Feature

One week after reporting promising results from the trial of their COVID-19 vaccine in children ages 5-11, Pfizer and BioNTech announced they’d submitted the data to the Food and Drug Administration. But that hasn’t stopped some parents from discreetly getting their children under age 12 vaccinated.

“The FDA, you never want to get ahead of their judgment,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told MSNBC on Sept. 28. “But I would imagine in the next few weeks, they will examine that data and hopefully they’ll give the okay so that we can start vaccinating children, hopefully before the end of October.”
 

Lying to vaccinate now

More than half of all parents with children under 12 say they plan to get their kids vaccinated, according to a Gallup poll. Among those who say they’re “very worried” or “somewhat worried” about their children catching COVID, that number goes up to 90% and 72%, respectively.

And although the FDA and the American Academy of Pediatrics have warned against it, some parents whose children can pass for 12 have lied to get them vaccinated already.

Dawn G. is a mom of two in southwest Missouri, where less than 45% of the population has been fully vaccinated. Her son turns 12 in early October, but in-person school started in mid-August.

“It was scary, thinking of him going to school for even 2 months,” she said. “Some parents thought their kid had a low chance of getting COVID, and their kid died. Nobody expects it to be them.”

In July, she and her husband took their son to a walk-in clinic and lied about his age.

“So many things can happen, from bullying to school shootings, and now this added pandemic risk,” she said. “I’ll do anything I can to protect my child, and a birthdate seems so arbitrary. He’ll be 12 in a matter of weeks. It seems ridiculous that that date would stop me from protecting him.”

In northern California, Carrie S. had a similar thought. When the vaccine was authorized for children ages 12-15 in May, the older of her two children got the shot right away. But her youngest doesn’t turn 12 until November.

“We were tempted to get the younger one vaccinated in May, but it didn’t seem like a rush. We were willing to wait to get the dosage right,” she ssaid. “But as Delta came through, there were no options for online school, the CDC was dropping mask expectations –it seemed like the world was ready to forget the pandemic was happening. It seemed like the least-bad option to get her vaccinated so she could go back to school, and we could find some balance of risk in our lives.”
 

Adult vs. pediatric doses

For now, experts advise against getting younger children vaccinated, even those who are the size of an adult, because of the way the human immune system develops.

“It’s not really about size,” said Anne Liu, MD, an immunologist and pediatrics professor at Stanford (Calif.) University. “The immune system behaves differently at different ages. Younger kids tend to have a more exuberant innate immune system, which is the part of the immune system that senses danger, even before it has developed a memory response.”

The adult Pfizer-BioNTech vaccine contains 30 mcg of mRNA, while the pediatric dose is just 10 mcg. That smaller dose produces an immune response similar to what’s seen in adults who receive 30 mcg, according to Pfizer.

“We were one of the sites that was involved in the phase 1 trial, a lot of times that’s called a dose-finding trial,” said Michael Smith, MD, a coinvestigator for the COVID vaccine trials done at Duke University. “And basically, if younger kids got a higher dose, they had more of a reaction, so it hurt more. They had fever, they had more redness and swelling at the site of the injection, and they just felt lousy, more than at the lower doses.”

At this point, with Pfizer’s data showing that younger children need a smaller dose, it doesn’t make sense to lie about your child’s age, said Dr. Smith.

“If my two options were having my child get the infection versus getting the vaccine, I’d get the vaccine. But we’re a few weeks away from getting the lower dose approved in kids,” he said. “It’s certainly safer. I don’t expect major, lifelong side effects from the higher dose, but it’s going to hurt, your kid’s going to have a fever, they’re going to feel lousy for a couple days, and they just don’t need that much antigen.”

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

One week after reporting promising results from the trial of their COVID-19 vaccine in children ages 5-11, Pfizer and BioNTech announced they’d submitted the data to the Food and Drug Administration. But that hasn’t stopped some parents from discreetly getting their children under age 12 vaccinated.

“The FDA, you never want to get ahead of their judgment,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told MSNBC on Sept. 28. “But I would imagine in the next few weeks, they will examine that data and hopefully they’ll give the okay so that we can start vaccinating children, hopefully before the end of October.”
 

Lying to vaccinate now

More than half of all parents with children under 12 say they plan to get their kids vaccinated, according to a Gallup poll. Among those who say they’re “very worried” or “somewhat worried” about their children catching COVID, that number goes up to 90% and 72%, respectively.

And although the FDA and the American Academy of Pediatrics have warned against it, some parents whose children can pass for 12 have lied to get them vaccinated already.

Dawn G. is a mom of two in southwest Missouri, where less than 45% of the population has been fully vaccinated. Her son turns 12 in early October, but in-person school started in mid-August.

“It was scary, thinking of him going to school for even 2 months,” she said. “Some parents thought their kid had a low chance of getting COVID, and their kid died. Nobody expects it to be them.”

In July, she and her husband took their son to a walk-in clinic and lied about his age.

“So many things can happen, from bullying to school shootings, and now this added pandemic risk,” she said. “I’ll do anything I can to protect my child, and a birthdate seems so arbitrary. He’ll be 12 in a matter of weeks. It seems ridiculous that that date would stop me from protecting him.”

In northern California, Carrie S. had a similar thought. When the vaccine was authorized for children ages 12-15 in May, the older of her two children got the shot right away. But her youngest doesn’t turn 12 until November.

“We were tempted to get the younger one vaccinated in May, but it didn’t seem like a rush. We were willing to wait to get the dosage right,” she ssaid. “But as Delta came through, there were no options for online school, the CDC was dropping mask expectations –it seemed like the world was ready to forget the pandemic was happening. It seemed like the least-bad option to get her vaccinated so she could go back to school, and we could find some balance of risk in our lives.”
 

Adult vs. pediatric doses

For now, experts advise against getting younger children vaccinated, even those who are the size of an adult, because of the way the human immune system develops.

“It’s not really about size,” said Anne Liu, MD, an immunologist and pediatrics professor at Stanford (Calif.) University. “The immune system behaves differently at different ages. Younger kids tend to have a more exuberant innate immune system, which is the part of the immune system that senses danger, even before it has developed a memory response.”

The adult Pfizer-BioNTech vaccine contains 30 mcg of mRNA, while the pediatric dose is just 10 mcg. That smaller dose produces an immune response similar to what’s seen in adults who receive 30 mcg, according to Pfizer.

“We were one of the sites that was involved in the phase 1 trial, a lot of times that’s called a dose-finding trial,” said Michael Smith, MD, a coinvestigator for the COVID vaccine trials done at Duke University. “And basically, if younger kids got a higher dose, they had more of a reaction, so it hurt more. They had fever, they had more redness and swelling at the site of the injection, and they just felt lousy, more than at the lower doses.”

At this point, with Pfizer’s data showing that younger children need a smaller dose, it doesn’t make sense to lie about your child’s age, said Dr. Smith.

“If my two options were having my child get the infection versus getting the vaccine, I’d get the vaccine. But we’re a few weeks away from getting the lower dose approved in kids,” he said. “It’s certainly safer. I don’t expect major, lifelong side effects from the higher dose, but it’s going to hurt, your kid’s going to have a fever, they’re going to feel lousy for a couple days, and they just don’t need that much antigen.”

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

One week after reporting promising results from the trial of their COVID-19 vaccine in children ages 5-11, Pfizer and BioNTech announced they’d submitted the data to the Food and Drug Administration. But that hasn’t stopped some parents from discreetly getting their children under age 12 vaccinated.

“The FDA, you never want to get ahead of their judgment,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told MSNBC on Sept. 28. “But I would imagine in the next few weeks, they will examine that data and hopefully they’ll give the okay so that we can start vaccinating children, hopefully before the end of October.”
 

Lying to vaccinate now

More than half of all parents with children under 12 say they plan to get their kids vaccinated, according to a Gallup poll. Among those who say they’re “very worried” or “somewhat worried” about their children catching COVID, that number goes up to 90% and 72%, respectively.

And although the FDA and the American Academy of Pediatrics have warned against it, some parents whose children can pass for 12 have lied to get them vaccinated already.

Dawn G. is a mom of two in southwest Missouri, where less than 45% of the population has been fully vaccinated. Her son turns 12 in early October, but in-person school started in mid-August.

“It was scary, thinking of him going to school for even 2 months,” she said. “Some parents thought their kid had a low chance of getting COVID, and their kid died. Nobody expects it to be them.”

In July, she and her husband took their son to a walk-in clinic and lied about his age.

“So many things can happen, from bullying to school shootings, and now this added pandemic risk,” she said. “I’ll do anything I can to protect my child, and a birthdate seems so arbitrary. He’ll be 12 in a matter of weeks. It seems ridiculous that that date would stop me from protecting him.”

In northern California, Carrie S. had a similar thought. When the vaccine was authorized for children ages 12-15 in May, the older of her two children got the shot right away. But her youngest doesn’t turn 12 until November.

“We were tempted to get the younger one vaccinated in May, but it didn’t seem like a rush. We were willing to wait to get the dosage right,” she ssaid. “But as Delta came through, there were no options for online school, the CDC was dropping mask expectations –it seemed like the world was ready to forget the pandemic was happening. It seemed like the least-bad option to get her vaccinated so she could go back to school, and we could find some balance of risk in our lives.”
 

Adult vs. pediatric doses

For now, experts advise against getting younger children vaccinated, even those who are the size of an adult, because of the way the human immune system develops.

“It’s not really about size,” said Anne Liu, MD, an immunologist and pediatrics professor at Stanford (Calif.) University. “The immune system behaves differently at different ages. Younger kids tend to have a more exuberant innate immune system, which is the part of the immune system that senses danger, even before it has developed a memory response.”

The adult Pfizer-BioNTech vaccine contains 30 mcg of mRNA, while the pediatric dose is just 10 mcg. That smaller dose produces an immune response similar to what’s seen in adults who receive 30 mcg, according to Pfizer.

“We were one of the sites that was involved in the phase 1 trial, a lot of times that’s called a dose-finding trial,” said Michael Smith, MD, a coinvestigator for the COVID vaccine trials done at Duke University. “And basically, if younger kids got a higher dose, they had more of a reaction, so it hurt more. They had fever, they had more redness and swelling at the site of the injection, and they just felt lousy, more than at the lower doses.”

At this point, with Pfizer’s data showing that younger children need a smaller dose, it doesn’t make sense to lie about your child’s age, said Dr. Smith.

“If my two options were having my child get the infection versus getting the vaccine, I’d get the vaccine. But we’re a few weeks away from getting the lower dose approved in kids,” he said. “It’s certainly safer. I don’t expect major, lifelong side effects from the higher dose, but it’s going to hurt, your kid’s going to have a fever, they’re going to feel lousy for a couple days, and they just don’t need that much antigen.”

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

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than 4 years trying medications before getting her disease under control with a biologic drug called Remicade.

So Ms. Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Ms. Moxley, who recently started a job as a public relations coordinator for Kansas City (Mo.) Public Schools. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Ms. Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the United States has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, MD, MPH, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anticompetitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the United States but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the health care system at large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much – 14.6% – according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the United States

Biosimilars provide a roughly 30% discount over brand biologics in the United States but have the potential to reduce spending by more than $100 billion in the next 5 years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Ms. Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, MD, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Ms. Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Ms. Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Ms. Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Ms. Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

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

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than 4 years trying medications before getting her disease under control with a biologic drug called Remicade.

So Ms. Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Ms. Moxley, who recently started a job as a public relations coordinator for Kansas City (Mo.) Public Schools. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Ms. Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the United States has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, MD, MPH, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anticompetitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the United States but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the health care system at large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much – 14.6% – according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the United States

Biosimilars provide a roughly 30% discount over brand biologics in the United States but have the potential to reduce spending by more than $100 billion in the next 5 years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Ms. Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, MD, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Ms. Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Ms. Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Ms. Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Ms. Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

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

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than 4 years trying medications before getting her disease under control with a biologic drug called Remicade.

So Ms. Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Ms. Moxley, who recently started a job as a public relations coordinator for Kansas City (Mo.) Public Schools. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Ms. Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the United States has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, MD, MPH, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anticompetitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the United States but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the health care system at large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much – 14.6% – according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the United States

Biosimilars provide a roughly 30% discount over brand biologics in the United States but have the potential to reduce spending by more than $100 billion in the next 5 years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Ms. Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, MD, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Ms. Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Ms. Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Ms. Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Ms. Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

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

Judy C. Washington, MD, a mentor of many young academic family physicians, particularly underrepresented-in-medicine (URM) physicians, advises her mentees on how to see ahead and plot paths to leadership.

Courtesy Dr. Judy C. Washington

For URM physicians, she also imparts a shared experience of being a minority in the field and helps prepare them for the challenges of facing racism or feeling marginalized or not equitably supported in academic life – and for making change.

While family medicine’s demographics have become more diverse over time, and more so than other specialties, they are not yet representative of the U.S. population. Within academia, male physicians who are Black or African American, or Hispanic or Latino, comprised about 4% and 5% of family medicine faculty, respectively, at the end of 2019, according to data from the Association of American Medical Colleges. For women, these numbers were about 9% and 4%, respectively. (Only those with an MD degree exclusively were included in the report.)

“When you have the privilege to serve in leadership, you have the responsibility to reach back and identify and help others who would not otherwise have the opportunity to be recognized,” Dr. Washington said.

Her mentorship work stems in large part from her long-time involvement and leadership roles in the Society of Teachers of Family Medicine (STFM) – roles she considers a pillar of her professional life. She currently serves as president of the STFM Foundation and is associate chief medical officer of the Atlantic Medical Group, a large multisite physician-led organization. She is also coordinator of women’s health for the Overlook Family Medicine Residency Program, which is affiliated with Atlantic Medical Group.

In Dr. Washington’s role as associate chief medical officer of Atlantic Medical Group in Summit, N.J., she focuses on physician engagement, satisfaction, and diversity. She also assists in areas such as population health. For the Overlook Family Medicine Residency Program also in Summit, she precepts residents in the obstetrics clinic and in the family medicine outpatient clinic.

Diana N. Carvajal, MD, MPH, one of Dr. Washington’s mentees, called her an “inspirational leader” for young academic faculty and said she is a familiar speaker at STFM meetings on topics of workforce diversity, equity, and leadership. She is “passionate” about mentorship, Dr. Carvajal said, and has understood “that URMs and women of color were not always getting [the mentorship they need to be successful].”
 

Guiding future leaders

Ivonne McLean, MD, assistant professor of family and community medicine at Icahn School of Medicine at Mount Sinai, New York, and an attending at a community health center in the Bronx, called Dr. Washington for advice a couple of years ago when she was considering her next career move.

Courtesy Society of Teachers of Family Medicine Foundation

“She took a genuine interest in me. She never said, this is what you should do. But the questions she asked and the examples she gave from her own life were incredibly helpful to me [in deciding to pursue a research fellowship] ... it was a pivotal conversation,” said Dr. McLean, associate director of a reproductive health fellowship and a research fellow in a New York State–funded program.

“From a lived experience angle, she also told me, here are some of the challenges you’ll have as a woman of color, and here are some of the ways you can approach that,” she said.

Dr. Carvajal, also a URM family physician, credits Dr. Washington’s mentorship with the development of a day-long workshop – held before the annual Society of Teachers of Family Medicine (STFM) meeting – on the low and declining rates of Black males in medicine. “We’d planned it as a presentation, and [she heard of it and] helped us expand it,” she said, calling Dr. Washington “warm, welcoming, and encouraging.

“That work and collaboration with her and the others she brought [into the process] have resulted in publications and more presentations and strategy building for diversifying the workforce,” said Dr. Carvajal, assistant professor, director of reproductive health education in family medicine, and codirector of the research section, all in the department of family and community medicine at the University of Maryland, Baltimore.

STFM involvement

Dr. Washington, who says that all or almost all of her mentees are now leaders in their academic institutions and communities, has been instrumental in developing STFM’s mentoring programming and in facilitating the organization’s multifaceted URM Initiative.

She has been active in STFM since the start of her academic career, and in 2009, while serving as assistant program director for the residency program in which she’d trained, she joined two other African American women, Monique Y. Davis-Smith, MD, and Joedrecka Brown-Speights, MD, in cochairing the society’s Group on Minority and Multicultural Health.

It was in this space, that Dr. Washington said she “heard people’s stories of being in major academic institutions and not feeling supported, not being given roadmaps to success, not getting assistance with publishing, or just kind of feeling like an outsider ... of not being pulled in.” Hispanic and African American females, in particular, “were feeling marginalized,” she said.

In 2018, having co-led development of the STFM Quality Mentoring Program for URM faculty, Dr. Washington was asked to join the STFM Foundation and subsequently led the STFM Foundation’s fundraising campaign for a new URM Initiative. She exceeded her goal, increasing support for URM participation in meetings and activities, and then participated in an STFM steering committee to create broader and longer-lasting support for URM faculty, community teachers, and medical students and residents going into academic family medicine.

Increasing the percentage of URM family medicine faculty in leadership positions – and raising awareness of structural barriers to achievement – is one of the current pillars of the URM Initiative.
 

Navigating the ‘minority tax’

As part of her mentoring, Dr. Washington helps URM physicians navigate the minority tax – a term referring to the uncompensated citizenship tasks that are more often assigned to Black and other URM physicians than to White physicians, and that take time away from scholarship, further perpetuating inequities.

Courtesy Society of Teahcers of Family Medicine Foundation

“Some of our young faculty members find themselves thrust into being the diversity and inclusion leaders in their institutions at a level at which they feel little power and little buy-in from [leadership],” she noted.

A commentary written by Dr. Washington and several colleagues on the minority tax as it impacts women – and the need to build a “tax shelter” to make academic medicine a more just environment for URM women – was published earlier this year in the Journal of Women’s Health.

She also answers e-mails and fields phone calls from young URM faculty who are mulling career moves and facing other familiar challenges.

