Ob.Gyn. News

The U.S. Supreme Court upheld the Affordable Care Act June 17 in a 7 to 2 vote, rejecting claims by the challengers that the requirement for all Americans to obtain health insurance is unconstitutional.

ETIENJones/thinkstockphotos

The challengers were comprised of 18 GOP-dominated states, led by Texas, that took issue with the ACA’s individual mandate – which required most Americans to have health insurance or pay a tax penalty.

But Congress reduced the penalty to zero in 2017. Challengers argued that without the mandate,  the rest of the law should be scrapped, too. The court ruled that eliminated the harm the states were claiming.

“To have standing, a plaintiff must ‘allege personal injury fairly traceable to the defendant’s allegedly unlawful conduct and likely to be redressed by the requested relief,’” the majority wrote. “No plaintiff has shown such an injury ‘fairly traceable’ to the ‘allegedly unlawful conduct’ challenged here.”

Justice Stephen Breyer authored the opinion. Justices Samuel Alito and Neil Gorsuch dissented.

The decision said that the mandate in question did not require the 18 states that brought the complaint to pay anything, and therefore they had no standing.

President Joe Biden has said he plans to build on the ACA – which was enacted while he was vice president – to offer coverage to more Americans.

This marks the third time the Supreme Court spared the Obama-era law from GOP attacks. The mandate was also upheld in 2012 in a 5 to 4 ruling.

American Medical Association president Gerald Harmon, MD, also called for building on the ruling to expand the law.

“With yet another court decision upholding the ACA now behind us, we remain committed to strengthening the current law and look forward to policymakers advancing solutions to improve the ACA,” Dr. Harmon said in a statement. “The AMA will continue working to expand access to health care and ensure that all Americans have meaningful, comprehensive, and affordable health coverage to improve the health of the nation.”

House Speaker Nancy Pelosi (D-Calif.), a longtime advocate for the ACA, called the decision a “landmark victory for Democrats.”

“Thanks to the tireless advocacy of Americans across the country and Democrats in Congress, the Affordable Care Act endures as a pillar of American health and economic security alongside Medicare, Medicaid and Social Security,” she said in a statement.

Senate Majority Leader Chuck Schumer (D-N.Y.) also celebrated the ruling.

“The Affordable Care Act has won. The Supreme Court has just ruled: the ACA is here to stay and now we’re going to try to make it bigger and better,” he said, according to CNN. “For more than a decade, the assault on our health care law was relentless from Republicans in Congress, from the executive branch itself and from Republican attorneys general in the courts. Each time in each arena, the ACA has prevailed.”

This article was updated June 17, 2021.

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

The U.S. Supreme Court upheld the Affordable Care Act June 17 in a 7 to 2 vote, rejecting claims by the challengers that the requirement for all Americans to obtain health insurance is unconstitutional.

ETIENJones/thinkstockphotos

The challengers were comprised of 18 GOP-dominated states, led by Texas, that took issue with the ACA’s individual mandate – which required most Americans to have health insurance or pay a tax penalty.

But Congress reduced the penalty to zero in 2017. Challengers argued that without the mandate,  the rest of the law should be scrapped, too. The court ruled that eliminated the harm the states were claiming.

“To have standing, a plaintiff must ‘allege personal injury fairly traceable to the defendant’s allegedly unlawful conduct and likely to be redressed by the requested relief,’” the majority wrote. “No plaintiff has shown such an injury ‘fairly traceable’ to the ‘allegedly unlawful conduct’ challenged here.”

Justice Stephen Breyer authored the opinion. Justices Samuel Alito and Neil Gorsuch dissented.

The decision said that the mandate in question did not require the 18 states that brought the complaint to pay anything, and therefore they had no standing.

President Joe Biden has said he plans to build on the ACA – which was enacted while he was vice president – to offer coverage to more Americans.

This marks the third time the Supreme Court spared the Obama-era law from GOP attacks. The mandate was also upheld in 2012 in a 5 to 4 ruling.

American Medical Association president Gerald Harmon, MD, also called for building on the ruling to expand the law.

“With yet another court decision upholding the ACA now behind us, we remain committed to strengthening the current law and look forward to policymakers advancing solutions to improve the ACA,” Dr. Harmon said in a statement. “The AMA will continue working to expand access to health care and ensure that all Americans have meaningful, comprehensive, and affordable health coverage to improve the health of the nation.”

House Speaker Nancy Pelosi (D-Calif.), a longtime advocate for the ACA, called the decision a “landmark victory for Democrats.”

“Thanks to the tireless advocacy of Americans across the country and Democrats in Congress, the Affordable Care Act endures as a pillar of American health and economic security alongside Medicare, Medicaid and Social Security,” she said in a statement.

Senate Majority Leader Chuck Schumer (D-N.Y.) also celebrated the ruling.

“The Affordable Care Act has won. The Supreme Court has just ruled: the ACA is here to stay and now we’re going to try to make it bigger and better,” he said, according to CNN. “For more than a decade, the assault on our health care law was relentless from Republicans in Congress, from the executive branch itself and from Republican attorneys general in the courts. Each time in each arena, the ACA has prevailed.”

This article was updated June 17, 2021.

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

The U.S. Supreme Court upheld the Affordable Care Act June 17 in a 7 to 2 vote, rejecting claims by the challengers that the requirement for all Americans to obtain health insurance is unconstitutional.

ETIENJones/thinkstockphotos

The challengers were comprised of 18 GOP-dominated states, led by Texas, that took issue with the ACA’s individual mandate – which required most Americans to have health insurance or pay a tax penalty.

But Congress reduced the penalty to zero in 2017. Challengers argued that without the mandate,  the rest of the law should be scrapped, too. The court ruled that eliminated the harm the states were claiming.

“To have standing, a plaintiff must ‘allege personal injury fairly traceable to the defendant’s allegedly unlawful conduct and likely to be redressed by the requested relief,’” the majority wrote. “No plaintiff has shown such an injury ‘fairly traceable’ to the ‘allegedly unlawful conduct’ challenged here.”

Justice Stephen Breyer authored the opinion. Justices Samuel Alito and Neil Gorsuch dissented.

The decision said that the mandate in question did not require the 18 states that brought the complaint to pay anything, and therefore they had no standing.

President Joe Biden has said he plans to build on the ACA – which was enacted while he was vice president – to offer coverage to more Americans.

This marks the third time the Supreme Court spared the Obama-era law from GOP attacks. The mandate was also upheld in 2012 in a 5 to 4 ruling.

American Medical Association president Gerald Harmon, MD, also called for building on the ruling to expand the law.

“With yet another court decision upholding the ACA now behind us, we remain committed to strengthening the current law and look forward to policymakers advancing solutions to improve the ACA,” Dr. Harmon said in a statement. “The AMA will continue working to expand access to health care and ensure that all Americans have meaningful, comprehensive, and affordable health coverage to improve the health of the nation.”

House Speaker Nancy Pelosi (D-Calif.), a longtime advocate for the ACA, called the decision a “landmark victory for Democrats.”

“Thanks to the tireless advocacy of Americans across the country and Democrats in Congress, the Affordable Care Act endures as a pillar of American health and economic security alongside Medicare, Medicaid and Social Security,” she said in a statement.

Senate Majority Leader Chuck Schumer (D-N.Y.) also celebrated the ruling.

“The Affordable Care Act has won. The Supreme Court has just ruled: the ACA is here to stay and now we’re going to try to make it bigger and better,” he said, according to CNN. “For more than a decade, the assault on our health care law was relentless from Republicans in Congress, from the executive branch itself and from Republican attorneys general in the courts. Each time in each arena, the ACA has prevailed.”

This article was updated June 17, 2021.

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

While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay.

“We remain confident that the benefits of vaccination far exceed the very unusual risks,” the leadership of the AHA/ASA said in a statement issued June 12.

“The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,” they point out.

Late last week, the Centers for Disease Control and Prevention alerted health care providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna.

The CDC is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

These cases may occur more often in males than females and more frequently after the second dose than the first dose of either mRNA vaccine. Symptoms typically occur in the 3 days after administration.

“The CDC’s ongoing investigation into cases of suspected myocarditis reflects a strong and steadfast commitment to transparency and the importance of scientific rigor on all fronts. We applaud the CDC’s unwavering efforts to lead our nation’s scientific and public health efforts, including ensuring the continued safety of the COVID-19 vaccines,” the AHA/ASA states.

They emphasize that vaccinations should continue, and say it’s important to consider the details of the suspected myocarditis cases being investigated by the CDC.

As of June 11, more than 306 million doses of COVID-19 vaccines have been administered in the United States (since Dec. 14, 2020) and nearly 43% of Americans – more than 142 million people – are now fully vaccinated.

According to the June 10 CDC VAERS report detailing adverse events through May 31:

• 789 cases of suspected myocarditis have been reported, with 475 involving people younger than 30 years; 79 cases reported were in patients 16 or 17 years old.
• The vast majority (81%) of the 270 patients younger than 30 years who were discharged from care after suspected myocarditis related to COVID-19 vaccination have recovered fully; the remaining 19% of patients report ongoing symptoms or complete data are missing.
• 196 cases of suspected myocarditis after a COVID-19 vaccine were reported in young adults 18 to 24 years of age, which is higher than expected for this age group.

As of May 31, only about 9% of the COVID-19 vaccine doses administered were to people 16 to 24 years of age, which is why this “higher-than-normal rate of possible myocarditis cases” warrants investigation, the AHA/ASA says.

They note that these suspected myocarditis cases were reported to VAERS because of their proximity to COVID-19 vaccine administration.

It remains to be determined which cases meet the clinical criteria for a diagnosis of myocarditis and whether they have any direct connection to the COVID-19 vaccine, the AHA/ASA says.

They urge all health care professionals to be aware of “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation.

They advise asking patients who present with symptoms related to these conditions about the timing of recent COVID vaccinations, as needed, to confirm the diagnosis and provide appropriate treatment quickly.

The AHA will be at the CDC’s June 18 meeting to review the latest evidence on cases of suspected myocarditis after the COVID-19 vaccine, the statement adds.

The statement notes that it reflects the views of the AHA/ASA and its scientific leadership, including current president Mitchel S.V. Elkind, MD, PhD; immediate past-president Robert A. Harrington, MD; president-elect Donald M. Lloyd-Jones, MD; AHA/ASA chief science and medical officer Mariell Jessup, MD; and chief medical officer for prevention Eduardo Sanchez, MD, MPH.

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

While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay.

“We remain confident that the benefits of vaccination far exceed the very unusual risks,” the leadership of the AHA/ASA said in a statement issued June 12.

“The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,” they point out.

Late last week, the Centers for Disease Control and Prevention alerted health care providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna.

The CDC is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

These cases may occur more often in males than females and more frequently after the second dose than the first dose of either mRNA vaccine. Symptoms typically occur in the 3 days after administration.

“The CDC’s ongoing investigation into cases of suspected myocarditis reflects a strong and steadfast commitment to transparency and the importance of scientific rigor on all fronts. We applaud the CDC’s unwavering efforts to lead our nation’s scientific and public health efforts, including ensuring the continued safety of the COVID-19 vaccines,” the AHA/ASA states.

They emphasize that vaccinations should continue, and say it’s important to consider the details of the suspected myocarditis cases being investigated by the CDC.

As of June 11, more than 306 million doses of COVID-19 vaccines have been administered in the United States (since Dec. 14, 2020) and nearly 43% of Americans – more than 142 million people – are now fully vaccinated.

According to the June 10 CDC VAERS report detailing adverse events through May 31:

• 789 cases of suspected myocarditis have been reported, with 475 involving people younger than 30 years; 79 cases reported were in patients 16 or 17 years old.
• The vast majority (81%) of the 270 patients younger than 30 years who were discharged from care after suspected myocarditis related to COVID-19 vaccination have recovered fully; the remaining 19% of patients report ongoing symptoms or complete data are missing.
• 196 cases of suspected myocarditis after a COVID-19 vaccine were reported in young adults 18 to 24 years of age, which is higher than expected for this age group.

