Fed Worker Health Plans Ban Maximizers and Copay Accumulators: Why Not for the Rest of the US?

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Changed
Mon, 07/29/2024 - 11:51

The escalating costs of medications and the prevalence of medical bankruptcy in our country have drawn criticism from governments, regulators, and the media. Federal and state governments are exploring various strategies to mitigate this issue, including the Inflation Reduction Act (IRA) for drug price negotiations and the establishment of state Pharmaceutical Drug Affordability Boards (PDABs). However, it’s uncertain whether these measures will effectively reduce patients’ medication expenses, given the tendency of pharmacy benefit managers (PBMs) to favor more expensive drugs on their formularies and the implementation challenges faced by PDABs.

The question then arises: How can we promptly assist patients, especially those with multiple chronic conditions, in affording their healthcare? Many of these patients are enrolled in high-deductible plans and struggle to cover all their medical and pharmacy costs.

Dr. Madelaine A. Feldman

A significant obstacle to healthcare affordability emerged in 2018 with the introduction of Copay Accumulator Programs by PBMs. These programs prevent patients from applying manufacturer copay cards toward their deductible and maximum out-of-pocket (OOP) costs. The impact of these policies has been devastating, leading to decreased adherence to medications and delayed necessary medical procedures, such as colonoscopies. Copay accumulators do nothing to address the high cost of medical care. They merely shift the burden from insurance companies to patients.

There is a direct solution to help patients, particularly those burdened with high pharmacy bills, afford their medical care. It would be that all payments from patients, including manufacturer copay cards, count toward their deductible and maximum OOP costs. This should apply regardless of whether the insurance plan is fully funded or a self-insured employer plan. This would be an immediate step toward making healthcare more affordable for patients.
 

Copay Accumulator Programs

How did these detrimental policies, which have been proven to harm patients, originate? It’s interesting that health insurance policies for federal employees do not allow these programs and yet the federal government has done little to protect its citizens from these egregious policies. More on that later.

In 2018, insurance companies and PBMs conceived an idea to introduce what they called copay accumulator adjustment programs. These programs would prevent the use of manufacturer copay cards from counting toward patient deductibles or OOP maximums. They justified this by arguing that manufacturer copay cards encouraged patients to opt for higher-priced brand drugs when lower-cost generics were available.

However, data from IQVIA contradicts this claim. An analysis of copay card usage from 2013 to 2017 revealed that a mere 0.4% of these cards were used for brand-name drugs that had already lost their exclusivity. This indicates that the vast majority of copay cards were not being used to purchase more expensive brand-name drugs when cheaper, generic alternatives were available.

Another argument put forth by one of the large PBMs was that patients with high deductibles don’t have enough “skin in the game” due to their low premiums, and therefore don’t deserve to have their deductible covered by a copay card. This raises the question, “Does a patient with hemophilia or systemic lupus who can’t afford a low deductible plan not have ‘skin in the game’? Is that a fair assessment?” It’s disconcerting to see a multibillion-dollar company dictating who deserves to have their deductible covered. These policies clearly disproportionately harm patients with chronic illnesses, especially those with high deductibles. As a result, many organizations have labeled these policies as discriminatory.

Following the implementation of accumulator programs in 2018 and 2019, many patients were unaware that their copay cards weren’t contributing toward their deductibles. They were taken aback when specialty pharmacies informed them of owing substantial amounts because of unmet deductibles. Consequently, patients discontinued their medications, leading to disease progression and increased costs. The only downside for health insurers and PBMs was the negative publicity associated with patients losing medication access.
 

 

 

Maximizer Programs

By the end of 2019, the three major PBMs had devised a strategy to keep patients on their medication throughout the year, without counting copay cards toward the deductible, and found a way to profit more from these cards, sometimes quadrupling their value. This was the birth of the maximizer programs.

Maximizers exploit a “loophole” in the Affordable Care Act (ACA). The ACA defines Essential Healthcare Benefits (EHB); anything not listed as an EHB is deemed “non-essential.” As a result, neither personal payments nor copay cards count toward deductibles or OOP maximums. Patients were informed that neither their own money nor manufacturer copay cards would count toward their deductible/OOP max.

One of my patients was warned that without enrolling in the maximizer program through SaveOnSP (owned by Express Scripts), she would bear the full cost of the drug, and nothing would count toward her OOP max. Frightened, she enrolled and surrendered her manufacturer copay card to SaveOnSP. Maximizers pocket the maximum value of the copay card, even if it exceeds the insurance plan’s yearly cost share by threefold or more. To do this legally, PBMs increase the patient’s original cost share amount during the plan year to match the value of the manufacturer copay card.
 

Combating These Programs

Nineteen states, the District of Columbia, and Puerto Rico have outlawed copay accumulators in health plans under state jurisdiction. I personally testified in Louisiana, leading to a ban in our state. CSRO’s award-winning map tool can show if your state has passed the ban on copay accumulator programs. However, many states have not passed bans on copay accumulators and self-insured employer groups, which fall under the Department of Labor and not state regulation, are still unaffected. There is also proposed federal legislation, the “Help Ensure Lower Patient Copays Act,” that would prohibit the use of copay accumulators in exchange plans. Despite having bipartisan support, it is having a hard time getting across the finish line in Congress.

In 2020, the Department of Health and Human Services (HHS) issued a rule prohibiting accumulator programs in all plans if the product was a brand name without a generic alternative. Unfortunately, this rule was rescinded in 2021, allowing copay accumulators even if a lower-cost generic was available.

In a positive turn of events, the US District Court of the District of Columbia overturned the 2021 rule in late 2023, reinstating the 2020 ban on copay accumulators. However, HHS has yet to enforce this ban.
 

Double Standard

Why is it that our federal government refrains from enforcing bans on copay accumulators for the American public, yet the US Office of Personnel Management (OPM) in its 2024 health plan for federal employees has explicitly stated that it “will decline any arrangements which may manipulate the prescription drug benefit design or incorporate any programs such as copay maximizers, copay optimizers, or other similar programs as these types of benefit designs are not in the best interest of enrollees or the Government.”

If such practices are deemed unsuitable for federal employees, why are they considered acceptable for the rest of the American population? This discrepancy raises important questions about healthcare equity.

In conclusion, the prevalence of medical bankruptcy in our country is a pressing issue that requires immediate attention. The introduction of copay accumulator programs and maximizers by PBMs has led to decreased adherence to needed medications, as well as delay in important medical procedures, exacerbating this situation. An across-the-board ban on these programs would offer immediate relief to many families that no longer can afford needed care.

It is clear that more needs to be done to ensure that all patients, regardless of their financial situation or the nature of their health insurance plan, can afford the healthcare they need. This includes ensuring that patients are not penalized for using manufacturer copay cards to help cover their costs. As we move forward, it is crucial that we continue to advocate for policies that prioritize the health and well-being of all patients.
 

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

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The escalating costs of medications and the prevalence of medical bankruptcy in our country have drawn criticism from governments, regulators, and the media. Federal and state governments are exploring various strategies to mitigate this issue, including the Inflation Reduction Act (IRA) for drug price negotiations and the establishment of state Pharmaceutical Drug Affordability Boards (PDABs). However, it’s uncertain whether these measures will effectively reduce patients’ medication expenses, given the tendency of pharmacy benefit managers (PBMs) to favor more expensive drugs on their formularies and the implementation challenges faced by PDABs.

The question then arises: How can we promptly assist patients, especially those with multiple chronic conditions, in affording their healthcare? Many of these patients are enrolled in high-deductible plans and struggle to cover all their medical and pharmacy costs.

Dr. Madelaine A. Feldman

A significant obstacle to healthcare affordability emerged in 2018 with the introduction of Copay Accumulator Programs by PBMs. These programs prevent patients from applying manufacturer copay cards toward their deductible and maximum out-of-pocket (OOP) costs. The impact of these policies has been devastating, leading to decreased adherence to medications and delayed necessary medical procedures, such as colonoscopies. Copay accumulators do nothing to address the high cost of medical care. They merely shift the burden from insurance companies to patients.

There is a direct solution to help patients, particularly those burdened with high pharmacy bills, afford their medical care. It would be that all payments from patients, including manufacturer copay cards, count toward their deductible and maximum OOP costs. This should apply regardless of whether the insurance plan is fully funded or a self-insured employer plan. This would be an immediate step toward making healthcare more affordable for patients.
 

Copay Accumulator Programs

How did these detrimental policies, which have been proven to harm patients, originate? It’s interesting that health insurance policies for federal employees do not allow these programs and yet the federal government has done little to protect its citizens from these egregious policies. More on that later.

In 2018, insurance companies and PBMs conceived an idea to introduce what they called copay accumulator adjustment programs. These programs would prevent the use of manufacturer copay cards from counting toward patient deductibles or OOP maximums. They justified this by arguing that manufacturer copay cards encouraged patients to opt for higher-priced brand drugs when lower-cost generics were available.

However, data from IQVIA contradicts this claim. An analysis of copay card usage from 2013 to 2017 revealed that a mere 0.4% of these cards were used for brand-name drugs that had already lost their exclusivity. This indicates that the vast majority of copay cards were not being used to purchase more expensive brand-name drugs when cheaper, generic alternatives were available.

Another argument put forth by one of the large PBMs was that patients with high deductibles don’t have enough “skin in the game” due to their low premiums, and therefore don’t deserve to have their deductible covered by a copay card. This raises the question, “Does a patient with hemophilia or systemic lupus who can’t afford a low deductible plan not have ‘skin in the game’? Is that a fair assessment?” It’s disconcerting to see a multibillion-dollar company dictating who deserves to have their deductible covered. These policies clearly disproportionately harm patients with chronic illnesses, especially those with high deductibles. As a result, many organizations have labeled these policies as discriminatory.

Following the implementation of accumulator programs in 2018 and 2019, many patients were unaware that their copay cards weren’t contributing toward their deductibles. They were taken aback when specialty pharmacies informed them of owing substantial amounts because of unmet deductibles. Consequently, patients discontinued their medications, leading to disease progression and increased costs. The only downside for health insurers and PBMs was the negative publicity associated with patients losing medication access.
 

 

 

Maximizer Programs

By the end of 2019, the three major PBMs had devised a strategy to keep patients on their medication throughout the year, without counting copay cards toward the deductible, and found a way to profit more from these cards, sometimes quadrupling their value. This was the birth of the maximizer programs.

Maximizers exploit a “loophole” in the Affordable Care Act (ACA). The ACA defines Essential Healthcare Benefits (EHB); anything not listed as an EHB is deemed “non-essential.” As a result, neither personal payments nor copay cards count toward deductibles or OOP maximums. Patients were informed that neither their own money nor manufacturer copay cards would count toward their deductible/OOP max.

One of my patients was warned that without enrolling in the maximizer program through SaveOnSP (owned by Express Scripts), she would bear the full cost of the drug, and nothing would count toward her OOP max. Frightened, she enrolled and surrendered her manufacturer copay card to SaveOnSP. Maximizers pocket the maximum value of the copay card, even if it exceeds the insurance plan’s yearly cost share by threefold or more. To do this legally, PBMs increase the patient’s original cost share amount during the plan year to match the value of the manufacturer copay card.
 

Combating These Programs

Nineteen states, the District of Columbia, and Puerto Rico have outlawed copay accumulators in health plans under state jurisdiction. I personally testified in Louisiana, leading to a ban in our state. CSRO’s award-winning map tool can show if your state has passed the ban on copay accumulator programs. However, many states have not passed bans on copay accumulators and self-insured employer groups, which fall under the Department of Labor and not state regulation, are still unaffected. There is also proposed federal legislation, the “Help Ensure Lower Patient Copays Act,” that would prohibit the use of copay accumulators in exchange plans. Despite having bipartisan support, it is having a hard time getting across the finish line in Congress.

In 2020, the Department of Health and Human Services (HHS) issued a rule prohibiting accumulator programs in all plans if the product was a brand name without a generic alternative. Unfortunately, this rule was rescinded in 2021, allowing copay accumulators even if a lower-cost generic was available.

In a positive turn of events, the US District Court of the District of Columbia overturned the 2021 rule in late 2023, reinstating the 2020 ban on copay accumulators. However, HHS has yet to enforce this ban.
 

Double Standard

Why is it that our federal government refrains from enforcing bans on copay accumulators for the American public, yet the US Office of Personnel Management (OPM) in its 2024 health plan for federal employees has explicitly stated that it “will decline any arrangements which may manipulate the prescription drug benefit design or incorporate any programs such as copay maximizers, copay optimizers, or other similar programs as these types of benefit designs are not in the best interest of enrollees or the Government.”

If such practices are deemed unsuitable for federal employees, why are they considered acceptable for the rest of the American population? This discrepancy raises important questions about healthcare equity.

In conclusion, the prevalence of medical bankruptcy in our country is a pressing issue that requires immediate attention. The introduction of copay accumulator programs and maximizers by PBMs has led to decreased adherence to needed medications, as well as delay in important medical procedures, exacerbating this situation. An across-the-board ban on these programs would offer immediate relief to many families that no longer can afford needed care.

It is clear that more needs to be done to ensure that all patients, regardless of their financial situation or the nature of their health insurance plan, can afford the healthcare they need. This includes ensuring that patients are not penalized for using manufacturer copay cards to help cover their costs. As we move forward, it is crucial that we continue to advocate for policies that prioritize the health and well-being of all patients.
 

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

The escalating costs of medications and the prevalence of medical bankruptcy in our country have drawn criticism from governments, regulators, and the media. Federal and state governments are exploring various strategies to mitigate this issue, including the Inflation Reduction Act (IRA) for drug price negotiations and the establishment of state Pharmaceutical Drug Affordability Boards (PDABs). However, it’s uncertain whether these measures will effectively reduce patients’ medication expenses, given the tendency of pharmacy benefit managers (PBMs) to favor more expensive drugs on their formularies and the implementation challenges faced by PDABs.

The question then arises: How can we promptly assist patients, especially those with multiple chronic conditions, in affording their healthcare? Many of these patients are enrolled in high-deductible plans and struggle to cover all their medical and pharmacy costs.

Dr. Madelaine A. Feldman

A significant obstacle to healthcare affordability emerged in 2018 with the introduction of Copay Accumulator Programs by PBMs. These programs prevent patients from applying manufacturer copay cards toward their deductible and maximum out-of-pocket (OOP) costs. The impact of these policies has been devastating, leading to decreased adherence to medications and delayed necessary medical procedures, such as colonoscopies. Copay accumulators do nothing to address the high cost of medical care. They merely shift the burden from insurance companies to patients.

There is a direct solution to help patients, particularly those burdened with high pharmacy bills, afford their medical care. It would be that all payments from patients, including manufacturer copay cards, count toward their deductible and maximum OOP costs. This should apply regardless of whether the insurance plan is fully funded or a self-insured employer plan. This would be an immediate step toward making healthcare more affordable for patients.
 

Copay Accumulator Programs

How did these detrimental policies, which have been proven to harm patients, originate? It’s interesting that health insurance policies for federal employees do not allow these programs and yet the federal government has done little to protect its citizens from these egregious policies. More on that later.

In 2018, insurance companies and PBMs conceived an idea to introduce what they called copay accumulator adjustment programs. These programs would prevent the use of manufacturer copay cards from counting toward patient deductibles or OOP maximums. They justified this by arguing that manufacturer copay cards encouraged patients to opt for higher-priced brand drugs when lower-cost generics were available.

However, data from IQVIA contradicts this claim. An analysis of copay card usage from 2013 to 2017 revealed that a mere 0.4% of these cards were used for brand-name drugs that had already lost their exclusivity. This indicates that the vast majority of copay cards were not being used to purchase more expensive brand-name drugs when cheaper, generic alternatives were available.

Another argument put forth by one of the large PBMs was that patients with high deductibles don’t have enough “skin in the game” due to their low premiums, and therefore don’t deserve to have their deductible covered by a copay card. This raises the question, “Does a patient with hemophilia or systemic lupus who can’t afford a low deductible plan not have ‘skin in the game’? Is that a fair assessment?” It’s disconcerting to see a multibillion-dollar company dictating who deserves to have their deductible covered. These policies clearly disproportionately harm patients with chronic illnesses, especially those with high deductibles. As a result, many organizations have labeled these policies as discriminatory.

Following the implementation of accumulator programs in 2018 and 2019, many patients were unaware that their copay cards weren’t contributing toward their deductibles. They were taken aback when specialty pharmacies informed them of owing substantial amounts because of unmet deductibles. Consequently, patients discontinued their medications, leading to disease progression and increased costs. The only downside for health insurers and PBMs was the negative publicity associated with patients losing medication access.
 

 

 

Maximizer Programs

By the end of 2019, the three major PBMs had devised a strategy to keep patients on their medication throughout the year, without counting copay cards toward the deductible, and found a way to profit more from these cards, sometimes quadrupling their value. This was the birth of the maximizer programs.

Maximizers exploit a “loophole” in the Affordable Care Act (ACA). The ACA defines Essential Healthcare Benefits (EHB); anything not listed as an EHB is deemed “non-essential.” As a result, neither personal payments nor copay cards count toward deductibles or OOP maximums. Patients were informed that neither their own money nor manufacturer copay cards would count toward their deductible/OOP max.

One of my patients was warned that without enrolling in the maximizer program through SaveOnSP (owned by Express Scripts), she would bear the full cost of the drug, and nothing would count toward her OOP max. Frightened, she enrolled and surrendered her manufacturer copay card to SaveOnSP. Maximizers pocket the maximum value of the copay card, even if it exceeds the insurance plan’s yearly cost share by threefold or more. To do this legally, PBMs increase the patient’s original cost share amount during the plan year to match the value of the manufacturer copay card.
 

Combating These Programs

Nineteen states, the District of Columbia, and Puerto Rico have outlawed copay accumulators in health plans under state jurisdiction. I personally testified in Louisiana, leading to a ban in our state. CSRO’s award-winning map tool can show if your state has passed the ban on copay accumulator programs. However, many states have not passed bans on copay accumulators and self-insured employer groups, which fall under the Department of Labor and not state regulation, are still unaffected. There is also proposed federal legislation, the “Help Ensure Lower Patient Copays Act,” that would prohibit the use of copay accumulators in exchange plans. Despite having bipartisan support, it is having a hard time getting across the finish line in Congress.

In 2020, the Department of Health and Human Services (HHS) issued a rule prohibiting accumulator programs in all plans if the product was a brand name without a generic alternative. Unfortunately, this rule was rescinded in 2021, allowing copay accumulators even if a lower-cost generic was available.

In a positive turn of events, the US District Court of the District of Columbia overturned the 2021 rule in late 2023, reinstating the 2020 ban on copay accumulators. However, HHS has yet to enforce this ban.
 

Double Standard

Why is it that our federal government refrains from enforcing bans on copay accumulators for the American public, yet the US Office of Personnel Management (OPM) in its 2024 health plan for federal employees has explicitly stated that it “will decline any arrangements which may manipulate the prescription drug benefit design or incorporate any programs such as copay maximizers, copay optimizers, or other similar programs as these types of benefit designs are not in the best interest of enrollees or the Government.”

If such practices are deemed unsuitable for federal employees, why are they considered acceptable for the rest of the American population? This discrepancy raises important questions about healthcare equity.

In conclusion, the prevalence of medical bankruptcy in our country is a pressing issue that requires immediate attention. The introduction of copay accumulator programs and maximizers by PBMs has led to decreased adherence to needed medications, as well as delay in important medical procedures, exacerbating this situation. An across-the-board ban on these programs would offer immediate relief to many families that no longer can afford needed care.

It is clear that more needs to be done to ensure that all patients, regardless of their financial situation or the nature of their health insurance plan, can afford the healthcare they need. This includes ensuring that patients are not penalized for using manufacturer copay cards to help cover their costs. As we move forward, it is crucial that we continue to advocate for policies that prioritize the health and well-being of all patients.
 

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

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Introducing: A New Way to Get Teens Mental Health Care

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Fri, 07/26/2024 - 14:54

 

Lauren Opladen remembers the agonizing wait all too well.

At age 17, struggling with paralyzing depression after losing her brother to suicide and her father to amyotrophic lateral sclerosis, her teacher suggested she seek help.

So, she did. But she had to spend 3 days inside an emergency department at the University of Rochester Medical Center in Rochester, New York, where the Comprehensive Psychiatric Emergency Program (CPEP) provides immediate care for youth and adults experiencing psychiatric emergencies.

“We were sleeping on a couch just waiting for all these services, when that’s precious time wasted,” Ms. Opladen said.

Ms. Opladen made it through that dark period, and 5 years later, she is a registered nurse at the same hospital. Every day she walks past a new facility she wishes had existed during her troubled teenage years: An urgent care center for children and adolescents experiencing mental health crises.

Brighter Days Pediatric Mental Health Urgent Care Center, Rochester, New York, opened in July as a walk-in clinic offering rapid assessment, crisis intervention, and short-term stabilization, provides referrals to counseling or psychiatric care. Children and adolescents at immediate risk of harming themselves or others, or who need inpatient care, are sent to CPEP or another emergency department in the area.

Similar walk-in facilities linking youth to longer-term services are popping up in nearly a dozen states, including New York, OhioMassachusetts, and Wisconsin. The emerging model of care may offer a crucial bridge between traditional outpatient services and emergency room (ER) visits for some young people experiencing mental health crises.

“We’ve seen a significant increase in the number of children and adolescents presenting to emergency departments with mental health concerns,” said Michael A. Scharf, MD, chief of the Division of Child and Adolescent Psychiatry at the University of Rochester Medical Center, who oversees operations at Brighter Days. “These urgent care centers provide a more appropriate setting for many of these cases, offering specialized care without the often overwhelming environment of an ER.”

The urgency of addressing youth behavioral health has become increasingly apparent. The most recent data from the US Centers for Disease Control and Prevention showed that over a 6-month period in 2020, during the early months of the COVID-19 pandemic, visits to the emergency department for mental health problems spiked 24% among children aged 5-11 years and 31% among 12-17-year-olds compared with the same period in 2019. Between March 2021 and February 2022, such emergency visits rose by 22% for teen girls, while falling by 15% for boys ages 5-12 years and 9% for older boys. Most visits occur during the school year.