Physicians who are URM, and African American physicians in particular, tend to “get pulled into the [often underserved] communities, into the patient care and community service areas,” Dr. Washington explained. “But unless you convert these projects into scholarship and publications, and unless you serve on a national committee outside of your institution, you’re not going to be promoted.”

Dr. Washington helps junior faculty envision themselves 5-plus years down the road, find what she calls scholarly “passion projects,” and prepare themselves for their next steps.

She helps her mentees navigate other parts of the continuum of unconscious bias and racism as well, from microaggressions from colleagues to overt discrimination from patients.

“I spend countless minutes fielding texts and phone calls from those who need support,” she wrote in a blog post. “They are a constant reminder that I must continue to speak up when I get the opportunity to do so.”
 

A journey through family medicine, and through bias and racism

Dr. Washington’s early days in medicine included graduating from Meharry Medical College in 1983 and the Mountainside Family Practice Residency Program in 1990. Following 6 years of working in a private practice in rural Maryland, she moved to academia, spending 6 years at East Tennessee State University and 4 years at the UMDNJ–New Jersey Medical School in Newark as an assistant professor of family medicine.

As had happened in rural Maryland, bias and racism have too often lurked during her career as a physician.

“I grew up in Alabama so I was pretty much ready to deal with racism in the South,” Dr. Washington said. “What I was not ready for was coming to the Northeast and seeing that you’re marginalized because you’re not invited into the room. Or if you do go into spaces when you’re the only one, you often don’t feel as welcomed as you thought you might be.”

Her ideas and contributions were too often dismissed, she wrote in a 2020 blog entry posted on her LinkedIn page. And during contract negotiations, “I was not aware of all the information that my White colleagues had. They had the advantage of inside information.”

Dr. Washington says that “it took a village” to make her who she is today: teachers in her segregated schools in Alabama, one of her college professors, her best friend in medical school – and STFM, “where the list [of her own mentors] is long.”

Judy C. Washington, MD, a mentor of many young academic family physicians, particularly underrepresented-in-medicine (URM) physicians, advises her mentees on how to see ahead and plot paths to leadership.

Courtesy Dr. Judy C. Washington

For URM physicians, she also imparts a shared experience of being a minority in the field and helps prepare them for the challenges of facing racism or feeling marginalized or not equitably supported in academic life – and for making change.

While family medicine’s demographics have become more diverse over time, and more so than other specialties, they are not yet representative of the U.S. population. Within academia, male physicians who are Black or African American, or Hispanic or Latino, comprised about 4% and 5% of family medicine faculty, respectively, at the end of 2019, according to data from the Association of American Medical Colleges. For women, these numbers were about 9% and 4%, respectively. (Only those with an MD degree exclusively were included in the report.)

“When you have the privilege to serve in leadership, you have the responsibility to reach back and identify and help others who would not otherwise have the opportunity to be recognized,” Dr. Washington said.

Her mentorship work stems in large part from her long-time involvement and leadership roles in the Society of Teachers of Family Medicine (STFM) – roles she considers a pillar of her professional life. She currently serves as president of the STFM Foundation and is associate chief medical officer of the Atlantic Medical Group, a large multisite physician-led organization. She is also coordinator of women’s health for the Overlook Family Medicine Residency Program, which is affiliated with Atlantic Medical Group.

In Dr. Washington’s role as associate chief medical officer of Atlantic Medical Group in Summit, N.J., she focuses on physician engagement, satisfaction, and diversity. She also assists in areas such as population health. For the Overlook Family Medicine Residency Program also in Summit, she precepts residents in the obstetrics clinic and in the family medicine outpatient clinic.

Diana N. Carvajal, MD, MPH, one of Dr. Washington’s mentees, called her an “inspirational leader” for young academic faculty and said she is a familiar speaker at STFM meetings on topics of workforce diversity, equity, and leadership. She is “passionate” about mentorship, Dr. Carvajal said, and has understood “that URMs and women of color were not always getting [the mentorship they need to be successful].”
 

Guiding future leaders

Ivonne McLean, MD, assistant professor of family and community medicine at Icahn School of Medicine at Mount Sinai, New York, and an attending at a community health center in the Bronx, called Dr. Washington for advice a couple of years ago when she was considering her next career move.

Courtesy Society of Teachers of Family Medicine Foundation

“She took a genuine interest in me. She never said, this is what you should do. But the questions she asked and the examples she gave from her own life were incredibly helpful to me [in deciding to pursue a research fellowship] ... it was a pivotal conversation,” said Dr. McLean, associate director of a reproductive health fellowship and a research fellow in a New York State–funded program.

“From a lived experience angle, she also told me, here are some of the challenges you’ll have as a woman of color, and here are some of the ways you can approach that,” she said.

Dr. Carvajal, also a URM family physician, credits Dr. Washington’s mentorship with the development of a day-long workshop – held before the annual Society of Teachers of Family Medicine (STFM) meeting – on the low and declining rates of Black males in medicine. “We’d planned it as a presentation, and [she heard of it and] helped us expand it,” she said, calling Dr. Washington “warm, welcoming, and encouraging.

“That work and collaboration with her and the others she brought [into the process] have resulted in publications and more presentations and strategy building for diversifying the workforce,” said Dr. Carvajal, assistant professor, director of reproductive health education in family medicine, and codirector of the research section, all in the department of family and community medicine at the University of Maryland, Baltimore.

STFM involvement

Dr. Washington, who says that all or almost all of her mentees are now leaders in their academic institutions and communities, has been instrumental in developing STFM’s mentoring programming and in facilitating the organization’s multifaceted URM Initiative.

She has been active in STFM since the start of her academic career, and in 2009, while serving as assistant program director for the residency program in which she’d trained, she joined two other African American women, Monique Y. Davis-Smith, MD, and Joedrecka Brown-Speights, MD, in cochairing the society’s Group on Minority and Multicultural Health.

It was in this space, that Dr. Washington said she “heard people’s stories of being in major academic institutions and not feeling supported, not being given roadmaps to success, not getting assistance with publishing, or just kind of feeling like an outsider ... of not being pulled in.” Hispanic and African American females, in particular, “were feeling marginalized,” she said.

In 2018, having co-led development of the STFM Quality Mentoring Program for URM faculty, Dr. Washington was asked to join the STFM Foundation and subsequently led the STFM Foundation’s fundraising campaign for a new URM Initiative. She exceeded her goal, increasing support for URM participation in meetings and activities, and then participated in an STFM steering committee to create broader and longer-lasting support for URM faculty, community teachers, and medical students and residents going into academic family medicine.

Increasing the percentage of URM family medicine faculty in leadership positions – and raising awareness of structural barriers to achievement – is one of the current pillars of the URM Initiative.
 

Navigating the ‘minority tax’

As part of her mentoring, Dr. Washington helps URM physicians navigate the minority tax – a term referring to the uncompensated citizenship tasks that are more often assigned to Black and other URM physicians than to White physicians, and that take time away from scholarship, further perpetuating inequities.

Courtesy Society of Teahcers of Family Medicine Foundation

“Some of our young faculty members find themselves thrust into being the diversity and inclusion leaders in their institutions at a level at which they feel little power and little buy-in from [leadership],” she noted.

A commentary written by Dr. Washington and several colleagues on the minority tax as it impacts women – and the need to build a “tax shelter” to make academic medicine a more just environment for URM women – was published earlier this year in the Journal of Women’s Health.

She also answers e-mails and fields phone calls from young URM faculty who are mulling career moves and facing other familiar challenges.

Physicians who are URM, and African American physicians in particular, tend to “get pulled into the [often underserved] communities, into the patient care and community service areas,” Dr. Washington explained. “But unless you convert these projects into scholarship and publications, and unless you serve on a national committee outside of your institution, you’re not going to be promoted.”

Dr. Washington helps junior faculty envision themselves 5-plus years down the road, find what she calls scholarly “passion projects,” and prepare themselves for their next steps.

She helps her mentees navigate other parts of the continuum of unconscious bias and racism as well, from microaggressions from colleagues to overt discrimination from patients.

“I spend countless minutes fielding texts and phone calls from those who need support,” she wrote in a blog post. “They are a constant reminder that I must continue to speak up when I get the opportunity to do so.”
 

A journey through family medicine, and through bias and racism

Dr. Washington’s early days in medicine included graduating from Meharry Medical College in 1983 and the Mountainside Family Practice Residency Program in 1990. Following 6 years of working in a private practice in rural Maryland, she moved to academia, spending 6 years at East Tennessee State University and 4 years at the UMDNJ–New Jersey Medical School in Newark as an assistant professor of family medicine.

As had happened in rural Maryland, bias and racism have too often lurked during her career as a physician.

“I grew up in Alabama so I was pretty much ready to deal with racism in the South,” Dr. Washington said. “What I was not ready for was coming to the Northeast and seeing that you’re marginalized because you’re not invited into the room. Or if you do go into spaces when you’re the only one, you often don’t feel as welcomed as you thought you might be.”

Her ideas and contributions were too often dismissed, she wrote in a 2020 blog entry posted on her LinkedIn page. And during contract negotiations, “I was not aware of all the information that my White colleagues had. They had the advantage of inside information.”

Dr. Washington says that “it took a village” to make her who she is today: teachers in her segregated schools in Alabama, one of her college professors, her best friend in medical school – and STFM, “where the list [of her own mentors] is long.”

Judy C. Washington, MD, a mentor of many young academic family physicians, particularly underrepresented-in-medicine (URM) physicians, advises her mentees on how to see ahead and plot paths to leadership.

Courtesy Dr. Judy C. Washington

For URM physicians, she also imparts a shared experience of being a minority in the field and helps prepare them for the challenges of facing racism or feeling marginalized or not equitably supported in academic life – and for making change.

While family medicine’s demographics have become more diverse over time, and more so than other specialties, they are not yet representative of the U.S. population. Within academia, male physicians who are Black or African American, or Hispanic or Latino, comprised about 4% and 5% of family medicine faculty, respectively, at the end of 2019, according to data from the Association of American Medical Colleges. For women, these numbers were about 9% and 4%, respectively. (Only those with an MD degree exclusively were included in the report.)

“When you have the privilege to serve in leadership, you have the responsibility to reach back and identify and help others who would not otherwise have the opportunity to be recognized,” Dr. Washington said.

Her mentorship work stems in large part from her long-time involvement and leadership roles in the Society of Teachers of Family Medicine (STFM) – roles she considers a pillar of her professional life. She currently serves as president of the STFM Foundation and is associate chief medical officer of the Atlantic Medical Group, a large multisite physician-led organization. She is also coordinator of women’s health for the Overlook Family Medicine Residency Program, which is affiliated with Atlantic Medical Group.

In Dr. Washington’s role as associate chief medical officer of Atlantic Medical Group in Summit, N.J., she focuses on physician engagement, satisfaction, and diversity. She also assists in areas such as population health. For the Overlook Family Medicine Residency Program also in Summit, she precepts residents in the obstetrics clinic and in the family medicine outpatient clinic.

Diana N. Carvajal, MD, MPH, one of Dr. Washington’s mentees, called her an “inspirational leader” for young academic faculty and said she is a familiar speaker at STFM meetings on topics of workforce diversity, equity, and leadership. She is “passionate” about mentorship, Dr. Carvajal said, and has understood “that URMs and women of color were not always getting [the mentorship they need to be successful].”
 

Guiding future leaders

Ivonne McLean, MD, assistant professor of family and community medicine at Icahn School of Medicine at Mount Sinai, New York, and an attending at a community health center in the Bronx, called Dr. Washington for advice a couple of years ago when she was considering her next career move.

Courtesy Society of Teachers of Family Medicine Foundation

“She took a genuine interest in me. She never said, this is what you should do. But the questions she asked and the examples she gave from her own life were incredibly helpful to me [in deciding to pursue a research fellowship] ... it was a pivotal conversation,” said Dr. McLean, associate director of a reproductive health fellowship and a research fellow in a New York State–funded program.

“From a lived experience angle, she also told me, here are some of the challenges you’ll have as a woman of color, and here are some of the ways you can approach that,” she said.

Dr. Carvajal, also a URM family physician, credits Dr. Washington’s mentorship with the development of a day-long workshop – held before the annual Society of Teachers of Family Medicine (STFM) meeting – on the low and declining rates of Black males in medicine. “We’d planned it as a presentation, and [she heard of it and] helped us expand it,” she said, calling Dr. Washington “warm, welcoming, and encouraging.

“That work and collaboration with her and the others she brought [into the process] have resulted in publications and more presentations and strategy building for diversifying the workforce,” said Dr. Carvajal, assistant professor, director of reproductive health education in family medicine, and codirector of the research section, all in the department of family and community medicine at the University of Maryland, Baltimore.

STFM involvement

Dr. Washington, who says that all or almost all of her mentees are now leaders in their academic institutions and communities, has been instrumental in developing STFM’s mentoring programming and in facilitating the organization’s multifaceted URM Initiative.

She has been active in STFM since the start of her academic career, and in 2009, while serving as assistant program director for the residency program in which she’d trained, she joined two other African American women, Monique Y. Davis-Smith, MD, and Joedrecka Brown-Speights, MD, in cochairing the society’s Group on Minority and Multicultural Health.

It was in this space, that Dr. Washington said she “heard people’s stories of being in major academic institutions and not feeling supported, not being given roadmaps to success, not getting assistance with publishing, or just kind of feeling like an outsider ... of not being pulled in.” Hispanic and African American females, in particular, “were feeling marginalized,” she said.

In 2018, having co-led development of the STFM Quality Mentoring Program for URM faculty, Dr. Washington was asked to join the STFM Foundation and subsequently led the STFM Foundation’s fundraising campaign for a new URM Initiative. She exceeded her goal, increasing support for URM participation in meetings and activities, and then participated in an STFM steering committee to create broader and longer-lasting support for URM faculty, community teachers, and medical students and residents going into academic family medicine.

Increasing the percentage of URM family medicine faculty in leadership positions – and raising awareness of structural barriers to achievement – is one of the current pillars of the URM Initiative.
 

Navigating the ‘minority tax’

As part of her mentoring, Dr. Washington helps URM physicians navigate the minority tax – a term referring to the uncompensated citizenship tasks that are more often assigned to Black and other URM physicians than to White physicians, and that take time away from scholarship, further perpetuating inequities.

Courtesy Society of Teahcers of Family Medicine Foundation

“Some of our young faculty members find themselves thrust into being the diversity and inclusion leaders in their institutions at a level at which they feel little power and little buy-in from [leadership],” she noted.

A commentary written by Dr. Washington and several colleagues on the minority tax as it impacts women – and the need to build a “tax shelter” to make academic medicine a more just environment for URM women – was published earlier this year in the Journal of Women’s Health.

She also answers e-mails and fields phone calls from young URM faculty who are mulling career moves and facing other familiar challenges.

Physicians who are URM, and African American physicians in particular, tend to “get pulled into the [often underserved] communities, into the patient care and community service areas,” Dr. Washington explained. “But unless you convert these projects into scholarship and publications, and unless you serve on a national committee outside of your institution, you’re not going to be promoted.”

Dr. Washington helps junior faculty envision themselves 5-plus years down the road, find what she calls scholarly “passion projects,” and prepare themselves for their next steps.

She helps her mentees navigate other parts of the continuum of unconscious bias and racism as well, from microaggressions from colleagues to overt discrimination from patients.

“I spend countless minutes fielding texts and phone calls from those who need support,” she wrote in a blog post. “They are a constant reminder that I must continue to speak up when I get the opportunity to do so.”
 

A journey through family medicine, and through bias and racism

Dr. Washington’s early days in medicine included graduating from Meharry Medical College in 1983 and the Mountainside Family Practice Residency Program in 1990. Following 6 years of working in a private practice in rural Maryland, she moved to academia, spending 6 years at East Tennessee State University and 4 years at the UMDNJ–New Jersey Medical School in Newark as an assistant professor of family medicine.

As had happened in rural Maryland, bias and racism have too often lurked during her career as a physician.

“I grew up in Alabama so I was pretty much ready to deal with racism in the South,” Dr. Washington said. “What I was not ready for was coming to the Northeast and seeing that you’re marginalized because you’re not invited into the room. Or if you do go into spaces when you’re the only one, you often don’t feel as welcomed as you thought you might be.”

Her ideas and contributions were too often dismissed, she wrote in a 2020 blog entry posted on her LinkedIn page. And during contract negotiations, “I was not aware of all the information that my White colleagues had. They had the advantage of inside information.”

Dr. Washington says that “it took a village” to make her who she is today: teachers in her segregated schools in Alabama, one of her college professors, her best friend in medical school – and STFM, “where the list [of her own mentors] is long.”

Many people are confused — patients and healthcare providers alike — in the wake of the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announcements about who is authorized to get a third or ‘booster’ shot of the Pfizer/BioNTech COVID-19 vaccine.

The official word on boosters from the CDC in the early morning hours of September 24 sparked a jump in people calling about or coming in for a third shot, healthcare providers report. At the same time, the uncertainty from changing federal messages about boosters is causing some chaos, especially in the form of vaccine misinformation.

The confusion started, in part, with the August 13 announcement that immunocompromised Americans were eligible for a booster shot. Next came the initial Biden administration intention to provide most U.S. adults with a third shot starting September 20 — an announcement later rolled back — followed by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) limiting boosters to select groups last week.

“It was only 3% of the population that was going to be getting a third dose, then it was back to everyone being able to get the booster, and then it’s back to a select crew,” Louito Edje, MD, a family physician in private practice in Cincinnati, said in an interview with this news organization.

This kind of mixed messaging is generating more questions than answers.  

“Even though that is following the science, translating the science into policy, it’s really fraught with confusion for patients, especially,” added Dr. Edje, professor educator in the departments of medical education and family and community medicine at UC Health and a fellow of the American Academy of Family Physicians.

