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Immune reconstitution inflammatory syndrome: ‘Why is my patient getting worse?’
Over the past 25 years, antiretroviral therapy (ART) has led to a dramatic decrease in HIV-associated morbidity and mortality. Patients who initiate ART today can now expect a nearly normal life expectancy.1 Despite the overwhelming benefits of ART, some patients experience immune reconstitution inflammatory syndrome (IRIS), a disease- or pathogen-specific immune response that can mimic the presentation of an active opportunistic infection (OI). IRIS can occur at any CD4 count. However, it is most often associated with the rapid increase in CD4 count and decrease in viral load that typically follows ART initiation in patients who are severely immunocompromised and have high viral loads.2-6
IRIS manifests in two primary ways. Paradoxical IRIS refers to the worsening of a previously diagnosed disease after ART initiation, whereas unmasking IRIS refers to the appearance of a previously undiagnosed disease following ART initiation.
The Medical Care Criteria Committee of the New York State Department of Health AIDS Institute Clinical Guidelines Program recently published an update to its guideline, Management of IRIS . This update incorporates recent data and summarizes how to identify and manage IRIS associated with several OIs. Important goals of this update were to raise awareness among healthcare providers about IRIS, including its clinical presentation, and provide treatment recommendations.
For most patients, ART should be started quickly
Over the past few years, rapid initiation of ART has become the new standard of care, with same-day initiation on the day of HIV diagnosis recommended whenever possible. For many years, however, the presence of an active OI was felt to justify delaying ART initiation until the OI was completely treated. This approach changed in 2009 when a randomized trial by the AIDS Clinical Trials Group demonstrated that patients who initiated ART within 2 weeks of OI diagnosis did not experience more adverse events than those who waited.7 Moreover, although the finding did not reach statistical significance, participants in the early ART arm appeared to experience lower mortality and progression of AIDS than those in the delayed ART arm. Therefore, patients diagnosed with most OIs can start ART as soon as they are tolerating the treatment for the OI.
Some OIs do require a delay in ART
Symptoms associated with IRIS are typically mild or moderate; life-threatening complications are rare. Most patients newly diagnosed with HIV who have an active OI can therefore initiate ART quickly. However, IRIS involving the central nervous system or eye carries a much greater risk of morbidity and mortality. OIs that do warrant a delay in ART initiation, therefore, include tuberculosis (TB) meningitis, cryptococcal meningitis, and cytomegalovirus (CMV) retinitis.
Several randomized clinical trials have found that in patients with HIV and pulmonary TB coinfection, ART should be started as soon as the patient is tolerating anti-TB therapy.8-10 What’s more, in patients with CD4 counts less than 50 cells/microL, there is a mortality benefit when ART is initiated within 2 weeks of starting TB treatment, compared with waiting 8 weeks.
For TB meningitis, however, a clinical trial conducted in Vietnam did not show any mortality benefit when ART was started within 7 days (vs. 2 months); however, severe adverse events were more common in the immediate ART group, raising the concern that patients in that group had experienced complications of IRIS of the central nervous system.11 Limited data are available to guide specific timing of ART in patients with TB meningitis, but based on the results of this trial, most clinicians wait approximately 2 months before initiating ART, and consultation with an expert is recommended.
Optimal timing of ART in patients with cryptococcal meningitis is also uncertain, and there have been contradictory results from several small studies. However, in 2014, the larger COAT trial, conducted in Uganda and South Africa, found 15% higher mortality in patients who initiated ART within 2 weeks, compared with more than 5 weeks.12 Although exactly how long to wait is still unknown, ART should be delayed by at least 2 weeks after a patient starts antifungal therapy.
CMV-IRIS can have devastating effects, including vision loss or blindness. Therefore, ART initiation should be delayed in patients with diagnosed or strongly suspected CMV.13 Importantly, however, patients with advanced HIV may have asymptomatic or subclinical CMV retinitis. As a result, all patients with HIV who have CD4 counts less than 100 cells/mm3 who do not have known or strongly suspected CMV should be screened for signs of CMV by dilated ophthalmological examination as soon as possible after initiation of ART. If signs of CMV are seen on dilated exam, clinicians should consult with an experienced HIV care provider to determine if ART must be temporarily paused.
Diagnosing IRIS
Broadly, IRIS presents as a clinical deterioration after ART initiation, with localized tissue inflammation, with or without a systemic inflammatory response, but the presentation of IRIS varies depending on the underlying OI or illness. In most cases, IRIS occurs within 4-8 weeks of ART initiation or regimen change. A rise in CD4 count often but does not always precede IRIS and is not a diagnostic criterion. There is no diagnostic test for IRIS, and when assessing a patient for possible IRIS, clinicians should exclude HIV disease progression, new infections, OI drug resistance, OI treatment nonadherence, and drug reactions as possible causes for inflammatory signs or symptoms.
Treatment of IRIS
Most cases of IRIS are mild, and patients can be reassured that the symptoms will resolve with time. Clinicians should interrupt ART only if a patient has a severe, life-threatening case of IRIS. Unnecessary ART interruption may increase a patient’s risk of new opportunistic infections, recurring IRIS upon resumption of ART, and development of HIV-drug resistance. Any newly unmasked OIs should be treated promptly while ART is continued. For patients with severe IRIS, clinicians can use prednisone to treat inflammatory symptoms – generally for 1-2 weeks, followed by a taper as needed. Prednisone, however, should not be used in patients with cryptococcal meningitis or Kaposi sarcoma as it is associated with worse outcomes.14-17
In patients newly diagnosed with HIV, prompt initiation of ART is, with the exceptions outlined above, the highest priority. IRIS is an unfortunate complication of ART, and patients may be discouraged when they find themselves feeling worse shortly after starting treatment. While providing supportive and symptomatic care, clinicians can reassure patients by explaining that immune reconstitution is, in fact, the goal of ART and that their symptoms do not represent the progression of HIV disease. It is hoped that with more frequent HIV testing, earlier diagnosis, and earlier ART initiation at higher CD4 counts, IRIS will become a less frequent nuisance to patients and providers.
Dr. Brust is in the department of medicine at Albert Einstein College of Medicine/Montefiore Medical Center, New York. He reported having no relevant financial relationships. A version of this article first appeared on Medscape.com.
References
1. Marcus JL et al. JAMA Netw Open. 2020;3:e207954.
2. Breton G et al. Clin Infect Dis. 2004;39:1709-12.
3. Shelburne SA et al. Clin Infect Dis. 2005;40:1049-52.
4. Shelburne SA et al. AIDS. 2005;19:399-406.
5. Muller M et al. Lancet Infect Dis. 2010;10:251-61.
6. Novak RM et al. AIDS. 2012;26:721-30.
7. Zolopa A et al. PLoS One. 2009;4:e5575.
8. Havlir DV et al. N Engl J Med. 2011;365:1482-91.
9. Abdool Karim SS et al. N Engl J Med. 2011;365:1492-501.
10. Blanc FX et al. N Engl J Med. 2011;365:1471-81.
11. Torok ME et al. Clin Infect Dis. 2011;52:1374-83.
12. Boulware DR et al. N Engl J Med. 2014;370:2487-98.
13. Ortega-Larrocea G et al. AIDS. 2005;19:735-8.
14. Beardsley J et al. N Engl J Med. 2016;374:542-54.
15. Gill PS, Loureiro C et al. Ann Intern Med. 1989;110:937-40.
16. Elliott AM et al. J Infect Dis. 2004;190:869-78.
17. Volkow PF et al. AIDS. 2008;22:663-5.
Over the past 25 years, antiretroviral therapy (ART) has led to a dramatic decrease in HIV-associated morbidity and mortality. Patients who initiate ART today can now expect a nearly normal life expectancy.1 Despite the overwhelming benefits of ART, some patients experience immune reconstitution inflammatory syndrome (IRIS), a disease- or pathogen-specific immune response that can mimic the presentation of an active opportunistic infection (OI). IRIS can occur at any CD4 count. However, it is most often associated with the rapid increase in CD4 count and decrease in viral load that typically follows ART initiation in patients who are severely immunocompromised and have high viral loads.2-6
IRIS manifests in two primary ways. Paradoxical IRIS refers to the worsening of a previously diagnosed disease after ART initiation, whereas unmasking IRIS refers to the appearance of a previously undiagnosed disease following ART initiation.
The Medical Care Criteria Committee of the New York State Department of Health AIDS Institute Clinical Guidelines Program recently published an update to its guideline, Management of IRIS . This update incorporates recent data and summarizes how to identify and manage IRIS associated with several OIs. Important goals of this update were to raise awareness among healthcare providers about IRIS, including its clinical presentation, and provide treatment recommendations.
For most patients, ART should be started quickly
Over the past few years, rapid initiation of ART has become the new standard of care, with same-day initiation on the day of HIV diagnosis recommended whenever possible. For many years, however, the presence of an active OI was felt to justify delaying ART initiation until the OI was completely treated. This approach changed in 2009 when a randomized trial by the AIDS Clinical Trials Group demonstrated that patients who initiated ART within 2 weeks of OI diagnosis did not experience more adverse events than those who waited.7 Moreover, although the finding did not reach statistical significance, participants in the early ART arm appeared to experience lower mortality and progression of AIDS than those in the delayed ART arm. Therefore, patients diagnosed with most OIs can start ART as soon as they are tolerating the treatment for the OI.
Some OIs do require a delay in ART
Symptoms associated with IRIS are typically mild or moderate; life-threatening complications are rare. Most patients newly diagnosed with HIV who have an active OI can therefore initiate ART quickly. However, IRIS involving the central nervous system or eye carries a much greater risk of morbidity and mortality. OIs that do warrant a delay in ART initiation, therefore, include tuberculosis (TB) meningitis, cryptococcal meningitis, and cytomegalovirus (CMV) retinitis.
Several randomized clinical trials have found that in patients with HIV and pulmonary TB coinfection, ART should be started as soon as the patient is tolerating anti-TB therapy.8-10 What’s more, in patients with CD4 counts less than 50 cells/microL, there is a mortality benefit when ART is initiated within 2 weeks of starting TB treatment, compared with waiting 8 weeks.
For TB meningitis, however, a clinical trial conducted in Vietnam did not show any mortality benefit when ART was started within 7 days (vs. 2 months); however, severe adverse events were more common in the immediate ART group, raising the concern that patients in that group had experienced complications of IRIS of the central nervous system.11 Limited data are available to guide specific timing of ART in patients with TB meningitis, but based on the results of this trial, most clinicians wait approximately 2 months before initiating ART, and consultation with an expert is recommended.
Optimal timing of ART in patients with cryptococcal meningitis is also uncertain, and there have been contradictory results from several small studies. However, in 2014, the larger COAT trial, conducted in Uganda and South Africa, found 15% higher mortality in patients who initiated ART within 2 weeks, compared with more than 5 weeks.12 Although exactly how long to wait is still unknown, ART should be delayed by at least 2 weeks after a patient starts antifungal therapy.
CMV-IRIS can have devastating effects, including vision loss or blindness. Therefore, ART initiation should be delayed in patients with diagnosed or strongly suspected CMV.13 Importantly, however, patients with advanced HIV may have asymptomatic or subclinical CMV retinitis. As a result, all patients with HIV who have CD4 counts less than 100 cells/mm3 who do not have known or strongly suspected CMV should be screened for signs of CMV by dilated ophthalmological examination as soon as possible after initiation of ART. If signs of CMV are seen on dilated exam, clinicians should consult with an experienced HIV care provider to determine if ART must be temporarily paused.
Diagnosing IRIS
Broadly, IRIS presents as a clinical deterioration after ART initiation, with localized tissue inflammation, with or without a systemic inflammatory response, but the presentation of IRIS varies depending on the underlying OI or illness. In most cases, IRIS occurs within 4-8 weeks of ART initiation or regimen change. A rise in CD4 count often but does not always precede IRIS and is not a diagnostic criterion. There is no diagnostic test for IRIS, and when assessing a patient for possible IRIS, clinicians should exclude HIV disease progression, new infections, OI drug resistance, OI treatment nonadherence, and drug reactions as possible causes for inflammatory signs or symptoms.
Treatment of IRIS
Most cases of IRIS are mild, and patients can be reassured that the symptoms will resolve with time. Clinicians should interrupt ART only if a patient has a severe, life-threatening case of IRIS. Unnecessary ART interruption may increase a patient’s risk of new opportunistic infections, recurring IRIS upon resumption of ART, and development of HIV-drug resistance. Any newly unmasked OIs should be treated promptly while ART is continued. For patients with severe IRIS, clinicians can use prednisone to treat inflammatory symptoms – generally for 1-2 weeks, followed by a taper as needed. Prednisone, however, should not be used in patients with cryptococcal meningitis or Kaposi sarcoma as it is associated with worse outcomes.14-17
In patients newly diagnosed with HIV, prompt initiation of ART is, with the exceptions outlined above, the highest priority. IRIS is an unfortunate complication of ART, and patients may be discouraged when they find themselves feeling worse shortly after starting treatment. While providing supportive and symptomatic care, clinicians can reassure patients by explaining that immune reconstitution is, in fact, the goal of ART and that their symptoms do not represent the progression of HIV disease. It is hoped that with more frequent HIV testing, earlier diagnosis, and earlier ART initiation at higher CD4 counts, IRIS will become a less frequent nuisance to patients and providers.
Dr. Brust is in the department of medicine at Albert Einstein College of Medicine/Montefiore Medical Center, New York. He reported having no relevant financial relationships. A version of this article first appeared on Medscape.com.
