Cardiology News

The largest nonprofit health system in Texas has secured a temporary restraining order against cardiologist Peter A. McCullough, MD, MPH, a COVID-19 vaccine skeptic who allegedly continued to claim an affiliation with Baylor Scott & White Health months after he entered into a confidential separation agreement in which he agreed to stop mentioning his prior leadership and academic appointments.

Baylor was the first institution to cut ties with Dr. McCullough, who has promoted the use of therapies seen as unproven for the treatment of COVID-19 and has questioned the effectiveness of COVID-19 vaccines. Since the Baylor suit, the Texas A&M College of Medicine, and the Texas Christian University (TCU) and University of North Texas Health Science Center (UNTHSC) School of Medicine have both removed Dr. McCullough from their faculties.

Granted by the 191st District Court in Dallas County, Tex., the Baylor restraining order – which is in effect at least until a hearing on the case on September 30 – was sought as part of Baylor Scott & White’s breach of contract suit against McCullough, who had previously been known as a well-respected expert in cardiorenal issues. The suit is seeking $1 million in damages, as well as attorneys’ fees.

The suit seeks to “enforce the terms” of the confidential employment separation agreement signed by Dr. McCullough in February and prevent Dr. McCullough from continuing “improper use of titles and claimed affiliations that have already confused the media, the medical community and the public,” it reads.

“This ongoing confusion regarding [Dr.] McCullough’s affiliations, and whether Plaintiffs support his opinions, is exactly what Plaintiffs bargained to avoid in the Separation Agreement,” and is likely to cause “irreparable reputational and business harm that is incapable of remedy by money damages alone,” the suit states.

One of Dr. McCullough’s attorneys, Clinton Mikel, maintains that all the times the physician was identified in the “thousands of hours of media interviews and countless publications since his departure from Baylor” were “said/printed by a third party with no encouragement from Dr. McCullough,” and that the doctor “does not and cannot control third parties.”

Mr. Mikel said in a statement emailed to this news organization by Dr. McCullough that the suit is “a politically motivated attempt to silence Dr. McCullough,” because it was filed on the same day the organization mandated COVID-19 vaccination for employees.

Dr. McCullough “intends to vigorously defend against Baylor’s unfounded lawsuit,” will seek to dissolve the restraining order, and recover “all payments due him from Baylor under the terms of the settlement agreement,” wrote Mr. Mikel.

The cardiologist’s legal team filed a motion to dismiss the suit on Aug. 9, essentially arguing that Baylor Scott & White’s action restricted Dr. McCullough’s right to free speech under the Texas Citizen’s Participation Act.
 

COVID-19 vaccines = bioterrorism?

Dr. McCullough accumulated a following in 2020 by promoting early at-home multidrug treatment of COVID-19 in interviews with conservative websites and at a U.S. Senate hearing in November.

Although Dr. McCullough does not appear to have any personal social media accounts, his broadcast and podcast interviews are tweeted by thousands daily around the world and featured on Facebook pages like “Pandemic Debate.”

Some Facebook posts with Dr. McCullough’s pronouncements have been labeled as misinformation or removed. Some of his videos remain on YouTube, where they are posted by the Association of American Physicians and Surgeons, a group that believes Dr. McCullough is “under fierce attack for speaking out about COVID-19 early treatment and vaccine safety.”

Dr. McCullough’s March 2021 testimony to the Texas Senate’s Health and Human Services Committee – in which he claimed that COVID-19 patients are being denied what he called proven treatments like hydroxychloroquine – has been viewed more than 3.7 million times on YouTube. The appearance has also been tweeted repeatedly.

Most of Dr. McCullough’s interviews and presentations are aggregated on Rumble, an alternative to YouTube.

In interviews, Dr. McCullough promotes the use of zinc, hydroxychloroquine, azithromycin, doxycycline, favipiravir, prednisone, and ivermectin as COVID-19 treatments – based on an outpatient treatment algorithm published in August 2020 in the American Journal of Medicine. The cardiologist was the lead author of that paper, which proposed treating people with COVID-like symptoms whether or not they had confirmed infection.

Dr. McCullough and colleagues published a follow-up paper that added colchicine to the mix in Reviews in Cardiovascular Medicine. Dr. McCullough is editor-in-chief of the journal, but this was not noted in the disclosures.

Similarly, Dr. McCullough has not disclosed in his COVID-19 publications or any interviews that he has received consulting fees from a host of pharmaceutical manufacturers that produce COVID-19 drugs and vaccines, including AstraZeneca, Eli Lilly, and Regeneron Pharmaceuticals. According to the Centers for Medicare & Medicaid Services’ Open Payments database, Dr. McCullough was paid about $300,000 annually by drug companies from 2014 to 2019, mostly for consulting on cardiovascular and diabetes medications. His payments dropped to $169,406.06 in 2020.

Dr. McCullough appeared on “The Ingraham Angle” on Fox News in December 2020, claiming that sequential, early treatment with “anti-infectives, corticosteroids, and then antithrombotics” could “reduce [COVID-19] hospitalizations by 85% and cut mortality in half.”

He repeated the claim on the Ingraham show in July and agreed with host Laura Ingraham that the vast majority of healthy people would do fine if they got COVID. He also made the claim that 84% of the COVID-19 cases in Israel were in people who had been vaccinated. “So it’s clear, we can’t vaccinate our way out of this,” he said. An Associated Press “fact check” report has pushed back on similar assertions about vaccine data from Israel. 

In a separate interview posted in June, Dr. McCullough called the pandemic the first phase of a bioterrorism event, which was “all about keeping the population in fear and in isolation and preparing them to accept the vaccine, which appears to be phase two of a bioterrorism operation.”

In addition, he said, “good doctors are doing unthinkable things like injecting biologically active messenger RNA that produces this pathogenic spike protein into pregnant women.”

According to the Centers for Disease Control and Prevention, the vaccines teach the body to produce the spike protein, which then triggers an immune response that creates antibodies that will attack the virus.

A PolitiFact review debunks the notion that the mRNA vaccines are toxic, cytotoxic, or introduce live, active virus proteins into the body.

FactCheck.org also disputed Dr. McCullough’s claim in a July 13 Ingraham Angle appearance that the mRNA vaccines are ineffective against the Delta variant.

In the FactCheck article, Frederic Bushman, codirector of the University of Pennsylvania’s Center for Research on Coronaviruses and Other Emerging Pathogens, said that people were much better off being vaccinated than not,” adding, “the Delta variant may reduce the effectiveness [of the vaccines] a little, but still, they’re so effective that you get a lot of benefit.”

“The vaccines are failing,” Dr. McCullough asserted in an Aug. 3 video interview posted on Odysee. “As we sit here today, we have 11,000 Americans that the CDC has certified have died after the vaccine,” he said, citing two analyses – one by Jessica Rose, PhD, and another by British researchers.

Similar figures reportedly based on cases reported to the Food and Drug Administration’s Vaccine Adverse Events Reporting System (VAERS) were forwarded to this news organization by Dr. McCullough.  

The CDC website notes that the agency has received reports of 7,653 deaths in people who received a vaccine as of Sept. 13 (0.0020% of vaccine doses given since Dec. 14, 2020), but it cautions that those deaths do not mean the vaccine was the cause.

Dr. McCullough repeatedly claimed in the Aug. 3 interview that the government has not been transparent on vaccine safety. Since June 2020, the CDC’s Advisory Committee on Immunization Practices has held 16 public meetings on the COVID-19 vaccines.

To date, the agency has advised clinicians to monitor for rare side effects including Guillain-Barré syndrome and thrombosis with thrombocytopenia syndrome after the Johnson & Johnson vaccine and myocarditis after mRNA (Pfizer-BioNTech and Moderna) vaccines.
 

Med schools distance themselves

According to the Baylor Scott & White suit, Dr. McCullough agreed on Feb. 24 in a confidential separation agreement that he would no longer use his academic or leadership titles nor hold himself out to be affiliated with Baylor University Medical Center, Baylor Heart and Vascular Institute, the Baylor Research Institute, or any other related institutions.

However, as of August, according to a Baylor spokesperson, McCullough continued to have privileges at Baylor University Medical Center and Baylor Scott & White Heart and Vascular Hospital, Dallas.

The lawsuit points to three interviews posted in June and July where Dr. McCullough is identified as a “vice chief of medicine” or a “vice chief of internal medicine,” both at Baylor University. It also cites a profile at the Cardiometabolic Health Congress website – which this news organization had also viewed – that was still active in late July with a similar title. The profile was later scrubbed from the site.

Social media posts and other media continue to refer to Dr. McCullough’s Baylor credentials. An episode of the Faith and Freedom podcast posted on Aug. 2 identified McCullough as a “professor of medicine at Baylor University Medical Center.”

As of Sept. 16, Dr. McCullough’s bio page at his current practice, Heart Place, lists him as a professor of medicine at Texas A&M College of Medicine. A spokesperson for Texas A&M told this news organization that McCullough is no longer affiliated with the school.

Dr. McCullough acknowledged in the Aug. 3 interview that his Texas A&M title had been “stripped away” at “around the same time this lawsuit was filed.”

He was still a professor of medicine at the TCU and UNTHSC School of Medicine in Fort Worth, but a school spokesperson notified this news organization on Aug. 19 that Dr. McCullough was no longer with the school.

Dr. McCullough has portrayed himself as both a victim and a truth-teller, a “concerned physician” warning the world about the dangers of COVID-19 vaccines. The Baylor Scott & White lawsuit “is really a strong-armed tactic,” he said in the Aug. 3 interview. “I’m just a little guy, so I have to hire my legal teams, and in a sense be drained dry on legal fees,” he said.

But Dr. McCullough apparently has a plan for helping to defray his legal costs. In the Aug. 3 interview, he said a foundation he helped start, Truth for Health, has a “donation side to it,” adding “some of that may be used for legal expense.”  

Cheryl Jones, an attorney with PK Law in Towson, Md., said that might draw interest from the Internal Revenue Service. “I would expect IRS scrutiny if contributions to the Medical Censorship Defense Fund are used to defend Dr McCullough in his personal breach of contract lawsuit,” she told this news organization.

The IRS generally recognizes defending “human and civil rights secured by law” as a legitimate charitable purpose for a legal defense fund, she said, adding that such a fund “must serve only public, rather than private, interests.”
 

Misinformation from a physician more damaging?

Some in the medical field have refuted Dr. McCullough’s pronouncements on how to treat COVID-19, including two infectious disease specialists with Monash University, Melbourne, who responded to the cardiologist’s original paper in the American Journal of Medicine.

Tony Korman, MBBS, a professor at the Centre for Inflammatory Diseases at Monash, told this news organization, “we had concerns that reputable medical journals would accept and publish papers proposing treatment of COVID-19 which was not supported by evidence.”

The website Healthfeedback.org has also challenged McCullough’s and his supporters’ claims, including that the American Journal of Medicine endorsed the use of hydroxychloroquine and that the COVID-19 vaccines have caused thousands of deaths.

David Broniatowski, PhD, associate director for the Institute for Data, Democracy and Politics at George Washington University, Washington, said in an interview that Dr. McCullough’s casting himself as a “rebel doctor” is a well-known trope in the vaccine misinformation universe.

Although he was not familiar with Dr. McCullough, Dr. Broniatowski said the cardiologist’s claims are not unique – they’ve been circulating among antivaccine and conspiracy-oriented groups for months.

For instance, Dr. McCullough has claimed in interviews that a whistleblower within the CDC knows of 50,000 vaccine-related deaths. Using data from the supposed whistleblower, the group America’s Frontline Doctors sued the federal government in July to stop the administration of COVID-19 vaccines to those under 18, people who have already had COVID, and individuals who the group said have not been adequately informed about the risks.

The idea of a whistleblower inside the CDC is recycled from antivaccine claims from decades ago, Dr. Broniatowski said.

But, he added, “somebody who speaks with the credibility of a major institution will be more likely to be listened to by some people.” That vulnerable group is “being taken advantage of by a relatively small number of disinformation purveyors, who, in some cases, profit from that disinformation,” said Dr. Broniatowski.

“We rely on our doctors because we trust them,” he said. “And we trust them because we believe that as physicians, their value system places the patient’s best interests first. That’s why it’s so much of a disappointment when you have a physician that appears to be exercising this sort of bad judgment.”

Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, also said that he was not familiar with Dr. McCullough. But apprised of his claims, Dr. Offit told this news organization, “Peter McCullough is a friend of the virus.”

“The kind of information he promotes allows the virus to continue to spread, continue to do an enormous amount of harm, and continue to mutate and create variants that have become more contagious and more resistant to vaccine-induced immunity,” said Dr. Offit, the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia.

Dr. Offit added that the war should be against SARS-CoV-2, but “because this virus has so many supporters, the war in essence becomes a war against ourselves, which is much harder.”

Dr. McCullough maintains he is doing a service to his patients. “I’m just giving and trying to help America understand the pandemic,” he told Ms. Ingraham on Fox News on July 29.

But he acknowledged concern about the Federation of State Medical Board’s announcement that physicians who spread COVID-19 vaccine misinformation risk suspension or revocation of their license.

“I have to tell you I’m worried – that no matter what I do and how careful I am to cite the scientific studies, I’m still gonna be hunted down for quote, misinformation,” he said in the Aug. 3 interview.

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

The largest nonprofit health system in Texas has secured a temporary restraining order against cardiologist Peter A. McCullough, MD, MPH, a COVID-19 vaccine skeptic who allegedly continued to claim an affiliation with Baylor Scott & White Health months after he entered into a confidential separation agreement in which he agreed to stop mentioning his prior leadership and academic appointments.

Baylor was the first institution to cut ties with Dr. McCullough, who has promoted the use of therapies seen as unproven for the treatment of COVID-19 and has questioned the effectiveness of COVID-19 vaccines. Since the Baylor suit, the Texas A&M College of Medicine, and the Texas Christian University (TCU) and University of North Texas Health Science Center (UNTHSC) School of Medicine have both removed Dr. McCullough from their faculties.

Granted by the 191st District Court in Dallas County, Tex., the Baylor restraining order – which is in effect at least until a hearing on the case on September 30 – was sought as part of Baylor Scott & White’s breach of contract suit against McCullough, who had previously been known as a well-respected expert in cardiorenal issues. The suit is seeking $1 million in damages, as well as attorneys’ fees.

The suit seeks to “enforce the terms” of the confidential employment separation agreement signed by Dr. McCullough in February and prevent Dr. McCullough from continuing “improper use of titles and claimed affiliations that have already confused the media, the medical community and the public,” it reads.

“This ongoing confusion regarding [Dr.] McCullough’s affiliations, and whether Plaintiffs support his opinions, is exactly what Plaintiffs bargained to avoid in the Separation Agreement,” and is likely to cause “irreparable reputational and business harm that is incapable of remedy by money damages alone,” the suit states.

One of Dr. McCullough’s attorneys, Clinton Mikel, maintains that all the times the physician was identified in the “thousands of hours of media interviews and countless publications since his departure from Baylor” were “said/printed by a third party with no encouragement from Dr. McCullough,” and that the doctor “does not and cannot control third parties.”

Mr. Mikel said in a statement emailed to this news organization by Dr. McCullough that the suit is “a politically motivated attempt to silence Dr. McCullough,” because it was filed on the same day the organization mandated COVID-19 vaccination for employees.

Dr. McCullough “intends to vigorously defend against Baylor’s unfounded lawsuit,” will seek to dissolve the restraining order, and recover “all payments due him from Baylor under the terms of the settlement agreement,” wrote Mr. Mikel.

The cardiologist’s legal team filed a motion to dismiss the suit on Aug. 9, essentially arguing that Baylor Scott & White’s action restricted Dr. McCullough’s right to free speech under the Texas Citizen’s Participation Act.
 

COVID-19 vaccines = bioterrorism?

Dr. McCullough accumulated a following in 2020 by promoting early at-home multidrug treatment of COVID-19 in interviews with conservative websites and at a U.S. Senate hearing in November.

Although Dr. McCullough does not appear to have any personal social media accounts, his broadcast and podcast interviews are tweeted by thousands daily around the world and featured on Facebook pages like “Pandemic Debate.”

Some Facebook posts with Dr. McCullough’s pronouncements have been labeled as misinformation or removed. Some of his videos remain on YouTube, where they are posted by the Association of American Physicians and Surgeons, a group that believes Dr. McCullough is “under fierce attack for speaking out about COVID-19 early treatment and vaccine safety.”

Dr. McCullough’s March 2021 testimony to the Texas Senate’s Health and Human Services Committee – in which he claimed that COVID-19 patients are being denied what he called proven treatments like hydroxychloroquine – has been viewed more than 3.7 million times on YouTube. The appearance has also been tweeted repeatedly.

Most of Dr. McCullough’s interviews and presentations are aggregated on Rumble, an alternative to YouTube.

In interviews, Dr. McCullough promotes the use of zinc, hydroxychloroquine, azithromycin, doxycycline, favipiravir, prednisone, and ivermectin as COVID-19 treatments – based on an outpatient treatment algorithm published in August 2020 in the American Journal of Medicine. The cardiologist was the lead author of that paper, which proposed treating people with COVID-like symptoms whether or not they had confirmed infection.

