This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study.

Basically, all cancers are caused by a mix of genetic and environmental factors, with some cancers driven more strongly by one or the other. When it comes to ovarian cancer, which kills more than 13,000 women per year in the United States, genetic factors like the BRCA gene mutations are well described.

Other risk factors, like early menarche and nulliparity, are difficult to modify. The only slam-dunk environmental toxin to be linked to ovarian cancer is asbestos. Still, the vast majority of women who develop ovarian cancer do not have a known high-risk gene or asbestos exposure, so other triggers may be out there. How do we find them? The answer may just be good old-fashioned epidemiology.

When you’re looking for a new culprit agent that causes a relatively rare disease, the case-control study design is your best friend.

That’s just what researchers, led by Anita Koushik at the University of Montreal, did in a new study appearing in the journal Occupational and Environmental Medicine.

They identified 497 women in Montreal who had recently been diagnosed with ovarian cancer. They then matched those women to 897 women without ovarian cancer, based on age and address. (This approach would not work well in the United States, as diagnosis of ovarian cancer might depend on access to medical care, which is not universal here. In Canada, however, it’s safer to assume that anyone who could have gotten ovarian cancer in Montreal would have been detected.)

Cases and controls identified, the researchers took a detailed occupational history for each participant: every job they ever worked, and when, and for how long. Each occupation was mapped to a standardized set of industries and, interestingly, to a set of environmental exposures ranging from cosmetic talc to cooking fumes to cotton dust, in what is known as a job-exposure matrix. Of course, they also collected data on other ovarian cancer risk factors.

Dr. F. Perry Wilson

Dr. F. Perry Wilson

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale University’s Clinical and Translational Research Accelerator in New Haven, Conn. He reported no conflicts of interest.

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

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study.

Basically, all cancers are caused by a mix of genetic and environmental factors, with some cancers driven more strongly by one or the other. When it comes to ovarian cancer, which kills more than 13,000 women per year in the United States, genetic factors like the BRCA gene mutations are well described.

Other risk factors, like early menarche and nulliparity, are difficult to modify. The only slam-dunk environmental toxin to be linked to ovarian cancer is asbestos. Still, the vast majority of women who develop ovarian cancer do not have a known high-risk gene or asbestos exposure, so other triggers may be out there. How do we find them? The answer may just be good old-fashioned epidemiology.

When you’re looking for a new culprit agent that causes a relatively rare disease, the case-control study design is your best friend.

That’s just what researchers, led by Anita Koushik at the University of Montreal, did in a new study appearing in the journal Occupational and Environmental Medicine.

They identified 497 women in Montreal who had recently been diagnosed with ovarian cancer. They then matched those women to 897 women without ovarian cancer, based on age and address. (This approach would not work well in the United States, as diagnosis of ovarian cancer might depend on access to medical care, which is not universal here. In Canada, however, it’s safer to assume that anyone who could have gotten ovarian cancer in Montreal would have been detected.)

Cases and controls identified, the researchers took a detailed occupational history for each participant: every job they ever worked, and when, and for how long. Each occupation was mapped to a standardized set of industries and, interestingly, to a set of environmental exposures ranging from cosmetic talc to cooking fumes to cotton dust, in what is known as a job-exposure matrix. Of course, they also collected data on other ovarian cancer risk factors.

Dr. F. Perry Wilson

Dr. F. Perry Wilson

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale University’s Clinical and Translational Research Accelerator in New Haven, Conn. He reported no conflicts of interest.

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

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study.

Basically, all cancers are caused by a mix of genetic and environmental factors, with some cancers driven more strongly by one or the other. When it comes to ovarian cancer, which kills more than 13,000 women per year in the United States, genetic factors like the BRCA gene mutations are well described.

Other risk factors, like early menarche and nulliparity, are difficult to modify. The only slam-dunk environmental toxin to be linked to ovarian cancer is asbestos. Still, the vast majority of women who develop ovarian cancer do not have a known high-risk gene or asbestos exposure, so other triggers may be out there. How do we find them? The answer may just be good old-fashioned epidemiology.

When you’re looking for a new culprit agent that causes a relatively rare disease, the case-control study design is your best friend.

That’s just what researchers, led by Anita Koushik at the University of Montreal, did in a new study appearing in the journal Occupational and Environmental Medicine.

They identified 497 women in Montreal who had recently been diagnosed with ovarian cancer. They then matched those women to 897 women without ovarian cancer, based on age and address. (This approach would not work well in the United States, as diagnosis of ovarian cancer might depend on access to medical care, which is not universal here. In Canada, however, it’s safer to assume that anyone who could have gotten ovarian cancer in Montreal would have been detected.)

Cases and controls identified, the researchers took a detailed occupational history for each participant: every job they ever worked, and when, and for how long. Each occupation was mapped to a standardized set of industries and, interestingly, to a set of environmental exposures ranging from cosmetic talc to cooking fumes to cotton dust, in what is known as a job-exposure matrix. Of course, they also collected data on other ovarian cancer risk factors.

Dr. F. Perry Wilson

Dr. F. Perry Wilson

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale University’s Clinical and Translational Research Accelerator in New Haven, Conn. He reported no conflicts of interest.

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

Well-demarcated symmetrical scaly plaques and dactylitis are consistent with psoriasis and psoriatic arthritis (PsA). Even in the absence of significant skin disease, a patient like this should be evaluated by Rheumatology for initiation of disease-modifying antirheumatic drugs (DMARDs).

Psoriatic arthritis manifests as a peripheral arthritis affecting the small joints of the wrists and hands, pain at the insertion of tendons and ligaments (enthesitis), or as axial arthritis. This variable presentation and the lack of specific serological marker can make diagnosis challenging. Associated symptoms beyond the musculoskeletal system include uveitis, inflammatory bowel disease, and cutaneous psoriasis.¹ In contrast to osteoarthritis, PsA symptoms are often worse in the morning and improve over the course of the day. Patients with a history of psoriasis on the skin have about a 10% chance of developing PsA, with increased rates in patients who have more widespread plaques and patients with psoriasis at a young age.² Although not pathognomonic for PsA, pitting of the fingernails may reflect episodic enthesitis in the extensor tendons of the fingers.³ Radiographs of the hands in severe cases may demonstrate narrowing of the proximal portion of the distal or proximal interphalangeal joints with a cup-like concavity of the distal half of the joint.

Conventional DMARDs (such as methotrexate and azathioprine) and biologic DMARDs (including TNF-alpha inhibitors, IL-17 inhibitors, IL-23 inhibitors) are first-line treatments and can stop or slow the progression of disease but will not reverse existing damage. For this reason, it is important to promptly start DMARD therapy after the diagnosis has been established.⁴

This patient was initiated on adalimumab 40 mg subcutaneously every other week. Her pain improved after 2 months of therapy and her skin plaques almost entirely resolved at 6 months.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

Well-demarcated symmetrical scaly plaques and dactylitis are consistent with psoriasis and psoriatic arthritis (PsA). Even in the absence of significant skin disease, a patient like this should be evaluated by Rheumatology for initiation of disease-modifying antirheumatic drugs (DMARDs).

Psoriatic arthritis manifests as a peripheral arthritis affecting the small joints of the wrists and hands, pain at the insertion of tendons and ligaments (enthesitis), or as axial arthritis. This variable presentation and the lack of specific serological marker can make diagnosis challenging. Associated symptoms beyond the musculoskeletal system include uveitis, inflammatory bowel disease, and cutaneous psoriasis.¹ In contrast to osteoarthritis, PsA symptoms are often worse in the morning and improve over the course of the day. Patients with a history of psoriasis on the skin have about a 10% chance of developing PsA, with increased rates in patients who have more widespread plaques and patients with psoriasis at a young age.² Although not pathognomonic for PsA, pitting of the fingernails may reflect episodic enthesitis in the extensor tendons of the fingers.³ Radiographs of the hands in severe cases may demonstrate narrowing of the proximal portion of the distal or proximal interphalangeal joints with a cup-like concavity of the distal half of the joint.

Conventional DMARDs (such as methotrexate and azathioprine) and biologic DMARDs (including TNF-alpha inhibitors, IL-17 inhibitors, IL-23 inhibitors) are first-line treatments and can stop or slow the progression of disease but will not reverse existing damage. For this reason, it is important to promptly start DMARD therapy after the diagnosis has been established.⁴

This patient was initiated on adalimumab 40 mg subcutaneously every other week. Her pain improved after 2 months of therapy and her skin plaques almost entirely resolved at 6 months.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

Well-demarcated symmetrical scaly plaques and dactylitis are consistent with psoriasis and psoriatic arthritis (PsA). Even in the absence of significant skin disease, a patient like this should be evaluated by Rheumatology for initiation of disease-modifying antirheumatic drugs (DMARDs).

Psoriatic arthritis manifests as a peripheral arthritis affecting the small joints of the wrists and hands, pain at the insertion of tendons and ligaments (enthesitis), or as axial arthritis. This variable presentation and the lack of specific serological marker can make diagnosis challenging. Associated symptoms beyond the musculoskeletal system include uveitis, inflammatory bowel disease, and cutaneous psoriasis.¹ In contrast to osteoarthritis, PsA symptoms are often worse in the morning and improve over the course of the day. Patients with a history of psoriasis on the skin have about a 10% chance of developing PsA, with increased rates in patients who have more widespread plaques and patients with psoriasis at a young age.² Although not pathognomonic for PsA, pitting of the fingernails may reflect episodic enthesitis in the extensor tendons of the fingers.³ Radiographs of the hands in severe cases may demonstrate narrowing of the proximal portion of the distal or proximal interphalangeal joints with a cup-like concavity of the distal half of the joint.

Conventional DMARDs (such as methotrexate and azathioprine) and biologic DMARDs (including TNF-alpha inhibitors, IL-17 inhibitors, IL-23 inhibitors) are first-line treatments and can stop or slow the progression of disease but will not reverse existing damage. For this reason, it is important to promptly start DMARD therapy after the diagnosis has been established.⁴

This patient was initiated on adalimumab 40 mg subcutaneously every other week. Her pain improved after 2 months of therapy and her skin plaques almost entirely resolved at 6 months.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

ILLUSTRATION: PAUL ZWOLAK

“If you don’t have a seat at the table, you are probably on the menu.” I first heard this quote in 2013, and it launched my interest in health care leadership and influenced me countless times over the last 10 years.

As Chief of Staff at Cleveland Clinic, I oversee nearly 5,000 physicians and scientists across the globe. I am involved in the physician life cycle: recruiting, hiring, privileging and credentialing, talent development, promotion, professionalism, and career transitions. I also sit at the intersection of medical care and the business of medicine. This means leading 18 clinical service lines responsible for 5.6 million visits, 161,000 surgeries, and billions of dollars in operating revenue per year. How I spend most of my time is a far cry from what I spent 11 years’ training to do—gynecologic surgery. This shift in my career was not because I changed my mind about caring for patients or that I tired of being a full-time surgeon. Nothing could be further from the truth. Women’s health remains my “why,” and my leadership journey has taught me that it is critical to have a seat at the table for the sake of ObGyns and women everywhere.

Women’s health on the menu

I will start with a concrete example of when we, as women and ObGyns, were on the menu. In late 2019, the Ohio state House of Representatives introduced a bill that subjected doctors to potential murder charges if they did not try everything to save the life of a mother and fetus, “including attempting to reimplant an ectopic pregnancy into the woman’s uterus.”¹ This bill was based on 2 case reports—one from 1915 and one from 1980—which were both low quality, and the latter case was deemed to be fraudulent.² How did this happen?

An Ohio state representative developed the bill with help from a lobbyist and without input from physicians or content experts. When asked, the representative shared that “he never researched whether re-implanting an ectopic pregnancy into a woman’s uterus was a viable medical procedure before including it in the bill.”³ He added, “I heard about it over the years. I never questioned it or gave it a lot of thought.”³

This example resonates deeply with many of us; it inspires us to speak up and act. As ObGyns, we clearly understand the consequences of legal and regulatory change in women’s health and how it directly impacts our patients and each of us as physicians. Let’s shift to something that you may feel less passion about, but I believe is equally important. This is where obstetrician-gynecologists sit in the intersection of medical care and business. This is the space where I spend most of my time, and from this vantage point, I worry about our field.

The business of medicine

Starting at the macroeconomic level, let’s think about how we as physicians are reimbursed and who makes these decisions. Looking at the national health care expenditure data, Medicare and Medicaid spending makes up nearly 40% of the total spend, and it is growing.⁴ Additionally, private health insurance tends to follow Centers for Medicare and Medicaid Services (CMS) decision making, further compounding its influence.⁴ In simple terms, CMS decides what is covered and how much we are paid. Whether you are in a solo private practice, an employer health care organization, or an academic medical center, physician reimbursement is declining.

In fact, Congress passed its year-end omnibus legislation in the final days of 2022, including a 2% Medicare physician payment cut for 2023,⁵ at a time when expenses to practice medicine, including nonphysician staff and supplies, are at an all-time high and we are living in a 6% inflationary state. This translates into being asked to serve more patients and cut costs. Our day-to-day feels much tighter, and this is why: Medicare physician pay increased just 11% over the past 20 years⁶ (2001–2021) in comparison to the cost of running a medical practice, which increased nearly 40% during that time. In other words, adjusting for inflation in practice costs, Medicare physician payment has fallen 22% over the last 20 years.⁷

Depending on your employment model, you may feel insulated from these changes as increases in reimbursement have occurred in other areas, such as hospitals and ambulatory surgery centers.⁸ In the short term, these increases help, as organizations will see additional funds. But there are 2 main issues: First, it is not nearly enough when you consider the soaring costs of running a hospital. And second, looking at our national population, we rely tremendously on self-employed doctors to serve our patients.

More than 80% of US counties lack adequate health care infrastructure.⁹ More than a third of the US population has less-than-adequate access to pharmacies, primary care physicians, hospitals, trauma centers, and low-cost health centers.⁹ To put things into perspective, more than 20% of counties in the United States are hospital deserts, where most people must drive more than 30 minutes to reach the closest hospital.⁹

There is good reason for this. Operating a hospital is a challenging endeavor. Even before the COVID-19 pandemic and the most recent health care financial challenges, most health care systems and large hospitals operated with very low operating margins (2%–3%). Businesses with similar margins include grocery stores and car dealerships. These low-margin businesses, including health care, rely on high volume for sustainability. High patient volumes distribute expensive hospital costs over many encounters. If physicians cannot sustain practices across the country, it is challenging to have sufficient admission and surgical volumes to justify the cost base of hospitals.

To tie this together, we have very little influence on what we are paid for our services. Reimbursement is declining, which makes it hard to have financially sustainable practices. As hospitals struggle, there is more pressure to prioritize highly profitable service lines, like orthopedics and urology, which are associated with favorable technical revenue. As hospitals are threatened, health care deserts widen, which leaves our entire health care system in jeopardy. Not surprisingly, this most likely affects those who face additional barriers to access, such as those with lower income, limited internet access, and lack of insurance. Together, these barriers further widen disparities in health care outcomes, including outcomes for women. Additionally, this death by a thousand cuts has eroded morale and increased physician burnout.

Transforming how we practice medicine is the only viable solution. I have good news: You are the leaders you have been waiting for.

Continue to: Physicians make good managers...

Physicians make good managers

To successfully transform how we practice medicine, it is critical that those leading the transformation deeply understand how medicine is practiced. The level of understanding required can be achieved only through years of medical practice, as a doctor. We understand how medical teams interact and that different sectors of our health care system are interdependent. Also, because physicians drive patient activity and ultimately reimbursement, having a seat at the table is crucial.

Some health care systems are run by businesspeople—people with finance backgrounds—and others are led by physicians. In 2017, Becker’s Hospital Review listed the chief executive officers (CEOs) of 183 nonprofit hospital and health systems.¹⁰ Of these, only 25% were led by individuals with an MD. Looking at the 115 largest hospitals in the United States, 30% are physician led.¹⁰ Considering the top 10 hospitals ranked by U.S. News & World Report for 2022, 8 of 10 have a physician at the helm.

Beyond raters and rankers, physician-led hospitals do better. Goodall compared CEOs in the top 100 best hospitals in U.S. News & World Report in 3 key medical specialties: cancer, digestive disorders, and cardiac care.¹¹ The study explored the question: “Are hospitals’ quality ranked more highly when they are led by a medically trained doctor or non-MD professional managers?”¹¹ Analysis revealed that hospital quality scores are about 25% higher in physician-run hospitals than in manager-run hospitals.¹¹ Additional research shows that good management practices correlate with hospital performance, and that “the proportion of managers with a clinical degree has the largest positive effect.”¹²

Several theories exist as to why doctors make good managers in the health care setting.^13,14 Doctors may create a more sympathetic and productive work environment for other clinicians because they are one of them. They have peer-to-peer credibility—because they have walked the walk, they have insight and perspective into how medicine is practiced.

Physicians serve as effective change agents for their organizations in several ways:

• First, physicians take a clinical approach in their leadership roles¹³ and focus on patient care at the center of their decisions. We see the people behind the numbers. Simply put, we humanize the operational side of health care.
• As physicians, we understand the interconnectivity in the practice of medicine. While closing certain service lines may be financially beneficial, these services are often closely linked to profitable service lines.
• Beyond physicians taking a clinical approach to leadership, we emphasize quality.¹³ Because we all have experienced complications and lived through bad outcomes alongside our patients, we understand deeply how important patient safety and quality is, and we are not willing to sacrifice that for financial gain. For us, this is personal. We don’t see our solution to health care challenges as an “or” situation, instead we view it as an “and” situation.
• Physician leaders often can improve medical staff engagement.¹³ A 2018 national survey of physicians found that those who are satisfied with their leadership are more engaged at work, have greater job satisfaction, and are less likely to experience signs of burnout.¹⁵ Physician administrators add value here.

Continue to: Surgeons as leaders...

Surgeons as leaders

What do we know about surgeons as physician leaders? Looking at the previously mentioned lists of physician leaders, surgeons are relatively absent. In the Becker’s Hospital Review study of nonprofit hospitals, only 9% of CEOs were surgeons.¹⁰ In addition, when reviewing data that associated physician leaders and hospital performance, only 3 of the CEOs were surgeons.¹¹ Given that surgeons make up approximately 19% of US physicians, we are underrepresented.

The omission of surgeons as leaders seems inappropriate given that most hospitals are financially reliant on revenue related to surgical care and optimizing this space is an enormous opportunity. Berger and colleagues offered 3 theories as to why there are fewer surgeon leaders¹⁶:

• The relative pay of surgeons exceeds that of most other specialties, and there may be less incentive to accept the challenges presented by leadership roles. (I will add that surgeon leadership is more costly to a system.)
• The craftsmanship nature of surgery discourages the development of other career interests beginning at the trainee level.
• Surgeons have been perceived stereotypically to exhibit arrogance, a characteristic that others may not warm to.

