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PCPs lag on albuminuria tests in patients with type 2 diabetes
U.S. primary care physicians are not properly checking patients with type 2 diabetes for chronic kidney disease (CKD) nearly as often as they should, meaning many of these patients miss getting a timely diagnosis.
Inadequate measurement of urinary albumin-to-creatinine ratio (uACR) is the issue.
Review of data from more than half a million U.S. primary care patients with type 2 diabetes seen at any of 1,164 practice sites run by any of 24 health care organizations during 2016-2019 showed that barely more than half, 52%, had both their uACR and estimated glomerular filtration rate (eGFR) checked annually as recommended by several U.S. medical societies, and just 73% had both values checked during a 3-year period, Nikita Stempniewicz, MSc, and associates reported in Diabetes Care.
More detailed data showed that measurement of eGFR was reasonably robust, measured at a 90% rate annually and in 97% of patients at least once every 3 years. But recording uACR values lagged, with a 53% annual rate and a 74% rate of measurement at least once every 3 years, reported Mr. Stempniewicz, director of research and analytics for the American Medical Group Association, a trade association based in Alexandria, Va. The 24 health care organizations that supplied the study’s data are all members of this association.
Prevailing recommendations from various medical societies call for annual monitoring of urinary albumin in patients with type 2 diabetes and specify the uACR, such as in the Standards of Medical Care in Diabetes from the American Diabetes Association, as well as in recommendations promoted by the National Kidney Foundation.
Missing half the CKD patients with eGFR only
“Half the patients with type 2 diabetes and chronic kidney disease have elevated albuminuria without decreased eGFR and would not be detected with eGFR testing alone,” Mr. Stempniewicz noted in an interview.
“Many patients who present for nephrology care are incompletely assessed with only low eGFR but no urine testing. Missing albuminuria testing and uACR values means patients with high levels of albuminuria but normal kidney function go undetected and thus are not able to benefit from evidenced-based interventions, including nephrology services,” said Joseph A. Vassalotti, MD, a nephrologist, chief medical officer for the National Kidney Foundation, and a coauthor of the report.
Not testing patients with type 2 diabetes regularly for their uACR “is a missed opportunity to identify the highest-risk patients and treat them,” added Josef Coresh, MD, PhD, a professor of clinical epidemiology at Johns Hopkins University, Baltimore, and senior author on the study. Measurement of albuminuria is especially important for these patients because medications from the sodium-glucose cotransporter 2 inhibitor class have been proven to slow progression of CKD in patients with type 2 diabetes, but these drugs are expensive, and in some cases have labeling that specifies the presence of albuminuria.
“I have no doubt that improving albuminuria testing is a critical step to identify patients with diabetes at highest risk who should get the best treatment possible, including SGLT2 inhibitors,” Dr. Coresh said in an interview.
The new report is not the first to document inadequate assessment of albuminuria and uACR among primary care physicians (PCPs), but it came from the largest reported U.S. study to date. “eGFR is commonly collected in a routine laboratory blood panel, but collecting urine requires additional work flow,” noted Cara B. Litvin, MD, a general internal medicine researcher at the Medical University of South Carolina, Charleston, who has tested interventions aimed at boosting CKD assessment by PCPs and was not involved in the new study.
“There have also been conflicting guidelines,” such as a “now-inactive guideline from the American College of Physicians that recommended against routine urine albumin screening in patients with diabetes and already on treatment with an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker,” she said.
New renal drugs change the stakes
The availability of newer drugs for slowing CKD progression such as the SGLT2 inhibitors will help trigger greater support for routine albuminuria testing, Dr. Litvin predicted in an interview. “Now that we have more medications that can reduce albuminuria and improve outcomes, I see screening for albuminuria increasing.” Finerenone (Kerendia) is another new agent from a new class that recently received Food and Drug Administration approval for treating CKD in patients with type 2 diabetes.
Other drivers of increased uACR testing she expects include revised clinical practice guidelines, and new quality measures of clinical care.
“Undertesting of albuminuria means that [nephrologists] have incomplete data to detect and completely risk stratify the CKD population. That in turn results in a reduced ability to match population health interventions to the severity of the condition or the risk stratification based on eGFR and uACR,” Dr. Vassalotti said in an interview.
“We are missing opportunities to prevent or delay kidney failure and reduce the risk of cardiovascular events and cardiovascular death in these patients, particularly now that we have a number of medications that offer kidney and cardiovascular protection such as SGLT2 inhibitors,” he added. “Leaders in nephrology are beginning to understand the consequences of undertesting, and are working to innovate to improve risk stratification, CKD detection, and apply interventions to give Americans living with CKD better outcomes.”
Strategies proven to boost albuminuria testing
Mr. Stempniewicz and coauthors cited in their report potential strategies for improving albuminuria testing, including benchmarking to identify best-performing sites for albumin testing within a health system and encouraging replication of identified best practices at lower-performing sites, and implementation of clinical-decision support tools in the EHR such as pop-up test reminders.
These were among the tools tested in two studies led by Dr. Litvin. One study, with results reported in 2016, involved 12 small U.S. primary care practices with a total of more than 30,000 patients and compared performance in a series of clinical quality measures at baseline with performance after 2 years of receiving various interventions designed to boost awareness for albuminuria testing.
The second study, with findings reported in 2019, involved 21 U.S. primary care practices that collectively cared for more than 100,000 patients and randomized the practices to either undergo interventions aimed at boosting testing awareness or to serve as controls.
Results from both studies showed significant and substantial increases in serial testing for albuminuria in patients with diabetes or hypertension when practices received the interventions.
“We showed that [using a] clinical-decision support tool, along with standing orders to automatically collect urine specimens, dramatically increased screening for urinary albumin in primary care practices,” Dr. Litvin said. “However, perhaps because of conflicting guidelines and clinical inertia there hasn’t been a major impetus for primary care practices in general to improve screening.” She hopes that will quickly change.
“As we have shown, adoption of EHR-based reminders along with standing orders can very quickly improve screening for albuminuria in primary care.”
Variation in testing rates among sites ‘tremendous’
One finding of the new study gives Mr. Stempniewicz hope for greater future testing: The large variance that the researchers saw in albuminuria testing rates within individual health systems.
“The paper shows that higher rates of testing are completely achievable within each system. Some clinics do very well, and the other units can learn from these local successes,” he said. At least half the organizations in the study had individual sites that fell into the top 10% for testing rates across all the greater than 1,000 sites included, and those same organizations also had at least one site that fell into the bottom 10% for testing.
“The variation is tremendous, and highlights an opportunity for improvement,” declared Mr. Stempniewicz.
“For routine testing, you need systems that help people. Clinicians shouldn’t have to think about doing routine testing. It should just happen,” said Dr. Coresh.
The study was funded in part by Janssen. Mr. Stempniewicz and Dr. Litvin had no disclosures. Dr. Coresh is an adviser to Healthy.io, a company that markets a home albuminuria testing kit to patients. Dr. Vassalotti has received personal fees from Renalytix.
U.S. primary care physicians are not properly checking patients with type 2 diabetes for chronic kidney disease (CKD) nearly as often as they should, meaning many of these patients miss getting a timely diagnosis.
Inadequate measurement of urinary albumin-to-creatinine ratio (uACR) is the issue.
Review of data from more than half a million U.S. primary care patients with type 2 diabetes seen at any of 1,164 practice sites run by any of 24 health care organizations during 2016-2019 showed that barely more than half, 52%, had both their uACR and estimated glomerular filtration rate (eGFR) checked annually as recommended by several U.S. medical societies, and just 73% had both values checked during a 3-year period, Nikita Stempniewicz, MSc, and associates reported in Diabetes Care.
More detailed data showed that measurement of eGFR was reasonably robust, measured at a 90% rate annually and in 97% of patients at least once every 3 years. But recording uACR values lagged, with a 53% annual rate and a 74% rate of measurement at least once every 3 years, reported Mr. Stempniewicz, director of research and analytics for the American Medical Group Association, a trade association based in Alexandria, Va. The 24 health care organizations that supplied the study’s data are all members of this association.
Prevailing recommendations from various medical societies call for annual monitoring of urinary albumin in patients with type 2 diabetes and specify the uACR, such as in the Standards of Medical Care in Diabetes from the American Diabetes Association, as well as in recommendations promoted by the National Kidney Foundation.
Missing half the CKD patients with eGFR only
“Half the patients with type 2 diabetes and chronic kidney disease have elevated albuminuria without decreased eGFR and would not be detected with eGFR testing alone,” Mr. Stempniewicz noted in an interview.
“Many patients who present for nephrology care are incompletely assessed with only low eGFR but no urine testing. Missing albuminuria testing and uACR values means patients with high levels of albuminuria but normal kidney function go undetected and thus are not able to benefit from evidenced-based interventions, including nephrology services,” said Joseph A. Vassalotti, MD, a nephrologist, chief medical officer for the National Kidney Foundation, and a coauthor of the report.
Not testing patients with type 2 diabetes regularly for their uACR “is a missed opportunity to identify the highest-risk patients and treat them,” added Josef Coresh, MD, PhD, a professor of clinical epidemiology at Johns Hopkins University, Baltimore, and senior author on the study. Measurement of albuminuria is especially important for these patients because medications from the sodium-glucose cotransporter 2 inhibitor class have been proven to slow progression of CKD in patients with type 2 diabetes, but these drugs are expensive, and in some cases have labeling that specifies the presence of albuminuria.
“I have no doubt that improving albuminuria testing is a critical step to identify patients with diabetes at highest risk who should get the best treatment possible, including SGLT2 inhibitors,” Dr. Coresh said in an interview.
The new report is not the first to document inadequate assessment of albuminuria and uACR among primary care physicians (PCPs), but it came from the largest reported U.S. study to date. “eGFR is commonly collected in a routine laboratory blood panel, but collecting urine requires additional work flow,” noted Cara B. Litvin, MD, a general internal medicine researcher at the Medical University of South Carolina, Charleston, who has tested interventions aimed at boosting CKD assessment by PCPs and was not involved in the new study.
