MDedge Rheumatology

The number of physicians who have chosen early retirement or have left medicine because of the COVID-19 pandemic may be considerably lower than previously thought, results of a new study suggest.

The research letter in the Journal of the American Medical Association, based on Medicare claims data, stated that “practice interruption rates were similar before and during the COVID-19 pandemic, except for a spike in April 2020.”

By contrast, in a Physicians Foundation Survey conducted in August 2020, 8% of physicians said they had closed their practices as a result of COVID, and 4% of the respondents said they planned to leave their practices within the next 12 months.

Similarly, a Jackson Physician Search survey in the fourth quarter of 2020 found that 54% of physicians surveyed had changed their employment plans. Of those doctors, 21% said they might hang up their white coat for early retirement. That works out to about 11% of the respondents.

The JAMA study’s authors analyzed the Medicare claims data from Jan. 1, 2019, to Dec. 30, 2020, to see how many physicians with Medicare patients had stopped filing claims for a period during those 2 years.

If a doctor had ceased submitting claims and then resumed filing them within 6 months after the last billing month, the lapse in filing was defined as “interruption with return.” If a physician stopped filing claims to Medicare and did not resume within 6 months, the gap in filing was called “interruption without return.”

In April 2020, 6.9% of physicians billing Medicare had a practice interruption, compared to 1.4% in 2019. But only 1.1% of physicians stopped practice in April 2020 and did not return, compared with 0.33% in 2019.

Physicians aged 55 or older had higher rates of interruption both with and without return than younger doctors did. The change in interruption rates for older doctors was 7.2% vs. 3.9% for younger physicians. The change in older physicians’ interruption-without-return rate was 1.3% vs. 0.34% for younger colleagues.

“Female physicians, specialists, physicians in smaller practices, those not in a health professional shortage area, and those practicing in a metropolitan area experienced greater increases in practice interruption rates in April 2020 vs. April 2019,” the study states. “But those groups typically had higher rates of return, so the overall changes in practice interruptions without return were similar across characteristics other than age.”
 

Significance for retirement rate

Discussing these results, the authors stressed that practice interruptions without return can’t necessarily be attributed to retirement, and that practice interruptions with return don’t necessarily signify that doctors had been furloughed from their practices.

Also, they said, “this measure of practice interruption likely misses meaningful interruptions that lasted for less than a month or did not involve complete cessation in treating Medicare patients.”

Nevertheless, “the study does capture a signal of some doctors probably retiring,” Jonathan Weiner, DPH, professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, said in an interview.

But he added, “Some of those people who interrupted their practices and didn’t return may still come back. And there are probably a lot of other doctors who are leaving or changing practices that they didn’t capture.” For example, it’s possible that some doctors who went to work for other health care organizations stopped billing under their own names.

In Dr. Weiner’s view, the true percentage of physicians who have retired since the start of the pandemic is probably somewhere between the portion of doctors who interrupted their practice without return, according to the JAMA study, and the percentage of physicians who said they had closed their practices in the Physicians Foundation survey.
 

No mass exodus seen

Michael Belkin, JD, divisional vice president of recruiting for Merritt Hawkins, a physician search firm, said in an interview that the real number may be closer to the interruption-without-return figure in the JAMA study.

While many physician practices were disrupted in spring of 2020, he said, “it really didn’t result in a mass exodus [from health care]. We’re not talking to a lot of candidates who retired or walked away from their practices. We are talking to candidates who slowed down last year and then realized that they wanted to get back into medicine. And now they’re actively looking.”

One change in job candidates’ attitude, Mr. Belkin said, is that, because of COVID-19–related burnout, their quality of life is more important to them.

“They want to know, ‘What’s the culture of the employer like? What did they do last year during COVID? How did they handle it? Have they put together any protocols for the next pandemic?’ “
 

Demand for doctors has returned

In the summer of 2020, there was a major drop in physician recruitment by hospitals and health systems, partly because of fewer patient visits and procedures. But demand for doctors has bounced back over the past year, Mr. Belkin noted. One reason is the pent-up need for care among patients who avoided health care providers in 2020.

Another reason is that some employed doctors – particularly older physicians – have slowed down. Many doctors prefer to work remotely 1 or 2 days a week, providing telehealth visits to patients. That has led to a loss of productivity in many health care organizations and, consequently, a need to hire additional physicians.

Nevertheless, not many doctors are heading for the exit earlier than physicians did before COVID-19.

“They may work reduced hours,” Mr. Belkin said. “But the sense from a physician’s perspective is that this is all they know. For them to walk away from their life in medicine, from who they are, is problematic. So they’re continuing to practice, but at a reduced capacity.”

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

The number of physicians who have chosen early retirement or have left medicine because of the COVID-19 pandemic may be considerably lower than previously thought, results of a new study suggest.

The research letter in the Journal of the American Medical Association, based on Medicare claims data, stated that “practice interruption rates were similar before and during the COVID-19 pandemic, except for a spike in April 2020.”

By contrast, in a Physicians Foundation Survey conducted in August 2020, 8% of physicians said they had closed their practices as a result of COVID, and 4% of the respondents said they planned to leave their practices within the next 12 months.

Similarly, a Jackson Physician Search survey in the fourth quarter of 2020 found that 54% of physicians surveyed had changed their employment plans. Of those doctors, 21% said they might hang up their white coat for early retirement. That works out to about 11% of the respondents.

The JAMA study’s authors analyzed the Medicare claims data from Jan. 1, 2019, to Dec. 30, 2020, to see how many physicians with Medicare patients had stopped filing claims for a period during those 2 years.

If a doctor had ceased submitting claims and then resumed filing them within 6 months after the last billing month, the lapse in filing was defined as “interruption with return.” If a physician stopped filing claims to Medicare and did not resume within 6 months, the gap in filing was called “interruption without return.”

In April 2020, 6.9% of physicians billing Medicare had a practice interruption, compared to 1.4% in 2019. But only 1.1% of physicians stopped practice in April 2020 and did not return, compared with 0.33% in 2019.

Physicians aged 55 or older had higher rates of interruption both with and without return than younger doctors did. The change in interruption rates for older doctors was 7.2% vs. 3.9% for younger physicians. The change in older physicians’ interruption-without-return rate was 1.3% vs. 0.34% for younger colleagues.

“Female physicians, specialists, physicians in smaller practices, those not in a health professional shortage area, and those practicing in a metropolitan area experienced greater increases in practice interruption rates in April 2020 vs. April 2019,” the study states. “But those groups typically had higher rates of return, so the overall changes in practice interruptions without return were similar across characteristics other than age.”
 

Significance for retirement rate

Discussing these results, the authors stressed that practice interruptions without return can’t necessarily be attributed to retirement, and that practice interruptions with return don’t necessarily signify that doctors had been furloughed from their practices.

Also, they said, “this measure of practice interruption likely misses meaningful interruptions that lasted for less than a month or did not involve complete cessation in treating Medicare patients.”

Nevertheless, “the study does capture a signal of some doctors probably retiring,” Jonathan Weiner, DPH, professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, said in an interview.

But he added, “Some of those people who interrupted their practices and didn’t return may still come back. And there are probably a lot of other doctors who are leaving or changing practices that they didn’t capture.” For example, it’s possible that some doctors who went to work for other health care organizations stopped billing under their own names.

In Dr. Weiner’s view, the true percentage of physicians who have retired since the start of the pandemic is probably somewhere between the portion of doctors who interrupted their practice without return, according to the JAMA study, and the percentage of physicians who said they had closed their practices in the Physicians Foundation survey.
 

No mass exodus seen

Michael Belkin, JD, divisional vice president of recruiting for Merritt Hawkins, a physician search firm, said in an interview that the real number may be closer to the interruption-without-return figure in the JAMA study.

While many physician practices were disrupted in spring of 2020, he said, “it really didn’t result in a mass exodus [from health care]. We’re not talking to a lot of candidates who retired or walked away from their practices. We are talking to candidates who slowed down last year and then realized that they wanted to get back into medicine. And now they’re actively looking.”

One change in job candidates’ attitude, Mr. Belkin said, is that, because of COVID-19–related burnout, their quality of life is more important to them.

“They want to know, ‘What’s the culture of the employer like? What did they do last year during COVID? How did they handle it? Have they put together any protocols for the next pandemic?’ “
 

Demand for doctors has returned

In the summer of 2020, there was a major drop in physician recruitment by hospitals and health systems, partly because of fewer patient visits and procedures. But demand for doctors has bounced back over the past year, Mr. Belkin noted. One reason is the pent-up need for care among patients who avoided health care providers in 2020.

