News

TOPLINE:

Adjuvant everolimus does not improve recurrence-free or overall survival in patients with papillary and chromophobe subtypes of non–clear cell renal cell carcinoma (RCC) and is associated with higher rates of severe adverse events, compared with placebo.

METHODOLOGY:

• Non–clear cell RCC accounts for approximately 25% of RCC cases and includes various distinct tumor types such as papillary and chromophobe RCC. A common design flaw in clinical trials has been applying treatments effective in clear cell RCC to non–clear cell RCC subtypes without a strong biological rationale. The broad approval of drugs for RCC without considering subtype differences complicates treatment decisions.
• The EVEREST phase 3 randomized clinical trial evaluated everolimus in the adjuvant setting, enrolling patients with either clear cell (n = 1248) or non–clear cell (n = 208) RCC at high risk for recurrence after resection. The patients were randomly assigned to receive either everolimus or placebo.
• To assess the benefits of everolimus in patients with non–clear cell RCC, this analysis focused on the subgroup of 109 patients with papillary RCC (median age, 60 years) and 99 patients with chromophobe RCC (median age, 51 years).
• The primary outcome was recurrence-free survival, and the secondary outcome was overall survival. The median follow-up was 76 months.

TAKEAWAY:

• In the papillary RCC subgroup, the 5-year recurrence-free survival was lower among patients receiving everolimus vs placebo (62% vs 70%), but this difference was not significant (hazard ratio [HR], 1.19; 95% CI, 0.61-2.33; P = .61).
• In the chromophobe RCC subgroup, the 5-year recurrence-free survival was similar between the two groups — 79% for everolimus vs 77% for placebo (HR, 0.89; 95% CI, 0.37-2.13; P = .79).
• Everolimus was also not associated with a significant overall survival benefit in patients with papillary RCC (HR, 1.47; 95% CI, 0.67-3.24; P = .34) or chromophobe RCC (HR, 0.93; 95% CI, 0.33-2.65; P = .89). In the papillary RCC subgroup, 5-year overall survival rates were slightly lower in the everolimus group than in the placebo group (76% vs 82%); however, in the chromophobe RCC subgroup, the rates were the same for both arms (89%).
• Patients treated with everolimus reported an increased incidence of grade 3 or higher adverse events, compared with those treated with placebo (48% vs 9%). No treatment-related deaths were reported, but a significant number of patients — 54% with papillary RCC and 51% with chromophobe RCC — discontinued treatment early because of adverse events.

IN PRACTICE:

This secondary analysis “found that patients with papillary or chromophobe RCC did not benefit from treatment with everolimus in the adjuvant setting,” the authors wrote. “Our study highlights an area of unmet need in the kidney cancer field. It thus serves to provide a foundational background for future randomized clinical trials to address specific subgroups of RCC for risk mitigation strategies in the adjuvant setting.”

SOURCE:

The study was led by Shuchi Gulati, MD, MSc, University of California Davis Comprehensive Cancer Center, Sacramento, and was published online on August 6, 2024, in JAMA Network Open, along with an accompanying editorial.

LIMITATIONS:

The subgroup analyses were underpowered to detect a significant difference. Additionally, the study lacked a central pathology review to confirm non–clear cell histologies.

DISCLOSURES:

The study was supported by awards from the National Institutes of Health, National Cancer Institute, and National Clinical Trials Network. Several authors reported receiving grants or personal fees from various sources outside the submitted work.

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

TOPLINE:

Adjuvant everolimus does not improve recurrence-free or overall survival in patients with papillary and chromophobe subtypes of non–clear cell renal cell carcinoma (RCC) and is associated with higher rates of severe adverse events, compared with placebo.

METHODOLOGY:

• Non–clear cell RCC accounts for approximately 25% of RCC cases and includes various distinct tumor types such as papillary and chromophobe RCC. A common design flaw in clinical trials has been applying treatments effective in clear cell RCC to non–clear cell RCC subtypes without a strong biological rationale. The broad approval of drugs for RCC without considering subtype differences complicates treatment decisions.
• The EVEREST phase 3 randomized clinical trial evaluated everolimus in the adjuvant setting, enrolling patients with either clear cell (n = 1248) or non–clear cell (n = 208) RCC at high risk for recurrence after resection. The patients were randomly assigned to receive either everolimus or placebo.
• To assess the benefits of everolimus in patients with non–clear cell RCC, this analysis focused on the subgroup of 109 patients with papillary RCC (median age, 60 years) and 99 patients with chromophobe RCC (median age, 51 years).
• The primary outcome was recurrence-free survival, and the secondary outcome was overall survival. The median follow-up was 76 months.

TAKEAWAY:

• In the papillary RCC subgroup, the 5-year recurrence-free survival was lower among patients receiving everolimus vs placebo (62% vs 70%), but this difference was not significant (hazard ratio [HR], 1.19; 95% CI, 0.61-2.33; P = .61).
• In the chromophobe RCC subgroup, the 5-year recurrence-free survival was similar between the two groups — 79% for everolimus vs 77% for placebo (HR, 0.89; 95% CI, 0.37-2.13; P = .79).
• Everolimus was also not associated with a significant overall survival benefit in patients with papillary RCC (HR, 1.47; 95% CI, 0.67-3.24; P = .34) or chromophobe RCC (HR, 0.93; 95% CI, 0.33-2.65; P = .89). In the papillary RCC subgroup, 5-year overall survival rates were slightly lower in the everolimus group than in the placebo group (76% vs 82%); however, in the chromophobe RCC subgroup, the rates were the same for both arms (89%).
• Patients treated with everolimus reported an increased incidence of grade 3 or higher adverse events, compared with those treated with placebo (48% vs 9%). No treatment-related deaths were reported, but a significant number of patients — 54% with papillary RCC and 51% with chromophobe RCC — discontinued treatment early because of adverse events.

IN PRACTICE:

This secondary analysis “found that patients with papillary or chromophobe RCC did not benefit from treatment with everolimus in the adjuvant setting,” the authors wrote. “Our study highlights an area of unmet need in the kidney cancer field. It thus serves to provide a foundational background for future randomized clinical trials to address specific subgroups of RCC for risk mitigation strategies in the adjuvant setting.”

SOURCE:

The study was led by Shuchi Gulati, MD, MSc, University of California Davis Comprehensive Cancer Center, Sacramento, and was published online on August 6, 2024, in JAMA Network Open, along with an accompanying editorial.

LIMITATIONS:

The subgroup analyses were underpowered to detect a significant difference. Additionally, the study lacked a central pathology review to confirm non–clear cell histologies.

DISCLOSURES:

The study was supported by awards from the National Institutes of Health, National Cancer Institute, and National Clinical Trials Network. Several authors reported receiving grants or personal fees from various sources outside the submitted work.

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

TOPLINE:

Adjuvant everolimus does not improve recurrence-free or overall survival in patients with papillary and chromophobe subtypes of non–clear cell renal cell carcinoma (RCC) and is associated with higher rates of severe adverse events, compared with placebo.

METHODOLOGY:

• Non–clear cell RCC accounts for approximately 25% of RCC cases and includes various distinct tumor types such as papillary and chromophobe RCC. A common design flaw in clinical trials has been applying treatments effective in clear cell RCC to non–clear cell RCC subtypes without a strong biological rationale. The broad approval of drugs for RCC without considering subtype differences complicates treatment decisions.
• The EVEREST phase 3 randomized clinical trial evaluated everolimus in the adjuvant setting, enrolling patients with either clear cell (n = 1248) or non–clear cell (n = 208) RCC at high risk for recurrence after resection. The patients were randomly assigned to receive either everolimus or placebo.
• To assess the benefits of everolimus in patients with non–clear cell RCC, this analysis focused on the subgroup of 109 patients with papillary RCC (median age, 60 years) and 99 patients with chromophobe RCC (median age, 51 years).
• The primary outcome was recurrence-free survival, and the secondary outcome was overall survival. The median follow-up was 76 months.

TAKEAWAY:

• In the papillary RCC subgroup, the 5-year recurrence-free survival was lower among patients receiving everolimus vs placebo (62% vs 70%), but this difference was not significant (hazard ratio [HR], 1.19; 95% CI, 0.61-2.33; P = .61).
• In the chromophobe RCC subgroup, the 5-year recurrence-free survival was similar between the two groups — 79% for everolimus vs 77% for placebo (HR, 0.89; 95% CI, 0.37-2.13; P = .79).
• Everolimus was also not associated with a significant overall survival benefit in patients with papillary RCC (HR, 1.47; 95% CI, 0.67-3.24; P = .34) or chromophobe RCC (HR, 0.93; 95% CI, 0.33-2.65; P = .89). In the papillary RCC subgroup, 5-year overall survival rates were slightly lower in the everolimus group than in the placebo group (76% vs 82%); however, in the chromophobe RCC subgroup, the rates were the same for both arms (89%).
• Patients treated with everolimus reported an increased incidence of grade 3 or higher adverse events, compared with those treated with placebo (48% vs 9%). No treatment-related deaths were reported, but a significant number of patients — 54% with papillary RCC and 51% with chromophobe RCC — discontinued treatment early because of adverse events.

IN PRACTICE:

This secondary analysis “found that patients with papillary or chromophobe RCC did not benefit from treatment with everolimus in the adjuvant setting,” the authors wrote. “Our study highlights an area of unmet need in the kidney cancer field. It thus serves to provide a foundational background for future randomized clinical trials to address specific subgroups of RCC for risk mitigation strategies in the adjuvant setting.”

SOURCE:

The study was led by Shuchi Gulati, MD, MSc, University of California Davis Comprehensive Cancer Center, Sacramento, and was published online on August 6, 2024, in JAMA Network Open, along with an accompanying editorial.

LIMITATIONS:

The subgroup analyses were underpowered to detect a significant difference. Additionally, the study lacked a central pathology review to confirm non–clear cell histologies.

DISCLOSURES:

The study was supported by awards from the National Institutes of Health, National Cancer Institute, and National Clinical Trials Network. Several authors reported receiving grants or personal fees from various sources outside the submitted work.

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

Stigma around obesity can have a crippling effect on patients. Janese Laster, MD, sees the impact of this problem every day.

It takes a long time for some patients with obesity to acknowledge that they need help, said Dr. Laster, a bariatric endoscopist who specializes in gastroenterology, nutrition, and obesity medicine at Gut Theory Total Digestive Care, and Georgetown University Hospital in Washington. “If somebody has high blood pressure or has a cut or has chest pain, you don’t wait for things. You would go seek help immediately. I wish more patients reached out sooner and didn’t struggle.”

Courtesy Dr. Janese Laster

Another big challenge is making sure patients have insurance coverage for things like medications, surgery, and bariatric endoscopy, she added.

Her response: education and advocacy. “I’m giving as many talks as I can to fellows, creating courses for residents and fellows and medical students” to change the way physicians talk about obesity and excess weight, she said. Patients need to understand that physicians care about them, that “we’re not judging and we’re changing that perspective.”

Dr. Laster is also working with members of Congress to get bills passed for coverage of obesity medication and procedures. In an interview with GI & Hepatology News, she spoke more about the intersection between nutrition, medicine and bariatric procedures and the importance of offering patients multiple solutions.
 

Q: Why did you choose GI? 

It allowed me a little bit of everything. You have clinic, where you can really interact with patients and get to the root of their problem. You have preventative care with routine colonoscopies and upper endoscopies to prevent for cancer. But then you also have fun stuff — which my mom told me to stop saying out loud — ‘bleeders’ and acute things that you get to fix immediately. So, you get the adrenaline rush too. I like it because you get the best of all worlds and it’s really hard to get bored.

Q: How did you become interested in nutrition and bariatric endoscopy?

My parents had a garden and never let us eat processed foods. In residency, I kept seeing the same medical problems over and over again. Everybody had high blood pressure, high cholesterol, and diabetes. Then in GI clinic, everybody had abdominal pain, bloating, constipation, heartburn, and a million GI appointments for these same things. Everyone’s upper endoscopy or colonoscopy was negative. Something else had to be going on.

And that’s sort of where it came from; figuring out the common denominator. It had to be what people were eating. There’s also the prevalence of patients with obesity going up every single year. Correlating all these other medical problems with people’s diets led me down the rabbit hole of: What else can we be doing?

Most people don’t want to undergo surgery. Only 2% of people eligible for surgery actually do it, even though it works. The reasons are because it’s invasive or there’s shame behind it. Bariatric endoscopy is another option that’s out here, that’s less invasive. I’m an endoscopist and gastroenterologist. I should be able to offer all those things and I should know more about nutrition. We don’t talk about it enough.
 

Q: Do you think more GI doctors should become better educated about nutrition?

100%. Every patient I see has seen a GI doctor before and says, ‘No one has ever told me that if I have carbonated beverages and cheese every day, I’m going to be bloated and constipated.’ And that shouldn’t be the case.

Q: Why do you think that more GI doctors don’t get the education on nutrition during their medical training?

I think it’s our healthcare system. It’s very much focused on secondary treatment rather than preventative care. There’s no emphasis on preventing things from happening.

We’re really good at reactionary medicine. People who have an ulcer, big polyps and colon cancer, esophageal cancer — we do those things really well. But I think because there’s no ICD-10 codes for preventive care via nutrition education, and no good reimbursement, then there’s no incentive for hospital systems to pay for these things. It’s a system based on RVUs (relative value units) and numbers. That’s been our trajectory. We’ve been so focused on reactionary medicine rather than saying, ‘Okay, let’s stop this from happening.’

We just didn’t talk about nutrition in medical school, in residency, or in fellowship. It was looked at as a soft science. When I was in school, people would also say, ‘No one’s going to change. So it’s a waste of your time essentially to talk to people about making dietary changes.’ I feel like if you give people the opportunity, you have to give them the chance. You can’t just write everybody off. Some people won’t change, but that’s okay. They should at least have the opportunity to do so.
 

Q: How do you determine whether a patient is a good candidate for bariatric surgery?

It’s based on the guidelines: If they meet the BMI requirements, if they have obesity-associated comorbidities, their risk for surgery is low. But it’s also whether they want to do it or not. A patient has to be in the mindset and be ready for it. They need to want to have surgery or bariatric endoscopy, or to use medications, or start to make a change. Some people aren’t there yet — that preemptive stage of making a change. They want the solution, but they’re not ready to do that legwork yet.

And all of it is work. I tell patients, ‘Whether it’s medication or bariatric endoscopy or bariatric surgery, you still have work to do. None of it is going to just magically happen where you could just continue to do the same thing you’re doing now and you’re going to lose weight and keep it off.’
 

Q: What advances in obesity prevention are you excited about?

I’m excited that bariatric endoscopy came about in the first place, because in every other field there are less invasive approaches that have become available. I’m also excited about the emergence of weight loss medication, like GLP-1s. I think they are a tool that we need.

Q: Do you think the weight loss medications may negate the need for surgery?

I don’t think they necessarily reduce the need for surgery. There’s still a lot we don’t know about why they work in some patients and why they don’t work in others.

Some of our colleagues have come up with phenotypes and blood tests so we can better understand which things will work in different patients. Surgery doesn’t work for some patients. People may need a combination of both after they reach a plateau. I’m excited that people see this as something that we should be researching and putting more effort into — that obesity isn’t a disease of moral failure, that people with excess weight just need to ‘move more’ or ‘eat less’ and it’s their fault. I’m glad people are starting to understand that.
 

Q: What teacher or mentor had the greatest impact on you?

Probably two. One of them is Andrea E Reid, MD, MPH, a dean of medicine at Harvard. She gives you such motivation to achieve things, no matter how big your idea is or how crazy it may seem. If you have something that you think is important, you go after it. Another person is Christopher C. Thompson, MD, at Brigham and Women’s Hospital, the father of bariatric endoscopy in a sense. He embodies what Dr. Reid talks about: crazy big ideas. And he goes after them and he succeeds. Having him push me and giving me that type of encouragement was invaluable.

Q: Describe how you would spend a free Saturday afternoon.

Every Saturday is yoga or some type of movement. Spending some time outside doing something, whether it’s messing around with plants that I’m not very good at, or going for a walk.

Lightning Round

Texting or talking?

Text

Favorite city in U.S. besides the one you live in?

New York

Favorite breakfast?

Avocado toast

Place you most want to travel to?

Istanbul

Favorite season?

Fall

Favorite ice cream flavor?

Raspberry sorbet

How many cups of coffee do you drink per day?

One

Best place you ever went on vacation?

Greece

If you weren’t a gastroenterologist, what would you be?

Own a clothing store

Favorite type of music?

Old school R&B

Favorite movie genre?

Romantic comedy or drama

Cat person or dog person?

Dog

Favorite sport?

Football

Favorite holiday?

Christmas

Optimist or pessimist?

Optimist

Stigma around obesity can have a crippling effect on patients. Janese Laster, MD, sees the impact of this problem every day.

It takes a long time for some patients with obesity to acknowledge that they need help, said Dr. Laster, a bariatric endoscopist who specializes in gastroenterology, nutrition, and obesity medicine at Gut Theory Total Digestive Care, and Georgetown University Hospital in Washington. “If somebody has high blood pressure or has a cut or has chest pain, you don’t wait for things. You would go seek help immediately. I wish more patients reached out sooner and didn’t struggle.”