“There have also been conflicting guidelines,” such as a “now-inactive guideline from the American College of Physicians that recommended against routine urine albumin screening in patients with diabetes and already on treatment with an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker,” she said.
New renal drugs change the stakes
The availability of newer drugs for slowing CKD progression such as the SGLT2 inhibitors will help trigger greater support for routine albuminuria testing, Dr. Litvin predicted in an interview. “Now that we have more medications that can reduce albuminuria and improve outcomes, I see screening for albuminuria increasing.” Finerenone (Kerendia) is another new agent from a new class that recently received Food and Drug Administration approval for treating CKD in patients with type 2 diabetes.
Other drivers of increased uACR testing she expects include revised clinical practice guidelines, and new quality measures of clinical care.
“Undertesting of albuminuria means that [nephrologists] have incomplete data to detect and completely risk stratify the CKD population. That in turn results in a reduced ability to match population health interventions to the severity of the condition or the risk stratification based on eGFR and uACR,” Dr. Vassalotti said in an interview.
“We are missing opportunities to prevent or delay kidney failure and reduce the risk of cardiovascular events and cardiovascular death in these patients, particularly now that we have a number of medications that offer kidney and cardiovascular protection such as SGLT2 inhibitors,” he added. “Leaders in nephrology are beginning to understand the consequences of undertesting, and are working to innovate to improve risk stratification, CKD detection, and apply interventions to give Americans living with CKD better outcomes.”
Strategies proven to boost albuminuria testing
Mr. Stempniewicz and coauthors cited in their report potential strategies for improving albuminuria testing, including benchmarking to identify best-performing sites for albumin testing within a health system and encouraging replication of identified best practices at lower-performing sites, and implementation of clinical-decision support tools in the EHR such as pop-up test reminders.
These were among the tools tested in two studies led by Dr. Litvin. One study, with results reported in 2016, involved 12 small U.S. primary care practices with a total of more than 30,000 patients and compared performance in a series of clinical quality measures at baseline with performance after 2 years of receiving various interventions designed to boost awareness for albuminuria testing.
The second study, with findings reported in 2019, involved 21 U.S. primary care practices that collectively cared for more than 100,000 patients and randomized the practices to either undergo interventions aimed at boosting testing awareness or to serve as controls.
Results from both studies showed significant and substantial increases in serial testing for albuminuria in patients with diabetes or hypertension when practices received the interventions.
“We showed that [using a] clinical-decision support tool, along with standing orders to automatically collect urine specimens, dramatically increased screening for urinary albumin in primary care practices,” Dr. Litvin said. “However, perhaps because of conflicting guidelines and clinical inertia there hasn’t been a major impetus for primary care practices in general to improve screening.” She hopes that will quickly change.
“As we have shown, adoption of EHR-based reminders along with standing orders can very quickly improve screening for albuminuria in primary care.”
Variation in testing rates among sites ‘tremendous’
One finding of the new study gives Mr. Stempniewicz hope for greater future testing: The large variance that the researchers saw in albuminuria testing rates within individual health systems.
“The paper shows that higher rates of testing are completely achievable within each system. Some clinics do very well, and the other units can learn from these local successes,” he said. At least half the organizations in the study had individual sites that fell into the top 10% for testing rates across all the greater than 1,000 sites included, and those same organizations also had at least one site that fell into the bottom 10% for testing.
“The variation is tremendous, and highlights an opportunity for improvement,” declared Mr. Stempniewicz.
“For routine testing, you need systems that help people. Clinicians shouldn’t have to think about doing routine testing. It should just happen,” said Dr. Coresh.
The study was funded in part by Janssen. Mr. Stempniewicz and Dr. Litvin had no disclosures. Dr. Coresh is an adviser to Healthy.io, a company that markets a home albuminuria testing kit to patients. Dr. Vassalotti has received personal fees from Renalytix.
U.S. primary care physicians are not properly checking patients with type 2 diabetes for chronic kidney disease (CKD) nearly as often as they should, meaning many of these patients miss getting a timely diagnosis.
Inadequate measurement of urinary albumin-to-creatinine ratio (uACR) is the issue.
Review of data from more than half a million U.S. primary care patients with type 2 diabetes seen at any of 1,164 practice sites run by any of 24 health care organizations during 2016-2019 showed that barely more than half, 52%, had both their uACR and estimated glomerular filtration rate (eGFR) checked annually as recommended by several U.S. medical societies, and just 73% had both values checked during a 3-year period, Nikita Stempniewicz, MSc, and associates reported in Diabetes Care.
More detailed data showed that measurement of eGFR was reasonably robust, measured at a 90% rate annually and in 97% of patients at least once every 3 years. But recording uACR values lagged, with a 53% annual rate and a 74% rate of measurement at least once every 3 years, reported Mr. Stempniewicz, director of research and analytics for the American Medical Group Association, a trade association based in Alexandria, Va. The 24 health care organizations that supplied the study’s data are all members of this association.
Prevailing recommendations from various medical societies call for annual monitoring of urinary albumin in patients with type 2 diabetes and specify the uACR, such as in the Standards of Medical Care in Diabetes from the American Diabetes Association, as well as in recommendations promoted by the National Kidney Foundation.
Missing half the CKD patients with eGFR only
“Half the patients with type 2 diabetes and chronic kidney disease have elevated albuminuria without decreased eGFR and would not be detected with eGFR testing alone,” Mr. Stempniewicz noted in an interview.
“Many patients who present for nephrology care are incompletely assessed with only low eGFR but no urine testing. Missing albuminuria testing and uACR values means patients with high levels of albuminuria but normal kidney function go undetected and thus are not able to benefit from evidenced-based interventions, including nephrology services,” said Joseph A. Vassalotti, MD, a nephrologist, chief medical officer for the National Kidney Foundation, and a coauthor of the report.
Not testing patients with type 2 diabetes regularly for their uACR “is a missed opportunity to identify the highest-risk patients and treat them,” added Josef Coresh, MD, PhD, a professor of clinical epidemiology at Johns Hopkins University, Baltimore, and senior author on the study. Measurement of albuminuria is especially important for these patients because medications from the sodium-glucose cotransporter 2 inhibitor class have been proven to slow progression of CKD in patients with type 2 diabetes, but these drugs are expensive, and in some cases have labeling that specifies the presence of albuminuria.
“I have no doubt that improving albuminuria testing is a critical step to identify patients with diabetes at highest risk who should get the best treatment possible, including SGLT2 inhibitors,” Dr. Coresh said in an interview.
The new report is not the first to document inadequate assessment of albuminuria and uACR among primary care physicians (PCPs), but it came from the largest reported U.S. study to date. “eGFR is commonly collected in a routine laboratory blood panel, but collecting urine requires additional work flow,” noted Cara B. Litvin, MD, a general internal medicine researcher at the Medical University of South Carolina, Charleston, who has tested interventions aimed at boosting CKD assessment by PCPs and was not involved in the new study.
“There have also been conflicting guidelines,” such as a “now-inactive guideline from the American College of Physicians that recommended against routine urine albumin screening in patients with diabetes and already on treatment with an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker,” she said.
New renal drugs change the stakes
The availability of newer drugs for slowing CKD progression such as the SGLT2 inhibitors will help trigger greater support for routine albuminuria testing, Dr. Litvin predicted in an interview. “Now that we have more medications that can reduce albuminuria and improve outcomes, I see screening for albuminuria increasing.” Finerenone (Kerendia) is another new agent from a new class that recently received Food and Drug Administration approval for treating CKD in patients with type 2 diabetes.
Other drivers of increased uACR testing she expects include revised clinical practice guidelines, and new quality measures of clinical care.
“Undertesting of albuminuria means that [nephrologists] have incomplete data to detect and completely risk stratify the CKD population. That in turn results in a reduced ability to match population health interventions to the severity of the condition or the risk stratification based on eGFR and uACR,” Dr. Vassalotti said in an interview.
“We are missing opportunities to prevent or delay kidney failure and reduce the risk of cardiovascular events and cardiovascular death in these patients, particularly now that we have a number of medications that offer kidney and cardiovascular protection such as SGLT2 inhibitors,” he added. “Leaders in nephrology are beginning to understand the consequences of undertesting, and are working to innovate to improve risk stratification, CKD detection, and apply interventions to give Americans living with CKD better outcomes.”
Strategies proven to boost albuminuria testing
Mr. Stempniewicz and coauthors cited in their report potential strategies for improving albuminuria testing, including benchmarking to identify best-performing sites for albumin testing within a health system and encouraging replication of identified best practices at lower-performing sites, and implementation of clinical-decision support tools in the EHR such as pop-up test reminders.
These were among the tools tested in two studies led by Dr. Litvin. One study, with results reported in 2016, involved 12 small U.S. primary care practices with a total of more than 30,000 patients and compared performance in a series of clinical quality measures at baseline with performance after 2 years of receiving various interventions designed to boost awareness for albuminuria testing.
The second study, with findings reported in 2019, involved 21 U.S. primary care practices that collectively cared for more than 100,000 patients and randomized the practices to either undergo interventions aimed at boosting testing awareness or to serve as controls.
Results from both studies showed significant and substantial increases in serial testing for albuminuria in patients with diabetes or hypertension when practices received the interventions.
“We showed that [using a] clinical-decision support tool, along with standing orders to automatically collect urine specimens, dramatically increased screening for urinary albumin in primary care practices,” Dr. Litvin said. “However, perhaps because of conflicting guidelines and clinical inertia there hasn’t been a major impetus for primary care practices in general to improve screening.” She hopes that will quickly change.
“As we have shown, adoption of EHR-based reminders along with standing orders can very quickly improve screening for albuminuria in primary care.”
Variation in testing rates among sites ‘tremendous’
One finding of the new study gives Mr. Stempniewicz hope for greater future testing: The large variance that the researchers saw in albuminuria testing rates within individual health systems.