Dr. McCullough and colleagues published a follow-up paper that added colchicine to the mix in Reviews in Cardiovascular Medicine. Dr. McCullough is editor-in-chief of the journal, but this was not noted in the disclosures.

Similarly, Dr. McCullough has not disclosed in his COVID-19 publications or any interviews that he has received consulting fees from a host of pharmaceutical manufacturers that produce COVID-19 drugs and vaccines, including AstraZeneca, Eli Lilly, and Regeneron Pharmaceuticals. According to the Centers for Medicare & Medicaid Services’ Open Payments database, Dr. McCullough was paid about $300,000 annually by drug companies from 2014 to 2019, mostly for consulting on cardiovascular and diabetes medications. His payments dropped to $169,406.06 in 2020.

Dr. McCullough appeared on “The Ingraham Angle” on Fox News in December 2020, claiming that sequential, early treatment with “anti-infectives, corticosteroids, and then antithrombotics” could “reduce [COVID-19] hospitalizations by 85% and cut mortality in half.”

He repeated the claim on the Ingraham show in July and agreed with host Laura Ingraham that the vast majority of healthy people would do fine if they got COVID. He also made the claim that 84% of the COVID-19 cases in Israel were in people who had been vaccinated. “So it’s clear, we can’t vaccinate our way out of this,” he said. An Associated Press “fact check” report has pushed back on similar assertions about vaccine data from Israel. 

In a separate interview posted in June, Dr. McCullough called the pandemic the first phase of a bioterrorism event, which was “all about keeping the population in fear and in isolation and preparing them to accept the vaccine, which appears to be phase two of a bioterrorism operation.”

In addition, he said, “good doctors are doing unthinkable things like injecting biologically active messenger RNA that produces this pathogenic spike protein into pregnant women.”

According to the Centers for Disease Control and Prevention, the vaccines teach the body to produce the spike protein, which then triggers an immune response that creates antibodies that will attack the virus.

A PolitiFact review debunks the notion that the mRNA vaccines are toxic, cytotoxic, or introduce live, active virus proteins into the body.

FactCheck.org also disputed Dr. McCullough’s claim in a July 13 Ingraham Angle appearance that the mRNA vaccines are ineffective against the Delta variant.

In the FactCheck article, Frederic Bushman, codirector of the University of Pennsylvania’s Center for Research on Coronaviruses and Other Emerging Pathogens, said that people were much better off being vaccinated than not,” adding, “the Delta variant may reduce the effectiveness [of the vaccines] a little, but still, they’re so effective that you get a lot of benefit.”

“The vaccines are failing,” Dr. McCullough asserted in an Aug. 3 video interview posted on Odysee. “As we sit here today, we have 11,000 Americans that the CDC has certified have died after the vaccine,” he said, citing two analyses – one by Jessica Rose, PhD, and another by British researchers.

Similar figures reportedly based on cases reported to the Food and Drug Administration’s Vaccine Adverse Events Reporting System (VAERS) were forwarded to this news organization by Dr. McCullough.  

The CDC website notes that the agency has received reports of 7,653 deaths in people who received a vaccine as of Sept. 13 (0.0020% of vaccine doses given since Dec. 14, 2020), but it cautions that those deaths do not mean the vaccine was the cause.

Dr. McCullough repeatedly claimed in the Aug. 3 interview that the government has not been transparent on vaccine safety. Since June 2020, the CDC’s Advisory Committee on Immunization Practices has held 16 public meetings on the COVID-19 vaccines.

To date, the agency has advised clinicians to monitor for rare side effects including Guillain-Barré syndrome and thrombosis with thrombocytopenia syndrome after the Johnson & Johnson vaccine and myocarditis after mRNA (Pfizer-BioNTech and Moderna) vaccines.
 

Med schools distance themselves

According to the Baylor Scott & White suit, Dr. McCullough agreed on Feb. 24 in a confidential separation agreement that he would no longer use his academic or leadership titles nor hold himself out to be affiliated with Baylor University Medical Center, Baylor Heart and Vascular Institute, the Baylor Research Institute, or any other related institutions.

However, as of August, according to a Baylor spokesperson, McCullough continued to have privileges at Baylor University Medical Center and Baylor Scott & White Heart and Vascular Hospital, Dallas.

The lawsuit points to three interviews posted in June and July where Dr. McCullough is identified as a “vice chief of medicine” or a “vice chief of internal medicine,” both at Baylor University. It also cites a profile at the Cardiometabolic Health Congress website – which this news organization had also viewed – that was still active in late July with a similar title. The profile was later scrubbed from the site.

Social media posts and other media continue to refer to Dr. McCullough’s Baylor credentials. An episode of the Faith and Freedom podcast posted on Aug. 2 identified McCullough as a “professor of medicine at Baylor University Medical Center.”

As of Sept. 16, Dr. McCullough’s bio page at his current practice, Heart Place, lists him as a professor of medicine at Texas A&M College of Medicine. A spokesperson for Texas A&M told this news organization that McCullough is no longer affiliated with the school.

Dr. McCullough acknowledged in the Aug. 3 interview that his Texas A&M title had been “stripped away” at “around the same time this lawsuit was filed.”

He was still a professor of medicine at the TCU and UNTHSC School of Medicine in Fort Worth, but a school spokesperson notified this news organization on Aug. 19 that Dr. McCullough was no longer with the school.

Dr. McCullough has portrayed himself as both a victim and a truth-teller, a “concerned physician” warning the world about the dangers of COVID-19 vaccines. The Baylor Scott & White lawsuit “is really a strong-armed tactic,” he said in the Aug. 3 interview. “I’m just a little guy, so I have to hire my legal teams, and in a sense be drained dry on legal fees,” he said.

But Dr. McCullough apparently has a plan for helping to defray his legal costs. In the Aug. 3 interview, he said a foundation he helped start, Truth for Health, has a “donation side to it,” adding “some of that may be used for legal expense.”  

Cheryl Jones, an attorney with PK Law in Towson, Md., said that might draw interest from the Internal Revenue Service. “I would expect IRS scrutiny if contributions to the Medical Censorship Defense Fund are used to defend Dr McCullough in his personal breach of contract lawsuit,” she told this news organization.

The IRS generally recognizes defending “human and civil rights secured by law” as a legitimate charitable purpose for a legal defense fund, she said, adding that such a fund “must serve only public, rather than private, interests.”
 

Misinformation from a physician more damaging?

Some in the medical field have refuted Dr. McCullough’s pronouncements on how to treat COVID-19, including two infectious disease specialists with Monash University, Melbourne, who responded to the cardiologist’s original paper in the American Journal of Medicine.

Tony Korman, MBBS, a professor at the Centre for Inflammatory Diseases at Monash, told this news organization, “we had concerns that reputable medical journals would accept and publish papers proposing treatment of COVID-19 which was not supported by evidence.”

The website Healthfeedback.org has also challenged McCullough’s and his supporters’ claims, including that the American Journal of Medicine endorsed the use of hydroxychloroquine and that the COVID-19 vaccines have caused thousands of deaths.

David Broniatowski, PhD, associate director for the Institute for Data, Democracy and Politics at George Washington University, Washington, said in an interview that Dr. McCullough’s casting himself as a “rebel doctor” is a well-known trope in the vaccine misinformation universe.

Although he was not familiar with Dr. McCullough, Dr. Broniatowski said the cardiologist’s claims are not unique – they’ve been circulating among antivaccine and conspiracy-oriented groups for months.

For instance, Dr. McCullough has claimed in interviews that a whistleblower within the CDC knows of 50,000 vaccine-related deaths. Using data from the supposed whistleblower, the group America’s Frontline Doctors sued the federal government in July to stop the administration of COVID-19 vaccines to those under 18, people who have already had COVID, and individuals who the group said have not been adequately informed about the risks.

The idea of a whistleblower inside the CDC is recycled from antivaccine claims from decades ago, Dr. Broniatowski said.

But, he added, “somebody who speaks with the credibility of a major institution will be more likely to be listened to by some people.” That vulnerable group is “being taken advantage of by a relatively small number of disinformation purveyors, who, in some cases, profit from that disinformation,” said Dr. Broniatowski.

“We rely on our doctors because we trust them,” he said. “And we trust them because we believe that as physicians, their value system places the patient’s best interests first. That’s why it’s so much of a disappointment when you have a physician that appears to be exercising this sort of bad judgment.”

Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, also said that he was not familiar with Dr. McCullough. But apprised of his claims, Dr. Offit told this news organization, “Peter McCullough is a friend of the virus.”

“The kind of information he promotes allows the virus to continue to spread, continue to do an enormous amount of harm, and continue to mutate and create variants that have become more contagious and more resistant to vaccine-induced immunity,” said Dr. Offit, the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia.

Dr. Offit added that the war should be against SARS-CoV-2, but “because this virus has so many supporters, the war in essence becomes a war against ourselves, which is much harder.”

Dr. McCullough maintains he is doing a service to his patients. “I’m just giving and trying to help America understand the pandemic,” he told Ms. Ingraham on Fox News on July 29.

But he acknowledged concern about the Federation of State Medical Board’s announcement that physicians who spread COVID-19 vaccine misinformation risk suspension or revocation of their license.

“I have to tell you I’m worried – that no matter what I do and how careful I am to cite the scientific studies, I’m still gonna be hunted down for quote, misinformation,” he said in the Aug. 3 interview.

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

The largest nonprofit health system in Texas has secured a temporary restraining order against cardiologist Peter A. McCullough, MD, MPH, a COVID-19 vaccine skeptic who allegedly continued to claim an affiliation with Baylor Scott & White Health months after he entered into a confidential separation agreement in which he agreed to stop mentioning his prior leadership and academic appointments.

Baylor was the first institution to cut ties with Dr. McCullough, who has promoted the use of therapies seen as unproven for the treatment of COVID-19 and has questioned the effectiveness of COVID-19 vaccines. Since the Baylor suit, the Texas A&M College of Medicine, and the Texas Christian University (TCU) and University of North Texas Health Science Center (UNTHSC) School of Medicine have both removed Dr. McCullough from their faculties.

Granted by the 191st District Court in Dallas County, Tex., the Baylor restraining order – which is in effect at least until a hearing on the case on September 30 – was sought as part of Baylor Scott & White’s breach of contract suit against McCullough, who had previously been known as a well-respected expert in cardiorenal issues. The suit is seeking $1 million in damages, as well as attorneys’ fees.

The suit seeks to “enforce the terms” of the confidential employment separation agreement signed by Dr. McCullough in February and prevent Dr. McCullough from continuing “improper use of titles and claimed affiliations that have already confused the media, the medical community and the public,” it reads.

“This ongoing confusion regarding [Dr.] McCullough’s affiliations, and whether Plaintiffs support his opinions, is exactly what Plaintiffs bargained to avoid in the Separation Agreement,” and is likely to cause “irreparable reputational and business harm that is incapable of remedy by money damages alone,” the suit states.

One of Dr. McCullough’s attorneys, Clinton Mikel, maintains that all the times the physician was identified in the “thousands of hours of media interviews and countless publications since his departure from Baylor” were “said/printed by a third party with no encouragement from Dr. McCullough,” and that the doctor “does not and cannot control third parties.”

Mr. Mikel said in a statement emailed to this news organization by Dr. McCullough that the suit is “a politically motivated attempt to silence Dr. McCullough,” because it was filed on the same day the organization mandated COVID-19 vaccination for employees.

Dr. McCullough “intends to vigorously defend against Baylor’s unfounded lawsuit,” will seek to dissolve the restraining order, and recover “all payments due him from Baylor under the terms of the settlement agreement,” wrote Mr. Mikel.

The cardiologist’s legal team filed a motion to dismiss the suit on Aug. 9, essentially arguing that Baylor Scott & White’s action restricted Dr. McCullough’s right to free speech under the Texas Citizen’s Participation Act.
 

COVID-19 vaccines = bioterrorism?

Dr. McCullough accumulated a following in 2020 by promoting early at-home multidrug treatment of COVID-19 in interviews with conservative websites and at a U.S. Senate hearing in November.

Although Dr. McCullough does not appear to have any personal social media accounts, his broadcast and podcast interviews are tweeted by thousands daily around the world and featured on Facebook pages like “Pandemic Debate.”

Some Facebook posts with Dr. McCullough’s pronouncements have been labeled as misinformation or removed. Some of his videos remain on YouTube, where they are posted by the Association of American Physicians and Surgeons, a group that believes Dr. McCullough is “under fierce attack for speaking out about COVID-19 early treatment and vaccine safety.”

Dr. McCullough’s March 2021 testimony to the Texas Senate’s Health and Human Services Committee – in which he claimed that COVID-19 patients are being denied what he called proven treatments like hydroxychloroquine – has been viewed more than 3.7 million times on YouTube. The appearance has also been tweeted repeatedly.

Most of Dr. McCullough’s interviews and presentations are aggregated on Rumble, an alternative to YouTube.

In interviews, Dr. McCullough promotes the use of zinc, hydroxychloroquine, azithromycin, doxycycline, favipiravir, prednisone, and ivermectin as COVID-19 treatments – based on an outpatient treatment algorithm published in August 2020 in the American Journal of Medicine. The cardiologist was the lead author of that paper, which proposed treating people with COVID-like symptoms whether or not they had confirmed infection.

Dr. McCullough and colleagues published a follow-up paper that added colchicine to the mix in Reviews in Cardiovascular Medicine. Dr. McCullough is editor-in-chief of the journal, but this was not noted in the disclosures.

Similarly, Dr. McCullough has not disclosed in his COVID-19 publications or any interviews that he has received consulting fees from a host of pharmaceutical manufacturers that produce COVID-19 drugs and vaccines, including AstraZeneca, Eli Lilly, and Regeneron Pharmaceuticals. According to the Centers for Medicare & Medicaid Services’ Open Payments database, Dr. McCullough was paid about $300,000 annually by drug companies from 2014 to 2019, mostly for consulting on cardiovascular and diabetes medications. His payments dropped to $169,406.06 in 2020.

Dr. McCullough appeared on “The Ingraham Angle” on Fox News in December 2020, claiming that sequential, early treatment with “anti-infectives, corticosteroids, and then antithrombotics” could “reduce [COVID-19] hospitalizations by 85% and cut mortality in half.”

He repeated the claim on the Ingraham show in July and agreed with host Laura Ingraham that the vast majority of healthy people would do fine if they got COVID. He also made the claim that 84% of the COVID-19 cases in Israel were in people who had been vaccinated. “So it’s clear, we can’t vaccinate our way out of this,” he said. An Associated Press “fact check” report has pushed back on similar assertions about vaccine data from Israel. 

In a separate interview posted in June, Dr. McCullough called the pandemic the first phase of a bioterrorism event, which was “all about keeping the population in fear and in isolation and preparing them to accept the vaccine, which appears to be phase two of a bioterrorism operation.”

In addition, he said, “good doctors are doing unthinkable things like injecting biologically active messenger RNA that produces this pathogenic spike protein into pregnant women.”

According to the Centers for Disease Control and Prevention, the vaccines teach the body to produce the spike protein, which then triggers an immune response that creates antibodies that will attack the virus.

A PolitiFact review debunks the notion that the mRNA vaccines are toxic, cytotoxic, or introduce live, active virus proteins into the body.

FactCheck.org also disputed Dr. McCullough’s claim in a July 13 Ingraham Angle appearance that the mRNA vaccines are ineffective against the Delta variant.

In the FactCheck article, Frederic Bushman, codirector of the University of Pennsylvania’s Center for Research on Coronaviruses and Other Emerging Pathogens, said that people were much better off being vaccinated than not,” adding, “the Delta variant may reduce the effectiveness [of the vaccines] a little, but still, they’re so effective that you get a lot of benefit.”

“The vaccines are failing,” Dr. McCullough asserted in an Aug. 3 video interview posted on Odysee. “As we sit here today, we have 11,000 Americans that the CDC has certified have died after the vaccine,” he said, citing two analyses – one by Jessica Rose, PhD, and another by British researchers.

Similar figures reportedly based on cases reported to the Food and Drug Administration’s Vaccine Adverse Events Reporting System (VAERS) were forwarded to this news organization by Dr. McCullough.  

The CDC website notes that the agency has received reports of 7,653 deaths in people who received a vaccine as of Sept. 13 (0.0020% of vaccine doses given since Dec. 14, 2020), but it cautions that those deaths do not mean the vaccine was the cause.

Dr. McCullough repeatedly claimed in the Aug. 3 interview that the government has not been transparent on vaccine safety. Since June 2020, the CDC’s Advisory Committee on Immunization Practices has held 16 public meetings on the COVID-19 vaccines.

To date, the agency has advised clinicians to monitor for rare side effects including Guillain-Barré syndrome and thrombosis with thrombocytopenia syndrome after the Johnson & Johnson vaccine and myocarditis after mRNA (Pfizer-BioNTech and Moderna) vaccines.
 

Med schools distance themselves

According to the Baylor Scott & White suit, Dr. McCullough agreed on Feb. 24 in a confidential separation agreement that he would no longer use his academic or leadership titles nor hold himself out to be affiliated with Baylor University Medical Center, Baylor Heart and Vascular Institute, the Baylor Research Institute, or any other related institutions.