Courtesy Dr. Janese Laster

Another big challenge is making sure patients have insurance coverage for things like medications, surgery, and bariatric endoscopy, she added.

Her response: education and advocacy. “I’m giving as many talks as I can to fellows, creating courses for residents and fellows and medical students” to change the way physicians talk about obesity and excess weight, she said. Patients need to understand that physicians care about them, that “we’re not judging and we’re changing that perspective.”

Dr. Laster is also working with members of Congress to get bills passed for coverage of obesity medication and procedures. In an interview with GI & Hepatology News, she spoke more about the intersection between nutrition, medicine and bariatric procedures and the importance of offering patients multiple solutions.
 

Q: Why did you choose GI? 

It allowed me a little bit of everything. You have clinic, where you can really interact with patients and get to the root of their problem. You have preventative care with routine colonoscopies and upper endoscopies to prevent for cancer. But then you also have fun stuff — which my mom told me to stop saying out loud — ‘bleeders’ and acute things that you get to fix immediately. So, you get the adrenaline rush too. I like it because you get the best of all worlds and it’s really hard to get bored.

Q: How did you become interested in nutrition and bariatric endoscopy?

My parents had a garden and never let us eat processed foods. In residency, I kept seeing the same medical problems over and over again. Everybody had high blood pressure, high cholesterol, and diabetes. Then in GI clinic, everybody had abdominal pain, bloating, constipation, heartburn, and a million GI appointments for these same things. Everyone’s upper endoscopy or colonoscopy was negative. Something else had to be going on.

And that’s sort of where it came from; figuring out the common denominator. It had to be what people were eating. There’s also the prevalence of patients with obesity going up every single year. Correlating all these other medical problems with people’s diets led me down the rabbit hole of: What else can we be doing?

Most people don’t want to undergo surgery. Only 2% of people eligible for surgery actually do it, even though it works. The reasons are because it’s invasive or there’s shame behind it. Bariatric endoscopy is another option that’s out here, that’s less invasive. I’m an endoscopist and gastroenterologist. I should be able to offer all those things and I should know more about nutrition. We don’t talk about it enough.
 

Q: Do you think more GI doctors should become better educated about nutrition?

100%. Every patient I see has seen a GI doctor before and says, ‘No one has ever told me that if I have carbonated beverages and cheese every day, I’m going to be bloated and constipated.’ And that shouldn’t be the case.

Q: Why do you think that more GI doctors don’t get the education on nutrition during their medical training?

I think it’s our healthcare system. It’s very much focused on secondary treatment rather than preventative care. There’s no emphasis on preventing things from happening.

We’re really good at reactionary medicine. People who have an ulcer, big polyps and colon cancer, esophageal cancer — we do those things really well. But I think because there’s no ICD-10 codes for preventive care via nutrition education, and no good reimbursement, then there’s no incentive for hospital systems to pay for these things. It’s a system based on RVUs (relative value units) and numbers. That’s been our trajectory. We’ve been so focused on reactionary medicine rather than saying, ‘Okay, let’s stop this from happening.’

We just didn’t talk about nutrition in medical school, in residency, or in fellowship. It was looked at as a soft science. When I was in school, people would also say, ‘No one’s going to change. So it’s a waste of your time essentially to talk to people about making dietary changes.’ I feel like if you give people the opportunity, you have to give them the chance. You can’t just write everybody off. Some people won’t change, but that’s okay. They should at least have the opportunity to do so.
 

Q: How do you determine whether a patient is a good candidate for bariatric surgery?

It’s based on the guidelines: If they meet the BMI requirements, if they have obesity-associated comorbidities, their risk for surgery is low. But it’s also whether they want to do it or not. A patient has to be in the mindset and be ready for it. They need to want to have surgery or bariatric endoscopy, or to use medications, or start to make a change. Some people aren’t there yet — that preemptive stage of making a change. They want the solution, but they’re not ready to do that legwork yet.

And all of it is work. I tell patients, ‘Whether it’s medication or bariatric endoscopy or bariatric surgery, you still have work to do. None of it is going to just magically happen where you could just continue to do the same thing you’re doing now and you’re going to lose weight and keep it off.’
 

Q: What advances in obesity prevention are you excited about?

I’m excited that bariatric endoscopy came about in the first place, because in every other field there are less invasive approaches that have become available. I’m also excited about the emergence of weight loss medication, like GLP-1s. I think they are a tool that we need.

Q: Do you think the weight loss medications may negate the need for surgery?

I don’t think they necessarily reduce the need for surgery. There’s still a lot we don’t know about why they work in some patients and why they don’t work in others.

Some of our colleagues have come up with phenotypes and blood tests so we can better understand which things will work in different patients. Surgery doesn’t work for some patients. People may need a combination of both after they reach a plateau. I’m excited that people see this as something that we should be researching and putting more effort into — that obesity isn’t a disease of moral failure, that people with excess weight just need to ‘move more’ or ‘eat less’ and it’s their fault. I’m glad people are starting to understand that.
 

Q: What teacher or mentor had the greatest impact on you?

Probably two. One of them is Andrea E Reid, MD, MPH, a dean of medicine at Harvard. She gives you such motivation to achieve things, no matter how big your idea is or how crazy it may seem. If you have something that you think is important, you go after it. Another person is Christopher C. Thompson, MD, at Brigham and Women’s Hospital, the father of bariatric endoscopy in a sense. He embodies what Dr. Reid talks about: crazy big ideas. And he goes after them and he succeeds. Having him push me and giving me that type of encouragement was invaluable.

Q: Describe how you would spend a free Saturday afternoon.

Every Saturday is yoga or some type of movement. Spending some time outside doing something, whether it’s messing around with plants that I’m not very good at, or going for a walk.

Lightning Round

Texting or talking?

Text

Favorite city in U.S. besides the one you live in?

New York

Favorite breakfast?

Avocado toast

Place you most want to travel to?

Istanbul

Favorite season?

Fall

Favorite ice cream flavor?

Raspberry sorbet

How many cups of coffee do you drink per day?

One

Best place you ever went on vacation?

Greece

If you weren’t a gastroenterologist, what would you be?

Own a clothing store

Favorite type of music?

Old school R&B

Favorite movie genre?

Romantic comedy or drama

Cat person or dog person?

Dog

Favorite sport?

Football

Favorite holiday?

Christmas

Optimist or pessimist?

Optimist

Stigma around obesity can have a crippling effect on patients. Janese Laster, MD, sees the impact of this problem every day.

It takes a long time for some patients with obesity to acknowledge that they need help, said Dr. Laster, a bariatric endoscopist who specializes in gastroenterology, nutrition, and obesity medicine at Gut Theory Total Digestive Care, and Georgetown University Hospital in Washington. “If somebody has high blood pressure or has a cut or has chest pain, you don’t wait for things. You would go seek help immediately. I wish more patients reached out sooner and didn’t struggle.”

Courtesy Dr. Janese Laster

Another big challenge is making sure patients have insurance coverage for things like medications, surgery, and bariatric endoscopy, she added.

Her response: education and advocacy. “I’m giving as many talks as I can to fellows, creating courses for residents and fellows and medical students” to change the way physicians talk about obesity and excess weight, she said. Patients need to understand that physicians care about them, that “we’re not judging and we’re changing that perspective.”

Dr. Laster is also working with members of Congress to get bills passed for coverage of obesity medication and procedures. In an interview with GI & Hepatology News, she spoke more about the intersection between nutrition, medicine and bariatric procedures and the importance of offering patients multiple solutions.
 

Q: Why did you choose GI? 

It allowed me a little bit of everything. You have clinic, where you can really interact with patients and get to the root of their problem. You have preventative care with routine colonoscopies and upper endoscopies to prevent for cancer. But then you also have fun stuff — which my mom told me to stop saying out loud — ‘bleeders’ and acute things that you get to fix immediately. So, you get the adrenaline rush too. I like it because you get the best of all worlds and it’s really hard to get bored.

Q: How did you become interested in nutrition and bariatric endoscopy?

My parents had a garden and never let us eat processed foods. In residency, I kept seeing the same medical problems over and over again. Everybody had high blood pressure, high cholesterol, and diabetes. Then in GI clinic, everybody had abdominal pain, bloating, constipation, heartburn, and a million GI appointments for these same things. Everyone’s upper endoscopy or colonoscopy was negative. Something else had to be going on.

And that’s sort of where it came from; figuring out the common denominator. It had to be what people were eating. There’s also the prevalence of patients with obesity going up every single year. Correlating all these other medical problems with people’s diets led me down the rabbit hole of: What else can we be doing?

Most people don’t want to undergo surgery. Only 2% of people eligible for surgery actually do it, even though it works. The reasons are because it’s invasive or there’s shame behind it. Bariatric endoscopy is another option that’s out here, that’s less invasive. I’m an endoscopist and gastroenterologist. I should be able to offer all those things and I should know more about nutrition. We don’t talk about it enough.
 

Q: Do you think more GI doctors should become better educated about nutrition?

100%. Every patient I see has seen a GI doctor before and says, ‘No one has ever told me that if I have carbonated beverages and cheese every day, I’m going to be bloated and constipated.’ And that shouldn’t be the case.

Q: Why do you think that more GI doctors don’t get the education on nutrition during their medical training?

I think it’s our healthcare system. It’s very much focused on secondary treatment rather than preventative care. There’s no emphasis on preventing things from happening.

We’re really good at reactionary medicine. People who have an ulcer, big polyps and colon cancer, esophageal cancer — we do those things really well. But I think because there’s no ICD-10 codes for preventive care via nutrition education, and no good reimbursement, then there’s no incentive for hospital systems to pay for these things. It’s a system based on RVUs (relative value units) and numbers. That’s been our trajectory. We’ve been so focused on reactionary medicine rather than saying, ‘Okay, let’s stop this from happening.’

We just didn’t talk about nutrition in medical school, in residency, or in fellowship. It was looked at as a soft science. When I was in school, people would also say, ‘No one’s going to change. So it’s a waste of your time essentially to talk to people about making dietary changes.’ I feel like if you give people the opportunity, you have to give them the chance. You can’t just write everybody off. Some people won’t change, but that’s okay. They should at least have the opportunity to do so.
 

Q: How do you determine whether a patient is a good candidate for bariatric surgery?

It’s based on the guidelines: If they meet the BMI requirements, if they have obesity-associated comorbidities, their risk for surgery is low. But it’s also whether they want to do it or not. A patient has to be in the mindset and be ready for it. They need to want to have surgery or bariatric endoscopy, or to use medications, or start to make a change. Some people aren’t there yet — that preemptive stage of making a change. They want the solution, but they’re not ready to do that legwork yet.

And all of it is work. I tell patients, ‘Whether it’s medication or bariatric endoscopy or bariatric surgery, you still have work to do. None of it is going to just magically happen where you could just continue to do the same thing you’re doing now and you’re going to lose weight and keep it off.’
 

Q: What advances in obesity prevention are you excited about?

I’m excited that bariatric endoscopy came about in the first place, because in every other field there are less invasive approaches that have become available. I’m also excited about the emergence of weight loss medication, like GLP-1s. I think they are a tool that we need.

Q: Do you think the weight loss medications may negate the need for surgery?

I don’t think they necessarily reduce the need for surgery. There’s still a lot we don’t know about why they work in some patients and why they don’t work in others.

Some of our colleagues have come up with phenotypes and blood tests so we can better understand which things will work in different patients. Surgery doesn’t work for some patients. People may need a combination of both after they reach a plateau. I’m excited that people see this as something that we should be researching and putting more effort into — that obesity isn’t a disease of moral failure, that people with excess weight just need to ‘move more’ or ‘eat less’ and it’s their fault. I’m glad people are starting to understand that.
 

Q: What teacher or mentor had the greatest impact on you?

Probably two. One of them is Andrea E Reid, MD, MPH, a dean of medicine at Harvard. She gives you such motivation to achieve things, no matter how big your idea is or how crazy it may seem. If you have something that you think is important, you go after it. Another person is Christopher C. Thompson, MD, at Brigham and Women’s Hospital, the father of bariatric endoscopy in a sense. He embodies what Dr. Reid talks about: crazy big ideas. And he goes after them and he succeeds. Having him push me and giving me that type of encouragement was invaluable.

Q: Describe how you would spend a free Saturday afternoon.

Every Saturday is yoga or some type of movement. Spending some time outside doing something, whether it’s messing around with plants that I’m not very good at, or going for a walk.

Lightning Round

Texting or talking?

Text

Favorite city in U.S. besides the one you live in?

New York

Favorite breakfast?

Avocado toast

Place you most want to travel to?

Istanbul

Favorite season?

Fall

Favorite ice cream flavor?

Raspberry sorbet

How many cups of coffee do you drink per day?

One

Best place you ever went on vacation?

Greece

If you weren’t a gastroenterologist, what would you be?

Own a clothing store

Favorite type of music?

Old school R&B

Favorite movie genre?

Romantic comedy or drama

Cat person or dog person?

Dog

Favorite sport?

Football

Favorite holiday?

Christmas

Optimist or pessimist?

Optimist

As a resident, rheumatologist Daniel Albert, MD, did his first volunteer mission to Afghanistan. The clinic had one portable chest x-ray machine, and physicians could order a complete blood count but no other laboratory studies.

“We could do sputum stains, but that was about it. You had to use your clinical acumen and make decisions based on examining the patient and taking a history,” said Dr. Albert, a professor of medicine and pediatrics at the Geisel School of Medicine at Dartmouth, Hanover, and The Dartmouth Institute in Lebanon, both in New Hampshire. Such tasks can be difficult in a non–English-speaking country.

“There’s a language barrier no matter where you are,” Dr. Albert said.

In Nashville, Tennessee, James Gore, MD, had an epiphany about opening a free rheumatology clinic during a church service. His priest was discussing St. Sampson the Hospitable’s story and closed with “you don’t have to change the world. All you have to do is your little part,” Dr. Gore said. He knew he didn’t need much: a computer, a stethoscope, and a printer for prescriptions.

When his church expanded its building space, Dr. Gore took the opportunity to achieve his goal.

“I didn’t feel responsible for the clinic to succeed, but I did feel responsible to try my best,” he said. That was 14 years ago. To date, the monthly clinic has served 1124 patients representing 55 counties in Tennessee and several other patients from Kentucky.

Tennessee Clients Get Access to Care, Medications

In some parts of the United States, good rheumatology care is hard to come by. One in four people in Tennessee have no health insurance. There’s a big need for rheumatology care in the state, Dr. Gore said.

On the second Saturday of each month, he volunteers his services at the St. Sampson Medical Clinic at Holy Trinity Greek Orthodox Church, Nashville, Tennessee, from 9 AM to 4 PM, providing care for uninsured adult rheumatology patients.

courtesy Tim Weeks

Patients come by referral from a charity clinic or health department and appointment only. The clinic asks for a $10 payment for their visits. “If they can’t pay, we still see them. But we only take care of patients who don’t have insurance,” Dr. Gore said. Allowing patients to pay gives them an opportunity to show they are vested in their own care. Often, patients will donate extra in gratitude.

Dr. Gore, along with VUMC colleague and rheumatologist Narender Annapureddy, MD, and nurse practitioner Julie Barnes, treats a variety of rheumatic diseases. For Ms. Barnes, volunteering has many rewarding aspects, “as the patients would be unable to have the treatments they need without insurance,” she said.

“We have had patients waiting for many months or sometimes years and have not had a diagnosis, and in a short time, we have been able to diagnose and get them on specific treatment,” Dr. Annapureddy said.

Most people come in for rheumatoid arthritis (RA) and lupus and also positive antinuclear antibody tests. They also see patients with psoriatic arthritis, Sjögren’s disease, gout, scleroderma, Behçet disease, and leukocytoclastic vasculitis. On a typical clinic day, the team can treat up to 30-plus patients. The clinic recently expanded its services to include cardiology care, seeing about 10 patients each month.

Prior to St. Sampson, there were no volunteer clinics in Tennessee specifically dedicated to helping patients with rheumatologic disease. Untreated, these diseases may cause chronic, severe pain, lead to irreversible joint damage, and increase the risk for death.

Many patients have received medications such as adalimumab, etanercept, or tofacitinib for free. The drug companies will provide free medications, provided that they’re prescribed by a board-certified rheumatologist and the patient is uninsured and qualifies for the medication, Dr. Gore said.

Drugs like these can cost about $50,000 a year. “We have pharmacists that donate their time to help these patients get approved for those medicines,” Dr. Gore said. To date, more than 100 patients have received a biologic or targeted synthetic disease-modifying antirheumatic drug through the clinic.

The clinic has received more than $100,000 in donated professional fees, including $48,706 for consultations. Dr. Gore and colleagues relied on other volunteers to bring the clinic to life. He worked with his sister to develop an electronic medical record system that the clinic still uses today. “We did not buy expensive laptops or printers. I had a very generous volunteer, Damon Miltner, our IT guy, who set everything up to make our intranet secure,” he said.

courtesy Tim Weeks

The volunteer nurses, IT, and front desk all work together to make the clinic run efficiently, said Ms. Barnes, who also works as a nurse practitioner with Vanderbilt Rheumatology Cool Springs in Franklin, Tennessee. “We share a lunch together, all in a beautiful and holy church. I do not think of this as work, but as spending time with people who are appreciative and kind,” she said.