“The paper shows that higher rates of testing are completely achievable within each system. Some clinics do very well, and the other units can learn from these local successes,” he said. At least half the organizations in the study had individual sites that fell into the top 10% for testing rates across all the greater than 1,000 sites included, and those same organizations also had at least one site that fell into the bottom 10% for testing.
“The variation is tremendous, and highlights an opportunity for improvement,” declared Mr. Stempniewicz.
“For routine testing, you need systems that help people. Clinicians shouldn’t have to think about doing routine testing. It should just happen,” said Dr. Coresh.
The study was funded in part by Janssen. Mr. Stempniewicz and Dr. Litvin had no disclosures. Dr. Coresh is an adviser to Healthy.io, a company that markets a home albuminuria testing kit to patients. Dr. Vassalotti has received personal fees from Renalytix.
FROM DIABETES CARE
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.
ACC issues decision pathway for hypertriglyceridemia management
A new decision pathway for the management of hypertriglyceridemia, prompted by a large and growing body of evidence that elevated triglycerides to a targetable risk factor for atherosclerotic cardiovascular disease (ASCVD), has been issued by the American College of Cardiology.
According to the chairman of the writing committee, Salim S. Virani, MD, PhD, the recommendations amplify and update more than alter the hypertriglyceridemia treatment recommendations in the 2018 joint multisociety blood cholesterol guidelines issued in 2018.
This decision pathway, however, is focused on triglycerides alone.
“The previous guidelines included a section on strategies for addressing hypertriglyceridemia to reduce ASCVD risk, but this new decision pathway builds on the recommendations with more details and with additional information,” explained Dr. Virani, professor of medicine in the section of cardiovascular research, Baylor College of Medicine, Houston.
Within this newly published document, the definitions of hypertriglyceridemia and rationale for treatment are followed by detailed algorithms for four specific patient groups with varying triglyceride levels:
- Adults with ASCVD.
- Adults at least 40 years of age with diabetes but no ASCVD.
- Adults at least 20 years of age with no ASCVD or diabetes.
- Adults at least 20 years of age with severe hypertriglyceridemia.
“In the design of these algorithms, we made an active effort to make them suitable for use by primary care physicians as well as specialists,” said Dr. Virani. Despite “lots of boxes and arrows,” the flowcharts for each of these patient groups permit clinicians to follow the decision pathway without having to reread the text.
The common emphasis in all four algorithms is to begin by evaluating patients for secondary causes of hypertriglyceridemia, such as multifactorial chylomicronemia syndrome and other diseases associated with elevated triglycerides. The next steps, also common to all algorithms, are to optimize diet and lifestyle changes that lower triglycerides, optimize glycemic control, and optimize statin therapy.
“Although commonly recognized for their impact on LDL-C, statins also provide a 10%-30% dose-dependent reduction in triglycerides in patients with elevated levels,” the guidelines state. Statins are considered a fundamental step to secondary prevention of ASCVD regardless of triglyceride levels.
Once treatable causes or contributors to hypertriglyceridemia have been addressed, lifestyle interventions and statin therapy have been optimized, pharmacologic therapy directed specifically at control of hypertriglyceridemia “can be considered” in those at highest risk of ASCVD events, but Dr. Virani explained that this is never an early or first step in control of elevated triglycerides.
“The entire working group agreed that lifestyle interventions should be highlighted front and center before considering any other intervention,” Dr. Virani explained.
Pharmacologic therapy for hypertriglyceridemia is not ignored. Prescription omega-3 fatty acid products are preferred over nonprescription dietary supplements, which may vary in quality and purity. But these products, rather than a standalone solution, are best applied within the context of efforts to improve diet, lower body weight, and increase physical activity.
Several trials have associated ethyl ester and carboxylic acid preparations with meaningful reductions in triglycerides, but these drugs, including icosapent ethyl (IPE), are not without adverse events. In the pivotal REDUCE-IT trial, IPE was linked with an increased risk of atrial fibrillation relative to placebo.
IPE is “the best option” and the only therapy with an indication for reduction in ASCVD risk, according to Dr. Virani, but he explained that safety concerns led the authors of the new decision pathway to employ cautious language in regard to its use, suggesting that it be “considered” in high-risk patients after other methods of lowering triglycerides have been optimized.
In the algorithm for the four different risk groups, the decision pathways follow stratifications for different levels of hypertriglyceridemia (defined under fasting and nonfasting conditions) and also for specific levels of LDL cholesterol. ASCVD risk assessment is also a factor in determining the next steps along the decision pathway.
According to Michael Davidson, MD, director of the lipid clinic at the University of Chicago, the emphasis on lifestyle changes for hypertriglyceridemia and the prudent language in regard to pharmacologic therapy is appropriate.
“In light of the controversies regarding the REDUCE-IT trial, the writing committee has done a nice job with providing useful guidance regarding the utilization of icosapent ethyl in higher risk patients,” Dr. Davidson said.
Calling the ACC decision pathway “a welcome enhancement of the 2018 ACC/AHA cholesterol guidelines,” Dr. Davidson praised the way in which the limitations of the evidence regarding pharmacologic therapies were explained.
“Most importantly, this decision pathway helps clinicians appreciate that hypertriglyceridemia can be best managed with lifestyle changes and addressing potential secondary causes,” Dr. Davidson said.
Dr. Virani reports no potential conflicts of interest. Dr. Davidson reports financial relationships with multiple pharmaceutical companies including those making or pursuing therapies for control of hypertriglyceridemia.
A new decision pathway for the management of hypertriglyceridemia, prompted by a large and growing body of evidence that elevated triglycerides to a targetable risk factor for atherosclerotic cardiovascular disease (ASCVD), has been issued by the American College of Cardiology.
According to the chairman of the writing committee, Salim S. Virani, MD, PhD, the recommendations amplify and update more than alter the hypertriglyceridemia treatment recommendations in the 2018 joint multisociety blood cholesterol guidelines issued in 2018.
This decision pathway, however, is focused on triglycerides alone.
“The previous guidelines included a section on strategies for addressing hypertriglyceridemia to reduce ASCVD risk, but this new decision pathway builds on the recommendations with more details and with additional information,” explained Dr. Virani, professor of medicine in the section of cardiovascular research, Baylor College of Medicine, Houston.
Within this newly published document, the definitions of hypertriglyceridemia and rationale for treatment are followed by detailed algorithms for four specific patient groups with varying triglyceride levels:
- Adults with ASCVD.
- Adults at least 40 years of age with diabetes but no ASCVD.
- Adults at least 20 years of age with no ASCVD or diabetes.
- Adults at least 20 years of age with severe hypertriglyceridemia.
“In the design of these algorithms, we made an active effort to make them suitable for use by primary care physicians as well as specialists,” said Dr. Virani. Despite “lots of boxes and arrows,” the flowcharts for each of these patient groups permit clinicians to follow the decision pathway without having to reread the text.
The common emphasis in all four algorithms is to begin by evaluating patients for secondary causes of hypertriglyceridemia, such as multifactorial chylomicronemia syndrome and other diseases associated with elevated triglycerides. The next steps, also common to all algorithms, are to optimize diet and lifestyle changes that lower triglycerides, optimize glycemic control, and optimize statin therapy.
“Although commonly recognized for their impact on LDL-C, statins also provide a 10%-30% dose-dependent reduction in triglycerides in patients with elevated levels,” the guidelines state. Statins are considered a fundamental step to secondary prevention of ASCVD regardless of triglyceride levels.
Once treatable causes or contributors to hypertriglyceridemia have been addressed, lifestyle interventions and statin therapy have been optimized, pharmacologic therapy directed specifically at control of hypertriglyceridemia “can be considered” in those at highest risk of ASCVD events, but Dr. Virani explained that this is never an early or first step in control of elevated triglycerides.
“The entire working group agreed that lifestyle interventions should be highlighted front and center before considering any other intervention,” Dr. Virani explained.
Pharmacologic therapy for hypertriglyceridemia is not ignored. Prescription omega-3 fatty acid products are preferred over nonprescription dietary supplements, which may vary in quality and purity. But these products, rather than a standalone solution, are best applied within the context of efforts to improve diet, lower body weight, and increase physical activity.
Several trials have associated ethyl ester and carboxylic acid preparations with meaningful reductions in triglycerides, but these drugs, including icosapent ethyl (IPE), are not without adverse events. In the pivotal REDUCE-IT trial, IPE was linked with an increased risk of atrial fibrillation relative to placebo.
IPE is “the best option” and the only therapy with an indication for reduction in ASCVD risk, according to Dr. Virani, but he explained that safety concerns led the authors of the new decision pathway to employ cautious language in regard to its use, suggesting that it be “considered” in high-risk patients after other methods of lowering triglycerides have been optimized.
In the algorithm for the four different risk groups, the decision pathways follow stratifications for different levels of hypertriglyceridemia (defined under fasting and nonfasting conditions) and also for specific levels of LDL cholesterol. ASCVD risk assessment is also a factor in determining the next steps along the decision pathway.
According to Michael Davidson, MD, director of the lipid clinic at the University of Chicago, the emphasis on lifestyle changes for hypertriglyceridemia and the prudent language in regard to pharmacologic therapy is appropriate.
“In light of the controversies regarding the REDUCE-IT trial, the writing committee has done a nice job with providing useful guidance regarding the utilization of icosapent ethyl in higher risk patients,” Dr. Davidson said.
Calling the ACC decision pathway “a welcome enhancement of the 2018 ACC/AHA cholesterol guidelines,” Dr. Davidson praised the way in which the limitations of the evidence regarding pharmacologic therapies were explained.
“Most importantly, this decision pathway helps clinicians appreciate that hypertriglyceridemia can be best managed with lifestyle changes and addressing potential secondary causes,” Dr. Davidson said.
Dr. Virani reports no potential conflicts of interest. Dr. Davidson reports financial relationships with multiple pharmaceutical companies including those making or pursuing therapies for control of hypertriglyceridemia.