When asked if he’s seeing more uncertainty about boosters, community pharmacist Brian Caswell, RPh, said: “I’m going to have to say yes because I’ve been confused myself at times.”

“Yes, there is a lot of confusion,” added Mr. Caswell, owner or co-owner of four pharmacies in Kansas and Missouri and president of the National Community Pharmacists Association. 
 

Boosting misinformation?

“Unfortunately, confusion leads to an acceleration of misinformation,” Mr. Caswell said.

Dr. Edje shared an example. “The folks who have been hesitant to even get the first vaccine appear now a little less likely to want to go ahead and get vaccinated.”

These patients point to breakthrough COVID-19 cases of the Delta variant, which “reinforces that they don’t need to get vaccinated in the first place,” Dr. Edje said.

“That’s unfortunate because it’s a complete fallacy.”

Clearer communication from the federal government could help alleviate confusion, Mr. Caswell said. “I would like to see an official CDC chart that states who is eligible as of a certain date. Something that is accessible through their webpage or a social media source that can be updated. That would help all of us.”

“For myself, I’ve got patients from Kansas, Oklahoma, and Missouri that might be operating under different guidelines. That makes it even more confusing,” he said.

More clarity is needed for individuals seeking boosters as well. “It would help to be very clear with the general public, who are becoming very knowledgeable within this vaccine realm,” Mr. Caswell said.
 

‘Gaming the system’

Although most people seeking a booster shot at one of Caswell’s pharmacies are following official recommendations, there are some who remain ineligible but nonetheless come in for an additional vaccine.

“Even before this announcement last Friday, in the latter part of August when the CDC talked about a booster for immunocompromised, we had interest from people who did not meet the criteria,” Mr. Caswell said.

To the ineligible, he and his staff explain the approval process, why certain decisions are made, and point out that the number of eligible Americans is likely to expand in the future.

“The vast majority of them are understanding,” Mr. Caswell said. “But we’ve had some people who really didn’t want to accept the information, and I don’t know what they’ve done.”

“Some people are gaming the system to get their booster or second shot of J&J,” he said.

For example, Mr. Caswell had a patient who crossed over state lines from Missouri seeking a vaccine booster at Wolkar Drug, a pharmacy in Baxter Springs, Kan. “We found out later he had a J&J shot at a facility or provider in Missouri. He came over to Kansas, signed up for it and got a booster with Moderna.”

“We called and asked him if he was aware of it. He said, ‘yes.’ When we questioned him more about it, he hung up.”

Dr. Edje is likewise seeing interest from some ineligible patients, she said.
 

Crossing a liability line?

Mr. Caswell has asked for advice from lawyers and the State Board of Pharmacy on potential liability if a pharmacist gives a booster to a patient not eligible under the official FDA and CDC guidance.

“We ask patients direct questions about whether they’ve had the COVID vaccine, COVID, and a whole litany of questions they must answer. And we’re assuming they are going to be honest and forthright,” he said. “The pharmacist needs to make sure they make every effort to get that information from the patient.”

Normally, healthcare providers like Mr. Caswell report each COVID-19 vaccination to the state registry after administration. “We have not gone through a police action and checked the registry first,” he said.

But, if people continue to try ‘gaming the system,’ he said, he might have to start checking the state registry before giving someone a booster.

The American Academy of Family Physicians offers advice from the CDC about legal protections for providers.

“As outlined by CDC, any off-label use of the Comirnaty/Pfizer-BioNTech COVID-19 vaccine is not authorized at this time and may not be covered under the PREP Act or the PREP Act declaration. This means that clinicians providing the vaccine outside of the authorized/approved use may not have immunity from claims,” the AAFP website states.

“Per CDC, individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 vaccination program provider agreement and therefore may not be reimbursable and may impact the ability of a provider to remain in the CDC program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.”
 

Despite confusion, demand is up

Even amid all the uncertainty, there appears to be a jump in enthusiasm for the booster shots.

“The requests have gone up quite a bit. We’ve seen a number of requests from people in person and over the phone looking to get a booster,” Mr. Caswell said. “Since the discussion at the federal level...there has been a lot of interest in the third shot booster, itself, as well as about a booster for J&J.”

“There is quite a bit of excitement out there,” he said.

Dr. Edje agreed: “I take care of a fair number of folks...including the elderly and healthcare professionals. They are already asking for the booster.”

Interestingly, Dr. Edje would like to get a booster herself but is not eligible for the Pfizer third shot. She is a participant in a Moderna vaccine trial and can only receive additional immunization as part of the study.
 

‘Walk, don’t run’

To quell any potential early rush to get a third shot, U.S. health officials are reminding booster-ineligible people that they still have some protection against COVID-19.

“If you’re a person who ultimately might get a booster that will make you optimally protected, you don’t necessarily need to get it tomorrow,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases told CNN.

CDC Director Rochelle Walensky, MD, also weighed in. She told ABC that boosters for people who received a Moderna or Johnson & Johnson vaccine will be addressed with urgency.

“I want to reiterate that this is a very slow wane. There is no urgency here to go and get your booster immediately. You know, walk don’t run to your booster appointment,” she said.

“We will come and look at the data for Moderna and J&J in very short order.”

Dr. Edje and Mr. Caswell have reported no relevant financial relationships.

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

Many people are confused — patients and healthcare providers alike — in the wake of the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announcements about who is authorized to get a third or ‘booster’ shot of the Pfizer/BioNTech COVID-19 vaccine.

The official word on boosters from the CDC in the early morning hours of September 24 sparked a jump in people calling about or coming in for a third shot, healthcare providers report. At the same time, the uncertainty from changing federal messages about boosters is causing some chaos, especially in the form of vaccine misinformation.

The confusion started, in part, with the August 13 announcement that immunocompromised Americans were eligible for a booster shot. Next came the initial Biden administration intention to provide most U.S. adults with a third shot starting September 20 — an announcement later rolled back — followed by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) limiting boosters to select groups last week.

“It was only 3% of the population that was going to be getting a third dose, then it was back to everyone being able to get the booster, and then it’s back to a select crew,” Louito Edje, MD, a family physician in private practice in Cincinnati, said in an interview with this news organization.

This kind of mixed messaging is generating more questions than answers.  

“Even though that is following the science, translating the science into policy, it’s really fraught with confusion for patients, especially,” added Dr. Edje, professor educator in the departments of medical education and family and community medicine at UC Health and a fellow of the American Academy of Family Physicians.

When asked if he’s seeing more uncertainty about boosters, community pharmacist Brian Caswell, RPh, said: “I’m going to have to say yes because I’ve been confused myself at times.”

“Yes, there is a lot of confusion,” added Mr. Caswell, owner or co-owner of four pharmacies in Kansas and Missouri and president of the National Community Pharmacists Association. 
 

Boosting misinformation?

“Unfortunately, confusion leads to an acceleration of misinformation,” Mr. Caswell said.

Dr. Edje shared an example. “The folks who have been hesitant to even get the first vaccine appear now a little less likely to want to go ahead and get vaccinated.”

These patients point to breakthrough COVID-19 cases of the Delta variant, which “reinforces that they don’t need to get vaccinated in the first place,” Dr. Edje said.

“That’s unfortunate because it’s a complete fallacy.”

Clearer communication from the federal government could help alleviate confusion, Mr. Caswell said. “I would like to see an official CDC chart that states who is eligible as of a certain date. Something that is accessible through their webpage or a social media source that can be updated. That would help all of us.”

“For myself, I’ve got patients from Kansas, Oklahoma, and Missouri that might be operating under different guidelines. That makes it even more confusing,” he said.

More clarity is needed for individuals seeking boosters as well. “It would help to be very clear with the general public, who are becoming very knowledgeable within this vaccine realm,” Mr. Caswell said.
 

‘Gaming the system’

Although most people seeking a booster shot at one of Caswell’s pharmacies are following official recommendations, there are some who remain ineligible but nonetheless come in for an additional vaccine.

“Even before this announcement last Friday, in the latter part of August when the CDC talked about a booster for immunocompromised, we had interest from people who did not meet the criteria,” Mr. Caswell said.

To the ineligible, he and his staff explain the approval process, why certain decisions are made, and point out that the number of eligible Americans is likely to expand in the future.

“The vast majority of them are understanding,” Mr. Caswell said. “But we’ve had some people who really didn’t want to accept the information, and I don’t know what they’ve done.”

“Some people are gaming the system to get their booster or second shot of J&J,” he said.

For example, Mr. Caswell had a patient who crossed over state lines from Missouri seeking a vaccine booster at Wolkar Drug, a pharmacy in Baxter Springs, Kan. “We found out later he had a J&J shot at a facility or provider in Missouri. He came over to Kansas, signed up for it and got a booster with Moderna.”

“We called and asked him if he was aware of it. He said, ‘yes.’ When we questioned him more about it, he hung up.”

Dr. Edje is likewise seeing interest from some ineligible patients, she said.
 

Crossing a liability line?

Mr. Caswell has asked for advice from lawyers and the State Board of Pharmacy on potential liability if a pharmacist gives a booster to a patient not eligible under the official FDA and CDC guidance.

“We ask patients direct questions about whether they’ve had the COVID vaccine, COVID, and a whole litany of questions they must answer. And we’re assuming they are going to be honest and forthright,” he said. “The pharmacist needs to make sure they make every effort to get that information from the patient.”

Normally, healthcare providers like Mr. Caswell report each COVID-19 vaccination to the state registry after administration. “We have not gone through a police action and checked the registry first,” he said.

But, if people continue to try ‘gaming the system,’ he said, he might have to start checking the state registry before giving someone a booster.

The American Academy of Family Physicians offers advice from the CDC about legal protections for providers.

“As outlined by CDC, any off-label use of the Comirnaty/Pfizer-BioNTech COVID-19 vaccine is not authorized at this time and may not be covered under the PREP Act or the PREP Act declaration. This means that clinicians providing the vaccine outside of the authorized/approved use may not have immunity from claims,” the AAFP website states.

“Per CDC, individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 vaccination program provider agreement and therefore may not be reimbursable and may impact the ability of a provider to remain in the CDC program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.”
 

Despite confusion, demand is up

Even amid all the uncertainty, there appears to be a jump in enthusiasm for the booster shots.

“The requests have gone up quite a bit. We’ve seen a number of requests from people in person and over the phone looking to get a booster,” Mr. Caswell said. “Since the discussion at the federal level...there has been a lot of interest in the third shot booster, itself, as well as about a booster for J&J.”

“There is quite a bit of excitement out there,” he said.

Dr. Edje agreed: “I take care of a fair number of folks...including the elderly and healthcare professionals. They are already asking for the booster.”

Interestingly, Dr. Edje would like to get a booster herself but is not eligible for the Pfizer third shot. She is a participant in a Moderna vaccine trial and can only receive additional immunization as part of the study.
 

‘Walk, don’t run’

To quell any potential early rush to get a third shot, U.S. health officials are reminding booster-ineligible people that they still have some protection against COVID-19.

“If you’re a person who ultimately might get a booster that will make you optimally protected, you don’t necessarily need to get it tomorrow,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases told CNN.

CDC Director Rochelle Walensky, MD, also weighed in. She told ABC that boosters for people who received a Moderna or Johnson & Johnson vaccine will be addressed with urgency.

“I want to reiterate that this is a very slow wane. There is no urgency here to go and get your booster immediately. You know, walk don’t run to your booster appointment,” she said.

“We will come and look at the data for Moderna and J&J in very short order.”

Dr. Edje and Mr. Caswell have reported no relevant financial relationships.

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

Many people are confused — patients and healthcare providers alike — in the wake of the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announcements about who is authorized to get a third or ‘booster’ shot of the Pfizer/BioNTech COVID-19 vaccine.

The official word on boosters from the CDC in the early morning hours of September 24 sparked a jump in people calling about or coming in for a third shot, healthcare providers report. At the same time, the uncertainty from changing federal messages about boosters is causing some chaos, especially in the form of vaccine misinformation.

The confusion started, in part, with the August 13 announcement that immunocompromised Americans were eligible for a booster shot. Next came the initial Biden administration intention to provide most U.S. adults with a third shot starting September 20 — an announcement later rolled back — followed by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) limiting boosters to select groups last week.

“It was only 3% of the population that was going to be getting a third dose, then it was back to everyone being able to get the booster, and then it’s back to a select crew,” Louito Edje, MD, a family physician in private practice in Cincinnati, said in an interview with this news organization.

This kind of mixed messaging is generating more questions than answers.  

“Even though that is following the science, translating the science into policy, it’s really fraught with confusion for patients, especially,” added Dr. Edje, professor educator in the departments of medical education and family and community medicine at UC Health and a fellow of the American Academy of Family Physicians.

When asked if he’s seeing more uncertainty about boosters, community pharmacist Brian Caswell, RPh, said: “I’m going to have to say yes because I’ve been confused myself at times.”

“Yes, there is a lot of confusion,” added Mr. Caswell, owner or co-owner of four pharmacies in Kansas and Missouri and president of the National Community Pharmacists Association. 
 

Boosting misinformation?

“Unfortunately, confusion leads to an acceleration of misinformation,” Mr. Caswell said.

Dr. Edje shared an example. “The folks who have been hesitant to even get the first vaccine appear now a little less likely to want to go ahead and get vaccinated.”

These patients point to breakthrough COVID-19 cases of the Delta variant, which “reinforces that they don’t need to get vaccinated in the first place,” Dr. Edje said.

“That’s unfortunate because it’s a complete fallacy.”

Clearer communication from the federal government could help alleviate confusion, Mr. Caswell said. “I would like to see an official CDC chart that states who is eligible as of a certain date. Something that is accessible through their webpage or a social media source that can be updated. That would help all of us.”

“For myself, I’ve got patients from Kansas, Oklahoma, and Missouri that might be operating under different guidelines. That makes it even more confusing,” he said.

More clarity is needed for individuals seeking boosters as well. “It would help to be very clear with the general public, who are becoming very knowledgeable within this vaccine realm,” Mr. Caswell said.
 

‘Gaming the system’

Although most people seeking a booster shot at one of Caswell’s pharmacies are following official recommendations, there are some who remain ineligible but nonetheless come in for an additional vaccine.

“Even before this announcement last Friday, in the latter part of August when the CDC talked about a booster for immunocompromised, we had interest from people who did not meet the criteria,” Mr. Caswell said.

To the ineligible, he and his staff explain the approval process, why certain decisions are made, and point out that the number of eligible Americans is likely to expand in the future.

“The vast majority of them are understanding,” Mr. Caswell said. “But we’ve had some people who really didn’t want to accept the information, and I don’t know what they’ve done.”

“Some people are gaming the system to get their booster or second shot of J&J,” he said.

For example, Mr. Caswell had a patient who crossed over state lines from Missouri seeking a vaccine booster at Wolkar Drug, a pharmacy in Baxter Springs, Kan. “We found out later he had a J&J shot at a facility or provider in Missouri. He came over to Kansas, signed up for it and got a booster with Moderna.”

“We called and asked him if he was aware of it. He said, ‘yes.’ When we questioned him more about it, he hung up.”

Dr. Edje is likewise seeing interest from some ineligible patients, she said.
 

Crossing a liability line?

Mr. Caswell has asked for advice from lawyers and the State Board of Pharmacy on potential liability if a pharmacist gives a booster to a patient not eligible under the official FDA and CDC guidance.

“We ask patients direct questions about whether they’ve had the COVID vaccine, COVID, and a whole litany of questions they must answer. And we’re assuming they are going to be honest and forthright,” he said. “The pharmacist needs to make sure they make every effort to get that information from the patient.”

Normally, healthcare providers like Mr. Caswell report each COVID-19 vaccination to the state registry after administration. “We have not gone through a police action and checked the registry first,” he said.

But, if people continue to try ‘gaming the system,’ he said, he might have to start checking the state registry before giving someone a booster.

The American Academy of Family Physicians offers advice from the CDC about legal protections for providers.

“As outlined by CDC, any off-label use of the Comirnaty/Pfizer-BioNTech COVID-19 vaccine is not authorized at this time and may not be covered under the PREP Act or the PREP Act declaration. This means that clinicians providing the vaccine outside of the authorized/approved use may not have immunity from claims,” the AAFP website states.

“Per CDC, individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 vaccination program provider agreement and therefore may not be reimbursable and may impact the ability of a provider to remain in the CDC program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.”
 

Despite confusion, demand is up

Even amid all the uncertainty, there appears to be a jump in enthusiasm for the booster shots.

“The requests have gone up quite a bit. We’ve seen a number of requests from people in person and over the phone looking to get a booster,” Mr. Caswell said. “Since the discussion at the federal level...there has been a lot of interest in the third shot booster, itself, as well as about a booster for J&J.”

“There is quite a bit of excitement out there,” he said.

Dr. Edje agreed: “I take care of a fair number of folks...including the elderly and healthcare professionals. They are already asking for the booster.”

Interestingly, Dr. Edje would like to get a booster herself but is not eligible for the Pfizer third shot. She is a participant in a Moderna vaccine trial and can only receive additional immunization as part of the study.
 

‘Walk, don’t run’

To quell any potential early rush to get a third shot, U.S. health officials are reminding booster-ineligible people that they still have some protection against COVID-19.

“If you’re a person who ultimately might get a booster that will make you optimally protected, you don’t necessarily need to get it tomorrow,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases told CNN.

CDC Director Rochelle Walensky, MD, also weighed in. She told ABC that boosters for people who received a Moderna or Johnson & Johnson vaccine will be addressed with urgency.

“I want to reiterate that this is a very slow wane. There is no urgency here to go and get your booster immediately. You know, walk don’t run to your booster appointment,” she said.