“It is amazing to see patients who are able to walk in by themselves after having used a cane for years,” Dr. Annapureddy said. “While doing this on weekends with young kids is challenging, having a supportive spouse who shares the same value makes it much easier to be able to do volunteer work.”
 

Working Outside Your Comfort Zone

Dr. Albert has traveled to all parts of the world to volunteer his services as a rheumatologist and general practitioner. This includes missions to Uganda, Rwanda, Ecuador, Peru, Nepal, and Borneo. He’s participated with several volunteer organizations, among them the International Student & Scholar Services program at the University of Pennsylvania, CARE, Global Volunteers, Project Amazonas, Asha Nepal, Health in Harmony, and several others.

Rheumatologists who volunteer in underdeveloped countries should be prepared to work outside of their specialty — and their comfort zone. In some instances, Dr. Albert took care of AIDS-related infectious diseases. “It’s not something I am particularly knowledgeable about, and I actually spent a fair amount of time reading about it before I went on the plane in order to get some comfort level.”

Dr. Albert often found himself doing more primary care and general pediatrics than rheumatology care. “I would see rheumatic conditions. But there’s not a lot of RA in developing countries, which is something that people have noted before. And the same goes for other autoimmune conditions. They’re just not that common.”

He did see a lot of septic arthritis and tuberculosis in Uganda. “We had a rheum clinic and saw a mixture of the consequences of septic arthritis and also a few RA and lupus patients.”

Limited resources are another thing to prepare for.

Whenever he traveled to a place that didn’t have a lot of resources, Dr. Albert would collect as many supplies as he could from the nearest hospital, pack them away, and try to get the supplies to the mission location.

Sometimes it worked out, and sometimes it didn’t, he said. “I probably had $10,000 worth of medical supplies when I went to Armenia, and American Airlines lost it. It ended up back in my apartment 3 months later. That was unfortunate because there was lot of good stuff there.”

He thought about FedEx-ing some supplies to a mission in Uganda, but it was astronomically expensive, so that didn’t work.

Luggage weight restrictions are another obstacle that sometimes requires a waiver. Dr. Albert once had to get the Red Cross to work with an airline to get a luggage waiver. “Other airlines were very good and didn’t have those kinds of restrictions. But most of the time I got some supplies to go with me, and sometimes that was a very helpful addition,” especially if the mission site was lacking in resources, he said.
 

When Charity Work Produces Success Stories

During one of his missions in Uganda with the University of Pennsylvania, Dr. Albert helped the Makerere University Medical School, Kampala, to establish a rheumatology clinic, which was affiliated with Mulago National Specialised Hospital. The clinic operated once a week for half a day, mostly treating patients with RA and lupus.

The mission also established an AIDS clinic. Many of the patients with musculoskeletal complaints also had HIV and were able to get antiretroviral drugs through the clinic, he said.

For Dr. Gore, seeing patients from more than half the counties in Tennessee was one of the clinic’s biggest accomplishments. “That was all through word of mouth,” he said.

In rheumatology, many patients may feel their condition is hopeless, Ms. Barnes noted. “There have been many patients that, through months of proper treatment, have normal lives. A high percentage would be disabled without the needed medical therapies.”

Dr. Gore has seen patients who literally couldn’t walk or had severe, painful psoriasis all over their body. The clinic would put them on medicine that would give them new life. The psoriasis would clear up, or their joints would heal, and they could walk again.

One of Dr. Gore’s patients, a woman in her mid-50s, got on an expensive medication that brought her arthritis into remission. She’s now able to care for her grandchildren.

The fact that the clinic, with the help of volunteer pharmacologists, can provide medications to enable patients to have a less destructive disease and improved quality of life “is a major reward,” Ms. Barnes said.
 

Balancing Your Priorities

Overseas missions can last for a few weeks to several months, depending on the mission, the organization, and the type of care involved.

Rheumatologists who want to volunteer need to do so in a way that doesn’t generate a lot of angst with supervisors or colleagues. Dr. Albert balanced this by keeping his missions reasonably short. “I would have someone cover my service. And since there’s reciprocity in the places I worked for, if they covered me for a month, I would cover them for a month, so it wasn’t a burden on anybody.”

“By and large, I used my vacation time to do it, and it does cost some money, but it’s a lot less than the cost of a typical vacation,” Dr. Albert said.

Volunteer work can also compete with family time. Dr. Albert ended up taking his family along on several of his missions to Ecuador and Uganda. He would tell the organization: “My family wants to come. Is there anything they can do while I’m working in the program? And they usually found an occupation.”

At St. Sampson, volunteering is also a family affair. “My wife acts as the administrator, so she’s the one that helps schedule patients and deals with a lot of the faxes.” It’s a big commitment for Dr. Gore’s family and for the church, which gives up a significant chunk of the building one Saturday a month.

“However, for us, I think that it’s a real manifestation of giving back and trying to help those in need and doing what we can do,” he said.
 

Volunteer Work Involves Prep Work

Establishing the St. Sampson clinic took some planning. Dr. Gore and colleagues had to fill out a 501(c)(3) application; establish a charter, bylaws, articles of incorporation, policies, and procedures; and obtain medical malpractice and general liability insurance.

The clinic was able to get financing from the Mid-South Chapter of the Lupus Foundation of America as well as in-kind donations from the church. “We’ve had a lot of different companies who were very generous in donating money and excited to help the clinic continue,” Dr. Gore said.

All volunteers sign a Health Insurance Portability and Accountability Act consent form.

Although the clinic operates for about 7 hours a month, it’s still important to have malpractice insurance, Dr. Gore said. He and his colleagues also have tail insurance that covers medical malpractice insurance for up to 7 years if the clinic closes.

“If somebody were to slip and fall and then try to sue the church, we have a separate policy for the clinic for that. We also have a director’s and officer’s insurance policy,” he said.

Anyone who volunteers abroad should get a travel medicine clinic consultation. “Most of the time, it’s of very little consequence. You might have to get [a] yellow fever vaccine” when traveling to certain parts of the world, Dr. Albert said.

“If you’re going into an area that is all volatile politically or in some way a threat to your personal security, I think you have to think very carefully about that,” he said, suggesting that doctors consult with the US Department of State about potential dangers.

Talk to other physicians who have gone on missions and your sponsoring institution. “By and large, you want to go with a large organization that’s been doing ongoing work,” Dr. Albert said.

Volunteer work teaches you about the breadth of humanist endeavors across the world, he noted. “The people that you deal with are very grateful for your help. Whether you’re successful or not, they’re still very appreciative of the efforts that you’re making to help.”

Dr. Albert and Dr. Gore had no disclosures. Dr. Annapureddy has done consulting for GlaxoSmithKline. Ms. Barnes had no disclosures.

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

As a resident, rheumatologist Daniel Albert, MD, did his first volunteer mission to Afghanistan. The clinic had one portable chest x-ray machine, and physicians could order a complete blood count but no other laboratory studies.

“We could do sputum stains, but that was about it. You had to use your clinical acumen and make decisions based on examining the patient and taking a history,” said Dr. Albert, a professor of medicine and pediatrics at the Geisel School of Medicine at Dartmouth, Hanover, and The Dartmouth Institute in Lebanon, both in New Hampshire. Such tasks can be difficult in a non–English-speaking country.

“There’s a language barrier no matter where you are,” Dr. Albert said.

In Nashville, Tennessee, James Gore, MD, had an epiphany about opening a free rheumatology clinic during a church service. His priest was discussing St. Sampson the Hospitable’s story and closed with “you don’t have to change the world. All you have to do is your little part,” Dr. Gore said. He knew he didn’t need much: a computer, a stethoscope, and a printer for prescriptions.

When his church expanded its building space, Dr. Gore took the opportunity to achieve his goal.

“I didn’t feel responsible for the clinic to succeed, but I did feel responsible to try my best,” he said. That was 14 years ago. To date, the monthly clinic has served 1124 patients representing 55 counties in Tennessee and several other patients from Kentucky.

Tennessee Clients Get Access to Care, Medications

In some parts of the United States, good rheumatology care is hard to come by. One in four people in Tennessee have no health insurance. There’s a big need for rheumatology care in the state, Dr. Gore said.

On the second Saturday of each month, he volunteers his services at the St. Sampson Medical Clinic at Holy Trinity Greek Orthodox Church, Nashville, Tennessee, from 9 AM to 4 PM, providing care for uninsured adult rheumatology patients.

courtesy Tim Weeks

Patients come by referral from a charity clinic or health department and appointment only. The clinic asks for a $10 payment for their visits. “If they can’t pay, we still see them. But we only take care of patients who don’t have insurance,” Dr. Gore said. Allowing patients to pay gives them an opportunity to show they are vested in their own care. Often, patients will donate extra in gratitude.

Dr. Gore, along with VUMC colleague and rheumatologist Narender Annapureddy, MD, and nurse practitioner Julie Barnes, treats a variety of rheumatic diseases. For Ms. Barnes, volunteering has many rewarding aspects, “as the patients would be unable to have the treatments they need without insurance,” she said.

“We have had patients waiting for many months or sometimes years and have not had a diagnosis, and in a short time, we have been able to diagnose and get them on specific treatment,” Dr. Annapureddy said.

Most people come in for rheumatoid arthritis (RA) and lupus and also positive antinuclear antibody tests. They also see patients with psoriatic arthritis, Sjögren’s disease, gout, scleroderma, Behçet disease, and leukocytoclastic vasculitis. On a typical clinic day, the team can treat up to 30-plus patients. The clinic recently expanded its services to include cardiology care, seeing about 10 patients each month.

Prior to St. Sampson, there were no volunteer clinics in Tennessee specifically dedicated to helping patients with rheumatologic disease. Untreated, these diseases may cause chronic, severe pain, lead to irreversible joint damage, and increase the risk for death.

Many patients have received medications such as adalimumab, etanercept, or tofacitinib for free. The drug companies will provide free medications, provided that they’re prescribed by a board-certified rheumatologist and the patient is uninsured and qualifies for the medication, Dr. Gore said.

Drugs like these can cost about $50,000 a year. “We have pharmacists that donate their time to help these patients get approved for those medicines,” Dr. Gore said. To date, more than 100 patients have received a biologic or targeted synthetic disease-modifying antirheumatic drug through the clinic.

The clinic has received more than $100,000 in donated professional fees, including $48,706 for consultations. Dr. Gore and colleagues relied on other volunteers to bring the clinic to life. He worked with his sister to develop an electronic medical record system that the clinic still uses today. “We did not buy expensive laptops or printers. I had a very generous volunteer, Damon Miltner, our IT guy, who set everything up to make our intranet secure,” he said.

courtesy Tim Weeks

The volunteer nurses, IT, and front desk all work together to make the clinic run efficiently, said Ms. Barnes, who also works as a nurse practitioner with Vanderbilt Rheumatology Cool Springs in Franklin, Tennessee. “We share a lunch together, all in a beautiful and holy church. I do not think of this as work, but as spending time with people who are appreciative and kind,” she said.

“It is amazing to see patients who are able to walk in by themselves after having used a cane for years,” Dr. Annapureddy said. “While doing this on weekends with young kids is challenging, having a supportive spouse who shares the same value makes it much easier to be able to do volunteer work.”
 

Working Outside Your Comfort Zone

Dr. Albert has traveled to all parts of the world to volunteer his services as a rheumatologist and general practitioner. This includes missions to Uganda, Rwanda, Ecuador, Peru, Nepal, and Borneo. He’s participated with several volunteer organizations, among them the International Student & Scholar Services program at the University of Pennsylvania, CARE, Global Volunteers, Project Amazonas, Asha Nepal, Health in Harmony, and several others.

Rheumatologists who volunteer in underdeveloped countries should be prepared to work outside of their specialty — and their comfort zone. In some instances, Dr. Albert took care of AIDS-related infectious diseases. “It’s not something I am particularly knowledgeable about, and I actually spent a fair amount of time reading about it before I went on the plane in order to get some comfort level.”

Dr. Albert often found himself doing more primary care and general pediatrics than rheumatology care. “I would see rheumatic conditions. But there’s not a lot of RA in developing countries, which is something that people have noted before. And the same goes for other autoimmune conditions. They’re just not that common.”

He did see a lot of septic arthritis and tuberculosis in Uganda. “We had a rheum clinic and saw a mixture of the consequences of septic arthritis and also a few RA and lupus patients.”

Limited resources are another thing to prepare for.

Whenever he traveled to a place that didn’t have a lot of resources, Dr. Albert would collect as many supplies as he could from the nearest hospital, pack them away, and try to get the supplies to the mission location.

Sometimes it worked out, and sometimes it didn’t, he said. “I probably had $10,000 worth of medical supplies when I went to Armenia, and American Airlines lost it. It ended up back in my apartment 3 months later. That was unfortunate because there was lot of good stuff there.”

He thought about FedEx-ing some supplies to a mission in Uganda, but it was astronomically expensive, so that didn’t work.

Luggage weight restrictions are another obstacle that sometimes requires a waiver. Dr. Albert once had to get the Red Cross to work with an airline to get a luggage waiver. “Other airlines were very good and didn’t have those kinds of restrictions. But most of the time I got some supplies to go with me, and sometimes that was a very helpful addition,” especially if the mission site was lacking in resources, he said.
 

When Charity Work Produces Success Stories

During one of his missions in Uganda with the University of Pennsylvania, Dr. Albert helped the Makerere University Medical School, Kampala, to establish a rheumatology clinic, which was affiliated with Mulago National Specialised Hospital. The clinic operated once a week for half a day, mostly treating patients with RA and lupus.

The mission also established an AIDS clinic. Many of the patients with musculoskeletal complaints also had HIV and were able to get antiretroviral drugs through the clinic, he said.

For Dr. Gore, seeing patients from more than half the counties in Tennessee was one of the clinic’s biggest accomplishments. “That was all through word of mouth,” he said.

In rheumatology, many patients may feel their condition is hopeless, Ms. Barnes noted. “There have been many patients that, through months of proper treatment, have normal lives. A high percentage would be disabled without the needed medical therapies.”

Dr. Gore has seen patients who literally couldn’t walk or had severe, painful psoriasis all over their body. The clinic would put them on medicine that would give them new life. The psoriasis would clear up, or their joints would heal, and they could walk again.

One of Dr. Gore’s patients, a woman in her mid-50s, got on an expensive medication that brought her arthritis into remission. She’s now able to care for her grandchildren.

The fact that the clinic, with the help of volunteer pharmacologists, can provide medications to enable patients to have a less destructive disease and improved quality of life “is a major reward,” Ms. Barnes said.
 

Balancing Your Priorities

Overseas missions can last for a few weeks to several months, depending on the mission, the organization, and the type of care involved.

Rheumatologists who want to volunteer need to do so in a way that doesn’t generate a lot of angst with supervisors or colleagues. Dr. Albert balanced this by keeping his missions reasonably short. “I would have someone cover my service. And since there’s reciprocity in the places I worked for, if they covered me for a month, I would cover them for a month, so it wasn’t a burden on anybody.”

“By and large, I used my vacation time to do it, and it does cost some money, but it’s a lot less than the cost of a typical vacation,” Dr. Albert said.

Volunteer work can also compete with family time. Dr. Albert ended up taking his family along on several of his missions to Ecuador and Uganda. He would tell the organization: “My family wants to come. Is there anything they can do while I’m working in the program? And they usually found an occupation.”

At St. Sampson, volunteering is also a family affair. “My wife acts as the administrator, so she’s the one that helps schedule patients and deals with a lot of the faxes.” It’s a big commitment for Dr. Gore’s family and for the church, which gives up a significant chunk of the building one Saturday a month.

“However, for us, I think that it’s a real manifestation of giving back and trying to help those in need and doing what we can do,” he said.
 

Volunteer Work Involves Prep Work

Establishing the St. Sampson clinic took some planning. Dr. Gore and colleagues had to fill out a 501(c)(3) application; establish a charter, bylaws, articles of incorporation, policies, and procedures; and obtain medical malpractice and general liability insurance.

The clinic was able to get financing from the Mid-South Chapter of the Lupus Foundation of America as well as in-kind donations from the church. “We’ve had a lot of different companies who were very generous in donating money and excited to help the clinic continue,” Dr. Gore said.

All volunteers sign a Health Insurance Portability and Accountability Act consent form.

Although the clinic operates for about 7 hours a month, it’s still important to have malpractice insurance, Dr. Gore said. He and his colleagues also have tail insurance that covers medical malpractice insurance for up to 7 years if the clinic closes.

“If somebody were to slip and fall and then try to sue the church, we have a separate policy for the clinic for that. We also have a director’s and officer’s insurance policy,” he said.

Anyone who volunteers abroad should get a travel medicine clinic consultation. “Most of the time, it’s of very little consequence. You might have to get [a] yellow fever vaccine” when traveling to certain parts of the world, Dr. Albert said.