However, as of August, according to a Baylor spokesperson, McCullough continued to have privileges at Baylor University Medical Center and Baylor Scott & White Heart and Vascular Hospital, Dallas.

The lawsuit points to three interviews posted in June and July where Dr. McCullough is identified as a “vice chief of medicine” or a “vice chief of internal medicine,” both at Baylor University. It also cites a profile at the Cardiometabolic Health Congress website – which this news organization had also viewed – that was still active in late July with a similar title. The profile was later scrubbed from the site.

Social media posts and other media continue to refer to Dr. McCullough’s Baylor credentials. An episode of the Faith and Freedom podcast posted on Aug. 2 identified McCullough as a “professor of medicine at Baylor University Medical Center.”

As of Sept. 16, Dr. McCullough’s bio page at his current practice, Heart Place, lists him as a professor of medicine at Texas A&M College of Medicine. A spokesperson for Texas A&M told this news organization that McCullough is no longer affiliated with the school.

Dr. McCullough acknowledged in the Aug. 3 interview that his Texas A&M title had been “stripped away” at “around the same time this lawsuit was filed.”

He was still a professor of medicine at the TCU and UNTHSC School of Medicine in Fort Worth, but a school spokesperson notified this news organization on Aug. 19 that Dr. McCullough was no longer with the school.

Dr. McCullough has portrayed himself as both a victim and a truth-teller, a “concerned physician” warning the world about the dangers of COVID-19 vaccines. The Baylor Scott & White lawsuit “is really a strong-armed tactic,” he said in the Aug. 3 interview. “I’m just a little guy, so I have to hire my legal teams, and in a sense be drained dry on legal fees,” he said.

But Dr. McCullough apparently has a plan for helping to defray his legal costs. In the Aug. 3 interview, he said a foundation he helped start, Truth for Health, has a “donation side to it,” adding “some of that may be used for legal expense.”  

Cheryl Jones, an attorney with PK Law in Towson, Md., said that might draw interest from the Internal Revenue Service. “I would expect IRS scrutiny if contributions to the Medical Censorship Defense Fund are used to defend Dr McCullough in his personal breach of contract lawsuit,” she told this news organization.

The IRS generally recognizes defending “human and civil rights secured by law” as a legitimate charitable purpose for a legal defense fund, she said, adding that such a fund “must serve only public, rather than private, interests.”
 

Misinformation from a physician more damaging?

Some in the medical field have refuted Dr. McCullough’s pronouncements on how to treat COVID-19, including two infectious disease specialists with Monash University, Melbourne, who responded to the cardiologist’s original paper in the American Journal of Medicine.

Tony Korman, MBBS, a professor at the Centre for Inflammatory Diseases at Monash, told this news organization, “we had concerns that reputable medical journals would accept and publish papers proposing treatment of COVID-19 which was not supported by evidence.”

The website Healthfeedback.org has also challenged McCullough’s and his supporters’ claims, including that the American Journal of Medicine endorsed the use of hydroxychloroquine and that the COVID-19 vaccines have caused thousands of deaths.

David Broniatowski, PhD, associate director for the Institute for Data, Democracy and Politics at George Washington University, Washington, said in an interview that Dr. McCullough’s casting himself as a “rebel doctor” is a well-known trope in the vaccine misinformation universe.

Although he was not familiar with Dr. McCullough, Dr. Broniatowski said the cardiologist’s claims are not unique – they’ve been circulating among antivaccine and conspiracy-oriented groups for months.

For instance, Dr. McCullough has claimed in interviews that a whistleblower within the CDC knows of 50,000 vaccine-related deaths. Using data from the supposed whistleblower, the group America’s Frontline Doctors sued the federal government in July to stop the administration of COVID-19 vaccines to those under 18, people who have already had COVID, and individuals who the group said have not been adequately informed about the risks.

The idea of a whistleblower inside the CDC is recycled from antivaccine claims from decades ago, Dr. Broniatowski said.

But, he added, “somebody who speaks with the credibility of a major institution will be more likely to be listened to by some people.” That vulnerable group is “being taken advantage of by a relatively small number of disinformation purveyors, who, in some cases, profit from that disinformation,” said Dr. Broniatowski.

“We rely on our doctors because we trust them,” he said. “And we trust them because we believe that as physicians, their value system places the patient’s best interests first. That’s why it’s so much of a disappointment when you have a physician that appears to be exercising this sort of bad judgment.”

Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, also said that he was not familiar with Dr. McCullough. But apprised of his claims, Dr. Offit told this news organization, “Peter McCullough is a friend of the virus.”

“The kind of information he promotes allows the virus to continue to spread, continue to do an enormous amount of harm, and continue to mutate and create variants that have become more contagious and more resistant to vaccine-induced immunity,” said Dr. Offit, the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia.

Dr. Offit added that the war should be against SARS-CoV-2, but “because this virus has so many supporters, the war in essence becomes a war against ourselves, which is much harder.”

Dr. McCullough maintains he is doing a service to his patients. “I’m just giving and trying to help America understand the pandemic,” he told Ms. Ingraham on Fox News on July 29.

But he acknowledged concern about the Federation of State Medical Board’s announcement that physicians who spread COVID-19 vaccine misinformation risk suspension or revocation of their license.

“I have to tell you I’m worried – that no matter what I do and how careful I am to cite the scientific studies, I’m still gonna be hunted down for quote, misinformation,” he said in the Aug. 3 interview.

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

Heidi Erickson, MD, is tired. As a pulmonary and critical care physician at Hennepin Healthcare in Minneapolis, she has been providing care for patients with COVID-19 since the start of the pandemic.

rclassenlayouts/Getty Images

It was exhausting from the beginning, as she and her colleagues scrambled to understand how to deal with this new disease. But lately, she has noticed a different kind of exhaustion arising from the knowledge that with vaccines widely available, the latest surge was preventable.

Her intensive care unit is currently as full as it has ever been with COVID-19 patients, many of them young adults and most of them unvaccinated. After the recent death of one patient, an unvaccinated man with teenage children, she had to face his family’s questions about why ivermectin, an antiparasitic medication that was falsely promoted as a COVID-19 treatment, was not administered.

“I’m fatigued because I’m working more than ever, but more people don’t have to die,” Dr. Erickson said in an interview . “It’s been very hard physically, mentally, emotionally.”

Amid yet another surge in COVID-19 cases around the United States, clinicians are speaking out about their growing frustration with this preventable crisis.

Some are using the terms “empathy fatigue” and “compassion fatigue” – a sense that they are losing empathy for unvaccinated individuals who are fueling the pandemic.

Dr. Erickson says she is frustrated not by individual patients but by a system that has allowed disinformation to proliferate. Experts say these types of feelings fit into a widespread pattern of physician burnout that has taken a new turn at this stage of the pandemic.

Paradoxical choices

Empathy is a cornerstone of what clinicians do, and the ability to understand and share a patient’s feelings is an essential skill for providing effective care, says Kaz Nelson, MD, a psychiatrist at the University of Minnesota, Minneapolis.

Practitioners face paradoxical situations all the time, she notes. These include individuals who break bones and go skydiving again, people who have high cholesterol but continue to eat fried foods, and those with advanced lung cancer who continue to smoke.

To treat patients with compassion, practitioners learn to set aside judgment by acknowledging the complexity of human behavior. They may lament the addictive nature of nicotine and advertising that targets children, for example, while still listening and caring.

Empathy requires high-level brain function, but as stress levels rise, brain function that drives empathy tends to shut down. It’s a survival mechanism, Dr. Nelson says.

When health care workers feel overwhelmed, trapped, or threatened by patients demanding unproven treatments or by ICUs with more patients than ventilators, they may experience a fight-or-flight response that makes them defensive, frustrated, angry, or uncaring, notes Mona Masood, DO, a Philadelphia-area psychiatrist and founder of Physician Support Line, a free mental health hotline for doctors.

Some clinicians have taken to Twitter and other social media platforms to post about these types of experiences.

These feelings, which have been brewing for months, have been exacerbated by the complexity of the current situation. Clinicians see a disconnect between what is and what could be, Dr. Nelson notes.

“Prior to vaccines, there weren’t other options, and so we had toxic stress and we had fatigue, but we could still maintain little bits of empathy by saying, ‘You know, people didn’t choose to get infected, and we are in a pandemic.’ We could kind of hate the virus. Now with access to vaccines, that last connection to empathy is removed for many people,” she says.

Self-preservation vs. empathy

Compassion fatigue or empathy fatigue is just one reaction to feeling completely maxed out and overstressed, Dr. Nelson says. Anger at society, such as what Dr. Erickson experienced, is another response.

Practitioners may also feel as if they are just going through the motions of their job, or they might disassociate, ceasing to feel that their patients are human. Plenty of doctors and nurses have cried in their cars after shifts and have posted tearful videos on social media.

Early in the pandemic, Dr. Masood says, physicians who called the support hotline expressed sadness and grief. Now, she had her colleagues hear frustration and anger, along with guilt and shame for having feelings they believe they shouldn’t be having, especially toward patients. They may feel unprofessional or worse – unworthy of being physicians, she says.

One recent caller to the hotline was a long-time ICU physician who had been told so many times by patients that ivermectin was the only medicine that would cure them that he began to doubt himself, says Dr. Masood. This caller needed to be reassured by another physician that he was doing the right thing.

Another emergency department physician told Dr. Masood about a young child who had arrived at the hospital with COVID-19 symptoms. When asked whether the family had been exposed to anyone with COVID-19, the child’s parent lied so that they could be triaged faster.

The physician, who needed to step away from the situation, reached out to Dr. Masood to express her frustration so that she wouldn’t “let it out” on the patient.

“It’s hard to have empathy for people who, for all intents and purposes, are very self-centered,” Dr. Masood says. “We’re at a place where we’re having to choose between self-preservation and empathy.”
 

How to cope

To help practitioners cope, Dr. Masood offers words that describe what they’re experiencing. She often hears clinicians say things such as, “This is a type of burnout that I feel to my bones,” or “This makes me want to quit,” or “I feel like I’m at the end of my rope.”

She encourages them to consider the terms “empathy fatigue,” and “moral injury” in order to reconcile how their sense of responsibility to take care of people is compromised by factors outside of their control.

It is not shameful to acknowledge that they experience emotions, including difficult ones such as frustration, anger, sadness, and anxiety, Dr. Masood adds.

Being frustrated with a patient doesn’t make someone a bad doctor, and admitting those emotions is the first step toward dealing with them, she says.

Dr. Nelson adds that taking breaks from work can help. She also recommends setting boundaries, seeking therapy, and acknowledging feelings early before they cause a sense of callousness or other consequences that become harder to heal from as time goes on.

“We’re trained to just go, go, go and sometimes not pause and check in,” she says. Clinicians who open up are likely to find they are not the only ones feeling tired or frustrated right now, she adds.

“Connect with peers and colleagues, because chances are, they can relate,” Dr. Nelson says.

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

Heidi Erickson, MD, is tired. As a pulmonary and critical care physician at Hennepin Healthcare in Minneapolis, she has been providing care for patients with COVID-19 since the start of the pandemic.

rclassenlayouts/Getty Images

It was exhausting from the beginning, as she and her colleagues scrambled to understand how to deal with this new disease. But lately, she has noticed a different kind of exhaustion arising from the knowledge that with vaccines widely available, the latest surge was preventable.

Her intensive care unit is currently as full as it has ever been with COVID-19 patients, many of them young adults and most of them unvaccinated. After the recent death of one patient, an unvaccinated man with teenage children, she had to face his family’s questions about why ivermectin, an antiparasitic medication that was falsely promoted as a COVID-19 treatment, was not administered.

“I’m fatigued because I’m working more than ever, but more people don’t have to die,” Dr. Erickson said in an interview . “It’s been very hard physically, mentally, emotionally.”

Amid yet another surge in COVID-19 cases around the United States, clinicians are speaking out about their growing frustration with this preventable crisis.

Some are using the terms “empathy fatigue” and “compassion fatigue” – a sense that they are losing empathy for unvaccinated individuals who are fueling the pandemic.

Dr. Erickson says she is frustrated not by individual patients but by a system that has allowed disinformation to proliferate. Experts say these types of feelings fit into a widespread pattern of physician burnout that has taken a new turn at this stage of the pandemic.

Paradoxical choices

Empathy is a cornerstone of what clinicians do, and the ability to understand and share a patient’s feelings is an essential skill for providing effective care, says Kaz Nelson, MD, a psychiatrist at the University of Minnesota, Minneapolis.

Practitioners face paradoxical situations all the time, she notes. These include individuals who break bones and go skydiving again, people who have high cholesterol but continue to eat fried foods, and those with advanced lung cancer who continue to smoke.

To treat patients with compassion, practitioners learn to set aside judgment by acknowledging the complexity of human behavior. They may lament the addictive nature of nicotine and advertising that targets children, for example, while still listening and caring.

Empathy requires high-level brain function, but as stress levels rise, brain function that drives empathy tends to shut down. It’s a survival mechanism, Dr. Nelson says.

When health care workers feel overwhelmed, trapped, or threatened by patients demanding unproven treatments or by ICUs with more patients than ventilators, they may experience a fight-or-flight response that makes them defensive, frustrated, angry, or uncaring, notes Mona Masood, DO, a Philadelphia-area psychiatrist and founder of Physician Support Line, a free mental health hotline for doctors.

Some clinicians have taken to Twitter and other social media platforms to post about these types of experiences.

These feelings, which have been brewing for months, have been exacerbated by the complexity of the current situation. Clinicians see a disconnect between what is and what could be, Dr. Nelson notes.

“Prior to vaccines, there weren’t other options, and so we had toxic stress and we had fatigue, but we could still maintain little bits of empathy by saying, ‘You know, people didn’t choose to get infected, and we are in a pandemic.’ We could kind of hate the virus. Now with access to vaccines, that last connection to empathy is removed for many people,” she says.

Self-preservation vs. empathy

Compassion fatigue or empathy fatigue is just one reaction to feeling completely maxed out and overstressed, Dr. Nelson says. Anger at society, such as what Dr. Erickson experienced, is another response.

Practitioners may also feel as if they are just going through the motions of their job, or they might disassociate, ceasing to feel that their patients are human. Plenty of doctors and nurses have cried in their cars after shifts and have posted tearful videos on social media.

Early in the pandemic, Dr. Masood says, physicians who called the support hotline expressed sadness and grief. Now, she had her colleagues hear frustration and anger, along with guilt and shame for having feelings they believe they shouldn’t be having, especially toward patients. They may feel unprofessional or worse – unworthy of being physicians, she says.

One recent caller to the hotline was a long-time ICU physician who had been told so many times by patients that ivermectin was the only medicine that would cure them that he began to doubt himself, says Dr. Masood. This caller needed to be reassured by another physician that he was doing the right thing.

Another emergency department physician told Dr. Masood about a young child who had arrived at the hospital with COVID-19 symptoms. When asked whether the family had been exposed to anyone with COVID-19, the child’s parent lied so that they could be triaged faster.

The physician, who needed to step away from the situation, reached out to Dr. Masood to express her frustration so that she wouldn’t “let it out” on the patient.

“It’s hard to have empathy for people who, for all intents and purposes, are very self-centered,” Dr. Masood says. “We’re at a place where we’re having to choose between self-preservation and empathy.”
 

How to cope

To help practitioners cope, Dr. Masood offers words that describe what they’re experiencing. She often hears clinicians say things such as, “This is a type of burnout that I feel to my bones,” or “This makes me want to quit,” or “I feel like I’m at the end of my rope.”

She encourages them to consider the terms “empathy fatigue,” and “moral injury” in order to reconcile how their sense of responsibility to take care of people is compromised by factors outside of their control.

It is not shameful to acknowledge that they experience emotions, including difficult ones such as frustration, anger, sadness, and anxiety, Dr. Masood adds.

Being frustrated with a patient doesn’t make someone a bad doctor, and admitting those emotions is the first step toward dealing with them, she says.

Dr. Nelson adds that taking breaks from work can help. She also recommends setting boundaries, seeking therapy, and acknowledging feelings early before they cause a sense of callousness or other consequences that become harder to heal from as time goes on.

“We’re trained to just go, go, go and sometimes not pause and check in,” she says. Clinicians who open up are likely to find they are not the only ones feeling tired or frustrated right now, she adds.

“Connect with peers and colleagues, because chances are, they can relate,” Dr. Nelson says.

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

Heidi Erickson, MD, is tired. As a pulmonary and critical care physician at Hennepin Healthcare in Minneapolis, she has been providing care for patients with COVID-19 since the start of the pandemic.

rclassenlayouts/Getty Images

It was exhausting from the beginning, as she and her colleagues scrambled to understand how to deal with this new disease. But lately, she has noticed a different kind of exhaustion arising from the knowledge that with vaccines widely available, the latest surge was preventable.

Her intensive care unit is currently as full as it has ever been with COVID-19 patients, many of them young adults and most of them unvaccinated. After the recent death of one patient, an unvaccinated man with teenage children, she had to face his family’s questions about why ivermectin, an antiparasitic medication that was falsely promoted as a COVID-19 treatment, was not administered.