“We will come and look at the data for Moderna and J&J in very short order.”

Dr. Edje and Mr. Caswell have reported no relevant financial relationships.

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

Novel food for thought

When you were growing up, your parents probably told you to brush your teeth before you went to bed, warned you not to run with the scissors or play with matches, and punished you whenever you used the neighbor children to play Schrödinger’s cat.

World Wildlife/StockSnap

They did those things for your own good, of course, and now the nation’s mother – the Centers for Disease Control and Prevention – is doing the same by warning us about novel outbreak–associated foods. As in, “Put down that novel outbreak–associated food! You don’t know where it’s been!”

Seriously, you don’t know where it’s been. CDC investigators identified 28 novel foods that were linked to 36 foodborne-disease outbreaks that occurred during 2007-2016, including moringa leaf (herb/spice), tempeh (grain), frog, sprouted nut butter, and skate.

The novel foods implicated in these outbreaks were more likely to be imported, compared with 14,216 outbreaks that occurred from 1973 to 2016, and about half didn’t require refrigeration. Two-thirds did not need to be cooked after purchase. Another thing your parents wouldn’t like: Some can’t be washed, like sheep milk, sugar cane, or the aforementioned nut butter.

We wanted to get a food expert to comment on these novel foods, but our editor said that the assistant manager of our local Burger King wasn’t expert enough, so we’ve commandeered someone else’s expert. Cynthia Sears, MD, of Johns Hopkins University in Baltimore, told Today.com all about the dangers of frogs: “Essentially all amphibians are contaminated, often with salmonella. Eating any amphibian that is not thoroughly cooked is a risk.”

Be sure to cook your amphibians before you eat them. Advice that your parents would be proud to share.
 

Dieters should stay away from diet drinks

When a drink is labeled “diet” many assume that the calorie-free beverage is the best choice. However, one of the largest studies to date on artificial sweeteners is out to set the record straight.

American Heart Association

Artificial sweeteners, or nonnutritive sweeteners (NNS), are used in most if not all diet products to give the illusion of sweetness without the caloric guilt. Some studies say they help with weight loss for that very reason, but others say they can contribute to weight gain. So which is it?

Researchers at the University of Southern California sought to add some clarity to the research already out there.

They looked at an even-gendered split of 74 participants who drank 300 mL of drinks sweetened with NNS, table sugar, or water. The researchers then used functional MRI to see how parts of the brain responsible for appetite and cravings responded to images of high-calorie foods. They also looked at glucose, insulin, and other metabolic hormone levels, as well as how much food the participants ate at their free buffet. (In the participants’ defense, who can say no to a free buffet?)

The researchers made some interesting observations:

• Women who drank the NNS drink ate more than did the table-sugar group, but all men ate the same.
• Images of those calorie-packed goodies increased cravings and appetite for obese men and women in the NNS group, compared with the table-sugar group.
• For all participants who drank the NNS drink, there was a decrease in the hormone that tells the body it’s full.

“By studying different groups we were able to show that females and people with obesity may be more sensitive to artificial sweeteners. For these groups, drinking artificially sweetened drinks may trick the brain into feeling hungry, which may in turn result in more calories being consumed,” Kathleen Page, MD, the study’s corresponding author, said in a separate statement.

Today’s lesson? Don’t believe every label you read.
 

Instagram vegetables and the triumph of peer pressure

You and your family are sitting down for dinner. You’ve taken the time to prepare a healthy, nutritious meal. Vegetables, rice, seafood – all the right things. But the children around you refuse to partake. What can you do? Why, show them a highly liked photo of broccoli on Instagram!

Teresa Burton/IMNG Medical Media

In reality, kids will probably never like to eat their vegetables, but according to a study published in Appetite, viewing highly liked images on social media can compel adults to eat theirs.

The investigators recruited a group of 169 adults aged 18-28 (average age, 21) and showed them a series of mock Instagram posts of all sorts of food, everything from Brussels sprouts to chocolate cake, as well as nonfood images to act as a baseline. The images had a varying amount of likes. After viewing the images, study participants were offered a snack buffet consisting of grapes and cookies.

The results were a triumph of peer pressure. Those who viewed highly liked images of nutritious foods ate a significantly larger proportion of grapes, compared with those who saw highly liked images of unhealthy food or nonfood.

The authors cautioned that more research is needed, but they said that they’re onto something in the eternal struggle of getting people to eat better. If Mikey liked it, maybe you should, too. Just as long as you don’t try to encourage the eating of peas. That is a dark road none should take, and no one should ever be subjected to that cursed food.
 

It’s nice to share … hypertension?

You may have heard that, over time, you begin to resemble your spouse. You may have also heard that, as time goes by, your pet might start to resemble you, but that is a story for another time.

sabelskaya/iStock/Getty Images Plus

A lot of the time, it’s human nature that people partner with someone who is similar to them in physical and environmental status. If you like to go jogging at 5 a.m., you might want a spouse who does the same. A study done using data from couples in Japan and the Netherlands found that couples who had the same lifestyle had similar levels of blood pressure, cholesterol, and triglycerides. They also had similar illnesses such as hypertension and diabetes.

It’s important to note that many of the couples were not very genetically similar but had similar lifestyles. Encourage your partner to have a healthier lifestyle, so you can live on for many years to come!

Novel food for thought

When you were growing up, your parents probably told you to brush your teeth before you went to bed, warned you not to run with the scissors or play with matches, and punished you whenever you used the neighbor children to play Schrödinger’s cat.

World Wildlife/StockSnap

They did those things for your own good, of course, and now the nation’s mother – the Centers for Disease Control and Prevention – is doing the same by warning us about novel outbreak–associated foods. As in, “Put down that novel outbreak–associated food! You don’t know where it’s been!”

Seriously, you don’t know where it’s been. CDC investigators identified 28 novel foods that were linked to 36 foodborne-disease outbreaks that occurred during 2007-2016, including moringa leaf (herb/spice), tempeh (grain), frog, sprouted nut butter, and skate.

The novel foods implicated in these outbreaks were more likely to be imported, compared with 14,216 outbreaks that occurred from 1973 to 2016, and about half didn’t require refrigeration. Two-thirds did not need to be cooked after purchase. Another thing your parents wouldn’t like: Some can’t be washed, like sheep milk, sugar cane, or the aforementioned nut butter.

We wanted to get a food expert to comment on these novel foods, but our editor said that the assistant manager of our local Burger King wasn’t expert enough, so we’ve commandeered someone else’s expert. Cynthia Sears, MD, of Johns Hopkins University in Baltimore, told Today.com all about the dangers of frogs: “Essentially all amphibians are contaminated, often with salmonella. Eating any amphibian that is not thoroughly cooked is a risk.”

Be sure to cook your amphibians before you eat them. Advice that your parents would be proud to share.
 

Dieters should stay away from diet drinks

When a drink is labeled “diet” many assume that the calorie-free beverage is the best choice. However, one of the largest studies to date on artificial sweeteners is out to set the record straight.

American Heart Association

Artificial sweeteners, or nonnutritive sweeteners (NNS), are used in most if not all diet products to give the illusion of sweetness without the caloric guilt. Some studies say they help with weight loss for that very reason, but others say they can contribute to weight gain. So which is it?

Researchers at the University of Southern California sought to add some clarity to the research already out there.

They looked at an even-gendered split of 74 participants who drank 300 mL of drinks sweetened with NNS, table sugar, or water. The researchers then used functional MRI to see how parts of the brain responsible for appetite and cravings responded to images of high-calorie foods. They also looked at glucose, insulin, and other metabolic hormone levels, as well as how much food the participants ate at their free buffet. (In the participants’ defense, who can say no to a free buffet?)

The researchers made some interesting observations:

• Women who drank the NNS drink ate more than did the table-sugar group, but all men ate the same.
• Images of those calorie-packed goodies increased cravings and appetite for obese men and women in the NNS group, compared with the table-sugar group.
• For all participants who drank the NNS drink, there was a decrease in the hormone that tells the body it’s full.

“By studying different groups we were able to show that females and people with obesity may be more sensitive to artificial sweeteners. For these groups, drinking artificially sweetened drinks may trick the brain into feeling hungry, which may in turn result in more calories being consumed,” Kathleen Page, MD, the study’s corresponding author, said in a separate statement.

Today’s lesson? Don’t believe every label you read.
 

Instagram vegetables and the triumph of peer pressure

You and your family are sitting down for dinner. You’ve taken the time to prepare a healthy, nutritious meal. Vegetables, rice, seafood – all the right things. But the children around you refuse to partake. What can you do? Why, show them a highly liked photo of broccoli on Instagram!

Teresa Burton/IMNG Medical Media

In reality, kids will probably never like to eat their vegetables, but according to a study published in Appetite, viewing highly liked images on social media can compel adults to eat theirs.

The investigators recruited a group of 169 adults aged 18-28 (average age, 21) and showed them a series of mock Instagram posts of all sorts of food, everything from Brussels sprouts to chocolate cake, as well as nonfood images to act as a baseline. The images had a varying amount of likes. After viewing the images, study participants were offered a snack buffet consisting of grapes and cookies.

The results were a triumph of peer pressure. Those who viewed highly liked images of nutritious foods ate a significantly larger proportion of grapes, compared with those who saw highly liked images of unhealthy food or nonfood.

The authors cautioned that more research is needed, but they said that they’re onto something in the eternal struggle of getting people to eat better. If Mikey liked it, maybe you should, too. Just as long as you don’t try to encourage the eating of peas. That is a dark road none should take, and no one should ever be subjected to that cursed food.
 

It’s nice to share … hypertension?

You may have heard that, over time, you begin to resemble your spouse. You may have also heard that, as time goes by, your pet might start to resemble you, but that is a story for another time.

sabelskaya/iStock/Getty Images Plus

A lot of the time, it’s human nature that people partner with someone who is similar to them in physical and environmental status. If you like to go jogging at 5 a.m., you might want a spouse who does the same. A study done using data from couples in Japan and the Netherlands found that couples who had the same lifestyle had similar levels of blood pressure, cholesterol, and triglycerides. They also had similar illnesses such as hypertension and diabetes.

It’s important to note that many of the couples were not very genetically similar but had similar lifestyles. Encourage your partner to have a healthier lifestyle, so you can live on for many years to come!

Novel food for thought

When you were growing up, your parents probably told you to brush your teeth before you went to bed, warned you not to run with the scissors or play with matches, and punished you whenever you used the neighbor children to play Schrödinger’s cat.

World Wildlife/StockSnap

They did those things for your own good, of course, and now the nation’s mother – the Centers for Disease Control and Prevention – is doing the same by warning us about novel outbreak–associated foods. As in, “Put down that novel outbreak–associated food! You don’t know where it’s been!”

Seriously, you don’t know where it’s been. CDC investigators identified 28 novel foods that were linked to 36 foodborne-disease outbreaks that occurred during 2007-2016, including moringa leaf (herb/spice), tempeh (grain), frog, sprouted nut butter, and skate.

The novel foods implicated in these outbreaks were more likely to be imported, compared with 14,216 outbreaks that occurred from 1973 to 2016, and about half didn’t require refrigeration. Two-thirds did not need to be cooked after purchase. Another thing your parents wouldn’t like: Some can’t be washed, like sheep milk, sugar cane, or the aforementioned nut butter.

We wanted to get a food expert to comment on these novel foods, but our editor said that the assistant manager of our local Burger King wasn’t expert enough, so we’ve commandeered someone else’s expert. Cynthia Sears, MD, of Johns Hopkins University in Baltimore, told Today.com all about the dangers of frogs: “Essentially all amphibians are contaminated, often with salmonella. Eating any amphibian that is not thoroughly cooked is a risk.”

Be sure to cook your amphibians before you eat them. Advice that your parents would be proud to share.
 

Dieters should stay away from diet drinks

When a drink is labeled “diet” many assume that the calorie-free beverage is the best choice. However, one of the largest studies to date on artificial sweeteners is out to set the record straight.

American Heart Association

Artificial sweeteners, or nonnutritive sweeteners (NNS), are used in most if not all diet products to give the illusion of sweetness without the caloric guilt. Some studies say they help with weight loss for that very reason, but others say they can contribute to weight gain. So which is it?

Researchers at the University of Southern California sought to add some clarity to the research already out there.

They looked at an even-gendered split of 74 participants who drank 300 mL of drinks sweetened with NNS, table sugar, or water. The researchers then used functional MRI to see how parts of the brain responsible for appetite and cravings responded to images of high-calorie foods. They also looked at glucose, insulin, and other metabolic hormone levels, as well as how much food the participants ate at their free buffet. (In the participants’ defense, who can say no to a free buffet?)

The researchers made some interesting observations:

• Women who drank the NNS drink ate more than did the table-sugar group, but all men ate the same.
• Images of those calorie-packed goodies increased cravings and appetite for obese men and women in the NNS group, compared with the table-sugar group.
• For all participants who drank the NNS drink, there was a decrease in the hormone that tells the body it’s full.

“By studying different groups we were able to show that females and people with obesity may be more sensitive to artificial sweeteners. For these groups, drinking artificially sweetened drinks may trick the brain into feeling hungry, which may in turn result in more calories being consumed,” Kathleen Page, MD, the study’s corresponding author, said in a separate statement.

Today’s lesson? Don’t believe every label you read.
 

Instagram vegetables and the triumph of peer pressure

You and your family are sitting down for dinner. You’ve taken the time to prepare a healthy, nutritious meal. Vegetables, rice, seafood – all the right things. But the children around you refuse to partake. What can you do? Why, show them a highly liked photo of broccoli on Instagram!

Teresa Burton/IMNG Medical Media

In reality, kids will probably never like to eat their vegetables, but according to a study published in Appetite, viewing highly liked images on social media can compel adults to eat theirs.

The investigators recruited a group of 169 adults aged 18-28 (average age, 21) and showed them a series of mock Instagram posts of all sorts of food, everything from Brussels sprouts to chocolate cake, as well as nonfood images to act as a baseline. The images had a varying amount of likes. After viewing the images, study participants were offered a snack buffet consisting of grapes and cookies.

The results were a triumph of peer pressure. Those who viewed highly liked images of nutritious foods ate a significantly larger proportion of grapes, compared with those who saw highly liked images of unhealthy food or nonfood.

The authors cautioned that more research is needed, but they said that they’re onto something in the eternal struggle of getting people to eat better. If Mikey liked it, maybe you should, too. Just as long as you don’t try to encourage the eating of peas. That is a dark road none should take, and no one should ever be subjected to that cursed food.
 

It’s nice to share … hypertension?

You may have heard that, over time, you begin to resemble your spouse. You may have also heard that, as time goes by, your pet might start to resemble you, but that is a story for another time.

sabelskaya/iStock/Getty Images Plus

A lot of the time, it’s human nature that people partner with someone who is similar to them in physical and environmental status. If you like to go jogging at 5 a.m., you might want a spouse who does the same. A study done using data from couples in Japan and the Netherlands found that couples who had the same lifestyle had similar levels of blood pressure, cholesterol, and triglycerides. They also had similar illnesses such as hypertension and diabetes.

It’s important to note that many of the couples were not very genetically similar but had similar lifestyles. Encourage your partner to have a healthier lifestyle, so you can live on for many years to come!

In July 2021, University Hospitals, in Cleveland, announced that its staff had transplanted a kidney into the wrong patient. Although the patient who received the kidney was recovering well, the patient who was supposed to have received the kidney was skipped over. As a result of the error, two employees were placed on administrative leave and the incident was being investigated, the hospital announced.

In April 2020, an interventional radiologist at Boca Raton Regional Hospital, in Boca Raton, Fla., was sued for allegedly placing a stent into the wrong kidney of an 80-year-old patient. Using fluoroscopic guidance, the doctor removed an old stent from the right side but incorrectly replaced it with a new stent on the left side, according to an interview conducted by this news organization with the patient’s lawyers at Searcy Law, in West Palm Beach.

Wrong-site surgery -- surgery performed on the wrong patient, the wrong body part, or the wrong side of the body -- is a rare but distressing event and garners much attention when it happens. “The problem is that it is so rare that doctors don’t focus on it,” says Mary R. Kwaan, MD, a colorectal surgeon at UCLA Medical Center, Los Angeles.

A 2006 study in which Kwaan was the lead author concluded that there was one wrong-site surgery for every 112,994 surgeries. Those mistakes can add up. A 2006 study estimated that 25 to 52 wrong-site surgeries were performed each week in the United States.

“Many surgeons don’t think it can happen to them, so they don’t take extra precautions,” says David Mayer, MD, executive director of the MedStar Institute for Quality and Safety, in Washington, DC. “When they make a wrong-site error, usually the first thing they say is, ‘I never thought this would happen to me,’ ” he says.

Wrong-site surgeries are considered sentinel events -- the worst kinds of medical errors. The Sullivan Group, a patient safety consultancy based in Colorado, reports that in 2013, 2.7% of patients who were involved in wrong-site surgeries died and 41% experienced some type of permanent injury. The mean malpractice payment was $127,000.

Some malpractice payments are much higher. In 2013, a Maryland ob.gyn paid a $1.42 million malpractice award for removing the wrong ovary from a woman in 2009. In 2017, a Pennsylvania urologist paid $870,000 for removing the wrong testicle from a man in 2013.
 

Wrong-site surgery often involves experienced surgeons

One might think that wrong-site surgeries usually involve younger or less-experienced surgeons, but that’s not the case; two thirds of the surgeons who perform wrong-site surgeries are in their 40s and 50s, compared with fewer than 25% younger than 40.

In a rather chilling statistic, in a 2013 survey, 12.4% of doctors who were involved in sentinel events in general had claims for more than one event.

These errors are more common in certain specialties. In a study reported in the Journal of Neurology, Neurosurgery and Spine, 25% of orthopedic surgeons reported performing at least one wrong-site surgery during their career.