Another reason is that some employed doctors – particularly older physicians – have slowed down. Many doctors prefer to work remotely 1 or 2 days a week, providing telehealth visits to patients. That has led to a loss of productivity in many health care organizations and, consequently, a need to hire additional physicians.

Nevertheless, not many doctors are heading for the exit earlier than physicians did before COVID-19.

“They may work reduced hours,” Mr. Belkin said. “But the sense from a physician’s perspective is that this is all they know. For them to walk away from their life in medicine, from who they are, is problematic. So they’re continuing to practice, but at a reduced capacity.”

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

The number of physicians who have chosen early retirement or have left medicine because of the COVID-19 pandemic may be considerably lower than previously thought, results of a new study suggest.

The research letter in the Journal of the American Medical Association, based on Medicare claims data, stated that “practice interruption rates were similar before and during the COVID-19 pandemic, except for a spike in April 2020.”

By contrast, in a Physicians Foundation Survey conducted in August 2020, 8% of physicians said they had closed their practices as a result of COVID, and 4% of the respondents said they planned to leave their practices within the next 12 months.

Similarly, a Jackson Physician Search survey in the fourth quarter of 2020 found that 54% of physicians surveyed had changed their employment plans. Of those doctors, 21% said they might hang up their white coat for early retirement. That works out to about 11% of the respondents.

The JAMA study’s authors analyzed the Medicare claims data from Jan. 1, 2019, to Dec. 30, 2020, to see how many physicians with Medicare patients had stopped filing claims for a period during those 2 years.

If a doctor had ceased submitting claims and then resumed filing them within 6 months after the last billing month, the lapse in filing was defined as “interruption with return.” If a physician stopped filing claims to Medicare and did not resume within 6 months, the gap in filing was called “interruption without return.”

In April 2020, 6.9% of physicians billing Medicare had a practice interruption, compared to 1.4% in 2019. But only 1.1% of physicians stopped practice in April 2020 and did not return, compared with 0.33% in 2019.

Physicians aged 55 or older had higher rates of interruption both with and without return than younger doctors did. The change in interruption rates for older doctors was 7.2% vs. 3.9% for younger physicians. The change in older physicians’ interruption-without-return rate was 1.3% vs. 0.34% for younger colleagues.

“Female physicians, specialists, physicians in smaller practices, those not in a health professional shortage area, and those practicing in a metropolitan area experienced greater increases in practice interruption rates in April 2020 vs. April 2019,” the study states. “But those groups typically had higher rates of return, so the overall changes in practice interruptions without return were similar across characteristics other than age.”
 

Significance for retirement rate

Discussing these results, the authors stressed that practice interruptions without return can’t necessarily be attributed to retirement, and that practice interruptions with return don’t necessarily signify that doctors had been furloughed from their practices.

Also, they said, “this measure of practice interruption likely misses meaningful interruptions that lasted for less than a month or did not involve complete cessation in treating Medicare patients.”

Nevertheless, “the study does capture a signal of some doctors probably retiring,” Jonathan Weiner, DPH, professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, said in an interview.

But he added, “Some of those people who interrupted their practices and didn’t return may still come back. And there are probably a lot of other doctors who are leaving or changing practices that they didn’t capture.” For example, it’s possible that some doctors who went to work for other health care organizations stopped billing under their own names.

In Dr. Weiner’s view, the true percentage of physicians who have retired since the start of the pandemic is probably somewhere between the portion of doctors who interrupted their practice without return, according to the JAMA study, and the percentage of physicians who said they had closed their practices in the Physicians Foundation survey.
 

No mass exodus seen

Michael Belkin, JD, divisional vice president of recruiting for Merritt Hawkins, a physician search firm, said in an interview that the real number may be closer to the interruption-without-return figure in the JAMA study.

While many physician practices were disrupted in spring of 2020, he said, “it really didn’t result in a mass exodus [from health care]. We’re not talking to a lot of candidates who retired or walked away from their practices. We are talking to candidates who slowed down last year and then realized that they wanted to get back into medicine. And now they’re actively looking.”

One change in job candidates’ attitude, Mr. Belkin said, is that, because of COVID-19–related burnout, their quality of life is more important to them.

“They want to know, ‘What’s the culture of the employer like? What did they do last year during COVID? How did they handle it? Have they put together any protocols for the next pandemic?’ “
 

Demand for doctors has returned

In the summer of 2020, there was a major drop in physician recruitment by hospitals and health systems, partly because of fewer patient visits and procedures. But demand for doctors has bounced back over the past year, Mr. Belkin noted. One reason is the pent-up need for care among patients who avoided health care providers in 2020.

Another reason is that some employed doctors – particularly older physicians – have slowed down. Many doctors prefer to work remotely 1 or 2 days a week, providing telehealth visits to patients. That has led to a loss of productivity in many health care organizations and, consequently, a need to hire additional physicians.

Nevertheless, not many doctors are heading for the exit earlier than physicians did before COVID-19.

“They may work reduced hours,” Mr. Belkin said. “But the sense from a physician’s perspective is that this is all they know. For them to walk away from their life in medicine, from who they are, is problematic. So they’re continuing to practice, but at a reduced capacity.”

A version of this article first appeared on Medscape.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.

Paying people to participate in clinical trials remains controversial. But to date, most reservations are based on hypothetical scenarios or expert opinion with few real-world data to support them.

Research released this week could change that.

Investigators offered nearly 1,300 participants in two clinical trials either no payment or incentives up to $500 to partake in a smoking cessation study or an analysis of a behavioral intervention to increase ambulation in hospitalized patients.

More cash was associated with greater agreement to participate in the smoking cessation study but not the ambulation trial.

But the bigger news may be that offering payment did not appear to get people to accept more risks or skew participation to lower-income individuals, as some ethicists have warned.

“With the publication of our study, investigators finally have data that they can cite to put to rest any lingering concerns about offering moderate incentives in low-risk trials,” lead author Scott D. Halpern, MD, PhD, the John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy at the University of Pennsylvania, Philadelphia, told this news organization.

This initial real-world data centers on low-risk interventions and more research is needed to analyze the ethics and effectiveness of paying people to join clinical trials with more inherent risk, the researchers note.

The study was published online Sept. 20 in JAMA Internal Medicine.
 

A good first step?

“Payments to research participants are notoriously controversial. Many people oppose payments altogether or insist on minimal payments out of concern that people might be unduly influenced to participate,” Ana S. Iltis, PhD, told this news organization when asked for comment. “Others worry that incentives will disproportionately motivate the less well-off to participate.” 

“This is an important study that begins to assess whether these concerns are justified in a real-world context,” added Dr. Iltis, director of the Center for Bioethics, Health and Society and professor of philosophy at Wake Forest University in Winston-Salem, N.C.

In an accompanying invited commentary, Sang Ngo, Anthony S. Kim, MD, and Winston Chiong, MD, PhD, write: “This work is welcome, as it presents experimental data to a bioethical debate that so far has been largely driven by conjecture and competing suppositions.”

The commentary authors, however, question the conclusiveness of the findings. “Interpreting the authors’ findings is complex and illustrates some of the challenges inherent to applying empirical data to ethical problems,” they write.
 

Recruitment realities

When asked his advice for researchers considering financial incentives, Dr. Halpern said: “All researchers would happily include incentives in their trial budgets if not for concerns that the sponsor or institutional review board might not approve of them.”

“By far the biggest threat to a trial’s success is the inability to enroll enough participants,” he added.

Dr. Iltis agreed, framing the need to boost enrollment in ethical terms. “There is another important ethical issue that often gets ignored, and that is the issue of studies that fail to enroll enough participants and are never completed or are underpowered,” she said.

“These studies end up exposing people to research risks and burdens without a compensating social benefit.”

“If incentives help to increase enrollment and do not necessarily result in undue influence or unfair participant selection, then there might be ethical reasons to offer incentives,” Dr. Iltis added.

Building on previous work assessing financial incentives in hypothetical clinical trials, Dr. Halpern and colleagues studied 654 participants with major depressive disorder in a smoking cessation trial. They also studied another 642 participants in a study that compared a gamification strategy to usual care for encouraging hospitalized patients to get out of bed and walk.

Dr. Halpern and colleagues randomly assigned people in the smoking cessation study to receive no financial compensation, $200, or $500. In the ambulation trial, participants were randomly allocated to receive no compensation, $100, or $300.
 

Key findings

A total of 22% of those offered no incentive enrolled in the smoking cessation study. In contrast, 36% offered $200 agreed, as did 47% of those offered $500, which the investigators say supports offering cash incentives to boost enrollment. The differences were significant (P < .001).