A new decision pathway for the management of hypertriglyceridemia, prompted by a large and growing body of evidence that elevated triglycerides to a targetable risk factor for atherosclerotic cardiovascular disease (ASCVD), has been issued by the American College of Cardiology.
According to the chairman of the writing committee, Salim S. Virani, MD, PhD, the recommendations amplify and update more than alter the hypertriglyceridemia treatment recommendations in the 2018 joint multisociety blood cholesterol guidelines issued in 2018.
This decision pathway, however, is focused on triglycerides alone.
“The previous guidelines included a section on strategies for addressing hypertriglyceridemia to reduce ASCVD risk, but this new decision pathway builds on the recommendations with more details and with additional information,” explained Dr. Virani, professor of medicine in the section of cardiovascular research, Baylor College of Medicine, Houston.
Within this newly published document, the definitions of hypertriglyceridemia and rationale for treatment are followed by detailed algorithms for four specific patient groups with varying triglyceride levels:
- Adults with ASCVD.
- Adults at least 40 years of age with diabetes but no ASCVD.
- Adults at least 20 years of age with no ASCVD or diabetes.
- Adults at least 20 years of age with severe hypertriglyceridemia.
“In the design of these algorithms, we made an active effort to make them suitable for use by primary care physicians as well as specialists,” said Dr. Virani. Despite “lots of boxes and arrows,” the flowcharts for each of these patient groups permit clinicians to follow the decision pathway without having to reread the text.
The common emphasis in all four algorithms is to begin by evaluating patients for secondary causes of hypertriglyceridemia, such as multifactorial chylomicronemia syndrome and other diseases associated with elevated triglycerides. The next steps, also common to all algorithms, are to optimize diet and lifestyle changes that lower triglycerides, optimize glycemic control, and optimize statin therapy.
“Although commonly recognized for their impact on LDL-C, statins also provide a 10%-30% dose-dependent reduction in triglycerides in patients with elevated levels,” the guidelines state. Statins are considered a fundamental step to secondary prevention of ASCVD regardless of triglyceride levels.
Once treatable causes or contributors to hypertriglyceridemia have been addressed, lifestyle interventions and statin therapy have been optimized, pharmacologic therapy directed specifically at control of hypertriglyceridemia “can be considered” in those at highest risk of ASCVD events, but Dr. Virani explained that this is never an early or first step in control of elevated triglycerides.
“The entire working group agreed that lifestyle interventions should be highlighted front and center before considering any other intervention,” Dr. Virani explained.
Pharmacologic therapy for hypertriglyceridemia is not ignored. Prescription omega-3 fatty acid products are preferred over nonprescription dietary supplements, which may vary in quality and purity. But these products, rather than a standalone solution, are best applied within the context of efforts to improve diet, lower body weight, and increase physical activity.
Several trials have associated ethyl ester and carboxylic acid preparations with meaningful reductions in triglycerides, but these drugs, including icosapent ethyl (IPE), are not without adverse events. In the pivotal REDUCE-IT trial, IPE was linked with an increased risk of atrial fibrillation relative to placebo.
IPE is “the best option” and the only therapy with an indication for reduction in ASCVD risk, according to Dr. Virani, but he explained that safety concerns led the authors of the new decision pathway to employ cautious language in regard to its use, suggesting that it be “considered” in high-risk patients after other methods of lowering triglycerides have been optimized.
In the algorithm for the four different risk groups, the decision pathways follow stratifications for different levels of hypertriglyceridemia (defined under fasting and nonfasting conditions) and also for specific levels of LDL cholesterol. ASCVD risk assessment is also a factor in determining the next steps along the decision pathway.
According to Michael Davidson, MD, director of the lipid clinic at the University of Chicago, the emphasis on lifestyle changes for hypertriglyceridemia and the prudent language in regard to pharmacologic therapy is appropriate.
“In light of the controversies regarding the REDUCE-IT trial, the writing committee has done a nice job with providing useful guidance regarding the utilization of icosapent ethyl in higher risk patients,” Dr. Davidson said.
Calling the ACC decision pathway “a welcome enhancement of the 2018 ACC/AHA cholesterol guidelines,” Dr. Davidson praised the way in which the limitations of the evidence regarding pharmacologic therapies were explained.
“Most importantly, this decision pathway helps clinicians appreciate that hypertriglyceridemia can be best managed with lifestyle changes and addressing potential secondary causes,” Dr. Davidson said.
Dr. Virani reports no potential conflicts of interest. Dr. Davidson reports financial relationships with multiple pharmaceutical companies including those making or pursuing therapies for control of hypertriglyceridemia.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
ARBs equal ACE inhibitors for hypertension, and better tolerated
In the largest comparison of angiotensin receptor blockers (ARBs) and ACE inhibitors to date, a study of nearly 2.3 million patients starting the drugs as monotherapy shows no significant differences between the two in the long-term prevention of hypertension-related cardiovascular events.
However, side effects were notably lower with ARBs.
“This is a very large, well-executed observational study that confirms that ARBs appear to have fewer side effects than ACE inhibitors, and no unexpected ARB side effects were detected,” senior author George Hripcsak, MD, professor and chair of biomedical informatics at Columbia University, New York, told this news organization.
“Despite being equally guideline-recommended first-line therapies for hypertension, these results support preferentially starting ARBs rather than ACE inhibitors when initiating treatment for hypertension for physicians and patients considering renin-angiotensin system (RAS) inhibition,” the authors added in the study, published online July 26, 2021, in the journal Hypertension.
They noted that both drug classes have been on the market a long time, with proven efficacy in hypertension and “a wide availability of inexpensive generic forms.”
They also stressed that their findings only apply to patients with hypertension for whom a RAS inhibitor would be the best choice of therapy.
Commenting on the research, George Bakris, MD, of the American Heart Association’s Comprehensive Hypertension Center at the University of Chicago, said the findings were consistent with his experience in prescribing as well as researching the two drug classes.
“I have been in practice for over 30 years and studied both classes, including head-to-head prospective trials to assess blood pressure, and found in many cases better blood pressure lowering by some ARBs and always better tolerability,” he told this news organization. “I think this study confirms and extends my thoughts between the two classes of blood pressure–lowering agents.”
Head-to-head comparisons of ACE inhibitors and ARBs limited to date
ACE inhibitors and ARBs each have extensive evidence supporting their roles as first-line medications in the treatment of hypertension, and each have the strongest recommendations in international guidelines.
However, ACE inhibitors are prescribed more commonly than ARBs as the first-line drug for lowering blood pressure, and head-to-head comparisons of the two are limited, with conflicting results.
For the study, Dr. Hripcsak and colleagues evaluated data on almost 3 million patients starting monotherapy with an ACE inhibitor or ARB for the first time between 1996 and 2018 in the United States, Germany, and South Korea, who had no history of heart disease or stroke.
They identified a total of 2,297,881 patients initiating ACE inhibitors and 673,938 starting ARBs. Among new users of ACE inhibitors, most received lisinopril (80%), followed by ramipril and enalapril, while most patients prescribed ARBs received losartan (45%), followed by valsartan and olmesartan.
With follow-up times ranging from about 4 months to more than 18 months, the data show no statistically significant differences between ACE inhibitors versus ARBs in the primary outcomes of acute myocardial infarction (hazard ratio, 1.11), heart failure (HR, 1.03), stroke (HR, 1.07), or composite cardiovascular events (HR, 1.06).
For secondary and safety outcomes, including an analysis of 51 possible side effects, ACE inhibitors, compared with ARBs, were associated with a significantly higher risk of angioedema (HR, 3.31; P < .01), cough (HR, 1.32; P < .01), acute pancreatitis (HR, 1.32; P = .02), gastrointestinal bleeding (HR, 1.18; P = .04), and abnormal weight loss (HR, 1.18; P = .04).
While the link between ACE inhibitors and pancreatitis has been previously reported, the association with GI bleeding may be a novel finding, with no prior studies comparing those effects in the two drug classes, the authors noted.
Despite most patients taking just a couple of drugs in either class, Dr. Hripcsak said, “we don’t expect that other drugs from those classes will have fewer differences. It is possible, of course, but that is not our expectation.”
Results only applicable to those starting therapy with RAS inhibitors
First author RuiJun Chen, MD, added that, importantly, the results may not apply to patients switching therapies or adding on therapy, “such as for the patient whose hypertension is not effectively controlled with one drug and requires the addition of a second medication,” he said in an interview.
“Also, the suggestion of preferentially prescribing ARBs only applies to those patients and providers intending to control blood pressure through RAS inhibition,” said Dr. Chen, an assistant professor in translational data science and informatics at Geisinger Medical Center in Danville, Pa., who was a National Library of Medicine postdoctoral fellow at Columbia University at the time of the study.
Hence, he stressed the results do not extend to other classes of recommended first-line blood pressure medications.
“Essentially, since this is an ACE inhibitor versus ARB study, we would not claim that ARBs are preferred over all other types of hypertension medications which were not studied here,” the researchers emphasize.
In addition to ARBs and ACE inhibitors, other medications recommended by the AHA/American College of Cardiology in the 2017 “Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults” for the primary treatment of hypertension include thiazide diuretics and calcium channel blockers.
The study received support from the National Library of Medicine and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health; the National Science Foundation; and the Ministries of Health & Welfare and of Trade, Industry & Energy of the Republic of Korea. Dr. Hripcsak reported receiving grants from the National Library of Medicine during the study and grants from Janssen Research outside the submitted work. Dr. Bakris reported being a consultant for Merck, KBP Biosciences, and Ionis.
A version of this article first appeared on Medscape.com.
In the largest comparison of angiotensin receptor blockers (ARBs) and ACE inhibitors to date, a study of nearly 2.3 million patients starting the drugs as monotherapy shows no significant differences between the two in the long-term prevention of hypertension-related cardiovascular events.
However, side effects were notably lower with ARBs.
