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Dr. Faith Fitzgerald was dedicated to her patients, students, and friends
Dr. Fitzgerald adopted this means of transportation to allow her to examine and talk to her patients, following a hip injury and surgery, which left her unable to do the amount of walking typically required to conduct rounds at a hospital.
Her colleague, Mark C. Henderson, MD, MACP, described Dr. Fitzgerald as being “extremely dedicated to each patient,” having taken care of many of them for decades. Her will to find a way to practice with severe physical limitations exemplified this dedication, said Dr. Henderson, who worked in the hospital alongside her, including handing over patients to her.
Dr. Fitzgerald died on Dec. 3, 2021, at 78 years, after working in a career spanning 6 decades, including actively practicing internal medicine at UC Davis Medical Center for 40 years.
Her career also included working as a medical educator, influencing several people interviewed for this story in that role, and advising the staff of Internal Medicine News for more than 3 decades.
“Faith Fitzgerald was an incredible teacher and mentor for so many people,” noted Robert H. Hopkins Jr., MD, who practices general internal medicine and med-peds at the University of Arkansans for Medical Sciences, Little Rock and is a member of the editorial advisory board of Internal Medicine News.
‘The patient and the next generation’ were always in mind
A contributor to Dr. Fitzgerald’s success as an educator was her dogged commitment to her patients, said Dr. Henderson, who is associate dean for admissions at the University of California, Davis, and professor and vice chair for education in the department of internal medicine. The latter of these positions was previously held by Dr. Fitzgerald.
“She always arrived early for hospital rounds, often waking up her patients,” he said. “She evolved this practice to be present before all the chaos of the day ensued and honestly to spend quality of time with patients.”
“She always had two things in mind: the patient and the next generation,” Dr. Henderson continued. “A lot of times, because she had seen the patients earlier in the morning, she knew where to focus the team she was training” and “she could show her students and residents all of these interesting findings.”
“It was a very efficient way of conducting bedside teaching,” he added.
Dr. Fitzgerald taught primarily in the department of internal medicine at UC Davis Health. She joined the faculty of that school in 1980. Her 38-year-long career there included serving as residency program director for nearly 20 years, chief of general medicine, vice chair for education, and the medical school’s first associate dean for humanities and bioethics.
Several people who knew Dr. Fitzgerald well also attributed her effectiveness as a teacher and a doctor to the kindness she showed all people no matter their background or station in life.
“Every patient she saw in clinic, she booked for an hour ‘til the day she left UC Davis,” noted Carmelina Raffetto, Dr. Fitzgerald’s closest friend and former administrative assistant, during UC Davis Health’s virtual memorial ceremony for Dr. Fitzgerald.
“Her patients all had her phone number, her pager. ... She loved teaching, she loved her patients, and she loved staff.
“She treated all of us equally. Whether you were in housekeeping or in the cafeteria, or if you were just walking down the hall, she had kind words and she never wanted anyone to feel that they weren’t’ special,” added Ms. Raffetto, who is currently executive director of the Northern California American College of Physicians chapter.
Throughout her career, she received over three dozen teaching awards, according to a statement from UC Davis. In 2002, for example, Dr. Fitzgerald received the Alpha Omega Alpha medical honor society’s Robert J. Glaser Award for providing medical students with an outstanding educational experience. Additional teaching awards included the American College of Physicians Distinguished Teacher Award, the California Medical Association Golden Apple Award and the UC San Francisco Gold Headed Cane.
She also received awards from UC Davis, including the Hibbard Williams Lifetime Achievement award, the Tupper Award for Excellence in Teaching and the UC Davis School of Medicine Golden Apple Award. She was also chosen as the UC Davis Senior Class Outstanding Clinical Teacher seven times and was named the Department of Medicine Distinguished Faculty Teacher on four separate occasions, the statement said.
Her early life and family
Dr. Fitzgerald was born in Boston on Sept. 24, 1943, and “knew from early childhood that she would be a physician,” according to her biography on Changing the Face of Medicine.
She completed undergraduate studies at the University of California, Santa Barbara. She graduated from the University of California, San Francisco, in 1969 and completed her residency in internal medicine at the same institution. In addition to teaching at UC Davis, Dr. Fitzgerald served as assistant professor of medicine at University of Michigan, Ann Arbor, for 2 years early in her career.
Dr. Fitzgerald is survived by her brother, Sean, and sister-in-law, Deborah Fitzgerald. Dr. Fitzgerald lived with and cared for her mother, Irene Fitzgerald – who passed away in 2005 – for more than a decade.
Dr. Fitzgerald asked for any donations in her memory to be used to establish scholarships for medical students with financial need, as she had been supported by scholarship money long ago while a student at the University of California. Donations to the Faith Fitzgerald, MD, Medical Student Scholarship Fund can be made here.
Dr. Fitzgerald adopted this means of transportation to allow her to examine and talk to her patients, following a hip injury and surgery, which left her unable to do the amount of walking typically required to conduct rounds at a hospital.
Her colleague, Mark C. Henderson, MD, MACP, described Dr. Fitzgerald as being “extremely dedicated to each patient,” having taken care of many of them for decades. Her will to find a way to practice with severe physical limitations exemplified this dedication, said Dr. Henderson, who worked in the hospital alongside her, including handing over patients to her.
Dr. Fitzgerald died on Dec. 3, 2021, at 78 years, after working in a career spanning 6 decades, including actively practicing internal medicine at UC Davis Medical Center for 40 years.
Her career also included working as a medical educator, influencing several people interviewed for this story in that role, and advising the staff of Internal Medicine News for more than 3 decades.
“Faith Fitzgerald was an incredible teacher and mentor for so many people,” noted Robert H. Hopkins Jr., MD, who practices general internal medicine and med-peds at the University of Arkansans for Medical Sciences, Little Rock and is a member of the editorial advisory board of Internal Medicine News.
‘The patient and the next generation’ were always in mind
A contributor to Dr. Fitzgerald’s success as an educator was her dogged commitment to her patients, said Dr. Henderson, who is associate dean for admissions at the University of California, Davis, and professor and vice chair for education in the department of internal medicine. The latter of these positions was previously held by Dr. Fitzgerald.
“She always arrived early for hospital rounds, often waking up her patients,” he said. “She evolved this practice to be present before all the chaos of the day ensued and honestly to spend quality of time with patients.”
“She always had two things in mind: the patient and the next generation,” Dr. Henderson continued. “A lot of times, because she had seen the patients earlier in the morning, she knew where to focus the team she was training” and “she could show her students and residents all of these interesting findings.”
“It was a very efficient way of conducting bedside teaching,” he added.
Dr. Fitzgerald taught primarily in the department of internal medicine at UC Davis Health. She joined the faculty of that school in 1980. Her 38-year-long career there included serving as residency program director for nearly 20 years, chief of general medicine, vice chair for education, and the medical school’s first associate dean for humanities and bioethics.
Several people who knew Dr. Fitzgerald well also attributed her effectiveness as a teacher and a doctor to the kindness she showed all people no matter their background or station in life.
“Every patient she saw in clinic, she booked for an hour ‘til the day she left UC Davis,” noted Carmelina Raffetto, Dr. Fitzgerald’s closest friend and former administrative assistant, during UC Davis Health’s virtual memorial ceremony for Dr. Fitzgerald.
“Her patients all had her phone number, her pager. ... She loved teaching, she loved her patients, and she loved staff.
“She treated all of us equally. Whether you were in housekeeping or in the cafeteria, or if you were just walking down the hall, she had kind words and she never wanted anyone to feel that they weren’t’ special,” added Ms. Raffetto, who is currently executive director of the Northern California American College of Physicians chapter.
Throughout her career, she received over three dozen teaching awards, according to a statement from UC Davis. In 2002, for example, Dr. Fitzgerald received the Alpha Omega Alpha medical honor society’s Robert J. Glaser Award for providing medical students with an outstanding educational experience. Additional teaching awards included the American College of Physicians Distinguished Teacher Award, the California Medical Association Golden Apple Award and the UC San Francisco Gold Headed Cane.
She also received awards from UC Davis, including the Hibbard Williams Lifetime Achievement award, the Tupper Award for Excellence in Teaching and the UC Davis School of Medicine Golden Apple Award. She was also chosen as the UC Davis Senior Class Outstanding Clinical Teacher seven times and was named the Department of Medicine Distinguished Faculty Teacher on four separate occasions, the statement said.
Her early life and family
Dr. Fitzgerald was born in Boston on Sept. 24, 1943, and “knew from early childhood that she would be a physician,” according to her biography on Changing the Face of Medicine.
She completed undergraduate studies at the University of California, Santa Barbara. She graduated from the University of California, San Francisco, in 1969 and completed her residency in internal medicine at the same institution. In addition to teaching at UC Davis, Dr. Fitzgerald served as assistant professor of medicine at University of Michigan, Ann Arbor, for 2 years early in her career.
Dr. Fitzgerald is survived by her brother, Sean, and sister-in-law, Deborah Fitzgerald. Dr. Fitzgerald lived with and cared for her mother, Irene Fitzgerald – who passed away in 2005 – for more than a decade.
Dr. Fitzgerald asked for any donations in her memory to be used to establish scholarships for medical students with financial need, as she had been supported by scholarship money long ago while a student at the University of California. Donations to the Faith Fitzgerald, MD, Medical Student Scholarship Fund can be made here.
Dr. Fitzgerald adopted this means of transportation to allow her to examine and talk to her patients, following a hip injury and surgery, which left her unable to do the amount of walking typically required to conduct rounds at a hospital.
Her colleague, Mark C. Henderson, MD, MACP, described Dr. Fitzgerald as being “extremely dedicated to each patient,” having taken care of many of them for decades. Her will to find a way to practice with severe physical limitations exemplified this dedication, said Dr. Henderson, who worked in the hospital alongside her, including handing over patients to her.
Dr. Fitzgerald died on Dec. 3, 2021, at 78 years, after working in a career spanning 6 decades, including actively practicing internal medicine at UC Davis Medical Center for 40 years.
Her career also included working as a medical educator, influencing several people interviewed for this story in that role, and advising the staff of Internal Medicine News for more than 3 decades.
“Faith Fitzgerald was an incredible teacher and mentor for so many people,” noted Robert H. Hopkins Jr., MD, who practices general internal medicine and med-peds at the University of Arkansans for Medical Sciences, Little Rock and is a member of the editorial advisory board of Internal Medicine News.
‘The patient and the next generation’ were always in mind
A contributor to Dr. Fitzgerald’s success as an educator was her dogged commitment to her patients, said Dr. Henderson, who is associate dean for admissions at the University of California, Davis, and professor and vice chair for education in the department of internal medicine. The latter of these positions was previously held by Dr. Fitzgerald.
“She always arrived early for hospital rounds, often waking up her patients,” he said. “She evolved this practice to be present before all the chaos of the day ensued and honestly to spend quality of time with patients.”
“She always had two things in mind: the patient and the next generation,” Dr. Henderson continued. “A lot of times, because she had seen the patients earlier in the morning, she knew where to focus the team she was training” and “she could show her students and residents all of these interesting findings.”
“It was a very efficient way of conducting bedside teaching,” he added.
Dr. Fitzgerald taught primarily in the department of internal medicine at UC Davis Health. She joined the faculty of that school in 1980. Her 38-year-long career there included serving as residency program director for nearly 20 years, chief of general medicine, vice chair for education, and the medical school’s first associate dean for humanities and bioethics.
Several people who knew Dr. Fitzgerald well also attributed her effectiveness as a teacher and a doctor to the kindness she showed all people no matter their background or station in life.
“Every patient she saw in clinic, she booked for an hour ‘til the day she left UC Davis,” noted Carmelina Raffetto, Dr. Fitzgerald’s closest friend and former administrative assistant, during UC Davis Health’s virtual memorial ceremony for Dr. Fitzgerald.
“Her patients all had her phone number, her pager. ... She loved teaching, she loved her patients, and she loved staff.
“She treated all of us equally. Whether you were in housekeeping or in the cafeteria, or if you were just walking down the hall, she had kind words and she never wanted anyone to feel that they weren’t’ special,” added Ms. Raffetto, who is currently executive director of the Northern California American College of Physicians chapter.
Throughout her career, she received over three dozen teaching awards, according to a statement from UC Davis. In 2002, for example, Dr. Fitzgerald received the Alpha Omega Alpha medical honor society’s Robert J. Glaser Award for providing medical students with an outstanding educational experience. Additional teaching awards included the American College of Physicians Distinguished Teacher Award, the California Medical Association Golden Apple Award and the UC San Francisco Gold Headed Cane.
She also received awards from UC Davis, including the Hibbard Williams Lifetime Achievement award, the Tupper Award for Excellence in Teaching and the UC Davis School of Medicine Golden Apple Award. She was also chosen as the UC Davis Senior Class Outstanding Clinical Teacher seven times and was named the Department of Medicine Distinguished Faculty Teacher on four separate occasions, the statement said.
Her early life and family
Dr. Fitzgerald was born in Boston on Sept. 24, 1943, and “knew from early childhood that she would be a physician,” according to her biography on Changing the Face of Medicine.
She completed undergraduate studies at the University of California, Santa Barbara. She graduated from the University of California, San Francisco, in 1969 and completed her residency in internal medicine at the same institution. In addition to teaching at UC Davis, Dr. Fitzgerald served as assistant professor of medicine at University of Michigan, Ann Arbor, for 2 years early in her career.
Dr. Fitzgerald is survived by her brother, Sean, and sister-in-law, Deborah Fitzgerald. Dr. Fitzgerald lived with and cared for her mother, Irene Fitzgerald – who passed away in 2005 – for more than a decade.
Dr. Fitzgerald asked for any donations in her memory to be used to establish scholarships for medical students with financial need, as she had been supported by scholarship money long ago while a student at the University of California. Donations to the Faith Fitzgerald, MD, Medical Student Scholarship Fund can be made here.
Women in rheumatology: A look back, a look forward
Jean Liew, MD, recalls the long list of women mentors who have guided her career in rheumatology.
It started during her residency, when Jennifer Barton, MD, at Oregon Health & Science University, Portland, exposed her to new ways of conducting clinical research on patient outcomes.
In fellowship, she met Lianne Gensler, MD, a leader in axial spondyloarthritis, at the annual meeting of the American College of Rheumatology. Through Dr. Gensler’s mentorship and sponsorship, she was introduced to Maureen Dubreuil, MD, at Boston University, whose research focuses on pharmacoepidemiologic approaches using large databases.
Dr. Liew currently practices rheumatology under the leadership of Tuhina Neogi, MD, a world-renowned expert in osteoarthritis and gout. “She’s my research mentor,” Dr. Liew, an assistant professor of medicine at Boston University, said in an interview.
Her academic timeline reflects the powerful network and influence of women rheumatologists, who represent half of the adult rheumatology workforce in the United States. “In the research arena, many experts are women and they serve as role models and mentors to many,” Dr. Liew said.
But there’s more work to do, she and others acknowledged.
Rheumatology faces ongoing workforce shortages while struggling with a gender gap that’s closing but not as quickly as many women rheumatologists would like to see.
The gap persists, despite overall gains in the field of medicine, Vaneet Sandhu, MD, a rheumatologist with Loma Linda (Calif.) University, said in an interview. Women have exceeded men as enrollees in medical colleges, reported the Association of American Medical Colleges. And yet, “our colleagues reported last year that, in academic rheumatology, women are less likely to be full or associate professors than men,” she said.
The odds of being a fellowship program director or division director is similar in both males and females. “So, we’ve had some gains, but there’s always room for more,” Dr. Sandhu said.
Too few physicians
The next 10 years forecasts a dearth in American physicians.
AAMC projects a shortage of 124,000 doctors in the United States by 2034. Following on a similar trajectory, the ACR in 2015 anticipated a 25% drop in the supply of rheumatology clinical providers by 2030, with demand exceeding supply by more than 4,100 clinical employees.
The ACR’s workforce study projected that more women would come into rheumatology, noted Marcy Bolster, MD, director of the rheumatology fellowship training program at Massachusetts General Hospital, Boston. Women make up at least 50% of the workforce and 66% of fellows If these numbers hold, “we’ll definitely see an increase in the percent of women in the workforce” moving forward, Dr. Bolster said in an interview.
Women have helped the shortage to a great extent, said Nilanjana Bose, MD, a rheumatologist at Lonestar Rheumatology, Houston.
The work-life balance that rheumatology offers, combined with its focus on the cognitive part of internal medicine, explains why the field has attracted so many women. Rheumatology provides flexible work options. Women “get to teach or do rounds in the hospital or have a private practice where you’re mostly outpatient with some hospital work,” Dr. Bose said in an interview.
With anticipated shortages looming over the next decade, the profession needs to be cognizant of the different demands women face in their careers and how it can accommodate the workforce to meet the needs of its providers and maintain access for patients, Dr. Bolster said.
There are many innovative ways to match the demand for access. One thought is to create shared positions. Instead of employing four full-time physicians and one person part time, have two people who are working part time, Dr. Bolster suggested. “It is also important to not only expand our workforce with advanced practice providers, but to ensure their retention in the rheumatology workforce, to improve access to care for those with rheumatic diseases.”
Increasing the number of residency positions is another step toward addressing the shortage, Dr. Sandhu offered.
Women rheumatologists should make their voices heard by contacting members of Congress to support legislation that advocates for workforce shortage solutions, “in addition to generally supporting women’s rights and growth in the workplace,” she said.
The gender divide continues
Rosalind Ramsey-Goldman, MD, DrPH, remembers being the only woman in a group of five during her fellowship in the mid-1980s. Few women role models existed within the ACR, especially those in academic careers. “Now, most fellowships have more than 50% women, reflecting the number of women going to medical school,” said Dr. Ramsey-Goldman, Gallagher Research Professor in Rheumatology at Northwestern University and Northwestern Medicine, Chicago.
As more women enter the profession, women rheumatologists in academic rheumatology have started to outpace men in recent years. Some research suggests they’ve made headway in gaining leadership spots at institutions.
One recent paper, a cross-sectional national study of more than 6,100 rheumatologists, found that women had similar odds of attaining fellowship program or division director positions as men. As directors of training programs, women in rheumatology “instill this collaborative and growth mindset that encourages learners to self-reflect and work as a team,” Dr. Sandhu said.
Women bring a different perspective to training, and how curriculum works, Dr. Bose said. Studies have shown that women tend to be more empathic. They ask more questions. “That’s not to say men aren’t good. Women just have an inborn ability for connecting,” and this perspective helps to enrich the educational experience for trainees.
Women who lead training programs are also attuned to realities that female trainees confront, such as dealing with the challenges of achieving the best possible education while also raising a family, noted Graciela S. Alarcón, MD, MPH, who holds emeritus positions at the University of Alabama at Birmingham and the Universidad Peruana Cayetano Heredia in Lima, Peru.
“These program directors cultivate the ability to relate to women trainees in a very personal manner, supporting them in their efforts to achieve a balance between their training demands and their family/personal responsibilities,” she said.
Other research suggests the gender gap hasn’t gone away. Women continue to have lower odds of holding a higher-level professorship, receiving a federal grant, or speaking at academic conferences. They are also less likely to serve as first authors on rheumatology guidelines or recommendations.
Some studies suggest that women see fewer patients and earn less than their male counterparts. At peak difference, men can earn up to $100,000+ more than women. “My own impression is that it takes more efforts for women to reach the same level of recognition than men, and although overt discrimination is rare nowadays, subtle discrimination still occurs,” according to Dr. Alarcón.
Over a lifetime, female physicians can expect to earn less than their male counterparts, with clear implications for different retirement income levels, she said.
Fixing a leaky academic pipeline
The reality is the academic pipeline, and especially the physician-scientist pipeline, “continues to be leaky,” Dr. Liew said. “We know that caregivers to young children have larger barriers to surmount in academics and in research, and that there is a gender disparity present.” The toll of academic medicine on early career women who are parents is especially pronounced. While the pandemic has intensified this problem, it was around pre-COVID, she added.
Women who start in academia as academic clinicians or clinician researchers aren’t always able to meet their goals for promotion within the appropriate time frame. This is because of inequities in the system and lack of support related to maternity leave, childcare, and other issues. As a result, they leave academia and go into private practice or industry, Dr. Liew said.
The ACR in its 2015 survey projected that more women would be seeking part-time positions.
The good news is many academic institutions are taking a more equitable view about different career paths, offering equal parental leave to both men and women, Dr. Bolster noted. “It is essential that workforce planning encompasses the changing responsibilities within families and account for more parental leave by both men and women.” If certain projections come true, with 50% of the profession retiring between 2015 and 2030, combined with more men and women working part time, “it is requisite that workforce strategies plan for this.”
When Dr. Ramsey-Goldman was a trainee and junior faculty, there were no formal maternity leave policies.
Now, this benefit is available, she said. In another critical change, the ACR has made childcare services and a lactation room available for young mothers during its annual meeting. “Virtual meetings afford further ways to interact with colleagues,” she added.
Whether women choose to stay in academia or go into clinical practice is a very personal decision. “But it is also fair that, in some programs, training directors and faculty members can encourage trainees toward academia and its fascinating research possibilities,” Dr. Alarcón offered.
Making gains in research
Women are increasingly driving groundbreaking rheumatology research at all levels, Dr. Sandhu said. “And women empower women. Not infrequently, our female leaders, veterans in rheumatology research, seek younger female rheumatologists to help them grow in their niches. This has been one of the most beautiful things of the sisterhood in rheumatology that I have been blessed to be part of.”
In pediatric rheumatology, young female researchers are leading global research efforts. Some standouts include Kate Webb, MD, a pediatric rheumatologist in Cape Town, South Africa, and scientist who has worked on multisystem inflammatory syndrome during the pandemic. Sheila Angeles-Han, MD, who works on uveitis in juvenile idiopathic arthritis, had a role in recent ACR guidelines. Laura Lewandowski, MD, has also contributed to global rheumatology efforts, especially in low- and middle-income countries, Dr. Liew said.
The 2021 ACR annual meeting highlighted the research efforts of women rheumatologists from around the world. A global rheumatology summit at the meeting featured many women voices, including Dzifa Dey, MD, from Ghana, who received the ACR Distinguished International Rheumatology Professional Award. Ashira Blazer, MD, and Irene Blanco, MD, have spearheaded the ACR’s diversity, equity, and inclusion initiatives.
Women researchers have many opportunities to study rheumatologic diseases that disproportionately affect women, Dr. Alarcón said.
Lupus, for example, affects women in a much higher proportion than men (90% vs. 10%). This may be an attractive target for the best and brightest among future women researchers, Dr. Alarcón suggested. “It is a fact that publications related to lupus in leading internal medicine and rheumatology journals often include women either as first or senior authors. In that context, it can be said that several advances in the study of lupus worldwide can be attributed to women.”
This applies to disparities in social determinants of health that account for extremely complex outcomes in lupus among women of color, compared with White women, in addition to the costs associated with the disease and its impact on morbidity, mortality, and quality of life.
Women rheumatologists have advanced the work in reproductive management of rheumatic diseases, including a recent ACR-endorsed publication that provides formal guidance on managing reproductive health in women with rheumatic disease, Dr. Sandhu said. “One thing is clear: Without women, the work on reproductive diseases in rheumatology to date would not likely be where it is.”