But staffing shortages and limited physical space are taxing the capacity of the healthcare system to screen, diagnose, and manage these patients, according to a 2023 report published in Pediatrics.
 

Urgent Care: A Misnomer?

Some in the mental health community said the label “urgent” in these centers’ titles is misleading. Brighter Days and similar facilities do not conduct involuntary holds, administer medication, or handle serious cases like psychotic episodes.

David Mathison, MD, senior vice president of clinic operations at PM Pediatrics, a chain of pediatric urgent care clinics in Maryland, said patients and their families may mistakenly believe the centers will address mental health problems quickly.

“It’s really not urgent behavioral health. It’s really just another access point to get behavioral health,” Dr. Mathison said. “Crises in pediatrics are so much more complex” than physical injuries or acute infections, which are the bread and butter of urgent care centers.

“An urgent care center almost implies you’re going to come in for a solution to a simple problem, and it’s going to be done relatively quickly on demand, and it’s just not what the behavioral health centers do,” he said.

Dr. Mathison, who also serves on the executive committee for the section on urgent care at the American Academy of Pediatrics, likened the centers to in-person versions of crisis center hotlines, which offer virtual counseling and talk therapy and may refer individuals to specialists who can provide clinical care over the long term.

Instead, Brighter Days and other centers provide crisis de-escalation for individuals experiencing an exacerbation of a diagnosed mental illness, such a manic episode from bipolar disorder.

“Most places aren’t just going to change their therapy without either contacting their psychiatrist or having psychiatrists on staff,” Dr. Mathison said.

Other challenges at Brighter Days and similar centers include staffing with appropriately trained mental health professionals, given the nationwide shortage of child and adolescent psychiatrists, Dr. Scharf said.

The number of child and adolescent psychiatrists per 100,000 children varies significantly across states. Nationally, the average stands at 14 psychiatrists per 100,000 children, but ranges from as low as 4 to 65, according to the American Academy of Child & Adolescent Psychiatry.

For now, Dr. Scharf said, patients who visit Brighter Days are billed as if they are having a routine pediatric office visit as opposed to a pricier trip to the emergency department. And the center accepts all individuals, regardless of their insurance status.

Ms. Opladen said the urgent care center represents a significant improvement over her experience at the emergency department’s psychiatric triage.

“I saw how awful it was and just the environment,” she said. “The first thing I thought was, what do I need to do to get out of here?”

She said the pediatric mental health urgent care centers are “the complete opposite.” Like Brighter Days, these centers are designed to look more like a pediatrician’s office, with bright welcoming colors and games and toys.

“It’s separated from everything else. There’s a welcome, relaxed space,” she said. “The welcoming feel is just a whole different environment, and that’s really how it should be.”
 

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

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Lauren Opladen remembers the agonizing wait all too well.

At age 17, struggling with paralyzing depression after losing her brother to suicide and her father to amyotrophic lateral sclerosis, her teacher suggested she seek help.

So, she did. But she had to spend 3 days inside an emergency department at the University of Rochester Medical Center in Rochester, New York, where the Comprehensive Psychiatric Emergency Program (CPEP) provides immediate care for youth and adults experiencing psychiatric emergencies.

“We were sleeping on a couch just waiting for all these services, when that’s precious time wasted,” Ms. Opladen said.

Ms. Opladen made it through that dark period, and 5 years later, she is a registered nurse at the same hospital. Every day she walks past a new facility she wishes had existed during her troubled teenage years: An urgent care center for children and adolescents experiencing mental health crises.

Brighter Days Pediatric Mental Health Urgent Care Center, Rochester, New York, opened in July as a walk-in clinic offering rapid assessment, crisis intervention, and short-term stabilization, provides referrals to counseling or psychiatric care. Children and adolescents at immediate risk of harming themselves or others, or who need inpatient care, are sent to CPEP or another emergency department in the area.

Similar walk-in facilities linking youth to longer-term services are popping up in nearly a dozen states, including New York, OhioMassachusetts, and Wisconsin. The emerging model of care may offer a crucial bridge between traditional outpatient services and emergency room (ER) visits for some young people experiencing mental health crises.

“We’ve seen a significant increase in the number of children and adolescents presenting to emergency departments with mental health concerns,” said Michael A. Scharf, MD, chief of the Division of Child and Adolescent Psychiatry at the University of Rochester Medical Center, who oversees operations at Brighter Days. “These urgent care centers provide a more appropriate setting for many of these cases, offering specialized care without the often overwhelming environment of an ER.”

The urgency of addressing youth behavioral health has become increasingly apparent. The most recent data from the US Centers for Disease Control and Prevention showed that over a 6-month period in 2020, during the early months of the COVID-19 pandemic, visits to the emergency department for mental health problems spiked 24% among children aged 5-11 years and 31% among 12-17-year-olds compared with the same period in 2019. Between March 2021 and February 2022, such emergency visits rose by 22% for teen girls, while falling by 15% for boys ages 5-12 years and 9% for older boys. Most visits occur during the school year.

But staffing shortages and limited physical space are taxing the capacity of the healthcare system to screen, diagnose, and manage these patients, according to a 2023 report published in Pediatrics.
 

Urgent Care: A Misnomer?

Some in the mental health community said the label “urgent” in these centers’ titles is misleading. Brighter Days and similar facilities do not conduct involuntary holds, administer medication, or handle serious cases like psychotic episodes.

David Mathison, MD, senior vice president of clinic operations at PM Pediatrics, a chain of pediatric urgent care clinics in Maryland, said patients and their families may mistakenly believe the centers will address mental health problems quickly.

“It’s really not urgent behavioral health. It’s really just another access point to get behavioral health,” Dr. Mathison said. “Crises in pediatrics are so much more complex” than physical injuries or acute infections, which are the bread and butter of urgent care centers.

“An urgent care center almost implies you’re going to come in for a solution to a simple problem, and it’s going to be done relatively quickly on demand, and it’s just not what the behavioral health centers do,” he said.

Dr. Mathison, who also serves on the executive committee for the section on urgent care at the American Academy of Pediatrics, likened the centers to in-person versions of crisis center hotlines, which offer virtual counseling and talk therapy and may refer individuals to specialists who can provide clinical care over the long term.

Instead, Brighter Days and other centers provide crisis de-escalation for individuals experiencing an exacerbation of a diagnosed mental illness, such a manic episode from bipolar disorder.

“Most places aren’t just going to change their therapy without either contacting their psychiatrist or having psychiatrists on staff,” Dr. Mathison said.

Other challenges at Brighter Days and similar centers include staffing with appropriately trained mental health professionals, given the nationwide shortage of child and adolescent psychiatrists, Dr. Scharf said.

The number of child and adolescent psychiatrists per 100,000 children varies significantly across states. Nationally, the average stands at 14 psychiatrists per 100,000 children, but ranges from as low as 4 to 65, according to the American Academy of Child & Adolescent Psychiatry.

For now, Dr. Scharf said, patients who visit Brighter Days are billed as if they are having a routine pediatric office visit as opposed to a pricier trip to the emergency department. And the center accepts all individuals, regardless of their insurance status.

Ms. Opladen said the urgent care center represents a significant improvement over her experience at the emergency department’s psychiatric triage.

“I saw how awful it was and just the environment,” she said. “The first thing I thought was, what do I need to do to get out of here?”

She said the pediatric mental health urgent care centers are “the complete opposite.” Like Brighter Days, these centers are designed to look more like a pediatrician’s office, with bright welcoming colors and games and toys.

“It’s separated from everything else. There’s a welcome, relaxed space,” she said. “The welcoming feel is just a whole different environment, and that’s really how it should be.”
 

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

 

Lauren Opladen remembers the agonizing wait all too well.

At age 17, struggling with paralyzing depression after losing her brother to suicide and her father to amyotrophic lateral sclerosis, her teacher suggested she seek help.

So, she did. But she had to spend 3 days inside an emergency department at the University of Rochester Medical Center in Rochester, New York, where the Comprehensive Psychiatric Emergency Program (CPEP) provides immediate care for youth and adults experiencing psychiatric emergencies.

“We were sleeping on a couch just waiting for all these services, when that’s precious time wasted,” Ms. Opladen said.

Ms. Opladen made it through that dark period, and 5 years later, she is a registered nurse at the same hospital. Every day she walks past a new facility she wishes had existed during her troubled teenage years: An urgent care center for children and adolescents experiencing mental health crises.

Brighter Days Pediatric Mental Health Urgent Care Center, Rochester, New York, opened in July as a walk-in clinic offering rapid assessment, crisis intervention, and short-term stabilization, provides referrals to counseling or psychiatric care. Children and adolescents at immediate risk of harming themselves or others, or who need inpatient care, are sent to CPEP or another emergency department in the area.

Similar walk-in facilities linking youth to longer-term services are popping up in nearly a dozen states, including New York, OhioMassachusetts, and Wisconsin. The emerging model of care may offer a crucial bridge between traditional outpatient services and emergency room (ER) visits for some young people experiencing mental health crises.

“We’ve seen a significant increase in the number of children and adolescents presenting to emergency departments with mental health concerns,” said Michael A. Scharf, MD, chief of the Division of Child and Adolescent Psychiatry at the University of Rochester Medical Center, who oversees operations at Brighter Days. “These urgent care centers provide a more appropriate setting for many of these cases, offering specialized care without the often overwhelming environment of an ER.”

The urgency of addressing youth behavioral health has become increasingly apparent. The most recent data from the US Centers for Disease Control and Prevention showed that over a 6-month period in 2020, during the early months of the COVID-19 pandemic, visits to the emergency department for mental health problems spiked 24% among children aged 5-11 years and 31% among 12-17-year-olds compared with the same period in 2019. Between March 2021 and February 2022, such emergency visits rose by 22% for teen girls, while falling by 15% for boys ages 5-12 years and 9% for older boys. Most visits occur during the school year.

But staffing shortages and limited physical space are taxing the capacity of the healthcare system to screen, diagnose, and manage these patients, according to a 2023 report published in Pediatrics.
 

Urgent Care: A Misnomer?

Some in the mental health community said the label “urgent” in these centers’ titles is misleading. Brighter Days and similar facilities do not conduct involuntary holds, administer medication, or handle serious cases like psychotic episodes.

David Mathison, MD, senior vice president of clinic operations at PM Pediatrics, a chain of pediatric urgent care clinics in Maryland, said patients and their families may mistakenly believe the centers will address mental health problems quickly.

“It’s really not urgent behavioral health. It’s really just another access point to get behavioral health,” Dr. Mathison said. “Crises in pediatrics are so much more complex” than physical injuries or acute infections, which are the bread and butter of urgent care centers.

“An urgent care center almost implies you’re going to come in for a solution to a simple problem, and it’s going to be done relatively quickly on demand, and it’s just not what the behavioral health centers do,” he said.

Dr. Mathison, who also serves on the executive committee for the section on urgent care at the American Academy of Pediatrics, likened the centers to in-person versions of crisis center hotlines, which offer virtual counseling and talk therapy and may refer individuals to specialists who can provide clinical care over the long term.

Instead, Brighter Days and other centers provide crisis de-escalation for individuals experiencing an exacerbation of a diagnosed mental illness, such a manic episode from bipolar disorder.

“Most places aren’t just going to change their therapy without either contacting their psychiatrist or having psychiatrists on staff,” Dr. Mathison said.

Other challenges at Brighter Days and similar centers include staffing with appropriately trained mental health professionals, given the nationwide shortage of child and adolescent psychiatrists, Dr. Scharf said.

The number of child and adolescent psychiatrists per 100,000 children varies significantly across states. Nationally, the average stands at 14 psychiatrists per 100,000 children, but ranges from as low as 4 to 65, according to the American Academy of Child & Adolescent Psychiatry.

For now, Dr. Scharf said, patients who visit Brighter Days are billed as if they are having a routine pediatric office visit as opposed to a pricier trip to the emergency department. And the center accepts all individuals, regardless of their insurance status.

Ms. Opladen said the urgent care center represents a significant improvement over her experience at the emergency department’s psychiatric triage.

“I saw how awful it was and just the environment,” she said. “The first thing I thought was, what do I need to do to get out of here?”

She said the pediatric mental health urgent care centers are “the complete opposite.” Like Brighter Days, these centers are designed to look more like a pediatrician’s office, with bright welcoming colors and games and toys.

“It’s separated from everything else. There’s a welcome, relaxed space,” she said. “The welcoming feel is just a whole different environment, and that’s really how it should be.”
 

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

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Twice-Yearly PrEP Gives ‘Huge’ 100% Protection

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Wed, 07/31/2024 - 13:19

 

Twice-yearly injections are 100% effective in preventing new infections, according to the final results from the PURPOSE 1 trial of lenacapavir.

For weeks, the HIV community has been talking about this highly anticipated clinical trial and whether the strong — and to many, surprising — interim results would hold at final presentation at the International AIDS Conference 2024 in Munich, Germany.

Presenting the results, Linda-Gail Bekker, MD, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, reported zero new infections in those who got the shots in the study of about 5000 young women. In the group given daily oral preexposure prophylaxis (PrEP), roughly 2% contracted HIV from infected partners.

“A twice-yearly PrEP choice could overcome some of the adherence and persistence challenges and contribute critically to our quest to reduce HIV infection in women around the world,” Dr. Bekker said about the results, which were published simultaneously in The New England Journal of Medicine.

PURPOSE 1 confirmed that lenacapavir is a “breakthrough” for HIV prevention, said International AIDS Society president Sharon Lewin, PhD, MBBS. It has “huge public health potential,” said Dr. Lewin, the AIDS 2024 conference cochair and director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne in Australia.

Lenacapavir is a novel, first-in-class multistage HIV-1 capsid inhibitor with a long half-life, which enables the twice-yearly dosing.

PURPOSE 1 enrolled women aged 15-25 years who were at risk for HIV in South Africa and Uganda, with a primary endpoint of HIV infection. Because of the previously announced interim results, which showed the injection was preventing infections, study sponsor Gilead Sciences discontinued the randomized phase of the trial and shifted to an open-label design for lenacapavir.

“One hundred percent efficacy is more that we could ever have hoped for a potential prevention efficacy,” said Christoph Spinner, MD, MBA, an infectious disease specialist at the University Hospital of the Technical University of Munich and AIDS 2024 conference cochair.

Dr. Spinner added that while this is the first study of lenacapavir for PrEP, it’s also the first to explore outcomes of emtricitabine-tenofovir in cisgender women.
 

Strong Adherence Rates

The twice-yearly injection demonstrated adherence rates above 90% in the trial for both the 6- and 12-month injection intervals.

“Adherence was 91.5% at week 26 and 92.8% at week 52,” Dr. Bekker reported. 

The trial compared three PrEP options including the lenacapavir injection to once-daily oral emtricitabine 200 mg and tenofovir-alafenamide 25 mg (F/TAF) and once-daily emtricitabine 200 mg and tenofovir–disoproxil fumarate 300 mg (F/TDF).

“Most participants in both the F/TAF and F/TDF groups had low adherence, and this declined over time,” Dr. Bekker reported. At 52 weeks, the vast majority of patients on both oral therapies had low adherence with dosing, defined at less than two doses a week.

Dr. Bekker called the adherence to the oral agents in this trial “disappointing.”

Findings from the trial underscore the challenges of adherence to a daily oral medication, Rochelle Walensky, MD, and Lindsey Baden, MD, from the Harvard Kennedy School of Government and Harvard Business School in Cambridge, Massachusetts, wrote in an editorial accompanying the published results.

With almost 92% attendance for the twice-yearly lenacapavir injections, the “well-done,” large, randomized, controlled trial “exemplifies not only that women can dependably adhere to this administration schedule, but also that levels of an HIV-1 capsid inhibitor can remain high enough over a period of 6 months to reliably prevent infection,” they added. 

Another key focus of the presentation was adverse events. The rate of adverse events grade 3 or more in the lenacapavir arm was 4.1%, Bekker said, which is slightly lower than the rates in the oral arms. The rates of serious adverse events were 2.8% for lenacapavir, 4% for F/TAF and 3.3% for F/TDF. 
 

 

 

Injection Site Reactions

Injection site reactions occurred in 68% of the lenacapavir group, including 63% with subcutaneous nodules.

The injection can form “a drug depot which may be palpable as a nodule,” Dr. Bekker said. In the placebo group, 34% of patients had injection-site reactions and 16% had nodules. Nearly all injection-site reactions were grade 1 or 2, she said. “Higher grade injection-site reactions were rare and not serious and occurred in a similar percentage in lenacapavir and placebo,” she said.

Overall, more than 25,000 injections of lenacapavir have been given, Dr. Bekker said, and four patients discontinued treatment because of injection-site reactions. “Reporting of injection-site reactions, including nodules, decreased with subsequent doses,” she said.

Contraception was not a requirement for enrollment in the study, Dr. Bekker pointed out, and pregnancy outcomes across the treatment arms were similar to the general population.
 

First in a Series of Trials

This is the first in a series of PURPOSE trials, Bekker reported. The phase 3 PURPOSE 2 trial, enrolling 3000 gay men, transgender women, transgender men and gender nonbinary people who have sex with male partners, is the second pivotal trial now underway.

Three other smaller trials are in the clinic in the United States and Europe.

PURPOSE 1 participants will continue to access lenacapavir until the product is available in South Africa and Uganda, Dr. Bekker said. Trial sponsor Gilead Sciences is also developing a direct licensing program to expedite generic access to the drug in high-incidence, resource-limited countries, she said.

Dr. Walensky and Dr. Baden report that lenacapavir currently costs about $43,000 annually in the United States. “But the results of the PURPOSE 1 trial have now created a moral imperative to make lenacapavir broadly accessible and affordable as PrEP” to people who were enrolled, as well as all those who are similarly eligible and could benefit.

So now we have a PrEP product with high efficacy, they added. “That is great news for science but not (yet) great for women.” 

Given the high pregnancy rate among participants in the PURPOSE 1 trial, Dr. Walensky and Dr. Baden point out the assessment of lenacapavir safety is a priority. They are also interested in learning more about drug resistance with this new option. 

“I f approved and delivered — rapidly, affordably, and equitably — to those who need or want it, this long-acting tool could help accelerate global progress in HIV prevention,” Dr. Lewin said.

Now, she added, “we eagerly await results from PURPOSE 2.”
 

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

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Twice-yearly injections are 100% effective in preventing new infections, according to the final results from the PURPOSE 1 trial of lenacapavir.

For weeks, the HIV community has been talking about this highly anticipated clinical trial and whether the strong — and to many, surprising — interim results would hold at final presentation at the International AIDS Conference 2024 in Munich, Germany.

Presenting the results, Linda-Gail Bekker, MD, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, reported zero new infections in those who got the shots in the study of about 5000 young women. In the group given daily oral preexposure prophylaxis (PrEP), roughly 2% contracted HIV from infected partners.

“A twice-yearly PrEP choice could overcome some of the adherence and persistence challenges and contribute critically to our quest to reduce HIV infection in women around the world,” Dr. Bekker said about the results, which were published simultaneously in The New England Journal of Medicine.

PURPOSE 1 confirmed that lenacapavir is a “breakthrough” for HIV prevention, said International AIDS Society president Sharon Lewin, PhD, MBBS. It has “huge public health potential,” said Dr. Lewin, the AIDS 2024 conference cochair and director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne in Australia.

Lenacapavir is a novel, first-in-class multistage HIV-1 capsid inhibitor with a long half-life, which enables the twice-yearly dosing.

PURPOSE 1 enrolled women aged 15-25 years who were at risk for HIV in South Africa and Uganda, with a primary endpoint of HIV infection. Because of the previously announced interim results, which showed the injection was preventing infections, study sponsor Gilead Sciences discontinued the randomized phase of the trial and shifted to an open-label design for lenacapavir.

“One hundred percent efficacy is more that we could ever have hoped for a potential prevention efficacy,” said Christoph Spinner, MD, MBA, an infectious disease specialist at the University Hospital of the Technical University of Munich and AIDS 2024 conference cochair.

Dr. Spinner added that while this is the first study of lenacapavir for PrEP, it’s also the first to explore outcomes of emtricitabine-tenofovir in cisgender women.
 

Strong Adherence Rates

The twice-yearly injection demonstrated adherence rates above 90% in the trial for both the 6- and 12-month injection intervals.

“Adherence was 91.5% at week 26 and 92.8% at week 52,” Dr. Bekker reported. 

The trial compared three PrEP options including the lenacapavir injection to once-daily oral emtricitabine 200 mg and tenofovir-alafenamide 25 mg (F/TAF) and once-daily emtricitabine 200 mg and tenofovir–disoproxil fumarate 300 mg (F/TDF).

“Most participants in both the F/TAF and F/TDF groups had low adherence, and this declined over time,” Dr. Bekker reported. At 52 weeks, the vast majority of patients on both oral therapies had low adherence with dosing, defined at less than two doses a week.

Dr. Bekker called the adherence to the oral agents in this trial “disappointing.”

Findings from the trial underscore the challenges of adherence to a daily oral medication, Rochelle Walensky, MD, and Lindsey Baden, MD, from the Harvard Kennedy School of Government and Harvard Business School in Cambridge, Massachusetts, wrote in an editorial accompanying the published results.

With almost 92% attendance for the twice-yearly lenacapavir injections, the “well-done,” large, randomized, controlled trial “exemplifies not only that women can dependably adhere to this administration schedule, but also that levels of an HIV-1 capsid inhibitor can remain high enough over a period of 6 months to reliably prevent infection,” they added. 

Another key focus of the presentation was adverse events. The rate of adverse events grade 3 or more in the lenacapavir arm was 4.1%, Bekker said, which is slightly lower than the rates in the oral arms. The rates of serious adverse events were 2.8% for lenacapavir, 4% for F/TAF and 3.3% for F/TDF. 
 

 

 

Injection Site Reactions

Injection site reactions occurred in 68% of the lenacapavir group, including 63% with subcutaneous nodules.

The injection can form “a drug depot which may be palpable as a nodule,” Dr. Bekker said. In the placebo group, 34% of patients had injection-site reactions and 16% had nodules. Nearly all injection-site reactions were grade 1 or 2, she said. “Higher grade injection-site reactions were rare and not serious and occurred in a similar percentage in lenacapavir and placebo,” she said.