“This is a very large, well-executed observational study that confirms that ARBs appear to have fewer side effects than ACE inhibitors, and no unexpected ARB side effects were detected,” senior author George Hripcsak, MD, professor and chair of biomedical informatics at Columbia University, New York, told this news organization.
“Despite being equally guideline-recommended first-line therapies for hypertension, these results support preferentially starting ARBs rather than ACE inhibitors when initiating treatment for hypertension for physicians and patients considering renin-angiotensin system (RAS) inhibition,” the authors added in the study, published online July 26, 2021, in the journal Hypertension.
They noted that both drug classes have been on the market a long time, with proven efficacy in hypertension and “a wide availability of inexpensive generic forms.”
They also stressed that their findings only apply to patients with hypertension for whom a RAS inhibitor would be the best choice of therapy.
Commenting on the research, George Bakris, MD, of the American Heart Association’s Comprehensive Hypertension Center at the University of Chicago, said the findings were consistent with his experience in prescribing as well as researching the two drug classes.
“I have been in practice for over 30 years and studied both classes, including head-to-head prospective trials to assess blood pressure, and found in many cases better blood pressure lowering by some ARBs and always better tolerability,” he told this news organization. “I think this study confirms and extends my thoughts between the two classes of blood pressure–lowering agents.”
Head-to-head comparisons of ACE inhibitors and ARBs limited to date
ACE inhibitors and ARBs each have extensive evidence supporting their roles as first-line medications in the treatment of hypertension, and each have the strongest recommendations in international guidelines.
However, ACE inhibitors are prescribed more commonly than ARBs as the first-line drug for lowering blood pressure, and head-to-head comparisons of the two are limited, with conflicting results.
For the study, Dr. Hripcsak and colleagues evaluated data on almost 3 million patients starting monotherapy with an ACE inhibitor or ARB for the first time between 1996 and 2018 in the United States, Germany, and South Korea, who had no history of heart disease or stroke.
They identified a total of 2,297,881 patients initiating ACE inhibitors and 673,938 starting ARBs. Among new users of ACE inhibitors, most received lisinopril (80%), followed by ramipril and enalapril, while most patients prescribed ARBs received losartan (45%), followed by valsartan and olmesartan.
With follow-up times ranging from about 4 months to more than 18 months, the data show no statistically significant differences between ACE inhibitors versus ARBs in the primary outcomes of acute myocardial infarction (hazard ratio, 1.11), heart failure (HR, 1.03), stroke (HR, 1.07), or composite cardiovascular events (HR, 1.06).
For secondary and safety outcomes, including an analysis of 51 possible side effects, ACE inhibitors, compared with ARBs, were associated with a significantly higher risk of angioedema (HR, 3.31; P < .01), cough (HR, 1.32; P < .01), acute pancreatitis (HR, 1.32; P = .02), gastrointestinal bleeding (HR, 1.18; P = .04), and abnormal weight loss (HR, 1.18; P = .04).
While the link between ACE inhibitors and pancreatitis has been previously reported, the association with GI bleeding may be a novel finding, with no prior studies comparing those effects in the two drug classes, the authors noted.
Despite most patients taking just a couple of drugs in either class, Dr. Hripcsak said, “we don’t expect that other drugs from those classes will have fewer differences. It is possible, of course, but that is not our expectation.”
Results only applicable to those starting therapy with RAS inhibitors
First author RuiJun Chen, MD, added that, importantly, the results may not apply to patients switching therapies or adding on therapy, “such as for the patient whose hypertension is not effectively controlled with one drug and requires the addition of a second medication,” he said in an interview.
“Also, the suggestion of preferentially prescribing ARBs only applies to those patients and providers intending to control blood pressure through RAS inhibition,” said Dr. Chen, an assistant professor in translational data science and informatics at Geisinger Medical Center in Danville, Pa., who was a National Library of Medicine postdoctoral fellow at Columbia University at the time of the study.
Hence, he stressed the results do not extend to other classes of recommended first-line blood pressure medications.
“Essentially, since this is an ACE inhibitor versus ARB study, we would not claim that ARBs are preferred over all other types of hypertension medications which were not studied here,” the researchers emphasize.
In addition to ARBs and ACE inhibitors, other medications recommended by the AHA/American College of Cardiology in the 2017 “Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults” for the primary treatment of hypertension include thiazide diuretics and calcium channel blockers.
The study received support from the National Library of Medicine and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health; the National Science Foundation; and the Ministries of Health & Welfare and of Trade, Industry & Energy of the Republic of Korea. Dr. Hripcsak reported receiving grants from the National Library of Medicine during the study and grants from Janssen Research outside the submitted work. Dr. Bakris reported being a consultant for Merck, KBP Biosciences, and Ionis.
A version of this article first appeared on Medscape.com.
In the largest comparison of angiotensin receptor blockers (ARBs) and ACE inhibitors to date, a study of nearly 2.3 million patients starting the drugs as monotherapy shows no significant differences between the two in the long-term prevention of hypertension-related cardiovascular events.
However, side effects were notably lower with ARBs.
“This is a very large, well-executed observational study that confirms that ARBs appear to have fewer side effects than ACE inhibitors, and no unexpected ARB side effects were detected,” senior author George Hripcsak, MD, professor and chair of biomedical informatics at Columbia University, New York, told this news organization.
“Despite being equally guideline-recommended first-line therapies for hypertension, these results support preferentially starting ARBs rather than ACE inhibitors when initiating treatment for hypertension for physicians and patients considering renin-angiotensin system (RAS) inhibition,” the authors added in the study, published online July 26, 2021, in the journal Hypertension.
They noted that both drug classes have been on the market a long time, with proven efficacy in hypertension and “a wide availability of inexpensive generic forms.”
They also stressed that their findings only apply to patients with hypertension for whom a RAS inhibitor would be the best choice of therapy.
Commenting on the research, George Bakris, MD, of the American Heart Association’s Comprehensive Hypertension Center at the University of Chicago, said the findings were consistent with his experience in prescribing as well as researching the two drug classes.
“I have been in practice for over 30 years and studied both classes, including head-to-head prospective trials to assess blood pressure, and found in many cases better blood pressure lowering by some ARBs and always better tolerability,” he told this news organization. “I think this study confirms and extends my thoughts between the two classes of blood pressure–lowering agents.”
Head-to-head comparisons of ACE inhibitors and ARBs limited to date
ACE inhibitors and ARBs each have extensive evidence supporting their roles as first-line medications in the treatment of hypertension, and each have the strongest recommendations in international guidelines.
However, ACE inhibitors are prescribed more commonly than ARBs as the first-line drug for lowering blood pressure, and head-to-head comparisons of the two are limited, with conflicting results.
For the study, Dr. Hripcsak and colleagues evaluated data on almost 3 million patients starting monotherapy with an ACE inhibitor or ARB for the first time between 1996 and 2018 in the United States, Germany, and South Korea, who had no history of heart disease or stroke.
They identified a total of 2,297,881 patients initiating ACE inhibitors and 673,938 starting ARBs. Among new users of ACE inhibitors, most received lisinopril (80%), followed by ramipril and enalapril, while most patients prescribed ARBs received losartan (45%), followed by valsartan and olmesartan.
With follow-up times ranging from about 4 months to more than 18 months, the data show no statistically significant differences between ACE inhibitors versus ARBs in the primary outcomes of acute myocardial infarction (hazard ratio, 1.11), heart failure (HR, 1.03), stroke (HR, 1.07), or composite cardiovascular events (HR, 1.06).
For secondary and safety outcomes, including an analysis of 51 possible side effects, ACE inhibitors, compared with ARBs, were associated with a significantly higher risk of angioedema (HR, 3.31; P < .01), cough (HR, 1.32; P < .01), acute pancreatitis (HR, 1.32; P = .02), gastrointestinal bleeding (HR, 1.18; P = .04), and abnormal weight loss (HR, 1.18; P = .04).
While the link between ACE inhibitors and pancreatitis has been previously reported, the association with GI bleeding may be a novel finding, with no prior studies comparing those effects in the two drug classes, the authors noted.
Despite most patients taking just a couple of drugs in either class, Dr. Hripcsak said, “we don’t expect that other drugs from those classes will have fewer differences. It is possible, of course, but that is not our expectation.”
Results only applicable to those starting therapy with RAS inhibitors
First author RuiJun Chen, MD, added that, importantly, the results may not apply to patients switching therapies or adding on therapy, “such as for the patient whose hypertension is not effectively controlled with one drug and requires the addition of a second medication,” he said in an interview.
“Also, the suggestion of preferentially prescribing ARBs only applies to those patients and providers intending to control blood pressure through RAS inhibition,” said Dr. Chen, an assistant professor in translational data science and informatics at Geisinger Medical Center in Danville, Pa., who was a National Library of Medicine postdoctoral fellow at Columbia University at the time of the study.
Hence, he stressed the results do not extend to other classes of recommended first-line blood pressure medications.
“Essentially, since this is an ACE inhibitor versus ARB study, we would not claim that ARBs are preferred over all other types of hypertension medications which were not studied here,” the researchers emphasize.
In addition to ARBs and ACE inhibitors, other medications recommended by the AHA/American College of Cardiology in the 2017 “Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults” for the primary treatment of hypertension include thiazide diuretics and calcium channel blockers.
The study received support from the National Library of Medicine and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health; the National Science Foundation; and the Ministries of Health & Welfare and of Trade, Industry & Energy of the Republic of Korea. Dr. Hripcsak reported receiving grants from the National Library of Medicine during the study and grants from Janssen Research outside the submitted work. Dr. Bakris reported being a consultant for Merck, KBP Biosciences, and Ionis.
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.
MDs rebut claims of toxic culture after resident suicides
The tragic loss of three medical residents in our beloved South Bronx hospital shook us to the core. They were our colleagues and friends – promising young physicians whose lives and contributions to our hospital family will never be forgotten. We miss them and we grieve them.