Dr. Ramsey-Goldman added that “this critical work will not only set the stage for clinical care of both women and men regarding their reproductive health but will also inform education strategies for trainees and future research activities, and help direct policy regarding access to care, medication development, and costs of treatment.”
Obtaining grant funding to support salaries and researcher endeavors remains a challenge, Dr. Liew said. “It takes working evenings, weekends, and holidays to meet those goals within a set time frame. So you can see why a female faculty member with children might be disadvantaged, compared to a male counterpart without children.”
Competition for grant funding remains fierce as budgets become tighter, she added.
“We will lose a lot more brilliant and compassionate rheumatologists (clinicians, physician-scientists, and scientists alike) if we do not think of ways to make things more equitable or do not acknowledge the privileges that support some to continued career successes and leave others behind,” Dr. Liew said.
Women who choose a research field should seek out mentor and financial support that will allow them enough protected time to balance out research with other clinical activities, such as teaching and patient care, Dr. Alarcón said.
Training directors, mentors, and faculty should prioritize the needs of current and future women researchers, she said. “The guidance provided to young female trainees toward a successful research career is a formidable challenge that may provide, in turn, enormous satisfaction. There are established avenues to seek funding as new investigators.”
Progress in diversity
Rheumatology as a field is attracting more candidates and all races and genders, Dr. Bose said. “I think in the coming years we will see more and more women from minorities being incorporated into the rheumatology workforce.”
Others would like to see further improvements in diversity and attracting women from historically excluded backgrounds. Patients will benefit from rheumatologists who are able to connect with them through shared languages, cultures, and other life experiences, Dr. Liew said. “It is imperative that we work on recruitment, mentorship, and retention in this regard.”
While the representation of women of color is still inadequate, there has been some progress, Dr. Sandhu said. The number of female Hispanic, Latinx, and Black or African American graduates from medical school has seen a steady rise since 2017. And, AAMC has established task forces such as the Women of Color Initiative to identify strategies for furthering the careers of women of color in academic medicine.
“There’s still a lot of room to grow. I am, however, proud to say we will finally have a woman of color as the president of ACR in 2023,” said Dr. Sandhu, referring to Deborah Dyett Desir, MD.
Dr. Desir discussed the importance of diversifying the ACR in a recent interview.
All rheumatologists know that there is a place for them in the ACR, she stressed. “The demographics of our membership should reflect that of our population.”
As growth in diverse representation occurs, so will recruitment, retention, and a greater awareness and distribution of knowledge and means to address implicit biases and microaggressions, Dr. Sandhu said. “We will see a greater quality of health care, where patients may feel more connected to someone they can identify with.”
Looking ahead
Dr. Alarcón expects women to continue to play a major role in rheumatology, not just in research, education, and patient care but in leadership of academic societies and professional organizations.
“Women in rheumatology have come a long way – a piece of history that I have been fortunate to witness from my beginnings in the early 1970s. We have, I think, paved the way for the next generations of leaders in our beloved specialty field.”
Dr. Bolster is a member of the ACR board of directors and board liaison of the ACR Workforce Solutions Committee. Dr. Ramsey-Goldman has been a GlaxoSmithKline consultant for lupus studies, a consultant and site investigator with Exagen Diagnostics for lupus biomarker studies, and a site investigator for Xencor and Horizon Pharma lupus trials. Dr. Sandhu serves on the ACR’s Committee on Rheumatology Training and Workforce Issues.
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Pioneer days of rheumatology: One veteran looks back
Patricia Woo, CBE, FMedSci, FRCP, has seen it all.
As a member of the British Rheumatology Society and fellow of the Royal College of Physicians, she presented the case for and obtained official training approval for pediatric rheumatology in the 1990s. She also set the wheels in motion to form the Paediatric Rheumatology International Trials Organisation and the Paediatric Rheumatology European Society.
Now 74, Dr. Woo remembers the discrimination she faced in the 1970s. “I was told I couldn’t become an investigator or consultant if I were to marry or have children.” Around the same time, she found out a male clinician researcher didn’t want to work with her, not because of her qualifications, but because she was a woman.
That wouldn’t happen now with all the antidiscrimination laws in place, noted Dr. Woo, an emeritus professor of pediatric rheumatology and previous head of the Centre for Paediatric and Adolescent Rheumatology at UCL, London. Looking at the advances made by women in rheumatology, “there’s a major difference between 3 decades ago and today. If anyone discriminates today, they are called out.”
As the founding president of the Paediatric Rheumatology European Society, Dr. Woo is one of many early trailblazers who weathered many changes and made gains in the profession.
It’s important to recognize the work of Barbara Ansell, MD, the founder of pediatric rheumatology in the Canadian Red Cross Memorial Hospital, said Dr. Woo. Back in the 1960s, this wasn’t even a subspecialty. “Sick kids in general were taken either to pediatricians who didn’t know much about undescribed rheumatological conditions, and rheumatologists who didn’t know or have facilities for pediatric care.”
Dr. Ansell started this work, and Dr. Woo took over when she retired. With her colleagues, she set up a syllabus for pediatric rheumatology to formalize training for all junior doctors. This established a model of multidisciplinary clinical care and research. “Over the years, more women doctors have been attracted to pediatric rheumatology and have done well,” she said.
The rise of female leaders in rheumatology over the past few decades has been exponential, she continued. Women have become presidents of rheumatologic societies. Some established themselves as leaders in specific disciplines.
Carol Black, MD, from the United Kingdom is renowned for her international collaborative work in scleroderma research and clinical care. Patience White, MD in Washington, D.C., started research on the process of transitioning from childhood to adolescent to adult clinical care, a discipline that now has a strong international presence, Dr. Woo said.
The European Alliance of Associations for Rheumatology, which created a task force on gender equity in academic rheumatology, is evolving, she continued. The Academy of Medical Sciences in the United Kingdom also has active gender equality and mentoring programs, including a program to boost the careers of all researchers.
It’s also much easier now for women to become lead authors on papers since many are heads of lab or clinical services, Dr. Woo continued. “I don’t think there’s much discrimination if you’re a good clinician, and/or a good scientist. If women do their work well, they get the appropriate acknowledgment.”
Jean Liew, MD, recalls the long list of women mentors who have guided her career in rheumatology.
It started during her residency, when Jennifer Barton, MD, at Oregon Health & Science University, Portland, exposed her to new ways of conducting clinical research on patient outcomes.
In fellowship, she met Lianne Gensler, MD, a leader in axial spondyloarthritis, at the annual meeting of the American College of Rheumatology. Through Dr. Gensler’s mentorship and sponsorship, she was introduced to Maureen Dubreuil, MD, at Boston University, whose research focuses on pharmacoepidemiologic approaches using large databases.
Dr. Liew currently practices rheumatology under the leadership of Tuhina Neogi, MD, a world-renowned expert in osteoarthritis and gout. “She’s my research mentor,” Dr. Liew, an assistant professor of medicine at Boston University, said in an interview.
Her academic timeline reflects the powerful network and influence of women rheumatologists, who represent half of the adult rheumatology workforce in the United States. “In the research arena, many experts are women and they serve as role models and mentors to many,” Dr. Liew said.
But there’s more work to do, she and others acknowledged.
Rheumatology faces ongoing workforce shortages while struggling with a gender gap that’s closing but not as quickly as many women rheumatologists would like to see.
The gap persists, despite overall gains in the field of medicine, Vaneet Sandhu, MD, a rheumatologist with Loma Linda (Calif.) University, said in an interview. Women have exceeded men as enrollees in medical colleges, reported the Association of American Medical Colleges. And yet, “our colleagues reported last year that, in academic rheumatology, women are less likely to be full or associate professors than men,” she said.
The odds of being a fellowship program director or division director is similar in both males and females. “So, we’ve had some gains, but there’s always room for more,” Dr. Sandhu said.
Too few physicians
The next 10 years forecasts a dearth in American physicians.
AAMC projects a shortage of 124,000 doctors in the United States by 2034. Following on a similar trajectory, the ACR in 2015 anticipated a 25% drop in the supply of rheumatology clinical providers by 2030, with demand exceeding supply by more than 4,100 clinical employees.
The ACR’s workforce study projected that more women would come into rheumatology, noted Marcy Bolster, MD, director of the rheumatology fellowship training program at Massachusetts General Hospital, Boston. Women make up at least 50% of the workforce and 66% of fellows If these numbers hold, “we’ll definitely see an increase in the percent of women in the workforce” moving forward, Dr. Bolster said in an interview.
Women have helped the shortage to a great extent, said Nilanjana Bose, MD, a rheumatologist at Lonestar Rheumatology, Houston.
The work-life balance that rheumatology offers, combined with its focus on the cognitive part of internal medicine, explains why the field has attracted so many women. Rheumatology provides flexible work options. Women “get to teach or do rounds in the hospital or have a private practice where you’re mostly outpatient with some hospital work,” Dr. Bose said in an interview.
With anticipated shortages looming over the next decade, the profession needs to be cognizant of the different demands women face in their careers and how it can accommodate the workforce to meet the needs of its providers and maintain access for patients, Dr. Bolster said.
There are many innovative ways to match the demand for access. One thought is to create shared positions. Instead of employing four full-time physicians and one person part time, have two people who are working part time, Dr. Bolster suggested. “It is also important to not only expand our workforce with advanced practice providers, but to ensure their retention in the rheumatology workforce, to improve access to care for those with rheumatic diseases.”
Increasing the number of residency positions is another step toward addressing the shortage, Dr. Sandhu offered.
Women rheumatologists should make their voices heard by contacting members of Congress to support legislation that advocates for workforce shortage solutions, “in addition to generally supporting women’s rights and growth in the workplace,” she said.
The gender divide continues
Rosalind Ramsey-Goldman, MD, DrPH, remembers being the only woman in a group of five during her fellowship in the mid-1980s. Few women role models existed within the ACR, especially those in academic careers. “Now, most fellowships have more than 50% women, reflecting the number of women going to medical school,” said Dr. Ramsey-Goldman, Gallagher Research Professor in Rheumatology at Northwestern University and Northwestern Medicine, Chicago.
As more women enter the profession, women rheumatologists in academic rheumatology have started to outpace men in recent years. Some research suggests they’ve made headway in gaining leadership spots at institutions.
One recent paper, a cross-sectional national study of more than 6,100 rheumatologists, found that women had similar odds of attaining fellowship program or division director positions as men. As directors of training programs, women in rheumatology “instill this collaborative and growth mindset that encourages learners to self-reflect and work as a team,” Dr. Sandhu said.
Women bring a different perspective to training, and how curriculum works, Dr. Bose said. Studies have shown that women tend to be more empathic. They ask more questions. “That’s not to say men aren’t good. Women just have an inborn ability for connecting,” and this perspective helps to enrich the educational experience for trainees.
Women who lead training programs are also attuned to realities that female trainees confront, such as dealing with the challenges of achieving the best possible education while also raising a family, noted Graciela S. Alarcón, MD, MPH, who holds emeritus positions at the University of Alabama at Birmingham and the Universidad Peruana Cayetano Heredia in Lima, Peru.
“These program directors cultivate the ability to relate to women trainees in a very personal manner, supporting them in their efforts to achieve a balance between their training demands and their family/personal responsibilities,” she said.
Other research suggests the gender gap hasn’t gone away. Women continue to have lower odds of holding a higher-level professorship, receiving a federal grant, or speaking at academic conferences. They are also less likely to serve as first authors on rheumatology guidelines or recommendations.
Some studies suggest that women see fewer patients and earn less than their male counterparts. At peak difference, men can earn up to $100,000+ more than women. “My own impression is that it takes more efforts for women to reach the same level of recognition than men, and although overt discrimination is rare nowadays, subtle discrimination still occurs,” according to Dr. Alarcón.
Over a lifetime, female physicians can expect to earn less than their male counterparts, with clear implications for different retirement income levels, she said.
Fixing a leaky academic pipeline
The reality is the academic pipeline, and especially the physician-scientist pipeline, “continues to be leaky,” Dr. Liew said. “We know that caregivers to young children have larger barriers to surmount in academics and in research, and that there is a gender disparity present.” The toll of academic medicine on early career women who are parents is especially pronounced. While the pandemic has intensified this problem, it was around pre-COVID, she added.
Women who start in academia as academic clinicians or clinician researchers aren’t always able to meet their goals for promotion within the appropriate time frame. This is because of inequities in the system and lack of support related to maternity leave, childcare, and other issues. As a result, they leave academia and go into private practice or industry, Dr. Liew said.
The ACR in its 2015 survey projected that more women would be seeking part-time positions.
The good news is many academic institutions are taking a more equitable view about different career paths, offering equal parental leave to both men and women, Dr. Bolster noted. “It is essential that workforce planning encompasses the changing responsibilities within families and account for more parental leave by both men and women.” If certain projections come true, with 50% of the profession retiring between 2015 and 2030, combined with more men and women working part time, “it is requisite that workforce strategies plan for this.”
When Dr. Ramsey-Goldman was a trainee and junior faculty, there were no formal maternity leave policies.
Now, this benefit is available, she said. In another critical change, the ACR has made childcare services and a lactation room available for young mothers during its annual meeting. “Virtual meetings afford further ways to interact with colleagues,” she added.
Whether women choose to stay in academia or go into clinical practice is a very personal decision. “But it is also fair that, in some programs, training directors and faculty members can encourage trainees toward academia and its fascinating research possibilities,” Dr. Alarcón offered.
Making gains in research
Women are increasingly driving groundbreaking rheumatology research at all levels, Dr. Sandhu said. “And women empower women. Not infrequently, our female leaders, veterans in rheumatology research, seek younger female rheumatologists to help them grow in their niches. This has been one of the most beautiful things of the sisterhood in rheumatology that I have been blessed to be part of.”
In pediatric rheumatology, young female researchers are leading global research efforts. Some standouts include Kate Webb, MD, a pediatric rheumatologist in Cape Town, South Africa, and scientist who has worked on multisystem inflammatory syndrome during the pandemic. Sheila Angeles-Han, MD, who works on uveitis in juvenile idiopathic arthritis, had a role in recent ACR guidelines. Laura Lewandowski, MD, has also contributed to global rheumatology efforts, especially in low- and middle-income countries, Dr. Liew said.
The 2021 ACR annual meeting highlighted the research efforts of women rheumatologists from around the world. A global rheumatology summit at the meeting featured many women voices, including Dzifa Dey, MD, from Ghana, who received the ACR Distinguished International Rheumatology Professional Award. Ashira Blazer, MD, and Irene Blanco, MD, have spearheaded the ACR’s diversity, equity, and inclusion initiatives.
Women researchers have many opportunities to study rheumatologic diseases that disproportionately affect women, Dr. Alarcón said.
Lupus, for example, affects women in a much higher proportion than men (90% vs. 10%). This may be an attractive target for the best and brightest among future women researchers, Dr. Alarcón suggested. “It is a fact that publications related to lupus in leading internal medicine and rheumatology journals often include women either as first or senior authors. In that context, it can be said that several advances in the study of lupus worldwide can be attributed to women.”
This applies to disparities in social determinants of health that account for extremely complex outcomes in lupus among women of color, compared with White women, in addition to the costs associated with the disease and its impact on morbidity, mortality, and quality of life.
Women rheumatologists have advanced the work in reproductive management of rheumatic diseases, including a recent ACR-endorsed publication that provides formal guidance on managing reproductive health in women with rheumatic disease, Dr. Sandhu said. “One thing is clear: Without women, the work on reproductive diseases in rheumatology to date would not likely be where it is.”
Dr. Ramsey-Goldman added that “this critical work will not only set the stage for clinical care of both women and men regarding their reproductive health but will also inform education strategies for trainees and future research activities, and help direct policy regarding access to care, medication development, and costs of treatment.”
Obtaining grant funding to support salaries and researcher endeavors remains a challenge, Dr. Liew said. “It takes working evenings, weekends, and holidays to meet those goals within a set time frame. So you can see why a female faculty member with children might be disadvantaged, compared to a male counterpart without children.”
Competition for grant funding remains fierce as budgets become tighter, she added.
“We will lose a lot more brilliant and compassionate rheumatologists (clinicians, physician-scientists, and scientists alike) if we do not think of ways to make things more equitable or do not acknowledge the privileges that support some to continued career successes and leave others behind,” Dr. Liew said.
Women who choose a research field should seek out mentor and financial support that will allow them enough protected time to balance out research with other clinical activities, such as teaching and patient care, Dr. Alarcón said.
Training directors, mentors, and faculty should prioritize the needs of current and future women researchers, she said. “The guidance provided to young female trainees toward a successful research career is a formidable challenge that may provide, in turn, enormous satisfaction. There are established avenues to seek funding as new investigators.”
Progress in diversity
Rheumatology as a field is attracting more candidates and all races and genders, Dr. Bose said. “I think in the coming years we will see more and more women from minorities being incorporated into the rheumatology workforce.”
Others would like to see further improvements in diversity and attracting women from historically excluded backgrounds. Patients will benefit from rheumatologists who are able to connect with them through shared languages, cultures, and other life experiences, Dr. Liew said. “It is imperative that we work on recruitment, mentorship, and retention in this regard.”
While the representation of women of color is still inadequate, there has been some progress, Dr. Sandhu said. The number of female Hispanic, Latinx, and Black or African American graduates from medical school has seen a steady rise since 2017. And, AAMC has established task forces such as the Women of Color Initiative to identify strategies for furthering the careers of women of color in academic medicine.
“There’s still a lot of room to grow. I am, however, proud to say we will finally have a woman of color as the president of ACR in 2023,” said Dr. Sandhu, referring to Deborah Dyett Desir, MD.
Dr. Desir discussed the importance of diversifying the ACR in a recent interview.
All rheumatologists know that there is a place for them in the ACR, she stressed. “The demographics of our membership should reflect that of our population.”
As growth in diverse representation occurs, so will recruitment, retention, and a greater awareness and distribution of knowledge and means to address implicit biases and microaggressions, Dr. Sandhu said. “We will see a greater quality of health care, where patients may feel more connected to someone they can identify with.”
Looking ahead
Dr. Alarcón expects women to continue to play a major role in rheumatology, not just in research, education, and patient care but in leadership of academic societies and professional organizations.
“Women in rheumatology have come a long way – a piece of history that I have been fortunate to witness from my beginnings in the early 1970s. We have, I think, paved the way for the next generations of leaders in our beloved specialty field.”
Dr. Bolster is a member of the ACR board of directors and board liaison of the ACR Workforce Solutions Committee. Dr. Ramsey-Goldman has been a GlaxoSmithKline consultant for lupus studies, a consultant and site investigator with Exagen Diagnostics for lupus biomarker studies, and a site investigator for Xencor and Horizon Pharma lupus trials. Dr. Sandhu serves on the ACR’s Committee on Rheumatology Training and Workforce Issues.
Related article
Pioneer days of rheumatology: One veteran looks back
Patricia Woo, CBE, FMedSci, FRCP, has seen it all.
As a member of the British Rheumatology Society and fellow of the Royal College of Physicians, she presented the case for and obtained official training approval for pediatric rheumatology in the 1990s. She also set the wheels in motion to form the Paediatric Rheumatology International Trials Organisation and the Paediatric Rheumatology European Society.
Now 74, Dr. Woo remembers the discrimination she faced in the 1970s. “I was told I couldn’t become an investigator or consultant if I were to marry or have children.” Around the same time, she found out a male clinician researcher didn’t want to work with her, not because of her qualifications, but because she was a woman.
That wouldn’t happen now with all the antidiscrimination laws in place, noted Dr. Woo, an emeritus professor of pediatric rheumatology and previous head of the Centre for Paediatric and Adolescent Rheumatology at UCL, London. Looking at the advances made by women in rheumatology, “there’s a major difference between 3 decades ago and today. If anyone discriminates today, they are called out.”
As the founding president of the Paediatric Rheumatology European Society, Dr. Woo is one of many early trailblazers who weathered many changes and made gains in the profession.
It’s important to recognize the work of Barbara Ansell, MD, the founder of pediatric rheumatology in the Canadian Red Cross Memorial Hospital, said Dr. Woo. Back in the 1960s, this wasn’t even a subspecialty. “Sick kids in general were taken either to pediatricians who didn’t know much about undescribed rheumatological conditions, and rheumatologists who didn’t know or have facilities for pediatric care.”
Dr. Ansell started this work, and Dr. Woo took over when she retired. With her colleagues, she set up a syllabus for pediatric rheumatology to formalize training for all junior doctors. This established a model of multidisciplinary clinical care and research. “Over the years, more women doctors have been attracted to pediatric rheumatology and have done well,” she said.
The rise of female leaders in rheumatology over the past few decades has been exponential, she continued. Women have become presidents of rheumatologic societies. Some established themselves as leaders in specific disciplines.
Carol Black, MD, from the United Kingdom is renowned for her international collaborative work in scleroderma research and clinical care. Patience White, MD in Washington, D.C., started research on the process of transitioning from childhood to adolescent to adult clinical care, a discipline that now has a strong international presence, Dr. Woo said.
The European Alliance of Associations for Rheumatology, which created a task force on gender equity in academic rheumatology, is evolving, she continued. The Academy of Medical Sciences in the United Kingdom also has active gender equality and mentoring programs, including a program to boost the careers of all researchers.
It’s also much easier now for women to become lead authors on papers since many are heads of lab or clinical services, Dr. Woo continued. “I don’t think there’s much discrimination if you’re a good clinician, and/or a good scientist. If women do their work well, they get the appropriate acknowledgment.”
Jean Liew, MD, recalls the long list of women mentors who have guided her career in rheumatology.
It started during her residency, when Jennifer Barton, MD, at Oregon Health & Science University, Portland, exposed her to new ways of conducting clinical research on patient outcomes.
In fellowship, she met Lianne Gensler, MD, a leader in axial spondyloarthritis, at the annual meeting of the American College of Rheumatology. Through Dr. Gensler’s mentorship and sponsorship, she was introduced to Maureen Dubreuil, MD, at Boston University, whose research focuses on pharmacoepidemiologic approaches using large databases.
Dr. Liew currently practices rheumatology under the leadership of Tuhina Neogi, MD, a world-renowned expert in osteoarthritis and gout. “She’s my research mentor,” Dr. Liew, an assistant professor of medicine at Boston University, said in an interview.
Her academic timeline reflects the powerful network and influence of women rheumatologists, who represent half of the adult rheumatology workforce in the United States. “In the research arena, many experts are women and they serve as role models and mentors to many,” Dr. Liew said.
But there’s more work to do, she and others acknowledged.
Rheumatology faces ongoing workforce shortages while struggling with a gender gap that’s closing but not as quickly as many women rheumatologists would like to see.
The gap persists, despite overall gains in the field of medicine, Vaneet Sandhu, MD, a rheumatologist with Loma Linda (Calif.) University, said in an interview. Women have exceeded men as enrollees in medical colleges, reported the Association of American Medical Colleges. And yet, “our colleagues reported last year that, in academic rheumatology, women are less likely to be full or associate professors than men,” she said.
The odds of being a fellowship program director or division director is similar in both males and females. “So, we’ve had some gains, but there’s always room for more,” Dr. Sandhu said.
Too few physicians
The next 10 years forecasts a dearth in American physicians.
