Feature

Physician assistants (PAs) are educated as generalists — with the ability to switch medical specialties during their careers. Andrzej Kozikowski, PhD, senior director of research at the National Commission on Certification of Physician Assistants (NCCPA), said that having that kind of career flexibility is often a motivating factor for students who pursue the PA path.

“If you look at the research literature on physicians, you can see that choosing a specialty can be quite stressful,” he told this news organization. “It’s a lifelong decision. You have to commit to a residency, maybe fellowship training, and if you don’t like it and want to switch your specialty, you have to go back and do it again. It’s a decision that weighs heavily on your [physicians] shoulders.”

The PA profession, however, offers lateral movement. Rachel Porter, PhD, interim director of preclinical education at PA program, Duke University, Durham, North Carolina, said that the didactic portion of a PA’s medical education is very broad to support that kind of flexibility. And most PA students, depending on their program, have the opportunity to go through several clinical rotations to see which specialty might be the best fit.

“That initial medical education is meant to provide a good foundation across all systems, across all age groups, subpopulations, and settings — hospital, ambulatory, or outpatient,” she explained. “Once they are exposed to clinical experiences later, we find that students discover their niche and where they want to be once they start their career.”

 

Making a Lateral Move

According to the 2022 Statistical Profile of Board-Certified PAs by Specialty, based on a survey conducted by the NCCPA, approximately half of board-certified PAs have switched to a different specialty at least once during their career. Nearly 31% have done so at least twice.

Eric Van Hecke, DMSc, MPAS, PA-C, CAQ-EM, assistant professor and PA program director at Concordia University, St. Paul in St. Paul, Minnesota, works in emergency medicine, thanks to his clinical rotations during PA school, which helped him determine that a surgical specialty was not for him.

“I did some surgical rotations, and I found I hated being in the operating room,” he said. “I didn’t like the way PAs were utilized there. But then, toward the end of my PA program, I had the opportunity to do an emergency department rotation and found it was a much better fit.”

Other PAs, however, may not be as lucky to find the right practice straight out of school. Some may be limited by job availability in a specific geographic area, while others may feel more comfortable starting in a hospital setting. Lyndsey Milcarek, PA-C, MPH, a PA in Buffalo, New York, said she started in a primary care role after school but moved to geriatric home health after a year. Then, 3 years later, she switched specialties again to join an emergency department. She said her decisions to move were largely driven by organizational issues.

“In one case, I saw the organization was headed for a buyout and I wanted to get ahead of it,” she said. “In another, the workload was a lot, and you couldn’t go home at the end of your shift if there were still patients to see. It was a recipe for burnout.”

Amanda Michaud, DMSc, PA-C, in Jacksonville, Florida, said she initially enjoyed the “fast-paced environment” of emergency medicine after graduating from PA school. But when her family was looking at a move out of state, she started to consider a specialty change and ultimately ended up joining an allergy practice.

“I wanted to have a more nine-to-five kind of job. I wanted my weekends. I had missed a lot of holidays with my family,” she said. “But I also was interested in becoming more of an expert in a particular field. In the ER, you become an expert in saving lives and stabilizing patients. But I wanted an opportunity to truly learn the medicine and science behind one area.”

 

Understand Your Why — and Do the Work

The reasons a PA might choose to make a specialty switch aren’t unlike the reasons a corporate attorney might want to practice family law or a nurse practitioner might want to switch from the ICU to the pediatric ward. People might consider it a change of scenery. Some may be looking to relocate, support a better work-life balance, reduce their stress, expand their skills and knowledge, find a more palatable work environment, or make more money. But those who have made lateral moves said it isn’t as easy as it may look.

“It will take time, not just to learn the new specialty but to understand how your new practice does things,” said Michaud. “You need to expect a huge learning curve ahead when you make a change.”

Milcarek added that PAs who are considering a switch should think long and hard about the kind of environment they want to work in and, as they look at other departments or practices, spend time talking to and shadowing PAs to understand what working there will look like. Just because a particular specialty has a reputation for being low stress (or high paying) doesn’t mean that’s what you’ll find once you come on board. So much depends on your employer — and the people you work with.

“There are a lot of opportunities for PA jobs, but employers aren’t always transparent about workflows and management,” Milcarek said. “You want to have good intel upfront before you make a decision.”

Kozikowski agreed. “It takes a while to adapt to a new environment and to understand how things are done,” he explained. “Research suggests that having a good network, mentors, and good onboarding programs are really important. It’s not just finding continuing medical education, you also need to have the right support system in place.”

Despite the challenges involved with a specialty switch, Milcarek said her moves have made her a stronger overall clinician.

“I have a unique perspective because I’ve worked in so many different areas,” she said. “I’ve learned a lot in each and can apply those things in my new roles. I feel fortunate that I’ve been able to make these switches and continue to learn and grow and become a better PA.”

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

Physician assistants (PAs) are educated as generalists — with the ability to switch medical specialties during their careers. Andrzej Kozikowski, PhD, senior director of research at the National Commission on Certification of Physician Assistants (NCCPA), said that having that kind of career flexibility is often a motivating factor for students who pursue the PA path.

“If you look at the research literature on physicians, you can see that choosing a specialty can be quite stressful,” he told this news organization. “It’s a lifelong decision. You have to commit to a residency, maybe fellowship training, and if you don’t like it and want to switch your specialty, you have to go back and do it again. It’s a decision that weighs heavily on your [physicians] shoulders.”

The PA profession, however, offers lateral movement. Rachel Porter, PhD, interim director of preclinical education at PA program, Duke University, Durham, North Carolina, said that the didactic portion of a PA’s medical education is very broad to support that kind of flexibility. And most PA students, depending on their program, have the opportunity to go through several clinical rotations to see which specialty might be the best fit.

“That initial medical education is meant to provide a good foundation across all systems, across all age groups, subpopulations, and settings — hospital, ambulatory, or outpatient,” she explained. “Once they are exposed to clinical experiences later, we find that students discover their niche and where they want to be once they start their career.”

 

Making a Lateral Move

According to the 2022 Statistical Profile of Board-Certified PAs by Specialty, based on a survey conducted by the NCCPA, approximately half of board-certified PAs have switched to a different specialty at least once during their career. Nearly 31% have done so at least twice.

Eric Van Hecke, DMSc, MPAS, PA-C, CAQ-EM, assistant professor and PA program director at Concordia University, St. Paul in St. Paul, Minnesota, works in emergency medicine, thanks to his clinical rotations during PA school, which helped him determine that a surgical specialty was not for him.

“I did some surgical rotations, and I found I hated being in the operating room,” he said. “I didn’t like the way PAs were utilized there. But then, toward the end of my PA program, I had the opportunity to do an emergency department rotation and found it was a much better fit.”

Other PAs, however, may not be as lucky to find the right practice straight out of school. Some may be limited by job availability in a specific geographic area, while others may feel more comfortable starting in a hospital setting. Lyndsey Milcarek, PA-C, MPH, a PA in Buffalo, New York, said she started in a primary care role after school but moved to geriatric home health after a year. Then, 3 years later, she switched specialties again to join an emergency department. She said her decisions to move were largely driven by organizational issues.

“In one case, I saw the organization was headed for a buyout and I wanted to get ahead of it,” she said. “In another, the workload was a lot, and you couldn’t go home at the end of your shift if there were still patients to see. It was a recipe for burnout.”

Amanda Michaud, DMSc, PA-C, in Jacksonville, Florida, said she initially enjoyed the “fast-paced environment” of emergency medicine after graduating from PA school. But when her family was looking at a move out of state, she started to consider a specialty change and ultimately ended up joining an allergy practice.

“I wanted to have a more nine-to-five kind of job. I wanted my weekends. I had missed a lot of holidays with my family,” she said. “But I also was interested in becoming more of an expert in a particular field. In the ER, you become an expert in saving lives and stabilizing patients. But I wanted an opportunity to truly learn the medicine and science behind one area.”

 

Understand Your Why — and Do the Work

The reasons a PA might choose to make a specialty switch aren’t unlike the reasons a corporate attorney might want to practice family law or a nurse practitioner might want to switch from the ICU to the pediatric ward. People might consider it a change of scenery. Some may be looking to relocate, support a better work-life balance, reduce their stress, expand their skills and knowledge, find a more palatable work environment, or make more money. But those who have made lateral moves said it isn’t as easy as it may look.

“It will take time, not just to learn the new specialty but to understand how your new practice does things,” said Michaud. “You need to expect a huge learning curve ahead when you make a change.”

Milcarek added that PAs who are considering a switch should think long and hard about the kind of environment they want to work in and, as they look at other departments or practices, spend time talking to and shadowing PAs to understand what working there will look like. Just because a particular specialty has a reputation for being low stress (or high paying) doesn’t mean that’s what you’ll find once you come on board. So much depends on your employer — and the people you work with.

“There are a lot of opportunities for PA jobs, but employers aren’t always transparent about workflows and management,” Milcarek said. “You want to have good intel upfront before you make a decision.”

Kozikowski agreed. “It takes a while to adapt to a new environment and to understand how things are done,” he explained. “Research suggests that having a good network, mentors, and good onboarding programs are really important. It’s not just finding continuing medical education, you also need to have the right support system in place.”

Despite the challenges involved with a specialty switch, Milcarek said her moves have made her a stronger overall clinician.

“I have a unique perspective because I’ve worked in so many different areas,” she said. “I’ve learned a lot in each and can apply those things in my new roles. I feel fortunate that I’ve been able to make these switches and continue to learn and grow and become a better PA.”

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

Physician assistants (PAs) are educated as generalists — with the ability to switch medical specialties during their careers. Andrzej Kozikowski, PhD, senior director of research at the National Commission on Certification of Physician Assistants (NCCPA), said that having that kind of career flexibility is often a motivating factor for students who pursue the PA path.

“If you look at the research literature on physicians, you can see that choosing a specialty can be quite stressful,” he told this news organization. “It’s a lifelong decision. You have to commit to a residency, maybe fellowship training, and if you don’t like it and want to switch your specialty, you have to go back and do it again. It’s a decision that weighs heavily on your [physicians] shoulders.”

The PA profession, however, offers lateral movement. Rachel Porter, PhD, interim director of preclinical education at PA program, Duke University, Durham, North Carolina, said that the didactic portion of a PA’s medical education is very broad to support that kind of flexibility. And most PA students, depending on their program, have the opportunity to go through several clinical rotations to see which specialty might be the best fit.