This last observation stings. Successful leadership takes social skill and teamwork.¹⁴ Although medical care is one of the few disciplines in which lack of teamwork might cost lives, physicians are not trained to be team players. We recognize how our training has led us to be lone wolves or gunners, situations where we as individuals had to beat others to secure our spot. We have been trained in command-and-control environments, in stepping up as a leader in highly stressful situations. This part of surgical culture may handicap surgeons in their quest to be health care leaders.

Other traits, however, make us particularly great leaders in health care. Our desire to succeed, willingness to push ourselves to extremes, ability to laser focus on a task, acceptance of delayed gratification, and aptitude for making timely decisions on limited data help us succeed in leadership roles. Seven years of surgical training helped me develop the grit I use every day in the C-suite.

We need more physician and surgeon leadership to thrive in the challenging health care landscape. Berger and colleagues proposed 3 potential solutions to increase the number of surgeons in hospital leadership positions¹⁶:

Nurture future surgical leaders through exposure to management training. Given the contribution to both expense in support services and resources and revenue related to surgical care, each organization needs a content expert to guide these decisions.

Recognize the important contributions that surgeons already make regarding quality, safety, and operational efficiency. An excellent example of this is the American College of Surgeons National Surgical Quality Improvement Program. Because surgeons are content experts in this area, we are primed to lead.

Hospitals, medical schools, and academic departments of surgery should recognize administrative efforts as an important part of the overall academic mission. As the adage states, “No margin, no mission.” We need bright minds to preserve and grow our margins so that we can further invest in our missions.

This is not easy. Given the barriers, this will not happen organically. Charan and colleagues provided an outline for a leadership pathway adapted for physicians (FIGURE).^17,18 It starts with the individual practitioner who is a practicing physician and spends most of their time focused on patient care. As a physician becomes more interested in leadership, they develop new skills and take on more and more responsibility. As they increase in leadership responsibility, they tend to reduce clinical time and increase time spent on strategic and business management. This framework creates a pipeline so that physicians and surgeons can be developed strategically and given increasing responsibility as they develop their capabilities and expand their skill sets.

The leadership challenge

To thrive, we must transform health care by changing how we practice medicine. As ObGyns, we are the leaders we have been waiting for. As you ponder your future, think of your current career and the opportunities you might have. Do you have a seat at the table? What table is that? How are you using your knowledge, expertise, and privilege to advance health care and medicine? I challenge you to critically evaluate this—and lead. ●

ILLUSTRATION: PAUL ZWOLAK

“If you don’t have a seat at the table, you are probably on the menu.” I first heard this quote in 2013, and it launched my interest in health care leadership and influenced me countless times over the last 10 years.

As Chief of Staff at Cleveland Clinic, I oversee nearly 5,000 physicians and scientists across the globe. I am involved in the physician life cycle: recruiting, hiring, privileging and credentialing, talent development, promotion, professionalism, and career transitions. I also sit at the intersection of medical care and the business of medicine. This means leading 18 clinical service lines responsible for 5.6 million visits, 161,000 surgeries, and billions of dollars in operating revenue per year. How I spend most of my time is a far cry from what I spent 11 years’ training to do—gynecologic surgery. This shift in my career was not because I changed my mind about caring for patients or that I tired of being a full-time surgeon. Nothing could be further from the truth. Women’s health remains my “why,” and my leadership journey has taught me that it is critical to have a seat at the table for the sake of ObGyns and women everywhere.

Women’s health on the menu

I will start with a concrete example of when we, as women and ObGyns, were on the menu. In late 2019, the Ohio state House of Representatives introduced a bill that subjected doctors to potential murder charges if they did not try everything to save the life of a mother and fetus, “including attempting to reimplant an ectopic pregnancy into the woman’s uterus.”¹ This bill was based on 2 case reports—one from 1915 and one from 1980—which were both low quality, and the latter case was deemed to be fraudulent.² How did this happen?

An Ohio state representative developed the bill with help from a lobbyist and without input from physicians or content experts. When asked, the representative shared that “he never researched whether re-implanting an ectopic pregnancy into a woman’s uterus was a viable medical procedure before including it in the bill.”³ He added, “I heard about it over the years. I never questioned it or gave it a lot of thought.”³

This example resonates deeply with many of us; it inspires us to speak up and act. As ObGyns, we clearly understand the consequences of legal and regulatory change in women’s health and how it directly impacts our patients and each of us as physicians. Let’s shift to something that you may feel less passion about, but I believe is equally important. This is where obstetrician-gynecologists sit in the intersection of medical care and business. This is the space where I spend most of my time, and from this vantage point, I worry about our field.

The business of medicine

Starting at the macroeconomic level, let’s think about how we as physicians are reimbursed and who makes these decisions. Looking at the national health care expenditure data, Medicare and Medicaid spending makes up nearly 40% of the total spend, and it is growing.⁴ Additionally, private health insurance tends to follow Centers for Medicare and Medicaid Services (CMS) decision making, further compounding its influence.⁴ In simple terms, CMS decides what is covered and how much we are paid. Whether you are in a solo private practice, an employer health care organization, or an academic medical center, physician reimbursement is declining.

In fact, Congress passed its year-end omnibus legislation in the final days of 2022, including a 2% Medicare physician payment cut for 2023,⁵ at a time when expenses to practice medicine, including nonphysician staff and supplies, are at an all-time high and we are living in a 6% inflationary state. This translates into being asked to serve more patients and cut costs. Our day-to-day feels much tighter, and this is why: Medicare physician pay increased just 11% over the past 20 years⁶ (2001–2021) in comparison to the cost of running a medical practice, which increased nearly 40% during that time. In other words, adjusting for inflation in practice costs, Medicare physician payment has fallen 22% over the last 20 years.⁷

Depending on your employment model, you may feel insulated from these changes as increases in reimbursement have occurred in other areas, such as hospitals and ambulatory surgery centers.⁸ In the short term, these increases help, as organizations will see additional funds. But there are 2 main issues: First, it is not nearly enough when you consider the soaring costs of running a hospital. And second, looking at our national population, we rely tremendously on self-employed doctors to serve our patients.

More than 80% of US counties lack adequate health care infrastructure.⁹ More than a third of the US population has less-than-adequate access to pharmacies, primary care physicians, hospitals, trauma centers, and low-cost health centers.⁹ To put things into perspective, more than 20% of counties in the United States are hospital deserts, where most people must drive more than 30 minutes to reach the closest hospital.⁹

There is good reason for this. Operating a hospital is a challenging endeavor. Even before the COVID-19 pandemic and the most recent health care financial challenges, most health care systems and large hospitals operated with very low operating margins (2%–3%). Businesses with similar margins include grocery stores and car dealerships. These low-margin businesses, including health care, rely on high volume for sustainability. High patient volumes distribute expensive hospital costs over many encounters. If physicians cannot sustain practices across the country, it is challenging to have sufficient admission and surgical volumes to justify the cost base of hospitals.

To tie this together, we have very little influence on what we are paid for our services. Reimbursement is declining, which makes it hard to have financially sustainable practices. As hospitals struggle, there is more pressure to prioritize highly profitable service lines, like orthopedics and urology, which are associated with favorable technical revenue. As hospitals are threatened, health care deserts widen, which leaves our entire health care system in jeopardy. Not surprisingly, this most likely affects those who face additional barriers to access, such as those with lower income, limited internet access, and lack of insurance. Together, these barriers further widen disparities in health care outcomes, including outcomes for women. Additionally, this death by a thousand cuts has eroded morale and increased physician burnout.

Transforming how we practice medicine is the only viable solution. I have good news: You are the leaders you have been waiting for.

Continue to: Physicians make good managers...

Physicians make good managers

To successfully transform how we practice medicine, it is critical that those leading the transformation deeply understand how medicine is practiced. The level of understanding required can be achieved only through years of medical practice, as a doctor. We understand how medical teams interact and that different sectors of our health care system are interdependent. Also, because physicians drive patient activity and ultimately reimbursement, having a seat at the table is crucial.

Some health care systems are run by businesspeople—people with finance backgrounds—and others are led by physicians. In 2017, Becker’s Hospital Review listed the chief executive officers (CEOs) of 183 nonprofit hospital and health systems.¹⁰ Of these, only 25% were led by individuals with an MD. Looking at the 115 largest hospitals in the United States, 30% are physician led.¹⁰ Considering the top 10 hospitals ranked by U.S. News & World Report for 2022, 8 of 10 have a physician at the helm.

Beyond raters and rankers, physician-led hospitals do better. Goodall compared CEOs in the top 100 best hospitals in U.S. News & World Report in 3 key medical specialties: cancer, digestive disorders, and cardiac care.¹¹ The study explored the question: “Are hospitals’ quality ranked more highly when they are led by a medically trained doctor or non-MD professional managers?”¹¹ Analysis revealed that hospital quality scores are about 25% higher in physician-run hospitals than in manager-run hospitals.¹¹ Additional research shows that good management practices correlate with hospital performance, and that “the proportion of managers with a clinical degree has the largest positive effect.”¹²

Several theories exist as to why doctors make good managers in the health care setting.^13,14 Doctors may create a more sympathetic and productive work environment for other clinicians because they are one of them. They have peer-to-peer credibility—because they have walked the walk, they have insight and perspective into how medicine is practiced.

Physicians serve as effective change agents for their organizations in several ways:

• First, physicians take a clinical approach in their leadership roles¹³ and focus on patient care at the center of their decisions. We see the people behind the numbers. Simply put, we humanize the operational side of health care.
• As physicians, we understand the interconnectivity in the practice of medicine. While closing certain service lines may be financially beneficial, these services are often closely linked to profitable service lines.
• Beyond physicians taking a clinical approach to leadership, we emphasize quality.¹³ Because we all have experienced complications and lived through bad outcomes alongside our patients, we understand deeply how important patient safety and quality is, and we are not willing to sacrifice that for financial gain. For us, this is personal. We don’t see our solution to health care challenges as an “or” situation, instead we view it as an “and” situation.
• Physician leaders often can improve medical staff engagement.¹³ A 2018 national survey of physicians found that those who are satisfied with their leadership are more engaged at work, have greater job satisfaction, and are less likely to experience signs of burnout.¹⁵ Physician administrators add value here.

Continue to: Surgeons as leaders...

Surgeons as leaders

What do we know about surgeons as physician leaders? Looking at the previously mentioned lists of physician leaders, surgeons are relatively absent. In the Becker’s Hospital Review study of nonprofit hospitals, only 9% of CEOs were surgeons.¹⁰ In addition, when reviewing data that associated physician leaders and hospital performance, only 3 of the CEOs were surgeons.¹¹ Given that surgeons make up approximately 19% of US physicians, we are underrepresented.

The omission of surgeons as leaders seems inappropriate given that most hospitals are financially reliant on revenue related to surgical care and optimizing this space is an enormous opportunity. Berger and colleagues offered 3 theories as to why there are fewer surgeon leaders¹⁶:

• The relative pay of surgeons exceeds that of most other specialties, and there may be less incentive to accept the challenges presented by leadership roles. (I will add that surgeon leadership is more costly to a system.)
• The craftsmanship nature of surgery discourages the development of other career interests beginning at the trainee level.
• Surgeons have been perceived stereotypically to exhibit arrogance, a characteristic that others may not warm to.

This last observation stings. Successful leadership takes social skill and teamwork.¹⁴ Although medical care is one of the few disciplines in which lack of teamwork might cost lives, physicians are not trained to be team players. We recognize how our training has led us to be lone wolves or gunners, situations where we as individuals had to beat others to secure our spot. We have been trained in command-and-control environments, in stepping up as a leader in highly stressful situations. This part of surgical culture may handicap surgeons in their quest to be health care leaders.

Other traits, however, make us particularly great leaders in health care. Our desire to succeed, willingness to push ourselves to extremes, ability to laser focus on a task, acceptance of delayed gratification, and aptitude for making timely decisions on limited data help us succeed in leadership roles. Seven years of surgical training helped me develop the grit I use every day in the C-suite.

We need more physician and surgeon leadership to thrive in the challenging health care landscape. Berger and colleagues proposed 3 potential solutions to increase the number of surgeons in hospital leadership positions¹⁶:

Nurture future surgical leaders through exposure to management training. Given the contribution to both expense in support services and resources and revenue related to surgical care, each organization needs a content expert to guide these decisions.

Recognize the important contributions that surgeons already make regarding quality, safety, and operational efficiency. An excellent example of this is the American College of Surgeons National Surgical Quality Improvement Program. Because surgeons are content experts in this area, we are primed to lead.

Hospitals, medical schools, and academic departments of surgery should recognize administrative efforts as an important part of the overall academic mission. As the adage states, “No margin, no mission.” We need bright minds to preserve and grow our margins so that we can further invest in our missions.

This is not easy. Given the barriers, this will not happen organically. Charan and colleagues provided an outline for a leadership pathway adapted for physicians (FIGURE).^17,18 It starts with the individual practitioner who is a practicing physician and spends most of their time focused on patient care. As a physician becomes more interested in leadership, they develop new skills and take on more and more responsibility. As they increase in leadership responsibility, they tend to reduce clinical time and increase time spent on strategic and business management. This framework creates a pipeline so that physicians and surgeons can be developed strategically and given increasing responsibility as they develop their capabilities and expand their skill sets.

The leadership challenge

To thrive, we must transform health care by changing how we practice medicine. As ObGyns, we are the leaders we have been waiting for. As you ponder your future, think of your current career and the opportunities you might have. Do you have a seat at the table? What table is that? How are you using your knowledge, expertise, and privilege to advance health care and medicine? I challenge you to critically evaluate this—and lead. ●

ILLUSTRATION: PAUL ZWOLAK

“If you don’t have a seat at the table, you are probably on the menu.” I first heard this quote in 2013, and it launched my interest in health care leadership and influenced me countless times over the last 10 years.

As Chief of Staff at Cleveland Clinic, I oversee nearly 5,000 physicians and scientists across the globe. I am involved in the physician life cycle: recruiting, hiring, privileging and credentialing, talent development, promotion, professionalism, and career transitions. I also sit at the intersection of medical care and the business of medicine. This means leading 18 clinical service lines responsible for 5.6 million visits, 161,000 surgeries, and billions of dollars in operating revenue per year. How I spend most of my time is a far cry from what I spent 11 years’ training to do—gynecologic surgery. This shift in my career was not because I changed my mind about caring for patients or that I tired of being a full-time surgeon. Nothing could be further from the truth. Women’s health remains my “why,” and my leadership journey has taught me that it is critical to have a seat at the table for the sake of ObGyns and women everywhere.

Women’s health on the menu

I will start with a concrete example of when we, as women and ObGyns, were on the menu. In late 2019, the Ohio state House of Representatives introduced a bill that subjected doctors to potential murder charges if they did not try everything to save the life of a mother and fetus, “including attempting to reimplant an ectopic pregnancy into the woman’s uterus.”¹ This bill was based on 2 case reports—one from 1915 and one from 1980—which were both low quality, and the latter case was deemed to be fraudulent.² How did this happen?

An Ohio state representative developed the bill with help from a lobbyist and without input from physicians or content experts. When asked, the representative shared that “he never researched whether re-implanting an ectopic pregnancy into a woman’s uterus was a viable medical procedure before including it in the bill.”³ He added, “I heard about it over the years. I never questioned it or gave it a lot of thought.”³

This example resonates deeply with many of us; it inspires us to speak up and act. As ObGyns, we clearly understand the consequences of legal and regulatory change in women’s health and how it directly impacts our patients and each of us as physicians. Let’s shift to something that you may feel less passion about, but I believe is equally important. This is where obstetrician-gynecologists sit in the intersection of medical care and business. This is the space where I spend most of my time, and from this vantage point, I worry about our field.

The business of medicine

Starting at the macroeconomic level, let’s think about how we as physicians are reimbursed and who makes these decisions. Looking at the national health care expenditure data, Medicare and Medicaid spending makes up nearly 40% of the total spend, and it is growing.⁴ Additionally, private health insurance tends to follow Centers for Medicare and Medicaid Services (CMS) decision making, further compounding its influence.⁴ In simple terms, CMS decides what is covered and how much we are paid. Whether you are in a solo private practice, an employer health care organization, or an academic medical center, physician reimbursement is declining.

In fact, Congress passed its year-end omnibus legislation in the final days of 2022, including a 2% Medicare physician payment cut for 2023,⁵ at a time when expenses to practice medicine, including nonphysician staff and supplies, are at an all-time high and we are living in a 6% inflationary state. This translates into being asked to serve more patients and cut costs. Our day-to-day feels much tighter, and this is why: Medicare physician pay increased just 11% over the past 20 years⁶ (2001–2021) in comparison to the cost of running a medical practice, which increased nearly 40% during that time. In other words, adjusting for inflation in practice costs, Medicare physician payment has fallen 22% over the last 20 years.⁷

Depending on your employment model, you may feel insulated from these changes as increases in reimbursement have occurred in other areas, such as hospitals and ambulatory surgery centers.⁸ In the short term, these increases help, as organizations will see additional funds. But there are 2 main issues: First, it is not nearly enough when you consider the soaring costs of running a hospital. And second, looking at our national population, we rely tremendously on self-employed doctors to serve our patients.

More than 80% of US counties lack adequate health care infrastructure.⁹ More than a third of the US population has less-than-adequate access to pharmacies, primary care physicians, hospitals, trauma centers, and low-cost health centers.⁹ To put things into perspective, more than 20% of counties in the United States are hospital deserts, where most people must drive more than 30 minutes to reach the closest hospital.⁹

There is good reason for this. Operating a hospital is a challenging endeavor. Even before the COVID-19 pandemic and the most recent health care financial challenges, most health care systems and large hospitals operated with very low operating margins (2%–3%). Businesses with similar margins include grocery stores and car dealerships. These low-margin businesses, including health care, rely on high volume for sustainability. High patient volumes distribute expensive hospital costs over many encounters. If physicians cannot sustain practices across the country, it is challenging to have sufficient admission and surgical volumes to justify the cost base of hospitals.

To tie this together, we have very little influence on what we are paid for our services. Reimbursement is declining, which makes it hard to have financially sustainable practices. As hospitals struggle, there is more pressure to prioritize highly profitable service lines, like orthopedics and urology, which are associated with favorable technical revenue. As hospitals are threatened, health care deserts widen, which leaves our entire health care system in jeopardy. Not surprisingly, this most likely affects those who face additional barriers to access, such as those with lower income, limited internet access, and lack of insurance. Together, these barriers further widen disparities in health care outcomes, including outcomes for women. Additionally, this death by a thousand cuts has eroded morale and increased physician burnout.

Transforming how we practice medicine is the only viable solution. I have good news: You are the leaders you have been waiting for.

Continue to: Physicians make good managers...

Physicians make good managers

To successfully transform how we practice medicine, it is critical that those leading the transformation deeply understand how medicine is practiced. The level of understanding required can be achieved only through years of medical practice, as a doctor. We understand how medical teams interact and that different sectors of our health care system are interdependent. Also, because physicians drive patient activity and ultimately reimbursement, having a seat at the table is crucial.