We have been keenly aware of the growing trend of physician suicides across the country. That’s one of the reasons why, years ago, we established the nationally recognized Helping Healers Heal program across our health system and more recently expanded other mental health counseling and support to our frontline clinicians.
Our focus is wellness and prevention, as well as helping address the sadness, anxiety, and depression that so many of us experience after a traumatic event. During the surge of the COVID pandemic, these programs proved to be essential, as we expanded these services to all staff, not just those on the frontlines of patient care.
We share Dr. Pamela Wible’s concerns about the physician suicide crisis in this country. However, she misrepresented our residency program and made numerous statements that are false and simply hurtful.
Out of respect for our colleagues and their families, we cannot share everything that we know about this tragic and irreparable loss. But we must set the record straight about a number of incorrect references made by Dr. Wible:
1. We lost two residents to suicide. Though no less horrific, the third death was investigated and declared an accident by the police department.
2. Resident work hours and workload are closely monitored to follow guidance set by the New York State Department of Health and by ACGME. In fact, at the peak of the COVID pandemic, when we were caring for nearly 130 intubated patients at a time, we adopted a strict residency program schedule with built-in breaks and reduced shifts and hours. Even at that tasking time, no one worked more than 80 hours. Although the maximum number of patients assigned to an intern allowed by ACGME is 10, we rarely have more than five or six patients assigned to each of our interns.
3. We swiftly investigate any allegation and do not hesitate to take the appropriate action against anyone who does not honor our values of professionalism and respect.
4. Our ACGME survey results are close to the mean of all internal medicine residency programs in the country. The fact that the results range from 75% to 95% clearly indicates that residents respond independently, and there is no coaching.
5. No resident has ever been threatened to have their visa canceled or withdrawn. Never. And the implication that we were intolerant because of their nationality is reprehensible. At NYC Health + Hospitals, we celebrate diversity. We are deeply committed to serving everyone, regardless of where they come from, what language they speak, what religion they practice. If you spend one day, or one hour, in our facility, you will see and feel our pride and commitment to this mission. We take pride in the fact that our staff and residents reflect the diversity of the community we serve.
6. As for the allegations of “toxic culture at Lincoln” – many of our graduates chose to stay on as attendings, serve the local community, and train new residents. Out of the 67 attendings in our department, 24 are former graduates. They are being joined by another five graduates from this year’s graduating class. There is no better testament to how our graduates feel about our residency program, Department of Medicine, and Lincoln Hospital.
Dr. Wible poses a legitimate question: How to prevent another suicide. No one has the exact answer. But it is a question we will keep asking ourselves as we continue to do all we can to meet our residents’ needs, extend the social and mental health support they need to thrive, and provide the learning and training they need to offer the best care to our patients.
A version of this article first appeared on Medscape.com.
The tragic loss of three medical residents in our beloved South Bronx hospital shook us to the core. They were our colleagues and friends – promising young physicians whose lives and contributions to our hospital family will never be forgotten. We miss them and we grieve them.
We have been keenly aware of the growing trend of physician suicides across the country. That’s one of the reasons why, years ago, we established the nationally recognized Helping Healers Heal program across our health system and more recently expanded other mental health counseling and support to our frontline clinicians.
Our focus is wellness and prevention, as well as helping address the sadness, anxiety, and depression that so many of us experience after a traumatic event. During the surge of the COVID pandemic, these programs proved to be essential, as we expanded these services to all staff, not just those on the frontlines of patient care.
We share Dr. Pamela Wible’s concerns about the physician suicide crisis in this country. However, she misrepresented our residency program and made numerous statements that are false and simply hurtful.
Out of respect for our colleagues and their families, we cannot share everything that we know about this tragic and irreparable loss. But we must set the record straight about a number of incorrect references made by Dr. Wible:
1. We lost two residents to suicide. Though no less horrific, the third death was investigated and declared an accident by the police department.
2. Resident work hours and workload are closely monitored to follow guidance set by the New York State Department of Health and by ACGME. In fact, at the peak of the COVID pandemic, when we were caring for nearly 130 intubated patients at a time, we adopted a strict residency program schedule with built-in breaks and reduced shifts and hours. Even at that tasking time, no one worked more than 80 hours. Although the maximum number of patients assigned to an intern allowed by ACGME is 10, we rarely have more than five or six patients assigned to each of our interns.
3. We swiftly investigate any allegation and do not hesitate to take the appropriate action against anyone who does not honor our values of professionalism and respect.
4. Our ACGME survey results are close to the mean of all internal medicine residency programs in the country. The fact that the results range from 75% to 95% clearly indicates that residents respond independently, and there is no coaching.
5. No resident has ever been threatened to have their visa canceled or withdrawn. Never. And the implication that we were intolerant because of their nationality is reprehensible. At NYC Health + Hospitals, we celebrate diversity. We are deeply committed to serving everyone, regardless of where they come from, what language they speak, what religion they practice. If you spend one day, or one hour, in our facility, you will see and feel our pride and commitment to this mission. We take pride in the fact that our staff and residents reflect the diversity of the community we serve.
6. As for the allegations of “toxic culture at Lincoln” – many of our graduates chose to stay on as attendings, serve the local community, and train new residents. Out of the 67 attendings in our department, 24 are former graduates. They are being joined by another five graduates from this year’s graduating class. There is no better testament to how our graduates feel about our residency program, Department of Medicine, and Lincoln Hospital.
Dr. Wible poses a legitimate question: How to prevent another suicide. No one has the exact answer. But it is a question we will keep asking ourselves as we continue to do all we can to meet our residents’ needs, extend the social and mental health support they need to thrive, and provide the learning and training they need to offer the best care to our patients.
A version of this article first appeared on Medscape.com.
The tragic loss of three medical residents in our beloved South Bronx hospital shook us to the core. They were our colleagues and friends – promising young physicians whose lives and contributions to our hospital family will never be forgotten. We miss them and we grieve them.
We have been keenly aware of the growing trend of physician suicides across the country. That’s one of the reasons why, years ago, we established the nationally recognized Helping Healers Heal program across our health system and more recently expanded other mental health counseling and support to our frontline clinicians.
Our focus is wellness and prevention, as well as helping address the sadness, anxiety, and depression that so many of us experience after a traumatic event. During the surge of the COVID pandemic, these programs proved to be essential, as we expanded these services to all staff, not just those on the frontlines of patient care.
We share Dr. Pamela Wible’s concerns about the physician suicide crisis in this country. However, she misrepresented our residency program and made numerous statements that are false and simply hurtful.
Out of respect for our colleagues and their families, we cannot share everything that we know about this tragic and irreparable loss. But we must set the record straight about a number of incorrect references made by Dr. Wible:
1. We lost two residents to suicide. Though no less horrific, the third death was investigated and declared an accident by the police department.
2. Resident work hours and workload are closely monitored to follow guidance set by the New York State Department of Health and by ACGME. In fact, at the peak of the COVID pandemic, when we were caring for nearly 130 intubated patients at a time, we adopted a strict residency program schedule with built-in breaks and reduced shifts and hours. Even at that tasking time, no one worked more than 80 hours. Although the maximum number of patients assigned to an intern allowed by ACGME is 10, we rarely have more than five or six patients assigned to each of our interns.
3. We swiftly investigate any allegation and do not hesitate to take the appropriate action against anyone who does not honor our values of professionalism and respect.
4. Our ACGME survey results are close to the mean of all internal medicine residency programs in the country. The fact that the results range from 75% to 95% clearly indicates that residents respond independently, and there is no coaching.
5. No resident has ever been threatened to have their visa canceled or withdrawn. Never. And the implication that we were intolerant because of their nationality is reprehensible. At NYC Health + Hospitals, we celebrate diversity. We are deeply committed to serving everyone, regardless of where they come from, what language they speak, what religion they practice. If you spend one day, or one hour, in our facility, you will see and feel our pride and commitment to this mission. We take pride in the fact that our staff and residents reflect the diversity of the community we serve.
6. As for the allegations of “toxic culture at Lincoln” – many of our graduates chose to stay on as attendings, serve the local community, and train new residents. Out of the 67 attendings in our department, 24 are former graduates. They are being joined by another five graduates from this year’s graduating class. There is no better testament to how our graduates feel about our residency program, Department of Medicine, and Lincoln Hospital.
Dr. Wible poses a legitimate question: How to prevent another suicide. No one has the exact answer. But it is a question we will keep asking ourselves as we continue to do all we can to meet our residents’ needs, extend the social and mental health support they need to thrive, and provide the learning and training they need to offer the best care to our patients.
A version of this article first appeared on Medscape.com.
The VA, California, and NYC requiring employee vaccinations
-- or, in the case of California and New York City, undergo regular testing.
The VA becomes the first federal agency to mandate COVID vaccinations for workers. In a news release, VA Secretary Denis McDonough said the mandate is “the best way to keep Veterans safe, especially as the Delta variant spreads across the country.”
VA health care personnel -- including doctors, dentists, podiatrists, optometrists, registered nurses, physician assistants, and chiropractors -- have 8 weeks to become fully vaccinated, the news release said. The New York Times reported that about 115,000 workers will be affected.
The trifecta of federal-state-municipal vaccine requirements arrived as the nation searches for ways to get more people vaccinated to tamp down the Delta variant.
Some organizations, including the military, have already said vaccinations will be required as soon as the Food and Drug Administration formally approves the vaccines, which are now given under emergency use authorizations. The FDA has said the Pfizer vaccine could receive full approval within months.
California Gov. Gavin Newsom said the requirements he announced July 27 were the first in the nation on the state level.
“As the state’s largest employer, we are leading by example and requiring all state and health care workers to show proof of vaccination or be tested regularly, and we are encouraging local governments and businesses to do the same,” he said in a news release.
California employees must provide proof of vaccination or get tested at least once a week. The policy starts Aug. 2 for state employees and Aug. 9 for state health care workers and employees of congregate facilities, such as jails or homeless shelters.
