Clinician Reviews

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.

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.

If you have a gut feeling something is preventing you from losing as much weight as you would like to, you could be right.

Researchers found that the gut microbiome – the bacteria that help digest food and absorb nutrients in the intestines – can influence attempts at weight loss.

They identified genes within these bacteria that determine how quickly the bacteria grow, how well people can take advantage of nutrients in food, and whether starches and fiber, in particular, get broken down into sugars too quickly to aid weight loss.

“Some people have a harder time losing weight than others,” study author Sean Gibbons, PhD, told this news organization. “For example, some people are able to control their weight through basic lifestyle interventions, while others may not.”

Furthermore, it is difficult to predict which individuals will respond to changes in diet or exercise and who might require more intense strategies.

The study, which was published online September 14 in mSystems, a journal of the American Society for Microbiology, could bring us closer to an answer.

“We’ve identified specific genetic signatures in the gut microbiome that were predictive of weight loss response in a small cohort of patients following a healthy lifestyle intervention,” explained Dr. Gibbons, Washington Research Foundation distinguished investigator and assistant professor at the Institute for Systems Biology in Seattle.
 

Weight loss takes guts?

Differences in 31 functional genes emerged from the gut microbiome in 48 people who lost 1% or more of their weight each month compared with 57 others whose weight remained the same. These findings came from stool samples taken 6 to 12 months after people started a commercial weight loss coaching program.

In contrast, lead author Christian Diener, PhD, also of the Institute for Systems Biology, and colleagues found only one factor in the blood that differed between the weight loss and weight maintenance groups. (They specifically evaluated proteins associated with obesity in the blood and genetic data from stool samples in a subset of 25 participants.)

Their findings align with previous research showing different types of bacteria in the gut microbiome can affect the success of weight loss interventions, but they took it a step further to determine how this works.

“We know that the gut microbiome plays an important role in weight management and can also influence a response to weight loss interventions. However, specific gut microbiome features that can explain this observation in more detail are still to be discovered,” Hana Kahleova, MD, PhD, MBA, director of clinical research at the Physicians Committee for Responsible Medicine in Washington, D.C., told this news organization when asked for comment.
 

Good versus bad players

On the plus side, genes that help bacteria grow more rapidly were associated with weight loss. These bacteria take more of the nutrients in food for themselves, leaving less to go toward human weight gain compared with slower growing bacteria.

In fact, prior evidence points to a particular gut bacteria, Prevotella, as being beneficial for weight loss. “In our study,” Dr. Gibbons said, “we found that some of the fastest-growing microbes in the weight-loss responder group were from the genus Prevotella.”

On the other hand, bacteria that produce more enzymes to breakdown starches or fiber quickly into sugars, for example, were linked with making people more resistant to weight loss.

“By understanding these functional patterns, we may one day be able to engineer resistant microbiomes to be more permissive to weight loss,” Dr. Gibbons said.

Dr. Kahleova agreed. “These findings expand our understanding of the specific features of the gut microbiome that play a role in weight loss,” she said.
 

Moving beyond BMI

Interestingly, the researchers controlled for baseline body mass index (BMI) and other factors that could affect weight loss. People who start off with a higher BMI tend to lose more weight than others, a phenomenon known as ‘regression to the mean.” This factor confounded some earlier research, they noted.

“The vast majority of features associated with weight loss, independent of BMI, were functional genes within the gut metagenome,” Dr. Gibbons said.

“This tells us that the gut microbiome is an important modulator of weight loss, independent of your underlying metabolic health state, baseline diet, or BMI status.”

“This study described several metagenomic functional features that were associated with weight loss after controlling for potential confounders, such as age, sex, and baseline BMI,” Dr. Kahleova said. “These findings ... may help optimize the weight-loss protocols in future studies.”
 

Fecal microbiota transplants?

What do the findings mean for people willing to adjust their diet – or undergo a fecal transplant – to include more of the gut bacteria that facilitate weight loss?

It could be too soon for such interventions, Dr. Gibbons said. “It is still very difficult to rationally engineer your gut microbiome.”

“Interestingly, a recent study suggests that fecal transplants from a high-Prevotella donor may be able to flip low-Prevotella recipients to high-Prevotella,” Dr. Gibbons said.

More research is required, however, to understand whether or not these fecal microbial transplant-flipped individuals are also more capable of weight loss, he added.

Beyond that, “I can’t give any specific recommendations, other than that [people] should eat more fiber-rich, plant-based, whole foods and reduce their consumption of red meat. That’s well-supported.”

“Also, prepare your own meals, rather than relying on sugar and sodium-rich processed foods,” Dr. Gibbons said.

Dr. Gibbons and his team hope to validate their work in larger human studies “and perhaps develop clinical diagnostics or interventions for people trying to lose weight.”

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

If you have a gut feeling something is preventing you from losing as much weight as you would like to, you could be right.

Researchers found that the gut microbiome – the bacteria that help digest food and absorb nutrients in the intestines – can influence attempts at weight loss.

They identified genes within these bacteria that determine how quickly the bacteria grow, how well people can take advantage of nutrients in food, and whether starches and fiber, in particular, get broken down into sugars too quickly to aid weight loss.

“Some people have a harder time losing weight than others,” study author Sean Gibbons, PhD, told this news organization. “For example, some people are able to control their weight through basic lifestyle interventions, while others may not.”

Furthermore, it is difficult to predict which individuals will respond to changes in diet or exercise and who might require more intense strategies.

The study, which was published online September 14 in mSystems, a journal of the American Society for Microbiology, could bring us closer to an answer.

“We’ve identified specific genetic signatures in the gut microbiome that were predictive of weight loss response in a small cohort of patients following a healthy lifestyle intervention,” explained Dr. Gibbons, Washington Research Foundation distinguished investigator and assistant professor at the Institute for Systems Biology in Seattle.
 

Weight loss takes guts?

Differences in 31 functional genes emerged from the gut microbiome in 48 people who lost 1% or more of their weight each month compared with 57 others whose weight remained the same. These findings came from stool samples taken 6 to 12 months after people started a commercial weight loss coaching program.

In contrast, lead author Christian Diener, PhD, also of the Institute for Systems Biology, and colleagues found only one factor in the blood that differed between the weight loss and weight maintenance groups. (They specifically evaluated proteins associated with obesity in the blood and genetic data from stool samples in a subset of 25 participants.)

Their findings align with previous research showing different types of bacteria in the gut microbiome can affect the success of weight loss interventions, but they took it a step further to determine how this works.

“We know that the gut microbiome plays an important role in weight management and can also influence a response to weight loss interventions. However, specific gut microbiome features that can explain this observation in more detail are still to be discovered,” Hana Kahleova, MD, PhD, MBA, director of clinical research at the Physicians Committee for Responsible Medicine in Washington, D.C., told this news organization when asked for comment.
 

Good versus bad players

On the plus side, genes that help bacteria grow more rapidly were associated with weight loss. These bacteria take more of the nutrients in food for themselves, leaving less to go toward human weight gain compared with slower growing bacteria.

In fact, prior evidence points to a particular gut bacteria, Prevotella, as being beneficial for weight loss. “In our study,” Dr. Gibbons said, “we found that some of the fastest-growing microbes in the weight-loss responder group were from the genus Prevotella.”

On the other hand, bacteria that produce more enzymes to breakdown starches or fiber quickly into sugars, for example, were linked with making people more resistant to weight loss.

“By understanding these functional patterns, we may one day be able to engineer resistant microbiomes to be more permissive to weight loss,” Dr. Gibbons said.

Dr. Kahleova agreed. “These findings expand our understanding of the specific features of the gut microbiome that play a role in weight loss,” she said.
 

Moving beyond BMI

Interestingly, the researchers controlled for baseline body mass index (BMI) and other factors that could affect weight loss. People who start off with a higher BMI tend to lose more weight than others, a phenomenon known as ‘regression to the mean.” This factor confounded some earlier research, they noted.

“The vast majority of features associated with weight loss, independent of BMI, were functional genes within the gut metagenome,” Dr. Gibbons said.

“This tells us that the gut microbiome is an important modulator of weight loss, independent of your underlying metabolic health state, baseline diet, or BMI status.”

“This study described several metagenomic functional features that were associated with weight loss after controlling for potential confounders, such as age, sex, and baseline BMI,” Dr. Kahleova said. “These findings ... may help optimize the weight-loss protocols in future studies.”
 

Fecal microbiota transplants?

What do the findings mean for people willing to adjust their diet – or undergo a fecal transplant – to include more of the gut bacteria that facilitate weight loss?

It could be too soon for such interventions, Dr. Gibbons said. “It is still very difficult to rationally engineer your gut microbiome.”