“I’m fatigued because I’m working more than ever, but more people don’t have to die,” Dr. Erickson said in an interview . “It’s been very hard physically, mentally, emotionally.”

Amid yet another surge in COVID-19 cases around the United States, clinicians are speaking out about their growing frustration with this preventable crisis.

Some are using the terms “empathy fatigue” and “compassion fatigue” – a sense that they are losing empathy for unvaccinated individuals who are fueling the pandemic.

Dr. Erickson says she is frustrated not by individual patients but by a system that has allowed disinformation to proliferate. Experts say these types of feelings fit into a widespread pattern of physician burnout that has taken a new turn at this stage of the pandemic.

Paradoxical choices

Empathy is a cornerstone of what clinicians do, and the ability to understand and share a patient’s feelings is an essential skill for providing effective care, says Kaz Nelson, MD, a psychiatrist at the University of Minnesota, Minneapolis.

Practitioners face paradoxical situations all the time, she notes. These include individuals who break bones and go skydiving again, people who have high cholesterol but continue to eat fried foods, and those with advanced lung cancer who continue to smoke.

To treat patients with compassion, practitioners learn to set aside judgment by acknowledging the complexity of human behavior. They may lament the addictive nature of nicotine and advertising that targets children, for example, while still listening and caring.

Empathy requires high-level brain function, but as stress levels rise, brain function that drives empathy tends to shut down. It’s a survival mechanism, Dr. Nelson says.

When health care workers feel overwhelmed, trapped, or threatened by patients demanding unproven treatments or by ICUs with more patients than ventilators, they may experience a fight-or-flight response that makes them defensive, frustrated, angry, or uncaring, notes Mona Masood, DO, a Philadelphia-area psychiatrist and founder of Physician Support Line, a free mental health hotline for doctors.

Some clinicians have taken to Twitter and other social media platforms to post about these types of experiences.

These feelings, which have been brewing for months, have been exacerbated by the complexity of the current situation. Clinicians see a disconnect between what is and what could be, Dr. Nelson notes.

“Prior to vaccines, there weren’t other options, and so we had toxic stress and we had fatigue, but we could still maintain little bits of empathy by saying, ‘You know, people didn’t choose to get infected, and we are in a pandemic.’ We could kind of hate the virus. Now with access to vaccines, that last connection to empathy is removed for many people,” she says.

Self-preservation vs. empathy

Compassion fatigue or empathy fatigue is just one reaction to feeling completely maxed out and overstressed, Dr. Nelson says. Anger at society, such as what Dr. Erickson experienced, is another response.

Practitioners may also feel as if they are just going through the motions of their job, or they might disassociate, ceasing to feel that their patients are human. Plenty of doctors and nurses have cried in their cars after shifts and have posted tearful videos on social media.

Early in the pandemic, Dr. Masood says, physicians who called the support hotline expressed sadness and grief. Now, she had her colleagues hear frustration and anger, along with guilt and shame for having feelings they believe they shouldn’t be having, especially toward patients. They may feel unprofessional or worse – unworthy of being physicians, she says.

One recent caller to the hotline was a long-time ICU physician who had been told so many times by patients that ivermectin was the only medicine that would cure them that he began to doubt himself, says Dr. Masood. This caller needed to be reassured by another physician that he was doing the right thing.

Another emergency department physician told Dr. Masood about a young child who had arrived at the hospital with COVID-19 symptoms. When asked whether the family had been exposed to anyone with COVID-19, the child’s parent lied so that they could be triaged faster.

The physician, who needed to step away from the situation, reached out to Dr. Masood to express her frustration so that she wouldn’t “let it out” on the patient.

“It’s hard to have empathy for people who, for all intents and purposes, are very self-centered,” Dr. Masood says. “We’re at a place where we’re having to choose between self-preservation and empathy.”
 

How to cope

To help practitioners cope, Dr. Masood offers words that describe what they’re experiencing. She often hears clinicians say things such as, “This is a type of burnout that I feel to my bones,” or “This makes me want to quit,” or “I feel like I’m at the end of my rope.”

She encourages them to consider the terms “empathy fatigue,” and “moral injury” in order to reconcile how their sense of responsibility to take care of people is compromised by factors outside of their control.

It is not shameful to acknowledge that they experience emotions, including difficult ones such as frustration, anger, sadness, and anxiety, Dr. Masood adds.

Being frustrated with a patient doesn’t make someone a bad doctor, and admitting those emotions is the first step toward dealing with them, she says.

Dr. Nelson adds that taking breaks from work can help. She also recommends setting boundaries, seeking therapy, and acknowledging feelings early before they cause a sense of callousness or other consequences that become harder to heal from as time goes on.

“We’re trained to just go, go, go and sometimes not pause and check in,” she says. Clinicians who open up are likely to find they are not the only ones feeling tired or frustrated right now, she adds.

“Connect with peers and colleagues, because chances are, they can relate,” Dr. Nelson says.

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

As private practices try to recover and rebuild in the wake of the COVID-19 pandemic, many have faced an unexpected challenge: a paucity of employees.

My own office is prime example: I have had job listings for both front- and back-office positions posted on all the major job boards and other employment portals for months, with a disappointing response. Of the few who do respond, many, incredibly, do not show up for their interviews!

It turns out that this is a widespread problem, and not just in medicine. A recent survey by the National Federation of Independent Business found that 42% of business owners, in all walks of life, had job openings that could not be filled, a record high. Over 90% of those hiring reported few or no qualified applicants and an increase in interview no-shows.

Clearly, this is a huge obstacle to growth – and even to conducting normal operations – for my practice and many others.

Reasons for the situation vary, but a big one has been the unfortunate fact that many open job positions actually pay less than the expanded unemployment benefits that many people have received under the March 2020 CARES Act. By one estimate, almost 70% of unemployed workers have been collecting more on unemployment than they earned while working. The CARES benefits expired in early September, but many potential workers continue to receive payments through a newer FEMA program, and some states have their own ongoing benefit programs.

Other reasons have been offered: Some candidates are unvaccinated (an immediate deal-breaker in my office), and some working parents continue to face a lack of childcare or in-person schooling for their children. Some applicants – regardless of vaccination status – have said they are hesitant to work in a medical office setting and risk getting COVID-19, despite all the precautions we have in place. Others have said they are waiting until the job market improves.

There are no easy solutions to this complicated problem, but here are a few suggestions culled from my research and conversations with HR professionals and others.

One obvious option is to offer higher wages, and perhaps even signing bonuses. “Whenever anyone says they can’t find the workers they need,” a consultant told me, “they are really saying they can’t find them at the wages they want to pay.” There are limits to the wages and benefits a private office with a very finite salary budget can offer, of course – but a few higher-paid employees may be preferable to no new workers at all.

For job candidates who fear COVID-19 exposure, assure them that their health and safety is a priority by spelling out the procedures your office is following (social distancing, reduced patient capacity, interaction barriers, face masks, avoidance of handshakes, enhanced cleaning procedures, symptom questionnaires, temperature checks, etc.) to minimize the risk of exposure.

You also may need to rework your interview process. In the Zoom era, most preliminary interviews can be conducted remotely. For on-site interviews, explain how you’re maintaining a safe interview environment by applying the same office safety policies to interactions with interviewees.

If a promising candidate doesn’t show up for an interview, the applicant could be making a token effort to obtain a job in order to perpetuate unemployment payments, but don’t jump to that conclusion. There may be extenuating circumstances, such as an emergency, illness, or traffic issues. Also, consider the possibility that it was your fault. If you waited too long to schedule the interview, another office could have lured them away. Or you may not have adequately explained your COVID-19 exposure safeguards. At the very least, a drawn-out process or a lack of transparency can make applicants apprehensive about accepting a job with you, particularly if other employers are pursuing them.

To counter the shortsighted appeal of collecting unemployment benefits, it may help to highlight the long-term growth opportunities available at your office. Consider outlining typical career tracks, or providing specific examples of how people have advanced their careers at your facility. I frequently cite the example of my current office manager, who began as an assistant receptionist almost 30 years ago.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As private practices try to recover and rebuild in the wake of the COVID-19 pandemic, many have faced an unexpected challenge: a paucity of employees.

My own office is prime example: I have had job listings for both front- and back-office positions posted on all the major job boards and other employment portals for months, with a disappointing response. Of the few who do respond, many, incredibly, do not show up for their interviews!

It turns out that this is a widespread problem, and not just in medicine. A recent survey by the National Federation of Independent Business found that 42% of business owners, in all walks of life, had job openings that could not be filled, a record high. Over 90% of those hiring reported few or no qualified applicants and an increase in interview no-shows.

Clearly, this is a huge obstacle to growth – and even to conducting normal operations – for my practice and many others.

Reasons for the situation vary, but a big one has been the unfortunate fact that many open job positions actually pay less than the expanded unemployment benefits that many people have received under the March 2020 CARES Act. By one estimate, almost 70% of unemployed workers have been collecting more on unemployment than they earned while working. The CARES benefits expired in early September, but many potential workers continue to receive payments through a newer FEMA program, and some states have their own ongoing benefit programs.

Other reasons have been offered: Some candidates are unvaccinated (an immediate deal-breaker in my office), and some working parents continue to face a lack of childcare or in-person schooling for their children. Some applicants – regardless of vaccination status – have said they are hesitant to work in a medical office setting and risk getting COVID-19, despite all the precautions we have in place. Others have said they are waiting until the job market improves.

There are no easy solutions to this complicated problem, but here are a few suggestions culled from my research and conversations with HR professionals and others.

One obvious option is to offer higher wages, and perhaps even signing bonuses. “Whenever anyone says they can’t find the workers they need,” a consultant told me, “they are really saying they can’t find them at the wages they want to pay.” There are limits to the wages and benefits a private office with a very finite salary budget can offer, of course – but a few higher-paid employees may be preferable to no new workers at all.

For job candidates who fear COVID-19 exposure, assure them that their health and safety is a priority by spelling out the procedures your office is following (social distancing, reduced patient capacity, interaction barriers, face masks, avoidance of handshakes, enhanced cleaning procedures, symptom questionnaires, temperature checks, etc.) to minimize the risk of exposure.

You also may need to rework your interview process. In the Zoom era, most preliminary interviews can be conducted remotely. For on-site interviews, explain how you’re maintaining a safe interview environment by applying the same office safety policies to interactions with interviewees.

If a promising candidate doesn’t show up for an interview, the applicant could be making a token effort to obtain a job in order to perpetuate unemployment payments, but don’t jump to that conclusion. There may be extenuating circumstances, such as an emergency, illness, or traffic issues. Also, consider the possibility that it was your fault. If you waited too long to schedule the interview, another office could have lured them away. Or you may not have adequately explained your COVID-19 exposure safeguards. At the very least, a drawn-out process or a lack of transparency can make applicants apprehensive about accepting a job with you, particularly if other employers are pursuing them.

To counter the shortsighted appeal of collecting unemployment benefits, it may help to highlight the long-term growth opportunities available at your office. Consider outlining typical career tracks, or providing specific examples of how people have advanced their careers at your facility. I frequently cite the example of my current office manager, who began as an assistant receptionist almost 30 years ago.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As private practices try to recover and rebuild in the wake of the COVID-19 pandemic, many have faced an unexpected challenge: a paucity of employees.

My own office is prime example: I have had job listings for both front- and back-office positions posted on all the major job boards and other employment portals for months, with a disappointing response. Of the few who do respond, many, incredibly, do not show up for their interviews!

It turns out that this is a widespread problem, and not just in medicine. A recent survey by the National Federation of Independent Business found that 42% of business owners, in all walks of life, had job openings that could not be filled, a record high. Over 90% of those hiring reported few or no qualified applicants and an increase in interview no-shows.

Clearly, this is a huge obstacle to growth – and even to conducting normal operations – for my practice and many others.

Reasons for the situation vary, but a big one has been the unfortunate fact that many open job positions actually pay less than the expanded unemployment benefits that many people have received under the March 2020 CARES Act. By one estimate, almost 70% of unemployed workers have been collecting more on unemployment than they earned while working. The CARES benefits expired in early September, but many potential workers continue to receive payments through a newer FEMA program, and some states have their own ongoing benefit programs.

Other reasons have been offered: Some candidates are unvaccinated (an immediate deal-breaker in my office), and some working parents continue to face a lack of childcare or in-person schooling for their children. Some applicants – regardless of vaccination status – have said they are hesitant to work in a medical office setting and risk getting COVID-19, despite all the precautions we have in place. Others have said they are waiting until the job market improves.

There are no easy solutions to this complicated problem, but here are a few suggestions culled from my research and conversations with HR professionals and others.

One obvious option is to offer higher wages, and perhaps even signing bonuses. “Whenever anyone says they can’t find the workers they need,” a consultant told me, “they are really saying they can’t find them at the wages they want to pay.” There are limits to the wages and benefits a private office with a very finite salary budget can offer, of course – but a few higher-paid employees may be preferable to no new workers at all.

For job candidates who fear COVID-19 exposure, assure them that their health and safety is a priority by spelling out the procedures your office is following (social distancing, reduced patient capacity, interaction barriers, face masks, avoidance of handshakes, enhanced cleaning procedures, symptom questionnaires, temperature checks, etc.) to minimize the risk of exposure.

You also may need to rework your interview process. In the Zoom era, most preliminary interviews can be conducted remotely. For on-site interviews, explain how you’re maintaining a safe interview environment by applying the same office safety policies to interactions with interviewees.

If a promising candidate doesn’t show up for an interview, the applicant could be making a token effort to obtain a job in order to perpetuate unemployment payments, but don’t jump to that conclusion. There may be extenuating circumstances, such as an emergency, illness, or traffic issues. Also, consider the possibility that it was your fault. If you waited too long to schedule the interview, another office could have lured them away. Or you may not have adequately explained your COVID-19 exposure safeguards. At the very least, a drawn-out process or a lack of transparency can make applicants apprehensive about accepting a job with you, particularly if other employers are pursuing them.

To counter the shortsighted appeal of collecting unemployment benefits, it may help to highlight the long-term growth opportunities available at your office. Consider outlining typical career tracks, or providing specific examples of how people have advanced their careers at your facility. I frequently cite the example of my current office manager, who began as an assistant receptionist almost 30 years ago.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Premature menopause is well known to be linked to cardiovascular disease in women, but it may not carry as much weight as more traditional cardiovascular risk factors in determining a patient’s 10-year risk of having a heart attack or stroke in this population, a cohort study that evaluated the veracity of premature menopause found.

Premature menopause can serve as a “marker or warning sign” that cardiologists should pay closer attention to traditional atherosclerotic cardiovascular disease (ASCVD) risk factors, lead study author Sadiya S. Khan, MD, MS, said in an interview. “When we looked at the addition of premature menopause into the risk-prediction equation, we did not see that it meaningfully improved the ability of the risk predictions of pooled cohort equations [PCEs] to identify who developed cardiovascular disease,” said Dr. Khan, a cardiologist at Northwestern University, Chicago.

The cohort study included 5,466 Black women and 10,584 White women from seven U.S. population-based cohorts, including the Women’s Health Initiative, of whom 951 and 1,039, respectively, self-reported early menopause. The cohort study researchers noted that the 2019 American College of Cardiology/American Heart Association guideline for prevention of CVD acknowledged premature menopause as risk-enhancing factor in the CVD assessment in women younger than 40.

The cohort study found that Black women had almost twice the rate of premature menopause than White women, 17.4% and 9.8%, respectively. And it found that premature menopause was significantly linked with ASCVD in both populations independent of traditional risk factors – a 24% greater risk for Black women and 28% greater risk for White women.
 

‘Surprising’ finding

However, when premature menopause was added to the pooled cohort equations per the 2013 ACC/AHA guideline, the researchers found no incremental benefit, a finding Dr. Khan called “really surprising to us.”

She added, “If we look at the differences in the characteristics of women who have premature menopause, compared with those who didn’t, there were slight differences in terms of higher blood pressure, higher body mass index, and slightly higher glucose. So maybe what we’re seeing – and this is more speculative – is that risk factors are developing after early menopause, and the focus should be earlier in the patient’s life course to try to prevent hypertension, diabetes, and obesity.”

Dr. Khan emphasized that the findings don’t obviate the value of premature menopause in assessing ASCVD risk in women. “We still know that this is an important marker for women and their risk for heart disease, and it should be a warning sign to pay close attention to those other risk factors and what other preventive measures can be taken,” she said.

Christie Ballantyne, MD, said it’s important to note that the study did not dismiss the relevance of premature menopause in shared decision-making for postmenopausal women. “It certainly doesn’t mean that premature menopause is not a risk,” Dr. Ballantyne said in an interview. “Premature menopause may cause a worsening of traditional CVD risk factors, so that’s one possible explanation for it. The other possible explanation is that women with worse ASCVD risk factors – who are more overweight, have higher blood pressure, and have more diabetes and insulin resistance – are more likely to have earlier menopause.” Dr. Ballantyne is chief of cardiology at Baylor College of Medicine and director of cardiovascular disease prevention at Methodist DeBakey Heart Center, both in Houston.

