IQR, 5.0–9.0) for the colchicine group vs. 9.0 (IQR, 7.0–12.0) for the placebo group (log rank test, 10.6; P = .001).

The researchers also reported the percentage of patients who needed supplemental oxygen at day 2 as 67% with colchicine vs. 86% with placebo, and at day 7 as 9% vs. 42% (log rank test, 10.6; P = .001). Two patients in the placebo group died, both from ventilator-associated pneumonia.

As for side effects, new or worsened diarrhea was reported more often in the colchicine group (17% vs. 6% with placebo), but the difference was not statistically significant (P = .26), and diarrhea was controlled via medication.

The researchers reported that limitations include the exclusion criteria and their inability to link colchicine to rates of ICU admissions and death.

The drug appears to help patients with COVID-19, the study authors wrote, by “inhibiting inflammasome, reducing neutrophil migration and activation, or preventing endothelial damage.”

A “well-conceived and well-designed” study

In an interview, NYU Langone Health rheumatologist Michael H. Pillinger, MD – an investigator with the ColCORONA trial – praised the Brazilian study. It “appears well-conceived and well-designed, and was enrolled at a rate that was greater than the sample size that was estimated to be needed based on power analysis,” he said.

The Brazilian study is small, he noted. (In contrast, the ColCORONA trial had 4,488 outpatient participants.) “This study differs from ColCORONA in several ways – the most important being that it is a study of inpatients with moderate to severe COVID (really mostly moderate),” he added. “ColCORONA is looking at a target audience that is much larger – outpatients with mild to moderate COVID with risk factors for hospitalization. Both questions are really important and certainly not mutually exclusive, since our care remains inadequate in both venues. This study also adds value in that several other studies have been conducted in hospital patients with enrollment criteria relatively similar to this one, and all showed benefit, but those were open-label or retrospective, and this is blinded and placebo-controlled.”
 

Using colchicine in patients with COVID-19

Should physicians turn to colchicine in patients with COVID-19? “I would rather that it still be used in the context of research until formal recommendations can be made by bodies like the NIH and CDC,” Dr. Pillinger said. “But certainly, there may be times when physicians feel compelled to treat patients off label.”

He cautioned, however, that colchicine should never be used with some other drugs. Its interaction with the antibiotic clarithromycin can be fatal, he noted. And, he said, the drug must be monitored in general since it can cause rare, severe problems.

“Overall, colchicine probably works on the overabundant inflammatory response to COVID, and it may be that it can be combined with other drugs that affect viral replication or promote immunity – e.g. vaccines,” Dr. Pillinger said. “So far, it seems as if there is no safety problem with combining colchicine with other approaches, but this has not been studied in a rigorous manner.”

Moving forward, he said, the drug’s very low price outside of the United States “could provide resource-poor countries with a way to help keep patients out of precious hospital beds – or help them go home sooner once admitted.” For now, however, “we need a large-scale inpatient study, and one is currently going on in Great Britain. We also need validation of the outpatient ColCORONA study, and studies to look at whether colchicine can work in conjunction with other strategies.”

The study was funded by grants from the São Paulo Research Foundation, Brazilian National Council for Scientific and Technological Development, and CAPES Foundation. No disclosures are reported. Dr. Pillinger reports serving as an investigator for the ColCORONA trial and receiving a unrelated investigator-initiated grant from Hikma, a colchicine manufacturer.

The gout drug colchicine appears to lower the severity of COVID-19, a small new Brazilian study finds, adding to evidence that the familiar medication holds promise as a treatment for hospitalized patients.

Patients who received colchicine in this randomized, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. ... Colchicine was safe and well tolerated,” the study authors wrote in RMD Open. However, deaths were rare in the trial, they added, and it is impossible to “evaluate the capacity of colchicine to avoid admission to ICU and reduce mortality.”

The oral anti-inflammatory colchicine, widely used as treatment in rheumatic disease, was first approved in the United States 60 years ago. Researchers began to explore its potential as a COVID-19 treatment in the early months of the pandemic.