“If you’re going into an area that is all volatile politically or in some way a threat to your personal security, I think you have to think very carefully about that,” he said, suggesting that doctors consult with the US Department of State about potential dangers.

Talk to other physicians who have gone on missions and your sponsoring institution. “By and large, you want to go with a large organization that’s been doing ongoing work,” Dr. Albert said.

Volunteer work teaches you about the breadth of humanist endeavors across the world, he noted. “The people that you deal with are very grateful for your help. Whether you’re successful or not, they’re still very appreciative of the efforts that you’re making to help.”

Dr. Albert and Dr. Gore had no disclosures. Dr. Annapureddy has done consulting for GlaxoSmithKline. Ms. Barnes had no disclosures.

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

As a resident, rheumatologist Daniel Albert, MD, did his first volunteer mission to Afghanistan. The clinic had one portable chest x-ray machine, and physicians could order a complete blood count but no other laboratory studies.

“We could do sputum stains, but that was about it. You had to use your clinical acumen and make decisions based on examining the patient and taking a history,” said Dr. Albert, a professor of medicine and pediatrics at the Geisel School of Medicine at Dartmouth, Hanover, and The Dartmouth Institute in Lebanon, both in New Hampshire. Such tasks can be difficult in a non–English-speaking country.

“There’s a language barrier no matter where you are,” Dr. Albert said.

In Nashville, Tennessee, James Gore, MD, had an epiphany about opening a free rheumatology clinic during a church service. His priest was discussing St. Sampson the Hospitable’s story and closed with “you don’t have to change the world. All you have to do is your little part,” Dr. Gore said. He knew he didn’t need much: a computer, a stethoscope, and a printer for prescriptions.

When his church expanded its building space, Dr. Gore took the opportunity to achieve his goal.

“I didn’t feel responsible for the clinic to succeed, but I did feel responsible to try my best,” he said. That was 14 years ago. To date, the monthly clinic has served 1124 patients representing 55 counties in Tennessee and several other patients from Kentucky.

Tennessee Clients Get Access to Care, Medications

In some parts of the United States, good rheumatology care is hard to come by. One in four people in Tennessee have no health insurance. There’s a big need for rheumatology care in the state, Dr. Gore said.

On the second Saturday of each month, he volunteers his services at the St. Sampson Medical Clinic at Holy Trinity Greek Orthodox Church, Nashville, Tennessee, from 9 AM to 4 PM, providing care for uninsured adult rheumatology patients.

courtesy Tim Weeks

Patients come by referral from a charity clinic or health department and appointment only. The clinic asks for a $10 payment for their visits. “If they can’t pay, we still see them. But we only take care of patients who don’t have insurance,” Dr. Gore said. Allowing patients to pay gives them an opportunity to show they are vested in their own care. Often, patients will donate extra in gratitude.

Dr. Gore, along with VUMC colleague and rheumatologist Narender Annapureddy, MD, and nurse practitioner Julie Barnes, treats a variety of rheumatic diseases. For Ms. Barnes, volunteering has many rewarding aspects, “as the patients would be unable to have the treatments they need without insurance,” she said.

“We have had patients waiting for many months or sometimes years and have not had a diagnosis, and in a short time, we have been able to diagnose and get them on specific treatment,” Dr. Annapureddy said.

Most people come in for rheumatoid arthritis (RA) and lupus and also positive antinuclear antibody tests. They also see patients with psoriatic arthritis, Sjögren’s disease, gout, scleroderma, Behçet disease, and leukocytoclastic vasculitis. On a typical clinic day, the team can treat up to 30-plus patients. The clinic recently expanded its services to include cardiology care, seeing about 10 patients each month.

Prior to St. Sampson, there were no volunteer clinics in Tennessee specifically dedicated to helping patients with rheumatologic disease. Untreated, these diseases may cause chronic, severe pain, lead to irreversible joint damage, and increase the risk for death.

Many patients have received medications such as adalimumab, etanercept, or tofacitinib for free. The drug companies will provide free medications, provided that they’re prescribed by a board-certified rheumatologist and the patient is uninsured and qualifies for the medication, Dr. Gore said.

Drugs like these can cost about $50,000 a year. “We have pharmacists that donate their time to help these patients get approved for those medicines,” Dr. Gore said. To date, more than 100 patients have received a biologic or targeted synthetic disease-modifying antirheumatic drug through the clinic.

The clinic has received more than $100,000 in donated professional fees, including $48,706 for consultations. Dr. Gore and colleagues relied on other volunteers to bring the clinic to life. He worked with his sister to develop an electronic medical record system that the clinic still uses today. “We did not buy expensive laptops or printers. I had a very generous volunteer, Damon Miltner, our IT guy, who set everything up to make our intranet secure,” he said.

courtesy Tim Weeks

The volunteer nurses, IT, and front desk all work together to make the clinic run efficiently, said Ms. Barnes, who also works as a nurse practitioner with Vanderbilt Rheumatology Cool Springs in Franklin, Tennessee. “We share a lunch together, all in a beautiful and holy church. I do not think of this as work, but as spending time with people who are appreciative and kind,” she said.

“It is amazing to see patients who are able to walk in by themselves after having used a cane for years,” Dr. Annapureddy said. “While doing this on weekends with young kids is challenging, having a supportive spouse who shares the same value makes it much easier to be able to do volunteer work.”
 

Working Outside Your Comfort Zone

Dr. Albert has traveled to all parts of the world to volunteer his services as a rheumatologist and general practitioner. This includes missions to Uganda, Rwanda, Ecuador, Peru, Nepal, and Borneo. He’s participated with several volunteer organizations, among them the International Student & Scholar Services program at the University of Pennsylvania, CARE, Global Volunteers, Project Amazonas, Asha Nepal, Health in Harmony, and several others.

Rheumatologists who volunteer in underdeveloped countries should be prepared to work outside of their specialty — and their comfort zone. In some instances, Dr. Albert took care of AIDS-related infectious diseases. “It’s not something I am particularly knowledgeable about, and I actually spent a fair amount of time reading about it before I went on the plane in order to get some comfort level.”

Dr. Albert often found himself doing more primary care and general pediatrics than rheumatology care. “I would see rheumatic conditions. But there’s not a lot of RA in developing countries, which is something that people have noted before. And the same goes for other autoimmune conditions. They’re just not that common.”

He did see a lot of septic arthritis and tuberculosis in Uganda. “We had a rheum clinic and saw a mixture of the consequences of septic arthritis and also a few RA and lupus patients.”

Limited resources are another thing to prepare for.

Whenever he traveled to a place that didn’t have a lot of resources, Dr. Albert would collect as many supplies as he could from the nearest hospital, pack them away, and try to get the supplies to the mission location.

Sometimes it worked out, and sometimes it didn’t, he said. “I probably had $10,000 worth of medical supplies when I went to Armenia, and American Airlines lost it. It ended up back in my apartment 3 months later. That was unfortunate because there was lot of good stuff there.”

He thought about FedEx-ing some supplies to a mission in Uganda, but it was astronomically expensive, so that didn’t work.

Luggage weight restrictions are another obstacle that sometimes requires a waiver. Dr. Albert once had to get the Red Cross to work with an airline to get a luggage waiver. “Other airlines were very good and didn’t have those kinds of restrictions. But most of the time I got some supplies to go with me, and sometimes that was a very helpful addition,” especially if the mission site was lacking in resources, he said.
 

When Charity Work Produces Success Stories

During one of his missions in Uganda with the University of Pennsylvania, Dr. Albert helped the Makerere University Medical School, Kampala, to establish a rheumatology clinic, which was affiliated with Mulago National Specialised Hospital. The clinic operated once a week for half a day, mostly treating patients with RA and lupus.

The mission also established an AIDS clinic. Many of the patients with musculoskeletal complaints also had HIV and were able to get antiretroviral drugs through the clinic, he said.

For Dr. Gore, seeing patients from more than half the counties in Tennessee was one of the clinic’s biggest accomplishments. “That was all through word of mouth,” he said.

In rheumatology, many patients may feel their condition is hopeless, Ms. Barnes noted. “There have been many patients that, through months of proper treatment, have normal lives. A high percentage would be disabled without the needed medical therapies.”

Dr. Gore has seen patients who literally couldn’t walk or had severe, painful psoriasis all over their body. The clinic would put them on medicine that would give them new life. The psoriasis would clear up, or their joints would heal, and they could walk again.

One of Dr. Gore’s patients, a woman in her mid-50s, got on an expensive medication that brought her arthritis into remission. She’s now able to care for her grandchildren.

The fact that the clinic, with the help of volunteer pharmacologists, can provide medications to enable patients to have a less destructive disease and improved quality of life “is a major reward,” Ms. Barnes said.
 

Balancing Your Priorities

Overseas missions can last for a few weeks to several months, depending on the mission, the organization, and the type of care involved.

Rheumatologists who want to volunteer need to do so in a way that doesn’t generate a lot of angst with supervisors or colleagues. Dr. Albert balanced this by keeping his missions reasonably short. “I would have someone cover my service. And since there’s reciprocity in the places I worked for, if they covered me for a month, I would cover them for a month, so it wasn’t a burden on anybody.”

“By and large, I used my vacation time to do it, and it does cost some money, but it’s a lot less than the cost of a typical vacation,” Dr. Albert said.

Volunteer work can also compete with family time. Dr. Albert ended up taking his family along on several of his missions to Ecuador and Uganda. He would tell the organization: “My family wants to come. Is there anything they can do while I’m working in the program? And they usually found an occupation.”

At St. Sampson, volunteering is also a family affair. “My wife acts as the administrator, so she’s the one that helps schedule patients and deals with a lot of the faxes.” It’s a big commitment for Dr. Gore’s family and for the church, which gives up a significant chunk of the building one Saturday a month.

“However, for us, I think that it’s a real manifestation of giving back and trying to help those in need and doing what we can do,” he said.
 

Volunteer Work Involves Prep Work

Establishing the St. Sampson clinic took some planning. Dr. Gore and colleagues had to fill out a 501(c)(3) application; establish a charter, bylaws, articles of incorporation, policies, and procedures; and obtain medical malpractice and general liability insurance.

The clinic was able to get financing from the Mid-South Chapter of the Lupus Foundation of America as well as in-kind donations from the church. “We’ve had a lot of different companies who were very generous in donating money and excited to help the clinic continue,” Dr. Gore said.

All volunteers sign a Health Insurance Portability and Accountability Act consent form.

Although the clinic operates for about 7 hours a month, it’s still important to have malpractice insurance, Dr. Gore said. He and his colleagues also have tail insurance that covers medical malpractice insurance for up to 7 years if the clinic closes.

“If somebody were to slip and fall and then try to sue the church, we have a separate policy for the clinic for that. We also have a director’s and officer’s insurance policy,” he said.

Anyone who volunteers abroad should get a travel medicine clinic consultation. “Most of the time, it’s of very little consequence. You might have to get [a] yellow fever vaccine” when traveling to certain parts of the world, Dr. Albert said.

“If you’re going into an area that is all volatile politically or in some way a threat to your personal security, I think you have to think very carefully about that,” he said, suggesting that doctors consult with the US Department of State about potential dangers.

Talk to other physicians who have gone on missions and your sponsoring institution. “By and large, you want to go with a large organization that’s been doing ongoing work,” Dr. Albert said.

Volunteer work teaches you about the breadth of humanist endeavors across the world, he noted. “The people that you deal with are very grateful for your help. Whether you’re successful or not, they’re still very appreciative of the efforts that you’re making to help.”

Dr. Albert and Dr. Gore had no disclosures. Dr. Annapureddy has done consulting for GlaxoSmithKline. Ms. Barnes had no disclosures.

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

A US government report showed how a Medicare policy change made the drug ustekinumab (Stelara) for autoimmune diseases much more expensive, a finding that experts say illustrates the need for reforms created by the Inflation Reduction Act of 2022 (IRA).

The topline findings of an August report from the Department of Health and Human Services (HHS) about ustekinumab may seem somewhat surprising and a bit counterintuitive.

Ustekinumab costs spiked as Medicare pushed patients to get their supply through the Part D pharmacy program. The aim of Part D is to make medicines more affordable and accessible for patients. It runs on a model of insurers to negotiate deals for pharmaceuticals.

Earlier, many patients who needed ustekinumab had the drug covered by Medicare Part B. For many years, Medicare Part B has been largely a passive purchaser of medicines. Part B covers drugs administered by physicians. Its longtime model has been to add a premium of 6% to the reported average sales price to reimburse physicians who buy and administer the drug for patients.

But it was Part D, the Medicare program based on insurers’ negotiating clout, that saw a spike in ustekinumab costs after patients were shifted out of Part B coverage, where the cost of the medicine fell.

The average reported Part B cost for an ustekinumab injection slipped from $14,450 in 2016 to $12,912 by 2023, according to the report from HHS’ Office of Inspector General (OIG).

The Part D cost jumped in the same period. It rose by 84% from $17,717 in 2016 to $32,559 by 2023.

The IRA is intended to curb these kinds of increases in the future for drugs covered by Medicare, said Stacie B. Dusetzina, PhD, professor of health policy at Vanderbilt University School of Medicine, Nashville, Tennessee. The law demands companies pay rebates to Medicare if they increase drug prices faster than consumer inflation.

“That should at least help with some of this price growth that over time has seemed quite egregious,” Dr. Dusetzina told this news organization.

The IRA contains several provisions intended to curb rising drug costs for people enrolled in Medicare, including allowing the federal government to directly negotiate on some medicines.

Ustekinumab is one of the first 10 medicines that are subject to negotiations. Medicare will select as many as 15 additional drugs covered under Part D for negotiation in 2025, another 15 Part B and D drugs in 2026, and up to 20 drugs every year after that.

Earlier in August, the Centers for Medicare & Medicaid Services (CMS) announced the results of its first drug negotiations, with prices set to take effect in 2026. The Part D price for a 30-day supply of ustekinumab will be $4695 in 2026, a 66% reduction from the list price last year of $13,836.

Even at the negotiated price, ustekinumab’s cost will be high enough to trigger a new cap on out-of-pocket Part D spending, Dr. Dusetzina said.

Starting in 2025, Part D will have a cap of $2000 on individuals’ out-of-pocket costs, with annual adjustments in future years.

“It may not be better for someone who was filling this on Part B, who had a supplement [that covered their share of the ustekinumab cost], but it will be better for a lot of people that it’s covered under Part D,” Dr. Dusetzina said. “The good news is that at least from a beneficiary affordability standpoint, they’re going to have some price protection.”

OIG noted that the US Food and Drug Administration has approved three competing biosimilar versions of ustekinumab. These could also potentially work to lower costs.
 

‘A Complicated and Not Particularly Transparent Process’

OIG said it expects to release a report later this year with more detail about the decision that shifted ustekinumab coverage from Part B to Part D.

First cleared for US sales in 2009, ustekinumab is approved for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It can be given subcutaneously or intravenously.

Part B does not generally cover self-administered drugs. The infused version of ustekinumab has been covered under Medicare Part B since it reached the market.

“However, Part B coverage of the subcutaneous versions has been less straightforward,” OIG said in the report.

In 2020, Medicare administrative contractors — the units or affiliates of insurers that for decades have processed Part B claims for the traditional Medicare programs — determined that subcutaneous ustekinumab did not meet the criteria for coverage under Part B. Implementation of this change was delayed due to the COVID public health emergency but has since taken effect.

The shift in ustekinumab coverage to Part D eroded financial protections of many people on Medicare when Part B covered the drug.

Almost 9 in 10 people enrolled in Medicare Part B have supplemental insurance such as Medigap, employer coverage, or Medicaid to fully or partially cover their cost-sharing requirements, the OIG report said. That means Part B coverage shielded many patients from high ustekinumab costs. 

In contrast, patients who self-administered the drug at home under Part D coverage paid an average of almost $6000 out of pocket if they did not receive any type of financial assistance, OIG said.

“From a financial standpoint, as long as you have Part B coinsurance, it would be much cheaper to get the drug in your doctor’s office than getting it through a pharmacy, unless you qualify for the low-income subsidy,” OIG Regional Inspector General David Tawes, who supervised the team that produced the report, told this news organization.

OIG has previously reported that post–point-of-sale rebates paid by manufacturers sometimes lower the costs incurred by Part D plans by a significant margin. But this was not the case with ustekinumab. Instead, OIG said the gap between initial and actual costs of ustekinumab was reduced by less than one third even with rebates. Rebate information is considered confidential.

“The whole negotiation structure is a complicated and not particularly transparent process,” Mr. Tawes said.
 

Backchannel Discounts, Top-Line Prices

The IRA is bringing some more transparency to the process through negotiations, said Mariana P. Socal, MD, associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Patients who buy medicines that have been through the CMS negotiation process will be able to see if they are being charged correctly.

Dr. Socal noted that there’s something of a disconnect in discussions of Part D between how insurers and consumers view prices. 

For Part D plans, the list prices represent the beginning of negotiations. They get rebates from drugmakers’ list prices for medicines, which insurers say work to lower premium costs. 

“For plans, those prices are unrealistic. They are simply a sticker price. But for patients, for the Medicare beneficiaries, these prices are very real” because they are used to set copays, Dr. Socal said.