As of May 31, only about 9% of the COVID-19 vaccine doses administered were to people 16 to 24 years of age, which is why this “higher-than-normal rate of possible myocarditis cases” warrants investigation, the AHA/ASA says.

They note that these suspected myocarditis cases were reported to VAERS because of their proximity to COVID-19 vaccine administration.

It remains to be determined which cases meet the clinical criteria for a diagnosis of myocarditis and whether they have any direct connection to the COVID-19 vaccine, the AHA/ASA says.

They urge all health care professionals to be aware of “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation.

They advise asking patients who present with symptoms related to these conditions about the timing of recent COVID vaccinations, as needed, to confirm the diagnosis and provide appropriate treatment quickly.

The AHA will be at the CDC’s June 18 meeting to review the latest evidence on cases of suspected myocarditis after the COVID-19 vaccine, the statement adds.

The statement notes that it reflects the views of the AHA/ASA and its scientific leadership, including current president Mitchel S.V. Elkind, MD, PhD; immediate past-president Robert A. Harrington, MD; president-elect Donald M. Lloyd-Jones, MD; AHA/ASA chief science and medical officer Mariell Jessup, MD; and chief medical officer for prevention Eduardo Sanchez, MD, MPH.

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

While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay.

“We remain confident that the benefits of vaccination far exceed the very unusual risks,” the leadership of the AHA/ASA said in a statement issued June 12.

“The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,” they point out.

Late last week, the Centers for Disease Control and Prevention alerted health care providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna.

The CDC is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

These cases may occur more often in males than females and more frequently after the second dose than the first dose of either mRNA vaccine. Symptoms typically occur in the 3 days after administration.

“The CDC’s ongoing investigation into cases of suspected myocarditis reflects a strong and steadfast commitment to transparency and the importance of scientific rigor on all fronts. We applaud the CDC’s unwavering efforts to lead our nation’s scientific and public health efforts, including ensuring the continued safety of the COVID-19 vaccines,” the AHA/ASA states.

They emphasize that vaccinations should continue, and say it’s important to consider the details of the suspected myocarditis cases being investigated by the CDC.

As of June 11, more than 306 million doses of COVID-19 vaccines have been administered in the United States (since Dec. 14, 2020) and nearly 43% of Americans – more than 142 million people – are now fully vaccinated.

According to the June 10 CDC VAERS report detailing adverse events through May 31:

• 789 cases of suspected myocarditis have been reported, with 475 involving people younger than 30 years; 79 cases reported were in patients 16 or 17 years old.
• The vast majority (81%) of the 270 patients younger than 30 years who were discharged from care after suspected myocarditis related to COVID-19 vaccination have recovered fully; the remaining 19% of patients report ongoing symptoms or complete data are missing.
• 196 cases of suspected myocarditis after a COVID-19 vaccine were reported in young adults 18 to 24 years of age, which is higher than expected for this age group.

As of May 31, only about 9% of the COVID-19 vaccine doses administered were to people 16 to 24 years of age, which is why this “higher-than-normal rate of possible myocarditis cases” warrants investigation, the AHA/ASA says.

They note that these suspected myocarditis cases were reported to VAERS because of their proximity to COVID-19 vaccine administration.

It remains to be determined which cases meet the clinical criteria for a diagnosis of myocarditis and whether they have any direct connection to the COVID-19 vaccine, the AHA/ASA says.

They urge all health care professionals to be aware of “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation.

They advise asking patients who present with symptoms related to these conditions about the timing of recent COVID vaccinations, as needed, to confirm the diagnosis and provide appropriate treatment quickly.

The AHA will be at the CDC’s June 18 meeting to review the latest evidence on cases of suspected myocarditis after the COVID-19 vaccine, the statement adds.

The statement notes that it reflects the views of the AHA/ASA and its scientific leadership, including current president Mitchel S.V. Elkind, MD, PhD; immediate past-president Robert A. Harrington, MD; president-elect Donald M. Lloyd-Jones, MD; AHA/ASA chief science and medical officer Mariell Jessup, MD; and chief medical officer for prevention Eduardo Sanchez, MD, MPH.

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

“It’s good to be in something from the ground floor. I came too late for that. ... But lately, I’m getting the feeling that I came in at the end. The best is over.” –Tony Soprano

If you could choose, would you rather be transported to live 25 years ago in the past or 25 years from now in the future? For me, I’m unsure. Sometimes it feels like our best days are behind us. When I was a kid, we explored life in pond water, watching water fleas and hydra swim under our Child World toy microscopes. Today, kids learn to eat Tide Pods from TikTok. Back when I was young, a doctor’s appointment was a special occasion! My brothers and I had a bath and got dressed in our Sunday best for our appointment with Dr. Bellin, a genteel, gray-haired pediatrician who worked out of his Victorian office with wooden floors and crystal door handles. Contrast that with the appointment I had with a patient the other day, done by telephone while she was in line ordering at Starbucks. I waited patiently for her to give her order.

This ache I feel for the past is called nostalgia. At one time, it was a diagnosable condition. It was first used by Dr. Johannes Hofer in the 17th century to describe Swiss soldiers fighting in foreign lands. From the Greek, it means “homecoming pain.” Although over time nostalgia has lost its clinical meaning, the feeling of yearning for the past has dramatically gained in prevalence. The word “nostalgia” appears more in print now than at any point since 1800. We are most nostalgic during times of duress, it seems. This, no doubt, is because it’s comforting to think we’d be better off back in pastoral, idyll times, back when work ended at 5 p.m. and cotton balls were soaked in alcohol and office visits ended with a lollipop on a loop.

Of course, the good old days weren’t really better. We have a selective view of history – as many things were contemptible or bad then as now. Yes, Dr. Bellin was the consummate professional, but thank goodness, I didn’t have acute lymphocytic leukemia or Haemophilus influenzae type B or even suffocate under a pile of blankets while sleeping on my stomach. Without doubt, clinically we’re much better today. Also back then, there was hardly a consideration for atrocious racial disparities in care. We’ve not come far, but we are at least better off today than a few decades ago. And what about medicine as a profession? Although he had loads of autonomy and respect, Dr. Bellin also started every day of his 50-year career at 6 a.m. rounding in the newborn nursery before seeing patients in the office 6 days a week. Not many of us would trade our practice for his.

Yet, there’s reasons to be nostalgic. Chart notes might have been barely legible, but at least they served a purpose. The problem-oriented medical record was intended to logically capture and organize data. SOAP notes were invented to help us think better, to get diagnoses correct, to succinctly see progress. Today, notes are written for administrators and payers and patients. As a result, they’re often useless to us.

And although it may have been inconvenient to sit in the waiting room reading Highlights magazine, I’m unsure it was a worse user experience, compared with a chain pharmacy “virtual” doctor visit. (Particularly because you could always drop pennies down the large hot-air iron floor grate in the corner).

The thrumming undercurrent of progress promises artificial intelligence and genomics and wearable diagnostics in our future. But the assumption is the new things will be better suited to our needs than the old. Sometimes, they are not. Sometimes technology diminishes us instead of enhancing us.

I cannot count how many times I’ve hit my head or whacked my shin because our Tesla Model X doors open by magic and of their own accord. Back when I was young, we opened car doors by pulling on the door handle. I sometimes miss those days.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

“It’s good to be in something from the ground floor. I came too late for that. ... But lately, I’m getting the feeling that I came in at the end. The best is over.” –Tony Soprano

If you could choose, would you rather be transported to live 25 years ago in the past or 25 years from now in the future? For me, I’m unsure. Sometimes it feels like our best days are behind us. When I was a kid, we explored life in pond water, watching water fleas and hydra swim under our Child World toy microscopes. Today, kids learn to eat Tide Pods from TikTok. Back when I was young, a doctor’s appointment was a special occasion! My brothers and I had a bath and got dressed in our Sunday best for our appointment with Dr. Bellin, a genteel, gray-haired pediatrician who worked out of his Victorian office with wooden floors and crystal door handles. Contrast that with the appointment I had with a patient the other day, done by telephone while she was in line ordering at Starbucks. I waited patiently for her to give her order.

This ache I feel for the past is called nostalgia. At one time, it was a diagnosable condition. It was first used by Dr. Johannes Hofer in the 17th century to describe Swiss soldiers fighting in foreign lands. From the Greek, it means “homecoming pain.” Although over time nostalgia has lost its clinical meaning, the feeling of yearning for the past has dramatically gained in prevalence. The word “nostalgia” appears more in print now than at any point since 1800. We are most nostalgic during times of duress, it seems. This, no doubt, is because it’s comforting to think we’d be better off back in pastoral, idyll times, back when work ended at 5 p.m. and cotton balls were soaked in alcohol and office visits ended with a lollipop on a loop.

Of course, the good old days weren’t really better. We have a selective view of history – as many things were contemptible or bad then as now. Yes, Dr. Bellin was the consummate professional, but thank goodness, I didn’t have acute lymphocytic leukemia or Haemophilus influenzae type B or even suffocate under a pile of blankets while sleeping on my stomach. Without doubt, clinically we’re much better today. Also back then, there was hardly a consideration for atrocious racial disparities in care. We’ve not come far, but we are at least better off today than a few decades ago. And what about medicine as a profession? Although he had loads of autonomy and respect, Dr. Bellin also started every day of his 50-year career at 6 a.m. rounding in the newborn nursery before seeing patients in the office 6 days a week. Not many of us would trade our practice for his.

Yet, there’s reasons to be nostalgic. Chart notes might have been barely legible, but at least they served a purpose. The problem-oriented medical record was intended to logically capture and organize data. SOAP notes were invented to help us think better, to get diagnoses correct, to succinctly see progress. Today, notes are written for administrators and payers and patients. As a result, they’re often useless to us.

And although it may have been inconvenient to sit in the waiting room reading Highlights magazine, I’m unsure it was a worse user experience, compared with a chain pharmacy “virtual” doctor visit. (Particularly because you could always drop pennies down the large hot-air iron floor grate in the corner).

The thrumming undercurrent of progress promises artificial intelligence and genomics and wearable diagnostics in our future. But the assumption is the new things will be better suited to our needs than the old. Sometimes, they are not. Sometimes technology diminishes us instead of enhancing us.

I cannot count how many times I’ve hit my head or whacked my shin because our Tesla Model X doors open by magic and of their own accord. Back when I was young, we opened car doors by pulling on the door handle. I sometimes miss those days.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

“It’s good to be in something from the ground floor. I came too late for that. ... But lately, I’m getting the feeling that I came in at the end. The best is over.” –Tony Soprano

If you could choose, would you rather be transported to live 25 years ago in the past or 25 years from now in the future? For me, I’m unsure. Sometimes it feels like our best days are behind us. When I was a kid, we explored life in pond water, watching water fleas and hydra swim under our Child World toy microscopes. Today, kids learn to eat Tide Pods from TikTok. Back when I was young, a doctor’s appointment was a special occasion! My brothers and I had a bath and got dressed in our Sunday best for our appointment with Dr. Bellin, a genteel, gray-haired pediatrician who worked out of his Victorian office with wooden floors and crystal door handles. Contrast that with the appointment I had with a patient the other day, done by telephone while she was in line ordering at Starbucks. I waited patiently for her to give her order.

This ache I feel for the past is called nostalgia. At one time, it was a diagnosable condition. It was first used by Dr. Johannes Hofer in the 17th century to describe Swiss soldiers fighting in foreign lands. From the Greek, it means “homecoming pain.” Although over time nostalgia has lost its clinical meaning, the feeling of yearning for the past has dramatically gained in prevalence. The word “nostalgia” appears more in print now than at any point since 1800. We are most nostalgic during times of duress, it seems. This, no doubt, is because it’s comforting to think we’d be better off back in pastoral, idyll times, back when work ended at 5 p.m. and cotton balls were soaked in alcohol and office visits ended with a lollipop on a loop.