“You should still look very carefully at the patient’s risk factors, calculate the pooled cohort equations, and make sure you get a recommendation,” he said. “If their risks are up, give recommendations on how to improve diet and exercise. Consider if you need to treat lipids or treat blood pressure with more than diet and exercise because there’s nothing magical about 7.5%”, the threshold for lipid-lowering therapy in the ASCVD risk calculator.

Dr. Khan and coauthors disclosed receiving grants from the National Institutes of Health and the American Heart Association. One coauthor reported a financial relationship with HGM Biopharmaceuticals. Dr. Ballantyne is a lead investigator of the Atherosclerosis Risk in Communities study, one of the population-based cohorts used in the cohort study. He has no other relevant relationships to disclose.

Premature menopause is well known to be linked to cardiovascular disease in women, but it may not carry as much weight as more traditional cardiovascular risk factors in determining a patient’s 10-year risk of having a heart attack or stroke in this population, a cohort study that evaluated the veracity of premature menopause found.

Premature menopause can serve as a “marker or warning sign” that cardiologists should pay closer attention to traditional atherosclerotic cardiovascular disease (ASCVD) risk factors, lead study author Sadiya S. Khan, MD, MS, said in an interview. “When we looked at the addition of premature menopause into the risk-prediction equation, we did not see that it meaningfully improved the ability of the risk predictions of pooled cohort equations [PCEs] to identify who developed cardiovascular disease,” said Dr. Khan, a cardiologist at Northwestern University, Chicago.

The cohort study included 5,466 Black women and 10,584 White women from seven U.S. population-based cohorts, including the Women’s Health Initiative, of whom 951 and 1,039, respectively, self-reported early menopause. The cohort study researchers noted that the 2019 American College of Cardiology/American Heart Association guideline for prevention of CVD acknowledged premature menopause as risk-enhancing factor in the CVD assessment in women younger than 40.

The cohort study found that Black women had almost twice the rate of premature menopause than White women, 17.4% and 9.8%, respectively. And it found that premature menopause was significantly linked with ASCVD in both populations independent of traditional risk factors – a 24% greater risk for Black women and 28% greater risk for White women.
 

‘Surprising’ finding

However, when premature menopause was added to the pooled cohort equations per the 2013 ACC/AHA guideline, the researchers found no incremental benefit, a finding Dr. Khan called “really surprising to us.”

She added, “If we look at the differences in the characteristics of women who have premature menopause, compared with those who didn’t, there were slight differences in terms of higher blood pressure, higher body mass index, and slightly higher glucose. So maybe what we’re seeing – and this is more speculative – is that risk factors are developing after early menopause, and the focus should be earlier in the patient’s life course to try to prevent hypertension, diabetes, and obesity.”

Dr. Khan emphasized that the findings don’t obviate the value of premature menopause in assessing ASCVD risk in women. “We still know that this is an important marker for women and their risk for heart disease, and it should be a warning sign to pay close attention to those other risk factors and what other preventive measures can be taken,” she said.

Christie Ballantyne, MD, said it’s important to note that the study did not dismiss the relevance of premature menopause in shared decision-making for postmenopausal women. “It certainly doesn’t mean that premature menopause is not a risk,” Dr. Ballantyne said in an interview. “Premature menopause may cause a worsening of traditional CVD risk factors, so that’s one possible explanation for it. The other possible explanation is that women with worse ASCVD risk factors – who are more overweight, have higher blood pressure, and have more diabetes and insulin resistance – are more likely to have earlier menopause.” Dr. Ballantyne is chief of cardiology at Baylor College of Medicine and director of cardiovascular disease prevention at Methodist DeBakey Heart Center, both in Houston.

“You should still look very carefully at the patient’s risk factors, calculate the pooled cohort equations, and make sure you get a recommendation,” he said. “If their risks are up, give recommendations on how to improve diet and exercise. Consider if you need to treat lipids or treat blood pressure with more than diet and exercise because there’s nothing magical about 7.5%”, the threshold for lipid-lowering therapy in the ASCVD risk calculator.

Dr. Khan and coauthors disclosed receiving grants from the National Institutes of Health and the American Heart Association. One coauthor reported a financial relationship with HGM Biopharmaceuticals. Dr. Ballantyne is a lead investigator of the Atherosclerosis Risk in Communities study, one of the population-based cohorts used in the cohort study. He has no other relevant relationships to disclose.

Premature menopause is well known to be linked to cardiovascular disease in women, but it may not carry as much weight as more traditional cardiovascular risk factors in determining a patient’s 10-year risk of having a heart attack or stroke in this population, a cohort study that evaluated the veracity of premature menopause found.

Premature menopause can serve as a “marker or warning sign” that cardiologists should pay closer attention to traditional atherosclerotic cardiovascular disease (ASCVD) risk factors, lead study author Sadiya S. Khan, MD, MS, said in an interview. “When we looked at the addition of premature menopause into the risk-prediction equation, we did not see that it meaningfully improved the ability of the risk predictions of pooled cohort equations [PCEs] to identify who developed cardiovascular disease,” said Dr. Khan, a cardiologist at Northwestern University, Chicago.

The cohort study included 5,466 Black women and 10,584 White women from seven U.S. population-based cohorts, including the Women’s Health Initiative, of whom 951 and 1,039, respectively, self-reported early menopause. The cohort study researchers noted that the 2019 American College of Cardiology/American Heart Association guideline for prevention of CVD acknowledged premature menopause as risk-enhancing factor in the CVD assessment in women younger than 40.

The cohort study found that Black women had almost twice the rate of premature menopause than White women, 17.4% and 9.8%, respectively. And it found that premature menopause was significantly linked with ASCVD in both populations independent of traditional risk factors – a 24% greater risk for Black women and 28% greater risk for White women.
 

‘Surprising’ finding

However, when premature menopause was added to the pooled cohort equations per the 2013 ACC/AHA guideline, the researchers found no incremental benefit, a finding Dr. Khan called “really surprising to us.”

She added, “If we look at the differences in the characteristics of women who have premature menopause, compared with those who didn’t, there were slight differences in terms of higher blood pressure, higher body mass index, and slightly higher glucose. So maybe what we’re seeing – and this is more speculative – is that risk factors are developing after early menopause, and the focus should be earlier in the patient’s life course to try to prevent hypertension, diabetes, and obesity.”

Dr. Khan emphasized that the findings don’t obviate the value of premature menopause in assessing ASCVD risk in women. “We still know that this is an important marker for women and their risk for heart disease, and it should be a warning sign to pay close attention to those other risk factors and what other preventive measures can be taken,” she said.

Christie Ballantyne, MD, said it’s important to note that the study did not dismiss the relevance of premature menopause in shared decision-making for postmenopausal women. “It certainly doesn’t mean that premature menopause is not a risk,” Dr. Ballantyne said in an interview. “Premature menopause may cause a worsening of traditional CVD risk factors, so that’s one possible explanation for it. The other possible explanation is that women with worse ASCVD risk factors – who are more overweight, have higher blood pressure, and have more diabetes and insulin resistance – are more likely to have earlier menopause.” Dr. Ballantyne is chief of cardiology at Baylor College of Medicine and director of cardiovascular disease prevention at Methodist DeBakey Heart Center, both in Houston.

“You should still look very carefully at the patient’s risk factors, calculate the pooled cohort equations, and make sure you get a recommendation,” he said. “If their risks are up, give recommendations on how to improve diet and exercise. Consider if you need to treat lipids or treat blood pressure with more than diet and exercise because there’s nothing magical about 7.5%”, the threshold for lipid-lowering therapy in the ASCVD risk calculator.

Dr. Khan and coauthors disclosed receiving grants from the National Institutes of Health and the American Heart Association. One coauthor reported a financial relationship with HGM Biopharmaceuticals. Dr. Ballantyne is a lead investigator of the Atherosclerosis Risk in Communities study, one of the population-based cohorts used in the cohort study. He has no other relevant relationships to disclose.

Muscle symptoms, such as cramps, pain, and other discomfort many patients blame on their recently prescribed statin usually aren’t caused by the drug at all, but by the expectation of such adverse effects, conclude researchers behind the randomized SAMSON trial, now fully published .

It’s common for patients to stop taking their statin because of muscle pain and their belief that the drug itself is to blame. That can sometimes be true, but the SAMSON trial, owing to its unusual design, makes a strong case that such symptoms are usually a nocebo effect.

That is, most statin-related muscle symptoms are likely “driven by the act of taking tablets rather than whether the tablets contain a statin,” concludes the report, which appears in the September 21 issue of the Journal of the American College of Cardiology, with lead authors James P. Howard, PhD, and Frances A. Wood, MPhil, Imperial College London.

SAMSON had been presented at the American Heart Association Scientific Sessions 2020 virtual meeting, covered at the time by this news organization, and simultaneously published in abbreviated form as correspondence in the New England Journal of Medicine.

“SAMSON suggests that the bulk of statin-related intolerable side effects arise from the taking of a tablet, not from statin therapy per se,” agrees an editorial accompanying the new publication.

“The study also demonstrates that the informal experimentation of stopping and restarting a statin to evaluate symptom resolution and reinduction without use of a placebo leads to nocebo symptoms misattributed to the statin,” writes Peter P. Toth, MD, PhD, Johns Hopkins University, Baltimore.

Statin intolerance, he continues, “warrants considerable further investigation, because it undermines standard of care for a very large number of patients worldwide,” leaving them vulnerable to atherosclerotic cardiovascular disease events. “Aches and pains are a fact of life; just because a patient has them does not mean they should be attributed to their statin.”

SAMSON assigned 35 men and 25 women to take atorvastatin 20 mg/day, its matching placebo, or neither pill each for 1 month in randomly alternating order for 12 months, with double-blinding, such that each of the three regimens was maintained for a total of 4 months.

The patients, 77% of whom were prescribed statins for primary prevention and all of whom had a history of stopping the drugs because of adverse effects, documented the severity of any perceived adverse effects on a smartphone app, with a “symptom score” ranging from 0 to 100.

The symptom score averaged 8.0 in months when no tablet was taken, but it was much higher in other months: 15.4 in placebo-pill months and 16.3 in months when atorvastatin was taken. The no-tablet score was significantly lower (P < .001) than either of the two other scores, which themselves were not significantly different from each other.

Eleven patients were unable to complete all 12 one-month segments of the trial, including five because of severe symptoms, but discontinuation was no more likely to occur in the atorvastatin group than in the placebo group.

The authors calculated an overall 0.90 “nocebo ratio” for the study, defined as the difference between symptom intensity on placebo and on no pill, divided by the difference between symptom intensity on atorvastatin and on no pill.

That means, the authors propose, that 90% of the symptom burden felt by patients receiving atorvastatin was also felt on the placebo pill and could be attributed to the nocebo effect.

“Prompt onset and offset of symptoms after starting and stopping tablets is often interpreted by patients and clinicians as evidence of causation. Our data indicate that this is true,” the authors write, but “the causation is from taking a tablet, rather than from the tablet being a statin.”

SAMSON was funded by the British Heart Foundation and supported by the National Institute for Health Research Imperial Biomedical Research Centre and the Imperial Clinical Trials Unit. Dr. Howard is supported by the Wellcome Trust. Dr. Wood declared no conflicts. Disclosures for the other authors are in the report. Dr. Toth discloses serving as a consultant to Amarin, Amgen, AstraZeneca, nio89, Kowa, Merck, Resverlogix, and Theravance; and serving on a speaker’s bureau for Amarin, Amgen, Esperion, and NovoNordisk.

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

Muscle symptoms, such as cramps, pain, and other discomfort many patients blame on their recently prescribed statin usually aren’t caused by the drug at all, but by the expectation of such adverse effects, conclude researchers behind the randomized SAMSON trial, now fully published .

It’s common for patients to stop taking their statin because of muscle pain and their belief that the drug itself is to blame. That can sometimes be true, but the SAMSON trial, owing to its unusual design, makes a strong case that such symptoms are usually a nocebo effect.

That is, most statin-related muscle symptoms are likely “driven by the act of taking tablets rather than whether the tablets contain a statin,” concludes the report, which appears in the September 21 issue of the Journal of the American College of Cardiology, with lead authors James P. Howard, PhD, and Frances A. Wood, MPhil, Imperial College London.

SAMSON had been presented at the American Heart Association Scientific Sessions 2020 virtual meeting, covered at the time by this news organization, and simultaneously published in abbreviated form as correspondence in the New England Journal of Medicine.

“SAMSON suggests that the bulk of statin-related intolerable side effects arise from the taking of a tablet, not from statin therapy per se,” agrees an editorial accompanying the new publication.

“The study also demonstrates that the informal experimentation of stopping and restarting a statin to evaluate symptom resolution and reinduction without use of a placebo leads to nocebo symptoms misattributed to the statin,” writes Peter P. Toth, MD, PhD, Johns Hopkins University, Baltimore.

Statin intolerance, he continues, “warrants considerable further investigation, because it undermines standard of care for a very large number of patients worldwide,” leaving them vulnerable to atherosclerotic cardiovascular disease events. “Aches and pains are a fact of life; just because a patient has them does not mean they should be attributed to their statin.”

SAMSON assigned 35 men and 25 women to take atorvastatin 20 mg/day, its matching placebo, or neither pill each for 1 month in randomly alternating order for 12 months, with double-blinding, such that each of the three regimens was maintained for a total of 4 months.

The patients, 77% of whom were prescribed statins for primary prevention and all of whom had a history of stopping the drugs because of adverse effects, documented the severity of any perceived adverse effects on a smartphone app, with a “symptom score” ranging from 0 to 100.

The symptom score averaged 8.0 in months when no tablet was taken, but it was much higher in other months: 15.4 in placebo-pill months and 16.3 in months when atorvastatin was taken. The no-tablet score was significantly lower (P < .001) than either of the two other scores, which themselves were not significantly different from each other.

Eleven patients were unable to complete all 12 one-month segments of the trial, including five because of severe symptoms, but discontinuation was no more likely to occur in the atorvastatin group than in the placebo group.

The authors calculated an overall 0.90 “nocebo ratio” for the study, defined as the difference between symptom intensity on placebo and on no pill, divided by the difference between symptom intensity on atorvastatin and on no pill.

That means, the authors propose, that 90% of the symptom burden felt by patients receiving atorvastatin was also felt on the placebo pill and could be attributed to the nocebo effect.

“Prompt onset and offset of symptoms after starting and stopping tablets is often interpreted by patients and clinicians as evidence of causation. Our data indicate that this is true,” the authors write, but “the causation is from taking a tablet, rather than from the tablet being a statin.”

SAMSON was funded by the British Heart Foundation and supported by the National Institute for Health Research Imperial Biomedical Research Centre and the Imperial Clinical Trials Unit. Dr. Howard is supported by the Wellcome Trust. Dr. Wood declared no conflicts. Disclosures for the other authors are in the report. Dr. Toth discloses serving as a consultant to Amarin, Amgen, AstraZeneca, nio89, Kowa, Merck, Resverlogix, and Theravance; and serving on a speaker’s bureau for Amarin, Amgen, Esperion, and NovoNordisk.

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

Muscle symptoms, such as cramps, pain, and other discomfort many patients blame on their recently prescribed statin usually aren’t caused by the drug at all, but by the expectation of such adverse effects, conclude researchers behind the randomized SAMSON trial, now fully published .

It’s common for patients to stop taking their statin because of muscle pain and their belief that the drug itself is to blame. That can sometimes be true, but the SAMSON trial, owing to its unusual design, makes a strong case that such symptoms are usually a nocebo effect.

That is, most statin-related muscle symptoms are likely “driven by the act of taking tablets rather than whether the tablets contain a statin,” concludes the report, which appears in the September 21 issue of the Journal of the American College of Cardiology, with lead authors James P. Howard, PhD, and Frances A. Wood, MPhil, Imperial College London.

SAMSON had been presented at the American Heart Association Scientific Sessions 2020 virtual meeting, covered at the time by this news organization, and simultaneously published in abbreviated form as correspondence in the New England Journal of Medicine.

“SAMSON suggests that the bulk of statin-related intolerable side effects arise from the taking of a tablet, not from statin therapy per se,” agrees an editorial accompanying the new publication.

“The study also demonstrates that the informal experimentation of stopping and restarting a statin to evaluate symptom resolution and reinduction without use of a placebo leads to nocebo symptoms misattributed to the statin,” writes Peter P. Toth, MD, PhD, Johns Hopkins University, Baltimore.

Statin intolerance, he continues, “warrants considerable further investigation, because it undermines standard of care for a very large number of patients worldwide,” leaving them vulnerable to atherosclerotic cardiovascular disease events. “Aches and pains are a fact of life; just because a patient has them does not mean they should be attributed to their statin.”

SAMSON assigned 35 men and 25 women to take atorvastatin 20 mg/day, its matching placebo, or neither pill each for 1 month in randomly alternating order for 12 months, with double-blinding, such that each of the three regimens was maintained for a total of 4 months.

The patients, 77% of whom were prescribed statins for primary prevention and all of whom had a history of stopping the drugs because of adverse effects, documented the severity of any perceived adverse effects on a smartphone app, with a “symptom score” ranging from 0 to 100.

The symptom score averaged 8.0 in months when no tablet was taken, but it was much higher in other months: 15.4 in placebo-pill months and 16.3 in months when atorvastatin was taken. The no-tablet score was significantly lower (P < .001) than either of the two other scores, which themselves were not significantly different from each other.