Dr. Dusetzina reported receiving funding from Arnold Ventures and the Commonwealth Fund for research related to drug pricing. Dr. Socal reported receiving funding from Arnold Ventures. 

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

A US government report showed how a Medicare policy change made the drug ustekinumab (Stelara) for autoimmune diseases much more expensive, a finding that experts say illustrates the need for reforms created by the Inflation Reduction Act of 2022 (IRA).

The topline findings of an August report from the Department of Health and Human Services (HHS) about ustekinumab may seem somewhat surprising and a bit counterintuitive.

Ustekinumab costs spiked as Medicare pushed patients to get their supply through the Part D pharmacy program. The aim of Part D is to make medicines more affordable and accessible for patients. It runs on a model of insurers to negotiate deals for pharmaceuticals.

Earlier, many patients who needed ustekinumab had the drug covered by Medicare Part B. For many years, Medicare Part B has been largely a passive purchaser of medicines. Part B covers drugs administered by physicians. Its longtime model has been to add a premium of 6% to the reported average sales price to reimburse physicians who buy and administer the drug for patients.

But it was Part D, the Medicare program based on insurers’ negotiating clout, that saw a spike in ustekinumab costs after patients were shifted out of Part B coverage, where the cost of the medicine fell.

The average reported Part B cost for an ustekinumab injection slipped from $14,450 in 2016 to $12,912 by 2023, according to the report from HHS’ Office of Inspector General (OIG).

The Part D cost jumped in the same period. It rose by 84% from $17,717 in 2016 to $32,559 by 2023.

The IRA is intended to curb these kinds of increases in the future for drugs covered by Medicare, said Stacie B. Dusetzina, PhD, professor of health policy at Vanderbilt University School of Medicine, Nashville, Tennessee. The law demands companies pay rebates to Medicare if they increase drug prices faster than consumer inflation.

“That should at least help with some of this price growth that over time has seemed quite egregious,” Dr. Dusetzina told this news organization.

The IRA contains several provisions intended to curb rising drug costs for people enrolled in Medicare, including allowing the federal government to directly negotiate on some medicines.

Ustekinumab is one of the first 10 medicines that are subject to negotiations. Medicare will select as many as 15 additional drugs covered under Part D for negotiation in 2025, another 15 Part B and D drugs in 2026, and up to 20 drugs every year after that.

Earlier in August, the Centers for Medicare & Medicaid Services (CMS) announced the results of its first drug negotiations, with prices set to take effect in 2026. The Part D price for a 30-day supply of ustekinumab will be $4695 in 2026, a 66% reduction from the list price last year of $13,836.

Even at the negotiated price, ustekinumab’s cost will be high enough to trigger a new cap on out-of-pocket Part D spending, Dr. Dusetzina said.

Starting in 2025, Part D will have a cap of $2000 on individuals’ out-of-pocket costs, with annual adjustments in future years.

“It may not be better for someone who was filling this on Part B, who had a supplement [that covered their share of the ustekinumab cost], but it will be better for a lot of people that it’s covered under Part D,” Dr. Dusetzina said. “The good news is that at least from a beneficiary affordability standpoint, they’re going to have some price protection.”

OIG noted that the US Food and Drug Administration has approved three competing biosimilar versions of ustekinumab. These could also potentially work to lower costs.
 

‘A Complicated and Not Particularly Transparent Process’

OIG said it expects to release a report later this year with more detail about the decision that shifted ustekinumab coverage from Part B to Part D.

First cleared for US sales in 2009, ustekinumab is approved for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It can be given subcutaneously or intravenously.

Part B does not generally cover self-administered drugs. The infused version of ustekinumab has been covered under Medicare Part B since it reached the market.

“However, Part B coverage of the subcutaneous versions has been less straightforward,” OIG said in the report.

In 2020, Medicare administrative contractors — the units or affiliates of insurers that for decades have processed Part B claims for the traditional Medicare programs — determined that subcutaneous ustekinumab did not meet the criteria for coverage under Part B. Implementation of this change was delayed due to the COVID public health emergency but has since taken effect.

The shift in ustekinumab coverage to Part D eroded financial protections of many people on Medicare when Part B covered the drug.

Almost 9 in 10 people enrolled in Medicare Part B have supplemental insurance such as Medigap, employer coverage, or Medicaid to fully or partially cover their cost-sharing requirements, the OIG report said. That means Part B coverage shielded many patients from high ustekinumab costs. 

In contrast, patients who self-administered the drug at home under Part D coverage paid an average of almost $6000 out of pocket if they did not receive any type of financial assistance, OIG said.

“From a financial standpoint, as long as you have Part B coinsurance, it would be much cheaper to get the drug in your doctor’s office than getting it through a pharmacy, unless you qualify for the low-income subsidy,” OIG Regional Inspector General David Tawes, who supervised the team that produced the report, told this news organization.

OIG has previously reported that post–point-of-sale rebates paid by manufacturers sometimes lower the costs incurred by Part D plans by a significant margin. But this was not the case with ustekinumab. Instead, OIG said the gap between initial and actual costs of ustekinumab was reduced by less than one third even with rebates. Rebate information is considered confidential.

“The whole negotiation structure is a complicated and not particularly transparent process,” Mr. Tawes said.
 

Backchannel Discounts, Top-Line Prices

The IRA is bringing some more transparency to the process through negotiations, said Mariana P. Socal, MD, associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Patients who buy medicines that have been through the CMS negotiation process will be able to see if they are being charged correctly.

Dr. Socal noted that there’s something of a disconnect in discussions of Part D between how insurers and consumers view prices. 

For Part D plans, the list prices represent the beginning of negotiations. They get rebates from drugmakers’ list prices for medicines, which insurers say work to lower premium costs. 

“For plans, those prices are unrealistic. They are simply a sticker price. But for patients, for the Medicare beneficiaries, these prices are very real” because they are used to set copays, Dr. Socal said.

Dr. Dusetzina reported receiving funding from Arnold Ventures and the Commonwealth Fund for research related to drug pricing. Dr. Socal reported receiving funding from Arnold Ventures. 

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

A US government report showed how a Medicare policy change made the drug ustekinumab (Stelara) for autoimmune diseases much more expensive, a finding that experts say illustrates the need for reforms created by the Inflation Reduction Act of 2022 (IRA).

The topline findings of an August report from the Department of Health and Human Services (HHS) about ustekinumab may seem somewhat surprising and a bit counterintuitive.

Ustekinumab costs spiked as Medicare pushed patients to get their supply through the Part D pharmacy program. The aim of Part D is to make medicines more affordable and accessible for patients. It runs on a model of insurers to negotiate deals for pharmaceuticals.

Earlier, many patients who needed ustekinumab had the drug covered by Medicare Part B. For many years, Medicare Part B has been largely a passive purchaser of medicines. Part B covers drugs administered by physicians. Its longtime model has been to add a premium of 6% to the reported average sales price to reimburse physicians who buy and administer the drug for patients.

But it was Part D, the Medicare program based on insurers’ negotiating clout, that saw a spike in ustekinumab costs after patients were shifted out of Part B coverage, where the cost of the medicine fell.

The average reported Part B cost for an ustekinumab injection slipped from $14,450 in 2016 to $12,912 by 2023, according to the report from HHS’ Office of Inspector General (OIG).

The Part D cost jumped in the same period. It rose by 84% from $17,717 in 2016 to $32,559 by 2023.

The IRA is intended to curb these kinds of increases in the future for drugs covered by Medicare, said Stacie B. Dusetzina, PhD, professor of health policy at Vanderbilt University School of Medicine, Nashville, Tennessee. The law demands companies pay rebates to Medicare if they increase drug prices faster than consumer inflation.

“That should at least help with some of this price growth that over time has seemed quite egregious,” Dr. Dusetzina told this news organization.

The IRA contains several provisions intended to curb rising drug costs for people enrolled in Medicare, including allowing the federal government to directly negotiate on some medicines.

Ustekinumab is one of the first 10 medicines that are subject to negotiations. Medicare will select as many as 15 additional drugs covered under Part D for negotiation in 2025, another 15 Part B and D drugs in 2026, and up to 20 drugs every year after that.

Earlier in August, the Centers for Medicare & Medicaid Services (CMS) announced the results of its first drug negotiations, with prices set to take effect in 2026. The Part D price for a 30-day supply of ustekinumab will be $4695 in 2026, a 66% reduction from the list price last year of $13,836.

Even at the negotiated price, ustekinumab’s cost will be high enough to trigger a new cap on out-of-pocket Part D spending, Dr. Dusetzina said.

Starting in 2025, Part D will have a cap of $2000 on individuals’ out-of-pocket costs, with annual adjustments in future years.

“It may not be better for someone who was filling this on Part B, who had a supplement [that covered their share of the ustekinumab cost], but it will be better for a lot of people that it’s covered under Part D,” Dr. Dusetzina said. “The good news is that at least from a beneficiary affordability standpoint, they’re going to have some price protection.”

OIG noted that the US Food and Drug Administration has approved three competing biosimilar versions of ustekinumab. These could also potentially work to lower costs.
 

‘A Complicated and Not Particularly Transparent Process’

OIG said it expects to release a report later this year with more detail about the decision that shifted ustekinumab coverage from Part B to Part D.

First cleared for US sales in 2009, ustekinumab is approved for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It can be given subcutaneously or intravenously.

Part B does not generally cover self-administered drugs. The infused version of ustekinumab has been covered under Medicare Part B since it reached the market.

“However, Part B coverage of the subcutaneous versions has been less straightforward,” OIG said in the report.

In 2020, Medicare administrative contractors — the units or affiliates of insurers that for decades have processed Part B claims for the traditional Medicare programs — determined that subcutaneous ustekinumab did not meet the criteria for coverage under Part B. Implementation of this change was delayed due to the COVID public health emergency but has since taken effect.

The shift in ustekinumab coverage to Part D eroded financial protections of many people on Medicare when Part B covered the drug.

Almost 9 in 10 people enrolled in Medicare Part B have supplemental insurance such as Medigap, employer coverage, or Medicaid to fully or partially cover their cost-sharing requirements, the OIG report said. That means Part B coverage shielded many patients from high ustekinumab costs. 

In contrast, patients who self-administered the drug at home under Part D coverage paid an average of almost $6000 out of pocket if they did not receive any type of financial assistance, OIG said.

“From a financial standpoint, as long as you have Part B coinsurance, it would be much cheaper to get the drug in your doctor’s office than getting it through a pharmacy, unless you qualify for the low-income subsidy,” OIG Regional Inspector General David Tawes, who supervised the team that produced the report, told this news organization.

OIG has previously reported that post–point-of-sale rebates paid by manufacturers sometimes lower the costs incurred by Part D plans by a significant margin. But this was not the case with ustekinumab. Instead, OIG said the gap between initial and actual costs of ustekinumab was reduced by less than one third even with rebates. Rebate information is considered confidential.

“The whole negotiation structure is a complicated and not particularly transparent process,” Mr. Tawes said.
 

Backchannel Discounts, Top-Line Prices

The IRA is bringing some more transparency to the process through negotiations, said Mariana P. Socal, MD, associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Patients who buy medicines that have been through the CMS negotiation process will be able to see if they are being charged correctly.

Dr. Socal noted that there’s something of a disconnect in discussions of Part D between how insurers and consumers view prices. 

For Part D plans, the list prices represent the beginning of negotiations. They get rebates from drugmakers’ list prices for medicines, which insurers say work to lower premium costs. 

“For plans, those prices are unrealistic. They are simply a sticker price. But for patients, for the Medicare beneficiaries, these prices are very real” because they are used to set copays, Dr. Socal said.

Dr. Dusetzina reported receiving funding from Arnold Ventures and the Commonwealth Fund for research related to drug pricing. Dr. Socal reported receiving funding from Arnold Ventures. 

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

Holly Wyatt, MD, had spent 20 years in UCHealth with no plans to leave. Her home, support system, and lifestyle were all rooted in Denver. But in 2020, The University of Alabama at Birmingham (UAB) made the endocrinologist an offer she couldn’t resist.

The pay increase and a bump to full professorship weren’t enough to lure her across the country. But then UAB sweetened the deal with fewer clinic hours and paid time to create. “I didn’t have to fit into the typical ‘see patients 5 days a week, bill this many dollars,’ ” she said.

With no minimum billable hours, she could spend her time on clinical trials, designing programs, and recording podcasts. “When they offered that, I said, ‘Ooh, that’s enticing.’ ”

After a couple of visits to the campus, she began the job transition.

Doctors are looking for more than base pay. For many physicians, like Dr. Wyatt, non-salary incentives carry a lot of weight in the recruitment and job-hunting process.

“Some of the usual suspects are CME [continuing medical education] budget, signing bonuses, relocation assistance, loan repayment programs, and housing allowances,” said Jake Jorgovan, partner at Alpha Apex Group, a physician recruiting firm in Denver.

Post pandemic, doctors are vying for other benefits, perks that support their interests, work-life balance, and financial stability. “We’ve come across offers like sabbatical opportunities, paid time for research or personal projects, and even concierge services that handle things like grocery shopping or pet care,” said Mr. Jorgovan.

Amid physician shortages, doctors have more bargaining power than ever.
 

Money Still Talks

Financial perks are still the premiere portion of a benefits package, according to Marc Adam, physician recruiter at MASC Medical, a medical recruitment firm in Fort Lauderdale, Florida.

New data from the medical staffing company AMN Healthcare reported that the average signing bonus for physicians is $31,103. The average relocation allowance is $11,000, and the average CME allowance is $4000.

“CME budget and loan repayment programs are big because they directly impact career advancement and financial well-being,” Mr. Jorgovan said. He said that given the high cost of medical training, loan repayment help, especially, has become a huge deciding factor for clinicians. Employers have historically been hesitant to offer these kinds of long-term benefits because of the financial commitment and planning involved, but that’s changing.

Mr. Adam said that short-term financial perks, like relocation assistance and signing bonuses, tend to be more important for younger doctors. They’re not yet financially established, so the relocation support and bonus funds have more impact as they take on a new role, he said.

Mid- and late-career doctors, on the other hand, are less beholden to these types of bonuses. Mr. Adam has recruited established doctors from across the country to Florida, and he said that the relocation allowance and singing bonus didn’t even rank in their top five priorities. Similarly, in Birmingham, Dr. Wyatt recently reread her offer letter from UAB and was surprised to find a relocation stipend that she never used. “I had no idea,” she said.
 

Vying for Time

Mid- and late-career doctors who have a better financial safety net tend to seek benefits that boost their quality of life.

One of Mr. Adam’s recent job-searching clients was unwilling to compromise on priorities like specific location and a 4-day workweek.

Four-day workweeks, flexible scheduling, and options for remote work are increasingly popular, especially since the pandemic. Some physicians, like those in primary care, are looking for dedicated charting hours — paid days or half-days set aside for updating the electronic medical records. Other doctors are negotiating multistate telehealth licensing paid by their employer and work-from-home telehealth hours.

“Work life has been slowly increasing over the 14 years I’ve been doing this. And post COVID, the employer’s willingness to be flexible with those types of accommodations increased,” said Mr. Adam.

Priya Jaisinghani, MD, an endocrinologist and obesity medicine specialist in her second year of practice, NYU Langone Health, New York City, said work-life balance can be a priority for young doctors, too. After training in New York during the pandemic, Dr. Jaisinghani was all too aware of the risk for burnout. So she negotiated a 4-day workweek when she took her first job out of fellowship in 2022. “I was able to prioritize work-life balance from the start,” she said.
 

Support for the Career You Want

When Dr. Jaisinghani signed her first contract in 2022 with NYU, her move from New Jersey to New York wasn’t far enough to warrant a relocation allowance. “There was a signing bonus, sure,” she said. But what really grabbed her attention were perks like mentorship, access to trainees, and autonomy.

Perks that support long-term growth — like CME allowance, teaching opportunities, or access to leadership tracks — are especially important to young doctors. “After dedicating so many years to medical training, you want to look for some degree of autonomy in building your practice,” she said. NYU offered her that kind of freedom and support.

On top of personal growth, young physicians are looking for perks that will allow them to build the practice they want for their patients,Dr. Jaisinghani told this news organization. A lot of young doctors don’t know that they can negotiate for schedule preferences, office space, their own exam room, and dedicated support staff. However, they can and should because these factors influence their daily work life and patient experience.

Experienced doctors are also looking for perks that support the career they want. Recruitment experts say that doctors tend to look for opportunities that accommodate their interests. One of Mr. Jorgovan’s recent clients took a position because it offered a generous CME budget and dedicated research hours. Similarly, Dr. Wyatt at UAB moved because her contract included paid time to create.

“It really comes down to the need for balance — being able to keep learning while also having time for personal life and family,” Mr. Jorgovan said.
 

Making and Meeting Demand

Thanks to the rising demand, doctors have more power than ever to negotiate the perks they want and need.

The existing physician shortage — driven by retiring doctors and an aging patient population — was only exacerbated by the pandemic. Now, a number of new market entries are further increasing competition for talent, according to AMN Healthcare’s report. Retail clinics, urgent care, telehealth companies, and private equity firms compete for the same doctors, driving up salaries and doctor bargaining power.