Of course, the good old days weren’t really better. We have a selective view of history – as many things were contemptible or bad then as now. Yes, Dr. Bellin was the consummate professional, but thank goodness, I didn’t have acute lymphocytic leukemia or Haemophilus influenzae type B or even suffocate under a pile of blankets while sleeping on my stomach. Without doubt, clinically we’re much better today. Also back then, there was hardly a consideration for atrocious racial disparities in care. We’ve not come far, but we are at least better off today than a few decades ago. And what about medicine as a profession? Although he had loads of autonomy and respect, Dr. Bellin also started every day of his 50-year career at 6 a.m. rounding in the newborn nursery before seeing patients in the office 6 days a week. Not many of us would trade our practice for his.

Yet, there’s reasons to be nostalgic. Chart notes might have been barely legible, but at least they served a purpose. The problem-oriented medical record was intended to logically capture and organize data. SOAP notes were invented to help us think better, to get diagnoses correct, to succinctly see progress. Today, notes are written for administrators and payers and patients. As a result, they’re often useless to us.

And although it may have been inconvenient to sit in the waiting room reading Highlights magazine, I’m unsure it was a worse user experience, compared with a chain pharmacy “virtual” doctor visit. (Particularly because you could always drop pennies down the large hot-air iron floor grate in the corner).

The thrumming undercurrent of progress promises artificial intelligence and genomics and wearable diagnostics in our future. But the assumption is the new things will be better suited to our needs than the old. Sometimes, they are not. Sometimes technology diminishes us instead of enhancing us.

I cannot count how many times I’ve hit my head or whacked my shin because our Tesla Model X doors open by magic and of their own accord. Back when I was young, we opened car doors by pulling on the door handle. I sometimes miss those days.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Sex should be removed as a legal designation on the public part of birth certificates, the American Medical Association said June 15.

Requiring the designation can lead to discrimination and unnecessary burden on individuals whose current gender identity does not align with their designation at birth when they register for school or sports, adopt, get married, or request personal records.

A person’s sex designation at birth would still be submitted to the U.S. Standard Certificate of Live Birth for medical, public health, and statistical use only, report authors note.

Willie Underwood III, MD, MSc, author of Board Report 15, explained in reference committee testimony that a standard certificate of live birth is critical for uniformly collecting and processing data, but birth certificates are issued by the government to individuals.
 

Ten states allow gender-neutral designation

According to the report, 48 states (Tennessee and Ohio are the exceptions) and the District of Columbia allow people to amend their sex designation on their birth certificate to reflect their gender identities, but only 10 states allow for a gender-neutral designation, usually “X,” on birth certificates. The U.S. Department of State does not currently offer an option for a gender-neutral designation on U.S. passports.

“Assigning sex using binary variables in the public portion of the birth certificate fails to recognize the medical spectrum of gender identity,” Dr. Underwood said, and it can be used to discriminate.

Jeremy Toler, MD, a delegate from GLMA: Health Professionals Advancing LGBTQ Equality, testified that there is precedent for information to be removed from the public portion of the birth certificates. And much data is collected for each live birth that doesn’t show up on individuals’ birth certificates, he noted.

Dr. Toler said transgender, gender nonbinary, and individuals with differences in sex development can be placed at a disadvantage by the sex label on the birth certificate.

“We unfortunately still live in a world where it is unsafe in many cases for one’s gender to vary from the sex assigned at birth,” Dr. Toler said.

Not having this data on the widely used form will reduce unnecessary reliance on sex as a stand-in for gender, he said, and would “serve as an equalizer” since policies differ by state.

Robert Jackson, MD, an alternate delegate from the American Academy of Cosmetic Surgery, spoke against the measure.

“We as physicians need to report things accurately,” Dr. Jackson said. “All through medical school, residency, and specialty training we were supposed to delegate all of the physical findings of the patient we’re taking care of. I think when the child is born, they do have physical characteristics either male or female, and I think that probably should be on the public record. That’s just my personal opinion.”

Sarah Mae Smith, MD, delegate from California, speaking on behalf of the Women Physicians Section, said removing the sex designation is important for moving toward gender equity.

“We need to recognize [that] gender is not a binary but a spectrum,” she said. “Obligating our patients to jump through numerous administrative hoops to identify as who they are based on a sex assigned at birth primarily on genitalia is not only unnecessary but actively deleterious to their health.”
 

Race was once public on birth certificates

She noted that the report mentions that previously, information on the race of a person’s parents was included on the public portion of the birth certificate and that information was recognized to facilitate discrimination.

“Thankfully, a change was made to obviate at least that avenue for discriminatory practices,” she said. “Now, likewise, the information on sex assigned at birth is being used to undermine the rights of our transgender, intersex, and nonbinary patients.”

Arlene Seid, MD, MPH, an alternate delegate from the American Association of Public Health Physicians, said the resolution protects the aggregate data “without the discrimination associated with the individual data.”

Sex no longer has a role to play in the jobs people do, she noted, and the designation shouldn’t have to be evaluated for something like a job interview.

“Our society doesn’t need it on an individual basis for most of what occurs in public life,” Dr. Seid said.

Dr. Underwood, Dr. Toler, Dr. Jackson, Dr. Smith, and Dr. Seid declared no relevant financial relationships.

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

Sex should be removed as a legal designation on the public part of birth certificates, the American Medical Association said June 15.

Requiring the designation can lead to discrimination and unnecessary burden on individuals whose current gender identity does not align with their designation at birth when they register for school or sports, adopt, get married, or request personal records.

A person’s sex designation at birth would still be submitted to the U.S. Standard Certificate of Live Birth for medical, public health, and statistical use only, report authors note.

Willie Underwood III, MD, MSc, author of Board Report 15, explained in reference committee testimony that a standard certificate of live birth is critical for uniformly collecting and processing data, but birth certificates are issued by the government to individuals.
 

Ten states allow gender-neutral designation

According to the report, 48 states (Tennessee and Ohio are the exceptions) and the District of Columbia allow people to amend their sex designation on their birth certificate to reflect their gender identities, but only 10 states allow for a gender-neutral designation, usually “X,” on birth certificates. The U.S. Department of State does not currently offer an option for a gender-neutral designation on U.S. passports.

“Assigning sex using binary variables in the public portion of the birth certificate fails to recognize the medical spectrum of gender identity,” Dr. Underwood said, and it can be used to discriminate.

Jeremy Toler, MD, a delegate from GLMA: Health Professionals Advancing LGBTQ Equality, testified that there is precedent for information to be removed from the public portion of the birth certificates. And much data is collected for each live birth that doesn’t show up on individuals’ birth certificates, he noted.

Dr. Toler said transgender, gender nonbinary, and individuals with differences in sex development can be placed at a disadvantage by the sex label on the birth certificate.

“We unfortunately still live in a world where it is unsafe in many cases for one’s gender to vary from the sex assigned at birth,” Dr. Toler said.

Not having this data on the widely used form will reduce unnecessary reliance on sex as a stand-in for gender, he said, and would “serve as an equalizer” since policies differ by state.

Robert Jackson, MD, an alternate delegate from the American Academy of Cosmetic Surgery, spoke against the measure.

“We as physicians need to report things accurately,” Dr. Jackson said. “All through medical school, residency, and specialty training we were supposed to delegate all of the physical findings of the patient we’re taking care of. I think when the child is born, they do have physical characteristics either male or female, and I think that probably should be on the public record. That’s just my personal opinion.”

Sarah Mae Smith, MD, delegate from California, speaking on behalf of the Women Physicians Section, said removing the sex designation is important for moving toward gender equity.

“We need to recognize [that] gender is not a binary but a spectrum,” she said. “Obligating our patients to jump through numerous administrative hoops to identify as who they are based on a sex assigned at birth primarily on genitalia is not only unnecessary but actively deleterious to their health.”
 

Race was once public on birth certificates

She noted that the report mentions that previously, information on the race of a person’s parents was included on the public portion of the birth certificate and that information was recognized to facilitate discrimination.

“Thankfully, a change was made to obviate at least that avenue for discriminatory practices,” she said. “Now, likewise, the information on sex assigned at birth is being used to undermine the rights of our transgender, intersex, and nonbinary patients.”

Arlene Seid, MD, MPH, an alternate delegate from the American Association of Public Health Physicians, said the resolution protects the aggregate data “without the discrimination associated with the individual data.”

Sex no longer has a role to play in the jobs people do, she noted, and the designation shouldn’t have to be evaluated for something like a job interview.

“Our society doesn’t need it on an individual basis for most of what occurs in public life,” Dr. Seid said.

Dr. Underwood, Dr. Toler, Dr. Jackson, Dr. Smith, and Dr. Seid declared no relevant financial relationships.

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

Sex should be removed as a legal designation on the public part of birth certificates, the American Medical Association said June 15.

Requiring the designation can lead to discrimination and unnecessary burden on individuals whose current gender identity does not align with their designation at birth when they register for school or sports, adopt, get married, or request personal records.

A person’s sex designation at birth would still be submitted to the U.S. Standard Certificate of Live Birth for medical, public health, and statistical use only, report authors note.

Willie Underwood III, MD, MSc, author of Board Report 15, explained in reference committee testimony that a standard certificate of live birth is critical for uniformly collecting and processing data, but birth certificates are issued by the government to individuals.
 

Ten states allow gender-neutral designation

According to the report, 48 states (Tennessee and Ohio are the exceptions) and the District of Columbia allow people to amend their sex designation on their birth certificate to reflect their gender identities, but only 10 states allow for a gender-neutral designation, usually “X,” on birth certificates. The U.S. Department of State does not currently offer an option for a gender-neutral designation on U.S. passports.

“Assigning sex using binary variables in the public portion of the birth certificate fails to recognize the medical spectrum of gender identity,” Dr. Underwood said, and it can be used to discriminate.

Jeremy Toler, MD, a delegate from GLMA: Health Professionals Advancing LGBTQ Equality, testified that there is precedent for information to be removed from the public portion of the birth certificates. And much data is collected for each live birth that doesn’t show up on individuals’ birth certificates, he noted.

Dr. Toler said transgender, gender nonbinary, and individuals with differences in sex development can be placed at a disadvantage by the sex label on the birth certificate.

“We unfortunately still live in a world where it is unsafe in many cases for one’s gender to vary from the sex assigned at birth,” Dr. Toler said.

Not having this data on the widely used form will reduce unnecessary reliance on sex as a stand-in for gender, he said, and would “serve as an equalizer” since policies differ by state.

Robert Jackson, MD, an alternate delegate from the American Academy of Cosmetic Surgery, spoke against the measure.

“We as physicians need to report things accurately,” Dr. Jackson said. “All through medical school, residency, and specialty training we were supposed to delegate all of the physical findings of the patient we’re taking care of. I think when the child is born, they do have physical characteristics either male or female, and I think that probably should be on the public record. That’s just my personal opinion.”

Sarah Mae Smith, MD, delegate from California, speaking on behalf of the Women Physicians Section, said removing the sex designation is important for moving toward gender equity.

“We need to recognize [that] gender is not a binary but a spectrum,” she said. “Obligating our patients to jump through numerous administrative hoops to identify as who they are based on a sex assigned at birth primarily on genitalia is not only unnecessary but actively deleterious to their health.”
 

Race was once public on birth certificates

She noted that the report mentions that previously, information on the race of a person’s parents was included on the public portion of the birth certificate and that information was recognized to facilitate discrimination.

“Thankfully, a change was made to obviate at least that avenue for discriminatory practices,” she said. “Now, likewise, the information on sex assigned at birth is being used to undermine the rights of our transgender, intersex, and nonbinary patients.”

Arlene Seid, MD, MPH, an alternate delegate from the American Association of Public Health Physicians, said the resolution protects the aggregate data “without the discrimination associated with the individual data.”

Sex no longer has a role to play in the jobs people do, she noted, and the designation shouldn’t have to be evaluated for something like a job interview.

“Our society doesn’t need it on an individual basis for most of what occurs in public life,” Dr. Seid said.

Dr. Underwood, Dr. Toler, Dr. Jackson, Dr. Smith, and Dr. Seid declared no relevant financial relationships.

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

People may be absorbing and ingesting potentially toxic chemicals from their cosmetic products, a new study suggests.