Within orthopedics, spine surgery is ground zero for wrong-site surgery. “Finding the site in spine surgery can be more difficult than in common left-right orthopedic procedures,” says Joseph A. Bosco III, a New York City orthopedist.

A 2007 study found that 25% of neurosurgeons had performed wrong-site surgeries. In Missouri in 2013, for example, a 53-year-old patient who was scheduled to undergo a left-sided craniotomy bypass allegedly underwent a right-sided craniotomy and was unable to speak after surgery.

Wrong-site surgeries are also performed by general surgeons, urologists, cardiologists, otolaryngologists, and ophthalmologists. A 2021 lawsuit accused a Tampa urologist of removing the patient’s wrong testicle. And a 2019 lawsuit accused a Chicago ophthalmologist of operating on the wrong eye to remove a cyst.
 

It’s not just the surgeon’s mistake

Mistakes are not only made by the surgeon in the operating room (OR). They can be made by staff when scheduling a surgery, radiologists and pathologists when writing their reports for surgery, and by team members in the OR.

Many people are prone to confusing left and right. A 2020 study found that 14.9% of people had difficulty distinguishing left from right; other studies have shown higher rates. Distractions increase the likelihood of mistakes. In a 2015 study, background noise in a hospital ward made it more difficult for medical students to make left-right judgments.

OR personnel can be confused when patients are turned around. “To operate on the back of someone’s leg, the surgeon may turn the patient from supine to prone, and so left becomes right,” says Samuel C. Seiden, MD, an anesthesiologist in Roseville, Calif., who has studied wrong-site surgery.

Operative site markings that are drawn on the skin can be rubbed off when surgical prep is applied, and markings aren’t usually possible for procedures such as spine surgeries. Surgical draping can make it harder to distinguish the patient’s left and right, and a busy surgeon relying on memory may confuse cases and perform wrong-patient surgery.
 

A push to eliminate wrong-site surgery

In 2004, the Joint Commission, which accredits hospitals and many surgery centers, decided to do something about wrong-site surgery and related surgical errors. It released a universal protocol, which requires hospitals to take three steps to prevent errors: perform preoperative verification that is based on patient care documents; mark the operative site; and take a time-out just before surgery, during which the team should consider whether a mistake is about to be made.

Two years after the Joint Commission published its protocol, Dr. Seiden led a study to determine what effect it had had. The investigators found that wrong-site cases had decreased by only about one third. Preventing wrong-site surgery “turns out to be more complicated to eradicate than anybody thought,” Mark Chassin, MD, president of the Joint Commission, stated a few years later.

Why did the protocol have only a limited effect? Dr. Seiden says that it has been hard to change doctors’ traditional attitudes against standardization. “Some have had an attitude that checklists are for dummies, but that is changing,” he says.

For instance, some surgical teams were not paying attention during time-outs. “The time-out should be like the invocation of the National Anthem,” an orthopedic surgeon from Iowa wrote. “All other activities should stop.”

Even had surgeons followed the universal protocol, about one third of wrong-site surgeries would not have been identified, according to Dr. Kwaan’s study, which was published in the same year as Dr. Seiden’s. As an example, when the wrong kidney was removed at Methodist Hospital, in St. Louis Park, Minn., the hospital said it was following a protocol set by the Minnesota Hospital Association.
 

Redoubling efforts

In 2009, the Joint Commission decided to take another tack. It encouraged hospitals to make root-cause analyses not only of wrong-site surgeries but also of near misses, which are much more plentiful. It used the insights gained to change surgical routines and protocols.

The Safe Surgery Project, a collaboration between the Joint Commission’s Center for Transforming Healthcare and eight hospitals and surgery centers, reduced the number of errors and near misses by 46% in the scheduling area, 63% in pre-op, and 51% in the OR area.

From that project, the center developed the Targeted Solutions Tool, which basically uses the same methodology that the project used. The center told this news organization that 79 healthcare organizations have used the tool and have reduced the number of errors and near misses by 56% in scheduling, 24% in pre-op, and 48% in the OR.

For this approach to work, however, surgical teams must report their errors to the hospital, which had not been done before. A 2008 study by the Office of the Inspector General of the U.S. Department of Health and Human Services found that surgical staff did not report 86% of adverse events to their hospitals. Reasons given included lack of time, fear of punitive action, and skepticism that reporting would do any good.

Unlike some other adverse events, it’s hard to keep wrong-site surgeries secret from patients, because they can usually see the scars from it, but some surgeons invent ways to cover it up from patients, too, Dr. Mayer says. One wrong-side hernia repair was corrected in mid operation. Afterward, the surgeon told the patient that he had found another hernia on the other side and had fixed that one, too.
 

Changing the culture

Reformers argue that wrong-site surgeries can be prevented by changing the culture of the hospital or surgery center. “We have to think of wrong-site surgeries as a failure of the system, not of the individual,” says Ron Savrin, MD, a general surgeon in Chagrin Falls, Ohio, who is a surgery subject matter expert for the Sullivan Group. “It should never be only up to one individual to stop an error from occurring.”

Seeing oneself as part of a team can reduce errors. Although other people can introduce errors that make a person look bad, they can also stop the errors that might otherwise have occurred. Punishing individuals for making errors does little good in stopping errors.

“It’s human nature to want to punish somebody for making a mistake, and it’s hard to change that mentality,” Dr. Savrin says. He recalls that when he was a resident, “the morbidity and mortality conferences could be very difficult for anyone who made a mistake, but I think that attitude is changing.”

Studies have found wide variation in the number of wrong-site surgeries among hospitals. A recent Pennsylvania study found an average of one wrong-site surgery or near miss per hospital per year, but about one third of hospitals did not report any.

Wrong-site surgeries are often concentrated in certain hospitals -- even prestigious teaching hospitals are not immune. A decade ago, Rhode Island Hospital had five wrong-site surgeries in 2 years, and Boston’s Beth Israel Deaconess Medical Center had three wrong-spine surgeries within 2 months.
 

Other ways to reduce errors

Dr. Seiden thinks reform efforts should take a page from his own specialty. Anesthesiology has developed a variety of forcing functions, which are simple changes in technology that can stop errors. An example is the use of a valve that will not deliver a drug unless certain steps are followed.

The StartBox System, a new way to prevent surgical errors, delivers the surgery blade only after all safety information has been provided. Tested by 11 orthopedic surgeons performing 487 procedures, the system identified 17 near misses.

Another approach is to film time-outs so as to enforce compliance with protocols and help with root-cause analyses. NYU-Langone Medical Center, in New York City, not only films the time-out but also grades OR teams on compliance, says Dr. Bosco, who is vice chair of clinical affairs in the department of orthopedic surgery at the hospital.

In addition, more states are requiring hospitals to report adverse events, including wrong-site surgeries. According to the National Academy for State Health Policy, 28 states require the reporting of adverse events. However, only six states identify facilities in public reports; 16 states publish only aggregate data; and five states do not report error data to the public.
 

The goal is zero errors

Are there fewer wrong-site surgeries now? “My sense is that surgeons, hospitals, and surgery centers are taking wrong-site errors more seriously,” Dr. Savrin says.

Because reported information is spotty and no major studies on incidence have been conducted in recent years, “we don’t have a clear idea,” he says, “but my best guess is that the rate is declining.

“Absolute zero preventable errors has to be our goal,” Dr. Savrin says “We might not get there, but we can’t stop trying.”

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

In July 2021, University Hospitals, in Cleveland, announced that its staff had transplanted a kidney into the wrong patient. Although the patient who received the kidney was recovering well, the patient who was supposed to have received the kidney was skipped over. As a result of the error, two employees were placed on administrative leave and the incident was being investigated, the hospital announced.

In April 2020, an interventional radiologist at Boca Raton Regional Hospital, in Boca Raton, Fla., was sued for allegedly placing a stent into the wrong kidney of an 80-year-old patient. Using fluoroscopic guidance, the doctor removed an old stent from the right side but incorrectly replaced it with a new stent on the left side, according to an interview conducted by this news organization with the patient’s lawyers at Searcy Law, in West Palm Beach.

Wrong-site surgery -- surgery performed on the wrong patient, the wrong body part, or the wrong side of the body -- is a rare but distressing event and garners much attention when it happens. “The problem is that it is so rare that doctors don’t focus on it,” says Mary R. Kwaan, MD, a colorectal surgeon at UCLA Medical Center, Los Angeles.

A 2006 study in which Kwaan was the lead author concluded that there was one wrong-site surgery for every 112,994 surgeries. Those mistakes can add up. A 2006 study estimated that 25 to 52 wrong-site surgeries were performed each week in the United States.

“Many surgeons don’t think it can happen to them, so they don’t take extra precautions,” says David Mayer, MD, executive director of the MedStar Institute for Quality and Safety, in Washington, DC. “When they make a wrong-site error, usually the first thing they say is, ‘I never thought this would happen to me,’ ” he says.

Wrong-site surgeries are considered sentinel events -- the worst kinds of medical errors. The Sullivan Group, a patient safety consultancy based in Colorado, reports that in 2013, 2.7% of patients who were involved in wrong-site surgeries died and 41% experienced some type of permanent injury. The mean malpractice payment was $127,000.

Some malpractice payments are much higher. In 2013, a Maryland ob.gyn paid a $1.42 million malpractice award for removing the wrong ovary from a woman in 2009. In 2017, a Pennsylvania urologist paid $870,000 for removing the wrong testicle from a man in 2013.
 

Wrong-site surgery often involves experienced surgeons

One might think that wrong-site surgeries usually involve younger or less-experienced surgeons, but that’s not the case; two thirds of the surgeons who perform wrong-site surgeries are in their 40s and 50s, compared with fewer than 25% younger than 40.

In a rather chilling statistic, in a 2013 survey, 12.4% of doctors who were involved in sentinel events in general had claims for more than one event.

These errors are more common in certain specialties. In a study reported in the Journal of Neurology, Neurosurgery and Spine, 25% of orthopedic surgeons reported performing at least one wrong-site surgery during their career.

Within orthopedics, spine surgery is ground zero for wrong-site surgery. “Finding the site in spine surgery can be more difficult than in common left-right orthopedic procedures,” says Joseph A. Bosco III, a New York City orthopedist.

A 2007 study found that 25% of neurosurgeons had performed wrong-site surgeries. In Missouri in 2013, for example, a 53-year-old patient who was scheduled to undergo a left-sided craniotomy bypass allegedly underwent a right-sided craniotomy and was unable to speak after surgery.

Wrong-site surgeries are also performed by general surgeons, urologists, cardiologists, otolaryngologists, and ophthalmologists. A 2021 lawsuit accused a Tampa urologist of removing the patient’s wrong testicle. And a 2019 lawsuit accused a Chicago ophthalmologist of operating on the wrong eye to remove a cyst.
 

It’s not just the surgeon’s mistake

Mistakes are not only made by the surgeon in the operating room (OR). They can be made by staff when scheduling a surgery, radiologists and pathologists when writing their reports for surgery, and by team members in the OR.

Many people are prone to confusing left and right. A 2020 study found that 14.9% of people had difficulty distinguishing left from right; other studies have shown higher rates. Distractions increase the likelihood of mistakes. In a 2015 study, background noise in a hospital ward made it more difficult for medical students to make left-right judgments.

OR personnel can be confused when patients are turned around. “To operate on the back of someone’s leg, the surgeon may turn the patient from supine to prone, and so left becomes right,” says Samuel C. Seiden, MD, an anesthesiologist in Roseville, Calif., who has studied wrong-site surgery.

Operative site markings that are drawn on the skin can be rubbed off when surgical prep is applied, and markings aren’t usually possible for procedures such as spine surgeries. Surgical draping can make it harder to distinguish the patient’s left and right, and a busy surgeon relying on memory may confuse cases and perform wrong-patient surgery.
 

A push to eliminate wrong-site surgery

In 2004, the Joint Commission, which accredits hospitals and many surgery centers, decided to do something about wrong-site surgery and related surgical errors. It released a universal protocol, which requires hospitals to take three steps to prevent errors: perform preoperative verification that is based on patient care documents; mark the operative site; and take a time-out just before surgery, during which the team should consider whether a mistake is about to be made.

Two years after the Joint Commission published its protocol, Dr. Seiden led a study to determine what effect it had had. The investigators found that wrong-site cases had decreased by only about one third. Preventing wrong-site surgery “turns out to be more complicated to eradicate than anybody thought,” Mark Chassin, MD, president of the Joint Commission, stated a few years later.

Why did the protocol have only a limited effect? Dr. Seiden says that it has been hard to change doctors’ traditional attitudes against standardization. “Some have had an attitude that checklists are for dummies, but that is changing,” he says.

For instance, some surgical teams were not paying attention during time-outs. “The time-out should be like the invocation of the National Anthem,” an orthopedic surgeon from Iowa wrote. “All other activities should stop.”

Even had surgeons followed the universal protocol, about one third of wrong-site surgeries would not have been identified, according to Dr. Kwaan’s study, which was published in the same year as Dr. Seiden’s. As an example, when the wrong kidney was removed at Methodist Hospital, in St. Louis Park, Minn., the hospital said it was following a protocol set by the Minnesota Hospital Association.
 

Redoubling efforts

In 2009, the Joint Commission decided to take another tack. It encouraged hospitals to make root-cause analyses not only of wrong-site surgeries but also of near misses, which are much more plentiful. It used the insights gained to change surgical routines and protocols.

The Safe Surgery Project, a collaboration between the Joint Commission’s Center for Transforming Healthcare and eight hospitals and surgery centers, reduced the number of errors and near misses by 46% in the scheduling area, 63% in pre-op, and 51% in the OR area.

From that project, the center developed the Targeted Solutions Tool, which basically uses the same methodology that the project used. The center told this news organization that 79 healthcare organizations have used the tool and have reduced the number of errors and near misses by 56% in scheduling, 24% in pre-op, and 48% in the OR.

For this approach to work, however, surgical teams must report their errors to the hospital, which had not been done before. A 2008 study by the Office of the Inspector General of the U.S. Department of Health and Human Services found that surgical staff did not report 86% of adverse events to their hospitals. Reasons given included lack of time, fear of punitive action, and skepticism that reporting would do any good.

Unlike some other adverse events, it’s hard to keep wrong-site surgeries secret from patients, because they can usually see the scars from it, but some surgeons invent ways to cover it up from patients, too, Dr. Mayer says. One wrong-side hernia repair was corrected in mid operation. Afterward, the surgeon told the patient that he had found another hernia on the other side and had fixed that one, too.
 

Changing the culture

Reformers argue that wrong-site surgeries can be prevented by changing the culture of the hospital or surgery center. “We have to think of wrong-site surgeries as a failure of the system, not of the individual,” says Ron Savrin, MD, a general surgeon in Chagrin Falls, Ohio, who is a surgery subject matter expert for the Sullivan Group. “It should never be only up to one individual to stop an error from occurring.”

Seeing oneself as part of a team can reduce errors. Although other people can introduce errors that make a person look bad, they can also stop the errors that might otherwise have occurred. Punishing individuals for making errors does little good in stopping errors.

“It’s human nature to want to punish somebody for making a mistake, and it’s hard to change that mentality,” Dr. Savrin says. He recalls that when he was a resident, “the morbidity and mortality conferences could be very difficult for anyone who made a mistake, but I think that attitude is changing.”

Studies have found wide variation in the number of wrong-site surgeries among hospitals. A recent Pennsylvania study found an average of one wrong-site surgery or near miss per hospital per year, but about one third of hospitals did not report any.

Wrong-site surgeries are often concentrated in certain hospitals -- even prestigious teaching hospitals are not immune. A decade ago, Rhode Island Hospital had five wrong-site surgeries in 2 years, and Boston’s Beth Israel Deaconess Medical Center had three wrong-spine surgeries within 2 months.
 

Other ways to reduce errors

Dr. Seiden thinks reform efforts should take a page from his own specialty. Anesthesiology has developed a variety of forcing functions, which are simple changes in technology that can stop errors. An example is the use of a valve that will not deliver a drug unless certain steps are followed.

The StartBox System, a new way to prevent surgical errors, delivers the surgery blade only after all safety information has been provided. Tested by 11 orthopedic surgeons performing 487 procedures, the system identified 17 near misses.

Another approach is to film time-outs so as to enforce compliance with protocols and help with root-cause analyses. NYU-Langone Medical Center, in New York City, not only films the time-out but also grades OR teams on compliance, says Dr. Bosco, who is vice chair of clinical affairs in the department of orthopedic surgery at the hospital.

In addition, more states are requiring hospitals to report adverse events, including wrong-site surgeries. According to the National Academy for State Health Policy, 28 states require the reporting of adverse events. However, only six states identify facilities in public reports; 16 states publish only aggregate data; and five states do not report error data to the public.
 

The goal is zero errors

Are there fewer wrong-site surgeries now? “My sense is that surgeons, hospitals, and surgery centers are taking wrong-site errors more seriously,” Dr. Savrin says.

Because reported information is spotty and no major studies on incidence have been conducted in recent years, “we don’t have a clear idea,” he says, “but my best guess is that the rate is declining.

“Absolute zero preventable errors has to be our goal,” Dr. Savrin says “We might not get there, but we can’t stop trying.”

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

In July 2021, University Hospitals, in Cleveland, announced that its staff had transplanted a kidney into the wrong patient. Although the patient who received the kidney was recovering well, the patient who was supposed to have received the kidney was skipped over. As a result of the error, two employees were placed on administrative leave and the incident was being investigated, the hospital announced.

In April 2020, an interventional radiologist at Boca Raton Regional Hospital, in Boca Raton, Fla., was sued for allegedly placing a stent into the wrong kidney of an 80-year-old patient. Using fluoroscopic guidance, the doctor removed an old stent from the right side but incorrectly replaced it with a new stent on the left side, according to an interview conducted by this news organization with the patient’s lawyers at Searcy Law, in West Palm Beach.