“That initial medical education is meant to provide a good foundation across all systems, across all age groups, subpopulations, and settings — hospital, ambulatory, or outpatient,” she explained. “Once they are exposed to clinical experiences later, we find that students discover their niche and where they want to be once they start their career.”

 

Making a Lateral Move

According to the 2022 Statistical Profile of Board-Certified PAs by Specialty, based on a survey conducted by the NCCPA, approximately half of board-certified PAs have switched to a different specialty at least once during their career. Nearly 31% have done so at least twice.

Eric Van Hecke, DMSc, MPAS, PA-C, CAQ-EM, assistant professor and PA program director at Concordia University, St. Paul in St. Paul, Minnesota, works in emergency medicine, thanks to his clinical rotations during PA school, which helped him determine that a surgical specialty was not for him.

“I did some surgical rotations, and I found I hated being in the operating room,” he said. “I didn’t like the way PAs were utilized there. But then, toward the end of my PA program, I had the opportunity to do an emergency department rotation and found it was a much better fit.”

Other PAs, however, may not be as lucky to find the right practice straight out of school. Some may be limited by job availability in a specific geographic area, while others may feel more comfortable starting in a hospital setting. Lyndsey Milcarek, PA-C, MPH, a PA in Buffalo, New York, said she started in a primary care role after school but moved to geriatric home health after a year. Then, 3 years later, she switched specialties again to join an emergency department. She said her decisions to move were largely driven by organizational issues.

“In one case, I saw the organization was headed for a buyout and I wanted to get ahead of it,” she said. “In another, the workload was a lot, and you couldn’t go home at the end of your shift if there were still patients to see. It was a recipe for burnout.”

Amanda Michaud, DMSc, PA-C, in Jacksonville, Florida, said she initially enjoyed the “fast-paced environment” of emergency medicine after graduating from PA school. But when her family was looking at a move out of state, she started to consider a specialty change and ultimately ended up joining an allergy practice.

“I wanted to have a more nine-to-five kind of job. I wanted my weekends. I had missed a lot of holidays with my family,” she said. “But I also was interested in becoming more of an expert in a particular field. In the ER, you become an expert in saving lives and stabilizing patients. But I wanted an opportunity to truly learn the medicine and science behind one area.”

 

Understand Your Why — and Do the Work

The reasons a PA might choose to make a specialty switch aren’t unlike the reasons a corporate attorney might want to practice family law or a nurse practitioner might want to switch from the ICU to the pediatric ward. People might consider it a change of scenery. Some may be looking to relocate, support a better work-life balance, reduce their stress, expand their skills and knowledge, find a more palatable work environment, or make more money. But those who have made lateral moves said it isn’t as easy as it may look.

“It will take time, not just to learn the new specialty but to understand how your new practice does things,” said Michaud. “You need to expect a huge learning curve ahead when you make a change.”

Milcarek added that PAs who are considering a switch should think long and hard about the kind of environment they want to work in and, as they look at other departments or practices, spend time talking to and shadowing PAs to understand what working there will look like. Just because a particular specialty has a reputation for being low stress (or high paying) doesn’t mean that’s what you’ll find once you come on board. So much depends on your employer — and the people you work with.

“There are a lot of opportunities for PA jobs, but employers aren’t always transparent about workflows and management,” Milcarek said. “You want to have good intel upfront before you make a decision.”

Kozikowski agreed. “It takes a while to adapt to a new environment and to understand how things are done,” he explained. “Research suggests that having a good network, mentors, and good onboarding programs are really important. It’s not just finding continuing medical education, you also need to have the right support system in place.”

Despite the challenges involved with a specialty switch, Milcarek said her moves have made her a stronger overall clinician.

“I have a unique perspective because I’ve worked in so many different areas,” she said. “I’ve learned a lot in each and can apply those things in my new roles. I feel fortunate that I’ve been able to make these switches and continue to learn and grow and become a better PA.”

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

In our previous case-based review, I teased the opportunity to use biomarkers to increase the accuracy and expediency of the diagnosis of Alzheimer’s disease (AD). These tests are no longer confined to the research setting but are now available to specialists and primary care clinicians alike. Given that most cognitive disorders are first identified in primary care, however, I believe that their greatest impact will be in our clinical space.

The pathologic processes associated with AD can be detected approximately 2 decades before the advent of clinical symptoms, and the symptomatic period of cognitive impairment is estimated to occupy just the final third of the disease course of AD. Using imaging studies, primarily PET, as well as cerebrospinal fluid (CSF) and even blood biomarkers for beta amyloid and tau, the pathologic drivers of AD, clinicians can identify patients with AD pathology before any symptoms are present. Importantly for our present-day interventions, the application of biomarkers can also help to diagnose AD earlier.

Amyloid PET identifies one of the earliest markers of potential AD, but a barrier common to advanced diagnostic imaging has been cost. Medicare has now approved coverage for amyloid PET in cases of suspected cognitive impairment. In a large study of more than 16,000 older adults in the United States, PET scans were positive in 55.3% of cases with mild cognitive impairment (MCI). The PET positivity rate among adults with other dementia was 70.1%. The application of PET resulted in a change in care in more than 60% of patients with MCI and dementia. One quarter of participants had their diagnosis changed from AD to another form of dementia, and 10% were changed from a diagnosis of other dementia to AD.

Liquid biomarkers can involve either CSF or blood samples. To date, CSF testing has yielded more consistent results and has defined protocols for assessment. Still, collection of CSF is more challenging than collection of blood, and patients and their families may object to lumbar puncture. CSF assessment therefore remains generally in the province of specialists and research centers.

Primary care clinicians have been waiting for a reliable blood-based biomarker for AD, and that wait may be about to end. A study published in July 2024 included 1213 adults being evaluated for cognitive symptoms in Sweden. They completed a test measuring the ratio of phosphorylated tau 217 vs nonphosphorylated tau 217, with or without a test for serum amyloid ratios as well. These tests were compared with clinicians’ clinical diagnoses as well as CSF results, which were considered the gold standard.

Using only clinical tools, primary care clinicians’ and specialists’ diagnostic accuracy for MCI and dementia were just 61% and 73%, respectively. These values were substantially weaker vs the performance of either the serum tau or amyloid ratios (both 90% accurate). The authors concluded that serum testing has the potential to improve clinical care of patients with cognitive impairment.

Where does that leave us today? Commercially available blood biomarkers are available now which use different tests and cutoff values. These may be helpful but will probably be difficult to compare and interpret for primary care clinicians. In addition, insurance is less likely to cover these tests. Amyloid PET scans are a very reasonable option to augment clinician judgment of suspected cognitive impairment, but not all geographic areas will have ready access to this imaging study.

Still, it is an exciting time to have more objective tools at our disposal to identify MCI and AD. These tools can only be optimized by clinicians who recognize symptoms and perform the baseline testing necessary to determine pretest probability of MCI or dementia.

Charles P. Vega, Health Sciences Clinical Professor, Family Medicine, University of California, Irvine, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for McNeil Pharmaceuticals.

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

In our previous case-based review, I teased the opportunity to use biomarkers to increase the accuracy and expediency of the diagnosis of Alzheimer’s disease (AD). These tests are no longer confined to the research setting but are now available to specialists and primary care clinicians alike. Given that most cognitive disorders are first identified in primary care, however, I believe that their greatest impact will be in our clinical space.

The pathologic processes associated with AD can be detected approximately 2 decades before the advent of clinical symptoms, and the symptomatic period of cognitive impairment is estimated to occupy just the final third of the disease course of AD. Using imaging studies, primarily PET, as well as cerebrospinal fluid (CSF) and even blood biomarkers for beta amyloid and tau, the pathologic drivers of AD, clinicians can identify patients with AD pathology before any symptoms are present. Importantly for our present-day interventions, the application of biomarkers can also help to diagnose AD earlier.

Amyloid PET identifies one of the earliest markers of potential AD, but a barrier common to advanced diagnostic imaging has been cost. Medicare has now approved coverage for amyloid PET in cases of suspected cognitive impairment. In a large study of more than 16,000 older adults in the United States, PET scans were positive in 55.3% of cases with mild cognitive impairment (MCI). The PET positivity rate among adults with other dementia was 70.1%. The application of PET resulted in a change in care in more than 60% of patients with MCI and dementia. One quarter of participants had their diagnosis changed from AD to another form of dementia, and 10% were changed from a diagnosis of other dementia to AD.

Liquid biomarkers can involve either CSF or blood samples. To date, CSF testing has yielded more consistent results and has defined protocols for assessment. Still, collection of CSF is more challenging than collection of blood, and patients and their families may object to lumbar puncture. CSF assessment therefore remains generally in the province of specialists and research centers.

Primary care clinicians have been waiting for a reliable blood-based biomarker for AD, and that wait may be about to end. A study published in July 2024 included 1213 adults being evaluated for cognitive symptoms in Sweden. They completed a test measuring the ratio of phosphorylated tau 217 vs nonphosphorylated tau 217, with or without a test for serum amyloid ratios as well. These tests were compared with clinicians’ clinical diagnoses as well as CSF results, which were considered the gold standard.

Using only clinical tools, primary care clinicians’ and specialists’ diagnostic accuracy for MCI and dementia were just 61% and 73%, respectively. These values were substantially weaker vs the performance of either the serum tau or amyloid ratios (both 90% accurate). The authors concluded that serum testing has the potential to improve clinical care of patients with cognitive impairment.

Where does that leave us today? Commercially available blood biomarkers are available now which use different tests and cutoff values. These may be helpful but will probably be difficult to compare and interpret for primary care clinicians. In addition, insurance is less likely to cover these tests. Amyloid PET scans are a very reasonable option to augment clinician judgment of suspected cognitive impairment, but not all geographic areas will have ready access to this imaging study.

Still, it is an exciting time to have more objective tools at our disposal to identify MCI and AD. These tools can only be optimized by clinicians who recognize symptoms and perform the baseline testing necessary to determine pretest probability of MCI or dementia.

Charles P. Vega, Health Sciences Clinical Professor, Family Medicine, University of California, Irvine, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for McNeil Pharmaceuticals.