Researchers found high fluorine levels in most of the waterproof mascara, liquid lipsticks, and foundations they tested, indicating the probable presence of what’s known as PFAS – per- and polyfluoroalkyl substances. Many of these chemicals were not included on the product labels, making it difficult for consumers to consciously avoid them.

Environmental Science & Technology

“This study is very helpful for elucidating the PFAS content of different types of cosmetics in the U.S. and Canadian markets,” said Elsie Sunderland, PhD, an environmental scientist who was not involved with the study.

“Previously, all the data had been collected in Europe, and this study shows we are dealing with similar problems in the North American marketplace,” said Dr. Sunderland, a professor of environmental chemistry at the Harvard School of Public Health, Boston.

PFAS are a class of chemicals used in a variety of consumer products, such as nonstick cookware, stain-resistant carpeting, and water-repellent clothing, according to the Centers for Disease Control and Prevention. They are added to cosmetics to make the products more durable and spreadable, researchers said in the study.

“[PFAS] are added to change the properties of surfaces, to make them nonstick or resistant to stay in water or oils,” said study coauthor Tom Bruton, PhD, senior scientist at the Green Science Policy Institute in Berkeley, Calif. “The concerning thing about cosmetics is that these are products that you’re applying to your skin and face every day, so there’s the skin absorption route that’s of concern, but also incidental ingestion of cosmetics is also a concern as well.”

The CDC says some of the potential health effects of PFAS exposure includes increased cholesterol levels, increased risk of kidney and testicular cancer, changes in liver enzymes, decreased vaccine response in children, and a higher risk of high blood pressure or preeclampsia in pregnant women.

JackF/iStock/Getty Images

“PFAS are a large class of chemicals. In humans, exposure to some of these chemicals has been associated with impaired immune function, certain cancers, increased risks of diabetes, obesity and endocrine disruption,” Dr. Sunderland said. “They appear to be harmful to every major organ system in the human body.”

For the current study, published online in Environmental Science & Technology Letters, Dr. Bruton and colleagues purchased 231 cosmetic products in the United States and Canada from retailers such as Ulta Beauty, Sephora, Target, and Bed Bath & Beyond. They then screened them for fluorine.Three-quarters of waterproof mascara samples contained high fluorine concentrations, as did nearly two-thirds of foundations and liquid lipsticks, and more than half of the eye and lip products tested.

The authors found that different categories of makeup tended to have higher or lower fluorine concentrations. “High fluorine levels were found in products commonly advertised as ‘wear-resistant’ to water and oils or ‘long-lasting,’ including foundations, liquid lipsticks, and waterproof mascaras,” Dr. Bruton and colleagues wrote.

When they further analyzed a subset of 29 products to determine what types of chemicals were present, they found that each cosmetic product contained at least 4 PFAS, with one product containing 13.The PFAS substances found included some that break down into other chemicals that are known to be highly toxic and environmentally harmful.

“It’s concerning that some of the products we tested appear to be intentionally using PFAS, but not listing those ingredients on the label,” Dr. Bruton said. “I do think that it is helpful for consumers to read labels, but beyond that, there’s not a lot of ways that consumers themselves can solve this problem. ... We think that the industry needs to be more proactive about moving away from this group of chemicals.”

Dr. Sunderland said a resource people can use when trying to avoid PFAS is the Environmental Working Group, a nonprofit organization that maintains an extensive database of cosmetics and personal care products.

“At this point, there is very little regulatory activity related to PFAS in cosmetics,” Dr. Sunderland said. “The best thing to happen now would be for consumers to indicate that they prefer products without PFAS and to demand better transparency in product ingredient lists.”

A similar study done in 2018 by the Danish Environmental Protection Agency found high levels of PFAS in nearly one-third of the cosmetics products it tested.

People can also be exposed to PFAS by eating or drinking contaminated food or water and through food packaging. Dr. Sunderland said some wild foods like seafood are known to accumulate these compounds in the environment.

“There are examples of contaminated biosolids leading to accumulation of PFAS in vegetables and milk,” Dr. Sunderland explained. “Food packaging is another concern because it can also result in PFAS accumulation in the foods we eat.”

Although it’s difficult to avoid PFAS altogether, the CDC suggests lowering exposure rates by avoiding contaminated water and food. If you’re not sure if your water is contaminated, you should ask your local or state health and environmental quality departments for fish or water advisories in your area.

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

People may be absorbing and ingesting potentially toxic chemicals from their cosmetic products, a new study suggests.

Researchers found high fluorine levels in most of the waterproof mascara, liquid lipsticks, and foundations they tested, indicating the probable presence of what’s known as PFAS – per- and polyfluoroalkyl substances. Many of these chemicals were not included on the product labels, making it difficult for consumers to consciously avoid them.

Environmental Science & Technology

“This study is very helpful for elucidating the PFAS content of different types of cosmetics in the U.S. and Canadian markets,” said Elsie Sunderland, PhD, an environmental scientist who was not involved with the study.

“Previously, all the data had been collected in Europe, and this study shows we are dealing with similar problems in the North American marketplace,” said Dr. Sunderland, a professor of environmental chemistry at the Harvard School of Public Health, Boston.

PFAS are a class of chemicals used in a variety of consumer products, such as nonstick cookware, stain-resistant carpeting, and water-repellent clothing, according to the Centers for Disease Control and Prevention. They are added to cosmetics to make the products more durable and spreadable, researchers said in the study.

“[PFAS] are added to change the properties of surfaces, to make them nonstick or resistant to stay in water or oils,” said study coauthor Tom Bruton, PhD, senior scientist at the Green Science Policy Institute in Berkeley, Calif. “The concerning thing about cosmetics is that these are products that you’re applying to your skin and face every day, so there’s the skin absorption route that’s of concern, but also incidental ingestion of cosmetics is also a concern as well.”

The CDC says some of the potential health effects of PFAS exposure includes increased cholesterol levels, increased risk of kidney and testicular cancer, changes in liver enzymes, decreased vaccine response in children, and a higher risk of high blood pressure or preeclampsia in pregnant women.

JackF/iStock/Getty Images

“PFAS are a large class of chemicals. In humans, exposure to some of these chemicals has been associated with impaired immune function, certain cancers, increased risks of diabetes, obesity and endocrine disruption,” Dr. Sunderland said. “They appear to be harmful to every major organ system in the human body.”

For the current study, published online in Environmental Science & Technology Letters, Dr. Bruton and colleagues purchased 231 cosmetic products in the United States and Canada from retailers such as Ulta Beauty, Sephora, Target, and Bed Bath & Beyond. They then screened them for fluorine.Three-quarters of waterproof mascara samples contained high fluorine concentrations, as did nearly two-thirds of foundations and liquid lipsticks, and more than half of the eye and lip products tested.

The authors found that different categories of makeup tended to have higher or lower fluorine concentrations. “High fluorine levels were found in products commonly advertised as ‘wear-resistant’ to water and oils or ‘long-lasting,’ including foundations, liquid lipsticks, and waterproof mascaras,” Dr. Bruton and colleagues wrote.

When they further analyzed a subset of 29 products to determine what types of chemicals were present, they found that each cosmetic product contained at least 4 PFAS, with one product containing 13.The PFAS substances found included some that break down into other chemicals that are known to be highly toxic and environmentally harmful.

“It’s concerning that some of the products we tested appear to be intentionally using PFAS, but not listing those ingredients on the label,” Dr. Bruton said. “I do think that it is helpful for consumers to read labels, but beyond that, there’s not a lot of ways that consumers themselves can solve this problem. ... We think that the industry needs to be more proactive about moving away from this group of chemicals.”

Dr. Sunderland said a resource people can use when trying to avoid PFAS is the Environmental Working Group, a nonprofit organization that maintains an extensive database of cosmetics and personal care products.

“At this point, there is very little regulatory activity related to PFAS in cosmetics,” Dr. Sunderland said. “The best thing to happen now would be for consumers to indicate that they prefer products without PFAS and to demand better transparency in product ingredient lists.”

A similar study done in 2018 by the Danish Environmental Protection Agency found high levels of PFAS in nearly one-third of the cosmetics products it tested.

People can also be exposed to PFAS by eating or drinking contaminated food or water and through food packaging. Dr. Sunderland said some wild foods like seafood are known to accumulate these compounds in the environment.

“There are examples of contaminated biosolids leading to accumulation of PFAS in vegetables and milk,” Dr. Sunderland explained. “Food packaging is another concern because it can also result in PFAS accumulation in the foods we eat.”

Although it’s difficult to avoid PFAS altogether, the CDC suggests lowering exposure rates by avoiding contaminated water and food. If you’re not sure if your water is contaminated, you should ask your local or state health and environmental quality departments for fish or water advisories in your area.

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

People may be absorbing and ingesting potentially toxic chemicals from their cosmetic products, a new study suggests.

Researchers found high fluorine levels in most of the waterproof mascara, liquid lipsticks, and foundations they tested, indicating the probable presence of what’s known as PFAS – per- and polyfluoroalkyl substances. Many of these chemicals were not included on the product labels, making it difficult for consumers to consciously avoid them.

Environmental Science & Technology

“This study is very helpful for elucidating the PFAS content of different types of cosmetics in the U.S. and Canadian markets,” said Elsie Sunderland, PhD, an environmental scientist who was not involved with the study.

“Previously, all the data had been collected in Europe, and this study shows we are dealing with similar problems in the North American marketplace,” said Dr. Sunderland, a professor of environmental chemistry at the Harvard School of Public Health, Boston.

PFAS are a class of chemicals used in a variety of consumer products, such as nonstick cookware, stain-resistant carpeting, and water-repellent clothing, according to the Centers for Disease Control and Prevention. They are added to cosmetics to make the products more durable and spreadable, researchers said in the study.

“[PFAS] are added to change the properties of surfaces, to make them nonstick or resistant to stay in water or oils,” said study coauthor Tom Bruton, PhD, senior scientist at the Green Science Policy Institute in Berkeley, Calif. “The concerning thing about cosmetics is that these are products that you’re applying to your skin and face every day, so there’s the skin absorption route that’s of concern, but also incidental ingestion of cosmetics is also a concern as well.”

The CDC says some of the potential health effects of PFAS exposure includes increased cholesterol levels, increased risk of kidney and testicular cancer, changes in liver enzymes, decreased vaccine response in children, and a higher risk of high blood pressure or preeclampsia in pregnant women.

JackF/iStock/Getty Images

“PFAS are a large class of chemicals. In humans, exposure to some of these chemicals has been associated with impaired immune function, certain cancers, increased risks of diabetes, obesity and endocrine disruption,” Dr. Sunderland said. “They appear to be harmful to every major organ system in the human body.”

For the current study, published online in Environmental Science & Technology Letters, Dr. Bruton and colleagues purchased 231 cosmetic products in the United States and Canada from retailers such as Ulta Beauty, Sephora, Target, and Bed Bath & Beyond. They then screened them for fluorine.Three-quarters of waterproof mascara samples contained high fluorine concentrations, as did nearly two-thirds of foundations and liquid lipsticks, and more than half of the eye and lip products tested.

The authors found that different categories of makeup tended to have higher or lower fluorine concentrations. “High fluorine levels were found in products commonly advertised as ‘wear-resistant’ to water and oils or ‘long-lasting,’ including foundations, liquid lipsticks, and waterproof mascaras,” Dr. Bruton and colleagues wrote.

When they further analyzed a subset of 29 products to determine what types of chemicals were present, they found that each cosmetic product contained at least 4 PFAS, with one product containing 13.The PFAS substances found included some that break down into other chemicals that are known to be highly toxic and environmentally harmful.

“It’s concerning that some of the products we tested appear to be intentionally using PFAS, but not listing those ingredients on the label,” Dr. Bruton said. “I do think that it is helpful for consumers to read labels, but beyond that, there’s not a lot of ways that consumers themselves can solve this problem. ... We think that the industry needs to be more proactive about moving away from this group of chemicals.”

Dr. Sunderland said a resource people can use when trying to avoid PFAS is the Environmental Working Group, a nonprofit organization that maintains an extensive database of cosmetics and personal care products.