In contrast, the amount offered did not significantly incentivize more people to participate in the ambulation trial (P = .62). Rates were 45% with no compensation, 48% with $100 payment, and 43% with $300 payment.

In an analysis that adjusted for demographic differences, financial well-being, and Research Attitudes Questionnaire (RAQ-7) scores, each increase in cash incentive increased the odds of enrollment in the smoking cessation trial by 70% (adjusted odds ratio, 1.70; 95% confidence interval, 1.34-2.17).

The same effect was not seen in the ambulation trial, where each higher cash incentive did not make a significant difference (aOR, 0.88; 95% CI, 0.64-1.22).

“The ambulation trial was a lower-risk trial in which patients’ willingness to participate was higher in general. So there were likely fewer people whose participation decisions could be influenced by offers of money,” Dr. Halpern said.
 

Inducement vs. coercion

The incentives in the study “did not function as unjust inducements, as they were not preferentially motivating across groups with different income levels or financial well-being in either trial,” the researchers note.

Dr. Halpern and colleagues also checked for any perceptions of coercion. More than 70% of participants in each smoking cessation trial group perceived no coercion, as did more than 93% of participants in each ambulation trial group, according to scores on a modified Perceived Coercion Scale of the MacArthur Admission Experience Survey. 

Furthermore, perception of risks did not significantly alter the association between cash incentives and enrollment in either trial.

After collecting the findings, Dr. Halpern and colleagues informed participants about their participation in RETAIN and explained the rationale for using different cash incentives. They also let all participants know they would ultimately receive the maximum incentive – either $500 or $300, depending on the trial.
 

Research implications

A study limitation was reliance on participant risk perception, as was an inability to measure perceived coercion among people who chose not to participant in the trials. Another potential limitation is that “neither of these parent trials posed particularly high risks. Future tests of incentives of different sizes, and in the context of higher-risk parent trials, including trials that test treatments of serious illnesses, are warranted,” the researchers note.

“While there are many more questions to ask and contexts in which to study the effects of incentives, this study calls on opponents of incentivizing research participants with money to be more humble,” Dr. Iltis said. “Incentives might not have the effects they assume they have and which they have long held make such incentives unethical.”

“I encourage researchers who are offering incentives to consider working with people doing ethics research to assess the effects of incentives in their studies,” Dr. Halpern said. “Real-world, as opposed to hypothetical studies that can improve our understanding of the impact of incentives can improve the ethical conduct of research over time.”
 

Responding to criticism

The authors of the invited commentary questioned the definitions Dr. Halpern and colleagues used for undue or unjust inducement. “Among bioethicists, there is no consensus about what counts as undue inducement or an unjust distribution of research burdens. In this article, the authors have operationalized these constructs based on their own interpretations of undue and unjust inducement, which may not capture all the concerns that scholars have raised about inducement.”

Asked to respond to this and other criticisms raised in the commentary, Dr. Halpern said: “Did our study answer all possible questions about incentives? Absolutely not. But when it comes to incentives for research participation, an ounce of data is worth a pound of conjecture.”

There was agreement, however, that the findings could now put the onus on opponents of financial incentives for trial participants.

“I agree with the commentary’s authors that our study essentially shifts the burden of proof, such that, as they say, ‘those who would limit [incentives’] application may owe us an applicable criterion,’ ” Dr. Halpern said.  

The authors of the invited commentary also criticized use of the study’s noninferiority design to rule out undue or unjust inducement. They note this design “may be unfamiliar to many bioethicists and can place substantial evaluative demands on readers.”

“As for the authors’ claim that noninferiority designs are difficult to interpret and unfamiliar to most clinicians and ethicists, I certainly agree,” Dr. Halpern said. “But that is hardly a reason to not employ the most rigorous methods possible to answer important questions.”

The study was supported by funding from the National Cancer Institute.

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

Paying people to participate in clinical trials remains controversial. But to date, most reservations are based on hypothetical scenarios or expert opinion with few real-world data to support them.

Research released this week could change that.

Investigators offered nearly 1,300 participants in two clinical trials either no payment or incentives up to $500 to partake in a smoking cessation study or an analysis of a behavioral intervention to increase ambulation in hospitalized patients.

More cash was associated with greater agreement to participate in the smoking cessation study but not the ambulation trial.

But the bigger news may be that offering payment did not appear to get people to accept more risks or skew participation to lower-income individuals, as some ethicists have warned.

“With the publication of our study, investigators finally have data that they can cite to put to rest any lingering concerns about offering moderate incentives in low-risk trials,” lead author Scott D. Halpern, MD, PhD, the John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy at the University of Pennsylvania, Philadelphia, told this news organization.

This initial real-world data centers on low-risk interventions and more research is needed to analyze the ethics and effectiveness of paying people to join clinical trials with more inherent risk, the researchers note.

The study was published online Sept. 20 in JAMA Internal Medicine.
 

A good first step?

“Payments to research participants are notoriously controversial. Many people oppose payments altogether or insist on minimal payments out of concern that people might be unduly influenced to participate,” Ana S. Iltis, PhD, told this news organization when asked for comment. “Others worry that incentives will disproportionately motivate the less well-off to participate.” 

“This is an important study that begins to assess whether these concerns are justified in a real-world context,” added Dr. Iltis, director of the Center for Bioethics, Health and Society and professor of philosophy at Wake Forest University in Winston-Salem, N.C.

In an accompanying invited commentary, Sang Ngo, Anthony S. Kim, MD, and Winston Chiong, MD, PhD, write: “This work is welcome, as it presents experimental data to a bioethical debate that so far has been largely driven by conjecture and competing suppositions.”

The commentary authors, however, question the conclusiveness of the findings. “Interpreting the authors’ findings is complex and illustrates some of the challenges inherent to applying empirical data to ethical problems,” they write.
 

Recruitment realities

When asked his advice for researchers considering financial incentives, Dr. Halpern said: “All researchers would happily include incentives in their trial budgets if not for concerns that the sponsor or institutional review board might not approve of them.”

“By far the biggest threat to a trial’s success is the inability to enroll enough participants,” he added.

Dr. Iltis agreed, framing the need to boost enrollment in ethical terms. “There is another important ethical issue that often gets ignored, and that is the issue of studies that fail to enroll enough participants and are never completed or are underpowered,” she said.

“These studies end up exposing people to research risks and burdens without a compensating social benefit.”

“If incentives help to increase enrollment and do not necessarily result in undue influence or unfair participant selection, then there might be ethical reasons to offer incentives,” Dr. Iltis added.

Building on previous work assessing financial incentives in hypothetical clinical trials, Dr. Halpern and colleagues studied 654 participants with major depressive disorder in a smoking cessation trial. They also studied another 642 participants in a study that compared a gamification strategy to usual care for encouraging hospitalized patients to get out of bed and walk.

Dr. Halpern and colleagues randomly assigned people in the smoking cessation study to receive no financial compensation, $200, or $500. In the ambulation trial, participants were randomly allocated to receive no compensation, $100, or $300.
 

Key findings

A total of 22% of those offered no incentive enrolled in the smoking cessation study. In contrast, 36% offered $200 agreed, as did 47% of those offered $500, which the investigators say supports offering cash incentives to boost enrollment. The differences were significant (P < .001).

In contrast, the amount offered did not significantly incentivize more people to participate in the ambulation trial (P = .62). Rates were 45% with no compensation, 48% with $100 payment, and 43% with $300 payment.

In an analysis that adjusted for demographic differences, financial well-being, and Research Attitudes Questionnaire (RAQ-7) scores, each increase in cash incentive increased the odds of enrollment in the smoking cessation trial by 70% (adjusted odds ratio, 1.70; 95% confidence interval, 1.34-2.17).

The same effect was not seen in the ambulation trial, where each higher cash incentive did not make a significant difference (aOR, 0.88; 95% CI, 0.64-1.22).

“The ambulation trial was a lower-risk trial in which patients’ willingness to participate was higher in general. So there were likely fewer people whose participation decisions could be influenced by offers of money,” Dr. Halpern said.
 

Inducement vs. coercion

The incentives in the study “did not function as unjust inducements, as they were not preferentially motivating across groups with different income levels or financial well-being in either trial,” the researchers note.

Dr. Halpern and colleagues also checked for any perceptions of coercion. More than 70% of participants in each smoking cessation trial group perceived no coercion, as did more than 93% of participants in each ambulation trial group, according to scores on a modified Perceived Coercion Scale of the MacArthur Admission Experience Survey. 

Furthermore, perception of risks did not significantly alter the association between cash incentives and enrollment in either trial.

After collecting the findings, Dr. Halpern and colleagues informed participants about their participation in RETAIN and explained the rationale for using different cash incentives. They also let all participants know they would ultimately receive the maximum incentive – either $500 or $300, depending on the trial.
 