On Jan. 25, an international team of researchers reported in a press release – but not yet a published paper – that the drug seemed to reduce hospitalizations, mechanical ventilation, and deaths in the ColCORONA trial. Earlier, a much-smaller, randomized, open-label, Greek trial linked the drug to reduced time to clinical deterioration and hospital stay.

The Brazilian authors of the new study, led by Maria Isabel Lopes of the University of São Paulo’s Ribeirão Preto Medical School, randomly assigned 75 hospitalized patients with moderate to severe COVID-19 to colchicine or placebo. A total of 72 subjects completed the April-August 2020 trial: 36 received colchicine (typically 0.5 mg three times for 5 days, then 0.5 mg twice daily for 5 days; doses were adjusted in low-weight patients and those with chronic kidney disease). The other 36 received the placebo.

(In the United States, 0.6-mg tablets of generic colchicine cost as little as $1.90 each with free coupons, according to goodrx.com.)

The median age in the groups was similar (55 years); and the placebo group had more women (61% vs. 47% in the colchicine group, P = .34). All 72 patients received the same COVID-19 treatment at the time of the trial: azithromycin, hydroxychloroquine, and unfractionated heparin. Most patients, about two-thirds in both groups, also received methylprednisolone because they needed higher amounts of supplemental oxygen.

Patients in the colchicine group needed supplemental oxygen for less time: Their median time of need was 4.0 days (interquartile range [IQR], 2.0-6.0) vs. 6.5 days (IQR, 4.0-9.0) for the placebo group (P < .001). The median time for hospitalization was also lower at 7.0 days (IQR, 5.0–9.0) for the colchicine group vs. 9.0 (IQR, 7.0–12.0) for the placebo group (log rank test, 10.6; P = .001).

The researchers also reported the percentage of patients who needed supplemental oxygen at day 2 as 67% with colchicine vs. 86% with placebo, and at day 7 as 9% vs. 42% (log rank test, 10.6; P = .001). Two patients in the placebo group died, both from ventilator-associated pneumonia.

As for side effects, new or worsened diarrhea was reported more often in the colchicine group (17% vs. 6% with placebo), but the difference was not statistically significant (P = .26), and diarrhea was controlled via medication.

The researchers reported that limitations include the exclusion criteria and their inability to link colchicine to rates of ICU admissions and death.

The drug appears to help patients with COVID-19, the study authors wrote, by “inhibiting inflammasome, reducing neutrophil migration and activation, or preventing endothelial damage.”

A “well-conceived and well-designed” study

In an interview, NYU Langone Health rheumatologist Michael H. Pillinger, MD – an investigator with the ColCORONA trial – praised the Brazilian study. It “appears well-conceived and well-designed, and was enrolled at a rate that was greater than the sample size that was estimated to be needed based on power analysis,” he said.

The Brazilian study is small, he noted. (In contrast, the ColCORONA trial had 4,488 outpatient participants.) “This study differs from ColCORONA in several ways – the most important being that it is a study of inpatients with moderate to severe COVID (really mostly moderate),” he added. “ColCORONA is looking at a target audience that is much larger – outpatients with mild to moderate COVID with risk factors for hospitalization. Both questions are really important and certainly not mutually exclusive, since our care remains inadequate in both venues. This study also adds value in that several other studies have been conducted in hospital patients with enrollment criteria relatively similar to this one, and all showed benefit, but those were open-label or retrospective, and this is blinded and placebo-controlled.”
 

Using colchicine in patients with COVID-19

Should physicians turn to colchicine in patients with COVID-19? “I would rather that it still be used in the context of research until formal recommendations can be made by bodies like the NIH and CDC,” Dr. Pillinger said. “But certainly, there may be times when physicians feel compelled to treat patients off label.”