References
1. Marcus JL et al. JAMA Netw Open. 2020;3:e207954.
2. Breton G et al. Clin Infect Dis. 2004;39:1709-12.
3. Shelburne SA et al. Clin Infect Dis. 2005;40:1049-52.
4. Shelburne SA et al. AIDS. 2005;19:399-406.
5. Muller M et al. Lancet Infect Dis. 2010;10:251-61.
6. Novak RM et al. AIDS. 2012;26:721-30.
7. Zolopa A et al. PLoS One. 2009;4:e5575.
8. Havlir DV et al. N Engl J Med. 2011;365:1482-91.
9. Abdool Karim SS et al. N Engl J Med. 2011;365:1492-501.
10. Blanc FX et al. N Engl J Med. 2011;365:1471-81.
11. Torok ME et al. Clin Infect Dis. 2011;52:1374-83.
12. Boulware DR et al. N Engl J Med. 2014;370:2487-98.
13. Ortega-Larrocea G et al. AIDS. 2005;19:735-8.
14. Beardsley J et al. N Engl J Med. 2016;374:542-54.
15. Gill PS, Loureiro C et al. Ann Intern Med. 1989;110:937-40.
16. Elliott AM et al. J Infect Dis. 2004;190:869-78.
17. Volkow PF et al. AIDS. 2008;22:663-5.
Over the past 25 years, antiretroviral therapy (ART) has led to a dramatic decrease in HIV-associated morbidity and mortality. Patients who initiate ART today can now expect a nearly normal life expectancy.1 Despite the overwhelming benefits of ART, some patients experience immune reconstitution inflammatory syndrome (IRIS), a disease- or pathogen-specific immune response that can mimic the presentation of an active opportunistic infection (OI). IRIS can occur at any CD4 count. However, it is most often associated with the rapid increase in CD4 count and decrease in viral load that typically follows ART initiation in patients who are severely immunocompromised and have high viral loads.2-6
IRIS manifests in two primary ways. Paradoxical IRIS refers to the worsening of a previously diagnosed disease after ART initiation, whereas unmasking IRIS refers to the appearance of a previously undiagnosed disease following ART initiation.
The Medical Care Criteria Committee of the New York State Department of Health AIDS Institute Clinical Guidelines Program recently published an update to its guideline, Management of IRIS . This update incorporates recent data and summarizes how to identify and manage IRIS associated with several OIs. Important goals of this update were to raise awareness among healthcare providers about IRIS, including its clinical presentation, and provide treatment recommendations.
For most patients, ART should be started quickly
Over the past few years, rapid initiation of ART has become the new standard of care, with same-day initiation on the day of HIV diagnosis recommended whenever possible. For many years, however, the presence of an active OI was felt to justify delaying ART initiation until the OI was completely treated. This approach changed in 2009 when a randomized trial by the AIDS Clinical Trials Group demonstrated that patients who initiated ART within 2 weeks of OI diagnosis did not experience more adverse events than those who waited.7 Moreover, although the finding did not reach statistical significance, participants in the early ART arm appeared to experience lower mortality and progression of AIDS than those in the delayed ART arm. Therefore, patients diagnosed with most OIs can start ART as soon as they are tolerating the treatment for the OI.
Some OIs do require a delay in ART
Symptoms associated with IRIS are typically mild or moderate; life-threatening complications are rare. Most patients newly diagnosed with HIV who have an active OI can therefore initiate ART quickly. However, IRIS involving the central nervous system or eye carries a much greater risk of morbidity and mortality. OIs that do warrant a delay in ART initiation, therefore, include tuberculosis (TB) meningitis, cryptococcal meningitis, and cytomegalovirus (CMV) retinitis.
Several randomized clinical trials have found that in patients with HIV and pulmonary TB coinfection, ART should be started as soon as the patient is tolerating anti-TB therapy.8-10 What’s more, in patients with CD4 counts less than 50 cells/microL, there is a mortality benefit when ART is initiated within 2 weeks of starting TB treatment, compared with waiting 8 weeks.
For TB meningitis, however, a clinical trial conducted in Vietnam did not show any mortality benefit when ART was started within 7 days (vs. 2 months); however, severe adverse events were more common in the immediate ART group, raising the concern that patients in that group had experienced complications of IRIS of the central nervous system.11 Limited data are available to guide specific timing of ART in patients with TB meningitis, but based on the results of this trial, most clinicians wait approximately 2 months before initiating ART, and consultation with an expert is recommended.
Optimal timing of ART in patients with cryptococcal meningitis is also uncertain, and there have been contradictory results from several small studies. However, in 2014, the larger COAT trial, conducted in Uganda and South Africa, found 15% higher mortality in patients who initiated ART within 2 weeks, compared with more than 5 weeks.12 Although exactly how long to wait is still unknown, ART should be delayed by at least 2 weeks after a patient starts antifungal therapy.
CMV-IRIS can have devastating effects, including vision loss or blindness. Therefore, ART initiation should be delayed in patients with diagnosed or strongly suspected CMV.13 Importantly, however, patients with advanced HIV may have asymptomatic or subclinical CMV retinitis. As a result, all patients with HIV who have CD4 counts less than 100 cells/mm3 who do not have known or strongly suspected CMV should be screened for signs of CMV by dilated ophthalmological examination as soon as possible after initiation of ART. If signs of CMV are seen on dilated exam, clinicians should consult with an experienced HIV care provider to determine if ART must be temporarily paused.
Diagnosing IRIS
Broadly, IRIS presents as a clinical deterioration after ART initiation, with localized tissue inflammation, with or without a systemic inflammatory response, but the presentation of IRIS varies depending on the underlying OI or illness. In most cases, IRIS occurs within 4-8 weeks of ART initiation or regimen change. A rise in CD4 count often but does not always precede IRIS and is not a diagnostic criterion. There is no diagnostic test for IRIS, and when assessing a patient for possible IRIS, clinicians should exclude HIV disease progression, new infections, OI drug resistance, OI treatment nonadherence, and drug reactions as possible causes for inflammatory signs or symptoms.
Treatment of IRIS
Most cases of IRIS are mild, and patients can be reassured that the symptoms will resolve with time. Clinicians should interrupt ART only if a patient has a severe, life-threatening case of IRIS. Unnecessary ART interruption may increase a patient’s risk of new opportunistic infections, recurring IRIS upon resumption of ART, and development of HIV-drug resistance. Any newly unmasked OIs should be treated promptly while ART is continued. For patients with severe IRIS, clinicians can use prednisone to treat inflammatory symptoms – generally for 1-2 weeks, followed by a taper as needed. Prednisone, however, should not be used in patients with cryptococcal meningitis or Kaposi sarcoma as it is associated with worse outcomes.14-17
In patients newly diagnosed with HIV, prompt initiation of ART is, with the exceptions outlined above, the highest priority. IRIS is an unfortunate complication of ART, and patients may be discouraged when they find themselves feeling worse shortly after starting treatment. While providing supportive and symptomatic care, clinicians can reassure patients by explaining that immune reconstitution is, in fact, the goal of ART and that their symptoms do not represent the progression of HIV disease. It is hoped that with more frequent HIV testing, earlier diagnosis, and earlier ART initiation at higher CD4 counts, IRIS will become a less frequent nuisance to patients and providers.
Dr. Brust is in the department of medicine at Albert Einstein College of Medicine/Montefiore Medical Center, New York. He reported having no relevant financial relationships. A version of this article first appeared on Medscape.com.
References
1. Marcus JL et al. JAMA Netw Open. 2020;3:e207954.
2. Breton G et al. Clin Infect Dis. 2004;39:1709-12.
3. Shelburne SA et al. Clin Infect Dis. 2005;40:1049-52.
4. Shelburne SA et al. AIDS. 2005;19:399-406.
5. Muller M et al. Lancet Infect Dis. 2010;10:251-61.
6. Novak RM et al. AIDS. 2012;26:721-30.
7. Zolopa A et al. PLoS One. 2009;4:e5575.
8. Havlir DV et al. N Engl J Med. 2011;365:1482-91.
9. Abdool Karim SS et al. N Engl J Med. 2011;365:1492-501.
10. Blanc FX et al. N Engl J Med. 2011;365:1471-81.
11. Torok ME et al. Clin Infect Dis. 2011;52:1374-83.
12. Boulware DR et al. N Engl J Med. 2014;370:2487-98.
13. Ortega-Larrocea G et al. AIDS. 2005;19:735-8.
14. Beardsley J et al. N Engl J Med. 2016;374:542-54.
15. Gill PS, Loureiro C et al. Ann Intern Med. 1989;110:937-40.
16. Elliott AM et al. J Infect Dis. 2004;190:869-78.
17. Volkow PF et al. AIDS. 2008;22:663-5.
As common respiratory viruses resurface, children are at serious risk
Younger children may be vulnerable to the reemergence of common respiratory viruses such as influenza and respiratory syncytial virus (RSV) as COVID-19 restrictions wane, experts say. The impact could be detrimental.
The COVID-19 pandemic and the implementation of preventative measures such as social distancing, travel restrictions, mask use, and shelter in place, reduced the transmission of respiratory viruses, according to the Centers for Disease Control and Prevention. However, because older infants and toddlers have not been exposed to these bugs during the pandemic, they are vulnerable to suffering severe viral infections.
“[We’ve] been in the honeymoon for 18 months,” said Christopher J. Harrison, MD, professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics in Kansas City, Mo. “We are going to be coming out of the honeymoon and the children who didn’t get sick are going to start packing 2 years’ worth of infections into the next 9 months so there’s going to be twice as many as would be normal.”
The CDC issued a health advisory in June for parts of the southern United States, such as Texas, the Carolinas, and Oklahoma, encouraging broader testing for RSV – a virus that usually causes mild, cold-like symptoms and is the most common cause of bronchiolitis and pneumonia in children – among those who test negative for COVID-19. Virtually all children get an RSV infection by the time they are 2 years old, according to the CDC.
In previous years, RSV usually spread during the fall and spring seasons and usually peaked late December to mid-February. However, there’s been an offseason spike in the common illness this year, with nearly 2,000 confirmed cases each week of July.
Richard J. Webby, PhD, of the infectious diseases department at St. Jude Children’s Research Hospital, Memphis, Tenn., said that although RSV transmits more easily during the winter, the virus is able to thrive during this summer because many children have limited immunity and are more vulnerable to catching the virus than before. Population immunity normally limits a virus to circulating under its most favorable conditions, which is usually the winter. However, because there are a few more “susceptible hosts,” it gives the virus the ability to spread during a time when it typically wouldn’t be able to.
“Now we have a wider range of susceptible kids because they haven’t had that exposure over the past 18 months,” said Dr. Webby, who is on the World Health Organization’s Influenza Vaccine Composition Advisory Team. “It gives the virus more chances to transmit during conditions that are less favorable.”
Dr. Harrison said that, if children continue to take preventative measures such as wearing masks and sanitizing, they can delay catching the RSV – which can be severe in infants and young children – until they’re older and symptoms won’t be as severe.
“The swelling that these viruses cause in the trachea and the bronchial tubes is much bigger in proportion to the overall size of the tubes, so it takes less swelling to clog up the trachea or bronchial tube for the 9-month-old than it does of a 9-year-old,” Dr. Harrison said. “So if a 9-year-old was to get RSV, they’re not going to have nearly the same amount symptoms as the 9-month-old.
Dr. Harrison said delaying RSV in children was never an option before because it’s a virus that’s almost impossible to avoid.
“Hopefully, the mask means that if you get exposed, instead of getting a million virus particles from your classmate or your playmate, you may only get a couple thousand,” Dr. Harrison explained. “And maybe that’s enough that you can fight it off or it may be small enough that you get a mild infection instead of a severe infection.”
A summer surge of RSV has also occurred in Australia. A study published in Clinical Infectious Diseases found that Western Australia saw a 98% reduction in RSV cases. This suggests that COVID-19 restrictions also delayed the RSV season.
Dr. Webby said the lax in penetrative measures against COVID-19 may also affect this upcoming flu season. Usually, around 10%-30% of the population gets infected with the flu each year, but that hasn’t happened the past couple of seasons, he said.
“There might be slightly less overall immunity to these viruses,” Dr. Webby said. “When these viruses do come back, there’s a little bit more room for them to take off.”
Although a severe influenza season rebound this winter is a possibility, Australia continues to experience a historically low flu season. Dr. Harrison, who said the northern hemisphere looks at what’s happening in Australia and the rest of the “southern half of the world because their influenza season is during our summer,” hopes this is an indication that the northern hemisphere will also experience a mild season.
However, there’s no indication of how this upcoming flu season will hit the United States and there isn’t any guidance on what could happen because these historically low levels of respiratory viruses have never happened before, Dr. Webby explained.
He said that, if COVID-19’s delta variant continues to circulate during the fall and winter seasons, it will keep other viruses at low levels. This is because there is rarely a peak of activity of different viruses at the same time.
“When you get infected with the virus, your body’s immune response has this nonspecific reaction that protects you from anything else for a short period of time,” Dr. Webby explained. “When you get a lot of one virus circulating, it’s really hard for these other viruses to get into that population and sort of set off an epidemic of their own.”
To prepare for an unsure influenza season, Dr. Harrison suggests making the influenza vaccine available in August as opposed to October.
Dr. Harrison and Dr. Webby reported no conflicts of interest.
Younger children may be vulnerable to the reemergence of common respiratory viruses such as influenza and respiratory syncytial virus (RSV) as COVID-19 restrictions wane, experts say. The impact could be detrimental.
The COVID-19 pandemic and the implementation of preventative measures such as social distancing, travel restrictions, mask use, and shelter in place, reduced the transmission of respiratory viruses, according to the Centers for Disease Control and Prevention. However, because older infants and toddlers have not been exposed to these bugs during the pandemic, they are vulnerable to suffering severe viral infections.
“[We’ve] been in the honeymoon for 18 months,” said Christopher J. Harrison, MD, professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics in Kansas City, Mo. “We are going to be coming out of the honeymoon and the children who didn’t get sick are going to start packing 2 years’ worth of infections into the next 9 months so there’s going to be twice as many as would be normal.”
The CDC issued a health advisory in June for parts of the southern United States, such as Texas, the Carolinas, and Oklahoma, encouraging broader testing for RSV – a virus that usually causes mild, cold-like symptoms and is the most common cause of bronchiolitis and pneumonia in children – among those who test negative for COVID-19. Virtually all children get an RSV infection by the time they are 2 years old, according to the CDC.
In previous years, RSV usually spread during the fall and spring seasons and usually peaked late December to mid-February. However, there’s been an offseason spike in the common illness this year, with nearly 2,000 confirmed cases each week of July.
Richard J. Webby, PhD, of the infectious diseases department at St. Jude Children’s Research Hospital, Memphis, Tenn., said that although RSV transmits more easily during the winter, the virus is able to thrive during this summer because many children have limited immunity and are more vulnerable to catching the virus than before. Population immunity normally limits a virus to circulating under its most favorable conditions, which is usually the winter. However, because there are a few more “susceptible hosts,” it gives the virus the ability to spread during a time when it typically wouldn’t be able to.
“Now we have a wider range of susceptible kids because they haven’t had that exposure over the past 18 months,” said Dr. Webby, who is on the World Health Organization’s Influenza Vaccine Composition Advisory Team. “It gives the virus more chances to transmit during conditions that are less favorable.”
Dr. Harrison said that, if children continue to take preventative measures such as wearing masks and sanitizing, they can delay catching the RSV – which can be severe in infants and young children – until they’re older and symptoms won’t be as severe.