Some health care systems are run by businesspeople—people with finance backgrounds—and others are led by physicians. In 2017, Becker’s Hospital Review listed the chief executive officers (CEOs) of 183 nonprofit hospital and health systems.¹⁰ Of these, only 25% were led by individuals with an MD. Looking at the 115 largest hospitals in the United States, 30% are physician led.¹⁰ Considering the top 10 hospitals ranked by U.S. News & World Report for 2022, 8 of 10 have a physician at the helm.

Beyond raters and rankers, physician-led hospitals do better. Goodall compared CEOs in the top 100 best hospitals in U.S. News & World Report in 3 key medical specialties: cancer, digestive disorders, and cardiac care.¹¹ The study explored the question: “Are hospitals’ quality ranked more highly when they are led by a medically trained doctor or non-MD professional managers?”¹¹ Analysis revealed that hospital quality scores are about 25% higher in physician-run hospitals than in manager-run hospitals.¹¹ Additional research shows that good management practices correlate with hospital performance, and that “the proportion of managers with a clinical degree has the largest positive effect.”¹²

Several theories exist as to why doctors make good managers in the health care setting.^13,14 Doctors may create a more sympathetic and productive work environment for other clinicians because they are one of them. They have peer-to-peer credibility—because they have walked the walk, they have insight and perspective into how medicine is practiced.

Physicians serve as effective change agents for their organizations in several ways:

• First, physicians take a clinical approach in their leadership roles¹³ and focus on patient care at the center of their decisions. We see the people behind the numbers. Simply put, we humanize the operational side of health care.
• As physicians, we understand the interconnectivity in the practice of medicine. While closing certain service lines may be financially beneficial, these services are often closely linked to profitable service lines.
• Beyond physicians taking a clinical approach to leadership, we emphasize quality.¹³ Because we all have experienced complications and lived through bad outcomes alongside our patients, we understand deeply how important patient safety and quality is, and we are not willing to sacrifice that for financial gain. For us, this is personal. We don’t see our solution to health care challenges as an “or” situation, instead we view it as an “and” situation.
• Physician leaders often can improve medical staff engagement.¹³ A 2018 national survey of physicians found that those who are satisfied with their leadership are more engaged at work, have greater job satisfaction, and are less likely to experience signs of burnout.¹⁵ Physician administrators add value here.

Continue to: Surgeons as leaders...

Surgeons as leaders

What do we know about surgeons as physician leaders? Looking at the previously mentioned lists of physician leaders, surgeons are relatively absent. In the Becker’s Hospital Review study of nonprofit hospitals, only 9% of CEOs were surgeons.¹⁰ In addition, when reviewing data that associated physician leaders and hospital performance, only 3 of the CEOs were surgeons.¹¹ Given that surgeons make up approximately 19% of US physicians, we are underrepresented.

The omission of surgeons as leaders seems inappropriate given that most hospitals are financially reliant on revenue related to surgical care and optimizing this space is an enormous opportunity. Berger and colleagues offered 3 theories as to why there are fewer surgeon leaders¹⁶:

• The relative pay of surgeons exceeds that of most other specialties, and there may be less incentive to accept the challenges presented by leadership roles. (I will add that surgeon leadership is more costly to a system.)
• The craftsmanship nature of surgery discourages the development of other career interests beginning at the trainee level.
• Surgeons have been perceived stereotypically to exhibit arrogance, a characteristic that others may not warm to.

This last observation stings. Successful leadership takes social skill and teamwork.¹⁴ Although medical care is one of the few disciplines in which lack of teamwork might cost lives, physicians are not trained to be team players. We recognize how our training has led us to be lone wolves or gunners, situations where we as individuals had to beat others to secure our spot. We have been trained in command-and-control environments, in stepping up as a leader in highly stressful situations. This part of surgical culture may handicap surgeons in their quest to be health care leaders.

Other traits, however, make us particularly great leaders in health care. Our desire to succeed, willingness to push ourselves to extremes, ability to laser focus on a task, acceptance of delayed gratification, and aptitude for making timely decisions on limited data help us succeed in leadership roles. Seven years of surgical training helped me develop the grit I use every day in the C-suite.

We need more physician and surgeon leadership to thrive in the challenging health care landscape. Berger and colleagues proposed 3 potential solutions to increase the number of surgeons in hospital leadership positions¹⁶:

Nurture future surgical leaders through exposure to management training. Given the contribution to both expense in support services and resources and revenue related to surgical care, each organization needs a content expert to guide these decisions.

Recognize the important contributions that surgeons already make regarding quality, safety, and operational efficiency. An excellent example of this is the American College of Surgeons National Surgical Quality Improvement Program. Because surgeons are content experts in this area, we are primed to lead.

Hospitals, medical schools, and academic departments of surgery should recognize administrative efforts as an important part of the overall academic mission. As the adage states, “No margin, no mission.” We need bright minds to preserve and grow our margins so that we can further invest in our missions.

This is not easy. Given the barriers, this will not happen organically. Charan and colleagues provided an outline for a leadership pathway adapted for physicians (FIGURE).^17,18 It starts with the individual practitioner who is a practicing physician and spends most of their time focused on patient care. As a physician becomes more interested in leadership, they develop new skills and take on more and more responsibility. As they increase in leadership responsibility, they tend to reduce clinical time and increase time spent on strategic and business management. This framework creates a pipeline so that physicians and surgeons can be developed strategically and given increasing responsibility as they develop their capabilities and expand their skill sets.

The leadership challenge

To thrive, we must transform health care by changing how we practice medicine. As ObGyns, we are the leaders we have been waiting for. As you ponder your future, think of your current career and the opportunities you might have. Do you have a seat at the table? What table is that? How are you using your knowledge, expertise, and privilege to advance health care and medicine? I challenge you to critically evaluate this—and lead. ●

Over the last 3 decades, abundant evidence has demonstrated the association between surgical volume and outcomes. Patients operated on by high-volume surgeons and at high-volume hospitals have superior outcomes.^1,2 This relationship has provided a framework for a number of public health policies to try to align patients with appropriate providers and centers to optimize perioperative outcomes. In this article, we examine the volume-outcomes paradigm for gynecologic surgery and explore how this relationship is influencing patterns of care and policy.

Surgical volume in gynecology

The association between both hospital and surgeon volume and outcomes has been explored across a number of gynecologic procedures.³ A meta-analysis that included 741,000 patients found that low-volume surgeons had an increased rate of complications overall, a higher rate of intraoperative complications, and a higher rate of postoperative complications compared with high-volume surgeons. While there was no association between volume and mortality overall, when limited to gynecologic oncology studies, low surgeon volume was associated with increased perioperative mortality.³

While these studies demonstrated a statistically significant association between surgeon volume and perioperative outcomes, the magnitude of the effect is modest compared with other higher-risk procedures associated with greater perioperative morbidity. For example, in a large study that examined oncologic and cardiovascular surgery, perioperative mortality in patients who underwent pancreatic resection was reduced from 15% for low-volume surgeons to 5% for high-volume surgeons.¹ By contrast, for gynecologic surgery, complications occurred in 97 per 1,000 patients operated on by high-volume surgeons compared with between 114 and 137 per 1,000 for low-volume surgeons. Thus, to avoid 1 in-hospital complication, 30 surgeries performed by low-volume surgeons would need to be moved to high-volume surgeons. For intraoperative complications, 38 patients would need to be moved from low- to high-volume surgeons to prevent 1 such complication.³ In addition to morbidity and mortality, higher surgeon volume is associated with greater use of minimally invasive surgery, a lower likelihood of conversion to laparotomy, and lower costs.³

Continue to: Public health applications of gynecologic surgical volume...

Public health applications of gynecologic surgical volume

The large body of literature on volume and outcomes has led to a number of public health initiatives aimed at reducing perioperative morbidity and mortality. Broadly, these efforts focus on regionalization of care, targeted quality improvement, and the development of minimum volume standards. Each strategy holds promise but also the potential to lead to unwanted consequences.

Regionalization of care

Recognition of the volume-outcomes paradigm has led to efforts to regionalize care for complex procedures to high-volume surgeons and centers.¹⁰ A cohort study of surgical patterns of care for Medicare recipients who underwent cancer resections or abdominal aortic aneurysm repair from 1999 to 2008 demonstrated these shifting practice patterns. For example, in 1999–2000, pancreatectomy was performed in 1,308 hospitals, with a median case volume of 5 procedures per year. By 2007–2008, the number of hospitals in which pancreatectomy was performed declined to 978, and the median case volume rose to 16 procedures per year. Importantly, over this time period, risk-adjusted mortality for pancreatectomy declined by 19%, and increased hospital volume was responsible for more than two-thirds of the decline in mortality.¹⁰

There has similarly been a gradual concentration of some gynecologic procedures to higher-volume surgeons and centers.^11,12 Among patients undergoing hysterectomy for endometrial cancer in New York State, 845 surgeons with a mean case volume of 3 procedures per year treated patients in 2000. By 2014, the number of surgeons who performed these operations declined to 317 while mean annual case volume rose to 10 procedures per year. The number of hospitals in which women with endometrial cancer were treated declined from 182 to 98 over the same time period.¹¹ Similar trends were noted for patients undergoing ovarian cancer resection.¹² While patterns of gynecologic care for some surgical procedures have clearly changed, it has been more difficult to link these changes to improvements in outcomes.^11,12

Despite the intuitive appeal of regionalization of surgical care, such a strategy has a number of limitations and practical challenges. Not surprisingly, limiting the number of surgeons and hospitals that perform a given procedure necessitates that patients travel a greater distance to obtain necessary surgical care.^13,14 An analysis of endometrial cancer patients in New York State stratified patients based on their area of residence into 10 hospital referral regions (HRRs), which represent health care markets for tertiary medical care. From 2000 to 2014, the distance patients traveled to receive their surgical care increased in all of the HRRs studied. This was most pronounced in 1 of the HRRs in which the median travel distance rose by 47 miles over the 15-year period (FIGURE 1; FIGURE 2).¹⁴

Whether patients are willing to travel for care remains a matter of debate and depends on the disease, the surgical procedure, and the anticipated benefit associated with a longer travel distance.^15,16 In a discrete choice experiment, 100 participants were given a hypothetical scenario in which they had potentially resectable pancreatic cancer; they were queried on their willingness to travel for care based on varying differences in mortality between a local and regional hospital.¹⁵ When mortality at the local hospital was double that of the regional hospital (6% vs 3%), 45% of patients chose to remain at the local hospital. When the differential increased to a 4 times greater mortality at the local hospital (12% vs 3%), 23% of patients still chose to remain at the local hospital.¹⁵

Lastly, a number of studies have shown that regionalization of surgical care disproportionately affects Black and Hispanic patients and those with low socioeconomic status.^12,13,17 A simulation study on the effect of regionalizing care for pancreatectomy noted that using a hospital volume threshold of 20 procedures per year, a higher percentage of Black and Hispanic patients than White patients would be required to travel to a higher-volume center.¹³ Similarly, Medicaid recipients were more likely to be affected.¹³ Despite the inequities in who must travel for regionalized care, prior work has suggested that regionalization of cancer care to high-volume centers may reduce racial and socioeconomic disparities in survival for some cancers.¹⁸

Targeted quality improvement

Realizing the practical limitations of regionalization of care, an alternative strategy is to improve the quality of care at low-volume hospitals.^5,19 Quality of care and surgical volume often are correlated, and the delivery of high-quality care can mitigate some of the influence of surgical volume on outcomes.

These principles were demonstrated in a study of more than 100,000 patients with ovarian cancer that stratified treating hospitals into volume quintiles.⁵ As expected, survival (both 2- and 5-year) was highest in the highest-volume quintile hospitals (FIGURE 3).⁵ Similarly, quality of care, measured through adherence to various process measures, was also highest in the highest-volume quintile hospitals. Interestingly, in the second-fourth volume quintile hospitals, there was substantial variation in adherence to quality metrics. Among hospitals with higher quality care, an improved survival was noted compared with lower quality care hospitals within the same volume quintile. Survival at high-quality, intermediate-volume hospitals approached that of the high-volume quintile hospitals.⁵

Continue to: Minimum volume standards...

While efforts to regionalize surgical care have gradually evolved, calls have been growing to formalize policies that limit the performance of some procedures to surgeons and centers that meet a minimum volume threshold or standard.²¹ One such effort, based on consensus from 3 academic hospital systems, was a campaign for hospitals to “Take the Volume Pledge.”²¹ The campaign’s goal is to encourage health care systems to restrict the performance of 10 procedures to surgeons and hospitals within their systems that meet a minimum volume standard for the given operations.²¹ In essence, procedures would be restricted for low-volume providers and centers and triaged to higher-volume surgeons and hospitals within a given health care system.²¹

Proponents of the Volume Pledge argue that it is a relatively straightforward way to align patients and providers to optimize outcomes. The Volume Pledge focuses on larger hospital systems and encourages referral within the given system, thus mitigating competitive and financial concerns about referring patients to outside providers. Those who have argued against the Volume Pledge point out that the volume cut points chosen are somewhat arbitrary, that these policies have the potential to negatively impact rural hospitals and those serving smaller communities, and that quality is a more appropriate metric than volume.²² The Volume Pledge does not include any gynecologic procedures, and to date it has met with only limited success.²³

Perhaps more directly applicable to gynecologic surgeons are ongoing national trends to base hospital credentialing on surgical volume. In essence, individual surgeons must demonstrate that they have performed a minimum number of procedures to obtain or retain privileges.^24,25 While there is strong evidence of the association between volume and outcomes for some complex surgical procedures, linking volume to credentialing has a number of potential pitfalls. Studies of surgical outcomes based on volume represent average performance, and many low-volume providers have better-than-expected outcomes. Volume measures typically represent recent performance; it is difficult to measure the overall experience of individual surgeons. Similarly, surgical outcomes depend on both the surgeon and the system in which the surgeon operates. It is difficult, if not impossible, to account for differences in the environment in which a surgeon works.²⁵

A study of gynecologic surgeons who performed hysterectomy in New York State demonstrates many of the complexities of volume-based credentialing.²⁶ In a cohort of more than55,000 patients who underwent abdominal hysterectomy, there was a strong association between low surgeon volume and a higher-than-expected rate of complications. If one were to consider limiting privileges to even the lowest-volume providers, there would be a significant impact on the surgical workforce. In this cohort, limiting credentialing to the lowest-volume providers, those who performed only 1 abdominal hysterectomy in the prior year would restrict the privileges of 17.5% of the surgeons in the cohort. Further, in this low-volume cohort that performed only 1 abdominal hysterectomy in the prior year, 69% of the surgeons actually had outcomes that were better than predicted.²⁶ These data highlight not only the difficulty of applying averages to individual surgeons but also the profound impact that policy changes could have on the practice of gynecologic surgery.

Volume-outcomes paradigm discussions continue

The association between higher surgeon and hospital procedural volume for gynecologic surgeries and improved outcomes now has been convincingly demonstrated. With this knowledge, over the last decade the patterns of care for patients undergoing gynecologic surgery have clearly shifted, and these operations are now more commonly being performed by a smaller number of physicians and at fewer hospitals.

While efforts to improve quality are clearly important, many policy interventions, such as regionalization of care, have untoward consequences that must be considered. As we move forward, it will be essential to ensure that there is a robust debate among patients, providers, and policymakers on the merits of public health policies based on the volume-outcomes paradigm. ●

Over the last 3 decades, abundant evidence has demonstrated the association between surgical volume and outcomes. Patients operated on by high-volume surgeons and at high-volume hospitals have superior outcomes.^1,2 This relationship has provided a framework for a number of public health policies to try to align patients with appropriate providers and centers to optimize perioperative outcomes. In this article, we examine the volume-outcomes paradigm for gynecologic surgery and explore how this relationship is influencing patterns of care and policy.

Surgical volume in gynecology

The association between both hospital and surgeon volume and outcomes has been explored across a number of gynecologic procedures.³ A meta-analysis that included 741,000 patients found that low-volume surgeons had an increased rate of complications overall, a higher rate of intraoperative complications, and a higher rate of postoperative complications compared with high-volume surgeons. While there was no association between volume and mortality overall, when limited to gynecologic oncology studies, low surgeon volume was associated with increased perioperative mortality.³

While these studies demonstrated a statistically significant association between surgeon volume and perioperative outcomes, the magnitude of the effect is modest compared with other higher-risk procedures associated with greater perioperative morbidity. For example, in a large study that examined oncologic and cardiovascular surgery, perioperative mortality in patients who underwent pancreatic resection was reduced from 15% for low-volume surgeons to 5% for high-volume surgeons.¹ By contrast, for gynecologic surgery, complications occurred in 97 per 1,000 patients operated on by high-volume surgeons compared with between 114 and 137 per 1,000 for low-volume surgeons. Thus, to avoid 1 in-hospital complication, 30 surgeries performed by low-volume surgeons would need to be moved to high-volume surgeons. For intraoperative complications, 38 patients would need to be moved from low- to high-volume surgeons to prevent 1 such complication.³ In addition to morbidity and mortality, higher surgeon volume is associated with greater use of minimally invasive surgery, a lower likelihood of conversion to laparotomy, and lower costs.³

Continue to: Public health applications of gynecologic surgical volume...

Public health applications of gynecologic surgical volume

The large body of literature on volume and outcomes has led to a number of public health initiatives aimed at reducing perioperative morbidity and mortality. Broadly, these efforts focus on regionalization of care, targeted quality improvement, and the development of minimum volume standards. Each strategy holds promise but also the potential to lead to unwanted consequences.