Research implications

A study limitation was reliance on participant risk perception, as was an inability to measure perceived coercion among people who chose not to participant in the trials. Another potential limitation is that “neither of these parent trials posed particularly high risks. Future tests of incentives of different sizes, and in the context of higher-risk parent trials, including trials that test treatments of serious illnesses, are warranted,” the researchers note.

“While there are many more questions to ask and contexts in which to study the effects of incentives, this study calls on opponents of incentivizing research participants with money to be more humble,” Dr. Iltis said. “Incentives might not have the effects they assume they have and which they have long held make such incentives unethical.”

“I encourage researchers who are offering incentives to consider working with people doing ethics research to assess the effects of incentives in their studies,” Dr. Halpern said. “Real-world, as opposed to hypothetical studies that can improve our understanding of the impact of incentives can improve the ethical conduct of research over time.”
 

Responding to criticism

The authors of the invited commentary questioned the definitions Dr. Halpern and colleagues used for undue or unjust inducement. “Among bioethicists, there is no consensus about what counts as undue inducement or an unjust distribution of research burdens. In this article, the authors have operationalized these constructs based on their own interpretations of undue and unjust inducement, which may not capture all the concerns that scholars have raised about inducement.”

Asked to respond to this and other criticisms raised in the commentary, Dr. Halpern said: “Did our study answer all possible questions about incentives? Absolutely not. But when it comes to incentives for research participation, an ounce of data is worth a pound of conjecture.”

There was agreement, however, that the findings could now put the onus on opponents of financial incentives for trial participants.

“I agree with the commentary’s authors that our study essentially shifts the burden of proof, such that, as they say, ‘those who would limit [incentives’] application may owe us an applicable criterion,’ ” Dr. Halpern said.  

The authors of the invited commentary also criticized use of the study’s noninferiority design to rule out undue or unjust inducement. They note this design “may be unfamiliar to many bioethicists and can place substantial evaluative demands on readers.”

“As for the authors’ claim that noninferiority designs are difficult to interpret and unfamiliar to most clinicians and ethicists, I certainly agree,” Dr. Halpern said. “But that is hardly a reason to not employ the most rigorous methods possible to answer important questions.”

The study was supported by funding from the National Cancer Institute.

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

Paying people to participate in clinical trials remains controversial. But to date, most reservations are based on hypothetical scenarios or expert opinion with few real-world data to support them.

Research released this week could change that.

Investigators offered nearly 1,300 participants in two clinical trials either no payment or incentives up to $500 to partake in a smoking cessation study or an analysis of a behavioral intervention to increase ambulation in hospitalized patients.

More cash was associated with greater agreement to participate in the smoking cessation study but not the ambulation trial.

But the bigger news may be that offering payment did not appear to get people to accept more risks or skew participation to lower-income individuals, as some ethicists have warned.

“With the publication of our study, investigators finally have data that they can cite to put to rest any lingering concerns about offering moderate incentives in low-risk trials,” lead author Scott D. Halpern, MD, PhD, the John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy at the University of Pennsylvania, Philadelphia, told this news organization.

This initial real-world data centers on low-risk interventions and more research is needed to analyze the ethics and effectiveness of paying people to join clinical trials with more inherent risk, the researchers note.

The study was published online Sept. 20 in JAMA Internal Medicine.
 

A good first step?

“Payments to research participants are notoriously controversial. Many people oppose payments altogether or insist on minimal payments out of concern that people might be unduly influenced to participate,” Ana S. Iltis, PhD, told this news organization when asked for comment. “Others worry that incentives will disproportionately motivate the less well-off to participate.” 

“This is an important study that begins to assess whether these concerns are justified in a real-world context,” added Dr. Iltis, director of the Center for Bioethics, Health and Society and professor of philosophy at Wake Forest University in Winston-Salem, N.C.

In an accompanying invited commentary, Sang Ngo, Anthony S. Kim, MD, and Winston Chiong, MD, PhD, write: “This work is welcome, as it presents experimental data to a bioethical debate that so far has been largely driven by conjecture and competing suppositions.”

The commentary authors, however, question the conclusiveness of the findings. “Interpreting the authors’ findings is complex and illustrates some of the challenges inherent to applying empirical data to ethical problems,” they write.
 

Recruitment realities

When asked his advice for researchers considering financial incentives, Dr. Halpern said: “All researchers would happily include incentives in their trial budgets if not for concerns that the sponsor or institutional review board might not approve of them.”

“By far the biggest threat to a trial’s success is the inability to enroll enough participants,” he added.

Dr. Iltis agreed, framing the need to boost enrollment in ethical terms. “There is another important ethical issue that often gets ignored, and that is the issue of studies that fail to enroll enough participants and are never completed or are underpowered,” she said.

“These studies end up exposing people to research risks and burdens without a compensating social benefit.”

“If incentives help to increase enrollment and do not necessarily result in undue influence or unfair participant selection, then there might be ethical reasons to offer incentives,” Dr. Iltis added.

Building on previous work assessing financial incentives in hypothetical clinical trials, Dr. Halpern and colleagues studied 654 participants with major depressive disorder in a smoking cessation trial. They also studied another 642 participants in a study that compared a gamification strategy to usual care for encouraging hospitalized patients to get out of bed and walk.

Dr. Halpern and colleagues randomly assigned people in the smoking cessation study to receive no financial compensation, $200, or $500. In the ambulation trial, participants were randomly allocated to receive no compensation, $100, or $300.
 

Key findings

A total of 22% of those offered no incentive enrolled in the smoking cessation study. In contrast, 36% offered $200 agreed, as did 47% of those offered $500, which the investigators say supports offering cash incentives to boost enrollment. The differences were significant (P < .001).

In contrast, the amount offered did not significantly incentivize more people to participate in the ambulation trial (P = .62). Rates were 45% with no compensation, 48% with $100 payment, and 43% with $300 payment.

In an analysis that adjusted for demographic differences, financial well-being, and Research Attitudes Questionnaire (RAQ-7) scores, each increase in cash incentive increased the odds of enrollment in the smoking cessation trial by 70% (adjusted odds ratio, 1.70; 95% confidence interval, 1.34-2.17).

The same effect was not seen in the ambulation trial, where each higher cash incentive did not make a significant difference (aOR, 0.88; 95% CI, 0.64-1.22).

“The ambulation trial was a lower-risk trial in which patients’ willingness to participate was higher in general. So there were likely fewer people whose participation decisions could be influenced by offers of money,” Dr. Halpern said.
 

Inducement vs. coercion

The incentives in the study “did not function as unjust inducements, as they were not preferentially motivating across groups with different income levels or financial well-being in either trial,” the researchers note.

Dr. Halpern and colleagues also checked for any perceptions of coercion. More than 70% of participants in each smoking cessation trial group perceived no coercion, as did more than 93% of participants in each ambulation trial group, according to scores on a modified Perceived Coercion Scale of the MacArthur Admission Experience Survey. 

Furthermore, perception of risks did not significantly alter the association between cash incentives and enrollment in either trial.

After collecting the findings, Dr. Halpern and colleagues informed participants about their participation in RETAIN and explained the rationale for using different cash incentives. They also let all participants know they would ultimately receive the maximum incentive – either $500 or $300, depending on the trial.
 

Research implications

A study limitation was reliance on participant risk perception, as was an inability to measure perceived coercion among people who chose not to participant in the trials. Another potential limitation is that “neither of these parent trials posed particularly high risks. Future tests of incentives of different sizes, and in the context of higher-risk parent trials, including trials that test treatments of serious illnesses, are warranted,” the researchers note.

“While there are many more questions to ask and contexts in which to study the effects of incentives, this study calls on opponents of incentivizing research participants with money to be more humble,” Dr. Iltis said. “Incentives might not have the effects they assume they have and which they have long held make such incentives unethical.”

“I encourage researchers who are offering incentives to consider working with people doing ethics research to assess the effects of incentives in their studies,” Dr. Halpern said. “Real-world, as opposed to hypothetical studies that can improve our understanding of the impact of incentives can improve the ethical conduct of research over time.”
 

Responding to criticism

The authors of the invited commentary questioned the definitions Dr. Halpern and colleagues used for undue or unjust inducement. “Among bioethicists, there is no consensus about what counts as undue inducement or an unjust distribution of research burdens. In this article, the authors have operationalized these constructs based on their own interpretations of undue and unjust inducement, which may not capture all the concerns that scholars have raised about inducement.”

Asked to respond to this and other criticisms raised in the commentary, Dr. Halpern said: “Did our study answer all possible questions about incentives? Absolutely not. But when it comes to incentives for research participation, an ounce of data is worth a pound of conjecture.”