“Interestingly, a recent study suggests that fecal transplants from a high-Prevotella donor may be able to flip low-Prevotella recipients to high-Prevotella,” Dr. Gibbons said.

More research is required, however, to understand whether or not these fecal microbial transplant-flipped individuals are also more capable of weight loss, he added.

Beyond that, “I can’t give any specific recommendations, other than that [people] should eat more fiber-rich, plant-based, whole foods and reduce their consumption of red meat. That’s well-supported.”

“Also, prepare your own meals, rather than relying on sugar and sodium-rich processed foods,” Dr. Gibbons said.

Dr. Gibbons and his team hope to validate their work in larger human studies “and perhaps develop clinical diagnostics or interventions for people trying to lose weight.”

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

If you have a gut feeling something is preventing you from losing as much weight as you would like to, you could be right.

Researchers found that the gut microbiome – the bacteria that help digest food and absorb nutrients in the intestines – can influence attempts at weight loss.

They identified genes within these bacteria that determine how quickly the bacteria grow, how well people can take advantage of nutrients in food, and whether starches and fiber, in particular, get broken down into sugars too quickly to aid weight loss.

“Some people have a harder time losing weight than others,” study author Sean Gibbons, PhD, told this news organization. “For example, some people are able to control their weight through basic lifestyle interventions, while others may not.”

Furthermore, it is difficult to predict which individuals will respond to changes in diet or exercise and who might require more intense strategies.

The study, which was published online September 14 in mSystems, a journal of the American Society for Microbiology, could bring us closer to an answer.

“We’ve identified specific genetic signatures in the gut microbiome that were predictive of weight loss response in a small cohort of patients following a healthy lifestyle intervention,” explained Dr. Gibbons, Washington Research Foundation distinguished investigator and assistant professor at the Institute for Systems Biology in Seattle.
 

Weight loss takes guts?

Differences in 31 functional genes emerged from the gut microbiome in 48 people who lost 1% or more of their weight each month compared with 57 others whose weight remained the same. These findings came from stool samples taken 6 to 12 months after people started a commercial weight loss coaching program.

In contrast, lead author Christian Diener, PhD, also of the Institute for Systems Biology, and colleagues found only one factor in the blood that differed between the weight loss and weight maintenance groups. (They specifically evaluated proteins associated with obesity in the blood and genetic data from stool samples in a subset of 25 participants.)

Their findings align with previous research showing different types of bacteria in the gut microbiome can affect the success of weight loss interventions, but they took it a step further to determine how this works.

“We know that the gut microbiome plays an important role in weight management and can also influence a response to weight loss interventions. However, specific gut microbiome features that can explain this observation in more detail are still to be discovered,” Hana Kahleova, MD, PhD, MBA, director of clinical research at the Physicians Committee for Responsible Medicine in Washington, D.C., told this news organization when asked for comment.
 

Good versus bad players

On the plus side, genes that help bacteria grow more rapidly were associated with weight loss. These bacteria take more of the nutrients in food for themselves, leaving less to go toward human weight gain compared with slower growing bacteria.

In fact, prior evidence points to a particular gut bacteria, Prevotella, as being beneficial for weight loss. “In our study,” Dr. Gibbons said, “we found that some of the fastest-growing microbes in the weight-loss responder group were from the genus Prevotella.”

On the other hand, bacteria that produce more enzymes to breakdown starches or fiber quickly into sugars, for example, were linked with making people more resistant to weight loss.

“By understanding these functional patterns, we may one day be able to engineer resistant microbiomes to be more permissive to weight loss,” Dr. Gibbons said.

Dr. Kahleova agreed. “These findings expand our understanding of the specific features of the gut microbiome that play a role in weight loss,” she said.
 

Moving beyond BMI

Interestingly, the researchers controlled for baseline body mass index (BMI) and other factors that could affect weight loss. People who start off with a higher BMI tend to lose more weight than others, a phenomenon known as ‘regression to the mean.” This factor confounded some earlier research, they noted.

“The vast majority of features associated with weight loss, independent of BMI, were functional genes within the gut metagenome,” Dr. Gibbons said.

“This tells us that the gut microbiome is an important modulator of weight loss, independent of your underlying metabolic health state, baseline diet, or BMI status.”

“This study described several metagenomic functional features that were associated with weight loss after controlling for potential confounders, such as age, sex, and baseline BMI,” Dr. Kahleova said. “These findings ... may help optimize the weight-loss protocols in future studies.”
 

Fecal microbiota transplants?

What do the findings mean for people willing to adjust their diet – or undergo a fecal transplant – to include more of the gut bacteria that facilitate weight loss?

It could be too soon for such interventions, Dr. Gibbons said. “It is still very difficult to rationally engineer your gut microbiome.”

“Interestingly, a recent study suggests that fecal transplants from a high-Prevotella donor may be able to flip low-Prevotella recipients to high-Prevotella,” Dr. Gibbons said.

More research is required, however, to understand whether or not these fecal microbial transplant-flipped individuals are also more capable of weight loss, he added.

Beyond that, “I can’t give any specific recommendations, other than that [people] should eat more fiber-rich, plant-based, whole foods and reduce their consumption of red meat. That’s well-supported.”

“Also, prepare your own meals, rather than relying on sugar and sodium-rich processed foods,” Dr. Gibbons said.

Dr. Gibbons and his team hope to validate their work in larger human studies “and perhaps develop clinical diagnostics or interventions for people trying to lose weight.”

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.

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.

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.

A preprint study finding that the Pfizer-BioNTech mRNA COVID vaccine is associated with an increased risk for cardiac adverse events in teenage boys has elicited a firestorm on Twitter. Although some people issued thoughtful critiques, others lobbed insults against the authors, and still others accused them of either being antivaccine or stoking the fires of the vaccine skeptic movement.

The controversy began soon after the study was posted online September 8 on medRxiv. The authors conclude that for boys, the risk for a cardiac adverse event or hospitalization after the second dose of the Pfizer mRNA vaccine was “considerably higher” than the 120-day risk for hospitalization for COVID-19, “even at times of peak disease prevalence.” This was especially true for those aged 12 to 15 years and even those with no underlying health conditions.

The conclusion – as well as the paper’s source, the Vaccine Adverse Event Reporting System (VAERS), and its methodology, modeled after the Centers for Disease Control and Prevention assessment of the database – did not sit well with many.

“Your methodology hugely overestimates risk, which many commentators who are specialists in the field have highlighted,” tweeted Deepti Gurdasani, senior lecturer in epidemiology at Queen Mary University of London. “Why make this claim when you must know it’s wrong?”

“The authors don’t know what they are doing and they are following their own ideology,” tweeted Boback Ziaeian, MD, PhD, assistant professor of medicine at the University of California, Los Angeles, in the cardiology division. Dr. Ziaeian also tweeted, “I believe the CDC is doing honest work and not dredging slop like you are.”

“Holy shit. Truly terrible methods in that paper,” tweeted Michael Mina, MD, PhD, an epidemiologist and immunologist at the Harvard School of Public Health, Boston, more bluntly.

Some pointed out that VAERS is often used by vaccine skeptics to spread misinformation. “‘Dumpster diving’ describes studies using #VAERS by authors (almost always antivaxxers) who don’t understand its limitations,” tweeted David Gorski, MD, PhD, the editor of Science-Based Medicine, who says in his Twitter bio that he “exposes quackery.”

Added Dr. Gorski: “Doctors fell into this trap with their study suggesting #CovidVaccine is more dangerous to children than #COVID19.”

Dr. Gorski said he did not think that the authors were antivaccine. But, he tweeted, “I’d argue that at least one of the authors (Stevenson) is grossly unqualified to analyze the data. Mandrola? Marginal. The other two *might* be qualified in public health/epi, but they clearly either had no clue about #VAERS limitations or didn’t take them seriously enough.” 

Two of the authors, John Mandrola, MD, a cardiac electrophysiologist who is also a columnist for Medscape, and Tracy Beth Hoeg, MD, PhD, an epidemiologist and sports medicine specialist, told this news organization that their estimates are not definitive, owing to the nature of the VAERS database.

“I want to emphasize that our signal is hypothesis-generating,” said Dr. Mandrola. “There’s obviously more research that needs to be done.” 

“I don’t think it should be used to establish a for-certain rate,” said Dr. Hoeg, about the study. “It’s not a perfect way of establishing what the rate of cardiac adverse events was, but it gives you an estimate, and generally with VAERS, it’s a significant underestimate.”

Both Dr. Hoeg and Dr. Mandrola said their analysis showed enough of a signal that it warranted a rush to publish. “We felt that it was super time-sensitive,” Dr. Mandrola said.
 