Eleven patients were unable to complete all 12 one-month segments of the trial, including five because of severe symptoms, but discontinuation was no more likely to occur in the atorvastatin group than in the placebo group.

The authors calculated an overall 0.90 “nocebo ratio” for the study, defined as the difference between symptom intensity on placebo and on no pill, divided by the difference between symptom intensity on atorvastatin and on no pill.

That means, the authors propose, that 90% of the symptom burden felt by patients receiving atorvastatin was also felt on the placebo pill and could be attributed to the nocebo effect.

“Prompt onset and offset of symptoms after starting and stopping tablets is often interpreted by patients and clinicians as evidence of causation. Our data indicate that this is true,” the authors write, but “the causation is from taking a tablet, rather than from the tablet being a statin.”

SAMSON was funded by the British Heart Foundation and supported by the National Institute for Health Research Imperial Biomedical Research Centre and the Imperial Clinical Trials Unit. Dr. Howard is supported by the Wellcome Trust. Dr. Wood declared no conflicts. Disclosures for the other authors are in the report. Dr. Toth discloses serving as a consultant to Amarin, Amgen, AstraZeneca, nio89, Kowa, Merck, Resverlogix, and Theravance; and serving on a speaker’s bureau for Amarin, Amgen, Esperion, and NovoNordisk.

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

Poor lung function appears to be a stronger marker of risk for sudden cardiac death than for a survivable first coronary event, results of a prospective population-based study suggest.

Among 28,584 adults with no history of acute coronary events who were followed over 4 decades, every standard deviation decrease in forced expiratory volume in 1 second (FEV₁) was associated with a 23% increase in risk for sudden cardiac death, reported Suneela Zaigham, PhD, a cardiovascular epidemiology fellow at the University of Lund, Sweden, and colleagues.

“Our main findings and subsequent conclusions are that low FEV₁ is associated with both sudden cardiac death and nonfatal coronary events but is consistently more strongly associated with future sudden cardiac death,” Dr. Zaigham said in a narrated poster presented at the European Respiratory Society (ERS) 2021 International Congress, which was held online.

“We propose that measurement with spirometry in early life could aid in the risk stratification of future sudden cardiac death, and our results support the use of spirometry for cardiovascular risk assessment,” she said.

Marc Humbert, MD, PhD, professor of respiratory medicine at Université Paris–Saclay, who was not involved in the study, said that “this is something we can measure fairly easily, meaning that lung function could be used as part of a screening tool.

“We need to do more research to understand the links between lung function and sudden cardiac death and to investigate whether we can use lung function tests to help prevent deaths in the future,” he said.
 

Fatal vs. nonfatal events

It is well known that poor lung function is a strong predictor of future coronary events, but it was unknown whether patterns of lung impairment differ in their ability to predict future nonfatal coronary events or sudden cardiac death, Dr. Zaigham said.

To see whether measurable differences in lung function could predict risk for both fatal and nonfatal coronary events, the investigators studied 28,584 middle-aged residents of Malmö, Sweden. Baseline spirometry test results were available for all study participants.

The patients were followed for approximately 40 years for sudden cardiac death, defined as death on the day of a coronary event, or nonfatal events, defined as survival for at least 24 hours after an event.

Dr. Zaigham and colleagues used a modified version of Lunn McNeil’s competing risks method to create Cox regression models.

Results of an analysis that was adjusted for potential confounding factors indicated that one standard deviation reduction in FEV₁ was associated with a hazard ratio (HR) for sudden cardiac death of 1.23 (95% confidence interval, 1.15-1.31). In contrast, one standard deviation in FEV₁ was associated with a lower but still significant risk for nonfatal events, with an HR of 1.08 (95% CI, 1.04-1.13; P for equal associations = .002).

The results remained significant among participants who had never smoked, with an HR for sudden cardiac death of 1.34 (95% CI, 1.15-1.55) and for nonfatal events of 1.11 (95% CI, 1.02-1.21; P for equal associations = .038).

“This study suggests a link between lung health and sudden cardiac death. It shows a higher risk of fatal than nonfatal coronary events even in people whose lung function is moderately lower but may still be within a normal range,” Dr. Humbert said.

The study was supported by the Swedish Heart-Lung Foundation. Dr. Zaigham and Dr. Humbert reported having no relevant financial relationships.

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

Poor lung function appears to be a stronger marker of risk for sudden cardiac death than for a survivable first coronary event, results of a prospective population-based study suggest.

Among 28,584 adults with no history of acute coronary events who were followed over 4 decades, every standard deviation decrease in forced expiratory volume in 1 second (FEV₁) was associated with a 23% increase in risk for sudden cardiac death, reported Suneela Zaigham, PhD, a cardiovascular epidemiology fellow at the University of Lund, Sweden, and colleagues.

“Our main findings and subsequent conclusions are that low FEV₁ is associated with both sudden cardiac death and nonfatal coronary events but is consistently more strongly associated with future sudden cardiac death,” Dr. Zaigham said in a narrated poster presented at the European Respiratory Society (ERS) 2021 International Congress, which was held online.

“We propose that measurement with spirometry in early life could aid in the risk stratification of future sudden cardiac death, and our results support the use of spirometry for cardiovascular risk assessment,” she said.

Marc Humbert, MD, PhD, professor of respiratory medicine at Université Paris–Saclay, who was not involved in the study, said that “this is something we can measure fairly easily, meaning that lung function could be used as part of a screening tool.

“We need to do more research to understand the links between lung function and sudden cardiac death and to investigate whether we can use lung function tests to help prevent deaths in the future,” he said.
 

Fatal vs. nonfatal events

It is well known that poor lung function is a strong predictor of future coronary events, but it was unknown whether patterns of lung impairment differ in their ability to predict future nonfatal coronary events or sudden cardiac death, Dr. Zaigham said.

To see whether measurable differences in lung function could predict risk for both fatal and nonfatal coronary events, the investigators studied 28,584 middle-aged residents of Malmö, Sweden. Baseline spirometry test results were available for all study participants.

The patients were followed for approximately 40 years for sudden cardiac death, defined as death on the day of a coronary event, or nonfatal events, defined as survival for at least 24 hours after an event.

Dr. Zaigham and colleagues used a modified version of Lunn McNeil’s competing risks method to create Cox regression models.

Results of an analysis that was adjusted for potential confounding factors indicated that one standard deviation reduction in FEV₁ was associated with a hazard ratio (HR) for sudden cardiac death of 1.23 (95% confidence interval, 1.15-1.31). In contrast, one standard deviation in FEV₁ was associated with a lower but still significant risk for nonfatal events, with an HR of 1.08 (95% CI, 1.04-1.13; P for equal associations = .002).

The results remained significant among participants who had never smoked, with an HR for sudden cardiac death of 1.34 (95% CI, 1.15-1.55) and for nonfatal events of 1.11 (95% CI, 1.02-1.21; P for equal associations = .038).

“This study suggests a link between lung health and sudden cardiac death. It shows a higher risk of fatal than nonfatal coronary events even in people whose lung function is moderately lower but may still be within a normal range,” Dr. Humbert said.

The study was supported by the Swedish Heart-Lung Foundation. Dr. Zaigham and Dr. Humbert reported having no relevant financial relationships.

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

Poor lung function appears to be a stronger marker of risk for sudden cardiac death than for a survivable first coronary event, results of a prospective population-based study suggest.

Among 28,584 adults with no history of acute coronary events who were followed over 4 decades, every standard deviation decrease in forced expiratory volume in 1 second (FEV₁) was associated with a 23% increase in risk for sudden cardiac death, reported Suneela Zaigham, PhD, a cardiovascular epidemiology fellow at the University of Lund, Sweden, and colleagues.

“Our main findings and subsequent conclusions are that low FEV₁ is associated with both sudden cardiac death and nonfatal coronary events but is consistently more strongly associated with future sudden cardiac death,” Dr. Zaigham said in a narrated poster presented at the European Respiratory Society (ERS) 2021 International Congress, which was held online.

“We propose that measurement with spirometry in early life could aid in the risk stratification of future sudden cardiac death, and our results support the use of spirometry for cardiovascular risk assessment,” she said.

Marc Humbert, MD, PhD, professor of respiratory medicine at Université Paris–Saclay, who was not involved in the study, said that “this is something we can measure fairly easily, meaning that lung function could be used as part of a screening tool.

“We need to do more research to understand the links between lung function and sudden cardiac death and to investigate whether we can use lung function tests to help prevent deaths in the future,” he said.
 

Fatal vs. nonfatal events

It is well known that poor lung function is a strong predictor of future coronary events, but it was unknown whether patterns of lung impairment differ in their ability to predict future nonfatal coronary events or sudden cardiac death, Dr. Zaigham said.

To see whether measurable differences in lung function could predict risk for both fatal and nonfatal coronary events, the investigators studied 28,584 middle-aged residents of Malmö, Sweden. Baseline spirometry test results were available for all study participants.

The patients were followed for approximately 40 years for sudden cardiac death, defined as death on the day of a coronary event, or nonfatal events, defined as survival for at least 24 hours after an event.

Dr. Zaigham and colleagues used a modified version of Lunn McNeil’s competing risks method to create Cox regression models.

Results of an analysis that was adjusted for potential confounding factors indicated that one standard deviation reduction in FEV₁ was associated with a hazard ratio (HR) for sudden cardiac death of 1.23 (95% confidence interval, 1.15-1.31). In contrast, one standard deviation in FEV₁ was associated with a lower but still significant risk for nonfatal events, with an HR of 1.08 (95% CI, 1.04-1.13; P for equal associations = .002).

The results remained significant among participants who had never smoked, with an HR for sudden cardiac death of 1.34 (95% CI, 1.15-1.55) and for nonfatal events of 1.11 (95% CI, 1.02-1.21; P for equal associations = .038).

“This study suggests a link between lung health and sudden cardiac death. It shows a higher risk of fatal than nonfatal coronary events even in people whose lung function is moderately lower but may still be within a normal range,” Dr. Humbert said.

The study was supported by the Swedish Heart-Lung Foundation. Dr. Zaigham and Dr. Humbert reported having no relevant financial relationships.

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

Treatment with acetylsalicylic acid (ASA) or heparin is associated with an increased risk for symptomatic intracranial hemorrhage (sICH) in patients with ischemic stroke who are undergoing endovascular therapy (EVT), new data show.

In this population, ASA and heparin are each associated with an approximately doubled risk for sICH when administered during EVT.

“We did not find any evidence for a beneficial effect on functional outcome,” investigator Wouter van der Steen, MD, research physician and PhD student at Erasmus University Medical Center, Rotterdam, the Netherlands, told this news organization. The possibility that a positive effect would be observed if the trial were continued was considered negligible, he added.

The researchers stopped the trial for safety reasons and recommend avoiding the evaluated dosages of both medications during EVT for ischemic stroke, said Dr. van der Steen.

He presented the findings from the MR CLEAN-MED trial at the European Stroke Organisation Conference (ESOC) 2021, which was held online.
 

Trial stopped for safety

Previous research has supported the safety and efficacy of EVT for ischemic stroke. Still, more than 30% of patients do not recover, despite fast and complete recanalization. Incomplete microvascular reperfusion (IMR) could explain this incomplete recovery, the researchers note.

Microthrombi, which occlude distal vessels, and neutrophil extracellular traps can cause IMR. This problem can be reduced through treatment with ASA, which has an antithrombotic effect, or with heparin, which dissolves neutrophil extracellular traps, they add. Although these drugs are associated with good clinical outcomes, they entail an increased risk for sICH.

The investigators conducted the multicenter, randomized controlled MR CLEAN-MED trial to evaluate the effect of intravenous (IV) ASA and heparin, alone or in combination, during EVT for acute ischemic stroke. Treatment was open label, but outcome assessment was blinded. Eligible participants were adults with a National Institutes of Health Stroke Scale (NIHSS) score of greater than or equal to 2 and an anterior circulation large-vessel occlusion for whom EVT could be initiated in fewer than 6 hours.

Investigators randomly assigned patients to receive or not to receive ASA. Within each of these two treatment groups, patients were randomly assigned to receive no heparin, low-dose heparin, or moderate-dose heparin.

ASA was given in a loading dose of 300 mg. Patients who were given low-dose heparin received a loading dose of 5,000 IU followed by 500 IU/h for 6 hours. Patients who received moderate-dose heparin were given a loading dose of 5,000 IU followed by 1,250 IU/h for 6 hours.

The study’s primary outcome was Modified Rankin Scale (mRS) score at 90 days. Secondary outcomes were NIHSS score at 24 hours, NIHSS score at 5 to 7 days, and recanalization grade at 24 hours on CT angiography or MRI. The primary safety outcomes were sICH and death within 90 days.

An independent, unblinded data and safety monitoring board (DSMB) assessed the risk for the primary safety outcomes throughout the trial. The board performed interim analyses of safety and efficacy for every 300 patients.

After the fourth safety assessment, the DSMB recommended that enrollment in the moderate-dose heparin arm be discontinued for safety reasons. Enrollment in other arms continued.

After the second interim analysis, the DSMB advised that the trial steering committee be unblinded to decide whether to stop or continue the trial. The steering committee decided to stop the trial for reasons of safety.
 

Increased risk for sICH

In all, 628 patients were included in the study. The ASA groups included 310 patients, and the no-ASA groups included 318 patients. In all, 332 participants received heparin, and 296 received no heparin.

The demographic characteristics were well balanced between groups. The population’s median age was 73 years, and about 53% were men. The median baseline NIHSS score was approximately 15. About 74% of patients received IV thrombolysis. The median baseline Alberta Stroke Program Early CT Scan score was 9.

The investigators observed a slight shift toward worse outcome in the ASA group, compared with the no-ASA group (adjusted OR, 0.91). In addition, the ASA group had a significantly increased risk for sICH, compared with the no-ASA group (14% vs. 7.2%; aOR, 1.95).

Patients in the ASA group were less likely to have good functional outcome (mRS of 0 to 2; aOR, 0.76), and the mortality rate tended to be higher.

The researchers found a nonsignificant shift toward a worse functional outcome in the heparin group, compared with the no-heparin group (aOR, 0.81). The risk for sICH was significantly higher in the heparin group, compared with the no-heparin group (13% vs. 7.4%; aOR, 2.00).

Patients in the heparin group were also less likely to have a good functional outcome (aOR, 0.78), and there was a nonsignificant increase in risk for death among those patients.

The rate of sICH was 11% in the group that received low-dose heparin; it was 26% in the group that received moderate-dose heparin (aOR, 6.05). The mortality rate was 23% in the low-dose group and 47% in the moderate-dose group (aOR, 5.45).

There was no significant interaction between ASA and heparin on the primary outcome and on sICH occurrence.
 

‘A unique trial’

“MR CLEAN-MED is a unique trial because it investigated a widely used treatment but until now without any proof of effectiveness,” said Dr. van der Steen. The researchers expect that their findings will have a strong impact on the management of patients with acute ischemic stroke. They suggest that the administration of antithrombotic agents during EVT be avoided.

“We consider it probable that the increased risk of sICH explains at least a part of the nonsignificant shift towards a worse functional outcome,” co-investigator Bob Roozenbeek, MD, PhD, a neurologist at the Erasmus Medical Center, said in an interview. “However, to make more definite statements, we will have to do more in-depth analyses.”

It remains unclear whether the periprocedural use of lower dosages of antithrombotic agents or of a single bolus of heparin could be safe and effective, said Dr. van der Steen.

To gain insight into these questions, the investigators will evaluate the effect of the medications and dosages examined in this trial on primary hemostasis and coagulation activity in the trial population. They also plan to examine the effect of primary hemostasis and coagulation activity on risk for sICH and functional outcome.

Enhancing the effectiveness of thrombectomy for acute ischemic stroke continues to be an important goal for stroke therapy, said Mark Fisher, MD, professor of neurology and pathology and laboratory medicine at the University of California, Irvine, who commented on the findings for this news organization.

At least three strategies are available: The use of ancillary antithrombotic medications, neuroprotection, and modulation of the vasoconstrictive properties of the microcirculation.

“Results of MR CLEAN-MED argue against the antithrombotic strategy,” said Dr. Fisher. “The alternate strategies remain viable, and results of interventions using those approaches are awaited with great interest.”

The study was funded by the CONTRAST consortium, which is supported by the Netherlands Cardiovascular Research Initiative and the Brain Foundation Netherlands. Funding also was provided by Stryker, Medtronic, and Cerenovus. Dr. van der Steen and Dr. Fisher have disclosed no relevant financial relationships.

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

Treatment with acetylsalicylic acid (ASA) or heparin is associated with an increased risk for symptomatic intracranial hemorrhage (sICH) in patients with ischemic stroke who are undergoing endovascular therapy (EVT), new data show.

In this population, ASA and heparin are each associated with an approximately doubled risk for sICH when administered during EVT.

“We did not find any evidence for a beneficial effect on functional outcome,” investigator Wouter van der Steen, MD, research physician and PhD student at Erasmus University Medical Center, Rotterdam, the Netherlands, told this news organization. The possibility that a positive effect would be observed if the trial were continued was considered negligible, he added.