Regionalization of care

Recognition of the volume-outcomes paradigm has led to efforts to regionalize care for complex procedures to high-volume surgeons and centers.¹⁰ A cohort study of surgical patterns of care for Medicare recipients who underwent cancer resections or abdominal aortic aneurysm repair from 1999 to 2008 demonstrated these shifting practice patterns. For example, in 1999–2000, pancreatectomy was performed in 1,308 hospitals, with a median case volume of 5 procedures per year. By 2007–2008, the number of hospitals in which pancreatectomy was performed declined to 978, and the median case volume rose to 16 procedures per year. Importantly, over this time period, risk-adjusted mortality for pancreatectomy declined by 19%, and increased hospital volume was responsible for more than two-thirds of the decline in mortality.¹⁰

There has similarly been a gradual concentration of some gynecologic procedures to higher-volume surgeons and centers.^11,12 Among patients undergoing hysterectomy for endometrial cancer in New York State, 845 surgeons with a mean case volume of 3 procedures per year treated patients in 2000. By 2014, the number of surgeons who performed these operations declined to 317 while mean annual case volume rose to 10 procedures per year. The number of hospitals in which women with endometrial cancer were treated declined from 182 to 98 over the same time period.¹¹ Similar trends were noted for patients undergoing ovarian cancer resection.¹² While patterns of gynecologic care for some surgical procedures have clearly changed, it has been more difficult to link these changes to improvements in outcomes.^11,12

Despite the intuitive appeal of regionalization of surgical care, such a strategy has a number of limitations and practical challenges. Not surprisingly, limiting the number of surgeons and hospitals that perform a given procedure necessitates that patients travel a greater distance to obtain necessary surgical care.^13,14 An analysis of endometrial cancer patients in New York State stratified patients based on their area of residence into 10 hospital referral regions (HRRs), which represent health care markets for tertiary medical care. From 2000 to 2014, the distance patients traveled to receive their surgical care increased in all of the HRRs studied. This was most pronounced in 1 of the HRRs in which the median travel distance rose by 47 miles over the 15-year period (FIGURE 1; FIGURE 2).¹⁴

Whether patients are willing to travel for care remains a matter of debate and depends on the disease, the surgical procedure, and the anticipated benefit associated with a longer travel distance.^15,16 In a discrete choice experiment, 100 participants were given a hypothetical scenario in which they had potentially resectable pancreatic cancer; they were queried on their willingness to travel for care based on varying differences in mortality between a local and regional hospital.¹⁵ When mortality at the local hospital was double that of the regional hospital (6% vs 3%), 45% of patients chose to remain at the local hospital. When the differential increased to a 4 times greater mortality at the local hospital (12% vs 3%), 23% of patients still chose to remain at the local hospital.¹⁵

Lastly, a number of studies have shown that regionalization of surgical care disproportionately affects Black and Hispanic patients and those with low socioeconomic status.^12,13,17 A simulation study on the effect of regionalizing care for pancreatectomy noted that using a hospital volume threshold of 20 procedures per year, a higher percentage of Black and Hispanic patients than White patients would be required to travel to a higher-volume center.¹³ Similarly, Medicaid recipients were more likely to be affected.¹³ Despite the inequities in who must travel for regionalized care, prior work has suggested that regionalization of cancer care to high-volume centers may reduce racial and socioeconomic disparities in survival for some cancers.¹⁸

Targeted quality improvement

Realizing the practical limitations of regionalization of care, an alternative strategy is to improve the quality of care at low-volume hospitals.^5,19 Quality of care and surgical volume often are correlated, and the delivery of high-quality care can mitigate some of the influence of surgical volume on outcomes.

These principles were demonstrated in a study of more than 100,000 patients with ovarian cancer that stratified treating hospitals into volume quintiles.⁵ As expected, survival (both 2- and 5-year) was highest in the highest-volume quintile hospitals (FIGURE 3).⁵ Similarly, quality of care, measured through adherence to various process measures, was also highest in the highest-volume quintile hospitals. Interestingly, in the second-fourth volume quintile hospitals, there was substantial variation in adherence to quality metrics. Among hospitals with higher quality care, an improved survival was noted compared with lower quality care hospitals within the same volume quintile. Survival at high-quality, intermediate-volume hospitals approached that of the high-volume quintile hospitals.⁵

Continue to: Minimum volume standards...

While efforts to regionalize surgical care have gradually evolved, calls have been growing to formalize policies that limit the performance of some procedures to surgeons and centers that meet a minimum volume threshold or standard.²¹ One such effort, based on consensus from 3 academic hospital systems, was a campaign for hospitals to “Take the Volume Pledge.”²¹ The campaign’s goal is to encourage health care systems to restrict the performance of 10 procedures to surgeons and hospitals within their systems that meet a minimum volume standard for the given operations.²¹ In essence, procedures would be restricted for low-volume providers and centers and triaged to higher-volume surgeons and hospitals within a given health care system.²¹

Proponents of the Volume Pledge argue that it is a relatively straightforward way to align patients and providers to optimize outcomes. The Volume Pledge focuses on larger hospital systems and encourages referral within the given system, thus mitigating competitive and financial concerns about referring patients to outside providers. Those who have argued against the Volume Pledge point out that the volume cut points chosen are somewhat arbitrary, that these policies have the potential to negatively impact rural hospitals and those serving smaller communities, and that quality is a more appropriate metric than volume.²² The Volume Pledge does not include any gynecologic procedures, and to date it has met with only limited success.²³

Perhaps more directly applicable to gynecologic surgeons are ongoing national trends to base hospital credentialing on surgical volume. In essence, individual surgeons must demonstrate that they have performed a minimum number of procedures to obtain or retain privileges.^24,25 While there is strong evidence of the association between volume and outcomes for some complex surgical procedures, linking volume to credentialing has a number of potential pitfalls. Studies of surgical outcomes based on volume represent average performance, and many low-volume providers have better-than-expected outcomes. Volume measures typically represent recent performance; it is difficult to measure the overall experience of individual surgeons. Similarly, surgical outcomes depend on both the surgeon and the system in which the surgeon operates. It is difficult, if not impossible, to account for differences in the environment in which a surgeon works.²⁵

A study of gynecologic surgeons who performed hysterectomy in New York State demonstrates many of the complexities of volume-based credentialing.²⁶ In a cohort of more than55,000 patients who underwent abdominal hysterectomy, there was a strong association between low surgeon volume and a higher-than-expected rate of complications. If one were to consider limiting privileges to even the lowest-volume providers, there would be a significant impact on the surgical workforce. In this cohort, limiting credentialing to the lowest-volume providers, those who performed only 1 abdominal hysterectomy in the prior year would restrict the privileges of 17.5% of the surgeons in the cohort. Further, in this low-volume cohort that performed only 1 abdominal hysterectomy in the prior year, 69% of the surgeons actually had outcomes that were better than predicted.²⁶ These data highlight not only the difficulty of applying averages to individual surgeons but also the profound impact that policy changes could have on the practice of gynecologic surgery.

Volume-outcomes paradigm discussions continue

The association between higher surgeon and hospital procedural volume for gynecologic surgeries and improved outcomes now has been convincingly demonstrated. With this knowledge, over the last decade the patterns of care for patients undergoing gynecologic surgery have clearly shifted, and these operations are now more commonly being performed by a smaller number of physicians and at fewer hospitals.

While efforts to improve quality are clearly important, many policy interventions, such as regionalization of care, have untoward consequences that must be considered. As we move forward, it will be essential to ensure that there is a robust debate among patients, providers, and policymakers on the merits of public health policies based on the volume-outcomes paradigm. ●

Over the last 3 decades, abundant evidence has demonstrated the association between surgical volume and outcomes. Patients operated on by high-volume surgeons and at high-volume hospitals have superior outcomes.^1,2 This relationship has provided a framework for a number of public health policies to try to align patients with appropriate providers and centers to optimize perioperative outcomes. In this article, we examine the volume-outcomes paradigm for gynecologic surgery and explore how this relationship is influencing patterns of care and policy.

Surgical volume in gynecology

The association between both hospital and surgeon volume and outcomes has been explored across a number of gynecologic procedures.³ A meta-analysis that included 741,000 patients found that low-volume surgeons had an increased rate of complications overall, a higher rate of intraoperative complications, and a higher rate of postoperative complications compared with high-volume surgeons. While there was no association between volume and mortality overall, when limited to gynecologic oncology studies, low surgeon volume was associated with increased perioperative mortality.³

While these studies demonstrated a statistically significant association between surgeon volume and perioperative outcomes, the magnitude of the effect is modest compared with other higher-risk procedures associated with greater perioperative morbidity. For example, in a large study that examined oncologic and cardiovascular surgery, perioperative mortality in patients who underwent pancreatic resection was reduced from 15% for low-volume surgeons to 5% for high-volume surgeons.¹ By contrast, for gynecologic surgery, complications occurred in 97 per 1,000 patients operated on by high-volume surgeons compared with between 114 and 137 per 1,000 for low-volume surgeons. Thus, to avoid 1 in-hospital complication, 30 surgeries performed by low-volume surgeons would need to be moved to high-volume surgeons. For intraoperative complications, 38 patients would need to be moved from low- to high-volume surgeons to prevent 1 such complication.³ In addition to morbidity and mortality, higher surgeon volume is associated with greater use of minimally invasive surgery, a lower likelihood of conversion to laparotomy, and lower costs.³

Continue to: Public health applications of gynecologic surgical volume...

Public health applications of gynecologic surgical volume

The large body of literature on volume and outcomes has led to a number of public health initiatives aimed at reducing perioperative morbidity and mortality. Broadly, these efforts focus on regionalization of care, targeted quality improvement, and the development of minimum volume standards. Each strategy holds promise but also the potential to lead to unwanted consequences.

Regionalization of care

Recognition of the volume-outcomes paradigm has led to efforts to regionalize care for complex procedures to high-volume surgeons and centers.¹⁰ A cohort study of surgical patterns of care for Medicare recipients who underwent cancer resections or abdominal aortic aneurysm repair from 1999 to 2008 demonstrated these shifting practice patterns. For example, in 1999–2000, pancreatectomy was performed in 1,308 hospitals, with a median case volume of 5 procedures per year. By 2007–2008, the number of hospitals in which pancreatectomy was performed declined to 978, and the median case volume rose to 16 procedures per year. Importantly, over this time period, risk-adjusted mortality for pancreatectomy declined by 19%, and increased hospital volume was responsible for more than two-thirds of the decline in mortality.¹⁰

There has similarly been a gradual concentration of some gynecologic procedures to higher-volume surgeons and centers.^11,12 Among patients undergoing hysterectomy for endometrial cancer in New York State, 845 surgeons with a mean case volume of 3 procedures per year treated patients in 2000. By 2014, the number of surgeons who performed these operations declined to 317 while mean annual case volume rose to 10 procedures per year. The number of hospitals in which women with endometrial cancer were treated declined from 182 to 98 over the same time period.¹¹ Similar trends were noted for patients undergoing ovarian cancer resection.¹² While patterns of gynecologic care for some surgical procedures have clearly changed, it has been more difficult to link these changes to improvements in outcomes.^11,12

Despite the intuitive appeal of regionalization of surgical care, such a strategy has a number of limitations and practical challenges. Not surprisingly, limiting the number of surgeons and hospitals that perform a given procedure necessitates that patients travel a greater distance to obtain necessary surgical care.^13,14 An analysis of endometrial cancer patients in New York State stratified patients based on their area of residence into 10 hospital referral regions (HRRs), which represent health care markets for tertiary medical care. From 2000 to 2014, the distance patients traveled to receive their surgical care increased in all of the HRRs studied. This was most pronounced in 1 of the HRRs in which the median travel distance rose by 47 miles over the 15-year period (FIGURE 1; FIGURE 2).¹⁴

Whether patients are willing to travel for care remains a matter of debate and depends on the disease, the surgical procedure, and the anticipated benefit associated with a longer travel distance.^15,16 In a discrete choice experiment, 100 participants were given a hypothetical scenario in which they had potentially resectable pancreatic cancer; they were queried on their willingness to travel for care based on varying differences in mortality between a local and regional hospital.¹⁵ When mortality at the local hospital was double that of the regional hospital (6% vs 3%), 45% of patients chose to remain at the local hospital. When the differential increased to a 4 times greater mortality at the local hospital (12% vs 3%), 23% of patients still chose to remain at the local hospital.¹⁵

Lastly, a number of studies have shown that regionalization of surgical care disproportionately affects Black and Hispanic patients and those with low socioeconomic status.^12,13,17 A simulation study on the effect of regionalizing care for pancreatectomy noted that using a hospital volume threshold of 20 procedures per year, a higher percentage of Black and Hispanic patients than White patients would be required to travel to a higher-volume center.¹³ Similarly, Medicaid recipients were more likely to be affected.¹³ Despite the inequities in who must travel for regionalized care, prior work has suggested that regionalization of cancer care to high-volume centers may reduce racial and socioeconomic disparities in survival for some cancers.¹⁸

Targeted quality improvement

Realizing the practical limitations of regionalization of care, an alternative strategy is to improve the quality of care at low-volume hospitals.^5,19 Quality of care and surgical volume often are correlated, and the delivery of high-quality care can mitigate some of the influence of surgical volume on outcomes.

These principles were demonstrated in a study of more than 100,000 patients with ovarian cancer that stratified treating hospitals into volume quintiles.⁵ As expected, survival (both 2- and 5-year) was highest in the highest-volume quintile hospitals (FIGURE 3).⁵ Similarly, quality of care, measured through adherence to various process measures, was also highest in the highest-volume quintile hospitals. Interestingly, in the second-fourth volume quintile hospitals, there was substantial variation in adherence to quality metrics. Among hospitals with higher quality care, an improved survival was noted compared with lower quality care hospitals within the same volume quintile. Survival at high-quality, intermediate-volume hospitals approached that of the high-volume quintile hospitals.⁵

Continue to: Minimum volume standards...

While efforts to regionalize surgical care have gradually evolved, calls have been growing to formalize policies that limit the performance of some procedures to surgeons and centers that meet a minimum volume threshold or standard.²¹ One such effort, based on consensus from 3 academic hospital systems, was a campaign for hospitals to “Take the Volume Pledge.”²¹ The campaign’s goal is to encourage health care systems to restrict the performance of 10 procedures to surgeons and hospitals within their systems that meet a minimum volume standard for the given operations.²¹ In essence, procedures would be restricted for low-volume providers and centers and triaged to higher-volume surgeons and hospitals within a given health care system.²¹

Proponents of the Volume Pledge argue that it is a relatively straightforward way to align patients and providers to optimize outcomes. The Volume Pledge focuses on larger hospital systems and encourages referral within the given system, thus mitigating competitive and financial concerns about referring patients to outside providers. Those who have argued against the Volume Pledge point out that the volume cut points chosen are somewhat arbitrary, that these policies have the potential to negatively impact rural hospitals and those serving smaller communities, and that quality is a more appropriate metric than volume.²² The Volume Pledge does not include any gynecologic procedures, and to date it has met with only limited success.²³

Perhaps more directly applicable to gynecologic surgeons are ongoing national trends to base hospital credentialing on surgical volume. In essence, individual surgeons must demonstrate that they have performed a minimum number of procedures to obtain or retain privileges.^24,25 While there is strong evidence of the association between volume and outcomes for some complex surgical procedures, linking volume to credentialing has a number of potential pitfalls. Studies of surgical outcomes based on volume represent average performance, and many low-volume providers have better-than-expected outcomes. Volume measures typically represent recent performance; it is difficult to measure the overall experience of individual surgeons. Similarly, surgical outcomes depend on both the surgeon and the system in which the surgeon operates. It is difficult, if not impossible, to account for differences in the environment in which a surgeon works.²⁵

A study of gynecologic surgeons who performed hysterectomy in New York State demonstrates many of the complexities of volume-based credentialing.²⁶ In a cohort of more than55,000 patients who underwent abdominal hysterectomy, there was a strong association between low surgeon volume and a higher-than-expected rate of complications. If one were to consider limiting privileges to even the lowest-volume providers, there would be a significant impact on the surgical workforce. In this cohort, limiting credentialing to the lowest-volume providers, those who performed only 1 abdominal hysterectomy in the prior year would restrict the privileges of 17.5% of the surgeons in the cohort. Further, in this low-volume cohort that performed only 1 abdominal hysterectomy in the prior year, 69% of the surgeons actually had outcomes that were better than predicted.²⁶ These data highlight not only the difficulty of applying averages to individual surgeons but also the profound impact that policy changes could have on the practice of gynecologic surgery.

Volume-outcomes paradigm discussions continue

The association between higher surgeon and hospital procedural volume for gynecologic surgeries and improved outcomes now has been convincingly demonstrated. With this knowledge, over the last decade the patterns of care for patients undergoing gynecologic surgery have clearly shifted, and these operations are now more commonly being performed by a smaller number of physicians and at fewer hospitals.

While efforts to improve quality are clearly important, many policy interventions, such as regionalization of care, have untoward consequences that must be considered. As we move forward, it will be essential to ensure that there is a robust debate among patients, providers, and policymakers on the merits of public health policies based on the volume-outcomes paradigm. ●

The investigational gene therapy exagamglogene autotemcel (exa-cel) shows encouraging efficacy, safety, and patient-reported outcomes for transfusion-dependent beta-thalassemia and sickle cell disease (SCD), in findings that could lead to the first-ever approval of a therapy that utilizes CRISPR-Cas9 gene-editing.

Results from the prespecified interim analyses of the phase 3 CLIMB THAL-111 and CLIMB SCD-121 studies, presented at the European Hematology Association annual congress, show that patients with beta-thalassemia who received exa-cel were able to remain transfusion-free for up to 40.7 consecutive months, while in patients with sickle cell disease, the treatment likewise provided up to 36.5 months of freedom from vaso-occlusive crises.

The findings underscore that “exa-cel can provide a one-time, functional cure to patients with beta-thalassemia and sickle cell disease,” said coauthor Franco Locatelli, MD, of Catholic University of the Sacred Heart, Bambino Gesù Children’s Hospital, Rome.

In a comment, senior investigator Haydar Frangoul, MD, noted that, “with almost 4 years of follow-up on patients with beta-thalassemia and sickle cell disease, it appears that the benefit is holding.”

“The engraftment of our edited cells appears very stable over time. There is no reason to believe it will change,” said Dr. Frangoul, who is medical director of pediatric hematology/oncology, Sarah Cannon Center for Blood Cancer at The Children’s Hospital at TriStar Centennial, Nashville, Tenn.
 

Burden is high; current curative options have caveats

Patients with transfusion-dependent beta-thalassemia may require blood transfusions as often as every 2-5 weeks because of genetic mutations causing the absence of functional hemoglobin and subsequent depletions in red blood cells. And with hemoglobin being an iron-rich protein, patients are also at risk of an iron accumulation in the body, adding the possible need for uncomfortable iron chelation therapy to prevent organ damage.

The measures are burdensome, but the need is dire. Life expectancy in beta-thalassemia without them is only about 5 years.

With SCD, patients can face severe pain from vaso-occlusive crises as sickled red blood cells block blood flow, potentially causing hospitalization and complications including kidney failure or stroke.

A cure does already exist for both genetic disorders in the form of allogeneic stem cell transplantation. However, that option requires a matched related stem cell donor, and fewer than 20% of patients have accessibility to such donors.
 

Gene therapy

Gene therapy offers a potentially ideal alternative, providing a possible “functional cure” without the need for a donor, by instead harvesting patients’ cells, fixing the mutation and transferring them back to the patient.

The Food and Drug Administration already approved a first gene therapy, betibeglogene autotemcel (beti-cel), for children and adults with transfusion dependent beta-thalassemia, in August 2022.

While beti-cel utilizes a viral vector to insert functional copies of a modified gene into patients’ extracted hematopoietic stem cells before transfusing them back, exa-cel instead uses CRISPR-CAS9 technology to edit the gene, allowing the body to produce fetal hemoglobin, in an approach believed to be more precise and efficient.

“As we explain to patients, it’s a difference between gene addition, which is what beti-cel is, or gene editing, which is what exa-cel is,” Dr. Frangoul explained.
 

Phase 3 trial interim results

In investigating exa-cel for beta-thalassemia, the ongoing CLIMB THAL-111 has enrolled 48 patients with a mean baseline age of 20, with 16 between the ages of 12 and 18. Of the patients, 28 (58.3%) had severe genotypes of disease.

Among 27 patients who were evaluable for the study endpoints of the current interim analysis, 24 (88.9%), achieved the primary endpoint of maintaining a weighted average hemoglobin of at least 9 g/dL without the need for a transfusion for at least 12 months (P < .0001).