Overall, more than 25,000 injections of lenacapavir have been given, Dr. Bekker said, and four patients discontinued treatment because of injection-site reactions. “Reporting of injection-site reactions, including nodules, decreased with subsequent doses,” she said.

Contraception was not a requirement for enrollment in the study, Dr. Bekker pointed out, and pregnancy outcomes across the treatment arms were similar to the general population.
 

First in a Series of Trials

This is the first in a series of PURPOSE trials, Bekker reported. The phase 3 PURPOSE 2 trial, enrolling 3000 gay men, transgender women, transgender men and gender nonbinary people who have sex with male partners, is the second pivotal trial now underway.

Three other smaller trials are in the clinic in the United States and Europe.

PURPOSE 1 participants will continue to access lenacapavir until the product is available in South Africa and Uganda, Dr. Bekker said. Trial sponsor Gilead Sciences is also developing a direct licensing program to expedite generic access to the drug in high-incidence, resource-limited countries, she said.

Dr. Walensky and Dr. Baden report that lenacapavir currently costs about $43,000 annually in the United States. “But the results of the PURPOSE 1 trial have now created a moral imperative to make lenacapavir broadly accessible and affordable as PrEP” to people who were enrolled, as well as all those who are similarly eligible and could benefit.

So now we have a PrEP product with high efficacy, they added. “That is great news for science but not (yet) great for women.” 

Given the high pregnancy rate among participants in the PURPOSE 1 trial, Dr. Walensky and Dr. Baden point out the assessment of lenacapavir safety is a priority. They are also interested in learning more about drug resistance with this new option. 

“I f approved and delivered — rapidly, affordably, and equitably — to those who need or want it, this long-acting tool could help accelerate global progress in HIV prevention,” Dr. Lewin said.

Now, she added, “we eagerly await results from PURPOSE 2.”
 

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

 

Twice-yearly injections are 100% effective in preventing new infections, according to the final results from the PURPOSE 1 trial of lenacapavir.

For weeks, the HIV community has been talking about this highly anticipated clinical trial and whether the strong — and to many, surprising — interim results would hold at final presentation at the International AIDS Conference 2024 in Munich, Germany.

Presenting the results, Linda-Gail Bekker, MD, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, reported zero new infections in those who got the shots in the study of about 5000 young women. In the group given daily oral preexposure prophylaxis (PrEP), roughly 2% contracted HIV from infected partners.

“A twice-yearly PrEP choice could overcome some of the adherence and persistence challenges and contribute critically to our quest to reduce HIV infection in women around the world,” Dr. Bekker said about the results, which were published simultaneously in The New England Journal of Medicine.

PURPOSE 1 confirmed that lenacapavir is a “breakthrough” for HIV prevention, said International AIDS Society president Sharon Lewin, PhD, MBBS. It has “huge public health potential,” said Dr. Lewin, the AIDS 2024 conference cochair and director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne in Australia.

Lenacapavir is a novel, first-in-class multistage HIV-1 capsid inhibitor with a long half-life, which enables the twice-yearly dosing.

PURPOSE 1 enrolled women aged 15-25 years who were at risk for HIV in South Africa and Uganda, with a primary endpoint of HIV infection. Because of the previously announced interim results, which showed the injection was preventing infections, study sponsor Gilead Sciences discontinued the randomized phase of the trial and shifted to an open-label design for lenacapavir.

“One hundred percent efficacy is more that we could ever have hoped for a potential prevention efficacy,” said Christoph Spinner, MD, MBA, an infectious disease specialist at the University Hospital of the Technical University of Munich and AIDS 2024 conference cochair.

Dr. Spinner added that while this is the first study of lenacapavir for PrEP, it’s also the first to explore outcomes of emtricitabine-tenofovir in cisgender women.
 

Strong Adherence Rates

The twice-yearly injection demonstrated adherence rates above 90% in the trial for both the 6- and 12-month injection intervals.

“Adherence was 91.5% at week 26 and 92.8% at week 52,” Dr. Bekker reported. 

The trial compared three PrEP options including the lenacapavir injection to once-daily oral emtricitabine 200 mg and tenofovir-alafenamide 25 mg (F/TAF) and once-daily emtricitabine 200 mg and tenofovir–disoproxil fumarate 300 mg (F/TDF).

“Most participants in both the F/TAF and F/TDF groups had low adherence, and this declined over time,” Dr. Bekker reported. At 52 weeks, the vast majority of patients on both oral therapies had low adherence with dosing, defined at less than two doses a week.

Dr. Bekker called the adherence to the oral agents in this trial “disappointing.”

Findings from the trial underscore the challenges of adherence to a daily oral medication, Rochelle Walensky, MD, and Lindsey Baden, MD, from the Harvard Kennedy School of Government and Harvard Business School in Cambridge, Massachusetts, wrote in an editorial accompanying the published results.

With almost 92% attendance for the twice-yearly lenacapavir injections, the “well-done,” large, randomized, controlled trial “exemplifies not only that women can dependably adhere to this administration schedule, but also that levels of an HIV-1 capsid inhibitor can remain high enough over a period of 6 months to reliably prevent infection,” they added. 

Another key focus of the presentation was adverse events. The rate of adverse events grade 3 or more in the lenacapavir arm was 4.1%, Bekker said, which is slightly lower than the rates in the oral arms. The rates of serious adverse events were 2.8% for lenacapavir, 4% for F/TAF and 3.3% for F/TDF. 
 

 

 

Injection Site Reactions

Injection site reactions occurred in 68% of the lenacapavir group, including 63% with subcutaneous nodules.

The injection can form “a drug depot which may be palpable as a nodule,” Dr. Bekker said. In the placebo group, 34% of patients had injection-site reactions and 16% had nodules. Nearly all injection-site reactions were grade 1 or 2, she said. “Higher grade injection-site reactions were rare and not serious and occurred in a similar percentage in lenacapavir and placebo,” she said.

Overall, more than 25,000 injections of lenacapavir have been given, Dr. Bekker said, and four patients discontinued treatment because of injection-site reactions. “Reporting of injection-site reactions, including nodules, decreased with subsequent doses,” she said.

Contraception was not a requirement for enrollment in the study, Dr. Bekker pointed out, and pregnancy outcomes across the treatment arms were similar to the general population.
 

First in a Series of Trials

This is the first in a series of PURPOSE trials, Bekker reported. The phase 3 PURPOSE 2 trial, enrolling 3000 gay men, transgender women, transgender men and gender nonbinary people who have sex with male partners, is the second pivotal trial now underway.

Three other smaller trials are in the clinic in the United States and Europe.

PURPOSE 1 participants will continue to access lenacapavir until the product is available in South Africa and Uganda, Dr. Bekker said. Trial sponsor Gilead Sciences is also developing a direct licensing program to expedite generic access to the drug in high-incidence, resource-limited countries, she said.

Dr. Walensky and Dr. Baden report that lenacapavir currently costs about $43,000 annually in the United States. “But the results of the PURPOSE 1 trial have now created a moral imperative to make lenacapavir broadly accessible and affordable as PrEP” to people who were enrolled, as well as all those who are similarly eligible and could benefit.

So now we have a PrEP product with high efficacy, they added. “That is great news for science but not (yet) great for women.” 

Given the high pregnancy rate among participants in the PURPOSE 1 trial, Dr. Walensky and Dr. Baden point out the assessment of lenacapavir safety is a priority. They are also interested in learning more about drug resistance with this new option. 

“I f approved and delivered — rapidly, affordably, and equitably — to those who need or want it, this long-acting tool could help accelerate global progress in HIV prevention,” Dr. Lewin said.

Now, she added, “we eagerly await results from PURPOSE 2.”
 

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

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The Rise of the Scribes

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Fri, 07/26/2024 - 09:27

 

“We really aren’t taking care of records — we’re taking care of people.”Dr. Lawrence Weed

What is the purpose of a progress note? Anyone? Yes, you there. “Insurance billing?” Yes, that’s a good one. Anyone else? “To remember what you did?” Excellent. Another? Yes, that’s right, for others to follow along in your care. These are all good reasons for a progress note to exist. But they aren’t the whole story. Let’s start at the beginning.

Charts were once a collection of paper sheets with handwritten notes. Sometimes illegible, sometimes beautiful, always efficient. A progress note back then could be just 10 characters, AK, LN2, X,X,X,X,X (with X’s marking nitrogen sprays). Then came the healthcare K-Pg event: the conversion to EMRs. Those doctors who survived evolved into computer programmers, creating blocks of text from a few keystrokes. But like toddler-sized Legos, the blocks made it impossible to build a note that is nuanced or precise. Worse yet, many notes consisting of blocks from one note added awkwardly to a new note, creating grotesque structures unrecognizable as anything that should exist in nature. Words and numbers, but no information.

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Paper medical records

Thanks to the eternity of EMR, these creations live on, hideous and useless. They waste not only the server’s energy but also our time. Few things are more maddening than scrolling to reach the bottom of another physician’s note only to find there is nothing there.

Whose fault is this? Anyone? Yes, that’s right, insurers. As there are probably no payers in this audience, let’s blame them. I agree, the crushing burden of documentation-to-get-reimbursed has forced us to create “notes” that add no value to us but add up points for us to get paid for them. CMS, payers, prior authorizations, and now even patients, it seems we are documenting for lots of people except for us. There isn’t time to satisfy all and this significant burden for every encounter is a proximate cause for doctors despair. Until now.

In 2024, came our story’s deus ex machina: the AI scribe. A tool that can listen to a doctor visit, then from the ether, generate a note. A fully formed, comprehensive, sometimes pretty note that satisfies all audiences. Dr. Larry Weed must be dancing in heaven. It was Dr. Weed who led us from the nicotine-stained logs of the 1950s to the powerful problem-based notes we use today, an innovation that rivals the stethoscope in its impact.

Professor Weed also predicted that computers would be important to capture and make sense of patient data, helping us make accurate diagnoses and efficient plans. Again, he was right. He would surely be advocating to take advantage of AI scribes’ marvelous ability to capture salient data and present it in the form of a problem-oriented medical record.

AI scribes will be ubiquitous soon; I’m fast and even for me they save time. They also allow, for the first time in a decade, to turn from the glow of a screen to actually face the patient – we no longer have to scribe and care simultaneously. Hallelujah. And yet, lest I disappoint you without a twist, it seems with AI scribes, like EMRs we lose a little something too.

Like self-driving cars or ChatGPT-generated letters, they remove cognitive loads. They are lovely when you have to multitask or are trying to recall a visit from hours (days) ago. Using them, you’ll feel faster, lighter, freer, happier. But what’s missing is the thinking. At the end, you have an exquisite note, but you didn’t write it. It has the salient points, but none of the mental work to create it. AI scribes subvert the valuable work of synthesis. That was the critical part of Dr. Weed’s discovery: writing problem-oriented notes helped us think better.

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Dr. Jeffrey Benabio

Writing allows for the friction that helps us process what is going on with a patient. It allows for the discovery of diagnoses and prompts plans. When I was an intern, one of my attendings would hand write notes, succinctly showing what he had observed and was thinking. He’d sketch diagrams in the chart, for example, to help illustrate how we’d work though the toxic, metabolic, and infectious etiologies of acute liver failure. Sublime.

The act of writing also helps remind us there is a person attached to these words. Like a handwritten sympathy card, it is intimate, human. Even using our EMR, I’d still often type sentences that help tell the patient’s story. “Her sister just died. Utterly devastated. I’ll forward chart to Bob (her PCP) to check in on her.” Or: “Scratch golfer wants to know why he is getting so many SCCs now. ‘Like bankruptcy, gradually then suddenly,’ I explained. I think I broke through.”

Since we’ve concluded the purpose of a note is mostly to capture data, AI scribes are a godsend. They do so with remarkable quality and efficiency. We’ll just have to remember if the diagnosis is unclear, then it might help to write the note out yourself. And even when done by the AI machine, we might add human touches now and again lest there be no art left in what we do.

“For sale. Sun hat. Never worn.”

 

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

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“We really aren’t taking care of records — we’re taking care of people.”Dr. Lawrence Weed

What is the purpose of a progress note? Anyone? Yes, you there. “Insurance billing?” Yes, that’s a good one. Anyone else? “To remember what you did?” Excellent. Another? Yes, that’s right, for others to follow along in your care. These are all good reasons for a progress note to exist. But they aren’t the whole story. Let’s start at the beginning.

Charts were once a collection of paper sheets with handwritten notes. Sometimes illegible, sometimes beautiful, always efficient. A progress note back then could be just 10 characters, AK, LN2, X,X,X,X,X (with X’s marking nitrogen sprays). Then came the healthcare K-Pg event: the conversion to EMRs. Those doctors who survived evolved into computer programmers, creating blocks of text from a few keystrokes. But like toddler-sized Legos, the blocks made it impossible to build a note that is nuanced or precise. Worse yet, many notes consisting of blocks from one note added awkwardly to a new note, creating grotesque structures unrecognizable as anything that should exist in nature. Words and numbers, but no information.

Newtown grafitti / flickr / CC BY-2.0
Paper medical records

Thanks to the eternity of EMR, these creations live on, hideous and useless. They waste not only the server’s energy but also our time. Few things are more maddening than scrolling to reach the bottom of another physician’s note only to find there is nothing there.

Whose fault is this? Anyone? Yes, that’s right, insurers. As there are probably no payers in this audience, let’s blame them. I agree, the crushing burden of documentation-to-get-reimbursed has forced us to create “notes” that add no value to us but add up points for us to get paid for them. CMS, payers, prior authorizations, and now even patients, it seems we are documenting for lots of people except for us. There isn’t time to satisfy all and this significant burden for every encounter is a proximate cause for doctors despair. Until now.

In 2024, came our story’s deus ex machina: the AI scribe. A tool that can listen to a doctor visit, then from the ether, generate a note. A fully formed, comprehensive, sometimes pretty note that satisfies all audiences. Dr. Larry Weed must be dancing in heaven. It was Dr. Weed who led us from the nicotine-stained logs of the 1950s to the powerful problem-based notes we use today, an innovation that rivals the stethoscope in its impact.

Professor Weed also predicted that computers would be important to capture and make sense of patient data, helping us make accurate diagnoses and efficient plans. Again, he was right. He would surely be advocating to take advantage of AI scribes’ marvelous ability to capture salient data and present it in the form of a problem-oriented medical record.

AI scribes will be ubiquitous soon; I’m fast and even for me they save time. They also allow, for the first time in a decade, to turn from the glow of a screen to actually face the patient – we no longer have to scribe and care simultaneously. Hallelujah. And yet, lest I disappoint you without a twist, it seems with AI scribes, like EMRs we lose a little something too.

Like self-driving cars or ChatGPT-generated letters, they remove cognitive loads. They are lovely when you have to multitask or are trying to recall a visit from hours (days) ago. Using them, you’ll feel faster, lighter, freer, happier. But what’s missing is the thinking. At the end, you have an exquisite note, but you didn’t write it. It has the salient points, but none of the mental work to create it. AI scribes subvert the valuable work of synthesis. That was the critical part of Dr. Weed’s discovery: writing problem-oriented notes helped us think better.

Kaiser Permanente
Dr. Jeffrey Benabio

Writing allows for the friction that helps us process what is going on with a patient. It allows for the discovery of diagnoses and prompts plans. When I was an intern, one of my attendings would hand write notes, succinctly showing what he had observed and was thinking. He’d sketch diagrams in the chart, for example, to help illustrate how we’d work though the toxic, metabolic, and infectious etiologies of acute liver failure. Sublime.

The act of writing also helps remind us there is a person attached to these words. Like a handwritten sympathy card, it is intimate, human. Even using our EMR, I’d still often type sentences that help tell the patient’s story. “Her sister just died. Utterly devastated. I’ll forward chart to Bob (her PCP) to check in on her.” Or: “Scratch golfer wants to know why he is getting so many SCCs now. ‘Like bankruptcy, gradually then suddenly,’ I explained. I think I broke through.”

Since we’ve concluded the purpose of a note is mostly to capture data, AI scribes are a godsend. They do so with remarkable quality and efficiency. We’ll just have to remember if the diagnosis is unclear, then it might help to write the note out yourself. And even when done by the AI machine, we might add human touches now and again lest there be no art left in what we do.

“For sale. Sun hat. Never worn.”

 

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

 

“We really aren’t taking care of records — we’re taking care of people.”Dr. Lawrence Weed

What is the purpose of a progress note? Anyone? Yes, you there. “Insurance billing?” Yes, that’s a good one. Anyone else? “To remember what you did?” Excellent. Another? Yes, that’s right, for others to follow along in your care. These are all good reasons for a progress note to exist. But they aren’t the whole story. Let’s start at the beginning.

Charts were once a collection of paper sheets with handwritten notes. Sometimes illegible, sometimes beautiful, always efficient. A progress note back then could be just 10 characters, AK, LN2, X,X,X,X,X (with X’s marking nitrogen sprays). Then came the healthcare K-Pg event: the conversion to EMRs. Those doctors who survived evolved into computer programmers, creating blocks of text from a few keystrokes. But like toddler-sized Legos, the blocks made it impossible to build a note that is nuanced or precise. Worse yet, many notes consisting of blocks from one note added awkwardly to a new note, creating grotesque structures unrecognizable as anything that should exist in nature. Words and numbers, but no information.

Newtown grafitti / flickr / CC BY-2.0
Paper medical records

Thanks to the eternity of EMR, these creations live on, hideous and useless. They waste not only the server’s energy but also our time. Few things are more maddening than scrolling to reach the bottom of another physician’s note only to find there is nothing there.

Whose fault is this? Anyone? Yes, that’s right, insurers. As there are probably no payers in this audience, let’s blame them. I agree, the crushing burden of documentation-to-get-reimbursed has forced us to create “notes” that add no value to us but add up points for us to get paid for them. CMS, payers, prior authorizations, and now even patients, it seems we are documenting for lots of people except for us. There isn’t time to satisfy all and this significant burden for every encounter is a proximate cause for doctors despair. Until now.

In 2024, came our story’s deus ex machina: the AI scribe. A tool that can listen to a doctor visit, then from the ether, generate a note. A fully formed, comprehensive, sometimes pretty note that satisfies all audiences. Dr. Larry Weed must be dancing in heaven. It was Dr. Weed who led us from the nicotine-stained logs of the 1950s to the powerful problem-based notes we use today, an innovation that rivals the stethoscope in its impact.

Professor Weed also predicted that computers would be important to capture and make sense of patient data, helping us make accurate diagnoses and efficient plans. Again, he was right. He would surely be advocating to take advantage of AI scribes’ marvelous ability to capture salient data and present it in the form of a problem-oriented medical record.

AI scribes will be ubiquitous soon; I’m fast and even for me they save time. They also allow, for the first time in a decade, to turn from the glow of a screen to actually face the patient – we no longer have to scribe and care simultaneously. Hallelujah. And yet, lest I disappoint you without a twist, it seems with AI scribes, like EMRs we lose a little something too.

Like self-driving cars or ChatGPT-generated letters, they remove cognitive loads. They are lovely when you have to multitask or are trying to recall a visit from hours (days) ago. Using them, you’ll feel faster, lighter, freer, happier. But what’s missing is the thinking. At the end, you have an exquisite note, but you didn’t write it. It has the salient points, but none of the mental work to create it. AI scribes subvert the valuable work of synthesis. That was the critical part of Dr. Weed’s discovery: writing problem-oriented notes helped us think better.

Kaiser Permanente
Dr. Jeffrey Benabio

Writing allows for the friction that helps us process what is going on with a patient. It allows for the discovery of diagnoses and prompts plans. When I was an intern, one of my attendings would hand write notes, succinctly showing what he had observed and was thinking. He’d sketch diagrams in the chart, for example, to help illustrate how we’d work though the toxic, metabolic, and infectious etiologies of acute liver failure. Sublime.

The act of writing also helps remind us there is a person attached to these words. Like a handwritten sympathy card, it is intimate, human. Even using our EMR, I’d still often type sentences that help tell the patient’s story. “Her sister just died. Utterly devastated. I’ll forward chart to Bob (her PCP) to check in on her.” Or: “Scratch golfer wants to know why he is getting so many SCCs now. ‘Like bankruptcy, gradually then suddenly,’ I explained. I think I broke through.”

Since we’ve concluded the purpose of a note is mostly to capture data, AI scribes are a godsend. They do so with remarkable quality and efficiency. We’ll just have to remember if the diagnosis is unclear, then it might help to write the note out yourself. And even when done by the AI machine, we might add human touches now and again lest there be no art left in what we do.

“For sale. Sun hat. Never worn.”

 

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

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Will Artificial Intelligence Replace Some Primary Care?

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Thu, 07/25/2024 - 11:53

Within the next few years, patients will go to their primary care facility for a medical problem. They’ll be greeted by a nonhuman who speaks in the language of their choice. Based upon the initial interview, which will be taken in note form, the patient will be diagnosed, and a prescription called into the pharmacy. They’ll pay the robot at a reception kiosk, and their meds will be delivered via driverless car.

Or so suggests Allan Stewart, MD, medical director and chief of cardiothoracic surgery at HCA Florida Mercy Hospital in Miami.

The writing is on the wall. Artificial intelligence (AI) is only going to play a more significant role in healthcare, and the entire patient experience will be much different in the next 5 years, he said.

If that sounds far too futuristic, buckle up. AI is already here and being used by most medical specialties. However, it’s primary care that stands to gain the most from this technology — right now — thanks to its ability to radically streamline patient care.
 

Seeing the Doctor and His or Her AI Assistant

AI is making doctors’ work lives easier, whether the technology helps with risk prevention and intervention or closing care gaps. It can also triage patient complaints, monitor patients remotely, or even perform digital health coaching to keep patients on track with their lifestyle regimens or monitor their health conditions.

Each of these AI components enables primary care physicians to reduce some of the paperwork requirements of their jobs and do what they were trained to do — listen and assess patients. Doctors currently spend 12 hours on average each week submitting prior authorization requests, according to an American Medical Association survey.