“Physicians were always in the driver’s seat, and their bargaining power has only increased,” Mr. Adam said. Healthcare systems, once reticent about flexible working arrangements or loan repayment, are reconsidering.

Even young doctors have more negotiating power than they realize, but they might need help. “It’s underrated to get a contracts lawyer as a young doctor, but I think it’s smart,” Dr. Jaisinghani said. They’re often more familiar with salaries in the area, flexibility options, and potential benefits, none of which doctors are taught in training, she said.

Mr. Adam said that the pandemic opened employers’ eyes to the fact that doctors have the bargaining power. There’s a stark need for their talent and a lot of public support for their service. So hiring managers are listening and are ready to offer “creative benefits to accommodate the market demand,” he said.

In her new position at UAB, Dr. Wyatt said that money will always matter. “When your salary is low, bumping that salary will make you happier.” But after a certain point, she said, other things become more important — like your time, the work you do, and the people you work with. Her perks at UAB offer more than money can. “I get up in the morning, and I’m excited — [the work] excites me,” she said.

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

Holly Wyatt, MD, had spent 20 years in UCHealth with no plans to leave. Her home, support system, and lifestyle were all rooted in Denver. But in 2020, The University of Alabama at Birmingham (UAB) made the endocrinologist an offer she couldn’t resist.

The pay increase and a bump to full professorship weren’t enough to lure her across the country. But then UAB sweetened the deal with fewer clinic hours and paid time to create. “I didn’t have to fit into the typical ‘see patients 5 days a week, bill this many dollars,’ ” she said.

With no minimum billable hours, she could spend her time on clinical trials, designing programs, and recording podcasts. “When they offered that, I said, ‘Ooh, that’s enticing.’ ”

After a couple of visits to the campus, she began the job transition.

Doctors are looking for more than base pay. For many physicians, like Dr. Wyatt, non-salary incentives carry a lot of weight in the recruitment and job-hunting process.

“Some of the usual suspects are CME [continuing medical education] budget, signing bonuses, relocation assistance, loan repayment programs, and housing allowances,” said Jake Jorgovan, partner at Alpha Apex Group, a physician recruiting firm in Denver.

Post pandemic, doctors are vying for other benefits, perks that support their interests, work-life balance, and financial stability. “We’ve come across offers like sabbatical opportunities, paid time for research or personal projects, and even concierge services that handle things like grocery shopping or pet care,” said Mr. Jorgovan.

Amid physician shortages, doctors have more bargaining power than ever.
 

Money Still Talks

Financial perks are still the premiere portion of a benefits package, according to Marc Adam, physician recruiter at MASC Medical, a medical recruitment firm in Fort Lauderdale, Florida.

New data from the medical staffing company AMN Healthcare reported that the average signing bonus for physicians is $31,103. The average relocation allowance is $11,000, and the average CME allowance is $4000.

“CME budget and loan repayment programs are big because they directly impact career advancement and financial well-being,” Mr. Jorgovan said. He said that given the high cost of medical training, loan repayment help, especially, has become a huge deciding factor for clinicians. Employers have historically been hesitant to offer these kinds of long-term benefits because of the financial commitment and planning involved, but that’s changing.

Mr. Adam said that short-term financial perks, like relocation assistance and signing bonuses, tend to be more important for younger doctors. They’re not yet financially established, so the relocation support and bonus funds have more impact as they take on a new role, he said.

Mid- and late-career doctors, on the other hand, are less beholden to these types of bonuses. Mr. Adam has recruited established doctors from across the country to Florida, and he said that the relocation allowance and singing bonus didn’t even rank in their top five priorities. Similarly, in Birmingham, Dr. Wyatt recently reread her offer letter from UAB and was surprised to find a relocation stipend that she never used. “I had no idea,” she said.
 

Vying for Time

Mid- and late-career doctors who have a better financial safety net tend to seek benefits that boost their quality of life.

One of Mr. Adam’s recent job-searching clients was unwilling to compromise on priorities like specific location and a 4-day workweek.

Four-day workweeks, flexible scheduling, and options for remote work are increasingly popular, especially since the pandemic. Some physicians, like those in primary care, are looking for dedicated charting hours — paid days or half-days set aside for updating the electronic medical records. Other doctors are negotiating multistate telehealth licensing paid by their employer and work-from-home telehealth hours.

“Work life has been slowly increasing over the 14 years I’ve been doing this. And post COVID, the employer’s willingness to be flexible with those types of accommodations increased,” said Mr. Adam.

Priya Jaisinghani, MD, an endocrinologist and obesity medicine specialist in her second year of practice, NYU Langone Health, New York City, said work-life balance can be a priority for young doctors, too. After training in New York during the pandemic, Dr. Jaisinghani was all too aware of the risk for burnout. So she negotiated a 4-day workweek when she took her first job out of fellowship in 2022. “I was able to prioritize work-life balance from the start,” she said.
 

Support for the Career You Want

When Dr. Jaisinghani signed her first contract in 2022 with NYU, her move from New Jersey to New York wasn’t far enough to warrant a relocation allowance. “There was a signing bonus, sure,” she said. But what really grabbed her attention were perks like mentorship, access to trainees, and autonomy.

Perks that support long-term growth — like CME allowance, teaching opportunities, or access to leadership tracks — are especially important to young doctors. “After dedicating so many years to medical training, you want to look for some degree of autonomy in building your practice,” she said. NYU offered her that kind of freedom and support.

On top of personal growth, young physicians are looking for perks that will allow them to build the practice they want for their patients,Dr. Jaisinghani told this news organization. A lot of young doctors don’t know that they can negotiate for schedule preferences, office space, their own exam room, and dedicated support staff. However, they can and should because these factors influence their daily work life and patient experience.

Experienced doctors are also looking for perks that support the career they want. Recruitment experts say that doctors tend to look for opportunities that accommodate their interests. One of Mr. Jorgovan’s recent clients took a position because it offered a generous CME budget and dedicated research hours. Similarly, Dr. Wyatt at UAB moved because her contract included paid time to create.

“It really comes down to the need for balance — being able to keep learning while also having time for personal life and family,” Mr. Jorgovan said.
 

Making and Meeting Demand

Thanks to the rising demand, doctors have more power than ever to negotiate the perks they want and need.

The existing physician shortage — driven by retiring doctors and an aging patient population — was only exacerbated by the pandemic. Now, a number of new market entries are further increasing competition for talent, according to AMN Healthcare’s report. Retail clinics, urgent care, telehealth companies, and private equity firms compete for the same doctors, driving up salaries and doctor bargaining power.

“Physicians were always in the driver’s seat, and their bargaining power has only increased,” Mr. Adam said. Healthcare systems, once reticent about flexible working arrangements or loan repayment, are reconsidering.

Even young doctors have more negotiating power than they realize, but they might need help. “It’s underrated to get a contracts lawyer as a young doctor, but I think it’s smart,” Dr. Jaisinghani said. They’re often more familiar with salaries in the area, flexibility options, and potential benefits, none of which doctors are taught in training, she said.

Mr. Adam said that the pandemic opened employers’ eyes to the fact that doctors have the bargaining power. There’s a stark need for their talent and a lot of public support for their service. So hiring managers are listening and are ready to offer “creative benefits to accommodate the market demand,” he said.

In her new position at UAB, Dr. Wyatt said that money will always matter. “When your salary is low, bumping that salary will make you happier.” But after a certain point, she said, other things become more important — like your time, the work you do, and the people you work with. Her perks at UAB offer more than money can. “I get up in the morning, and I’m excited — [the work] excites me,” she said.

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

Holly Wyatt, MD, had spent 20 years in UCHealth with no plans to leave. Her home, support system, and lifestyle were all rooted in Denver. But in 2020, The University of Alabama at Birmingham (UAB) made the endocrinologist an offer she couldn’t resist.

The pay increase and a bump to full professorship weren’t enough to lure her across the country. But then UAB sweetened the deal with fewer clinic hours and paid time to create. “I didn’t have to fit into the typical ‘see patients 5 days a week, bill this many dollars,’ ” she said.

With no minimum billable hours, she could spend her time on clinical trials, designing programs, and recording podcasts. “When they offered that, I said, ‘Ooh, that’s enticing.’ ”

After a couple of visits to the campus, she began the job transition.

Doctors are looking for more than base pay. For many physicians, like Dr. Wyatt, non-salary incentives carry a lot of weight in the recruitment and job-hunting process.

“Some of the usual suspects are CME [continuing medical education] budget, signing bonuses, relocation assistance, loan repayment programs, and housing allowances,” said Jake Jorgovan, partner at Alpha Apex Group, a physician recruiting firm in Denver.

Post pandemic, doctors are vying for other benefits, perks that support their interests, work-life balance, and financial stability. “We’ve come across offers like sabbatical opportunities, paid time for research or personal projects, and even concierge services that handle things like grocery shopping or pet care,” said Mr. Jorgovan.

Amid physician shortages, doctors have more bargaining power than ever.
 

Money Still Talks

Financial perks are still the premiere portion of a benefits package, according to Marc Adam, physician recruiter at MASC Medical, a medical recruitment firm in Fort Lauderdale, Florida.

New data from the medical staffing company AMN Healthcare reported that the average signing bonus for physicians is $31,103. The average relocation allowance is $11,000, and the average CME allowance is $4000.

“CME budget and loan repayment programs are big because they directly impact career advancement and financial well-being,” Mr. Jorgovan said. He said that given the high cost of medical training, loan repayment help, especially, has become a huge deciding factor for clinicians. Employers have historically been hesitant to offer these kinds of long-term benefits because of the financial commitment and planning involved, but that’s changing.

Mr. Adam said that short-term financial perks, like relocation assistance and signing bonuses, tend to be more important for younger doctors. They’re not yet financially established, so the relocation support and bonus funds have more impact as they take on a new role, he said.

Mid- and late-career doctors, on the other hand, are less beholden to these types of bonuses. Mr. Adam has recruited established doctors from across the country to Florida, and he said that the relocation allowance and singing bonus didn’t even rank in their top five priorities. Similarly, in Birmingham, Dr. Wyatt recently reread her offer letter from UAB and was surprised to find a relocation stipend that she never used. “I had no idea,” she said.
 

Vying for Time

Mid- and late-career doctors who have a better financial safety net tend to seek benefits that boost their quality of life.

One of Mr. Adam’s recent job-searching clients was unwilling to compromise on priorities like specific location and a 4-day workweek.

Four-day workweeks, flexible scheduling, and options for remote work are increasingly popular, especially since the pandemic. Some physicians, like those in primary care, are looking for dedicated charting hours — paid days or half-days set aside for updating the electronic medical records. Other doctors are negotiating multistate telehealth licensing paid by their employer and work-from-home telehealth hours.

“Work life has been slowly increasing over the 14 years I’ve been doing this. And post COVID, the employer’s willingness to be flexible with those types of accommodations increased,” said Mr. Adam.

Priya Jaisinghani, MD, an endocrinologist and obesity medicine specialist in her second year of practice, NYU Langone Health, New York City, said work-life balance can be a priority for young doctors, too. After training in New York during the pandemic, Dr. Jaisinghani was all too aware of the risk for burnout. So she negotiated a 4-day workweek when she took her first job out of fellowship in 2022. “I was able to prioritize work-life balance from the start,” she said.
 

Support for the Career You Want

When Dr. Jaisinghani signed her first contract in 2022 with NYU, her move from New Jersey to New York wasn’t far enough to warrant a relocation allowance. “There was a signing bonus, sure,” she said. But what really grabbed her attention were perks like mentorship, access to trainees, and autonomy.

Perks that support long-term growth — like CME allowance, teaching opportunities, or access to leadership tracks — are especially important to young doctors. “After dedicating so many years to medical training, you want to look for some degree of autonomy in building your practice,” she said. NYU offered her that kind of freedom and support.

On top of personal growth, young physicians are looking for perks that will allow them to build the practice they want for their patients,Dr. Jaisinghani told this news organization. A lot of young doctors don’t know that they can negotiate for schedule preferences, office space, their own exam room, and dedicated support staff. However, they can and should because these factors influence their daily work life and patient experience.

Experienced doctors are also looking for perks that support the career they want. Recruitment experts say that doctors tend to look for opportunities that accommodate their interests. One of Mr. Jorgovan’s recent clients took a position because it offered a generous CME budget and dedicated research hours. Similarly, Dr. Wyatt at UAB moved because her contract included paid time to create.

“It really comes down to the need for balance — being able to keep learning while also having time for personal life and family,” Mr. Jorgovan said.
 

Making and Meeting Demand

Thanks to the rising demand, doctors have more power than ever to negotiate the perks they want and need.

The existing physician shortage — driven by retiring doctors and an aging patient population — was only exacerbated by the pandemic. Now, a number of new market entries are further increasing competition for talent, according to AMN Healthcare’s report. Retail clinics, urgent care, telehealth companies, and private equity firms compete for the same doctors, driving up salaries and doctor bargaining power.

“Physicians were always in the driver’s seat, and their bargaining power has only increased,” Mr. Adam said. Healthcare systems, once reticent about flexible working arrangements or loan repayment, are reconsidering.

Even young doctors have more negotiating power than they realize, but they might need help. “It’s underrated to get a contracts lawyer as a young doctor, but I think it’s smart,” Dr. Jaisinghani said. They’re often more familiar with salaries in the area, flexibility options, and potential benefits, none of which doctors are taught in training, she said.

Mr. Adam said that the pandemic opened employers’ eyes to the fact that doctors have the bargaining power. There’s a stark need for their talent and a lot of public support for their service. So hiring managers are listening and are ready to offer “creative benefits to accommodate the market demand,” he said.

In her new position at UAB, Dr. Wyatt said that money will always matter. “When your salary is low, bumping that salary will make you happier.” But after a certain point, she said, other things become more important — like your time, the work you do, and the people you work with. Her perks at UAB offer more than money can. “I get up in the morning, and I’m excited — [the work] excites me,” she said.

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

TOPLINE:

A higher intake of lignans (found in plant-based foods such as seeds, whole grains, some fruits and vegetables, and coffee, tea, and cocoa) is linked to a reduced risk for type 2 diabetes (T2D), especially in individuals with obesity or premenopausal women.

METHODOLOGY:

• Lignans, polyphenolic compounds abundant in plant-based foods, are the primary dietary source of phytoestrogens in Western diets and are associated with a reduced risk for cardiometabolic conditions, but the relative associations of individual lignans with T2D are unknown.
• Researchers assessed the associations between the risk for T2D and the intake of total and four primary lignans using the data of 201,111 participants (mean age, 44.7 years; 80.2% women; 96.7% White individuals) from three large prospective US cohorts with over 30 years of follow-up, as well as the association between lignan intake and hemoglobin A1c in 496 participants from the Men’s Lifestyle Validation Study (MLVS).
• For the three large cohorts, lignan intake (total, secoisolariciresinol, matairesinol, pinoresinol, and lariciresinol) was assessed using a validated food frequency questionnaire updated every 2-4 years and categorized into quintiles. For MLVS, diet was assessed by two sets of 7-day diet records and presented as percentage changes in A1c for linear increases in lignan intake.
• Incident T2D was confirmed using diagnostic tests, symptoms, hypoglycemic medication, elevated glucose by several measures.

TAKEAWAY:

• Across the three cohorts, 20,291 cases of T2D were recorded in the full follow-up.
• Higher intakes of total and individual ligands, except for lariciresinol, were associated with about 8%-27% lower T2D incidents (approximate hazard ratio [HR], 0.72-0.93)
• Of the individual lignans, secoisolariciresinol (but not others) showed a significant inverse association with the risk for T2D among those with a body mass index ≥ 30 (HR, 0.75; 95% CI, 0.71-0.79) and premenopausal women (HR, 0.67; 95% CI, 0.65-0.69).
• The dietary intake of lignans assessed using the 7-day diet records in MLVS was associated with lower levels of A1c (percentage changes ranging from −0.92% to −1.50%.

IN PRACTICE:

“Our findings underscore the importance of a healthy plant-based diet rich in lignan-containing foods, including flaxseed products, whole grains, and coffee for the primary prevention of T2D,” the authors wrote.

SOURCE:

The study, led by Siyue Wang, PhD, Department of Nutrition, Harvard TH Chan School of Public Health, Boston, Massachusetts, and the School of Public Health, Peking University, Beijing, China, was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations include the potential for measurement errors in dietary assessments. Flax seed, the most concentrated source of lignans, was not assessed until midway through the three large cohort follow-ups, and this may have resulted in misclassification of the intake levels of secoisolariciresinol. The lack of diversity in the socioeconomic status and race within the population may restrict the generalizability of the findings. Despite making multivariable adjustments, residual confounding cannot be fully ruled out.

DISCLOSURES:

The three cohort studies were supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

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

TOPLINE:

A higher intake of lignans (found in plant-based foods such as seeds, whole grains, some fruits and vegetables, and coffee, tea, and cocoa) is linked to a reduced risk for type 2 diabetes (T2D), especially in individuals with obesity or premenopausal women.

