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Fed Pract
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gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
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Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
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pedophilia
poker
porn
pornography
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recreational drug
sex slave rings
slot machine
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Texas hold 'em
UFC
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bunges
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butt
butt fuck
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buttfucked
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cock sucker
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What’s the best age to stop smoking? Study offers clue

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Smokers who quit before age 35 showed a "substantial" reduction in risk, compared with people who never smoked, according to a new national study.

Researchers also quantified the benefit of quitting for those older than 35. The added risk of death associated with smoking was reduced by 90% for those who quit before age 45 and 66% for those who quit at ages 45 to 64.

“The distal nature of the health consequences for young smokers is a challenge for professionals trying to motivate quitting in younger age groups. Without a proximal goal, it is tempting for smokers to abandon a quit attempt with cognitions such as ‘I don’t really need to do it just now,’ ” John P. Pierce, PhD, director for Population Sciences at UC-San Diego’s Moores Cancer Center, wrote in a commentary. 

Current smokers were twice as likely to die from any cause during the study, compared with the group researchers called “never smokers,” who were defined as smoking fewer than 100 lifetime cigarettes. 

Published in JAMA Network Open, the study involved 551,388 U.S. participants using information collected by the CDC from 1997 to 2018. Researchers collected data for specific causes of death of participants through the end of 2019.

The results echo past findings but also established whether demographic factors such as a smoker’s race and gender impact the benefits of quitting. (In many areas of health research, a person’s race or gender is associated with varying risks.)

The researchers found that the benefits of quitting smoking in reducing risk of death are comparable across demographic groups.

“Among former smokers in each racial and ethnic group, whether male or female, quitting was associated with reductions of approximately 80% of the excess mortality associated with continued smoking,” the authors stated. “These associations were generally consistent for deaths from cancer, cardiovascular disease, and lower respiratory disease.”

The findings are also important for guiding stop-smoking efforts because while smoking nationwide has decreased, the reduction has varied across demographic groups.

“Monitoring the association of smoking with mortality by race, ethnicity, and sex is critical to understanding how the U.S. tobacco epidemic continues to evolve over time and who is most affected by the changes,” the authors stated. “Despite continued decreases in U.S. smoking prevalence in recent decades, progress has not been equal across demographic groups. Recent progress in raising the quit ratio among U.S. ever-smokers overall has been modest, and the quit ratio has been consistently lower among Black and Hispanic ever-smokers than among non-Hispanic White ever-smokers.”

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

This article was updated 10/27/22.

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Smokers who quit before age 35 showed a "substantial" reduction in risk, compared with people who never smoked, according to a new national study.

Researchers also quantified the benefit of quitting for those older than 35. The added risk of death associated with smoking was reduced by 90% for those who quit before age 45 and 66% for those who quit at ages 45 to 64.

“The distal nature of the health consequences for young smokers is a challenge for professionals trying to motivate quitting in younger age groups. Without a proximal goal, it is tempting for smokers to abandon a quit attempt with cognitions such as ‘I don’t really need to do it just now,’ ” John P. Pierce, PhD, director for Population Sciences at UC-San Diego’s Moores Cancer Center, wrote in a commentary. 

Current smokers were twice as likely to die from any cause during the study, compared with the group researchers called “never smokers,” who were defined as smoking fewer than 100 lifetime cigarettes. 

Published in JAMA Network Open, the study involved 551,388 U.S. participants using information collected by the CDC from 1997 to 2018. Researchers collected data for specific causes of death of participants through the end of 2019.

The results echo past findings but also established whether demographic factors such as a smoker’s race and gender impact the benefits of quitting. (In many areas of health research, a person’s race or gender is associated with varying risks.)

The researchers found that the benefits of quitting smoking in reducing risk of death are comparable across demographic groups.

“Among former smokers in each racial and ethnic group, whether male or female, quitting was associated with reductions of approximately 80% of the excess mortality associated with continued smoking,” the authors stated. “These associations were generally consistent for deaths from cancer, cardiovascular disease, and lower respiratory disease.”

The findings are also important for guiding stop-smoking efforts because while smoking nationwide has decreased, the reduction has varied across demographic groups.

“Monitoring the association of smoking with mortality by race, ethnicity, and sex is critical to understanding how the U.S. tobacco epidemic continues to evolve over time and who is most affected by the changes,” the authors stated. “Despite continued decreases in U.S. smoking prevalence in recent decades, progress has not been equal across demographic groups. Recent progress in raising the quit ratio among U.S. ever-smokers overall has been modest, and the quit ratio has been consistently lower among Black and Hispanic ever-smokers than among non-Hispanic White ever-smokers.”

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

This article was updated 10/27/22.

Smokers who quit before age 35 showed a "substantial" reduction in risk, compared with people who never smoked, according to a new national study.

Researchers also quantified the benefit of quitting for those older than 35. The added risk of death associated with smoking was reduced by 90% for those who quit before age 45 and 66% for those who quit at ages 45 to 64.

“The distal nature of the health consequences for young smokers is a challenge for professionals trying to motivate quitting in younger age groups. Without a proximal goal, it is tempting for smokers to abandon a quit attempt with cognitions such as ‘I don’t really need to do it just now,’ ” John P. Pierce, PhD, director for Population Sciences at UC-San Diego’s Moores Cancer Center, wrote in a commentary. 

Current smokers were twice as likely to die from any cause during the study, compared with the group researchers called “never smokers,” who were defined as smoking fewer than 100 lifetime cigarettes. 

Published in JAMA Network Open, the study involved 551,388 U.S. participants using information collected by the CDC from 1997 to 2018. Researchers collected data for specific causes of death of participants through the end of 2019.

The results echo past findings but also established whether demographic factors such as a smoker’s race and gender impact the benefits of quitting. (In many areas of health research, a person’s race or gender is associated with varying risks.)

The researchers found that the benefits of quitting smoking in reducing risk of death are comparable across demographic groups.

“Among former smokers in each racial and ethnic group, whether male or female, quitting was associated with reductions of approximately 80% of the excess mortality associated with continued smoking,” the authors stated. “These associations were generally consistent for deaths from cancer, cardiovascular disease, and lower respiratory disease.”

The findings are also important for guiding stop-smoking efforts because while smoking nationwide has decreased, the reduction has varied across demographic groups.

“Monitoring the association of smoking with mortality by race, ethnicity, and sex is critical to understanding how the U.S. tobacco epidemic continues to evolve over time and who is most affected by the changes,” the authors stated. “Despite continued decreases in U.S. smoking prevalence in recent decades, progress has not been equal across demographic groups. Recent progress in raising the quit ratio among U.S. ever-smokers overall has been modest, and the quit ratio has been consistently lower among Black and Hispanic ever-smokers than among non-Hispanic White ever-smokers.”

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

This article was updated 10/27/22.

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$38,398 for a single shot of a very old cancer drug

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Josie Tenore, MD, and Paul Hinds were introduced by a mutual friend in 2017 and hadn’t been going out long when she laid down the law: He had to get a physical.

“I don’t date people who don’t take care of their health,” said Dr. Tenore, who practices cosmetic dermatology and functional medicine in suburban Chicago.

One of Mr. Hinds’ blood tests that summer came back with an alarming result: His prostate-specific antigen (PSA), level was very high. A biopsy confirmed he had advanced prostate cancer.

There aren’t a lot of comfortable alternatives for treating prostate cancer, which generally progresses as long as testosterone levels remain high. Marijuana appears to lower testosterone levels, so after his diagnosis, he dosed a liquid form of cannabis for several weeks. That cut his PSA in half, but Mr. Hinds, a cybersecurity expert who likes yoga and bicycling, “was stoned out of his mind and couldn’t function,” Dr. Tenore recalled.

With Dr. Tenore guiding his decisions, Mr. Hinds next tried high-frequency ultrasound treatment, but it failed. And in the summer of 2019 doctors removed his prostate gland. Still, the PSA levels climbed again, and doctors assessed that the cancer had metastasized. The only alternative was to drastically lower Mr. Hinds’ testosterone levels – either via surgery or drugs that block all testosterone. In May 2021, he got his first intramuscular shot of Lupron Depot, a brand name for leuprolide, designed to suppress the prostate gland’s release of the hormone for 3 months. That August, he got his second shot.

And then the bills came.

The patient: Paul Hinds, now 60, is covered by United Healthcare through a COBRA plan from his former employer.

Medical service: Two 3-month Lupron Depot injections for metastatic prostate cancer.

Service provider: University of Chicago Medicine, a 900-physician nonprofit system that includes an 811-bed medical center, a suburban hospital, the Pritzker School of Medicine, and outpatient clinics and physician offices throughout the Chicago area.

Total bill: $73,812 for the two shots ($35,414 for the first, $38,398 for the second), including lab work and physician charges. United Healthcare’s negotiated rate for the two shots plus associated fees was $27,568, of which the insurer paid $19,567. After Mr. Hinds haggled with the hospital and insurer for more than a year, his share of the bills was determined to be nearly $7,000.

What gives: The first issue is unrelenting price increases on old drugs that have remained branded as manufacturers find ways to extend patents for decades and maintain sales through marketing.

Though Lupron was invented in 1973, its manufacturer got patent extensions in 1989 by offering a slow-release version. Drugmakers commonly use this tactic to extend their exclusive rights to sell a product.

The development of Lupron Depot as an intramuscular shot that suppressed testosterone for months at a time improved patient compliance and also enabled its maker, Abbott Laboratories, and its Japanese partner, Takeda, to extend their patents on the drug into the 2000s, said Gerald Weisberg, MD, a former Abbott scientist who has been critical of the company’s pricing policies.

In subsequent years, Abbott and Takeda, in a joint venture called TAP Pharmaceuticals, steadily marked up the price of their slow-release product. In 2000, the average wholesale U.S. price for a 3-month shot was $1,245; currently that figure is $5,866. (It is manufactured in the United States by AbbVie now.)

In the United Kingdom, where health care is generally free and Takeda sells the drug under the name Prostap, all physicians can purchase a 3-month dose for about $260.

It’s likely that Chicago Medicine, where Mr. Hinds got his shots, paid something close to the British price. That’s because the health system’s hospital on Chicago’s South Side participates in a federal program called 340B, which allows hospitals that serve low-income populations to purchase drugs at deep discounts.

Lupron Depot is given as a simple injection into the muscle. It takes minutes for a nurse or doctor to administer. Yet hospital systems like Chicago Medicine can and typically do charge lavishly for such services, to enhance revenue, said Morgan Henderson, principal data scientist at the Hilltop Institute at the University of Maryland-Baltimore County. Chicago Medicine declined to say what it paid for the drug.

While U.S. drugmakers can price their drugs however they please, TAP has gotten into trouble for its Lupron sales policies in the past. In 2001, after a Justice Department probe, it paid an $875 million settlement for illegally stimulating sales by giving urologists free and discounted vials of the drug while enabling them to charge Medicare full price.

Since then, many other drugs aimed at lowering testosterone levels have entered the market, including a pill, relugolix (Orgovyx). So why wouldn’t a patient use them?

Lupron Depot is long acting, is easy to prepare and store, and employs a small needle, which some patients prefer, said Brian McNeil, MD, chief of urology at University Hospital of Brooklyn. Orgovyx is convenient, but “a patient has to be very compliant. They have to take it every day around the same time,” he said. “Some people just forget.”

But there is another important factor that may well explain Lupron Depot’s ongoing popularity among medical providers: Doctors and hospitals can earn tens of thousands of dollars each visit by marking up its price and administration fees – as they did with Mr. Hinds. If they merely write a prescription for a drug that can be taken at home, they earn nothing.

Asked about this high patient charge and the possibility of using alternatives, United spokesperson Maria Gordon Shydlo said payment was “appropriately based on the hospital’s contract and the member’s benefit plan,” adding that the insurer encourages customers to shop around for the best quality and price.

Resolution: In addition to leaving Mr. Hinds listless, the Lupron Depot shots were, literally, a pain in the rear end. “Each time he was miserable for 2 weeks,” Dr. Tenore said. After looking over his first bill for the Lupron shot, Dr. Tenore told Mr. Hinds he should ask his doctor whether there was a less expensive drug that was easier to take.

After the second shot, in August 2021, a pharmacist told him he could instead receive the pill. His doctor prescribed Mr. Hinds 3 months’ worth of Orgovyx last November, for which he paid $216 and the insurer paid over $6,000. The drug’s list price is about $2,700 a month. There is evidence that Orgovyx works a little better than leuprolide.

Orgovyx was a “no-brainer,” Mr. Hinds said. “Why would you want a sore ass for two weeks when you can take a pill that kicks in sooner, functions the same way, and clears your body of testosterone faster?”

While Orgovyx is increasingly used for prostate cancer, Lupron and other injections usually remain the standard of care, hospital spokesperson Ashley Heher said. Clinicians “work with patients to determine what treatments are the most medically effective and, when necessary, to find reasonable alternatives that may be less financially burdensome due to insurance coverage limitations.”

Mr. Hinds was baffled by the size of the charges. During months of phone calls and emails, the hospital reversed and then reapplied part of the charge, and then in July agreed to a $666.34 monthly payment plan. After Hinds had made two payments, however, the hospital announced Aug. 29 it was canceling the agreement and sending the remainder of his bill to a collection agency. Two weeks later, the hospital reinstated the payment plan – after KHN asked about the cancellation.

As for Mr. Hinds, he remains active, though his bike rides have been shortened from 50 or 60 miles to about 30, he said.

He’s grateful to have Dr. Tenore as a free consultant and empathizes with those who lack a knowledgeable guide through their disease and health care’s financial maze.

“I’ve got Dr. Josie as an advocate who knows the system,” Mr. Hinds said.

The takeaway: First tip: If you are prescribed an infusion or injection, ask your physician if there are cheaper oral medications to treat your condition. Also, many drugs that are given by injection – ones that are given “subcutaneously,” rather than into a muscle – can be administered by a patient at home, avoiding hefty administration fees. Drugs like Dupixent for eczema fall into this category.

Keep in mind that where you get treatment could make a big difference in your charges: A study found that leading U.S. cancer centers charge enormous markups to private insurers for drug injections or infusions. Another study found that hospital systems charge an average of 86% more than private clinics for cancer drug infusions. And the percentage of cancer infusions done in hospital-operated clinics increased from 6% in 2004 to 43% in 2014, and has grown since.

Under a law that took effect in 2021, hospitals are required to list their charges, though they currently do so in a way that is not user friendly. But it’s worth taking a look at the price list – the hospital chargemaster – to try to decipher the pricing and markup for your medicine. If you’re about to get an injection, infusion, or procedure done in a hospital system, ask ahead of time for an estimate of what you will owe.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Josie Tenore, MD, and Paul Hinds were introduced by a mutual friend in 2017 and hadn’t been going out long when she laid down the law: He had to get a physical.

“I don’t date people who don’t take care of their health,” said Dr. Tenore, who practices cosmetic dermatology and functional medicine in suburban Chicago.

One of Mr. Hinds’ blood tests that summer came back with an alarming result: His prostate-specific antigen (PSA), level was very high. A biopsy confirmed he had advanced prostate cancer.

There aren’t a lot of comfortable alternatives for treating prostate cancer, which generally progresses as long as testosterone levels remain high. Marijuana appears to lower testosterone levels, so after his diagnosis, he dosed a liquid form of cannabis for several weeks. That cut his PSA in half, but Mr. Hinds, a cybersecurity expert who likes yoga and bicycling, “was stoned out of his mind and couldn’t function,” Dr. Tenore recalled.

With Dr. Tenore guiding his decisions, Mr. Hinds next tried high-frequency ultrasound treatment, but it failed. And in the summer of 2019 doctors removed his prostate gland. Still, the PSA levels climbed again, and doctors assessed that the cancer had metastasized. The only alternative was to drastically lower Mr. Hinds’ testosterone levels – either via surgery or drugs that block all testosterone. In May 2021, he got his first intramuscular shot of Lupron Depot, a brand name for leuprolide, designed to suppress the prostate gland’s release of the hormone for 3 months. That August, he got his second shot.

And then the bills came.

The patient: Paul Hinds, now 60, is covered by United Healthcare through a COBRA plan from his former employer.

Medical service: Two 3-month Lupron Depot injections for metastatic prostate cancer.

Service provider: University of Chicago Medicine, a 900-physician nonprofit system that includes an 811-bed medical center, a suburban hospital, the Pritzker School of Medicine, and outpatient clinics and physician offices throughout the Chicago area.

Total bill: $73,812 for the two shots ($35,414 for the first, $38,398 for the second), including lab work and physician charges. United Healthcare’s negotiated rate for the two shots plus associated fees was $27,568, of which the insurer paid $19,567. After Mr. Hinds haggled with the hospital and insurer for more than a year, his share of the bills was determined to be nearly $7,000.

What gives: The first issue is unrelenting price increases on old drugs that have remained branded as manufacturers find ways to extend patents for decades and maintain sales through marketing.

Though Lupron was invented in 1973, its manufacturer got patent extensions in 1989 by offering a slow-release version. Drugmakers commonly use this tactic to extend their exclusive rights to sell a product.

The development of Lupron Depot as an intramuscular shot that suppressed testosterone for months at a time improved patient compliance and also enabled its maker, Abbott Laboratories, and its Japanese partner, Takeda, to extend their patents on the drug into the 2000s, said Gerald Weisberg, MD, a former Abbott scientist who has been critical of the company’s pricing policies.

In subsequent years, Abbott and Takeda, in a joint venture called TAP Pharmaceuticals, steadily marked up the price of their slow-release product. In 2000, the average wholesale U.S. price for a 3-month shot was $1,245; currently that figure is $5,866. (It is manufactured in the United States by AbbVie now.)

In the United Kingdom, where health care is generally free and Takeda sells the drug under the name Prostap, all physicians can purchase a 3-month dose for about $260.

It’s likely that Chicago Medicine, where Mr. Hinds got his shots, paid something close to the British price. That’s because the health system’s hospital on Chicago’s South Side participates in a federal program called 340B, which allows hospitals that serve low-income populations to purchase drugs at deep discounts.