“Primary care can be overwhelming, especially today, with the advent of electronic records and data,” said Davin Lundquist, MD, a family medicine physician and chief medical officer at Augmedix, an automated medical documentation company that provides tools to reduce clinician burnout. “The amount of data we have to go through to try to get a complete and clear picture of our patients can be overwhelming on top of the referrals, administrative burdens, and regulatory requirements, which seem to be focused on the primary care space,” Dr. Lundquist said.

With an AI assist, primary care physicians can reduce their prep and pre-charting time, lessen the time needed for paperwork outside of clinic hours, and streamline information, including access to lab results, radiology reports, and consults.

“AI is already helping doctors manage their practices, make differential diagnoses, and input progress notes or histories,” said Dr. Stewart.

In Seattle, Ford Parsons, MD, chief of operational analytics at Providence Hospitals in Seattle, has been leading a generative AI project that recently developed a tool called Provaria to prioritize incoming messages from patients. The tool ensures that those with more urgent needs get immediate attention, and it supports the personnel who lead the responses.

The process begins with Provaria reviewing patient messages to ensure those with more urgent needs, such as a mental health crisis, get immediate attention instead of answering messages in the order they were received.

Provaria also provides resources to help responding staff craft a reply. If a patient’s message cites back pain, for example, the system might suggest a referral to a physical therapist, include a link to that department, and prompt the staff to ask about red flags that indicate a more urgent situation.

After an initial rollout, Providence recently deployed Provaria to manage the messages for all 4000 of its primary care, family medicine, and internal medicine providers. The system has reviewed and categorized more than 500,000 messages so far.

“This is another example where AI can increase the human connection in healthcare,” Dr. Parsons said. “That’s the opposite of what others are saying, but by using AI, you can automate the stuff that isn’t critical that doctors have wound up doing.”
 

 

 

AI Helps Foster Better Person-to-Person Communication

In recent years, the first thing most doctors do when they enter the exam room with a patient is log into the in-room computer and start to take notes — which can be off-putting to patients.

Now devices can ease this process, such as PLAUD, an AI voice recognition device that attaches to a cell phone. Just the size of a credit card, the device enables conversations to be easily recorded. It not only streamlines note-taking but also enables a physician to listen intently to a patient’s concerns instead of furiously jotting down notes.

“That device is already helping transcribe conversations into notes and then into a patient’s electronic medical record,” Dr. Stewart said. “This helps save doctors the work of having to input patient information.”
 

AI Can’t Be a Compassionate Human

The one thing AI can’t do is show compassion, at least not yet. The someday “vision” when a robot will gather intel about a patient’s symptoms and even offer a diagnosis does have some downsides. There is no replacement for human interaction, especially in the case of dire health news.

“If you have signs of a metastatic cancer and a nonhuman is delivering this news, there’s no way AI can share this news with compassion,” said Dr. Stewart.

For now, AI is becoming instrumental in helping reduce the number of extra demands on primary care doctors, as well as physicians in other specialties, so that they can continue focusing on what matters — healing patients.
 

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

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Within the next few years, patients will go to their primary care facility for a medical problem. They’ll be greeted by a nonhuman who speaks in the language of their choice. Based upon the initial interview, which will be taken in note form, the patient will be diagnosed, and a prescription called into the pharmacy. They’ll pay the robot at a reception kiosk, and their meds will be delivered via driverless car.

Or so suggests Allan Stewart, MD, medical director and chief of cardiothoracic surgery at HCA Florida Mercy Hospital in Miami.

The writing is on the wall. Artificial intelligence (AI) is only going to play a more significant role in healthcare, and the entire patient experience will be much different in the next 5 years, he said.

If that sounds far too futuristic, buckle up. AI is already here and being used by most medical specialties. However, it’s primary care that stands to gain the most from this technology — right now — thanks to its ability to radically streamline patient care.
 

Seeing the Doctor and His or Her AI Assistant

AI is making doctors’ work lives easier, whether the technology helps with risk prevention and intervention or closing care gaps. It can also triage patient complaints, monitor patients remotely, or even perform digital health coaching to keep patients on track with their lifestyle regimens or monitor their health conditions.

Each of these AI components enables primary care physicians to reduce some of the paperwork requirements of their jobs and do what they were trained to do — listen and assess patients. Doctors currently spend 12 hours on average each week submitting prior authorization requests, according to an American Medical Association survey.

“Primary care can be overwhelming, especially today, with the advent of electronic records and data,” said Davin Lundquist, MD, a family medicine physician and chief medical officer at Augmedix, an automated medical documentation company that provides tools to reduce clinician burnout. “The amount of data we have to go through to try to get a complete and clear picture of our patients can be overwhelming on top of the referrals, administrative burdens, and regulatory requirements, which seem to be focused on the primary care space,” Dr. Lundquist said.

With an AI assist, primary care physicians can reduce their prep and pre-charting time, lessen the time needed for paperwork outside of clinic hours, and streamline information, including access to lab results, radiology reports, and consults.

“AI is already helping doctors manage their practices, make differential diagnoses, and input progress notes or histories,” said Dr. Stewart.

In Seattle, Ford Parsons, MD, chief of operational analytics at Providence Hospitals in Seattle, has been leading a generative AI project that recently developed a tool called Provaria to prioritize incoming messages from patients. The tool ensures that those with more urgent needs get immediate attention, and it supports the personnel who lead the responses.

The process begins with Provaria reviewing patient messages to ensure those with more urgent needs, such as a mental health crisis, get immediate attention instead of answering messages in the order they were received.

Provaria also provides resources to help responding staff craft a reply. If a patient’s message cites back pain, for example, the system might suggest a referral to a physical therapist, include a link to that department, and prompt the staff to ask about red flags that indicate a more urgent situation.

After an initial rollout, Providence recently deployed Provaria to manage the messages for all 4000 of its primary care, family medicine, and internal medicine providers. The system has reviewed and categorized more than 500,000 messages so far.

“This is another example where AI can increase the human connection in healthcare,” Dr. Parsons said. “That’s the opposite of what others are saying, but by using AI, you can automate the stuff that isn’t critical that doctors have wound up doing.”
 

 

 

AI Helps Foster Better Person-to-Person Communication

In recent years, the first thing most doctors do when they enter the exam room with a patient is log into the in-room computer and start to take notes — which can be off-putting to patients.

Now devices can ease this process, such as PLAUD, an AI voice recognition device that attaches to a cell phone. Just the size of a credit card, the device enables conversations to be easily recorded. It not only streamlines note-taking but also enables a physician to listen intently to a patient’s concerns instead of furiously jotting down notes.

“That device is already helping transcribe conversations into notes and then into a patient’s electronic medical record,” Dr. Stewart said. “This helps save doctors the work of having to input patient information.”
 

AI Can’t Be a Compassionate Human

The one thing AI can’t do is show compassion, at least not yet. The someday “vision” when a robot will gather intel about a patient’s symptoms and even offer a diagnosis does have some downsides. There is no replacement for human interaction, especially in the case of dire health news.

“If you have signs of a metastatic cancer and a nonhuman is delivering this news, there’s no way AI can share this news with compassion,” said Dr. Stewart.

For now, AI is becoming instrumental in helping reduce the number of extra demands on primary care doctors, as well as physicians in other specialties, so that they can continue focusing on what matters — healing patients.
 

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

Within the next few years, patients will go to their primary care facility for a medical problem. They’ll be greeted by a nonhuman who speaks in the language of their choice. Based upon the initial interview, which will be taken in note form, the patient will be diagnosed, and a prescription called into the pharmacy. They’ll pay the robot at a reception kiosk, and their meds will be delivered via driverless car.

Or so suggests Allan Stewart, MD, medical director and chief of cardiothoracic surgery at HCA Florida Mercy Hospital in Miami.

The writing is on the wall. Artificial intelligence (AI) is only going to play a more significant role in healthcare, and the entire patient experience will be much different in the next 5 years, he said.

If that sounds far too futuristic, buckle up. AI is already here and being used by most medical specialties. However, it’s primary care that stands to gain the most from this technology — right now — thanks to its ability to radically streamline patient care.
 

Seeing the Doctor and His or Her AI Assistant

AI is making doctors’ work lives easier, whether the technology helps with risk prevention and intervention or closing care gaps. It can also triage patient complaints, monitor patients remotely, or even perform digital health coaching to keep patients on track with their lifestyle regimens or monitor their health conditions.

Each of these AI components enables primary care physicians to reduce some of the paperwork requirements of their jobs and do what they were trained to do — listen and assess patients. Doctors currently spend 12 hours on average each week submitting prior authorization requests, according to an American Medical Association survey.

“Primary care can be overwhelming, especially today, with the advent of electronic records and data,” said Davin Lundquist, MD, a family medicine physician and chief medical officer at Augmedix, an automated medical documentation company that provides tools to reduce clinician burnout. “The amount of data we have to go through to try to get a complete and clear picture of our patients can be overwhelming on top of the referrals, administrative burdens, and regulatory requirements, which seem to be focused on the primary care space,” Dr. Lundquist said.

With an AI assist, primary care physicians can reduce their prep and pre-charting time, lessen the time needed for paperwork outside of clinic hours, and streamline information, including access to lab results, radiology reports, and consults.

“AI is already helping doctors manage their practices, make differential diagnoses, and input progress notes or histories,” said Dr. Stewart.

In Seattle, Ford Parsons, MD, chief of operational analytics at Providence Hospitals in Seattle, has been leading a generative AI project that recently developed a tool called Provaria to prioritize incoming messages from patients. The tool ensures that those with more urgent needs get immediate attention, and it supports the personnel who lead the responses.

The process begins with Provaria reviewing patient messages to ensure those with more urgent needs, such as a mental health crisis, get immediate attention instead of answering messages in the order they were received.

Provaria also provides resources to help responding staff craft a reply. If a patient’s message cites back pain, for example, the system might suggest a referral to a physical therapist, include a link to that department, and prompt the staff to ask about red flags that indicate a more urgent situation.

After an initial rollout, Providence recently deployed Provaria to manage the messages for all 4000 of its primary care, family medicine, and internal medicine providers. The system has reviewed and categorized more than 500,000 messages so far.

“This is another example where AI can increase the human connection in healthcare,” Dr. Parsons said. “That’s the opposite of what others are saying, but by using AI, you can automate the stuff that isn’t critical that doctors have wound up doing.”
 

 

 

AI Helps Foster Better Person-to-Person Communication

In recent years, the first thing most doctors do when they enter the exam room with a patient is log into the in-room computer and start to take notes — which can be off-putting to patients.

Now devices can ease this process, such as PLAUD, an AI voice recognition device that attaches to a cell phone. Just the size of a credit card, the device enables conversations to be easily recorded. It not only streamlines note-taking but also enables a physician to listen intently to a patient’s concerns instead of furiously jotting down notes.

“That device is already helping transcribe conversations into notes and then into a patient’s electronic medical record,” Dr. Stewart said. “This helps save doctors the work of having to input patient information.”
 

AI Can’t Be a Compassionate Human

The one thing AI can’t do is show compassion, at least not yet. The someday “vision” when a robot will gather intel about a patient’s symptoms and even offer a diagnosis does have some downsides. There is no replacement for human interaction, especially in the case of dire health news.

“If you have signs of a metastatic cancer and a nonhuman is delivering this news, there’s no way AI can share this news with compassion,” said Dr. Stewart.

For now, AI is becoming instrumental in helping reduce the number of extra demands on primary care doctors, as well as physicians in other specialties, so that they can continue focusing on what matters — healing patients.
 

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

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Giving Cash to Improve Health

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Tue, 07/23/2024 - 11:47

This transcript has been edited for clarity

It doesn’t really matter what disease you are looking at — cancer, heart disease, dementia, drug abuse, psychiatric disorders. In every case, poverty is associated with worse disease. 

Dr. Wilson


But the word “associated” is doing a lot of work there. Many of us feel that poverty itself is causally linked to worse disease outcomes through things like poor access to care and poor access to medicines. 

And there is an argument that the arrow goes the other way; perhaps people with worse illness are more likely to be poor because, in this country at least, being sick is incredibly expensive. 

Causality is what all medical research is fundamentally about. We want to know if A causes B, because if A causes B, then changing A changes B. If poverty causes bad health outcomes, then alleviating poverty should alleviate bad health outcomes.

But that’s a hard proposition to test. You can’t exactly randomize some people to get extra money and some not to, right? Actually, you can. And in Massachusetts, they did.

What happened in Chelsea, Massachusetts, wasn’t exactly a randomized trial of cash supplementation to avoid bad health outcomes. It was actually a government program instituted during the pandemic. Chelsea has a large immigrant population, many of whom are living in poverty. From April to August 2020, the city ran a food distribution program to aid those in need. But the decision was then made to convert the money spent on that program to cash distributions — free of obligations. Chelsea residents making less than 30% of the median income for the Boston metro area — around $30,000 per family — were invited to enter a lottery. Only one member of any given family could enter. If selected, an individual would receive $200 a month, or $300 for a family of two, or $400 for a family of three or more. These payments went on for about 9 months.

The key thing here is that not everyone won the lottery. The lottery picked winners randomly; 1746 individuals were selected to receive the benefits in the form of a reloadable gift card, and 1134 applied but did not receive any assistance. 

This is a perfect natural experiment. As you can see here — and as expected, given that the lottery winners were chosen randomly — winners and losers were similar in terms of age, sex, race, language, income, and more.

Dr. Wilson


Researchers, led by Sumit Agarwal at the Brigham, leveraged that randomization to ask how these cash benefits would affect healthcare utilization. Their results appeared this week in JAMA.

I know what you’re thinking: Is $400 a month really enough to make a difference? Does $400 a month, less than $5000 a year, really fix poverty? We’ll get to that. But I will point out that the average family income of individuals in this study was about $1400 a month. An extra $400 might not change someone’s life, but it may really make a difference.

The primary outcome of this study was ED visits. There are a few ways this could go. Perhaps the money would lead to improved health and thus fewer ED visits. Or perhaps it would help people get transportation to primary care or other services that would offload the ED. Or maybe it would make things worse. Some folks have suggested that cash payments could increase the use of drugs and alcohol, and lead to more ED visits associated with the complications of using those substances.

Here are the actual data. Per 1000 individuals, there were 217 ED visits in the cash-benefit group, 318 in the no-benefit group. That was a statistically significant finding. 

Breaking those ED visits down, you can see that fewer visits resulted in hospital admission, with fewer behavioral health–related visits and — a key finding — fewer visits for substance use disorder. This puts the lie to the idea that cash benefits increase drug use.

Dr. Wilson


But the authors also looked at other causes of healthcare utilization. Outpatient visits were slightly higher in the cash-benefit group, driven largely by an increase in specialty care visits. The authors note that this is likely due to the fact that reaching a specialist often requires more travel, which can be costly. Indeed, this effect was most pronounced among the people living furthest from a specialty center.

Dr. Wilson


Outside of utilization, the researchers examined a variety of individual health markers — things like blood pressure — to see if the cash benefit had any effect. A bit of caution here because these data were available only among those who interacted with the healthcare system, which may bias the results a bit. Regardless, no major differences were seen in blood pressure, weight, hemoglobin A1c, cholesterol, or COVID vaccination.

JAMA


So, it seems that $400 a month doesn’t move the needle too much on risk factors for cardiovascular disease, but the effect on ED visits on their own is fairly impressive.

Is it worth it? The authors did their best to calculate the net effect of this program, accounting for the reduced ED visits and hospitalizations (that’s a big one), but also for the increased number of specialty visits. All told, the program saves about $450 per person in healthcare costs over 9 months. That’s about one seventh of the cost of the overall program.

But remember that they only looked at outcomes for the individual who got the gift cards; it’s likely that there were benefits to their family members as well. And, of course, programs like this can recoup costs indirectly though increases in economic activity, a phenomenon known as the multiplier effect.

I’m not here to tell you whether this program was a good idea; people tend to have quite strong feelings about this sort of thing. But I can tell you what it tells me about healthcare in America. It may not be surprising, but it confirms that access is far from fairly distributed. 

I started this story asking about the arrow of causality between poverty and poor health. The truth is, you probably have causality in both directions. Making people healthier will make them less poor. And, as this study suggests, making them less poor may make them healthier.

Dr. Wilson



 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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This transcript has been edited for clarity

It doesn’t really matter what disease you are looking at — cancer, heart disease, dementia, drug abuse, psychiatric disorders. In every case, poverty is associated with worse disease. 

Dr. Wilson


But the word “associated” is doing a lot of work there. Many of us feel that poverty itself is causally linked to worse disease outcomes through things like poor access to care and poor access to medicines. 

And there is an argument that the arrow goes the other way; perhaps people with worse illness are more likely to be poor because, in this country at least, being sick is incredibly expensive. 

Causality is what all medical research is fundamentally about. We want to know if A causes B, because if A causes B, then changing A changes B. If poverty causes bad health outcomes, then alleviating poverty should alleviate bad health outcomes.

But that’s a hard proposition to test. You can’t exactly randomize some people to get extra money and some not to, right? Actually, you can. And in Massachusetts, they did.

What happened in Chelsea, Massachusetts, wasn’t exactly a randomized trial of cash supplementation to avoid bad health outcomes. It was actually a government program instituted during the pandemic. Chelsea has a large immigrant population, many of whom are living in poverty. From April to August 2020, the city ran a food distribution program to aid those in need. But the decision was then made to convert the money spent on that program to cash distributions — free of obligations. Chelsea residents making less than 30% of the median income for the Boston metro area — around $30,000 per family — were invited to enter a lottery. Only one member of any given family could enter. If selected, an individual would receive $200 a month, or $300 for a family of two, or $400 for a family of three or more. These payments went on for about 9 months.

The key thing here is that not everyone won the lottery. The lottery picked winners randomly; 1746 individuals were selected to receive the benefits in the form of a reloadable gift card, and 1134 applied but did not receive any assistance. 

This is a perfect natural experiment. As you can see here — and as expected, given that the lottery winners were chosen randomly — winners and losers were similar in terms of age, sex, race, language, income, and more.

Dr. Wilson


Researchers, led by Sumit Agarwal at the Brigham, leveraged that randomization to ask how these cash benefits would affect healthcare utilization. Their results appeared this week in JAMA.

I know what you’re thinking: Is $400 a month really enough to make a difference? Does $400 a month, less than $5000 a year, really fix poverty? We’ll get to that. But I will point out that the average family income of individuals in this study was about $1400 a month. An extra $400 might not change someone’s life, but it may really make a difference.

The primary outcome of this study was ED visits. There are a few ways this could go. Perhaps the money would lead to improved health and thus fewer ED visits. Or perhaps it would help people get transportation to primary care or other services that would offload the ED. Or maybe it would make things worse. Some folks have suggested that cash payments could increase the use of drugs and alcohol, and lead to more ED visits associated with the complications of using those substances.

Here are the actual data. Per 1000 individuals, there were 217 ED visits in the cash-benefit group, 318 in the no-benefit group. That was a statistically significant finding. 

Breaking those ED visits down, you can see that fewer visits resulted in hospital admission, with fewer behavioral health–related visits and — a key finding — fewer visits for substance use disorder. This puts the lie to the idea that cash benefits increase drug use.

Dr. Wilson


But the authors also looked at other causes of healthcare utilization. Outpatient visits were slightly higher in the cash-benefit group, driven largely by an increase in specialty care visits. The authors note that this is likely due to the fact that reaching a specialist often requires more travel, which can be costly. Indeed, this effect was most pronounced among the people living furthest from a specialty center.

Dr. Wilson


Outside of utilization, the researchers examined a variety of individual health markers — things like blood pressure — to see if the cash benefit had any effect. A bit of caution here because these data were available only among those who interacted with the healthcare system, which may bias the results a bit. Regardless, no major differences were seen in blood pressure, weight, hemoglobin A1c, cholesterol, or COVID vaccination.

JAMA


So, it seems that $400 a month doesn’t move the needle too much on risk factors for cardiovascular disease, but the effect on ED visits on their own is fairly impressive.

Is it worth it? The authors did their best to calculate the net effect of this program, accounting for the reduced ED visits and hospitalizations (that’s a big one), but also for the increased number of specialty visits. All told, the program saves about $450 per person in healthcare costs over 9 months. That’s about one seventh of the cost of the overall program.

But remember that they only looked at outcomes for the individual who got the gift cards; it’s likely that there were benefits to their family members as well. And, of course, programs like this can recoup costs indirectly though increases in economic activity, a phenomenon known as the multiplier effect.

I’m not here to tell you whether this program was a good idea; people tend to have quite strong feelings about this sort of thing. But I can tell you what it tells me about healthcare in America. It may not be surprising, but it confirms that access is far from fairly distributed. 

I started this story asking about the arrow of causality between poverty and poor health. The truth is, you probably have causality in both directions. Making people healthier will make them less poor. And, as this study suggests, making them less poor may make them healthier.

Dr. Wilson



 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity

It doesn’t really matter what disease you are looking at — cancer, heart disease, dementia, drug abuse, psychiatric disorders. In every case, poverty is associated with worse disease. 

Dr. Wilson


But the word “associated” is doing a lot of work there. Many of us feel that poverty itself is causally linked to worse disease outcomes through things like poor access to care and poor access to medicines. 

And there is an argument that the arrow goes the other way; perhaps people with worse illness are more likely to be poor because, in this country at least, being sick is incredibly expensive. 

Causality is what all medical research is fundamentally about. We want to know if A causes B, because if A causes B, then changing A changes B. If poverty causes bad health outcomes, then alleviating poverty should alleviate bad health outcomes.

But that’s a hard proposition to test. You can’t exactly randomize some people to get extra money and some not to, right? Actually, you can. And in Massachusetts, they did.

What happened in Chelsea, Massachusetts, wasn’t exactly a randomized trial of cash supplementation to avoid bad health outcomes. It was actually a government program instituted during the pandemic. Chelsea has a large immigrant population, many of whom are living in poverty. From April to August 2020, the city ran a food distribution program to aid those in need. But the decision was then made to convert the money spent on that program to cash distributions — free of obligations. Chelsea residents making less than 30% of the median income for the Boston metro area — around $30,000 per family — were invited to enter a lottery. Only one member of any given family could enter. If selected, an individual would receive $200 a month, or $300 for a family of two, or $400 for a family of three or more. These payments went on for about 9 months.

The key thing here is that not everyone won the lottery. The lottery picked winners randomly; 1746 individuals were selected to receive the benefits in the form of a reloadable gift card, and 1134 applied but did not receive any assistance. 