Wrong-site surgery -- surgery performed on the wrong patient, the wrong body part, or the wrong side of the body -- is a rare but distressing event and garners much attention when it happens. “The problem is that it is so rare that doctors don’t focus on it,” says Mary R. Kwaan, MD, a colorectal surgeon at UCLA Medical Center, Los Angeles.

A 2006 study in which Kwaan was the lead author concluded that there was one wrong-site surgery for every 112,994 surgeries. Those mistakes can add up. A 2006 study estimated that 25 to 52 wrong-site surgeries were performed each week in the United States.

“Many surgeons don’t think it can happen to them, so they don’t take extra precautions,” says David Mayer, MD, executive director of the MedStar Institute for Quality and Safety, in Washington, DC. “When they make a wrong-site error, usually the first thing they say is, ‘I never thought this would happen to me,’ ” he says.

Wrong-site surgeries are considered sentinel events -- the worst kinds of medical errors. The Sullivan Group, a patient safety consultancy based in Colorado, reports that in 2013, 2.7% of patients who were involved in wrong-site surgeries died and 41% experienced some type of permanent injury. The mean malpractice payment was $127,000.

Some malpractice payments are much higher. In 2013, a Maryland ob.gyn paid a $1.42 million malpractice award for removing the wrong ovary from a woman in 2009. In 2017, a Pennsylvania urologist paid $870,000 for removing the wrong testicle from a man in 2013.
 

Wrong-site surgery often involves experienced surgeons

One might think that wrong-site surgeries usually involve younger or less-experienced surgeons, but that’s not the case; two thirds of the surgeons who perform wrong-site surgeries are in their 40s and 50s, compared with fewer than 25% younger than 40.

In a rather chilling statistic, in a 2013 survey, 12.4% of doctors who were involved in sentinel events in general had claims for more than one event.

These errors are more common in certain specialties. In a study reported in the Journal of Neurology, Neurosurgery and Spine, 25% of orthopedic surgeons reported performing at least one wrong-site surgery during their career.

Within orthopedics, spine surgery is ground zero for wrong-site surgery. “Finding the site in spine surgery can be more difficult than in common left-right orthopedic procedures,” says Joseph A. Bosco III, a New York City orthopedist.

A 2007 study found that 25% of neurosurgeons had performed wrong-site surgeries. In Missouri in 2013, for example, a 53-year-old patient who was scheduled to undergo a left-sided craniotomy bypass allegedly underwent a right-sided craniotomy and was unable to speak after surgery.

Wrong-site surgeries are also performed by general surgeons, urologists, cardiologists, otolaryngologists, and ophthalmologists. A 2021 lawsuit accused a Tampa urologist of removing the patient’s wrong testicle. And a 2019 lawsuit accused a Chicago ophthalmologist of operating on the wrong eye to remove a cyst.
 

It’s not just the surgeon’s mistake

Mistakes are not only made by the surgeon in the operating room (OR). They can be made by staff when scheduling a surgery, radiologists and pathologists when writing their reports for surgery, and by team members in the OR.

Many people are prone to confusing left and right. A 2020 study found that 14.9% of people had difficulty distinguishing left from right; other studies have shown higher rates. Distractions increase the likelihood of mistakes. In a 2015 study, background noise in a hospital ward made it more difficult for medical students to make left-right judgments.

OR personnel can be confused when patients are turned around. “To operate on the back of someone’s leg, the surgeon may turn the patient from supine to prone, and so left becomes right,” says Samuel C. Seiden, MD, an anesthesiologist in Roseville, Calif., who has studied wrong-site surgery.

Operative site markings that are drawn on the skin can be rubbed off when surgical prep is applied, and markings aren’t usually possible for procedures such as spine surgeries. Surgical draping can make it harder to distinguish the patient’s left and right, and a busy surgeon relying on memory may confuse cases and perform wrong-patient surgery.
 

A push to eliminate wrong-site surgery

In 2004, the Joint Commission, which accredits hospitals and many surgery centers, decided to do something about wrong-site surgery and related surgical errors. It released a universal protocol, which requires hospitals to take three steps to prevent errors: perform preoperative verification that is based on patient care documents; mark the operative site; and take a time-out just before surgery, during which the team should consider whether a mistake is about to be made.

Two years after the Joint Commission published its protocol, Dr. Seiden led a study to determine what effect it had had. The investigators found that wrong-site cases had decreased by only about one third. Preventing wrong-site surgery “turns out to be more complicated to eradicate than anybody thought,” Mark Chassin, MD, president of the Joint Commission, stated a few years later.

Why did the protocol have only a limited effect? Dr. Seiden says that it has been hard to change doctors’ traditional attitudes against standardization. “Some have had an attitude that checklists are for dummies, but that is changing,” he says.

For instance, some surgical teams were not paying attention during time-outs. “The time-out should be like the invocation of the National Anthem,” an orthopedic surgeon from Iowa wrote. “All other activities should stop.”

Even had surgeons followed the universal protocol, about one third of wrong-site surgeries would not have been identified, according to Dr. Kwaan’s study, which was published in the same year as Dr. Seiden’s. As an example, when the wrong kidney was removed at Methodist Hospital, in St. Louis Park, Minn., the hospital said it was following a protocol set by the Minnesota Hospital Association.
 

Redoubling efforts

In 2009, the Joint Commission decided to take another tack. It encouraged hospitals to make root-cause analyses not only of wrong-site surgeries but also of near misses, which are much more plentiful. It used the insights gained to change surgical routines and protocols.

The Safe Surgery Project, a collaboration between the Joint Commission’s Center for Transforming Healthcare and eight hospitals and surgery centers, reduced the number of errors and near misses by 46% in the scheduling area, 63% in pre-op, and 51% in the OR area.

From that project, the center developed the Targeted Solutions Tool, which basically uses the same methodology that the project used. The center told this news organization that 79 healthcare organizations have used the tool and have reduced the number of errors and near misses by 56% in scheduling, 24% in pre-op, and 48% in the OR.

For this approach to work, however, surgical teams must report their errors to the hospital, which had not been done before. A 2008 study by the Office of the Inspector General of the U.S. Department of Health and Human Services found that surgical staff did not report 86% of adverse events to their hospitals. Reasons given included lack of time, fear of punitive action, and skepticism that reporting would do any good.

Unlike some other adverse events, it’s hard to keep wrong-site surgeries secret from patients, because they can usually see the scars from it, but some surgeons invent ways to cover it up from patients, too, Dr. Mayer says. One wrong-side hernia repair was corrected in mid operation. Afterward, the surgeon told the patient that he had found another hernia on the other side and had fixed that one, too.
 

Changing the culture

Reformers argue that wrong-site surgeries can be prevented by changing the culture of the hospital or surgery center. “We have to think of wrong-site surgeries as a failure of the system, not of the individual,” says Ron Savrin, MD, a general surgeon in Chagrin Falls, Ohio, who is a surgery subject matter expert for the Sullivan Group. “It should never be only up to one individual to stop an error from occurring.”

Seeing oneself as part of a team can reduce errors. Although other people can introduce errors that make a person look bad, they can also stop the errors that might otherwise have occurred. Punishing individuals for making errors does little good in stopping errors.

“It’s human nature to want to punish somebody for making a mistake, and it’s hard to change that mentality,” Dr. Savrin says. He recalls that when he was a resident, “the morbidity and mortality conferences could be very difficult for anyone who made a mistake, but I think that attitude is changing.”

Studies have found wide variation in the number of wrong-site surgeries among hospitals. A recent Pennsylvania study found an average of one wrong-site surgery or near miss per hospital per year, but about one third of hospitals did not report any.

Wrong-site surgeries are often concentrated in certain hospitals -- even prestigious teaching hospitals are not immune. A decade ago, Rhode Island Hospital had five wrong-site surgeries in 2 years, and Boston’s Beth Israel Deaconess Medical Center had three wrong-spine surgeries within 2 months.
 

Other ways to reduce errors

Dr. Seiden thinks reform efforts should take a page from his own specialty. Anesthesiology has developed a variety of forcing functions, which are simple changes in technology that can stop errors. An example is the use of a valve that will not deliver a drug unless certain steps are followed.

The StartBox System, a new way to prevent surgical errors, delivers the surgery blade only after all safety information has been provided. Tested by 11 orthopedic surgeons performing 487 procedures, the system identified 17 near misses.

Another approach is to film time-outs so as to enforce compliance with protocols and help with root-cause analyses. NYU-Langone Medical Center, in New York City, not only films the time-out but also grades OR teams on compliance, says Dr. Bosco, who is vice chair of clinical affairs in the department of orthopedic surgery at the hospital.

In addition, more states are requiring hospitals to report adverse events, including wrong-site surgeries. According to the National Academy for State Health Policy, 28 states require the reporting of adverse events. However, only six states identify facilities in public reports; 16 states publish only aggregate data; and five states do not report error data to the public.
 

The goal is zero errors

Are there fewer wrong-site surgeries now? “My sense is that surgeons, hospitals, and surgery centers are taking wrong-site errors more seriously,” Dr. Savrin says.

Because reported information is spotty and no major studies on incidence have been conducted in recent years, “we don’t have a clear idea,” he says, “but my best guess is that the rate is declining.

“Absolute zero preventable errors has to be our goal,” Dr. Savrin says “We might not get there, but we can’t stop trying.”

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

For primary care patients feeling well enough to discontinue antidepressant medication, there was a higher rate of depressive relapse among those who discontinued therapy, compared with those who did not, a new study shows.

The results of the Antidepressants to Prevent Relapse in Depression (ANTLER) trial also suggest that “many patients can discontinue their antidepressants safely in primary care without relapsing, when there is a tapering regime,” said lead investigator Gemma Lewis, PhD, from University College London, in an interview.

The multicenter, randomized, double-blind trial, which was published in the New England Journal of Medicine (2021;385:1257-67), included 478 patients, from 150 primary care practices in the United Kingdom.

The participants (73% female, average age 54 years) had a history of at least two depressive episodes or had been taking antidepressants (citalopram, fluoxetine, sertraline, or mirtazapine) for at least 2 years. The vast majority of patients – 70% – had been using the drugs for more than 3 years, the researchers wrote.

Study participants were randomized to either maintain their antidepressant regimen or to taper off for up to 2 months before switching to a placebo.

Over a follow-up of 52 weeks, relapse occurred in 56% of those who discontinued, compared with 39% of those who maintained their regimen (hazard ratio, 2.06; P < .001). Relapse also occurred sooner in the discontinuation group (13 weeks vs. 19 weeks).

The definition of relapse was answering yes to either of the following two questions:

• Have you had a spell of feeling sad, miserable, or depressed?
• Have you been unable to enjoy or take an interest in things as much as you usually do?

Patients also had to report that one of these experiences had lasted for 2 weeks or more, and having had at least one of the following symptoms: depressive thoughts, fatigue, loss of concentration, or sleep disturbance.

By the end of the trial, 39% of patients in the group who discontinued taking an antidepressant had returned to taking that type of drug.

“We found that remaining on antidepressants long-term does effectively reduce the risk of relapse. However, we also found that 44% of those who discontinued their antidepressants did not relapse after a full year,” Dr. Lewis said.

Who can stop medications without relapsing is unknown

“Many people can stop their medication without relapsing, though at present we cannot identify who those people are,” noted Dr. Lewis.

“Our study did not investigate who is at higher risk of relapse … but this is something we will focus on in the future,” she said.

For primary care clinicians whose patients are considering discontinuation of antidepressant medication, “current best practice is to engage with patients’ priorities and collaborate in coming to a decision,” she noted.

“For the individual patient, it is only possible to know about the average likelihood of relapse – and the severity of potential relapses will also be unpredictable. Our findings will give patients and clinicians an estimate of the likely benefits and harms of stopping long-term maintenance antidepressants to inform shared decision-making in primary care.”

Findings are ‘important’ but ‘disappointing’

In an editorial published alongside the study (N Engl J Med. 2021;385:1327-8), Jeffrey L. Jackson, MD, MPH, from the Zablocki VA Medical Center and the Medical College of Wisconsin in Milwaukee characterized the findings as “important but disappointing.”

“They confirm what most primary care physicians already knew or intuited. The frequency of relapse after the discontinuation of treatment is high, particularly among patients with several previous depressive episodes,” he explained.

Dr. Jackson also pointed out some unknowns about the trial, including the length trial participants had been in remission for depression.

“It is unclear whether the trial results are generalizable to primary care patients with a first episode of depression,” he said, and noted that participants with three or more previous depressive episodes were more than twice as likely to relapse, compared with participants with fewer episodes.

“I encourage patients with a single bout of depression, especially episodes that are triggered by a life event, such as loss of a loved one, to consider weaning antidepressant treatment after at least 6 months of remission,” he wrote. “For those with three or more previous bouts of depression, my practice has been to recommend that they anticipate medical treatment for life or, if they wish to stop taking medication, explore nonpharmacologic approaches, such as cognitive-behavior therapy.”

Protective effect of antidepressants was clear

“This is an important paper providing an evidence base to the often-cited recommendation that after two or more episodes of depression, antidepressant medication should be continued indefinitely,” said Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College, Thomas Jefferson University in Philadelphia, who was not involved in the study.

“The protective effect of antidepressant medication here was clear – those who discontinued antidepressant medication had a clinically and significantly higher rate of relapse at the end of a year.”

Side effects can be significant

“It is important to note, though, that in the discontinuation group, 44% of patients did not experience a relapse,” Dr. Skolnik said. “While antidepressants work without significant side effects for many patients, for others there are significant side effects that include adverse sexual side effects, effects on appetite and weight, nighttime sweats, and other side effects.”

“So, this study should not be confused to mean that all patients who have had recurrent depression should remain on antidepressants long term. The decision about whether to continue an antidepressant is influenced by many things and should be a shared decision-making process between clinician and patient, informed by the important results of this study, the current situation of the patient, and most importantly, the patient’s informed decision of what they would like to do,” he said.

The study was funded by the U.K. National Institute for Health Research

Dr. Lewis, Dr. Jackson, and Dr. Skolnik reported no conflicts of interest.

For primary care patients feeling well enough to discontinue antidepressant medication, there was a higher rate of depressive relapse among those who discontinued therapy, compared with those who did not, a new study shows.

The results of the Antidepressants to Prevent Relapse in Depression (ANTLER) trial also suggest that “many patients can discontinue their antidepressants safely in primary care without relapsing, when there is a tapering regime,” said lead investigator Gemma Lewis, PhD, from University College London, in an interview.

The multicenter, randomized, double-blind trial, which was published in the New England Journal of Medicine (2021;385:1257-67), included 478 patients, from 150 primary care practices in the United Kingdom.

The participants (73% female, average age 54 years) had a history of at least two depressive episodes or had been taking antidepressants (citalopram, fluoxetine, sertraline, or mirtazapine) for at least 2 years. The vast majority of patients – 70% – had been using the drugs for more than 3 years, the researchers wrote.

Study participants were randomized to either maintain their antidepressant regimen or to taper off for up to 2 months before switching to a placebo.

Over a follow-up of 52 weeks, relapse occurred in 56% of those who discontinued, compared with 39% of those who maintained their regimen (hazard ratio, 2.06; P < .001). Relapse also occurred sooner in the discontinuation group (13 weeks vs. 19 weeks).

The definition of relapse was answering yes to either of the following two questions:

• Have you had a spell of feeling sad, miserable, or depressed?
• Have you been unable to enjoy or take an interest in things as much as you usually do?

Patients also had to report that one of these experiences had lasted for 2 weeks or more, and having had at least one of the following symptoms: depressive thoughts, fatigue, loss of concentration, or sleep disturbance.

By the end of the trial, 39% of patients in the group who discontinued taking an antidepressant had returned to taking that type of drug.

“We found that remaining on antidepressants long-term does effectively reduce the risk of relapse. However, we also found that 44% of those who discontinued their antidepressants did not relapse after a full year,” Dr. Lewis said.

Who can stop medications without relapsing is unknown

“Many people can stop their medication without relapsing, though at present we cannot identify who those people are,” noted Dr. Lewis.

“Our study did not investigate who is at higher risk of relapse … but this is something we will focus on in the future,” she said.

For primary care clinicians whose patients are considering discontinuation of antidepressant medication, “current best practice is to engage with patients’ priorities and collaborate in coming to a decision,” she noted.

“For the individual patient, it is only possible to know about the average likelihood of relapse – and the severity of potential relapses will also be unpredictable. Our findings will give patients and clinicians an estimate of the likely benefits and harms of stopping long-term maintenance antidepressants to inform shared decision-making in primary care.”

Findings are ‘important’ but ‘disappointing’

In an editorial published alongside the study (N Engl J Med. 2021;385:1327-8), Jeffrey L. Jackson, MD, MPH, from the Zablocki VA Medical Center and the Medical College of Wisconsin in Milwaukee characterized the findings as “important but disappointing.”

“They confirm what most primary care physicians already knew or intuited. The frequency of relapse after the discontinuation of treatment is high, particularly among patients with several previous depressive episodes,” he explained.

Dr. Jackson also pointed out some unknowns about the trial, including the length trial participants had been in remission for depression.

“It is unclear whether the trial results are generalizable to primary care patients with a first episode of depression,” he said, and noted that participants with three or more previous depressive episodes were more than twice as likely to relapse, compared with participants with fewer episodes.

“I encourage patients with a single bout of depression, especially episodes that are triggered by a life event, such as loss of a loved one, to consider weaning antidepressant treatment after at least 6 months of remission,” he wrote. “For those with three or more previous bouts of depression, my practice has been to recommend that they anticipate medical treatment for life or, if they wish to stop taking medication, explore nonpharmacologic approaches, such as cognitive-behavior therapy.”