AAMC projects a shortage of 124,000 doctors in the United States by 2034. Following on a similar trajectory, the ACR in 2015 anticipated a 25% drop in the supply of rheumatology clinical providers by 2030, with demand exceeding supply by more than 4,100 clinical employees.
The ACR’s workforce study projected that more women would come into rheumatology, noted Marcy Bolster, MD, director of the rheumatology fellowship training program at Massachusetts General Hospital, Boston. Women make up at least 50% of the workforce and 66% of fellows If these numbers hold, “we’ll definitely see an increase in the percent of women in the workforce” moving forward, Dr. Bolster said in an interview.
Women have helped the shortage to a great extent, said Nilanjana Bose, MD, a rheumatologist at Lonestar Rheumatology, Houston.
The work-life balance that rheumatology offers, combined with its focus on the cognitive part of internal medicine, explains why the field has attracted so many women. Rheumatology provides flexible work options. Women “get to teach or do rounds in the hospital or have a private practice where you’re mostly outpatient with some hospital work,” Dr. Bose said in an interview.
With anticipated shortages looming over the next decade, the profession needs to be cognizant of the different demands women face in their careers and how it can accommodate the workforce to meet the needs of its providers and maintain access for patients, Dr. Bolster said.
There are many innovative ways to match the demand for access. One thought is to create shared positions. Instead of employing four full-time physicians and one person part time, have two people who are working part time, Dr. Bolster suggested. “It is also important to not only expand our workforce with advanced practice providers, but to ensure their retention in the rheumatology workforce, to improve access to care for those with rheumatic diseases.”
Increasing the number of residency positions is another step toward addressing the shortage, Dr. Sandhu offered.
Women rheumatologists should make their voices heard by contacting members of Congress to support legislation that advocates for workforce shortage solutions, “in addition to generally supporting women’s rights and growth in the workplace,” she said.
The gender divide continues
Rosalind Ramsey-Goldman, MD, DrPH, remembers being the only woman in a group of five during her fellowship in the mid-1980s. Few women role models existed within the ACR, especially those in academic careers. “Now, most fellowships have more than 50% women, reflecting the number of women going to medical school,” said Dr. Ramsey-Goldman, Gallagher Research Professor in Rheumatology at Northwestern University and Northwestern Medicine, Chicago.
As more women enter the profession, women rheumatologists in academic rheumatology have started to outpace men in recent years. Some research suggests they’ve made headway in gaining leadership spots at institutions.
One recent paper, a cross-sectional national study of more than 6,100 rheumatologists, found that women had similar odds of attaining fellowship program or division director positions as men. As directors of training programs, women in rheumatology “instill this collaborative and growth mindset that encourages learners to self-reflect and work as a team,” Dr. Sandhu said.
Women bring a different perspective to training, and how curriculum works, Dr. Bose said. Studies have shown that women tend to be more empathic. They ask more questions. “That’s not to say men aren’t good. Women just have an inborn ability for connecting,” and this perspective helps to enrich the educational experience for trainees.
Women who lead training programs are also attuned to realities that female trainees confront, such as dealing with the challenges of achieving the best possible education while also raising a family, noted Graciela S. Alarcón, MD, MPH, who holds emeritus positions at the University of Alabama at Birmingham and the Universidad Peruana Cayetano Heredia in Lima, Peru.
“These program directors cultivate the ability to relate to women trainees in a very personal manner, supporting them in their efforts to achieve a balance between their training demands and their family/personal responsibilities,” she said.
Other research suggests the gender gap hasn’t gone away. Women continue to have lower odds of holding a higher-level professorship, receiving a federal grant, or speaking at academic conferences. They are also less likely to serve as first authors on rheumatology guidelines or recommendations.
Some studies suggest that women see fewer patients and earn less than their male counterparts. At peak difference, men can earn up to $100,000+ more than women. “My own impression is that it takes more efforts for women to reach the same level of recognition than men, and although overt discrimination is rare nowadays, subtle discrimination still occurs,” according to Dr. Alarcón.
Over a lifetime, female physicians can expect to earn less than their male counterparts, with clear implications for different retirement income levels, she said.
Fixing a leaky academic pipeline
The reality is the academic pipeline, and especially the physician-scientist pipeline, “continues to be leaky,” Dr. Liew said. “We know that caregivers to young children have larger barriers to surmount in academics and in research, and that there is a gender disparity present.” The toll of academic medicine on early career women who are parents is especially pronounced. While the pandemic has intensified this problem, it was around pre-COVID, she added.
Women who start in academia as academic clinicians or clinician researchers aren’t always able to meet their goals for promotion within the appropriate time frame. This is because of inequities in the system and lack of support related to maternity leave, childcare, and other issues. As a result, they leave academia and go into private practice or industry, Dr. Liew said.
The ACR in its 2015 survey projected that more women would be seeking part-time positions.
The good news is many academic institutions are taking a more equitable view about different career paths, offering equal parental leave to both men and women, Dr. Bolster noted. “It is essential that workforce planning encompasses the changing responsibilities within families and account for more parental leave by both men and women.” If certain projections come true, with 50% of the profession retiring between 2015 and 2030, combined with more men and women working part time, “it is requisite that workforce strategies plan for this.”
When Dr. Ramsey-Goldman was a trainee and junior faculty, there were no formal maternity leave policies.
Now, this benefit is available, she said. In another critical change, the ACR has made childcare services and a lactation room available for young mothers during its annual meeting. “Virtual meetings afford further ways to interact with colleagues,” she added.
Whether women choose to stay in academia or go into clinical practice is a very personal decision. “But it is also fair that, in some programs, training directors and faculty members can encourage trainees toward academia and its fascinating research possibilities,” Dr. Alarcón offered.
Making gains in research
Women are increasingly driving groundbreaking rheumatology research at all levels, Dr. Sandhu said. “And women empower women. Not infrequently, our female leaders, veterans in rheumatology research, seek younger female rheumatologists to help them grow in their niches. This has been one of the most beautiful things of the sisterhood in rheumatology that I have been blessed to be part of.”
In pediatric rheumatology, young female researchers are leading global research efforts. Some standouts include Kate Webb, MD, a pediatric rheumatologist in Cape Town, South Africa, and scientist who has worked on multisystem inflammatory syndrome during the pandemic. Sheila Angeles-Han, MD, who works on uveitis in juvenile idiopathic arthritis, had a role in recent ACR guidelines. Laura Lewandowski, MD, has also contributed to global rheumatology efforts, especially in low- and middle-income countries, Dr. Liew said.
The 2021 ACR annual meeting highlighted the research efforts of women rheumatologists from around the world. A global rheumatology summit at the meeting featured many women voices, including Dzifa Dey, MD, from Ghana, who received the ACR Distinguished International Rheumatology Professional Award. Ashira Blazer, MD, and Irene Blanco, MD, have spearheaded the ACR’s diversity, equity, and inclusion initiatives.
Women researchers have many opportunities to study rheumatologic diseases that disproportionately affect women, Dr. Alarcón said.
Lupus, for example, affects women in a much higher proportion than men (90% vs. 10%). This may be an attractive target for the best and brightest among future women researchers, Dr. Alarcón suggested. “It is a fact that publications related to lupus in leading internal medicine and rheumatology journals often include women either as first or senior authors. In that context, it can be said that several advances in the study of lupus worldwide can be attributed to women.”
This applies to disparities in social determinants of health that account for extremely complex outcomes in lupus among women of color, compared with White women, in addition to the costs associated with the disease and its impact on morbidity, mortality, and quality of life.
Women rheumatologists have advanced the work in reproductive management of rheumatic diseases, including a recent ACR-endorsed publication that provides formal guidance on managing reproductive health in women with rheumatic disease, Dr. Sandhu said. “One thing is clear: Without women, the work on reproductive diseases in rheumatology to date would not likely be where it is.”
Dr. Ramsey-Goldman added that “this critical work will not only set the stage for clinical care of both women and men regarding their reproductive health but will also inform education strategies for trainees and future research activities, and help direct policy regarding access to care, medication development, and costs of treatment.”
Obtaining grant funding to support salaries and researcher endeavors remains a challenge, Dr. Liew said. “It takes working evenings, weekends, and holidays to meet those goals within a set time frame. So you can see why a female faculty member with children might be disadvantaged, compared to a male counterpart without children.”
Competition for grant funding remains fierce as budgets become tighter, she added.
“We will lose a lot more brilliant and compassionate rheumatologists (clinicians, physician-scientists, and scientists alike) if we do not think of ways to make things more equitable or do not acknowledge the privileges that support some to continued career successes and leave others behind,” Dr. Liew said.
Women who choose a research field should seek out mentor and financial support that will allow them enough protected time to balance out research with other clinical activities, such as teaching and patient care, Dr. Alarcón said.
Training directors, mentors, and faculty should prioritize the needs of current and future women researchers, she said. “The guidance provided to young female trainees toward a successful research career is a formidable challenge that may provide, in turn, enormous satisfaction. There are established avenues to seek funding as new investigators.”
Progress in diversity
Rheumatology as a field is attracting more candidates and all races and genders, Dr. Bose said. “I think in the coming years we will see more and more women from minorities being incorporated into the rheumatology workforce.”
Others would like to see further improvements in diversity and attracting women from historically excluded backgrounds. Patients will benefit from rheumatologists who are able to connect with them through shared languages, cultures, and other life experiences, Dr. Liew said. “It is imperative that we work on recruitment, mentorship, and retention in this regard.”
While the representation of women of color is still inadequate, there has been some progress, Dr. Sandhu said. The number of female Hispanic, Latinx, and Black or African American graduates from medical school has seen a steady rise since 2017. And, AAMC has established task forces such as the Women of Color Initiative to identify strategies for furthering the careers of women of color in academic medicine.
“There’s still a lot of room to grow. I am, however, proud to say we will finally have a woman of color as the president of ACR in 2023,” said Dr. Sandhu, referring to Deborah Dyett Desir, MD.
Dr. Desir discussed the importance of diversifying the ACR in a recent interview.
All rheumatologists know that there is a place for them in the ACR, she stressed. “The demographics of our membership should reflect that of our population.”
As growth in diverse representation occurs, so will recruitment, retention, and a greater awareness and distribution of knowledge and means to address implicit biases and microaggressions, Dr. Sandhu said. “We will see a greater quality of health care, where patients may feel more connected to someone they can identify with.”
Looking ahead
Dr. Alarcón expects women to continue to play a major role in rheumatology, not just in research, education, and patient care but in leadership of academic societies and professional organizations.
“Women in rheumatology have come a long way – a piece of history that I have been fortunate to witness from my beginnings in the early 1970s. We have, I think, paved the way for the next generations of leaders in our beloved specialty field.”
Dr. Bolster is a member of the ACR board of directors and board liaison of the ACR Workforce Solutions Committee. Dr. Ramsey-Goldman has been a GlaxoSmithKline consultant for lupus studies, a consultant and site investigator with Exagen Diagnostics for lupus biomarker studies, and a site investigator for Xencor and Horizon Pharma lupus trials. Dr. Sandhu serves on the ACR’s Committee on Rheumatology Training and Workforce Issues.
Related article
Pioneer days of rheumatology: One veteran looks back
Patricia Woo, CBE, FMedSci, FRCP, has seen it all.
As a member of the British Rheumatology Society and fellow of the Royal College of Physicians, she presented the case for and obtained official training approval for pediatric rheumatology in the 1990s. She also set the wheels in motion to form the Paediatric Rheumatology International Trials Organisation and the Paediatric Rheumatology European Society.
Now 74, Dr. Woo remembers the discrimination she faced in the 1970s. “I was told I couldn’t become an investigator or consultant if I were to marry or have children.” Around the same time, she found out a male clinician researcher didn’t want to work with her, not because of her qualifications, but because she was a woman.
That wouldn’t happen now with all the antidiscrimination laws in place, noted Dr. Woo, an emeritus professor of pediatric rheumatology and previous head of the Centre for Paediatric and Adolescent Rheumatology at UCL, London. Looking at the advances made by women in rheumatology, “there’s a major difference between 3 decades ago and today. If anyone discriminates today, they are called out.”
As the founding president of the Paediatric Rheumatology European Society, Dr. Woo is one of many early trailblazers who weathered many changes and made gains in the profession.
It’s important to recognize the work of Barbara Ansell, MD, the founder of pediatric rheumatology in the Canadian Red Cross Memorial Hospital, said Dr. Woo. Back in the 1960s, this wasn’t even a subspecialty. “Sick kids in general were taken either to pediatricians who didn’t know much about undescribed rheumatological conditions, and rheumatologists who didn’t know or have facilities for pediatric care.”
Dr. Ansell started this work, and Dr. Woo took over when she retired. With her colleagues, she set up a syllabus for pediatric rheumatology to formalize training for all junior doctors. This established a model of multidisciplinary clinical care and research. “Over the years, more women doctors have been attracted to pediatric rheumatology and have done well,” she said.
The rise of female leaders in rheumatology over the past few decades has been exponential, she continued. Women have become presidents of rheumatologic societies. Some established themselves as leaders in specific disciplines.
Carol Black, MD, from the United Kingdom is renowned for her international collaborative work in scleroderma research and clinical care. Patience White, MD in Washington, D.C., started research on the process of transitioning from childhood to adolescent to adult clinical care, a discipline that now has a strong international presence, Dr. Woo said.
The European Alliance of Associations for Rheumatology, which created a task force on gender equity in academic rheumatology, is evolving, she continued. The Academy of Medical Sciences in the United Kingdom also has active gender equality and mentoring programs, including a program to boost the careers of all researchers.
It’s also much easier now for women to become lead authors on papers since many are heads of lab or clinical services, Dr. Woo continued. “I don’t think there’s much discrimination if you’re a good clinician, and/or a good scientist. If women do their work well, they get the appropriate acknowledgment.”
Real-world data suggest coprescribing PDE5 inhibitors and nitrates may be safe
The authors of the new research specifically examined how frequently phosphodiesterase type 5 (PDE5) inhibitors, such as Viagra, were prescribed. The U.S. Food and Drug Administration and the European Medicines Agency have warned that these drugs for erectile dysfunction are contraindicated for use with nitrates because of concerns about cardiovascular risks.
“Small, randomized, pharmacologic studies have reported an amplified decrease in blood pressure during controlled coexposure with nitrates and [phosphodiesterase type 5 inhibitors], both in healthy participants and in participants with IHD,” wrote lead author Anders Holt, MD, of Copenhagen University Hospital–Herlev and Gentofte and colleagues, in Annals of Internal Medicine. “Potentially, this increases the risk for vascular ischemic events including myocardial infarction and stroke.”
But there is a scarcity of real-world data showing that using both types of drugs together increase these risks, the researchers noted.
To address this knowledge gap, Dr. Holt and colleagues conducted a retrospective study involving 249,541 Danish men with IHD. In this overall population, from 2000 to 2018, prescriptions for PDE5 inhibitors increased 10-fold, from 3.1 to 30.9 prescriptions per 100 persons per year. Within a subgroup of 42,073 patients continuously prescribed oral organic nitrates, PDE5-inhibitor prescriptions jumped twice that magnitude, from 0.9 to 19.7 prescriptions per 100 persons per year.
Despite this surge in coprescribing, the investigators did not observe a significant increase in either of two composite measures of cardiovascular adverse events. The first composite included ischemic stroke, shock, cardiac arrest, myocardial infarction, or acute coronary arteriography (odds ratio, 0.58; 95% confidence interval, 0.28-1.13). The second composite included drug-related adverse events, angina pectoris, or syncope (OR, 0.73; CI, 0.40-1.32).
Lead author speculates on reasons for findings
“I propose several explanations [for these findings],” Dr. Holt said in an interview, “but I want to emphasize that our study does not contain any data to back it up. It is just speculation. First, the observed drop in blood pressure may not cause a condition for which patients seek a hospital. A drop in blood pressure has been shown in pharmacologic trials, but it might not translate to a real-life risk for cardiovascular outcomes. Second, patients could be well informed and adherent to guidance that the prescribing physician has provided. For example, patients are aware of the recommended pause in nitrate treatment before PDE5-inhibitor use and follow these recommendations. Third, nitrates are often taken in the morning, and with the careful assumption that most PDE5-inhibitor activities take place in the evening, the nitrates could be metabolized to a degree such that the synergistic interaction is negligible.”
Dr. Holt went on to suggest a novel clinical approach based on the new findings.
“Coadministration should still be contraindicated due to the proven drop in blood pressure,” he said. “However, perhaps physicians can allow for coprescription if patients are adequately informed.”
A qualitative study is needed to determine how patients and physicians discuss coprescription, including avoidance of coadministration, Dr. Holt added.
Findings call for a reassessment of whether the contraindication is warranted
Robert A. Kloner, MD, PhD, chief science officer at the Huntington Medical Research Institutes in Pasadena, Calif., and professor of medicine at University of Southern California, Los Angeles, previously conducted research exploring drug interactions with PDE5 inhibitors, and in 2018, coauthored a literature review that concluded that PDE5 inhibitors and nitrates are contraindicated.
But now, considering these new findings, Dr. Kloner is offering a fresh perspective.
“This study is reassuring,” Dr. Kloner said in an interview. “I think that it’s time to reassess whether there should be an absolute contraindication, or this should be more of like a warning.”
He noted that in controlled studies, like the ones he previously conducted, PDE5 inhibitors and nitrates were administered “very close to each other, on purpose,” yet this probably doesn’t reflect typical practice, in which clinicians can guide usage based on durations of drug metabolism.
“I think that physicians might be more comfortable now prescribing the drugs at the same time, but then telling patients that they shouldn’t take the two drugs simultaneously; they should wait and take the nitrate 24 hours after the last Viagra, or the nitrate 48 hours after the last Cialis,” Dr. Kloner said. “I suspect that that is happening. I suspect also the fact that people would be more likely to take the nitrate in the morning and the PDE5 inhibitor at night probably also contributes to the safety findings.”
Dr. Kloner noted that blood pressures vary throughout the day based on circadian rhythm, and that the body can adapt to some fluctuations without negative effects.
There could still be some people who experience a drop in blood pressure and get sick from it from the two drugs interacting, but that’s probably not that common, he said.
The study was supported by several grants. The investigators disclosed relationships with Merck, BMS, Bayer, and others. Dr. Kloner consults for Sanofi.
The authors of the new research specifically examined how frequently phosphodiesterase type 5 (PDE5) inhibitors, such as Viagra, were prescribed. The U.S. Food and Drug Administration and the European Medicines Agency have warned that these drugs for erectile dysfunction are contraindicated for use with nitrates because of concerns about cardiovascular risks.
“Small, randomized, pharmacologic studies have reported an amplified decrease in blood pressure during controlled coexposure with nitrates and [phosphodiesterase type 5 inhibitors], both in healthy participants and in participants with IHD,” wrote lead author Anders Holt, MD, of Copenhagen University Hospital–Herlev and Gentofte and colleagues, in Annals of Internal Medicine. “Potentially, this increases the risk for vascular ischemic events including myocardial infarction and stroke.”
But there is a scarcity of real-world data showing that using both types of drugs together increase these risks, the researchers noted.
To address this knowledge gap, Dr. Holt and colleagues conducted a retrospective study involving 249,541 Danish men with IHD. In this overall population, from 2000 to 2018, prescriptions for PDE5 inhibitors increased 10-fold, from 3.1 to 30.9 prescriptions per 100 persons per year. Within a subgroup of 42,073 patients continuously prescribed oral organic nitrates, PDE5-inhibitor prescriptions jumped twice that magnitude, from 0.9 to 19.7 prescriptions per 100 persons per year.
Despite this surge in coprescribing, the investigators did not observe a significant increase in either of two composite measures of cardiovascular adverse events. The first composite included ischemic stroke, shock, cardiac arrest, myocardial infarction, or acute coronary arteriography (odds ratio, 0.58; 95% confidence interval, 0.28-1.13). The second composite included drug-related adverse events, angina pectoris, or syncope (OR, 0.73; CI, 0.40-1.32).
Lead author speculates on reasons for findings
“I propose several explanations [for these findings],” Dr. Holt said in an interview, “but I want to emphasize that our study does not contain any data to back it up. It is just speculation. First, the observed drop in blood pressure may not cause a condition for which patients seek a hospital. A drop in blood pressure has been shown in pharmacologic trials, but it might not translate to a real-life risk for cardiovascular outcomes. Second, patients could be well informed and adherent to guidance that the prescribing physician has provided. For example, patients are aware of the recommended pause in nitrate treatment before PDE5-inhibitor use and follow these recommendations. Third, nitrates are often taken in the morning, and with the careful assumption that most PDE5-inhibitor activities take place in the evening, the nitrates could be metabolized to a degree such that the synergistic interaction is negligible.”
Dr. Holt went on to suggest a novel clinical approach based on the new findings.
“Coadministration should still be contraindicated due to the proven drop in blood pressure,” he said. “However, perhaps physicians can allow for coprescription if patients are adequately informed.”
A qualitative study is needed to determine how patients and physicians discuss coprescription, including avoidance of coadministration, Dr. Holt added.
Findings call for a reassessment of whether the contraindication is warranted
Robert A. Kloner, MD, PhD, chief science officer at the Huntington Medical Research Institutes in Pasadena, Calif., and professor of medicine at University of Southern California, Los Angeles, previously conducted research exploring drug interactions with PDE5 inhibitors, and in 2018, coauthored a literature review that concluded that PDE5 inhibitors and nitrates are contraindicated.
But now, considering these new findings, Dr. Kloner is offering a fresh perspective.
“This study is reassuring,” Dr. Kloner said in an interview. “I think that it’s time to reassess whether there should be an absolute contraindication, or this should be more of like a warning.”
He noted that in controlled studies, like the ones he previously conducted, PDE5 inhibitors and nitrates were administered “very close to each other, on purpose,” yet this probably doesn’t reflect typical practice, in which clinicians can guide usage based on durations of drug metabolism.
“I think that physicians might be more comfortable now prescribing the drugs at the same time, but then telling patients that they shouldn’t take the two drugs simultaneously; they should wait and take the nitrate 24 hours after the last Viagra, or the nitrate 48 hours after the last Cialis,” Dr. Kloner said. “I suspect that that is happening. I suspect also the fact that people would be more likely to take the nitrate in the morning and the PDE5 inhibitor at night probably also contributes to the safety findings.”
Dr. Kloner noted that blood pressures vary throughout the day based on circadian rhythm, and that the body can adapt to some fluctuations without negative effects.
There could still be some people who experience a drop in blood pressure and get sick from it from the two drugs interacting, but that’s probably not that common, he said.
The study was supported by several grants. The investigators disclosed relationships with Merck, BMS, Bayer, and others. Dr. Kloner consults for Sanofi.
The authors of the new research specifically examined how frequently phosphodiesterase type 5 (PDE5) inhibitors, such as Viagra, were prescribed. The U.S. Food and Drug Administration and the European Medicines Agency have warned that these drugs for erectile dysfunction are contraindicated for use with nitrates because of concerns about cardiovascular risks.
“Small, randomized, pharmacologic studies have reported an amplified decrease in blood pressure during controlled coexposure with nitrates and [phosphodiesterase type 5 inhibitors], both in healthy participants and in participants with IHD,” wrote lead author Anders Holt, MD, of Copenhagen University Hospital–Herlev and Gentofte and colleagues, in Annals of Internal Medicine. “Potentially, this increases the risk for vascular ischemic events including myocardial infarction and stroke.”