METHODOLOGY:

• Lignans, polyphenolic compounds abundant in plant-based foods, are the primary dietary source of phytoestrogens in Western diets and are associated with a reduced risk for cardiometabolic conditions, but the relative associations of individual lignans with T2D are unknown.
• Researchers assessed the associations between the risk for T2D and the intake of total and four primary lignans using the data of 201,111 participants (mean age, 44.7 years; 80.2% women; 96.7% White individuals) from three large prospective US cohorts with over 30 years of follow-up, as well as the association between lignan intake and hemoglobin A1c in 496 participants from the Men’s Lifestyle Validation Study (MLVS).
• For the three large cohorts, lignan intake (total, secoisolariciresinol, matairesinol, pinoresinol, and lariciresinol) was assessed using a validated food frequency questionnaire updated every 2-4 years and categorized into quintiles. For MLVS, diet was assessed by two sets of 7-day diet records and presented as percentage changes in A1c for linear increases in lignan intake.
• Incident T2D was confirmed using diagnostic tests, symptoms, hypoglycemic medication, elevated glucose by several measures.

TAKEAWAY:

• Across the three cohorts, 20,291 cases of T2D were recorded in the full follow-up.
• Higher intakes of total and individual ligands, except for lariciresinol, were associated with about 8%-27% lower T2D incidents (approximate hazard ratio [HR], 0.72-0.93)
• Of the individual lignans, secoisolariciresinol (but not others) showed a significant inverse association with the risk for T2D among those with a body mass index ≥ 30 (HR, 0.75; 95% CI, 0.71-0.79) and premenopausal women (HR, 0.67; 95% CI, 0.65-0.69).
• The dietary intake of lignans assessed using the 7-day diet records in MLVS was associated with lower levels of A1c (percentage changes ranging from −0.92% to −1.50%.

IN PRACTICE:

“Our findings underscore the importance of a healthy plant-based diet rich in lignan-containing foods, including flaxseed products, whole grains, and coffee for the primary prevention of T2D,” the authors wrote.

SOURCE:

The study, led by Siyue Wang, PhD, Department of Nutrition, Harvard TH Chan School of Public Health, Boston, Massachusetts, and the School of Public Health, Peking University, Beijing, China, was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations include the potential for measurement errors in dietary assessments. Flax seed, the most concentrated source of lignans, was not assessed until midway through the three large cohort follow-ups, and this may have resulted in misclassification of the intake levels of secoisolariciresinol. The lack of diversity in the socioeconomic status and race within the population may restrict the generalizability of the findings. Despite making multivariable adjustments, residual confounding cannot be fully ruled out.

DISCLOSURES:

The three cohort studies were supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

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

TOPLINE:

A higher intake of lignans (found in plant-based foods such as seeds, whole grains, some fruits and vegetables, and coffee, tea, and cocoa) is linked to a reduced risk for type 2 diabetes (T2D), especially in individuals with obesity or premenopausal women.

METHODOLOGY:

• Lignans, polyphenolic compounds abundant in plant-based foods, are the primary dietary source of phytoestrogens in Western diets and are associated with a reduced risk for cardiometabolic conditions, but the relative associations of individual lignans with T2D are unknown.
• Researchers assessed the associations between the risk for T2D and the intake of total and four primary lignans using the data of 201,111 participants (mean age, 44.7 years; 80.2% women; 96.7% White individuals) from three large prospective US cohorts with over 30 years of follow-up, as well as the association between lignan intake and hemoglobin A1c in 496 participants from the Men’s Lifestyle Validation Study (MLVS).
• For the three large cohorts, lignan intake (total, secoisolariciresinol, matairesinol, pinoresinol, and lariciresinol) was assessed using a validated food frequency questionnaire updated every 2-4 years and categorized into quintiles. For MLVS, diet was assessed by two sets of 7-day diet records and presented as percentage changes in A1c for linear increases in lignan intake.
• Incident T2D was confirmed using diagnostic tests, symptoms, hypoglycemic medication, elevated glucose by several measures.

TAKEAWAY:

• Across the three cohorts, 20,291 cases of T2D were recorded in the full follow-up.
• Higher intakes of total and individual ligands, except for lariciresinol, were associated with about 8%-27% lower T2D incidents (approximate hazard ratio [HR], 0.72-0.93)
• Of the individual lignans, secoisolariciresinol (but not others) showed a significant inverse association with the risk for T2D among those with a body mass index ≥ 30 (HR, 0.75; 95% CI, 0.71-0.79) and premenopausal women (HR, 0.67; 95% CI, 0.65-0.69).
• The dietary intake of lignans assessed using the 7-day diet records in MLVS was associated with lower levels of A1c (percentage changes ranging from −0.92% to −1.50%.

IN PRACTICE:

“Our findings underscore the importance of a healthy plant-based diet rich in lignan-containing foods, including flaxseed products, whole grains, and coffee for the primary prevention of T2D,” the authors wrote.

SOURCE:

The study, led by Siyue Wang, PhD, Department of Nutrition, Harvard TH Chan School of Public Health, Boston, Massachusetts, and the School of Public Health, Peking University, Beijing, China, was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations include the potential for measurement errors in dietary assessments. Flax seed, the most concentrated source of lignans, was not assessed until midway through the three large cohort follow-ups, and this may have resulted in misclassification of the intake levels of secoisolariciresinol. The lack of diversity in the socioeconomic status and race within the population may restrict the generalizability of the findings. Despite making multivariable adjustments, residual confounding cannot be fully ruled out.

DISCLOSURES:

The three cohort studies were supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

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

Sitting at a patient’s bedside is one of the behaviors associated with better doctor-patient communication, patient satisfaction, and trust. During a busy day of consultations, however, it can be difficult for healthcare professionals to sit regularly with patients. Previous studies have revealed that hospital doctors sit during one out of every five meetings with patients.

A recent US study evaluated the impact of the practitioner’s seated position next to the patient on the quality of the doctor-patient interaction in an internal medicine department. This research involved a sample of 51 doctors (average age, 35 years; 51% men) and analyzed 125 clinical interviews (n = 125 patients; average age, 53 years; 55% men). Participants were not informed of the real objective of the study. The patient’s perception of medical care was also solicited.

The experimental protocol involved two distinct configurations. Either the chair was positioned near the bed (within 90 cm) before the doctor arrived or it remained visible in its usual place. Each meeting with a patient was randomized according to the chair location (intervention group: n = 60; control group: n = 65).

The primary criterion was the doctor’s binary decision to sit or not at a given moment during a meeting with a patient. Secondary criteria included patient satisfaction, time spent in the room, and the perception of time spent in the room by doctors and patients.

The chair’s location had no effect on the average duration of the interview, whether actual or estimated. When a chair was placed near the bed, the doctor sat in more than six out of 10 cases (63%), compared with fewer than one case out of 10 (8%) when the chair was less easily accessible (odds ratio, 20.7; 95% CI, 7.2-59.4; P < .001).

The chair arrangement did not lead to a significant difference in the average duration of presence in the room (10.6 min for both groups). Likewise, no notable difference was observed regarding the subjective estimation of this duration from the practitioners’ point of view (9.4 min vs 9.8 min) or from the patients’ point of view (13.1 min vs 13.5 min).

In the group in which the doctor sat to converse, patient satisfaction was significantly higher, with an overall difference of 3.9% (P = .02). Patients felt that the information provided was better (72% vs 52%; P =.03), and their confidence in the proposed care was also higher (58% vs 35%; P = .01). On the other hand, no significant difference appeared between the two groups regarding the information retained by the patient (doctor’s name and reason for hospitalization) or the doctor’s behavior.

The study authors acknowledged the study’s methodological limitations, which included a sample size that was lower than initially projected and the restriction to a single hospital setting. In addition, they noted that all patients were housed in individual rooms, which could be a source of bias. Despite these reservations, they suggested that even minimal environmental changes, such as the thoughtful placement of a chair, can significantly affect patients’ perceptions of the quality of care provided.
 

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

Sitting at a patient’s bedside is one of the behaviors associated with better doctor-patient communication, patient satisfaction, and trust. During a busy day of consultations, however, it can be difficult for healthcare professionals to sit regularly with patients. Previous studies have revealed that hospital doctors sit during one out of every five meetings with patients.

A recent US study evaluated the impact of the practitioner’s seated position next to the patient on the quality of the doctor-patient interaction in an internal medicine department. This research involved a sample of 51 doctors (average age, 35 years; 51% men) and analyzed 125 clinical interviews (n = 125 patients; average age, 53 years; 55% men). Participants were not informed of the real objective of the study. The patient’s perception of medical care was also solicited.

The experimental protocol involved two distinct configurations. Either the chair was positioned near the bed (within 90 cm) before the doctor arrived or it remained visible in its usual place. Each meeting with a patient was randomized according to the chair location (intervention group: n = 60; control group: n = 65).

The primary criterion was the doctor’s binary decision to sit or not at a given moment during a meeting with a patient. Secondary criteria included patient satisfaction, time spent in the room, and the perception of time spent in the room by doctors and patients.

The chair’s location had no effect on the average duration of the interview, whether actual or estimated. When a chair was placed near the bed, the doctor sat in more than six out of 10 cases (63%), compared with fewer than one case out of 10 (8%) when the chair was less easily accessible (odds ratio, 20.7; 95% CI, 7.2-59.4; P < .001).

The chair arrangement did not lead to a significant difference in the average duration of presence in the room (10.6 min for both groups). Likewise, no notable difference was observed regarding the subjective estimation of this duration from the practitioners’ point of view (9.4 min vs 9.8 min) or from the patients’ point of view (13.1 min vs 13.5 min).

In the group in which the doctor sat to converse, patient satisfaction was significantly higher, with an overall difference of 3.9% (P = .02). Patients felt that the information provided was better (72% vs 52%; P =.03), and their confidence in the proposed care was also higher (58% vs 35%; P = .01). On the other hand, no significant difference appeared between the two groups regarding the information retained by the patient (doctor’s name and reason for hospitalization) or the doctor’s behavior.

The study authors acknowledged the study’s methodological limitations, which included a sample size that was lower than initially projected and the restriction to a single hospital setting. In addition, they noted that all patients were housed in individual rooms, which could be a source of bias. Despite these reservations, they suggested that even minimal environmental changes, such as the thoughtful placement of a chair, can significantly affect patients’ perceptions of the quality of care provided.
 

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

Sitting at a patient’s bedside is one of the behaviors associated with better doctor-patient communication, patient satisfaction, and trust. During a busy day of consultations, however, it can be difficult for healthcare professionals to sit regularly with patients. Previous studies have revealed that hospital doctors sit during one out of every five meetings with patients.

A recent US study evaluated the impact of the practitioner’s seated position next to the patient on the quality of the doctor-patient interaction in an internal medicine department. This research involved a sample of 51 doctors (average age, 35 years; 51% men) and analyzed 125 clinical interviews (n = 125 patients; average age, 53 years; 55% men). Participants were not informed of the real objective of the study. The patient’s perception of medical care was also solicited.

The experimental protocol involved two distinct configurations. Either the chair was positioned near the bed (within 90 cm) before the doctor arrived or it remained visible in its usual place. Each meeting with a patient was randomized according to the chair location (intervention group: n = 60; control group: n = 65).

The primary criterion was the doctor’s binary decision to sit or not at a given moment during a meeting with a patient. Secondary criteria included patient satisfaction, time spent in the room, and the perception of time spent in the room by doctors and patients.

The chair’s location had no effect on the average duration of the interview, whether actual or estimated. When a chair was placed near the bed, the doctor sat in more than six out of 10 cases (63%), compared with fewer than one case out of 10 (8%) when the chair was less easily accessible (odds ratio, 20.7; 95% CI, 7.2-59.4; P < .001).

The chair arrangement did not lead to a significant difference in the average duration of presence in the room (10.6 min for both groups). Likewise, no notable difference was observed regarding the subjective estimation of this duration from the practitioners’ point of view (9.4 min vs 9.8 min) or from the patients’ point of view (13.1 min vs 13.5 min).

In the group in which the doctor sat to converse, patient satisfaction was significantly higher, with an overall difference of 3.9% (P = .02). Patients felt that the information provided was better (72% vs 52%; P =.03), and their confidence in the proposed care was also higher (58% vs 35%; P = .01). On the other hand, no significant difference appeared between the two groups regarding the information retained by the patient (doctor’s name and reason for hospitalization) or the doctor’s behavior.

The study authors acknowledged the study’s methodological limitations, which included a sample size that was lower than initially projected and the restriction to a single hospital setting. In addition, they noted that all patients were housed in individual rooms, which could be a source of bias. Despite these reservations, they suggested that even minimal environmental changes, such as the thoughtful placement of a chair, can significantly affect patients’ perceptions of the quality of care provided.
 

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

TOPLINE:

Statin usage in patients with metabolic dysfunction–associated steatotic liver disease (MASLD) is associated with a lower long-term risk for all-cause mortality, liver-related events, and progression of liver stiffness.

METHODOLOGY:

• Although many patients with MASLD have indications for statins, including cardiovascular disease, they are not widely used owing to concerns about possible liver damage and muscle weakness.
• Researchers conducted an observational cohort study to evaluate the long-term effects of statin use in 7988 patients (mean age, 53 years; 58.2% women) with MASLD who underwent at least two vibration-controlled transient elastography exams. The study involved 16 centers in the United States, Europe, and Asia.
• Patients were classified into those with compensated advanced chronic liver disease (cACLD; liver stiffness measurement ≥ 10 kPa) and those without cACLD (liver stiffness measurement < 10 kPa). At baseline, 17% of patients had cACLD.
• Statin prescriptions included simvastatin, pravastatin, atorvastatin, rosuvastatin, lovastatin, fluvastatin, and pitavastatin. At baseline, 40.5% of patients used statins.
• The primary outcome was the composite of all-cause mortality and liver-related events, including cirrhosis, hepatocellular carcinoma, or liver-related mortality. Secondary outcomes included changes in liver stiffness assessed over a median follow-up duration of 4.6 years.

TAKEAWAY:

• Statin usage was associated with a 76.7% lower risk for all-cause mortality and a 62% lower risk of liver-related events than non-use (both P < .001).
• Statin use also was associated with a 46% and 55% lower risk for liver stiffness progression in the cACLD and non-cACLD groups, respectively, than non-use (both P < .001).
• No significant association was found between statin use and liver stiffness regression.

IN PRACTICE:

“The results of this cohort study suggest that statin usage may help reduce CVD [cardiovascular disease] morbidity and mortality rates and slow down liver stiffness progression in both cACLD and non-cALCD patients,” the authors wrote.

SOURCE:

The study, led by Xiao-Dong Zhou, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, was published online in Gut.

LIMITATIONS:

The assessment of patients at different intervals may have affected the interpretation of the data. The median follow-up period may be considered short for assessing the progression of CLD. Additionally, residual confounding in statin users could have led to an overestimation of the benefits of statins.

DISCLOSURES:

This study was supported by grants from the National Natural Science Foundation of China and National Key R&D Program of China. Some authors reported receiving personal fees, consulting fees, speaker bureau fees, grants, nonfinancial support, and honoraria for lectures and travel expenses and owning stock options with pharmaceutical and medical device companies outside of the submitted work. Two researchers were employed by Echosens during the conduct of the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Statin usage in patients with metabolic dysfunction–associated steatotic liver disease (MASLD) is associated with a lower long-term risk for all-cause mortality, liver-related events, and progression of liver stiffness.

METHODOLOGY:

• Although many patients with MASLD have indications for statins, including cardiovascular disease, they are not widely used owing to concerns about possible liver damage and muscle weakness.
• Researchers conducted an observational cohort study to evaluate the long-term effects of statin use in 7988 patients (mean age, 53 years; 58.2% women) with MASLD who underwent at least two vibration-controlled transient elastography exams. The study involved 16 centers in the United States, Europe, and Asia.
• Patients were classified into those with compensated advanced chronic liver disease (cACLD; liver stiffness measurement ≥ 10 kPa) and those without cACLD (liver stiffness measurement < 10 kPa). At baseline, 17% of patients had cACLD.
• Statin prescriptions included simvastatin, pravastatin, atorvastatin, rosuvastatin, lovastatin, fluvastatin, and pitavastatin. At baseline, 40.5% of patients used statins.
• The primary outcome was the composite of all-cause mortality and liver-related events, including cirrhosis, hepatocellular carcinoma, or liver-related mortality. Secondary outcomes included changes in liver stiffness assessed over a median follow-up duration of 4.6 years.

TAKEAWAY:

• Statin usage was associated with a 76.7% lower risk for all-cause mortality and a 62% lower risk of liver-related events than non-use (both P < .001).
• Statin use also was associated with a 46% and 55% lower risk for liver stiffness progression in the cACLD and non-cACLD groups, respectively, than non-use (both P < .001).
• No significant association was found between statin use and liver stiffness regression.

IN PRACTICE:

“The results of this cohort study suggest that statin usage may help reduce CVD [cardiovascular disease] morbidity and mortality rates and slow down liver stiffness progression in both cACLD and non-cALCD patients,” the authors wrote.