Vaccine risks versus COVID harm

The authors searched the VAERS system for children aged 12 to 17 years who had received one or two doses of an mRNA vaccine and had symptoms of myocarditis, pericarditis, myopericarditis, or chest pain, and also troponin levels available in the lab data.

Of the 257 patients they examined, 211 had peak troponin values available for analysis. All but one received the Pfizer vaccine. Results were stratified by age and sex.

The authors found that the rates of cardiac adverse events (CAEs) after dose 1 were 12.0 per million for 12- to 15-year-old boys and 8.2 per million for 16- and 17-year-old boys, compared with 0.0 per million and 2.0 per million for girls the same ages.

The estimates for the 12- to 15-year-old boys were 22% to 150% higher than what the CDC had previously reported.

After the second dose, the rate of CAEs for boys 12 to 15 years was 162.2 per million (143% to 280% higher than the CDC estimate) and for boys 16 and 17 years, it was 94.0 per million, or 30% to 40% higher than CDC estimate.

Dr. Mandrola said he and his colleagues found potentially more cases by using slightly broader search terms than those employed by the CDC but agreed with some critics that a limitation was that they did not call the reporting physicians, as is typical with CDC follow-up on VAERS reports.

The authors point to troponin levels as valid indicators of myocardial damage. Peak troponin levels exceeded 2 ng/mL in 71% of the 12- to 15-year-olds and 82% of 16- and 17-year-olds.

The study shows that for boys 12 to 15 years with no comorbidities, the risk for a CAE after the second dose would be 22.8 times higher than the risk for hospitalization for COVID-19 during periods of low disease burden, 6.0 times higher during periods of moderate transmission, and 4.3 times higher during periods of high transmission.

The authors acknowledge in the paper that their analysis “does not take into account any benefits the vaccine provides against transmission to others, long-term COVID-19 disease risk, or protection from nonsevere COVID-19 symptoms.”

Both Dr. Mandrola and Dr. Hoeg told this news organization that they are currently recalculating their estimates because of the rising numbers of pediatric hospitalizations from the Delta variant surge.
 

Paper rejected by journals

Dr. Hoeg said in an interview that the paper went through peer-review at three journals but was rejected by all three, for reasons that were not made clear.

She and the other authors incorporated the reviewers’ feedback at each turn and included all of their suggestions in the paper that was ultimately uploaded to medRxiv, said Dr. Hoeg.

They decided to put it out as a preprint after the U.S. Food and Drug Administration issued its data and then a warning on June 25 about myocarditis with use of the Pfizer vaccine in children 12 to 15 years of age.

The preprint study was picked up by some media outlets, including The Telegraph and The Guardian newspapers, and tweeted out by vaccine skeptics like Robert W. Malone, MD. 

Rep. Marjorie Taylor Greene (R-Georgia), an outspoken vaccine skeptic, tweeted out the Guardian story saying that the findings mean “there is every reason to stop the covid vaccine mandates.”

Dr. Gorski noted in tweets and in a blog post that one of the paper’s coauthors, Josh Stevenson, is part of Rational Ground, a group that supports the Great Barrington Declaration and is against lockdowns and mask mandates.

Mr. Stevenson did not disclose his affiliation in the paper, and Dr. Hoeg said in an interview that she was unaware of the group and Mr. Stevenson’s association with it and that she did not have the impression that he was altering the data to show any bias.

Both Dr. Mandrola and Dr. Hoeg said they are provaccine and that they were dismayed to find their work being used to support any agenda. “It’s very frustrating,” said Dr. Hoeg, adding that she understands that “when you publish research on a controversial topic, people are going to take it and use it for their agendas.”

Some on Twitter blamed the open and free-wheeling nature of preprints.

Harlan Krumholz, MD, SM, the Harold H. Hines, junior professor of medicine and public health at Yale University, New Haven, Conn., which oversees medRxiv, tweeted, “Do you get that the discussion about the preprint is exactly the purpose of #preprints. So that way when someone claims something, you can look at the source and experts can comment.”

But Dr. Ziaeian tweeted back, “Preprints like this one can be weaponized to stir anti-vaccine lies and damage public health.”

In turn, the Yale physician replied, “Unfortunately these days, almost anything can be weaponized, distorted, misunderstood.” Dr. Krumholz added: “There is no question that this preprint is worthy of deep vetting and discussion. But there is a #preprint artifact to examine.”
 

Measured support

Some clinicians signaled their support for open debate and the preprint’s findings.

“I’ve been very critical of preprints that are too quickly disseminated in the media, and this one is no exception,” tweeted Walid Gellad, MD, MPH, associate professor of medicine at the University of Pittsburgh. “On the other hand, I think the vitriol directed at these authors is wrong,” he added.

“Like it or not, the issue of myocarditis in kids is an issue. Other countries have made vaccination decisions because of this issue, not because they’re driven by some ideology,” he tweeted.

Dr. Gellad also notes that the FDA has estimated the risk could be as high as one in 5,000 and that the preprint numbers could actually be underestimates.

In a long thread, Frank Han, MD, an adult congenital and pediatric cardiologist at the University of Illinois, tweets that relying on the VAERS reports might be faulty and that advanced cardiac imaging – guided by strict criteria – is the best way to determine myocarditis. And, he tweeted, “Physician review of VAERS reports really matters.”

Dr. Han concluded that vaccination “trades in a significant risk with a much smaller risk. That’s what counts in the end.”

In a response, Dr. Mandrola called Han’s tweets “reasoned criticism of our analysis.” He adds that his and Dr. Hoeg’s study have limits, but “our point is not to avoid protecting kids, but how to do so most safely.”

Both Dr. Mandrola and Dr. Hoeg said they welcomed critiques, but they felt blindsided by the vehemence of some of the Twitter debate.

“Some of the vitriol was surprising,” Dr. Mandrola said. “I kind of have this naive notion that people would assume that we’re not bad people,” he added.

However, Dr. Mandrola is known on Twitter for sometimes being highly critical of other researchers’ work, referring to some studies as “howlers,” and has in the past called out others for citing those papers.

Dr. Hoeg said she found critiques about weaknesses in the methods to be helpful. But she said many tweets were “attacking us as people, or not really attacking anything about our study, but just attacking the finding,” which does not help anyone “figure out what we should do about the safety signal or how we can research it further.”

Said Dr. Mandrola: “Why would we just ignore that and go forward with two-shot vaccination as a mandate when other countries are looking at other strategies?”

He noted that the United Kingdom has announced that children 12 to 15 years of age should receive just one shot of the mRNA vaccines instead of two because of the risk for myocarditis. Sixteen- to 18-year-olds have already been advised to get only one dose.

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

A preprint study finding that the Pfizer-BioNTech mRNA COVID vaccine is associated with an increased risk for cardiac adverse events in teenage boys has elicited a firestorm on Twitter. Although some people issued thoughtful critiques, others lobbed insults against the authors, and still others accused them of either being antivaccine or stoking the fires of the vaccine skeptic movement.

The controversy began soon after the study was posted online September 8 on medRxiv. The authors conclude that for boys, the risk for a cardiac adverse event or hospitalization after the second dose of the Pfizer mRNA vaccine was “considerably higher” than the 120-day risk for hospitalization for COVID-19, “even at times of peak disease prevalence.” This was especially true for those aged 12 to 15 years and even those with no underlying health conditions.

The conclusion – as well as the paper’s source, the Vaccine Adverse Event Reporting System (VAERS), and its methodology, modeled after the Centers for Disease Control and Prevention assessment of the database – did not sit well with many.

“Your methodology hugely overestimates risk, which many commentators who are specialists in the field have highlighted,” tweeted Deepti Gurdasani, senior lecturer in epidemiology at Queen Mary University of London. “Why make this claim when you must know it’s wrong?”

“The authors don’t know what they are doing and they are following their own ideology,” tweeted Boback Ziaeian, MD, PhD, assistant professor of medicine at the University of California, Los Angeles, in the cardiology division. Dr. Ziaeian also tweeted, “I believe the CDC is doing honest work and not dredging slop like you are.”

“Holy shit. Truly terrible methods in that paper,” tweeted Michael Mina, MD, PhD, an epidemiologist and immunologist at the Harvard School of Public Health, Boston, more bluntly.

Some pointed out that VAERS is often used by vaccine skeptics to spread misinformation. “‘Dumpster diving’ describes studies using #VAERS by authors (almost always antivaxxers) who don’t understand its limitations,” tweeted David Gorski, MD, PhD, the editor of Science-Based Medicine, who says in his Twitter bio that he “exposes quackery.”

Added Dr. Gorski: “Doctors fell into this trap with their study suggesting #CovidVaccine is more dangerous to children than #COVID19.”