Lupron Depot is given as a simple injection into the muscle. It takes minutes for a nurse or doctor to administer. Yet hospital systems like Chicago Medicine can and typically do charge lavishly for such services, to enhance revenue, said Morgan Henderson, principal data scientist at the Hilltop Institute at the University of Maryland-Baltimore County. Chicago Medicine declined to say what it paid for the drug.

While U.S. drugmakers can price their drugs however they please, TAP has gotten into trouble for its Lupron sales policies in the past. In 2001, after a Justice Department probe, it paid an $875 million settlement for illegally stimulating sales by giving urologists free and discounted vials of the drug while enabling them to charge Medicare full price.

Since then, many other drugs aimed at lowering testosterone levels have entered the market, including a pill, relugolix (Orgovyx). So why wouldn’t a patient use them?

Lupron Depot is long acting, is easy to prepare and store, and employs a small needle, which some patients prefer, said Brian McNeil, MD, chief of urology at University Hospital of Brooklyn. Orgovyx is convenient, but “a patient has to be very compliant. They have to take it every day around the same time,” he said. “Some people just forget.”

But there is another important factor that may well explain Lupron Depot’s ongoing popularity among medical providers: Doctors and hospitals can earn tens of thousands of dollars each visit by marking up its price and administration fees – as they did with Mr. Hinds. If they merely write a prescription for a drug that can be taken at home, they earn nothing.

Asked about this high patient charge and the possibility of using alternatives, United spokesperson Maria Gordon Shydlo said payment was “appropriately based on the hospital’s contract and the member’s benefit plan,” adding that the insurer encourages customers to shop around for the best quality and price.

Resolution: In addition to leaving Mr. Hinds listless, the Lupron Depot shots were, literally, a pain in the rear end. “Each time he was miserable for 2 weeks,” Dr. Tenore said. After looking over his first bill for the Lupron shot, Dr. Tenore told Mr. Hinds he should ask his doctor whether there was a less expensive drug that was easier to take.

After the second shot, in August 2021, a pharmacist told him he could instead receive the pill. His doctor prescribed Mr. Hinds 3 months’ worth of Orgovyx last November, for which he paid $216 and the insurer paid over $6,000. The drug’s list price is about $2,700 a month. There is evidence that Orgovyx works a little better than leuprolide.

Orgovyx was a “no-brainer,” Mr. Hinds said. “Why would you want a sore ass for two weeks when you can take a pill that kicks in sooner, functions the same way, and clears your body of testosterone faster?”

While Orgovyx is increasingly used for prostate cancer, Lupron and other injections usually remain the standard of care, hospital spokesperson Ashley Heher said. Clinicians “work with patients to determine what treatments are the most medically effective and, when necessary, to find reasonable alternatives that may be less financially burdensome due to insurance coverage limitations.”

Mr. Hinds was baffled by the size of the charges. During months of phone calls and emails, the hospital reversed and then reapplied part of the charge, and then in July agreed to a $666.34 monthly payment plan. After Hinds had made two payments, however, the hospital announced Aug. 29 it was canceling the agreement and sending the remainder of his bill to a collection agency. Two weeks later, the hospital reinstated the payment plan – after KHN asked about the cancellation.

As for Mr. Hinds, he remains active, though his bike rides have been shortened from 50 or 60 miles to about 30, he said.

He’s grateful to have Dr. Tenore as a free consultant and empathizes with those who lack a knowledgeable guide through their disease and health care’s financial maze.

“I’ve got Dr. Josie as an advocate who knows the system,” Mr. Hinds said.

The takeaway: First tip: If you are prescribed an infusion or injection, ask your physician if there are cheaper oral medications to treat your condition. Also, many drugs that are given by injection – ones that are given “subcutaneously,” rather than into a muscle – can be administered by a patient at home, avoiding hefty administration fees. Drugs like Dupixent for eczema fall into this category.

Keep in mind that where you get treatment could make a big difference in your charges: A study found that leading U.S. cancer centers charge enormous markups to private insurers for drug injections or infusions. Another study found that hospital systems charge an average of 86% more than private clinics for cancer drug infusions. And the percentage of cancer infusions done in hospital-operated clinics increased from 6% in 2004 to 43% in 2014, and has grown since.

Under a law that took effect in 2021, hospitals are required to list their charges, though they currently do so in a way that is not user friendly. But it’s worth taking a look at the price list – the hospital chargemaster – to try to decipher the pricing and markup for your medicine. If you’re about to get an injection, infusion, or procedure done in a hospital system, ask ahead of time for an estimate of what you will owe.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Josie Tenore, MD, and Paul Hinds were introduced by a mutual friend in 2017 and hadn’t been going out long when she laid down the law: He had to get a physical.

“I don’t date people who don’t take care of their health,” said Dr. Tenore, who practices cosmetic dermatology and functional medicine in suburban Chicago.

One of Mr. Hinds’ blood tests that summer came back with an alarming result: His prostate-specific antigen (PSA), level was very high. A biopsy confirmed he had advanced prostate cancer.

There aren’t a lot of comfortable alternatives for treating prostate cancer, which generally progresses as long as testosterone levels remain high. Marijuana appears to lower testosterone levels, so after his diagnosis, he dosed a liquid form of cannabis for several weeks. That cut his PSA in half, but Mr. Hinds, a cybersecurity expert who likes yoga and bicycling, “was stoned out of his mind and couldn’t function,” Dr. Tenore recalled.

With Dr. Tenore guiding his decisions, Mr. Hinds next tried high-frequency ultrasound treatment, but it failed. And in the summer of 2019 doctors removed his prostate gland. Still, the PSA levels climbed again, and doctors assessed that the cancer had metastasized. The only alternative was to drastically lower Mr. Hinds’ testosterone levels – either via surgery or drugs that block all testosterone. In May 2021, he got his first intramuscular shot of Lupron Depot, a brand name for leuprolide, designed to suppress the prostate gland’s release of the hormone for 3 months. That August, he got his second shot.

And then the bills came.

The patient: Paul Hinds, now 60, is covered by United Healthcare through a COBRA plan from his former employer.

Medical service: Two 3-month Lupron Depot injections for metastatic prostate cancer.

Service provider: University of Chicago Medicine, a 900-physician nonprofit system that includes an 811-bed medical center, a suburban hospital, the Pritzker School of Medicine, and outpatient clinics and physician offices throughout the Chicago area.

Total bill: $73,812 for the two shots ($35,414 for the first, $38,398 for the second), including lab work and physician charges. United Healthcare’s negotiated rate for the two shots plus associated fees was $27,568, of which the insurer paid $19,567. After Mr. Hinds haggled with the hospital and insurer for more than a year, his share of the bills was determined to be nearly $7,000.

What gives: The first issue is unrelenting price increases on old drugs that have remained branded as manufacturers find ways to extend patents for decades and maintain sales through marketing.

Though Lupron was invented in 1973, its manufacturer got patent extensions in 1989 by offering a slow-release version. Drugmakers commonly use this tactic to extend their exclusive rights to sell a product.

The development of Lupron Depot as an intramuscular shot that suppressed testosterone for months at a time improved patient compliance and also enabled its maker, Abbott Laboratories, and its Japanese partner, Takeda, to extend their patents on the drug into the 2000s, said Gerald Weisberg, MD, a former Abbott scientist who has been critical of the company’s pricing policies.

In subsequent years, Abbott and Takeda, in a joint venture called TAP Pharmaceuticals, steadily marked up the price of their slow-release product. In 2000, the average wholesale U.S. price for a 3-month shot was $1,245; currently that figure is $5,866. (It is manufactured in the United States by AbbVie now.)

In the United Kingdom, where health care is generally free and Takeda sells the drug under the name Prostap, all physicians can purchase a 3-month dose for about $260.

It’s likely that Chicago Medicine, where Mr. Hinds got his shots, paid something close to the British price. That’s because the health system’s hospital on Chicago’s South Side participates in a federal program called 340B, which allows hospitals that serve low-income populations to purchase drugs at deep discounts.

Lupron Depot is given as a simple injection into the muscle. It takes minutes for a nurse or doctor to administer. Yet hospital systems like Chicago Medicine can and typically do charge lavishly for such services, to enhance revenue, said Morgan Henderson, principal data scientist at the Hilltop Institute at the University of Maryland-Baltimore County. Chicago Medicine declined to say what it paid for the drug.

While U.S. drugmakers can price their drugs however they please, TAP has gotten into trouble for its Lupron sales policies in the past. In 2001, after a Justice Department probe, it paid an $875 million settlement for illegally stimulating sales by giving urologists free and discounted vials of the drug while enabling them to charge Medicare full price.

Since then, many other drugs aimed at lowering testosterone levels have entered the market, including a pill, relugolix (Orgovyx). So why wouldn’t a patient use them?

Lupron Depot is long acting, is easy to prepare and store, and employs a small needle, which some patients prefer, said Brian McNeil, MD, chief of urology at University Hospital of Brooklyn. Orgovyx is convenient, but “a patient has to be very compliant. They have to take it every day around the same time,” he said. “Some people just forget.”

But there is another important factor that may well explain Lupron Depot’s ongoing popularity among medical providers: Doctors and hospitals can earn tens of thousands of dollars each visit by marking up its price and administration fees – as they did with Mr. Hinds. If they merely write a prescription for a drug that can be taken at home, they earn nothing.

Asked about this high patient charge and the possibility of using alternatives, United spokesperson Maria Gordon Shydlo said payment was “appropriately based on the hospital’s contract and the member’s benefit plan,” adding that the insurer encourages customers to shop around for the best quality and price.

Resolution: In addition to leaving Mr. Hinds listless, the Lupron Depot shots were, literally, a pain in the rear end. “Each time he was miserable for 2 weeks,” Dr. Tenore said. After looking over his first bill for the Lupron shot, Dr. Tenore told Mr. Hinds he should ask his doctor whether there was a less expensive drug that was easier to take.

After the second shot, in August 2021, a pharmacist told him he could instead receive the pill. His doctor prescribed Mr. Hinds 3 months’ worth of Orgovyx last November, for which he paid $216 and the insurer paid over $6,000. The drug’s list price is about $2,700 a month. There is evidence that Orgovyx works a little better than leuprolide.

Orgovyx was a “no-brainer,” Mr. Hinds said. “Why would you want a sore ass for two weeks when you can take a pill that kicks in sooner, functions the same way, and clears your body of testosterone faster?”

While Orgovyx is increasingly used for prostate cancer, Lupron and other injections usually remain the standard of care, hospital spokesperson Ashley Heher said. Clinicians “work with patients to determine what treatments are the most medically effective and, when necessary, to find reasonable alternatives that may be less financially burdensome due to insurance coverage limitations.”

Mr. Hinds was baffled by the size of the charges. During months of phone calls and emails, the hospital reversed and then reapplied part of the charge, and then in July agreed to a $666.34 monthly payment plan. After Hinds had made two payments, however, the hospital announced Aug. 29 it was canceling the agreement and sending the remainder of his bill to a collection agency. Two weeks later, the hospital reinstated the payment plan – after KHN asked about the cancellation.

As for Mr. Hinds, he remains active, though his bike rides have been shortened from 50 or 60 miles to about 30, he said.

He’s grateful to have Dr. Tenore as a free consultant and empathizes with those who lack a knowledgeable guide through their disease and health care’s financial maze.

“I’ve got Dr. Josie as an advocate who knows the system,” Mr. Hinds said.

The takeaway: First tip: If you are prescribed an infusion or injection, ask your physician if there are cheaper oral medications to treat your condition. Also, many drugs that are given by injection – ones that are given “subcutaneously,” rather than into a muscle – can be administered by a patient at home, avoiding hefty administration fees. Drugs like Dupixent for eczema fall into this category.

Keep in mind that where you get treatment could make a big difference in your charges: A study found that leading U.S. cancer centers charge enormous markups to private insurers for drug injections or infusions. Another study found that hospital systems charge an average of 86% more than private clinics for cancer drug infusions. And the percentage of cancer infusions done in hospital-operated clinics increased from 6% in 2004 to 43% in 2014, and has grown since.

Under a law that took effect in 2021, hospitals are required to list their charges, though they currently do so in a way that is not user friendly. But it’s worth taking a look at the price list – the hospital chargemaster – to try to decipher the pricing and markup for your medicine. If you’re about to get an injection, infusion, or procedure done in a hospital system, ask ahead of time for an estimate of what you will owe.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Is it flu, RSV, or COVID? Experts fear the ‘tripledemic’

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Just when we thought this holiday season, finally, would be the back-to-normal one, some infectious disease experts are warning that a so-called “tripledemic” – influenza, COVID-19, and RSV – may be in the forecast.

The warning isn’t without basis. 

The flu season has gotten an early start. As of Oct. 21, early increases in seasonal flu activity have been reported in most of the country, the Centers for Disease Control and Prevention said, with the southeast and south-central areas having the highest activity levels. 

Children’s hospitals and EDs are seeing a surge in children with RSV.

COVID-19 cases are trending down, according to the CDC, but epidemiologists – scientists who study disease outbreaks – always have their eyes on emerging variants. 

Predicting exactly when cases will peak is difficult, said Justin Lessler, PhD, a professor of epidemiology at the University of North Carolina at Chapel Hill. Dr. Lessler is on the coordinating team for the COVID-19 Scenario Modeling Hub, which aims to predict the course COVID-19, and the Flu Scenario Modeling Hub, which does the same for influenza.

For COVID-19, some models are predicting some spikes before Christmas, he said, and others see a new wave in 2023. For the flu, the model is predicting an earlier-than-usual start, as the CDC has reported.  

While flu activity is relatively low, the CDC said, the season is off to an early start. For the week ending Oct. 21, 1,674 patients were hospitalized for flu, higher than in the summer months but fewer than the 2,675 hospitalizations for the week of May 15, 2022. 

As of Oct. 20, COVID-19 cases have declined 12% over the last 2 weeks, nationwide. But hospitalizations are up 10% in much of the Northeast, The New York Times reports, and the improvement in cases and deaths has been slowing down. 

As of Oct. 15, 15% of RSV tests reported nationwide were positive, compared with about 11% at that time in 2021, the CDC said. The surveillance collects information from 75 counties in 12 states. 

Experts point out that the viruses – all three are respiratory viruses – are simply playing catchup. 

“They spread the same way and along with lots of other viruses, and you tend to see an increase in them during the cold months,” said Timothy Brewer, MD, professor of medicine and epidemiology at UCLA.

The increase in all three viruses “is almost predictable at this point in the pandemic,” said Dean Blumberg, MD, a professor and chief of pediatric infectious diseases at the University of California Davis Health. “All the respiratory viruses are out of whack.” 

Last year, RSV cases were up, too, and began to appear very early, he said, in the summer instead of in the cooler months. Flu also appeared early in 2021, as it has in 2022. 

That contrasts with the flu season of 2020-2021, when COVID precautions were nearly universal, and cases were down. At UC Davis, “we didn’t have one pediatric admission due to influenza in the 2020-2021 [flu] season,” Dr. Blumberg said. 

The number of pediatric flu deaths usually range from 37 to 199 per year, according to CDC records. But in the 2020-2021 season, the CDC recorded one pediatric flu death in the U.S.

Both children and adults have had less contact with others the past two seasons, Dr. Blumberg said, “and they don’t get the immunity they got with those infections [previously]. That’s why we are seeing out-of-season, early season [viruses].” 

Eventually, he said, the cases of flu and RSV will return to previous levels. “It could be as soon as next year,” Dr. Blumberg said. And COVID-19, hopefully, will become like influenza, he said.

“RSV has always come around in the fall and winter,” said Elizabeth Murray, DO, a pediatric emergency medicine doctor at the University of Rochester (N.Y.) Medical Center and a spokesperson for the American Academy of Pediatrics. In 2022, children are back in school and for the most part not masking. “It’s a perfect storm for all the germs to spread now. They’ve just been waiting for their opportunity to come back.”
 

 

 

Self-care vs. not

RSV can pose a risk for anyone, but most at risk are children under age 5, especially infants under age 1, and adults over age 65. There is no vaccine for it. Symptoms include a runny nose, decreased appetite, coughing, sneezing, fever, and wheezing. But in young infants, there may only be decreased activity, crankiness, and breathing issues, the CDC said.

Keep an eye on the breathing if RSV is suspected, Dr. Murray tells parents. If your child can’t breathe easily, is unable to lie down comfortably, can’t speak clearly, or is sucking in the chest muscles to breathe, get medical help. Most kids with RSV can stay home and recover, she said, but often will need to be checked by a medical professional.

She advises against getting an oximeter to measure oxygen levels for home use. “They are often not accurate,” she said. If in doubt about how serious your child’s symptoms are, “don’t wait it out,” and don’t hesitate to call 911.

Symptoms of flu, COVID, and RSV can overlap. But each can involve breathing problems, which can be an emergency. 

“It’s important to seek medical attention for any concerning symptoms, but especially severe shortness of breath or difficulty breathing, as these could signal the need for supplemental oxygen or other emergency interventions,” said Mandy De Vries, a respiratory therapist and director of education at the American Association for Respiratory Care. Inhalation treatment or mechanical ventilation may be needed for severe respiratory issues.
 

Precautions

To avoid the tripledemic – or any single infection – Timothy Brewer, MD, a professor of medicine and epidemiology at the University of California, Los Angeles, suggests some familiar measures: “Stay home if you’re feeling sick. Make sure you are up to date on your vaccinations. Wear a mask indoors.”

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

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Just when we thought this holiday season, finally, would be the back-to-normal one, some infectious disease experts are warning that a so-called “tripledemic” – influenza, COVID-19, and RSV – may be in the forecast.

The warning isn’t without basis. 

The flu season has gotten an early start. As of Oct. 21, early increases in seasonal flu activity have been reported in most of the country, the Centers for Disease Control and Prevention said, with the southeast and south-central areas having the highest activity levels. 

Children’s hospitals and EDs are seeing a surge in children with RSV.

COVID-19 cases are trending down, according to the CDC, but epidemiologists – scientists who study disease outbreaks – always have their eyes on emerging variants. 