There was agreement, however, that the findings could now put the onus on opponents of financial incentives for trial participants.

“I agree with the commentary’s authors that our study essentially shifts the burden of proof, such that, as they say, ‘those who would limit [incentives’] application may owe us an applicable criterion,’ ” Dr. Halpern said.  

The authors of the invited commentary also criticized use of the study’s noninferiority design to rule out undue or unjust inducement. They note this design “may be unfamiliar to many bioethicists and can place substantial evaluative demands on readers.”

“As for the authors’ claim that noninferiority designs are difficult to interpret and unfamiliar to most clinicians and ethicists, I certainly agree,” Dr. Halpern said. “But that is hardly a reason to not employ the most rigorous methods possible to answer important questions.”

The study was supported by funding from the National Cancer Institute.

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

A nationwide, retrospective, case-control study of older adults in Denmark suggests that the bisphosphonate alendronate that is widely used to treat osteoporosis may protect against new-onset type 2 diabetes. But these preliminary findings need to be confirmed in a randomized controlled trial, experts said.

The registry study showed that from 2008 to 2018, among individuals in Denmark age 50 and older (with a mean age of 67), those who were taking alendronate were 36% less likely to have new-onset type 2 diabetes than age- and sex-matched individuals who were not taking the drug, after controlling for multiple risk factors.

The results also suggest that longer alendronate use and higher compliance might be more protective.

Rikke Viggers, MD, a PhD student in the department of clinical medicine, Aalborg (Denmark) University, presented the findings during an oral session at the annual meeting of the European Association for the Study of Diabetes.

“Excitingly, our research suggests that alendronate, an inexpensive medicine widely used to treat osteoporosis, may also protect against type 2 diabetes,” Dr. Viggers summarized in a press release issued by the EASD.

“Type 2 diabetes is a serious lifelong condition that can lead to other serious health issues such as stroke, heart disease, blindness, and limb amputation,” she noted, “and anything that prevents or even delays it will also reduce a person’s risk of all these other conditions.”

“We believe that doctors should consider this when prescribing osteoporosis drugs to those with prediabetes or at high risk of type 2 diabetes,” she added.
 

Preliminary results, need for RCT

However, these are preliminary results, Dr. Viggers cautioned during the oral presentation and in an email. “This is a registry-based study,” she stressed, “and we cannot conclude causality.”

“We do not know if this effect [of decreased risk of developing diabetes among people taking alendronate] is ‘real’ and what the mechanisms are.”

“It could be a direct effect on peripheral tissues, for example, muscle and adipose tissue,” Dr. Viggers speculated, “or an indirect effect through bone metabolites that may impact glucose metabolism.”

The group is now conducting a randomized controlled trial in patients with diabetes and osteopenia or osteoporosis to examine the relationship between alendronate and insulin sensitivity, bone indices, and glycemic control.

They also aim to investigate whether alendronate is the optimal antiosteoporotic therapy for patients with type 2 diabetes. Preliminary results suggest that other bisphosphonates have similar effects.

“Alendronate decreases bone turnover and may not be beneficial in healthy bones,” Dr. Viggers noted. “However, as far as I know, potential other side effects have not been tested in healthy bones,” so further research is needed.

Current registry study findings

Glucose homeostasis has been linked to bone metabolism, Dr. Viggers said, and bisphosphonates were associated with increased insulin sensitivity and decreased risk of diabetes risk in two registry studies from Denmark and Taiwan.

The researchers aimed to investigate if the risk of developing type 2 diabetes was altered by previous use of alendronate.

Using data from the national Danish Patient Registry, they identified 163,588 individuals age 50 and older newly diagnosed with type 2 diabetes in 2008-2018.

They matched each patient with three individuals of the same gender and age range who did not have diabetes, for a total of 490,764 controls.

Roughly two-thirds of participants were in their 50s or 60s, a quarter were in their 70s, and 10% were 80 or older. About half of participants were women (45%).

Compared to the patients with new-onset type 2 diabetes, the control participants were healthier: they were less likely to have obesity (6% vs. 17%) and had a lower mean Charlson Comorbidity Index (0.38 vs. 0.88).

Using data from the national Danish Health Service Prescription Registry, the researchers identified individuals who filled prescriptions for alendronate in 2008-2018.

After controlling for heavy smoking, alcohol abuse, obesity, pancreatitis, hyperthyroidism, hypothyroidism, glucocorticoid use, marital status, household income, and Charlson Comorbidity Index, people taking alendronate were less likely to have new-onset diabetes than those not taking this drug (odds ratio, 0.64; 95% confidence interval, 0.62-0.66).

The odds of developing type 2 diabetes were even lower among those who took alendronate for 8 years or more versus never-users (OR, 0.47; 95% CI, 0.40-0.56), after controlling for the same variables.

Session Chair Zhila Semnani-Azad, a PhD student in nutritional science, University of Toronto, wanted to know if the researchers accounted for physical activity and vitamin D use. Dr. Viggers replied that the registries did not have this information.

The study was funded by a Steno Collaborative Project grant from the Novo Nordisk Foundation, Denmark. Dr. Viggers has disclosed receiving a grant from the foundation. Dr. Vega has disclosed serving as a consultant for Johnson & Johnson.

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

A nationwide, retrospective, case-control study of older adults in Denmark suggests that the bisphosphonate alendronate that is widely used to treat osteoporosis may protect against new-onset type 2 diabetes. But these preliminary findings need to be confirmed in a randomized controlled trial, experts said.

The registry study showed that from 2008 to 2018, among individuals in Denmark age 50 and older (with a mean age of 67), those who were taking alendronate were 36% less likely to have new-onset type 2 diabetes than age- and sex-matched individuals who were not taking the drug, after controlling for multiple risk factors.

The results also suggest that longer alendronate use and higher compliance might be more protective.

Rikke Viggers, MD, a PhD student in the department of clinical medicine, Aalborg (Denmark) University, presented the findings during an oral session at the annual meeting of the European Association for the Study of Diabetes.

“Excitingly, our research suggests that alendronate, an inexpensive medicine widely used to treat osteoporosis, may also protect against type 2 diabetes,” Dr. Viggers summarized in a press release issued by the EASD.

“Type 2 diabetes is a serious lifelong condition that can lead to other serious health issues such as stroke, heart disease, blindness, and limb amputation,” she noted, “and anything that prevents or even delays it will also reduce a person’s risk of all these other conditions.”

“We believe that doctors should consider this when prescribing osteoporosis drugs to those with prediabetes or at high risk of type 2 diabetes,” she added.
 

Preliminary results, need for RCT

However, these are preliminary results, Dr. Viggers cautioned during the oral presentation and in an email. “This is a registry-based study,” she stressed, “and we cannot conclude causality.”

“We do not know if this effect [of decreased risk of developing diabetes among people taking alendronate] is ‘real’ and what the mechanisms are.”

“It could be a direct effect on peripheral tissues, for example, muscle and adipose tissue,” Dr. Viggers speculated, “or an indirect effect through bone metabolites that may impact glucose metabolism.”

The group is now conducting a randomized controlled trial in patients with diabetes and osteopenia or osteoporosis to examine the relationship between alendronate and insulin sensitivity, bone indices, and glycemic control.

They also aim to investigate whether alendronate is the optimal antiosteoporotic therapy for patients with type 2 diabetes. Preliminary results suggest that other bisphosphonates have similar effects.

“Alendronate decreases bone turnover and may not be beneficial in healthy bones,” Dr. Viggers noted. “However, as far as I know, potential other side effects have not been tested in healthy bones,” so further research is needed.

Current registry study findings

Glucose homeostasis has been linked to bone metabolism, Dr. Viggers said, and bisphosphonates were associated with increased insulin sensitivity and decreased risk of diabetes risk in two registry studies from Denmark and Taiwan.

The researchers aimed to investigate if the risk of developing type 2 diabetes was altered by previous use of alendronate.

Using data from the national Danish Patient Registry, they identified 163,588 individuals age 50 and older newly diagnosed with type 2 diabetes in 2008-2018.

They matched each patient with three individuals of the same gender and age range who did not have diabetes, for a total of 490,764 controls.

Roughly two-thirds of participants were in their 50s or 60s, a quarter were in their 70s, and 10% were 80 or older. About half of participants were women (45%).

Compared to the patients with new-onset type 2 diabetes, the control participants were healthier: they were less likely to have obesity (6% vs. 17%) and had a lower mean Charlson Comorbidity Index (0.38 vs. 0.88).

Using data from the national Danish Health Service Prescription Registry, the researchers identified individuals who filled prescriptions for alendronate in 2008-2018.