“The swelling that these viruses cause in the trachea and the bronchial tubes is much bigger in proportion to the overall size of the tubes, so it takes less swelling to clog up the trachea or bronchial tube for the 9-month-old than it does of a 9-year-old,” Dr. Harrison said. “So if a 9-year-old was to get RSV, they’re not going to have nearly the same amount symptoms as the 9-month-old.
Dr. Harrison said delaying RSV in children was never an option before because it’s a virus that’s almost impossible to avoid.
“Hopefully, the mask means that if you get exposed, instead of getting a million virus particles from your classmate or your playmate, you may only get a couple thousand,” Dr. Harrison explained. “And maybe that’s enough that you can fight it off or it may be small enough that you get a mild infection instead of a severe infection.”
A summer surge of RSV has also occurred in Australia. A study published in Clinical Infectious Diseases found that Western Australia saw a 98% reduction in RSV cases. This suggests that COVID-19 restrictions also delayed the RSV season.
Dr. Webby said the lax in penetrative measures against COVID-19 may also affect this upcoming flu season. Usually, around 10%-30% of the population gets infected with the flu each year, but that hasn’t happened the past couple of seasons, he said.
“There might be slightly less overall immunity to these viruses,” Dr. Webby said. “When these viruses do come back, there’s a little bit more room for them to take off.”
Although a severe influenza season rebound this winter is a possibility, Australia continues to experience a historically low flu season. Dr. Harrison, who said the northern hemisphere looks at what’s happening in Australia and the rest of the “southern half of the world because their influenza season is during our summer,” hopes this is an indication that the northern hemisphere will also experience a mild season.
However, there’s no indication of how this upcoming flu season will hit the United States and there isn’t any guidance on what could happen because these historically low levels of respiratory viruses have never happened before, Dr. Webby explained.
He said that, if COVID-19’s delta variant continues to circulate during the fall and winter seasons, it will keep other viruses at low levels. This is because there is rarely a peak of activity of different viruses at the same time.
“When you get infected with the virus, your body’s immune response has this nonspecific reaction that protects you from anything else for a short period of time,” Dr. Webby explained. “When you get a lot of one virus circulating, it’s really hard for these other viruses to get into that population and sort of set off an epidemic of their own.”
To prepare for an unsure influenza season, Dr. Harrison suggests making the influenza vaccine available in August as opposed to October.
Dr. Harrison and Dr. Webby reported no conflicts of interest.
Younger children may be vulnerable to the reemergence of common respiratory viruses such as influenza and respiratory syncytial virus (RSV) as COVID-19 restrictions wane, experts say. The impact could be detrimental.
The COVID-19 pandemic and the implementation of preventative measures such as social distancing, travel restrictions, mask use, and shelter in place, reduced the transmission of respiratory viruses, according to the Centers for Disease Control and Prevention. However, because older infants and toddlers have not been exposed to these bugs during the pandemic, they are vulnerable to suffering severe viral infections.
“[We’ve] been in the honeymoon for 18 months,” said Christopher J. Harrison, MD, professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics in Kansas City, Mo. “We are going to be coming out of the honeymoon and the children who didn’t get sick are going to start packing 2 years’ worth of infections into the next 9 months so there’s going to be twice as many as would be normal.”
The CDC issued a health advisory in June for parts of the southern United States, such as Texas, the Carolinas, and Oklahoma, encouraging broader testing for RSV – a virus that usually causes mild, cold-like symptoms and is the most common cause of bronchiolitis and pneumonia in children – among those who test negative for COVID-19. Virtually all children get an RSV infection by the time they are 2 years old, according to the CDC.
In previous years, RSV usually spread during the fall and spring seasons and usually peaked late December to mid-February. However, there’s been an offseason spike in the common illness this year, with nearly 2,000 confirmed cases each week of July.
Richard J. Webby, PhD, of the infectious diseases department at St. Jude Children’s Research Hospital, Memphis, Tenn., said that although RSV transmits more easily during the winter, the virus is able to thrive during this summer because many children have limited immunity and are more vulnerable to catching the virus than before. Population immunity normally limits a virus to circulating under its most favorable conditions, which is usually the winter. However, because there are a few more “susceptible hosts,” it gives the virus the ability to spread during a time when it typically wouldn’t be able to.
“Now we have a wider range of susceptible kids because they haven’t had that exposure over the past 18 months,” said Dr. Webby, who is on the World Health Organization’s Influenza Vaccine Composition Advisory Team. “It gives the virus more chances to transmit during conditions that are less favorable.”
Dr. Harrison said that, if children continue to take preventative measures such as wearing masks and sanitizing, they can delay catching the RSV – which can be severe in infants and young children – until they’re older and symptoms won’t be as severe.
“The swelling that these viruses cause in the trachea and the bronchial tubes is much bigger in proportion to the overall size of the tubes, so it takes less swelling to clog up the trachea or bronchial tube for the 9-month-old than it does of a 9-year-old,” Dr. Harrison said. “So if a 9-year-old was to get RSV, they’re not going to have nearly the same amount symptoms as the 9-month-old.
Dr. Harrison said delaying RSV in children was never an option before because it’s a virus that’s almost impossible to avoid.
“Hopefully, the mask means that if you get exposed, instead of getting a million virus particles from your classmate or your playmate, you may only get a couple thousand,” Dr. Harrison explained. “And maybe that’s enough that you can fight it off or it may be small enough that you get a mild infection instead of a severe infection.”
A summer surge of RSV has also occurred in Australia. A study published in Clinical Infectious Diseases found that Western Australia saw a 98% reduction in RSV cases. This suggests that COVID-19 restrictions also delayed the RSV season.
Dr. Webby said the lax in penetrative measures against COVID-19 may also affect this upcoming flu season. Usually, around 10%-30% of the population gets infected with the flu each year, but that hasn’t happened the past couple of seasons, he said.
“There might be slightly less overall immunity to these viruses,” Dr. Webby said. “When these viruses do come back, there’s a little bit more room for them to take off.”
Although a severe influenza season rebound this winter is a possibility, Australia continues to experience a historically low flu season. Dr. Harrison, who said the northern hemisphere looks at what’s happening in Australia and the rest of the “southern half of the world because their influenza season is during our summer,” hopes this is an indication that the northern hemisphere will also experience a mild season.
However, there’s no indication of how this upcoming flu season will hit the United States and there isn’t any guidance on what could happen because these historically low levels of respiratory viruses have never happened before, Dr. Webby explained.
He said that, if COVID-19’s delta variant continues to circulate during the fall and winter seasons, it will keep other viruses at low levels. This is because there is rarely a peak of activity of different viruses at the same time.
“When you get infected with the virus, your body’s immune response has this nonspecific reaction that protects you from anything else for a short period of time,” Dr. Webby explained. “When you get a lot of one virus circulating, it’s really hard for these other viruses to get into that population and sort of set off an epidemic of their own.”
To prepare for an unsure influenza season, Dr. Harrison suggests making the influenza vaccine available in August as opposed to October.
Dr. Harrison and Dr. Webby reported no conflicts of interest.
Pfizer vaccine protection wanes after 6 months, study finds
, according to a new study.
The July 28 preprint report of the study, which has not been peer reviewed, suggests a gradual “declining trend in vaccine efficacy” over 6 months after two doses of the Pfizer vaccine in more than 45,000 people worldwide.
The study finds overall effectiveness falls from 96% to 84%.
At the same time, a third booster dose of the Pfizer vaccine increases neutralizing antibody levels against the Delta variant by more than five times, compared to levels after just a second dose in people aged 18-55 years, new data from Pfizer shows.
The third-dose immune response appears even more robust – more than 11 times higher than the second shot – among people aged 65-85 years.
The company noted this could mean an estimated 100-fold increase in Delta variant protection after a third dose. These new findings are outlined in a Pfizer second-quarter 2021 earnings report, which notes that the data are submitted for publication in a medical journal.
The data come from a relatively small number of people studied. There were 11 people in the 18- to 55-year-old group and 12 people in the 65- to 85-year-old group.
“These preliminary data are very encouraging as Delta continues to spread,” Mikael Dolsten, MD, chief scientific officer and president of the Worldwide Research, Development, and Medical organization at Pfizer, said during prepared remarks on a company earnings call July 28, CNN reported.
Availability of a third dose of any of the current COVID-19 vaccines would require amendment of the Food and Drug Administration’s emergency use authorization, or full FDA approval for the vaccine.
The possibility of a third dose authorization or approval has not been without controversy. For example, when Pfizer announced intentions to file for FDA authorization of a booster dose on July 8, the Centers for Disease Control and Prevention, the FDA, and the National Institutes of Health were quick to issue a joint statement saying they would decide when the timing is right for Americans to have a third immunization. The agencies stated, in part, “We are prepared for booster doses if and when the science demonstrates that they are needed.”
In addition, the World Health Organization said at a media briefing on July 12 that rich countries should prioritize sharing of COVID-19 vaccine supplies to other countries in need worldwide before allocating doses for a booster shot for its own residents.
A version of this article first appeared on WebMD.com.
, according to a new study.
The July 28 preprint report of the study, which has not been peer reviewed, suggests a gradual “declining trend in vaccine efficacy” over 6 months after two doses of the Pfizer vaccine in more than 45,000 people worldwide.
The study finds overall effectiveness falls from 96% to 84%.
At the same time, a third booster dose of the Pfizer vaccine increases neutralizing antibody levels against the Delta variant by more than five times, compared to levels after just a second dose in people aged 18-55 years, new data from Pfizer shows.
The third-dose immune response appears even more robust – more than 11 times higher than the second shot – among people aged 65-85 years.
The company noted this could mean an estimated 100-fold increase in Delta variant protection after a third dose. These new findings are outlined in a Pfizer second-quarter 2021 earnings report, which notes that the data are submitted for publication in a medical journal.
The data come from a relatively small number of people studied. There were 11 people in the 18- to 55-year-old group and 12 people in the 65- to 85-year-old group.
“These preliminary data are very encouraging as Delta continues to spread,” Mikael Dolsten, MD, chief scientific officer and president of the Worldwide Research, Development, and Medical organization at Pfizer, said during prepared remarks on a company earnings call July 28, CNN reported.
Availability of a third dose of any of the current COVID-19 vaccines would require amendment of the Food and Drug Administration’s emergency use authorization, or full FDA approval for the vaccine.
The possibility of a third dose authorization or approval has not been without controversy. For example, when Pfizer announced intentions to file for FDA authorization of a booster dose on July 8, the Centers for Disease Control and Prevention, the FDA, and the National Institutes of Health were quick to issue a joint statement saying they would decide when the timing is right for Americans to have a third immunization. The agencies stated, in part, “We are prepared for booster doses if and when the science demonstrates that they are needed.”
In addition, the World Health Organization said at a media briefing on July 12 that rich countries should prioritize sharing of COVID-19 vaccine supplies to other countries in need worldwide before allocating doses for a booster shot for its own residents.
A version of this article first appeared on WebMD.com.
, according to a new study.
The July 28 preprint report of the study, which has not been peer reviewed, suggests a gradual “declining trend in vaccine efficacy” over 6 months after two doses of the Pfizer vaccine in more than 45,000 people worldwide.
The study finds overall effectiveness falls from 96% to 84%.
At the same time, a third booster dose of the Pfizer vaccine increases neutralizing antibody levels against the Delta variant by more than five times, compared to levels after just a second dose in people aged 18-55 years, new data from Pfizer shows.
The third-dose immune response appears even more robust – more than 11 times higher than the second shot – among people aged 65-85 years.
The company noted this could mean an estimated 100-fold increase in Delta variant protection after a third dose. These new findings are outlined in a Pfizer second-quarter 2021 earnings report, which notes that the data are submitted for publication in a medical journal.
The data come from a relatively small number of people studied. There were 11 people in the 18- to 55-year-old group and 12 people in the 65- to 85-year-old group.
“These preliminary data are very encouraging as Delta continues to spread,” Mikael Dolsten, MD, chief scientific officer and president of the Worldwide Research, Development, and Medical organization at Pfizer, said during prepared remarks on a company earnings call July 28, CNN reported.
Availability of a third dose of any of the current COVID-19 vaccines would require amendment of the Food and Drug Administration’s emergency use authorization, or full FDA approval for the vaccine.
The possibility of a third dose authorization or approval has not been without controversy. For example, when Pfizer announced intentions to file for FDA authorization of a booster dose on July 8, the Centers for Disease Control and Prevention, the FDA, and the National Institutes of Health were quick to issue a joint statement saying they would decide when the timing is right for Americans to have a third immunization. The agencies stated, in part, “We are prepared for booster doses if and when the science demonstrates that they are needed.”
In addition, the World Health Organization said at a media briefing on July 12 that rich countries should prioritize sharing of COVID-19 vaccine supplies to other countries in need worldwide before allocating doses for a booster shot for its own residents.
A version of this article first appeared on WebMD.com.
Money buys life, and a cigarette maker wants to ‘unsmoke the world’
With COVID, the fun never ends
Welcome to America’s favorite pandemic-themed game show! Let’s play Covidiot Proof! And now, here’s your host, the lovely and talented Anthony Grouchy!
Tony: Hello everyone! Our first category today is America or [blank], and the first clue is for you, Don. This country requires “individuals to use a health pass to patronize indoor establishments such as restaurants, bars, nightclubs and cinemas.”
Don: Freedom-loving Americans would never stand for that, Tony, so I’m going to say Greece.
Tony: That’s correct, Don. One hundred points for you. Okay Joe, here’s your clue: In this country, some people wear disguises to get a COVID vaccination so their friends and families won’t find out.
Joe: Sounds like communism to me, Tony. I’ll say Cuba.
Tony: Sorry Joe, that’s incorrect. Don?
Don: The friends and families sound like freedom-loving Americans, so it must be America.
Tony: It is America. Missouri, to be exact. And now, one last question for both of you to win the game. True or false? Did the pastor of a church in Tennessee say that mask-wearers would be kicked out of the building because “I am not playing these Democrat games up in this church”?
Joe: That’s fake news, Tony. It’s gotta be false.
Tony: Incorrect! It’s absolutely true. That means today’s winner is … Joe? Yes, I’m being told that Tennessee goes to Joe.
Don: That’s bulls#&@! I won this thing! I’ll see you in court!
More money, more life
Does it seem to you that the wealthy live forever, while the less financially comfortable live shorter lives? If you answered, yes, it turns out that you’re right.
Researchers analyzed the effect of net worth at midlife with mortality. To take out genetic differences among the sample of 5,400 adults aged 46 years, the investigators also studied a subset of 2,490 twin and sibling pairs.