This is a perfect natural experiment. As you can see here — and as expected, given that the lottery winners were chosen randomly — winners and losers were similar in terms of age, sex, race, language, income, and more.

Dr. Wilson


Researchers, led by Sumit Agarwal at the Brigham, leveraged that randomization to ask how these cash benefits would affect healthcare utilization. Their results appeared this week in JAMA.

I know what you’re thinking: Is $400 a month really enough to make a difference? Does $400 a month, less than $5000 a year, really fix poverty? We’ll get to that. But I will point out that the average family income of individuals in this study was about $1400 a month. An extra $400 might not change someone’s life, but it may really make a difference.

The primary outcome of this study was ED visits. There are a few ways this could go. Perhaps the money would lead to improved health and thus fewer ED visits. Or perhaps it would help people get transportation to primary care or other services that would offload the ED. Or maybe it would make things worse. Some folks have suggested that cash payments could increase the use of drugs and alcohol, and lead to more ED visits associated with the complications of using those substances.

Here are the actual data. Per 1000 individuals, there were 217 ED visits in the cash-benefit group, 318 in the no-benefit group. That was a statistically significant finding. 

Breaking those ED visits down, you can see that fewer visits resulted in hospital admission, with fewer behavioral health–related visits and — a key finding — fewer visits for substance use disorder. This puts the lie to the idea that cash benefits increase drug use.

Dr. Wilson


But the authors also looked at other causes of healthcare utilization. Outpatient visits were slightly higher in the cash-benefit group, driven largely by an increase in specialty care visits. The authors note that this is likely due to the fact that reaching a specialist often requires more travel, which can be costly. Indeed, this effect was most pronounced among the people living furthest from a specialty center.

Dr. Wilson


Outside of utilization, the researchers examined a variety of individual health markers — things like blood pressure — to see if the cash benefit had any effect. A bit of caution here because these data were available only among those who interacted with the healthcare system, which may bias the results a bit. Regardless, no major differences were seen in blood pressure, weight, hemoglobin A1c, cholesterol, or COVID vaccination.

JAMA


So, it seems that $400 a month doesn’t move the needle too much on risk factors for cardiovascular disease, but the effect on ED visits on their own is fairly impressive.

Is it worth it? The authors did their best to calculate the net effect of this program, accounting for the reduced ED visits and hospitalizations (that’s a big one), but also for the increased number of specialty visits. All told, the program saves about $450 per person in healthcare costs over 9 months. That’s about one seventh of the cost of the overall program.

But remember that they only looked at outcomes for the individual who got the gift cards; it’s likely that there were benefits to their family members as well. And, of course, programs like this can recoup costs indirectly though increases in economic activity, a phenomenon known as the multiplier effect.

I’m not here to tell you whether this program was a good idea; people tend to have quite strong feelings about this sort of thing. But I can tell you what it tells me about healthcare in America. It may not be surprising, but it confirms that access is far from fairly distributed. 

I started this story asking about the arrow of causality between poverty and poor health. The truth is, you probably have causality in both directions. Making people healthier will make them less poor. And, as this study suggests, making them less poor may make them healthier.

Dr. Wilson



 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Doctor on Death Row: Ahmad Reza Djalali Begins Hunger Strike

Article Type
Changed
Tue, 07/23/2024 - 11:40

Ahmad Reza Djalali, an Iranian-Swedish physician specializing in disaster medicine, has begun a hunger strike after being sentenced to death in 2017.

Last year, Iran set a grim record, leading the world in executions. The country carried out at least 853 executions, which accounted for three quarters of the officially recorded executions worldwide. The Iranian government uses the death penalty to intimidate political opponents, especially since the women’s uprising in 2022, and to exert pressure on Western states in diplomatic standoffs.

Among the thousands of political prisoners currently on death row in Tehran’s notorious Evin prison is Dr. Djalali, a 52-year-old physician.

He emigrated to Sweden in 2009 and joined the Karolinska Institutet in Stockholm, Sweden. Over the years, he became one of Europe’s leading experts in disaster medicine. His work has been cited more than 700 times in medical literature, and he played a key role in establishing the emergency and disaster research center at the University of Piedmont.

In Italy, Denmark, and Sweden, Dr. Djalali helped hospitals and healthcare professionals in preparing for earthquakes, nuclear accidents, and terrorist attacks and designed several disaster medicine training programs.
 

‘Spreading Corruption’

Despite settling in Sweden with his family, Dr. Djalali never forgot his Iranian roots. His doctoral thesis was dedicated to the victims of the 2003 Bam earthquake in Iran, which killed 23,000 people. He expressed a desire to share his knowledge with his Iranian colleagues to help people. So when he was invited to participate in a 2016 conference at the University of Tehran, he accepted without hesitation.

Unfortunately, this decision had severe consequences. On April 25, 2016, as he was concluding his trip to Iran, the researcher was arrested by intelligence agents. After being held incommunicado for several days, he was officially accused of passing confidential information to Israeli intelligence services. According to his family, this accusation was baseless. They believed he was targeted for refusing to work for Iranian intelligence services in Europe.

On October 21, 2017, Dr. Djalali was sentenced to death for “spreading corruption on Earth,” a vague charge often used by Islamic courts against those who allegedly have challenged the regime. A few days later, a video of his “confessions” was broadcast on Iranian television. These confessions were coerced; Dr. Djalali later revealed that Iranian police had threatened to harm his mother in Iran and his family in Sweden.

Since then, Dr. Djalali and his loved ones have anxiously awaited the moment when the regime might carry out the sentence. Several times over the years, he has seemed on the verge of execution, only to receive a last-minute reprieve each time.

His imprisonment has taken a severe toll on his physical and mental health. He has reportedly lost 24 kg since his incarceration, and his family, who receive sporadic updates, suspect he has leukemia. Despite his deteriorating condition, the authorities have refused him access to a hematologist.
 

‘Forgotten’ in Exchange

The international medical community has rallied to secure Dr. Djalali’s release, but their efforts have so far been fruitless. The United Nations, the European Union, Amnesty International, several universities, and the World Medical Association have called for his release. In 2018, Sweden granted him citizenship in an attempt to increase pressure on Tehran, but Iranian law does not recognize dual citizenship.

On June 16, after nearly 7 years on death row, Dr. Djalali informed his family that he had begun a hunger strike. “It’s the only way to make my voice heard in the world,” he explained. “As a doctor, Ahmad Reza knows all too well that his fragile physical state makes a hunger strike potentially fatal, but he sees no other option. He suffers from cardiac arrhythmia, bradycardia, hypotension, chronic gastritisanemia, and extreme weight loss following his two previous hunger strikes,” his wife told the press.

Aside from a potential (and unlikely) act of clemency by the Iranian authorities, Dr. Djalali’s best hope lies in a prisoner exchange. The Iranian government often imprisons foreign nationals to exchange them for Iranians detained in Western countries.

On June 15, Sweden agreed to release an Iranian dignitary serving a life sentence in exchange for the release of Swedish nationals detained in Iran. For a long time, Dr. Djalali’s family had hoped he would be included in this exchange.

However, to avoid jeopardizing the deal, the Swedish prime minister chose to accept the release of only two other Swedish nationals, leaving Dr. Djalali to his grim fate. “Mr Prime Minister, you have decided to abandon me at the enormous risk of being executed,” Dr. Djalali responded bitterly, knowing he could be hanged at any moment.
 

This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Ahmad Reza Djalali, an Iranian-Swedish physician specializing in disaster medicine, has begun a hunger strike after being sentenced to death in 2017.

Last year, Iran set a grim record, leading the world in executions. The country carried out at least 853 executions, which accounted for three quarters of the officially recorded executions worldwide. The Iranian government uses the death penalty to intimidate political opponents, especially since the women’s uprising in 2022, and to exert pressure on Western states in diplomatic standoffs.

Among the thousands of political prisoners currently on death row in Tehran’s notorious Evin prison is Dr. Djalali, a 52-year-old physician.

He emigrated to Sweden in 2009 and joined the Karolinska Institutet in Stockholm, Sweden. Over the years, he became one of Europe’s leading experts in disaster medicine. His work has been cited more than 700 times in medical literature, and he played a key role in establishing the emergency and disaster research center at the University of Piedmont.

In Italy, Denmark, and Sweden, Dr. Djalali helped hospitals and healthcare professionals in preparing for earthquakes, nuclear accidents, and terrorist attacks and designed several disaster medicine training programs.
 

‘Spreading Corruption’

Despite settling in Sweden with his family, Dr. Djalali never forgot his Iranian roots. His doctoral thesis was dedicated to the victims of the 2003 Bam earthquake in Iran, which killed 23,000 people. He expressed a desire to share his knowledge with his Iranian colleagues to help people. So when he was invited to participate in a 2016 conference at the University of Tehran, he accepted without hesitation.

Unfortunately, this decision had severe consequences. On April 25, 2016, as he was concluding his trip to Iran, the researcher was arrested by intelligence agents. After being held incommunicado for several days, he was officially accused of passing confidential information to Israeli intelligence services. According to his family, this accusation was baseless. They believed he was targeted for refusing to work for Iranian intelligence services in Europe.

On October 21, 2017, Dr. Djalali was sentenced to death for “spreading corruption on Earth,” a vague charge often used by Islamic courts against those who allegedly have challenged the regime. A few days later, a video of his “confessions” was broadcast on Iranian television. These confessions were coerced; Dr. Djalali later revealed that Iranian police had threatened to harm his mother in Iran and his family in Sweden.

Since then, Dr. Djalali and his loved ones have anxiously awaited the moment when the regime might carry out the sentence. Several times over the years, he has seemed on the verge of execution, only to receive a last-minute reprieve each time.

His imprisonment has taken a severe toll on his physical and mental health. He has reportedly lost 24 kg since his incarceration, and his family, who receive sporadic updates, suspect he has leukemia. Despite his deteriorating condition, the authorities have refused him access to a hematologist.
 

‘Forgotten’ in Exchange

The international medical community has rallied to secure Dr. Djalali’s release, but their efforts have so far been fruitless. The United Nations, the European Union, Amnesty International, several universities, and the World Medical Association have called for his release. In 2018, Sweden granted him citizenship in an attempt to increase pressure on Tehran, but Iranian law does not recognize dual citizenship.

On June 16, after nearly 7 years on death row, Dr. Djalali informed his family that he had begun a hunger strike. “It’s the only way to make my voice heard in the world,” he explained. “As a doctor, Ahmad Reza knows all too well that his fragile physical state makes a hunger strike potentially fatal, but he sees no other option. He suffers from cardiac arrhythmia, bradycardia, hypotension, chronic gastritisanemia, and extreme weight loss following his two previous hunger strikes,” his wife told the press.

Aside from a potential (and unlikely) act of clemency by the Iranian authorities, Dr. Djalali’s best hope lies in a prisoner exchange. The Iranian government often imprisons foreign nationals to exchange them for Iranians detained in Western countries.

On June 15, Sweden agreed to release an Iranian dignitary serving a life sentence in exchange for the release of Swedish nationals detained in Iran. For a long time, Dr. Djalali’s family had hoped he would be included in this exchange.

However, to avoid jeopardizing the deal, the Swedish prime minister chose to accept the release of only two other Swedish nationals, leaving Dr. Djalali to his grim fate. “Mr Prime Minister, you have decided to abandon me at the enormous risk of being executed,” Dr. Djalali responded bitterly, knowing he could be hanged at any moment.
 

This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Ahmad Reza Djalali, an Iranian-Swedish physician specializing in disaster medicine, has begun a hunger strike after being sentenced to death in 2017.

Last year, Iran set a grim record, leading the world in executions. The country carried out at least 853 executions, which accounted for three quarters of the officially recorded executions worldwide. The Iranian government uses the death penalty to intimidate political opponents, especially since the women’s uprising in 2022, and to exert pressure on Western states in diplomatic standoffs.

Among the thousands of political prisoners currently on death row in Tehran’s notorious Evin prison is Dr. Djalali, a 52-year-old physician.

He emigrated to Sweden in 2009 and joined the Karolinska Institutet in Stockholm, Sweden. Over the years, he became one of Europe’s leading experts in disaster medicine. His work has been cited more than 700 times in medical literature, and he played a key role in establishing the emergency and disaster research center at the University of Piedmont.

In Italy, Denmark, and Sweden, Dr. Djalali helped hospitals and healthcare professionals in preparing for earthquakes, nuclear accidents, and terrorist attacks and designed several disaster medicine training programs.
 

‘Spreading Corruption’

Despite settling in Sweden with his family, Dr. Djalali never forgot his Iranian roots. His doctoral thesis was dedicated to the victims of the 2003 Bam earthquake in Iran, which killed 23,000 people. He expressed a desire to share his knowledge with his Iranian colleagues to help people. So when he was invited to participate in a 2016 conference at the University of Tehran, he accepted without hesitation.

Unfortunately, this decision had severe consequences. On April 25, 2016, as he was concluding his trip to Iran, the researcher was arrested by intelligence agents. After being held incommunicado for several days, he was officially accused of passing confidential information to Israeli intelligence services. According to his family, this accusation was baseless. They believed he was targeted for refusing to work for Iranian intelligence services in Europe.

On October 21, 2017, Dr. Djalali was sentenced to death for “spreading corruption on Earth,” a vague charge often used by Islamic courts against those who allegedly have challenged the regime. A few days later, a video of his “confessions” was broadcast on Iranian television. These confessions were coerced; Dr. Djalali later revealed that Iranian police had threatened to harm his mother in Iran and his family in Sweden.

Since then, Dr. Djalali and his loved ones have anxiously awaited the moment when the regime might carry out the sentence. Several times over the years, he has seemed on the verge of execution, only to receive a last-minute reprieve each time.

His imprisonment has taken a severe toll on his physical and mental health. He has reportedly lost 24 kg since his incarceration, and his family, who receive sporadic updates, suspect he has leukemia. Despite his deteriorating condition, the authorities have refused him access to a hematologist.
 

‘Forgotten’ in Exchange

The international medical community has rallied to secure Dr. Djalali’s release, but their efforts have so far been fruitless. The United Nations, the European Union, Amnesty International, several universities, and the World Medical Association have called for his release. In 2018, Sweden granted him citizenship in an attempt to increase pressure on Tehran, but Iranian law does not recognize dual citizenship.

On June 16, after nearly 7 years on death row, Dr. Djalali informed his family that he had begun a hunger strike. “It’s the only way to make my voice heard in the world,” he explained. “As a doctor, Ahmad Reza knows all too well that his fragile physical state makes a hunger strike potentially fatal, but he sees no other option. He suffers from cardiac arrhythmia, bradycardia, hypotension, chronic gastritisanemia, and extreme weight loss following his two previous hunger strikes,” his wife told the press.

Aside from a potential (and unlikely) act of clemency by the Iranian authorities, Dr. Djalali’s best hope lies in a prisoner exchange. The Iranian government often imprisons foreign nationals to exchange them for Iranians detained in Western countries.

On June 15, Sweden agreed to release an Iranian dignitary serving a life sentence in exchange for the release of Swedish nationals detained in Iran. For a long time, Dr. Djalali’s family had hoped he would be included in this exchange.

However, to avoid jeopardizing the deal, the Swedish prime minister chose to accept the release of only two other Swedish nationals, leaving Dr. Djalali to his grim fate. “Mr Prime Minister, you have decided to abandon me at the enormous risk of being executed,” Dr. Djalali responded bitterly, knowing he could be hanged at any moment.
 

This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Greater Transparency of Oncologists’ Pharma Relationships Needed

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Changed
Wed, 07/31/2024 - 09:12

Three-quarters of oncologists participating in a recent global survey failed to identify one or more situations representing a conflict of interest, according to a new study.

The findings reflect limited awareness in low-income countries about what scenarios constitute a conflict of interest, first author, Khalid El Bairi, MD, said during an interview. “There is a lack of training in ethics and integrity in medical schools [in countries in Africa], so people are not informed about conflicts of interest,” continued Dr. El Bairi, who presented the new research at the annual meeting of the American Society of Clinical Oncology. “There is also a lack of policies in universities and hospitals to guide clinicians about conflict of interest reporting.”

Overall, 58.5% of survey participants categorized honoraria as a conflict of interest that required disclosure, while 50% said the same of gifts from pharmaceutical representatives, and 44.5% identified travel grants for attending conferences as conflicts of interests. The report was published in JCO Global Oncology. Less often considered conflicts of interest were personal and institutional research funding, trips to conferences, consulting or advisory roles, food and beverages, expert testimony, and sample drugs provided by the pharmaceutical industry.

Just 24% of participants indicated that all of the listed items were deemed conflicts of interest. The survey — called Oncology Transparency Under Scrutiny and Tracking, or ONCOTRUST-1 — considered the perceptions of 200 oncologists, about 70% of whom practice in low- and middle-income countries.

What’s more, 37.5% of respondents identified fear of losing financial support as a reason not to report a conflict of interest. Still, 75% indicated that industry-sponsored speaking does not affect treatment decisions, and 60% said conflicts of interest do not impair objective appraisal of clinical trials.

Dr. El Bairi, a research associate in the department of medical oncology at Mohammed VI University Hospital, Oujda, Morocco, and his colleagues undertook the study in part because of an editorial published in The Lancet Oncology last year. First author Fidel Rubagumya, MD, a consultant oncologist and director of research at Rwanda Military Hospital, Kigali, and colleagues called for more research on the ties between oncologists and industry in Africa. The ONCOTRUST-1 findings set the stage for a planned follow-up study, which aims to compare views surrounding conflicts of interests between oncologists in different economic settings.
 

Open Payments Houses US Physicians’ Conflicts of Interest

To be sure, many authors of research published in major US journals are based outside of the United States. According to JAMA Network Open, 69% of submissions to the journal are from international authors. However, Dr. El Bairi also raised other potential signs of industry influence that he said need global discussion, such as the role of pharmaceutical companies in presentations of clinical trial findings at large cancer societies’ conferences, a shift toward progression-free survival as the endpoint in clinical cancer trials, and the rise of third-party writing assistance.

“There are two sides of the story,” Dr. El Bairi said. “The good side is that unfortunately, sometimes [industry money is] the only way for African oncologists to go abroad for training, to conferences for their continuous medical education. The bad is now we may harm patients, we might harm science by having conflicts of interest not reported.”

Unlike other countries, the United States has plentiful data on the scale of physicians’ financial conflicts of interest in the form of the Open Payments platform. Championed by Sen. Chuck Grassley (R-Iowa), the federal repository of payments to doctors and teaching hospitals by drug and medical device companies was established as part of the Affordable Care Act (ACA).

The health care reform law, which passed in 2010, requires pharmaceutical companies and medical device makers to report this information.

From 2013 to 2021, the pharmaceutical and medical device industry paid physicians $12.1 billion, according to a research letter published in JAMA in March of 2024 that reviewed Open Payments data.

Ranked by specialty, hematologists and oncologists received the fourth-largest amount of money in aggregate, the study shows. Their total of $825.8 million trailed only physicians in orthopedics ($1.36 billion), neurology and psychiatry ($1.32 billion) and cardiology ($1.29 billion). What’s more, this specialty had the biggest share of physicians taking industry money, with 74.2% of hematologists and oncologists receiving payments.

The payments from industry include fees for consulting services and speaking, as well as food and beverages, travel and lodging, education, gifts, grants, and honoraria.

Joseph S. Ross, MD, MHS, one of the JAMA study’s coauthors, said in an interview that the continued prevalence of such funding runs counter to the expectation behind the measure, which was that transparency would lead to physicians’ becoming less likely to accept a payment.

“We as a profession need to take a cold hard look in the mirror,” he said, referring to physicians in general.

Dr. Ross, professor of medicine at Yale University School of Medicine, New Haven, Connecticut, said he hopes that the profession will self-police, and that patients will make a bigger deal of the issue. Still, he acknowledged that “the vast majority” of patient advocacy groups, too, are funded by the pharmaceutical industry.
 

 

 

Exposing Industry Payments May Have Perverse Effect

A growing body of research explores the effect that physicians’ financial relationships with pharmaceutical companies can have on their prescribing practices. Indeed, oncologists taking industry payments seem to be more likely to prescribe nonrecommended and low-value drugs in some clinical settings, according to a study published in The BMJ last year.

That study’s first author, Aaron P. Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, New York City, suggested in an interview that exposing industry payments to the sunlight may have had a perverse effect on physicians.

“There’s this idea of having license to do something,” Dr. Mitchell said, speaking broadly about human psychology rather than drawing on empirical data. “You might feel a little less bad about then prescribing more of that company’s drug, because the disclosure has already been done.”

The influence of pharmaceutical industry money on oncologists goes beyond what’s prescribed to which treatments get studied, approved, and recommended by guidelines, Dr. Mitchell said. He was also first author of a 2016 paper published in JAMA Oncology that found 86% of authors of the National Comprehensive Cancer Network guidelines had at least one conflict of interest reported on Open Systems in 2014.

Meanwhile, the fact that physicians’ payments from industry are a matter of public record on Open Systems has not guaranteed that doctors will disclose their conflicts of interest in other forums. A study published in JAMA earlier this year, for which Dr. Mitchell served as first author, found that almost one in three physicians endorsing drugs and devices on the social media platform X failed to disclose that the manufacturer paid them.

The lack of disclosure seems to extend beyond social media. A 2018 study published in JAMA Oncology found that 32% of oncologist authors of clinical drug trials for drugs approved over a 20-month period from 2016 to 2017 did not fully disclose payments from the trial sponsor when checked against the Open Payments database.

A lion’s share of industry payments within oncology appears to be going to a small group of high-profile physicians, suggested a 2022 study published in JCO Oncology Practice. It found that just 1% of all US oncologists accounted for 37% of industry payments, with each receiving more than $100,000 a year.
 

Experts: Professional Societies Should Further Limit Industry Payments

While partnerships between drug companies and physicians are necessary and have often been positive, more than disclosure is needed to minimize the risk of patient harm, according to an editorial published in March in JCO Oncology Practice. In it, Nina Niu Sanford, MD, a radiation oncologist UT Southwestern Medical Center, Dallas, and Bishal Gyawali, MD, PhD, a medical oncologist at Queen’s University, Kingston, Ontario, Canada, argue that following a specific blueprint could help mitigate financial conflicts of interest.