After controlling for heavy smoking, alcohol abuse, obesity, pancreatitis, hyperthyroidism, hypothyroidism, glucocorticoid use, marital status, household income, and Charlson Comorbidity Index, people taking alendronate were less likely to have new-onset diabetes than those not taking this drug (odds ratio, 0.64; 95% confidence interval, 0.62-0.66).

The odds of developing type 2 diabetes were even lower among those who took alendronate for 8 years or more versus never-users (OR, 0.47; 95% CI, 0.40-0.56), after controlling for the same variables.

Session Chair Zhila Semnani-Azad, a PhD student in nutritional science, University of Toronto, wanted to know if the researchers accounted for physical activity and vitamin D use. Dr. Viggers replied that the registries did not have this information.

The study was funded by a Steno Collaborative Project grant from the Novo Nordisk Foundation, Denmark. Dr. Viggers has disclosed receiving a grant from the foundation. Dr. Vega has disclosed serving as a consultant for Johnson & Johnson.

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

A nationwide, retrospective, case-control study of older adults in Denmark suggests that the bisphosphonate alendronate that is widely used to treat osteoporosis may protect against new-onset type 2 diabetes. But these preliminary findings need to be confirmed in a randomized controlled trial, experts said.

The registry study showed that from 2008 to 2018, among individuals in Denmark age 50 and older (with a mean age of 67), those who were taking alendronate were 36% less likely to have new-onset type 2 diabetes than age- and sex-matched individuals who were not taking the drug, after controlling for multiple risk factors.

The results also suggest that longer alendronate use and higher compliance might be more protective.

Rikke Viggers, MD, a PhD student in the department of clinical medicine, Aalborg (Denmark) University, presented the findings during an oral session at the annual meeting of the European Association for the Study of Diabetes.

“Excitingly, our research suggests that alendronate, an inexpensive medicine widely used to treat osteoporosis, may also protect against type 2 diabetes,” Dr. Viggers summarized in a press release issued by the EASD.

“Type 2 diabetes is a serious lifelong condition that can lead to other serious health issues such as stroke, heart disease, blindness, and limb amputation,” she noted, “and anything that prevents or even delays it will also reduce a person’s risk of all these other conditions.”

“We believe that doctors should consider this when prescribing osteoporosis drugs to those with prediabetes or at high risk of type 2 diabetes,” she added.
 

Preliminary results, need for RCT

However, these are preliminary results, Dr. Viggers cautioned during the oral presentation and in an email. “This is a registry-based study,” she stressed, “and we cannot conclude causality.”

“We do not know if this effect [of decreased risk of developing diabetes among people taking alendronate] is ‘real’ and what the mechanisms are.”

“It could be a direct effect on peripheral tissues, for example, muscle and adipose tissue,” Dr. Viggers speculated, “or an indirect effect through bone metabolites that may impact glucose metabolism.”

The group is now conducting a randomized controlled trial in patients with diabetes and osteopenia or osteoporosis to examine the relationship between alendronate and insulin sensitivity, bone indices, and glycemic control.

They also aim to investigate whether alendronate is the optimal antiosteoporotic therapy for patients with type 2 diabetes. Preliminary results suggest that other bisphosphonates have similar effects.

“Alendronate decreases bone turnover and may not be beneficial in healthy bones,” Dr. Viggers noted. “However, as far as I know, potential other side effects have not been tested in healthy bones,” so further research is needed.

Current registry study findings

Glucose homeostasis has been linked to bone metabolism, Dr. Viggers said, and bisphosphonates were associated with increased insulin sensitivity and decreased risk of diabetes risk in two registry studies from Denmark and Taiwan.

The researchers aimed to investigate if the risk of developing type 2 diabetes was altered by previous use of alendronate.

Using data from the national Danish Patient Registry, they identified 163,588 individuals age 50 and older newly diagnosed with type 2 diabetes in 2008-2018.

They matched each patient with three individuals of the same gender and age range who did not have diabetes, for a total of 490,764 controls.

Roughly two-thirds of participants were in their 50s or 60s, a quarter were in their 70s, and 10% were 80 or older. About half of participants were women (45%).

Compared to the patients with new-onset type 2 diabetes, the control participants were healthier: they were less likely to have obesity (6% vs. 17%) and had a lower mean Charlson Comorbidity Index (0.38 vs. 0.88).

Using data from the national Danish Health Service Prescription Registry, the researchers identified individuals who filled prescriptions for alendronate in 2008-2018.

After controlling for heavy smoking, alcohol abuse, obesity, pancreatitis, hyperthyroidism, hypothyroidism, glucocorticoid use, marital status, household income, and Charlson Comorbidity Index, people taking alendronate were less likely to have new-onset diabetes than those not taking this drug (odds ratio, 0.64; 95% confidence interval, 0.62-0.66).

The odds of developing type 2 diabetes were even lower among those who took alendronate for 8 years or more versus never-users (OR, 0.47; 95% CI, 0.40-0.56), after controlling for the same variables.

Session Chair Zhila Semnani-Azad, a PhD student in nutritional science, University of Toronto, wanted to know if the researchers accounted for physical activity and vitamin D use. Dr. Viggers replied that the registries did not have this information.

The study was funded by a Steno Collaborative Project grant from the Novo Nordisk Foundation, Denmark. Dr. Viggers has disclosed receiving a grant from the foundation. Dr. Vega has disclosed serving as a consultant for Johnson & Johnson.

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

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!

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.

After nearly a decade, the American Academy of Orthopaedic Surgeons has updated its guidance on nonoperative treatment for knee osteoarthritis.

The clinical practice guidelines, released Sept. 13, 2021, is the third edition of the orthopedic society’s clinical practice recommendations.

According to Robert Brophy, MD, FAAOS, an orthopedic surgeon at Washington University, St. Louis, and cochair of the AAOS clinical practice guideline work group, the AAOS guidelines are a “living document” that needs periodic updating as new research comes to light.

“The methodology for maintaining the AAOS guidelines aims to update guideline documents at least every 10 years,” Dr. Brophy said in an interview. “Since the last edition was from 2013, it was time to provide an updated guideline on this very important topic that affects such a high percentage of our patients and providers.”

The guidelines work group, composed of 12 medical doctors and 1 physical therapist, evaluated the evidence for 29 areas of treatment.

A rating scale based on available evidence and the strength of related medical studies labeled each treatment area as demonstrating strong, moderate, or limited evidence.

Eight treatment modalities weighed in with strong evidence for or against their use: lateral wedge insoles, topical or oral NSAIDs, exercise (supervised or unsupervised), self-management programs, patient education programs, oral acetaminophen, and oral opioids.

According to Dr. Brophy, many of the recommendations assigned a strong evidence base were similar to the prior edition of the guidelines.
 

Oral medications

NSAIDs and acetaminophen still remain steadfast options for the treatment of knee pain secondary to OA.

decade3d/Thinkstock

The most notable change was that opioids, which have a long history of being used to treat pain, are strongly recommended not to be used for arthritis.

“Reflecting the growing awareness of and emphasis on the opioid epidemic, one of the strongest changes between the current and prior guidelines centers on the use of opioid medications,” Dr. Brophy said. “In the prior guideline, a strong recommendation was made in favor of tramadol with an inconclusive recommendation made regarding other opioid medications. The updated guideline demonstrates clearly the evidence does not support the use of opioid medications – including tramadol – to treat knee osteoarthritis.”

This may require some education for both patients and doctors to buy in that knee pain can be treated adequately with NSAIDs and acetaminophen.

Patients may not understand that anti-inflammatory drugs treat the pain they are experiencing. They may equate an opioid with a “pain pill” and may need education from their doctor that NSAIDs and acetaminophen not only can relieve their pain, but also avoid potential adverse events prior to or after surgery should they progress to knee replacement surgery.

Furthermore, primary care physicians may not be looking at the long-term picture. Solving a short-term pain problem with opioids may limit the medication’s ability to provide pain relief after surgery should a patient develop a tolerance to the medication’s effects.
 

Recommendations on hip and foot alignment interventions

When it comes to alignment and joint stresses, the knee is sometimes considered the innocent bystander of hip and foot alignment.

Insoles. How the hip and foot align with each can determine the amount of weight that passes through the medial (inner) or lateral (outer) compartment of the knee. To that end, lateral foot insoles have been used in the past for unloading parts of the knee.

Nevertheless, recent evidence has failed to demonstrate a significant benefit for insoles in the setting of OA knee pain, earning the practice a strong recommendation against its use.

High-tibial osteotomy (HTO). The weight-bearing axis of the lower-extremity axis can also be realigned with HTO. The procedure shifts the body’s weight slightly to the opposite side of the knee.