Patients who achieved the transfusion independence for at least 12 months remained transfusion-free for a mean duration of 20.5 months, with a range of 12.1-40.7 months.

Of 3 patients who did not achieve the 12-month transfusion-free endpoint, substantial reductions in transfusion volume were nevertheless achieved, of 70.3%, 79.6%, and 95.5%, among the 3.

And for the CLIMB SCD-121 trial of SCD, 35 participants have been dosed with exa-cel; in the primary efficacy set of 17 patients, 16 of the 17 (94.1%) achieved the primary endpoint of having no severe vaso-occlusive crises for at least 12 months (P < .0001).

All patients, however, achieved the secondary endpoint of being free from in-patient hospitalizations for severe vaso-occlusive crises for at least 12 months (P < .0001).

Patients who achieved freedom from vaso-occlusive crises for at least 12 months remained free of the events for a mean of 18.7 months, ranging from 13.1 months to 36.5 months.
 

Durability, patient-reported outcomes favorable

Importantly, in both studies, hemoglobin levels, as well as levels of the edited BCL11A alleles in bone marrow CD34+ and peripheral blood nucleated cells, showed sustained stability over time, indicating durable editing of the cells, Dr. Locatelli said.

In terms of patient-reported quality-of-life, measures significantly improved during both trials at 24 months of follow-up, with significant improvements on the EuroQol visual analog scale, Functional Assessment of Cancer Therapy–General, and the Bone Marrow Transplantation Subscale.

Safety results were consistent with those observed with myeloablative busulfan-based conditioning regimen and autologous transplantation procedures, with adverse events that were manageable.

In the beta-thalassemia study, two patients experienced serious adverse events that were determined to be related to exa-cel, including one patient having symptoms in the context of hemophagocytic lymphohistiocytosis.

For the other patient, the serious adverse events consisted of delayed engraftment and thrombocytopenia, each also considered related to busulfan. None of the patients with SCD had serious adverse events related to exa-cel.

All serious adverse events were resolved, with no reports of deaths, study discontinuations, or malignancies.
 

Potentially first ever CRISPR-based FDA approval

While CRISPR-CAS9 gene editing is being investigated in multiple other trials in humans for various disorders, to date none have received FDA approval, which would make an approval for exa-cel a landmark development.

The therapy is currently under review, and Dr. Frangoul said the FDA has stated that a decision on the indication for SCD is expected by Dec. 8, 2023, and for beta-thalassemia, by March 2024.

Commenting on the research, Raffaella Colombatti, MD, a pediatric hematologist-oncologist and assistant professor of pediatrics at the University of Padova (Italy), underscored the need for a better curative alternative.

“Unfortunately, the other curative option, bone marrow transplant, is not available for all candidates due to the lack of suitable donors,” Dr. Colombatti said in an interview.

“And, although there are promising results from alternative donors and new conditioning regimens, a further option for selected patients with sickle cell disease and thalassemia utilizing gene therapy and gene editing is needed.”

Caveats regarding gene therapy for the two diseases that still need consideration include: “long-term safety results are still not available and eligibility criteria still needs to be explored outside clinical trials,” she said.

Furthermore, “costs and sustainability are also an issue,” Dr. Colombatti added.

The price of gene therapy is not cheap. With beti-cel priced at more than $2 million for the treatment, its manufacturer, Bluebird Bio, has reportedly already indicated that it will not pursue marketing in Europe because of unfavorable reimbursement policies, and a similar high price is anticipated for exa-cel.

Overall, however, the findings bode well for groundbreaking improvements in treatment of the two red blood cell disorders, Michael J. Eckrich, MD, MPH, medical director of pediatric stem cell transplant & cellular therapy at Atrium Health Levine Children’s Hospital Cancer and Blood Disorders in Charlotte, N.C., said in an interview.

“I do think that this is transformative therapy and will change our approach for patients with severe sickle cell disease in need of transplant,” said Dr. Eckrich, who has also been an investigator on the research of exa-cel for sickle cell disease.

“It might not be hard to imagine, that with the progress in gene therapies and gene editing, that allogeneic transplant will soon become obsolete for patients with sickle cell disease and beta-thalassemia.”

Dr. Locatelli is on the advisory board for Vertex Pharma and the speaker’s bureau for BluebirdBio. Dr. Frangoul and Dr. Colombatti are or have been consultants for Vertex Pharma.

The investigational gene therapy exagamglogene autotemcel (exa-cel) shows encouraging efficacy, safety, and patient-reported outcomes for transfusion-dependent beta-thalassemia and sickle cell disease (SCD), in findings that could lead to the first-ever approval of a therapy that utilizes CRISPR-Cas9 gene-editing.

Results from the prespecified interim analyses of the phase 3 CLIMB THAL-111 and CLIMB SCD-121 studies, presented at the European Hematology Association annual congress, show that patients with beta-thalassemia who received exa-cel were able to remain transfusion-free for up to 40.7 consecutive months, while in patients with sickle cell disease, the treatment likewise provided up to 36.5 months of freedom from vaso-occlusive crises.

The findings underscore that “exa-cel can provide a one-time, functional cure to patients with beta-thalassemia and sickle cell disease,” said coauthor Franco Locatelli, MD, of Catholic University of the Sacred Heart, Bambino Gesù Children’s Hospital, Rome.

In a comment, senior investigator Haydar Frangoul, MD, noted that, “with almost 4 years of follow-up on patients with beta-thalassemia and sickle cell disease, it appears that the benefit is holding.”

“The engraftment of our edited cells appears very stable over time. There is no reason to believe it will change,” said Dr. Frangoul, who is medical director of pediatric hematology/oncology, Sarah Cannon Center for Blood Cancer at The Children’s Hospital at TriStar Centennial, Nashville, Tenn.
 

Burden is high; current curative options have caveats

Patients with transfusion-dependent beta-thalassemia may require blood transfusions as often as every 2-5 weeks because of genetic mutations causing the absence of functional hemoglobin and subsequent depletions in red blood cells. And with hemoglobin being an iron-rich protein, patients are also at risk of an iron accumulation in the body, adding the possible need for uncomfortable iron chelation therapy to prevent organ damage.

The measures are burdensome, but the need is dire. Life expectancy in beta-thalassemia without them is only about 5 years.

With SCD, patients can face severe pain from vaso-occlusive crises as sickled red blood cells block blood flow, potentially causing hospitalization and complications including kidney failure or stroke.

A cure does already exist for both genetic disorders in the form of allogeneic stem cell transplantation. However, that option requires a matched related stem cell donor, and fewer than 20% of patients have accessibility to such donors.
 

Gene therapy

Gene therapy offers a potentially ideal alternative, providing a possible “functional cure” without the need for a donor, by instead harvesting patients’ cells, fixing the mutation and transferring them back to the patient.

The Food and Drug Administration already approved a first gene therapy, betibeglogene autotemcel (beti-cel), for children and adults with transfusion dependent beta-thalassemia, in August 2022.

While beti-cel utilizes a viral vector to insert functional copies of a modified gene into patients’ extracted hematopoietic stem cells before transfusing them back, exa-cel instead uses CRISPR-CAS9 technology to edit the gene, allowing the body to produce fetal hemoglobin, in an approach believed to be more precise and efficient.

“As we explain to patients, it’s a difference between gene addition, which is what beti-cel is, or gene editing, which is what exa-cel is,” Dr. Frangoul explained.
 

Phase 3 trial interim results

In investigating exa-cel for beta-thalassemia, the ongoing CLIMB THAL-111 has enrolled 48 patients with a mean baseline age of 20, with 16 between the ages of 12 and 18. Of the patients, 28 (58.3%) had severe genotypes of disease.

Among 27 patients who were evaluable for the study endpoints of the current interim analysis, 24 (88.9%), achieved the primary endpoint of maintaining a weighted average hemoglobin of at least 9 g/dL without the need for a transfusion for at least 12 months (P < .0001).

Patients who achieved the transfusion independence for at least 12 months remained transfusion-free for a mean duration of 20.5 months, with a range of 12.1-40.7 months.

Of 3 patients who did not achieve the 12-month transfusion-free endpoint, substantial reductions in transfusion volume were nevertheless achieved, of 70.3%, 79.6%, and 95.5%, among the 3.

And for the CLIMB SCD-121 trial of SCD, 35 participants have been dosed with exa-cel; in the primary efficacy set of 17 patients, 16 of the 17 (94.1%) achieved the primary endpoint of having no severe vaso-occlusive crises for at least 12 months (P < .0001).

All patients, however, achieved the secondary endpoint of being free from in-patient hospitalizations for severe vaso-occlusive crises for at least 12 months (P < .0001).

Patients who achieved freedom from vaso-occlusive crises for at least 12 months remained free of the events for a mean of 18.7 months, ranging from 13.1 months to 36.5 months.
 

Durability, patient-reported outcomes favorable

Importantly, in both studies, hemoglobin levels, as well as levels of the edited BCL11A alleles in bone marrow CD34+ and peripheral blood nucleated cells, showed sustained stability over time, indicating durable editing of the cells, Dr. Locatelli said.

In terms of patient-reported quality-of-life, measures significantly improved during both trials at 24 months of follow-up, with significant improvements on the EuroQol visual analog scale, Functional Assessment of Cancer Therapy–General, and the Bone Marrow Transplantation Subscale.

Safety results were consistent with those observed with myeloablative busulfan-based conditioning regimen and autologous transplantation procedures, with adverse events that were manageable.

In the beta-thalassemia study, two patients experienced serious adverse events that were determined to be related to exa-cel, including one patient having symptoms in the context of hemophagocytic lymphohistiocytosis.

For the other patient, the serious adverse events consisted of delayed engraftment and thrombocytopenia, each also considered related to busulfan. None of the patients with SCD had serious adverse events related to exa-cel.

All serious adverse events were resolved, with no reports of deaths, study discontinuations, or malignancies.
 

Potentially first ever CRISPR-based FDA approval

While CRISPR-CAS9 gene editing is being investigated in multiple other trials in humans for various disorders, to date none have received FDA approval, which would make an approval for exa-cel a landmark development.

The therapy is currently under review, and Dr. Frangoul said the FDA has stated that a decision on the indication for SCD is expected by Dec. 8, 2023, and for beta-thalassemia, by March 2024.

Commenting on the research, Raffaella Colombatti, MD, a pediatric hematologist-oncologist and assistant professor of pediatrics at the University of Padova (Italy), underscored the need for a better curative alternative.

“Unfortunately, the other curative option, bone marrow transplant, is not available for all candidates due to the lack of suitable donors,” Dr. Colombatti said in an interview.

“And, although there are promising results from alternative donors and new conditioning regimens, a further option for selected patients with sickle cell disease and thalassemia utilizing gene therapy and gene editing is needed.”

Caveats regarding gene therapy for the two diseases that still need consideration include: “long-term safety results are still not available and eligibility criteria still needs to be explored outside clinical trials,” she said.

Furthermore, “costs and sustainability are also an issue,” Dr. Colombatti added.

The price of gene therapy is not cheap. With beti-cel priced at more than $2 million for the treatment, its manufacturer, Bluebird Bio, has reportedly already indicated that it will not pursue marketing in Europe because of unfavorable reimbursement policies, and a similar high price is anticipated for exa-cel.

Overall, however, the findings bode well for groundbreaking improvements in treatment of the two red blood cell disorders, Michael J. Eckrich, MD, MPH, medical director of pediatric stem cell transplant & cellular therapy at Atrium Health Levine Children’s Hospital Cancer and Blood Disorders in Charlotte, N.C., said in an interview.

“I do think that this is transformative therapy and will change our approach for patients with severe sickle cell disease in need of transplant,” said Dr. Eckrich, who has also been an investigator on the research of exa-cel for sickle cell disease.

“It might not be hard to imagine, that with the progress in gene therapies and gene editing, that allogeneic transplant will soon become obsolete for patients with sickle cell disease and beta-thalassemia.”

Dr. Locatelli is on the advisory board for Vertex Pharma and the speaker’s bureau for BluebirdBio. Dr. Frangoul and Dr. Colombatti are or have been consultants for Vertex Pharma.

The investigational gene therapy exagamglogene autotemcel (exa-cel) shows encouraging efficacy, safety, and patient-reported outcomes for transfusion-dependent beta-thalassemia and sickle cell disease (SCD), in findings that could lead to the first-ever approval of a therapy that utilizes CRISPR-Cas9 gene-editing.

Results from the prespecified interim analyses of the phase 3 CLIMB THAL-111 and CLIMB SCD-121 studies, presented at the European Hematology Association annual congress, show that patients with beta-thalassemia who received exa-cel were able to remain transfusion-free for up to 40.7 consecutive months, while in patients with sickle cell disease, the treatment likewise provided up to 36.5 months of freedom from vaso-occlusive crises.

The findings underscore that “exa-cel can provide a one-time, functional cure to patients with beta-thalassemia and sickle cell disease,” said coauthor Franco Locatelli, MD, of Catholic University of the Sacred Heart, Bambino Gesù Children’s Hospital, Rome.

In a comment, senior investigator Haydar Frangoul, MD, noted that, “with almost 4 years of follow-up on patients with beta-thalassemia and sickle cell disease, it appears that the benefit is holding.”

“The engraftment of our edited cells appears very stable over time. There is no reason to believe it will change,” said Dr. Frangoul, who is medical director of pediatric hematology/oncology, Sarah Cannon Center for Blood Cancer at The Children’s Hospital at TriStar Centennial, Nashville, Tenn.
 

Burden is high; current curative options have caveats

Patients with transfusion-dependent beta-thalassemia may require blood transfusions as often as every 2-5 weeks because of genetic mutations causing the absence of functional hemoglobin and subsequent depletions in red blood cells. And with hemoglobin being an iron-rich protein, patients are also at risk of an iron accumulation in the body, adding the possible need for uncomfortable iron chelation therapy to prevent organ damage.

The measures are burdensome, but the need is dire. Life expectancy in beta-thalassemia without them is only about 5 years.

With SCD, patients can face severe pain from vaso-occlusive crises as sickled red blood cells block blood flow, potentially causing hospitalization and complications including kidney failure or stroke.

A cure does already exist for both genetic disorders in the form of allogeneic stem cell transplantation. However, that option requires a matched related stem cell donor, and fewer than 20% of patients have accessibility to such donors.
 

Gene therapy

Gene therapy offers a potentially ideal alternative, providing a possible “functional cure” without the need for a donor, by instead harvesting patients’ cells, fixing the mutation and transferring them back to the patient.

The Food and Drug Administration already approved a first gene therapy, betibeglogene autotemcel (beti-cel), for children and adults with transfusion dependent beta-thalassemia, in August 2022.

While beti-cel utilizes a viral vector to insert functional copies of a modified gene into patients’ extracted hematopoietic stem cells before transfusing them back, exa-cel instead uses CRISPR-CAS9 technology to edit the gene, allowing the body to produce fetal hemoglobin, in an approach believed to be more precise and efficient.

“As we explain to patients, it’s a difference between gene addition, which is what beti-cel is, or gene editing, which is what exa-cel is,” Dr. Frangoul explained.
 

Phase 3 trial interim results

In investigating exa-cel for beta-thalassemia, the ongoing CLIMB THAL-111 has enrolled 48 patients with a mean baseline age of 20, with 16 between the ages of 12 and 18. Of the patients, 28 (58.3%) had severe genotypes of disease.

Among 27 patients who were evaluable for the study endpoints of the current interim analysis, 24 (88.9%), achieved the primary endpoint of maintaining a weighted average hemoglobin of at least 9 g/dL without the need for a transfusion for at least 12 months (P < .0001).

Patients who achieved the transfusion independence for at least 12 months remained transfusion-free for a mean duration of 20.5 months, with a range of 12.1-40.7 months.

Of 3 patients who did not achieve the 12-month transfusion-free endpoint, substantial reductions in transfusion volume were nevertheless achieved, of 70.3%, 79.6%, and 95.5%, among the 3.

And for the CLIMB SCD-121 trial of SCD, 35 participants have been dosed with exa-cel; in the primary efficacy set of 17 patients, 16 of the 17 (94.1%) achieved the primary endpoint of having no severe vaso-occlusive crises for at least 12 months (P < .0001).

All patients, however, achieved the secondary endpoint of being free from in-patient hospitalizations for severe vaso-occlusive crises for at least 12 months (P < .0001).

Patients who achieved freedom from vaso-occlusive crises for at least 12 months remained free of the events for a mean of 18.7 months, ranging from 13.1 months to 36.5 months.
 

Durability, patient-reported outcomes favorable

Importantly, in both studies, hemoglobin levels, as well as levels of the edited BCL11A alleles in bone marrow CD34+ and peripheral blood nucleated cells, showed sustained stability over time, indicating durable editing of the cells, Dr. Locatelli said.

In terms of patient-reported quality-of-life, measures significantly improved during both trials at 24 months of follow-up, with significant improvements on the EuroQol visual analog scale, Functional Assessment of Cancer Therapy–General, and the Bone Marrow Transplantation Subscale.

Safety results were consistent with those observed with myeloablative busulfan-based conditioning regimen and autologous transplantation procedures, with adverse events that were manageable.

In the beta-thalassemia study, two patients experienced serious adverse events that were determined to be related to exa-cel, including one patient having symptoms in the context of hemophagocytic lymphohistiocytosis.

For the other patient, the serious adverse events consisted of delayed engraftment and thrombocytopenia, each also considered related to busulfan. None of the patients with SCD had serious adverse events related to exa-cel.

All serious adverse events were resolved, with no reports of deaths, study discontinuations, or malignancies.
 

Potentially first ever CRISPR-based FDA approval

While CRISPR-CAS9 gene editing is being investigated in multiple other trials in humans for various disorders, to date none have received FDA approval, which would make an approval for exa-cel a landmark development.

The therapy is currently under review, and Dr. Frangoul said the FDA has stated that a decision on the indication for SCD is expected by Dec. 8, 2023, and for beta-thalassemia, by March 2024.

Commenting on the research, Raffaella Colombatti, MD, a pediatric hematologist-oncologist and assistant professor of pediatrics at the University of Padova (Italy), underscored the need for a better curative alternative.

“Unfortunately, the other curative option, bone marrow transplant, is not available for all candidates due to the lack of suitable donors,” Dr. Colombatti said in an interview.

“And, although there are promising results from alternative donors and new conditioning regimens, a further option for selected patients with sickle cell disease and thalassemia utilizing gene therapy and gene editing is needed.”

Caveats regarding gene therapy for the two diseases that still need consideration include: “long-term safety results are still not available and eligibility criteria still needs to be explored outside clinical trials,” she said.

Furthermore, “costs and sustainability are also an issue,” Dr. Colombatti added.

The price of gene therapy is not cheap. With beti-cel priced at more than $2 million for the treatment, its manufacturer, Bluebird Bio, has reportedly already indicated that it will not pursue marketing in Europe because of unfavorable reimbursement policies, and a similar high price is anticipated for exa-cel.

Overall, however, the findings bode well for groundbreaking improvements in treatment of the two red blood cell disorders, Michael J. Eckrich, MD, MPH, medical director of pediatric stem cell transplant & cellular therapy at Atrium Health Levine Children’s Hospital Cancer and Blood Disorders in Charlotte, N.C., said in an interview.