But there is a scarcity of real-world data showing that using both types of drugs together increase these risks, the researchers noted.
To address this knowledge gap, Dr. Holt and colleagues conducted a retrospective study involving 249,541 Danish men with IHD. In this overall population, from 2000 to 2018, prescriptions for PDE5 inhibitors increased 10-fold, from 3.1 to 30.9 prescriptions per 100 persons per year. Within a subgroup of 42,073 patients continuously prescribed oral organic nitrates, PDE5-inhibitor prescriptions jumped twice that magnitude, from 0.9 to 19.7 prescriptions per 100 persons per year.
Despite this surge in coprescribing, the investigators did not observe a significant increase in either of two composite measures of cardiovascular adverse events. The first composite included ischemic stroke, shock, cardiac arrest, myocardial infarction, or acute coronary arteriography (odds ratio, 0.58; 95% confidence interval, 0.28-1.13). The second composite included drug-related adverse events, angina pectoris, or syncope (OR, 0.73; CI, 0.40-1.32).
Lead author speculates on reasons for findings
“I propose several explanations [for these findings],” Dr. Holt said in an interview, “but I want to emphasize that our study does not contain any data to back it up. It is just speculation. First, the observed drop in blood pressure may not cause a condition for which patients seek a hospital. A drop in blood pressure has been shown in pharmacologic trials, but it might not translate to a real-life risk for cardiovascular outcomes. Second, patients could be well informed and adherent to guidance that the prescribing physician has provided. For example, patients are aware of the recommended pause in nitrate treatment before PDE5-inhibitor use and follow these recommendations. Third, nitrates are often taken in the morning, and with the careful assumption that most PDE5-inhibitor activities take place in the evening, the nitrates could be metabolized to a degree such that the synergistic interaction is negligible.”
Dr. Holt went on to suggest a novel clinical approach based on the new findings.
“Coadministration should still be contraindicated due to the proven drop in blood pressure,” he said. “However, perhaps physicians can allow for coprescription if patients are adequately informed.”
A qualitative study is needed to determine how patients and physicians discuss coprescription, including avoidance of coadministration, Dr. Holt added.
Findings call for a reassessment of whether the contraindication is warranted
Robert A. Kloner, MD, PhD, chief science officer at the Huntington Medical Research Institutes in Pasadena, Calif., and professor of medicine at University of Southern California, Los Angeles, previously conducted research exploring drug interactions with PDE5 inhibitors, and in 2018, coauthored a literature review that concluded that PDE5 inhibitors and nitrates are contraindicated.
But now, considering these new findings, Dr. Kloner is offering a fresh perspective.
“This study is reassuring,” Dr. Kloner said in an interview. “I think that it’s time to reassess whether there should be an absolute contraindication, or this should be more of like a warning.”
He noted that in controlled studies, like the ones he previously conducted, PDE5 inhibitors and nitrates were administered “very close to each other, on purpose,” yet this probably doesn’t reflect typical practice, in which clinicians can guide usage based on durations of drug metabolism.
“I think that physicians might be more comfortable now prescribing the drugs at the same time, but then telling patients that they shouldn’t take the two drugs simultaneously; they should wait and take the nitrate 24 hours after the last Viagra, or the nitrate 48 hours after the last Cialis,” Dr. Kloner said. “I suspect that that is happening. I suspect also the fact that people would be more likely to take the nitrate in the morning and the PDE5 inhibitor at night probably also contributes to the safety findings.”
Dr. Kloner noted that blood pressures vary throughout the day based on circadian rhythm, and that the body can adapt to some fluctuations without negative effects.
There could still be some people who experience a drop in blood pressure and get sick from it from the two drugs interacting, but that’s probably not that common, he said.
The study was supported by several grants. The investigators disclosed relationships with Merck, BMS, Bayer, and others. Dr. Kloner consults for Sanofi.
FROM ANNALS OF INTERNAL MEDICINE
Who doesn’t text in 2022? Most state Medicaid programs
West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.
What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.
“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.
Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.
“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.
State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.
As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.
West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.
“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.
The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.
In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.
In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.
“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”
CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.
Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.
CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.
Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.
That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.
In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.
Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.
Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”
California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.
California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.
A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.
In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.
Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.
What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.
“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.
Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.
“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.
State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.
As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.
West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.
“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.
The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.
In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.
In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.
“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”
CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.
Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.
CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.
Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.
That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.
In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.
Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.
Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”
California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.
California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.
A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.
In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.
Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.
What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.
“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.
Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.
“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.
State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.
As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.
West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.
“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.
The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.
In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.
In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.
“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”
CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.
Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.
CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.
Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.
That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.
In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.
Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.
Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”
California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.
California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.
A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.
In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.
Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Omicron BA.2: What do we know so far?
Omicron has 30 mutations of the spike protein, compared with the original Wuhan-Hu-1 variant, with 15 mutations of the receptor-binding domain (which are linked to a decrease in antibody binding), mutations at the furin S1/S2 site (which improves furin binding and increases infectiousness), and mutations of the amino terminal domain (which is the main binding site for some of the therapeutic antibodies used to treat COVID-19 infections).
Omicron’s functional characteristics
Non–peer-reviewed studies have shown a replication of Omicron in pulmonary epithelial cells, which was shown to be less efficient, when compared with Delta and Wuhan-Hu-1. The number of viral copies from an Omicron infection in pulmonary epithelial cells was significantly lower, compared with infection with the Delta or Wuhan-Hu-1 variants. The association of these characteristics found an increase in the number of viral copies in human epithelial cells (taken from the nasal airways) infected with Omicron. This supports the understanding that Omicron is more transmissible but results in a less severe manifestation of the disease.
As for the phenotypic expression of the infection, attention has been focused on Omicron’s reduced capacity to cause syncytia in pulmonary tissue cultures, information which is relevant to its clinical significance, if we consider that the formation of syncytia has been associated with a more severe manifestation of the disease. Furthermore, it has emerged that Omicron can use different cellular entry routes, with a preference for endosomal fusion over superficial cellular fusion. This characteristic allows Omicron to significantly increase the number of types of cells it can infect.
Omicron BA.2 evolves
Between November and December 2021, Omicron progressed, evolving into a variant with characteristics similar to those of its predecessors (that is, it underwent a gradual and progressive increase in transmissibility). Early studies on the Omicron variant were mainly based on the BA.1 subvariant. Since the start of January 2022, there has been an unexpected increase in BA.2 in Europe and Asia. Since then, continued surveillance on the evolution of Omicron has shown an increased prevalence of two subvariants: BA.1 with a R346K mutation (BA.1 + R346K) and B.1.1.529.2 (BA.2), with the latter containing eight unique spike mutations and 13 missing spike mutations, compared with those found in BA.1.
From these differences, we cannot presume that their antigenic properties are similar or different, but they seem to be antigenically equidistant from wild-type SARS-CoV-2, likely jeopardizing in equal measures the efficacy of current COVID-19 vaccines. Furthermore, BA.2 shows significant resistance to 17 out of 19 neutralizing monoclonal antibodies tested in this study, demonstrating that current monoclonal antibody therapy may have significant limitations in terms of adequate coverage for all subvariants of the Omicron variant.
Omicron BA.2 and reinfection
BA.2 initially represented only 13% of Omicron sequences at a global level, quickly becoming the dominant form in some countries, such as Denmark. At the end of 2021, BA.2 represented around 20% of all Danish cases of SARS-CoV-2. Halfway through January 2022, this had increased to around 45%, data that indicate that BA.2 carries an advantage over BA.1 within the highly vaccinated population of Denmark.
BA.2 is associated with an increased susceptibility of infection for unvaccinated individuals (odds ratio, 2.19; 95% confidence interval, 1.58-3.04), fully vaccinated individuals (OR, 2.45; 95% CI, 1.77-3.40), and booster-vaccinated individuals (OR, 2.99; 95% CI, 2.11-4.24), compared with BA.1. The pattern of increased transmissibility in BA.2 households was not observed for fully vaccinated and booster-vaccinated primary cases, where the OR of transmission was below 1 for BA.2, compared with BA.1. These data confirm the immune-evasive properties of BA.2 that further reduce the protective effect of vaccination against infection, but do not increase its transmissibility from vaccinated individuals with breakthrough infections.
Omicron, BA.2, and vaccination
The understanding of serum neutralizing activity, in correlation to the efficacy of a vaccine, is a priority of research because of the growing epidemiological significance of BA.2. There is evidence to support the claim that the immune-evasive nature of BA.2 doesn›t seem to be as severe as that of BA.1, and it is possible that there are other viral or host factors that are enabling the rapid diffusion of BA.2. A study published in Science Immunology investigated humoral and cellular immune responses to Omicron and other variants of concern (VOCs), looking to understand how, and to what degree, vaccinated individuals are protected against Omicron. From the results, a very low level of antibody cross-neutralization of Omicron, or a lack thereof, was seen when compared with wild type, Beta, and Delta variants, which could be partially restored by a third booster vaccination. Furthermore, T lymphocytes were shown to recognize Omicron with the same efficacy as seen for the other VOCs, suggesting that vaccinated individuals maintain T lymphocyte immunity, an element that is capable of providing protection in the absence of neutralizing antibodies, limiting the chance of serious disease.
These results are consistent with those available from a study performed in a population from Qatar made up of 2,239,193 people who had received at least two doses of a BNT162b2 or mRNA-1273 vaccine. The efficacy of the booster against a symptomatic Omicron infection, compared with that from the primary series, was 49.4% (95% CI, 47.1-51.6). The efficacy of the booster against hospitalization for COVID-19 and the death rate from Omicron infection, compared with the primary series, was 76.5% (95% CI, 55.9-87.5). The efficacy of the BNT162b2 booster against a symptomatic Delta variant infection (or B.1.617.2), compared with the primary series, was 86.1% (95% CI, 67.3-94.1).
To summarize, the constant increase in the prevalence of BA.2 in more countries over the world has confirmed the growth advantage that this variant has compared with others. BA.2 reduces the protective effect of vaccination against infection. Omicron antibody cross-neutralization can be partially restored by a third booster vaccination, an aspect that becomes problematic in the context of a low vaccination rate, where peaks of Omicron may increase the likelihood of infection in the elderly and in other groups at a higher risk of severe disease. Omicron BA.2 opens up new evolution channels, but what do the experts think will happen?
A version of this article was originally published in Italian on Univadis.
Omicron has 30 mutations of the spike protein, compared with the original Wuhan-Hu-1 variant, with 15 mutations of the receptor-binding domain (which are linked to a decrease in antibody binding), mutations at the furin S1/S2 site (which improves furin binding and increases infectiousness), and mutations of the amino terminal domain (which is the main binding site for some of the therapeutic antibodies used to treat COVID-19 infections).
Omicron’s functional characteristics
Non–peer-reviewed studies have shown a replication of Omicron in pulmonary epithelial cells, which was shown to be less efficient, when compared with Delta and Wuhan-Hu-1. The number of viral copies from an Omicron infection in pulmonary epithelial cells was significantly lower, compared with infection with the Delta or Wuhan-Hu-1 variants. The association of these characteristics found an increase in the number of viral copies in human epithelial cells (taken from the nasal airways) infected with Omicron. This supports the understanding that Omicron is more transmissible but results in a less severe manifestation of the disease.
As for the phenotypic expression of the infection, attention has been focused on Omicron’s reduced capacity to cause syncytia in pulmonary tissue cultures, information which is relevant to its clinical significance, if we consider that the formation of syncytia has been associated with a more severe manifestation of the disease. Furthermore, it has emerged that Omicron can use different cellular entry routes, with a preference for endosomal fusion over superficial cellular fusion. This characteristic allows Omicron to significantly increase the number of types of cells it can infect.
Omicron BA.2 evolves
Between November and December 2021, Omicron progressed, evolving into a variant with characteristics similar to those of its predecessors (that is, it underwent a gradual and progressive increase in transmissibility). Early studies on the Omicron variant were mainly based on the BA.1 subvariant. Since the start of January 2022, there has been an unexpected increase in BA.2 in Europe and Asia. Since then, continued surveillance on the evolution of Omicron has shown an increased prevalence of two subvariants: BA.1 with a R346K mutation (BA.1 + R346K) and B.1.1.529.2 (BA.2), with the latter containing eight unique spike mutations and 13 missing spike mutations, compared with those found in BA.1.
From these differences, we cannot presume that their antigenic properties are similar or different, but they seem to be antigenically equidistant from wild-type SARS-CoV-2, likely jeopardizing in equal measures the efficacy of current COVID-19 vaccines. Furthermore, BA.2 shows significant resistance to 17 out of 19 neutralizing monoclonal antibodies tested in this study, demonstrating that current monoclonal antibody therapy may have significant limitations in terms of adequate coverage for all subvariants of the Omicron variant.
Omicron BA.2 and reinfection
BA.2 initially represented only 13% of Omicron sequences at a global level, quickly becoming the dominant form in some countries, such as Denmark. At the end of 2021, BA.2 represented around 20% of all Danish cases of SARS-CoV-2. Halfway through January 2022, this had increased to around 45%, data that indicate that BA.2 carries an advantage over BA.1 within the highly vaccinated population of Denmark.
BA.2 is associated with an increased susceptibility of infection for unvaccinated individuals (odds ratio, 2.19; 95% confidence interval, 1.58-3.04), fully vaccinated individuals (OR, 2.45; 95% CI, 1.77-3.40), and booster-vaccinated individuals (OR, 2.99; 95% CI, 2.11-4.24), compared with BA.1. The pattern of increased transmissibility in BA.2 households was not observed for fully vaccinated and booster-vaccinated primary cases, where the OR of transmission was below 1 for BA.2, compared with BA.1. These data confirm the immune-evasive properties of BA.2 that further reduce the protective effect of vaccination against infection, but do not increase its transmissibility from vaccinated individuals with breakthrough infections.
Omicron, BA.2, and vaccination
The understanding of serum neutralizing activity, in correlation to the efficacy of a vaccine, is a priority of research because of the growing epidemiological significance of BA.2. There is evidence to support the claim that the immune-evasive nature of BA.2 doesn›t seem to be as severe as that of BA.1, and it is possible that there are other viral or host factors that are enabling the rapid diffusion of BA.2. A study published in Science Immunology investigated humoral and cellular immune responses to Omicron and other variants of concern (VOCs), looking to understand how, and to what degree, vaccinated individuals are protected against Omicron. From the results, a very low level of antibody cross-neutralization of Omicron, or a lack thereof, was seen when compared with wild type, Beta, and Delta variants, which could be partially restored by a third booster vaccination. Furthermore, T lymphocytes were shown to recognize Omicron with the same efficacy as seen for the other VOCs, suggesting that vaccinated individuals maintain T lymphocyte immunity, an element that is capable of providing protection in the absence of neutralizing antibodies, limiting the chance of serious disease.
These results are consistent with those available from a study performed in a population from Qatar made up of 2,239,193 people who had received at least two doses of a BNT162b2 or mRNA-1273 vaccine. The efficacy of the booster against a symptomatic Omicron infection, compared with that from the primary series, was 49.4% (95% CI, 47.1-51.6). The efficacy of the booster against hospitalization for COVID-19 and the death rate from Omicron infection, compared with the primary series, was 76.5% (95% CI, 55.9-87.5). The efficacy of the BNT162b2 booster against a symptomatic Delta variant infection (or B.1.617.2), compared with the primary series, was 86.1% (95% CI, 67.3-94.1).
To summarize, the constant increase in the prevalence of BA.2 in more countries over the world has confirmed the growth advantage that this variant has compared with others. BA.2 reduces the protective effect of vaccination against infection. Omicron antibody cross-neutralization can be partially restored by a third booster vaccination, an aspect that becomes problematic in the context of a low vaccination rate, where peaks of Omicron may increase the likelihood of infection in the elderly and in other groups at a higher risk of severe disease. Omicron BA.2 opens up new evolution channels, but what do the experts think will happen?
A version of this article was originally published in Italian on Univadis.
Omicron has 30 mutations of the spike protein, compared with the original Wuhan-Hu-1 variant, with 15 mutations of the receptor-binding domain (which are linked to a decrease in antibody binding), mutations at the furin S1/S2 site (which improves furin binding and increases infectiousness), and mutations of the amino terminal domain (which is the main binding site for some of the therapeutic antibodies used to treat COVID-19 infections).
Omicron’s functional characteristics
Non–peer-reviewed studies have shown a replication of Omicron in pulmonary epithelial cells, which was shown to be less efficient, when compared with Delta and Wuhan-Hu-1. The number of viral copies from an Omicron infection in pulmonary epithelial cells was significantly lower, compared with infection with the Delta or Wuhan-Hu-1 variants. The association of these characteristics found an increase in the number of viral copies in human epithelial cells (taken from the nasal airways) infected with Omicron. This supports the understanding that Omicron is more transmissible but results in a less severe manifestation of the disease.
As for the phenotypic expression of the infection, attention has been focused on Omicron’s reduced capacity to cause syncytia in pulmonary tissue cultures, information which is relevant to its clinical significance, if we consider that the formation of syncytia has been associated with a more severe manifestation of the disease. Furthermore, it has emerged that Omicron can use different cellular entry routes, with a preference for endosomal fusion over superficial cellular fusion. This characteristic allows Omicron to significantly increase the number of types of cells it can infect.
Omicron BA.2 evolves
Between November and December 2021, Omicron progressed, evolving into a variant with characteristics similar to those of its predecessors (that is, it underwent a gradual and progressive increase in transmissibility). Early studies on the Omicron variant were mainly based on the BA.1 subvariant. Since the start of January 2022, there has been an unexpected increase in BA.2 in Europe and Asia. Since then, continued surveillance on the evolution of Omicron has shown an increased prevalence of two subvariants: BA.1 with a R346K mutation (BA.1 + R346K) and B.1.1.529.2 (BA.2), with the latter containing eight unique spike mutations and 13 missing spike mutations, compared with those found in BA.1.
From these differences, we cannot presume that their antigenic properties are similar or different, but they seem to be antigenically equidistant from wild-type SARS-CoV-2, likely jeopardizing in equal measures the efficacy of current COVID-19 vaccines. Furthermore, BA.2 shows significant resistance to 17 out of 19 neutralizing monoclonal antibodies tested in this study, demonstrating that current monoclonal antibody therapy may have significant limitations in terms of adequate coverage for all subvariants of the Omicron variant.
Omicron BA.2 and reinfection
BA.2 initially represented only 13% of Omicron sequences at a global level, quickly becoming the dominant form in some countries, such as Denmark. At the end of 2021, BA.2 represented around 20% of all Danish cases of SARS-CoV-2. Halfway through January 2022, this had increased to around 45%, data that indicate that BA.2 carries an advantage over BA.1 within the highly vaccinated population of Denmark.
BA.2 is associated with an increased susceptibility of infection for unvaccinated individuals (odds ratio, 2.19; 95% confidence interval, 1.58-3.04), fully vaccinated individuals (OR, 2.45; 95% CI, 1.77-3.40), and booster-vaccinated individuals (OR, 2.99; 95% CI, 2.11-4.24), compared with BA.1. The pattern of increased transmissibility in BA.2 households was not observed for fully vaccinated and booster-vaccinated primary cases, where the OR of transmission was below 1 for BA.2, compared with BA.1. These data confirm the immune-evasive properties of BA.2 that further reduce the protective effect of vaccination against infection, but do not increase its transmissibility from vaccinated individuals with breakthrough infections.
Omicron, BA.2, and vaccination
The understanding of serum neutralizing activity, in correlation to the efficacy of a vaccine, is a priority of research because of the growing epidemiological significance of BA.2. There is evidence to support the claim that the immune-evasive nature of BA.2 doesn›t seem to be as severe as that of BA.1, and it is possible that there are other viral or host factors that are enabling the rapid diffusion of BA.2. A study published in Science Immunology investigated humoral and cellular immune responses to Omicron and other variants of concern (VOCs), looking to understand how, and to what degree, vaccinated individuals are protected against Omicron. From the results, a very low level of antibody cross-neutralization of Omicron, or a lack thereof, was seen when compared with wild type, Beta, and Delta variants, which could be partially restored by a third booster vaccination. Furthermore, T lymphocytes were shown to recognize Omicron with the same efficacy as seen for the other VOCs, suggesting that vaccinated individuals maintain T lymphocyte immunity, an element that is capable of providing protection in the absence of neutralizing antibodies, limiting the chance of serious disease.
These results are consistent with those available from a study performed in a population from Qatar made up of 2,239,193 people who had received at least two doses of a BNT162b2 or mRNA-1273 vaccine. The efficacy of the booster against a symptomatic Omicron infection, compared with that from the primary series, was 49.4% (95% CI, 47.1-51.6). The efficacy of the booster against hospitalization for COVID-19 and the death rate from Omicron infection, compared with the primary series, was 76.5% (95% CI, 55.9-87.5). The efficacy of the BNT162b2 booster against a symptomatic Delta variant infection (or B.1.617.2), compared with the primary series, was 86.1% (95% CI, 67.3-94.1).
To summarize, the constant increase in the prevalence of BA.2 in more countries over the world has confirmed the growth advantage that this variant has compared with others. BA.2 reduces the protective effect of vaccination against infection. Omicron antibody cross-neutralization can be partially restored by a third booster vaccination, an aspect that becomes problematic in the context of a low vaccination rate, where peaks of Omicron may increase the likelihood of infection in the elderly and in other groups at a higher risk of severe disease. Omicron BA.2 opens up new evolution channels, but what do the experts think will happen?
A version of this article was originally published in Italian on Univadis.
More medical schools build training in transgender care
Klay Noto wants to be the kind of doctor he never had when he began to question his gender identity.
A second-year student at Tulane University in New Orleans, he wants to listen compassionately to patients’ concerns and recognize the hurt when they question who they are. He will be the kind of doctor who knows that a breast exam can be traumatizing if someone has been breast binding or that instructing a patient to take everything off and put on a gown can be triggering for someone with gender dysphoria.
Being in the room for hard conversations is part of why he pursued med school. “There aren’t many LGBT people in medicine and as I started to understand all the dynamics that go into it, I started to see that I could do it and I could be that different kind of doctor,” he told this news organization.
Mr. Noto, who transitioned after college, wants to see more transgender people like himself teaching gender medicine, and for all medical students to be trained in what it means to be transgender and how to give compassionate and comprehensive care to all patients.
Gains have been made in providing curriculum in transgender care that trains medical students in such concepts as how to approach gender identity with sensitivity and how to manage hormone therapy and surgery for transitioning patients who request that, according to those interviewed for this story.
But they agree there’s a long way to go to having widespread medical school integration of the health care needs of about 1.4 million transgender people in the United States.
According to the Association of American Medical Colleges (AAMC) Curriculum Inventory data collected from 131 U.S. medical schools, more than 65% offered some form of transgender-related education in 2018, and more than 80% of those provided such curriculum in required courses.
Lack of transgender, nonbinary faculty
Jason Klein, MD, is a pediatric endocrinologist and medical director of the Transgender Youth Health Program at New York (N.Y.) University.
He said in an interview that the number of programs nationally that have gender medicine as a structured part of their curriculum has increased over the last 5-10 years, but that education is not standardized from program to program.