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

In our previous case-based review, I teased the opportunity to use biomarkers to increase the accuracy and expediency of the diagnosis of Alzheimer’s disease (AD). These tests are no longer confined to the research setting but are now available to specialists and primary care clinicians alike. Given that most cognitive disorders are first identified in primary care, however, I believe that their greatest impact will be in our clinical space.

The pathologic processes associated with AD can be detected approximately 2 decades before the advent of clinical symptoms, and the symptomatic period of cognitive impairment is estimated to occupy just the final third of the disease course of AD. Using imaging studies, primarily PET, as well as cerebrospinal fluid (CSF) and even blood biomarkers for beta amyloid and tau, the pathologic drivers of AD, clinicians can identify patients with AD pathology before any symptoms are present. Importantly for our present-day interventions, the application of biomarkers can also help to diagnose AD earlier.

Amyloid PET identifies one of the earliest markers of potential AD, but a barrier common to advanced diagnostic imaging has been cost. Medicare has now approved coverage for amyloid PET in cases of suspected cognitive impairment. In a large study of more than 16,000 older adults in the United States, PET scans were positive in 55.3% of cases with mild cognitive impairment (MCI). The PET positivity rate among adults with other dementia was 70.1%. The application of PET resulted in a change in care in more than 60% of patients with MCI and dementia. One quarter of participants had their diagnosis changed from AD to another form of dementia, and 10% were changed from a diagnosis of other dementia to AD.

Liquid biomarkers can involve either CSF or blood samples. To date, CSF testing has yielded more consistent results and has defined protocols for assessment. Still, collection of CSF is more challenging than collection of blood, and patients and their families may object to lumbar puncture. CSF assessment therefore remains generally in the province of specialists and research centers.

Primary care clinicians have been waiting for a reliable blood-based biomarker for AD, and that wait may be about to end. A study published in July 2024 included 1213 adults being evaluated for cognitive symptoms in Sweden. They completed a test measuring the ratio of phosphorylated tau 217 vs nonphosphorylated tau 217, with or without a test for serum amyloid ratios as well. These tests were compared with clinicians’ clinical diagnoses as well as CSF results, which were considered the gold standard.

Using only clinical tools, primary care clinicians’ and specialists’ diagnostic accuracy for MCI and dementia were just 61% and 73%, respectively. These values were substantially weaker vs the performance of either the serum tau or amyloid ratios (both 90% accurate). The authors concluded that serum testing has the potential to improve clinical care of patients with cognitive impairment.

Where does that leave us today? Commercially available blood biomarkers are available now which use different tests and cutoff values. These may be helpful but will probably be difficult to compare and interpret for primary care clinicians. In addition, insurance is less likely to cover these tests. Amyloid PET scans are a very reasonable option to augment clinician judgment of suspected cognitive impairment, but not all geographic areas will have ready access to this imaging study.

Still, it is an exciting time to have more objective tools at our disposal to identify MCI and AD. These tools can only be optimized by clinicians who recognize symptoms and perform the baseline testing necessary to determine pretest probability of MCI or dementia.

Charles P. Vega, Health Sciences Clinical Professor, Family Medicine, University of California, Irvine, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for McNeil Pharmaceuticals.

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

If the name of leukemia specialist Jorge Cortes, MD, appears any more often in PubMed, they’ll need to name a wing after him. 

Over 30 years, Cortes has led or coauthored hundreds of studies, including many trials of landmark drugs to treat chronic myeloid leukemia (CML). His work has helped transform CML into an often-survivable disease instead of one that took the lives of most patients within 5 years.

“It’s been remarkable to see the evolution in CML and to be part of that transition as a fellow, as faculty, and as leader of some of the trials,” said Cortes, who directs the Georgia Cancer Center at Augusta University. “I’m the luckiest person in the world.”

In an interview, Cortes talked about his youth in Mexico, his research path, and his close connections to cancer medicine in Latin America.

Q: You grew up in Mexico City. What was your family like?

A: “My father grew up very poor in a small town in Michoacán in the southwest part of Mexico. In Mexico City, he had a tiny grocery store in an old-fashioned market, and we were lower middle class.

One of the things I learned was to work hard. There’s nobody I know who worked as hard as my father. He opened his store every day of the year, [Mexican] Independence Day or New Year’s or Christmas. He worked hard so we could have a better life than he did.

We learned English from a very young age. My elementary school was called Westminster School because he wanted a school where we would learn English.

As for my mother, she stayed with us [at home] and made sure we did our homework and were taken care of. I learned about being honest and dedicating to what you were doing.”

Q: You trained at the Salvador Zubirán National Institute of Health Sciences and Nutrition in Mexico City. Then what happened? 

A: “Through encouragement by my dermatologist older brother and a mentor at the institution where I was training as a hematologist, I decided to come to the United States.

My initial focus was going to be on coagulation and thrombosis. I came to Houston (Texas) for a fellowship at the University of Texas Health Science Center.

Then I started doing my rotation for the malignant part of the fellowship at MD Anderson Cancer Center [Houston]. One of my first rotations was with Susan M. O’Brien, [MD,] who became my greatest mentor throughout my career. I really enjoyed my rotation. I thought she was great clinically, and she was doing research and teaching. That’s what I wanted for my career.”

Q: What drew you to leukemia specifically?

A: “Dr O’Brien worked in leukemia during my initial rotation, and I really loved it. It was hard work, but it was very inspiring to see the clinical research and the things you could for patients. She had a lot of joy doing that. 

I told my program director I’d change and transfer to MD Anderson, and I ended up staying at MD Anderson for 23 years.”

Q: What was leukemia research like in those days?

A: “We didn’t have the understanding of the biology and the new drugs that we have now. When I started in Mexico, we didn’t even have hydroxyurea. What we were doing was much more basic. But still, the field sounded like a great field to be involved with because they were doing so many trials and had an outstanding database. 

Because of the influence of Dr [Moshe] Talpaz, [MD,] I started getting very involved with CML. In my initial years as a young faculty, I started working with him on interferon. Then imatinib appeared. I saw even from the phase 1 study how impressive the outcomes were in patients who had no response to anything and were in bad shape.”

Q: What CML medications have you worked on?

A: “I’ve been involved with all of them. Imatinib early on, then I led trials with dasatinib and nilotinib. Then, I led the registration trials of bosutinib and ponatinib. More recently, I was part of the development of asciminib.”

Q: What were some of the biggest challenges in CML research?

A: “We had an opportunity to do a lot of analysis about TKIs [tyrosine kinase inhibitors] when these were new drugs. It was a very steep curve of learning, how to monitor and manage side effects.

Then patients were starting to have resistance to two to three TKIs. Ponatinib came along, and it was an incredibly effective drug. But after it was approved, we started to recognize the occurrence of heart attacks and strokes.

That was unexpected and not something that was known for any TKI. It was a big challenge. The drug was taken off the market for some time, and trials were put on hold by the FDA [US Food and Drug Administration].

We scrambled to understand the mechanism of action. For a year or two, it was a stressful time. But eventually we moved past it, and we learned a lot.”

Q: What sort of work have you done in Latin America?

A: “I’ve always been very close to Latin America. I have many good friends and colleagues there, and I’ve always been interested in working with them. 

We’ve done research and studies and created an organization called Latin American Leukemia Net to develop more trials in Latin America. The most rewarding thing has been the educational programs for patients that we’ve done, helping them understand the disease, the treatments, and the goals of treatment. 

We’ve conducted a number of programs, and they have been effective, well-attended, and well received. I still work with my colleagues to develop local guidelines and do collaborative research.”

Q: What convinced you to leave MD Anderson for Georgia?

A: “I never thought I’d leave MD Anderson. I had my well-oiled machine of clinical trials, my clinic, and my fellowship program. But the one thing that I wanted to see if I could try next was to develop an institution.

That was the goal here, to take the Georgia Cancer Center to NCI [National Cancer Institute] designation. So, I thought, ‘That’s a nice challenge.’ It may be a good opportunity to try a different aspect of what it means to be an oncologist.

There are days that you think, ‘What am I doing here?’ when you have to deal with budgets and personnel and all these things. But it’s part of the process. It’s still good to know that we have a goal, and that we’re going to make it. 

Also, I still see my patients, and I enjoy that I still do some research and mentoring.”

Q: What’s the current state of CML treatment?

A: “Many patients have a pretty much normal life expectancy while [on therapy]. Still, one of the goals of many patients is to stop therapy. But that’s a reality only for a small percentage of patients. How can we make that happen for more patients?”

Q: By stopping therapy, do you mean curing the cancer?

A: “Yes, pretty much. You have a good response, you stop the therapy, and it doesn’t come back.

There are also patients who really don’t do well. We hear about CML being with a disease with such a good outcome, but we have patients for whom nothing works. Is it a matter of [needing] another TKI, or do we need to look at something else?”

Q: What do you see on the horizon?

A: “We are developing new approaches like combination therapies. We’re scratching the surface on that. We need to understand which combinations work, and where and when.

And we can make more efficient uses of the drugs we have now in terms of which ones to use when, the doses, the safety profiles. I think we can do better.”

Cortes disclosed consulting for Amphivena, Astellas, Bio-Path, BioLineRx, Bristol Myers Squibb, Daiichi Sankyo, Jazz, Novartis, Pfizer, and Takeda and research funding from Astellas Pharma, Bristol Myers Squibb, Daiichi Sankyo, Immunogen, Jazz, Merus, Novartis, Pfizer, Sun Pharma, Takeda, Tolero and Trovagene.
 

A version of this article appeared on Medscape.com.

If the name of leukemia specialist Jorge Cortes, MD, appears any more often in PubMed, they’ll need to name a wing after him. 

Over 30 years, Cortes has led or coauthored hundreds of studies, including many trials of landmark drugs to treat chronic myeloid leukemia (CML). His work has helped transform CML into an often-survivable disease instead of one that took the lives of most patients within 5 years.

“It’s been remarkable to see the evolution in CML and to be part of that transition as a fellow, as faculty, and as leader of some of the trials,” said Cortes, who directs the Georgia Cancer Center at Augusta University. “I’m the luckiest person in the world.”

In an interview, Cortes talked about his youth in Mexico, his research path, and his close connections to cancer medicine in Latin America.

Q: You grew up in Mexico City. What was your family like?