“At this point, there is very little regulatory activity related to PFAS in cosmetics,” Dr. Sunderland said. “The best thing to happen now would be for consumers to indicate that they prefer products without PFAS and to demand better transparency in product ingredient lists.”

A similar study done in 2018 by the Danish Environmental Protection Agency found high levels of PFAS in nearly one-third of the cosmetics products it tested.

People can also be exposed to PFAS by eating or drinking contaminated food or water and through food packaging. Dr. Sunderland said some wild foods like seafood are known to accumulate these compounds in the environment.

“There are examples of contaminated biosolids leading to accumulation of PFAS in vegetables and milk,” Dr. Sunderland explained. “Food packaging is another concern because it can also result in PFAS accumulation in the foods we eat.”

Although it’s difficult to avoid PFAS altogether, the CDC suggests lowering exposure rates by avoiding contaminated water and food. If you’re not sure if your water is contaminated, you should ask your local or state health and environmental quality departments for fish or water advisories in your area.

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

A report by the American Medical Association’s medical education advisory body points to systemic racism or other systems of oppression as causing a lack of representation, exclusion, and marginalization in medical education and medicine.

The report received overwhelming support at the House of Delegates, the AMA’s legislative policy making body, during an online meeting held June 13.

The Council on Medical Education’s report recommends that the AMA acknowledge the harm caused by the Flexner Report, which was issued in 1910 and has since shaped medical education. The Flexner Report caused harm not only to historically Black medical schools, but also to physician workforce diversity and to the clinical outcomes of minority and marginalized patients, according to the medical education advisory body.

The council also recommended conducting a study on medical education with a focus on health equity and racial justice, improving diversity among healthcare workers, and fixing inequitable outcomes from minorities and marginalized patient populations.

The report comes on the heels of the resignation of JAMA editor-in-chief Howard Bauchner, MD, and another high-ranking editor following a February podcast on systemic racism in medicine. The AMA has since released a strategic plan addressing racism and health inequity that has divided membership.
 

Flexner Report’s effect on physician diversity

The Council on Medical Education’s report observed that as a result of the Flexner Report’s recommendations, 89 medical schools, including 5 of the 7 existing medical schools training Black physicians, were closed because they didn’t meet the report’s standards. In addition, the report created a limited role for Black physicians while “hint[ing] that Black physicians possessed less potential and ability than their White counterparts,” read the Council’s report.

In addition to consigning the role of the Black physician to “educating the [Black] race to know and to practice fundamental hygienic principles,” the Flexner Report also observed that “a well-taught negro sanitarian will be immensely useful,” per the Council’s report.

The impact of the closure of medical schools training Black physicians was dramatic. According to the Council’s report, in 1964, 93% of medical students in the United States were men and 97% of those students were non-Hispanic White.

Today, 56% of physicians identify as White, 17% as Asian, 6% as Hispanic, and 5% as Black or African American, per the Association of American Medical Colleges; nearly 14% of active physicians didn’t report their race in the survey. By means of contrast, the U.S. population in 2019 was 60% White, 19% Latino/Hispanic, 13% Black or African American, and 6% Asian American, according to the Brookings Institute.

Abraham Flexner, who wrote the Flexner Report, is often referred to as the “father of modern medical education,” according to the AAMC. In November, the AAMC observed that the Flexner Report contained racist and sexist ideas and that his work contributed to the closure of historically Black medical schools. Both statements were included in AAMC’s announcement about the removal of Flexner’s name from its most prestigious award. As of January, the award is now called the AAMC Award for Excellence in Medical Education.
 

Pathway programs can increase diversity

Pathway programs, which leverage targeted milestones along the journey to becoming a physician in order to increase diversity, were an area of focus in the council’s report. These programs “can exert a meaningful, positive effect on student outcomes and increase diversity across various levels of educational settings,” according to its report.

Centers of Excellence, which provides grants for mentorship and training programs, is one of many pathway programs. During the 2018-2019 academic year, Centers of Excellence supported more than 1,300 trainees – 99% of them were underrepresented minorities and 64% came from financially or educationally disadvantaged backgrounds. In 2006, federal funding was cut to these programs and the number of Centers of Excellence fell.

Still, the report cites the passage of federal funding in 2020 of $50 million for public institutions of higher education that train physicians; educational institutions in states with a projected primary care shortage in 2025 are given priority in the grant-funding process.
 

AMA council’s report garners support from delegates

Delegates voiced overwhelming support of the council’s report during the June 13 meeting. Lou Edje, MD, a Perrysburgh, Ohio–based family physician, voiced strong support for the council’s report, in particular its recommendations that recognize the harm caused by the Flexner Report. Dr. Edje observed that the Flexner Report, with its elimination of five of seven Black medical schools, “[set] back admissions of Black students into medicine by 50 years.”

“Empathy is what we are called to have as physicians. I implore you to simply substitute your ethnicity into these quotes to help understand the historic need for health equity in medicine today. This CME report is part of the antidote to Flexner. We support [it] fully,” concluded Dr. Edje, who spoke for the Great Lakes States Coalition of the AMA.

Rohan Khazanchi, a medical student at the University of Nebraska, Omaha, and a member of the council, said, “Our broad attempt with this report was twofold: to fill gaps in AMA policy with evidence-based recommendations which could improve diversity in our health workforce and, second, to enhance our organization’s vision for truth, reconciliation, and healing to redress the historic marginalization of minoritized physicians in medicine.”

According to an AMA spokesperson, the House of Delegates will vote on this and other policies this week, after which the policies are considered final.

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

A report by the American Medical Association’s medical education advisory body points to systemic racism or other systems of oppression as causing a lack of representation, exclusion, and marginalization in medical education and medicine.

The report received overwhelming support at the House of Delegates, the AMA’s legislative policy making body, during an online meeting held June 13.

The Council on Medical Education’s report recommends that the AMA acknowledge the harm caused by the Flexner Report, which was issued in 1910 and has since shaped medical education. The Flexner Report caused harm not only to historically Black medical schools, but also to physician workforce diversity and to the clinical outcomes of minority and marginalized patients, according to the medical education advisory body.

The council also recommended conducting a study on medical education with a focus on health equity and racial justice, improving diversity among healthcare workers, and fixing inequitable outcomes from minorities and marginalized patient populations.

The report comes on the heels of the resignation of JAMA editor-in-chief Howard Bauchner, MD, and another high-ranking editor following a February podcast on systemic racism in medicine. The AMA has since released a strategic plan addressing racism and health inequity that has divided membership.
 

Flexner Report’s effect on physician diversity

The Council on Medical Education’s report observed that as a result of the Flexner Report’s recommendations, 89 medical schools, including 5 of the 7 existing medical schools training Black physicians, were closed because they didn’t meet the report’s standards. In addition, the report created a limited role for Black physicians while “hint[ing] that Black physicians possessed less potential and ability than their White counterparts,” read the Council’s report.

In addition to consigning the role of the Black physician to “educating the [Black] race to know and to practice fundamental hygienic principles,” the Flexner Report also observed that “a well-taught negro sanitarian will be immensely useful,” per the Council’s report.

The impact of the closure of medical schools training Black physicians was dramatic. According to the Council’s report, in 1964, 93% of medical students in the United States were men and 97% of those students were non-Hispanic White.

Today, 56% of physicians identify as White, 17% as Asian, 6% as Hispanic, and 5% as Black or African American, per the Association of American Medical Colleges; nearly 14% of active physicians didn’t report their race in the survey. By means of contrast, the U.S. population in 2019 was 60% White, 19% Latino/Hispanic, 13% Black or African American, and 6% Asian American, according to the Brookings Institute.

Abraham Flexner, who wrote the Flexner Report, is often referred to as the “father of modern medical education,” according to the AAMC. In November, the AAMC observed that the Flexner Report contained racist and sexist ideas and that his work contributed to the closure of historically Black medical schools. Both statements were included in AAMC’s announcement about the removal of Flexner’s name from its most prestigious award. As of January, the award is now called the AAMC Award for Excellence in Medical Education.
 

Pathway programs can increase diversity

Pathway programs, which leverage targeted milestones along the journey to becoming a physician in order to increase diversity, were an area of focus in the council’s report. These programs “can exert a meaningful, positive effect on student outcomes and increase diversity across various levels of educational settings,” according to its report.

Centers of Excellence, which provides grants for mentorship and training programs, is one of many pathway programs. During the 2018-2019 academic year, Centers of Excellence supported more than 1,300 trainees – 99% of them were underrepresented minorities and 64% came from financially or educationally disadvantaged backgrounds. In 2006, federal funding was cut to these programs and the number of Centers of Excellence fell.

Still, the report cites the passage of federal funding in 2020 of $50 million for public institutions of higher education that train physicians; educational institutions in states with a projected primary care shortage in 2025 are given priority in the grant-funding process.
 

AMA council’s report garners support from delegates

Delegates voiced overwhelming support of the council’s report during the June 13 meeting. Lou Edje, MD, a Perrysburgh, Ohio–based family physician, voiced strong support for the council’s report, in particular its recommendations that recognize the harm caused by the Flexner Report. Dr. Edje observed that the Flexner Report, with its elimination of five of seven Black medical schools, “[set] back admissions of Black students into medicine by 50 years.”

“Empathy is what we are called to have as physicians. I implore you to simply substitute your ethnicity into these quotes to help understand the historic need for health equity in medicine today. This CME report is part of the antidote to Flexner. We support [it] fully,” concluded Dr. Edje, who spoke for the Great Lakes States Coalition of the AMA.

Rohan Khazanchi, a medical student at the University of Nebraska, Omaha, and a member of the council, said, “Our broad attempt with this report was twofold: to fill gaps in AMA policy with evidence-based recommendations which could improve diversity in our health workforce and, second, to enhance our organization’s vision for truth, reconciliation, and healing to redress the historic marginalization of minoritized physicians in medicine.”

According to an AMA spokesperson, the House of Delegates will vote on this and other policies this week, after which the policies are considered final.

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

A report by the American Medical Association’s medical education advisory body points to systemic racism or other systems of oppression as causing a lack of representation, exclusion, and marginalization in medical education and medicine.

The report received overwhelming support at the House of Delegates, the AMA’s legislative policy making body, during an online meeting held June 13.

The Council on Medical Education’s report recommends that the AMA acknowledge the harm caused by the Flexner Report, which was issued in 1910 and has since shaped medical education. The Flexner Report caused harm not only to historically Black medical schools, but also to physician workforce diversity and to the clinical outcomes of minority and marginalized patients, according to the medical education advisory body.

The council also recommended conducting a study on medical education with a focus on health equity and racial justice, improving diversity among healthcare workers, and fixing inequitable outcomes from minorities and marginalized patient populations.

The report comes on the heels of the resignation of JAMA editor-in-chief Howard Bauchner, MD, and another high-ranking editor following a February podcast on systemic racism in medicine. The AMA has since released a strategic plan addressing racism and health inequity that has divided membership.
 

Flexner Report’s effect on physician diversity

The Council on Medical Education’s report observed that as a result of the Flexner Report’s recommendations, 89 medical schools, including 5 of the 7 existing medical schools training Black physicians, were closed because they didn’t meet the report’s standards. In addition, the report created a limited role for Black physicians while “hint[ing] that Black physicians possessed less potential and ability than their White counterparts,” read the Council’s report.

In addition to consigning the role of the Black physician to “educating the [Black] race to know and to practice fundamental hygienic principles,” the Flexner Report also observed that “a well-taught negro sanitarian will be immensely useful,” per the Council’s report.

The impact of the closure of medical schools training Black physicians was dramatic. According to the Council’s report, in 1964, 93% of medical students in the United States were men and 97% of those students were non-Hispanic White.

Today, 56% of physicians identify as White, 17% as Asian, 6% as Hispanic, and 5% as Black or African American, per the Association of American Medical Colleges; nearly 14% of active physicians didn’t report their race in the survey. By means of contrast, the U.S. population in 2019 was 60% White, 19% Latino/Hispanic, 13% Black or African American, and 6% Asian American, according to the Brookings Institute.