The program at NYU includes lecture-style learning, case presentations, real-world conversations with people in the community, group discussions, and patient care, Dr. Klein said. There are formal lectures as part of adolescent medicine where students learn the differences between gender and sexual identity, and education on medical treatment of transgender and nonbinary adolescents, starting with puberty blockers and moving into affirming hormones.
Doctors also learn to know their limits and decide when to refer patients to a specialist.
“The focus is really about empathic and supportive care,” said Dr. Klein, assistant professor in the department of pediatrics at Hassenfeld Children’s Hospital at NYU Langone Health. “It’s about communication and understanding and the language we use and how to deliver affirming care in a health care setting in general.”
Imagine the potential stressors, he said, of a transgender person entering a typical health care setting. The electronic health record may only have room for the legal name of a person and not the name a person may currently be using. The intake form typically asks patients to check either male or female. The bathrooms give the same two choices.
“Every physician should know how to speak with, treat, emote with, and empathize with care for the trans and nonbinary individual,” Dr. Klein said.
Dr. Klein noted there is a glaring shortage of trans and nonbinary physicians to lead efforts to expand education on integrating the medical, psychological, and psychosocial care that patients will receive.
Currently, gender medicine is not included on board exams for adolescent medicine or endocrinology, he said.
“Adding formal training in gender medicine to board exams would really help solidify the importance of this arena of medicine,” he noted.
First AAMC standards
In 2014, the AAMC released the first standards to guide curricula across medical school and residency to support training doctors to be competent in caring for transgender patients.
The standards include recommending that all doctors be able to communicate with patients related to their gender identity and understand how to deliver high-quality care to transgender and gender-diverse patients within their specialty, Kristen L. Eckstrand, MD, a coauthor of the guidelines, told this news organization.
“Many medical schools have developed their own curricula to meet these standards,” said Dr. Eckstrand, medical director for LGBTQIA+ Health at the University of Pittsburgh Medical Center.
Norma Poll-Hunter, PhD, AAMC’s senior director for workforce diversity, noted that the organization recently released its diversity, equity, and inclusion competencies that guide the medical education of students, residents, and faculty.
Dr. Poll-Hunter told this news organization that AAMC partners with the Building the Next Generation of Academic Physicians LGBT Health Workforce Conference “to support safe spaces for scholarly efforts and mentorship to advance this area of work.”
Team approach at Rutgers
Among the medical schools that incorporate comprehensive transgender care into the curriculum is Rutgers University’s Robert Wood Johnson Medical School in New Brunswick, N.J.
Gloria Bachmann, MD, is professor of obstetrics and gynecology at the school and medical director of its partner, the PROUD Gender Center of New Jersey. PROUD stands for “Promoting Respect, Outreach, Understanding, and Dignity,” and the center provides comprehensive care for transgender and nonbinary patients in one location.
Dr. Bachmann said Rutgers takes a team approach with both instructors and learners teaching medical students about transgender care. The teachers are not only professors in traditional classroom lectures, but patient navigators and nurses at the PROUD center, established as part of the medical school in 2020. Students learn from the navigators, for instance, how to help patients through the spectrum of inpatient and outpatient care.
“All of our learners do get to care for individuals who identify as transgender,” said Dr. Bachmann.
Among the improvements in educating students on transgender care over the years, she said, is the emphasis on social determinants of health. In the transgender population, initial questions may include whether the person is able to access care through insurance as laws vary widely on what care and procedures are covered.
As another example, Dr. Bachmann cites: “If they are seen on an emergency basis and are sent home with medication and follow-up, can they afford it?”
Another consideration is whether there is a home to which they can return.
“Many individuals who are transgender may not have a home. Their family may not be accepting of them. Therefore, it’s the social determinants of health as well as their transgender identity that have to be put into the equation of best care,” she said.
Giving back to the trans community
Mr. Noto doesn’t know whether he will specialize in gender medicine, but he is committed to serving the transgender community in whatever physician path he chooses.
He said he realizes he is fortunate to have strong family support and good insurance and that he can afford fees, such as the copay to see transgender care specialists. Many in the community do not have those resources and are likely to get care “only if they have to.”
At Tulane, training in transgender care starts during orientation week and continues on different levels, with different options, throughout medical school and residency, he added.
Mr. Noto said he would like to see more mandatory learning such as a “queer-centered exam, where you have to give an organ inventory and you have to ask patients if it’s OK to talk about X, Y, and Z.” He’d also like more opportunities for clinical interaction with transgender patients, such as queer-centered rotations.
When physicians aren’t well trained in transgender care, you have patients educating the doctors, which, Mr. Noto said, should not be acceptable.
“People come to you on their worst day. And to not be informed about them in my mind is negligent. In what other population can you choose not to learn about someone just because you don’t want to?” he said.
A version of this article first appeared on Medscape.com.
Klay Noto wants to be the kind of doctor he never had when he began to question his gender identity.
A second-year student at Tulane University in New Orleans, he wants to listen compassionately to patients’ concerns and recognize the hurt when they question who they are. He will be the kind of doctor who knows that a breast exam can be traumatizing if someone has been breast binding or that instructing a patient to take everything off and put on a gown can be triggering for someone with gender dysphoria.
Being in the room for hard conversations is part of why he pursued med school. “There aren’t many LGBT people in medicine and as I started to understand all the dynamics that go into it, I started to see that I could do it and I could be that different kind of doctor,” he told this news organization.
Mr. Noto, who transitioned after college, wants to see more transgender people like himself teaching gender medicine, and for all medical students to be trained in what it means to be transgender and how to give compassionate and comprehensive care to all patients.
Gains have been made in providing curriculum in transgender care that trains medical students in such concepts as how to approach gender identity with sensitivity and how to manage hormone therapy and surgery for transitioning patients who request that, according to those interviewed for this story.
But they agree there’s a long way to go to having widespread medical school integration of the health care needs of about 1.4 million transgender people in the United States.
According to the Association of American Medical Colleges (AAMC) Curriculum Inventory data collected from 131 U.S. medical schools, more than 65% offered some form of transgender-related education in 2018, and more than 80% of those provided such curriculum in required courses.
Lack of transgender, nonbinary faculty
Jason Klein, MD, is a pediatric endocrinologist and medical director of the Transgender Youth Health Program at New York (N.Y.) University.
He said in an interview that the number of programs nationally that have gender medicine as a structured part of their curriculum has increased over the last 5-10 years, but that education is not standardized from program to program.
The program at NYU includes lecture-style learning, case presentations, real-world conversations with people in the community, group discussions, and patient care, Dr. Klein said. There are formal lectures as part of adolescent medicine where students learn the differences between gender and sexual identity, and education on medical treatment of transgender and nonbinary adolescents, starting with puberty blockers and moving into affirming hormones.
Doctors also learn to know their limits and decide when to refer patients to a specialist.
“The focus is really about empathic and supportive care,” said Dr. Klein, assistant professor in the department of pediatrics at Hassenfeld Children’s Hospital at NYU Langone Health. “It’s about communication and understanding and the language we use and how to deliver affirming care in a health care setting in general.”
Imagine the potential stressors, he said, of a transgender person entering a typical health care setting. The electronic health record may only have room for the legal name of a person and not the name a person may currently be using. The intake form typically asks patients to check either male or female. The bathrooms give the same two choices.
“Every physician should know how to speak with, treat, emote with, and empathize with care for the trans and nonbinary individual,” Dr. Klein said.
Dr. Klein noted there is a glaring shortage of trans and nonbinary physicians to lead efforts to expand education on integrating the medical, psychological, and psychosocial care that patients will receive.
Currently, gender medicine is not included on board exams for adolescent medicine or endocrinology, he said.
“Adding formal training in gender medicine to board exams would really help solidify the importance of this arena of medicine,” he noted.
First AAMC standards
In 2014, the AAMC released the first standards to guide curricula across medical school and residency to support training doctors to be competent in caring for transgender patients.
The standards include recommending that all doctors be able to communicate with patients related to their gender identity and understand how to deliver high-quality care to transgender and gender-diverse patients within their specialty, Kristen L. Eckstrand, MD, a coauthor of the guidelines, told this news organization.
“Many medical schools have developed their own curricula to meet these standards,” said Dr. Eckstrand, medical director for LGBTQIA+ Health at the University of Pittsburgh Medical Center.
Norma Poll-Hunter, PhD, AAMC’s senior director for workforce diversity, noted that the organization recently released its diversity, equity, and inclusion competencies that guide the medical education of students, residents, and faculty.
Dr. Poll-Hunter told this news organization that AAMC partners with the Building the Next Generation of Academic Physicians LGBT Health Workforce Conference “to support safe spaces for scholarly efforts and mentorship to advance this area of work.”
Team approach at Rutgers
Among the medical schools that incorporate comprehensive transgender care into the curriculum is Rutgers University’s Robert Wood Johnson Medical School in New Brunswick, N.J.
Gloria Bachmann, MD, is professor of obstetrics and gynecology at the school and medical director of its partner, the PROUD Gender Center of New Jersey. PROUD stands for “Promoting Respect, Outreach, Understanding, and Dignity,” and the center provides comprehensive care for transgender and nonbinary patients in one location.
Dr. Bachmann said Rutgers takes a team approach with both instructors and learners teaching medical students about transgender care. The teachers are not only professors in traditional classroom lectures, but patient navigators and nurses at the PROUD center, established as part of the medical school in 2020. Students learn from the navigators, for instance, how to help patients through the spectrum of inpatient and outpatient care.
“All of our learners do get to care for individuals who identify as transgender,” said Dr. Bachmann.
Among the improvements in educating students on transgender care over the years, she said, is the emphasis on social determinants of health. In the transgender population, initial questions may include whether the person is able to access care through insurance as laws vary widely on what care and procedures are covered.
As another example, Dr. Bachmann cites: “If they are seen on an emergency basis and are sent home with medication and follow-up, can they afford it?”
Another consideration is whether there is a home to which they can return.
“Many individuals who are transgender may not have a home. Their family may not be accepting of them. Therefore, it’s the social determinants of health as well as their transgender identity that have to be put into the equation of best care,” she said.
Giving back to the trans community
Mr. Noto doesn’t know whether he will specialize in gender medicine, but he is committed to serving the transgender community in whatever physician path he chooses.
He said he realizes he is fortunate to have strong family support and good insurance and that he can afford fees, such as the copay to see transgender care specialists. Many in the community do not have those resources and are likely to get care “only if they have to.”
At Tulane, training in transgender care starts during orientation week and continues on different levels, with different options, throughout medical school and residency, he added.
Mr. Noto said he would like to see more mandatory learning such as a “queer-centered exam, where you have to give an organ inventory and you have to ask patients if it’s OK to talk about X, Y, and Z.” He’d also like more opportunities for clinical interaction with transgender patients, such as queer-centered rotations.
When physicians aren’t well trained in transgender care, you have patients educating the doctors, which, Mr. Noto said, should not be acceptable.
“People come to you on their worst day. And to not be informed about them in my mind is negligent. In what other population can you choose not to learn about someone just because you don’t want to?” he said.
A version of this article first appeared on Medscape.com.
Klay Noto wants to be the kind of doctor he never had when he began to question his gender identity.
A second-year student at Tulane University in New Orleans, he wants to listen compassionately to patients’ concerns and recognize the hurt when they question who they are. He will be the kind of doctor who knows that a breast exam can be traumatizing if someone has been breast binding or that instructing a patient to take everything off and put on a gown can be triggering for someone with gender dysphoria.
Being in the room for hard conversations is part of why he pursued med school. “There aren’t many LGBT people in medicine and as I started to understand all the dynamics that go into it, I started to see that I could do it and I could be that different kind of doctor,” he told this news organization.
Mr. Noto, who transitioned after college, wants to see more transgender people like himself teaching gender medicine, and for all medical students to be trained in what it means to be transgender and how to give compassionate and comprehensive care to all patients.
Gains have been made in providing curriculum in transgender care that trains medical students in such concepts as how to approach gender identity with sensitivity and how to manage hormone therapy and surgery for transitioning patients who request that, according to those interviewed for this story.
But they agree there’s a long way to go to having widespread medical school integration of the health care needs of about 1.4 million transgender people in the United States.
According to the Association of American Medical Colleges (AAMC) Curriculum Inventory data collected from 131 U.S. medical schools, more than 65% offered some form of transgender-related education in 2018, and more than 80% of those provided such curriculum in required courses.
Lack of transgender, nonbinary faculty
Jason Klein, MD, is a pediatric endocrinologist and medical director of the Transgender Youth Health Program at New York (N.Y.) University.
He said in an interview that the number of programs nationally that have gender medicine as a structured part of their curriculum has increased over the last 5-10 years, but that education is not standardized from program to program.
The program at NYU includes lecture-style learning, case presentations, real-world conversations with people in the community, group discussions, and patient care, Dr. Klein said. There are formal lectures as part of adolescent medicine where students learn the differences between gender and sexual identity, and education on medical treatment of transgender and nonbinary adolescents, starting with puberty blockers and moving into affirming hormones.
Doctors also learn to know their limits and decide when to refer patients to a specialist.
“The focus is really about empathic and supportive care,” said Dr. Klein, assistant professor in the department of pediatrics at Hassenfeld Children’s Hospital at NYU Langone Health. “It’s about communication and understanding and the language we use and how to deliver affirming care in a health care setting in general.”
Imagine the potential stressors, he said, of a transgender person entering a typical health care setting. The electronic health record may only have room for the legal name of a person and not the name a person may currently be using. The intake form typically asks patients to check either male or female. The bathrooms give the same two choices.
“Every physician should know how to speak with, treat, emote with, and empathize with care for the trans and nonbinary individual,” Dr. Klein said.
Dr. Klein noted there is a glaring shortage of trans and nonbinary physicians to lead efforts to expand education on integrating the medical, psychological, and psychosocial care that patients will receive.
Currently, gender medicine is not included on board exams for adolescent medicine or endocrinology, he said.
“Adding formal training in gender medicine to board exams would really help solidify the importance of this arena of medicine,” he noted.
First AAMC standards
In 2014, the AAMC released the first standards to guide curricula across medical school and residency to support training doctors to be competent in caring for transgender patients.
The standards include recommending that all doctors be able to communicate with patients related to their gender identity and understand how to deliver high-quality care to transgender and gender-diverse patients within their specialty, Kristen L. Eckstrand, MD, a coauthor of the guidelines, told this news organization.
“Many medical schools have developed their own curricula to meet these standards,” said Dr. Eckstrand, medical director for LGBTQIA+ Health at the University of Pittsburgh Medical Center.
Norma Poll-Hunter, PhD, AAMC’s senior director for workforce diversity, noted that the organization recently released its diversity, equity, and inclusion competencies that guide the medical education of students, residents, and faculty.
Dr. Poll-Hunter told this news organization that AAMC partners with the Building the Next Generation of Academic Physicians LGBT Health Workforce Conference “to support safe spaces for scholarly efforts and mentorship to advance this area of work.”
Team approach at Rutgers
Among the medical schools that incorporate comprehensive transgender care into the curriculum is Rutgers University’s Robert Wood Johnson Medical School in New Brunswick, N.J.
Gloria Bachmann, MD, is professor of obstetrics and gynecology at the school and medical director of its partner, the PROUD Gender Center of New Jersey. PROUD stands for “Promoting Respect, Outreach, Understanding, and Dignity,” and the center provides comprehensive care for transgender and nonbinary patients in one location.
Dr. Bachmann said Rutgers takes a team approach with both instructors and learners teaching medical students about transgender care. The teachers are not only professors in traditional classroom lectures, but patient navigators and nurses at the PROUD center, established as part of the medical school in 2020. Students learn from the navigators, for instance, how to help patients through the spectrum of inpatient and outpatient care.
“All of our learners do get to care for individuals who identify as transgender,” said Dr. Bachmann.
Among the improvements in educating students on transgender care over the years, she said, is the emphasis on social determinants of health. In the transgender population, initial questions may include whether the person is able to access care through insurance as laws vary widely on what care and procedures are covered.
As another example, Dr. Bachmann cites: “If they are seen on an emergency basis and are sent home with medication and follow-up, can they afford it?”
Another consideration is whether there is a home to which they can return.
“Many individuals who are transgender may not have a home. Their family may not be accepting of them. Therefore, it’s the social determinants of health as well as their transgender identity that have to be put into the equation of best care,” she said.
Giving back to the trans community
Mr. Noto doesn’t know whether he will specialize in gender medicine, but he is committed to serving the transgender community in whatever physician path he chooses.
He said he realizes he is fortunate to have strong family support and good insurance and that he can afford fees, such as the copay to see transgender care specialists. Many in the community do not have those resources and are likely to get care “only if they have to.”
At Tulane, training in transgender care starts during orientation week and continues on different levels, with different options, throughout medical school and residency, he added.
Mr. Noto said he would like to see more mandatory learning such as a “queer-centered exam, where you have to give an organ inventory and you have to ask patients if it’s OK to talk about X, Y, and Z.” He’d also like more opportunities for clinical interaction with transgender patients, such as queer-centered rotations.
When physicians aren’t well trained in transgender care, you have patients educating the doctors, which, Mr. Noto said, should not be acceptable.
“People come to you on their worst day. And to not be informed about them in my mind is negligent. In what other population can you choose not to learn about someone just because you don’t want to?” he said.
A version of this article first appeared on Medscape.com.
When CPI fails, HL patients should get timely allo-HCT
In fact, prior treatment with PD-1–directed therapies nivolumab (Opdivo) and pembrolizumab (Keytruda) appears to improve outcomes in allo-HCT patients, said Miguel-Angel Perales, MD, chief of the adult bone marrow transplant service at Memorial Sloan Kettering Cancer Center in New York.
“The use of allogeneic HCT is decreasing for Hodgkin even though it is a curative option, and we see patients referred after they have had multiple lines of therapy,” Dr. Perales said in an interview. “The lymphoma MDs have a perception that outcomes are poor, and therefore don’t refer.”
To illustrate his point, Dr. Perales shared data from the EBMT database. In 2014, the registry accrued approximately 450 allo-HCT cases; by 2021 this had fallen to fewer than 200 procedures.
Ironically, this declining enthusiasm for transplantation coincides with a steady improvement in transplant outcomes following PD-1 blockade, Dr. Perales noted. For example, an analysis, published in Nature, yielded an 82% overall survival (OS) at 3 years in patients who underwent allo-HCT after CPI treatment (n =209).
“Results of allo-HCT in patients with Hodgkin show a remarkable cure rate,” said Dr. Perales. “Part of that is probably driven by lower relapse due to enhanced graft-versus-lymphoma effect due to long CPI half-life.” (The half-lives of pembrolizumab and nivolumab are 22 and 25 days, respectively.)
At the EBMT meeting, Dr. Perales presented a new retrospective analysis that tested the hypothesis that CPIs might actually improve outcomes for allo-HCT patients. An international team of clinicians from EBMT and the Center for International Blood and Marrow Transplant Research (CIBMTR) compared allo-HCT outcomes with (n = 347) and without (n = 1,382) prior treatment with a checkpoint inhibitor.
They found that prior CPI therapy was, indeed, associated with lower relapse (hazard ratio, 0.53; P = .00023) and longer progression-free survival (PFS) (HR, 0.75; P = .0171).
However, prior PD-1 drugs provided no survival advantage, Dr. Perales said. “The easiest explanation for a study showing a difference in PFS/relapse, not OS, is that we have good treatments that can treat patients who relapse and so their overall survival ends up being the same.”
The researchers also confirmed previous reports that patients who received PD-1 inhibitors prior to transplant had a higher incidence of GVHD. Prevalence of acute grades 2-4 GVHD was significantly higher (P = .027); however, acute grades 3-4 GVHD and chronic GVHD were not significantly different between the two groups.
Dr. Perales speculated that the use of posttransplant cyclophosphamide for GVHD prophylaxis would mitigate the risk of GVHD associated with PD-1 inhibitors, “we have not yet proven that formally ... [we] are still analyzing our data.”
Commenting on the results of the new analysis, Dr. Perales expressed concern that patients are being recruited to early-phase clinical trials after failing on a checkpoint inhibitor, instead of being offered allo-HCT – a potentially curative treatment – because treaters are misinformed about the safety of transplant after these drugs.
The NIH clinical-trials database backs up Dr. Perales’ worries. In the United States, for example, there are currently 19 trials recruiting for relapsed/refractory Hodgkin lymphoma patients prior to transplant. Of these, 15 studies permit enrollment of patients who have failed on CPIs, and 8 are phase 1 or 2 studies.
“The good news is that new drugs, including CPIs, have dramatically changed outcomes in this disease and that fewer patients now need an allo-HCT,” said Dr. Perales. And if a transplant is needed, “it is safe to perform allo-HCT in patients treated with prior CPI.”
However, time is of the essence. “Patients with Hodgkin lymphoma should be referred to allo-HCT if they are not responding or tolerating CPI, rather than go on a series of phase 1 trials,” Dr. Perales said. “Median age is 32, and we should be going for a cure, nothing less.”
Dr. Perales reported receiving honoraria from numerous pharmaceutical companies; serving on the data and safety monitoring boards of Cidara Therapeutics, Medigene, Sellas Life Sciences, and Servier; and serving on the scientific advisory board of NexImmune. He has ownership interests in NexImmune and Omeros, and has received institutional research support for clinical trials from Incyte, Kite/Gilead, Miltenyi Biotec, Nektar Therapeutics, and Novartis.
In fact, prior treatment with PD-1–directed therapies nivolumab (Opdivo) and pembrolizumab (Keytruda) appears to improve outcomes in allo-HCT patients, said Miguel-Angel Perales, MD, chief of the adult bone marrow transplant service at Memorial Sloan Kettering Cancer Center in New York.
“The use of allogeneic HCT is decreasing for Hodgkin even though it is a curative option, and we see patients referred after they have had multiple lines of therapy,” Dr. Perales said in an interview. “The lymphoma MDs have a perception that outcomes are poor, and therefore don’t refer.”
To illustrate his point, Dr. Perales shared data from the EBMT database. In 2014, the registry accrued approximately 450 allo-HCT cases; by 2021 this had fallen to fewer than 200 procedures.
Ironically, this declining enthusiasm for transplantation coincides with a steady improvement in transplant outcomes following PD-1 blockade, Dr. Perales noted. For example, an analysis, published in Nature, yielded an 82% overall survival (OS) at 3 years in patients who underwent allo-HCT after CPI treatment (n =209).
“Results of allo-HCT in patients with Hodgkin show a remarkable cure rate,” said Dr. Perales. “Part of that is probably driven by lower relapse due to enhanced graft-versus-lymphoma effect due to long CPI half-life.” (The half-lives of pembrolizumab and nivolumab are 22 and 25 days, respectively.)
At the EBMT meeting, Dr. Perales presented a new retrospective analysis that tested the hypothesis that CPIs might actually improve outcomes for allo-HCT patients. An international team of clinicians from EBMT and the Center for International Blood and Marrow Transplant Research (CIBMTR) compared allo-HCT outcomes with (n = 347) and without (n = 1,382) prior treatment with a checkpoint inhibitor.
They found that prior CPI therapy was, indeed, associated with lower relapse (hazard ratio, 0.53; P = .00023) and longer progression-free survival (PFS) (HR, 0.75; P = .0171).