Newer research has led the practice to be downgraded one level in the new guideline, from moderate to limited, despite its widespread use.

It will, however, likely continue to be used as an alternative to total knee replacement in younger patients and to shift weight away from an area of the knee where cartilage is being restored with a concomitant surgical procedure, according to the work group. They noted that additional research studies on the long-term efficacy of the procedure are still needed.

Topical treatments. The guideline authors gave these a strong recommendation. Gels with anti-inflammatory medication have long been available but were prescription only or of considerable cost. Now several affordable over-the-counter options with the same prescription strength can be found in pharmacies and supermarkets.

What makes these medications unique is that they have an NSAID medication in the formulation, which the vast majority of topical treatments found on shelves do not. They also benefit patients who are unable to tolerate oral NSAIDs because of gastrointestinal side effects.

Comparison with 2019 OARSI recommendations

In 2019, the Osteoarthritis Research Society International also published guidelines for the management of OA of the hand, hip, and knee.

Thomas Trojian, MD, a family medicine physician with expertise in sports medicine in York, Pa., and member of both the AAOS and OARSI recommendation committees, noted that the OARSI guidelines are meant to be practical guidelines of stepwise nonoperative treatment.

He said in an interview that “the OARSI guidelines recommend dietary weight management, education, and land-based [exercise] therapy, next topical NSAIDs, then injection therapy.”

Intra-articular steroids and viscosupplementation injection therapy in the form of hyaluronic acid derivatives continue to be a mainstay of treatment for both groups.

The AAOS group notably gave a moderate strength recommendation for intra-articular steroid injections with the caveat that the effects typically only last for 3 months. They also included newer extended-release steroid injections in the recommendation, stating that the evidence moderately suggests they provide more benefit than traditional short-acting steroid injections.
 

Methodology differs between guidelines

In the areas where the guidelines don’t fully line up, it is important to remember the methodology of each group often drives the guidelines and recommendations.

According to Yale Fillingham, MD, an orthopedic surgeon in group private practice in the greater Philadelphia area and the other cochair of the AAOS guidelines committee, the biggest difference between the AAOS and OARSI guidelines is that, although the OARSI guidelines are also grounded in the literature, the recommendation level was based on voting among panel members.

“The AAOS methodology requires the recommendation and strength of the recommendation to be dictated primarily by the best available evidence in the literature and much less on the expertise and opinion of the voting panel,” Dr. Fillingham said in an interview.

He pointed out that the AAOS voting panel can alter the guideline by adjusting the strength of the recommendation but noted it was only in very clearly defined situations. Therefore, the differences in methodology between the groups make it difficult to directly compare the two guidelines.

Multiple guidelines do, however, point to the importance of the issue. Dr. Fillingham commented: “The numerous organizations that have produced guidelines on the treatment of knee osteoarthritis are a testament to the widespread and profound impact of knee osteoarthritis on our health care system and society.”

As a member of both recommendation groups, Dr. Trojian finds both guidelines reveal the importance of understanding that knee OA is a chronic illness. “There are ways we can manage knee OA and reduce the morbidity. ... The core skills of motivational interviewing are important. Open-ended questions, affirmation, reflection, and summarizing are needed to help patients find and remove roadblocks to promote lifestyle changes.”

Dr. Brophy, Dr. Trojian, and Dr. Fillingham have disclosed no relevant financial relationships.

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

After nearly a decade, the American Academy of Orthopaedic Surgeons has updated its guidance on nonoperative treatment for knee osteoarthritis.

The clinical practice guidelines, released Sept. 13, 2021, is the third edition of the orthopedic society’s clinical practice recommendations.

According to Robert Brophy, MD, FAAOS, an orthopedic surgeon at Washington University, St. Louis, and cochair of the AAOS clinical practice guideline work group, the AAOS guidelines are a “living document” that needs periodic updating as new research comes to light.

“The methodology for maintaining the AAOS guidelines aims to update guideline documents at least every 10 years,” Dr. Brophy said in an interview. “Since the last edition was from 2013, it was time to provide an updated guideline on this very important topic that affects such a high percentage of our patients and providers.”

The guidelines work group, composed of 12 medical doctors and 1 physical therapist, evaluated the evidence for 29 areas of treatment.

A rating scale based on available evidence and the strength of related medical studies labeled each treatment area as demonstrating strong, moderate, or limited evidence.

Eight treatment modalities weighed in with strong evidence for or against their use: lateral wedge insoles, topical or oral NSAIDs, exercise (supervised or unsupervised), self-management programs, patient education programs, oral acetaminophen, and oral opioids.

According to Dr. Brophy, many of the recommendations assigned a strong evidence base were similar to the prior edition of the guidelines.
 

Oral medications

NSAIDs and acetaminophen still remain steadfast options for the treatment of knee pain secondary to OA.

decade3d/Thinkstock

The most notable change was that opioids, which have a long history of being used to treat pain, are strongly recommended not to be used for arthritis.

“Reflecting the growing awareness of and emphasis on the opioid epidemic, one of the strongest changes between the current and prior guidelines centers on the use of opioid medications,” Dr. Brophy said. “In the prior guideline, a strong recommendation was made in favor of tramadol with an inconclusive recommendation made regarding other opioid medications. The updated guideline demonstrates clearly the evidence does not support the use of opioid medications – including tramadol – to treat knee osteoarthritis.”

This may require some education for both patients and doctors to buy in that knee pain can be treated adequately with NSAIDs and acetaminophen.

Patients may not understand that anti-inflammatory drugs treat the pain they are experiencing. They may equate an opioid with a “pain pill” and may need education from their doctor that NSAIDs and acetaminophen not only can relieve their pain, but also avoid potential adverse events prior to or after surgery should they progress to knee replacement surgery.

Furthermore, primary care physicians may not be looking at the long-term picture. Solving a short-term pain problem with opioids may limit the medication’s ability to provide pain relief after surgery should a patient develop a tolerance to the medication’s effects.
 

Recommendations on hip and foot alignment interventions

When it comes to alignment and joint stresses, the knee is sometimes considered the innocent bystander of hip and foot alignment.

Insoles. How the hip and foot align with each can determine the amount of weight that passes through the medial (inner) or lateral (outer) compartment of the knee. To that end, lateral foot insoles have been used in the past for unloading parts of the knee.

Nevertheless, recent evidence has failed to demonstrate a significant benefit for insoles in the setting of OA knee pain, earning the practice a strong recommendation against its use.

High-tibial osteotomy (HTO). The weight-bearing axis of the lower-extremity axis can also be realigned with HTO. The procedure shifts the body’s weight slightly to the opposite side of the knee.

Newer research has led the practice to be downgraded one level in the new guideline, from moderate to limited, despite its widespread use.

It will, however, likely continue to be used as an alternative to total knee replacement in younger patients and to shift weight away from an area of the knee where cartilage is being restored with a concomitant surgical procedure, according to the work group. They noted that additional research studies on the long-term efficacy of the procedure are still needed.

Topical treatments. The guideline authors gave these a strong recommendation. Gels with anti-inflammatory medication have long been available but were prescription only or of considerable cost. Now several affordable over-the-counter options with the same prescription strength can be found in pharmacies and supermarkets.

What makes these medications unique is that they have an NSAID medication in the formulation, which the vast majority of topical treatments found on shelves do not. They also benefit patients who are unable to tolerate oral NSAIDs because of gastrointestinal side effects.

Comparison with 2019 OARSI recommendations

In 2019, the Osteoarthritis Research Society International also published guidelines for the management of OA of the hand, hip, and knee.

Thomas Trojian, MD, a family medicine physician with expertise in sports medicine in York, Pa., and member of both the AAOS and OARSI recommendation committees, noted that the OARSI guidelines are meant to be practical guidelines of stepwise nonoperative treatment.

He said in an interview that “the OARSI guidelines recommend dietary weight management, education, and land-based [exercise] therapy, next topical NSAIDs, then injection therapy.”

Intra-articular steroids and viscosupplementation injection therapy in the form of hyaluronic acid derivatives continue to be a mainstay of treatment for both groups.

The AAOS group notably gave a moderate strength recommendation for intra-articular steroid injections with the caveat that the effects typically only last for 3 months. They also included newer extended-release steroid injections in the recommendation, stating that the evidence moderately suggests they provide more benefit than traditional short-acting steroid injections.
 

Methodology differs between guidelines

In the areas where the guidelines don’t fully line up, it is important to remember the methodology of each group often drives the guidelines and recommendations.