Abraham Flexner, who wrote the Flexner Report, is often referred to as the “father of modern medical education,” according to the AAMC. In November, the AAMC observed that the Flexner Report contained racist and sexist ideas and that his work contributed to the closure of historically Black medical schools. Both statements were included in AAMC’s announcement about the removal of Flexner’s name from its most prestigious award. As of January, the award is now called the AAMC Award for Excellence in Medical Education.
 

Pathway programs can increase diversity

Pathway programs, which leverage targeted milestones along the journey to becoming a physician in order to increase diversity, were an area of focus in the council’s report. These programs “can exert a meaningful, positive effect on student outcomes and increase diversity across various levels of educational settings,” according to its report.

Centers of Excellence, which provides grants for mentorship and training programs, is one of many pathway programs. During the 2018-2019 academic year, Centers of Excellence supported more than 1,300 trainees – 99% of them were underrepresented minorities and 64% came from financially or educationally disadvantaged backgrounds. In 2006, federal funding was cut to these programs and the number of Centers of Excellence fell.

Still, the report cites the passage of federal funding in 2020 of $50 million for public institutions of higher education that train physicians; educational institutions in states with a projected primary care shortage in 2025 are given priority in the grant-funding process.
 

AMA council’s report garners support from delegates

Delegates voiced overwhelming support of the council’s report during the June 13 meeting. Lou Edje, MD, a Perrysburgh, Ohio–based family physician, voiced strong support for the council’s report, in particular its recommendations that recognize the harm caused by the Flexner Report. Dr. Edje observed that the Flexner Report, with its elimination of five of seven Black medical schools, “[set] back admissions of Black students into medicine by 50 years.”

“Empathy is what we are called to have as physicians. I implore you to simply substitute your ethnicity into these quotes to help understand the historic need for health equity in medicine today. This CME report is part of the antidote to Flexner. We support [it] fully,” concluded Dr. Edje, who spoke for the Great Lakes States Coalition of the AMA.

Rohan Khazanchi, a medical student at the University of Nebraska, Omaha, and a member of the council, said, “Our broad attempt with this report was twofold: to fill gaps in AMA policy with evidence-based recommendations which could improve diversity in our health workforce and, second, to enhance our organization’s vision for truth, reconciliation, and healing to redress the historic marginalization of minoritized physicians in medicine.”

According to an AMA spokesperson, the House of Delegates will vote on this and other policies this week, after which the policies are considered final.

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

In the United States, cryoablation or freezing tissue to death is a primary treatment option for a variety of cancers, including those originating in or spread to the bone, cervix, eye, kidney, liver, lung, pancreas, prostate, and skin.

Cryoablation for prostate cancer, one of the most common cancers in men, was first approved in the 1990s.

But unlike in Europe, this nonsurgical approach is not approved for breast cancer in the United States; it is one of the most common cancers in women.

So why is this approach still experimental for breast cancer?

“I don’t know,” answered cryoablation researcher Richard Fine, MD, of West Cancer Center in Germantown, Tenn., when asked by this news organization.

“It’s very interesting how slow the [Food and Drug Administration] is in approving devices for breast cancer [when compared with] other cancers,” he said.
 

New clinical data

Perhaps new clinical data will eventually lead to approval of this nonsurgical technique for use in low-risk breast cancer. However, the related trial had a controversial design that might discourage uptake by practitioners if it is approved, said an expert not involved in the study.

Nevertheless, the new data show that cryoablation can be an effective treatment for small, low-risk, early-stage breast cancers in older patients.

The findings come from ICE-3, a multicenter single-arm study of cryoablation in 194 such patients with mean follow-up of roughly 3 years.

It used liquid nitrogen-based cryoablation technology from IceCure Medical Ltd., an Israeli company and the study sponsor.

The results show that 2.06% (n = 4) of patients had a recurrence in the same breast, which is “basically the same” as lumpectomy, the surgical standard for this patient group, said Dr. Fine, the lead investigator on the trial.

These are interim data, Dr. Fine said at the American Society of Breast Surgeons annual meeting, held virtually.

The primary outcome is the 5-year recurrence rate, and this is the first-ever cryoablation trial that does not involve follow-up surgery, he said.

Cryoablation, which delivers a gas to a tumor via a thin needle-like probe that is guided by ultrasound, has multiple advantages over surgery, Dr. Fine said.

“The noninvasive procedure is fast, painless, and can be delivered under local anesthesia in a doctor’s office. Recovery time is minimal and cosmetic outcomes are excellent with little loss of breast tissue and no scarring,” he said in a meeting press statement.

The potential market for cryoablation in breast cancer is large, as it is intended for tumors ≤1.5 cm, which comprise approximately 60%-70% of stage 1 breast cancers that are hormone receptor–positive (HR+), and HER2-negative (HER2–), Dr. Fine said in an interview.

Cryoablation is part of a logical, de-escalation of breast cancer care, he added. “We have moved from radical mastectomy to modified mastectomy to lumpectomy – so the next step in that evolution is ablative technology, which is ‘nonsurgical.’ ”

There are other experimental ablative treatments for breast cancer including high-frequency ultrasound and laser, but cryoablation is the furthest along in development.

Cryoablation as a primary cancer treatment was first approved for coverage by the Centers for Medicare & Medicaid Services for localized prostate cancer in 1999.

But the concept extends back to 1845, when English physician James Arnott first used iced salt solutions (about –20 °C or – 4 °F) to induce tissue necrosis, reducing tumor size and ameliorating pain. Because the crude cryogen needed to be applied topically, the pioneering technique was limited to breast and cervical cancers because of their accessibility.
 

Not likely to show superiority

The new study’s population was composed of women aged 60 years or older (mean of 75 years) with unifocal invasive ductal cancers measuring ≤1.5 cm or less that were all low-grade, HR+, and HER2–, as noted.

The liquid nitrogen–based cryoablation consisted of a freeze-thaw-freeze cycle that totals 20-40 minutes, with freezing temperatures targeting the tumor area and turning it into an “ice ball.”

That ice ball eventually surrounds the tumor, creating a “lethal zone,” and thus a margin in which no cancer exists, akin to surgery, said Dr. Fine.

There were no significant device-related adverse events or complications reported, say the investigators. Most of the adverse events were minor and included bruising, localized edema, minor skin freeze burn, rash, minor bleeding from needle insertion, minor local hematoma, skin induration, minor infection, and pruritis.

Two of 15 patients who underwent sentinel lymph node biopsies had a positive sentinel node. At the discretion of their treating physician, 27 patients underwent adjuvant radiation, 1 patient received chemotherapy, and 148 began endocrine therapy. More than 95% of the patients and 98% of physicians reported satisfaction from the cosmetic results during follow-up visits.

Because not all patients underwent sentinel lymph node biopsy and adjuvant radiation, there is likely to be controversy about this approach, suggested Deanna J. Attai, MD, a breast surgeon at the University of California, Los Angeles, and past president of the American Society of Breast Surgeons, who was asked for comment.

“We have studies that [indicate that] these treatments don’t add significant benefit [in this patient population] but there still is this hesitation [to forgo them],” she told this news organization.

“The patients in this study were exceedingly low risk,” she emphasized.

“Is 5 years enough to assess recurrence rates? The answer is probably no. Recurrences or distant metastases are more likely to happen 10-20 years later.”

Thus, it will be difficult to show that cryoablation is superior to surgery, she said.

“You can show that cryoablation is not inferior to lumpectomy alone – which allows patients to avoid the operating room,” Dr. Attai summarized.
 

The surgical mindset and breast cancer

Dr. Attai, who was not involved in the current trial, was an investigator in an earlier single-arm cooperative group study of cryoablation for breast cancer, which had the rate of complete tumor ablation as the primary outcome. The study, known as the American College of Surgeons Oncology Group Z1072 trial, enrolled 99 patients, all of whom underwent ablation followed by surgery. The study reported results in 2014 but was very slow to develop, she observed.

“I did my first training in 2004 and I don’t think the study opened for several years after that. I think there’s been a lot of hesitation to change the mindset that every cancer needs to be removed surgically,” Dr. Attai stated.

“When you put breast cancer in the context of the other organs, we are lagging behind a bit [with cryoablation],” she added.

“I don’t want to go there but … the innovation for male diseases and procedures sometimes surpasses that of women’s diseases,” she said.

But she also defended her fellow practitioners. “There’s been tremendous changes in management over the 27 years I’ve been in practice,” she said, citing the movement from mastectomy to lumpectomy as one of multiple big changes.

The disparity between the development of cryoablation for breast and prostate cancer is a mystery when you contemplate the potential side effects, Dr. Fine observed. “There’s not a lot of vital structures inside the breast, so you don’t have risks that you have with the prostate, including urinary incontinence and impotence.”

As a next move, the American Society of Breast Surgeons is planning to establish a cryoablation registry and aims to enroll 50 sites and 500 patients who are aged 55-85 years; for those aged 65-70, radiation therapy will be required, said Dr. Fine.

Currently, cryoablation for breast cancer is allowed only in a clinical trial, so a registry would expand usage considerably, he said.

However, cryoablation, including from IceCure, has FDA clearance for ablating cancerous tissue in general (but not breast cancer specifically).  

Dr. Attai hopes the field is ready for the nonsurgical approach.

“Halsted died in 1922 and the Halsted radical mastectomy really didn’t start to fall out of favor until the 1950s, 1960,” said Dr. Attai, referring to Dr William Halsted, who pioneered the procedure in the 1890s. “I would hope we are better at speeding up our progress. Changing the surgical mindset takes time,” she said.

Dr. Fine was an investigator in the ICE3 trial, which is funded by IceCure Medical. Dr. Attai has disclosed no relevant financial relationships.

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

In the United States, cryoablation or freezing tissue to death is a primary treatment option for a variety of cancers, including those originating in or spread to the bone, cervix, eye, kidney, liver, lung, pancreas, prostate, and skin.

Cryoablation for prostate cancer, one of the most common cancers in men, was first approved in the 1990s.

But unlike in Europe, this nonsurgical approach is not approved for breast cancer in the United States; it is one of the most common cancers in women.

So why is this approach still experimental for breast cancer?

“I don’t know,” answered cryoablation researcher Richard Fine, MD, of West Cancer Center in Germantown, Tenn., when asked by this news organization.

“It’s very interesting how slow the [Food and Drug Administration] is in approving devices for breast cancer [when compared with] other cancers,” he said.
 

New clinical data

Perhaps new clinical data will eventually lead to approval of this nonsurgical technique for use in low-risk breast cancer. However, the related trial had a controversial design that might discourage uptake by practitioners if it is approved, said an expert not involved in the study.

Nevertheless, the new data show that cryoablation can be an effective treatment for small, low-risk, early-stage breast cancers in older patients.

The findings come from ICE-3, a multicenter single-arm study of cryoablation in 194 such patients with mean follow-up of roughly 3 years.

It used liquid nitrogen-based cryoablation technology from IceCure Medical Ltd., an Israeli company and the study sponsor.

The results show that 2.06% (n = 4) of patients had a recurrence in the same breast, which is “basically the same” as lumpectomy, the surgical standard for this patient group, said Dr. Fine, the lead investigator on the trial.

These are interim data, Dr. Fine said at the American Society of Breast Surgeons annual meeting, held virtually.

The primary outcome is the 5-year recurrence rate, and this is the first-ever cryoablation trial that does not involve follow-up surgery, he said.

Cryoablation, which delivers a gas to a tumor via a thin needle-like probe that is guided by ultrasound, has multiple advantages over surgery, Dr. Fine said.

“The noninvasive procedure is fast, painless, and can be delivered under local anesthesia in a doctor’s office. Recovery time is minimal and cosmetic outcomes are excellent with little loss of breast tissue and no scarring,” he said in a meeting press statement.

The potential market for cryoablation in breast cancer is large, as it is intended for tumors ≤1.5 cm, which comprise approximately 60%-70% of stage 1 breast cancers that are hormone receptor–positive (HR+), and HER2-negative (HER2–), Dr. Fine said in an interview.