However, prior PD-1 drugs provided no survival advantage, Dr. Perales said. “The easiest explanation for a study showing a difference in PFS/relapse, not OS, is that we have good treatments that can treat patients who relapse and so their overall survival ends up being the same.”
The researchers also confirmed previous reports that patients who received PD-1 inhibitors prior to transplant had a higher incidence of GVHD. Prevalence of acute grades 2-4 GVHD was significantly higher (P = .027); however, acute grades 3-4 GVHD and chronic GVHD were not significantly different between the two groups.
Dr. Perales speculated that the use of posttransplant cyclophosphamide for GVHD prophylaxis would mitigate the risk of GVHD associated with PD-1 inhibitors, “we have not yet proven that formally ... [we] are still analyzing our data.”
Commenting on the results of the new analysis, Dr. Perales expressed concern that patients are being recruited to early-phase clinical trials after failing on a checkpoint inhibitor, instead of being offered allo-HCT – a potentially curative treatment – because treaters are misinformed about the safety of transplant after these drugs.
The NIH clinical-trials database backs up Dr. Perales’ worries. In the United States, for example, there are currently 19 trials recruiting for relapsed/refractory Hodgkin lymphoma patients prior to transplant. Of these, 15 studies permit enrollment of patients who have failed on CPIs, and 8 are phase 1 or 2 studies.
“The good news is that new drugs, including CPIs, have dramatically changed outcomes in this disease and that fewer patients now need an allo-HCT,” said Dr. Perales. And if a transplant is needed, “it is safe to perform allo-HCT in patients treated with prior CPI.”
However, time is of the essence. “Patients with Hodgkin lymphoma should be referred to allo-HCT if they are not responding or tolerating CPI, rather than go on a series of phase 1 trials,” Dr. Perales said. “Median age is 32, and we should be going for a cure, nothing less.”
Dr. Perales reported receiving honoraria from numerous pharmaceutical companies; serving on the data and safety monitoring boards of Cidara Therapeutics, Medigene, Sellas Life Sciences, and Servier; and serving on the scientific advisory board of NexImmune. He has ownership interests in NexImmune and Omeros, and has received institutional research support for clinical trials from Incyte, Kite/Gilead, Miltenyi Biotec, Nektar Therapeutics, and Novartis.
In fact, prior treatment with PD-1–directed therapies nivolumab (Opdivo) and pembrolizumab (Keytruda) appears to improve outcomes in allo-HCT patients, said Miguel-Angel Perales, MD, chief of the adult bone marrow transplant service at Memorial Sloan Kettering Cancer Center in New York.
“The use of allogeneic HCT is decreasing for Hodgkin even though it is a curative option, and we see patients referred after they have had multiple lines of therapy,” Dr. Perales said in an interview. “The lymphoma MDs have a perception that outcomes are poor, and therefore don’t refer.”
To illustrate his point, Dr. Perales shared data from the EBMT database. In 2014, the registry accrued approximately 450 allo-HCT cases; by 2021 this had fallen to fewer than 200 procedures.
Ironically, this declining enthusiasm for transplantation coincides with a steady improvement in transplant outcomes following PD-1 blockade, Dr. Perales noted. For example, an analysis, published in Nature, yielded an 82% overall survival (OS) at 3 years in patients who underwent allo-HCT after CPI treatment (n =209).
“Results of allo-HCT in patients with Hodgkin show a remarkable cure rate,” said Dr. Perales. “Part of that is probably driven by lower relapse due to enhanced graft-versus-lymphoma effect due to long CPI half-life.” (The half-lives of pembrolizumab and nivolumab are 22 and 25 days, respectively.)
At the EBMT meeting, Dr. Perales presented a new retrospective analysis that tested the hypothesis that CPIs might actually improve outcomes for allo-HCT patients. An international team of clinicians from EBMT and the Center for International Blood and Marrow Transplant Research (CIBMTR) compared allo-HCT outcomes with (n = 347) and without (n = 1,382) prior treatment with a checkpoint inhibitor.
They found that prior CPI therapy was, indeed, associated with lower relapse (hazard ratio, 0.53; P = .00023) and longer progression-free survival (PFS) (HR, 0.75; P = .0171).
However, prior PD-1 drugs provided no survival advantage, Dr. Perales said. “The easiest explanation for a study showing a difference in PFS/relapse, not OS, is that we have good treatments that can treat patients who relapse and so their overall survival ends up being the same.”
The researchers also confirmed previous reports that patients who received PD-1 inhibitors prior to transplant had a higher incidence of GVHD. Prevalence of acute grades 2-4 GVHD was significantly higher (P = .027); however, acute grades 3-4 GVHD and chronic GVHD were not significantly different between the two groups.
Dr. Perales speculated that the use of posttransplant cyclophosphamide for GVHD prophylaxis would mitigate the risk of GVHD associated with PD-1 inhibitors, “we have not yet proven that formally ... [we] are still analyzing our data.”
Commenting on the results of the new analysis, Dr. Perales expressed concern that patients are being recruited to early-phase clinical trials after failing on a checkpoint inhibitor, instead of being offered allo-HCT – a potentially curative treatment – because treaters are misinformed about the safety of transplant after these drugs.
The NIH clinical-trials database backs up Dr. Perales’ worries. In the United States, for example, there are currently 19 trials recruiting for relapsed/refractory Hodgkin lymphoma patients prior to transplant. Of these, 15 studies permit enrollment of patients who have failed on CPIs, and 8 are phase 1 or 2 studies.
“The good news is that new drugs, including CPIs, have dramatically changed outcomes in this disease and that fewer patients now need an allo-HCT,” said Dr. Perales. And if a transplant is needed, “it is safe to perform allo-HCT in patients treated with prior CPI.”
However, time is of the essence. “Patients with Hodgkin lymphoma should be referred to allo-HCT if they are not responding or tolerating CPI, rather than go on a series of phase 1 trials,” Dr. Perales said. “Median age is 32, and we should be going for a cure, nothing less.”
Dr. Perales reported receiving honoraria from numerous pharmaceutical companies; serving on the data and safety monitoring boards of Cidara Therapeutics, Medigene, Sellas Life Sciences, and Servier; and serving on the scientific advisory board of NexImmune. He has ownership interests in NexImmune and Omeros, and has received institutional research support for clinical trials from Incyte, Kite/Gilead, Miltenyi Biotec, Nektar Therapeutics, and Novartis.
Persistent problem: High C-section rates plague the South
All along, Julia Maeda knew she wanted to have her baby naturally. For her, that meant in a hospital, vaginally, without an epidural for pain relief.
This was her first pregnancy. And although she is a nurse, she was working with cancer patients at the time, not with laboring mothers or babies. “I really didn’t know what I was getting into,” said Ms. Maeda, now 32. “I didn’t do much preparation.”
Her home state of Mississippi has the highest cesarean section rate in the United States – nearly 4 in 10 women who give birth there deliver their babies via C-section. Almost 2 weeks past her due date in 2019, Ms. Maeda became one of them after her doctor came to her bedside while she was in labor.
“‘You’re not in distress, and your baby is not in distress – but we don’t want you to get that way, so we need to think about a C-section,’” she recalled her doctor saying. “I was totally defeated. I just gave in.”
C-sections are sometimes necessary and even lifesaving, but public health experts have long contended that too many performed in the U.S. aren’t. They argue it is major surgery accompanied by significant risk and a high price tag.
Overall, 31.8% of all births in the U.S. were C-sections in 2020, just a slight tick up from 31.7% the year before, according to the latest data from the Centers for Disease Control and Prevention. But that’s close to the peak in 2009, when it was 32.9%. And the rates are far higher in many states, especially across the South.
These high C-section rates have persisted – and in some states, such as Alabama and Kentucky, even grown slightly – despite continual calls to reduce them. And although the pandemic presented new challenges for pregnant women, research suggests that the U.S. C-section rate was unaffected by COVID. Instead, obstetricians and other health experts say the high rate is an intractable problem.
Some states, such as California and New Jersey, have reduced their rates through a variety of strategies, including sharing C-section data with doctors and hospitals. But change has proved difficult elsewhere, especially in the South and in Texas, where women are generally less healthy heading into their pregnancies and maternal and infant health problems are among the highest in the United States.
“We have to restructure how we think about C-sections,” said Veronica Gillispie-Bell, MD, an ob.gyn. who is medical director of the Louisiana Perinatal Quality Collaborative, Kenner, La., a group of 43 birthing hospitals focused on lowering Louisiana’s C-section rate. “It’s a lifesaving technique, but it’s also not without risks.”
She said C-sections, like any operation, create scar tissue, including in the uterus, which may complicate future pregnancies or abdominal surgeries. C-sections also typically lead to an extended hospital stay and recovery period and increase the chance of infection. Babies face risks, too. In rare cases, they can be nicked or cut during an incision.
Although C-sections are sometimes necessary, public health leaders say these surgeries have been overused in many places. Black women, particularly, are more likely to give birth by C-section than any other racial group in the country. Often, hospitals and even regions have wide, unexplained variations in rates.
“If you were delivering in Miami-Dade County, you had a 75% greater chance of having a cesarean than in northern Florida,” said William Sappenfield, MD, an ob.gyn. and epidemiologist at the University of South Florida, Tampa, who has studied the state’s high C-section rate.
Some physicians say their rates are driven by mothers who request the procedure, not by doctors. But Rebekah Gee, MD, an ob.gyn. at Louisiana State University Healthcare Network, New Orleans, and former secretary of the Louisiana Department of Health, said she saw C-section rates go dramatically up at 4 and 5 p.m. – around the time when doctors tend to want to go home.
She led several initiatives to improve birth outcomes in Louisiana, including leveling Medicaid payment rates to hospitals for vaginal deliveries and C-sections. In most places, C-sections are significantly more expensive than vaginal deliveries, making high C-section rates not only a concern for expectant mothers but also for taxpayers.
Medicaid pays for 60% of all births in Louisiana, according to KFF, and about half of all births in most Southern states, compared with 42% nationally. That’s one reason some states – including Louisiana, Tennessee, and Minnesota – have tried to tackle high C-section rates by changing how much Medicaid pays for them. But payment reform alone isn’t enough, Dr. Gee said.
“There was a guy in central Louisiana who was doing more C-sections and early elective deliveries than anyone in the U.S.,” she said. “When you have a culture like that, it’s hard to shift from it.”
Linda Schwimmer, president and CEO of the New Jersey Health Care Quality Institute, said many hospitals and doctors don’t even know their C-section rates. Sharing this data with doctors and hospitals – and making it public – made some providers uncomfortable, she said, but it ultimately worked. New Jersey’s C-section rate among first-time, low-risk mothers dropped from 33.1% in 2013 to 26.7% 6 years later once the state began sharing these data, among other initiatives.
The New Jersey Health Care Quality Institute and other groups like it around the country focus on reducing a subset of C-sections called “nulliparous, term, singleton, vertex” C-sections, or surgeries on first-time, full-term moms giving birth to a single infant who is positioned head-down in the uterus.
NTSV C-sections are important to track because women who have a C-section during their first pregnancy face a 90% chance of having another in subsequent pregnancies. Across the U.S., the rate for these C-sections was 25.9% in 2020 and 25.6% in 2019.
Elliott Main, MD, a maternal-fetal specialist at Stanford (Calif.) University and the medical director of the California Maternal Quality Care Collaborative, coauthored a paper, published in JAMA last year, that outlines interventions the collaborative took that lowered California’s NTSV C-Section rate from 26.0% in 2014 to 22.8% in 2019. Nationally, the rate was unchanged during that period.
Allowing women to labor for longer stretches of time before resorting to surgery is important, he said.
The cervix must be 10 cm dilated before a woman gives birth. The threshold for “active labor” used to be when the cervix was dilated at least 4 cm. In more recent years, though, the onset of active labor has been changed to 5-6 cm.
“People show up at the hospital too early,” said Toni Hill, president of the Mississippi Midwives Alliance. “If you show up to the hospital at 2-3 centimeters, you can be at 2-3 centimeters for weeks. I don’t even consider that labor.”
Too often, she said, women at an early stage of labor end up being induced and deliver via C-section.
“It’s almost like, at this point, C-sections are being handed out like lollipops,” said LA’Patricia Washington, a doula based in Jackson, Miss. Doulas are trained, nonmedical workers who help parents before, during, and after delivery.
Ms. Washington works with a nonprofit group, the Jackson Safer Childbirth Experience, that pays for doulas to help expectant mothers in the region. Some state Medicaid programs, such as New Jersey’s, reimburse for services by doulas because research shows they can reduce C-section rates. California has been trying to roll out the same benefit for its Medicaid members.
In 2020, when Julia Maeda became pregnant again, she paid out-of-pocket for a doula to attend the birth. The experience of having her son via C-section the previous year had been “emotionally and psychologically traumatic,” Ms. Maeda said.
She told her ob.gyn. that she wanted a VBAC, short for “vaginal birth after cesarean.” But, she said, “he just shook his head and said, ‘That’s not a good idea.’”
She had VBAC anyway. Ms. Maeda credits her doula with making it happen.
“Maybe just her presence relayed to the nursing staff that this was something I was serious about,” Ms. Maeda said. “They want you to have your baby during business hours. And biology doesn’t work that way.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
All along, Julia Maeda knew she wanted to have her baby naturally. For her, that meant in a hospital, vaginally, without an epidural for pain relief.
This was her first pregnancy. And although she is a nurse, she was working with cancer patients at the time, not with laboring mothers or babies. “I really didn’t know what I was getting into,” said Ms. Maeda, now 32. “I didn’t do much preparation.”
Her home state of Mississippi has the highest cesarean section rate in the United States – nearly 4 in 10 women who give birth there deliver their babies via C-section. Almost 2 weeks past her due date in 2019, Ms. Maeda became one of them after her doctor came to her bedside while she was in labor.
“‘You’re not in distress, and your baby is not in distress – but we don’t want you to get that way, so we need to think about a C-section,’” she recalled her doctor saying. “I was totally defeated. I just gave in.”
C-sections are sometimes necessary and even lifesaving, but public health experts have long contended that too many performed in the U.S. aren’t. They argue it is major surgery accompanied by significant risk and a high price tag.
Overall, 31.8% of all births in the U.S. were C-sections in 2020, just a slight tick up from 31.7% the year before, according to the latest data from the Centers for Disease Control and Prevention. But that’s close to the peak in 2009, when it was 32.9%. And the rates are far higher in many states, especially across the South.
These high C-section rates have persisted – and in some states, such as Alabama and Kentucky, even grown slightly – despite continual calls to reduce them. And although the pandemic presented new challenges for pregnant women, research suggests that the U.S. C-section rate was unaffected by COVID. Instead, obstetricians and other health experts say the high rate is an intractable problem.
Some states, such as California and New Jersey, have reduced their rates through a variety of strategies, including sharing C-section data with doctors and hospitals. But change has proved difficult elsewhere, especially in the South and in Texas, where women are generally less healthy heading into their pregnancies and maternal and infant health problems are among the highest in the United States.
“We have to restructure how we think about C-sections,” said Veronica Gillispie-Bell, MD, an ob.gyn. who is medical director of the Louisiana Perinatal Quality Collaborative, Kenner, La., a group of 43 birthing hospitals focused on lowering Louisiana’s C-section rate. “It’s a lifesaving technique, but it’s also not without risks.”
She said C-sections, like any operation, create scar tissue, including in the uterus, which may complicate future pregnancies or abdominal surgeries. C-sections also typically lead to an extended hospital stay and recovery period and increase the chance of infection. Babies face risks, too. In rare cases, they can be nicked or cut during an incision.
Although C-sections are sometimes necessary, public health leaders say these surgeries have been overused in many places. Black women, particularly, are more likely to give birth by C-section than any other racial group in the country. Often, hospitals and even regions have wide, unexplained variations in rates.
“If you were delivering in Miami-Dade County, you had a 75% greater chance of having a cesarean than in northern Florida,” said William Sappenfield, MD, an ob.gyn. and epidemiologist at the University of South Florida, Tampa, who has studied the state’s high C-section rate.
Some physicians say their rates are driven by mothers who request the procedure, not by doctors. But Rebekah Gee, MD, an ob.gyn. at Louisiana State University Healthcare Network, New Orleans, and former secretary of the Louisiana Department of Health, said she saw C-section rates go dramatically up at 4 and 5 p.m. – around the time when doctors tend to want to go home.
She led several initiatives to improve birth outcomes in Louisiana, including leveling Medicaid payment rates to hospitals for vaginal deliveries and C-sections. In most places, C-sections are significantly more expensive than vaginal deliveries, making high C-section rates not only a concern for expectant mothers but also for taxpayers.
Medicaid pays for 60% of all births in Louisiana, according to KFF, and about half of all births in most Southern states, compared with 42% nationally. That’s one reason some states – including Louisiana, Tennessee, and Minnesota – have tried to tackle high C-section rates by changing how much Medicaid pays for them. But payment reform alone isn’t enough, Dr. Gee said.
“There was a guy in central Louisiana who was doing more C-sections and early elective deliveries than anyone in the U.S.,” she said. “When you have a culture like that, it’s hard to shift from it.”
Linda Schwimmer, president and CEO of the New Jersey Health Care Quality Institute, said many hospitals and doctors don’t even know their C-section rates. Sharing this data with doctors and hospitals – and making it public – made some providers uncomfortable, she said, but it ultimately worked. New Jersey’s C-section rate among first-time, low-risk mothers dropped from 33.1% in 2013 to 26.7% 6 years later once the state began sharing these data, among other initiatives.
The New Jersey Health Care Quality Institute and other groups like it around the country focus on reducing a subset of C-sections called “nulliparous, term, singleton, vertex” C-sections, or surgeries on first-time, full-term moms giving birth to a single infant who is positioned head-down in the uterus.
NTSV C-sections are important to track because women who have a C-section during their first pregnancy face a 90% chance of having another in subsequent pregnancies. Across the U.S., the rate for these C-sections was 25.9% in 2020 and 25.6% in 2019.
Elliott Main, MD, a maternal-fetal specialist at Stanford (Calif.) University and the medical director of the California Maternal Quality Care Collaborative, coauthored a paper, published in JAMA last year, that outlines interventions the collaborative took that lowered California’s NTSV C-Section rate from 26.0% in 2014 to 22.8% in 2019. Nationally, the rate was unchanged during that period.
Allowing women to labor for longer stretches of time before resorting to surgery is important, he said.
The cervix must be 10 cm dilated before a woman gives birth. The threshold for “active labor” used to be when the cervix was dilated at least 4 cm. In more recent years, though, the onset of active labor has been changed to 5-6 cm.
“People show up at the hospital too early,” said Toni Hill, president of the Mississippi Midwives Alliance. “If you show up to the hospital at 2-3 centimeters, you can be at 2-3 centimeters for weeks. I don’t even consider that labor.”
Too often, she said, women at an early stage of labor end up being induced and deliver via C-section.
“It’s almost like, at this point, C-sections are being handed out like lollipops,” said LA’Patricia Washington, a doula based in Jackson, Miss. Doulas are trained, nonmedical workers who help parents before, during, and after delivery.
Ms. Washington works with a nonprofit group, the Jackson Safer Childbirth Experience, that pays for doulas to help expectant mothers in the region. Some state Medicaid programs, such as New Jersey’s, reimburse for services by doulas because research shows they can reduce C-section rates. California has been trying to roll out the same benefit for its Medicaid members.
In 2020, when Julia Maeda became pregnant again, she paid out-of-pocket for a doula to attend the birth. The experience of having her son via C-section the previous year had been “emotionally and psychologically traumatic,” Ms. Maeda said.
She told her ob.gyn. that she wanted a VBAC, short for “vaginal birth after cesarean.” But, she said, “he just shook his head and said, ‘That’s not a good idea.’”
She had VBAC anyway. Ms. Maeda credits her doula with making it happen.
“Maybe just her presence relayed to the nursing staff that this was something I was serious about,” Ms. Maeda said. “They want you to have your baby during business hours. And biology doesn’t work that way.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
All along, Julia Maeda knew she wanted to have her baby naturally. For her, that meant in a hospital, vaginally, without an epidural for pain relief.
This was her first pregnancy. And although she is a nurse, she was working with cancer patients at the time, not with laboring mothers or babies. “I really didn’t know what I was getting into,” said Ms. Maeda, now 32. “I didn’t do much preparation.”
Her home state of Mississippi has the highest cesarean section rate in the United States – nearly 4 in 10 women who give birth there deliver their babies via C-section. Almost 2 weeks past her due date in 2019, Ms. Maeda became one of them after her doctor came to her bedside while she was in labor.
“‘You’re not in distress, and your baby is not in distress – but we don’t want you to get that way, so we need to think about a C-section,’” she recalled her doctor saying. “I was totally defeated. I just gave in.”
C-sections are sometimes necessary and even lifesaving, but public health experts have long contended that too many performed in the U.S. aren’t. They argue it is major surgery accompanied by significant risk and a high price tag.
Overall, 31.8% of all births in the U.S. were C-sections in 2020, just a slight tick up from 31.7% the year before, according to the latest data from the Centers for Disease Control and Prevention. But that’s close to the peak in 2009, when it was 32.9%. And the rates are far higher in many states, especially across the South.
These high C-section rates have persisted – and in some states, such as Alabama and Kentucky, even grown slightly – despite continual calls to reduce them. And although the pandemic presented new challenges for pregnant women, research suggests that the U.S. C-section rate was unaffected by COVID. Instead, obstetricians and other health experts say the high rate is an intractable problem.
Some states, such as California and New Jersey, have reduced their rates through a variety of strategies, including sharing C-section data with doctors and hospitals. But change has proved difficult elsewhere, especially in the South and in Texas, where women are generally less healthy heading into their pregnancies and maternal and infant health problems are among the highest in the United States.
“We have to restructure how we think about C-sections,” said Veronica Gillispie-Bell, MD, an ob.gyn. who is medical director of the Louisiana Perinatal Quality Collaborative, Kenner, La., a group of 43 birthing hospitals focused on lowering Louisiana’s C-section rate. “It’s a lifesaving technique, but it’s also not without risks.”
She said C-sections, like any operation, create scar tissue, including in the uterus, which may complicate future pregnancies or abdominal surgeries. C-sections also typically lead to an extended hospital stay and recovery period and increase the chance of infection. Babies face risks, too. In rare cases, they can be nicked or cut during an incision.
Although C-sections are sometimes necessary, public health leaders say these surgeries have been overused in many places. Black women, particularly, are more likely to give birth by C-section than any other racial group in the country. Often, hospitals and even regions have wide, unexplained variations in rates.
“If you were delivering in Miami-Dade County, you had a 75% greater chance of having a cesarean than in northern Florida,” said William Sappenfield, MD, an ob.gyn. and epidemiologist at the University of South Florida, Tampa, who has studied the state’s high C-section rate.
Some physicians say their rates are driven by mothers who request the procedure, not by doctors. But Rebekah Gee, MD, an ob.gyn. at Louisiana State University Healthcare Network, New Orleans, and former secretary of the Louisiana Department of Health, said she saw C-section rates go dramatically up at 4 and 5 p.m. – around the time when doctors tend to want to go home.
She led several initiatives to improve birth outcomes in Louisiana, including leveling Medicaid payment rates to hospitals for vaginal deliveries and C-sections. In most places, C-sections are significantly more expensive than vaginal deliveries, making high C-section rates not only a concern for expectant mothers but also for taxpayers.
