Rheumatology News

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.

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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.

Avanos medical to pay $22 million to resolve criminal charge for fraudulent misbranding of PPE

A U.S.-based multinational medical device corporation will pay more than $22 million to resolve a criminal charge regarding fraudulent misbranding of their surgical gowns.

Avanos Medical Inc, which as its U.S. headquarters in Alpharetta, Georgia, is charged with one count of introducing misbranded surgical gowns into interstate commerce with the intent to defraud and mislead.

According to the Department of Justice, the company knowingly falsely labeled its MicroCool surgical gowns as providing AAMI Level 4 protection (the highest level) against fluid and virus penetration. Under the standards set by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI), the highest protection level for surgical gowns is reserved for gowns intended to be used in surgeries and other high-risk medical procedures on patients suspected of having infectious diseases.

Avanos admitted to selling hundreds of thousands of MicroCool gowns that were falsely labeled as AAMI Level 4 between late 2014 and early 2015, as well as directly lying to customers about the gowns’ protective capacities. In total, Avanos sold almost $9 million of misbranded MicroCool gowns.

“The last thing health care workers should have to worry about is whether their personal protective equipment lives up to manufacturers’ claims,” said Acting U.S. Attorney Prerak Shah for the Northern District of Texas. “Misbranded PPE can pose serious risks to medical professionals and patients alike.”
 

Company pays $38.75 million to settle allegations of knowingly selling defective devices 

Medical device manufacturers Alere and Alere San Diego (collectively, Alere) have agreed to pay almost $39 million to resolve allegations that they violated the False Claims Act by billing, and causing others to bill, the Medicare program for defective rapid point-of-care testing devices. 

From 2008 to 2016, the Department of Justice alleges, Alere knowingly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries who were taking anticoagulants. The software algorithms in the monitors contained a material defect, which Alere had found in their research, to cause inaccurate readings. Blood coagulation monitoring is essential for the safety of these patients, enabling them to maintain a safe dosage of their medications. Taking too much of an anticoagulant can cause major bleeding, while taking too little can cause blood clots that lead to strokes. 

While Alere was aware that these devices were linked to over a dozen deaths and hundreds of injuries, the company continued to conceal the defect and billed Medicare for the devices.

In 2016, the product was taken off the market at the request of the FDA.
 

Mass. doctor, wife charged in international money laundering, fraud scheme

Massachusetts psychiatrist Rahim Shafa, MD, and his wife and office manager, Nahid Tormosi Shafa, are charged in connection to an international money laundering scheme involving importing illegal and misbranded drugs. 

Through Shafa’s company, Novel Psychopharmacology, the two allegedly filed false and fraudulent Medicare reimbursement claims from 2016-2019, then deposited the money in their bank accounts, according to federal officials. From 2008-2018, the couple also engaged in an international money laundering scheme to purchase naltrexone pellet implants, disulfiram pellet implants, and injections from Hong Kong that were not approved by the FDA. According to officials, they falsified shipping documents, disguising the naltrexone pellet implants as “plastic beads in plastic tubes” to receive the drugs. They then offered to sell these drugs to patients of Novel Psychopharmacology. 

Rahim Shafa was indicted on conspiracies of international money laundering, health care fraud, and defrauding the United States, as well as illegally importing merchandise and purposely delivering misbranded drugs. His wife was indicted on one count each of health care fraud conspiracy and international money laundering conspiracy.
 

Jury convicts medical equipment company owners of $27 million fraud

A federal jury in Texas convicted the owners of two durable medical equipment (DME) companies linked to a scheme to defraud Medicare.

Leah Hagen, 49, and Michael Hagen, 54, were convicted of one count of conspiracy to defraud the United States and to pay and receive health care kickbacks and one count of conspiracy to commit money laundering. The defendants owned and operated Metro DME Supply and Ortho Pain Solutions. 

Ms. Hagen and Mr. Hagen paid a fixed rate per DME item in exchange for prescriptions and paperwork completed by telemedicine doctors that were used to submit false claims to Medicare, which totaled about $59 million. They were paid $27 million, and wired millions to their personal bank accounts. The defendants paid illegal bribes and kickbacks and wired money to their co-conspirator’s call center in the Philippines that provided signed doctor’s orders for orthotic braces. 

At trial, evidence showed emails between Leah and Michael Hagen and their co-conspirators outlining a per-product pricing structure for orthotic braces, but not disclosing their agreement as one for marketing and other services.

At sentencing, the Hagens each face a maximum sentence of 25 years in prison.