Predicting exactly when cases will peak is difficult, said Justin Lessler, PhD, a professor of epidemiology at the University of North Carolina at Chapel Hill. Dr. Lessler is on the coordinating team for the COVID-19 Scenario Modeling Hub, which aims to predict the course COVID-19, and the Flu Scenario Modeling Hub, which does the same for influenza.

For COVID-19, some models are predicting some spikes before Christmas, he said, and others see a new wave in 2023. For the flu, the model is predicting an earlier-than-usual start, as the CDC has reported.  

While flu activity is relatively low, the CDC said, the season is off to an early start. For the week ending Oct. 21, 1,674 patients were hospitalized for flu, higher than in the summer months but fewer than the 2,675 hospitalizations for the week of May 15, 2022. 

As of Oct. 20, COVID-19 cases have declined 12% over the last 2 weeks, nationwide. But hospitalizations are up 10% in much of the Northeast, The New York Times reports, and the improvement in cases and deaths has been slowing down. 

As of Oct. 15, 15% of RSV tests reported nationwide were positive, compared with about 11% at that time in 2021, the CDC said. The surveillance collects information from 75 counties in 12 states. 

Experts point out that the viruses – all three are respiratory viruses – are simply playing catchup. 

“They spread the same way and along with lots of other viruses, and you tend to see an increase in them during the cold months,” said Timothy Brewer, MD, professor of medicine and epidemiology at UCLA.

The increase in all three viruses “is almost predictable at this point in the pandemic,” said Dean Blumberg, MD, a professor and chief of pediatric infectious diseases at the University of California Davis Health. “All the respiratory viruses are out of whack.” 

Last year, RSV cases were up, too, and began to appear very early, he said, in the summer instead of in the cooler months. Flu also appeared early in 2021, as it has in 2022. 

That contrasts with the flu season of 2020-2021, when COVID precautions were nearly universal, and cases were down. At UC Davis, “we didn’t have one pediatric admission due to influenza in the 2020-2021 [flu] season,” Dr. Blumberg said. 

The number of pediatric flu deaths usually range from 37 to 199 per year, according to CDC records. But in the 2020-2021 season, the CDC recorded one pediatric flu death in the U.S.

Both children and adults have had less contact with others the past two seasons, Dr. Blumberg said, “and they don’t get the immunity they got with those infections [previously]. That’s why we are seeing out-of-season, early season [viruses].” 

Eventually, he said, the cases of flu and RSV will return to previous levels. “It could be as soon as next year,” Dr. Blumberg said. And COVID-19, hopefully, will become like influenza, he said.

“RSV has always come around in the fall and winter,” said Elizabeth Murray, DO, a pediatric emergency medicine doctor at the University of Rochester (N.Y.) Medical Center and a spokesperson for the American Academy of Pediatrics. In 2022, children are back in school and for the most part not masking. “It’s a perfect storm for all the germs to spread now. They’ve just been waiting for their opportunity to come back.”
 

 

 

Self-care vs. not

RSV can pose a risk for anyone, but most at risk are children under age 5, especially infants under age 1, and adults over age 65. There is no vaccine for it. Symptoms include a runny nose, decreased appetite, coughing, sneezing, fever, and wheezing. But in young infants, there may only be decreased activity, crankiness, and breathing issues, the CDC said.

Keep an eye on the breathing if RSV is suspected, Dr. Murray tells parents. If your child can’t breathe easily, is unable to lie down comfortably, can’t speak clearly, or is sucking in the chest muscles to breathe, get medical help. Most kids with RSV can stay home and recover, she said, but often will need to be checked by a medical professional.

She advises against getting an oximeter to measure oxygen levels for home use. “They are often not accurate,” she said. If in doubt about how serious your child’s symptoms are, “don’t wait it out,” and don’t hesitate to call 911.

Symptoms of flu, COVID, and RSV can overlap. But each can involve breathing problems, which can be an emergency. 

“It’s important to seek medical attention for any concerning symptoms, but especially severe shortness of breath or difficulty breathing, as these could signal the need for supplemental oxygen or other emergency interventions,” said Mandy De Vries, a respiratory therapist and director of education at the American Association for Respiratory Care. Inhalation treatment or mechanical ventilation may be needed for severe respiratory issues.
 

Precautions

To avoid the tripledemic – or any single infection – Timothy Brewer, MD, a professor of medicine and epidemiology at the University of California, Los Angeles, suggests some familiar measures: “Stay home if you’re feeling sick. Make sure you are up to date on your vaccinations. Wear a mask indoors.”

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

Just when we thought this holiday season, finally, would be the back-to-normal one, some infectious disease experts are warning that a so-called “tripledemic” – influenza, COVID-19, and RSV – may be in the forecast.

The warning isn’t without basis. 

The flu season has gotten an early start. As of Oct. 21, early increases in seasonal flu activity have been reported in most of the country, the Centers for Disease Control and Prevention said, with the southeast and south-central areas having the highest activity levels. 

Children’s hospitals and EDs are seeing a surge in children with RSV.

COVID-19 cases are trending down, according to the CDC, but epidemiologists – scientists who study disease outbreaks – always have their eyes on emerging variants. 

Predicting exactly when cases will peak is difficult, said Justin Lessler, PhD, a professor of epidemiology at the University of North Carolina at Chapel Hill. Dr. Lessler is on the coordinating team for the COVID-19 Scenario Modeling Hub, which aims to predict the course COVID-19, and the Flu Scenario Modeling Hub, which does the same for influenza.

For COVID-19, some models are predicting some spikes before Christmas, he said, and others see a new wave in 2023. For the flu, the model is predicting an earlier-than-usual start, as the CDC has reported.  

While flu activity is relatively low, the CDC said, the season is off to an early start. For the week ending Oct. 21, 1,674 patients were hospitalized for flu, higher than in the summer months but fewer than the 2,675 hospitalizations for the week of May 15, 2022. 

As of Oct. 20, COVID-19 cases have declined 12% over the last 2 weeks, nationwide. But hospitalizations are up 10% in much of the Northeast, The New York Times reports, and the improvement in cases and deaths has been slowing down. 

As of Oct. 15, 15% of RSV tests reported nationwide were positive, compared with about 11% at that time in 2021, the CDC said. The surveillance collects information from 75 counties in 12 states. 

Experts point out that the viruses – all three are respiratory viruses – are simply playing catchup. 

“They spread the same way and along with lots of other viruses, and you tend to see an increase in them during the cold months,” said Timothy Brewer, MD, professor of medicine and epidemiology at UCLA.

The increase in all three viruses “is almost predictable at this point in the pandemic,” said Dean Blumberg, MD, a professor and chief of pediatric infectious diseases at the University of California Davis Health. “All the respiratory viruses are out of whack.” 

Last year, RSV cases were up, too, and began to appear very early, he said, in the summer instead of in the cooler months. Flu also appeared early in 2021, as it has in 2022. 

That contrasts with the flu season of 2020-2021, when COVID precautions were nearly universal, and cases were down. At UC Davis, “we didn’t have one pediatric admission due to influenza in the 2020-2021 [flu] season,” Dr. Blumberg said. 

The number of pediatric flu deaths usually range from 37 to 199 per year, according to CDC records. But in the 2020-2021 season, the CDC recorded one pediatric flu death in the U.S.

Both children and adults have had less contact with others the past two seasons, Dr. Blumberg said, “and they don’t get the immunity they got with those infections [previously]. That’s why we are seeing out-of-season, early season [viruses].” 

Eventually, he said, the cases of flu and RSV will return to previous levels. “It could be as soon as next year,” Dr. Blumberg said. And COVID-19, hopefully, will become like influenza, he said.

“RSV has always come around in the fall and winter,” said Elizabeth Murray, DO, a pediatric emergency medicine doctor at the University of Rochester (N.Y.) Medical Center and a spokesperson for the American Academy of Pediatrics. In 2022, children are back in school and for the most part not masking. “It’s a perfect storm for all the germs to spread now. They’ve just been waiting for their opportunity to come back.”
 

 

 

Self-care vs. not

RSV can pose a risk for anyone, but most at risk are children under age 5, especially infants under age 1, and adults over age 65. There is no vaccine for it. Symptoms include a runny nose, decreased appetite, coughing, sneezing, fever, and wheezing. But in young infants, there may only be decreased activity, crankiness, and breathing issues, the CDC said.

Keep an eye on the breathing if RSV is suspected, Dr. Murray tells parents. If your child can’t breathe easily, is unable to lie down comfortably, can’t speak clearly, or is sucking in the chest muscles to breathe, get medical help. Most kids with RSV can stay home and recover, she said, but often will need to be checked by a medical professional.

She advises against getting an oximeter to measure oxygen levels for home use. “They are often not accurate,” she said. If in doubt about how serious your child’s symptoms are, “don’t wait it out,” and don’t hesitate to call 911.

Symptoms of flu, COVID, and RSV can overlap. But each can involve breathing problems, which can be an emergency. 

“It’s important to seek medical attention for any concerning symptoms, but especially severe shortness of breath or difficulty breathing, as these could signal the need for supplemental oxygen or other emergency interventions,” said Mandy De Vries, a respiratory therapist and director of education at the American Association for Respiratory Care. Inhalation treatment or mechanical ventilation may be needed for severe respiratory issues.
 

Precautions

To avoid the tripledemic – or any single infection – Timothy Brewer, MD, a professor of medicine and epidemiology at the University of California, Los Angeles, suggests some familiar measures: “Stay home if you’re feeling sick. Make sure you are up to date on your vaccinations. Wear a mask indoors.”

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

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‘Financial toxicity’: Harsh side effect of cancer care

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When 32-year-old Brittany Dicks was diagnosed with stage II triple negative breast cancer in January 2022, she wasn’t worried about the cost of treatment. A medical assistant in Charleston, S.C., Ms. Dicks had full-time employment with health benefits.

But when she wasn’t able to work for several months because of chemotherapy and its side effects, Ms. Dicks lost her job. Her health insurance coverage ended in May. And although she filed for Medicaid at the beginning of June, it wasn’t approved until September.

Meanwhile, Ms. Dicks still needed treatment. She estimates that she ran up close to $20,000 in medical debt while finishing chemotherapy during the 4 months she was uninsured.

The surgeon she had seen since her diagnosis terminated her care when she could no longer pay her bills. That left her delaying a much-needed mastectomy.

“I don’t sleep at night,” said Ms. Dicks, a single mother of two young kids, ages 3 and 11. “Mentally, I’m drained. Just because I have cancer, doesn’t mean the bills aren’t due every month.”

As soon as she felt well enough over the summer, she started working as a part-time delivery driver for DoorDash to help pay for food and gas.

But that was just a Band-Aid. Even when her new insurance kicked in, covering the costs of daily life remained a struggle.

Ms. Dicks is still in deep medical debt. Her Medicaid has covered new medical expenses, and she hopes Medicaid will reimburse her for the debt she incurred over the summer while she waited for her coverage to kick in. So far, though, Medicaid has not touched her $20,000 debt.

“I fear that I’m not going to be able to dig out of this hole,” Ms. Dicks said.

Researchers who study the financial impacts of cancer have a term for Ms. Dicks’ experience: financial toxicity.

Financial toxicity is a catchall term for the burden many Americans with cancer experience.

“Financial toxicity is a multidimensional concept. There’s both a material burden and a psychosocial one,” said Grace Li Smith, MD, PhD, MPH, a radiation oncologist at the University of Texas MD Anderson Cancer Center, Houston.

Financial toxicity encompasses the direct costs of medical care, including copays, deductibles, and other out-of-pocket expenses for treatment and medications as well as the indirect costs from loss of income or savings associated with cancer care.

Researchers are also now beginning to understand the psychological effects these financial burdens can have on patients and their family.

“Financial toxicity is not unique to the patient,” said Dr. Li Smith. It “very directly impacts the whole family or household.”
 

Stifling financial pressures

Early in her career, Dr. Li Smith was already seeing how her patients’ worries extended beyond their physical disease.

One of Dr. Li Smith’s first patients told her their greatest worry wasn’t whether the treatment would work or what physical toxicity to expect, it was how they would pay for their care.

“There was much more anxiety and true distress about the financial burden than about the treatment itself,” Dr. Li Smith recalled.

This fear about the costs of cancer care is well founded. In the United States, cancer treatment costs reached an estimated $150 billion in 2020 and continue to rise. Patients shoulder a significant portion of that burden – with one study estimating that patients paid $21 billion for their cancer care in 2019.

The burden is often compounded by decreased income. Between 40% and 85% of patients with cancer needed to take time off work or quit their jobs during treatment. And for those, like Dicks, who find themselves with no insurance, out-of-pocket costs can quickly skyrocket.

In fact, one study of newly diagnosed cancer patients over age 50 reported that more than 42% of patients fully depleted their financial assets and around 30% incurred debt by the second year of their diagnosis.

Younger adults may be even more financially vulnerable. A study of patients in Washington found that those under 65 – which represent about half of cancer cases – were two to five times more likely to declare bankruptcy than patients over 65.

Dr. Li Smith and colleagues have found that younger patients aged 18-64 experienced greater monetary hardships, which meant less money for food, worse adherence to medications, as well as greater distress and anxiety overall. In fact, younger adults were over 4.5 times more likely to encounter severe financial toxicity, compared with older adults, and about 4 times more likely to experience severe psychological effects from this burden.

The distress, if left unchecked, can spiral out of control.

Molly MacDonald had just gone through a financially devastating divorce in 2005 when she was diagnosed with breast cancer. Recently out of work and dealing with a $1,300 monthly COBRA premium, the mother of five had no financial safety net. She risked having her car repossessed and her utilities shut off.

“I gave tentative thought to how I could take my life and make it look like an accident,” said Ms. MacDonald. “I thought the kids would be better off without me.”

For some, the loss of income can be even more worrisome than the medical bills. Some patients may go back to work during treatment, often against medical advice.

When Stephanie Caputo, 43, of Monroe, N.J., began treatment for stage III breast cancer in 2021, her physician recommended she stop working. Treatment would make her immunocompromised, and her job in a medical clinic could expose her to harmful pathogens, including the coronavirus.

Ms. Caputo went on disability and received $900 every 2 weeks. But that wasn’t enough to pay her mortgage, let alone cover her other monthly expenses as a single mother of 4 teenagers.

After finishing chemotherapy, and during radiation, Ms. Caputo went back to work, part time, against her doctor’s advice.

“My doctor is telling me I can’t work, but I also can’t have my house go into default,” said Ms. Caputo.

But being on her feet through 12-hour shifts made treatment side effects, especially back and joint pain, kick into overdrive. “The physicality of my job was really difficult to tolerate,” she said.

The physical burden was too great to take on more work, but the extra money also wasn’t enough to keep her afloat. Fortunately, her brother stepped in and covered 6 months of her mortgage payments.
 

 

 

Financial toxicity impacts families

Although financial toxicity research to date has largely focused on the patient, researchers are also starting to understand that family members and caregivers often share in the burden.

“We are just at the beginning of realizing that this is a real problem,” said Fumiko Chino, MD, a radiation oncologist at Memorial Sloan Kettering Cancer Center, New York.

Dr. Chino and colleagues recently showed that family members of patients with cancer were more likely to delay or forgo medical care than family members of people without cancer. The study found the effect was greatest among family members of younger adults with cancer.

“The caregiver and family burden related to cancer diagnosis and treatment is really underappreciated,” said Dr. Chino. “Family members and caregivers are neglecting their own health concerns, passing up career opportunities, struggling with financial concerns.”

Dr. Chino speaks from personal experience. When her fiancé, later husband, was diagnosed with neuroendocrine carcinoma in 2005, Dr. Chino quit her job as art director at a television production company to take care of him.

The couple, both in their 20s, struggled to afford his care. Dr. Chino put her own dental, medical, and mental health care on hold. She never, for instance, went to physical therapy to address injuries sustained sleeping in hospital chairs and moving around her husband who was over 6 feet tall. At one point, she walked with a limp.

Dr. Chino’s husband passed away in 2007, and even 15 years later, her injury from sleeping in hospital chairs remains “a significant physical burden,” she said. But like many caregivers “I wasn’t really thinking about my own health.”

Danielle Hadfield, 35, an ED nurse in Rochester, N.Y., also delayed her own care when her mom got sick.

Ms. Hadfield quit her job shortly after her mom was diagnosed with cholangiocarcinoma in August 2020. Ms. Hadfield knew her mom, who lived 3.5 hours away in Albany, N.Y., would need a lot of care in the upcoming months.

“I knew this was going to be the last year or so of her life, and I wanted to be there for her,” said Ms. Hadfield.

When Ms. Hadfield quit her job, she and her husband – who was self-employed – purchased health insurance coverage through the New York state marketplace. The monthly insurance payments for Ms. Hadfield, who was pregnant with her second child, her husband, and their toddler cost as much as the family’s monthly mortgage payments.

In addition to providing childcare for her young daughter and making frequent trips to Albany, Ms. Hadfield began a side business as a legal nurse consultant, working mostly at night, to replace a portion of her lost income. During this time, she began to experience pain attacks that would migrate through her body along with intermittent tongue and facial numbness. She ignored these health issues for nearly a year, until after her mother died in November 2021.

Only after her mother passed away did Ms. Hadfield begin seeking answers to her own pain. In September 2022, she finally got them. She had a nerve condition called small-fiber sensory neuropathy.

But even with a diagnosis, she is still facing more tests to root out the cause and understand the best treatment.
 

 

 

Is help out there?

What can physicians do to help patients and families at risk for financial toxicity?

Specific guidelines for dealing with financial toxicity do not exist in most professional guidelines, nor are there standard screening tools to identify it, said Dr. Li Smith.

These gaps put pressure on physicians to ask about financial barriers and concerns, but most do not know how to broach the topic or how to help. “Physicians may not know how to fix the problem or what resources exist,” Dr. Li Smith said.

Patients and family members, on the other hand, are often reluctant to bring up cost with physicians. Some may be ashamed to talk about their financial problems while others may fear doing so will prevent them from being offered the best possible treatments, said Ms. MacDonald.

But, experts say, financial toxicity needs to be dealt with head on. That means involving financial navigators or counselors and social workers who can, for instance, help patients and families find financial support for their basic living expenses.

From a research perspective, more clinical trials should include financial toxicity outcomes, said Joshua Palmer, MD, a radiation oncologist at the University of Michigan, Ann Arbor.