“I do think that this is transformative therapy and will change our approach for patients with severe sickle cell disease in need of transplant,” said Dr. Eckrich, who has also been an investigator on the research of exa-cel for sickle cell disease.

“It might not be hard to imagine, that with the progress in gene therapies and gene editing, that allogeneic transplant will soon become obsolete for patients with sickle cell disease and beta-thalassemia.”

Dr. Locatelli is on the advisory board for Vertex Pharma and the speaker’s bureau for BluebirdBio. Dr. Frangoul and Dr. Colombatti are or have been consultants for Vertex Pharma.

A teenager who weighed 300 lb and was homeschooled because he was too big to fit in a classroom chair is among the patients Manal Habib, MD, has seen in her pediatric endocrinology practice.

The boy, a social butterfly who hated isolation and blamed himself for his “poor choices,” turned out to have an MC4R mutation that interfered with proper metabolism and satiation signals.

“People often blame obese and overweight people for not having enough willpower, but it’s often a physiological problem,” said Dr. Habib, who works at the University of California, Los Angeles.

She is among the clinicians offering more aggressive forms of weight management, prescribing medications, including metformin, semaglutide, and liraglutide – often off-label – to help children and teens with obesity who do not respond to lifestyle changes.

The results of intensive interventions can be life-changing: The teen Dr. Habib treated is back at school, playing sports, and no longer needs drugs to reduce cholesterol and blood pressure. He now takes a low maintenance dose of a weight-loss medication.

But the long-term effects of these new agents on children and teens are poorly understood, and both medication and surgery are associated with significant complications. Pediatricians treating kids pre- or post-intervention should be alert to a range of physical, psychological, and behavioral risks and complications.
 

Keeping bones healthy

Pediatricians should be aware of the risk to bone health in patients who undergo surgery, according to Misra Madhusmita, MD, chief of pediatric endocrinology at Massachusetts General Hospital in Boston. In a recent study, Dr. Madhusmita and her colleagues found that sleeve gastrectomy reduced vertebral bone strength in adolescents and young adults.

“This is a time of life when bone mass is typically accruing rapidly,” Dr. Madhusmita told this news organization. “A deleterious effect on bone accrual at this time of life raises concerns about suboptimal acquisition of peak bone mass, which is typically attained in early adult life and is a key factor determining bone health and fracture risk in later life.”

Reduced skeletal loading and muscle mass can weaken bones, as can malabsorption of nutrients. Fat loss can trigger lower levels of bioavailable androgens and their subsequent conversion to estrogen, negatively affecting bone density. And sleeve gastrectomy in particular lowers ghrelin, another hormone influencing skeletal health.

Clinicians should advise patients who have had surgery to follow a healthy diet and consume sufficient levels of calcium and vitamin D, said Dr. Madhusmita. Weight-bearing exercises, weight training, and resistance training are also imperative to build bone mass and muscle. Any preexisting conditions or lifestyle factors that weaken the bones should be taken into consideration.
 

Managing expectations

The long-term effects of weight loss medications on children are less documented than with surgery, according to Caren Mangarelli, MD, a former primary care physician who is now medical director of both the adolescent bariatric program and the children’s wellness and weight management clinic at Lurie Children’s Hospital in Chicago, Ill.

But one significant known risk is the potential for rebound weight gain and the complications like high blood pressure and high blood sugar that go with it if the patient stops medication. Dr. Mangarelli said that many clinicians lack the training required to safely facilitate weight loss medications for kids.

“We have to remember that obesity is a chronic disease, especially for those with more severe forms,” she said. “They’re not likely to outgrow it. It’s not like, ‘Oh, we’ll just put a patient on medication, they’ll lose weight, and we’ll take them off of it,’ because you could create a bad cycle of losing weight, followed by metabolism slowing down, hunger cues going up, and weight going back up.”

Making the risks of stopping medication clear and supporting compliance are essential, especially when it comes to injectables like semaglutide, which can be more burdensome than taking pills, requiring weekly subcutaneous injections. Pediatricians should ensure that families understand that medication is a long-term solution, Dr. Habib said.

Many families and patients “want a quick result. They’re focused on a specific size or weight, and they want to take the medication for a short period without changing anything else,” Dr. Habib said.

But children with genetic abnormalities or severe obesity could be on medication for their entire lives. Patients who make significant healthy lifestyle changes have a greater chance of weaning off drug therapy.

But “it’s hard with children because they’re dependent on their family,” Dr. Habib said. “One of the first things that I talk about with families is that it’s very important for everyone to be involved in making healthy changes, especially the parents, because the kids are going to follow their lifestyle and choices, not necessarily what they tell them to do.”
 

The behavioral and mental

One of Dr. Habib’s most striking cases was a 6-year-old patient with autism spectrum disorder experiencing early-onset puberty. Her condition made it difficult for her parents to enforce behavioral and lifestyle changes, making medication the best option to normalize the young girl’s body.

“The goal in this case is not necessarily to help her lose weight, but to prevent her from having severe health risks at such a young age,” said Habib.

Though medication may be the best solution when other options have failed, the ease of using medication may mean clinicians fail to address the complex emotional and psychosocial factors that can both cause and result from obesity.

“A lot of families think that if just this one thing were better, everything else would fall into place,” Habib said. “But there often are multiple layers to treating the patient.”

According to Cambria Garrell, MD, a pediatrician at the UCLA Fit for Healthy Weight Program in Los Angeles, pediatricians should be aware of the psychosocial and mental health factors such as undiagnosed mental illness or family dysfunction.

Dr. Garrell sometimes cares for children with undiagnosed mental health disorders. Children with conditions like attention-deficit/hyperactivity disorder and autism spectrum disorders may struggle with eating because of impulse control and sensory processing issues. Family functioning, issues at school, and lack of sleep are also major contributors to obesity to screen for.

“We really like to think about the environmental and psychosocial factors contributing to obesity instead of just pathologizing the weight,” Dr. Garrell said.
 

Risk for alcohol abuse

Bariatric and metabolic surgeries are associated with an increased risk for alcohol use disorder (AUD). Pediatricians treating children pre- or post-op should ensure that patients receive behavioral and mental health services to minimize the risk for alcohol abuse.

The risk for AUD is likely the result of changes to the way the body metabolizes alcohol, resulting in heightened sensitivity to it, although research is not conclusive, according to Dr. Mangarelli.

The risk for AUD is likely multifactorial, Dr. Mangarelli said.

“We don’t totally understand all of it, but if you’re experiencing a high more easily, that may lead to misuse,” Dr. Mangarelli said. “It’s also important to remember that this population of patients has experienced stigma for a very long time, and they often have associated mental health and body image issues.”

“Those problems don’t disappear on their own,” she added. “You want to make sure that patients are hooked into behavioral and mental health services before surgery so that they have somebody who’s following them after surgery.”

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

A teenager who weighed 300 lb and was homeschooled because he was too big to fit in a classroom chair is among the patients Manal Habib, MD, has seen in her pediatric endocrinology practice.

The boy, a social butterfly who hated isolation and blamed himself for his “poor choices,” turned out to have an MC4R mutation that interfered with proper metabolism and satiation signals.

“People often blame obese and overweight people for not having enough willpower, but it’s often a physiological problem,” said Dr. Habib, who works at the University of California, Los Angeles.

She is among the clinicians offering more aggressive forms of weight management, prescribing medications, including metformin, semaglutide, and liraglutide – often off-label – to help children and teens with obesity who do not respond to lifestyle changes.

The results of intensive interventions can be life-changing: The teen Dr. Habib treated is back at school, playing sports, and no longer needs drugs to reduce cholesterol and blood pressure. He now takes a low maintenance dose of a weight-loss medication.

But the long-term effects of these new agents on children and teens are poorly understood, and both medication and surgery are associated with significant complications. Pediatricians treating kids pre- or post-intervention should be alert to a range of physical, psychological, and behavioral risks and complications.
 

Keeping bones healthy

Pediatricians should be aware of the risk to bone health in patients who undergo surgery, according to Misra Madhusmita, MD, chief of pediatric endocrinology at Massachusetts General Hospital in Boston. In a recent study, Dr. Madhusmita and her colleagues found that sleeve gastrectomy reduced vertebral bone strength in adolescents and young adults.

“This is a time of life when bone mass is typically accruing rapidly,” Dr. Madhusmita told this news organization. “A deleterious effect on bone accrual at this time of life raises concerns about suboptimal acquisition of peak bone mass, which is typically attained in early adult life and is a key factor determining bone health and fracture risk in later life.”

Reduced skeletal loading and muscle mass can weaken bones, as can malabsorption of nutrients. Fat loss can trigger lower levels of bioavailable androgens and their subsequent conversion to estrogen, negatively affecting bone density. And sleeve gastrectomy in particular lowers ghrelin, another hormone influencing skeletal health.

Clinicians should advise patients who have had surgery to follow a healthy diet and consume sufficient levels of calcium and vitamin D, said Dr. Madhusmita. Weight-bearing exercises, weight training, and resistance training are also imperative to build bone mass and muscle. Any preexisting conditions or lifestyle factors that weaken the bones should be taken into consideration.
 

Managing expectations

The long-term effects of weight loss medications on children are less documented than with surgery, according to Caren Mangarelli, MD, a former primary care physician who is now medical director of both the adolescent bariatric program and the children’s wellness and weight management clinic at Lurie Children’s Hospital in Chicago, Ill.

But one significant known risk is the potential for rebound weight gain and the complications like high blood pressure and high blood sugar that go with it if the patient stops medication. Dr. Mangarelli said that many clinicians lack the training required to safely facilitate weight loss medications for kids.

“We have to remember that obesity is a chronic disease, especially for those with more severe forms,” she said. “They’re not likely to outgrow it. It’s not like, ‘Oh, we’ll just put a patient on medication, they’ll lose weight, and we’ll take them off of it,’ because you could create a bad cycle of losing weight, followed by metabolism slowing down, hunger cues going up, and weight going back up.”

Making the risks of stopping medication clear and supporting compliance are essential, especially when it comes to injectables like semaglutide, which can be more burdensome than taking pills, requiring weekly subcutaneous injections. Pediatricians should ensure that families understand that medication is a long-term solution, Dr. Habib said.

Many families and patients “want a quick result. They’re focused on a specific size or weight, and they want to take the medication for a short period without changing anything else,” Dr. Habib said.

But children with genetic abnormalities or severe obesity could be on medication for their entire lives. Patients who make significant healthy lifestyle changes have a greater chance of weaning off drug therapy.

But “it’s hard with children because they’re dependent on their family,” Dr. Habib said. “One of the first things that I talk about with families is that it’s very important for everyone to be involved in making healthy changes, especially the parents, because the kids are going to follow their lifestyle and choices, not necessarily what they tell them to do.”
 

The behavioral and mental

One of Dr. Habib’s most striking cases was a 6-year-old patient with autism spectrum disorder experiencing early-onset puberty. Her condition made it difficult for her parents to enforce behavioral and lifestyle changes, making medication the best option to normalize the young girl’s body.

“The goal in this case is not necessarily to help her lose weight, but to prevent her from having severe health risks at such a young age,” said Habib.

Though medication may be the best solution when other options have failed, the ease of using medication may mean clinicians fail to address the complex emotional and psychosocial factors that can both cause and result from obesity.

“A lot of families think that if just this one thing were better, everything else would fall into place,” Habib said. “But there often are multiple layers to treating the patient.”

According to Cambria Garrell, MD, a pediatrician at the UCLA Fit for Healthy Weight Program in Los Angeles, pediatricians should be aware of the psychosocial and mental health factors such as undiagnosed mental illness or family dysfunction.

Dr. Garrell sometimes cares for children with undiagnosed mental health disorders. Children with conditions like attention-deficit/hyperactivity disorder and autism spectrum disorders may struggle with eating because of impulse control and sensory processing issues. Family functioning, issues at school, and lack of sleep are also major contributors to obesity to screen for.

“We really like to think about the environmental and psychosocial factors contributing to obesity instead of just pathologizing the weight,” Dr. Garrell said.
 

Risk for alcohol abuse

Bariatric and metabolic surgeries are associated with an increased risk for alcohol use disorder (AUD). Pediatricians treating children pre- or post-op should ensure that patients receive behavioral and mental health services to minimize the risk for alcohol abuse.

The risk for AUD is likely the result of changes to the way the body metabolizes alcohol, resulting in heightened sensitivity to it, although research is not conclusive, according to Dr. Mangarelli.

The risk for AUD is likely multifactorial, Dr. Mangarelli said.

“We don’t totally understand all of it, but if you’re experiencing a high more easily, that may lead to misuse,” Dr. Mangarelli said. “It’s also important to remember that this population of patients has experienced stigma for a very long time, and they often have associated mental health and body image issues.”

“Those problems don’t disappear on their own,” she added. “You want to make sure that patients are hooked into behavioral and mental health services before surgery so that they have somebody who’s following them after surgery.”

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

A teenager who weighed 300 lb and was homeschooled because he was too big to fit in a classroom chair is among the patients Manal Habib, MD, has seen in her pediatric endocrinology practice.

The boy, a social butterfly who hated isolation and blamed himself for his “poor choices,” turned out to have an MC4R mutation that interfered with proper metabolism and satiation signals.

“People often blame obese and overweight people for not having enough willpower, but it’s often a physiological problem,” said Dr. Habib, who works at the University of California, Los Angeles.

She is among the clinicians offering more aggressive forms of weight management, prescribing medications, including metformin, semaglutide, and liraglutide – often off-label – to help children and teens with obesity who do not respond to lifestyle changes.

The results of intensive interventions can be life-changing: The teen Dr. Habib treated is back at school, playing sports, and no longer needs drugs to reduce cholesterol and blood pressure. He now takes a low maintenance dose of a weight-loss medication.

But the long-term effects of these new agents on children and teens are poorly understood, and both medication and surgery are associated with significant complications. Pediatricians treating kids pre- or post-intervention should be alert to a range of physical, psychological, and behavioral risks and complications.
 

Keeping bones healthy

Pediatricians should be aware of the risk to bone health in patients who undergo surgery, according to Misra Madhusmita, MD, chief of pediatric endocrinology at Massachusetts General Hospital in Boston. In a recent study, Dr. Madhusmita and her colleagues found that sleeve gastrectomy reduced vertebral bone strength in adolescents and young adults.

“This is a time of life when bone mass is typically accruing rapidly,” Dr. Madhusmita told this news organization. “A deleterious effect on bone accrual at this time of life raises concerns about suboptimal acquisition of peak bone mass, which is typically attained in early adult life and is a key factor determining bone health and fracture risk in later life.”

Reduced skeletal loading and muscle mass can weaken bones, as can malabsorption of nutrients. Fat loss can trigger lower levels of bioavailable androgens and their subsequent conversion to estrogen, negatively affecting bone density. And sleeve gastrectomy in particular lowers ghrelin, another hormone influencing skeletal health.

Clinicians should advise patients who have had surgery to follow a healthy diet and consume sufficient levels of calcium and vitamin D, said Dr. Madhusmita. Weight-bearing exercises, weight training, and resistance training are also imperative to build bone mass and muscle. Any preexisting conditions or lifestyle factors that weaken the bones should be taken into consideration.
 

Managing expectations

The long-term effects of weight loss medications on children are less documented than with surgery, according to Caren Mangarelli, MD, a former primary care physician who is now medical director of both the adolescent bariatric program and the children’s wellness and weight management clinic at Lurie Children’s Hospital in Chicago, Ill.

But one significant known risk is the potential for rebound weight gain and the complications like high blood pressure and high blood sugar that go with it if the patient stops medication. Dr. Mangarelli said that many clinicians lack the training required to safely facilitate weight loss medications for kids.

“We have to remember that obesity is a chronic disease, especially for those with more severe forms,” she said. “They’re not likely to outgrow it. It’s not like, ‘Oh, we’ll just put a patient on medication, they’ll lose weight, and we’ll take them off of it,’ because you could create a bad cycle of losing weight, followed by metabolism slowing down, hunger cues going up, and weight going back up.”

Making the risks of stopping medication clear and supporting compliance are essential, especially when it comes to injectables like semaglutide, which can be more burdensome than taking pills, requiring weekly subcutaneous injections. Pediatricians should ensure that families understand that medication is a long-term solution, Dr. Habib said.

Many families and patients “want a quick result. They’re focused on a specific size or weight, and they want to take the medication for a short period without changing anything else,” Dr. Habib said.

But children with genetic abnormalities or severe obesity could be on medication for their entire lives. Patients who make significant healthy lifestyle changes have a greater chance of weaning off drug therapy.

But “it’s hard with children because they’re dependent on their family,” Dr. Habib said. “One of the first things that I talk about with families is that it’s very important for everyone to be involved in making healthy changes, especially the parents, because the kids are going to follow their lifestyle and choices, not necessarily what they tell them to do.”
 

The behavioral and mental

One of Dr. Habib’s most striking cases was a 6-year-old patient with autism spectrum disorder experiencing early-onset puberty. Her condition made it difficult for her parents to enforce behavioral and lifestyle changes, making medication the best option to normalize the young girl’s body.

“The goal in this case is not necessarily to help her lose weight, but to prevent her from having severe health risks at such a young age,” said Habib.

Though medication may be the best solution when other options have failed, the ease of using medication may mean clinicians fail to address the complex emotional and psychosocial factors that can both cause and result from obesity.

“A lot of families think that if just this one thing were better, everything else would fall into place,” Habib said. “But there often are multiple layers to treating the patient.”

According to Cambria Garrell, MD, a pediatrician at the UCLA Fit for Healthy Weight Program in Los Angeles, pediatricians should be aware of the psychosocial and mental health factors such as undiagnosed mental illness or family dysfunction.

Dr. Garrell sometimes cares for children with undiagnosed mental health disorders. Children with conditions like attention-deficit/hyperactivity disorder and autism spectrum disorders may struggle with eating because of impulse control and sensory processing issues. Family functioning, issues at school, and lack of sleep are also major contributors to obesity to screen for.

“We really like to think about the environmental and psychosocial factors contributing to obesity instead of just pathologizing the weight,” Dr. Garrell said.
 

Risk for alcohol abuse

Bariatric and metabolic surgeries are associated with an increased risk for alcohol use disorder (AUD). Pediatricians treating children pre- or post-op should ensure that patients receive behavioral and mental health services to minimize the risk for alcohol abuse.

The risk for AUD is likely the result of changes to the way the body metabolizes alcohol, resulting in heightened sensitivity to it, although research is not conclusive, according to Dr. Mangarelli.

The risk for AUD is likely multifactorial, Dr. Mangarelli said.

“We don’t totally understand all of it, but if you’re experiencing a high more easily, that may lead to misuse,” Dr. Mangarelli said. “It’s also important to remember that this population of patients has experienced stigma for a very long time, and they often have associated mental health and body image issues.”

“Those problems don’t disappear on their own,” she added. “You want to make sure that patients are hooked into behavioral and mental health services before surgery so that they have somebody who’s following them after surgery.”