California, especially the southern part of the state, is grappling with a COVID-19 surge. The state’s daily case rate more than quadrupled, from a low of 1.9 cases per 100,000 in May to at least 9.5 cases per 100,000 today, the release said.
In New York City, Mayor Bill de Blasio had previously announced that city health and hospital employees and those working in Department of Health and Mental Hygiene clinical settings would be required to provide proof of vaccination or have regular testing.
On July 27 he expanded the rule to cover all city employees, with a Sept. 13 deadline for most of them, according to a news release.
“This is what it takes to continue our recovery for all of us while fighting back the Delta variant,” Mayor de Blasio said. “It’s going to take all of us to finally end the fight against COVID-19.”
“We have a moral responsibility to take every precaution possible to ensure we keep ourselves, our colleagues and loved ones safe,” NYC Health + Hospitals President and CEO Mitchell Katz, MD, said in the release. “Our city’s new testing requirement for city workers provides more [peace] of mind until more people get their safe and effective COVID-19 vaccine.”
NBC News reported the plan would affect about 340,000 employees.
A version of this article first appeared on WebMD.com.
-- or, in the case of California and New York City, undergo regular testing.
The VA becomes the first federal agency to mandate COVID vaccinations for workers. In a news release, VA Secretary Denis McDonough said the mandate is “the best way to keep Veterans safe, especially as the Delta variant spreads across the country.”
VA health care personnel -- including doctors, dentists, podiatrists, optometrists, registered nurses, physician assistants, and chiropractors -- have 8 weeks to become fully vaccinated, the news release said. The New York Times reported that about 115,000 workers will be affected.
The trifecta of federal-state-municipal vaccine requirements arrived as the nation searches for ways to get more people vaccinated to tamp down the Delta variant.
Some organizations, including the military, have already said vaccinations will be required as soon as the Food and Drug Administration formally approves the vaccines, which are now given under emergency use authorizations. The FDA has said the Pfizer vaccine could receive full approval within months.
California Gov. Gavin Newsom said the requirements he announced July 27 were the first in the nation on the state level.
“As the state’s largest employer, we are leading by example and requiring all state and health care workers to show proof of vaccination or be tested regularly, and we are encouraging local governments and businesses to do the same,” he said in a news release.
California employees must provide proof of vaccination or get tested at least once a week. The policy starts Aug. 2 for state employees and Aug. 9 for state health care workers and employees of congregate facilities, such as jails or homeless shelters.
California, especially the southern part of the state, is grappling with a COVID-19 surge. The state’s daily case rate more than quadrupled, from a low of 1.9 cases per 100,000 in May to at least 9.5 cases per 100,000 today, the release said.
In New York City, Mayor Bill de Blasio had previously announced that city health and hospital employees and those working in Department of Health and Mental Hygiene clinical settings would be required to provide proof of vaccination or have regular testing.
On July 27 he expanded the rule to cover all city employees, with a Sept. 13 deadline for most of them, according to a news release.
“This is what it takes to continue our recovery for all of us while fighting back the Delta variant,” Mayor de Blasio said. “It’s going to take all of us to finally end the fight against COVID-19.”
“We have a moral responsibility to take every precaution possible to ensure we keep ourselves, our colleagues and loved ones safe,” NYC Health + Hospitals President and CEO Mitchell Katz, MD, said in the release. “Our city’s new testing requirement for city workers provides more [peace] of mind until more people get their safe and effective COVID-19 vaccine.”
NBC News reported the plan would affect about 340,000 employees.
A version of this article first appeared on WebMD.com.
-- or, in the case of California and New York City, undergo regular testing.
The VA becomes the first federal agency to mandate COVID vaccinations for workers. In a news release, VA Secretary Denis McDonough said the mandate is “the best way to keep Veterans safe, especially as the Delta variant spreads across the country.”
VA health care personnel -- including doctors, dentists, podiatrists, optometrists, registered nurses, physician assistants, and chiropractors -- have 8 weeks to become fully vaccinated, the news release said. The New York Times reported that about 115,000 workers will be affected.
The trifecta of federal-state-municipal vaccine requirements arrived as the nation searches for ways to get more people vaccinated to tamp down the Delta variant.
Some organizations, including the military, have already said vaccinations will be required as soon as the Food and Drug Administration formally approves the vaccines, which are now given under emergency use authorizations. The FDA has said the Pfizer vaccine could receive full approval within months.
California Gov. Gavin Newsom said the requirements he announced July 27 were the first in the nation on the state level.
“As the state’s largest employer, we are leading by example and requiring all state and health care workers to show proof of vaccination or be tested regularly, and we are encouraging local governments and businesses to do the same,” he said in a news release.
California employees must provide proof of vaccination or get tested at least once a week. The policy starts Aug. 2 for state employees and Aug. 9 for state health care workers and employees of congregate facilities, such as jails or homeless shelters.
California, especially the southern part of the state, is grappling with a COVID-19 surge. The state’s daily case rate more than quadrupled, from a low of 1.9 cases per 100,000 in May to at least 9.5 cases per 100,000 today, the release said.
In New York City, Mayor Bill de Blasio had previously announced that city health and hospital employees and those working in Department of Health and Mental Hygiene clinical settings would be required to provide proof of vaccination or have regular testing.
On July 27 he expanded the rule to cover all city employees, with a Sept. 13 deadline for most of them, according to a news release.
“This is what it takes to continue our recovery for all of us while fighting back the Delta variant,” Mayor de Blasio said. “It’s going to take all of us to finally end the fight against COVID-19.”
“We have a moral responsibility to take every precaution possible to ensure we keep ourselves, our colleagues and loved ones safe,” NYC Health + Hospitals President and CEO Mitchell Katz, MD, said in the release. “Our city’s new testing requirement for city workers provides more [peace] of mind until more people get their safe and effective COVID-19 vaccine.”
NBC News reported the plan would affect about 340,000 employees.
A version of this article first appeared on WebMD.com.
Mayo, Cleveland Clinics top latest U.S. News & World Report hospital rankings
This year’s expanded report debuts new ratings for seven “important procedures and conditions to help patients, in consultation with their doctors, narrow down their choice of hospital based on the specific type of care they need,” Ben Harder, managing editor and chief of health analysis, said in a news release.
With new ratings for myocardial infarction, stroke, hip fracture, and back surgery (spinal fusion), the report now ranks 17 procedures and conditions.
Also new to the 2021 report, which marks the 32nd edition, is a look at racial disparities in health care and the inclusion of health equity measures alongside the hospital rankings.
The new measures examine whether the patients each hospital has treated reflect the racial and ethnic diversity of the surrounding community, among other aspects of health equity.
“At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures,” Mr. Harder said.
“Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents. These metrics are just a beginning; we aim to expand on our measurement of health equity in the future,” Mr. Harder added.
Mayo and Cleveland Clinic remain tops
Following the Mayo Clinic, the Cleveland Clinic once again takes the No. 2 spot in the magazine’s latest annual honor roll of best hospitals, which highlights hospitals that deliver exceptional treatment across multiple areas of care.
UCLA Medical Center, Los Angeles, holds the No. 3 spot in 2021. In 2020, UCLA Medical Center and New York–Presbyterian Hospital–Columbia and Cornell, New York, sat in a tie at No. 4.
In 2021, Johns Hopkins Hospital, Baltimore, which held the No. 3 spot in 2020, drops to No. 4, while Massachusetts General Hospital in Boston takes the No. 5 spot, up from No. 6 in 2020.
Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; New York–Presbyterian Hospital–Columbia and Cornell, New York; NYU Langone Hospitals, New York; UCSF Medical Center, San Francisco; and Northwestern Memorial Hospital, Chicago.
2021-2022 Best Hospitals honor roll
1. Mayo Clinic, Rochester, Minn.
2. Cleveland Clinic, Cleveland
3. UCLA Medical Center, Los Angeles
4. Johns Hopkins Hospital, Baltimore
5. Massachusetts General Hospital, Boston
6. Cedars-Sinai Medical Center, San Francisco
7. New York–Presbyterian Hospital–Columbia and Cornell, New York
8. NYU Langone Hospitals, New York
9. UCSF Medical Center, San Francisco
10. Northwestern Memorial Hospital, Chicago
11. University of Michigan Hospitals–Michigan Medicine, Ann Arbor.
12. Stanford Health Care–Stanford Hospital, Palo Alto, Calif.
13. Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia
14. Brigham and Women’s Hospital, Boston
15. Mayo Clinic–Phoenix, Phoenix
16. Houston Methodist Hospital, Houston
17. (tie) Barnes-Jewish Hospital, St. Louis
17. (tie) Mount Sinai Hospital, New York Rush University Medical Center, Chicago
19. Rush University Medical Center, Chicago
20. Vanderbilt University Medical Center, Nashville, Tenn.
For the 2021-2022 rankings and ratings, the magazine compared more than 4,750 hospitals nationwide in 15 specialties and 17 procedures and conditions.
At least 2,039 hospitals received a high performance rating in at least one of the services rated; 11 hospitals received high performance in all 17. A total of 175 hospitals were nationally ranked in at least one specialty
For specialty rankings, the University of Texas MD Anderson Cancer Center continues to hold the No. 1 spot in cancer care, the Hospital for Special Surgery continues to be No. 1 in orthopedics, and the Cleveland Clinic continues to be No. 1 in cardiology and heart surgery.
Top five for cancer
1. University of Texas MD Anderson Cancer Center, Houston
2. Memorial Sloan Kettering Cancer Center, New York
3. Mayo Clinic, Rochester, Minn.
4. Dana-Farber/Brigham & Women’s Cancer Center, Boston
5. Cleveland Clinic, Cleveland
Top five for cardiology and heart surgery
1. Cleveland Clinic, Cleveland
2. Mayo Clinic, Rochester, Minn.
3. Cedars-Sinai Medical Center, Los Angeles
4. New York–Presbyterian Hospital–Columbia and Cornell, New York
5. NYU Langone Hospitals, New York
Top five for orthopedics
1. Hospital for Special Surgery, New York
2. Mayo Clinic, Rochester, Minn.
3. Cedars-Sinai Medical Center, Los Angeles
4. NYU Langone Orthopedic Hospital, New York
5. UCLA Medical Center, Los Angeles
The magazine noted that data for the 2021-2022 Best Hospitals rankings and ratings were not affected by the COVID-19 pandemic, which began after the end of the data collection period.