He cautioned, however, that colchicine should never be used with some other drugs. Its interaction with the antibiotic clarithromycin can be fatal, he noted. And, he said, the drug must be monitored in general since it can cause rare, severe problems.

“Overall, colchicine probably works on the overabundant inflammatory response to COVID, and it may be that it can be combined with other drugs that affect viral replication or promote immunity – e.g. vaccines,” Dr. Pillinger said. “So far, it seems as if there is no safety problem with combining colchicine with other approaches, but this has not been studied in a rigorous manner.”

Moving forward, he said, the drug’s very low price outside of the United States “could provide resource-poor countries with a way to help keep patients out of precious hospital beds – or help them go home sooner once admitted.” For now, however, “we need a large-scale inpatient study, and one is currently going on in Great Britain. We also need validation of the outpatient ColCORONA study, and studies to look at whether colchicine can work in conjunction with other strategies.”

The study was funded by grants from the São Paulo Research Foundation, Brazilian National Council for Scientific and Technological Development, and CAPES Foundation. No disclosures are reported. Dr. Pillinger reports serving as an investigator for the ColCORONA trial and receiving a unrelated investigator-initiated grant from Hikma, a colchicine manufacturer.

The gout drug colchicine appears to lower the severity of COVID-19, a small new Brazilian study finds, adding to evidence that the familiar medication holds promise as a treatment for hospitalized patients.

Patients who received colchicine in this randomized, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. ... Colchicine was safe and well tolerated,” the study authors wrote in RMD Open. However, deaths were rare in the trial, they added, and it is impossible to “evaluate the capacity of colchicine to avoid admission to ICU and reduce mortality.”

The oral anti-inflammatory colchicine, widely used as treatment in rheumatic disease, was first approved in the United States 60 years ago. Researchers began to explore its potential as a COVID-19 treatment in the early months of the pandemic.

On Jan. 25, an international team of researchers reported in a press release – but not yet a published paper – that the drug seemed to reduce hospitalizations, mechanical ventilation, and deaths in the ColCORONA trial. Earlier, a much-smaller, randomized, open-label, Greek trial linked the drug to reduced time to clinical deterioration and hospital stay.

The Brazilian authors of the new study, led by Maria Isabel Lopes of the University of São Paulo’s Ribeirão Preto Medical School, randomly assigned 75 hospitalized patients with moderate to severe COVID-19 to colchicine or placebo. A total of 72 subjects completed the April-August 2020 trial: 36 received colchicine (typically 0.5 mg three times for 5 days, then 0.5 mg twice daily for 5 days; doses were adjusted in low-weight patients and those with chronic kidney disease). The other 36 received the placebo.

(In the United States, 0.6-mg tablets of generic colchicine cost as little as $1.90 each with free coupons, according to goodrx.com.)

The median age in the groups was similar (55 years); and the placebo group had more women (61% vs. 47% in the colchicine group, P = .34). All 72 patients received the same COVID-19 treatment at the time of the trial: azithromycin, hydroxychloroquine, and unfractionated heparin. Most patients, about two-thirds in both groups, also received methylprednisolone because they needed higher amounts of supplemental oxygen.

Patients in the colchicine group needed supplemental oxygen for less time: Their median time of need was 4.0 days (interquartile range [IQR], 2.0-6.0) vs. 6.5 days (IQR, 4.0-9.0) for the placebo group (P < .001). The median time for hospitalization was also lower at 7.0 days (IQR, 5.0–9.0) for the colchicine group vs. 9.0 (IQR, 7.0–12.0) for the placebo group (log rank test, 10.6; P = .001).

The researchers also reported the percentage of patients who needed supplemental oxygen at day 2 as 67% with colchicine vs. 86% with placebo, and at day 7 as 9% vs. 42% (log rank test, 10.6; P = .001). Two patients in the placebo group died, both from ventilator-associated pneumonia.

As for side effects, new or worsened diarrhea was reported more often in the colchicine group (17% vs. 6% with placebo), but the difference was not statistically significant (P = .26), and diarrhea was controlled via medication.