Dr. Palmer and colleagues recently showed that the number of radiation therapy clinical trials including financial toxicity endpoints increased significantly from 2001 to 2020, though the absolute rate of inclusion remains low, at roughly 1.5% of radiation therapy-based clinical trials including financial toxicity endpoints from 2016 to 2020.

“Financial burden is part of the broader discussion about shared decision-making,” said Dr. Palmer.

In shared decision-making, physicians discuss the risks and benefits of different treatment options, empowering the patient to make an informed choice with the physician.

What we want to avoid is patients feeling like they will get inferior care, if they have financial barriers, said Dr. Palmer.

And every little bit can help. In 2006, Ms. MacDonald started the Pink Fund – a nonprofit to help patients with cancer cover nonmedical cost-of-living expenses. Both Ms. Caputo and Ms. Dicks received grants from the Pink Fund. For Ms. Caputo, the funds covered 2 months of car payments and for Ms. Dicks, it covered 2 months of rent.

While the one-time grant was a big help, said Ms. Dicks, “cancer is an everyday thing.” And “we all deserve peace of mind” when trying to heal.

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

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When 32-year-old Brittany Dicks was diagnosed with stage II triple negative breast cancer in January 2022, she wasn’t worried about the cost of treatment. A medical assistant in Charleston, S.C., Ms. Dicks had full-time employment with health benefits.

But when she wasn’t able to work for several months because of chemotherapy and its side effects, Ms. Dicks lost her job. Her health insurance coverage ended in May. And although she filed for Medicaid at the beginning of June, it wasn’t approved until September.

Meanwhile, Ms. Dicks still needed treatment. She estimates that she ran up close to $20,000 in medical debt while finishing chemotherapy during the 4 months she was uninsured.

The surgeon she had seen since her diagnosis terminated her care when she could no longer pay her bills. That left her delaying a much-needed mastectomy.

“I don’t sleep at night,” said Ms. Dicks, a single mother of two young kids, ages 3 and 11. “Mentally, I’m drained. Just because I have cancer, doesn’t mean the bills aren’t due every month.”

As soon as she felt well enough over the summer, she started working as a part-time delivery driver for DoorDash to help pay for food and gas.

But that was just a Band-Aid. Even when her new insurance kicked in, covering the costs of daily life remained a struggle.

Ms. Dicks is still in deep medical debt. Her Medicaid has covered new medical expenses, and she hopes Medicaid will reimburse her for the debt she incurred over the summer while she waited for her coverage to kick in. So far, though, Medicaid has not touched her $20,000 debt.

“I fear that I’m not going to be able to dig out of this hole,” Ms. Dicks said.

Researchers who study the financial impacts of cancer have a term for Ms. Dicks’ experience: financial toxicity.

Financial toxicity is a catchall term for the burden many Americans with cancer experience.

“Financial toxicity is a multidimensional concept. There’s both a material burden and a psychosocial one,” said Grace Li Smith, MD, PhD, MPH, a radiation oncologist at the University of Texas MD Anderson Cancer Center, Houston.

Financial toxicity encompasses the direct costs of medical care, including copays, deductibles, and other out-of-pocket expenses for treatment and medications as well as the indirect costs from loss of income or savings associated with cancer care.

Researchers are also now beginning to understand the psychological effects these financial burdens can have on patients and their family.

“Financial toxicity is not unique to the patient,” said Dr. Li Smith. It “very directly impacts the whole family or household.”
 

Stifling financial pressures

Early in her career, Dr. Li Smith was already seeing how her patients’ worries extended beyond their physical disease.

One of Dr. Li Smith’s first patients told her their greatest worry wasn’t whether the treatment would work or what physical toxicity to expect, it was how they would pay for their care.

“There was much more anxiety and true distress about the financial burden than about the treatment itself,” Dr. Li Smith recalled.

This fear about the costs of cancer care is well founded. In the United States, cancer treatment costs reached an estimated $150 billion in 2020 and continue to rise. Patients shoulder a significant portion of that burden – with one study estimating that patients paid $21 billion for their cancer care in 2019.

The burden is often compounded by decreased income. Between 40% and 85% of patients with cancer needed to take time off work or quit their jobs during treatment. And for those, like Dicks, who find themselves with no insurance, out-of-pocket costs can quickly skyrocket.

In fact, one study of newly diagnosed cancer patients over age 50 reported that more than 42% of patients fully depleted their financial assets and around 30% incurred debt by the second year of their diagnosis.

Younger adults may be even more financially vulnerable. A study of patients in Washington found that those under 65 – which represent about half of cancer cases – were two to five times more likely to declare bankruptcy than patients over 65.

Dr. Li Smith and colleagues have found that younger patients aged 18-64 experienced greater monetary hardships, which meant less money for food, worse adherence to medications, as well as greater distress and anxiety overall. In fact, younger adults were over 4.5 times more likely to encounter severe financial toxicity, compared with older adults, and about 4 times more likely to experience severe psychological effects from this burden.

The distress, if left unchecked, can spiral out of control.

Molly MacDonald had just gone through a financially devastating divorce in 2005 when she was diagnosed with breast cancer. Recently out of work and dealing with a $1,300 monthly COBRA premium, the mother of five had no financial safety net. She risked having her car repossessed and her utilities shut off.

“I gave tentative thought to how I could take my life and make it look like an accident,” said Ms. MacDonald. “I thought the kids would be better off without me.”

For some, the loss of income can be even more worrisome than the medical bills. Some patients may go back to work during treatment, often against medical advice.

When Stephanie Caputo, 43, of Monroe, N.J., began treatment for stage III breast cancer in 2021, her physician recommended she stop working. Treatment would make her immunocompromised, and her job in a medical clinic could expose her to harmful pathogens, including the coronavirus.

Ms. Caputo went on disability and received $900 every 2 weeks. But that wasn’t enough to pay her mortgage, let alone cover her other monthly expenses as a single mother of 4 teenagers.

After finishing chemotherapy, and during radiation, Ms. Caputo went back to work, part time, against her doctor’s advice.

“My doctor is telling me I can’t work, but I also can’t have my house go into default,” said Ms. Caputo.

But being on her feet through 12-hour shifts made treatment side effects, especially back and joint pain, kick into overdrive. “The physicality of my job was really difficult to tolerate,” she said.

The physical burden was too great to take on more work, but the extra money also wasn’t enough to keep her afloat. Fortunately, her brother stepped in and covered 6 months of her mortgage payments.
 

 

 

Financial toxicity impacts families

Although financial toxicity research to date has largely focused on the patient, researchers are also starting to understand that family members and caregivers often share in the burden.

“We are just at the beginning of realizing that this is a real problem,” said Fumiko Chino, MD, a radiation oncologist at Memorial Sloan Kettering Cancer Center, New York.

Dr. Chino and colleagues recently showed that family members of patients with cancer were more likely to delay or forgo medical care than family members of people without cancer. The study found the effect was greatest among family members of younger adults with cancer.

“The caregiver and family burden related to cancer diagnosis and treatment is really underappreciated,” said Dr. Chino. “Family members and caregivers are neglecting their own health concerns, passing up career opportunities, struggling with financial concerns.”

Dr. Chino speaks from personal experience. When her fiancé, later husband, was diagnosed with neuroendocrine carcinoma in 2005, Dr. Chino quit her job as art director at a television production company to take care of him.

The couple, both in their 20s, struggled to afford his care. Dr. Chino put her own dental, medical, and mental health care on hold. She never, for instance, went to physical therapy to address injuries sustained sleeping in hospital chairs and moving around her husband who was over 6 feet tall. At one point, she walked with a limp.

Dr. Chino’s husband passed away in 2007, and even 15 years later, her injury from sleeping in hospital chairs remains “a significant physical burden,” she said. But like many caregivers “I wasn’t really thinking about my own health.”

Danielle Hadfield, 35, an ED nurse in Rochester, N.Y., also delayed her own care when her mom got sick.

Ms. Hadfield quit her job shortly after her mom was diagnosed with cholangiocarcinoma in August 2020. Ms. Hadfield knew her mom, who lived 3.5 hours away in Albany, N.Y., would need a lot of care in the upcoming months.

“I knew this was going to be the last year or so of her life, and I wanted to be there for her,” said Ms. Hadfield.

When Ms. Hadfield quit her job, she and her husband – who was self-employed – purchased health insurance coverage through the New York state marketplace. The monthly insurance payments for Ms. Hadfield, who was pregnant with her second child, her husband, and their toddler cost as much as the family’s monthly mortgage payments.

In addition to providing childcare for her young daughter and making frequent trips to Albany, Ms. Hadfield began a side business as a legal nurse consultant, working mostly at night, to replace a portion of her lost income. During this time, she began to experience pain attacks that would migrate through her body along with intermittent tongue and facial numbness. She ignored these health issues for nearly a year, until after her mother died in November 2021.

Only after her mother passed away did Ms. Hadfield begin seeking answers to her own pain. In September 2022, she finally got them. She had a nerve condition called small-fiber sensory neuropathy.

But even with a diagnosis, she is still facing more tests to root out the cause and understand the best treatment.
 

 

 

Is help out there?

What can physicians do to help patients and families at risk for financial toxicity?

Specific guidelines for dealing with financial toxicity do not exist in most professional guidelines, nor are there standard screening tools to identify it, said Dr. Li Smith.

These gaps put pressure on physicians to ask about financial barriers and concerns, but most do not know how to broach the topic or how to help. “Physicians may not know how to fix the problem or what resources exist,” Dr. Li Smith said.

Patients and family members, on the other hand, are often reluctant to bring up cost with physicians. Some may be ashamed to talk about their financial problems while others may fear doing so will prevent them from being offered the best possible treatments, said Ms. MacDonald.

But, experts say, financial toxicity needs to be dealt with head on. That means involving financial navigators or counselors and social workers who can, for instance, help patients and families find financial support for their basic living expenses.

From a research perspective, more clinical trials should include financial toxicity outcomes, said Joshua Palmer, MD, a radiation oncologist at the University of Michigan, Ann Arbor.

Dr. Palmer and colleagues recently showed that the number of radiation therapy clinical trials including financial toxicity endpoints increased significantly from 2001 to 2020, though the absolute rate of inclusion remains low, at roughly 1.5% of radiation therapy-based clinical trials including financial toxicity endpoints from 2016 to 2020.

“Financial burden is part of the broader discussion about shared decision-making,” said Dr. Palmer.

In shared decision-making, physicians discuss the risks and benefits of different treatment options, empowering the patient to make an informed choice with the physician.

What we want to avoid is patients feeling like they will get inferior care, if they have financial barriers, said Dr. Palmer.

And every little bit can help. In 2006, Ms. MacDonald started the Pink Fund – a nonprofit to help patients with cancer cover nonmedical cost-of-living expenses. Both Ms. Caputo and Ms. Dicks received grants from the Pink Fund. For Ms. Caputo, the funds covered 2 months of car payments and for Ms. Dicks, it covered 2 months of rent.

While the one-time grant was a big help, said Ms. Dicks, “cancer is an everyday thing.” And “we all deserve peace of mind” when trying to heal.

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

When 32-year-old Brittany Dicks was diagnosed with stage II triple negative breast cancer in January 2022, she wasn’t worried about the cost of treatment. A medical assistant in Charleston, S.C., Ms. Dicks had full-time employment with health benefits.

But when she wasn’t able to work for several months because of chemotherapy and its side effects, Ms. Dicks lost her job. Her health insurance coverage ended in May. And although she filed for Medicaid at the beginning of June, it wasn’t approved until September.

Meanwhile, Ms. Dicks still needed treatment. She estimates that she ran up close to $20,000 in medical debt while finishing chemotherapy during the 4 months she was uninsured.

The surgeon she had seen since her diagnosis terminated her care when she could no longer pay her bills. That left her delaying a much-needed mastectomy.

“I don’t sleep at night,” said Ms. Dicks, a single mother of two young kids, ages 3 and 11. “Mentally, I’m drained. Just because I have cancer, doesn’t mean the bills aren’t due every month.”

As soon as she felt well enough over the summer, she started working as a part-time delivery driver for DoorDash to help pay for food and gas.

But that was just a Band-Aid. Even when her new insurance kicked in, covering the costs of daily life remained a struggle.

Ms. Dicks is still in deep medical debt. Her Medicaid has covered new medical expenses, and she hopes Medicaid will reimburse her for the debt she incurred over the summer while she waited for her coverage to kick in. So far, though, Medicaid has not touched her $20,000 debt.

“I fear that I’m not going to be able to dig out of this hole,” Ms. Dicks said.

Researchers who study the financial impacts of cancer have a term for Ms. Dicks’ experience: financial toxicity.

Financial toxicity is a catchall term for the burden many Americans with cancer experience.

“Financial toxicity is a multidimensional concept. There’s both a material burden and a psychosocial one,” said Grace Li Smith, MD, PhD, MPH, a radiation oncologist at the University of Texas MD Anderson Cancer Center, Houston.

Financial toxicity encompasses the direct costs of medical care, including copays, deductibles, and other out-of-pocket expenses for treatment and medications as well as the indirect costs from loss of income or savings associated with cancer care.

Researchers are also now beginning to understand the psychological effects these financial burdens can have on patients and their family.

“Financial toxicity is not unique to the patient,” said Dr. Li Smith. It “very directly impacts the whole family or household.”
 

Stifling financial pressures

Early in her career, Dr. Li Smith was already seeing how her patients’ worries extended beyond their physical disease.

One of Dr. Li Smith’s first patients told her their greatest worry wasn’t whether the treatment would work or what physical toxicity to expect, it was how they would pay for their care.

“There was much more anxiety and true distress about the financial burden than about the treatment itself,” Dr. Li Smith recalled.

This fear about the costs of cancer care is well founded. In the United States, cancer treatment costs reached an estimated $150 billion in 2020 and continue to rise. Patients shoulder a significant portion of that burden – with one study estimating that patients paid $21 billion for their cancer care in 2019.

The burden is often compounded by decreased income. Between 40% and 85% of patients with cancer needed to take time off work or quit their jobs during treatment. And for those, like Dicks, who find themselves with no insurance, out-of-pocket costs can quickly skyrocket.

In fact, one study of newly diagnosed cancer patients over age 50 reported that more than 42% of patients fully depleted their financial assets and around 30% incurred debt by the second year of their diagnosis.

Younger adults may be even more financially vulnerable. A study of patients in Washington found that those under 65 – which represent about half of cancer cases – were two to five times more likely to declare bankruptcy than patients over 65.

Dr. Li Smith and colleagues have found that younger patients aged 18-64 experienced greater monetary hardships, which meant less money for food, worse adherence to medications, as well as greater distress and anxiety overall. In fact, younger adults were over 4.5 times more likely to encounter severe financial toxicity, compared with older adults, and about 4 times more likely to experience severe psychological effects from this burden.

The distress, if left unchecked, can spiral out of control.

Molly MacDonald had just gone through a financially devastating divorce in 2005 when she was diagnosed with breast cancer. Recently out of work and dealing with a $1,300 monthly COBRA premium, the mother of five had no financial safety net. She risked having her car repossessed and her utilities shut off.

“I gave tentative thought to how I could take my life and make it look like an accident,” said Ms. MacDonald. “I thought the kids would be better off without me.”

For some, the loss of income can be even more worrisome than the medical bills. Some patients may go back to work during treatment, often against medical advice.

When Stephanie Caputo, 43, of Monroe, N.J., began treatment for stage III breast cancer in 2021, her physician recommended she stop working. Treatment would make her immunocompromised, and her job in a medical clinic could expose her to harmful pathogens, including the coronavirus.

Ms. Caputo went on disability and received $900 every 2 weeks. But that wasn’t enough to pay her mortgage, let alone cover her other monthly expenses as a single mother of 4 teenagers.

After finishing chemotherapy, and during radiation, Ms. Caputo went back to work, part time, against her doctor’s advice.

“My doctor is telling me I can’t work, but I also can’t have my house go into default,” said Ms. Caputo.

But being on her feet through 12-hour shifts made treatment side effects, especially back and joint pain, kick into overdrive. “The physicality of my job was really difficult to tolerate,” she said.

The physical burden was too great to take on more work, but the extra money also wasn’t enough to keep her afloat. Fortunately, her brother stepped in and covered 6 months of her mortgage payments.
 

 

 

Financial toxicity impacts families

Although financial toxicity research to date has largely focused on the patient, researchers are also starting to understand that family members and caregivers often share in the burden.

“We are just at the beginning of realizing that this is a real problem,” said Fumiko Chino, MD, a radiation oncologist at Memorial Sloan Kettering Cancer Center, New York.

Dr. Chino and colleagues recently showed that family members of patients with cancer were more likely to delay or forgo medical care than family members of people without cancer. The study found the effect was greatest among family members of younger adults with cancer.

“The caregiver and family burden related to cancer diagnosis and treatment is really underappreciated,” said Dr. Chino. “Family members and caregivers are neglecting their own health concerns, passing up career opportunities, struggling with financial concerns.”

Dr. Chino speaks from personal experience. When her fiancé, later husband, was diagnosed with neuroendocrine carcinoma in 2005, Dr. Chino quit her job as art director at a television production company to take care of him.

The couple, both in their 20s, struggled to afford his care. Dr. Chino put her own dental, medical, and mental health care on hold. She never, for instance, went to physical therapy to address injuries sustained sleeping in hospital chairs and moving around her husband who was over 6 feet tall. At one point, she walked with a limp.

Dr. Chino’s husband passed away in 2007, and even 15 years later, her injury from sleeping in hospital chairs remains “a significant physical burden,” she said. But like many caregivers “I wasn’t really thinking about my own health.”

Danielle Hadfield, 35, an ED nurse in Rochester, N.Y., also delayed her own care when her mom got sick.

Ms. Hadfield quit her job shortly after her mom was diagnosed with cholangiocarcinoma in August 2020. Ms. Hadfield knew her mom, who lived 3.5 hours away in Albany, N.Y., would need a lot of care in the upcoming months.

“I knew this was going to be the last year or so of her life, and I wanted to be there for her,” said Ms. Hadfield.