A: “My father grew up very poor in a small town in Michoacán in the southwest part of Mexico. In Mexico City, he had a tiny grocery store in an old-fashioned market, and we were lower middle class.

One of the things I learned was to work hard. There’s nobody I know who worked as hard as my father. He opened his store every day of the year, [Mexican] Independence Day or New Year’s or Christmas. He worked hard so we could have a better life than he did.

We learned English from a very young age. My elementary school was called Westminster School because he wanted a school where we would learn English.

As for my mother, she stayed with us [at home] and made sure we did our homework and were taken care of. I learned about being honest and dedicating to what you were doing.”

Q: You trained at the Salvador Zubirán National Institute of Health Sciences and Nutrition in Mexico City. Then what happened? 

A: “Through encouragement by my dermatologist older brother and a mentor at the institution where I was training as a hematologist, I decided to come to the United States.

My initial focus was going to be on coagulation and thrombosis. I came to Houston (Texas) for a fellowship at the University of Texas Health Science Center.

Then I started doing my rotation for the malignant part of the fellowship at MD Anderson Cancer Center [Houston]. One of my first rotations was with Susan M. O’Brien, [MD,] who became my greatest mentor throughout my career. I really enjoyed my rotation. I thought she was great clinically, and she was doing research and teaching. That’s what I wanted for my career.”

Q: What drew you to leukemia specifically?

A: “Dr O’Brien worked in leukemia during my initial rotation, and I really loved it. It was hard work, but it was very inspiring to see the clinical research and the things you could for patients. She had a lot of joy doing that. 

I told my program director I’d change and transfer to MD Anderson, and I ended up staying at MD Anderson for 23 years.”

Q: What was leukemia research like in those days?

A: “We didn’t have the understanding of the biology and the new drugs that we have now. When I started in Mexico, we didn’t even have hydroxyurea. What we were doing was much more basic. But still, the field sounded like a great field to be involved with because they were doing so many trials and had an outstanding database. 

Because of the influence of Dr [Moshe] Talpaz, [MD,] I started getting very involved with CML. In my initial years as a young faculty, I started working with him on interferon. Then imatinib appeared. I saw even from the phase 1 study how impressive the outcomes were in patients who had no response to anything and were in bad shape.”

Q: What CML medications have you worked on?

A: “I’ve been involved with all of them. Imatinib early on, then I led trials with dasatinib and nilotinib. Then, I led the registration trials of bosutinib and ponatinib. More recently, I was part of the development of asciminib.”

Q: What were some of the biggest challenges in CML research?

A: “We had an opportunity to do a lot of analysis about TKIs [tyrosine kinase inhibitors] when these were new drugs. It was a very steep curve of learning, how to monitor and manage side effects.

Then patients were starting to have resistance to two to three TKIs. Ponatinib came along, and it was an incredibly effective drug. But after it was approved, we started to recognize the occurrence of heart attacks and strokes.

That was unexpected and not something that was known for any TKI. It was a big challenge. The drug was taken off the market for some time, and trials were put on hold by the FDA [US Food and Drug Administration].

We scrambled to understand the mechanism of action. For a year or two, it was a stressful time. But eventually we moved past it, and we learned a lot.”

Q: What sort of work have you done in Latin America?

A: “I’ve always been very close to Latin America. I have many good friends and colleagues there, and I’ve always been interested in working with them. 

We’ve done research and studies and created an organization called Latin American Leukemia Net to develop more trials in Latin America. The most rewarding thing has been the educational programs for patients that we’ve done, helping them understand the disease, the treatments, and the goals of treatment. 

We’ve conducted a number of programs, and they have been effective, well-attended, and well received. I still work with my colleagues to develop local guidelines and do collaborative research.”

Q: What convinced you to leave MD Anderson for Georgia?

A: “I never thought I’d leave MD Anderson. I had my well-oiled machine of clinical trials, my clinic, and my fellowship program. But the one thing that I wanted to see if I could try next was to develop an institution.

That was the goal here, to take the Georgia Cancer Center to NCI [National Cancer Institute] designation. So, I thought, ‘That’s a nice challenge.’ It may be a good opportunity to try a different aspect of what it means to be an oncologist.

There are days that you think, ‘What am I doing here?’ when you have to deal with budgets and personnel and all these things. But it’s part of the process. It’s still good to know that we have a goal, and that we’re going to make it. 

Also, I still see my patients, and I enjoy that I still do some research and mentoring.”

Q: What’s the current state of CML treatment?

A: “Many patients have a pretty much normal life expectancy while [on therapy]. Still, one of the goals of many patients is to stop therapy. But that’s a reality only for a small percentage of patients. How can we make that happen for more patients?”

Q: By stopping therapy, do you mean curing the cancer?

A: “Yes, pretty much. You have a good response, you stop the therapy, and it doesn’t come back.

There are also patients who really don’t do well. We hear about CML being with a disease with such a good outcome, but we have patients for whom nothing works. Is it a matter of [needing] another TKI, or do we need to look at something else?”

Q: What do you see on the horizon?

A: “We are developing new approaches like combination therapies. We’re scratching the surface on that. We need to understand which combinations work, and where and when.

And we can make more efficient uses of the drugs we have now in terms of which ones to use when, the doses, the safety profiles. I think we can do better.”

Cortes disclosed consulting for Amphivena, Astellas, Bio-Path, BioLineRx, Bristol Myers Squibb, Daiichi Sankyo, Jazz, Novartis, Pfizer, and Takeda and research funding from Astellas Pharma, Bristol Myers Squibb, Daiichi Sankyo, Immunogen, Jazz, Merus, Novartis, Pfizer, Sun Pharma, Takeda, Tolero and Trovagene.
 

A version of this article appeared on Medscape.com.

If the name of leukemia specialist Jorge Cortes, MD, appears any more often in PubMed, they’ll need to name a wing after him. 

Over 30 years, Cortes has led or coauthored hundreds of studies, including many trials of landmark drugs to treat chronic myeloid leukemia (CML). His work has helped transform CML into an often-survivable disease instead of one that took the lives of most patients within 5 years.

“It’s been remarkable to see the evolution in CML and to be part of that transition as a fellow, as faculty, and as leader of some of the trials,” said Cortes, who directs the Georgia Cancer Center at Augusta University. “I’m the luckiest person in the world.”

In an interview, Cortes talked about his youth in Mexico, his research path, and his close connections to cancer medicine in Latin America.

Q: You grew up in Mexico City. What was your family like?

A: “My father grew up very poor in a small town in Michoacán in the southwest part of Mexico. In Mexico City, he had a tiny grocery store in an old-fashioned market, and we were lower middle class.

One of the things I learned was to work hard. There’s nobody I know who worked as hard as my father. He opened his store every day of the year, [Mexican] Independence Day or New Year’s or Christmas. He worked hard so we could have a better life than he did.

We learned English from a very young age. My elementary school was called Westminster School because he wanted a school where we would learn English.

As for my mother, she stayed with us [at home] and made sure we did our homework and were taken care of. I learned about being honest and dedicating to what you were doing.”

Q: You trained at the Salvador Zubirán National Institute of Health Sciences and Nutrition in Mexico City. Then what happened? 

A: “Through encouragement by my dermatologist older brother and a mentor at the institution where I was training as a hematologist, I decided to come to the United States.

My initial focus was going to be on coagulation and thrombosis. I came to Houston (Texas) for a fellowship at the University of Texas Health Science Center.

Then I started doing my rotation for the malignant part of the fellowship at MD Anderson Cancer Center [Houston]. One of my first rotations was with Susan M. O’Brien, [MD,] who became my greatest mentor throughout my career. I really enjoyed my rotation. I thought she was great clinically, and she was doing research and teaching. That’s what I wanted for my career.”

Q: What drew you to leukemia specifically?

A: “Dr O’Brien worked in leukemia during my initial rotation, and I really loved it. It was hard work, but it was very inspiring to see the clinical research and the things you could for patients. She had a lot of joy doing that. 

I told my program director I’d change and transfer to MD Anderson, and I ended up staying at MD Anderson for 23 years.”

Q: What was leukemia research like in those days?

A: “We didn’t have the understanding of the biology and the new drugs that we have now. When I started in Mexico, we didn’t even have hydroxyurea. What we were doing was much more basic. But still, the field sounded like a great field to be involved with because they were doing so many trials and had an outstanding database. 

Because of the influence of Dr [Moshe] Talpaz, [MD,] I started getting very involved with CML. In my initial years as a young faculty, I started working with him on interferon. Then imatinib appeared. I saw even from the phase 1 study how impressive the outcomes were in patients who had no response to anything and were in bad shape.”

Q: What CML medications have you worked on?

A: “I’ve been involved with all of them. Imatinib early on, then I led trials with dasatinib and nilotinib. Then, I led the registration trials of bosutinib and ponatinib. More recently, I was part of the development of asciminib.”

Q: What were some of the biggest challenges in CML research?

A: “We had an opportunity to do a lot of analysis about TKIs [tyrosine kinase inhibitors] when these were new drugs. It was a very steep curve of learning, how to monitor and manage side effects.

Then patients were starting to have resistance to two to three TKIs. Ponatinib came along, and it was an incredibly effective drug. But after it was approved, we started to recognize the occurrence of heart attacks and strokes.

That was unexpected and not something that was known for any TKI. It was a big challenge. The drug was taken off the market for some time, and trials were put on hold by the FDA [US Food and Drug Administration].

We scrambled to understand the mechanism of action. For a year or two, it was a stressful time. But eventually we moved past it, and we learned a lot.”

Q: What sort of work have you done in Latin America?

A: “I’ve always been very close to Latin America. I have many good friends and colleagues there, and I’ve always been interested in working with them. 

We’ve done research and studies and created an organization called Latin American Leukemia Net to develop more trials in Latin America. The most rewarding thing has been the educational programs for patients that we’ve done, helping them understand the disease, the treatments, and the goals of treatment. 

We’ve conducted a number of programs, and they have been effective, well-attended, and well received. I still work with my colleagues to develop local guidelines and do collaborative research.”

Q: What convinced you to leave MD Anderson for Georgia?

A: “I never thought I’d leave MD Anderson. I had my well-oiled machine of clinical trials, my clinic, and my fellowship program. But the one thing that I wanted to see if I could try next was to develop an institution.