The researchers stopped the trial for safety reasons and recommend avoiding the evaluated dosages of both medications during EVT for ischemic stroke, said Dr. van der Steen.

He presented the findings from the MR CLEAN-MED trial at the European Stroke Organisation Conference (ESOC) 2021, which was held online.
 

Trial stopped for safety

Previous research has supported the safety and efficacy of EVT for ischemic stroke. Still, more than 30% of patients do not recover, despite fast and complete recanalization. Incomplete microvascular reperfusion (IMR) could explain this incomplete recovery, the researchers note.

Microthrombi, which occlude distal vessels, and neutrophil extracellular traps can cause IMR. This problem can be reduced through treatment with ASA, which has an antithrombotic effect, or with heparin, which dissolves neutrophil extracellular traps, they add. Although these drugs are associated with good clinical outcomes, they entail an increased risk for sICH.

The investigators conducted the multicenter, randomized controlled MR CLEAN-MED trial to evaluate the effect of intravenous (IV) ASA and heparin, alone or in combination, during EVT for acute ischemic stroke. Treatment was open label, but outcome assessment was blinded. Eligible participants were adults with a National Institutes of Health Stroke Scale (NIHSS) score of greater than or equal to 2 and an anterior circulation large-vessel occlusion for whom EVT could be initiated in fewer than 6 hours.

Investigators randomly assigned patients to receive or not to receive ASA. Within each of these two treatment groups, patients were randomly assigned to receive no heparin, low-dose heparin, or moderate-dose heparin.

ASA was given in a loading dose of 300 mg. Patients who were given low-dose heparin received a loading dose of 5,000 IU followed by 500 IU/h for 6 hours. Patients who received moderate-dose heparin were given a loading dose of 5,000 IU followed by 1,250 IU/h for 6 hours.

The study’s primary outcome was Modified Rankin Scale (mRS) score at 90 days. Secondary outcomes were NIHSS score at 24 hours, NIHSS score at 5 to 7 days, and recanalization grade at 24 hours on CT angiography or MRI. The primary safety outcomes were sICH and death within 90 days.

An independent, unblinded data and safety monitoring board (DSMB) assessed the risk for the primary safety outcomes throughout the trial. The board performed interim analyses of safety and efficacy for every 300 patients.

After the fourth safety assessment, the DSMB recommended that enrollment in the moderate-dose heparin arm be discontinued for safety reasons. Enrollment in other arms continued.

After the second interim analysis, the DSMB advised that the trial steering committee be unblinded to decide whether to stop or continue the trial. The steering committee decided to stop the trial for reasons of safety.
 

Increased risk for sICH

In all, 628 patients were included in the study. The ASA groups included 310 patients, and the no-ASA groups included 318 patients. In all, 332 participants received heparin, and 296 received no heparin.

The demographic characteristics were well balanced between groups. The population’s median age was 73 years, and about 53% were men. The median baseline NIHSS score was approximately 15. About 74% of patients received IV thrombolysis. The median baseline Alberta Stroke Program Early CT Scan score was 9.

The investigators observed a slight shift toward worse outcome in the ASA group, compared with the no-ASA group (adjusted OR, 0.91). In addition, the ASA group had a significantly increased risk for sICH, compared with the no-ASA group (14% vs. 7.2%; aOR, 1.95).

Patients in the ASA group were less likely to have good functional outcome (mRS of 0 to 2; aOR, 0.76), and the mortality rate tended to be higher.

The researchers found a nonsignificant shift toward a worse functional outcome in the heparin group, compared with the no-heparin group (aOR, 0.81). The risk for sICH was significantly higher in the heparin group, compared with the no-heparin group (13% vs. 7.4%; aOR, 2.00).

Patients in the heparin group were also less likely to have a good functional outcome (aOR, 0.78), and there was a nonsignificant increase in risk for death among those patients.

The rate of sICH was 11% in the group that received low-dose heparin; it was 26% in the group that received moderate-dose heparin (aOR, 6.05). The mortality rate was 23% in the low-dose group and 47% in the moderate-dose group (aOR, 5.45).

There was no significant interaction between ASA and heparin on the primary outcome and on sICH occurrence.
 

‘A unique trial’

“MR CLEAN-MED is a unique trial because it investigated a widely used treatment but until now without any proof of effectiveness,” said Dr. van der Steen. The researchers expect that their findings will have a strong impact on the management of patients with acute ischemic stroke. They suggest that the administration of antithrombotic agents during EVT be avoided.

“We consider it probable that the increased risk of sICH explains at least a part of the nonsignificant shift towards a worse functional outcome,” co-investigator Bob Roozenbeek, MD, PhD, a neurologist at the Erasmus Medical Center, said in an interview. “However, to make more definite statements, we will have to do more in-depth analyses.”

It remains unclear whether the periprocedural use of lower dosages of antithrombotic agents or of a single bolus of heparin could be safe and effective, said Dr. van der Steen.

To gain insight into these questions, the investigators will evaluate the effect of the medications and dosages examined in this trial on primary hemostasis and coagulation activity in the trial population. They also plan to examine the effect of primary hemostasis and coagulation activity on risk for sICH and functional outcome.

Enhancing the effectiveness of thrombectomy for acute ischemic stroke continues to be an important goal for stroke therapy, said Mark Fisher, MD, professor of neurology and pathology and laboratory medicine at the University of California, Irvine, who commented on the findings for this news organization.

At least three strategies are available: The use of ancillary antithrombotic medications, neuroprotection, and modulation of the vasoconstrictive properties of the microcirculation.

“Results of MR CLEAN-MED argue against the antithrombotic strategy,” said Dr. Fisher. “The alternate strategies remain viable, and results of interventions using those approaches are awaited with great interest.”

The study was funded by the CONTRAST consortium, which is supported by the Netherlands Cardiovascular Research Initiative and the Brain Foundation Netherlands. Funding also was provided by Stryker, Medtronic, and Cerenovus. Dr. van der Steen and Dr. Fisher have disclosed no relevant financial relationships.

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

Treatment with acetylsalicylic acid (ASA) or heparin is associated with an increased risk for symptomatic intracranial hemorrhage (sICH) in patients with ischemic stroke who are undergoing endovascular therapy (EVT), new data show.

In this population, ASA and heparin are each associated with an approximately doubled risk for sICH when administered during EVT.

“We did not find any evidence for a beneficial effect on functional outcome,” investigator Wouter van der Steen, MD, research physician and PhD student at Erasmus University Medical Center, Rotterdam, the Netherlands, told this news organization. The possibility that a positive effect would be observed if the trial were continued was considered negligible, he added.

The researchers stopped the trial for safety reasons and recommend avoiding the evaluated dosages of both medications during EVT for ischemic stroke, said Dr. van der Steen.

He presented the findings from the MR CLEAN-MED trial at the European Stroke Organisation Conference (ESOC) 2021, which was held online.
 

Trial stopped for safety

Previous research has supported the safety and efficacy of EVT for ischemic stroke. Still, more than 30% of patients do not recover, despite fast and complete recanalization. Incomplete microvascular reperfusion (IMR) could explain this incomplete recovery, the researchers note.

Microthrombi, which occlude distal vessels, and neutrophil extracellular traps can cause IMR. This problem can be reduced through treatment with ASA, which has an antithrombotic effect, or with heparin, which dissolves neutrophil extracellular traps, they add. Although these drugs are associated with good clinical outcomes, they entail an increased risk for sICH.

The investigators conducted the multicenter, randomized controlled MR CLEAN-MED trial to evaluate the effect of intravenous (IV) ASA and heparin, alone or in combination, during EVT for acute ischemic stroke. Treatment was open label, but outcome assessment was blinded. Eligible participants were adults with a National Institutes of Health Stroke Scale (NIHSS) score of greater than or equal to 2 and an anterior circulation large-vessel occlusion for whom EVT could be initiated in fewer than 6 hours.

Investigators randomly assigned patients to receive or not to receive ASA. Within each of these two treatment groups, patients were randomly assigned to receive no heparin, low-dose heparin, or moderate-dose heparin.

ASA was given in a loading dose of 300 mg. Patients who were given low-dose heparin received a loading dose of 5,000 IU followed by 500 IU/h for 6 hours. Patients who received moderate-dose heparin were given a loading dose of 5,000 IU followed by 1,250 IU/h for 6 hours.

The study’s primary outcome was Modified Rankin Scale (mRS) score at 90 days. Secondary outcomes were NIHSS score at 24 hours, NIHSS score at 5 to 7 days, and recanalization grade at 24 hours on CT angiography or MRI. The primary safety outcomes were sICH and death within 90 days.

An independent, unblinded data and safety monitoring board (DSMB) assessed the risk for the primary safety outcomes throughout the trial. The board performed interim analyses of safety and efficacy for every 300 patients.

After the fourth safety assessment, the DSMB recommended that enrollment in the moderate-dose heparin arm be discontinued for safety reasons. Enrollment in other arms continued.

After the second interim analysis, the DSMB advised that the trial steering committee be unblinded to decide whether to stop or continue the trial. The steering committee decided to stop the trial for reasons of safety.
 

Increased risk for sICH

In all, 628 patients were included in the study. The ASA groups included 310 patients, and the no-ASA groups included 318 patients. In all, 332 participants received heparin, and 296 received no heparin.

The demographic characteristics were well balanced between groups. The population’s median age was 73 years, and about 53% were men. The median baseline NIHSS score was approximately 15. About 74% of patients received IV thrombolysis. The median baseline Alberta Stroke Program Early CT Scan score was 9.

The investigators observed a slight shift toward worse outcome in the ASA group, compared with the no-ASA group (adjusted OR, 0.91). In addition, the ASA group had a significantly increased risk for sICH, compared with the no-ASA group (14% vs. 7.2%; aOR, 1.95).

Patients in the ASA group were less likely to have good functional outcome (mRS of 0 to 2; aOR, 0.76), and the mortality rate tended to be higher.

The researchers found a nonsignificant shift toward a worse functional outcome in the heparin group, compared with the no-heparin group (aOR, 0.81). The risk for sICH was significantly higher in the heparin group, compared with the no-heparin group (13% vs. 7.4%; aOR, 2.00).

Patients in the heparin group were also less likely to have a good functional outcome (aOR, 0.78), and there was a nonsignificant increase in risk for death among those patients.

The rate of sICH was 11% in the group that received low-dose heparin; it was 26% in the group that received moderate-dose heparin (aOR, 6.05). The mortality rate was 23% in the low-dose group and 47% in the moderate-dose group (aOR, 5.45).

There was no significant interaction between ASA and heparin on the primary outcome and on sICH occurrence.
 

‘A unique trial’

“MR CLEAN-MED is a unique trial because it investigated a widely used treatment but until now without any proof of effectiveness,” said Dr. van der Steen. The researchers expect that their findings will have a strong impact on the management of patients with acute ischemic stroke. They suggest that the administration of antithrombotic agents during EVT be avoided.

“We consider it probable that the increased risk of sICH explains at least a part of the nonsignificant shift towards a worse functional outcome,” co-investigator Bob Roozenbeek, MD, PhD, a neurologist at the Erasmus Medical Center, said in an interview. “However, to make more definite statements, we will have to do more in-depth analyses.”

It remains unclear whether the periprocedural use of lower dosages of antithrombotic agents or of a single bolus of heparin could be safe and effective, said Dr. van der Steen.

To gain insight into these questions, the investigators will evaluate the effect of the medications and dosages examined in this trial on primary hemostasis and coagulation activity in the trial population. They also plan to examine the effect of primary hemostasis and coagulation activity on risk for sICH and functional outcome.

Enhancing the effectiveness of thrombectomy for acute ischemic stroke continues to be an important goal for stroke therapy, said Mark Fisher, MD, professor of neurology and pathology and laboratory medicine at the University of California, Irvine, who commented on the findings for this news organization.

At least three strategies are available: The use of ancillary antithrombotic medications, neuroprotection, and modulation of the vasoconstrictive properties of the microcirculation.

“Results of MR CLEAN-MED argue against the antithrombotic strategy,” said Dr. Fisher. “The alternate strategies remain viable, and results of interventions using those approaches are awaited with great interest.”

The study was funded by the CONTRAST consortium, which is supported by the Netherlands Cardiovascular Research Initiative and the Brain Foundation Netherlands. Funding also was provided by Stryker, Medtronic, and Cerenovus. Dr. van der Steen and Dr. Fisher have disclosed no relevant financial relationships.

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

Individuals aged 18-24 years are at the highest risk of weight gain and developing overweight or obesity over the next 10 years, compared with all other adults, and should be a target for obesity prevention policies, say U.K. researchers.

The research, published online Sept. 2, 2021, in The Lancet Diabetes and Endocrinology, showed that factors more traditionally associated with obesity – such as socioeconomic status and ethnicity – play less of a role than age.

“Our results show clearly that age is the most important sociodemographic factor for BMI [body mass index] change,” lead author Michail Katsoulis, PhD, Institute of Health Informatics, University College London, said in a press release.

Cosenior author Claudia Langenberg, PhD, agreed, adding young people “go through big life changes. They may start work, go to university, or leave home for the first time,” and the habits formed during these years “may stick through adulthood.”

Current obesity prevention guidelines are mainly directed at individuals who already have obesity, the researchers said in their article.

“As the evidence presented in our study suggests, the opportunity to modify weight gain is greatest in individuals who are young and do not yet have obesity,” they observed.

“If we are serious about preventing obesity, then we should develop interventions that can be targeted and are relevant for young adults,” added Dr. Langenberg, of the MRC Epidemiology Unit, University of Cambridge, (England), and Berlin Institute of Health.
 

Risks for higher BMI substantially greater in the youngest adults

The researchers gathered data on more than 2 million adults aged 18-74 years registered with general practitioners in England. Participants had BMI and weight measurements recorded between Jan. 1, 1998, and June 30, 2016, with at least 1 year of follow-up. Overall, 58% were women, 76% were White, 9% had prevalent cardiovascular disease, and 4% had prevalent cancer.

Changes in BMI were assessed at 1 year, 5 years, and 10 years.

At 10 years, adults aged 18-24 years had the highest risk of transitioning from normal weight to overweight or obesity, compared with adults aged 65-74 years, at a greatest absolute risk of 37% versus 24% (odds ratio, 4.22).

Moreover, the results showed that adults aged 18-24 years who were already overweight or obese had a greater risk of transitioning to a higher BMI category during follow-up versus the oldest participants.

They had an absolute risk of 42% versus 18% of transitioning from overweight to class 1 and 2 obesity (OR, 4.60), and an absolute risk of transitioning from class 1 and 2 obesity to class 3 obesity of 22% versus 5% (OR, 5.87).

Online risk calculator and YouTube video help explain findings 

While factors other than age were associated with transitioning to a higher BMI category, the association was less pronounced.

For example, the OR of transitioning from normal weight to overweight or obesity in the most socially deprived versus the least deprived areas was 1.23 in men and 1.12 in women. The OR for making the same transition in Black versus White individuals was 1.13.

The findings allowed the researchers to develop a series of nomograms to determine an individual’s absolute risk of transitioning to a higher BMI category over 10 years based on their baseline BMI category, age, sex, and Index of Multiple Deprivation quintile.

“We show that, within each stratum, the risks for transitioning to higher BMI categories were substantially higher in the youngest adult age group than in older age groups,” the team writes.

From this, they developed an open-access online risk calculator to help individuals calculate their risk of weight change over the next 1, 5, and 10 years. The calculator takes into account current weight, height, age, sex, ethnicity, and socioeconomic-area characteristics.

They have also posted a video on YouTube to help explain their findings.
 

COVID and obesity pandemics collide

Cosenior author Harry Hemingway, MD, PhD, also of University College London, believes that focusing on this young age group is especially critical now because of the COVID-19 pandemic.

“Calculating personal risk of transitioning to a higher weight category is important” as COVID-19 “collides with the obesity pandemic,” he said, noting that “people are exercising less and finding it harder to eat healthy diets during lockdowns.

“Health systems like the NHS [National Health Service] need to identify new ways to prevent obesity and its consequences,” he continued. “This study demonstrates that NHS data collected over time in primary care holds an important key to unlocking new insights for public health action.”

The study was funded by the British Heart Foundation, Health Data Research UK, the UK Medical Research Council, and the National Institute for Health Research. The authors reported no relevant financial relationships.

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

Individuals aged 18-24 years are at the highest risk of weight gain and developing overweight or obesity over the next 10 years, compared with all other adults, and should be a target for obesity prevention policies, say U.K. researchers.

The research, published online Sept. 2, 2021, in The Lancet Diabetes and Endocrinology, showed that factors more traditionally associated with obesity – such as socioeconomic status and ethnicity – play less of a role than age.

“Our results show clearly that age is the most important sociodemographic factor for BMI [body mass index] change,” lead author Michail Katsoulis, PhD, Institute of Health Informatics, University College London, said in a press release.

Cosenior author Claudia Langenberg, PhD, agreed, adding young people “go through big life changes. They may start work, go to university, or leave home for the first time,” and the habits formed during these years “may stick through adulthood.”

Current obesity prevention guidelines are mainly directed at individuals who already have obesity, the researchers said in their article.