For starters, Dr. Sanford and Dr. Gyawali contend in the editorial that the maximum general payment NCCN members are allowed to receive from industry should be $0, compared with a current bar of $20,000 from a single entity or $50,000 from all external entities combined. They also urge professional societies to follow the current policy of the American Society of Clinical Oncology and ban members serving in their leadership from receiving any general payments from the industry.

The authors further suggest that investigators of clinical trials should be barred from holding stock for the drug or product while it is under study and that editorialists should not have conflicts of interest with the company whose drug or product they are discussing.

Pharmaceutical money can harm patients in ways that are not always obvious, Dr. Gyawali said in an interview.

“It can dominate the conversation by removing critical viewpoints from these top people about certain drugs,” he said. “It’s not always about saying good things about the drug.”

For instance, he suggested, a doctor receiving payments from Pfizer might openly criticize perceived flaws in drugs from other companies but refrain from weighing in negatively on a Pfizer drug.

From 2016 to 2018, industry made general payments to more than 52,000 physicians for 137 unique cancer drugs, according to a separate 2021 study published in the Journal of Cancer Policy, for which Dr. Gyawali served as one of the coauthors.

The results suggest that pharmaceutical money affects the entire cancer system, not relatively few oncology leaders. The amounts and dollar values grew each year covered by the study, to nearly 466,000 payments totaling $98.5 million in 2018.

Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, Washington, DC, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, has called for a ban on industry gifts to physicians.

When a publication asks physicians to disclose relevant conflicts of interest, physicians may choose not to disclose, because they don’t feel that their conflicts are relevant, Dr. Fugh-Berman said. Drug and device makers have also grown sophisticated about how they work with physicians, she suggested. “It’s illegal to market a drug before it comes on the market, but it’s not illegal to market the disease,” said Dr. Fugh-Berman, noting that drugmakers often work on long timelines.

“The doctor is going around saying we don’t have good therapies. They’re not pushing a drug. And so they feel totally fine about it.”

Anecdotally, Dr. Fugh-Berman noted that, if anything, speaking fees and similar payments only improve doctors’ reputations. She said that’s especially true if the physicians are paid by multiple companies, on the supposed theory that their conflicts of interest cancel each other out.

“I’m not defending this,” added Dr. Fugh-Berman, observing that, at the end of the day, such conflicts may go against the interests of patients.

“Sometimes the best drugs are older, generic, cheap drugs, and if oncologists or other specialists are only choosing among the most promoted drugs, they’re not necessarily choosing the best drugs.”

Beyond any prestige, doctors have other possible nonfinancial incentives for receiving industry payments. “It’s the relationships,” Dr. Fugh-Berman said. “Companies are very good at offering friendship.”

Dr. El Bairi reported NCODA leadership and honoraria along with expert testimony through techspert.io. Dr. Ross reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of or the review of the manuscript he authored and discussed in this article. Dr. Ross also reported receiving grants from the Food and Drug Administration, Johnson & Johnson, the Medical Device Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Mitchell reported no relevant financial relationships. Dr. Gyawali reported a consulting or advisory role with Vivio Health. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.

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Three-quarters of oncologists participating in a recent global survey failed to identify one or more situations representing a conflict of interest, according to a new study.

The findings reflect limited awareness in low-income countries about what scenarios constitute a conflict of interest, first author, Khalid El Bairi, MD, said during an interview. “There is a lack of training in ethics and integrity in medical schools [in countries in Africa], so people are not informed about conflicts of interest,” continued Dr. El Bairi, who presented the new research at the annual meeting of the American Society of Clinical Oncology. “There is also a lack of policies in universities and hospitals to guide clinicians about conflict of interest reporting.”

Overall, 58.5% of survey participants categorized honoraria as a conflict of interest that required disclosure, while 50% said the same of gifts from pharmaceutical representatives, and 44.5% identified travel grants for attending conferences as conflicts of interests. The report was published in JCO Global Oncology. Less often considered conflicts of interest were personal and institutional research funding, trips to conferences, consulting or advisory roles, food and beverages, expert testimony, and sample drugs provided by the pharmaceutical industry.

Just 24% of participants indicated that all of the listed items were deemed conflicts of interest. The survey — called Oncology Transparency Under Scrutiny and Tracking, or ONCOTRUST-1 — considered the perceptions of 200 oncologists, about 70% of whom practice in low- and middle-income countries.

What’s more, 37.5% of respondents identified fear of losing financial support as a reason not to report a conflict of interest. Still, 75% indicated that industry-sponsored speaking does not affect treatment decisions, and 60% said conflicts of interest do not impair objective appraisal of clinical trials.

Dr. El Bairi, a research associate in the department of medical oncology at Mohammed VI University Hospital, Oujda, Morocco, and his colleagues undertook the study in part because of an editorial published in The Lancet Oncology last year. First author Fidel Rubagumya, MD, a consultant oncologist and director of research at Rwanda Military Hospital, Kigali, and colleagues called for more research on the ties between oncologists and industry in Africa. The ONCOTRUST-1 findings set the stage for a planned follow-up study, which aims to compare views surrounding conflicts of interests between oncologists in different economic settings.
 

Open Payments Houses US Physicians’ Conflicts of Interest

To be sure, many authors of research published in major US journals are based outside of the United States. According to JAMA Network Open, 69% of submissions to the journal are from international authors. However, Dr. El Bairi also raised other potential signs of industry influence that he said need global discussion, such as the role of pharmaceutical companies in presentations of clinical trial findings at large cancer societies’ conferences, a shift toward progression-free survival as the endpoint in clinical cancer trials, and the rise of third-party writing assistance.

“There are two sides of the story,” Dr. El Bairi said. “The good side is that unfortunately, sometimes [industry money is] the only way for African oncologists to go abroad for training, to conferences for their continuous medical education. The bad is now we may harm patients, we might harm science by having conflicts of interest not reported.”

Unlike other countries, the United States has plentiful data on the scale of physicians’ financial conflicts of interest in the form of the Open Payments platform. Championed by Sen. Chuck Grassley (R-Iowa), the federal repository of payments to doctors and teaching hospitals by drug and medical device companies was established as part of the Affordable Care Act (ACA).

The health care reform law, which passed in 2010, requires pharmaceutical companies and medical device makers to report this information.

From 2013 to 2021, the pharmaceutical and medical device industry paid physicians $12.1 billion, according to a research letter published in JAMA in March of 2024 that reviewed Open Payments data.

Ranked by specialty, hematologists and oncologists received the fourth-largest amount of money in aggregate, the study shows. Their total of $825.8 million trailed only physicians in orthopedics ($1.36 billion), neurology and psychiatry ($1.32 billion) and cardiology ($1.29 billion). What’s more, this specialty had the biggest share of physicians taking industry money, with 74.2% of hematologists and oncologists receiving payments.

The payments from industry include fees for consulting services and speaking, as well as food and beverages, travel and lodging, education, gifts, grants, and honoraria.

Joseph S. Ross, MD, MHS, one of the JAMA study’s coauthors, said in an interview that the continued prevalence of such funding runs counter to the expectation behind the measure, which was that transparency would lead to physicians’ becoming less likely to accept a payment.

“We as a profession need to take a cold hard look in the mirror,” he said, referring to physicians in general.

Dr. Ross, professor of medicine at Yale University School of Medicine, New Haven, Connecticut, said he hopes that the profession will self-police, and that patients will make a bigger deal of the issue. Still, he acknowledged that “the vast majority” of patient advocacy groups, too, are funded by the pharmaceutical industry.
 

 

 

Exposing Industry Payments May Have Perverse Effect

A growing body of research explores the effect that physicians’ financial relationships with pharmaceutical companies can have on their prescribing practices. Indeed, oncologists taking industry payments seem to be more likely to prescribe nonrecommended and low-value drugs in some clinical settings, according to a study published in The BMJ last year.

That study’s first author, Aaron P. Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, New York City, suggested in an interview that exposing industry payments to the sunlight may have had a perverse effect on physicians.

“There’s this idea of having license to do something,” Dr. Mitchell said, speaking broadly about human psychology rather than drawing on empirical data. “You might feel a little less bad about then prescribing more of that company’s drug, because the disclosure has already been done.”

The influence of pharmaceutical industry money on oncologists goes beyond what’s prescribed to which treatments get studied, approved, and recommended by guidelines, Dr. Mitchell said. He was also first author of a 2016 paper published in JAMA Oncology that found 86% of authors of the National Comprehensive Cancer Network guidelines had at least one conflict of interest reported on Open Systems in 2014.

Meanwhile, the fact that physicians’ payments from industry are a matter of public record on Open Systems has not guaranteed that doctors will disclose their conflicts of interest in other forums. A study published in JAMA earlier this year, for which Dr. Mitchell served as first author, found that almost one in three physicians endorsing drugs and devices on the social media platform X failed to disclose that the manufacturer paid them.

The lack of disclosure seems to extend beyond social media. A 2018 study published in JAMA Oncology found that 32% of oncologist authors of clinical drug trials for drugs approved over a 20-month period from 2016 to 2017 did not fully disclose payments from the trial sponsor when checked against the Open Payments database.

A lion’s share of industry payments within oncology appears to be going to a small group of high-profile physicians, suggested a 2022 study published in JCO Oncology Practice. It found that just 1% of all US oncologists accounted for 37% of industry payments, with each receiving more than $100,000 a year.
 

Experts: Professional Societies Should Further Limit Industry Payments

While partnerships between drug companies and physicians are necessary and have often been positive, more than disclosure is needed to minimize the risk of patient harm, according to an editorial published in March in JCO Oncology Practice. In it, Nina Niu Sanford, MD, a radiation oncologist UT Southwestern Medical Center, Dallas, and Bishal Gyawali, MD, PhD, a medical oncologist at Queen’s University, Kingston, Ontario, Canada, argue that following a specific blueprint could help mitigate financial conflicts of interest.

For starters, Dr. Sanford and Dr. Gyawali contend in the editorial that the maximum general payment NCCN members are allowed to receive from industry should be $0, compared with a current bar of $20,000 from a single entity or $50,000 from all external entities combined. They also urge professional societies to follow the current policy of the American Society of Clinical Oncology and ban members serving in their leadership from receiving any general payments from the industry.

The authors further suggest that investigators of clinical trials should be barred from holding stock for the drug or product while it is under study and that editorialists should not have conflicts of interest with the company whose drug or product they are discussing.

Pharmaceutical money can harm patients in ways that are not always obvious, Dr. Gyawali said in an interview.

“It can dominate the conversation by removing critical viewpoints from these top people about certain drugs,” he said. “It’s not always about saying good things about the drug.”

For instance, he suggested, a doctor receiving payments from Pfizer might openly criticize perceived flaws in drugs from other companies but refrain from weighing in negatively on a Pfizer drug.

From 2016 to 2018, industry made general payments to more than 52,000 physicians for 137 unique cancer drugs, according to a separate 2021 study published in the Journal of Cancer Policy, for which Dr. Gyawali served as one of the coauthors.

The results suggest that pharmaceutical money affects the entire cancer system, not relatively few oncology leaders. The amounts and dollar values grew each year covered by the study, to nearly 466,000 payments totaling $98.5 million in 2018.

Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, Washington, DC, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, has called for a ban on industry gifts to physicians.

When a publication asks physicians to disclose relevant conflicts of interest, physicians may choose not to disclose, because they don’t feel that their conflicts are relevant, Dr. Fugh-Berman said. Drug and device makers have also grown sophisticated about how they work with physicians, she suggested. “It’s illegal to market a drug before it comes on the market, but it’s not illegal to market the disease,” said Dr. Fugh-Berman, noting that drugmakers often work on long timelines.

“The doctor is going around saying we don’t have good therapies. They’re not pushing a drug. And so they feel totally fine about it.”

Anecdotally, Dr. Fugh-Berman noted that, if anything, speaking fees and similar payments only improve doctors’ reputations. She said that’s especially true if the physicians are paid by multiple companies, on the supposed theory that their conflicts of interest cancel each other out.

“I’m not defending this,” added Dr. Fugh-Berman, observing that, at the end of the day, such conflicts may go against the interests of patients.

“Sometimes the best drugs are older, generic, cheap drugs, and if oncologists or other specialists are only choosing among the most promoted drugs, they’re not necessarily choosing the best drugs.”

Beyond any prestige, doctors have other possible nonfinancial incentives for receiving industry payments. “It’s the relationships,” Dr. Fugh-Berman said. “Companies are very good at offering friendship.”

Dr. El Bairi reported NCODA leadership and honoraria along with expert testimony through techspert.io. Dr. Ross reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of or the review of the manuscript he authored and discussed in this article. Dr. Ross also reported receiving grants from the Food and Drug Administration, Johnson & Johnson, the Medical Device Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Mitchell reported no relevant financial relationships. Dr. Gyawali reported a consulting or advisory role with Vivio Health. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.

Three-quarters of oncologists participating in a recent global survey failed to identify one or more situations representing a conflict of interest, according to a new study.

The findings reflect limited awareness in low-income countries about what scenarios constitute a conflict of interest, first author, Khalid El Bairi, MD, said during an interview. “There is a lack of training in ethics and integrity in medical schools [in countries in Africa], so people are not informed about conflicts of interest,” continued Dr. El Bairi, who presented the new research at the annual meeting of the American Society of Clinical Oncology. “There is also a lack of policies in universities and hospitals to guide clinicians about conflict of interest reporting.”

Overall, 58.5% of survey participants categorized honoraria as a conflict of interest that required disclosure, while 50% said the same of gifts from pharmaceutical representatives, and 44.5% identified travel grants for attending conferences as conflicts of interests. The report was published in JCO Global Oncology. Less often considered conflicts of interest were personal and institutional research funding, trips to conferences, consulting or advisory roles, food and beverages, expert testimony, and sample drugs provided by the pharmaceutical industry.

Just 24% of participants indicated that all of the listed items were deemed conflicts of interest. The survey — called Oncology Transparency Under Scrutiny and Tracking, or ONCOTRUST-1 — considered the perceptions of 200 oncologists, about 70% of whom practice in low- and middle-income countries.

What’s more, 37.5% of respondents identified fear of losing financial support as a reason not to report a conflict of interest. Still, 75% indicated that industry-sponsored speaking does not affect treatment decisions, and 60% said conflicts of interest do not impair objective appraisal of clinical trials.

Dr. El Bairi, a research associate in the department of medical oncology at Mohammed VI University Hospital, Oujda, Morocco, and his colleagues undertook the study in part because of an editorial published in The Lancet Oncology last year. First author Fidel Rubagumya, MD, a consultant oncologist and director of research at Rwanda Military Hospital, Kigali, and colleagues called for more research on the ties between oncologists and industry in Africa. The ONCOTRUST-1 findings set the stage for a planned follow-up study, which aims to compare views surrounding conflicts of interests between oncologists in different economic settings.
 

Open Payments Houses US Physicians’ Conflicts of Interest

To be sure, many authors of research published in major US journals are based outside of the United States. According to JAMA Network Open, 69% of submissions to the journal are from international authors. However, Dr. El Bairi also raised other potential signs of industry influence that he said need global discussion, such as the role of pharmaceutical companies in presentations of clinical trial findings at large cancer societies’ conferences, a shift toward progression-free survival as the endpoint in clinical cancer trials, and the rise of third-party writing assistance.

“There are two sides of the story,” Dr. El Bairi said. “The good side is that unfortunately, sometimes [industry money is] the only way for African oncologists to go abroad for training, to conferences for their continuous medical education. The bad is now we may harm patients, we might harm science by having conflicts of interest not reported.”

Unlike other countries, the United States has plentiful data on the scale of physicians’ financial conflicts of interest in the form of the Open Payments platform. Championed by Sen. Chuck Grassley (R-Iowa), the federal repository of payments to doctors and teaching hospitals by drug and medical device companies was established as part of the Affordable Care Act (ACA).

The health care reform law, which passed in 2010, requires pharmaceutical companies and medical device makers to report this information.

From 2013 to 2021, the pharmaceutical and medical device industry paid physicians $12.1 billion, according to a research letter published in JAMA in March of 2024 that reviewed Open Payments data.

Ranked by specialty, hematologists and oncologists received the fourth-largest amount of money in aggregate, the study shows. Their total of $825.8 million trailed only physicians in orthopedics ($1.36 billion), neurology and psychiatry ($1.32 billion) and cardiology ($1.29 billion). What’s more, this specialty had the biggest share of physicians taking industry money, with 74.2% of hematologists and oncologists receiving payments.

The payments from industry include fees for consulting services and speaking, as well as food and beverages, travel and lodging, education, gifts, grants, and honoraria.

Joseph S. Ross, MD, MHS, one of the JAMA study’s coauthors, said in an interview that the continued prevalence of such funding runs counter to the expectation behind the measure, which was that transparency would lead to physicians’ becoming less likely to accept a payment.

“We as a profession need to take a cold hard look in the mirror,” he said, referring to physicians in general.

Dr. Ross, professor of medicine at Yale University School of Medicine, New Haven, Connecticut, said he hopes that the profession will self-police, and that patients will make a bigger deal of the issue. Still, he acknowledged that “the vast majority” of patient advocacy groups, too, are funded by the pharmaceutical industry.
 

 

 

Exposing Industry Payments May Have Perverse Effect

A growing body of research explores the effect that physicians’ financial relationships with pharmaceutical companies can have on their prescribing practices. Indeed, oncologists taking industry payments seem to be more likely to prescribe nonrecommended and low-value drugs in some clinical settings, according to a study published in The BMJ last year.

That study’s first author, Aaron P. Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, New York City, suggested in an interview that exposing industry payments to the sunlight may have had a perverse effect on physicians.

“There’s this idea of having license to do something,” Dr. Mitchell said, speaking broadly about human psychology rather than drawing on empirical data. “You might feel a little less bad about then prescribing more of that company’s drug, because the disclosure has already been done.”

The influence of pharmaceutical industry money on oncologists goes beyond what’s prescribed to which treatments get studied, approved, and recommended by guidelines, Dr. Mitchell said. He was also first author of a 2016 paper published in JAMA Oncology that found 86% of authors of the National Comprehensive Cancer Network guidelines had at least one conflict of interest reported on Open Systems in 2014.

Meanwhile, the fact that physicians’ payments from industry are a matter of public record on Open Systems has not guaranteed that doctors will disclose their conflicts of interest in other forums. A study published in JAMA earlier this year, for which Dr. Mitchell served as first author, found that almost one in three physicians endorsing drugs and devices on the social media platform X failed to disclose that the manufacturer paid them.

The lack of disclosure seems to extend beyond social media. A 2018 study published in JAMA Oncology found that 32% of oncologist authors of clinical drug trials for drugs approved over a 20-month period from 2016 to 2017 did not fully disclose payments from the trial sponsor when checked against the Open Payments database.

A lion’s share of industry payments within oncology appears to be going to a small group of high-profile physicians, suggested a 2022 study published in JCO Oncology Practice. It found that just 1% of all US oncologists accounted for 37% of industry payments, with each receiving more than $100,000 a year.
 

Experts: Professional Societies Should Further Limit Industry Payments

While partnerships between drug companies and physicians are necessary and have often been positive, more than disclosure is needed to minimize the risk of patient harm, according to an editorial published in March in JCO Oncology Practice. In it, Nina Niu Sanford, MD, a radiation oncologist UT Southwestern Medical Center, Dallas, and Bishal Gyawali, MD, PhD, a medical oncologist at Queen’s University, Kingston, Ontario, Canada, argue that following a specific blueprint could help mitigate financial conflicts of interest.

For starters, Dr. Sanford and Dr. Gyawali contend in the editorial that the maximum general payment NCCN members are allowed to receive from industry should be $0, compared with a current bar of $20,000 from a single entity or $50,000 from all external entities combined. They also urge professional societies to follow the current policy of the American Society of Clinical Oncology and ban members serving in their leadership from receiving any general payments from the industry.

The authors further suggest that investigators of clinical trials should be barred from holding stock for the drug or product while it is under study and that editorialists should not have conflicts of interest with the company whose drug or product they are discussing.

Pharmaceutical money can harm patients in ways that are not always obvious, Dr. Gyawali said in an interview.

“It can dominate the conversation by removing critical viewpoints from these top people about certain drugs,” he said. “It’s not always about saying good things about the drug.”

For instance, he suggested, a doctor receiving payments from Pfizer might openly criticize perceived flaws in drugs from other companies but refrain from weighing in negatively on a Pfizer drug.

From 2016 to 2018, industry made general payments to more than 52,000 physicians for 137 unique cancer drugs, according to a separate 2021 study published in the Journal of Cancer Policy, for which Dr. Gyawali served as one of the coauthors.

The results suggest that pharmaceutical money affects the entire cancer system, not relatively few oncology leaders. The amounts and dollar values grew each year covered by the study, to nearly 466,000 payments totaling $98.5 million in 2018.

Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, Washington, DC, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, has called for a ban on industry gifts to physicians.

When a publication asks physicians to disclose relevant conflicts of interest, physicians may choose not to disclose, because they don’t feel that their conflicts are relevant, Dr. Fugh-Berman said. Drug and device makers have also grown sophisticated about how they work with physicians, she suggested. “It’s illegal to market a drug before it comes on the market, but it’s not illegal to market the disease,” said Dr. Fugh-Berman, noting that drugmakers often work on long timelines.

“The doctor is going around saying we don’t have good therapies. They’re not pushing a drug. And so they feel totally fine about it.”

Anecdotally, Dr. Fugh-Berman noted that, if anything, speaking fees and similar payments only improve doctors’ reputations. She said that’s especially true if the physicians are paid by multiple companies, on the supposed theory that their conflicts of interest cancel each other out.

“I’m not defending this,” added Dr. Fugh-Berman, observing that, at the end of the day, such conflicts may go against the interests of patients.

“Sometimes the best drugs are older, generic, cheap drugs, and if oncologists or other specialists are only choosing among the most promoted drugs, they’re not necessarily choosing the best drugs.”

Beyond any prestige, doctors have other possible nonfinancial incentives for receiving industry payments. “It’s the relationships,” Dr. Fugh-Berman said. “Companies are very good at offering friendship.”