That was the goal here, to take the Georgia Cancer Center to NCI [National Cancer Institute] designation. So, I thought, ‘That’s a nice challenge.’ It may be a good opportunity to try a different aspect of what it means to be an oncologist.

There are days that you think, ‘What am I doing here?’ when you have to deal with budgets and personnel and all these things. But it’s part of the process. It’s still good to know that we have a goal, and that we’re going to make it. 

Also, I still see my patients, and I enjoy that I still do some research and mentoring.”

Q: What’s the current state of CML treatment?

A: “Many patients have a pretty much normal life expectancy while [on therapy]. Still, one of the goals of many patients is to stop therapy. But that’s a reality only for a small percentage of patients. How can we make that happen for more patients?”

Q: By stopping therapy, do you mean curing the cancer?

A: “Yes, pretty much. You have a good response, you stop the therapy, and it doesn’t come back.

There are also patients who really don’t do well. We hear about CML being with a disease with such a good outcome, but we have patients for whom nothing works. Is it a matter of [needing] another TKI, or do we need to look at something else?”

Q: What do you see on the horizon?

A: “We are developing new approaches like combination therapies. We’re scratching the surface on that. We need to understand which combinations work, and where and when.

And we can make more efficient uses of the drugs we have now in terms of which ones to use when, the doses, the safety profiles. I think we can do better.”

Cortes disclosed consulting for Amphivena, Astellas, Bio-Path, BioLineRx, Bristol Myers Squibb, Daiichi Sankyo, Jazz, Novartis, Pfizer, and Takeda and research funding from Astellas Pharma, Bristol Myers Squibb, Daiichi Sankyo, Immunogen, Jazz, Merus, Novartis, Pfizer, Sun Pharma, Takeda, Tolero and Trovagene.
 

A version of this article appeared on Medscape.com.

I’ve tried to retire from medicine. Really. Proofs of my sincerity include a true retirement from performing procedures and the closing of two office practices. I even attended the wonderful retirement party my daughters threw for me. 

I had great plans for my newfound leisure time. I purchased about a thousand colored pencils to map my family ancestry. I wore out many magic erasers in my cleaning efforts. I cajoled my husband, Tony, to help me build not one, but three, gardens in our yard. Upon realizing I had no more weeds or closets to conquer, I began a Dante-like descent into a dark abyss. I felt my sadness was justified. After all, I had immensely enjoyed my early medical life. 

 

From Private Practice to Being Employed

I had a joint cardiology practice with the great Jim Whiteside, MD, in South Central Kentucky for 24 years. Our schedule was always bursting at the seams in the heart of tobacco country. We opened the first cath lab in our hospital, inspired the purchase of a new nuclear scanner, and expanded the stress echo lab. After a 6-year odyssey, we successfully championed primary PCI without surgery on site (along with Ephraim McDowell Regional Medical Center in Danville, Kentucky). As our services expanded, we remodeled to accommodate three cardiologists and two nurse practitioners. Simultaneously, we lobbied our city council and mayor to pass smoke-free legislation, a lightning rod topic in a culture still loyal to a burning weed whose worth had paled in comparison to the cost of its carnage. We were “running wide open” and believed that we were doing important work. 

But then our forward-thinking, appreciative CEO and friend died suddenly, and the open communication and innovation seemingly vanished. Those events inspired my first “retirement.” After this, I became employed for the first time and was blessed once again with a wonderful partner and colleagues. But despite those blessings, the global practice of medicine had begun to change. Physicians were now seen by some as widgets; their worth measured in productivity. A few years in, I needed part-time work to care for my aging parents. My employer needed more, thus inspiring my second “retirement”. 

 

My Second ‘Retirement’

My parents died within 4 months of each other in 2020. Suddenly, I was untethered from both my professional persona and role as caregiver. It was then that my sadness accelerated toward what seemed like the second circle of Hell, with many more to come. 

To many, my sadness made no sense. Our accountant reassured us that we no longer “needed” to work, and I was (and still am) happily married to my high school sweetheart. Our beautiful daughters were healthy and thriving. Although I mouthed appreciation for my blessings in prayer, I could not prevent myself from sinking further. 

My always supportive husband was worried. Tony had skipped happily into his retirement from teaching. He had hoped I would do that same. “You cannot sit on that couch and mope for the rest of your life,” he said, exasperated. 

I thought about doing just that, until one day I answered a phone call to hear, “Doctor, have you ever been to Montana?” Before I could cut her off, the woman charged into the description of a job opening for a locums cardiologist. I immediately sat up. “No office work?” I questioned. 

“No, this is strictly hospital call, rounds, and reading studies.” I didn’t know such jobs existed.

“What is the salary, and what do you cover?” I asked trying to conceal the fact that Tony would have gladly paid her to get me off the couch. 

 

Finding What Suits Me

If I’m honest, since my training days, hospital work is all I have ever wanted. I’ve always felt trapped by the imaginary timer that is part of every office visit. I found running a code less challenging than having to stand and end an office visit that might leave a patient wanting more. 

On hospital days, there are no scheduled time slots. I can triage patients according to their needs. My deadlines are self-imposed: To have a morning coffee with Tony. To deliver the best care possible. To educate as much as time will allow. To beat the midnight clock, after which billing is a little more difficult. 

I will soon begin my seventh year as an inpatient, acute-care cardiologist. Although I was flattered to be considered for full-time work, I couldn’t do that to Tony (who declined to move from Kentucky). We struck a deal that we’d travel to the same facility, where I work seven to nine jobs a year. 

I am now a less anxious “retiree.” My mood is bolstered by the knowledge that within days to weeks I’ll be back to doing what I love: Seeing patients. Making a difference. Enjoying professional comradery and appreciation.

Tony golfs while I work and he jokes that he is a “real go-getter,” explaining that “I take her to work in the morning and then at night, I go get her!” 

For those considering this line of work, it’s not for the faint of heart. My workday can stretch to over 16 hours. But I work in the best of hospital settings. On morning rounds, we present every single patient on the service. Our ER is staffed 100% of the time with at least four board-certified emergency medicine trained physicians. Everyone I work with shares a patient-first philosophy. 

Because of this, I have quite easily ascended from Dante’s inferno. I am happy again in my professional life. 

I know I’ll eventually have to retire for real, and I hope it will be at a time of my choosing and not enforced by the failings of modern medicine. I believe that these past few years will help ease that transition. And when that time comes, I’ll able to look back and know that I was blessed with a long and mostly satisfying career. 

Until then, my magic erasers, colored pencils and gardening will have to wait.

Dr. Walton-Shirley is a clinical cardiologist from Nashville, Tennessee. She reported no relevant conflicts of interest.

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

I’ve tried to retire from medicine. Really. Proofs of my sincerity include a true retirement from performing procedures and the closing of two office practices. I even attended the wonderful retirement party my daughters threw for me. 

I had great plans for my newfound leisure time. I purchased about a thousand colored pencils to map my family ancestry. I wore out many magic erasers in my cleaning efforts. I cajoled my husband, Tony, to help me build not one, but three, gardens in our yard. Upon realizing I had no more weeds or closets to conquer, I began a Dante-like descent into a dark abyss. I felt my sadness was justified. After all, I had immensely enjoyed my early medical life. 

 

From Private Practice to Being Employed

I had a joint cardiology practice with the great Jim Whiteside, MD, in South Central Kentucky for 24 years. Our schedule was always bursting at the seams in the heart of tobacco country. We opened the first cath lab in our hospital, inspired the purchase of a new nuclear scanner, and expanded the stress echo lab. After a 6-year odyssey, we successfully championed primary PCI without surgery on site (along with Ephraim McDowell Regional Medical Center in Danville, Kentucky). As our services expanded, we remodeled to accommodate three cardiologists and two nurse practitioners. Simultaneously, we lobbied our city council and mayor to pass smoke-free legislation, a lightning rod topic in a culture still loyal to a burning weed whose worth had paled in comparison to the cost of its carnage. We were “running wide open” and believed that we were doing important work. 

But then our forward-thinking, appreciative CEO and friend died suddenly, and the open communication and innovation seemingly vanished. Those events inspired my first “retirement.” After this, I became employed for the first time and was blessed once again with a wonderful partner and colleagues. But despite those blessings, the global practice of medicine had begun to change. Physicians were now seen by some as widgets; their worth measured in productivity. A few years in, I needed part-time work to care for my aging parents. My employer needed more, thus inspiring my second “retirement”. 

 

My Second ‘Retirement’

My parents died within 4 months of each other in 2020. Suddenly, I was untethered from both my professional persona and role as caregiver. It was then that my sadness accelerated toward what seemed like the second circle of Hell, with many more to come. 

To many, my sadness made no sense. Our accountant reassured us that we no longer “needed” to work, and I was (and still am) happily married to my high school sweetheart. Our beautiful daughters were healthy and thriving. Although I mouthed appreciation for my blessings in prayer, I could not prevent myself from sinking further. 

My always supportive husband was worried. Tony had skipped happily into his retirement from teaching. He had hoped I would do that same. “You cannot sit on that couch and mope for the rest of your life,” he said, exasperated. 

I thought about doing just that, until one day I answered a phone call to hear, “Doctor, have you ever been to Montana?” Before I could cut her off, the woman charged into the description of a job opening for a locums cardiologist. I immediately sat up. “No office work?” I questioned. 

“No, this is strictly hospital call, rounds, and reading studies.” I didn’t know such jobs existed.

“What is the salary, and what do you cover?” I asked trying to conceal the fact that Tony would have gladly paid her to get me off the couch. 

 

Finding What Suits Me

If I’m honest, since my training days, hospital work is all I have ever wanted. I’ve always felt trapped by the imaginary timer that is part of every office visit. I found running a code less challenging than having to stand and end an office visit that might leave a patient wanting more. 

On hospital days, there are no scheduled time slots. I can triage patients according to their needs. My deadlines are self-imposed: To have a morning coffee with Tony. To deliver the best care possible. To educate as much as time will allow. To beat the midnight clock, after which billing is a little more difficult. 

I will soon begin my seventh year as an inpatient, acute-care cardiologist. Although I was flattered to be considered for full-time work, I couldn’t do that to Tony (who declined to move from Kentucky). We struck a deal that we’d travel to the same facility, where I work seven to nine jobs a year. 