The researchers reported that limitations include the exclusion criteria and their inability to link colchicine to rates of ICU admissions and death.

The drug appears to help patients with COVID-19, the study authors wrote, by “inhibiting inflammasome, reducing neutrophil migration and activation, or preventing endothelial damage.”

A “well-conceived and well-designed” study

In an interview, NYU Langone Health rheumatologist Michael H. Pillinger, MD – an investigator with the ColCORONA trial – praised the Brazilian study. It “appears well-conceived and well-designed, and was enrolled at a rate that was greater than the sample size that was estimated to be needed based on power analysis,” he said.

The Brazilian study is small, he noted. (In contrast, the ColCORONA trial had 4,488 outpatient participants.) “This study differs from ColCORONA in several ways – the most important being that it is a study of inpatients with moderate to severe COVID (really mostly moderate),” he added. “ColCORONA is looking at a target audience that is much larger – outpatients with mild to moderate COVID with risk factors for hospitalization. Both questions are really important and certainly not mutually exclusive, since our care remains inadequate in both venues. This study also adds value in that several other studies have been conducted in hospital patients with enrollment criteria relatively similar to this one, and all showed benefit, but those were open-label or retrospective, and this is blinded and placebo-controlled.”
 

Using colchicine in patients with COVID-19

Should physicians turn to colchicine in patients with COVID-19? “I would rather that it still be used in the context of research until formal recommendations can be made by bodies like the NIH and CDC,” Dr. Pillinger said. “But certainly, there may be times when physicians feel compelled to treat patients off label.”

He cautioned, however, that colchicine should never be used with some other drugs. Its interaction with the antibiotic clarithromycin can be fatal, he noted. And, he said, the drug must be monitored in general since it can cause rare, severe problems.

“Overall, colchicine probably works on the overabundant inflammatory response to COVID, and it may be that it can be combined with other drugs that affect viral replication or promote immunity – e.g. vaccines,” Dr. Pillinger said. “So far, it seems as if there is no safety problem with combining colchicine with other approaches, but this has not been studied in a rigorous manner.”

Moving forward, he said, the drug’s very low price outside of the United States “could provide resource-poor countries with a way to help keep patients out of precious hospital beds – or help them go home sooner once admitted.” For now, however, “we need a large-scale inpatient study, and one is currently going on in Great Britain. We also need validation of the outpatient ColCORONA study, and studies to look at whether colchicine can work in conjunction with other strategies.”

The study was funded by grants from the São Paulo Research Foundation, Brazilian National Council for Scientific and Technological Development, and CAPES Foundation. No disclosures are reported. Dr. Pillinger reports serving as an investigator for the ColCORONA trial and receiving a unrelated investigator-initiated grant from Hikma, a colchicine manufacturer.

The United States has now reported more than 450,000 COVID-19 deaths during the pandemic, adding 3,912 more on Wednesday, according to data from Johns Hopkins University.

Daily COVID-19 deaths still remain high in the United States, though they’ve decreased slightly from the peak of 4,466 deaths on Jan. 12.

The United States also reported more than 121,000 new COVID-19 cases on Wednesday, which is down from a peak of more than 300,000 new cases on Tuesday. In total, more than 26.5 million people in the United States have been diagnosed with COVID-19, making up a quarter of the 104.5 million cases reported worldwide.

The 7-day average for COVID-19 hospitalizations and deaths continues to decline, according to the COVID Tracking Project. The 7-day average for hospitalizations is around 96,500, and the 7-day average for deaths is about 3,000. With the exception of Vermont, all states and territories have reported declines or no changes in their hospitalizations and deaths.

“We have seen the 7-day average for new deaths decrease for over a week. At the same time, states are reporting an average of 3,000 people dying per day,” the COVID Tracking Project wrote in a post on Twitter. “The data is hopeful and devastating.”