“The within-family association provides strong evidence that an association between wealth accumulation and life expectancy exists, because comparing siblings within the same family to each other controls for all of the life experience and biology that they share,” said coauthor Eric Finegood of Northwestern University, Chicago.
But what if one sibling has a history of cancer, heart disease, or other health conditions? The cost of treatment and employment limitations could affect someone’s ability to stack their wealth, right? Absolutely. The researchers took that into account and looked at only healthy individuals and found the same results. More money, longer life.
We have the policies and programs in place for heart health, diabetes prevention, and smoking cessation, as they are seen as major threats to public health. So why not do the same for financial security? A low bank account may just be more harmful.
Holding the ‘health care and wellness’ gun
Cigarettes are not good for us. We know this.
It’s, therefore, not surprising to learn that a business has requested for a U.K. ban on the sale of cigarettes by 2030. However, when that someone turns out to be the CEO of Philip Morris International, tobacco company and maker of Marlboro cigarettes, things get a little confusing.
Banning cigarettes, according to Jacek Olczak, would reduce confusion among consumers, many of whom feel that the alternatives are worse for their health. His company can “see the world without cigarettes ... and actually, the sooner it happens, the better it is for everyone.” A truly noble sentiment from the CEO of a large tobacco company. Nothing nefarious going on here.
And if those aren’t egregious business euphemisms, we don’t know what is.
Of course, for all the completely believable and sincere rhetoric, the fact is that Marlboros are still on the shelves. Philip Morris is still making and advertising them. If their concern was genuine, why wouldn’t they just stop manufacturing them now?
So, we ask ourselves if this a selfless act of kindness or is it an unscrupulous corporate act to get a leg up on their competitors? We’ll leave it up to the readers to decide.
Okay, we lied, it’s the second one.
Autopsy of the living dead
Imagine the absolute terror you’d feel if you opened your eyes to bright, blinding white lights only to see a bone saw 3 inches from your forehead and getting closer by the second. Horrifying for you, certainly, but think about the poor pathologist behind the saw who probably thought a zombie apocalypse was coming. This was close to being a reality for a 29-year-old prisoner at the Asturias Central Penitentiary in Spain.
Gonzalo Montoya Jiménez was discovered in his cell unresponsive. Three physicians examined him and found he was showing signs of death, such as cyanosis and rigor mortis. Mr. Jiménez was processed like any other body and was sent, in a body bag, to a hospital mortuary, where he spent time in a freezer for body preservation. Just before he was due for his autopsy, he began showing signs of life.
It’s not completely clear why this happened to poor Mr. Jiménez, but it was reported that he wasn’t feeling well the day before and that he has epilepsy. Hospital officials suggested he may have been cataleptic, possibly because he had trouble adhering to his medication schedule.
Mr. Jiménez was moved to another hospital under armed guard after coming back to life and regained consciousness after a day or so. Talk about cheating death.
With COVID, the fun never ends
Welcome to America’s favorite pandemic-themed game show! Let’s play Covidiot Proof! And now, here’s your host, the lovely and talented Anthony Grouchy!
Tony: Hello everyone! Our first category today is America or [blank], and the first clue is for you, Don. This country requires “individuals to use a health pass to patronize indoor establishments such as restaurants, bars, nightclubs and cinemas.”
Don: Freedom-loving Americans would never stand for that, Tony, so I’m going to say Greece.
Tony: That’s correct, Don. One hundred points for you. Okay Joe, here’s your clue: In this country, some people wear disguises to get a COVID vaccination so their friends and families won’t find out.
Joe: Sounds like communism to me, Tony. I’ll say Cuba.
Tony: Sorry Joe, that’s incorrect. Don?
Don: The friends and families sound like freedom-loving Americans, so it must be America.
Tony: It is America. Missouri, to be exact. And now, one last question for both of you to win the game. True or false? Did the pastor of a church in Tennessee say that mask-wearers would be kicked out of the building because “I am not playing these Democrat games up in this church”?
Joe: That’s fake news, Tony. It’s gotta be false.
Tony: Incorrect! It’s absolutely true. That means today’s winner is … Joe? Yes, I’m being told that Tennessee goes to Joe.
Don: That’s bulls#&@! I won this thing! I’ll see you in court!
More money, more life
Does it seem to you that the wealthy live forever, while the less financially comfortable live shorter lives? If you answered, yes, it turns out that you’re right.
Researchers analyzed the effect of net worth at midlife with mortality. To take out genetic differences among the sample of 5,400 adults aged 46 years, the investigators also studied a subset of 2,490 twin and sibling pairs.
“The within-family association provides strong evidence that an association between wealth accumulation and life expectancy exists, because comparing siblings within the same family to each other controls for all of the life experience and biology that they share,” said coauthor Eric Finegood of Northwestern University, Chicago.
But what if one sibling has a history of cancer, heart disease, or other health conditions? The cost of treatment and employment limitations could affect someone’s ability to stack their wealth, right? Absolutely. The researchers took that into account and looked at only healthy individuals and found the same results. More money, longer life.
We have the policies and programs in place for heart health, diabetes prevention, and smoking cessation, as they are seen as major threats to public health. So why not do the same for financial security? A low bank account may just be more harmful.
Holding the ‘health care and wellness’ gun
Cigarettes are not good for us. We know this.
It’s, therefore, not surprising to learn that a business has requested for a U.K. ban on the sale of cigarettes by 2030. However, when that someone turns out to be the CEO of Philip Morris International, tobacco company and maker of Marlboro cigarettes, things get a little confusing.
Banning cigarettes, according to Jacek Olczak, would reduce confusion among consumers, many of whom feel that the alternatives are worse for their health. His company can “see the world without cigarettes ... and actually, the sooner it happens, the better it is for everyone.” A truly noble sentiment from the CEO of a large tobacco company. Nothing nefarious going on here.
And if those aren’t egregious business euphemisms, we don’t know what is.
Of course, for all the completely believable and sincere rhetoric, the fact is that Marlboros are still on the shelves. Philip Morris is still making and advertising them. If their concern was genuine, why wouldn’t they just stop manufacturing them now?
So, we ask ourselves if this a selfless act of kindness or is it an unscrupulous corporate act to get a leg up on their competitors? We’ll leave it up to the readers to decide.
Okay, we lied, it’s the second one.
Autopsy of the living dead
Imagine the absolute terror you’d feel if you opened your eyes to bright, blinding white lights only to see a bone saw 3 inches from your forehead and getting closer by the second. Horrifying for you, certainly, but think about the poor pathologist behind the saw who probably thought a zombie apocalypse was coming. This was close to being a reality for a 29-year-old prisoner at the Asturias Central Penitentiary in Spain.
Gonzalo Montoya Jiménez was discovered in his cell unresponsive. Three physicians examined him and found he was showing signs of death, such as cyanosis and rigor mortis. Mr. Jiménez was processed like any other body and was sent, in a body bag, to a hospital mortuary, where he spent time in a freezer for body preservation. Just before he was due for his autopsy, he began showing signs of life.
It’s not completely clear why this happened to poor Mr. Jiménez, but it was reported that he wasn’t feeling well the day before and that he has epilepsy. Hospital officials suggested he may have been cataleptic, possibly because he had trouble adhering to his medication schedule.
Mr. Jiménez was moved to another hospital under armed guard after coming back to life and regained consciousness after a day or so. Talk about cheating death.
With COVID, the fun never ends
Welcome to America’s favorite pandemic-themed game show! Let’s play Covidiot Proof! And now, here’s your host, the lovely and talented Anthony Grouchy!
Tony: Hello everyone! Our first category today is America or [blank], and the first clue is for you, Don. This country requires “individuals to use a health pass to patronize indoor establishments such as restaurants, bars, nightclubs and cinemas.”
Don: Freedom-loving Americans would never stand for that, Tony, so I’m going to say Greece.
Tony: That’s correct, Don. One hundred points for you. Okay Joe, here’s your clue: In this country, some people wear disguises to get a COVID vaccination so their friends and families won’t find out.
Joe: Sounds like communism to me, Tony. I’ll say Cuba.
Tony: Sorry Joe, that’s incorrect. Don?
Don: The friends and families sound like freedom-loving Americans, so it must be America.
Tony: It is America. Missouri, to be exact. And now, one last question for both of you to win the game. True or false? Did the pastor of a church in Tennessee say that mask-wearers would be kicked out of the building because “I am not playing these Democrat games up in this church”?
Joe: That’s fake news, Tony. It’s gotta be false.
Tony: Incorrect! It’s absolutely true. That means today’s winner is … Joe? Yes, I’m being told that Tennessee goes to Joe.
Don: That’s bulls#&@! I won this thing! I’ll see you in court!
More money, more life
Does it seem to you that the wealthy live forever, while the less financially comfortable live shorter lives? If you answered, yes, it turns out that you’re right.
Researchers analyzed the effect of net worth at midlife with mortality. To take out genetic differences among the sample of 5,400 adults aged 46 years, the investigators also studied a subset of 2,490 twin and sibling pairs.
“The within-family association provides strong evidence that an association between wealth accumulation and life expectancy exists, because comparing siblings within the same family to each other controls for all of the life experience and biology that they share,” said coauthor Eric Finegood of Northwestern University, Chicago.
But what if one sibling has a history of cancer, heart disease, or other health conditions? The cost of treatment and employment limitations could affect someone’s ability to stack their wealth, right? Absolutely. The researchers took that into account and looked at only healthy individuals and found the same results. More money, longer life.
We have the policies and programs in place for heart health, diabetes prevention, and smoking cessation, as they are seen as major threats to public health. So why not do the same for financial security? A low bank account may just be more harmful.
Holding the ‘health care and wellness’ gun
Cigarettes are not good for us. We know this.
It’s, therefore, not surprising to learn that a business has requested for a U.K. ban on the sale of cigarettes by 2030. However, when that someone turns out to be the CEO of Philip Morris International, tobacco company and maker of Marlboro cigarettes, things get a little confusing.
Banning cigarettes, according to Jacek Olczak, would reduce confusion among consumers, many of whom feel that the alternatives are worse for their health. His company can “see the world without cigarettes ... and actually, the sooner it happens, the better it is for everyone.” A truly noble sentiment from the CEO of a large tobacco company. Nothing nefarious going on here.
And if those aren’t egregious business euphemisms, we don’t know what is.
Of course, for all the completely believable and sincere rhetoric, the fact is that Marlboros are still on the shelves. Philip Morris is still making and advertising them. If their concern was genuine, why wouldn’t they just stop manufacturing them now?
So, we ask ourselves if this a selfless act of kindness or is it an unscrupulous corporate act to get a leg up on their competitors? We’ll leave it up to the readers to decide.
Okay, we lied, it’s the second one.
Autopsy of the living dead
Imagine the absolute terror you’d feel if you opened your eyes to bright, blinding white lights only to see a bone saw 3 inches from your forehead and getting closer by the second. Horrifying for you, certainly, but think about the poor pathologist behind the saw who probably thought a zombie apocalypse was coming. This was close to being a reality for a 29-year-old prisoner at the Asturias Central Penitentiary in Spain.
Gonzalo Montoya Jiménez was discovered in his cell unresponsive. Three physicians examined him and found he was showing signs of death, such as cyanosis and rigor mortis. Mr. Jiménez was processed like any other body and was sent, in a body bag, to a hospital mortuary, where he spent time in a freezer for body preservation. Just before he was due for his autopsy, he began showing signs of life.
It’s not completely clear why this happened to poor Mr. Jiménez, but it was reported that he wasn’t feeling well the day before and that he has epilepsy. Hospital officials suggested he may have been cataleptic, possibly because he had trouble adhering to his medication schedule.
Mr. Jiménez was moved to another hospital under armed guard after coming back to life and regained consciousness after a day or so. Talk about cheating death.
Coffee and the brain: ‘Concerning’ new data
according to the results of a large study.
“With coffee intake, moderation is the key, and especially high levels of consumption may have adverse long-term effects on the brain,” said study investigator Elina Hypponen, PhD, professor of nutritional and genetic epidemiology and director of the Australian Center for Precision Health at the University of South Australia.
“These new data are concerning, and there is a need to conduct further carefully controlled studies to clarify the effects of coffee on the brain.”
The study was published online June 24 in Nutritional Neuroscience.
Potent stimulant
Coffee is a potent nervous system stimulant and is among the most popular nonalcoholic beverages. Some previous research suggests it benefits the brain, but the investigators noted that other research shows a negative or U-shaped relationship.
To investigate, the researchers examined data from the U.K. Biobank, a long-term prospective epidemiologic study of more than 500,000 participants aged 37-73 years who were recruited in 22 assessment centers in the United Kingdom between March 2006 and October 2010.
During the baseline assessment, information was gathered using touchscreen questionnaires, verbal interviews, and physical examinations that involved collection of blood, urine, and saliva samples. An imaging substudy was incorporated in 2014, the goal of which was to conduct brain, heart, and body MRI imaging for 100,000 participants.
The investigators conducted analyses on disease outcomes for 398,646 participants for whom information on habitual coffee consumption was available. Brain volume analyses were conducted in 17,702 participants for whom valid brain imaging data were available.
Participants reported coffee intake in cups per day. Researchers grouped coffee consumption into seven categories: nondrinkers, decaffeinated coffee drinkers, and caffeinated coffee drinkers who consumed less than 1 cup/d, 1-2 cups/d, 3-4 cups/d, 5-6 cups/d, and more than 6 cups/d.
The reference category was those who consumed 1-2 cups/d, rather than those who abstained from coffee, because persons who abstain are more likely to be at suboptimal health.
“Comparing the health of coffee drinkers to the health of those choosing to abstain from coffee will typically lead to an impression of a health benefit, even if there would not be one,” said Dr. Hypponen.
The researchers obtained total and regional brain volumes from the MRI imaging substudy starting 4-6 years after baseline assessment. They accessed information on incident dementia and stroke using primary care data, hospital admission electronic health records, national death registers, and self-reported medical conditions.
Covariates included socioeconomic, health, and other factors, such as smoking, alcohol and tea consumption, physical activity, stressful life events, and body mass index.
The investigators found that there was a linear inverse association between coffee consumption and total brain volume (fully adjusted beta per cup, –1.42; 95% confidence interval, –1.89 to –0.94), with consistent patterns for gray matter, white matter, and hippocampal volumes.
There was no evidence to support an association with white matter hyperintensity (WMH) volume (beta –0.01; 95% CI, –0.07 to 0.05).