I am now a less anxious “retiree.” My mood is bolstered by the knowledge that within days to weeks I’ll be back to doing what I love: Seeing patients. Making a difference. Enjoying professional comradery and appreciation.

Tony golfs while I work and he jokes that he is a “real go-getter,” explaining that “I take her to work in the morning and then at night, I go get her!” 

For those considering this line of work, it’s not for the faint of heart. My workday can stretch to over 16 hours. But I work in the best of hospital settings. On morning rounds, we present every single patient on the service. Our ER is staffed 100% of the time with at least four board-certified emergency medicine trained physicians. Everyone I work with shares a patient-first philosophy. 

Because of this, I have quite easily ascended from Dante’s inferno. I am happy again in my professional life. 

I know I’ll eventually have to retire for real, and I hope it will be at a time of my choosing and not enforced by the failings of modern medicine. I believe that these past few years will help ease that transition. And when that time comes, I’ll able to look back and know that I was blessed with a long and mostly satisfying career. 

Until then, my magic erasers, colored pencils and gardening will have to wait.

Dr. Walton-Shirley is a clinical cardiologist from Nashville, Tennessee. She reported no relevant conflicts of interest.

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

I’ve tried to retire from medicine. Really. Proofs of my sincerity include a true retirement from performing procedures and the closing of two office practices. I even attended the wonderful retirement party my daughters threw for me. 

I had great plans for my newfound leisure time. I purchased about a thousand colored pencils to map my family ancestry. I wore out many magic erasers in my cleaning efforts. I cajoled my husband, Tony, to help me build not one, but three, gardens in our yard. Upon realizing I had no more weeds or closets to conquer, I began a Dante-like descent into a dark abyss. I felt my sadness was justified. After all, I had immensely enjoyed my early medical life. 

 

From Private Practice to Being Employed

I had a joint cardiology practice with the great Jim Whiteside, MD, in South Central Kentucky for 24 years. Our schedule was always bursting at the seams in the heart of tobacco country. We opened the first cath lab in our hospital, inspired the purchase of a new nuclear scanner, and expanded the stress echo lab. After a 6-year odyssey, we successfully championed primary PCI without surgery on site (along with Ephraim McDowell Regional Medical Center in Danville, Kentucky). As our services expanded, we remodeled to accommodate three cardiologists and two nurse practitioners. Simultaneously, we lobbied our city council and mayor to pass smoke-free legislation, a lightning rod topic in a culture still loyal to a burning weed whose worth had paled in comparison to the cost of its carnage. We were “running wide open” and believed that we were doing important work. 

But then our forward-thinking, appreciative CEO and friend died suddenly, and the open communication and innovation seemingly vanished. Those events inspired my first “retirement.” After this, I became employed for the first time and was blessed once again with a wonderful partner and colleagues. But despite those blessings, the global practice of medicine had begun to change. Physicians were now seen by some as widgets; their worth measured in productivity. A few years in, I needed part-time work to care for my aging parents. My employer needed more, thus inspiring my second “retirement”. 

 

My Second ‘Retirement’

My parents died within 4 months of each other in 2020. Suddenly, I was untethered from both my professional persona and role as caregiver. It was then that my sadness accelerated toward what seemed like the second circle of Hell, with many more to come. 

To many, my sadness made no sense. Our accountant reassured us that we no longer “needed” to work, and I was (and still am) happily married to my high school sweetheart. Our beautiful daughters were healthy and thriving. Although I mouthed appreciation for my blessings in prayer, I could not prevent myself from sinking further. 

My always supportive husband was worried. Tony had skipped happily into his retirement from teaching. He had hoped I would do that same. “You cannot sit on that couch and mope for the rest of your life,” he said, exasperated. 

I thought about doing just that, until one day I answered a phone call to hear, “Doctor, have you ever been to Montana?” Before I could cut her off, the woman charged into the description of a job opening for a locums cardiologist. I immediately sat up. “No office work?” I questioned. 

“No, this is strictly hospital call, rounds, and reading studies.” I didn’t know such jobs existed.

“What is the salary, and what do you cover?” I asked trying to conceal the fact that Tony would have gladly paid her to get me off the couch. 

 

Finding What Suits Me

If I’m honest, since my training days, hospital work is all I have ever wanted. I’ve always felt trapped by the imaginary timer that is part of every office visit. I found running a code less challenging than having to stand and end an office visit that might leave a patient wanting more. 

On hospital days, there are no scheduled time slots. I can triage patients according to their needs. My deadlines are self-imposed: To have a morning coffee with Tony. To deliver the best care possible. To educate as much as time will allow. To beat the midnight clock, after which billing is a little more difficult. 

I will soon begin my seventh year as an inpatient, acute-care cardiologist. Although I was flattered to be considered for full-time work, I couldn’t do that to Tony (who declined to move from Kentucky). We struck a deal that we’d travel to the same facility, where I work seven to nine jobs a year. 

I am now a less anxious “retiree.” My mood is bolstered by the knowledge that within days to weeks I’ll be back to doing what I love: Seeing patients. Making a difference. Enjoying professional comradery and appreciation.

Tony golfs while I work and he jokes that he is a “real go-getter,” explaining that “I take her to work in the morning and then at night, I go get her!” 

For those considering this line of work, it’s not for the faint of heart. My workday can stretch to over 16 hours. But I work in the best of hospital settings. On morning rounds, we present every single patient on the service. Our ER is staffed 100% of the time with at least four board-certified emergency medicine trained physicians. Everyone I work with shares a patient-first philosophy. 

Because of this, I have quite easily ascended from Dante’s inferno. I am happy again in my professional life. 

I know I’ll eventually have to retire for real, and I hope it will be at a time of my choosing and not enforced by the failings of modern medicine. I believe that these past few years will help ease that transition. And when that time comes, I’ll able to look back and know that I was blessed with a long and mostly satisfying career. 

Until then, my magic erasers, colored pencils and gardening will have to wait.

Dr. Walton-Shirley is a clinical cardiologist from Nashville, Tennessee. She reported no relevant conflicts of interest.

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

The decision to prescribe a compounded or brand-name glucagon-like peptide 1 (GLP-1) medication for obesity treatment was never simple, but recent developments have complicated it further.

Both Eli Lilly and Novo Nordisk have asked the Food and Drug Administration (FDA) to place their GLP-1 medications, tirzepatide and semaglutide, on its Demonstrable Difficulties for Compounding or DDC Lists, which would prohibit compounding the medications. Lawsuits are another issue. The Outsourcing Facility Association, a trade group, filed a lawsuit against the FDA, calling on it to restore tirzepatide to the shortage list after the FDA removed it on October 2, despite pharmacies still experiencing shortages, according to the association. The FDA is reevaluating the decision and won’t take action against compounders in the interim, with a joint status report scheduled for November 21.

In the midst of the lawsuits and pending decisions, healthcare providers are taking a variety of approaches when they need to decide between compounded vs brand-name GLP-1s for obesity treatment. The Alliance for Pharmacy Compounding, another trade group, offers a number of suggestions for doctors faced with compound or brand-name decisions and has a website tool to be sure a compounding pharmacy meets standards.

According to the FDA, a drug may be compounded for a patient who can’t be treated with an FDA-approved medication, such as a patient who has an allergy to a certain ingredient and needs medication to be made without it, or for a medication that appears on the FDA Drug Shortages List.

Here’s how five healthcare providers make the decision.

 

Physicians Weigh in

Hard pass: “I have no experience with compounded formulations by choice,” said W. Timothy Garvey, MD, MACE, an obesity specialist and the Charles E. Butterworth Jr professor and university professor at the University of Alabama at Birmingham. “I think our patients deserve better.”

However, he acknowledged: “This is a difficult situation when there is a lack of access to medications patients need.” Even so, “online prescriptions [for compounded medications] are often done without an evaluation for obesity complications and related diseases and ongoing active management, making a complications-centric approach to care impossible.”

That’s not the optimal approach to treating obesity or other chronic diseases, he said in an interview.

Rather than prescribe compounded GLP-1s for weight loss, he said, other options exist. Among them: Prescribe Ozempic off label for obesity.

“Plus, we have a good first-generation obesity medication — phentermine/topiramate — that gets close to 10% weight loss on average in clinical trials that is available and less expensive.”

Other options, he said, are to switch to lower doses of the brand name that may be available until the treatment dose needed is out of shortage status or, the less desirable option, wait for availability, which means the patient may be off the medication for a month or more.

He acknowledged none of these options solves “the problem of high costs [for brand-name drugs] and lack of insurance coverage.”

In agreement is Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

Brand names preferred: “Brand-name versions as far as I’m concerned are always preferred,” said Sarah Stombaugh, MD, an obesity medicine and family medicine physician in Charlottesville, Virginia. She terms it irresponsible for a prescriber to give a patient a compounded GLP-1 if the patient has prescription coverage and the brand name is available.

Her approach: She first checks the patients’ coverage. Do they have coverage for these medications for obesity? If so, she said, she will do a prior authorization to get the brand name approved. If a brand name is available but not covered, she explores other options. One is the cash pay option for Zepbound in vials. It’s more affordable than the typical $1000 cash price for the brand name GLP-1s but still pricey, at about $400-$549 for lower doses.

She looks at drug makers’ discount coupons, or whether a patient with a history of cardiovascular issues might qualify for coverage on Wegovy. Another option is to give the patient a prescription for Mounjaro or Ozempic to fill from a Canadian pharmacy for about $400 a month.

“I think a lot of people jump quickly to compounding,” she said.

She views it as a last resort and reminds other healthcare providers that the compounded medications aren’t cheap, either, typically costing $100-$500 a month depending on dosage. And, she said, “we have many who get the brand name for $25 a month [by using discount cards and insurance coverage].”

When prescribing a compounded medication is necessary, it’s important for healthcare providers to know that the quality of the compounding pharmacies varies greatly, Stombaugh said. A prescriber needs to pick the compounding pharmacy, not the patient, and needs to vet it, she said, asking about protocols it follows for sterility and for chemical analysis, for instance.

Stombaugh is hopeful that several new medications under study and now in phase 3 trials will soon provide enough competition to drive down the price of the current brand-name GLP-1s.

History of mistrust: Robert Dubin, MD, associate professor of research at the Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and program director for its obesity medicine fellowship, sees a role for compounding and has for several years, but acknowledged that many in his community are against it.