Protective effect of antidepressants was clear

“This is an important paper providing an evidence base to the often-cited recommendation that after two or more episodes of depression, antidepressant medication should be continued indefinitely,” said Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College, Thomas Jefferson University in Philadelphia, who was not involved in the study.

“The protective effect of antidepressant medication here was clear – those who discontinued antidepressant medication had a clinically and significantly higher rate of relapse at the end of a year.”

Side effects can be significant

“It is important to note, though, that in the discontinuation group, 44% of patients did not experience a relapse,” Dr. Skolnik said. “While antidepressants work without significant side effects for many patients, for others there are significant side effects that include adverse sexual side effects, effects on appetite and weight, nighttime sweats, and other side effects.”

“So, this study should not be confused to mean that all patients who have had recurrent depression should remain on antidepressants long term. The decision about whether to continue an antidepressant is influenced by many things and should be a shared decision-making process between clinician and patient, informed by the important results of this study, the current situation of the patient, and most importantly, the patient’s informed decision of what they would like to do,” he said.

The study was funded by the U.K. National Institute for Health Research

Dr. Lewis, Dr. Jackson, and Dr. Skolnik reported no conflicts of interest.

For primary care patients feeling well enough to discontinue antidepressant medication, there was a higher rate of depressive relapse among those who discontinued therapy, compared with those who did not, a new study shows.

The results of the Antidepressants to Prevent Relapse in Depression (ANTLER) trial also suggest that “many patients can discontinue their antidepressants safely in primary care without relapsing, when there is a tapering regime,” said lead investigator Gemma Lewis, PhD, from University College London, in an interview.

The multicenter, randomized, double-blind trial, which was published in the New England Journal of Medicine (2021;385:1257-67), included 478 patients, from 150 primary care practices in the United Kingdom.

The participants (73% female, average age 54 years) had a history of at least two depressive episodes or had been taking antidepressants (citalopram, fluoxetine, sertraline, or mirtazapine) for at least 2 years. The vast majority of patients – 70% – had been using the drugs for more than 3 years, the researchers wrote.

Study participants were randomized to either maintain their antidepressant regimen or to taper off for up to 2 months before switching to a placebo.

Over a follow-up of 52 weeks, relapse occurred in 56% of those who discontinued, compared with 39% of those who maintained their regimen (hazard ratio, 2.06; P < .001). Relapse also occurred sooner in the discontinuation group (13 weeks vs. 19 weeks).

The definition of relapse was answering yes to either of the following two questions:

• Have you had a spell of feeling sad, miserable, or depressed?
• Have you been unable to enjoy or take an interest in things as much as you usually do?

Patients also had to report that one of these experiences had lasted for 2 weeks or more, and having had at least one of the following symptoms: depressive thoughts, fatigue, loss of concentration, or sleep disturbance.

By the end of the trial, 39% of patients in the group who discontinued taking an antidepressant had returned to taking that type of drug.

“We found that remaining on antidepressants long-term does effectively reduce the risk of relapse. However, we also found that 44% of those who discontinued their antidepressants did not relapse after a full year,” Dr. Lewis said.

Who can stop medications without relapsing is unknown

“Many people can stop their medication without relapsing, though at present we cannot identify who those people are,” noted Dr. Lewis.

“Our study did not investigate who is at higher risk of relapse … but this is something we will focus on in the future,” she said.

For primary care clinicians whose patients are considering discontinuation of antidepressant medication, “current best practice is to engage with patients’ priorities and collaborate in coming to a decision,” she noted.

“For the individual patient, it is only possible to know about the average likelihood of relapse – and the severity of potential relapses will also be unpredictable. Our findings will give patients and clinicians an estimate of the likely benefits and harms of stopping long-term maintenance antidepressants to inform shared decision-making in primary care.”

Findings are ‘important’ but ‘disappointing’

In an editorial published alongside the study (N Engl J Med. 2021;385:1327-8), Jeffrey L. Jackson, MD, MPH, from the Zablocki VA Medical Center and the Medical College of Wisconsin in Milwaukee characterized the findings as “important but disappointing.”

“They confirm what most primary care physicians already knew or intuited. The frequency of relapse after the discontinuation of treatment is high, particularly among patients with several previous depressive episodes,” he explained.

Dr. Jackson also pointed out some unknowns about the trial, including the length trial participants had been in remission for depression.

“It is unclear whether the trial results are generalizable to primary care patients with a first episode of depression,” he said, and noted that participants with three or more previous depressive episodes were more than twice as likely to relapse, compared with participants with fewer episodes.

“I encourage patients with a single bout of depression, especially episodes that are triggered by a life event, such as loss of a loved one, to consider weaning antidepressant treatment after at least 6 months of remission,” he wrote. “For those with three or more previous bouts of depression, my practice has been to recommend that they anticipate medical treatment for life or, if they wish to stop taking medication, explore nonpharmacologic approaches, such as cognitive-behavior therapy.”

Protective effect of antidepressants was clear

“This is an important paper providing an evidence base to the often-cited recommendation that after two or more episodes of depression, antidepressant medication should be continued indefinitely,” said Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College, Thomas Jefferson University in Philadelphia, who was not involved in the study.

“The protective effect of antidepressant medication here was clear – those who discontinued antidepressant medication had a clinically and significantly higher rate of relapse at the end of a year.”

Side effects can be significant

“It is important to note, though, that in the discontinuation group, 44% of patients did not experience a relapse,” Dr. Skolnik said. “While antidepressants work without significant side effects for many patients, for others there are significant side effects that include adverse sexual side effects, effects on appetite and weight, nighttime sweats, and other side effects.”

“So, this study should not be confused to mean that all patients who have had recurrent depression should remain on antidepressants long term. The decision about whether to continue an antidepressant is influenced by many things and should be a shared decision-making process between clinician and patient, informed by the important results of this study, the current situation of the patient, and most importantly, the patient’s informed decision of what they would like to do,” he said.

The study was funded by the U.K. National Institute for Health Research

Dr. Lewis, Dr. Jackson, and Dr. Skolnik reported no conflicts of interest.

The use of patient portals that provide access to electronic health records has dramatically increased in the past several years, and patients whose health care practitioner encouraged them to use their online portal accessed them at a higher rate than those who were not encouraged to do so.

These were among the top-line results of a national survey of U.S. adults conducted by the National Institutes of Health from January 2020 to April 2020. Although the COVID-19 pandemic hit the United States in the middle of that period, a report on the survey by the Office of the National Coordinator for Health IT stated, “These findings largely reflect prepandemic rates of individuals being offered and subsequently using their online medical record, also known as a patient portal.”

But with more patient access can come additional work for physicians and other health care practitioners, ranging from an onslaught of patient communications to managing data sent to them by patients.

According to the report, 59% of individuals were offered access to their patient portal, and 38% accessed their record at least once in 2020. By comparison, in 2014, just 42% were offered access to their portal, and 25% used it. But these percentages hardly changed from 2019 to 2020.

The increase in the percentage of people who accessed portals reflects the fact that more people were offered access. In addition, there were signs of rising activity among portal users.

Among patients offered access to their patient portal, 64% accessed it at least once in 2020 – 11 percentage points more than in 2017. Twenty-seven percent of those who had access to a portal used it once or twice; 20% accessed it three to five times; and 18% used it six or more times. The latter two percentages were significantly higher than in 2017.

Of the respondents who were offered access to portals but didn’t use them, 69% said they didn’t access the portal because they preferred to speak with their health care practitioner directly. Sixty-three percent said they didn’t see a need to use their online medical record. This was similar to the percentage 3 years earlier. Other reasons included respondents’ concerns about the privacy/security of online medical records (24%), their lack of comfort with computers (20%), and their lack of Internet access (13%).
 

The pros and cons of patient portals, greater access

Among portal users who accessed their records through a mobile health app, 51% used the app to facilitate discussions with their health care practitioner in 2020, an 8–percentage point increase from 2017. Fifty-percent of the mobile health app users utilized it to make a decision about how to treat an illness or condition, up from 45% in 2017. And 71% of these individuals used their app to track progress on a health-related goal, just a bit more than in 2017.

Individuals who were encouraged by their health care practitioner to use their patient portal viewed clinical notes and exchanged secure messages with their practitioner at higher rates than those who had not been encouraged. This is not surprising, but it reflects an unintended result of patient portals that many physicians have found burdensome, especially during the pandemic: overflowing electronic in-boxes.

Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, recently tweeted, “We’re seeing huge uptick in in-box messages for MDs during COVID – now seems like biggest driver of MD burnout. The fundamental problem: We turned on 24/7/365 access for patients (who of course like it) with no operational or business model to handle it. Crucial that we fix this.”

Steven Waldren, MD, vice president and chief medical informatics officer at the American Academy of Family Physicians, told this news organization that he agrees that this is a major challenge. “In-box management is a burden on physicians and practices,” he said. “However, it can be done better, either through a team in-box or through better use of technology.”

The team in-box he refers to is a mechanism for triaging patient messages. For example, a triage nurse can look at the messages and decide which ones can be handled by staff and which ones the doctor needs to see. Or physicians and front office staff can see the messages at the same time; a nurse can triage some messages according to protocols, and the physician can respond to any message, depending on what he or she knows about the patient.

Technology can also be enlisted in the effort, he suggested, perhaps by automating the triaging of messages such as prescription refill requests or using artificial intelligence to sort messages by content.

Making patient records portable

Nearly 40% of portal users accessed it using a smartphone app (17%) or with both their smartphone app and their computer (22%). Sixty-one percent of users relied exclusively on computers to access their portals.

About a third of patient portal users downloaded their online medical records in 2020. This proportion has nearly doubled from 17% since 2017, the ONC report noted.

Although the survey didn’t ask about multiple downloads, it appears that most people had to download their records separately from the patient portal of each practitioner who cared for them. Although the Apple Health app allows people to download records to their iPhones from multiple portals using a standard application programming interface, the ONC report says that only 5% of respondents transmitted their records to a service or app, up slightly from 3% in 2017.

Dr. Waldren hopes most patients will have the ability to download and integrate records from multiple practitioners in a few years, but he wouldn’t bet on it.

“A fair amount of work needs to be done on the business side and on figuring out how the data get connected together,” he said. “And there are still privacy concerns with apps.”

Overall, 21% of portal users transmitted their data to at least one outside party in 2020, compared with 14% in 2017. Seventeen percent of them sent their records to another health care practitioner, up from 10% in 2017. Five percent of the users transmitted their records to a caregiver, slightly more than in 2017.

Managing data is a challenge

Asked how physicians feel about portal users adding information to their record or correcting inaccurate information, Dr. Waldren says, “Doctors are already comfortable with patient-generated data. The challenge is managing it. If the patient provides data that’s not easy to put in the EHR, that’s going to add work, and they don’t want to see 100 blood pressure readings.

“You’d be hard-pressed to find a doctor who doesn’t welcome additional information about the patient’s health, but it can be onerous and can take time to enter the data,” Dr. Waldren said.

Overall, he said, “Giving patients the ability to take more ownership of their health and participate in their own care is good and can help us move forward. How this will be integrated into patient care is another question.”

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

The use of patient portals that provide access to electronic health records has dramatically increased in the past several years, and patients whose health care practitioner encouraged them to use their online portal accessed them at a higher rate than those who were not encouraged to do so.

These were among the top-line results of a national survey of U.S. adults conducted by the National Institutes of Health from January 2020 to April 2020. Although the COVID-19 pandemic hit the United States in the middle of that period, a report on the survey by the Office of the National Coordinator for Health IT stated, “These findings largely reflect prepandemic rates of individuals being offered and subsequently using their online medical record, also known as a patient portal.”

But with more patient access can come additional work for physicians and other health care practitioners, ranging from an onslaught of patient communications to managing data sent to them by patients.

According to the report, 59% of individuals were offered access to their patient portal, and 38% accessed their record at least once in 2020. By comparison, in 2014, just 42% were offered access to their portal, and 25% used it. But these percentages hardly changed from 2019 to 2020.

The increase in the percentage of people who accessed portals reflects the fact that more people were offered access. In addition, there were signs of rising activity among portal users.

Among patients offered access to their patient portal, 64% accessed it at least once in 2020 – 11 percentage points more than in 2017. Twenty-seven percent of those who had access to a portal used it once or twice; 20% accessed it three to five times; and 18% used it six or more times. The latter two percentages were significantly higher than in 2017.

Of the respondents who were offered access to portals but didn’t use them, 69% said they didn’t access the portal because they preferred to speak with their health care practitioner directly. Sixty-three percent said they didn’t see a need to use their online medical record. This was similar to the percentage 3 years earlier. Other reasons included respondents’ concerns about the privacy/security of online medical records (24%), their lack of comfort with computers (20%), and their lack of Internet access (13%).
 

The pros and cons of patient portals, greater access

Among portal users who accessed their records through a mobile health app, 51% used the app to facilitate discussions with their health care practitioner in 2020, an 8–percentage point increase from 2017. Fifty-percent of the mobile health app users utilized it to make a decision about how to treat an illness or condition, up from 45% in 2017. And 71% of these individuals used their app to track progress on a health-related goal, just a bit more than in 2017.

Individuals who were encouraged by their health care practitioner to use their patient portal viewed clinical notes and exchanged secure messages with their practitioner at higher rates than those who had not been encouraged. This is not surprising, but it reflects an unintended result of patient portals that many physicians have found burdensome, especially during the pandemic: overflowing electronic in-boxes.

Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, recently tweeted, “We’re seeing huge uptick in in-box messages for MDs during COVID – now seems like biggest driver of MD burnout. The fundamental problem: We turned on 24/7/365 access for patients (who of course like it) with no operational or business model to handle it. Crucial that we fix this.”

Steven Waldren, MD, vice president and chief medical informatics officer at the American Academy of Family Physicians, told this news organization that he agrees that this is a major challenge. “In-box management is a burden on physicians and practices,” he said. “However, it can be done better, either through a team in-box or through better use of technology.”

The team in-box he refers to is a mechanism for triaging patient messages. For example, a triage nurse can look at the messages and decide which ones can be handled by staff and which ones the doctor needs to see. Or physicians and front office staff can see the messages at the same time; a nurse can triage some messages according to protocols, and the physician can respond to any message, depending on what he or she knows about the patient.

Technology can also be enlisted in the effort, he suggested, perhaps by automating the triaging of messages such as prescription refill requests or using artificial intelligence to sort messages by content.

Making patient records portable

Nearly 40% of portal users accessed it using a smartphone app (17%) or with both their smartphone app and their computer (22%). Sixty-one percent of users relied exclusively on computers to access their portals.

About a third of patient portal users downloaded their online medical records in 2020. This proportion has nearly doubled from 17% since 2017, the ONC report noted.

Although the survey didn’t ask about multiple downloads, it appears that most people had to download their records separately from the patient portal of each practitioner who cared for them. Although the Apple Health app allows people to download records to their iPhones from multiple portals using a standard application programming interface, the ONC report says that only 5% of respondents transmitted their records to a service or app, up slightly from 3% in 2017.

Dr. Waldren hopes most patients will have the ability to download and integrate records from multiple practitioners in a few years, but he wouldn’t bet on it.

“A fair amount of work needs to be done on the business side and on figuring out how the data get connected together,” he said. “And there are still privacy concerns with apps.”

Overall, 21% of portal users transmitted their data to at least one outside party in 2020, compared with 14% in 2017. Seventeen percent of them sent their records to another health care practitioner, up from 10% in 2017. Five percent of the users transmitted their records to a caregiver, slightly more than in 2017.

Managing data is a challenge

Asked how physicians feel about portal users adding information to their record or correcting inaccurate information, Dr. Waldren says, “Doctors are already comfortable with patient-generated data. The challenge is managing it. If the patient provides data that’s not easy to put in the EHR, that’s going to add work, and they don’t want to see 100 blood pressure readings.

“You’d be hard-pressed to find a doctor who doesn’t welcome additional information about the patient’s health, but it can be onerous and can take time to enter the data,” Dr. Waldren said.

Overall, he said, “Giving patients the ability to take more ownership of their health and participate in their own care is good and can help us move forward. How this will be integrated into patient care is another question.”

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

The use of patient portals that provide access to electronic health records has dramatically increased in the past several years, and patients whose health care practitioner encouraged them to use their online portal accessed them at a higher rate than those who were not encouraged to do so.

These were among the top-line results of a national survey of U.S. adults conducted by the National Institutes of Health from January 2020 to April 2020. Although the COVID-19 pandemic hit the United States in the middle of that period, a report on the survey by the Office of the National Coordinator for Health IT stated, “These findings largely reflect prepandemic rates of individuals being offered and subsequently using their online medical record, also known as a patient portal.”

But with more patient access can come additional work for physicians and other health care practitioners, ranging from an onslaught of patient communications to managing data sent to them by patients.

According to the report, 59% of individuals were offered access to their patient portal, and 38% accessed their record at least once in 2020. By comparison, in 2014, just 42% were offered access to their portal, and 25% used it. But these percentages hardly changed from 2019 to 2020.

The increase in the percentage of people who accessed portals reflects the fact that more people were offered access. In addition, there were signs of rising activity among portal users.

Among patients offered access to their patient portal, 64% accessed it at least once in 2020 – 11 percentage points more than in 2017. Twenty-seven percent of those who had access to a portal used it once or twice; 20% accessed it three to five times; and 18% used it six or more times. The latter two percentages were significantly higher than in 2017.

Of the respondents who were offered access to portals but didn’t use them, 69% said they didn’t access the portal because they preferred to speak with their health care practitioner directly. Sixty-three percent said they didn’t see a need to use their online medical record. This was similar to the percentage 3 years earlier. Other reasons included respondents’ concerns about the privacy/security of online medical records (24%), their lack of comfort with computers (20%), and their lack of Internet access (13%).
 