Higher consumption, higher risk
The analysis also revealed a nonlinear association between coffee consumption and the odds of dementia (P nonlinearity = .0001), with slightly higher odds seen with non–coffee drinkers and decaffeinated-coffee drinkers and more notable increases for participants in the highest categories of coffee consumption compared with light coffee drinkers.
After adjustment for all covariates, the odds ratio of dementia among persons in the category of coffee intake was 1.53 (95% CI, 1.28-1.83). After full adjustments, the association with heavy coffee consumption and stroke was not significant, although “we can’t exclude a weak effect,” said Dr. Hypponen.
“For the highest coffee consumption group, the data support an association which may be anywhere from 0% to 37% higher odds of stroke after full adjustment,” she added.
People at risk for hypertension may develop “unpleasant sensations” and stop drinking coffee before a serious adverse event occurs, said Dr. Hypponen. In a previous study, she and her colleagues showed that those who have genetically higher blood pressure tend to drink less coffee than their counterparts without the condition.
“This type of effect might be expected to naturally limit the adverse effects of coffee on the risk of stroke,” said Dr. Hypponen.
The odds remained elevated for participants drinking more than 6 cups/d after the researchers accounted for sleep quality. There were no differences in risk between men and women or by age.
An examination of the consumption of tea, which often contains caffeine, did not show an association with brain volume or the odds of dementia or stroke.
“We don’t know whether the difference between associations seen for coffee and tea intake reflects the difference in related caffeine intake or some other explanation, such as dehydration or effects operating through blood cholesterol,” said Dr. Hypponen.
Although reverse causation is possible, there’s no reason to believe that it is relevant to the study results. Genetic evidence suggests a causal role of higher coffee intake on risk for Alzheimer’s disease. In addition, results of a clinical trial support the association between higher caffeine intake and smaller gray matter volume, said Dr. Hypponen.
The mechanisms linking coffee consumption to brain volumes and dementia are not well established. However, Dr. Hypponen noted that caffeine has been used to induce apoptosis in cancer studies using glial cells.
“Furthermore, adenosine receptors, which mediate many of the effects of caffeine in the brain, have been suggested to influence the release of growth factors, which in turn can have an influence on astrocyte proliferation and angiogenesis in the brain,” she said.
Some types of coffee contain cafestol, which increases blood cholesterol and can have adverse effects though related mechanisms, said Dr. Hypponen.
The mechanism may also involve dehydration, which may have a harmful effect on the brain. The study suggested a correlation between dehydration and high coffee intake. “Of course, if this is the case, it is good news, as then we can do something about it simply by drinking some water every time we have a cup of coffee,” she said.
Misleading conclusions
Coffee contains antioxidants, and although previous studies have suggested it might be beneficial, this hypothesis is “too simplistic,” said Dr. Hypponen. “While coffee is not going to be all ‘bad’ either, there are a lot of controversies and suggestions about beneficial effects of coffee which may not be true, or at least do not reflect the full story.”
If the drinking of coffee is at least partly determined by an individual’s health status, then that would often lead to misleading conclusions in observational studies, said Dr. Hypponen.
“When one uses as a comparison people who already have poor health and who do not drink coffee because of that, coffee intake will by default appear beneficial simply because there are more people with disease among those choosing abstinence,” she said.
Before now, there was “very little evidence about the association between coffee intake and brain morphology,” and the studies that were conducted were relatively small, said Dr. Hypponen.
One of these smaller studies included a group of women aged 13-30 years. It found that coffee consumption was not associated with total brain volumes, but the findings suggested a U-shaped association with hippocampal volume; higher values were seen both for nondrinkers and the groups with higher consumption.
A small study of elderly patients with diabetes showed no evidence of an association with white matter volume, but there was a possible age-dependent association with gray matter volume.
The largest of the earlier studies had results that were very similar to those of the current study, suggesting that increasing coffee intake is associated with smaller hippocampal volumes, said Dr. Hypponen.
One of the study’s limitations included the fact that full dietary information was available only for a subsample and that factors such as dehydration were measured at baseline rather than at the time of brain MRI.
Another possible study limitation was the use of self-reported data and the fact that lifestyle changes may have occurred between baseline and MRI or covariate measurement.
In addition, the study is subject to a healthy-volunteer bias, and its implications are restricted to White British persons. The association needs to be studied in other ethnic populations, the authors noted.
A reason to cut back?
Commenting on the findings, Walter Willett, MD, DrPH, professor of epidemiology and nutrition, Harvard T. H. Chan School of Public Health, Boston, said the study is large and quite well done.
“It does raise questions about an increase in risk of dementia with six or more cups of coffee per day,” said Dr. Willett. “At the same time, it provides reassurance about lack of adverse effects of coffee for those consuming three or four cups per day, and little increase in risk, if any, with five cups per day.”
It’s not entirely clear whether the increase in risk with six or more cups of coffee per day represents a “true effect” of coffee, inasmuch as the study did not seem to adjust fully for dietary factors, high consumption of alcohol, or past smoking, said Dr. Willett.
The findings don’t suggest that coffee lovers should give up their Java. “But six or more cups per day is a lot, and those who drink that much might consider cutting back a bit while research continues,” said Dr. Willett.
The study was supported by the National Health and Medical Research Council.
A version of this article first appeared on Medscape.com.
according to the results of a large study.
“With coffee intake, moderation is the key, and especially high levels of consumption may have adverse long-term effects on the brain,” said study investigator Elina Hypponen, PhD, professor of nutritional and genetic epidemiology and director of the Australian Center for Precision Health at the University of South Australia.
“These new data are concerning, and there is a need to conduct further carefully controlled studies to clarify the effects of coffee on the brain.”
The study was published online June 24 in Nutritional Neuroscience.
Potent stimulant
Coffee is a potent nervous system stimulant and is among the most popular nonalcoholic beverages. Some previous research suggests it benefits the brain, but the investigators noted that other research shows a negative or U-shaped relationship.
To investigate, the researchers examined data from the U.K. Biobank, a long-term prospective epidemiologic study of more than 500,000 participants aged 37-73 years who were recruited in 22 assessment centers in the United Kingdom between March 2006 and October 2010.
During the baseline assessment, information was gathered using touchscreen questionnaires, verbal interviews, and physical examinations that involved collection of blood, urine, and saliva samples. An imaging substudy was incorporated in 2014, the goal of which was to conduct brain, heart, and body MRI imaging for 100,000 participants.
The investigators conducted analyses on disease outcomes for 398,646 participants for whom information on habitual coffee consumption was available. Brain volume analyses were conducted in 17,702 participants for whom valid brain imaging data were available.
Participants reported coffee intake in cups per day. Researchers grouped coffee consumption into seven categories: nondrinkers, decaffeinated coffee drinkers, and caffeinated coffee drinkers who consumed less than 1 cup/d, 1-2 cups/d, 3-4 cups/d, 5-6 cups/d, and more than 6 cups/d.
The reference category was those who consumed 1-2 cups/d, rather than those who abstained from coffee, because persons who abstain are more likely to be at suboptimal health.
“Comparing the health of coffee drinkers to the health of those choosing to abstain from coffee will typically lead to an impression of a health benefit, even if there would not be one,” said Dr. Hypponen.
The researchers obtained total and regional brain volumes from the MRI imaging substudy starting 4-6 years after baseline assessment. They accessed information on incident dementia and stroke using primary care data, hospital admission electronic health records, national death registers, and self-reported medical conditions.
Covariates included socioeconomic, health, and other factors, such as smoking, alcohol and tea consumption, physical activity, stressful life events, and body mass index.
The investigators found that there was a linear inverse association between coffee consumption and total brain volume (fully adjusted beta per cup, –1.42; 95% confidence interval, –1.89 to –0.94), with consistent patterns for gray matter, white matter, and hippocampal volumes.
There was no evidence to support an association with white matter hyperintensity (WMH) volume (beta –0.01; 95% CI, –0.07 to 0.05).
Higher consumption, higher risk
The analysis also revealed a nonlinear association between coffee consumption and the odds of dementia (P nonlinearity = .0001), with slightly higher odds seen with non–coffee drinkers and decaffeinated-coffee drinkers and more notable increases for participants in the highest categories of coffee consumption compared with light coffee drinkers.
After adjustment for all covariates, the odds ratio of dementia among persons in the category of coffee intake was 1.53 (95% CI, 1.28-1.83). After full adjustments, the association with heavy coffee consumption and stroke was not significant, although “we can’t exclude a weak effect,” said Dr. Hypponen.
“For the highest coffee consumption group, the data support an association which may be anywhere from 0% to 37% higher odds of stroke after full adjustment,” she added.
People at risk for hypertension may develop “unpleasant sensations” and stop drinking coffee before a serious adverse event occurs, said Dr. Hypponen. In a previous study, she and her colleagues showed that those who have genetically higher blood pressure tend to drink less coffee than their counterparts without the condition.
“This type of effect might be expected to naturally limit the adverse effects of coffee on the risk of stroke,” said Dr. Hypponen.
The odds remained elevated for participants drinking more than 6 cups/d after the researchers accounted for sleep quality. There were no differences in risk between men and women or by age.
An examination of the consumption of tea, which often contains caffeine, did not show an association with brain volume or the odds of dementia or stroke.
“We don’t know whether the difference between associations seen for coffee and tea intake reflects the difference in related caffeine intake or some other explanation, such as dehydration or effects operating through blood cholesterol,” said Dr. Hypponen.
Although reverse causation is possible, there’s no reason to believe that it is relevant to the study results. Genetic evidence suggests a causal role of higher coffee intake on risk for Alzheimer’s disease. In addition, results of a clinical trial support the association between higher caffeine intake and smaller gray matter volume, said Dr. Hypponen.
The mechanisms linking coffee consumption to brain volumes and dementia are not well established. However, Dr. Hypponen noted that caffeine has been used to induce apoptosis in cancer studies using glial cells.
“Furthermore, adenosine receptors, which mediate many of the effects of caffeine in the brain, have been suggested to influence the release of growth factors, which in turn can have an influence on astrocyte proliferation and angiogenesis in the brain,” she said.
Some types of coffee contain cafestol, which increases blood cholesterol and can have adverse effects though related mechanisms, said Dr. Hypponen.
The mechanism may also involve dehydration, which may have a harmful effect on the brain. The study suggested a correlation between dehydration and high coffee intake. “Of course, if this is the case, it is good news, as then we can do something about it simply by drinking some water every time we have a cup of coffee,” she said.
Misleading conclusions
Coffee contains antioxidants, and although previous studies have suggested it might be beneficial, this hypothesis is “too simplistic,” said Dr. Hypponen. “While coffee is not going to be all ‘bad’ either, there are a lot of controversies and suggestions about beneficial effects of coffee which may not be true, or at least do not reflect the full story.”
If the drinking of coffee is at least partly determined by an individual’s health status, then that would often lead to misleading conclusions in observational studies, said Dr. Hypponen.
“When one uses as a comparison people who already have poor health and who do not drink coffee because of that, coffee intake will by default appear beneficial simply because there are more people with disease among those choosing abstinence,” she said.
Before now, there was “very little evidence about the association between coffee intake and brain morphology,” and the studies that were conducted were relatively small, said Dr. Hypponen.
One of these smaller studies included a group of women aged 13-30 years. It found that coffee consumption was not associated with total brain volumes, but the findings suggested a U-shaped association with hippocampal volume; higher values were seen both for nondrinkers and the groups with higher consumption.
A small study of elderly patients with diabetes showed no evidence of an association with white matter volume, but there was a possible age-dependent association with gray matter volume.
The largest of the earlier studies had results that were very similar to those of the current study, suggesting that increasing coffee intake is associated with smaller hippocampal volumes, said Dr. Hypponen.
One of the study’s limitations included the fact that full dietary information was available only for a subsample and that factors such as dehydration were measured at baseline rather than at the time of brain MRI.
Another possible study limitation was the use of self-reported data and the fact that lifestyle changes may have occurred between baseline and MRI or covariate measurement.
In addition, the study is subject to a healthy-volunteer bias, and its implications are restricted to White British persons. The association needs to be studied in other ethnic populations, the authors noted.
A reason to cut back?
Commenting on the findings, Walter Willett, MD, DrPH, professor of epidemiology and nutrition, Harvard T. H. Chan School of Public Health, Boston, said the study is large and quite well done.
“It does raise questions about an increase in risk of dementia with six or more cups of coffee per day,” said Dr. Willett. “At the same time, it provides reassurance about lack of adverse effects of coffee for those consuming three or four cups per day, and little increase in risk, if any, with five cups per day.”
It’s not entirely clear whether the increase in risk with six or more cups of coffee per day represents a “true effect” of coffee, inasmuch as the study did not seem to adjust fully for dietary factors, high consumption of alcohol, or past smoking, said Dr. Willett.
The findings don’t suggest that coffee lovers should give up their Java. “But six or more cups per day is a lot, and those who drink that much might consider cutting back a bit while research continues,” said Dr. Willett.
The study was supported by the National Health and Medical Research Council.
A version of this article first appeared on Medscape.com.
according to the results of a large study.
“With coffee intake, moderation is the key, and especially high levels of consumption may have adverse long-term effects on the brain,” said study investigator Elina Hypponen, PhD, professor of nutritional and genetic epidemiology and director of the Australian Center for Precision Health at the University of South Australia.
“These new data are concerning, and there is a need to conduct further carefully controlled studies to clarify the effects of coffee on the brain.”
The study was published online June 24 in Nutritional Neuroscience.
Potent stimulant
Coffee is a potent nervous system stimulant and is among the most popular nonalcoholic beverages. Some previous research suggests it benefits the brain, but the investigators noted that other research shows a negative or U-shaped relationship.
To investigate, the researchers examined data from the U.K. Biobank, a long-term prospective epidemiologic study of more than 500,000 participants aged 37-73 years who were recruited in 22 assessment centers in the United Kingdom between March 2006 and October 2010.
During the baseline assessment, information was gathered using touchscreen questionnaires, verbal interviews, and physical examinations that involved collection of blood, urine, and saliva samples. An imaging substudy was incorporated in 2014, the goal of which was to conduct brain, heart, and body MRI imaging for 100,000 participants.
The investigators conducted analyses on disease outcomes for 398,646 participants for whom information on habitual coffee consumption was available. Brain volume analyses were conducted in 17,702 participants for whom valid brain imaging data were available.
Participants reported coffee intake in cups per day. Researchers grouped coffee consumption into seven categories: nondrinkers, decaffeinated coffee drinkers, and caffeinated coffee drinkers who consumed less than 1 cup/d, 1-2 cups/d, 3-4 cups/d, 5-6 cups/d, and more than 6 cups/d.