Dr. El Bairi reported NCODA leadership and honoraria along with expert testimony through techspert.io. Dr. Ross reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of or the review of the manuscript he authored and discussed in this article. Dr. Ross also reported receiving grants from the Food and Drug Administration, Johnson & Johnson, the Medical Device Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Mitchell reported no relevant financial relationships. Dr. Gyawali reported a consulting or advisory role with Vivio Health. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.

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Push, Fail, Push Harder: Olympic Athletes Who Became MDs

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Fri, 07/19/2024 - 16:45

Your odds are 1 in 562,400.

Or, as Bill Mallon, the past president and cofounder of the International Society of Olympic Historians, has said, aspiring athletes have a 0.00000178% chance of making the Games.

Now imagine the odds of making the Olympics and then going on to become a physician. And maybe it’s not surprising that those who have done it credit the training they received as Olympic athletes as key to their success in medicine.

“Dealing with poor outcomes and having to get back up and try again,” said Olympian-turned-physician Ogonna Nnamani Silva, MD, “that reiterative process of trying to obtain perfection in your craft — that’s athletics 101.”

This connection isn’t just anecdotal. It has been discussed in medical journals and examined in surveys. The consensus is that, yes, there are specific characteristics elite athletes develop that physicians — regardless of their athletic background — can learn to apply to their work in medicine.

Maybe it’s something else, too: Certain mindsets don’t worry about long odds. They seek out crucibles again and again without concern for the heat involved. Because the outcome is worth it.

Here are four athletes who became high-performing physicians and how they did it.
 

The Gymnast/The Pediatric Surgeon

“Gymnastics helped me build a skill set for my career,” said Canadian Olympic gymnast-turned-pediatric orthopedic surgeon Lise Leveille, MD. “It led me to be successful as a medical student and ultimately obtain the job that I want in the area that I want working with the people that I want.”

The skills Dr. Leveille prizes include time management, teamwork, goal setting, and a strong work ethic, all of which propel an athlete to the crucial moment of “performance.”

“I miss performing,” said Dr. Leveille. “It defines who I was at that time. I miss being able to work toward something and then deliver when it counted” — like when she qualified for the 1998 Commonwealth games in Kuala Lumpur at 16.

The Canadian national team came third at that event, and Dr. Leveille built on that success at the Pan American Games, taking gold on the balance beam and as a team, and then qualifying for the Olympics at the 1999 World Championships. She competed in the team and five individual events at the 2000 Olympic Games in Sydney.

Though Dr. Leveille started gymnastics at age 3, her parents, both teachers, instilled in her the importance of education. Gymnastics opened academic doors for her, like being recruited to Stanford where she completed her undergraduate degree in biomedical engineering and human biology in 2004 before entering medical school at the University of British Columbia in Vancouver.

Now 41, Dr. Leveille accepts that she’ll never nail another gymnastics routine, but she channels that love of sticking the landing into the operating room at British Columbia Children’s Hospital, also in Vancouver.

“Some of the unknown variables within the operating room and how you deal with those unknown variables is exactly like showing up for a competition,” Dr. Leveille said. “When I have one of those cases where I have to perform under pressure and everything comes together, that’s exactly like nailing your routine when it counts most.”
 

 

 

The Pole Vaulter/The Emergency Medicine Physician

Tunisian American pole vaulter Leila Ben-Youssef, MD, had what could be considered a disappointing showing at the 2008 Olympic Games in Beijing. She collapsed from severe abdominal pain during the opening ceremony and had to be carried out. On the day of competition, she was still suffering. “I could barely run down the runway,” she recalled. “I cleared one bar. I was just happy to have been able to do that.”

When Dr. Ben-Youssef, who grew up in Montana, returned home, she underwent emergency surgery to remove the source of the pain: A large, benign tumor.

While some might be devastated by such bad luck, Dr. Ben-Youssef focuses on the success of her journey — the fact that she qualified and competed at the Olympics in the first place. The ability to accept setbacks is something she said comes with the territory.

“As an athlete, you’re always facing injury, and someone told me early in my career that the best athletes are the ones that know how to manage their expectations because it’s bound to happen,” she said. “So, there is disappointment. But recognizing that I did qualify for the Olympics despite being uncomfortable and having issues, I was still able to meet my goal.”

Prior to the games, Dr. Ben-Youssef had been accepted into medical school at the University of Washington School of Medicine at Montana State University in Bozeman, Montana. Thankfully, the school was supportive of Dr. Ben-Youssef’s Olympic dreams and allowed her to begin her studies a month behind her class. Upon her return from Beijing, she spent the rest of her medical school training with her head down, grinding.

“Medicine is hard,” said Dr. Ben-Youssef. “It’s grueling both physically and emotionally, and I think that’s similar to any elite sport. You’re going to deal with challenges and disappointment. I think having gone through that as an athlete really prepares you for the medical education system, for residency, and even for day-to-day work.”

Now a physician working in emergency medicine in Hawaii, Dr. Ben-Youssef feels the setbacks she experienced as an athlete help her connect with her patients as they deal with health challenges.

And as a volunteer pole vaulting coach for a local high school, Dr. Ben-Youssef has been able to surround herself with the positive, joyful energy of athletes. “Emergency medicine is often a sad place,” she said. “But in a sports environment, if people don’t succeed or are injured, there is still that energy there that strives for something, and it’s so fun to be around.”
 

The Rower/The Sports Medicine Specialist

Three-time US Olympic rower Genevra “Gevvie” Stone, MD, wanted to be a doctor even before she gave a thought to rowing. She was in eighth grade when she dislocated her knee for the third time. Her parents took her to a pediatric orthopedist, and Dr. Stone, according to her mom, declared: “That’s what I want to do when I grow up.”

“I’m a very stubborn person, and when I make a decision like that, I usually don’t veer from it,” Dr. Stone said.

That laser focus combined with a deep love of both sports and medicine has served Dr. Stone well. “Becoming a doctor and becoming an Olympian require you to dedicate not just your time and your energy but also your passion to that focus,” she said. “In both, you aren’t going to be successful if you don’t love what you’re doing. Finding the reward in it is what makes it achievable.”

Dr. Stone actually resisted rowing until she was 16 because both of her parents were Olympians in the sport and met on the US team. “It was their thing, and I didn’t want it to be my thing,” she recalled.

Nonetheless, Dr. Stone easily fell into the sport in her late teens and was recruited by Princeton University. “I had grown up around Olympians and kind of took it for granted that if you worked hard enough and were decent at rowing, then you could be one of the best in the world, without really realizing how difficult it would be to achieve that,” she said.

Dr. Stone’s team won the NCAA Championship in 2006 and was invited to try out for the 2008 Olympic team at the US training center after she graduated from college. But she didn’t make it.

Instead, Dr. Stone entered medical school at Tufts University School of Medicine, Boston, thinking her competitive rowing career had come to end. But her love for the sport was still strong, and she realized she wasn’t finished.

After 2 years of medical school, Dr. Stone requested 2 years off so she might have another shot at making the Olympic team. The timing was right. She went to the London Olympics in 2012, graduated from medical school in 2014, and then took 2 more years off to train full time for the 2016 Olympics in Rio where she won silver.

At the 2020 Olympic Games in Tokyo, Dr. Stone took fifth place in the double sculls. While she continues to race the master’s circuit, she’s primarily dedicated to completing her sports medicine fellowship at University of Utah Health.

Fortunately, Dr. Stone’s parents, coaches, and teachers always supported her goals. “No one turned to me and told me I was crazy, just choose medicine or rowing,” she said. “Everyone said that if this is what you want to do, we’re here to support you, and I wouldn’t have been able to do it without that support.”
 

 

 

The Volleyball Player/The Plastic Surgeon

Dr. Nnamani Silva’s journey to the Olympics was also paved with an extensive list of supporters, beginning with her parents. And she has taken that sense of collaboration, coordination, and teamwork into her medical career.

The daughter of Nigerian immigrants who came to the United States to escape civil war, Dr. Nnamani Silva said her parents embraced the American dream. “To see what they were able to do with hard work, dedication, and sacrifice, I had no choice but to work hard because I saw their example. And that love for and belief in America was so strong in my house growing up,” she said.

Dreams of practicing medicine came first. A severe asthmatic growing up, Dr. Nnamani Silva recalled having wonderful doctors. “I had so many emergency room visits and hospitalizations,” she said. “But the doctors always gave me hope, and they literally transformed my life. I thought if I could pass that on to my future patients, that would be the greatest honor of my life.”

Volleyball gave Dr. Nnamani Silva the opportunity to attend Stanford, and she took time off during her junior year to train and compete in the 2004 Olympic Games in Athens. She also played for the United States at the 2008 Olympic Games in Beijing where the team took silver. Afterward, she continued to play overseas for several years.

At 33, and with a newborn daughter, Dr. Nnamani Silva returned to her original goal of becoming a doctor. She attended the University of California, San Francisco, and is currently a resident in the Harvard Plastic Surgery Program. She includes her husband, parents, and in-laws in this achievement, whom she said “saved” her. “There is no chance I would have finished medical school and survived residency without them.”

As a volleyball player, Dr. Nnamani Silva said she “believes in teams wholeheartedly,” valuing the exchange of energy and skill that she feels brings out the best in people. As a medical student, she initially didn’t realize how her previous life would apply to teamwork in the operating room. But it soon became clear.

“In surgery, when you harness the talents of everyone around you and you create that synergy, it’s an amazing feeling,” she said. And the stakes are often high. “It requires a lot of focus, discipline, determination, and resilience because you’re going to be humbled all the time.” Something athletes know a little bit about.

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

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Your odds are 1 in 562,400.

Or, as Bill Mallon, the past president and cofounder of the International Society of Olympic Historians, has said, aspiring athletes have a 0.00000178% chance of making the Games.

Now imagine the odds of making the Olympics and then going on to become a physician. And maybe it’s not surprising that those who have done it credit the training they received as Olympic athletes as key to their success in medicine.

“Dealing with poor outcomes and having to get back up and try again,” said Olympian-turned-physician Ogonna Nnamani Silva, MD, “that reiterative process of trying to obtain perfection in your craft — that’s athletics 101.”

This connection isn’t just anecdotal. It has been discussed in medical journals and examined in surveys. The consensus is that, yes, there are specific characteristics elite athletes develop that physicians — regardless of their athletic background — can learn to apply to their work in medicine.

Maybe it’s something else, too: Certain mindsets don’t worry about long odds. They seek out crucibles again and again without concern for the heat involved. Because the outcome is worth it.

Here are four athletes who became high-performing physicians and how they did it.
 

The Gymnast/The Pediatric Surgeon

“Gymnastics helped me build a skill set for my career,” said Canadian Olympic gymnast-turned-pediatric orthopedic surgeon Lise Leveille, MD. “It led me to be successful as a medical student and ultimately obtain the job that I want in the area that I want working with the people that I want.”

The skills Dr. Leveille prizes include time management, teamwork, goal setting, and a strong work ethic, all of which propel an athlete to the crucial moment of “performance.”

“I miss performing,” said Dr. Leveille. “It defines who I was at that time. I miss being able to work toward something and then deliver when it counted” — like when she qualified for the 1998 Commonwealth games in Kuala Lumpur at 16.

The Canadian national team came third at that event, and Dr. Leveille built on that success at the Pan American Games, taking gold on the balance beam and as a team, and then qualifying for the Olympics at the 1999 World Championships. She competed in the team and five individual events at the 2000 Olympic Games in Sydney.

Though Dr. Leveille started gymnastics at age 3, her parents, both teachers, instilled in her the importance of education. Gymnastics opened academic doors for her, like being recruited to Stanford where she completed her undergraduate degree in biomedical engineering and human biology in 2004 before entering medical school at the University of British Columbia in Vancouver.

Now 41, Dr. Leveille accepts that she’ll never nail another gymnastics routine, but she channels that love of sticking the landing into the operating room at British Columbia Children’s Hospital, also in Vancouver.

“Some of the unknown variables within the operating room and how you deal with those unknown variables is exactly like showing up for a competition,” Dr. Leveille said. “When I have one of those cases where I have to perform under pressure and everything comes together, that’s exactly like nailing your routine when it counts most.”
 

 

 

The Pole Vaulter/The Emergency Medicine Physician

Tunisian American pole vaulter Leila Ben-Youssef, MD, had what could be considered a disappointing showing at the 2008 Olympic Games in Beijing. She collapsed from severe abdominal pain during the opening ceremony and had to be carried out. On the day of competition, she was still suffering. “I could barely run down the runway,” she recalled. “I cleared one bar. I was just happy to have been able to do that.”

When Dr. Ben-Youssef, who grew up in Montana, returned home, she underwent emergency surgery to remove the source of the pain: A large, benign tumor.

While some might be devastated by such bad luck, Dr. Ben-Youssef focuses on the success of her journey — the fact that she qualified and competed at the Olympics in the first place. The ability to accept setbacks is something she said comes with the territory.

“As an athlete, you’re always facing injury, and someone told me early in my career that the best athletes are the ones that know how to manage their expectations because it’s bound to happen,” she said. “So, there is disappointment. But recognizing that I did qualify for the Olympics despite being uncomfortable and having issues, I was still able to meet my goal.”

Prior to the games, Dr. Ben-Youssef had been accepted into medical school at the University of Washington School of Medicine at Montana State University in Bozeman, Montana. Thankfully, the school was supportive of Dr. Ben-Youssef’s Olympic dreams and allowed her to begin her studies a month behind her class. Upon her return from Beijing, she spent the rest of her medical school training with her head down, grinding.

“Medicine is hard,” said Dr. Ben-Youssef. “It’s grueling both physically and emotionally, and I think that’s similar to any elite sport. You’re going to deal with challenges and disappointment. I think having gone through that as an athlete really prepares you for the medical education system, for residency, and even for day-to-day work.”

Now a physician working in emergency medicine in Hawaii, Dr. Ben-Youssef feels the setbacks she experienced as an athlete help her connect with her patients as they deal with health challenges.

And as a volunteer pole vaulting coach for a local high school, Dr. Ben-Youssef has been able to surround herself with the positive, joyful energy of athletes. “Emergency medicine is often a sad place,” she said. “But in a sports environment, if people don’t succeed or are injured, there is still that energy there that strives for something, and it’s so fun to be around.”
 

The Rower/The Sports Medicine Specialist

Three-time US Olympic rower Genevra “Gevvie” Stone, MD, wanted to be a doctor even before she gave a thought to rowing. She was in eighth grade when she dislocated her knee for the third time. Her parents took her to a pediatric orthopedist, and Dr. Stone, according to her mom, declared: “That’s what I want to do when I grow up.”

“I’m a very stubborn person, and when I make a decision like that, I usually don’t veer from it,” Dr. Stone said.

That laser focus combined with a deep love of both sports and medicine has served Dr. Stone well. “Becoming a doctor and becoming an Olympian require you to dedicate not just your time and your energy but also your passion to that focus,” she said. “In both, you aren’t going to be successful if you don’t love what you’re doing. Finding the reward in it is what makes it achievable.”

Dr. Stone actually resisted rowing until she was 16 because both of her parents were Olympians in the sport and met on the US team. “It was their thing, and I didn’t want it to be my thing,” she recalled.

Nonetheless, Dr. Stone easily fell into the sport in her late teens and was recruited by Princeton University. “I had grown up around Olympians and kind of took it for granted that if you worked hard enough and were decent at rowing, then you could be one of the best in the world, without really realizing how difficult it would be to achieve that,” she said.

Dr. Stone’s team won the NCAA Championship in 2006 and was invited to try out for the 2008 Olympic team at the US training center after she graduated from college. But she didn’t make it.

Instead, Dr. Stone entered medical school at Tufts University School of Medicine, Boston, thinking her competitive rowing career had come to end. But her love for the sport was still strong, and she realized she wasn’t finished.

After 2 years of medical school, Dr. Stone requested 2 years off so she might have another shot at making the Olympic team. The timing was right. She went to the London Olympics in 2012, graduated from medical school in 2014, and then took 2 more years off to train full time for the 2016 Olympics in Rio where she won silver.

At the 2020 Olympic Games in Tokyo, Dr. Stone took fifth place in the double sculls. While she continues to race the master’s circuit, she’s primarily dedicated to completing her sports medicine fellowship at University of Utah Health.

Fortunately, Dr. Stone’s parents, coaches, and teachers always supported her goals. “No one turned to me and told me I was crazy, just choose medicine or rowing,” she said. “Everyone said that if this is what you want to do, we’re here to support you, and I wouldn’t have been able to do it without that support.”
 

 

 

The Volleyball Player/The Plastic Surgeon

Dr. Nnamani Silva’s journey to the Olympics was also paved with an extensive list of supporters, beginning with her parents. And she has taken that sense of collaboration, coordination, and teamwork into her medical career.

The daughter of Nigerian immigrants who came to the United States to escape civil war, Dr. Nnamani Silva said her parents embraced the American dream. “To see what they were able to do with hard work, dedication, and sacrifice, I had no choice but to work hard because I saw their example. And that love for and belief in America was so strong in my house growing up,” she said.

Dreams of practicing medicine came first. A severe asthmatic growing up, Dr. Nnamani Silva recalled having wonderful doctors. “I had so many emergency room visits and hospitalizations,” she said. “But the doctors always gave me hope, and they literally transformed my life. I thought if I could pass that on to my future patients, that would be the greatest honor of my life.”

Volleyball gave Dr. Nnamani Silva the opportunity to attend Stanford, and she took time off during her junior year to train and compete in the 2004 Olympic Games in Athens. She also played for the United States at the 2008 Olympic Games in Beijing where the team took silver. Afterward, she continued to play overseas for several years.

At 33, and with a newborn daughter, Dr. Nnamani Silva returned to her original goal of becoming a doctor. She attended the University of California, San Francisco, and is currently a resident in the Harvard Plastic Surgery Program. She includes her husband, parents, and in-laws in this achievement, whom she said “saved” her. “There is no chance I would have finished medical school and survived residency without them.”

As a volleyball player, Dr. Nnamani Silva said she “believes in teams wholeheartedly,” valuing the exchange of energy and skill that she feels brings out the best in people. As a medical student, she initially didn’t realize how her previous life would apply to teamwork in the operating room. But it soon became clear.

“In surgery, when you harness the talents of everyone around you and you create that synergy, it’s an amazing feeling,” she said. And the stakes are often high. “It requires a lot of focus, discipline, determination, and resilience because you’re going to be humbled all the time.” Something athletes know a little bit about.

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

Your odds are 1 in 562,400.

Or, as Bill Mallon, the past president and cofounder of the International Society of Olympic Historians, has said, aspiring athletes have a 0.00000178% chance of making the Games.

Now imagine the odds of making the Olympics and then going on to become a physician. And maybe it’s not surprising that those who have done it credit the training they received as Olympic athletes as key to their success in medicine.

“Dealing with poor outcomes and having to get back up and try again,” said Olympian-turned-physician Ogonna Nnamani Silva, MD, “that reiterative process of trying to obtain perfection in your craft — that’s athletics 101.”

This connection isn’t just anecdotal. It has been discussed in medical journals and examined in surveys. The consensus is that, yes, there are specific characteristics elite athletes develop that physicians — regardless of their athletic background — can learn to apply to their work in medicine.

Maybe it’s something else, too: Certain mindsets don’t worry about long odds. They seek out crucibles again and again without concern for the heat involved. Because the outcome is worth it.

Here are four athletes who became high-performing physicians and how they did it.
 

The Gymnast/The Pediatric Surgeon

“Gymnastics helped me build a skill set for my career,” said Canadian Olympic gymnast-turned-pediatric orthopedic surgeon Lise Leveille, MD. “It led me to be successful as a medical student and ultimately obtain the job that I want in the area that I want working with the people that I want.”

The skills Dr. Leveille prizes include time management, teamwork, goal setting, and a strong work ethic, all of which propel an athlete to the crucial moment of “performance.”

“I miss performing,” said Dr. Leveille. “It defines who I was at that time. I miss being able to work toward something and then deliver when it counted” — like when she qualified for the 1998 Commonwealth games in Kuala Lumpur at 16.

The Canadian national team came third at that event, and Dr. Leveille built on that success at the Pan American Games, taking gold on the balance beam and as a team, and then qualifying for the Olympics at the 1999 World Championships. She competed in the team and five individual events at the 2000 Olympic Games in Sydney.

Though Dr. Leveille started gymnastics at age 3, her parents, both teachers, instilled in her the importance of education. Gymnastics opened academic doors for her, like being recruited to Stanford where she completed her undergraduate degree in biomedical engineering and human biology in 2004 before entering medical school at the University of British Columbia in Vancouver.

Now 41, Dr. Leveille accepts that she’ll never nail another gymnastics routine, but she channels that love of sticking the landing into the operating room at British Columbia Children’s Hospital, also in Vancouver.

“Some of the unknown variables within the operating room and how you deal with those unknown variables is exactly like showing up for a competition,” Dr. Leveille said. “When I have one of those cases where I have to perform under pressure and everything comes together, that’s exactly like nailing your routine when it counts most.”
 

 

 

The Pole Vaulter/The Emergency Medicine Physician

Tunisian American pole vaulter Leila Ben-Youssef, MD, had what could be considered a disappointing showing at the 2008 Olympic Games in Beijing. She collapsed from severe abdominal pain during the opening ceremony and had to be carried out. On the day of competition, she was still suffering. “I could barely run down the runway,” she recalled. “I cleared one bar. I was just happy to have been able to do that.”

When Dr. Ben-Youssef, who grew up in Montana, returned home, she underwent emergency surgery to remove the source of the pain: A large, benign tumor.

While some might be devastated by such bad luck, Dr. Ben-Youssef focuses on the success of her journey — the fact that she qualified and competed at the Olympics in the first place. The ability to accept setbacks is something she said comes with the territory.

“As an athlete, you’re always facing injury, and someone told me early in my career that the best athletes are the ones that know how to manage their expectations because it’s bound to happen,” she said. “So, there is disappointment. But recognizing that I did qualify for the Olympics despite being uncomfortable and having issues, I was still able to meet my goal.”