Medicaid pays for 60% of all births in Louisiana, according to KFF, and about half of all births in most Southern states, compared with 42% nationally. That’s one reason some states – including Louisiana, Tennessee, and Minnesota – have tried to tackle high C-section rates by changing how much Medicaid pays for them. But payment reform alone isn’t enough, Dr. Gee said.
“There was a guy in central Louisiana who was doing more C-sections and early elective deliveries than anyone in the U.S.,” she said. “When you have a culture like that, it’s hard to shift from it.”
Linda Schwimmer, president and CEO of the New Jersey Health Care Quality Institute, said many hospitals and doctors don’t even know their C-section rates. Sharing this data with doctors and hospitals – and making it public – made some providers uncomfortable, she said, but it ultimately worked. New Jersey’s C-section rate among first-time, low-risk mothers dropped from 33.1% in 2013 to 26.7% 6 years later once the state began sharing these data, among other initiatives.
The New Jersey Health Care Quality Institute and other groups like it around the country focus on reducing a subset of C-sections called “nulliparous, term, singleton, vertex” C-sections, or surgeries on first-time, full-term moms giving birth to a single infant who is positioned head-down in the uterus.
NTSV C-sections are important to track because women who have a C-section during their first pregnancy face a 90% chance of having another in subsequent pregnancies. Across the U.S., the rate for these C-sections was 25.9% in 2020 and 25.6% in 2019.
Elliott Main, MD, a maternal-fetal specialist at Stanford (Calif.) University and the medical director of the California Maternal Quality Care Collaborative, coauthored a paper, published in JAMA last year, that outlines interventions the collaborative took that lowered California’s NTSV C-Section rate from 26.0% in 2014 to 22.8% in 2019. Nationally, the rate was unchanged during that period.
Allowing women to labor for longer stretches of time before resorting to surgery is important, he said.
The cervix must be 10 cm dilated before a woman gives birth. The threshold for “active labor” used to be when the cervix was dilated at least 4 cm. In more recent years, though, the onset of active labor has been changed to 5-6 cm.
“People show up at the hospital too early,” said Toni Hill, president of the Mississippi Midwives Alliance. “If you show up to the hospital at 2-3 centimeters, you can be at 2-3 centimeters for weeks. I don’t even consider that labor.”
Too often, she said, women at an early stage of labor end up being induced and deliver via C-section.
“It’s almost like, at this point, C-sections are being handed out like lollipops,” said LA’Patricia Washington, a doula based in Jackson, Miss. Doulas are trained, nonmedical workers who help parents before, during, and after delivery.
Ms. Washington works with a nonprofit group, the Jackson Safer Childbirth Experience, that pays for doulas to help expectant mothers in the region. Some state Medicaid programs, such as New Jersey’s, reimburse for services by doulas because research shows they can reduce C-section rates. California has been trying to roll out the same benefit for its Medicaid members.
In 2020, when Julia Maeda became pregnant again, she paid out-of-pocket for a doula to attend the birth. The experience of having her son via C-section the previous year had been “emotionally and psychologically traumatic,” Ms. Maeda said.
She told her ob.gyn. that she wanted a VBAC, short for “vaginal birth after cesarean.” But, she said, “he just shook his head and said, ‘That’s not a good idea.’”
She had VBAC anyway. Ms. Maeda credits her doula with making it happen.
“Maybe just her presence relayed to the nursing staff that this was something I was serious about,” Ms. Maeda said. “They want you to have your baby during business hours. And biology doesn’t work that way.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Aspirin exposure fails to reduce cardiovascular event risk
The benefits of aspirin use for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) have been questioned in light of data showing neutral outcomes in low-risk patients and concerns about increased bleeding risk and mortality in healthy older adults, wrote Rita Del Pinto, MD, of University of L’Aquila (Italy) and colleagues in JAMA Network Open.
In the study, Dr. Del Pinto and colleagues conducted a post hoc analysis of data from more than 2,500 participants in SPRINT (Systolic Blood Pressure Intervention Trial), a multicenter, randomized trial conducted from 2010 to 2013.
The goal of SPRINT was to compare intensive and standard blood pressure–lowering strategies for hypertension patients. The primary outcome of the current study was risk of a first cardiovascular event, which included adjudicated myocardial infarction, non–myocardial infarction acute coronary syndrome, stroke, acute heart failure, and CVD death.“There has been considerable improvement in the management of cardiovascular risk factors since the first reports on aspirin use for cardiovascular prevention,” Dr. Del Pinto said in an interview.
“As for hypertension, not only have more effective antihypertensive medications become available, but also evidence has recently emerged in support of a downwards redefinition of blood pressure targets during treatment,” she said. “In this context, in an era when great attention is paid to the personalization of treatment, no specific studies had addressed the association of aspirin use as a primary prevention strategy in a cohort of relatively old, high-risk individuals with treated systolic blood pressure steadily below the recommended target,” she added.
The researchers assessed whether aspirin use in addition to standard blood pressure management (a target of less than 140 mm Hg) decreased risk and improved survival.
The study population included 2,664 adult patients; 29.3% were women, and 24.5% were aged 75 years and older. Half of the patients (1,332) received aspirin and 1,332 did not.
In a multivariate analysis, 42 cardiovascular events occurred in the aspirin group, compared with 20 events in those not exposed to aspirin (hazard ratio, 2.30). The findings were consistent in subgroup analyses of younger individuals, current and former smokers, and patients on statins.
An additional subgroup analysis of individuals randomized to standard care or intensive care in the SPRINT study showed no significant difference in primary outcome rates between individuals who received aspirin and those who did not. The rates for aspirin use vs. non–aspirin use were 5.85% vs. 3.60% in the standard treatment group and 4.66% vs. 2.56% in the intensive treatment group.
The study findings were limited by several factors, including the post hoc design, short follow-up period, and lack of data on the initiation of aspirin and bleeding events, the researchers wrote. However, the results suggest that modern management of hypertension may have redefined the potential benefits of aspirin in patients with hypertension, they concluded.
Findings confirm value of preventive care
“The study was conducted as a post-hoc analysis on an experimental cohort, which must be considered when interpreting the results,” Dr. Del Pinto said.
Despite the limitations, the study findings affirm that effective treatment of major cardiovascular risk factors, such as hypertension, with proven drugs is “a mainstay of the primary prevention of ASCVD,” she emphasized.
As for additional research, “Testing our findings in a dedicated setting with sufficiently long follow-up, where aspirin dose and indication, as well as any possible bleeding event, are reported could expand the clinical meaning of our observations,” said Dr. Del Pinto. “Also, the clinical impact of aspirin, even in combination with novel cardiovascular drugs such as direct oral anticoagulants, in populations exposed to combinations of risk factors, deserves further investigation.”
Data support shared decision-making
“While recent evidence has not shown a benefit of aspirin in the primary prevention of ASCVD in several populations, the subpopulation of patients with hypertension as an ASCVD risk factor is also of interest to the clinician,” Suman Pal, MD, of the University of New Mexico, Albuquerque, said in an interview. “The lack of benefit of aspirin in this study, despite its limitations, was surprising, and I would be eager to see how the role of aspirin in ASCVD prevention would continue to evolve in conjunction with improvement in other therapies for modification of risk factors.”
“The decision to continue aspirin in this subgroup of patients should warrant a discussion with patients and a reexamination of risks and benefits until further data are available,” Dr. Pal emphasized.
Larger studies with long-term follow-ups would be required to further clarify the role of aspirin in primary prevention of ASCVD in patients with hypertension without diabetes or chronic kidney disease, he added.
Data were supplied courtesy of BioLINCC. The study received no outside funding. The researchers and Dr. Pal had no financial conflicts to disclose.
The benefits of aspirin use for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) have been questioned in light of data showing neutral outcomes in low-risk patients and concerns about increased bleeding risk and mortality in healthy older adults, wrote Rita Del Pinto, MD, of University of L’Aquila (Italy) and colleagues in JAMA Network Open.
In the study, Dr. Del Pinto and colleagues conducted a post hoc analysis of data from more than 2,500 participants in SPRINT (Systolic Blood Pressure Intervention Trial), a multicenter, randomized trial conducted from 2010 to 2013.
The goal of SPRINT was to compare intensive and standard blood pressure–lowering strategies for hypertension patients. The primary outcome of the current study was risk of a first cardiovascular event, which included adjudicated myocardial infarction, non–myocardial infarction acute coronary syndrome, stroke, acute heart failure, and CVD death.“There has been considerable improvement in the management of cardiovascular risk factors since the first reports on aspirin use for cardiovascular prevention,” Dr. Del Pinto said in an interview.
“As for hypertension, not only have more effective antihypertensive medications become available, but also evidence has recently emerged in support of a downwards redefinition of blood pressure targets during treatment,” she said. “In this context, in an era when great attention is paid to the personalization of treatment, no specific studies had addressed the association of aspirin use as a primary prevention strategy in a cohort of relatively old, high-risk individuals with treated systolic blood pressure steadily below the recommended target,” she added.
The researchers assessed whether aspirin use in addition to standard blood pressure management (a target of less than 140 mm Hg) decreased risk and improved survival.
The study population included 2,664 adult patients; 29.3% were women, and 24.5% were aged 75 years and older. Half of the patients (1,332) received aspirin and 1,332 did not.
In a multivariate analysis, 42 cardiovascular events occurred in the aspirin group, compared with 20 events in those not exposed to aspirin (hazard ratio, 2.30). The findings were consistent in subgroup analyses of younger individuals, current and former smokers, and patients on statins.
An additional subgroup analysis of individuals randomized to standard care or intensive care in the SPRINT study showed no significant difference in primary outcome rates between individuals who received aspirin and those who did not. The rates for aspirin use vs. non–aspirin use were 5.85% vs. 3.60% in the standard treatment group and 4.66% vs. 2.56% in the intensive treatment group.
The study findings were limited by several factors, including the post hoc design, short follow-up period, and lack of data on the initiation of aspirin and bleeding events, the researchers wrote. However, the results suggest that modern management of hypertension may have redefined the potential benefits of aspirin in patients with hypertension, they concluded.
Findings confirm value of preventive care
“The study was conducted as a post-hoc analysis on an experimental cohort, which must be considered when interpreting the results,” Dr. Del Pinto said.
Despite the limitations, the study findings affirm that effective treatment of major cardiovascular risk factors, such as hypertension, with proven drugs is “a mainstay of the primary prevention of ASCVD,” she emphasized.
As for additional research, “Testing our findings in a dedicated setting with sufficiently long follow-up, where aspirin dose and indication, as well as any possible bleeding event, are reported could expand the clinical meaning of our observations,” said Dr. Del Pinto. “Also, the clinical impact of aspirin, even in combination with novel cardiovascular drugs such as direct oral anticoagulants, in populations exposed to combinations of risk factors, deserves further investigation.”
Data support shared decision-making
“While recent evidence has not shown a benefit of aspirin in the primary prevention of ASCVD in several populations, the subpopulation of patients with hypertension as an ASCVD risk factor is also of interest to the clinician,” Suman Pal, MD, of the University of New Mexico, Albuquerque, said in an interview. “The lack of benefit of aspirin in this study, despite its limitations, was surprising, and I would be eager to see how the role of aspirin in ASCVD prevention would continue to evolve in conjunction with improvement in other therapies for modification of risk factors.”
“The decision to continue aspirin in this subgroup of patients should warrant a discussion with patients and a reexamination of risks and benefits until further data are available,” Dr. Pal emphasized.
Larger studies with long-term follow-ups would be required to further clarify the role of aspirin in primary prevention of ASCVD in patients with hypertension without diabetes or chronic kidney disease, he added.
Data were supplied courtesy of BioLINCC. The study received no outside funding. The researchers and Dr. Pal had no financial conflicts to disclose.
The benefits of aspirin use for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) have been questioned in light of data showing neutral outcomes in low-risk patients and concerns about increased bleeding risk and mortality in healthy older adults, wrote Rita Del Pinto, MD, of University of L’Aquila (Italy) and colleagues in JAMA Network Open.
In the study, Dr. Del Pinto and colleagues conducted a post hoc analysis of data from more than 2,500 participants in SPRINT (Systolic Blood Pressure Intervention Trial), a multicenter, randomized trial conducted from 2010 to 2013.
The goal of SPRINT was to compare intensive and standard blood pressure–lowering strategies for hypertension patients. The primary outcome of the current study was risk of a first cardiovascular event, which included adjudicated myocardial infarction, non–myocardial infarction acute coronary syndrome, stroke, acute heart failure, and CVD death.“There has been considerable improvement in the management of cardiovascular risk factors since the first reports on aspirin use for cardiovascular prevention,” Dr. Del Pinto said in an interview.
“As for hypertension, not only have more effective antihypertensive medications become available, but also evidence has recently emerged in support of a downwards redefinition of blood pressure targets during treatment,” she said. “In this context, in an era when great attention is paid to the personalization of treatment, no specific studies had addressed the association of aspirin use as a primary prevention strategy in a cohort of relatively old, high-risk individuals with treated systolic blood pressure steadily below the recommended target,” she added.
The researchers assessed whether aspirin use in addition to standard blood pressure management (a target of less than 140 mm Hg) decreased risk and improved survival.
The study population included 2,664 adult patients; 29.3% were women, and 24.5% were aged 75 years and older. Half of the patients (1,332) received aspirin and 1,332 did not.
In a multivariate analysis, 42 cardiovascular events occurred in the aspirin group, compared with 20 events in those not exposed to aspirin (hazard ratio, 2.30). The findings were consistent in subgroup analyses of younger individuals, current and former smokers, and patients on statins.
An additional subgroup analysis of individuals randomized to standard care or intensive care in the SPRINT study showed no significant difference in primary outcome rates between individuals who received aspirin and those who did not. The rates for aspirin use vs. non–aspirin use were 5.85% vs. 3.60% in the standard treatment group and 4.66% vs. 2.56% in the intensive treatment group.
The study findings were limited by several factors, including the post hoc design, short follow-up period, and lack of data on the initiation of aspirin and bleeding events, the researchers wrote. However, the results suggest that modern management of hypertension may have redefined the potential benefits of aspirin in patients with hypertension, they concluded.
Findings confirm value of preventive care
“The study was conducted as a post-hoc analysis on an experimental cohort, which must be considered when interpreting the results,” Dr. Del Pinto said.
Despite the limitations, the study findings affirm that effective treatment of major cardiovascular risk factors, such as hypertension, with proven drugs is “a mainstay of the primary prevention of ASCVD,” she emphasized.
As for additional research, “Testing our findings in a dedicated setting with sufficiently long follow-up, where aspirin dose and indication, as well as any possible bleeding event, are reported could expand the clinical meaning of our observations,” said Dr. Del Pinto. “Also, the clinical impact of aspirin, even in combination with novel cardiovascular drugs such as direct oral anticoagulants, in populations exposed to combinations of risk factors, deserves further investigation.”
Data support shared decision-making
“While recent evidence has not shown a benefit of aspirin in the primary prevention of ASCVD in several populations, the subpopulation of patients with hypertension as an ASCVD risk factor is also of interest to the clinician,” Suman Pal, MD, of the University of New Mexico, Albuquerque, said in an interview. “The lack of benefit of aspirin in this study, despite its limitations, was surprising, and I would be eager to see how the role of aspirin in ASCVD prevention would continue to evolve in conjunction with improvement in other therapies for modification of risk factors.”
“The decision to continue aspirin in this subgroup of patients should warrant a discussion with patients and a reexamination of risks and benefits until further data are available,” Dr. Pal emphasized.
Larger studies with long-term follow-ups would be required to further clarify the role of aspirin in primary prevention of ASCVD in patients with hypertension without diabetes or chronic kidney disease, he added.
Data were supplied courtesy of BioLINCC. The study received no outside funding. The researchers and Dr. Pal had no financial conflicts to disclose.
FROM JAMA NETWORK OPEN
Survivor’s story foreshadows one of oncology’s greatest successes
At 32 years old, the world was at Larry Unger’s feet. He was vice president at one of Wall Street’s most successful investment management firms, selling mutual funds to more than 1,000 brokers across New York. His clients relied on him for good advice, great jokes, and superlative Yankees tickets. His recent memories included fraternity days at Cornell University and a Harvard law degree. His childhood on the Lower East Side was behind him. He had his own apartment and a beautiful girlfriend.
Then his back started hurting, and he was drenched in sweat at night. His physician suggested it was a basketball injury. Weeks of tests followed, and he changed doctors. Mr. Unger met with an oncologist at Memorial Sloan Kettering Cancer Center who wouldn’t let him go home after the appointment. The next day brought exploratory surgery and an answer to all the questions.
Mr. Unger was diagnosed with stage IIIB Hodgkin lymphoma.
Thirty years later, Mr. Unger credited his survival to the late Subhash Gulati, MD, PhD, then MSKCC’s director of stem cell transplantation. He still recalls Dr. Gulati’s words to him: “Radical situations call for radical solutions.” In 1992, that “radical solution” was an autologous bone-marrow transplant.
“Mr. Unger was a patient pioneer,” said Kenneth Offit, MD, another MSKCC oncologist who also cared for him at that time.
Transplantation for Hodgkin: The early 90s
Hodgkin lymphoma is fairly rare, accounting for just 0.5% of all cancers and 15% of lymphomas. It tends to target young, male adults like Mr. Unger. Today 88% of patients with Hodgkin survive at least 5 years.
When Dr. Gulati offered Mr. Unger his “radical solution” 3 decades ago, the idea of autologous bone marrow transplantation in Hodgkin lymphoma was not new. The first attempt appeared in the literature in the 1950s, but it was still unclear how patients could survive the procedure. It involved destroying the patient’s own immune system prior to the transplant, a huge risk in itself. Worse, the patient was pummeled with chemotherapy and/or radiation to clear out the cancerous bone marrow – a process called “conditioning.”
However, throughout the 1980s, MSKCC had been running clinical trials to perfect the conditioning mix, so by 1992 Dr. Gulati was well-placed to help Mr. Unger.
It is unclear what conditioning Mr. Unger received because his records were not made available. However, around the time that Mr. Unger underwent his transplant, Dr. Gulati and colleagues published the conditioning regimens in use at MSKCC. Patients with refractory or relapsed Hodgkin disease received a conditioning mix of total nodal irradiation (TNI), etoposide (Vepesid) and cyclophosphamide. Patients who had already been through radiotherapy were given carmustine instead of TNI.
In that early publication, Dr. Gulati and the MSKCC team reported 0 “toxic deaths” with the TNI mix, and at the 2-year point 75% of the patients were still alive (n = 28). Patients who had already received radiation treatment did less well, with 55% survival at 2 years, at a cost of 14% toxic deaths (n = 22).
Mr. Unger’s experience, 30 years ago
According to Mr. Unger, the initial treatment for his stage IIIB Hodgkin lymphoma was MOPP (mechlorethamine hydrochloride, vincristine sulfate, procarbazine hydrochloride, and prednisone) plus ABVD (doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine).
“They wanted to give me two chemo programs at once because they said I was very sick,” Mr. Unger recalled. “I wound up staying in the hospital quite a bit because every time I got these [treatments] I’d get a fever. This went on for month after month after month. Finally, they said: ‘The tumors are starting to shrink. ... I want you to meet Dr. Gulati.’ ”
Mr. Unger said that Dr. Gulati told him: “There is another procedure called the bone marrow transplant which we’ve been doing. This would be like hitting it with a nuclear weapon. We would really wipe it out and make sure that you never come back.”
The alternative was high-dose radiotherapy. However, Dr. Gulati shared MSKCC’s hard-won knowledge that an autologous transplant was less successful after radiation. Dr. Gulati also told Mr. Unger that surgery was needed before the transplant: a laparotomy to restage his tumors.
After discussing the situation with his father, Mr. Unger decided to undergo the transplant.
The night before treatment started, he was laughing and joking with a friend in his room at MSKCC. The next day, the laughing stopped. The conditioning, he said, “was harrowing beyond belief ... 100 times worse than the chemo.”
Chemotherapy came first, followed 2 days later by radiation, presumably TNI. Mr. Unger experienced constant vomiting, intraocular bleeding and high fevers; the soft tissue of his throat “fell apart,” he said.
“I couldn’t move. It was like being dead,” he said. “Finally, maybe after a month or so, I could finally have a little water.” Mr. Unger said his immune system took 6-8 weeks to recover. He concluded, with heroic understatement, “it was rough.”
The battle against Hodgkin was over, but fallout from the chemotherapy lingered. Although Mr. Unger was able to return to his family and the job he loved, in the following years he was never entirely well. He contracted shingles soon after his transplant, then diabetes within 15 years. A heart attack followed in 2008 then, in 2015, an autoimmune disease that still affects his mobility.
However, Mr. Unger remains grateful: “The fact that we did these cutting-edge techniques with me got me to the point where – although I had some problems afterward, and I have problems now – it gave me well over 30 years of a really great life.”
“There are a lot of good doctors out there,” he added. “Some of them go to extraordinary lengths to help people. I try to do the same with the extra 30 years I’ve been given, try to be nice to people and make people feel good. I don’t really see any other reason to be on earth.”
Treatment for Hodgkin lymphoma: 2022
For a comparison of Mr. Unger’s experience with the current approach to Hodgkin lymphoma, this news organization spoke to Miguel-Angel Perales, MD, current chief of the adult bone marrow transplant service at MSKCC. Although Dr. Perales could not comment specifically on Mr. Unger’s case without his records, Dr. Perales was able to review the revolutions in treatment for all patients over the past 30 years.
Certainly, physicians no longer need to inflict a laparotomy on patients just to stage the disease, Dr. Perales said. “This sounds barbaric today. Nowadays we have PET scans.”
Another key change, Dr. Perales said, is in the up-front management of the disease.
For example, MOPP “is going back to the prehistory of chemotherapy,” Dr. Perales said. He was not surprised to learn that Mr. Unger later developed complications such as diabetes and heart disease.
“We’ve completely revolutionized the treatment,” Dr. Perales said. “We [now] use combinations that are much less toxic than MOPP, [and] we’re curing more patients up front.” Treatment is tailored by stage and the likelihood of response to therapy. Aggressive approaches are reserved for patients more likely to fail treatment.
Pretransplant conditioning has also changed for the better, with less toxicity and fewer long-term complications. Total body irradiation has “fallen by the wayside,” said Dr. Perales. Instead, patients get BEAM, a combination of carmustine, etoposide, cytarabine (Cytosar-U, Ara-C), and melphalan (Alkeran), 1 week before the transplant.
Perhaps the most profound change, which began in the 1990s shortly after Larry’s transplant, was that peripheral-blood stem cells gradually replaced bone marrow for both autologous and allogeneic transplant. In 2022, nearly all autologous transplants use peripheral-blood stem cells.
Instead of onerous bone-marrow aspiration in the operating room, the stem cells are collected from the patient’s blood. First, the patient’s bone marrow is hyperstimulated with high doses of filgrastim (G-CSF, Neupogen, Granix) for several days. Stem cells spill into the patient’s blood. Once blood is collected from the patient, the stem cells are separated and stored ready for the transplant. (In theory, stem cell products are “cancer free”; in practice there may be some contaminating cells, said Dr. Perales.)