Cryoablation is part of a logical, de-escalation of breast cancer care, he added. “We have moved from radical mastectomy to modified mastectomy to lumpectomy – so the next step in that evolution is ablative technology, which is ‘nonsurgical.’ ”

There are other experimental ablative treatments for breast cancer including high-frequency ultrasound and laser, but cryoablation is the furthest along in development.

Cryoablation as a primary cancer treatment was first approved for coverage by the Centers for Medicare & Medicaid Services for localized prostate cancer in 1999.

But the concept extends back to 1845, when English physician James Arnott first used iced salt solutions (about –20 °C or – 4 °F) to induce tissue necrosis, reducing tumor size and ameliorating pain. Because the crude cryogen needed to be applied topically, the pioneering technique was limited to breast and cervical cancers because of their accessibility.
 

Not likely to show superiority

The new study’s population was composed of women aged 60 years or older (mean of 75 years) with unifocal invasive ductal cancers measuring ≤1.5 cm or less that were all low-grade, HR+, and HER2–, as noted.

The liquid nitrogen–based cryoablation consisted of a freeze-thaw-freeze cycle that totals 20-40 minutes, with freezing temperatures targeting the tumor area and turning it into an “ice ball.”

That ice ball eventually surrounds the tumor, creating a “lethal zone,” and thus a margin in which no cancer exists, akin to surgery, said Dr. Fine.

There were no significant device-related adverse events or complications reported, say the investigators. Most of the adverse events were minor and included bruising, localized edema, minor skin freeze burn, rash, minor bleeding from needle insertion, minor local hematoma, skin induration, minor infection, and pruritis.

Two of 15 patients who underwent sentinel lymph node biopsies had a positive sentinel node. At the discretion of their treating physician, 27 patients underwent adjuvant radiation, 1 patient received chemotherapy, and 148 began endocrine therapy. More than 95% of the patients and 98% of physicians reported satisfaction from the cosmetic results during follow-up visits.

Because not all patients underwent sentinel lymph node biopsy and adjuvant radiation, there is likely to be controversy about this approach, suggested Deanna J. Attai, MD, a breast surgeon at the University of California, Los Angeles, and past president of the American Society of Breast Surgeons, who was asked for comment.

“We have studies that [indicate that] these treatments don’t add significant benefit [in this patient population] but there still is this hesitation [to forgo them],” she told this news organization.

“The patients in this study were exceedingly low risk,” she emphasized.

“Is 5 years enough to assess recurrence rates? The answer is probably no. Recurrences or distant metastases are more likely to happen 10-20 years later.”

Thus, it will be difficult to show that cryoablation is superior to surgery, she said.

“You can show that cryoablation is not inferior to lumpectomy alone – which allows patients to avoid the operating room,” Dr. Attai summarized.
 

The surgical mindset and breast cancer

Dr. Attai, who was not involved in the current trial, was an investigator in an earlier single-arm cooperative group study of cryoablation for breast cancer, which had the rate of complete tumor ablation as the primary outcome. The study, known as the American College of Surgeons Oncology Group Z1072 trial, enrolled 99 patients, all of whom underwent ablation followed by surgery. The study reported results in 2014 but was very slow to develop, she observed.

“I did my first training in 2004 and I don’t think the study opened for several years after that. I think there’s been a lot of hesitation to change the mindset that every cancer needs to be removed surgically,” Dr. Attai stated.

“When you put breast cancer in the context of the other organs, we are lagging behind a bit [with cryoablation],” she added.

“I don’t want to go there but … the innovation for male diseases and procedures sometimes surpasses that of women’s diseases,” she said.

But she also defended her fellow practitioners. “There’s been tremendous changes in management over the 27 years I’ve been in practice,” she said, citing the movement from mastectomy to lumpectomy as one of multiple big changes.

The disparity between the development of cryoablation for breast and prostate cancer is a mystery when you contemplate the potential side effects, Dr. Fine observed. “There’s not a lot of vital structures inside the breast, so you don’t have risks that you have with the prostate, including urinary incontinence and impotence.”

As a next move, the American Society of Breast Surgeons is planning to establish a cryoablation registry and aims to enroll 50 sites and 500 patients who are aged 55-85 years; for those aged 65-70, radiation therapy will be required, said Dr. Fine.

Currently, cryoablation for breast cancer is allowed only in a clinical trial, so a registry would expand usage considerably, he said.

However, cryoablation, including from IceCure, has FDA clearance for ablating cancerous tissue in general (but not breast cancer specifically).  

Dr. Attai hopes the field is ready for the nonsurgical approach.

“Halsted died in 1922 and the Halsted radical mastectomy really didn’t start to fall out of favor until the 1950s, 1960,” said Dr. Attai, referring to Dr William Halsted, who pioneered the procedure in the 1890s. “I would hope we are better at speeding up our progress. Changing the surgical mindset takes time,” she said.

Dr. Fine was an investigator in the ICE3 trial, which is funded by IceCure Medical. Dr. Attai has disclosed no relevant financial relationships.

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

In the United States, cryoablation or freezing tissue to death is a primary treatment option for a variety of cancers, including those originating in or spread to the bone, cervix, eye, kidney, liver, lung, pancreas, prostate, and skin.

Cryoablation for prostate cancer, one of the most common cancers in men, was first approved in the 1990s.

But unlike in Europe, this nonsurgical approach is not approved for breast cancer in the United States; it is one of the most common cancers in women.

So why is this approach still experimental for breast cancer?

“I don’t know,” answered cryoablation researcher Richard Fine, MD, of West Cancer Center in Germantown, Tenn., when asked by this news organization.

“It’s very interesting how slow the [Food and Drug Administration] is in approving devices for breast cancer [when compared with] other cancers,” he said.
 

New clinical data

Perhaps new clinical data will eventually lead to approval of this nonsurgical technique for use in low-risk breast cancer. However, the related trial had a controversial design that might discourage uptake by practitioners if it is approved, said an expert not involved in the study.

Nevertheless, the new data show that cryoablation can be an effective treatment for small, low-risk, early-stage breast cancers in older patients.

The findings come from ICE-3, a multicenter single-arm study of cryoablation in 194 such patients with mean follow-up of roughly 3 years.

It used liquid nitrogen-based cryoablation technology from IceCure Medical Ltd., an Israeli company and the study sponsor.

The results show that 2.06% (n = 4) of patients had a recurrence in the same breast, which is “basically the same” as lumpectomy, the surgical standard for this patient group, said Dr. Fine, the lead investigator on the trial.

These are interim data, Dr. Fine said at the American Society of Breast Surgeons annual meeting, held virtually.

The primary outcome is the 5-year recurrence rate, and this is the first-ever cryoablation trial that does not involve follow-up surgery, he said.

Cryoablation, which delivers a gas to a tumor via a thin needle-like probe that is guided by ultrasound, has multiple advantages over surgery, Dr. Fine said.

“The noninvasive procedure is fast, painless, and can be delivered under local anesthesia in a doctor’s office. Recovery time is minimal and cosmetic outcomes are excellent with little loss of breast tissue and no scarring,” he said in a meeting press statement.

The potential market for cryoablation in breast cancer is large, as it is intended for tumors ≤1.5 cm, which comprise approximately 60%-70% of stage 1 breast cancers that are hormone receptor–positive (HR+), and HER2-negative (HER2–), Dr. Fine said in an interview.

Cryoablation is part of a logical, de-escalation of breast cancer care, he added. “We have moved from radical mastectomy to modified mastectomy to lumpectomy – so the next step in that evolution is ablative technology, which is ‘nonsurgical.’ ”

There are other experimental ablative treatments for breast cancer including high-frequency ultrasound and laser, but cryoablation is the furthest along in development.

Cryoablation as a primary cancer treatment was first approved for coverage by the Centers for Medicare & Medicaid Services for localized prostate cancer in 1999.

But the concept extends back to 1845, when English physician James Arnott first used iced salt solutions (about –20 °C or – 4 °F) to induce tissue necrosis, reducing tumor size and ameliorating pain. Because the crude cryogen needed to be applied topically, the pioneering technique was limited to breast and cervical cancers because of their accessibility.
 

Not likely to show superiority

The new study’s population was composed of women aged 60 years or older (mean of 75 years) with unifocal invasive ductal cancers measuring ≤1.5 cm or less that were all low-grade, HR+, and HER2–, as noted.

The liquid nitrogen–based cryoablation consisted of a freeze-thaw-freeze cycle that totals 20-40 minutes, with freezing temperatures targeting the tumor area and turning it into an “ice ball.”

That ice ball eventually surrounds the tumor, creating a “lethal zone,” and thus a margin in which no cancer exists, akin to surgery, said Dr. Fine.

There were no significant device-related adverse events or complications reported, say the investigators. Most of the adverse events were minor and included bruising, localized edema, minor skin freeze burn, rash, minor bleeding from needle insertion, minor local hematoma, skin induration, minor infection, and pruritis.

Two of 15 patients who underwent sentinel lymph node biopsies had a positive sentinel node. At the discretion of their treating physician, 27 patients underwent adjuvant radiation, 1 patient received chemotherapy, and 148 began endocrine therapy. More than 95% of the patients and 98% of physicians reported satisfaction from the cosmetic results during follow-up visits.

Because not all patients underwent sentinel lymph node biopsy and adjuvant radiation, there is likely to be controversy about this approach, suggested Deanna J. Attai, MD, a breast surgeon at the University of California, Los Angeles, and past president of the American Society of Breast Surgeons, who was asked for comment.

“We have studies that [indicate that] these treatments don’t add significant benefit [in this patient population] but there still is this hesitation [to forgo them],” she told this news organization.

“The patients in this study were exceedingly low risk,” she emphasized.

“Is 5 years enough to assess recurrence rates? The answer is probably no. Recurrences or distant metastases are more likely to happen 10-20 years later.”

Thus, it will be difficult to show that cryoablation is superior to surgery, she said.

“You can show that cryoablation is not inferior to lumpectomy alone – which allows patients to avoid the operating room,” Dr. Attai summarized.
 

The surgical mindset and breast cancer

Dr. Attai, who was not involved in the current trial, was an investigator in an earlier single-arm cooperative group study of cryoablation for breast cancer, which had the rate of complete tumor ablation as the primary outcome. The study, known as the American College of Surgeons Oncology Group Z1072 trial, enrolled 99 patients, all of whom underwent ablation followed by surgery. The study reported results in 2014 but was very slow to develop, she observed.

“I did my first training in 2004 and I don’t think the study opened for several years after that. I think there’s been a lot of hesitation to change the mindset that every cancer needs to be removed surgically,” Dr. Attai stated.

“When you put breast cancer in the context of the other organs, we are lagging behind a bit [with cryoablation],” she added.

“I don’t want to go there but … the innovation for male diseases and procedures sometimes surpasses that of women’s diseases,” she said.

But she also defended her fellow practitioners. “There’s been tremendous changes in management over the 27 years I’ve been in practice,” she said, citing the movement from mastectomy to lumpectomy as one of multiple big changes.

The disparity between the development of cryoablation for breast and prostate cancer is a mystery when you contemplate the potential side effects, Dr. Fine observed. “There’s not a lot of vital structures inside the breast, so you don’t have risks that you have with the prostate, including urinary incontinence and impotence.”

As a next move, the American Society of Breast Surgeons is planning to establish a cryoablation registry and aims to enroll 50 sites and 500 patients who are aged 55-85 years; for those aged 65-70, radiation therapy will be required, said Dr. Fine.

Currently, cryoablation for breast cancer is allowed only in a clinical trial, so a registry would expand usage considerably, he said.

However, cryoablation, including from IceCure, has FDA clearance for ablating cancerous tissue in general (but not breast cancer specifically).  

Dr. Attai hopes the field is ready for the nonsurgical approach.

“Halsted died in 1922 and the Halsted radical mastectomy really didn’t start to fall out of favor until the 1950s, 1960,” said Dr. Attai, referring to Dr William Halsted, who pioneered the procedure in the 1890s. “I would hope we are better at speeding up our progress. Changing the surgical mindset takes time,” she said.

Dr. Fine was an investigator in the ICE3 trial, which is funded by IceCure Medical. Dr. Attai has disclosed no relevant financial relationships.