The pros and cons of patient portals, greater access

Among portal users who accessed their records through a mobile health app, 51% used the app to facilitate discussions with their health care practitioner in 2020, an 8–percentage point increase from 2017. Fifty-percent of the mobile health app users utilized it to make a decision about how to treat an illness or condition, up from 45% in 2017. And 71% of these individuals used their app to track progress on a health-related goal, just a bit more than in 2017.

Individuals who were encouraged by their health care practitioner to use their patient portal viewed clinical notes and exchanged secure messages with their practitioner at higher rates than those who had not been encouraged. This is not surprising, but it reflects an unintended result of patient portals that many physicians have found burdensome, especially during the pandemic: overflowing electronic in-boxes.

Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, recently tweeted, “We’re seeing huge uptick in in-box messages for MDs during COVID – now seems like biggest driver of MD burnout. The fundamental problem: We turned on 24/7/365 access for patients (who of course like it) with no operational or business model to handle it. Crucial that we fix this.”

Steven Waldren, MD, vice president and chief medical informatics officer at the American Academy of Family Physicians, told this news organization that he agrees that this is a major challenge. “In-box management is a burden on physicians and practices,” he said. “However, it can be done better, either through a team in-box or through better use of technology.”

The team in-box he refers to is a mechanism for triaging patient messages. For example, a triage nurse can look at the messages and decide which ones can be handled by staff and which ones the doctor needs to see. Or physicians and front office staff can see the messages at the same time; a nurse can triage some messages according to protocols, and the physician can respond to any message, depending on what he or she knows about the patient.

Technology can also be enlisted in the effort, he suggested, perhaps by automating the triaging of messages such as prescription refill requests or using artificial intelligence to sort messages by content.

Making patient records portable

Nearly 40% of portal users accessed it using a smartphone app (17%) or with both their smartphone app and their computer (22%). Sixty-one percent of users relied exclusively on computers to access their portals.

About a third of patient portal users downloaded their online medical records in 2020. This proportion has nearly doubled from 17% since 2017, the ONC report noted.

Although the survey didn’t ask about multiple downloads, it appears that most people had to download their records separately from the patient portal of each practitioner who cared for them. Although the Apple Health app allows people to download records to their iPhones from multiple portals using a standard application programming interface, the ONC report says that only 5% of respondents transmitted their records to a service or app, up slightly from 3% in 2017.

Dr. Waldren hopes most patients will have the ability to download and integrate records from multiple practitioners in a few years, but he wouldn’t bet on it.

“A fair amount of work needs to be done on the business side and on figuring out how the data get connected together,” he said. “And there are still privacy concerns with apps.”

Overall, 21% of portal users transmitted their data to at least one outside party in 2020, compared with 14% in 2017. Seventeen percent of them sent their records to another health care practitioner, up from 10% in 2017. Five percent of the users transmitted their records to a caregiver, slightly more than in 2017.

Managing data is a challenge

Asked how physicians feel about portal users adding information to their record or correcting inaccurate information, Dr. Waldren says, “Doctors are already comfortable with patient-generated data. The challenge is managing it. If the patient provides data that’s not easy to put in the EHR, that’s going to add work, and they don’t want to see 100 blood pressure readings.

“You’d be hard-pressed to find a doctor who doesn’t welcome additional information about the patient’s health, but it can be onerous and can take time to enter the data,” Dr. Waldren said.

Overall, he said, “Giving patients the ability to take more ownership of their health and participate in their own care is good and can help us move forward. How this will be integrated into patient care is another question.”

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

The U.S. Drug Enforcement Administration has issued a public safety alert over an “alarming” increase in fake prescription pills laced with the synthetic opioid fentanyl or the stimulant methamphetamine.

“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said in the alert.

“Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before. DEA is focusing resources on taking down the violent drug traffickers causing the greatest harm and posing the greatest threat to the safety and health of Americans,” Ms. Milgram said.

Criminal drug networks are mass-producing fake fentanyl- and methamphetamine-laced pills and deceptively marketing them as legitimate prescription pills, the DEA warns.

These lethal counterfeit pills are made to look like legitimate prescription opioid medications such as oxycodone (Oxycontin, Percocet), hydrocodone (Vicodin), and alprazolam (Xanax); or stimulants like amphetamines (Adderall).

The agency has seized fake pills in every U.S. state. More than 9.5 million fake pills have been seized so far this year – more than the last 2 years combined.

The number of seized counterfeit pills with fentanyl has jumped nearly 430% since 2019. DEA lab tests reveal that two out of every five pills with fentanyl contain a potentially lethal dose.

These deadly pills are widely accessible and often sold on social media and e-commerce platforms – making them available to anyone with a smartphone, including minors, the DEA warns.

More than 93,000 people died of a drug overdose in the United States last year, according to federal statistics, and fentanyl is the primary driver of this alarming increase in overdose deaths, the DEA says.

The agency has launched a “One Pill Can Kill” public awareness campaign to educate the public of the dangers of counterfeit pills purchased outside of a licensed pharmacy. These pills are “illegal, dangerous, and potentially lethal,” the DEA warns.

This alert does not apply to legitimate pharmaceutical medications prescribed by doctors and dispensed by licensed pharmacists, the DEA says.

“The legitimate prescription supply chain is not impacted. Anyone filling a prescription at a licensed pharmacy can be confident that the medications they receive are safe when taken as directed by a medical professional,” the agency says.

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

The U.S. Drug Enforcement Administration has issued a public safety alert over an “alarming” increase in fake prescription pills laced with the synthetic opioid fentanyl or the stimulant methamphetamine.

“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said in the alert.

“Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before. DEA is focusing resources on taking down the violent drug traffickers causing the greatest harm and posing the greatest threat to the safety and health of Americans,” Ms. Milgram said.

Criminal drug networks are mass-producing fake fentanyl- and methamphetamine-laced pills and deceptively marketing them as legitimate prescription pills, the DEA warns.

These lethal counterfeit pills are made to look like legitimate prescription opioid medications such as oxycodone (Oxycontin, Percocet), hydrocodone (Vicodin), and alprazolam (Xanax); or stimulants like amphetamines (Adderall).

The agency has seized fake pills in every U.S. state. More than 9.5 million fake pills have been seized so far this year – more than the last 2 years combined.

The number of seized counterfeit pills with fentanyl has jumped nearly 430% since 2019. DEA lab tests reveal that two out of every five pills with fentanyl contain a potentially lethal dose.

These deadly pills are widely accessible and often sold on social media and e-commerce platforms – making them available to anyone with a smartphone, including minors, the DEA warns.

More than 93,000 people died of a drug overdose in the United States last year, according to federal statistics, and fentanyl is the primary driver of this alarming increase in overdose deaths, the DEA says.

The agency has launched a “One Pill Can Kill” public awareness campaign to educate the public of the dangers of counterfeit pills purchased outside of a licensed pharmacy. These pills are “illegal, dangerous, and potentially lethal,” the DEA warns.

This alert does not apply to legitimate pharmaceutical medications prescribed by doctors and dispensed by licensed pharmacists, the DEA says.

“The legitimate prescription supply chain is not impacted. Anyone filling a prescription at a licensed pharmacy can be confident that the medications they receive are safe when taken as directed by a medical professional,” the agency says.

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

The U.S. Drug Enforcement Administration has issued a public safety alert over an “alarming” increase in fake prescription pills laced with the synthetic opioid fentanyl or the stimulant methamphetamine.

“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said in the alert.

“Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before. DEA is focusing resources on taking down the violent drug traffickers causing the greatest harm and posing the greatest threat to the safety and health of Americans,” Ms. Milgram said.

Criminal drug networks are mass-producing fake fentanyl- and methamphetamine-laced pills and deceptively marketing them as legitimate prescription pills, the DEA warns.

These lethal counterfeit pills are made to look like legitimate prescription opioid medications such as oxycodone (Oxycontin, Percocet), hydrocodone (Vicodin), and alprazolam (Xanax); or stimulants like amphetamines (Adderall).

The agency has seized fake pills in every U.S. state. More than 9.5 million fake pills have been seized so far this year – more than the last 2 years combined.

The number of seized counterfeit pills with fentanyl has jumped nearly 430% since 2019. DEA lab tests reveal that two out of every five pills with fentanyl contain a potentially lethal dose.

These deadly pills are widely accessible and often sold on social media and e-commerce platforms – making them available to anyone with a smartphone, including minors, the DEA warns.

More than 93,000 people died of a drug overdose in the United States last year, according to federal statistics, and fentanyl is the primary driver of this alarming increase in overdose deaths, the DEA says.

The agency has launched a “One Pill Can Kill” public awareness campaign to educate the public of the dangers of counterfeit pills purchased outside of a licensed pharmacy. These pills are “illegal, dangerous, and potentially lethal,” the DEA warns.

This alert does not apply to legitimate pharmaceutical medications prescribed by doctors and dispensed by licensed pharmacists, the DEA says.

“The legitimate prescription supply chain is not impacted. Anyone filling a prescription at a licensed pharmacy can be confident that the medications they receive are safe when taken as directed by a medical professional,” the agency says.

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

Bacteria get the rack ... the towel rack

Obviously, bathrooms have germs. Some people are cleaner about their bathrooms than others, but in general most people just try not to think about the microscopic critters crawling about.

Now you would probably think that the toilet is the dirtiest part of the bathroom because that’s where ... you know, most of the business takes place. Or maybe you’d guess the floor. Truth be told, though, the dirtiest part of the bathroom is where the towels are hung.

pxfuel

Anti-vaxxers would like to be called ‘purebloods’

COVID-19 anti-vaxxers are an interesting bunch, to be kind. And TikTok is a wacky place. So you can just imagine that anti-vaxxer TikTok is a very strange place. The citizens of anti-vax TikTok have decided that the real reason so many people dislike them is branding. They consider anti-vaccination to be a negative word (duh), so they now want to be referred to as “purebloods.”

peterschreiber_media/iStock/Getty Images

Harry Potter doesn’t quite occupy the zeitgeist as it once did, so let’s give you a reminder: In the books, purebloods came from old wizarding families and claimed not to have any Muggle, or nonmagic, blood. While having pure wizard blood was no guarantee of being a villain, most of them were. In addition, it is made quite clear throughout the novels that having supposedly pure blood had no relevance on one’s wizarding ability. Pureblood was a meaningless title, and only the characters with small, cruel minds concerned themselves over it.

Perhaps the anti-vaxxers have decided that they want to be called the same thing. Maybe they just like the name. It does sound impressive and vaguely regal: Pureblood. Like something the nobles of medieval Europe might have used.

Critical-thinking skills may be in short supply here, or maybe the anti-vaxxers know exactly what they’re doing.
 

Hated broccoli? Blame your DNA

Were you that kid who would rather sit at the table for hours than eat your broccoli? Well, as much as your parents might have pushed you, new research suggests that it might be their fault you didn’t like it to begin with.

Hans Braxmeier/Pixabay

Investigators at Australia’s national science agency, CSIRO, recently reported that distaste for Brassica vegetables – broccoli, Brussels sprouts, cabbage, and cauliflower – can be traced to the oral microbiome.

These vegetables have a compound called S-methyl-L-cysteine sulfoxide that gives off sulfurous odors ... mmm, sulfurous ... when mixed with an enzyme in the plant, and that enzyme is also produced by bacteria in some people’s oral microbiomes. So why do adults tolerate these Brassica veggies more than children? It’s all about levels.

The researchers tested the idea by asking 98 child/parent pairs to rate the odors and by using gas chromatography-olfactometry-mass spectrometry to identify the odor-active compounds in both raw and steamed cauliflower and broccoli. The children whose saliva produced high levels of sulfur volatiles disliked Brassica vegetables the most, they reported, and the children with high levels of sulfur volatiles usually had parents who produced high levels.

Despite that connection, however, the distaste for raw Brassica seen in children wasn’t seen in adults.

Maybe it’s not that taste buds change as we age, maybe we just learn to tolerate the sulfurousness.

Bacteria get the rack ... the towel rack

Obviously, bathrooms have germs. Some people are cleaner about their bathrooms than others, but in general most people just try not to think about the microscopic critters crawling about.

Now you would probably think that the toilet is the dirtiest part of the bathroom because that’s where ... you know, most of the business takes place. Or maybe you’d guess the floor. Truth be told, though, the dirtiest part of the bathroom is where the towels are hung.

pxfuel

Anti-vaxxers would like to be called ‘purebloods’

COVID-19 anti-vaxxers are an interesting bunch, to be kind. And TikTok is a wacky place. So you can just imagine that anti-vaxxer TikTok is a very strange place. The citizens of anti-vax TikTok have decided that the real reason so many people dislike them is branding. They consider anti-vaccination to be a negative word (duh), so they now want to be referred to as “purebloods.”

peterschreiber_media/iStock/Getty Images

Harry Potter doesn’t quite occupy the zeitgeist as it once did, so let’s give you a reminder: In the books, purebloods came from old wizarding families and claimed not to have any Muggle, or nonmagic, blood. While having pure wizard blood was no guarantee of being a villain, most of them were. In addition, it is made quite clear throughout the novels that having supposedly pure blood had no relevance on one’s wizarding ability. Pureblood was a meaningless title, and only the characters with small, cruel minds concerned themselves over it.

Perhaps the anti-vaxxers have decided that they want to be called the same thing. Maybe they just like the name. It does sound impressive and vaguely regal: Pureblood. Like something the nobles of medieval Europe might have used.

Critical-thinking skills may be in short supply here, or maybe the anti-vaxxers know exactly what they’re doing.
 

Hated broccoli? Blame your DNA

Were you that kid who would rather sit at the table for hours than eat your broccoli? Well, as much as your parents might have pushed you, new research suggests that it might be their fault you didn’t like it to begin with.

Hans Braxmeier/Pixabay

Investigators at Australia’s national science agency, CSIRO, recently reported that distaste for Brassica vegetables – broccoli, Brussels sprouts, cabbage, and cauliflower – can be traced to the oral microbiome.

These vegetables have a compound called S-methyl-L-cysteine sulfoxide that gives off sulfurous odors ... mmm, sulfurous ... when mixed with an enzyme in the plant, and that enzyme is also produced by bacteria in some people’s oral microbiomes. So why do adults tolerate these Brassica veggies more than children? It’s all about levels.

The researchers tested the idea by asking 98 child/parent pairs to rate the odors and by using gas chromatography-olfactometry-mass spectrometry to identify the odor-active compounds in both raw and steamed cauliflower and broccoli. The children whose saliva produced high levels of sulfur volatiles disliked Brassica vegetables the most, they reported, and the children with high levels of sulfur volatiles usually had parents who produced high levels.

Despite that connection, however, the distaste for raw Brassica seen in children wasn’t seen in adults.

Maybe it’s not that taste buds change as we age, maybe we just learn to tolerate the sulfurousness.

Bacteria get the rack ... the towel rack

Obviously, bathrooms have germs. Some people are cleaner about their bathrooms than others, but in general most people just try not to think about the microscopic critters crawling about.

Now you would probably think that the toilet is the dirtiest part of the bathroom because that’s where ... you know, most of the business takes place. Or maybe you’d guess the floor. Truth be told, though, the dirtiest part of the bathroom is where the towels are hung.

pxfuel

Anti-vaxxers would like to be called ‘purebloods’

COVID-19 anti-vaxxers are an interesting bunch, to be kind. And TikTok is a wacky place. So you can just imagine that anti-vaxxer TikTok is a very strange place. The citizens of anti-vax TikTok have decided that the real reason so many people dislike them is branding. They consider anti-vaccination to be a negative word (duh), so they now want to be referred to as “purebloods.”

peterschreiber_media/iStock/Getty Images

Harry Potter doesn’t quite occupy the zeitgeist as it once did, so let’s give you a reminder: In the books, purebloods came from old wizarding families and claimed not to have any Muggle, or nonmagic, blood. While having pure wizard blood was no guarantee of being a villain, most of them were. In addition, it is made quite clear throughout the novels that having supposedly pure blood had no relevance on one’s wizarding ability. Pureblood was a meaningless title, and only the characters with small, cruel minds concerned themselves over it.

Perhaps the anti-vaxxers have decided that they want to be called the same thing. Maybe they just like the name. It does sound impressive and vaguely regal: Pureblood. Like something the nobles of medieval Europe might have used.

Critical-thinking skills may be in short supply here, or maybe the anti-vaxxers know exactly what they’re doing.
 

Hated broccoli? Blame your DNA

Were you that kid who would rather sit at the table for hours than eat your broccoli? Well, as much as your parents might have pushed you, new research suggests that it might be their fault you didn’t like it to begin with.

Hans Braxmeier/Pixabay

Investigators at Australia’s national science agency, CSIRO, recently reported that distaste for Brassica vegetables – broccoli, Brussels sprouts, cabbage, and cauliflower – can be traced to the oral microbiome.

These vegetables have a compound called S-methyl-L-cysteine sulfoxide that gives off sulfurous odors ... mmm, sulfurous ... when mixed with an enzyme in the plant, and that enzyme is also produced by bacteria in some people’s oral microbiomes. So why do adults tolerate these Brassica veggies more than children? It’s all about levels.

The researchers tested the idea by asking 98 child/parent pairs to rate the odors and by using gas chromatography-olfactometry-mass spectrometry to identify the odor-active compounds in both raw and steamed cauliflower and broccoli. The children whose saliva produced high levels of sulfur volatiles disliked Brassica vegetables the most, they reported, and the children with high levels of sulfur volatiles usually had parents who produced high levels.

Despite that connection, however, the distaste for raw Brassica seen in children wasn’t seen in adults.

Maybe it’s not that taste buds change as we age, maybe we just learn to tolerate the sulfurousness.