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

As millions of Americans face another year of long COVID, some are finding they are unable to return to work or cannot work as they did before they got sick and are turning to doctors for help with documenting their disability.

For those who can return to work, a doctor’s diagnosis of long COVID is key to gaining access to workplace accommodations, such as working flex hours or remotely. For those who cannot work, a note from the doctor is the first step to collecting disability payments.

With no definitive blood tests or scans for long COVID that could confirm a diagnosis, some say doctors may feel uncomfortable in this role, which puts them in a tough spot, said Wes Ely, MD, MPH, codirector of the critical illness, brain dysfunction and survivorship center at Vanderbilt University, Nashville, Tenn.

Doctors typically are not taught to deal with vagueness in diagnostics.

“Long COVID falls straight into the gray zone,” he said. There are no tests and a long list of common symptoms. “It makes a lot of doctors feel super insecure,” he said.

Now, patients and their advocates are calling for doctors to be more open-minded about how they assess those with long COVID and other chronic illnesses. Although their disability may not be visible, many with long COVID struggle to function. If they need help, they say, they need a doctor to confirm their limitations – test results or no test results.

Better documentation of patient-reported symptoms would go a long way, according to a perspective published in The New England Journal of Medicine.

“There’s a long history of people with disabilities being forced to ask doctors to legitimize their symptoms,” said study author Zackary Berger, MD, PhD, Johns Hopkins University, Baltimore, Md. Dr. Berger believes doctors should learn to listen more closely to patients, turn their narratives into patient notes, and use the new International Classification of Diseases 10 (ICD-10) code, a worldwide system for identifying and generating data on diseases, when they diagnose long COVID. He also thinks doctors should become advocates for their patients.

The Americans With Disabilities Act allows employers to request medical proof of disability, “and thereby assigns physicians the gate-keeping role of determining patients’ eligibility for reasonable accommodations,” according to the analysis. Those accommodations may mean a handicapped parking space or extra days working remotely.

Without a definitive diagnostic test, long COVID joins fibromyalgia and ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome), which lack biomarkers or imaging tests to support a diagnosis, they write.

“These diagnoses are therefore contentious, and government agencies, employers, and many physicians do not accept these conditions as real,” they write.

Physicians make a good faith effort in trying to understand long COVID, but both doctors and the courts like to see evidence, said Michael Ashley Stein, JD, PHD, director of the Harvard Law School Project on Disability. Dr. Stein and others say that doctors should listen closely to their patients’ descriptions of their symptoms.

“In the absence of agreed-upon biomarkers, doctors need to listen to their patients and look for other [indications] and other consistent evidence of conditions, and then work from there rather than dismiss the existence of these conditions,” he said.

Dr. Ely said he and others were taught in medical school that if it doesn’t come up on a diagnostic test, there’s no problem. “I am absolutely complicit,” he said. “I’m part of the community that did that for so many years.”

Dr. Ely agreed that the demand for clinical test results does not work for long COVID and chronic diseases such as ME/CFS. People come in with complaints and they get a typical medical workup with labs, he said, and the labs look normal on paper.

“And [the doctor is] thinking: ‘I don’t know what is wrong with this person and there’s nothing on paper I can treat. I don’t know if I even believe in long COVID.’ ”

At the same time, patients might need support from a doctor to get accommodations at work under the ADA, such as flexible hours. Or doctors’ notes may be required if a patient is trying to collect private disability insurance, workers compensation, or federal disability payments through Social Security.

The U.S. Centers for Disease Control and Prevention guidelines on diagnosing long COVID, updated last December, point out that normal laboratory or imaging findings do not rule out long COVID.

In addition, 12 key symptoms of long COVID were identified in May by scientists working with the RECOVER Initiative, the federal government’s long COVID research program. These symptoms include fatigue, brain fog, dizziness, gastrointestinal symptoms, loss of or change in smell or taste, chest pain, and abnormal movements.

Still, patients with long COVID seeking help also face the “disability con,” a term coined by the second author of the NEJM article, Doron Dorfman, a professor at Seton Hall Law School in Newark, N.J.

“Nowadays, when people think disability, they immediately think fraud,” he said.

Prof. Dorfman thinks the perception that many people are faking disabilities to gain an unfair advantage is the biggest barrier for anyone seeking help. The disability system is “preventing people who deserve legal rights from actually obtaining them,” he said.

He urged doctors to believe their patients. One way is to try to “translate the person’s narrative into medical language.”

His coauthor Dr. Berger did not agree with the argument that doctors cannot diagnose without tests.

“Any clinician knows that lab tests are not everything,” he said. “There are conditions that don’t have specific biomarkers that we diagnose all the time.” He cited acquired pneumonia and urinary tract infections as examples.

Benefits lawyers have taken note of the complexities for people with long COVID who seek help through the ADA and federal disability program.

One law firm noted: “The government safety net is not designed to help an emerging disease with no clear diagnosis or treatment plans. Insurance carriers are denying claims, and long-term disability benefits are being denied.”

About 16 million working-age Americans have long COVID, according to an update of a 2022 report by the Brookings Institute. Up to 4 million of these people are out of work because of the condition, the study found. The research is based on newly collected U.S. Census Bureau data that show 24% of those with long COVID report “significant activity limitations.”

Dr. Ely said he sees progress in this area. Many of these issues have come up at the committee convened by the National Academy of Science to look at the working definition of long COVID. NAS, a Washington research group, held a public meeting on their findings on June 22.
 

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

As millions of Americans face another year of long COVID, some are finding they are unable to return to work or cannot work as they did before they got sick and are turning to doctors for help with documenting their disability.

For those who can return to work, a doctor’s diagnosis of long COVID is key to gaining access to workplace accommodations, such as working flex hours or remotely. For those who cannot work, a note from the doctor is the first step to collecting disability payments.

With no definitive blood tests or scans for long COVID that could confirm a diagnosis, some say doctors may feel uncomfortable in this role, which puts them in a tough spot, said Wes Ely, MD, MPH, codirector of the critical illness, brain dysfunction and survivorship center at Vanderbilt University, Nashville, Tenn.

Doctors typically are not taught to deal with vagueness in diagnostics.

“Long COVID falls straight into the gray zone,” he said. There are no tests and a long list of common symptoms. “It makes a lot of doctors feel super insecure,” he said.

Now, patients and their advocates are calling for doctors to be more open-minded about how they assess those with long COVID and other chronic illnesses. Although their disability may not be visible, many with long COVID struggle to function. If they need help, they say, they need a doctor to confirm their limitations – test results or no test results.

Better documentation of patient-reported symptoms would go a long way, according to a perspective published in The New England Journal of Medicine.

“There’s a long history of people with disabilities being forced to ask doctors to legitimize their symptoms,” said study author Zackary Berger, MD, PhD, Johns Hopkins University, Baltimore, Md. Dr. Berger believes doctors should learn to listen more closely to patients, turn their narratives into patient notes, and use the new International Classification of Diseases 10 (ICD-10) code, a worldwide system for identifying and generating data on diseases, when they diagnose long COVID. He also thinks doctors should become advocates for their patients.

The Americans With Disabilities Act allows employers to request medical proof of disability, “and thereby assigns physicians the gate-keeping role of determining patients’ eligibility for reasonable accommodations,” according to the analysis. Those accommodations may mean a handicapped parking space or extra days working remotely.

Without a definitive diagnostic test, long COVID joins fibromyalgia and ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome), which lack biomarkers or imaging tests to support a diagnosis, they write.

“These diagnoses are therefore contentious, and government agencies, employers, and many physicians do not accept these conditions as real,” they write.

Physicians make a good faith effort in trying to understand long COVID, but both doctors and the courts like to see evidence, said Michael Ashley Stein, JD, PHD, director of the Harvard Law School Project on Disability. Dr. Stein and others say that doctors should listen closely to their patients’ descriptions of their symptoms.

“In the absence of agreed-upon biomarkers, doctors need to listen to their patients and look for other [indications] and other consistent evidence of conditions, and then work from there rather than dismiss the existence of these conditions,” he said.

Dr. Ely said he and others were taught in medical school that if it doesn’t come up on a diagnostic test, there’s no problem. “I am absolutely complicit,” he said. “I’m part of the community that did that for so many years.”

Dr. Ely agreed that the demand for clinical test results does not work for long COVID and chronic diseases such as ME/CFS. People come in with complaints and they get a typical medical workup with labs, he said, and the labs look normal on paper.

“And [the doctor is] thinking: ‘I don’t know what is wrong with this person and there’s nothing on paper I can treat. I don’t know if I even believe in long COVID.’ ”

At the same time, patients might need support from a doctor to get accommodations at work under the ADA, such as flexible hours. Or doctors’ notes may be required if a patient is trying to collect private disability insurance, workers compensation, or federal disability payments through Social Security.

The U.S. Centers for Disease Control and Prevention guidelines on diagnosing long COVID, updated last December, point out that normal laboratory or imaging findings do not rule out long COVID.

In addition, 12 key symptoms of long COVID were identified in May by scientists working with the RECOVER Initiative, the federal government’s long COVID research program. These symptoms include fatigue, brain fog, dizziness, gastrointestinal symptoms, loss of or change in smell or taste, chest pain, and abnormal movements.

Still, patients with long COVID seeking help also face the “disability con,” a term coined by the second author of the NEJM article, Doron Dorfman, a professor at Seton Hall Law School in Newark, N.J.

“Nowadays, when people think disability, they immediately think fraud,” he said.

Prof. Dorfman thinks the perception that many people are faking disabilities to gain an unfair advantage is the biggest barrier for anyone seeking help. The disability system is “preventing people who deserve legal rights from actually obtaining them,” he said.

He urged doctors to believe their patients. One way is to try to “translate the person’s narrative into medical language.”

His coauthor Dr. Berger did not agree with the argument that doctors cannot diagnose without tests.

“Any clinician knows that lab tests are not everything,” he said. “There are conditions that don’t have specific biomarkers that we diagnose all the time.” He cited acquired pneumonia and urinary tract infections as examples.

Benefits lawyers have taken note of the complexities for people with long COVID who seek help through the ADA and federal disability program.

One law firm noted: “The government safety net is not designed to help an emerging disease with no clear diagnosis or treatment plans. Insurance carriers are denying claims, and long-term disability benefits are being denied.”

About 16 million working-age Americans have long COVID, according to an update of a 2022 report by the Brookings Institute. Up to 4 million of these people are out of work because of the condition, the study found. The research is based on newly collected U.S. Census Bureau data that show 24% of those with long COVID report “significant activity limitations.”

Dr. Ely said he sees progress in this area. Many of these issues have come up at the committee convened by the National Academy of Science to look at the working definition of long COVID. NAS, a Washington research group, held a public meeting on their findings on June 22.
 

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

As millions of Americans face another year of long COVID, some are finding they are unable to return to work or cannot work as they did before they got sick and are turning to doctors for help with documenting their disability.

For those who can return to work, a doctor’s diagnosis of long COVID is key to gaining access to workplace accommodations, such as working flex hours or remotely. For those who cannot work, a note from the doctor is the first step to collecting disability payments.

With no definitive blood tests or scans for long COVID that could confirm a diagnosis, some say doctors may feel uncomfortable in this role, which puts them in a tough spot, said Wes Ely, MD, MPH, codirector of the critical illness, brain dysfunction and survivorship center at Vanderbilt University, Nashville, Tenn.

Doctors typically are not taught to deal with vagueness in diagnostics.

“Long COVID falls straight into the gray zone,” he said. There are no tests and a long list of common symptoms. “It makes a lot of doctors feel super insecure,” he said.

Now, patients and their advocates are calling for doctors to be more open-minded about how they assess those with long COVID and other chronic illnesses. Although their disability may not be visible, many with long COVID struggle to function. If they need help, they say, they need a doctor to confirm their limitations – test results or no test results.

Better documentation of patient-reported symptoms would go a long way, according to a perspective published in The New England Journal of Medicine.

“There’s a long history of people with disabilities being forced to ask doctors to legitimize their symptoms,” said study author Zackary Berger, MD, PhD, Johns Hopkins University, Baltimore, Md. Dr. Berger believes doctors should learn to listen more closely to patients, turn their narratives into patient notes, and use the new International Classification of Diseases 10 (ICD-10) code, a worldwide system for identifying and generating data on diseases, when they diagnose long COVID. He also thinks doctors should become advocates for their patients.

The Americans With Disabilities Act allows employers to request medical proof of disability, “and thereby assigns physicians the gate-keeping role of determining patients’ eligibility for reasonable accommodations,” according to the analysis. Those accommodations may mean a handicapped parking space or extra days working remotely.

Without a definitive diagnostic test, long COVID joins fibromyalgia and ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome), which lack biomarkers or imaging tests to support a diagnosis, they write.

“These diagnoses are therefore contentious, and government agencies, employers, and many physicians do not accept these conditions as real,” they write.

Physicians make a good faith effort in trying to understand long COVID, but both doctors and the courts like to see evidence, said Michael Ashley Stein, JD, PHD, director of the Harvard Law School Project on Disability. Dr. Stein and others say that doctors should listen closely to their patients’ descriptions of their symptoms.

“In the absence of agreed-upon biomarkers, doctors need to listen to their patients and look for other [indications] and other consistent evidence of conditions, and then work from there rather than dismiss the existence of these conditions,” he said.

Dr. Ely said he and others were taught in medical school that if it doesn’t come up on a diagnostic test, there’s no problem. “I am absolutely complicit,” he said. “I’m part of the community that did that for so many years.”

Dr. Ely agreed that the demand for clinical test results does not work for long COVID and chronic diseases such as ME/CFS. People come in with complaints and they get a typical medical workup with labs, he said, and the labs look normal on paper.

“And [the doctor is] thinking: ‘I don’t know what is wrong with this person and there’s nothing on paper I can treat. I don’t know if I even believe in long COVID.’ ”

At the same time, patients might need support from a doctor to get accommodations at work under the ADA, such as flexible hours. Or doctors’ notes may be required if a patient is trying to collect private disability insurance, workers compensation, or federal disability payments through Social Security.

The U.S. Centers for Disease Control and Prevention guidelines on diagnosing long COVID, updated last December, point out that normal laboratory or imaging findings do not rule out long COVID.

In addition, 12 key symptoms of long COVID were identified in May by scientists working with the RECOVER Initiative, the federal government’s long COVID research program. These symptoms include fatigue, brain fog, dizziness, gastrointestinal symptoms, loss of or change in smell or taste, chest pain, and abnormal movements.

Still, patients with long COVID seeking help also face the “disability con,” a term coined by the second author of the NEJM article, Doron Dorfman, a professor at Seton Hall Law School in Newark, N.J.

“Nowadays, when people think disability, they immediately think fraud,” he said.

Prof. Dorfman thinks the perception that many people are faking disabilities to gain an unfair advantage is the biggest barrier for anyone seeking help. The disability system is “preventing people who deserve legal rights from actually obtaining them,” he said.

He urged doctors to believe their patients. One way is to try to “translate the person’s narrative into medical language.”

His coauthor Dr. Berger did not agree with the argument that doctors cannot diagnose without tests.

“Any clinician knows that lab tests are not everything,” he said. “There are conditions that don’t have specific biomarkers that we diagnose all the time.” He cited acquired pneumonia and urinary tract infections as examples.

Benefits lawyers have taken note of the complexities for people with long COVID who seek help through the ADA and federal disability program.

One law firm noted: “The government safety net is not designed to help an emerging disease with no clear diagnosis or treatment plans. Insurance carriers are denying claims, and long-term disability benefits are being denied.”

About 16 million working-age Americans have long COVID, according to an update of a 2022 report by the Brookings Institute. Up to 4 million of these people are out of work because of the condition, the study found. The research is based on newly collected U.S. Census Bureau data that show 24% of those with long COVID report “significant activity limitations.”

Dr. Ely said he sees progress in this area. Many of these issues have come up at the committee convened by the National Academy of Science to look at the working definition of long COVID. NAS, a Washington research group, held a public meeting on their findings on June 22.
 

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

Legislators in New York City recently approved a bill specifically prohibiting weight- and height-based discrimination, on par with existing protections for gender, race, sexual orientation, and other personal identities. Other U.S. cities, as well as New York state, are considering similar moves.

Weight-based discrimination in the United States has increased by an estimated 66% over the past decade, putting it on par with the prevalence of racial discrimination. More than 40% of adult Americans and 18% of children report experiencing weight discrimination in employment, school, and/or health care settings – as well as within interpersonal relationships – demonstrating a clear need to have legal protections in place.

For obesity advocates in Canada, the news from New York triggered a moment of reflection to consider how our own advocacy efforts have fared over the years, or not. Just like in the United States, body size and obesity (and appearance in general) are not specifically protected grounds under human rights legislation in Canada (for example, the Canadian Human Rights Act), unlike race, gender, sexual orientation, and religion.

Case law is uneven across the Canadian provinces when it comes to determining whether obesity is even a disease and/or a disability. And despite broad support for anti–weight discrimination policies in Canada (Front Public Health. 2023 Apr 17;11:1060794; Milbank Q. 2015 Dec;93[4]:691-731), years of advocacy at the national and provincial levels have not led to any legislative changes (Ramos Salas Obes Rev. 2017 Nov;18[11]:1323-35; Can J Diabetes. 2015 Apr. doi: 10.1016/j.jcjd.2015.01.009). A 2017 private members bill seeking to add protection for body size to Manitoba’s human rights code was defeated, with many members of the legislature citing enforcement difficulties as the reason for voting down the proposition.

Some obesity advocates have argued that people living with obesity can be protected under the grounds of disability in the Canadian Human Rights Act. To be protected, however, individuals must demonstrate that there is actual or perceived disability relating to their weight or size; yet, many people living with obesity and those who have a higher weight don’t perceive themselves as having a disability.

In our view, the disparate viewpoints on the worthiness of considering body size a human rights issue could be resolved, at least partially, by wider understanding and adoption of the relatively new clinical definition of obesity. This definition holds that obesity is not about size; an obesity diagnosis can be made only when objective clinical investigations identify that excess or abnormal adiposity (fat tissue) impairs health.

While obesity advocates use the clinical definition of obesity, weight and body size proponents disagree that obesity is a chronic disease, and in fact believe that treating it as such can be stigmatizing. In a sense, this can sometimes be true, as not all people with larger bodies have obesity per the new definition but risk being identified as “unhealthy” in the clinical world. Bias, it turns out, can be a two-way street.

Regardless of the advocacy strategy used, it’s clear that specific anti–weight discrimination laws are needed in Canada. One in four Canadian adults report experiencing discrimination in their day-to-day life, with race, gender, age, and weight being the most commonly reported forms. To refuse to protect them against some, but not all, forms of discrimination is itself unjust, and is surely rooted in the age-old misinformed concept that excess weight is the result of laziness, poor food choices, and lack of physical activity, among other moral failings.

Including body size in human rights codes may provide a mechanism to seek legal remedy from discriminatory acts, but it will do little to address rampant weight bias, in the same way that race-based legal protections don’t eradicate racism. And it’s not just the legal community that fails to understand that weight is, by and large, a product of our environment and our genes. Weight bias and stigma are well documented in media, workplaces, the home, and in health care systems.