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

For physicians who are just starting out or thinking about moving, the “Land of 10,000 Lakes” could be the land of opportunity, according to a recent Medscape analysis.

In a ranking of the 50 states, Minnesota “claimed top marks for livability, low incidence of adverse actions against doctors, and the performance of its health system,” Shelly Reese wrote in Medscape’s “Best & Worst Places to Practice 2021.”

Minnesota is below average where it’s good to be below average – share of physicians reporting burnout and/or depression – but above average in the share of physicians who say they’re “very happy” outside of work, Medscape said in the annual report.

Second on this year’s list is Wisconsin, which benefits from low levels of malpractice payouts and adverse actions and a high level of livability. Third place went to Washington (called the most livable state in the country by U.S. News and World Report), fourth to Colorado (physicians happy at and outside of work, high retention rate for residents), and fifth to Utah (low crime rate, high quality of life), Medscape said.

At the bottom of the list for 2021 is West Virginia, where physicians “may confront a bevy of challenges” in the form of low livability, a high rate of adverse actions, and relatively high malpractice payouts, Ms. Reese noted in the report.

State number 49 is Louisiana, where livability is low, malpractice payouts are high, and more than half of physicians say that they’re burned out and/or depressed. New Mexico is 48th (very high rate of adverse actions, poor resident retention), Nevada is 47th (low marks for avoidable hospital use and disparity in care), and Rhode Island is 46th (high malpractice payouts, low physician compensation), Medscape said.

Continuing with the group-of-five theme, America’s three most populous states finished in the top half of the ranking – California 16th, Texas 11th, and Florida 21st – but New York and Pennsylvania, numbers four and five by population size, did not.

The rankings are based on states’ performance in 10 different measures, three of which were sourced from Medscape surveys – happiness at work, happiness outside of work, and burnout/depression – and seven from other organizations: adverse actions against physicians, malpractice payouts, compensation (adjusted for cost of living), overall health, health system performance, overall livability, resident retention.
 

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For physicians who are just starting out or thinking about moving, the “Land of 10,000 Lakes” could be the land of opportunity, according to a recent Medscape analysis.

In a ranking of the 50 states, Minnesota “claimed top marks for livability, low incidence of adverse actions against doctors, and the performance of its health system,” Shelly Reese wrote in Medscape’s “Best & Worst Places to Practice 2021.”

Minnesota is below average where it’s good to be below average – share of physicians reporting burnout and/or depression – but above average in the share of physicians who say they’re “very happy” outside of work, Medscape said in the annual report.

Second on this year’s list is Wisconsin, which benefits from low levels of malpractice payouts and adverse actions and a high level of livability. Third place went to Washington (called the most livable state in the country by U.S. News and World Report), fourth to Colorado (physicians happy at and outside of work, high retention rate for residents), and fifth to Utah (low crime rate, high quality of life), Medscape said.

At the bottom of the list for 2021 is West Virginia, where physicians “may confront a bevy of challenges” in the form of low livability, a high rate of adverse actions, and relatively high malpractice payouts, Ms. Reese noted in the report.

State number 49 is Louisiana, where livability is low, malpractice payouts are high, and more than half of physicians say that they’re burned out and/or depressed. New Mexico is 48th (very high rate of adverse actions, poor resident retention), Nevada is 47th (low marks for avoidable hospital use and disparity in care), and Rhode Island is 46th (high malpractice payouts, low physician compensation), Medscape said.

Continuing with the group-of-five theme, America’s three most populous states finished in the top half of the ranking – California 16th, Texas 11th, and Florida 21st – but New York and Pennsylvania, numbers four and five by population size, did not.

The rankings are based on states’ performance in 10 different measures, three of which were sourced from Medscape surveys – happiness at work, happiness outside of work, and burnout/depression – and seven from other organizations: adverse actions against physicians, malpractice payouts, compensation (adjusted for cost of living), overall health, health system performance, overall livability, resident retention.
 

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For physicians who are just starting out or thinking about moving, the “Land of 10,000 Lakes” could be the land of opportunity, according to a recent Medscape analysis.

In a ranking of the 50 states, Minnesota “claimed top marks for livability, low incidence of adverse actions against doctors, and the performance of its health system,” Shelly Reese wrote in Medscape’s “Best & Worst Places to Practice 2021.”

Minnesota is below average where it’s good to be below average – share of physicians reporting burnout and/or depression – but above average in the share of physicians who say they’re “very happy” outside of work, Medscape said in the annual report.

Second on this year’s list is Wisconsin, which benefits from low levels of malpractice payouts and adverse actions and a high level of livability. Third place went to Washington (called the most livable state in the country by U.S. News and World Report), fourth to Colorado (physicians happy at and outside of work, high retention rate for residents), and fifth to Utah (low crime rate, high quality of life), Medscape said.

At the bottom of the list for 2021 is West Virginia, where physicians “may confront a bevy of challenges” in the form of low livability, a high rate of adverse actions, and relatively high malpractice payouts, Ms. Reese noted in the report.

State number 49 is Louisiana, where livability is low, malpractice payouts are high, and more than half of physicians say that they’re burned out and/or depressed. New Mexico is 48th (very high rate of adverse actions, poor resident retention), Nevada is 47th (low marks for avoidable hospital use and disparity in care), and Rhode Island is 46th (high malpractice payouts, low physician compensation), Medscape said.

Continuing with the group-of-five theme, America’s three most populous states finished in the top half of the ranking – California 16th, Texas 11th, and Florida 21st – but New York and Pennsylvania, numbers four and five by population size, did not.

The rankings are based on states’ performance in 10 different measures, three of which were sourced from Medscape surveys – happiness at work, happiness outside of work, and burnout/depression – and seven from other organizations: adverse actions against physicians, malpractice payouts, compensation (adjusted for cost of living), overall health, health system performance, overall livability, resident retention.
 

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It may not be always necessary to approach the treatment of HER2-positive, hormone receptor–negative (HER2+/HR–) early breast cancer with added chemotherapy, survival results of a prospective multicenter randomized trial suggest.

In the ADAPT-HER2+/HR– trial, comparing a de-escalated 12-week neoadjuvant regimen consisting of dual HER2 blockade with trastuzumab (Herceptin) and pertuzumab (Perjeta) with or without weekly paclitaxel, the three-drug regimen was associated with high pathologic complete response(pCR) rates and excellent 5-year survival, irrespective of whether patients received additional chemotherapy, reported Nadia Harbeck, MD, PhD, of the University of Munich.

“Chemotherapy-free regimens are promising in highly sensitive tumors with early response, but future investigation of such chemotherapy-free regimens need to be focused on selected patients, like those with HER2 3+ tumors, non–basal-like tumors, those showing early response to the de-escalated therapy, and those with predictive RNA signatures such as immune signatures,” she said in an oral abstract session during the American Society of Clinical Oncology annual meeting (Abstract 503).
 

Under the WGS umbrella

The ADAPT HER2+/HR– trial (NCT01779206) is one of several conducted by the West German Study Group (WGS) on therapy for intrinsic breast cancer types.

In this study, 134 patients with HER2-positive, estrogen and progesterone receptor–negative tumors with no metastatic disease and good performance status were assigned on a 5:2 basis to neoadjuvant therapy with trastuzumab at a loading dose of 8 mg/kg for the first cycle followed by 6 mg/kg for subsequent cycles every 3 weeks x 4, plus pertuzumab at a loading dose of 840 mg followed by 420 mg every 3 weeks x 4 (92 patients), or to trastuzumab and pertuzumab at the same dose and schedule plus paclitaxel 80 mg/m² once weekly for 12 weeks.

Patients had surgery within 3 weeks of the end of study therapy unless they did not have a histologically confirmed pCR, in which case they went on to receive standard neoadjuvant therapy prior to surgery.

Adjuvant therapy was performed according to national guidelines, although patients with a pCR after 12 weeks of study therapy could be spared from adjuvant chemotherapy at the investigator’s discretion.

Patients underwent biopsy at 3 weeks for therapy for early response assessment, defined as either a Ki67 decrease of at least 30% from baseline, or low cellularity (less than 500 invasive tumor cells).
 

First survival results

The investigators previously reported the primary pCR endpoint from the trial, which showed a rate of 90% after 12 weeks in the three-drug arm, and a “substantial and clinically meaningful” pCR rate of 34% after the trastuzumab plus pertuzumab alone.

At ASCO 2021, Dr. Harbeck reported the first survival data from the trial.

After a median follow-up of 59.9 months, there were no statistically significant differences between trial arms in either overall survival, invasive disease-free survival (iDFS), or distant disease-free survival (dDFS).

The 5-year iDFS rate in the three-drug arm was 98%, compared with 87% for the dual HER2 blockade-only arm, a difference that was not statistically significant.

The 5-year dDFS rates were 98% and 92% respectively. There were only seven dDFS events during follow-up, Dr. Harbeck noted.

There were only six deaths during follow-up, with overall survival rates of 98% in the paclitaxel-containing arm, and 94% in the anti-HER2 antibodies–only arm, a difference of one overall survival event, Dr. Harbeck said.
 

pCR counts

However, patients who did not have pathologic complete responses at the end of first-line de-escalated therapy had worse outcomes, with a 5-year iDFS rate of 82%, compared with 98% for patients who had achieved a pCR. This translated into a hazard ratio for invasive disease in patients with pCRs of 0.14 (P = .011).

This difference occurred despite the study requirement that all patients who did not have pCR after 12 weeks of initial therapy would receive additional chemotherapy.

Looking at the tumor subtype among patients in the paclitaxel-free arm to see whether they could identify predictors of early response, the researchers found a pCR rate of 36.5% among 85 patients with nonbasal tumors, but 0% among 7 patients with basal tumors.

The investigators identified a population of patients whose tumors could be considered nonsensitive to dual HER2 blockade alone: Those with basal tumors, those tumors with low immunohistochemical HER2 expression, and those without an early response to therapy on biopsy 3 weeks into initial therapy. Among 31 of the 92 patients in the dual HER2 arm who met this description, 2 had pCRs, Dr. Harbeck noted.

The 5-year iDFS rate among patients in the dual blockade–only arm with nonsensitive tumors was 79%, compared with 93% for patients with treatment-responsive types, although there were only 13 invasive events total in this arm.

“If we look at the whole trial population, the negative prognostic impact of what we termed nonsensitive tumors was even significant regarding dDFS, with a hazard ratio of about 5,” she said.
 

‘A consistent theme’

Invited discussant Lisa A. Carey, MD, ScM, of the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, noted that the trial was underpowered for outcomes, but that results nonetheless suggest that patients with strongly HER2-driven tumors might get comparable benefits from less chemotherapy.

“This trial included only hormone receptor–negative, HER2-positive tumors, and these we know are likely to be HER2-enriched in terms of subtype, about three-quarters of them,”she said.

The previously reported pCR rate of 90% in the paclitaxel-containing arm, with 80% of patients requiring no further chemotherapy, resulted in the excellent 5-year iDFS and dDFS in this group, despite the relatively highly clinical stage, with about 60% of patients having clinical stage 2 or higher tumors, and more than 40% being node positive.

The idea that pCR itself can predict which patients could be spared from more intensive chemotherapy “is starting to look like a consistent theme,” she said.

Dr. Carey pointed out that in the KRISTINE trial comparing the combination of trastuzumab emtansine (T-DM1) and pertuzumab with standard chemotherapy in patients with HER2-positive stage I-III breast cancer, although the experimental combination was associated with lower pCR rates and worse event-free survival, rates of iDFS/dDFS were virtually identical for patients in both arms who achieved a pCR.

“So the question is can pCR mean that we can either eliminate additional therapy,” she said, noting that the question is currently being addressed prospectively in two clinical trials, COMPASS-pCR and DECRESCENDO.

ADAPT HER2+/HR- is sponsored by F. Hoffman-La Roche. Dr. Harbeck disclosed institutional research funding from Roche/Genentech, as well as honoraria and consulting/advising for multiple companies. Dr. Carey disclosed institutional research funding and other relationships with various companies.