He estimates that about 75% of his colleagues in the Baton Rouge area are opposed to prescribing compounded GLP-1s. He chalks it up to a “track record of distrust,” based on reports of infractions called out by the FDA for some compounding pharmacies as well as physicians not being familiar with the process.

Dubin said he will prescribe a compounded medication if the brand name isn’t available. Cost is also a consideration. “If there’s not a problem with availability and there’s not a problem with cost, then why compound?”

For anyone considering prescribing compounded GLP-1s, he said, “The first step, I believe, is having a relationship with the compounding pharmacy. If you don’t have that, it could be very difficult. We don’t want to send people to a black hole, and we aren’t sure what is going to happen.” He urges colleagues to educate themselves about compounding pharmacies.

Official shortage list vs real world: “The official shortage list doesn’t always reflect the real world,” said Amanda Guarniere, NP, a nurse practitioner with a self-pay telehealth and in-person practice and director of growth for Collaborating Docs, a service based in Arlington, Virginia, that pairs nurse practitioners with supervising physicians.

“When Zepbound and Mounjaro came off the [FDA] shortage list a few weeks ago, patients were still calling around and couldn’t find it in their county.”

It’s important to vet compounding pharmacies before dealing with them, she said.

“I have accounts with two compounding pharmacies who I trust,” she said. She’s researched their quality control provided and is comfortable with their standards. When appropriate, the cost savings of compounded GLP-1s over brand name is “pretty significant,” with compounded medicine costs about 20% of brand-name costs.

When the brand name is back, how might a prescriber still write a prescription for a compounded version? “Compounded versions are typically compounded with something else,” Guarniere said.

For instance, compounded tirzepatide often includes vitamin B12 and other B vitamins, which may help with the side effect of nausea. So a prescriber might decide that the compounded prescription is more appropriate and justified because the patient would benefit from the additive, she said.

 

What Else to Know: Alliance Views

On November 7, the Alliance for Pharmacy Compounding, a trade group, responded to Lilly’s request to put tirzepatide on the “demonstrably difficult to compound (DDC)” list, asking the FDA to deny it. The group also took issue with criticism of compounded GLP-1s from the Novo Nordisk CEO.

The alliance offers perspective and a number of suggestions for doctors faced with compound or brand-name decisions, including using its website tool called “Is It Legit?” to be sure a compounding pharmacy meets standards.

“When these [GLP-1] drugs came out, I don’t think anybody anticipated them to be such blockbusters,” said Tenille Davis, PharmD, a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding. Shortages have plagued the GLP-1s since their approvals, with Wegovy approved on June 4, 2021, and Eli Lilly’s Zepbound on November 8, 2023.

The proposed “Demonstrably Difficult to Compound (DDC)” rule, published in March 2024, aims to finalize the six criteria for a medication to land on that list, she said. No drugs are currently on this list, Davis said.

For now, she said, prescribers faced with a compound vs brand-name decision should be aware of the pending lawsuit concerning tirzepatide and that the FDA has said it will cease most enforcement action until 2 weeks after it reviews the decision to remove the medication from the shortage list and issues a new determination.

Davis suggests prescribers have conversations now with their patients about their options and to tell them it may be necessary to transition from the compounded medicines to brand name. “This may require insurance prior authorizations, so if they are going to transition from compounded tirzepatide to Zepbound and Mounjaro, it’s good to start the process sooner rather than later so there isn’t an interruption in care.”

Earlier in 2024, the three leading obesity organizations issued a statement, advising patients that they do not recommend the use of compounded GLP-1s.

Garvey is a consultant on advisory boards for Eli Lilly, Novo Nordisk, and several other pharmaceutical companies. Apovian had no relevant disclosures. Stombaugh, Dubin, and Guarniere had no disclosures.

A version of this article appeared on Medscape.com.

The decision to prescribe a compounded or brand-name glucagon-like peptide 1 (GLP-1) medication for obesity treatment was never simple, but recent developments have complicated it further.

Both Eli Lilly and Novo Nordisk have asked the Food and Drug Administration (FDA) to place their GLP-1 medications, tirzepatide and semaglutide, on its Demonstrable Difficulties for Compounding or DDC Lists, which would prohibit compounding the medications. Lawsuits are another issue. The Outsourcing Facility Association, a trade group, filed a lawsuit against the FDA, calling on it to restore tirzepatide to the shortage list after the FDA removed it on October 2, despite pharmacies still experiencing shortages, according to the association. The FDA is reevaluating the decision and won’t take action against compounders in the interim, with a joint status report scheduled for November 21.

In the midst of the lawsuits and pending decisions, healthcare providers are taking a variety of approaches when they need to decide between compounded vs brand-name GLP-1s for obesity treatment. The Alliance for Pharmacy Compounding, another trade group, offers a number of suggestions for doctors faced with compound or brand-name decisions and has a website tool to be sure a compounding pharmacy meets standards.

According to the FDA, a drug may be compounded for a patient who can’t be treated with an FDA-approved medication, such as a patient who has an allergy to a certain ingredient and needs medication to be made without it, or for a medication that appears on the FDA Drug Shortages List.

Here’s how five healthcare providers make the decision.

 

Physicians Weigh in

Hard pass: “I have no experience with compounded formulations by choice,” said W. Timothy Garvey, MD, MACE, an obesity specialist and the Charles E. Butterworth Jr professor and university professor at the University of Alabama at Birmingham. “I think our patients deserve better.”

However, he acknowledged: “This is a difficult situation when there is a lack of access to medications patients need.” Even so, “online prescriptions [for compounded medications] are often done without an evaluation for obesity complications and related diseases and ongoing active management, making a complications-centric approach to care impossible.”

That’s not the optimal approach to treating obesity or other chronic diseases, he said in an interview.

Rather than prescribe compounded GLP-1s for weight loss, he said, other options exist. Among them: Prescribe Ozempic off label for obesity.

“Plus, we have a good first-generation obesity medication — phentermine/topiramate — that gets close to 10% weight loss on average in clinical trials that is available and less expensive.”

Other options, he said, are to switch to lower doses of the brand name that may be available until the treatment dose needed is out of shortage status or, the less desirable option, wait for availability, which means the patient may be off the medication for a month or more.

He acknowledged none of these options solves “the problem of high costs [for brand-name drugs] and lack of insurance coverage.”

In agreement is Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

Brand names preferred: “Brand-name versions as far as I’m concerned are always preferred,” said Sarah Stombaugh, MD, an obesity medicine and family medicine physician in Charlottesville, Virginia. She terms it irresponsible for a prescriber to give a patient a compounded GLP-1 if the patient has prescription coverage and the brand name is available.

Her approach: She first checks the patients’ coverage. Do they have coverage for these medications for obesity? If so, she said, she will do a prior authorization to get the brand name approved. If a brand name is available but not covered, she explores other options. One is the cash pay option for Zepbound in vials. It’s more affordable than the typical $1000 cash price for the brand name GLP-1s but still pricey, at about $400-$549 for lower doses.

She looks at drug makers’ discount coupons, or whether a patient with a history of cardiovascular issues might qualify for coverage on Wegovy. Another option is to give the patient a prescription for Mounjaro or Ozempic to fill from a Canadian pharmacy for about $400 a month.

“I think a lot of people jump quickly to compounding,” she said.

She views it as a last resort and reminds other healthcare providers that the compounded medications aren’t cheap, either, typically costing $100-$500 a month depending on dosage. And, she said, “we have many who get the brand name for $25 a month [by using discount cards and insurance coverage].”

When prescribing a compounded medication is necessary, it’s important for healthcare providers to know that the quality of the compounding pharmacies varies greatly, Stombaugh said. A prescriber needs to pick the compounding pharmacy, not the patient, and needs to vet it, she said, asking about protocols it follows for sterility and for chemical analysis, for instance.

Stombaugh is hopeful that several new medications under study and now in phase 3 trials will soon provide enough competition to drive down the price of the current brand-name GLP-1s.

History of mistrust: Robert Dubin, MD, associate professor of research at the Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and program director for its obesity medicine fellowship, sees a role for compounding and has for several years, but acknowledged that many in his community are against it.

He estimates that about 75% of his colleagues in the Baton Rouge area are opposed to prescribing compounded GLP-1s. He chalks it up to a “track record of distrust,” based on reports of infractions called out by the FDA for some compounding pharmacies as well as physicians not being familiar with the process.

Dubin said he will prescribe a compounded medication if the brand name isn’t available. Cost is also a consideration. “If there’s not a problem with availability and there’s not a problem with cost, then why compound?”

For anyone considering prescribing compounded GLP-1s, he said, “The first step, I believe, is having a relationship with the compounding pharmacy. If you don’t have that, it could be very difficult. We don’t want to send people to a black hole, and we aren’t sure what is going to happen.” He urges colleagues to educate themselves about compounding pharmacies.

Official shortage list vs real world: “The official shortage list doesn’t always reflect the real world,” said Amanda Guarniere, NP, a nurse practitioner with a self-pay telehealth and in-person practice and director of growth for Collaborating Docs, a service based in Arlington, Virginia, that pairs nurse practitioners with supervising physicians.

“When Zepbound and Mounjaro came off the [FDA] shortage list a few weeks ago, patients were still calling around and couldn’t find it in their county.”

It’s important to vet compounding pharmacies before dealing with them, she said.

“I have accounts with two compounding pharmacies who I trust,” she said. She’s researched their quality control provided and is comfortable with their standards. When appropriate, the cost savings of compounded GLP-1s over brand name is “pretty significant,” with compounded medicine costs about 20% of brand-name costs.

When the brand name is back, how might a prescriber still write a prescription for a compounded version? “Compounded versions are typically compounded with something else,” Guarniere said.

For instance, compounded tirzepatide often includes vitamin B12 and other B vitamins, which may help with the side effect of nausea. So a prescriber might decide that the compounded prescription is more appropriate and justified because the patient would benefit from the additive, she said.

 

What Else to Know: Alliance Views

On November 7, the Alliance for Pharmacy Compounding, a trade group, responded to Lilly’s request to put tirzepatide on the “demonstrably difficult to compound (DDC)” list, asking the FDA to deny it. The group also took issue with criticism of compounded GLP-1s from the Novo Nordisk CEO.