The solution, in our minds, is meaningful education across all these domains, reinforcing that weight is not a behavior, just as health is not a size. If we truly understand and embrace these concepts, then as a society we may someday recognize that body size is not a choice, just like race, sexual orientation, gender identity, and other individual characteristics. And if it’s not a choice, if it’s not a behavior, then it deserves the same protections.

At the same time, people with obesity deserve to seek evidence-based treatment, just as those at higher weights who experience no weight or adiposity-related health issues deserve not to be identified as having a disease simply because of their size.

If we all follow the science, we might yet turn a common understanding into more equitable outcomes for all.

Dr. Ramos Salas and Mr. Hussey are research consultants for Replica Communications, Hamilton, Ont. She disclosed ties with the Canadian Institutes of Health Research, European Association for the Study of Obesity, Novo Nordisk, Obesity Canada, The Obesity Society, World Obesity, and the World Health Organization. Mr. Hussey disclosed ties with the European Association for the Study of Obesity, Novo Nordisk, Obesity Canada, and the World Health Organization (Nutrition and Food Safety).

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

Legislators in New York City recently approved a bill specifically prohibiting weight- and height-based discrimination, on par with existing protections for gender, race, sexual orientation, and other personal identities. Other U.S. cities, as well as New York state, are considering similar moves.

Weight-based discrimination in the United States has increased by an estimated 66% over the past decade, putting it on par with the prevalence of racial discrimination. More than 40% of adult Americans and 18% of children report experiencing weight discrimination in employment, school, and/or health care settings – as well as within interpersonal relationships – demonstrating a clear need to have legal protections in place.

For obesity advocates in Canada, the news from New York triggered a moment of reflection to consider how our own advocacy efforts have fared over the years, or not. Just like in the United States, body size and obesity (and appearance in general) are not specifically protected grounds under human rights legislation in Canada (for example, the Canadian Human Rights Act), unlike race, gender, sexual orientation, and religion.

Case law is uneven across the Canadian provinces when it comes to determining whether obesity is even a disease and/or a disability. And despite broad support for anti–weight discrimination policies in Canada (Front Public Health. 2023 Apr 17;11:1060794; Milbank Q. 2015 Dec;93[4]:691-731), years of advocacy at the national and provincial levels have not led to any legislative changes (Ramos Salas Obes Rev. 2017 Nov;18[11]:1323-35; Can J Diabetes. 2015 Apr. doi: 10.1016/j.jcjd.2015.01.009). A 2017 private members bill seeking to add protection for body size to Manitoba’s human rights code was defeated, with many members of the legislature citing enforcement difficulties as the reason for voting down the proposition.

Some obesity advocates have argued that people living with obesity can be protected under the grounds of disability in the Canadian Human Rights Act. To be protected, however, individuals must demonstrate that there is actual or perceived disability relating to their weight or size; yet, many people living with obesity and those who have a higher weight don’t perceive themselves as having a disability.

In our view, the disparate viewpoints on the worthiness of considering body size a human rights issue could be resolved, at least partially, by wider understanding and adoption of the relatively new clinical definition of obesity. This definition holds that obesity is not about size; an obesity diagnosis can be made only when objective clinical investigations identify that excess or abnormal adiposity (fat tissue) impairs health.

While obesity advocates use the clinical definition of obesity, weight and body size proponents disagree that obesity is a chronic disease, and in fact believe that treating it as such can be stigmatizing. In a sense, this can sometimes be true, as not all people with larger bodies have obesity per the new definition but risk being identified as “unhealthy” in the clinical world. Bias, it turns out, can be a two-way street.

Regardless of the advocacy strategy used, it’s clear that specific anti–weight discrimination laws are needed in Canada. One in four Canadian adults report experiencing discrimination in their day-to-day life, with race, gender, age, and weight being the most commonly reported forms. To refuse to protect them against some, but not all, forms of discrimination is itself unjust, and is surely rooted in the age-old misinformed concept that excess weight is the result of laziness, poor food choices, and lack of physical activity, among other moral failings.

Including body size in human rights codes may provide a mechanism to seek legal remedy from discriminatory acts, but it will do little to address rampant weight bias, in the same way that race-based legal protections don’t eradicate racism. And it’s not just the legal community that fails to understand that weight is, by and large, a product of our environment and our genes. Weight bias and stigma are well documented in media, workplaces, the home, and in health care systems.

The solution, in our minds, is meaningful education across all these domains, reinforcing that weight is not a behavior, just as health is not a size. If we truly understand and embrace these concepts, then as a society we may someday recognize that body size is not a choice, just like race, sexual orientation, gender identity, and other individual characteristics. And if it’s not a choice, if it’s not a behavior, then it deserves the same protections.

At the same time, people with obesity deserve to seek evidence-based treatment, just as those at higher weights who experience no weight or adiposity-related health issues deserve not to be identified as having a disease simply because of their size.

If we all follow the science, we might yet turn a common understanding into more equitable outcomes for all.

Dr. Ramos Salas and Mr. Hussey are research consultants for Replica Communications, Hamilton, Ont. She disclosed ties with the Canadian Institutes of Health Research, European Association for the Study of Obesity, Novo Nordisk, Obesity Canada, The Obesity Society, World Obesity, and the World Health Organization. Mr. Hussey disclosed ties with the European Association for the Study of Obesity, Novo Nordisk, Obesity Canada, and the World Health Organization (Nutrition and Food Safety).

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

Legislators in New York City recently approved a bill specifically prohibiting weight- and height-based discrimination, on par with existing protections for gender, race, sexual orientation, and other personal identities. Other U.S. cities, as well as New York state, are considering similar moves.

Weight-based discrimination in the United States has increased by an estimated 66% over the past decade, putting it on par with the prevalence of racial discrimination. More than 40% of adult Americans and 18% of children report experiencing weight discrimination in employment, school, and/or health care settings – as well as within interpersonal relationships – demonstrating a clear need to have legal protections in place.

For obesity advocates in Canada, the news from New York triggered a moment of reflection to consider how our own advocacy efforts have fared over the years, or not. Just like in the United States, body size and obesity (and appearance in general) are not specifically protected grounds under human rights legislation in Canada (for example, the Canadian Human Rights Act), unlike race, gender, sexual orientation, and religion.

Case law is uneven across the Canadian provinces when it comes to determining whether obesity is even a disease and/or a disability. And despite broad support for anti–weight discrimination policies in Canada (Front Public Health. 2023 Apr 17;11:1060794; Milbank Q. 2015 Dec;93[4]:691-731), years of advocacy at the national and provincial levels have not led to any legislative changes (Ramos Salas Obes Rev. 2017 Nov;18[11]:1323-35; Can J Diabetes. 2015 Apr. doi: 10.1016/j.jcjd.2015.01.009). A 2017 private members bill seeking to add protection for body size to Manitoba’s human rights code was defeated, with many members of the legislature citing enforcement difficulties as the reason for voting down the proposition.

Some obesity advocates have argued that people living with obesity can be protected under the grounds of disability in the Canadian Human Rights Act. To be protected, however, individuals must demonstrate that there is actual or perceived disability relating to their weight or size; yet, many people living with obesity and those who have a higher weight don’t perceive themselves as having a disability.

In our view, the disparate viewpoints on the worthiness of considering body size a human rights issue could be resolved, at least partially, by wider understanding and adoption of the relatively new clinical definition of obesity. This definition holds that obesity is not about size; an obesity diagnosis can be made only when objective clinical investigations identify that excess or abnormal adiposity (fat tissue) impairs health.

While obesity advocates use the clinical definition of obesity, weight and body size proponents disagree that obesity is a chronic disease, and in fact believe that treating it as such can be stigmatizing. In a sense, this can sometimes be true, as not all people with larger bodies have obesity per the new definition but risk being identified as “unhealthy” in the clinical world. Bias, it turns out, can be a two-way street.

Regardless of the advocacy strategy used, it’s clear that specific anti–weight discrimination laws are needed in Canada. One in four Canadian adults report experiencing discrimination in their day-to-day life, with race, gender, age, and weight being the most commonly reported forms. To refuse to protect them against some, but not all, forms of discrimination is itself unjust, and is surely rooted in the age-old misinformed concept that excess weight is the result of laziness, poor food choices, and lack of physical activity, among other moral failings.

Including body size in human rights codes may provide a mechanism to seek legal remedy from discriminatory acts, but it will do little to address rampant weight bias, in the same way that race-based legal protections don’t eradicate racism. And it’s not just the legal community that fails to understand that weight is, by and large, a product of our environment and our genes. Weight bias and stigma are well documented in media, workplaces, the home, and in health care systems.

The solution, in our minds, is meaningful education across all these domains, reinforcing that weight is not a behavior, just as health is not a size. If we truly understand and embrace these concepts, then as a society we may someday recognize that body size is not a choice, just like race, sexual orientation, gender identity, and other individual characteristics. And if it’s not a choice, if it’s not a behavior, then it deserves the same protections.

At the same time, people with obesity deserve to seek evidence-based treatment, just as those at higher weights who experience no weight or adiposity-related health issues deserve not to be identified as having a disease simply because of their size.

If we all follow the science, we might yet turn a common understanding into more equitable outcomes for all.

Dr. Ramos Salas and Mr. Hussey are research consultants for Replica Communications, Hamilton, Ont. She disclosed ties with the Canadian Institutes of Health Research, European Association for the Study of Obesity, Novo Nordisk, Obesity Canada, The Obesity Society, World Obesity, and the World Health Organization. Mr. Hussey disclosed ties with the European Association for the Study of Obesity, Novo Nordisk, Obesity Canada, and the World Health Organization (Nutrition and Food Safety).

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

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

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

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

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

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

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

The recent decisions by the United States Supreme Court (SCOTUS) declaring the current admission policies at Harvard and the University of North Carolina illegal have sent shock waves through the university and graduate school communities. In the minds of many observers, these decisions have effectively eliminated affirmative action as a tool for leveling the playing field for ethnic minorities.

However, there are some commentators who feel that affirmative action has never been as effective as others have believed. They point out that the number of students admitted to the most selective schools is very small compared with the entire nation’s collection of colleges and universities. Regardless of where you come down on the effectiveness of past affirmative action policies, the SCOTUS decision is a done deal. It’s time to move on and begin anew our search for inclusion-promoting strategies that will pass the Court’s litmus test of legality.

I count myself among those who are optimistic that there are enough of us committed individuals that a new and better version of affirmative action is just over the horizon. Some of my supporting evidence can be found in a New York Times article by Stephanie Saul describing the admissions policy at the University of California Davis Medical School. The keystone of the university’s policy is a “socioeconomic disadvantage scale” that takes into account the applicant’s life circumstances, such as parental education and family income. This ranking – on a scale of 0 to 99 – is tossed into the standard mix of grades, test scores, essays, interviews, and recommendations. It shouldn’t surprise that UC Davis is now one of the most diverse medical schools in the United States despite the fact that California voted to ban affirmative action in 1996.

The socioeconomic disadvantage scale may, in the long run, be more effective than the current affirmative action strategies that have been race based. It certainly makes more sense to me. For example, in 2020 the Medical College Admission Test (MCAT) made a significant philosophical change by broadening and deepening its focus on the social sciences. To some extent, this refocusing may have reflected the American Association of Medical Colleges’ search for more well-rounded students and, by extension, more physicians sensitive to the plight of their disadvantaged patients. By weighting the questions more toward subjects such as how bias can influence patient care, it was hoped that the newly minted physicians would view and treat patients not just as victims of illness but as multifaceted individuals who reside in an environment that may be influencing their health.

While I agree with the goal of creating physicians with a broader and more holistic view, the notion that adding questions from social science disciplines is going to achieve this goal never made much sense to me. Answering questions posed by social scientists teaching in a selective academic setting doesn’t necessarily guarantee that the applicant has a full understanding of the real-world consequences of poverty and bias.

On the other hand, an applicant’s responses to a questionnaire about the socioeconomic conditions in which she or he grew up is far more likely to unearth candidates with a deep, broad, and very personal understanding of the challenges that disadvantaged patients face. It’s another one of those been-there-know-how-it-feels kind of things. Reading a book about how to ride a bicycle cannot quite capture the challenge of balancing yourself on two thin wheels.

Whether an affirmative action plan that includes a socioeconomic scale will indeed spawn a crop of physicians who will practice customer-friendly, understanding, and sensitive medicine remains to be seen. The pathway to becoming a practicing physician takes a minimum of 6 or 7 years. Much of that education comes in the form of watching and listening to physicians who, in turn, modeled their behavior after the cohort that preceded them in a very old system, and so on. There is no guarantee that even the most sensitively selected students will remain immune to incorporating into their practice style some of the systemic bias that will inevitably surround them. But a socioeconomic disadvantage scale is certainly worth a try.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The recent decisions by the United States Supreme Court (SCOTUS) declaring the current admission policies at Harvard and the University of North Carolina illegal have sent shock waves through the university and graduate school communities. In the minds of many observers, these decisions have effectively eliminated affirmative action as a tool for leveling the playing field for ethnic minorities.

However, there are some commentators who feel that affirmative action has never been as effective as others have believed. They point out that the number of students admitted to the most selective schools is very small compared with the entire nation’s collection of colleges and universities. Regardless of where you come down on the effectiveness of past affirmative action policies, the SCOTUS decision is a done deal. It’s time to move on and begin anew our search for inclusion-promoting strategies that will pass the Court’s litmus test of legality.

I count myself among those who are optimistic that there are enough of us committed individuals that a new and better version of affirmative action is just over the horizon. Some of my supporting evidence can be found in a New York Times article by Stephanie Saul describing the admissions policy at the University of California Davis Medical School. The keystone of the university’s policy is a “socioeconomic disadvantage scale” that takes into account the applicant’s life circumstances, such as parental education and family income. This ranking – on a scale of 0 to 99 – is tossed into the standard mix of grades, test scores, essays, interviews, and recommendations. It shouldn’t surprise that UC Davis is now one of the most diverse medical schools in the United States despite the fact that California voted to ban affirmative action in 1996.

The socioeconomic disadvantage scale may, in the long run, be more effective than the current affirmative action strategies that have been race based. It certainly makes more sense to me. For example, in 2020 the Medical College Admission Test (MCAT) made a significant philosophical change by broadening and deepening its focus on the social sciences. To some extent, this refocusing may have reflected the American Association of Medical Colleges’ search for more well-rounded students and, by extension, more physicians sensitive to the plight of their disadvantaged patients. By weighting the questions more toward subjects such as how bias can influence patient care, it was hoped that the newly minted physicians would view and treat patients not just as victims of illness but as multifaceted individuals who reside in an environment that may be influencing their health.

While I agree with the goal of creating physicians with a broader and more holistic view, the notion that adding questions from social science disciplines is going to achieve this goal never made much sense to me. Answering questions posed by social scientists teaching in a selective academic setting doesn’t necessarily guarantee that the applicant has a full understanding of the real-world consequences of poverty and bias.

On the other hand, an applicant’s responses to a questionnaire about the socioeconomic conditions in which she or he grew up is far more likely to unearth candidates with a deep, broad, and very personal understanding of the challenges that disadvantaged patients face. It’s another one of those been-there-know-how-it-feels kind of things. Reading a book about how to ride a bicycle cannot quite capture the challenge of balancing yourself on two thin wheels.

Whether an affirmative action plan that includes a socioeconomic scale will indeed spawn a crop of physicians who will practice customer-friendly, understanding, and sensitive medicine remains to be seen. The pathway to becoming a practicing physician takes a minimum of 6 or 7 years. Much of that education comes in the form of watching and listening to physicians who, in turn, modeled their behavior after the cohort that preceded them in a very old system, and so on. There is no guarantee that even the most sensitively selected students will remain immune to incorporating into their practice style some of the systemic bias that will inevitably surround them. But a socioeconomic disadvantage scale is certainly worth a try.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The recent decisions by the United States Supreme Court (SCOTUS) declaring the current admission policies at Harvard and the University of North Carolina illegal have sent shock waves through the university and graduate school communities. In the minds of many observers, these decisions have effectively eliminated affirmative action as a tool for leveling the playing field for ethnic minorities.

However, there are some commentators who feel that affirmative action has never been as effective as others have believed. They point out that the number of students admitted to the most selective schools is very small compared with the entire nation’s collection of colleges and universities. Regardless of where you come down on the effectiveness of past affirmative action policies, the SCOTUS decision is a done deal. It’s time to move on and begin anew our search for inclusion-promoting strategies that will pass the Court’s litmus test of legality.

I count myself among those who are optimistic that there are enough of us committed individuals that a new and better version of affirmative action is just over the horizon. Some of my supporting evidence can be found in a New York Times article by Stephanie Saul describing the admissions policy at the University of California Davis Medical School. The keystone of the university’s policy is a “socioeconomic disadvantage scale” that takes into account the applicant’s life circumstances, such as parental education and family income. This ranking – on a scale of 0 to 99 – is tossed into the standard mix of grades, test scores, essays, interviews, and recommendations. It shouldn’t surprise that UC Davis is now one of the most diverse medical schools in the United States despite the fact that California voted to ban affirmative action in 1996.

The socioeconomic disadvantage scale may, in the long run, be more effective than the current affirmative action strategies that have been race based. It certainly makes more sense to me. For example, in 2020 the Medical College Admission Test (MCAT) made a significant philosophical change by broadening and deepening its focus on the social sciences. To some extent, this refocusing may have reflected the American Association of Medical Colleges’ search for more well-rounded students and, by extension, more physicians sensitive to the plight of their disadvantaged patients. By weighting the questions more toward subjects such as how bias can influence patient care, it was hoped that the newly minted physicians would view and treat patients not just as victims of illness but as multifaceted individuals who reside in an environment that may be influencing their health.

While I agree with the goal of creating physicians with a broader and more holistic view, the notion that adding questions from social science disciplines is going to achieve this goal never made much sense to me. Answering questions posed by social scientists teaching in a selective academic setting doesn’t necessarily guarantee that the applicant has a full understanding of the real-world consequences of poverty and bias.

On the other hand, an applicant’s responses to a questionnaire about the socioeconomic conditions in which she or he grew up is far more likely to unearth candidates with a deep, broad, and very personal understanding of the challenges that disadvantaged patients face. It’s another one of those been-there-know-how-it-feels kind of things. Reading a book about how to ride a bicycle cannot quite capture the challenge of balancing yourself on two thin wheels.

Whether an affirmative action plan that includes a socioeconomic scale will indeed spawn a crop of physicians who will practice customer-friendly, understanding, and sensitive medicine remains to be seen. The pathway to becoming a practicing physician takes a minimum of 6 or 7 years. Much of that education comes in the form of watching and listening to physicians who, in turn, modeled their behavior after the cohort that preceded them in a very old system, and so on. There is no guarantee that even the most sensitively selected students will remain immune to incorporating into their practice style some of the systemic bias that will inevitably surround them. But a socioeconomic disadvantage scale is certainly worth a try.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].