When Ms. Hadfield quit her job, she and her husband – who was self-employed – purchased health insurance coverage through the New York state marketplace. The monthly insurance payments for Ms. Hadfield, who was pregnant with her second child, her husband, and their toddler cost as much as the family’s monthly mortgage payments.

In addition to providing childcare for her young daughter and making frequent trips to Albany, Ms. Hadfield began a side business as a legal nurse consultant, working mostly at night, to replace a portion of her lost income. During this time, she began to experience pain attacks that would migrate through her body along with intermittent tongue and facial numbness. She ignored these health issues for nearly a year, until after her mother died in November 2021.

Only after her mother passed away did Ms. Hadfield begin seeking answers to her own pain. In September 2022, she finally got them. She had a nerve condition called small-fiber sensory neuropathy.

But even with a diagnosis, she is still facing more tests to root out the cause and understand the best treatment.
 

 

 

Is help out there?

What can physicians do to help patients and families at risk for financial toxicity?

Specific guidelines for dealing with financial toxicity do not exist in most professional guidelines, nor are there standard screening tools to identify it, said Dr. Li Smith.

These gaps put pressure on physicians to ask about financial barriers and concerns, but most do not know how to broach the topic or how to help. “Physicians may not know how to fix the problem or what resources exist,” Dr. Li Smith said.

Patients and family members, on the other hand, are often reluctant to bring up cost with physicians. Some may be ashamed to talk about their financial problems while others may fear doing so will prevent them from being offered the best possible treatments, said Ms. MacDonald.

But, experts say, financial toxicity needs to be dealt with head on. That means involving financial navigators or counselors and social workers who can, for instance, help patients and families find financial support for their basic living expenses.

From a research perspective, more clinical trials should include financial toxicity outcomes, said Joshua Palmer, MD, a radiation oncologist at the University of Michigan, Ann Arbor.

Dr. Palmer and colleagues recently showed that the number of radiation therapy clinical trials including financial toxicity endpoints increased significantly from 2001 to 2020, though the absolute rate of inclusion remains low, at roughly 1.5% of radiation therapy-based clinical trials including financial toxicity endpoints from 2016 to 2020.

“Financial burden is part of the broader discussion about shared decision-making,” said Dr. Palmer.

In shared decision-making, physicians discuss the risks and benefits of different treatment options, empowering the patient to make an informed choice with the physician.

What we want to avoid is patients feeling like they will get inferior care, if they have financial barriers, said Dr. Palmer.

And every little bit can help. In 2006, Ms. MacDonald started the Pink Fund – a nonprofit to help patients with cancer cover nonmedical cost-of-living expenses. Both Ms. Caputo and Ms. Dicks received grants from the Pink Fund. For Ms. Caputo, the funds covered 2 months of car payments and for Ms. Dicks, it covered 2 months of rent.

While the one-time grant was a big help, said Ms. Dicks, “cancer is an everyday thing.” And “we all deserve peace of mind” when trying to heal.

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

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Tips on Better Patients Communication

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Healing starts with eye-to- eye contact

SAN DIEGO—Don’t stand when you talk at bedside. Ditch the white gowns, turn away from your computers and pagers, and stop yourself from interrupting all the time.

These tips—and more—can help clinicians provide better and more effective care, said a colorectal surgeon who spoke about communication skills at the annual meeting of the Association of VA Hematology/Oncology (AVAHO).

 

Research has suggested that nearly half of Americans don’t think their health care practitioners (HCPs) are compassionate, “and that’s really sad,” said Lorene Valdez-Boyle, MD, MS, surgery chief at the New Mexico VA Health Care Service.

 

To combat this perception, she said, HCPs can adopt multiple strategies as they work with veterans and their families. The goal, she said, is “to try to get them to trust you and want to be part of their treatment. This is how we're going to have better outcomes.”

 

Some strategies are simple. Dr. Valdez-Boyle, for example, doesn’t wear a white gown when she sees patients. “Obviously, they’re really gross,” she said. “But also, I want them to be comfortable with me. I sit down at their level, and we have a conversation. We talk about our dogs and we bond, because that’s going to help them trust me and want to work with me. I do that with families too. We joke, and we laugh.”

 

Sitting bedside instead of standing is important, she said, and a 2016 study backs up this idea. “It’s difficult when you’re running around or you want to get to the next one, and the patient just keeps talking,” she said. But research showed that “when the clinician sat, the patient felt like they listened more carefully, and they explained things in a better way that was much easier for them to understand. They definitely had an improved perception of their [clinician’s] communication skills.”

She highlighted another 2016 study that examined a Commit to Sit initiative in which nurses were urged to sit with patients during each shift. Nurse communication scores and overall patient experience scores went up.

 

The VA now has a Commit to Sit initiative, which urges clinicians to put away computers, smart phones, and pagers. “The patient feels that we’ve listened more intently to their concerns and care more about them as a patient,” Dr. Valdez-Boyle said. “We have an improved understanding of their health as a result of this. It allows the site employee to continue to be efficient while still delivering compassionate care and fosters trusted relationships in an empathetic and respectful manner.”

 

For more about the initiative, visit the VA PX SharePoint.

 

The VA, she said, also has a Take a Moment initiative that emphasizes eye contact, face-to-face interaction without electronics for at least the first 5 minutes of each visit, and seated conversations.

 

Dr. Valdez-Boyle also urged colleagues to pay attention to how often they interrupt. She pointed to a 2019 study that reported that patients had a median of 11 seconds—yes, seconds—to explain their problem in two-thirds of clinician encounters. “I think some of it is because we think we know what they're going to say.”

 

In the age of COVID-19, she suggested turning to fist or elbow bumps instead of handshakes. And she said, let patients wear street clothes when appropriate so they’re more comfortable. 

 

In the big picture, she said, good communication and a commitment to shared decision making “really create a shared responsibility. They give your patients ownership over their disease and the ability to make the decisions with their team.

 

Dr. Valdez-Boyle reported no disclosures.

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Healing starts with eye-to- eye contact
Healing starts with eye-to- eye contact

SAN DIEGO—Don’t stand when you talk at bedside. Ditch the white gowns, turn away from your computers and pagers, and stop yourself from interrupting all the time.

These tips—and more—can help clinicians provide better and more effective care, said a colorectal surgeon who spoke about communication skills at the annual meeting of the Association of VA Hematology/Oncology (AVAHO).

 

Research has suggested that nearly half of Americans don’t think their health care practitioners (HCPs) are compassionate, “and that’s really sad,” said Lorene Valdez-Boyle, MD, MS, surgery chief at the New Mexico VA Health Care Service.

 

To combat this perception, she said, HCPs can adopt multiple strategies as they work with veterans and their families. The goal, she said, is “to try to get them to trust you and want to be part of their treatment. This is how we're going to have better outcomes.”

 

Some strategies are simple. Dr. Valdez-Boyle, for example, doesn’t wear a white gown when she sees patients. “Obviously, they’re really gross,” she said. “But also, I want them to be comfortable with me. I sit down at their level, and we have a conversation. We talk about our dogs and we bond, because that’s going to help them trust me and want to work with me. I do that with families too. We joke, and we laugh.”

 

Sitting bedside instead of standing is important, she said, and a 2016 study backs up this idea. “It’s difficult when you’re running around or you want to get to the next one, and the patient just keeps talking,” she said. But research showed that “when the clinician sat, the patient felt like they listened more carefully, and they explained things in a better way that was much easier for them to understand. They definitely had an improved perception of their [clinician’s] communication skills.”

She highlighted another 2016 study that examined a Commit to Sit initiative in which nurses were urged to sit with patients during each shift. Nurse communication scores and overall patient experience scores went up.

 

The VA now has a Commit to Sit initiative, which urges clinicians to put away computers, smart phones, and pagers. “The patient feels that we’ve listened more intently to their concerns and care more about them as a patient,” Dr. Valdez-Boyle said. “We have an improved understanding of their health as a result of this. It allows the site employee to continue to be efficient while still delivering compassionate care and fosters trusted relationships in an empathetic and respectful manner.”

 

For more about the initiative, visit the VA PX SharePoint.

 

The VA, she said, also has a Take a Moment initiative that emphasizes eye contact, face-to-face interaction without electronics for at least the first 5 minutes of each visit, and seated conversations.

 

Dr. Valdez-Boyle also urged colleagues to pay attention to how often they interrupt. She pointed to a 2019 study that reported that patients had a median of 11 seconds—yes, seconds—to explain their problem in two-thirds of clinician encounters. “I think some of it is because we think we know what they're going to say.”

 

In the age of COVID-19, she suggested turning to fist or elbow bumps instead of handshakes. And she said, let patients wear street clothes when appropriate so they’re more comfortable. 

 

In the big picture, she said, good communication and a commitment to shared decision making “really create a shared responsibility. They give your patients ownership over their disease and the ability to make the decisions with their team.

 

Dr. Valdez-Boyle reported no disclosures.

SAN DIEGO—Don’t stand when you talk at bedside. Ditch the white gowns, turn away from your computers and pagers, and stop yourself from interrupting all the time.

These tips—and more—can help clinicians provide better and more effective care, said a colorectal surgeon who spoke about communication skills at the annual meeting of the Association of VA Hematology/Oncology (AVAHO).

 

Research has suggested that nearly half of Americans don’t think their health care practitioners (HCPs) are compassionate, “and that’s really sad,” said Lorene Valdez-Boyle, MD, MS, surgery chief at the New Mexico VA Health Care Service.

 

To combat this perception, she said, HCPs can adopt multiple strategies as they work with veterans and their families. The goal, she said, is “to try to get them to trust you and want to be part of their treatment. This is how we're going to have better outcomes.”

 

Some strategies are simple. Dr. Valdez-Boyle, for example, doesn’t wear a white gown when she sees patients. “Obviously, they’re really gross,” she said. “But also, I want them to be comfortable with me. I sit down at their level, and we have a conversation. We talk about our dogs and we bond, because that’s going to help them trust me and want to work with me. I do that with families too. We joke, and we laugh.”

 

Sitting bedside instead of standing is important, she said, and a 2016 study backs up this idea. “It’s difficult when you’re running around or you want to get to the next one, and the patient just keeps talking,” she said. But research showed that “when the clinician sat, the patient felt like they listened more carefully, and they explained things in a better way that was much easier for them to understand. They definitely had an improved perception of their [clinician’s] communication skills.”

She highlighted another 2016 study that examined a Commit to Sit initiative in which nurses were urged to sit with patients during each shift. Nurse communication scores and overall patient experience scores went up.

 

The VA now has a Commit to Sit initiative, which urges clinicians to put away computers, smart phones, and pagers. “The patient feels that we’ve listened more intently to their concerns and care more about them as a patient,” Dr. Valdez-Boyle said. “We have an improved understanding of their health as a result of this. It allows the site employee to continue to be efficient while still delivering compassionate care and fosters trusted relationships in an empathetic and respectful manner.”

 

For more about the initiative, visit the VA PX SharePoint.

 

The VA, she said, also has a Take a Moment initiative that emphasizes eye contact, face-to-face interaction without electronics for at least the first 5 minutes of each visit, and seated conversations.

 

Dr. Valdez-Boyle also urged colleagues to pay attention to how often they interrupt. She pointed to a 2019 study that reported that patients had a median of 11 seconds—yes, seconds—to explain their problem in two-thirds of clinician encounters. “I think some of it is because we think we know what they're going to say.”

 

In the age of COVID-19, she suggested turning to fist or elbow bumps instead of handshakes. And she said, let patients wear street clothes when appropriate so they’re more comfortable. 

 

In the big picture, she said, good communication and a commitment to shared decision making “really create a shared responsibility. They give your patients ownership over their disease and the ability to make the decisions with their team.

 

Dr. Valdez-Boyle reported no disclosures.

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Health care workers face unimaginable decisions in Ukraine

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The effects of the Russian invasion of Ukraine have been devastating, with the loss of tens of thousands of civilian lives and about one-third of the population having been displaced. The war has put a great strain on health care in the country.

“The Russian army is targeting civilian infrastructure, trying to plunge Ukrainians into cold and darkness. (It) is also deliberately targeting hospitals and clinics in Ukraine,” said Nataliya Kovalchuk, PhD, during a session on Ukraine health care at the annual meeting of the American Society for Radiation Oncology held this week in San Antonio. She is a clinical associate professor of radiation oncology at Stanford (Calif.) University.

Analysis of previous wars have shown an increase in cancer incidence and mortality, and the same should be expected in the future in Ukraine, according to Ruslan Zelinskyi, MS, who is president of the Ukrainian Association of Medical Physicists and practices at Spizhenko Clinic in Ukraine. “We must prepare for it now, and we do it. During the full-scale war in Ukraine, three new linear accelerators were installed and put into clinical use,” he said during his talk.

He also gave a personal perspective of the terrible conditions and choices facing Ukrainian health care workers. “I have often heard that science is outside of politics. Perhaps in peacetime, but when fragments of missiles pass through the wall” – here, Mr. Zelinskyi paused to swing the camera around to show bomb damage on the walls of the room where he was conducting his virtual talk – “it is impossible to be outside of politics when 900 medical facilities were destroyed or damaged.” Health care workers have been killed, and patients have lost months or years because they could not receive medical care.

That reality is forcing Ukrainians to make choices most health care workers would struggle to imagine. “For many years, I put on medical clothes and fight against cancer. But (for) me comes the moment when I will change my medical clothes to military (clothes), like many, many other Ukrainians of various professions, because we must preserve the freedom of Ukraine and the security of Europe to do science in a peaceful world,” Mr. Zelinskyi said.

Following Mr. Zelinskyi’s talk, Asya Agulnik, MD, MPH, director of the St. Jude’s Global Critical Care Program and a pediatric intensivist at St. Jude’s Children’s Research Hospital, Memphis, described St. Jude’s efforts with pediatric cancer patients. St. Jude’s Global Critical Care Program created a Eurasian Regional Program in 2018 to serve Central Asia and Eastern Europe, which now includes 48 institutions and more than 250 clinicians and members that help care for children with cancer.

In the aftermath of the invasion, the Eurasian Regional Program launched the Safer Ukraine network to ensure continued care for children with cancer and blood disorders. Initially, the patient’s family or physician identifies a child has having a medical need that cannot be met locally and requiring evacuation. The nongovernmental organization Tabletochki, which has worked with children with cancer in Ukraine since 2011, then arranges transport of the child and his or her medical records to the Ukrainian Specialized Children’s Center in Lviv, Ukraine, for evaluation and stabilization. From there, patients along with their mother and sometimes siblings are transferred to Poland. Transportation methods include ambulance, helicopter, bus, and medical trains that have a full intensive care unit aboard.

In Poland, hospitals estimated they could take on another 200 patients without compromising care for their existing patients, but evacuations reached that number within the first few weeks of the war. It was clear patients would have to be transferred to other countries. To do that, Safer Ukraine set up the Unicorn Marian Wilemski Clinic, which is a converted hotel operated as a partnership between many foundations and governments. It sends unstable patients to nearby emergency rooms, and stable patients stay at the clinic until they can be evaluated and matched with an international care provider from a registry of more than 200 hospitals in 29 countries that have agreed to take patients. A 24/7 Zoom call began on the first day of the war, initially staffed by St. Jude volunteers and now by a contractor. It serves as a command center.

Over the first 12 weeks of the war, the program evacuated over 1,000 children, and over 200 medical records per week were being translated at peak activity. Nearly 300 patients went to Poland, and the rest to 18 countries in Europe and North America.

The success of the initiative stems in part from the fact that it leveraged preexisting collaborations that focused on childhood cancer, according to Dr. Agulnik. “Many stakeholders that came together had previously worked together, but then quickly came together around this unified initiative with the goal of helping these patients,” she said during her talk.

Roman Kowalchuk, MD, who is a radiation oncology resident at Mayo Clinic, spoke about telemedicine efforts to assist physicians and patients in Ukraine.

“I’ve been especially interested in trying to help through telemedicine. We have so much expertise, so many things that we can offer, even if we can’t be there physically, through some of these avenues that really, especially through COVID, have been further developed in terms of virtual support, virtual expertise, and consultations. That presents the opportunity to be able to share some of that knowledge, some of that expertise, to help clinical care in Ukraine given the current circumstance,” said Dr. Kowalchuk during his presentation.

Efforts have used technology like the telemedicine platform Viveo, based in Estonia. One app, called HealUA, takes descriptions from physicians needing advice, and volunteers can scroll through inquiries and provide input. This is especially useful since most physicians in Ukraine are generalists, according to Dr. Kowalchuk, and so may need assistance with diagnosis and management of rare conditions.

Other telehealth approaches include TeleHelp Ukraine. There are WhatsApp groups with hundreds of volunteers who translate Ukrainian medical records to other languages to help non-Ukrainian physicians understand a patient’s history. Expertise is also needed in engineering, emergency medicine, surgery, various fields of oncology, and other specialties. Dr. Kowalchuk noted that Good Samaritan laws generally shield volunteers in these types of programs from legal liability.

International hospital networks taking part in these efforts include St. Jude, European Cancer Organization, American Cancer Society, American Society for Clinical Oncology, and ASTRO.

None of the presenters have relevant financial disclosures.

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The effects of the Russian invasion of Ukraine have been devastating, with the loss of tens of thousands of civilian lives and about one-third of the population having been displaced. The war has put a great strain on health care in the country.

“The Russian army is targeting civilian infrastructure, trying to plunge Ukrainians into cold and darkness. (It) is also deliberately targeting hospitals and clinics in Ukraine,” said Nataliya Kovalchuk, PhD, during a session on Ukraine health care at the annual meeting of the American Society for Radiation Oncology held this week in San Antonio. She is a clinical associate professor of radiation oncology at Stanford (Calif.) University.

Analysis of previous wars have shown an increase in cancer incidence and mortality, and the same should be expected in the future in Ukraine, according to Ruslan Zelinskyi, MS, who is president of the Ukrainian Association of Medical Physicists and practices at Spizhenko Clinic in Ukraine. “We must prepare for it now, and we do it. During the full-scale war in Ukraine, three new linear accelerators were installed and put into clinical use,” he said during his talk.