The alliance offers perspective and a number of suggestions for doctors faced with compound or brand-name decisions, including using its website tool called “Is It Legit?” to be sure a compounding pharmacy meets standards.

“When these [GLP-1] drugs came out, I don’t think anybody anticipated them to be such blockbusters,” said Tenille Davis, PharmD, a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding. Shortages have plagued the GLP-1s since their approvals, with Wegovy approved on June 4, 2021, and Eli Lilly’s Zepbound on November 8, 2023.

The proposed “Demonstrably Difficult to Compound (DDC)” rule, published in March 2024, aims to finalize the six criteria for a medication to land on that list, she said. No drugs are currently on this list, Davis said.

For now, she said, prescribers faced with a compound vs brand-name decision should be aware of the pending lawsuit concerning tirzepatide and that the FDA has said it will cease most enforcement action until 2 weeks after it reviews the decision to remove the medication from the shortage list and issues a new determination.

Davis suggests prescribers have conversations now with their patients about their options and to tell them it may be necessary to transition from the compounded medicines to brand name. “This may require insurance prior authorizations, so if they are going to transition from compounded tirzepatide to Zepbound and Mounjaro, it’s good to start the process sooner rather than later so there isn’t an interruption in care.”

Earlier in 2024, the three leading obesity organizations issued a statement, advising patients that they do not recommend the use of compounded GLP-1s.

Garvey is a consultant on advisory boards for Eli Lilly, Novo Nordisk, and several other pharmaceutical companies. Apovian had no relevant disclosures. Stombaugh, Dubin, and Guarniere had no disclosures.

A version of this article appeared on Medscape.com.

The decision to prescribe a compounded or brand-name glucagon-like peptide 1 (GLP-1) medication for obesity treatment was never simple, but recent developments have complicated it further.

Both Eli Lilly and Novo Nordisk have asked the Food and Drug Administration (FDA) to place their GLP-1 medications, tirzepatide and semaglutide, on its Demonstrable Difficulties for Compounding or DDC Lists, which would prohibit compounding the medications. Lawsuits are another issue. The Outsourcing Facility Association, a trade group, filed a lawsuit against the FDA, calling on it to restore tirzepatide to the shortage list after the FDA removed it on October 2, despite pharmacies still experiencing shortages, according to the association. The FDA is reevaluating the decision and won’t take action against compounders in the interim, with a joint status report scheduled for November 21.

In the midst of the lawsuits and pending decisions, healthcare providers are taking a variety of approaches when they need to decide between compounded vs brand-name GLP-1s for obesity treatment. The Alliance for Pharmacy Compounding, another trade group, offers a number of suggestions for doctors faced with compound or brand-name decisions and has a website tool to be sure a compounding pharmacy meets standards.

According to the FDA, a drug may be compounded for a patient who can’t be treated with an FDA-approved medication, such as a patient who has an allergy to a certain ingredient and needs medication to be made without it, or for a medication that appears on the FDA Drug Shortages List.

Here’s how five healthcare providers make the decision.

 

Physicians Weigh in

Hard pass: “I have no experience with compounded formulations by choice,” said W. Timothy Garvey, MD, MACE, an obesity specialist and the Charles E. Butterworth Jr professor and university professor at the University of Alabama at Birmingham. “I think our patients deserve better.”

However, he acknowledged: “This is a difficult situation when there is a lack of access to medications patients need.” Even so, “online prescriptions [for compounded medications] are often done without an evaluation for obesity complications and related diseases and ongoing active management, making a complications-centric approach to care impossible.”

That’s not the optimal approach to treating obesity or other chronic diseases, he said in an interview.

Rather than prescribe compounded GLP-1s for weight loss, he said, other options exist. Among them: Prescribe Ozempic off label for obesity.

“Plus, we have a good first-generation obesity medication — phentermine/topiramate — that gets close to 10% weight loss on average in clinical trials that is available and less expensive.”

Other options, he said, are to switch to lower doses of the brand name that may be available until the treatment dose needed is out of shortage status or, the less desirable option, wait for availability, which means the patient may be off the medication for a month or more.

He acknowledged none of these options solves “the problem of high costs [for brand-name drugs] and lack of insurance coverage.”

In agreement is Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

Brand names preferred: “Brand-name versions as far as I’m concerned are always preferred,” said Sarah Stombaugh, MD, an obesity medicine and family medicine physician in Charlottesville, Virginia. She terms it irresponsible for a prescriber to give a patient a compounded GLP-1 if the patient has prescription coverage and the brand name is available.

Her approach: She first checks the patients’ coverage. Do they have coverage for these medications for obesity? If so, she said, she will do a prior authorization to get the brand name approved. If a brand name is available but not covered, she explores other options. One is the cash pay option for Zepbound in vials. It’s more affordable than the typical $1000 cash price for the brand name GLP-1s but still pricey, at about $400-$549 for lower doses.

She looks at drug makers’ discount coupons, or whether a patient with a history of cardiovascular issues might qualify for coverage on Wegovy. Another option is to give the patient a prescription for Mounjaro or Ozempic to fill from a Canadian pharmacy for about $400 a month.

“I think a lot of people jump quickly to compounding,” she said.

She views it as a last resort and reminds other healthcare providers that the compounded medications aren’t cheap, either, typically costing $100-$500 a month depending on dosage. And, she said, “we have many who get the brand name for $25 a month [by using discount cards and insurance coverage].”

When prescribing a compounded medication is necessary, it’s important for healthcare providers to know that the quality of the compounding pharmacies varies greatly, Stombaugh said. A prescriber needs to pick the compounding pharmacy, not the patient, and needs to vet it, she said, asking about protocols it follows for sterility and for chemical analysis, for instance.

Stombaugh is hopeful that several new medications under study and now in phase 3 trials will soon provide enough competition to drive down the price of the current brand-name GLP-1s.

History of mistrust: Robert Dubin, MD, associate professor of research at the Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and program director for its obesity medicine fellowship, sees a role for compounding and has for several years, but acknowledged that many in his community are against it.

He estimates that about 75% of his colleagues in the Baton Rouge area are opposed to prescribing compounded GLP-1s. He chalks it up to a “track record of distrust,” based on reports of infractions called out by the FDA for some compounding pharmacies as well as physicians not being familiar with the process.

Dubin said he will prescribe a compounded medication if the brand name isn’t available. Cost is also a consideration. “If there’s not a problem with availability and there’s not a problem with cost, then why compound?”

For anyone considering prescribing compounded GLP-1s, he said, “The first step, I believe, is having a relationship with the compounding pharmacy. If you don’t have that, it could be very difficult. We don’t want to send people to a black hole, and we aren’t sure what is going to happen.” He urges colleagues to educate themselves about compounding pharmacies.

Official shortage list vs real world: “The official shortage list doesn’t always reflect the real world,” said Amanda Guarniere, NP, a nurse practitioner with a self-pay telehealth and in-person practice and director of growth for Collaborating Docs, a service based in Arlington, Virginia, that pairs nurse practitioners with supervising physicians.

“When Zepbound and Mounjaro came off the [FDA] shortage list a few weeks ago, patients were still calling around and couldn’t find it in their county.”

It’s important to vet compounding pharmacies before dealing with them, she said.

“I have accounts with two compounding pharmacies who I trust,” she said. She’s researched their quality control provided and is comfortable with their standards. When appropriate, the cost savings of compounded GLP-1s over brand name is “pretty significant,” with compounded medicine costs about 20% of brand-name costs.

When the brand name is back, how might a prescriber still write a prescription for a compounded version? “Compounded versions are typically compounded with something else,” Guarniere said.

For instance, compounded tirzepatide often includes vitamin B12 and other B vitamins, which may help with the side effect of nausea. So a prescriber might decide that the compounded prescription is more appropriate and justified because the patient would benefit from the additive, she said.

 

What Else to Know: Alliance Views

On November 7, the Alliance for Pharmacy Compounding, a trade group, responded to Lilly’s request to put tirzepatide on the “demonstrably difficult to compound (DDC)” list, asking the FDA to deny it. The group also took issue with criticism of compounded GLP-1s from the Novo Nordisk CEO.

The alliance offers perspective and a number of suggestions for doctors faced with compound or brand-name decisions, including using its website tool called “Is It Legit?” to be sure a compounding pharmacy meets standards.

“When these [GLP-1] drugs came out, I don’t think anybody anticipated them to be such blockbusters,” said Tenille Davis, PharmD, a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding. Shortages have plagued the GLP-1s since their approvals, with Wegovy approved on June 4, 2021, and Eli Lilly’s Zepbound on November 8, 2023.

The proposed “Demonstrably Difficult to Compound (DDC)” rule, published in March 2024, aims to finalize the six criteria for a medication to land on that list, she said. No drugs are currently on this list, Davis said.

For now, she said, prescribers faced with a compound vs brand-name decision should be aware of the pending lawsuit concerning tirzepatide and that the FDA has said it will cease most enforcement action until 2 weeks after it reviews the decision to remove the medication from the shortage list and issues a new determination.

Davis suggests prescribers have conversations now with their patients about their options and to tell them it may be necessary to transition from the compounded medicines to brand name. “This may require insurance prior authorizations, so if they are going to transition from compounded tirzepatide to Zepbound and Mounjaro, it’s good to start the process sooner rather than later so there isn’t an interruption in care.”

Earlier in 2024, the three leading obesity organizations issued a statement, advising patients that they do not recommend the use of compounded GLP-1s.

Garvey is a consultant on advisory boards for Eli Lilly, Novo Nordisk, and several other pharmaceutical companies. Apovian had no relevant disclosures. Stombaugh, Dubin, and Guarniere had no disclosures.

A version of this article appeared on Medscape.com.

Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.

Diabetes and Periodontitis

A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.

GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.

 

Cardiovascular Diseases and Periodontitis

Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.

 

Respiratory Diseases and Periodontitis

The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.

Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.

This story was translated from Univadis France 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.

Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.

Diabetes and Periodontitis

A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.

GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.

 

Cardiovascular Diseases and Periodontitis

Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.

 

Respiratory Diseases and Periodontitis

The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.

Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.

This story was translated from Univadis France 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.

Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.

Diabetes and Periodontitis

A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.

GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.

 

Cardiovascular Diseases and Periodontitis

Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.

 

Respiratory Diseases and Periodontitis

The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.

Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.

This story was translated from Univadis France 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.