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

Avanos medical to pay $22 million to resolve criminal charge for fraudulent misbranding of PPE

A U.S.-based multinational medical device corporation will pay more than $22 million to resolve a criminal charge regarding fraudulent misbranding of their surgical gowns.

Avanos Medical Inc, which as its U.S. headquarters in Alpharetta, Georgia, is charged with one count of introducing misbranded surgical gowns into interstate commerce with the intent to defraud and mislead.

According to the Department of Justice, the company knowingly falsely labeled its MicroCool surgical gowns as providing AAMI Level 4 protection (the highest level) against fluid and virus penetration. Under the standards set by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI), the highest protection level for surgical gowns is reserved for gowns intended to be used in surgeries and other high-risk medical procedures on patients suspected of having infectious diseases.

Avanos admitted to selling hundreds of thousands of MicroCool gowns that were falsely labeled as AAMI Level 4 between late 2014 and early 2015, as well as directly lying to customers about the gowns’ protective capacities. In total, Avanos sold almost $9 million of misbranded MicroCool gowns.

“The last thing health care workers should have to worry about is whether their personal protective equipment lives up to manufacturers’ claims,” said Acting U.S. Attorney Prerak Shah for the Northern District of Texas. “Misbranded PPE can pose serious risks to medical professionals and patients alike.”
 

Company pays $38.75 million to settle allegations of knowingly selling defective devices 

Medical device manufacturers Alere and Alere San Diego (collectively, Alere) have agreed to pay almost $39 million to resolve allegations that they violated the False Claims Act by billing, and causing others to bill, the Medicare program for defective rapid point-of-care testing devices. 

From 2008 to 2016, the Department of Justice alleges, Alere knowingly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries who were taking anticoagulants. The software algorithms in the monitors contained a material defect, which Alere had found in their research, to cause inaccurate readings. Blood coagulation monitoring is essential for the safety of these patients, enabling them to maintain a safe dosage of their medications. Taking too much of an anticoagulant can cause major bleeding, while taking too little can cause blood clots that lead to strokes. 

While Alere was aware that these devices were linked to over a dozen deaths and hundreds of injuries, the company continued to conceal the defect and billed Medicare for the devices.

In 2016, the product was taken off the market at the request of the FDA.
 

Mass. doctor, wife charged in international money laundering, fraud scheme

Massachusetts psychiatrist Rahim Shafa, MD, and his wife and office manager, Nahid Tormosi Shafa, are charged in connection to an international money laundering scheme involving importing illegal and misbranded drugs. 

Through Shafa’s company, Novel Psychopharmacology, the two allegedly filed false and fraudulent Medicare reimbursement claims from 2016-2019, then deposited the money in their bank accounts, according to federal officials. From 2008-2018, the couple also engaged in an international money laundering scheme to purchase naltrexone pellet implants, disulfiram pellet implants, and injections from Hong Kong that were not approved by the FDA. According to officials, they falsified shipping documents, disguising the naltrexone pellet implants as “plastic beads in plastic tubes” to receive the drugs. They then offered to sell these drugs to patients of Novel Psychopharmacology. 

Rahim Shafa was indicted on conspiracies of international money laundering, health care fraud, and defrauding the United States, as well as illegally importing merchandise and purposely delivering misbranded drugs. His wife was indicted on one count each of health care fraud conspiracy and international money laundering conspiracy.
 

Jury convicts medical equipment company owners of $27 million fraud

A federal jury in Texas convicted the owners of two durable medical equipment (DME) companies linked to a scheme to defraud Medicare.

Leah Hagen, 49, and Michael Hagen, 54, were convicted of one count of conspiracy to defraud the United States and to pay and receive health care kickbacks and one count of conspiracy to commit money laundering. The defendants owned and operated Metro DME Supply and Ortho Pain Solutions. 

Ms. Hagen and Mr. Hagen paid a fixed rate per DME item in exchange for prescriptions and paperwork completed by telemedicine doctors that were used to submit false claims to Medicare, which totaled about $59 million. They were paid $27 million, and wired millions to their personal bank accounts. The defendants paid illegal bribes and kickbacks and wired money to their co-conspirator’s call center in the Philippines that provided signed doctor’s orders for orthotic braces. 

At trial, evidence showed emails between Leah and Michael Hagen and their co-conspirators outlining a per-product pricing structure for orthotic braces, but not disclosing their agreement as one for marketing and other services.

At sentencing, the Hagens each face a maximum sentence of 25 years in prison.