He also gave a personal perspective of the terrible conditions and choices facing Ukrainian health care workers. “I have often heard that science is outside of politics. Perhaps in peacetime, but when fragments of missiles pass through the wall” – here, Mr. Zelinskyi paused to swing the camera around to show bomb damage on the walls of the room where he was conducting his virtual talk – “it is impossible to be outside of politics when 900 medical facilities were destroyed or damaged.” Health care workers have been killed, and patients have lost months or years because they could not receive medical care.

That reality is forcing Ukrainians to make choices most health care workers would struggle to imagine. “For many years, I put on medical clothes and fight against cancer. But (for) me comes the moment when I will change my medical clothes to military (clothes), like many, many other Ukrainians of various professions, because we must preserve the freedom of Ukraine and the security of Europe to do science in a peaceful world,” Mr. Zelinskyi said.

Following Mr. Zelinskyi’s talk, Asya Agulnik, MD, MPH, director of the St. Jude’s Global Critical Care Program and a pediatric intensivist at St. Jude’s Children’s Research Hospital, Memphis, described St. Jude’s efforts with pediatric cancer patients. St. Jude’s Global Critical Care Program created a Eurasian Regional Program in 2018 to serve Central Asia and Eastern Europe, which now includes 48 institutions and more than 250 clinicians and members that help care for children with cancer.

In the aftermath of the invasion, the Eurasian Regional Program launched the Safer Ukraine network to ensure continued care for children with cancer and blood disorders. Initially, the patient’s family or physician identifies a child has having a medical need that cannot be met locally and requiring evacuation. The nongovernmental organization Tabletochki, which has worked with children with cancer in Ukraine since 2011, then arranges transport of the child and his or her medical records to the Ukrainian Specialized Children’s Center in Lviv, Ukraine, for evaluation and stabilization. From there, patients along with their mother and sometimes siblings are transferred to Poland. Transportation methods include ambulance, helicopter, bus, and medical trains that have a full intensive care unit aboard.

In Poland, hospitals estimated they could take on another 200 patients without compromising care for their existing patients, but evacuations reached that number within the first few weeks of the war. It was clear patients would have to be transferred to other countries. To do that, Safer Ukraine set up the Unicorn Marian Wilemski Clinic, which is a converted hotel operated as a partnership between many foundations and governments. It sends unstable patients to nearby emergency rooms, and stable patients stay at the clinic until they can be evaluated and matched with an international care provider from a registry of more than 200 hospitals in 29 countries that have agreed to take patients. A 24/7 Zoom call began on the first day of the war, initially staffed by St. Jude volunteers and now by a contractor. It serves as a command center.

Over the first 12 weeks of the war, the program evacuated over 1,000 children, and over 200 medical records per week were being translated at peak activity. Nearly 300 patients went to Poland, and the rest to 18 countries in Europe and North America.

The success of the initiative stems in part from the fact that it leveraged preexisting collaborations that focused on childhood cancer, according to Dr. Agulnik. “Many stakeholders that came together had previously worked together, but then quickly came together around this unified initiative with the goal of helping these patients,” she said during her talk.

Roman Kowalchuk, MD, who is a radiation oncology resident at Mayo Clinic, spoke about telemedicine efforts to assist physicians and patients in Ukraine.

“I’ve been especially interested in trying to help through telemedicine. We have so much expertise, so many things that we can offer, even if we can’t be there physically, through some of these avenues that really, especially through COVID, have been further developed in terms of virtual support, virtual expertise, and consultations. That presents the opportunity to be able to share some of that knowledge, some of that expertise, to help clinical care in Ukraine given the current circumstance,” said Dr. Kowalchuk during his presentation.

Efforts have used technology like the telemedicine platform Viveo, based in Estonia. One app, called HealUA, takes descriptions from physicians needing advice, and volunteers can scroll through inquiries and provide input. This is especially useful since most physicians in Ukraine are generalists, according to Dr. Kowalchuk, and so may need assistance with diagnosis and management of rare conditions.

Other telehealth approaches include TeleHelp Ukraine. There are WhatsApp groups with hundreds of volunteers who translate Ukrainian medical records to other languages to help non-Ukrainian physicians understand a patient’s history. Expertise is also needed in engineering, emergency medicine, surgery, various fields of oncology, and other specialties. Dr. Kowalchuk noted that Good Samaritan laws generally shield volunteers in these types of programs from legal liability.

International hospital networks taking part in these efforts include St. Jude, European Cancer Organization, American Cancer Society, American Society for Clinical Oncology, and ASTRO.

None of the presenters have relevant financial disclosures.

The effects of the Russian invasion of Ukraine have been devastating, with the loss of tens of thousands of civilian lives and about one-third of the population having been displaced. The war has put a great strain on health care in the country.

“The Russian army is targeting civilian infrastructure, trying to plunge Ukrainians into cold and darkness. (It) is also deliberately targeting hospitals and clinics in Ukraine,” said Nataliya Kovalchuk, PhD, during a session on Ukraine health care at the annual meeting of the American Society for Radiation Oncology held this week in San Antonio. She is a clinical associate professor of radiation oncology at Stanford (Calif.) University.

Analysis of previous wars have shown an increase in cancer incidence and mortality, and the same should be expected in the future in Ukraine, according to Ruslan Zelinskyi, MS, who is president of the Ukrainian Association of Medical Physicists and practices at Spizhenko Clinic in Ukraine. “We must prepare for it now, and we do it. During the full-scale war in Ukraine, three new linear accelerators were installed and put into clinical use,” he said during his talk.

He also gave a personal perspective of the terrible conditions and choices facing Ukrainian health care workers. “I have often heard that science is outside of politics. Perhaps in peacetime, but when fragments of missiles pass through the wall” – here, Mr. Zelinskyi paused to swing the camera around to show bomb damage on the walls of the room where he was conducting his virtual talk – “it is impossible to be outside of politics when 900 medical facilities were destroyed or damaged.” Health care workers have been killed, and patients have lost months or years because they could not receive medical care.

That reality is forcing Ukrainians to make choices most health care workers would struggle to imagine. “For many years, I put on medical clothes and fight against cancer. But (for) me comes the moment when I will change my medical clothes to military (clothes), like many, many other Ukrainians of various professions, because we must preserve the freedom of Ukraine and the security of Europe to do science in a peaceful world,” Mr. Zelinskyi said.

Following Mr. Zelinskyi’s talk, Asya Agulnik, MD, MPH, director of the St. Jude’s Global Critical Care Program and a pediatric intensivist at St. Jude’s Children’s Research Hospital, Memphis, described St. Jude’s efforts with pediatric cancer patients. St. Jude’s Global Critical Care Program created a Eurasian Regional Program in 2018 to serve Central Asia and Eastern Europe, which now includes 48 institutions and more than 250 clinicians and members that help care for children with cancer.

In the aftermath of the invasion, the Eurasian Regional Program launched the Safer Ukraine network to ensure continued care for children with cancer and blood disorders. Initially, the patient’s family or physician identifies a child has having a medical need that cannot be met locally and requiring evacuation. The nongovernmental organization Tabletochki, which has worked with children with cancer in Ukraine since 2011, then arranges transport of the child and his or her medical records to the Ukrainian Specialized Children’s Center in Lviv, Ukraine, for evaluation and stabilization. From there, patients along with their mother and sometimes siblings are transferred to Poland. Transportation methods include ambulance, helicopter, bus, and medical trains that have a full intensive care unit aboard.

In Poland, hospitals estimated they could take on another 200 patients without compromising care for their existing patients, but evacuations reached that number within the first few weeks of the war. It was clear patients would have to be transferred to other countries. To do that, Safer Ukraine set up the Unicorn Marian Wilemski Clinic, which is a converted hotel operated as a partnership between many foundations and governments. It sends unstable patients to nearby emergency rooms, and stable patients stay at the clinic until they can be evaluated and matched with an international care provider from a registry of more than 200 hospitals in 29 countries that have agreed to take patients. A 24/7 Zoom call began on the first day of the war, initially staffed by St. Jude volunteers and now by a contractor. It serves as a command center.

Over the first 12 weeks of the war, the program evacuated over 1,000 children, and over 200 medical records per week were being translated at peak activity. Nearly 300 patients went to Poland, and the rest to 18 countries in Europe and North America.

The success of the initiative stems in part from the fact that it leveraged preexisting collaborations that focused on childhood cancer, according to Dr. Agulnik. “Many stakeholders that came together had previously worked together, but then quickly came together around this unified initiative with the goal of helping these patients,” she said during her talk.

Roman Kowalchuk, MD, who is a radiation oncology resident at Mayo Clinic, spoke about telemedicine efforts to assist physicians and patients in Ukraine.

“I’ve been especially interested in trying to help through telemedicine. We have so much expertise, so many things that we can offer, even if we can’t be there physically, through some of these avenues that really, especially through COVID, have been further developed in terms of virtual support, virtual expertise, and consultations. That presents the opportunity to be able to share some of that knowledge, some of that expertise, to help clinical care in Ukraine given the current circumstance,” said Dr. Kowalchuk during his presentation.

Efforts have used technology like the telemedicine platform Viveo, based in Estonia. One app, called HealUA, takes descriptions from physicians needing advice, and volunteers can scroll through inquiries and provide input. This is especially useful since most physicians in Ukraine are generalists, according to Dr. Kowalchuk, and so may need assistance with diagnosis and management of rare conditions.

Other telehealth approaches include TeleHelp Ukraine. There are WhatsApp groups with hundreds of volunteers who translate Ukrainian medical records to other languages to help non-Ukrainian physicians understand a patient’s history. Expertise is also needed in engineering, emergency medicine, surgery, various fields of oncology, and other specialties. Dr. Kowalchuk noted that Good Samaritan laws generally shield volunteers in these types of programs from legal liability.

International hospital networks taking part in these efforts include St. Jude, European Cancer Organization, American Cancer Society, American Society for Clinical Oncology, and ASTRO.

None of the presenters have relevant financial disclosures.

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Brussels terror attack victim euthanized in Belgium at age 23

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This article was originally published on MediQuality.com, an online service for health care professionals in the Benelux and a member of the Medscape Professional Network.

Performing euthanasia for “mental suffering that cannot be alleviated” is still considered an extraordinary measure in Belgium. Indeed, fewer than 2% of the requests for euthanasia fall within that category, and few such requests are made by young patients.

There is no doubt that people will talk about the case of Shanti De Corte not only because of the reason stated in her euthanasia request but also because someone so young was able to meet the strict conditions required for the law to be applicable. It’s something that Belgian broadcaster RTBF brought up during a recent episode of #Investigation, which reported on the aftermath of the 2016 Brussels attacks.

On May 7, surrounded by her family, Ms. De Corte was euthanized. She was 23 years old. Six years earlier, on March 22, 2016, Ms. De Corte had been at Brussels Airport when terrorists set off bombs. She was in the departures area with 90 other students from Sint-Rita Campus College, located in the northern town of Kontich. Ms. De Corte was only a few meters away from the blast. Although she was not physically injured, the Flemish teen was traumatized by the attack. This was confirmed by the school psychologist who treated the students. “There were some students who reacted worse than others to these traumatic events. And having had two discussions with Shanti, I can tell you that she was one of these students who were more sensitive to the effects. To me, it’s quite clear. Even before the attacks, she’d experienced serious psychological issues. Therefore, I referred her for psychiatric care.”
 

Eleven antidepressants daily

A few weeks after that March day, Ms. De Corte was admitted to a psychiatric hospital in Antwerp. It was a place she knew well, having been an inpatient there several times before the attacks. Ms. De Corte was treated with antidepressants. She shared her thoughts about them on numerous occasions. “I get several drugs at breakfast and up to 11 antidepressants a day. I couldn’t do without them. With all the drugs I take, I feel like a ghost who doesn’t feel anything anymore. Perhaps there were solutions other than the drugs.”

It was a brief respite. In 2020, Ms. De Corte attempted suicide. Her spirits were at their lowest. She was heavily medicated, and her medication had been increased over time. She turned down therapeutic help that was offered by a therapist who specializes in treating the victims of the Brussels attacks. The student got in touch with the Life End Information Forum, an association that supports the right to die with dignity. In April 2022, Ms. De Corte submitted a new euthanasia request, stating that she was in a medically futile condition of mental suffering. Two psychiatrists granted their approval.
 

A small proportion

Last March, Belgium’s Federal Commission for the Control and Evaluation of Euthanasia reported on data from 2021. “There continues to be a very small number of euthanasia requests that cite mental and behavioral disorders (psychiatric conditions, such as personality disorders, and cognitive issues, like Alzheimer’s disease, are included in this group): 1.9% of all cases of euthanasia. Like all euthanasia files, these requests meet the legal conditions (the patient is legally competent, the request is in writing, the condition is medically futile, and the suffering – which is constant, unbearable, and cannot be alleviated – results from a serious and incurable disorder; the request is well-considered and repeated),” the report states.



This article was translated from MediQuality and appeared on Medscape.com.

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This article was originally published on MediQuality.com, an online service for health care professionals in the Benelux and a member of the Medscape Professional Network.

Performing euthanasia for “mental suffering that cannot be alleviated” is still considered an extraordinary measure in Belgium. Indeed, fewer than 2% of the requests for euthanasia fall within that category, and few such requests are made by young patients.

There is no doubt that people will talk about the case of Shanti De Corte not only because of the reason stated in her euthanasia request but also because someone so young was able to meet the strict conditions required for the law to be applicable. It’s something that Belgian broadcaster RTBF brought up during a recent episode of #Investigation, which reported on the aftermath of the 2016 Brussels attacks.

On May 7, surrounded by her family, Ms. De Corte was euthanized. She was 23 years old. Six years earlier, on March 22, 2016, Ms. De Corte had been at Brussels Airport when terrorists set off bombs. She was in the departures area with 90 other students from Sint-Rita Campus College, located in the northern town of Kontich. Ms. De Corte was only a few meters away from the blast. Although she was not physically injured, the Flemish teen was traumatized by the attack. This was confirmed by the school psychologist who treated the students. “There were some students who reacted worse than others to these traumatic events. And having had two discussions with Shanti, I can tell you that she was one of these students who were more sensitive to the effects. To me, it’s quite clear. Even before the attacks, she’d experienced serious psychological issues. Therefore, I referred her for psychiatric care.”
 

Eleven antidepressants daily

A few weeks after that March day, Ms. De Corte was admitted to a psychiatric hospital in Antwerp. It was a place she knew well, having been an inpatient there several times before the attacks. Ms. De Corte was treated with antidepressants. She shared her thoughts about them on numerous occasions. “I get several drugs at breakfast and up to 11 antidepressants a day. I couldn’t do without them. With all the drugs I take, I feel like a ghost who doesn’t feel anything anymore. Perhaps there were solutions other than the drugs.”

It was a brief respite. In 2020, Ms. De Corte attempted suicide. Her spirits were at their lowest. She was heavily medicated, and her medication had been increased over time. She turned down therapeutic help that was offered by a therapist who specializes in treating the victims of the Brussels attacks. The student got in touch with the Life End Information Forum, an association that supports the right to die with dignity. In April 2022, Ms. De Corte submitted a new euthanasia request, stating that she was in a medically futile condition of mental suffering. Two psychiatrists granted their approval.
 

A small proportion

Last March, Belgium’s Federal Commission for the Control and Evaluation of Euthanasia reported on data from 2021. “There continues to be a very small number of euthanasia requests that cite mental and behavioral disorders (psychiatric conditions, such as personality disorders, and cognitive issues, like Alzheimer’s disease, are included in this group): 1.9% of all cases of euthanasia. Like all euthanasia files, these requests meet the legal conditions (the patient is legally competent, the request is in writing, the condition is medically futile, and the suffering – which is constant, unbearable, and cannot be alleviated – results from a serious and incurable disorder; the request is well-considered and repeated),” the report states.



This article was translated from MediQuality and appeared on Medscape.com.

This article was originally published on MediQuality.com, an online service for health care professionals in the Benelux and a member of the Medscape Professional Network.

Performing euthanasia for “mental suffering that cannot be alleviated” is still considered an extraordinary measure in Belgium. Indeed, fewer than 2% of the requests for euthanasia fall within that category, and few such requests are made by young patients.

There is no doubt that people will talk about the case of Shanti De Corte not only because of the reason stated in her euthanasia request but also because someone so young was able to meet the strict conditions required for the law to be applicable. It’s something that Belgian broadcaster RTBF brought up during a recent episode of #Investigation, which reported on the aftermath of the 2016 Brussels attacks.

On May 7, surrounded by her family, Ms. De Corte was euthanized. She was 23 years old. Six years earlier, on March 22, 2016, Ms. De Corte had been at Brussels Airport when terrorists set off bombs. She was in the departures area with 90 other students from Sint-Rita Campus College, located in the northern town of Kontich. Ms. De Corte was only a few meters away from the blast. Although she was not physically injured, the Flemish teen was traumatized by the attack. This was confirmed by the school psychologist who treated the students. “There were some students who reacted worse than others to these traumatic events. And having had two discussions with Shanti, I can tell you that she was one of these students who were more sensitive to the effects. To me, it’s quite clear. Even before the attacks, she’d experienced serious psychological issues. Therefore, I referred her for psychiatric care.”
 

Eleven antidepressants daily

A few weeks after that March day, Ms. De Corte was admitted to a psychiatric hospital in Antwerp. It was a place she knew well, having been an inpatient there several times before the attacks. Ms. De Corte was treated with antidepressants. She shared her thoughts about them on numerous occasions. “I get several drugs at breakfast and up to 11 antidepressants a day. I couldn’t do without them. With all the drugs I take, I feel like a ghost who doesn’t feel anything anymore. Perhaps there were solutions other than the drugs.”

It was a brief respite. In 2020, Ms. De Corte attempted suicide. Her spirits were at their lowest. She was heavily medicated, and her medication had been increased over time. She turned down therapeutic help that was offered by a therapist who specializes in treating the victims of the Brussels attacks. The student got in touch with the Life End Information Forum, an association that supports the right to die with dignity. In April 2022, Ms. De Corte submitted a new euthanasia request, stating that she was in a medically futile condition of mental suffering. Two psychiatrists granted their approval.
 