“As the evidence presented in our study suggests, the opportunity to modify weight gain is greatest in individuals who are young and do not yet have obesity,” they observed.

“If we are serious about preventing obesity, then we should develop interventions that can be targeted and are relevant for young adults,” added Dr. Langenberg, of the MRC Epidemiology Unit, University of Cambridge, (England), and Berlin Institute of Health.
 

Risks for higher BMI substantially greater in the youngest adults

The researchers gathered data on more than 2 million adults aged 18-74 years registered with general practitioners in England. Participants had BMI and weight measurements recorded between Jan. 1, 1998, and June 30, 2016, with at least 1 year of follow-up. Overall, 58% were women, 76% were White, 9% had prevalent cardiovascular disease, and 4% had prevalent cancer.

Changes in BMI were assessed at 1 year, 5 years, and 10 years.

At 10 years, adults aged 18-24 years had the highest risk of transitioning from normal weight to overweight or obesity, compared with adults aged 65-74 years, at a greatest absolute risk of 37% versus 24% (odds ratio, 4.22).

Moreover, the results showed that adults aged 18-24 years who were already overweight or obese had a greater risk of transitioning to a higher BMI category during follow-up versus the oldest participants.

They had an absolute risk of 42% versus 18% of transitioning from overweight to class 1 and 2 obesity (OR, 4.60), and an absolute risk of transitioning from class 1 and 2 obesity to class 3 obesity of 22% versus 5% (OR, 5.87).

Online risk calculator and YouTube video help explain findings 

While factors other than age were associated with transitioning to a higher BMI category, the association was less pronounced.

For example, the OR of transitioning from normal weight to overweight or obesity in the most socially deprived versus the least deprived areas was 1.23 in men and 1.12 in women. The OR for making the same transition in Black versus White individuals was 1.13.

The findings allowed the researchers to develop a series of nomograms to determine an individual’s absolute risk of transitioning to a higher BMI category over 10 years based on their baseline BMI category, age, sex, and Index of Multiple Deprivation quintile.

“We show that, within each stratum, the risks for transitioning to higher BMI categories were substantially higher in the youngest adult age group than in older age groups,” the team writes.

From this, they developed an open-access online risk calculator to help individuals calculate their risk of weight change over the next 1, 5, and 10 years. The calculator takes into account current weight, height, age, sex, ethnicity, and socioeconomic-area characteristics.

They have also posted a video on YouTube to help explain their findings.
 

COVID and obesity pandemics collide

Cosenior author Harry Hemingway, MD, PhD, also of University College London, believes that focusing on this young age group is especially critical now because of the COVID-19 pandemic.

“Calculating personal risk of transitioning to a higher weight category is important” as COVID-19 “collides with the obesity pandemic,” he said, noting that “people are exercising less and finding it harder to eat healthy diets during lockdowns.

“Health systems like the NHS [National Health Service] need to identify new ways to prevent obesity and its consequences,” he continued. “This study demonstrates that NHS data collected over time in primary care holds an important key to unlocking new insights for public health action.”

The study was funded by the British Heart Foundation, Health Data Research UK, the UK Medical Research Council, and the National Institute for Health Research. The authors reported no relevant financial relationships.

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

Individuals aged 18-24 years are at the highest risk of weight gain and developing overweight or obesity over the next 10 years, compared with all other adults, and should be a target for obesity prevention policies, say U.K. researchers.

The research, published online Sept. 2, 2021, in The Lancet Diabetes and Endocrinology, showed that factors more traditionally associated with obesity – such as socioeconomic status and ethnicity – play less of a role than age.

“Our results show clearly that age is the most important sociodemographic factor for BMI [body mass index] change,” lead author Michail Katsoulis, PhD, Institute of Health Informatics, University College London, said in a press release.

Cosenior author Claudia Langenberg, PhD, agreed, adding young people “go through big life changes. They may start work, go to university, or leave home for the first time,” and the habits formed during these years “may stick through adulthood.”

Current obesity prevention guidelines are mainly directed at individuals who already have obesity, the researchers said in their article.

“As the evidence presented in our study suggests, the opportunity to modify weight gain is greatest in individuals who are young and do not yet have obesity,” they observed.

“If we are serious about preventing obesity, then we should develop interventions that can be targeted and are relevant for young adults,” added Dr. Langenberg, of the MRC Epidemiology Unit, University of Cambridge, (England), and Berlin Institute of Health.
 

Risks for higher BMI substantially greater in the youngest adults

The researchers gathered data on more than 2 million adults aged 18-74 years registered with general practitioners in England. Participants had BMI and weight measurements recorded between Jan. 1, 1998, and June 30, 2016, with at least 1 year of follow-up. Overall, 58% were women, 76% were White, 9% had prevalent cardiovascular disease, and 4% had prevalent cancer.

Changes in BMI were assessed at 1 year, 5 years, and 10 years.

At 10 years, adults aged 18-24 years had the highest risk of transitioning from normal weight to overweight or obesity, compared with adults aged 65-74 years, at a greatest absolute risk of 37% versus 24% (odds ratio, 4.22).

Moreover, the results showed that adults aged 18-24 years who were already overweight or obese had a greater risk of transitioning to a higher BMI category during follow-up versus the oldest participants.

They had an absolute risk of 42% versus 18% of transitioning from overweight to class 1 and 2 obesity (OR, 4.60), and an absolute risk of transitioning from class 1 and 2 obesity to class 3 obesity of 22% versus 5% (OR, 5.87).

Online risk calculator and YouTube video help explain findings 

While factors other than age were associated with transitioning to a higher BMI category, the association was less pronounced.

For example, the OR of transitioning from normal weight to overweight or obesity in the most socially deprived versus the least deprived areas was 1.23 in men and 1.12 in women. The OR for making the same transition in Black versus White individuals was 1.13.

The findings allowed the researchers to develop a series of nomograms to determine an individual’s absolute risk of transitioning to a higher BMI category over 10 years based on their baseline BMI category, age, sex, and Index of Multiple Deprivation quintile.

“We show that, within each stratum, the risks for transitioning to higher BMI categories were substantially higher in the youngest adult age group than in older age groups,” the team writes.

From this, they developed an open-access online risk calculator to help individuals calculate their risk of weight change over the next 1, 5, and 10 years. The calculator takes into account current weight, height, age, sex, ethnicity, and socioeconomic-area characteristics.

They have also posted a video on YouTube to help explain their findings.
 

COVID and obesity pandemics collide

Cosenior author Harry Hemingway, MD, PhD, also of University College London, believes that focusing on this young age group is especially critical now because of the COVID-19 pandemic.

“Calculating personal risk of transitioning to a higher weight category is important” as COVID-19 “collides with the obesity pandemic,” he said, noting that “people are exercising less and finding it harder to eat healthy diets during lockdowns.

“Health systems like the NHS [National Health Service] need to identify new ways to prevent obesity and its consequences,” he continued. “This study demonstrates that NHS data collected over time in primary care holds an important key to unlocking new insights for public health action.”

The study was funded by the British Heart Foundation, Health Data Research UK, the UK Medical Research Council, and the National Institute for Health Research. The authors reported no relevant financial relationships.

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

Moderna has released new data that it said support the argument for COVID-19 booster shots – specifically showing that people who received a first shot of their mRNA vaccine a median of 13 months ago are more likely to experience a breakthrough infection compared to individuals who received a first shot a median of 8 months ago.

Geber86/Getty Images

The findings come from the ongoing phase 3 COVE clinical trial, the results of which the Food and Drug Administration considered in granting emergency use authorization for the vaccine. In the initial stage of the trial, people were randomly assigned to receive the company’s mRNA vaccine or placebo.

Participants in COVE who were immunized more recently were 36% less likely to experience a breakthrough infection, according to the analysis of the open-label extension of the study during which placebo participants could cross over and get immunized as well.  

The updated COVE trial data show that 88 breakthrough cases of COVID-19 occurred among 11,431 participants vaccinated between December 2020 and March 2021 (49.0 cases per 1,000 person-years).

In contrast, there were 162 breakthrough cases among 14,746 people vaccinated between July and October 2020 (77.1 cases per 1,000 person-years).

The breakthrough infections include 19 severe cases. Although not statically different, there was a trend toward fewer severe cases among the more recently vaccinated, at a rate of 3.3 per 1,000 person-years, compared with 6.2 per 1,000 person-years in the group vaccinated in 2020

The findings were posted as a preprint to the medRxiv server and have not yet been peer reviewed.

“The increased risk of breakthrough infections in COVE study participants who were vaccinated last year compared to more recently illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection,” Moderna CEO Stéphane Bancel said in a company statement.

An FDA advisory committee is meeting Sept. 17 to look at the available evidence on boosters to help the agency decide whether the additional shots are warranted.

There is still a lot of debate in the medical community about the need for boosters. U.S. physicians and nurses are divided about the need for them and about how the country should prioritize its vaccine supplies, according to a Medscape poll of more than 1,700 clinicians that collected responses from Aug. 25 to Sept. 6, 2020.

The research was funded by Moderna, and also supported by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, and by the National Institute of Allergy and Infectious Diseases.

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

Moderna has released new data that it said support the argument for COVID-19 booster shots – specifically showing that people who received a first shot of their mRNA vaccine a median of 13 months ago are more likely to experience a breakthrough infection compared to individuals who received a first shot a median of 8 months ago.

Geber86/Getty Images

The findings come from the ongoing phase 3 COVE clinical trial, the results of which the Food and Drug Administration considered in granting emergency use authorization for the vaccine. In the initial stage of the trial, people were randomly assigned to receive the company’s mRNA vaccine or placebo.

Participants in COVE who were immunized more recently were 36% less likely to experience a breakthrough infection, according to the analysis of the open-label extension of the study during which placebo participants could cross over and get immunized as well.  

The updated COVE trial data show that 88 breakthrough cases of COVID-19 occurred among 11,431 participants vaccinated between December 2020 and March 2021 (49.0 cases per 1,000 person-years).

In contrast, there were 162 breakthrough cases among 14,746 people vaccinated between July and October 2020 (77.1 cases per 1,000 person-years).

The breakthrough infections include 19 severe cases. Although not statically different, there was a trend toward fewer severe cases among the more recently vaccinated, at a rate of 3.3 per 1,000 person-years, compared with 6.2 per 1,000 person-years in the group vaccinated in 2020

The findings were posted as a preprint to the medRxiv server and have not yet been peer reviewed.

“The increased risk of breakthrough infections in COVE study participants who were vaccinated last year compared to more recently illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection,” Moderna CEO Stéphane Bancel said in a company statement.

An FDA advisory committee is meeting Sept. 17 to look at the available evidence on boosters to help the agency decide whether the additional shots are warranted.

There is still a lot of debate in the medical community about the need for boosters. U.S. physicians and nurses are divided about the need for them and about how the country should prioritize its vaccine supplies, according to a Medscape poll of more than 1,700 clinicians that collected responses from Aug. 25 to Sept. 6, 2020.

The research was funded by Moderna, and also supported by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, and by the National Institute of Allergy and Infectious Diseases.

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

Moderna has released new data that it said support the argument for COVID-19 booster shots – specifically showing that people who received a first shot of their mRNA vaccine a median of 13 months ago are more likely to experience a breakthrough infection compared to individuals who received a first shot a median of 8 months ago.

Geber86/Getty Images

The findings come from the ongoing phase 3 COVE clinical trial, the results of which the Food and Drug Administration considered in granting emergency use authorization for the vaccine. In the initial stage of the trial, people were randomly assigned to receive the company’s mRNA vaccine or placebo.

Participants in COVE who were immunized more recently were 36% less likely to experience a breakthrough infection, according to the analysis of the open-label extension of the study during which placebo participants could cross over and get immunized as well.  

The updated COVE trial data show that 88 breakthrough cases of COVID-19 occurred among 11,431 participants vaccinated between December 2020 and March 2021 (49.0 cases per 1,000 person-years).

In contrast, there were 162 breakthrough cases among 14,746 people vaccinated between July and October 2020 (77.1 cases per 1,000 person-years).

The breakthrough infections include 19 severe cases. Although not statically different, there was a trend toward fewer severe cases among the more recently vaccinated, at a rate of 3.3 per 1,000 person-years, compared with 6.2 per 1,000 person-years in the group vaccinated in 2020

The findings were posted as a preprint to the medRxiv server and have not yet been peer reviewed.

“The increased risk of breakthrough infections in COVE study participants who were vaccinated last year compared to more recently illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection,” Moderna CEO Stéphane Bancel said in a company statement.

An FDA advisory committee is meeting Sept. 17 to look at the available evidence on boosters to help the agency decide whether the additional shots are warranted.

There is still a lot of debate in the medical community about the need for boosters. U.S. physicians and nurses are divided about the need for them and about how the country should prioritize its vaccine supplies, according to a Medscape poll of more than 1,700 clinicians that collected responses from Aug. 25 to Sept. 6, 2020.

The research was funded by Moderna, and also supported by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, and by the National Institute of Allergy and Infectious Diseases.

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

Objectivity is tough, but essential: a critical part of patient care, allowing you to make appropriate decisions based on facts and circumstances, not emotions. We’re supposed to be compassionate Vulcans – able to logically weigh possibilities and treatment options under pressure, and at the same time exhibit empathy and sensitivity.

For the most part, all of us become very good at this juggling act. But we’re only human, and once the ability to do that with a given person is lost, it’s gone for good.

Have you ever lost objectivity with a patient? I have. Generally it involves the patient being so difficult, unpleasant, or dislikable that it exceeds my ability to remain impartial and pragmatic in their care.

I don’t know any physician it hasn’t happened to. And when it does, ending the doctor-patient relationship is the only effective answer.

It’s never easy sending that letter, telling someone that they need to seek care elsewhere, and often the specific reason is harder to define. In patients who are overtly rude or noncompliant it’s easy. But often a loss in objectivity is from something less tangible, such as the vagaries of personal chemistry.

I try to get along with all my patients. I really do. That’s part of the job. But sometimes, for whatever reason, it’s just an impossible task. Too many conflicts and differences of opinion over treatments, tests, diagnosis, what they read on Facebook … whatever. When these differences reach a point where they’re an impediment to good patient care … it’s time for both of us to move on.

Regardless of cause, professionalism requires that it be the end of the road. If I can’t objectively weigh a patient’s symptoms and treatment options, then I’m not going to be able to do my very best for them. And my very best is what every patient deserves.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Objectivity is tough, but essential: a critical part of patient care, allowing you to make appropriate decisions based on facts and circumstances, not emotions. We’re supposed to be compassionate Vulcans – able to logically weigh possibilities and treatment options under pressure, and at the same time exhibit empathy and sensitivity.

For the most part, all of us become very good at this juggling act. But we’re only human, and once the ability to do that with a given person is lost, it’s gone for good.

Have you ever lost objectivity with a patient? I have. Generally it involves the patient being so difficult, unpleasant, or dislikable that it exceeds my ability to remain impartial and pragmatic in their care.

I don’t know any physician it hasn’t happened to. And when it does, ending the doctor-patient relationship is the only effective answer.

It’s never easy sending that letter, telling someone that they need to seek care elsewhere, and often the specific reason is harder to define. In patients who are overtly rude or noncompliant it’s easy. But often a loss in objectivity is from something less tangible, such as the vagaries of personal chemistry.

I try to get along with all my patients. I really do. That’s part of the job. But sometimes, for whatever reason, it’s just an impossible task. Too many conflicts and differences of opinion over treatments, tests, diagnosis, what they read on Facebook … whatever. When these differences reach a point where they’re an impediment to good patient care … it’s time for both of us to move on.

Regardless of cause, professionalism requires that it be the end of the road. If I can’t objectively weigh a patient’s symptoms and treatment options, then I’m not going to be able to do my very best for them. And my very best is what every patient deserves.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Objectivity is tough, but essential: a critical part of patient care, allowing you to make appropriate decisions based on facts and circumstances, not emotions. We’re supposed to be compassionate Vulcans – able to logically weigh possibilities and treatment options under pressure, and at the same time exhibit empathy and sensitivity.

For the most part, all of us become very good at this juggling act. But we’re only human, and once the ability to do that with a given person is lost, it’s gone for good.

Have you ever lost objectivity with a patient? I have. Generally it involves the patient being so difficult, unpleasant, or dislikable that it exceeds my ability to remain impartial and pragmatic in their care.

I don’t know any physician it hasn’t happened to. And when it does, ending the doctor-patient relationship is the only effective answer.

It’s never easy sending that letter, telling someone that they need to seek care elsewhere, and often the specific reason is harder to define. In patients who are overtly rude or noncompliant it’s easy. But often a loss in objectivity is from something less tangible, such as the vagaries of personal chemistry.

I try to get along with all my patients. I really do. That’s part of the job. But sometimes, for whatever reason, it’s just an impossible task. Too many conflicts and differences of opinion over treatments, tests, diagnosis, what they read on Facebook … whatever. When these differences reach a point where they’re an impediment to good patient care … it’s time for both of us to move on.

Regardless of cause, professionalism requires that it be the end of the road. If I can’t objectively weigh a patient’s symptoms and treatment options, then I’m not going to be able to do my very best for them. And my very best is what every patient deserves.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.