The methodologies used in determining the rankings are based largely on objective measures, such as risk-adjusted survival, discharge-to-home rates, volume, and quality of nursing, among other care-related indicators.
The full report is available online.
A version of this article first appeared on Medscape.com.
This year’s expanded report debuts new ratings for seven “important procedures and conditions to help patients, in consultation with their doctors, narrow down their choice of hospital based on the specific type of care they need,” Ben Harder, managing editor and chief of health analysis, said in a news release.
With new ratings for myocardial infarction, stroke, hip fracture, and back surgery (spinal fusion), the report now ranks 17 procedures and conditions.
Also new to the 2021 report, which marks the 32nd edition, is a look at racial disparities in health care and the inclusion of health equity measures alongside the hospital rankings.
The new measures examine whether the patients each hospital has treated reflect the racial and ethnic diversity of the surrounding community, among other aspects of health equity.
“At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures,” Mr. Harder said.
“Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents. These metrics are just a beginning; we aim to expand on our measurement of health equity in the future,” Mr. Harder added.
Mayo and Cleveland Clinic remain tops
Following the Mayo Clinic, the Cleveland Clinic once again takes the No. 2 spot in the magazine’s latest annual honor roll of best hospitals, which highlights hospitals that deliver exceptional treatment across multiple areas of care.
UCLA Medical Center, Los Angeles, holds the No. 3 spot in 2021. In 2020, UCLA Medical Center and New York–Presbyterian Hospital–Columbia and Cornell, New York, sat in a tie at No. 4.
In 2021, Johns Hopkins Hospital, Baltimore, which held the No. 3 spot in 2020, drops to No. 4, while Massachusetts General Hospital in Boston takes the No. 5 spot, up from No. 6 in 2020.
Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; New York–Presbyterian Hospital–Columbia and Cornell, New York; NYU Langone Hospitals, New York; UCSF Medical Center, San Francisco; and Northwestern Memorial Hospital, Chicago.
2021-2022 Best Hospitals honor roll
1. Mayo Clinic, Rochester, Minn.
2. Cleveland Clinic, Cleveland
3. UCLA Medical Center, Los Angeles
4. Johns Hopkins Hospital, Baltimore
5. Massachusetts General Hospital, Boston
6. Cedars-Sinai Medical Center, San Francisco
7. New York–Presbyterian Hospital–Columbia and Cornell, New York
8. NYU Langone Hospitals, New York
9. UCSF Medical Center, San Francisco
10. Northwestern Memorial Hospital, Chicago
11. University of Michigan Hospitals–Michigan Medicine, Ann Arbor.
12. Stanford Health Care–Stanford Hospital, Palo Alto, Calif.
13. Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia
14. Brigham and Women’s Hospital, Boston
15. Mayo Clinic–Phoenix, Phoenix
16. Houston Methodist Hospital, Houston
17. (tie) Barnes-Jewish Hospital, St. Louis
17. (tie) Mount Sinai Hospital, New York Rush University Medical Center, Chicago
19. Rush University Medical Center, Chicago
20. Vanderbilt University Medical Center, Nashville, Tenn.
For the 2021-2022 rankings and ratings, the magazine compared more than 4,750 hospitals nationwide in 15 specialties and 17 procedures and conditions.
At least 2,039 hospitals received a high performance rating in at least one of the services rated; 11 hospitals received high performance in all 17. A total of 175 hospitals were nationally ranked in at least one specialty
For specialty rankings, the University of Texas MD Anderson Cancer Center continues to hold the No. 1 spot in cancer care, the Hospital for Special Surgery continues to be No. 1 in orthopedics, and the Cleveland Clinic continues to be No. 1 in cardiology and heart surgery.
Top five for cancer
1. University of Texas MD Anderson Cancer Center, Houston
2. Memorial Sloan Kettering Cancer Center, New York
3. Mayo Clinic, Rochester, Minn.
4. Dana-Farber/Brigham & Women’s Cancer Center, Boston
5. Cleveland Clinic, Cleveland
Top five for cardiology and heart surgery
1. Cleveland Clinic, Cleveland
2. Mayo Clinic, Rochester, Minn.
3. Cedars-Sinai Medical Center, Los Angeles
4. New York–Presbyterian Hospital–Columbia and Cornell, New York
5. NYU Langone Hospitals, New York
Top five for orthopedics
1. Hospital for Special Surgery, New York
2. Mayo Clinic, Rochester, Minn.
3. Cedars-Sinai Medical Center, Los Angeles
4. NYU Langone Orthopedic Hospital, New York
5. UCLA Medical Center, Los Angeles
The magazine noted that data for the 2021-2022 Best Hospitals rankings and ratings were not affected by the COVID-19 pandemic, which began after the end of the data collection period.
The methodologies used in determining the rankings are based largely on objective measures, such as risk-adjusted survival, discharge-to-home rates, volume, and quality of nursing, among other care-related indicators.
The full report is available online.
A version of this article first appeared on Medscape.com.
This year’s expanded report debuts new ratings for seven “important procedures and conditions to help patients, in consultation with their doctors, narrow down their choice of hospital based on the specific type of care they need,” Ben Harder, managing editor and chief of health analysis, said in a news release.
With new ratings for myocardial infarction, stroke, hip fracture, and back surgery (spinal fusion), the report now ranks 17 procedures and conditions.
Also new to the 2021 report, which marks the 32nd edition, is a look at racial disparities in health care and the inclusion of health equity measures alongside the hospital rankings.
The new measures examine whether the patients each hospital has treated reflect the racial and ethnic diversity of the surrounding community, among other aspects of health equity.
“At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures,” Mr. Harder said.
“Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents. These metrics are just a beginning; we aim to expand on our measurement of health equity in the future,” Mr. Harder added.
Mayo and Cleveland Clinic remain tops
Following the Mayo Clinic, the Cleveland Clinic once again takes the No. 2 spot in the magazine’s latest annual honor roll of best hospitals, which highlights hospitals that deliver exceptional treatment across multiple areas of care.
UCLA Medical Center, Los Angeles, holds the No. 3 spot in 2021. In 2020, UCLA Medical Center and New York–Presbyterian Hospital–Columbia and Cornell, New York, sat in a tie at No. 4.
In 2021, Johns Hopkins Hospital, Baltimore, which held the No. 3 spot in 2020, drops to No. 4, while Massachusetts General Hospital in Boston takes the No. 5 spot, up from No. 6 in 2020.
Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; New York–Presbyterian Hospital–Columbia and Cornell, New York; NYU Langone Hospitals, New York; UCSF Medical Center, San Francisco; and Northwestern Memorial Hospital, Chicago.
2021-2022 Best Hospitals honor roll
1. Mayo Clinic, Rochester, Minn.
2. Cleveland Clinic, Cleveland
3. UCLA Medical Center, Los Angeles
4. Johns Hopkins Hospital, Baltimore
5. Massachusetts General Hospital, Boston
6. Cedars-Sinai Medical Center, San Francisco
7. New York–Presbyterian Hospital–Columbia and Cornell, New York
8. NYU Langone Hospitals, New York
9. UCSF Medical Center, San Francisco
10. Northwestern Memorial Hospital, Chicago
11. University of Michigan Hospitals–Michigan Medicine, Ann Arbor.
12. Stanford Health Care–Stanford Hospital, Palo Alto, Calif.
13. Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia
14. Brigham and Women’s Hospital, Boston
15. Mayo Clinic–Phoenix, Phoenix
16. Houston Methodist Hospital, Houston
17. (tie) Barnes-Jewish Hospital, St. Louis
17. (tie) Mount Sinai Hospital, New York Rush University Medical Center, Chicago
19. Rush University Medical Center, Chicago
20. Vanderbilt University Medical Center, Nashville, Tenn.
For the 2021-2022 rankings and ratings, the magazine compared more than 4,750 hospitals nationwide in 15 specialties and 17 procedures and conditions.
At least 2,039 hospitals received a high performance rating in at least one of the services rated; 11 hospitals received high performance in all 17. A total of 175 hospitals were nationally ranked in at least one specialty
For specialty rankings, the University of Texas MD Anderson Cancer Center continues to hold the No. 1 spot in cancer care, the Hospital for Special Surgery continues to be No. 1 in orthopedics, and the Cleveland Clinic continues to be No. 1 in cardiology and heart surgery.
Top five for cancer
1. University of Texas MD Anderson Cancer Center, Houston
2. Memorial Sloan Kettering Cancer Center, New York
3. Mayo Clinic, Rochester, Minn.
4. Dana-Farber/Brigham & Women’s Cancer Center, Boston
5. Cleveland Clinic, Cleveland
Top five for cardiology and heart surgery
1. Cleveland Clinic, Cleveland
2. Mayo Clinic, Rochester, Minn.
3. Cedars-Sinai Medical Center, Los Angeles
4. New York–Presbyterian Hospital–Columbia and Cornell, New York
5. NYU Langone Hospitals, New York
Top five for orthopedics
1. Hospital for Special Surgery, New York
2. Mayo Clinic, Rochester, Minn.
3. Cedars-Sinai Medical Center, Los Angeles
4. NYU Langone Orthopedic Hospital, New York
5. UCLA Medical Center, Los Angeles
The magazine noted that data for the 2021-2022 Best Hospitals rankings and ratings were not affected by the COVID-19 pandemic, which began after the end of the data collection period.
The methodologies used in determining the rankings are based largely on objective measures, such as risk-adjusted survival, discharge-to-home rates, volume, and quality of nursing, among other care-related indicators.
The full report is available online.
A version of this article first appeared on Medscape.com.