The reference category was those who consumed 1-2 cups/d, rather than those who abstained from coffee, because persons who abstain are more likely to be at suboptimal health.
“Comparing the health of coffee drinkers to the health of those choosing to abstain from coffee will typically lead to an impression of a health benefit, even if there would not be one,” said Dr. Hypponen.
The researchers obtained total and regional brain volumes from the MRI imaging substudy starting 4-6 years after baseline assessment. They accessed information on incident dementia and stroke using primary care data, hospital admission electronic health records, national death registers, and self-reported medical conditions.
Covariates included socioeconomic, health, and other factors, such as smoking, alcohol and tea consumption, physical activity, stressful life events, and body mass index.
The investigators found that there was a linear inverse association between coffee consumption and total brain volume (fully adjusted beta per cup, –1.42; 95% confidence interval, –1.89 to –0.94), with consistent patterns for gray matter, white matter, and hippocampal volumes.
There was no evidence to support an association with white matter hyperintensity (WMH) volume (beta –0.01; 95% CI, –0.07 to 0.05).
Higher consumption, higher risk
The analysis also revealed a nonlinear association between coffee consumption and the odds of dementia (P nonlinearity = .0001), with slightly higher odds seen with non–coffee drinkers and decaffeinated-coffee drinkers and more notable increases for participants in the highest categories of coffee consumption compared with light coffee drinkers.
After adjustment for all covariates, the odds ratio of dementia among persons in the category of coffee intake was 1.53 (95% CI, 1.28-1.83). After full adjustments, the association with heavy coffee consumption and stroke was not significant, although “we can’t exclude a weak effect,” said Dr. Hypponen.
“For the highest coffee consumption group, the data support an association which may be anywhere from 0% to 37% higher odds of stroke after full adjustment,” she added.
People at risk for hypertension may develop “unpleasant sensations” and stop drinking coffee before a serious adverse event occurs, said Dr. Hypponen. In a previous study, she and her colleagues showed that those who have genetically higher blood pressure tend to drink less coffee than their counterparts without the condition.
“This type of effect might be expected to naturally limit the adverse effects of coffee on the risk of stroke,” said Dr. Hypponen.
The odds remained elevated for participants drinking more than 6 cups/d after the researchers accounted for sleep quality. There were no differences in risk between men and women or by age.
An examination of the consumption of tea, which often contains caffeine, did not show an association with brain volume or the odds of dementia or stroke.
“We don’t know whether the difference between associations seen for coffee and tea intake reflects the difference in related caffeine intake or some other explanation, such as dehydration or effects operating through blood cholesterol,” said Dr. Hypponen.
Although reverse causation is possible, there’s no reason to believe that it is relevant to the study results. Genetic evidence suggests a causal role of higher coffee intake on risk for Alzheimer’s disease. In addition, results of a clinical trial support the association between higher caffeine intake and smaller gray matter volume, said Dr. Hypponen.
The mechanisms linking coffee consumption to brain volumes and dementia are not well established. However, Dr. Hypponen noted that caffeine has been used to induce apoptosis in cancer studies using glial cells.
“Furthermore, adenosine receptors, which mediate many of the effects of caffeine in the brain, have been suggested to influence the release of growth factors, which in turn can have an influence on astrocyte proliferation and angiogenesis in the brain,” she said.
Some types of coffee contain cafestol, which increases blood cholesterol and can have adverse effects though related mechanisms, said Dr. Hypponen.
The mechanism may also involve dehydration, which may have a harmful effect on the brain. The study suggested a correlation between dehydration and high coffee intake. “Of course, if this is the case, it is good news, as then we can do something about it simply by drinking some water every time we have a cup of coffee,” she said.
Misleading conclusions
Coffee contains antioxidants, and although previous studies have suggested it might be beneficial, this hypothesis is “too simplistic,” said Dr. Hypponen. “While coffee is not going to be all ‘bad’ either, there are a lot of controversies and suggestions about beneficial effects of coffee which may not be true, or at least do not reflect the full story.”
If the drinking of coffee is at least partly determined by an individual’s health status, then that would often lead to misleading conclusions in observational studies, said Dr. Hypponen.
“When one uses as a comparison people who already have poor health and who do not drink coffee because of that, coffee intake will by default appear beneficial simply because there are more people with disease among those choosing abstinence,” she said.
Before now, there was “very little evidence about the association between coffee intake and brain morphology,” and the studies that were conducted were relatively small, said Dr. Hypponen.
One of these smaller studies included a group of women aged 13-30 years. It found that coffee consumption was not associated with total brain volumes, but the findings suggested a U-shaped association with hippocampal volume; higher values were seen both for nondrinkers and the groups with higher consumption.
A small study of elderly patients with diabetes showed no evidence of an association with white matter volume, but there was a possible age-dependent association with gray matter volume.
The largest of the earlier studies had results that were very similar to those of the current study, suggesting that increasing coffee intake is associated with smaller hippocampal volumes, said Dr. Hypponen.
One of the study’s limitations included the fact that full dietary information was available only for a subsample and that factors such as dehydration were measured at baseline rather than at the time of brain MRI.
Another possible study limitation was the use of self-reported data and the fact that lifestyle changes may have occurred between baseline and MRI or covariate measurement.
In addition, the study is subject to a healthy-volunteer bias, and its implications are restricted to White British persons. The association needs to be studied in other ethnic populations, the authors noted.
A reason to cut back?
Commenting on the findings, Walter Willett, MD, DrPH, professor of epidemiology and nutrition, Harvard T. H. Chan School of Public Health, Boston, said the study is large and quite well done.
“It does raise questions about an increase in risk of dementia with six or more cups of coffee per day,” said Dr. Willett. “At the same time, it provides reassurance about lack of adverse effects of coffee for those consuming three or four cups per day, and little increase in risk, if any, with five cups per day.”
It’s not entirely clear whether the increase in risk with six or more cups of coffee per day represents a “true effect” of coffee, inasmuch as the study did not seem to adjust fully for dietary factors, high consumption of alcohol, or past smoking, said Dr. Willett.
The findings don’t suggest that coffee lovers should give up their Java. “But six or more cups per day is a lot, and those who drink that much might consider cutting back a bit while research continues,” said Dr. Willett.
The study was supported by the National Health and Medical Research Council.
A version of this article first appeared on Medscape.com.
FROM NUTRITIONAL NEUROSCIENCE
Many pandemic-driven changes to cancer clinical trials should remain
Many of the changes to cancer clinical trials forced through by the COVID-19 pandemic should remain, as they have made trials “more patient centered and efficient,” according to a group of thought leaders in oncology.
Among the potential improvements were more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessment of adverse events, and streamlined data collection.
These changes should be implemented on a permanent basis, the group argues in a commentary published online July 21, 2021, in Cancer Discovery, a journal of the American Association for Cancer Research.
“The ability to distribute oral investigational drugs by mail to patients at their home has probably been the single most impactful change to clinical trial conduct, linked with virtual visits with patients to assess side effects and symptoms,” commented lead author Keith Flaherty, MD, who is director of clinical research at Massachusetts General Hospital, a professor at Harvard Medical School, Boston, and a member of the AACR board of directors.
“This has made it more feasible for patients for whom participation in clinical trials poses a disruption of their ability to work or provide care for family members to participate in trials,” he added in a press statement issued by the AACR.
Pandemic halted many clinical trials
A survey of cancer programs in early 2020 showed that nearly 60% halted screening and/or enrollment for at least some trials because of COVID-19.
“In the spring of 2020, clinical trial conduct halted and then restarted focusing on the bare minimum procedures that first allowed patients continued access to their experimental therapies, and then allowed clinical trial sites and sponsors to collect information on the effects of the therapies,” the authors said.
“The COVID-19–induced changes to clinical trials were a big challenge, probably the largest change in clinical trial conduct since the start of modern oncology clinical testing,” they commented.
“But it also represents an opportunity to rethink the key aspects of clinical trial conduct that are strictly necessary to reach the goal of testing the effectiveness of cancer therapies, and which others are dispensable or provide only minor additional contributions,” they added.
As previously reported at the time by this news organization, efforts to find alternative approaches to conducting trials amid the pandemic led to the emergence of a few “silver linings.”
Key adaptations made to clinical trials and highlighted by the authors include:
- Uptake of remote consenting and telemedicine
- Use of alternative laboratories and imaging centers
- Delivery or administration of investigational drugs at patients’ homes or local clinics
- Commercial attainment of study drugs already approved for other indications
Indeed, the restrictions encountered during the pandemic underscore the importance of designing patient-centered trials versus study site–centered trials, added Antoni Ribas, MD, commentary coauthor and immediate past president of the AACR.
Many of the changes implemented during the pandemic could help increase access for patients living in underserved communities who are underrepresented in clinical trials, he explained.
Harnessing the lessons learned
The authors also recommended the following additional adaptations, which they believe will enhance efficiency and further expand access to clinical trials:
- Incorporating patient-reported outcomes and alternative endpoints in efficacy assessments
- Aiming for 100% remote drug infusions and monitoring
- Increasing funding for clinical trials conducted in underserved communities
- Expanding clinical trial eligibility to include patients with a wide range of comorbidities
- Reducing collection of low-grade adverse events and allowing minor protocol deviations
The group’s recommendations are based on discussions by the AACR COVID-19 and Cancer Task Force, in which they participated.
The American Society of Clinical Oncology is also working to leverage pandemic-related lessons to streamline care and trial planning.
ASCO’s “Road to Recovery” recommendations, published in December 2020, aim to “ensure lessons learned from the COVID-19 experience are used to craft a more equitable, accessible, and efficient clinical research system that protects patient safety, ensures scientific integrity, and maintains data quality,” the authors explained.
Dr. Flaherty and colleagues further underscore the importance of focusing on improvements going forward.
“Guided by lessons learned, many of the remote assessments and trial efficiencies deployed during the pandemic can be preserved and improved upon. We strongly encourage use of these streamlined procedures where appropriate in future prospectively designed cancer clinical trials,” they wrote.
Dr. Flaherty reported receiving personal fees from numerous pharmaceutical companies. Dr. Ribas reported receiving grants from Agilent and Bristol Myers Squibb.
A version of this article first appeared on Medscape.com.
Many of the changes to cancer clinical trials forced through by the COVID-19 pandemic should remain, as they have made trials “more patient centered and efficient,” according to a group of thought leaders in oncology.
Among the potential improvements were more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessment of adverse events, and streamlined data collection.
These changes should be implemented on a permanent basis, the group argues in a commentary published online July 21, 2021, in Cancer Discovery, a journal of the American Association for Cancer Research.
“The ability to distribute oral investigational drugs by mail to patients at their home has probably been the single most impactful change to clinical trial conduct, linked with virtual visits with patients to assess side effects and symptoms,” commented lead author Keith Flaherty, MD, who is director of clinical research at Massachusetts General Hospital, a professor at Harvard Medical School, Boston, and a member of the AACR board of directors.
“This has made it more feasible for patients for whom participation in clinical trials poses a disruption of their ability to work or provide care for family members to participate in trials,” he added in a press statement issued by the AACR.
Pandemic halted many clinical trials
A survey of cancer programs in early 2020 showed that nearly 60% halted screening and/or enrollment for at least some trials because of COVID-19.
“In the spring of 2020, clinical trial conduct halted and then restarted focusing on the bare minimum procedures that first allowed patients continued access to their experimental therapies, and then allowed clinical trial sites and sponsors to collect information on the effects of the therapies,” the authors said.
“The COVID-19–induced changes to clinical trials were a big challenge, probably the largest change in clinical trial conduct since the start of modern oncology clinical testing,” they commented.
“But it also represents an opportunity to rethink the key aspects of clinical trial conduct that are strictly necessary to reach the goal of testing the effectiveness of cancer therapies, and which others are dispensable or provide only minor additional contributions,” they added.
As previously reported at the time by this news organization, efforts to find alternative approaches to conducting trials amid the pandemic led to the emergence of a few “silver linings.”
Key adaptations made to clinical trials and highlighted by the authors include:
- Uptake of remote consenting and telemedicine
- Use of alternative laboratories and imaging centers
- Delivery or administration of investigational drugs at patients’ homes or local clinics
- Commercial attainment of study drugs already approved for other indications
Indeed, the restrictions encountered during the pandemic underscore the importance of designing patient-centered trials versus study site–centered trials, added Antoni Ribas, MD, commentary coauthor and immediate past president of the AACR.
Many of the changes implemented during the pandemic could help increase access for patients living in underserved communities who are underrepresented in clinical trials, he explained.
Harnessing the lessons learned
The authors also recommended the following additional adaptations, which they believe will enhance efficiency and further expand access to clinical trials:
- Incorporating patient-reported outcomes and alternative endpoints in efficacy assessments
- Aiming for 100% remote drug infusions and monitoring
- Increasing funding for clinical trials conducted in underserved communities
- Expanding clinical trial eligibility to include patients with a wide range of comorbidities
- Reducing collection of low-grade adverse events and allowing minor protocol deviations
The group’s recommendations are based on discussions by the AACR COVID-19 and Cancer Task Force, in which they participated.
The American Society of Clinical Oncology is also working to leverage pandemic-related lessons to streamline care and trial planning.
ASCO’s “Road to Recovery” recommendations, published in December 2020, aim to “ensure lessons learned from the COVID-19 experience are used to craft a more equitable, accessible, and efficient clinical research system that protects patient safety, ensures scientific integrity, and maintains data quality,” the authors explained.
Dr. Flaherty and colleagues further underscore the importance of focusing on improvements going forward.
“Guided by lessons learned, many of the remote assessments and trial efficiencies deployed during the pandemic can be preserved and improved upon. We strongly encourage use of these streamlined procedures where appropriate in future prospectively designed cancer clinical trials,” they wrote.
Dr. Flaherty reported receiving personal fees from numerous pharmaceutical companies. Dr. Ribas reported receiving grants from Agilent and Bristol Myers Squibb.
A version of this article first appeared on Medscape.com.
Many of the changes to cancer clinical trials forced through by the COVID-19 pandemic should remain, as they have made trials “more patient centered and efficient,” according to a group of thought leaders in oncology.
Among the potential improvements were more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessment of adverse events, and streamlined data collection.
These changes should be implemented on a permanent basis, the group argues in a commentary published online July 21, 2021, in Cancer Discovery, a journal of the American Association for Cancer Research.