More than 2.2 million COVID-19 deaths have been reported worldwide. The United States continues to report the most deaths, followed by Brazil with 227,500, Mexico with 161,200, and India with 154,700 deaths.

The U.S. COVID-19 death toll could reach 496,000-534,000 by the end of February, according to a new forecast by the CDC, which includes models from 36 national groups. Deaths will likely decrease during the next 4 weeks, with about 11,300-22,600 deaths possibly reported during the last week of February.

The 534,000 total would equal about 1 death for every minute of the pandemic, according to CNN, given that the first U.S. death was reported on Feb. 29 last year.

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

The United States has now reported more than 450,000 COVID-19 deaths during the pandemic, adding 3,912 more on Wednesday, according to data from Johns Hopkins University.

Daily COVID-19 deaths still remain high in the United States, though they’ve decreased slightly from the peak of 4,466 deaths on Jan. 12.

The United States also reported more than 121,000 new COVID-19 cases on Wednesday, which is down from a peak of more than 300,000 new cases on Tuesday. In total, more than 26.5 million people in the United States have been diagnosed with COVID-19, making up a quarter of the 104.5 million cases reported worldwide.

The 7-day average for COVID-19 hospitalizations and deaths continues to decline, according to the COVID Tracking Project. The 7-day average for hospitalizations is around 96,500, and the 7-day average for deaths is about 3,000. With the exception of Vermont, all states and territories have reported declines or no changes in their hospitalizations and deaths.

“We have seen the 7-day average for new deaths decrease for over a week. At the same time, states are reporting an average of 3,000 people dying per day,” the COVID Tracking Project wrote in a post on Twitter. “The data is hopeful and devastating.”

More than 2.2 million COVID-19 deaths have been reported worldwide. The United States continues to report the most deaths, followed by Brazil with 227,500, Mexico with 161,200, and India with 154,700 deaths.

The U.S. COVID-19 death toll could reach 496,000-534,000 by the end of February, according to a new forecast by the CDC, which includes models from 36 national groups. Deaths will likely decrease during the next 4 weeks, with about 11,300-22,600 deaths possibly reported during the last week of February.

The 534,000 total would equal about 1 death for every minute of the pandemic, according to CNN, given that the first U.S. death was reported on Feb. 29 last year.

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

The United States has now reported more than 450,000 COVID-19 deaths during the pandemic, adding 3,912 more on Wednesday, according to data from Johns Hopkins University.

Daily COVID-19 deaths still remain high in the United States, though they’ve decreased slightly from the peak of 4,466 deaths on Jan. 12.

The United States also reported more than 121,000 new COVID-19 cases on Wednesday, which is down from a peak of more than 300,000 new cases on Tuesday. In total, more than 26.5 million people in the United States have been diagnosed with COVID-19, making up a quarter of the 104.5 million cases reported worldwide.

The 7-day average for COVID-19 hospitalizations and deaths continues to decline, according to the COVID Tracking Project. The 7-day average for hospitalizations is around 96,500, and the 7-day average for deaths is about 3,000. With the exception of Vermont, all states and territories have reported declines or no changes in their hospitalizations and deaths.

“We have seen the 7-day average for new deaths decrease for over a week. At the same time, states are reporting an average of 3,000 people dying per day,” the COVID Tracking Project wrote in a post on Twitter. “The data is hopeful and devastating.”

More than 2.2 million COVID-19 deaths have been reported worldwide. The United States continues to report the most deaths, followed by Brazil with 227,500, Mexico with 161,200, and India with 154,700 deaths.

The U.S. COVID-19 death toll could reach 496,000-534,000 by the end of February, according to a new forecast by the CDC, which includes models from 36 national groups. Deaths will likely decrease during the next 4 weeks, with about 11,300-22,600 deaths possibly reported during the last week of February.

The 534,000 total would equal about 1 death for every minute of the pandemic, according to CNN, given that the first U.S. death was reported on Feb. 29 last year.

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