A small proportion

Last March, Belgium’s Federal Commission for the Control and Evaluation of Euthanasia reported on data from 2021. “There continues to be a very small number of euthanasia requests that cite mental and behavioral disorders (psychiatric conditions, such as personality disorders, and cognitive issues, like Alzheimer’s disease, are included in this group): 1.9% of all cases of euthanasia. Like all euthanasia files, these requests meet the legal conditions (the patient is legally competent, the request is in writing, the condition is medically futile, and the suffering – which is constant, unbearable, and cannot be alleviated – results from a serious and incurable disorder; the request is well-considered and repeated),” the report states.



This article was translated from MediQuality and appeared on Medscape.com.

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Ivermectin for COVID-19: Final nail in the coffin

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Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.

It began in a petri dish.

Ivermectin, a widely available, cheap, and well-tolerated drug on the WHO’s list of essential medicines for its critical role in treating river blindness, was shown to dramatically reduce the proliferation of SARS-CoV-2 virus in cell culture.

You know the rest of the story. Despite the fact that the median inhibitory concentration in cell culture is about 100-fold higher than what one can achieve with oral dosing in humans, anecdotal reports of miraculous cures proliferated.

Cohort studies suggested that people who got ivermectin did very well in terms of COVID outcomes.

A narrative started to develop online – one that is still quite present today – that authorities were suppressing the good news about ivermectin in order to line their own pockets and those of the execs at Big Pharma. The official Twitter account of the Food and Drug Administration clapped back, reminding the populace that we are not horses or cows.

And every time a study came out that seemed like the nail in the coffin for the so-called horse paste, it rose again, vampire-like, feasting on the blood of social media outrage.

The truth is that, while excitement for ivermectin mounted online, it crashed quite quickly in scientific circles. Most randomized trials showed no effect of the drug. A couple of larger trials which seemed to show dramatic effects were subsequently shown to be fraudulent.

Then the TOGETHER trial was published. The 1,400-patient study from Brazil, which treated outpatients with COVID-19, found no significant difference in hospitalization or ER visits – the primary outcome – between those randomized to ivermectin vs. placebo or another therapy. 

But still, Brazil. Different population than the United States. Different health systems. And very different rates of Strongyloides infections (this is a parasite that may be incidentally treated by ivermectin, leading to improvement independent of the drug’s effect on COVID). We all wanted a U.S. trial.

And now we have it. ACTIV-6 was published Oct. 21 in JAMA, a study randomizing outpatients with COVID-19 from 93 sites around the United States to ivermectin or placebo.

A total of 1,591 individuals – median age 47, 60% female – with confirmed symptomatic COVID-19 were randomized from June 2021 to February 2022. About half had been vaccinated.

The primary outcome was straightforward: time to clinical recovery. Did ivermectin make people get better, faster?

It did not.
The time to recovery, defined as having three symptom-free days, was 12 days in the ivermectin group and 13 days in the placebo group – that’s within the margin of error.



But overall, everyone in the trial did fairly well. Serious outcomes, like death, hospitalization, urgent care, or ER visits, occurred in 32 people in the ivermectin group and 28 in the placebo group. Death itself was rare – just one occurred in the trial, in someone receiving ivermectin.OK, are we done with this drug yet? Is this nice U.S. randomized trial enough to convince people that results from a petri dish don’t always transfer to humans, regardless of the presence or absence of an evil pharmaceutical cabal?

No, of course not. At this point, I can predict the responses. The dose wasn’t high enough. It wasn’t given early enough. The patients weren’t sick enough, or they were too sick. This is motivated reasoning, plain and simple. It’s not to say that there isn’t a chance that this drug has some off-target effects on COVID that we haven’t adequately measured, but studies like ACTIV-6 effectively rule out the idea that it’s a miracle cure. And you know what? That’s OK. Miracle cures are vanishingly rare. Most things that work in medicine work OK; they make us a little better, and we learn why they do that and improve on them, and try again and again. It’s not flashy; it doesn’t have that allure of secret knowledge. But it’s what separates science from magic.



F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator; his science communication work can be found in the Huffington Post, on NPR, and on Medscape.

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

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Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.

It began in a petri dish.

Ivermectin, a widely available, cheap, and well-tolerated drug on the WHO’s list of essential medicines for its critical role in treating river blindness, was shown to dramatically reduce the proliferation of SARS-CoV-2 virus in cell culture.

You know the rest of the story. Despite the fact that the median inhibitory concentration in cell culture is about 100-fold higher than what one can achieve with oral dosing in humans, anecdotal reports of miraculous cures proliferated.

Cohort studies suggested that people who got ivermectin did very well in terms of COVID outcomes.

A narrative started to develop online – one that is still quite present today – that authorities were suppressing the good news about ivermectin in order to line their own pockets and those of the execs at Big Pharma. The official Twitter account of the Food and Drug Administration clapped back, reminding the populace that we are not horses or cows.

And every time a study came out that seemed like the nail in the coffin for the so-called horse paste, it rose again, vampire-like, feasting on the blood of social media outrage.

The truth is that, while excitement for ivermectin mounted online, it crashed quite quickly in scientific circles. Most randomized trials showed no effect of the drug. A couple of larger trials which seemed to show dramatic effects were subsequently shown to be fraudulent.

Then the TOGETHER trial was published. The 1,400-patient study from Brazil, which treated outpatients with COVID-19, found no significant difference in hospitalization or ER visits – the primary outcome – between those randomized to ivermectin vs. placebo or another therapy. 

But still, Brazil. Different population than the United States. Different health systems. And very different rates of Strongyloides infections (this is a parasite that may be incidentally treated by ivermectin, leading to improvement independent of the drug’s effect on COVID). We all wanted a U.S. trial.

And now we have it. ACTIV-6 was published Oct. 21 in JAMA, a study randomizing outpatients with COVID-19 from 93 sites around the United States to ivermectin or placebo.

A total of 1,591 individuals – median age 47, 60% female – with confirmed symptomatic COVID-19 were randomized from June 2021 to February 2022. About half had been vaccinated.

The primary outcome was straightforward: time to clinical recovery. Did ivermectin make people get better, faster?

It did not.
The time to recovery, defined as having three symptom-free days, was 12 days in the ivermectin group and 13 days in the placebo group – that’s within the margin of error.



But overall, everyone in the trial did fairly well. Serious outcomes, like death, hospitalization, urgent care, or ER visits, occurred in 32 people in the ivermectin group and 28 in the placebo group. Death itself was rare – just one occurred in the trial, in someone receiving ivermectin.OK, are we done with this drug yet? Is this nice U.S. randomized trial enough to convince people that results from a petri dish don’t always transfer to humans, regardless of the presence or absence of an evil pharmaceutical cabal?

No, of course not. At this point, I can predict the responses. The dose wasn’t high enough. It wasn’t given early enough. The patients weren’t sick enough, or they were too sick. This is motivated reasoning, plain and simple. It’s not to say that there isn’t a chance that this drug has some off-target effects on COVID that we haven’t adequately measured, but studies like ACTIV-6 effectively rule out the idea that it’s a miracle cure. And you know what? That’s OK. Miracle cures are vanishingly rare. Most things that work in medicine work OK; they make us a little better, and we learn why they do that and improve on them, and try again and again. It’s not flashy; it doesn’t have that allure of secret knowledge. But it’s what separates science from magic.



F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator; his science communication work can be found in the Huffington Post, on NPR, and on Medscape.

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

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.

It began in a petri dish.

Ivermectin, a widely available, cheap, and well-tolerated drug on the WHO’s list of essential medicines for its critical role in treating river blindness, was shown to dramatically reduce the proliferation of SARS-CoV-2 virus in cell culture.

You know the rest of the story. Despite the fact that the median inhibitory concentration in cell culture is about 100-fold higher than what one can achieve with oral dosing in humans, anecdotal reports of miraculous cures proliferated.

Cohort studies suggested that people who got ivermectin did very well in terms of COVID outcomes.

A narrative started to develop online – one that is still quite present today – that authorities were suppressing the good news about ivermectin in order to line their own pockets and those of the execs at Big Pharma. The official Twitter account of the Food and Drug Administration clapped back, reminding the populace that we are not horses or cows.

And every time a study came out that seemed like the nail in the coffin for the so-called horse paste, it rose again, vampire-like, feasting on the blood of social media outrage.

The truth is that, while excitement for ivermectin mounted online, it crashed quite quickly in scientific circles. Most randomized trials showed no effect of the drug. A couple of larger trials which seemed to show dramatic effects were subsequently shown to be fraudulent.

Then the TOGETHER trial was published. The 1,400-patient study from Brazil, which treated outpatients with COVID-19, found no significant difference in hospitalization or ER visits – the primary outcome – between those randomized to ivermectin vs. placebo or another therapy. 

But still, Brazil. Different population than the United States. Different health systems. And very different rates of Strongyloides infections (this is a parasite that may be incidentally treated by ivermectin, leading to improvement independent of the drug’s effect on COVID). We all wanted a U.S. trial.

And now we have it. ACTIV-6 was published Oct. 21 in JAMA, a study randomizing outpatients with COVID-19 from 93 sites around the United States to ivermectin or placebo.

A total of 1,591 individuals – median age 47, 60% female – with confirmed symptomatic COVID-19 were randomized from June 2021 to February 2022. About half had been vaccinated.

The primary outcome was straightforward: time to clinical recovery. Did ivermectin make people get better, faster?

It did not.
The time to recovery, defined as having three symptom-free days, was 12 days in the ivermectin group and 13 days in the placebo group – that’s within the margin of error.



But overall, everyone in the trial did fairly well. Serious outcomes, like death, hospitalization, urgent care, or ER visits, occurred in 32 people in the ivermectin group and 28 in the placebo group. Death itself was rare – just one occurred in the trial, in someone receiving ivermectin.OK, are we done with this drug yet? Is this nice U.S. randomized trial enough to convince people that results from a petri dish don’t always transfer to humans, regardless of the presence or absence of an evil pharmaceutical cabal?

No, of course not. At this point, I can predict the responses. The dose wasn’t high enough. It wasn’t given early enough. The patients weren’t sick enough, or they were too sick. This is motivated reasoning, plain and simple. It’s not to say that there isn’t a chance that this drug has some off-target effects on COVID that we haven’t adequately measured, but studies like ACTIV-6 effectively rule out the idea that it’s a miracle cure. And you know what? That’s OK. Miracle cures are vanishingly rare. Most things that work in medicine work OK; they make us a little better, and we learn why they do that and improve on them, and try again and again. It’s not flashy; it doesn’t have that allure of secret knowledge. But it’s what separates science from magic.



F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator; his science communication work can be found in the Huffington Post, on NPR, and on Medscape.

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

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Study affirms better breast cancer outcomes when chemo comes first

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New efficacy and safety data from the monarchE study show that chemotherapy administered before treatment with abemaciclib and estrogen therapy, led to a clinically meaningful improvement in invasive disease-free survival and distant relapse-free survival for women with HR-positive, ERBB2-negative, node-positive, early breast cancer at high risk of recurrence.

The study was published earlier this year in JAMA Oncology.

Neoadjuvant chemotherapy is often provided to such patients in hopes of achieving breast-conserving surgery. Although pathologic complete response rates can be higher than 50% after chemotherapy treatment in triple-negative and ERBB2-positive breast cancer, most patients with HR-positive and ERBB2-negative breast cancer have residual tumor at surgery after neoadjuvant chemotherapy, which is associated with an increased risk of recurrence.

Adjuvant estrogen therapy can reduce the risk of recurrence in this population, but a significant hazard remains.

“To our knowledge, abemaciclib is the first agent added to standard adjuvant estrogen therapy that has been shown to reduce the risk of recurrence in patients with HR-positive, ERBB2-negative early breast cancer with residual disease after neoadjuvant chemotherapy,” wrote the authors, who were led by Miguel Martin, MD, PhD, Hospital General Universitario Gregorio Marañon, Spain.

In 2021, Food and Drug Administration approved abemaciclib (Verzenio, Lilly) with endocrine therapy for the treatment of HR-positive/ERBB2-negative, node-positive, high-risk early breast cancer. Their decision was based on data from the monarchE study.

The study is at odds with the previously published Penelope-B study, which found no benefit from treatment with the CDK4/6 inhibitor palbociclib (Ibrance, Pfizer) after 42.8 months of follow-up. The authors suggest that the disparate outcomes may be due to pharmacological differences between the two drugs as well as different dosing schedules: In monarchE, patients received abemaciclib on a continuous basis, while patients in Penelope-B received palbociclib for 21 days, followed by 7 days off. The treatment duration was 2 years in monarchE and 1 year in Penelope-B. Abemaciclib can be dosed continuously because it is a stronger inhibitor of CDK4 versus CDK6 compared to abemaciclib, and in vitro studies suggest that continuous dosing could be a key factor in creating profound inhibition of DNA synthesis.

The monarchE study included 5,637 patients who were randomized to receive standard of care estrogen therapy for 5 years with or without abemaciclib (150 mg, twice per day) for 2 years; 36.5% received abemaciclib. The mean age was 49.9 years; 70.8% were White, 22.8% Asian, and 2.7% Black.

The abemaciclib group had a clinically and statistically significant benefit in invasive disease-free survival (IDFS) (hazard ratio, 0.61; nominal P < .001) and distant relapse-free survival (DRFS) (HR, 0.61; nominal P < .001). At 2 years, DRFS was 89.5% in the abemaciclib group and 82.8% in the estrogen therapy–only group. IDFS was 87.2% and 80.6%, respectively. Patients who underwent neoadjuvant chemotherapy had a similar safety profile to the estrogen therapy–only group, although there was a higher incidence of treatment-emergent adverse events. The most common were diarrhea, infections, neutropenia, and fatigue. The most frequent grade treatment-emergent adverse events (of at least 3) were neutropenia and leucopenia.

The researchers noted that patients who underwent neoadjuvant chemotherapy had a worse prognosis than the intent-to-treat arm, as evidenced by a higher risk of 2-year recurrence (19% versus 11%). Exploratory subgroup analyses revealed that treatment with abemaciclib and estrogen therapy conferred IDFS and DRFS benefits regardless of the pathological tumor size and number of positive axillary lymph nodes.

The study was limited by the fact that it was open label, and the subgroup analyses were not powered to find statistically significant associations.

Dr. Martin has received grants from Eli Lilly, which funded monarchE.

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New efficacy and safety data from the monarchE study show that chemotherapy administered before treatment with abemaciclib and estrogen therapy, led to a clinically meaningful improvement in invasive disease-free survival and distant relapse-free survival for women with HR-positive, ERBB2-negative, node-positive, early breast cancer at high risk of recurrence.

The study was published earlier this year in JAMA Oncology.

Neoadjuvant chemotherapy is often provided to such patients in hopes of achieving breast-conserving surgery. Although pathologic complete response rates can be higher than 50% after chemotherapy treatment in triple-negative and ERBB2-positive breast cancer, most patients with HR-positive and ERBB2-negative breast cancer have residual tumor at surgery after neoadjuvant chemotherapy, which is associated with an increased risk of recurrence.

Adjuvant estrogen therapy can reduce the risk of recurrence in this population, but a significant hazard remains.

“To our knowledge, abemaciclib is the first agent added to standard adjuvant estrogen therapy that has been shown to reduce the risk of recurrence in patients with HR-positive, ERBB2-negative early breast cancer with residual disease after neoadjuvant chemotherapy,” wrote the authors, who were led by Miguel Martin, MD, PhD, Hospital General Universitario Gregorio Marañon, Spain.

In 2021, Food and Drug Administration approved abemaciclib (Verzenio, Lilly) with endocrine therapy for the treatment of HR-positive/ERBB2-negative, node-positive, high-risk early breast cancer. Their decision was based on data from the monarchE study.

The study is at odds with the previously published Penelope-B study, which found no benefit from treatment with the CDK4/6 inhibitor palbociclib (Ibrance, Pfizer) after 42.8 months of follow-up. The authors suggest that the disparate outcomes may be due to pharmacological differences between the two drugs as well as different dosing schedules: In monarchE, patients received abemaciclib on a continuous basis, while patients in Penelope-B received palbociclib for 21 days, followed by 7 days off. The treatment duration was 2 years in monarchE and 1 year in Penelope-B. Abemaciclib can be dosed continuously because it is a stronger inhibitor of CDK4 versus CDK6 compared to abemaciclib, and in vitro studies suggest that continuous dosing could be a key factor in creating profound inhibition of DNA synthesis.

The monarchE study included 5,637 patients who were randomized to receive standard of care estrogen therapy for 5 years with or without abemaciclib (150 mg, twice per day) for 2 years; 36.5% received abemaciclib. The mean age was 49.9 years; 70.8% were White, 22.8% Asian, and 2.7% Black.

The abemaciclib group had a clinically and statistically significant benefit in invasive disease-free survival (IDFS) (hazard ratio, 0.61; nominal P < .001) and distant relapse-free survival (DRFS) (HR, 0.61; nominal P < .001). At 2 years, DRFS was 89.5% in the abemaciclib group and 82.8% in the estrogen therapy–only group. IDFS was 87.2% and 80.6%, respectively. Patients who underwent neoadjuvant chemotherapy had a similar safety profile to the estrogen therapy–only group, although there was a higher incidence of treatment-emergent adverse events. The most common were diarrhea, infections, neutropenia, and fatigue. The most frequent grade treatment-emergent adverse events (of at least 3) were neutropenia and leucopenia.

The researchers noted that patients who underwent neoadjuvant chemotherapy had a worse prognosis than the intent-to-treat arm, as evidenced by a higher risk of 2-year recurrence (19% versus 11%). Exploratory subgroup analyses revealed that treatment with abemaciclib and estrogen therapy conferred IDFS and DRFS benefits regardless of the pathological tumor size and number of positive axillary lymph nodes.

The study was limited by the fact that it was open label, and the subgroup analyses were not powered to find statistically significant associations.

Dr. Martin has received grants from Eli Lilly, which funded monarchE.

New efficacy and safety data from the monarchE study show that chemotherapy administered before treatment with abemaciclib and estrogen therapy, led to a clinically meaningful improvement in invasive disease-free survival and distant relapse-free survival for women with HR-positive, ERBB2-negative, node-positive, early breast cancer at high risk of recurrence.