Nowadays “transplanting” the stem cells back into the body bears no relation to what happened in 1992. The stem-cell infusion is typically an outpatient procedure, and one-third of patients may never be admitted to the hospital at all.
In contrast to Mr. Unger’s excruciating 8-week hospital stay, immune recovery currently takes 12-14 days, often entirely in the patient’s own home, with the option of extra filgrastim to speed things up.
Despite these profound changes, said Dr. Perales, the real quantum leap has occurred post transplant.
In 2015, a multinational team led by MSKCC’s Dr. Craig Moskowitz published a trial in the Lancet showing that brentuximab vedotin halved the risk of relapse after autologous transplantation in high-risk Hodgkin lymphoma patients versus placebo (hazard ratio, 0.57; P = .0013; n = 329). The CD30-directed antibody-drug conjugate was so successful that the placebo patients were encouraged to cross over into the treatment group; many of them were salvaged.
As a result, Dr. Perales said, brentuximab vedotin has now become the standard in high-risk Hodgkin patients following a transplant.
The checkpoint inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda) have also been “transformational” in Hodgkin lymphoma, Dr. Perales said. He explained that Hodgkin lymphoma is “exquisitely sensitive” to these therapies because the disease expresses high levels of the binding proteins for these drugs. This allows the immunotherapies to hit both the immune system and the disease.
Most cancers have response rates for checkpoint inhibitors below 40%, according to a recent analysis by Anas Younes, former chief of lymphoma at MSKCC, and his colleague Eri Matsuki, then a visiting fellow. By contrast, in Hodgkin lymphoma response to these drugs is 66%-87%.
Dr. Perales said: “It tells you how effective these drugs are, that we could move from somebody getting MOPP, which is like throwing a nuclear bomb at somebody, to a combination of two drugs that can easily be given out-patient and that have very little, if any, side effects.”
The future: No chemo, no transplants?
“One of the holy grails in Hodgkin would be if we could treat patients with the combination of a checkpoint inhibitor and brentuximab and what is being termed the ‘chemotherapy-free’ approach to Hodgkin disease,” said Dr. Perales.
What else remains to be done in the world of transplants for Hodgkin lymphoma?
Dr. Perales didn’t hesitate: “To eliminate the need for them. If we can have better targeted therapy up front that cures more patients, then we never even have to consider transplant. Basically, to put me out of work. I’m sure I’ll find other things to do.”
The current treatment of Hodgkin lymphoma “is really what we all consider one of the successes in oncology,” said Dr. Perales. “It’s a beautiful story.”
Dr. Perales reported receiving honoraria from numerous pharmaceutical companies; serves on data and safety monitoring boards for Cidara Therapeutics, Medigene, Sellas Life Sciences, and Servier; and serves on the scientific advisory board of NexImmune. He has ownership interests in NexImmune and Omeros, and has received institutional research support for clinical trials from Incyte, Kite/Gilead, Miltenyi Biotec, Nektar Therapeutics, and Novartis.
At 32 years old, the world was at Larry Unger’s feet. He was vice president at one of Wall Street’s most successful investment management firms, selling mutual funds to more than 1,000 brokers across New York. His clients relied on him for good advice, great jokes, and superlative Yankees tickets. His recent memories included fraternity days at Cornell University and a Harvard law degree. His childhood on the Lower East Side was behind him. He had his own apartment and a beautiful girlfriend.
Then his back started hurting, and he was drenched in sweat at night. His physician suggested it was a basketball injury. Weeks of tests followed, and he changed doctors. Mr. Unger met with an oncologist at Memorial Sloan Kettering Cancer Center who wouldn’t let him go home after the appointment. The next day brought exploratory surgery and an answer to all the questions.
Mr. Unger was diagnosed with stage IIIB Hodgkin lymphoma.
Thirty years later, Mr. Unger credited his survival to the late Subhash Gulati, MD, PhD, then MSKCC’s director of stem cell transplantation. He still recalls Dr. Gulati’s words to him: “Radical situations call for radical solutions.” In 1992, that “radical solution” was an autologous bone-marrow transplant.
“Mr. Unger was a patient pioneer,” said Kenneth Offit, MD, another MSKCC oncologist who also cared for him at that time.
Transplantation for Hodgkin: The early 90s
Hodgkin lymphoma is fairly rare, accounting for just 0.5% of all cancers and 15% of lymphomas. It tends to target young, male adults like Mr. Unger. Today 88% of patients with Hodgkin survive at least 5 years.
When Dr. Gulati offered Mr. Unger his “radical solution” 3 decades ago, the idea of autologous bone marrow transplantation in Hodgkin lymphoma was not new. The first attempt appeared in the literature in the 1950s, but it was still unclear how patients could survive the procedure. It involved destroying the patient’s own immune system prior to the transplant, a huge risk in itself. Worse, the patient was pummeled with chemotherapy and/or radiation to clear out the cancerous bone marrow – a process called “conditioning.”
However, throughout the 1980s, MSKCC had been running clinical trials to perfect the conditioning mix, so by 1992 Dr. Gulati was well-placed to help Mr. Unger.
It is unclear what conditioning Mr. Unger received because his records were not made available. However, around the time that Mr. Unger underwent his transplant, Dr. Gulati and colleagues published the conditioning regimens in use at MSKCC. Patients with refractory or relapsed Hodgkin disease received a conditioning mix of total nodal irradiation (TNI), etoposide (Vepesid) and cyclophosphamide. Patients who had already been through radiotherapy were given carmustine instead of TNI.
In that early publication, Dr. Gulati and the MSKCC team reported 0 “toxic deaths” with the TNI mix, and at the 2-year point 75% of the patients were still alive (n = 28). Patients who had already received radiation treatment did less well, with 55% survival at 2 years, at a cost of 14% toxic deaths (n = 22).
Mr. Unger’s experience, 30 years ago
According to Mr. Unger, the initial treatment for his stage IIIB Hodgkin lymphoma was MOPP (mechlorethamine hydrochloride, vincristine sulfate, procarbazine hydrochloride, and prednisone) plus ABVD (doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine).
“They wanted to give me two chemo programs at once because they said I was very sick,” Mr. Unger recalled. “I wound up staying in the hospital quite a bit because every time I got these [treatments] I’d get a fever. This went on for month after month after month. Finally, they said: ‘The tumors are starting to shrink. ... I want you to meet Dr. Gulati.’ ”
Mr. Unger said that Dr. Gulati told him: “There is another procedure called the bone marrow transplant which we’ve been doing. This would be like hitting it with a nuclear weapon. We would really wipe it out and make sure that you never come back.”
The alternative was high-dose radiotherapy. However, Dr. Gulati shared MSKCC’s hard-won knowledge that an autologous transplant was less successful after radiation. Dr. Gulati also told Mr. Unger that surgery was needed before the transplant: a laparotomy to restage his tumors.
After discussing the situation with his father, Mr. Unger decided to undergo the transplant.
The night before treatment started, he was laughing and joking with a friend in his room at MSKCC. The next day, the laughing stopped. The conditioning, he said, “was harrowing beyond belief ... 100 times worse than the chemo.”
Chemotherapy came first, followed 2 days later by radiation, presumably TNI. Mr. Unger experienced constant vomiting, intraocular bleeding and high fevers; the soft tissue of his throat “fell apart,” he said.
“I couldn’t move. It was like being dead,” he said. “Finally, maybe after a month or so, I could finally have a little water.” Mr. Unger said his immune system took 6-8 weeks to recover. He concluded, with heroic understatement, “it was rough.”
The battle against Hodgkin was over, but fallout from the chemotherapy lingered. Although Mr. Unger was able to return to his family and the job he loved, in the following years he was never entirely well. He contracted shingles soon after his transplant, then diabetes within 15 years. A heart attack followed in 2008 then, in 2015, an autoimmune disease that still affects his mobility.
However, Mr. Unger remains grateful: “The fact that we did these cutting-edge techniques with me got me to the point where – although I had some problems afterward, and I have problems now – it gave me well over 30 years of a really great life.”
“There are a lot of good doctors out there,” he added. “Some of them go to extraordinary lengths to help people. I try to do the same with the extra 30 years I’ve been given, try to be nice to people and make people feel good. I don’t really see any other reason to be on earth.”
Treatment for Hodgkin lymphoma: 2022
For a comparison of Mr. Unger’s experience with the current approach to Hodgkin lymphoma, this news organization spoke to Miguel-Angel Perales, MD, current chief of the adult bone marrow transplant service at MSKCC. Although Dr. Perales could not comment specifically on Mr. Unger’s case without his records, Dr. Perales was able to review the revolutions in treatment for all patients over the past 30 years.
Certainly, physicians no longer need to inflict a laparotomy on patients just to stage the disease, Dr. Perales said. “This sounds barbaric today. Nowadays we have PET scans.”
Another key change, Dr. Perales said, is in the up-front management of the disease.
For example, MOPP “is going back to the prehistory of chemotherapy,” Dr. Perales said. He was not surprised to learn that Mr. Unger later developed complications such as diabetes and heart disease.
“We’ve completely revolutionized the treatment,” Dr. Perales said. “We [now] use combinations that are much less toxic than MOPP, [and] we’re curing more patients up front.” Treatment is tailored by stage and the likelihood of response to therapy. Aggressive approaches are reserved for patients more likely to fail treatment.
Pretransplant conditioning has also changed for the better, with less toxicity and fewer long-term complications. Total body irradiation has “fallen by the wayside,” said Dr. Perales. Instead, patients get BEAM, a combination of carmustine, etoposide, cytarabine (Cytosar-U, Ara-C), and melphalan (Alkeran), 1 week before the transplant.
Perhaps the most profound change, which began in the 1990s shortly after Larry’s transplant, was that peripheral-blood stem cells gradually replaced bone marrow for both autologous and allogeneic transplant. In 2022, nearly all autologous transplants use peripheral-blood stem cells.
Instead of onerous bone-marrow aspiration in the operating room, the stem cells are collected from the patient’s blood. First, the patient’s bone marrow is hyperstimulated with high doses of filgrastim (G-CSF, Neupogen, Granix) for several days. Stem cells spill into the patient’s blood. Once blood is collected from the patient, the stem cells are separated and stored ready for the transplant. (In theory, stem cell products are “cancer free”; in practice there may be some contaminating cells, said Dr. Perales.)
Nowadays “transplanting” the stem cells back into the body bears no relation to what happened in 1992. The stem-cell infusion is typically an outpatient procedure, and one-third of patients may never be admitted to the hospital at all.
In contrast to Mr. Unger’s excruciating 8-week hospital stay, immune recovery currently takes 12-14 days, often entirely in the patient’s own home, with the option of extra filgrastim to speed things up.
Despite these profound changes, said Dr. Perales, the real quantum leap has occurred post transplant.
In 2015, a multinational team led by MSKCC’s Dr. Craig Moskowitz published a trial in the Lancet showing that brentuximab vedotin halved the risk of relapse after autologous transplantation in high-risk Hodgkin lymphoma patients versus placebo (hazard ratio, 0.57; P = .0013; n = 329). The CD30-directed antibody-drug conjugate was so successful that the placebo patients were encouraged to cross over into the treatment group; many of them were salvaged.
As a result, Dr. Perales said, brentuximab vedotin has now become the standard in high-risk Hodgkin patients following a transplant.
The checkpoint inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda) have also been “transformational” in Hodgkin lymphoma, Dr. Perales said. He explained that Hodgkin lymphoma is “exquisitely sensitive” to these therapies because the disease expresses high levels of the binding proteins for these drugs. This allows the immunotherapies to hit both the immune system and the disease.
Most cancers have response rates for checkpoint inhibitors below 40%, according to a recent analysis by Anas Younes, former chief of lymphoma at MSKCC, and his colleague Eri Matsuki, then a visiting fellow. By contrast, in Hodgkin lymphoma response to these drugs is 66%-87%.
Dr. Perales said: “It tells you how effective these drugs are, that we could move from somebody getting MOPP, which is like throwing a nuclear bomb at somebody, to a combination of two drugs that can easily be given out-patient and that have very little, if any, side effects.”
The future: No chemo, no transplants?
“One of the holy grails in Hodgkin would be if we could treat patients with the combination of a checkpoint inhibitor and brentuximab and what is being termed the ‘chemotherapy-free’ approach to Hodgkin disease,” said Dr. Perales.
What else remains to be done in the world of transplants for Hodgkin lymphoma?
Dr. Perales didn’t hesitate: “To eliminate the need for them. If we can have better targeted therapy up front that cures more patients, then we never even have to consider transplant. Basically, to put me out of work. I’m sure I’ll find other things to do.”
The current treatment of Hodgkin lymphoma “is really what we all consider one of the successes in oncology,” said Dr. Perales. “It’s a beautiful story.”
Dr. Perales reported receiving honoraria from numerous pharmaceutical companies; serves on data and safety monitoring boards for Cidara Therapeutics, Medigene, Sellas Life Sciences, and Servier; and serves on the scientific advisory board of NexImmune. He has ownership interests in NexImmune and Omeros, and has received institutional research support for clinical trials from Incyte, Kite/Gilead, Miltenyi Biotec, Nektar Therapeutics, and Novartis.
At 32 years old, the world was at Larry Unger’s feet. He was vice president at one of Wall Street’s most successful investment management firms, selling mutual funds to more than 1,000 brokers across New York. His clients relied on him for good advice, great jokes, and superlative Yankees tickets. His recent memories included fraternity days at Cornell University and a Harvard law degree. His childhood on the Lower East Side was behind him. He had his own apartment and a beautiful girlfriend.
Then his back started hurting, and he was drenched in sweat at night. His physician suggested it was a basketball injury. Weeks of tests followed, and he changed doctors. Mr. Unger met with an oncologist at Memorial Sloan Kettering Cancer Center who wouldn’t let him go home after the appointment. The next day brought exploratory surgery and an answer to all the questions.
Mr. Unger was diagnosed with stage IIIB Hodgkin lymphoma.
Thirty years later, Mr. Unger credited his survival to the late Subhash Gulati, MD, PhD, then MSKCC’s director of stem cell transplantation. He still recalls Dr. Gulati’s words to him: “Radical situations call for radical solutions.” In 1992, that “radical solution” was an autologous bone-marrow transplant.
“Mr. Unger was a patient pioneer,” said Kenneth Offit, MD, another MSKCC oncologist who also cared for him at that time.
Transplantation for Hodgkin: The early 90s
Hodgkin lymphoma is fairly rare, accounting for just 0.5% of all cancers and 15% of lymphomas. It tends to target young, male adults like Mr. Unger. Today 88% of patients with Hodgkin survive at least 5 years.
When Dr. Gulati offered Mr. Unger his “radical solution” 3 decades ago, the idea of autologous bone marrow transplantation in Hodgkin lymphoma was not new. The first attempt appeared in the literature in the 1950s, but it was still unclear how patients could survive the procedure. It involved destroying the patient’s own immune system prior to the transplant, a huge risk in itself. Worse, the patient was pummeled with chemotherapy and/or radiation to clear out the cancerous bone marrow – a process called “conditioning.”
However, throughout the 1980s, MSKCC had been running clinical trials to perfect the conditioning mix, so by 1992 Dr. Gulati was well-placed to help Mr. Unger.
It is unclear what conditioning Mr. Unger received because his records were not made available. However, around the time that Mr. Unger underwent his transplant, Dr. Gulati and colleagues published the conditioning regimens in use at MSKCC. Patients with refractory or relapsed Hodgkin disease received a conditioning mix of total nodal irradiation (TNI), etoposide (Vepesid) and cyclophosphamide. Patients who had already been through radiotherapy were given carmustine instead of TNI.
In that early publication, Dr. Gulati and the MSKCC team reported 0 “toxic deaths” with the TNI mix, and at the 2-year point 75% of the patients were still alive (n = 28). Patients who had already received radiation treatment did less well, with 55% survival at 2 years, at a cost of 14% toxic deaths (n = 22).
Mr. Unger’s experience, 30 years ago
According to Mr. Unger, the initial treatment for his stage IIIB Hodgkin lymphoma was MOPP (mechlorethamine hydrochloride, vincristine sulfate, procarbazine hydrochloride, and prednisone) plus ABVD (doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine).
“They wanted to give me two chemo programs at once because they said I was very sick,” Mr. Unger recalled. “I wound up staying in the hospital quite a bit because every time I got these [treatments] I’d get a fever. This went on for month after month after month. Finally, they said: ‘The tumors are starting to shrink. ... I want you to meet Dr. Gulati.’ ”
Mr. Unger said that Dr. Gulati told him: “There is another procedure called the bone marrow transplant which we’ve been doing. This would be like hitting it with a nuclear weapon. We would really wipe it out and make sure that you never come back.”
The alternative was high-dose radiotherapy. However, Dr. Gulati shared MSKCC’s hard-won knowledge that an autologous transplant was less successful after radiation. Dr. Gulati also told Mr. Unger that surgery was needed before the transplant: a laparotomy to restage his tumors.
After discussing the situation with his father, Mr. Unger decided to undergo the transplant.
The night before treatment started, he was laughing and joking with a friend in his room at MSKCC. The next day, the laughing stopped. The conditioning, he said, “was harrowing beyond belief ... 100 times worse than the chemo.”
Chemotherapy came first, followed 2 days later by radiation, presumably TNI. Mr. Unger experienced constant vomiting, intraocular bleeding and high fevers; the soft tissue of his throat “fell apart,” he said.
“I couldn’t move. It was like being dead,” he said. “Finally, maybe after a month or so, I could finally have a little water.” Mr. Unger said his immune system took 6-8 weeks to recover. He concluded, with heroic understatement, “it was rough.”
The battle against Hodgkin was over, but fallout from the chemotherapy lingered. Although Mr. Unger was able to return to his family and the job he loved, in the following years he was never entirely well. He contracted shingles soon after his transplant, then diabetes within 15 years. A heart attack followed in 2008 then, in 2015, an autoimmune disease that still affects his mobility.
However, Mr. Unger remains grateful: “The fact that we did these cutting-edge techniques with me got me to the point where – although I had some problems afterward, and I have problems now – it gave me well over 30 years of a really great life.”
“There are a lot of good doctors out there,” he added. “Some of them go to extraordinary lengths to help people. I try to do the same with the extra 30 years I’ve been given, try to be nice to people and make people feel good. I don’t really see any other reason to be on earth.”
Treatment for Hodgkin lymphoma: 2022
For a comparison of Mr. Unger’s experience with the current approach to Hodgkin lymphoma, this news organization spoke to Miguel-Angel Perales, MD, current chief of the adult bone marrow transplant service at MSKCC. Although Dr. Perales could not comment specifically on Mr. Unger’s case without his records, Dr. Perales was able to review the revolutions in treatment for all patients over the past 30 years.
Certainly, physicians no longer need to inflict a laparotomy on patients just to stage the disease, Dr. Perales said. “This sounds barbaric today. Nowadays we have PET scans.”
Another key change, Dr. Perales said, is in the up-front management of the disease.
For example, MOPP “is going back to the prehistory of chemotherapy,” Dr. Perales said. He was not surprised to learn that Mr. Unger later developed complications such as diabetes and heart disease.
“We’ve completely revolutionized the treatment,” Dr. Perales said. “We [now] use combinations that are much less toxic than MOPP, [and] we’re curing more patients up front.” Treatment is tailored by stage and the likelihood of response to therapy. Aggressive approaches are reserved for patients more likely to fail treatment.
Pretransplant conditioning has also changed for the better, with less toxicity and fewer long-term complications. Total body irradiation has “fallen by the wayside,” said Dr. Perales. Instead, patients get BEAM, a combination of carmustine, etoposide, cytarabine (Cytosar-U, Ara-C), and melphalan (Alkeran), 1 week before the transplant.
Perhaps the most profound change, which began in the 1990s shortly after Larry’s transplant, was that peripheral-blood stem cells gradually replaced bone marrow for both autologous and allogeneic transplant. In 2022, nearly all autologous transplants use peripheral-blood stem cells.
Instead of onerous bone-marrow aspiration in the operating room, the stem cells are collected from the patient’s blood. First, the patient’s bone marrow is hyperstimulated with high doses of filgrastim (G-CSF, Neupogen, Granix) for several days. Stem cells spill into the patient’s blood. Once blood is collected from the patient, the stem cells are separated and stored ready for the transplant. (In theory, stem cell products are “cancer free”; in practice there may be some contaminating cells, said Dr. Perales.)
Nowadays “transplanting” the stem cells back into the body bears no relation to what happened in 1992. The stem-cell infusion is typically an outpatient procedure, and one-third of patients may never be admitted to the hospital at all.
In contrast to Mr. Unger’s excruciating 8-week hospital stay, immune recovery currently takes 12-14 days, often entirely in the patient’s own home, with the option of extra filgrastim to speed things up.
Despite these profound changes, said Dr. Perales, the real quantum leap has occurred post transplant.
In 2015, a multinational team led by MSKCC’s Dr. Craig Moskowitz published a trial in the Lancet showing that brentuximab vedotin halved the risk of relapse after autologous transplantation in high-risk Hodgkin lymphoma patients versus placebo (hazard ratio, 0.57; P = .0013; n = 329). The CD30-directed antibody-drug conjugate was so successful that the placebo patients were encouraged to cross over into the treatment group; many of them were salvaged.
As a result, Dr. Perales said, brentuximab vedotin has now become the standard in high-risk Hodgkin patients following a transplant.
The checkpoint inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda) have also been “transformational” in Hodgkin lymphoma, Dr. Perales said. He explained that Hodgkin lymphoma is “exquisitely sensitive” to these therapies because the disease expresses high levels of the binding proteins for these drugs. This allows the immunotherapies to hit both the immune system and the disease.
Most cancers have response rates for checkpoint inhibitors below 40%, according to a recent analysis by Anas Younes, former chief of lymphoma at MSKCC, and his colleague Eri Matsuki, then a visiting fellow. By contrast, in Hodgkin lymphoma response to these drugs is 66%-87%.
Dr. Perales said: “It tells you how effective these drugs are, that we could move from somebody getting MOPP, which is like throwing a nuclear bomb at somebody, to a combination of two drugs that can easily be given out-patient and that have very little, if any, side effects.”
The future: No chemo, no transplants?
“One of the holy grails in Hodgkin would be if we could treat patients with the combination of a checkpoint inhibitor and brentuximab and what is being termed the ‘chemotherapy-free’ approach to Hodgkin disease,” said Dr. Perales.
What else remains to be done in the world of transplants for Hodgkin lymphoma?
Dr. Perales didn’t hesitate: “To eliminate the need for them. If we can have better targeted therapy up front that cures more patients, then we never even have to consider transplant. Basically, to put me out of work. I’m sure I’ll find other things to do.”
The current treatment of Hodgkin lymphoma “is really what we all consider one of the successes in oncology,” said Dr. Perales. “It’s a beautiful story.”
Dr. Perales reported receiving honoraria from numerous pharmaceutical companies; serves on data and safety monitoring boards for Cidara Therapeutics, Medigene, Sellas Life Sciences, and Servier; and serves on the scientific advisory board of NexImmune. He has ownership interests in NexImmune and Omeros, and has received institutional research support for clinical trials from Incyte, Kite/Gilead, Miltenyi Biotec, Nektar Therapeutics, and Novartis.