Prior to the games, Dr. Ben-Youssef had been accepted into medical school at the University of Washington School of Medicine at Montana State University in Bozeman, Montana. Thankfully, the school was supportive of Dr. Ben-Youssef’s Olympic dreams and allowed her to begin her studies a month behind her class. Upon her return from Beijing, she spent the rest of her medical school training with her head down, grinding.

“Medicine is hard,” said Dr. Ben-Youssef. “It’s grueling both physically and emotionally, and I think that’s similar to any elite sport. You’re going to deal with challenges and disappointment. I think having gone through that as an athlete really prepares you for the medical education system, for residency, and even for day-to-day work.”

Now a physician working in emergency medicine in Hawaii, Dr. Ben-Youssef feels the setbacks she experienced as an athlete help her connect with her patients as they deal with health challenges.

And as a volunteer pole vaulting coach for a local high school, Dr. Ben-Youssef has been able to surround herself with the positive, joyful energy of athletes. “Emergency medicine is often a sad place,” she said. “But in a sports environment, if people don’t succeed or are injured, there is still that energy there that strives for something, and it’s so fun to be around.”
 

The Rower/The Sports Medicine Specialist

Three-time US Olympic rower Genevra “Gevvie” Stone, MD, wanted to be a doctor even before she gave a thought to rowing. She was in eighth grade when she dislocated her knee for the third time. Her parents took her to a pediatric orthopedist, and Dr. Stone, according to her mom, declared: “That’s what I want to do when I grow up.”

“I’m a very stubborn person, and when I make a decision like that, I usually don’t veer from it,” Dr. Stone said.

That laser focus combined with a deep love of both sports and medicine has served Dr. Stone well. “Becoming a doctor and becoming an Olympian require you to dedicate not just your time and your energy but also your passion to that focus,” she said. “In both, you aren’t going to be successful if you don’t love what you’re doing. Finding the reward in it is what makes it achievable.”

Dr. Stone actually resisted rowing until she was 16 because both of her parents were Olympians in the sport and met on the US team. “It was their thing, and I didn’t want it to be my thing,” she recalled.

Nonetheless, Dr. Stone easily fell into the sport in her late teens and was recruited by Princeton University. “I had grown up around Olympians and kind of took it for granted that if you worked hard enough and were decent at rowing, then you could be one of the best in the world, without really realizing how difficult it would be to achieve that,” she said.

Dr. Stone’s team won the NCAA Championship in 2006 and was invited to try out for the 2008 Olympic team at the US training center after she graduated from college. But she didn’t make it.

Instead, Dr. Stone entered medical school at Tufts University School of Medicine, Boston, thinking her competitive rowing career had come to end. But her love for the sport was still strong, and she realized she wasn’t finished.

After 2 years of medical school, Dr. Stone requested 2 years off so she might have another shot at making the Olympic team. The timing was right. She went to the London Olympics in 2012, graduated from medical school in 2014, and then took 2 more years off to train full time for the 2016 Olympics in Rio where she won silver.

At the 2020 Olympic Games in Tokyo, Dr. Stone took fifth place in the double sculls. While she continues to race the master’s circuit, she’s primarily dedicated to completing her sports medicine fellowship at University of Utah Health.

Fortunately, Dr. Stone’s parents, coaches, and teachers always supported her goals. “No one turned to me and told me I was crazy, just choose medicine or rowing,” she said. “Everyone said that if this is what you want to do, we’re here to support you, and I wouldn’t have been able to do it without that support.”
 

 

 

The Volleyball Player/The Plastic Surgeon

Dr. Nnamani Silva’s journey to the Olympics was also paved with an extensive list of supporters, beginning with her parents. And she has taken that sense of collaboration, coordination, and teamwork into her medical career.

The daughter of Nigerian immigrants who came to the United States to escape civil war, Dr. Nnamani Silva said her parents embraced the American dream. “To see what they were able to do with hard work, dedication, and sacrifice, I had no choice but to work hard because I saw their example. And that love for and belief in America was so strong in my house growing up,” she said.

Dreams of practicing medicine came first. A severe asthmatic growing up, Dr. Nnamani Silva recalled having wonderful doctors. “I had so many emergency room visits and hospitalizations,” she said. “But the doctors always gave me hope, and they literally transformed my life. I thought if I could pass that on to my future patients, that would be the greatest honor of my life.”

Volleyball gave Dr. Nnamani Silva the opportunity to attend Stanford, and she took time off during her junior year to train and compete in the 2004 Olympic Games in Athens. She also played for the United States at the 2008 Olympic Games in Beijing where the team took silver. Afterward, she continued to play overseas for several years.

At 33, and with a newborn daughter, Dr. Nnamani Silva returned to her original goal of becoming a doctor. She attended the University of California, San Francisco, and is currently a resident in the Harvard Plastic Surgery Program. She includes her husband, parents, and in-laws in this achievement, whom she said “saved” her. “There is no chance I would have finished medical school and survived residency without them.”

As a volleyball player, Dr. Nnamani Silva said she “believes in teams wholeheartedly,” valuing the exchange of energy and skill that she feels brings out the best in people. As a medical student, she initially didn’t realize how her previous life would apply to teamwork in the operating room. But it soon became clear.

“In surgery, when you harness the talents of everyone around you and you create that synergy, it’s an amazing feeling,” she said. And the stakes are often high. “It requires a lot of focus, discipline, determination, and resilience because you’re going to be humbled all the time.” Something athletes know a little bit about.

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

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Healthcare Workers Face Gender-Based Violence

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Fri, 07/19/2024 - 16:05

Across the world, healthcare workers experience workplace violence, which can differ by gender, seniority, and the type of workplace, according to a recent study.

An analysis found that men were more likely to report physical violence, while women were more likely to face nonphysical violence, such as verbal abuse, sexual harassment, and bullying.

“Our study was sparked by the increasing research on workplace violence in healthcare settings. Yet, there’s less empirical data about workplace violence based on gender, its effects on individuals and the collective workforce, and its subsequent impact on patient care and healthcare organizations,” study author Basnama Ayaz, a PhD candidate in nursing at the University of Toronto, told this news organization.

“Workplace violence in healthcare settings is a critical issue that requires attention and action from all stakeholders, including individual providers, healthcare and other institutions, policymakers, and the community,” she said. “By recognizing the problem and implementing evidence-based solutions, we can create safer work environments that protect healthcare workers and improve quality care for patients and organizational effectiveness.”

The study was published online in PLOS Global Public Health.
 

Widespread and Severe

Although women represent most of the healthcare workforce worldwide, hierarchical structures tend to reflect traditional gender norms, where men hold leadership positions and women serve in front-line care roles, said Ms. Ayaz. Women are often marginalized, and their concerns dismissed, which can exacerbate their vulnerability to gender-based workplace violence, she added.

To better understand these imbalances on a global scale, the investigators conducted a scoping review of the prevalence of and risk factors for gender-based workplace violence in healthcare settings. Participants included physicians, nurses, and midwives, between 2010 and 2024. Although the authors acknowledged that gender-based workplace violence affects the full gender spectrum, only a handful of studies included information about nonbinary personnel, so the review focused on men and women.

Among 226 studies, half focused on physicians, 22% focused on nurses, and 28% included physicians, nurses, midwives, and other medical workers. About 64% of studies reported a higher prevalence of all forms of workplace violence for women, including sexual violence, verbal abuse, discrimination, bullying, and physical violence, while 17% reported a higher prevalence for men.

Overall, across most countries, men experienced more physical violence than did women, and women experienced more verbal abuse, sexual harassment, and bullying. Female nurses were particularly likely to experience violence.

Healthcare workers were also more likely to experience violence if they were younger, less experienced, had a lower professional status, or were part of a minority group based on ethnicity, nationality, culture, or language. These factors were sensitive to gender, “reflecting women’s structural disadvantages in the workplace,” wrote the authors.

As a result of workplace violence, women were more likely to report changes in mental health and social behaviors, as well as dissatisfaction, burnout, and changes in their career goals.

The research team identified various factors linked to violent episodes. In clinical settings where most perpetrators were patients and their relatives, abuse and violence could be related to overcrowding, waiting time, and heavy workloads for healthcare providers. When supervisors or colleagues were the perpetrators, workplace violence appeared to be more likely with long hours, night shifts, and certain clinical settings, such as emergency departments, psychiatric settings, operating rooms, and maternity wards, said Ms. Ayaz. Sexual or gender harassment toward women was more prevalent in male-dominated surgical specialties.

“We were surprised by the extent and severity of workplace violence that healthcare workers face around the globe based on gender,” she said. “One aspect that stood out was the significant role that organizational culture and support systems play either in mitigating or exacerbating these incidents, particularly the power structures between and within professions.”

For instance, trainees in lower hierarchical positions often face a higher risk for violence, especially gender-based harassment, she said. Many times, they feel they can’t report these incidents to trainers or managers, who may also be the perpetrators, she added.
 

 

 

Addressing Systemic Issues

In 2002, the World Health Organization, International Council of Nurses, and other major medical and labor groups worldwide launched a program focused on ways to eliminate workplace violence in healthcare settings. Since 2020, the call for a solution has grown louder as clinicians, nurses, and other health professionals faced more physical and verbal violence during the COVID-19 pandemic, often leading to burnout.

“Workplace violence is very important because it is more prevalent in healthcare workers than in many other settings and is on the rise,” said Karen Abrams, MD, assistant professor of psychiatry at the University of Toronto. Dr. Abrams, who wasn’t involved with this study, has researched physicians’ experiences of stalking by patients.

Workplace violence “can affect physical and mental health and lead to burnout, depression, anxiety, and symptoms of PTSD,” said Dr. Abrams. “It can affect one’s sleep and concentration and, therefore, ability to perform one’s job.”

Dr. Ayaz and colleagues suggested recommendations to improve gender-based workplace violence, noting the complex and multifaceted aspects of enhancing current policies, fortifying institutional capacities to respond, and implementing tailored interventions. Changes are needed at various levels, including at the healthcare system and provincial, territorial, and national levels, she said.

In Canada, for instance, lawmakers passed a bill in 2021 that amended the national criminal code to make intimidation or bullying a healthcare worker punishable by as many as 10 years in prison. The changes also required courts to consider more serious penalties for offenders who target healthcare workers aggressively.

But more needs to be done, medical professional groups say. The Canadian Nurses Association and Canadian Federation of Nurses Unions, as well as provincial groups, have called for a pan-Canadian violence-prevention framework, targeted funding for violence prevention infrastructure, and an update to the nation’s health human resources strategy to address severe staffing shortages across the country.

“Canada needs a bold vision for the future of our healthcare. Amid an ongoing staffing crisis, the cracks in our public healthcare systems have only grown deeper and wider, with too many going without the care they need when they need it,” Linda Silas, president of the Canadian Federation of Nurses Unions, told this news organization.

“Access to care relies on safe staffing. Years of unsafe working conditions and insufficient staffing are pushing nurses out of our public healthcare system,” she said. “Working collaboratively, we can make healthcare jobs the best jobs in our communities.”

The authors received no specific funding for the study. Ms. Ayaz, Dr. Abrams, and Ms. Silas reported no relevant financial relationships.

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

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Across the world, healthcare workers experience workplace violence, which can differ by gender, seniority, and the type of workplace, according to a recent study.

An analysis found that men were more likely to report physical violence, while women were more likely to face nonphysical violence, such as verbal abuse, sexual harassment, and bullying.

“Our study was sparked by the increasing research on workplace violence in healthcare settings. Yet, there’s less empirical data about workplace violence based on gender, its effects on individuals and the collective workforce, and its subsequent impact on patient care and healthcare organizations,” study author Basnama Ayaz, a PhD candidate in nursing at the University of Toronto, told this news organization.

“Workplace violence in healthcare settings is a critical issue that requires attention and action from all stakeholders, including individual providers, healthcare and other institutions, policymakers, and the community,” she said. “By recognizing the problem and implementing evidence-based solutions, we can create safer work environments that protect healthcare workers and improve quality care for patients and organizational effectiveness.”

The study was published online in PLOS Global Public Health.
 

Widespread and Severe

Although women represent most of the healthcare workforce worldwide, hierarchical structures tend to reflect traditional gender norms, where men hold leadership positions and women serve in front-line care roles, said Ms. Ayaz. Women are often marginalized, and their concerns dismissed, which can exacerbate their vulnerability to gender-based workplace violence, she added.

To better understand these imbalances on a global scale, the investigators conducted a scoping review of the prevalence of and risk factors for gender-based workplace violence in healthcare settings. Participants included physicians, nurses, and midwives, between 2010 and 2024. Although the authors acknowledged that gender-based workplace violence affects the full gender spectrum, only a handful of studies included information about nonbinary personnel, so the review focused on men and women.

Among 226 studies, half focused on physicians, 22% focused on nurses, and 28% included physicians, nurses, midwives, and other medical workers. About 64% of studies reported a higher prevalence of all forms of workplace violence for women, including sexual violence, verbal abuse, discrimination, bullying, and physical violence, while 17% reported a higher prevalence for men.

Overall, across most countries, men experienced more physical violence than did women, and women experienced more verbal abuse, sexual harassment, and bullying. Female nurses were particularly likely to experience violence.

Healthcare workers were also more likely to experience violence if they were younger, less experienced, had a lower professional status, or were part of a minority group based on ethnicity, nationality, culture, or language. These factors were sensitive to gender, “reflecting women’s structural disadvantages in the workplace,” wrote the authors.

As a result of workplace violence, women were more likely to report changes in mental health and social behaviors, as well as dissatisfaction, burnout, and changes in their career goals.

The research team identified various factors linked to violent episodes. In clinical settings where most perpetrators were patients and their relatives, abuse and violence could be related to overcrowding, waiting time, and heavy workloads for healthcare providers. When supervisors or colleagues were the perpetrators, workplace violence appeared to be more likely with long hours, night shifts, and certain clinical settings, such as emergency departments, psychiatric settings, operating rooms, and maternity wards, said Ms. Ayaz. Sexual or gender harassment toward women was more prevalent in male-dominated surgical specialties.

“We were surprised by the extent and severity of workplace violence that healthcare workers face around the globe based on gender,” she said. “One aspect that stood out was the significant role that organizational culture and support systems play either in mitigating or exacerbating these incidents, particularly the power structures between and within professions.”

For instance, trainees in lower hierarchical positions often face a higher risk for violence, especially gender-based harassment, she said. Many times, they feel they can’t report these incidents to trainers or managers, who may also be the perpetrators, she added.
 

 

 

Addressing Systemic Issues

In 2002, the World Health Organization, International Council of Nurses, and other major medical and labor groups worldwide launched a program focused on ways to eliminate workplace violence in healthcare settings. Since 2020, the call for a solution has grown louder as clinicians, nurses, and other health professionals faced more physical and verbal violence during the COVID-19 pandemic, often leading to burnout.

“Workplace violence is very important because it is more prevalent in healthcare workers than in many other settings and is on the rise,” said Karen Abrams, MD, assistant professor of psychiatry at the University of Toronto. Dr. Abrams, who wasn’t involved with this study, has researched physicians’ experiences of stalking by patients.

Workplace violence “can affect physical and mental health and lead to burnout, depression, anxiety, and symptoms of PTSD,” said Dr. Abrams. “It can affect one’s sleep and concentration and, therefore, ability to perform one’s job.”

Dr. Ayaz and colleagues suggested recommendations to improve gender-based workplace violence, noting the complex and multifaceted aspects of enhancing current policies, fortifying institutional capacities to respond, and implementing tailored interventions. Changes are needed at various levels, including at the healthcare system and provincial, territorial, and national levels, she said.

In Canada, for instance, lawmakers passed a bill in 2021 that amended the national criminal code to make intimidation or bullying a healthcare worker punishable by as many as 10 years in prison. The changes also required courts to consider more serious penalties for offenders who target healthcare workers aggressively.

But more needs to be done, medical professional groups say. The Canadian Nurses Association and Canadian Federation of Nurses Unions, as well as provincial groups, have called for a pan-Canadian violence-prevention framework, targeted funding for violence prevention infrastructure, and an update to the nation’s health human resources strategy to address severe staffing shortages across the country.

“Canada needs a bold vision for the future of our healthcare. Amid an ongoing staffing crisis, the cracks in our public healthcare systems have only grown deeper and wider, with too many going without the care they need when they need it,” Linda Silas, president of the Canadian Federation of Nurses Unions, told this news organization.

“Access to care relies on safe staffing. Years of unsafe working conditions and insufficient staffing are pushing nurses out of our public healthcare system,” she said. “Working collaboratively, we can make healthcare jobs the best jobs in our communities.”

The authors received no specific funding for the study. Ms. Ayaz, Dr. Abrams, and Ms. Silas reported no relevant financial relationships.

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

Across the world, healthcare workers experience workplace violence, which can differ by gender, seniority, and the type of workplace, according to a recent study.

An analysis found that men were more likely to report physical violence, while women were more likely to face nonphysical violence, such as verbal abuse, sexual harassment, and bullying.

“Our study was sparked by the increasing research on workplace violence in healthcare settings. Yet, there’s less empirical data about workplace violence based on gender, its effects on individuals and the collective workforce, and its subsequent impact on patient care and healthcare organizations,” study author Basnama Ayaz, a PhD candidate in nursing at the University of Toronto, told this news organization.

“Workplace violence in healthcare settings is a critical issue that requires attention and action from all stakeholders, including individual providers, healthcare and other institutions, policymakers, and the community,” she said. “By recognizing the problem and implementing evidence-based solutions, we can create safer work environments that protect healthcare workers and improve quality care for patients and organizational effectiveness.”

The study was published online in PLOS Global Public Health.
 

Widespread and Severe

Although women represent most of the healthcare workforce worldwide, hierarchical structures tend to reflect traditional gender norms, where men hold leadership positions and women serve in front-line care roles, said Ms. Ayaz. Women are often marginalized, and their concerns dismissed, which can exacerbate their vulnerability to gender-based workplace violence, she added.

To better understand these imbalances on a global scale, the investigators conducted a scoping review of the prevalence of and risk factors for gender-based workplace violence in healthcare settings. Participants included physicians, nurses, and midwives, between 2010 and 2024. Although the authors acknowledged that gender-based workplace violence affects the full gender spectrum, only a handful of studies included information about nonbinary personnel, so the review focused on men and women.

Among 226 studies, half focused on physicians, 22% focused on nurses, and 28% included physicians, nurses, midwives, and other medical workers. About 64% of studies reported a higher prevalence of all forms of workplace violence for women, including sexual violence, verbal abuse, discrimination, bullying, and physical violence, while 17% reported a higher prevalence for men.

Overall, across most countries, men experienced more physical violence than did women, and women experienced more verbal abuse, sexual harassment, and bullying. Female nurses were particularly likely to experience violence.

Healthcare workers were also more likely to experience violence if they were younger, less experienced, had a lower professional status, or were part of a minority group based on ethnicity, nationality, culture, or language. These factors were sensitive to gender, “reflecting women’s structural disadvantages in the workplace,” wrote the authors.

As a result of workplace violence, women were more likely to report changes in mental health and social behaviors, as well as dissatisfaction, burnout, and changes in their career goals.

The research team identified various factors linked to violent episodes. In clinical settings where most perpetrators were patients and their relatives, abuse and violence could be related to overcrowding, waiting time, and heavy workloads for healthcare providers. When supervisors or colleagues were the perpetrators, workplace violence appeared to be more likely with long hours, night shifts, and certain clinical settings, such as emergency departments, psychiatric settings, operating rooms, and maternity wards, said Ms. Ayaz. Sexual or gender harassment toward women was more prevalent in male-dominated surgical specialties.

“We were surprised by the extent and severity of workplace violence that healthcare workers face around the globe based on gender,” she said. “One aspect that stood out was the significant role that organizational culture and support systems play either in mitigating or exacerbating these incidents, particularly the power structures between and within professions.”

For instance, trainees in lower hierarchical positions often face a higher risk for violence, especially gender-based harassment, she said. Many times, they feel they can’t report these incidents to trainers or managers, who may also be the perpetrators, she added.
 

 

 

Addressing Systemic Issues

In 2002, the World Health Organization, International Council of Nurses, and other major medical and labor groups worldwide launched a program focused on ways to eliminate workplace violence in healthcare settings. Since 2020, the call for a solution has grown louder as clinicians, nurses, and other health professionals faced more physical and verbal violence during the COVID-19 pandemic, often leading to burnout.

“Workplace violence is very important because it is more prevalent in healthcare workers than in many other settings and is on the rise,” said Karen Abrams, MD, assistant professor of psychiatry at the University of Toronto. Dr. Abrams, who wasn’t involved with this study, has researched physicians’ experiences of stalking by patients.

Workplace violence “can affect physical and mental health and lead to burnout, depression, anxiety, and symptoms of PTSD,” said Dr. Abrams. “It can affect one’s sleep and concentration and, therefore, ability to perform one’s job.”

Dr. Ayaz and colleagues suggested recommendations to improve gender-based workplace violence, noting the complex and multifaceted aspects of enhancing current policies, fortifying institutional capacities to respond, and implementing tailored interventions. Changes are needed at various levels, including at the healthcare system and provincial, territorial, and national levels, she said.

In Canada, for instance, lawmakers passed a bill in 2021 that amended the national criminal code to make intimidation or bullying a healthcare worker punishable by as many as 10 years in prison. The changes also required courts to consider more serious penalties for offenders who target healthcare workers aggressively.

But more needs to be done, medical professional groups say. The Canadian Nurses Association and Canadian Federation of Nurses Unions, as well as provincial groups, have called for a pan-Canadian violence-prevention framework, targeted funding for violence prevention infrastructure, and an update to the nation’s health human resources strategy to address severe staffing shortages across the country.

“Canada needs a bold vision for the future of our healthcare. Amid an ongoing staffing crisis, the cracks in our public healthcare systems have only grown deeper and wider, with too many going without the care they need when they need it,” Linda Silas, president of the Canadian Federation of Nurses Unions, told this news organization.

“Access to care relies on safe staffing. Years of unsafe working conditions and insufficient staffing are pushing nurses out of our public healthcare system,” she said. “Working collaboratively, we can make healthcare jobs the best jobs in our communities.”

The authors received no specific funding for the study. Ms. Ayaz, Dr. Abrams, and Ms. Silas reported no relevant financial relationships.

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

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