The study was published earlier this year in JAMA Oncology.

Neoadjuvant chemotherapy is often provided to such patients in hopes of achieving breast-conserving surgery. Although pathologic complete response rates can be higher than 50% after chemotherapy treatment in triple-negative and ERBB2-positive breast cancer, most patients with HR-positive and ERBB2-negative breast cancer have residual tumor at surgery after neoadjuvant chemotherapy, which is associated with an increased risk of recurrence.

Adjuvant estrogen therapy can reduce the risk of recurrence in this population, but a significant hazard remains.

“To our knowledge, abemaciclib is the first agent added to standard adjuvant estrogen therapy that has been shown to reduce the risk of recurrence in patients with HR-positive, ERBB2-negative early breast cancer with residual disease after neoadjuvant chemotherapy,” wrote the authors, who were led by Miguel Martin, MD, PhD, Hospital General Universitario Gregorio Marañon, Spain.

In 2021, Food and Drug Administration approved abemaciclib (Verzenio, Lilly) with endocrine therapy for the treatment of HR-positive/ERBB2-negative, node-positive, high-risk early breast cancer. Their decision was based on data from the monarchE study.

The study is at odds with the previously published Penelope-B study, which found no benefit from treatment with the CDK4/6 inhibitor palbociclib (Ibrance, Pfizer) after 42.8 months of follow-up. The authors suggest that the disparate outcomes may be due to pharmacological differences between the two drugs as well as different dosing schedules: In monarchE, patients received abemaciclib on a continuous basis, while patients in Penelope-B received palbociclib for 21 days, followed by 7 days off. The treatment duration was 2 years in monarchE and 1 year in Penelope-B. Abemaciclib can be dosed continuously because it is a stronger inhibitor of CDK4 versus CDK6 compared to abemaciclib, and in vitro studies suggest that continuous dosing could be a key factor in creating profound inhibition of DNA synthesis.

The monarchE study included 5,637 patients who were randomized to receive standard of care estrogen therapy for 5 years with or without abemaciclib (150 mg, twice per day) for 2 years; 36.5% received abemaciclib. The mean age was 49.9 years; 70.8% were White, 22.8% Asian, and 2.7% Black.

The abemaciclib group had a clinically and statistically significant benefit in invasive disease-free survival (IDFS) (hazard ratio, 0.61; nominal P < .001) and distant relapse-free survival (DRFS) (HR, 0.61; nominal P < .001). At 2 years, DRFS was 89.5% in the abemaciclib group and 82.8% in the estrogen therapy–only group. IDFS was 87.2% and 80.6%, respectively. Patients who underwent neoadjuvant chemotherapy had a similar safety profile to the estrogen therapy–only group, although there was a higher incidence of treatment-emergent adverse events. The most common were diarrhea, infections, neutropenia, and fatigue. The most frequent grade treatment-emergent adverse events (of at least 3) were neutropenia and leucopenia.

The researchers noted that patients who underwent neoadjuvant chemotherapy had a worse prognosis than the intent-to-treat arm, as evidenced by a higher risk of 2-year recurrence (19% versus 11%). Exploratory subgroup analyses revealed that treatment with abemaciclib and estrogen therapy conferred IDFS and DRFS benefits regardless of the pathological tumor size and number of positive axillary lymph nodes.

The study was limited by the fact that it was open label, and the subgroup analyses were not powered to find statistically significant associations.

Dr. Martin has received grants from Eli Lilly, which funded monarchE.

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Vitamin D deficiency linked to death, new study finds

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Vitamin D deficiency increases mortality risk and raising levels even slightly could decrease the risk, researchers examining data from the UK Biobank have found.

They used a Mendelian randomization approach, which uses genetic variants as “proxy indicators” for external factors that affect vitamin D levels, such as sun exposure or dietary intake. It allows for analysis of the relationship between deficiency and outcomes including mortality, which can’t be done in randomized clinical trials for ethical reasons.

Using this method, nutritionist Joshua P. Sutherland, PhD, of the Australian Centre for Precision Health, Adelaide, and colleagues found an association between genetically predicted vitamin D levels [25-(OH)D] and mortality from several major causes, with evidence of causality among people with measured concentrations below, but not above, 50 nmol/L. The findings were published online in Annals of Internal Medicine.

 

“Unlike other types of observational studies, we have overcome some of the methodological obstacles. What is special about this new study is we were able to look at people with very low vitamin D concentrations and what would happen if their concentrations were a little bit higher. Most randomized controlled trials don’t show much of an effect. That’s because most people have sufficient concentrations. Ethically you can’t do a trial of people with very low levels without treating them,” senior author Elina Hyppönen, PhD, told this news organization.

The data support the 50 nmol/L cut-off endorsed by the United States National Academy of Medicine and align with previous data suggesting the benefit of vitamin D supplementation is largely seen in people with deficiency.

“Everybody with vitamin D levels less than 50 nmol/L is recommended to increase their levels. Our results suggest there’s no need to go very high. The positive message is that if we are able to raise levels to just the current U.S. recommendations, that’s fine. There’s no need to use large supplement doses,” Dr. Hyppönen explained.

Thus, she advised, “Supplementation will clearly help, especially during wintertime or if a person isn’t getting enough vitamin D from the sun or in places where food isn’t fortified with vitamin D.”

But the data don’t support the approach of using large intermittent doses, she added.

“Sometimes doctors want to fix the deficiency quickly with a large ‘bolus’ dose, then continue with a maintenance dose. Increasing evidence suggests that’s not beneficial and might disturb the body’s metabolism so that it can’t get the amount it needs. It’s safe overall but might not work the way we want it to work.”

Rather, Dr. Hyppönen said, “My sense is that daily modest vitamin D dose supplementation when it’s needed is the best way forward.”  

Genetic approach reveals causal relationship

The investigators analyzed data from 307,601 individuals in the UK Biobank, a prospective cohort of people recruited from England, Scotland, and Wales during March 2006 and July 2010. Most were of White European ancestry and were aged 37-73 years at baseline.

Genetically predicted vitamin D levels were estimated using 35 confirmed 25-(OH)D variants. Participants were followed for outcomes up to June 2020.

The average baseline measured 25-(OH)D concentration was 45.2 nmol/L, and 11.7% (n = 36,009) of participants had levels between 10.0  and 24.9 nmol/L. Higher levels were seen in people living in southern areas and nonsmokers as well as those with a higher level of physical activity, less socioeconomic deprivation, and lower body mass index.

During follow-up, 6.1% of participants died (n = 18,700). After adjustment for variables, odds ratios for all causes of mortality were highest among people with 25-(OH)D levels below 25 nmol/L and appeared to plateau between 50 and 75 nmol/L, with no further reduction in mortality at values of 75-125 nmol/L.
 

 

 

Mortality 36% higher in those deficient in vitamin D

The risk for mortality was a significant 36% higher for participants with 25-(OH)D 25 nmol/L compared with 50 nmol/L.

With the Mendelian randomization, there was an L-shaped association between genetically predicted 25-(OH)D level and all-cause mortality (P for nonlinearity < .001) and for mortality because of cancer and cardiovascular disease (P for nonlinearity ≤ .033).

Again, the strongest association with those outcomes and genetically predicted 25-(OH)D was found at levels below 25 nmol/L and a plateau was seen by 50 nmol/L.

Compared with a measured 25-(OH)D concentration of 50 nmol/L, investigators estimated that the genetically predicted odds of all-cause mortality would increase sixfold (odds ratio, 6.00) for participants at 10 nmol/L and by 25% (OR, 1.25) for those at 25 nmol/L.

And, compared with a measured 25-(OH)D concentration of 50 nmol/L, those with 10 nmol/L had genetically predicted odds ratios of 5.98 for cardiovascular mortality, 3.37 for cancer mortality, and 12.44 for respiratory mortality.

Comparing measured 25-(OH)D concentrations of 25 nmol/L versus 50 nmol/L, odds ratios for those outcomes were 1.25, 1.16, and 1.96 (95% confidence interval, 1.88-4.67), respectively. All were statistically significant.

Consistent results supportive of a causal effect of genetically predicted 25-(OH)D on all-cause mortality in those with low measured vitamin D concentrations were also found in a sensitivity analysis of 20,837 people of non-White ethnic origin.

The study was funded by the Australian National Health and Medical Research Council. Dr. Sutherland’s studentship is funded by an Australian Research Training Program Scholarship.

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

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Vitamin D deficiency increases mortality risk and raising levels even slightly could decrease the risk, researchers examining data from the UK Biobank have found.

They used a Mendelian randomization approach, which uses genetic variants as “proxy indicators” for external factors that affect vitamin D levels, such as sun exposure or dietary intake. It allows for analysis of the relationship between deficiency and outcomes including mortality, which can’t be done in randomized clinical trials for ethical reasons.

Using this method, nutritionist Joshua P. Sutherland, PhD, of the Australian Centre for Precision Health, Adelaide, and colleagues found an association between genetically predicted vitamin D levels [25-(OH)D] and mortality from several major causes, with evidence of causality among people with measured concentrations below, but not above, 50 nmol/L. The findings were published online in Annals of Internal Medicine.

 

“Unlike other types of observational studies, we have overcome some of the methodological obstacles. What is special about this new study is we were able to look at people with very low vitamin D concentrations and what would happen if their concentrations were a little bit higher. Most randomized controlled trials don’t show much of an effect. That’s because most people have sufficient concentrations. Ethically you can’t do a trial of people with very low levels without treating them,” senior author Elina Hyppönen, PhD, told this news organization.

The data support the 50 nmol/L cut-off endorsed by the United States National Academy of Medicine and align with previous data suggesting the benefit of vitamin D supplementation is largely seen in people with deficiency.

“Everybody with vitamin D levels less than 50 nmol/L is recommended to increase their levels. Our results suggest there’s no need to go very high. The positive message is that if we are able to raise levels to just the current U.S. recommendations, that’s fine. There’s no need to use large supplement doses,” Dr. Hyppönen explained.

Thus, she advised, “Supplementation will clearly help, especially during wintertime or if a person isn’t getting enough vitamin D from the sun or in places where food isn’t fortified with vitamin D.”

But the data don’t support the approach of using large intermittent doses, she added.

“Sometimes doctors want to fix the deficiency quickly with a large ‘bolus’ dose, then continue with a maintenance dose. Increasing evidence suggests that’s not beneficial and might disturb the body’s metabolism so that it can’t get the amount it needs. It’s safe overall but might not work the way we want it to work.”

Rather, Dr. Hyppönen said, “My sense is that daily modest vitamin D dose supplementation when it’s needed is the best way forward.”  

Genetic approach reveals causal relationship

The investigators analyzed data from 307,601 individuals in the UK Biobank, a prospective cohort of people recruited from England, Scotland, and Wales during March 2006 and July 2010. Most were of White European ancestry and were aged 37-73 years at baseline.

Genetically predicted vitamin D levels were estimated using 35 confirmed 25-(OH)D variants. Participants were followed for outcomes up to June 2020.

The average baseline measured 25-(OH)D concentration was 45.2 nmol/L, and 11.7% (n = 36,009) of participants had levels between 10.0  and 24.9 nmol/L. Higher levels were seen in people living in southern areas and nonsmokers as well as those with a higher level of physical activity, less socioeconomic deprivation, and lower body mass index.

During follow-up, 6.1% of participants died (n = 18,700). After adjustment for variables, odds ratios for all causes of mortality were highest among people with 25-(OH)D levels below 25 nmol/L and appeared to plateau between 50 and 75 nmol/L, with no further reduction in mortality at values of 75-125 nmol/L.
 

 

 

Mortality 36% higher in those deficient in vitamin D

The risk for mortality was a significant 36% higher for participants with 25-(OH)D 25 nmol/L compared with 50 nmol/L.

With the Mendelian randomization, there was an L-shaped association between genetically predicted 25-(OH)D level and all-cause mortality (P for nonlinearity < .001) and for mortality because of cancer and cardiovascular disease (P for nonlinearity ≤ .033).

Again, the strongest association with those outcomes and genetically predicted 25-(OH)D was found at levels below 25 nmol/L and a plateau was seen by 50 nmol/L.

Compared with a measured 25-(OH)D concentration of 50 nmol/L, investigators estimated that the genetically predicted odds of all-cause mortality would increase sixfold (odds ratio, 6.00) for participants at 10 nmol/L and by 25% (OR, 1.25) for those at 25 nmol/L.

And, compared with a measured 25-(OH)D concentration of 50 nmol/L, those with 10 nmol/L had genetically predicted odds ratios of 5.98 for cardiovascular mortality, 3.37 for cancer mortality, and 12.44 for respiratory mortality.

Comparing measured 25-(OH)D concentrations of 25 nmol/L versus 50 nmol/L, odds ratios for those outcomes were 1.25, 1.16, and 1.96 (95% confidence interval, 1.88-4.67), respectively. All were statistically significant.

Consistent results supportive of a causal effect of genetically predicted 25-(OH)D on all-cause mortality in those with low measured vitamin D concentrations were also found in a sensitivity analysis of 20,837 people of non-White ethnic origin.

The study was funded by the Australian National Health and Medical Research Council. Dr. Sutherland’s studentship is funded by an Australian Research Training Program Scholarship.

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

Vitamin D deficiency increases mortality risk and raising levels even slightly could decrease the risk, researchers examining data from the UK Biobank have found.

They used a Mendelian randomization approach, which uses genetic variants as “proxy indicators” for external factors that affect vitamin D levels, such as sun exposure or dietary intake. It allows for analysis of the relationship between deficiency and outcomes including mortality, which can’t be done in randomized clinical trials for ethical reasons.

Using this method, nutritionist Joshua P. Sutherland, PhD, of the Australian Centre for Precision Health, Adelaide, and colleagues found an association between genetically predicted vitamin D levels [25-(OH)D] and mortality from several major causes, with evidence of causality among people with measured concentrations below, but not above, 50 nmol/L. The findings were published online in Annals of Internal Medicine.

 

“Unlike other types of observational studies, we have overcome some of the methodological obstacles. What is special about this new study is we were able to look at people with very low vitamin D concentrations and what would happen if their concentrations were a little bit higher. Most randomized controlled trials don’t show much of an effect. That’s because most people have sufficient concentrations. Ethically you can’t do a trial of people with very low levels without treating them,” senior author Elina Hyppönen, PhD, told this news organization.

The data support the 50 nmol/L cut-off endorsed by the United States National Academy of Medicine and align with previous data suggesting the benefit of vitamin D supplementation is largely seen in people with deficiency.

“Everybody with vitamin D levels less than 50 nmol/L is recommended to increase their levels. Our results suggest there’s no need to go very high. The positive message is that if we are able to raise levels to just the current U.S. recommendations, that’s fine. There’s no need to use large supplement doses,” Dr. Hyppönen explained.

Thus, she advised, “Supplementation will clearly help, especially during wintertime or if a person isn’t getting enough vitamin D from the sun or in places where food isn’t fortified with vitamin D.”

But the data don’t support the approach of using large intermittent doses, she added.

“Sometimes doctors want to fix the deficiency quickly with a large ‘bolus’ dose, then continue with a maintenance dose. Increasing evidence suggests that’s not beneficial and might disturb the body’s metabolism so that it can’t get the amount it needs. It’s safe overall but might not work the way we want it to work.”

Rather, Dr. Hyppönen said, “My sense is that daily modest vitamin D dose supplementation when it’s needed is the best way forward.”  

Genetic approach reveals causal relationship

The investigators analyzed data from 307,601 individuals in the UK Biobank, a prospective cohort of people recruited from England, Scotland, and Wales during March 2006 and July 2010. Most were of White European ancestry and were aged 37-73 years at baseline.

Genetically predicted vitamin D levels were estimated using 35 confirmed 25-(OH)D variants. Participants were followed for outcomes up to June 2020.

The average baseline measured 25-(OH)D concentration was 45.2 nmol/L, and 11.7% (n = 36,009) of participants had levels between 10.0  and 24.9 nmol/L. Higher levels were seen in people living in southern areas and nonsmokers as well as those with a higher level of physical activity, less socioeconomic deprivation, and lower body mass index.

During follow-up, 6.1% of participants died (n = 18,700). After adjustment for variables, odds ratios for all causes of mortality were highest among people with 25-(OH)D levels below 25 nmol/L and appeared to plateau between 50 and 75 nmol/L, with no further reduction in mortality at values of 75-125 nmol/L.
 

 

 

Mortality 36% higher in those deficient in vitamin D

The risk for mortality was a significant 36% higher for participants with 25-(OH)D 25 nmol/L compared with 50 nmol/L.

With the Mendelian randomization, there was an L-shaped association between genetically predicted 25-(OH)D level and all-cause mortality (P for nonlinearity < .001) and for mortality because of cancer and cardiovascular disease (P for nonlinearity ≤ .033).

Again, the strongest association with those outcomes and genetically predicted 25-(OH)D was found at levels below 25 nmol/L and a plateau was seen by 50 nmol/L.

Compared with a measured 25-(OH)D concentration of 50 nmol/L, investigators estimated that the genetically predicted odds of all-cause mortality would increase sixfold (odds ratio, 6.00) for participants at 10 nmol/L and by 25% (OR, 1.25) for those at 25 nmol/L.

And, compared with a measured 25-(OH)D concentration of 50 nmol/L, those with 10 nmol/L had genetically predicted odds ratios of 5.98 for cardiovascular mortality, 3.37 for cancer mortality, and 12.44 for respiratory mortality.

Comparing measured 25-(OH)D concentrations of 25 nmol/L versus 50 nmol/L, odds ratios for those outcomes were 1.25, 1.16, and 1.96 (95% confidence interval, 1.88-4.67), respectively. All were statistically significant.

Consistent results supportive of a causal effect of genetically predicted 25-(OH)D on all-cause mortality in those with low measured vitamin D concentrations were also found in a sensitivity analysis of 20,837 people of non-White ethnic origin.

The study was funded by the Australian National Health and Medical Research Council. Dr. Sutherland’s studentship is funded by an Australian Research Training Program Scholarship.

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

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