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

Avanos medical to pay $22 million to resolve criminal charge for fraudulent misbranding of PPE

A U.S.-based multinational medical device corporation will pay more than $22 million to resolve a criminal charge regarding fraudulent misbranding of their surgical gowns.

Avanos Medical Inc, which as its U.S. headquarters in Alpharetta, Georgia, is charged with one count of introducing misbranded surgical gowns into interstate commerce with the intent to defraud and mislead.

According to the Department of Justice, the company knowingly falsely labeled its MicroCool surgical gowns as providing AAMI Level 4 protection (the highest level) against fluid and virus penetration. Under the standards set by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI), the highest protection level for surgical gowns is reserved for gowns intended to be used in surgeries and other high-risk medical procedures on patients suspected of having infectious diseases.

Avanos admitted to selling hundreds of thousands of MicroCool gowns that were falsely labeled as AAMI Level 4 between late 2014 and early 2015, as well as directly lying to customers about the gowns’ protective capacities. In total, Avanos sold almost $9 million of misbranded MicroCool gowns.

“The last thing health care workers should have to worry about is whether their personal protective equipment lives up to manufacturers’ claims,” said Acting U.S. Attorney Prerak Shah for the Northern District of Texas. “Misbranded PPE can pose serious risks to medical professionals and patients alike.”
 

Company pays $38.75 million to settle allegations of knowingly selling defective devices 

Medical device manufacturers Alere and Alere San Diego (collectively, Alere) have agreed to pay almost $39 million to resolve allegations that they violated the False Claims Act by billing, and causing others to bill, the Medicare program for defective rapid point-of-care testing devices. 

From 2008 to 2016, the Department of Justice alleges, Alere knowingly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries who were taking anticoagulants. The software algorithms in the monitors contained a material defect, which Alere had found in their research, to cause inaccurate readings. Blood coagulation monitoring is essential for the safety of these patients, enabling them to maintain a safe dosage of their medications. Taking too much of an anticoagulant can cause major bleeding, while taking too little can cause blood clots that lead to strokes. 

While Alere was aware that these devices were linked to over a dozen deaths and hundreds of injuries, the company continued to conceal the defect and billed Medicare for the devices.

In 2016, the product was taken off the market at the request of the FDA.
 

Mass. doctor, wife charged in international money laundering, fraud scheme

Massachusetts psychiatrist Rahim Shafa, MD, and his wife and office manager, Nahid Tormosi Shafa, are charged in connection to an international money laundering scheme involving importing illegal and misbranded drugs. 

Through Shafa’s company, Novel Psychopharmacology, the two allegedly filed false and fraudulent Medicare reimbursement claims from 2016-2019, then deposited the money in their bank accounts, according to federal officials. From 2008-2018, the couple also engaged in an international money laundering scheme to purchase naltrexone pellet implants, disulfiram pellet implants, and injections from Hong Kong that were not approved by the FDA. According to officials, they falsified shipping documents, disguising the naltrexone pellet implants as “plastic beads in plastic tubes” to receive the drugs. They then offered to sell these drugs to patients of Novel Psychopharmacology. 

Rahim Shafa was indicted on conspiracies of international money laundering, health care fraud, and defrauding the United States, as well as illegally importing merchandise and purposely delivering misbranded drugs. His wife was indicted on one count each of health care fraud conspiracy and international money laundering conspiracy.
 

Jury convicts medical equipment company owners of $27 million fraud

A federal jury in Texas convicted the owners of two durable medical equipment (DME) companies linked to a scheme to defraud Medicare.

Leah Hagen, 49, and Michael Hagen, 54, were convicted of one count of conspiracy to defraud the United States and to pay and receive health care kickbacks and one count of conspiracy to commit money laundering. The defendants owned and operated Metro DME Supply and Ortho Pain Solutions. 

Ms. Hagen and Mr. Hagen paid a fixed rate per DME item in exchange for prescriptions and paperwork completed by telemedicine doctors that were used to submit false claims to Medicare, which totaled about $59 million. They were paid $27 million, and wired millions to their personal bank accounts. The defendants paid illegal bribes and kickbacks and wired money to their co-conspirator’s call center in the Philippines that provided signed doctor’s orders for orthotic braces. 

At trial, evidence showed emails between Leah and Michael Hagen and their co-conspirators outlining a per-product pricing structure for orthotic braces, but not disclosing their agreement as one for marketing and other services.

At sentencing, the Hagens each face a maximum sentence of 25 years in prison.

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