“The ability to distribute oral investigational drugs by mail to patients at their home has probably been the single most impactful change to clinical trial conduct, linked with virtual visits with patients to assess side effects and symptoms,” commented lead author Keith Flaherty, MD, who is director of clinical research at Massachusetts General Hospital, a professor at Harvard Medical School, Boston, and a member of the AACR board of directors.
“This has made it more feasible for patients for whom participation in clinical trials poses a disruption of their ability to work or provide care for family members to participate in trials,” he added in a press statement issued by the AACR.
Pandemic halted many clinical trials
A survey of cancer programs in early 2020 showed that nearly 60% halted screening and/or enrollment for at least some trials because of COVID-19.
“In the spring of 2020, clinical trial conduct halted and then restarted focusing on the bare minimum procedures that first allowed patients continued access to their experimental therapies, and then allowed clinical trial sites and sponsors to collect information on the effects of the therapies,” the authors said.
“The COVID-19–induced changes to clinical trials were a big challenge, probably the largest change in clinical trial conduct since the start of modern oncology clinical testing,” they commented.
“But it also represents an opportunity to rethink the key aspects of clinical trial conduct that are strictly necessary to reach the goal of testing the effectiveness of cancer therapies, and which others are dispensable or provide only minor additional contributions,” they added.
As previously reported at the time by this news organization, efforts to find alternative approaches to conducting trials amid the pandemic led to the emergence of a few “silver linings.”
Key adaptations made to clinical trials and highlighted by the authors include:
- Uptake of remote consenting and telemedicine
- Use of alternative laboratories and imaging centers
- Delivery or administration of investigational drugs at patients’ homes or local clinics
- Commercial attainment of study drugs already approved for other indications
Indeed, the restrictions encountered during the pandemic underscore the importance of designing patient-centered trials versus study site–centered trials, added Antoni Ribas, MD, commentary coauthor and immediate past president of the AACR.
Many of the changes implemented during the pandemic could help increase access for patients living in underserved communities who are underrepresented in clinical trials, he explained.
Harnessing the lessons learned
The authors also recommended the following additional adaptations, which they believe will enhance efficiency and further expand access to clinical trials:
- Incorporating patient-reported outcomes and alternative endpoints in efficacy assessments
- Aiming for 100% remote drug infusions and monitoring
- Increasing funding for clinical trials conducted in underserved communities
- Expanding clinical trial eligibility to include patients with a wide range of comorbidities
- Reducing collection of low-grade adverse events and allowing minor protocol deviations
The group’s recommendations are based on discussions by the AACR COVID-19 and Cancer Task Force, in which they participated.
The American Society of Clinical Oncology is also working to leverage pandemic-related lessons to streamline care and trial planning.
ASCO’s “Road to Recovery” recommendations, published in December 2020, aim to “ensure lessons learned from the COVID-19 experience are used to craft a more equitable, accessible, and efficient clinical research system that protects patient safety, ensures scientific integrity, and maintains data quality,” the authors explained.
Dr. Flaherty and colleagues further underscore the importance of focusing on improvements going forward.
“Guided by lessons learned, many of the remote assessments and trial efficiencies deployed during the pandemic can be preserved and improved upon. We strongly encourage use of these streamlined procedures where appropriate in future prospectively designed cancer clinical trials,” they wrote.
Dr. Flaherty reported receiving personal fees from numerous pharmaceutical companies. Dr. Ribas reported receiving grants from Agilent and Bristol Myers Squibb.
A version of this article first appeared on Medscape.com.
CDC calls for masks in schools, hard-hit areas, even if vaccinated
The agency has called for masks in K-12 school settings and in areas of the United States experiencing high or substantial SARS-CoV-2 transmission, even for the fully vaccinated.
The move reverses a controversial announcement the agency made in May 2021 that fully vaccinated Americans could skip wearing a mask in most settings.
Unlike the increasing vaccination rates and decreasing case numbers reported in May, however, some regions of the United States are now reporting large jumps in COVID-19 case numbers. And the Delta variant as well as new evidence of transmission from breakthrough cases are largely driving these changes.
“Today we have new science related to the [D]elta variant that requires us to update the guidance on what you can do when you are fully vaccinated,” CDC Director Rochelle Walensky, MD, MPH, said during a media briefing July 27.
New evidence has emerged on breakthrough-case transmission risk, for example. “Information on the [D]elta variant from several states and other countries indicates that in rare cases, some people infected with the [D]elta variant after vaccination may be contagious and spread virus to others,” Dr. Walensky said, adding that the viral loads appear to be about the same in vaccinated and unvaccinated individuals.
“This new science is worrisome,” she said.
Even though unvaccinated people represent the vast majority of cases of transmission, Dr. Walensky said, “we thought it was important for [vaccinated] people to understand they have the potential to transmit the virus to others.”
As a result, in addition to continuing to strongly encourage everyone to get vaccinated, the CDC recommends that fully vaccinated people wear masks in public indoor settings to help prevent the spread of the Delta variant in areas with substantial or high transmission, Dr. Walensky said. “This includes schools.”
Masks in schools
The CDC is now recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Their goal is to optimize safety and allow children to return to full-time in-person learning in the fall.
The CDC tracks substantial and high transmission rates through the agency’s COVID Data Tracker site. Substantial transmission means between 50 and 100 cases per 100,000 people reported over 7 days and high means more than 100 cases per 100,000 people.
The B.1.617.2, or Delta, variant is believed to be responsible for COVID-19 cases increasing more than 300% nationally from June 19 to July 23, 2021.
“A prudent move”
“I think it’s a prudent move. Given the dominance of the [D]elta variant and the caseloads that we are seeing rising in many locations across the United States, including in my backyard here in San Francisco,” Joe DeRisi, PhD, copresident of the Chan Zuckerberg Biohub and professor of biochemistry and biophysics at the University of California San Francisco, said in an interview.
Dr. DeRisi said he was not surprised that vaccinated people with breakthrough infections could be capable of transmitting the virus. He added that clinical testing done by the Biohub and UCSF produced a lot of data on viral load levels, “and they cover an enormous range.”
What was unexpected to him was the rapid rise of the dominant variant. “The rise of the [D]elta strain is astonishing. It’s happened so fast,” he said.
“I know it’s difficult”
Reacting to the news, Colleen Kraft, MD, said, “One of the things that we’re learning is that if we’re going to have low vaccine uptake or we have a number of people that can’t be vaccinated yet, such as children, that we really need to go back to stopping transmission, which involves mask wearing.”
“I know that it’s very difficult and people feel like we’re sliding backward,” Dr. Kraft said during a media briefing sponsored by Emory University held shortly after the CDC announcement.
She added that the CDC updated guidance seems appropriate. “I don’t think any of us really want to be in this position or want to go back to masking but…we’re finding ourselves in the same place we were a year ago, in July 2020.
“In general we just don’t want anybody to be infected even if there’s a small chance for you to be infected and there’s a small chance for you to transmit it,” said Dr. Kraft, who’s an assistant professor in the department of pathology and associate professor in the department of medicine, division of infectious diseases at Emory University School of Medicine in Atlanta.
Breakthrough transmissions
“The good news is you’re still unlikely to get critically ill if you’re vaccinated. But what has changed with the [D]elta variant is instead of being 90% plus protected from getting the virus at all, you’re probably more in the 70% to 80% range,” James T. McDeavitt, MD, told this news organization.
“So we’re seeing breakthrough infections,” said Dr. McDeavitt, executive vice president and dean of clinical affairs at Baylor College of Medicine in Houston. “We are starting to see [such people] are potentially infectious.” Even if a vaccinated person is individually much less likely to experience serious COVID-19 outcomes, “they can spread it to someone else who spreads it to someone else who is more vulnerable. It puts the more at-risk populations at further risk.”
It breaks down to individual and public health concerns. “I am fully vaccinated. I am very confident I am not going to end up in a hospital,” he said. “Now if I were unvaccinated, with the prevalence of the virus around the country, I’m probably in more danger than I’ve ever been in the course of the pandemic. The unvaccinated are really at risk right now.”
IDSA and AMA support mask change
The Infectious Diseases Society of America (IDSA) has released a statement supporting the new CDC recommendations. “To stay ahead of the spread of the highly transmissible Delta variant, IDSA also urges that in communities with moderate transmission rates, all individuals, even those who are vaccinated, wear masks in indoor public places,” stated IDSA President Barbara D. Alexander, MD, MHS.
“IDSA also supports CDC’s guidance recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status, until vaccines are authorized and widely available to all children and vaccination rates are sufficient to control transmission.”
“Mask wearing will help reduce infections, prevent serious illnesses and death, limit strain on local hospitals and stave off the development of even more troubling variants,” she added.
The American Medical Association (AMA) also released a statement supporting the CDC’s policy changes.
“According to the CDC, emerging data indicates that vaccinated individuals infected with the Delta variant have similar viral loads as those who are unvaccinated and are capable of transmission,” AMA President Gerald E. Harmon, MD said in the statement.
“However, the science remains clear, the authorized vaccines remain safe and effective in preventing severe complications from COVID-19, including hospitalization and death,” he stated. “We strongly support the updated recommendations, which call for universal masking in areas of high or substantial COVID-19 transmission and in K-12 schools, to help reduce transmission of the virus. Wearing a mask is a small but important protective measure that can help us all stay safer.”
“The highest spread of cases and [most] severe outcomes are happening in places with low vaccination rates and among unvaccinated people,” Dr. Walensky said. “With the [D]elta variant, vaccinating more Americans now is more urgent than ever.”
“This moment, and the associated suffering, illness, and death, could have been avoided with higher vaccination coverage in this country,” she said.
A version of this article first appeared on Medscape.com.
The agency has called for masks in K-12 school settings and in areas of the United States experiencing high or substantial SARS-CoV-2 transmission, even for the fully vaccinated.
The move reverses a controversial announcement the agency made in May 2021 that fully vaccinated Americans could skip wearing a mask in most settings.
Unlike the increasing vaccination rates and decreasing case numbers reported in May, however, some regions of the United States are now reporting large jumps in COVID-19 case numbers. And the Delta variant as well as new evidence of transmission from breakthrough cases are largely driving these changes.
“Today we have new science related to the [D]elta variant that requires us to update the guidance on what you can do when you are fully vaccinated,” CDC Director Rochelle Walensky, MD, MPH, said during a media briefing July 27.
New evidence has emerged on breakthrough-case transmission risk, for example. “Information on the [D]elta variant from several states and other countries indicates that in rare cases, some people infected with the [D]elta variant after vaccination may be contagious and spread virus to others,” Dr. Walensky said, adding that the viral loads appear to be about the same in vaccinated and unvaccinated individuals.
“This new science is worrisome,” she said.
Even though unvaccinated people represent the vast majority of cases of transmission, Dr. Walensky said, “we thought it was important for [vaccinated] people to understand they have the potential to transmit the virus to others.”
As a result, in addition to continuing to strongly encourage everyone to get vaccinated, the CDC recommends that fully vaccinated people wear masks in public indoor settings to help prevent the spread of the Delta variant in areas with substantial or high transmission, Dr. Walensky said. “This includes schools.”
Masks in schools
The CDC is now recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Their goal is to optimize safety and allow children to return to full-time in-person learning in the fall.
The CDC tracks substantial and high transmission rates through the agency’s COVID Data Tracker site. Substantial transmission means between 50 and 100 cases per 100,000 people reported over 7 days and high means more than 100 cases per 100,000 people.
The B.1.617.2, or Delta, variant is believed to be responsible for COVID-19 cases increasing more than 300% nationally from June 19 to July 23, 2021.
“A prudent move”
“I think it’s a prudent move. Given the dominance of the [D]elta variant and the caseloads that we are seeing rising in many locations across the United States, including in my backyard here in San Francisco,” Joe DeRisi, PhD, copresident of the Chan Zuckerberg Biohub and professor of biochemistry and biophysics at the University of California San Francisco, said in an interview.
Dr. DeRisi said he was not surprised that vaccinated people with breakthrough infections could be capable of transmitting the virus. He added that clinical testing done by the Biohub and UCSF produced a lot of data on viral load levels, “and they cover an enormous range.”
What was unexpected to him was the rapid rise of the dominant variant. “The rise of the [D]elta strain is astonishing. It’s happened so fast,” he said.
“I know it’s difficult”
Reacting to the news, Colleen Kraft, MD, said, “One of the things that we’re learning is that if we’re going to have low vaccine uptake or we have a number of people that can’t be vaccinated yet, such as children, that we really need to go back to stopping transmission, which involves mask wearing.”
“I know that it’s very difficult and people feel like we’re sliding backward,” Dr. Kraft said during a media briefing sponsored by Emory University held shortly after the CDC announcement.
She added that the CDC updated guidance seems appropriate. “I don’t think any of us really want to be in this position or want to go back to masking but…we’re finding ourselves in the same place we were a year ago, in July 2020.
“In general we just don’t want anybody to be infected even if there’s a small chance for you to be infected and there’s a small chance for you to transmit it,” said Dr. Kraft, who’s an assistant professor in the department of pathology and associate professor in the department of medicine, division of infectious diseases at Emory University School of Medicine in Atlanta.
Breakthrough transmissions
“The good news is you’re still unlikely to get critically ill if you’re vaccinated. But what has changed with the [D]elta variant is instead of being 90% plus protected from getting the virus at all, you’re probably more in the 70% to 80% range,” James T. McDeavitt, MD, told this news organization.
“So we’re seeing breakthrough infections,” said Dr. McDeavitt, executive vice president and dean of clinical affairs at Baylor College of Medicine in Houston. “We are starting to see [such people] are potentially infectious.” Even if a vaccinated person is individually much less likely to experience serious COVID-19 outcomes, “they can spread it to someone else who spreads it to someone else who is more vulnerable. It puts the more at-risk populations at further risk.”
It breaks down to individual and public health concerns. “I am fully vaccinated. I am very confident I am not going to end up in a hospital,” he said. “Now if I were unvaccinated, with the prevalence of the virus around the country, I’m probably in more danger than I’ve ever been in the course of the pandemic. The unvaccinated are really at risk right now.”
IDSA and AMA support mask change
The Infectious Diseases Society of America (IDSA) has released a statement supporting the new CDC recommendations. “To stay ahead of the spread of the highly transmissible Delta variant, IDSA also urges that in communities with moderate transmission rates, all individuals, even those who are vaccinated, wear masks in indoor public places,” stated IDSA President Barbara D. Alexander, MD, MHS.
“IDSA also supports CDC’s guidance recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status, until vaccines are authorized and widely available to all children and vaccination rates are sufficient to control transmission.”