SOURCE:

The study, led by Xiao-Dong Zhou, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, was published online in Gut.

LIMITATIONS:

The assessment of patients at different intervals may have affected the interpretation of the data. The median follow-up period may be considered short for assessing the progression of CLD. Additionally, residual confounding in statin users could have led to an overestimation of the benefits of statins.

DISCLOSURES:

This study was supported by grants from the National Natural Science Foundation of China and National Key R&D Program of China. Some authors reported receiving personal fees, consulting fees, speaker bureau fees, grants, nonfinancial support, and honoraria for lectures and travel expenses and owning stock options with pharmaceutical and medical device companies outside of the submitted work. Two researchers were employed by Echosens during the conduct of the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Statin usage in patients with metabolic dysfunction–associated steatotic liver disease (MASLD) is associated with a lower long-term risk for all-cause mortality, liver-related events, and progression of liver stiffness.

METHODOLOGY:

• Although many patients with MASLD have indications for statins, including cardiovascular disease, they are not widely used owing to concerns about possible liver damage and muscle weakness.
• Researchers conducted an observational cohort study to evaluate the long-term effects of statin use in 7988 patients (mean age, 53 years; 58.2% women) with MASLD who underwent at least two vibration-controlled transient elastography exams. The study involved 16 centers in the United States, Europe, and Asia.
• Patients were classified into those with compensated advanced chronic liver disease (cACLD; liver stiffness measurement ≥ 10 kPa) and those without cACLD (liver stiffness measurement < 10 kPa). At baseline, 17% of patients had cACLD.
• Statin prescriptions included simvastatin, pravastatin, atorvastatin, rosuvastatin, lovastatin, fluvastatin, and pitavastatin. At baseline, 40.5% of patients used statins.
• The primary outcome was the composite of all-cause mortality and liver-related events, including cirrhosis, hepatocellular carcinoma, or liver-related mortality. Secondary outcomes included changes in liver stiffness assessed over a median follow-up duration of 4.6 years.

TAKEAWAY:

• Statin usage was associated with a 76.7% lower risk for all-cause mortality and a 62% lower risk of liver-related events than non-use (both P < .001).
• Statin use also was associated with a 46% and 55% lower risk for liver stiffness progression in the cACLD and non-cACLD groups, respectively, than non-use (both P < .001).
• No significant association was found between statin use and liver stiffness regression.

IN PRACTICE:

“The results of this cohort study suggest that statin usage may help reduce CVD [cardiovascular disease] morbidity and mortality rates and slow down liver stiffness progression in both cACLD and non-cALCD patients,” the authors wrote.

SOURCE:

The study, led by Xiao-Dong Zhou, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, was published online in Gut.

LIMITATIONS:

The assessment of patients at different intervals may have affected the interpretation of the data. The median follow-up period may be considered short for assessing the progression of CLD. Additionally, residual confounding in statin users could have led to an overestimation of the benefits of statins.

DISCLOSURES:

This study was supported by grants from the National Natural Science Foundation of China and National Key R&D Program of China. Some authors reported receiving personal fees, consulting fees, speaker bureau fees, grants, nonfinancial support, and honoraria for lectures and travel expenses and owning stock options with pharmaceutical and medical device companies outside of the submitted work. Two researchers were employed by Echosens during the conduct of the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Exposure to environmental particulate matter ≤ 10 μm in diameter (PM₁₀) is associated with an increased risk for giant cell arteritis, particularly in older individuals aged ≥ 70 years and those with prolonged exposure to high levels of air pollution.

METHODOLOGY:

• Researchers conducted a retrospective case-crossover study to examine the association between exposure to airborne PM₁₀ and the risk for giant cell arteritis and its ischemic complications.
• They included 232 patients with giant cell arteritis (median age at diagnosis, 73 years; 69% women) from three hospitals in northern Italy between June 2013 to December 2021.
• The hourly and daily average concentrations of PM₁₀ were collected from the Italian monitoring network; patients’ exposure to PM₁₀ was calculated using a space-time statistical model, incorporating meteorological variables, elevation, and proximity to main roads.
• The mean follow-up time of this cohort was 38 months.

TAKEAWAY:

• Every 10 μg/m³ increase in PM₁₀ exposure in the preceding 60 days increased the incremental risk (IR) for giant cell arteritis by 27.1% (95% CI, 5.8-52.6).
• This association was more pronounced (IR, 38.8%; 95% CI, 9.2-76.3) in the subgroup of patients aged ≥ 70 years.
• The positive association between incident giant cell arteritis and concentrations of PM₁₀ was seen only when patients were exposed to high concentrations of PM₁₀ (26.9 ± 13.8 μg/m³) but not low concentrations (11.9 ± 7.9 μg/m³).
• This study did not show any significant association between exposure to PM₁₀ and ischemic complications.

IN PRACTICE:

“Exposure to PM₁₀ in the 60 days preceding [giant cell arteritis] symptoms onset seems to be associated with an increased risk of developing the disease, especially in older individuals with prolonged exposure to high levels of air pollution,” the authors wrote.

SOURCE:

The study was led by Milena Bond, MD, Hospital of Bruneck, Teaching Hospital of the Paracelsus Medical University, Brunico, Italy, and was published online in Arthritis Care & Research.

LIMITATIONS:

The retrospective nature of the study may have introduced recall bias. The study did not include data for other particulate matter fractions or gaseous pollutants, which may have impacted the findings. The use of residential addresses at the time of diagnosis precluded assessment of potential recent relocations.

DISCLOSURES:

This study did not disclose any funding source. Some authors reported having financial relationships with multiple pharmaceutical companies.

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

TOPLINE:

Exposure to environmental particulate matter ≤ 10 μm in diameter (PM₁₀) is associated with an increased risk for giant cell arteritis, particularly in older individuals aged ≥ 70 years and those with prolonged exposure to high levels of air pollution.

METHODOLOGY:

• Researchers conducted a retrospective case-crossover study to examine the association between exposure to airborne PM₁₀ and the risk for giant cell arteritis and its ischemic complications.
• They included 232 patients with giant cell arteritis (median age at diagnosis, 73 years; 69% women) from three hospitals in northern Italy between June 2013 to December 2021.
• The hourly and daily average concentrations of PM₁₀ were collected from the Italian monitoring network; patients’ exposure to PM₁₀ was calculated using a space-time statistical model, incorporating meteorological variables, elevation, and proximity to main roads.
• The mean follow-up time of this cohort was 38 months.

TAKEAWAY:

• Every 10 μg/m³ increase in PM₁₀ exposure in the preceding 60 days increased the incremental risk (IR) for giant cell arteritis by 27.1% (95% CI, 5.8-52.6).
• This association was more pronounced (IR, 38.8%; 95% CI, 9.2-76.3) in the subgroup of patients aged ≥ 70 years.
• The positive association between incident giant cell arteritis and concentrations of PM₁₀ was seen only when patients were exposed to high concentrations of PM₁₀ (26.9 ± 13.8 μg/m³) but not low concentrations (11.9 ± 7.9 μg/m³).
• This study did not show any significant association between exposure to PM₁₀ and ischemic complications.

IN PRACTICE:

“Exposure to PM₁₀ in the 60 days preceding [giant cell arteritis] symptoms onset seems to be associated with an increased risk of developing the disease, especially in older individuals with prolonged exposure to high levels of air pollution,” the authors wrote.

SOURCE:

The study was led by Milena Bond, MD, Hospital of Bruneck, Teaching Hospital of the Paracelsus Medical University, Brunico, Italy, and was published online in Arthritis Care & Research.

LIMITATIONS:

The retrospective nature of the study may have introduced recall bias. The study did not include data for other particulate matter fractions or gaseous pollutants, which may have impacted the findings. The use of residential addresses at the time of diagnosis precluded assessment of potential recent relocations.

DISCLOSURES:

This study did not disclose any funding source. Some authors reported having financial relationships with multiple pharmaceutical companies.

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

TOPLINE:

Exposure to environmental particulate matter ≤ 10 μm in diameter (PM₁₀) is associated with an increased risk for giant cell arteritis, particularly in older individuals aged ≥ 70 years and those with prolonged exposure to high levels of air pollution.

METHODOLOGY:

• Researchers conducted a retrospective case-crossover study to examine the association between exposure to airborne PM₁₀ and the risk for giant cell arteritis and its ischemic complications.
• They included 232 patients with giant cell arteritis (median age at diagnosis, 73 years; 69% women) from three hospitals in northern Italy between June 2013 to December 2021.
• The hourly and daily average concentrations of PM₁₀ were collected from the Italian monitoring network; patients’ exposure to PM₁₀ was calculated using a space-time statistical model, incorporating meteorological variables, elevation, and proximity to main roads.
• The mean follow-up time of this cohort was 38 months.

TAKEAWAY:

• Every 10 μg/m³ increase in PM₁₀ exposure in the preceding 60 days increased the incremental risk (IR) for giant cell arteritis by 27.1% (95% CI, 5.8-52.6).
• This association was more pronounced (IR, 38.8%; 95% CI, 9.2-76.3) in the subgroup of patients aged ≥ 70 years.
• The positive association between incident giant cell arteritis and concentrations of PM₁₀ was seen only when patients were exposed to high concentrations of PM₁₀ (26.9 ± 13.8 μg/m³) but not low concentrations (11.9 ± 7.9 μg/m³).
• This study did not show any significant association between exposure to PM₁₀ and ischemic complications.

IN PRACTICE:

“Exposure to PM₁₀ in the 60 days preceding [giant cell arteritis] symptoms onset seems to be associated with an increased risk of developing the disease, especially in older individuals with prolonged exposure to high levels of air pollution,” the authors wrote.

SOURCE:

The study was led by Milena Bond, MD, Hospital of Bruneck, Teaching Hospital of the Paracelsus Medical University, Brunico, Italy, and was published online in Arthritis Care & Research.

LIMITATIONS:

The retrospective nature of the study may have introduced recall bias. The study did not include data for other particulate matter fractions or gaseous pollutants, which may have impacted the findings. The use of residential addresses at the time of diagnosis precluded assessment of potential recent relocations.

DISCLOSURES:

This study did not disclose any funding source. Some authors reported having financial relationships with multiple pharmaceutical companies.

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

TOPLINE:

Patients with axial spondyloarthritis (axSpA) treated with bimekizumab had a lower incidence of uveitis than those receiving placebo in pooled clinical trial data.

METHODOLOGY:

• Researchers pooled data from two phase 3 trials, one phase 2b trial, and their open-label extensions to evaluate the incidence of uveitis in patients with radiographic and nonradiographic axSpA who were treated with bimekizumab.
• Patients received either bimekizumab 160 mg (n = 349) or placebo (n = 237) every 4 weeks in the pooled phase 3 data during a 16-week, double-blind treatment period, while 848 patients (mean age, 40.3 years; 71.5% men) received at least one dose of 160 mg bimekizumab in the overall phase 2b/3 pool.
• Outcomes included the incidence of uveitis events reported as exposure-adjusted incidence rates (EAIRs) and exposure-adjusted event rates reported per 100 patient-years.

TAKEAWAY:

• The proportion of patients experiencing uveitis was lower in those treated with bimekizumab than in those receiving placebo over 16 weeks (0.6% vs 4.6%; nominal P = .001).
• In patients with a history of uveitis, incidence was lower with bimekizumab than with placebo (6.2 vs 70.4 per 100 patient-years).
• Among patients receiving bimekizumab, the EAIR of uveitis was lower among those without a history of uveitis than in those with a history of the condition (0.6 vs 4.6 per 100 patient-years).
• A higher proportion of patients who experienced uveitis had a history of uveitis, compared with those who did not (56.0% vs 14.1%).

IN PRACTICE:

“These data suggest that [bimekizumab], a dual IL [interleukin]-17A/F inhibitor, may confer protective effects for uveitis in patients with axSpA,” the authors wrote.

SOURCE:

The study, led by Matthew A. Brown, Genomics England, London, England, and Martin Rudwaleit, Klinikum Bielefeld, University of Bielefeld, Germany, was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The reporting of uveitis in the trials relied on the spontaneous reporting of adverse events, and not all events were evaluated by an ophthalmologist. The duration of the double-blind treatment period was relatively short, and the total number of patients with acute anterior uveitis was limited. Moreover, long-term placebo comparisons extending beyond 16 weeks were lacking.

DISCLOSURES:

The studies included in the pooled data were supported by UCB Pharma. Some authors reported financial ties with UCB and other pharmaceutical companies. Some authors reported being employees and shareholders of UCB Pharma.

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

TOPLINE:

Patients with axial spondyloarthritis (axSpA) treated with bimekizumab had a lower incidence of uveitis than those receiving placebo in pooled clinical trial data.

METHODOLOGY:

• Researchers pooled data from two phase 3 trials, one phase 2b trial, and their open-label extensions to evaluate the incidence of uveitis in patients with radiographic and nonradiographic axSpA who were treated with bimekizumab.
• Patients received either bimekizumab 160 mg (n = 349) or placebo (n = 237) every 4 weeks in the pooled phase 3 data during a 16-week, double-blind treatment period, while 848 patients (mean age, 40.3 years; 71.5% men) received at least one dose of 160 mg bimekizumab in the overall phase 2b/3 pool.
• Outcomes included the incidence of uveitis events reported as exposure-adjusted incidence rates (EAIRs) and exposure-adjusted event rates reported per 100 patient-years.

TAKEAWAY:

• The proportion of patients experiencing uveitis was lower in those treated with bimekizumab than in those receiving placebo over 16 weeks (0.6% vs 4.6%; nominal P = .001).
• In patients with a history of uveitis, incidence was lower with bimekizumab than with placebo (6.2 vs 70.4 per 100 patient-years).
• Among patients receiving bimekizumab, the EAIR of uveitis was lower among those without a history of uveitis than in those with a history of the condition (0.6 vs 4.6 per 100 patient-years).
• A higher proportion of patients who experienced uveitis had a history of uveitis, compared with those who did not (56.0% vs 14.1%).

IN PRACTICE:

“These data suggest that [bimekizumab], a dual IL [interleukin]-17A/F inhibitor, may confer protective effects for uveitis in patients with axSpA,” the authors wrote.

SOURCE:

The study, led by Matthew A. Brown, Genomics England, London, England, and Martin Rudwaleit, Klinikum Bielefeld, University of Bielefeld, Germany, was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The reporting of uveitis in the trials relied on the spontaneous reporting of adverse events, and not all events were evaluated by an ophthalmologist. The duration of the double-blind treatment period was relatively short, and the total number of patients with acute anterior uveitis was limited. Moreover, long-term placebo comparisons extending beyond 16 weeks were lacking.

DISCLOSURES:

The studies included in the pooled data were supported by UCB Pharma. Some authors reported financial ties with UCB and other pharmaceutical companies. Some authors reported being employees and shareholders of UCB Pharma.

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

TOPLINE:

Patients with axial spondyloarthritis (axSpA) treated with bimekizumab had a lower incidence of uveitis than those receiving placebo in pooled clinical trial data.

METHODOLOGY:

• Researchers pooled data from two phase 3 trials, one phase 2b trial, and their open-label extensions to evaluate the incidence of uveitis in patients with radiographic and nonradiographic axSpA who were treated with bimekizumab.
• Patients received either bimekizumab 160 mg (n = 349) or placebo (n = 237) every 4 weeks in the pooled phase 3 data during a 16-week, double-blind treatment period, while 848 patients (mean age, 40.3 years; 71.5% men) received at least one dose of 160 mg bimekizumab in the overall phase 2b/3 pool.
• Outcomes included the incidence of uveitis events reported as exposure-adjusted incidence rates (EAIRs) and exposure-adjusted event rates reported per 100 patient-years.

TAKEAWAY:

• The proportion of patients experiencing uveitis was lower in those treated with bimekizumab than in those receiving placebo over 16 weeks (0.6% vs 4.6%; nominal P = .001).
• In patients with a history of uveitis, incidence was lower with bimekizumab than with placebo (6.2 vs 70.4 per 100 patient-years).
• Among patients receiving bimekizumab, the EAIR of uveitis was lower among those without a history of uveitis than in those with a history of the condition (0.6 vs 4.6 per 100 patient-years).
• A higher proportion of patients who experienced uveitis had a history of uveitis, compared with those who did not (56.0% vs 14.1%).

IN PRACTICE:

“These data suggest that [bimekizumab], a dual IL [interleukin]-17A/F inhibitor, may confer protective effects for uveitis in patients with axSpA,” the authors wrote.

SOURCE:

The study, led by Matthew A. Brown, Genomics England, London, England, and Martin Rudwaleit, Klinikum Bielefeld, University of Bielefeld, Germany, was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The reporting of uveitis in the trials relied on the spontaneous reporting of adverse events, and not all events were evaluated by an ophthalmologist. The duration of the double-blind treatment period was relatively short, and the total number of patients with acute anterior uveitis was limited. Moreover, long-term placebo comparisons extending beyond 16 weeks were lacking.

DISCLOSURES:

The studies included in the pooled data were supported by UCB Pharma. Some authors reported financial ties with UCB and other pharmaceutical companies. Some authors reported being employees and shareholders of UCB Pharma.

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