Dr. Gorski said he did not think that the authors were antivaccine. But, he tweeted, “I’d argue that at least one of the authors (Stevenson) is grossly unqualified to analyze the data. Mandrola? Marginal. The other two *might* be qualified in public health/epi, but they clearly either had no clue about #VAERS limitations or didn’t take them seriously enough.” 

Two of the authors, John Mandrola, MD, a cardiac electrophysiologist who is also a columnist for Medscape, and Tracy Beth Hoeg, MD, PhD, an epidemiologist and sports medicine specialist, told this news organization that their estimates are not definitive, owing to the nature of the VAERS database.

“I want to emphasize that our signal is hypothesis-generating,” said Dr. Mandrola. “There’s obviously more research that needs to be done.” 

“I don’t think it should be used to establish a for-certain rate,” said Dr. Hoeg, about the study. “It’s not a perfect way of establishing what the rate of cardiac adverse events was, but it gives you an estimate, and generally with VAERS, it’s a significant underestimate.”

Both Dr. Hoeg and Dr. Mandrola said their analysis showed enough of a signal that it warranted a rush to publish. “We felt that it was super time-sensitive,” Dr. Mandrola said.
 

Vaccine risks versus COVID harm

The authors searched the VAERS system for children aged 12 to 17 years who had received one or two doses of an mRNA vaccine and had symptoms of myocarditis, pericarditis, myopericarditis, or chest pain, and also troponin levels available in the lab data.

Of the 257 patients they examined, 211 had peak troponin values available for analysis. All but one received the Pfizer vaccine. Results were stratified by age and sex.

The authors found that the rates of cardiac adverse events (CAEs) after dose 1 were 12.0 per million for 12- to 15-year-old boys and 8.2 per million for 16- and 17-year-old boys, compared with 0.0 per million and 2.0 per million for girls the same ages.

The estimates for the 12- to 15-year-old boys were 22% to 150% higher than what the CDC had previously reported.

After the second dose, the rate of CAEs for boys 12 to 15 years was 162.2 per million (143% to 280% higher than the CDC estimate) and for boys 16 and 17 years, it was 94.0 per million, or 30% to 40% higher than CDC estimate.

Dr. Mandrola said he and his colleagues found potentially more cases by using slightly broader search terms than those employed by the CDC but agreed with some critics that a limitation was that they did not call the reporting physicians, as is typical with CDC follow-up on VAERS reports.

The authors point to troponin levels as valid indicators of myocardial damage. Peak troponin levels exceeded 2 ng/mL in 71% of the 12- to 15-year-olds and 82% of 16- and 17-year-olds.

The study shows that for boys 12 to 15 years with no comorbidities, the risk for a CAE after the second dose would be 22.8 times higher than the risk for hospitalization for COVID-19 during periods of low disease burden, 6.0 times higher during periods of moderate transmission, and 4.3 times higher during periods of high transmission.

The authors acknowledge in the paper that their analysis “does not take into account any benefits the vaccine provides against transmission to others, long-term COVID-19 disease risk, or protection from nonsevere COVID-19 symptoms.”

Both Dr. Mandrola and Dr. Hoeg told this news organization that they are currently recalculating their estimates because of the rising numbers of pediatric hospitalizations from the Delta variant surge.
 

Paper rejected by journals

Dr. Hoeg said in an interview that the paper went through peer-review at three journals but was rejected by all three, for reasons that were not made clear.

She and the other authors incorporated the reviewers’ feedback at each turn and included all of their suggestions in the paper that was ultimately uploaded to medRxiv, said Dr. Hoeg.

They decided to put it out as a preprint after the U.S. Food and Drug Administration issued its data and then a warning on June 25 about myocarditis with use of the Pfizer vaccine in children 12 to 15 years of age.

The preprint study was picked up by some media outlets, including The Telegraph and The Guardian newspapers, and tweeted out by vaccine skeptics like Robert W. Malone, MD. 

Rep. Marjorie Taylor Greene (R-Georgia), an outspoken vaccine skeptic, tweeted out the Guardian story saying that the findings mean “there is every reason to stop the covid vaccine mandates.”

Dr. Gorski noted in tweets and in a blog post that one of the paper’s coauthors, Josh Stevenson, is part of Rational Ground, a group that supports the Great Barrington Declaration and is against lockdowns and mask mandates.

Mr. Stevenson did not disclose his affiliation in the paper, and Dr. Hoeg said in an interview that she was unaware of the group and Mr. Stevenson’s association with it and that she did not have the impression that he was altering the data to show any bias.

Both Dr. Mandrola and Dr. Hoeg said they are provaccine and that they were dismayed to find their work being used to support any agenda. “It’s very frustrating,” said Dr. Hoeg, adding that she understands that “when you publish research on a controversial topic, people are going to take it and use it for their agendas.”

Some on Twitter blamed the open and free-wheeling nature of preprints.

Harlan Krumholz, MD, SM, the Harold H. Hines, junior professor of medicine and public health at Yale University, New Haven, Conn., which oversees medRxiv, tweeted, “Do you get that the discussion about the preprint is exactly the purpose of #preprints. So that way when someone claims something, you can look at the source and experts can comment.”

But Dr. Ziaeian tweeted back, “Preprints like this one can be weaponized to stir anti-vaccine lies and damage public health.”

In turn, the Yale physician replied, “Unfortunately these days, almost anything can be weaponized, distorted, misunderstood.” Dr. Krumholz added: “There is no question that this preprint is worthy of deep vetting and discussion. But there is a #preprint artifact to examine.”
 

Measured support

Some clinicians signaled their support for open debate and the preprint’s findings.

“I’ve been very critical of preprints that are too quickly disseminated in the media, and this one is no exception,” tweeted Walid Gellad, MD, MPH, associate professor of medicine at the University of Pittsburgh. “On the other hand, I think the vitriol directed at these authors is wrong,” he added.

“Like it or not, the issue of myocarditis in kids is an issue. Other countries have made vaccination decisions because of this issue, not because they’re driven by some ideology,” he tweeted.

Dr. Gellad also notes that the FDA has estimated the risk could be as high as one in 5,000 and that the preprint numbers could actually be underestimates.

In a long thread, Frank Han, MD, an adult congenital and pediatric cardiologist at the University of Illinois, tweets that relying on the VAERS reports might be faulty and that advanced cardiac imaging – guided by strict criteria – is the best way to determine myocarditis. And, he tweeted, “Physician review of VAERS reports really matters.”

Dr. Han concluded that vaccination “trades in a significant risk with a much smaller risk. That’s what counts in the end.”

In a response, Dr. Mandrola called Han’s tweets “reasoned criticism of our analysis.” He adds that his and Dr. Hoeg’s study have limits, but “our point is not to avoid protecting kids, but how to do so most safely.”

Both Dr. Mandrola and Dr. Hoeg said they welcomed critiques, but they felt blindsided by the vehemence of some of the Twitter debate.

“Some of the vitriol was surprising,” Dr. Mandrola said. “I kind of have this naive notion that people would assume that we’re not bad people,” he added.

However, Dr. Mandrola is known on Twitter for sometimes being highly critical of other researchers’ work, referring to some studies as “howlers,” and has in the past called out others for citing those papers.

Dr. Hoeg said she found critiques about weaknesses in the methods to be helpful. But she said many tweets were “attacking us as people, or not really attacking anything about our study, but just attacking the finding,” which does not help anyone “figure out what we should do about the safety signal or how we can research it further.”

Said Dr. Mandrola: “Why would we just ignore that and go forward with two-shot vaccination as a mandate when other countries are looking at other strategies?”

He noted that the United Kingdom has announced that children 12 to 15 years of age should receive just one shot of the mRNA vaccines instead of two because of the risk for myocarditis. Sixteen- to 18-year-olds have already been advised to get only one dose.

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

A preprint study finding that the Pfizer-BioNTech mRNA COVID vaccine is associated with an increased risk for cardiac adverse events in teenage boys has elicited a firestorm on Twitter. Although some people issued thoughtful critiques, others lobbed insults against the authors, and still others accused them of either being antivaccine or stoking the fires of the vaccine skeptic movement.

The controversy began soon after the study was posted online September 8 on medRxiv. The authors conclude that for boys, the risk for a cardiac adverse event or hospitalization after the second dose of the Pfizer mRNA vaccine was “considerably higher” than the 120-day risk for hospitalization for COVID-19, “even at times of peak disease prevalence.” This was especially true for those aged 12 to 15 years and even those with no underlying health conditions.

The conclusion – as well as the paper’s source, the Vaccine Adverse Event Reporting System (VAERS), and its methodology, modeled after the Centers for Disease Control and Prevention assessment of the database – did not sit well with many.