“Mask wearing will help reduce infections, prevent serious illnesses and death, limit strain on local hospitals and stave off the development of even more troubling variants,” she added.
The American Medical Association (AMA) also released a statement supporting the CDC’s policy changes.
“According to the CDC, emerging data indicates that vaccinated individuals infected with the Delta variant have similar viral loads as those who are unvaccinated and are capable of transmission,” AMA President Gerald E. Harmon, MD said in the statement.
“However, the science remains clear, the authorized vaccines remain safe and effective in preventing severe complications from COVID-19, including hospitalization and death,” he stated. “We strongly support the updated recommendations, which call for universal masking in areas of high or substantial COVID-19 transmission and in K-12 schools, to help reduce transmission of the virus. Wearing a mask is a small but important protective measure that can help us all stay safer.”
“The highest spread of cases and [most] severe outcomes are happening in places with low vaccination rates and among unvaccinated people,” Dr. Walensky said. “With the [D]elta variant, vaccinating more Americans now is more urgent than ever.”
“This moment, and the associated suffering, illness, and death, could have been avoided with higher vaccination coverage in this country,” she said.
A version of this article first appeared on Medscape.com.
The agency has called for masks in K-12 school settings and in areas of the United States experiencing high or substantial SARS-CoV-2 transmission, even for the fully vaccinated.
The move reverses a controversial announcement the agency made in May 2021 that fully vaccinated Americans could skip wearing a mask in most settings.
Unlike the increasing vaccination rates and decreasing case numbers reported in May, however, some regions of the United States are now reporting large jumps in COVID-19 case numbers. And the Delta variant as well as new evidence of transmission from breakthrough cases are largely driving these changes.
“Today we have new science related to the [D]elta variant that requires us to update the guidance on what you can do when you are fully vaccinated,” CDC Director Rochelle Walensky, MD, MPH, said during a media briefing July 27.
New evidence has emerged on breakthrough-case transmission risk, for example. “Information on the [D]elta variant from several states and other countries indicates that in rare cases, some people infected with the [D]elta variant after vaccination may be contagious and spread virus to others,” Dr. Walensky said, adding that the viral loads appear to be about the same in vaccinated and unvaccinated individuals.
“This new science is worrisome,” she said.
Even though unvaccinated people represent the vast majority of cases of transmission, Dr. Walensky said, “we thought it was important for [vaccinated] people to understand they have the potential to transmit the virus to others.”
As a result, in addition to continuing to strongly encourage everyone to get vaccinated, the CDC recommends that fully vaccinated people wear masks in public indoor settings to help prevent the spread of the Delta variant in areas with substantial or high transmission, Dr. Walensky said. “This includes schools.”
Masks in schools
The CDC is now recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Their goal is to optimize safety and allow children to return to full-time in-person learning in the fall.
The CDC tracks substantial and high transmission rates through the agency’s COVID Data Tracker site. Substantial transmission means between 50 and 100 cases per 100,000 people reported over 7 days and high means more than 100 cases per 100,000 people.
The B.1.617.2, or Delta, variant is believed to be responsible for COVID-19 cases increasing more than 300% nationally from June 19 to July 23, 2021.
“A prudent move”
“I think it’s a prudent move. Given the dominance of the [D]elta variant and the caseloads that we are seeing rising in many locations across the United States, including in my backyard here in San Francisco,” Joe DeRisi, PhD, copresident of the Chan Zuckerberg Biohub and professor of biochemistry and biophysics at the University of California San Francisco, said in an interview.
Dr. DeRisi said he was not surprised that vaccinated people with breakthrough infections could be capable of transmitting the virus. He added that clinical testing done by the Biohub and UCSF produced a lot of data on viral load levels, “and they cover an enormous range.”
What was unexpected to him was the rapid rise of the dominant variant. “The rise of the [D]elta strain is astonishing. It’s happened so fast,” he said.
“I know it’s difficult”
Reacting to the news, Colleen Kraft, MD, said, “One of the things that we’re learning is that if we’re going to have low vaccine uptake or we have a number of people that can’t be vaccinated yet, such as children, that we really need to go back to stopping transmission, which involves mask wearing.”
“I know that it’s very difficult and people feel like we’re sliding backward,” Dr. Kraft said during a media briefing sponsored by Emory University held shortly after the CDC announcement.
She added that the CDC updated guidance seems appropriate. “I don’t think any of us really want to be in this position or want to go back to masking but…we’re finding ourselves in the same place we were a year ago, in July 2020.
“In general we just don’t want anybody to be infected even if there’s a small chance for you to be infected and there’s a small chance for you to transmit it,” said Dr. Kraft, who’s an assistant professor in the department of pathology and associate professor in the department of medicine, division of infectious diseases at Emory University School of Medicine in Atlanta.
Breakthrough transmissions
“The good news is you’re still unlikely to get critically ill if you’re vaccinated. But what has changed with the [D]elta variant is instead of being 90% plus protected from getting the virus at all, you’re probably more in the 70% to 80% range,” James T. McDeavitt, MD, told this news organization.
“So we’re seeing breakthrough infections,” said Dr. McDeavitt, executive vice president and dean of clinical affairs at Baylor College of Medicine in Houston. “We are starting to see [such people] are potentially infectious.” Even if a vaccinated person is individually much less likely to experience serious COVID-19 outcomes, “they can spread it to someone else who spreads it to someone else who is more vulnerable. It puts the more at-risk populations at further risk.”
It breaks down to individual and public health concerns. “I am fully vaccinated. I am very confident I am not going to end up in a hospital,” he said. “Now if I were unvaccinated, with the prevalence of the virus around the country, I’m probably in more danger than I’ve ever been in the course of the pandemic. The unvaccinated are really at risk right now.”
IDSA and AMA support mask change
The Infectious Diseases Society of America (IDSA) has released a statement supporting the new CDC recommendations. “To stay ahead of the spread of the highly transmissible Delta variant, IDSA also urges that in communities with moderate transmission rates, all individuals, even those who are vaccinated, wear masks in indoor public places,” stated IDSA President Barbara D. Alexander, MD, MHS.
“IDSA also supports CDC’s guidance recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status, until vaccines are authorized and widely available to all children and vaccination rates are sufficient to control transmission.”
“Mask wearing will help reduce infections, prevent serious illnesses and death, limit strain on local hospitals and stave off the development of even more troubling variants,” she added.
The American Medical Association (AMA) also released a statement supporting the CDC’s policy changes.
“According to the CDC, emerging data indicates that vaccinated individuals infected with the Delta variant have similar viral loads as those who are unvaccinated and are capable of transmission,” AMA President Gerald E. Harmon, MD said in the statement.
“However, the science remains clear, the authorized vaccines remain safe and effective in preventing severe complications from COVID-19, including hospitalization and death,” he stated. “We strongly support the updated recommendations, which call for universal masking in areas of high or substantial COVID-19 transmission and in K-12 schools, to help reduce transmission of the virus. Wearing a mask is a small but important protective measure that can help us all stay safer.”
“The highest spread of cases and [most] severe outcomes are happening in places with low vaccination rates and among unvaccinated people,” Dr. Walensky said. “With the [D]elta variant, vaccinating more Americans now is more urgent than ever.”
“This moment, and the associated suffering, illness, and death, could have been avoided with higher vaccination coverage in this country,” she said.
A version of this article first appeared on Medscape.com.
Are you at legal risk for speaking at conferences?
When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.
The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.
This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.
The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.
Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
Speakers ‘have to be careful’
Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?
John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.
Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.
Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.
Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
Big asks, big secrecy
Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.
Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.
The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.
The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.
The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.
An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.
The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.
The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
‘It’s all on you’
Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.
“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.
“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.
Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.
A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.
The agreements also reflect America’s litigation-prone culture.
Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”
Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.
The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.
The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.
DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.
“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
Other potential pitfalls
Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.
DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.
ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.
Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.
Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
How presenters must prepare
Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.
“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.
It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.
Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.
Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.
“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
Accept or negotiate?
Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.
“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.
Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.
Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.
If in doubt, talk with a lawyer.
“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.
Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.
As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.
A version of this article first appeared on Medscape.com.
When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.
The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.
This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.
The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.
Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
Speakers ‘have to be careful’
Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?
John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.
Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.
Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.
Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
Big asks, big secrecy
Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.
Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.
The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.
The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.
The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.
An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.
The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.
The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
‘It’s all on you’
Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.
“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.
“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.
Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.
A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.
The agreements also reflect America’s litigation-prone culture.
Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”
Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.
The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.
The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.
DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.
“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
Other potential pitfalls
Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.
DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.
ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.
Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.
Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
How presenters must prepare
Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.
“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.
It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.
Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.
Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.
“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
Accept or negotiate?
Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.
“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.
Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.
Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.
If in doubt, talk with a lawyer.
“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.
Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.
As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.
A version of this article first appeared on Medscape.com.
When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.
The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.
This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.
The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.
Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
Speakers ‘have to be careful’
Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?
John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.
Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.
Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.
Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
Big asks, big secrecy
Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.
Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.
The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.
The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.
The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.
An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.
The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.
The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
‘It’s all on you’
Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.
“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.
“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.
Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.
A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.
The agreements also reflect America’s litigation-prone culture.
Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”
Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.
The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.
The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.
DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.
“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
Other potential pitfalls
Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.
DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.
ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.
Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.
Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
How presenters must prepare
Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.
“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.
It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.
Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.
Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.
“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
Accept or negotiate?
Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.
“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.
Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.
Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.
If in doubt, talk with a lawyer.
“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.
Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.
As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.
A version of this article first appeared on Medscape.com.
Children and COVID: Vaccinations, new cases both rising
COVID-19 vaccine initiations rose in U.S. children for the second consecutive week, but new pediatric cases jumped by 64% in just 1 week, according to new data.
the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.
“After decreases in weekly reported cases over the past couple of months, in July we have seen steady increases in cases added to the cumulative total,” the AAP noted. In this latest reversal of COVID fortunes, the steady increase in new cases is in its fourth consecutive week since hitting a low of 8,447 in late June.
As of July 22, the total number of reported cases was over 4.12 million in 49 states, the District of Columbia, New York City, Puerto Rico, and Guam, and there have been 349 deaths in children in the 46 jurisdictions reporting age distributions of COVID-19 deaths, the AAP and CHA said in their report.
Meanwhile, over 9.3 million children received at least one dose of COVID vaccine as of July 26, according to the Centers for Disease Control and Prevention.
Vaccine initiation rose for the second week in a row after falling for several weeks as 301,000 children aged 12-15 years and almost 115,000 children aged 16-17 got their first dose during the week ending July 26. Children aged 12-15 represented 14.1% (up from 13.5% a week before) of all first vaccinations and 16- to 17-year-olds were 5.4% (up from 5.1%) of all vaccine initiators, according to the CDC’s COVID Data Tracker.
Just over 37% of all 12- to 15-year-olds have received at least one dose of the Pfizer-BioNTech vaccine since the CDC approved its use for children under age 16 in May, and almost 28% are fully vaccinated. Use in children aged 16-17 started earlier (December 2020), and 48% of that age group have received a first dose and over 39% have completed the vaccine regimen, the CDC said.
COVID-19 vaccine initiations rose in U.S. children for the second consecutive week, but new pediatric cases jumped by 64% in just 1 week, according to new data.
the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.
“After decreases in weekly reported cases over the past couple of months, in July we have seen steady increases in cases added to the cumulative total,” the AAP noted. In this latest reversal of COVID fortunes, the steady increase in new cases is in its fourth consecutive week since hitting a low of 8,447 in late June.
As of July 22, the total number of reported cases was over 4.12 million in 49 states, the District of Columbia, New York City, Puerto Rico, and Guam, and there have been 349 deaths in children in the 46 jurisdictions reporting age distributions of COVID-19 deaths, the AAP and CHA said in their report.
Meanwhile, over 9.3 million children received at least one dose of COVID vaccine as of July 26, according to the Centers for Disease Control and Prevention.
Vaccine initiation rose for the second week in a row after falling for several weeks as 301,000 children aged 12-15 years and almost 115,000 children aged 16-17 got their first dose during the week ending July 26. Children aged 12-15 represented 14.1% (up from 13.5% a week before) of all first vaccinations and 16- to 17-year-olds were 5.4% (up from 5.1%) of all vaccine initiators, according to the CDC’s COVID Data Tracker.
Just over 37% of all 12- to 15-year-olds have received at least one dose of the Pfizer-BioNTech vaccine since the CDC approved its use for children under age 16 in May, and almost 28% are fully vaccinated. Use in children aged 16-17 started earlier (December 2020), and 48% of that age group have received a first dose and over 39% have completed the vaccine regimen, the CDC said.
COVID-19 vaccine initiations rose in U.S. children for the second consecutive week, but new pediatric cases jumped by 64% in just 1 week, according to new data.
the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.
“After decreases in weekly reported cases over the past couple of months, in July we have seen steady increases in cases added to the cumulative total,” the AAP noted. In this latest reversal of COVID fortunes, the steady increase in new cases is in its fourth consecutive week since hitting a low of 8,447 in late June.
As of July 22, the total number of reported cases was over 4.12 million in 49 states, the District of Columbia, New York City, Puerto Rico, and Guam, and there have been 349 deaths in children in the 46 jurisdictions reporting age distributions of COVID-19 deaths, the AAP and CHA said in their report.
Meanwhile, over 9.3 million children received at least one dose of COVID vaccine as of July 26, according to the Centers for Disease Control and Prevention.
Vaccine initiation rose for the second week in a row after falling for several weeks as 301,000 children aged 12-15 years and almost 115,000 children aged 16-17 got their first dose during the week ending July 26. Children aged 12-15 represented 14.1% (up from 13.5% a week before) of all first vaccinations and 16- to 17-year-olds were 5.4% (up from 5.1%) of all vaccine initiators, according to the CDC’s COVID Data Tracker.
Just over 37% of all 12- to 15-year-olds have received at least one dose of the Pfizer-BioNTech vaccine since the CDC approved its use for children under age 16 in May, and almost 28% are fully vaccinated. Use in children aged 16-17 started earlier (December 2020), and 48% of that age group have received a first dose and over 39% have completed the vaccine regimen, the CDC said.
COVID-19 vaccination does not increase risk of flare in patients with lupus
COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.
“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.
To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).
Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).
Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).
In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.
When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”
He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.
“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”
More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”
The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”
“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”
Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.
COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.
“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.
To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).
Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).
Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).
In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.
When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”
He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.
“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”
More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”
The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”
“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”
Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.
COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.
“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.
To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).
Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).
Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).
In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.
When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”
He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.
“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”
More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”
The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”
“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”
Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.
FROM THE LANCET RHEUMATOLOGY