According to Yale Fillingham, MD, an orthopedic surgeon in group private practice in the greater Philadelphia area and the other cochair of the AAOS guidelines committee, the biggest difference between the AAOS and OARSI guidelines is that, although the OARSI guidelines are also grounded in the literature, the recommendation level was based on voting among panel members.

“The AAOS methodology requires the recommendation and strength of the recommendation to be dictated primarily by the best available evidence in the literature and much less on the expertise and opinion of the voting panel,” Dr. Fillingham said in an interview.

He pointed out that the AAOS voting panel can alter the guideline by adjusting the strength of the recommendation but noted it was only in very clearly defined situations. Therefore, the differences in methodology between the groups make it difficult to directly compare the two guidelines.

Multiple guidelines do, however, point to the importance of the issue. Dr. Fillingham commented: “The numerous organizations that have produced guidelines on the treatment of knee osteoarthritis are a testament to the widespread and profound impact of knee osteoarthritis on our health care system and society.”

As a member of both recommendation groups, Dr. Trojian finds both guidelines reveal the importance of understanding that knee OA is a chronic illness. “There are ways we can manage knee OA and reduce the morbidity. ... The core skills of motivational interviewing are important. Open-ended questions, affirmation, reflection, and summarizing are needed to help patients find and remove roadblocks to promote lifestyle changes.”

Dr. Brophy, Dr. Trojian, and Dr. Fillingham have disclosed no relevant financial relationships.

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

After nearly a decade, the American Academy of Orthopaedic Surgeons has updated its guidance on nonoperative treatment for knee osteoarthritis.

The clinical practice guidelines, released Sept. 13, 2021, is the third edition of the orthopedic society’s clinical practice recommendations.

According to Robert Brophy, MD, FAAOS, an orthopedic surgeon at Washington University, St. Louis, and cochair of the AAOS clinical practice guideline work group, the AAOS guidelines are a “living document” that needs periodic updating as new research comes to light.

“The methodology for maintaining the AAOS guidelines aims to update guideline documents at least every 10 years,” Dr. Brophy said in an interview. “Since the last edition was from 2013, it was time to provide an updated guideline on this very important topic that affects such a high percentage of our patients and providers.”

The guidelines work group, composed of 12 medical doctors and 1 physical therapist, evaluated the evidence for 29 areas of treatment.

A rating scale based on available evidence and the strength of related medical studies labeled each treatment area as demonstrating strong, moderate, or limited evidence.

Eight treatment modalities weighed in with strong evidence for or against their use: lateral wedge insoles, topical or oral NSAIDs, exercise (supervised or unsupervised), self-management programs, patient education programs, oral acetaminophen, and oral opioids.

According to Dr. Brophy, many of the recommendations assigned a strong evidence base were similar to the prior edition of the guidelines.
 

Oral medications

NSAIDs and acetaminophen still remain steadfast options for the treatment of knee pain secondary to OA.

decade3d/Thinkstock

The most notable change was that opioids, which have a long history of being used to treat pain, are strongly recommended not to be used for arthritis.

“Reflecting the growing awareness of and emphasis on the opioid epidemic, one of the strongest changes between the current and prior guidelines centers on the use of opioid medications,” Dr. Brophy said. “In the prior guideline, a strong recommendation was made in favor of tramadol with an inconclusive recommendation made regarding other opioid medications. The updated guideline demonstrates clearly the evidence does not support the use of opioid medications – including tramadol – to treat knee osteoarthritis.”

This may require some education for both patients and doctors to buy in that knee pain can be treated adequately with NSAIDs and acetaminophen.

Patients may not understand that anti-inflammatory drugs treat the pain they are experiencing. They may equate an opioid with a “pain pill” and may need education from their doctor that NSAIDs and acetaminophen not only can relieve their pain, but also avoid potential adverse events prior to or after surgery should they progress to knee replacement surgery.

Furthermore, primary care physicians may not be looking at the long-term picture. Solving a short-term pain problem with opioids may limit the medication’s ability to provide pain relief after surgery should a patient develop a tolerance to the medication’s effects.
 

Recommendations on hip and foot alignment interventions

When it comes to alignment and joint stresses, the knee is sometimes considered the innocent bystander of hip and foot alignment.

Insoles. How the hip and foot align with each can determine the amount of weight that passes through the medial (inner) or lateral (outer) compartment of the knee. To that end, lateral foot insoles have been used in the past for unloading parts of the knee.

Nevertheless, recent evidence has failed to demonstrate a significant benefit for insoles in the setting of OA knee pain, earning the practice a strong recommendation against its use.

High-tibial osteotomy (HTO). The weight-bearing axis of the lower-extremity axis can also be realigned with HTO. The procedure shifts the body’s weight slightly to the opposite side of the knee.

Newer research has led the practice to be downgraded one level in the new guideline, from moderate to limited, despite its widespread use.

It will, however, likely continue to be used as an alternative to total knee replacement in younger patients and to shift weight away from an area of the knee where cartilage is being restored with a concomitant surgical procedure, according to the work group. They noted that additional research studies on the long-term efficacy of the procedure are still needed.

Topical treatments. The guideline authors gave these a strong recommendation. Gels with anti-inflammatory medication have long been available but were prescription only or of considerable cost. Now several affordable over-the-counter options with the same prescription strength can be found in pharmacies and supermarkets.

What makes these medications unique is that they have an NSAID medication in the formulation, which the vast majority of topical treatments found on shelves do not. They also benefit patients who are unable to tolerate oral NSAIDs because of gastrointestinal side effects.

Comparison with 2019 OARSI recommendations

In 2019, the Osteoarthritis Research Society International also published guidelines for the management of OA of the hand, hip, and knee.

Thomas Trojian, MD, a family medicine physician with expertise in sports medicine in York, Pa., and member of both the AAOS and OARSI recommendation committees, noted that the OARSI guidelines are meant to be practical guidelines of stepwise nonoperative treatment.

He said in an interview that “the OARSI guidelines recommend dietary weight management, education, and land-based [exercise] therapy, next topical NSAIDs, then injection therapy.”

Intra-articular steroids and viscosupplementation injection therapy in the form of hyaluronic acid derivatives continue to be a mainstay of treatment for both groups.

The AAOS group notably gave a moderate strength recommendation for intra-articular steroid injections with the caveat that the effects typically only last for 3 months. They also included newer extended-release steroid injections in the recommendation, stating that the evidence moderately suggests they provide more benefit than traditional short-acting steroid injections.
 

Methodology differs between guidelines

In the areas where the guidelines don’t fully line up, it is important to remember the methodology of each group often drives the guidelines and recommendations.

According to Yale Fillingham, MD, an orthopedic surgeon in group private practice in the greater Philadelphia area and the other cochair of the AAOS guidelines committee, the biggest difference between the AAOS and OARSI guidelines is that, although the OARSI guidelines are also grounded in the literature, the recommendation level was based on voting among panel members.

“The AAOS methodology requires the recommendation and strength of the recommendation to be dictated primarily by the best available evidence in the literature and much less on the expertise and opinion of the voting panel,” Dr. Fillingham said in an interview.

He pointed out that the AAOS voting panel can alter the guideline by adjusting the strength of the recommendation but noted it was only in very clearly defined situations. Therefore, the differences in methodology between the groups make it difficult to directly compare the two guidelines.

Multiple guidelines do, however, point to the importance of the issue. Dr. Fillingham commented: “The numerous organizations that have produced guidelines on the treatment of knee osteoarthritis are a testament to the widespread and profound impact of knee osteoarthritis on our health care system and society.”

As a member of both recommendation groups, Dr. Trojian finds both guidelines reveal the importance of understanding that knee OA is a chronic illness. “There are ways we can manage knee OA and reduce the morbidity. ... The core skills of motivational interviewing are important. Open-ended questions, affirmation, reflection, and summarizing are needed to help patients find and remove roadblocks to promote lifestyle changes.”

Dr. Brophy, Dr. Trojian, and Dr. Fillingham have disclosed no relevant financial relationships.

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

Smokers are 80% more likely to be admitted to the hospital with COVID-19 than nonsmokers, according to an Oxford (England) University–led study.

Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.

The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.

When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.

Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
 

Time to quit

Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.

Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.

The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”

In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”

These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial,  Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”

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

Smokers are 80% more likely to be admitted to the hospital with COVID-19 than nonsmokers, according to an Oxford (England) University–led study.

Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.

The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.

When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.

Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
 

Time to quit

Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.

Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.

The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”

In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”

These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial,  Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”

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

Smokers are 80% more likely to be admitted to the hospital with COVID-19 than nonsmokers, according to an Oxford (England) University–led study.

Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.

The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.

When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.

Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
 

Time to quit

Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.

Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.

The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”

In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”

These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial,  Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”

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