“Your methodology hugely overestimates risk, which many commentators who are specialists in the field have highlighted,” tweeted Deepti Gurdasani, senior lecturer in epidemiology at Queen Mary University of London. “Why make this claim when you must know it’s wrong?”

“The authors don’t know what they are doing and they are following their own ideology,” tweeted Boback Ziaeian, MD, PhD, assistant professor of medicine at the University of California, Los Angeles, in the cardiology division. Dr. Ziaeian also tweeted, “I believe the CDC is doing honest work and not dredging slop like you are.”

“Holy shit. Truly terrible methods in that paper,” tweeted Michael Mina, MD, PhD, an epidemiologist and immunologist at the Harvard School of Public Health, Boston, more bluntly.

Some pointed out that VAERS is often used by vaccine skeptics to spread misinformation. “‘Dumpster diving’ describes studies using #VAERS by authors (almost always antivaxxers) who don’t understand its limitations,” tweeted David Gorski, MD, PhD, the editor of Science-Based Medicine, who says in his Twitter bio that he “exposes quackery.”

Added Dr. Gorski: “Doctors fell into this trap with their study suggesting #CovidVaccine is more dangerous to children than #COVID19.”

Dr. Gorski said he did not think that the authors were antivaccine. But, he tweeted, “I’d argue that at least one of the authors (Stevenson) is grossly unqualified to analyze the data. Mandrola? Marginal. The other two *might* be qualified in public health/epi, but they clearly either had no clue about #VAERS limitations or didn’t take them seriously enough.” 

Two of the authors, John Mandrola, MD, a cardiac electrophysiologist who is also a columnist for Medscape, and Tracy Beth Hoeg, MD, PhD, an epidemiologist and sports medicine specialist, told this news organization that their estimates are not definitive, owing to the nature of the VAERS database.

“I want to emphasize that our signal is hypothesis-generating,” said Dr. Mandrola. “There’s obviously more research that needs to be done.” 

“I don’t think it should be used to establish a for-certain rate,” said Dr. Hoeg, about the study. “It’s not a perfect way of establishing what the rate of cardiac adverse events was, but it gives you an estimate, and generally with VAERS, it’s a significant underestimate.”

Both Dr. Hoeg and Dr. Mandrola said their analysis showed enough of a signal that it warranted a rush to publish. “We felt that it was super time-sensitive,” Dr. Mandrola said.
 

Vaccine risks versus COVID harm

The authors searched the VAERS system for children aged 12 to 17 years who had received one or two doses of an mRNA vaccine and had symptoms of myocarditis, pericarditis, myopericarditis, or chest pain, and also troponin levels available in the lab data.

Of the 257 patients they examined, 211 had peak troponin values available for analysis. All but one received the Pfizer vaccine. Results were stratified by age and sex.

The authors found that the rates of cardiac adverse events (CAEs) after dose 1 were 12.0 per million for 12- to 15-year-old boys and 8.2 per million for 16- and 17-year-old boys, compared with 0.0 per million and 2.0 per million for girls the same ages.

The estimates for the 12- to 15-year-old boys were 22% to 150% higher than what the CDC had previously reported.

After the second dose, the rate of CAEs for boys 12 to 15 years was 162.2 per million (143% to 280% higher than the CDC estimate) and for boys 16 and 17 years, it was 94.0 per million, or 30% to 40% higher than CDC estimate.

Dr. Mandrola said he and his colleagues found potentially more cases by using slightly broader search terms than those employed by the CDC but agreed with some critics that a limitation was that they did not call the reporting physicians, as is typical with CDC follow-up on VAERS reports.

The authors point to troponin levels as valid indicators of myocardial damage. Peak troponin levels exceeded 2 ng/mL in 71% of the 12- to 15-year-olds and 82% of 16- and 17-year-olds.

The study shows that for boys 12 to 15 years with no comorbidities, the risk for a CAE after the second dose would be 22.8 times higher than the risk for hospitalization for COVID-19 during periods of low disease burden, 6.0 times higher during periods of moderate transmission, and 4.3 times higher during periods of high transmission.

The authors acknowledge in the paper that their analysis “does not take into account any benefits the vaccine provides against transmission to others, long-term COVID-19 disease risk, or protection from nonsevere COVID-19 symptoms.”

Both Dr. Mandrola and Dr. Hoeg told this news organization that they are currently recalculating their estimates because of the rising numbers of pediatric hospitalizations from the Delta variant surge.
 

Paper rejected by journals

Dr. Hoeg said in an interview that the paper went through peer-review at three journals but was rejected by all three, for reasons that were not made clear.

She and the other authors incorporated the reviewers’ feedback at each turn and included all of their suggestions in the paper that was ultimately uploaded to medRxiv, said Dr. Hoeg.

They decided to put it out as a preprint after the U.S. Food and Drug Administration issued its data and then a warning on June 25 about myocarditis with use of the Pfizer vaccine in children 12 to 15 years of age.

The preprint study was picked up by some media outlets, including The Telegraph and The Guardian newspapers, and tweeted out by vaccine skeptics like Robert W. Malone, MD. 

Rep. Marjorie Taylor Greene (R-Georgia), an outspoken vaccine skeptic, tweeted out the Guardian story saying that the findings mean “there is every reason to stop the covid vaccine mandates.”

Dr. Gorski noted in tweets and in a blog post that one of the paper’s coauthors, Josh Stevenson, is part of Rational Ground, a group that supports the Great Barrington Declaration and is against lockdowns and mask mandates.

Mr. Stevenson did not disclose his affiliation in the paper, and Dr. Hoeg said in an interview that she was unaware of the group and Mr. Stevenson’s association with it and that she did not have the impression that he was altering the data to show any bias.

Both Dr. Mandrola and Dr. Hoeg said they are provaccine and that they were dismayed to find their work being used to support any agenda. “It’s very frustrating,” said Dr. Hoeg, adding that she understands that “when you publish research on a controversial topic, people are going to take it and use it for their agendas.”

Some on Twitter blamed the open and free-wheeling nature of preprints.

Harlan Krumholz, MD, SM, the Harold H. Hines, junior professor of medicine and public health at Yale University, New Haven, Conn., which oversees medRxiv, tweeted, “Do you get that the discussion about the preprint is exactly the purpose of #preprints. So that way when someone claims something, you can look at the source and experts can comment.”

But Dr. Ziaeian tweeted back, “Preprints like this one can be weaponized to stir anti-vaccine lies and damage public health.”

In turn, the Yale physician replied, “Unfortunately these days, almost anything can be weaponized, distorted, misunderstood.” Dr. Krumholz added: “There is no question that this preprint is worthy of deep vetting and discussion. But there is a #preprint artifact to examine.”
 

Measured support

Some clinicians signaled their support for open debate and the preprint’s findings.

“I’ve been very critical of preprints that are too quickly disseminated in the media, and this one is no exception,” tweeted Walid Gellad, MD, MPH, associate professor of medicine at the University of Pittsburgh. “On the other hand, I think the vitriol directed at these authors is wrong,” he added.

“Like it or not, the issue of myocarditis in kids is an issue. Other countries have made vaccination decisions because of this issue, not because they’re driven by some ideology,” he tweeted.

Dr. Gellad also notes that the FDA has estimated the risk could be as high as one in 5,000 and that the preprint numbers could actually be underestimates.

In a long thread, Frank Han, MD, an adult congenital and pediatric cardiologist at the University of Illinois, tweets that relying on the VAERS reports might be faulty and that advanced cardiac imaging – guided by strict criteria – is the best way to determine myocarditis. And, he tweeted, “Physician review of VAERS reports really matters.”

Dr. Han concluded that vaccination “trades in a significant risk with a much smaller risk. That’s what counts in the end.”

In a response, Dr. Mandrola called Han’s tweets “reasoned criticism of our analysis.” He adds that his and Dr. Hoeg’s study have limits, but “our point is not to avoid protecting kids, but how to do so most safely.”

Both Dr. Mandrola and Dr. Hoeg said they welcomed critiques, but they felt blindsided by the vehemence of some of the Twitter debate.

“Some of the vitriol was surprising,” Dr. Mandrola said. “I kind of have this naive notion that people would assume that we’re not bad people,” he added.

However, Dr. Mandrola is known on Twitter for sometimes being highly critical of other researchers’ work, referring to some studies as “howlers,” and has in the past called out others for citing those papers.

Dr. Hoeg said she found critiques about weaknesses in the methods to be helpful. But she said many tweets were “attacking us as people, or not really attacking anything about our study, but just attacking the finding,” which does not help anyone “figure out what we should do about the safety signal or how we can research it further.”

Said Dr. Mandrola: “Why would we just ignore that and go forward with two-shot vaccination as a mandate when other countries are looking at other strategies?”

He noted that the United Kingdom has announced that children 12 to 15 years of age should receive just one shot of the mRNA vaccines instead of two because of the risk for myocarditis. Sixteen- to 18-year-olds have already been advised to get only one dose.

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

A 3-month lifestyle intervention that used a step counter and regular, personalized text messages to encourage increased mobility and adherence to medications led to a substantial rise in the quality of life in a randomized controlled study with 187 U.S. patients with heart failure and diabetes.

The TARGET-HF-DM study supplied a wrist-worn step counting device to adults with any type of heart failure and any type of diabetes at six U.S. sites and collected data on daily step counts and medication adherence through smartphone-based apps. Researchers randomized the patients to an intervention of thrice-weekly text messages that gave them personalized feedback on their recent activity and adherence and updated activity and adherence goals, or to a control group that only received a once-weekly generic message to wear the step counter.

After 3 months, patients in the intervention arm had an average incremental gain of 313 steps per day from baseline, compared with the controls, a significant difference for the study’s primary endpoint, G. Michael Felker, MD, reported at the annual scientific meeting of the Heart Failure Society of America.
 

A ‘quite large’ increase in quality of life.

Perhaps more importantly, a secondary analysis assessed quality of life with the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, which showed after 3 months a 5.5-point average increased improvement among patients in the intervention arm, compared with controls. Score increases of 5 of more points on the KCCQ represent clinically meaningful changes.

This average, incremental KCCQ score improvement was “quite large relative to what we typically see in placebo-controlled trials of effective drugs,” said Dr. Felker, professor of medicine at Duke University, Durham, N.C., and director of cardiovascular research at the Duke Clinical Research Institute. If a similar magnitude change in KCCQ was associated with a drug treatment “we would say it was an incredibly large signal in terms of quality of life, so I think the patients are telling us that [the intervention] is making a clinically important difference.”

But Dr. Felker cautioned that the study was not blinded, raising the possibility that the change in quality of life could have been partially explained by “patients feeling more engaged about doing something for their health.”

His report omitted data on the medication adherence facet of the study, which will come out in a subsequent report, raising the possibility that some of the quality of life benefit as well as the ability of patients to boost their step count was related to more consistent treatment with their prescribed medications, but Dr. Felker discounted this possibility.

“The adherence intervention was basically a digital tool that helped people better remember their medication regimen. While it is possible that this could have influenced the KCCQ data this seems quite unlikely to me,” he said in an interview.
 

‘Exercise is the new magic’

“Exercise is the new magic,” commented Mariann R. Piano, PhD, a professor at Vanderbilt University, Nashville, Tenn., and cochair of the session where Dr. Felker gave his report. “I love that the trial was pragmatic, randomized, and ran at six sites so the generalizability of the findings is really strong.” Dr. Piano also gave the study high marks for recruiting many African American patients, 47% of the study population, and its assessment of a patient-reported outcome, the KCCQ score.

Patients enrolled in TARGET-HF-DM averaged 59 years of age, about a third were women, and two-thirds had heart failure with a reduced ejection fraction of 40% or less. Eighty percent of participants had New York Heart Association class II functional limitations, and a third also had atrial fibrillation. Their average serum level of the N-terminal of the prohormone brain natriuretic peptide at baseline was 1,309 pg/mL. Most patients were on standard heart failure and diabetes medications, with 88% receiving an ACE inhibitor or angiotensin-receptor blocker (in some cases coupled with sacubitril), 90% were on a beta-blocker, 50% were on a mineralocorticoid receptor antagonist, 54% were on insulin, 47% were on a biguanidine, 25% were on a sulfonylurea, and 7% were on a sodium-glucose cotransporter inhibitor. About half the patients also had an implantable cardioverter defibrillator.

Dr. Felker acknowledged that the 313 average increment in steps per day among patients in the intervention group, compared with controls was modest, but it represented about a 10% increase from baseline among patients who in general had a very sedentary life. All patients had received at the start of the study guidelines from the American Heart Association on appropriate types and levels of physical activity for patients with heart failure and diabetes. The researcher previously published a description of the design and rationale of the study.

The study followed patients for an additional 3 months beyond the end of the intervention period, and the excess step count among people in the intervention arm persisted, although the between-group difference was no longer significant. The researchers also analyzed changes during the intervention phase in abnormal fatty acid metabolites among a subgroup of 110 patients and found that these levels tended to decline among those in the intervention group but not among the controls. These metabolites have been associated with disordered metabolism in patient with heart failure, so the observed reduced levels were consistent with the other outcomes. “The signals all went in the direction of reduced metabolic dysregulation,” said Dr. Felker.

Despite the positive outcomes of the intervention studied, Dr. Felker said that this type of approach needs further refinement and study before it’s ready for widespread use. “I think TARGET-HF-DM is another piece of the puzzle, but like all small trials it needs replication in larger trials before adoption into practice guidelines,” he added.

The study received no commercial funding. Dr. Felker has been a consultant to Amgen, Bristol-Myers Squibb, Cytokinetics, Medtronic, Novartis, Reprieve, and Sequana, and he has received research funding from several companies. Dr. Piano had no disclosures.

[email protected]

A 3-month lifestyle intervention that used a step counter and regular, personalized text messages to encourage increased mobility and adherence to medications led to a substantial rise in the quality of life in a randomized controlled study with 187 U.S. patients with heart failure and diabetes.

The TARGET-HF-DM study supplied a wrist-worn step counting device to adults with any type of heart failure and any type of diabetes at six U.S. sites and collected data on daily step counts and medication adherence through smartphone-based apps. Researchers randomized the patients to an intervention of thrice-weekly text messages that gave them personalized feedback on their recent activity and adherence and updated activity and adherence goals, or to a control group that only received a once-weekly generic message to wear the step counter.

After 3 months, patients in the intervention arm had an average incremental gain of 313 steps per day from baseline, compared with the controls, a significant difference for the study’s primary endpoint, G. Michael Felker, MD, reported at the annual scientific meeting of the Heart Failure Society of America.
 

A ‘quite large’ increase in quality of life.

Perhaps more importantly, a secondary analysis assessed quality of life with the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, which showed after 3 months a 5.5-point average increased improvement among patients in the intervention arm, compared with controls. Score increases of 5 of more points on the KCCQ represent clinically meaningful changes.

This average, incremental KCCQ score improvement was “quite large relative to what we typically see in placebo-controlled trials of effective drugs,” said Dr. Felker, professor of medicine at Duke University, Durham, N.C., and director of cardiovascular research at the Duke Clinical Research Institute. If a similar magnitude change in KCCQ was associated with a drug treatment “we would say it was an incredibly large signal in terms of quality of life, so I think the patients are telling us that [the intervention] is making a clinically important difference.”

But Dr. Felker cautioned that the study was not blinded, raising the possibility that the change in quality of life could have been partially explained by “patients feeling more engaged about doing something for their health.”

His report omitted data on the medication adherence facet of the study, which will come out in a subsequent report, raising the possibility that some of the quality of life benefit as well as the ability of patients to boost their step count was related to more consistent treatment with their prescribed medications, but Dr. Felker discounted this possibility.

“The adherence intervention was basically a digital tool that helped people better remember their medication regimen. While it is possible that this could have influenced the KCCQ data this seems quite unlikely to me,” he said in an interview.
 

‘Exercise is the new magic’

“Exercise is the new magic,” commented Mariann R. Piano, PhD, a professor at Vanderbilt University, Nashville, Tenn., and cochair of the session where Dr. Felker gave his report. “I love that the trial was pragmatic, randomized, and ran at six sites so the generalizability of the findings is really strong.” Dr. Piano also gave the study high marks for recruiting many African American patients, 47% of the study population, and its assessment of a patient-reported outcome, the KCCQ score.

Patients enrolled in TARGET-HF-DM averaged 59 years of age, about a third were women, and two-thirds had heart failure with a reduced ejection fraction of 40% or less. Eighty percent of participants had New York Heart Association class II functional limitations, and a third also had atrial fibrillation. Their average serum level of the N-terminal of the prohormone brain natriuretic peptide at baseline was 1,309 pg/mL. Most patients were on standard heart failure and diabetes medications, with 88% receiving an ACE inhibitor or angiotensin-receptor blocker (in some cases coupled with sacubitril), 90% were on a beta-blocker, 50% were on a mineralocorticoid receptor antagonist, 54% were on insulin, 47% were on a biguanidine, 25% were on a sulfonylurea, and 7% were on a sodium-glucose cotransporter inhibitor. About half the patients also had an implantable cardioverter defibrillator.

Dr. Felker acknowledged that the 313 average increment in steps per day among patients in the intervention group, compared with controls was modest, but it represented about a 10% increase from baseline among patients who in general had a very sedentary life. All patients had received at the start of the study guidelines from the American Heart Association on appropriate types and levels of physical activity for patients with heart failure and diabetes. The researcher previously published a description of the design and rationale of the study.

The study followed patients for an additional 3 months beyond the end of the intervention period, and the excess step count among people in the intervention arm persisted, although the between-group difference was no longer significant. The researchers also analyzed changes during the intervention phase in abnormal fatty acid metabolites among a subgroup of 110 patients and found that these levels tended to decline among those in the intervention group but not among the controls. These metabolites have been associated with disordered metabolism in patient with heart failure, so the observed reduced levels were consistent with the other outcomes. “The signals all went in the direction of reduced metabolic dysregulation,” said Dr. Felker.

Despite the positive outcomes of the intervention studied, Dr. Felker said that this type of approach needs further refinement and study before it’s ready for widespread use. “I think TARGET-HF-DM is another piece of the puzzle, but like all small trials it needs replication in larger trials before adoption into practice guidelines,” he added.

The study received no commercial funding. Dr. Felker has been a consultant to Amgen, Bristol-Myers Squibb, Cytokinetics, Medtronic, Novartis, Reprieve, and Sequana, and he has received research funding from several companies. Dr. Piano had no disclosures.

[email protected]

A 3-month lifestyle intervention that used a step counter and regular, personalized text messages to encourage increased mobility and adherence to medications led to a substantial rise in the quality of life in a randomized controlled study with 187 U.S. patients with heart failure and diabetes.

The TARGET-HF-DM study supplied a wrist-worn step counting device to adults with any type of heart failure and any type of diabetes at six U.S. sites and collected data on daily step counts and medication adherence through smartphone-based apps. Researchers randomized the patients to an intervention of thrice-weekly text messages that gave them personalized feedback on their recent activity and adherence and updated activity and adherence goals, or to a control group that only received a once-weekly generic message to wear the step counter.

After 3 months, patients in the intervention arm had an average incremental gain of 313 steps per day from baseline, compared with the controls, a significant difference for the study’s primary endpoint, G. Michael Felker, MD, reported at the annual scientific meeting of the Heart Failure Society of America.
 

A ‘quite large’ increase in quality of life.

Perhaps more importantly, a secondary analysis assessed quality of life with the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, which showed after 3 months a 5.5-point average increased improvement among patients in the intervention arm, compared with controls. Score increases of 5 of more points on the KCCQ represent clinically meaningful changes.

This average, incremental KCCQ score improvement was “quite large relative to what we typically see in placebo-controlled trials of effective drugs,” said Dr. Felker, professor of medicine at Duke University, Durham, N.C., and director of cardiovascular research at the Duke Clinical Research Institute. If a similar magnitude change in KCCQ was associated with a drug treatment “we would say it was an incredibly large signal in terms of quality of life, so I think the patients are telling us that [the intervention] is making a clinically important difference.”

But Dr. Felker cautioned that the study was not blinded, raising the possibility that the change in quality of life could have been partially explained by “patients feeling more engaged about doing something for their health.”

His report omitted data on the medication adherence facet of the study, which will come out in a subsequent report, raising the possibility that some of the quality of life benefit as well as the ability of patients to boost their step count was related to more consistent treatment with their prescribed medications, but Dr. Felker discounted this possibility.

“The adherence intervention was basically a digital tool that helped people better remember their medication regimen. While it is possible that this could have influenced the KCCQ data this seems quite unlikely to me,” he said in an interview.
 

‘Exercise is the new magic’

“Exercise is the new magic,” commented Mariann R. Piano, PhD, a professor at Vanderbilt University, Nashville, Tenn., and cochair of the session where Dr. Felker gave his report. “I love that the trial was pragmatic, randomized, and ran at six sites so the generalizability of the findings is really strong.” Dr. Piano also gave the study high marks for recruiting many African American patients, 47% of the study population, and its assessment of a patient-reported outcome, the KCCQ score.

Patients enrolled in TARGET-HF-DM averaged 59 years of age, about a third were women, and two-thirds had heart failure with a reduced ejection fraction of 40% or less. Eighty percent of participants had New York Heart Association class II functional limitations, and a third also had atrial fibrillation. Their average serum level of the N-terminal of the prohormone brain natriuretic peptide at baseline was 1,309 pg/mL. Most patients were on standard heart failure and diabetes medications, with 88% receiving an ACE inhibitor or angiotensin-receptor blocker (in some cases coupled with sacubitril), 90% were on a beta-blocker, 50% were on a mineralocorticoid receptor antagonist, 54% were on insulin, 47% were on a biguanidine, 25% were on a sulfonylurea, and 7% were on a sodium-glucose cotransporter inhibitor. About half the patients also had an implantable cardioverter defibrillator.

Dr. Felker acknowledged that the 313 average increment in steps per day among patients in the intervention group, compared with controls was modest, but it represented about a 10% increase from baseline among patients who in general had a very sedentary life. All patients had received at the start of the study guidelines from the American Heart Association on appropriate types and levels of physical activity for patients with heart failure and diabetes. The researcher previously published a description of the design and rationale of the study.

The study followed patients for an additional 3 months beyond the end of the intervention period, and the excess step count among people in the intervention arm persisted, although the between-group difference was no longer significant. The researchers also analyzed changes during the intervention phase in abnormal fatty acid metabolites among a subgroup of 110 patients and found that these levels tended to decline among those in the intervention group but not among the controls. These metabolites have been associated with disordered metabolism in patient with heart failure, so the observed reduced levels were consistent with the other outcomes. “The signals all went in the direction of reduced metabolic dysregulation,” said Dr. Felker.

Despite the positive outcomes of the intervention studied, Dr. Felker said that this type of approach needs further refinement and study before it’s ready for widespread use. “I think TARGET-HF-DM is another piece of the puzzle, but like all small trials it needs replication in larger trials before adoption into practice guidelines,” he added.

The study received no commercial funding. Dr. Felker has been a consultant to Amgen, Bristol-Myers Squibb, Cytokinetics, Medtronic, Novartis, Reprieve, and Sequana, and he has received research funding from several companies. Dr. Piano had no disclosures.

[email protected]

The U.S. Preventive Services Task Force (USPSTF) announced on Tuesday that it is standing by its 2014 recommendations that sexually active girls and young women be screened for chlamydia and gonorrhea. But the panel is not ready to provide guidance about screening males even amid an outbreak of gonorrhea infections among men who have sex with men (MSM).

“For men in general, there’s not enough evidence to determine whether screening will reduce the risk of complications or spreading infections to others,” said Marti Kubik, PhD, RN, in an interview. Dr. Kubik is a professor at the George Mason University School of Nursing, Fairfax, Va., and is a member of the task force. “We need further research so we will know how to make those recommendations,” she said.

The screening recommendations for chlamydia and gonorrhea were published Sept. 14 in the Journal of the American Medical Association. The guidance is identical to the panel’s 2014 recommendations. The task force recommends screening for chlamydia and gonorrhea in all sexually active females aged 24 years or younger and in sexually active women aged 25 and older if they are at higher risk because of factors such as new or multiple sex partners.

“We continue to see rising rates of these infections in spite of consistent screening recommendations,” Dr. Kubik said. “In 2019, the CDC recorded nearly 2 million cases of chlamydia and a half million cases of gonorrhea. The big clincher is that chlamydia and gonorrhea can occur without symptoms. It’s critical to screen if we’re going to prevent serious health complications.”

The report notes that chlamydia and gonorrhea may lead to pelvic inflammatory disease in women and to multiple complications in infants born to infected mothers. Men can develop urethritis and epididymitis. Both diseases can boost the risk for HIV infection and transmission.

“We want clinicians to review the new recommendation and feel confident about the evidence base that supports a need for us to be screening young women and older women who are at increased risk,” Dr. Kubik said. She noted that almost two-thirds of chlamydia cases and more than half of gonorrhea cases occur in men and women aged 15-24.

Unlike the CDC, which recommends annual chlamydia and gonorrhea screening in appropriate female patients, the task force provides no guidance on screening frequency. “We didn’t have the evidence base to make a recommendation about how often to screen,” Dr. Kubik said. “But recognizing that these often occur without symptoms, it’s reasonable for clinicians to screen patients whose sexual history reveals new or consistent risk factors.”

Philip A. Chan, MD, an associate professor at Brown University, Providence, R.I., who directs a sexually transmitted disease clinic, told this news organization that he found it frustrating that the task force didn’t make recommendations about screening of MSM. According to a commentary accompanying the new recommendations, the rate of gonorrhea in MSM – 5,166 cases per 100,000, or more than 5% – is at a historic high.

In contrast to the task force, the CDC recommends annual or more frequent testing for gonorrhea and chlamydia plus HIV and syphilis in sexually active MSM.

Dr. Chan noted that the task force’s guidance “tends to be the most evidence-based recommendations that exist. If the evidence isn’t there, they usually don’t make a recommendation.” Still, he said, “I would argue that there’s good evidence that in MSM, the risk for HIV acquisition warrants routine screening.”

Jeanne Marrazzo, MD, MPH, director of the division of infectious diseases at the University of Alabama at Birmingham, also noted the limits of the task force’s insistence on certain kinds of evidence. Dr. Marrazzo, who coauthored a commentary that accompanies the recommendations, said in an interview that the panel’s “reliance on randomized-controlled-trial-level evidence tends to limit its ability to evolve their recommendations in a way that could account for evolving epidemiology or advances in our understanding of pathophysiology of these infections.”

Dr. Chan noted that obstacles exist for patients even when screening recommendations are in place. Although insurers typically cover costs of chlamydia and gonorrhea screening tests, he said, the uninsured may have to pay $100 or more each.

The USPSTF is supported by the U.S. Agency for Healthcare Research and Quality. Dr. Kubik, Dr. Chan, and Dr. Marrazzo report no relevant financial relationships.

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

The U.S. Preventive Services Task Force (USPSTF) announced on Tuesday that it is standing by its 2014 recommendations that sexually active girls and young women be screened for chlamydia and gonorrhea. But the panel is not ready to provide guidance about screening males even amid an outbreak of gonorrhea infections among men who have sex with men (MSM).

“For men in general, there’s not enough evidence to determine whether screening will reduce the risk of complications or spreading infections to others,” said Marti Kubik, PhD, RN, in an interview. Dr. Kubik is a professor at the George Mason University School of Nursing, Fairfax, Va., and is a member of the task force. “We need further research so we will know how to make those recommendations,” she said.

The screening recommendations for chlamydia and gonorrhea were published Sept. 14 in the Journal of the American Medical Association. The guidance is identical to the panel’s 2014 recommendations. The task force recommends screening for chlamydia and gonorrhea in all sexually active females aged 24 years or younger and in sexually active women aged 25 and older if they are at higher risk because of factors such as new or multiple sex partners.

“We continue to see rising rates of these infections in spite of consistent screening recommendations,” Dr. Kubik said. “In 2019, the CDC recorded nearly 2 million cases of chlamydia and a half million cases of gonorrhea. The big clincher is that chlamydia and gonorrhea can occur without symptoms. It’s critical to screen if we’re going to prevent serious health complications.”

The report notes that chlamydia and gonorrhea may lead to pelvic inflammatory disease in women and to multiple complications in infants born to infected mothers. Men can develop urethritis and epididymitis. Both diseases can boost the risk for HIV infection and transmission.

“We want clinicians to review the new recommendation and feel confident about the evidence base that supports a need for us to be screening young women and older women who are at increased risk,” Dr. Kubik said. She noted that almost two-thirds of chlamydia cases and more than half of gonorrhea cases occur in men and women aged 15-24.

Unlike the CDC, which recommends annual chlamydia and gonorrhea screening in appropriate female patients, the task force provides no guidance on screening frequency. “We didn’t have the evidence base to make a recommendation about how often to screen,” Dr. Kubik said. “But recognizing that these often occur without symptoms, it’s reasonable for clinicians to screen patients whose sexual history reveals new or consistent risk factors.”

Philip A. Chan, MD, an associate professor at Brown University, Providence, R.I., who directs a sexually transmitted disease clinic, told this news organization that he found it frustrating that the task force didn’t make recommendations about screening of MSM. According to a commentary accompanying the new recommendations, the rate of gonorrhea in MSM – 5,166 cases per 100,000, or more than 5% – is at a historic high.

In contrast to the task force, the CDC recommends annual or more frequent testing for gonorrhea and chlamydia plus HIV and syphilis in sexually active MSM.

Dr. Chan noted that the task force’s guidance “tends to be the most evidence-based recommendations that exist. If the evidence isn’t there, they usually don’t make a recommendation.” Still, he said, “I would argue that there’s good evidence that in MSM, the risk for HIV acquisition warrants routine screening.”

Jeanne Marrazzo, MD, MPH, director of the division of infectious diseases at the University of Alabama at Birmingham, also noted the limits of the task force’s insistence on certain kinds of evidence. Dr. Marrazzo, who coauthored a commentary that accompanies the recommendations, said in an interview that the panel’s “reliance on randomized-controlled-trial-level evidence tends to limit its ability to evolve their recommendations in a way that could account for evolving epidemiology or advances in our understanding of pathophysiology of these infections.”

Dr. Chan noted that obstacles exist for patients even when screening recommendations are in place. Although insurers typically cover costs of chlamydia and gonorrhea screening tests, he said, the uninsured may have to pay $100 or more each.

The USPSTF is supported by the U.S. Agency for Healthcare Research and Quality. Dr. Kubik, Dr. Chan, and Dr. Marrazzo report no relevant financial relationships.

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

The U.S. Preventive Services Task Force (USPSTF) announced on Tuesday that it is standing by its 2014 recommendations that sexually active girls and young women be screened for chlamydia and gonorrhea. But the panel is not ready to provide guidance about screening males even amid an outbreak of gonorrhea infections among men who have sex with men (MSM).

“For men in general, there’s not enough evidence to determine whether screening will reduce the risk of complications or spreading infections to others,” said Marti Kubik, PhD, RN, in an interview. Dr. Kubik is a professor at the George Mason University School of Nursing, Fairfax, Va., and is a member of the task force. “We need further research so we will know how to make those recommendations,” she said.

The screening recommendations for chlamydia and gonorrhea were published Sept. 14 in the Journal of the American Medical Association. The guidance is identical to the panel’s 2014 recommendations. The task force recommends screening for chlamydia and gonorrhea in all sexually active females aged 24 years or younger and in sexually active women aged 25 and older if they are at higher risk because of factors such as new or multiple sex partners.

“We continue to see rising rates of these infections in spite of consistent screening recommendations,” Dr. Kubik said. “In 2019, the CDC recorded nearly 2 million cases of chlamydia and a half million cases of gonorrhea. The big clincher is that chlamydia and gonorrhea can occur without symptoms. It’s critical to screen if we’re going to prevent serious health complications.”

The report notes that chlamydia and gonorrhea may lead to pelvic inflammatory disease in women and to multiple complications in infants born to infected mothers. Men can develop urethritis and epididymitis. Both diseases can boost the risk for HIV infection and transmission.

“We want clinicians to review the new recommendation and feel confident about the evidence base that supports a need for us to be screening young women and older women who are at increased risk,” Dr. Kubik said. She noted that almost two-thirds of chlamydia cases and more than half of gonorrhea cases occur in men and women aged 15-24.

Unlike the CDC, which recommends annual chlamydia and gonorrhea screening in appropriate female patients, the task force provides no guidance on screening frequency. “We didn’t have the evidence base to make a recommendation about how often to screen,” Dr. Kubik said. “But recognizing that these often occur without symptoms, it’s reasonable for clinicians to screen patients whose sexual history reveals new or consistent risk factors.”

Philip A. Chan, MD, an associate professor at Brown University, Providence, R.I., who directs a sexually transmitted disease clinic, told this news organization that he found it frustrating that the task force didn’t make recommendations about screening of MSM. According to a commentary accompanying the new recommendations, the rate of gonorrhea in MSM – 5,166 cases per 100,000, or more than 5% – is at a historic high.

In contrast to the task force, the CDC recommends annual or more frequent testing for gonorrhea and chlamydia plus HIV and syphilis in sexually active MSM.

Dr. Chan noted that the task force’s guidance “tends to be the most evidence-based recommendations that exist. If the evidence isn’t there, they usually don’t make a recommendation.” Still, he said, “I would argue that there’s good evidence that in MSM, the risk for HIV acquisition warrants routine screening.”

Jeanne Marrazzo, MD, MPH, director of the division of infectious diseases at the University of Alabama at Birmingham, also noted the limits of the task force’s insistence on certain kinds of evidence. Dr. Marrazzo, who coauthored a commentary that accompanies the recommendations, said in an interview that the panel’s “reliance on randomized-controlled-trial-level evidence tends to limit its ability to evolve their recommendations in a way that could account for evolving epidemiology or advances in our understanding of pathophysiology of these infections.”

Dr. Chan noted that obstacles exist for patients even when screening recommendations are in place. Although insurers typically cover costs of chlamydia and gonorrhea screening tests, he said, the uninsured may have to pay $100 or more each.

The USPSTF is supported by the U.S. Agency for Healthcare Research and Quality. Dr. Kubik, Dr. Chan, and Dr. Marrazzo report no relevant financial relationships.

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